[Federal Register Volume 84, Number 80 (Thursday, April 25, 2019)]
[Proposed Rules]
[Pages 17692-17727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07716]
[[Page 17691]]
Vol. 84
Thursday,
No. 80
April 25, 2019
Part V
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Parts 704, 711, and 712
TSCA Chemical Data Reporting Revisions and Small Manufacturer
Definition Update for Reporting and Recordkeeping Requirements Under
TSCA Section 8(a); Proposed Rule
Federal Register / Vol. 84 , No. 80 / Thursday, April 25, 2019 /
Proposed Rules
[[Page 17692]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 704, 711, and 712
[EPA-HQ-OPPT-2018-0321; FRL-9982-16]
RIN 2070-AK33
TSCA Chemical Data Reporting Revisions and Small Manufacturer
Definition Update for Reporting and Recordkeeping Requirements Under
TSCA Section 8(a)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to amend the Toxic Substances Control Act
(TSCA) section 8(a) Chemical Data Reporting (CDR) requirements and the
TSCA section 8(a) size standards for small manufacturers. The current
CDR rule requires manufacturers (including importers) of certain
chemical substances listed on the TSCA Chemical Substance Inventory
(TSCA Inventory) to report data on chemical manufacturing, processing,
and use every 4 years. EPA is proposing several changes to the CDR rule
to make regulatory updates to align with new statutory requirements of
TSCA, improve the CDR data collected as necessary to support the
implementation of TSCA, and potentially reduce burden for certain CDR
reporters. Proposed updates to the definition for small manufacturers,
including a new definition for small governments, are being made in
accordance with TSCA section 8(a)(3)(C) and impact certain reporting
and recordkeeping requirements for TSCA section 8(a) rules, including
CDR. The definitions may reduce burden on chemical manufacturers by
increasing the number of manufacturers considered small. Overall, these
regulatory modifications may better address EPA and public information
needs by providing additional information that is currently not
collected; improve the usability and reliability of the reported data;
and ensure that data are available in a timely manner.
DATES: Comments must be received on or before June 24, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0321, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Susan Sharkey, Chemical Control
Division, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-8789; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined by statute at 15 U.S.C. 2602(9) to include import) chemical
substances, including chemical users or processors who may manufacture
byproduct chemical substances, and are therefore subject to either of
the following: (1) Reporting under the TSCA Chemical Data Reporting
(CDR) requirements at 40 CFR part 711 or (2) TSCA reporting and
recordkeeping requirements at 40 CFR part 704 or other TSCA reporting
requirements which reference the small manufacturer standards at 40 CFR
704.3. Any use of the term ``manufacture'' in this document will
encompass ``import,'' the term ``manufacturer'' will encompass
``importer,'' and the term ``chemical substance'' will encompass
``byproduct chemical substance,'' unless otherwise stated.
The regulated community consists of entities that produce
domestically or import into the United States chemical substances
listed on the TSCA Inventory. The Agency's previous experience with
TSCA section 8(a) collections has shown that most respondents affected
by this collection activity are from the following North American
Industrial Classification System (NAICS) code categories:
NAICS 325--Chemical Manufacturing; and
NAICS 324--Petroleum and Coal Product Manufacturing.
In addition to the anticipated respondents from the NAICS listed
previously, the regulated community consists of manufacturers of
byproducts that are required to report under certain TSCA section 8(a)
rules, including CDR. Byproduct manufacturers may be listed under a
different primary activity for a site, such as NAICS codes 22, 322,
327310, 331, and 3344 representing, utilities, paper manufacturing,
cement manufacturing, primary metal manufacturing, and semiconductor
and other electronic component manufacturing, respectively.
The NAICS codes have been provided to assist you and others in
determining whether this action might apply to certain entities. To
determine whether you or your business may be affected by this action,
you should carefully examine the applicable provisions at 40 CFR 711.8.
If you have any questions regarding the applicability of this action to
a particular entity, consult the technical contact person listed under
FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Section 8(a)(1) of TSCA authorizes the EPA Administrator to
promulgate rules under which manufacturers and processors of chemical
substances must maintain such records and submit such information as
the EPA Administrator may reasonably require (15 U.S.C. 2607). TSCA
section 8(a) generally excludes small manufacturers and processors of
chemical substances from the reporting requirements established in TSCA
section 8(a). However, EPA is authorized by TSCA section 8(a)(3)(A)(ii)
to require TSCA section 8(a) reporting from small manufacturers and
processors with respect to any chemical substance that is the subject
of a rule proposed or promulgated under TSCA section 4, 5(b)(4), or 6;
that is the subject of an order in effect under TSCA sections 4 or
5(e); that is subject to a consent agreement under TSCA section 4; or
that is the subject of relief granted pursuant to a civil action under
TSCA section 5 or 7.
TSCA section 8(a)(3)(B) authorizes the EPA Administrator, after
consultation with the Administrator of the Small Business
Administration (SBA), to prescribe by rule the standards for
determining the manufacturers and processors which qualify as small
manufacturers and processors. Pursuant
[[Page 17693]]
to TSCA section 8(a)(3)(C), on November 30, 2017, EPA determined that
revision of the standards is warranted (82 FR 56824).
TSCA section 8(a)(5) requires the EPA Administrator, to the extent
feasible, to not require unnecessary or duplicative reporting and
minimize the cost of compliance for small manufacturers.
TSCA section 14 imposes requirements for the assertion,
substantiation and review of confidential business information (CBI)
claims.
C. What action is the Agency taking?
In this action, EPA is proposing several amendments to the current
CDR rule requirements. These amendments, described in more detail in
Unit III., include:
Changing requirements for making confidentiality claims,
including to identify when upfront substantiation is required, update
the substantiation questions, and identify data elements that cannot be
claimed as confidential to align with the Lautenberg Chemical Safety
for the 21st Century Act (2016 Amendments);
Replacing certain processing and use codes (industrial
function and commercial/consumer product use) with codes based on the
Organisation for Economic Co-operation and Development's (OECD)
functional use and product and article use codes, including adding
reporting of the OECD-based functional use codes for consumer and
commercial use information;
Adding the requirement to report the NAICS code(s) for the
site of manufacture;
Modifying the requirement to indicate whether a chemical
is removed from the waste stream and recycled, remanufactured,
reprocessed, or reused with the requirement to indicate whether a
chemical is removed from the waste stream and recycled;
Adding a requirement to identify the percent total
production volume of a chemical substance that is a byproduct;
Requiring that the secondary submitter of a joint
submission report the chemical specific function along with the
percentage of the chemical in the imported product;
Adding a voluntary data element to provide a public
contact;
Modifying the definition of ``parent company'' to clarify
the definition, add the requirement to report a foreign parent company,
when applicable, and codify reporting scenarios;
Simplifying the reporting process for co-manufacturers by
enabling a multi-reporter process for reporters to separately report
directly to EPA within the e-CDRweb reporting tool;
Allowing reporting in specified metal categories for
inorganic byproducts;
Adding exemptions for specifically identified byproducts
that are recycled in a site-limited, enclosed system and for byproducts
that are manufactured as part of non-integral pollution control and
boiler equipment; and
Clarifying regulatory text by removing outdated text,
consolidating exemptions, and making other improvements.
Additionally, EPA is proposing an amendment to update the size
standards definition for small manufacturers for reporting and
recordkeeping requirements under TSCA section 8(a). Further details of
this amendment are in Unit IV.
EPA is also giving notice of some aspects of the amendments to TSCA
from the Frank R. Lautenberg Chemical Safety for the 21st Century Act
(2016 Amendments) that may impact, more broadly, TSCA submitters. For
example, under TSCA section 14(e)(1)(B), the Agency is charged with
implementing a ten year ``sunset'' provision for confidentiality
claims.
Because the small manufacturer size standard under TSCA section
8(a) impacts the CDR rule more than other TSCA section 8(a) reporting
rules at this time, EPA included these two actions as one proposed
rule. However, EPA recognizes that the changes made to the small
business definition will impact current and future TSCA section 8(a)
reporting rules and intends to finalize these amendments as two
separate actions.
EPA is taking other, non-regulatory steps to minimize the burden on
all reporters, including small entities, by improving the reporting
application and database to be user-friendly and dynamic, consisting of
straightforward questions that include fill-in-the-blank (number)
fields, check boxes, and drop-down menus. In addition, EPA is replacing
the current pre-formatted Form U with a customized report based on the
actual information submitted by a site through e-CDRweb, the electronic
reporting tool. Although these changes are not discussed further in
this proposal, they are an important component of the effort to reduce
burden and modernize the data collection system. EPA is adding an
addendum to the current CDR rule ICR (OMB Control Number 2070-0162) for
the regulatory changes proposed in this document. In addition to the
changes outlined in this proposed rule, if needed, EPA will provide a
second addendum to this ICR to address non-regulatory changes. As was
done for previous CDR collections, EPA will provide industry with the
opportunity to test and comment on the updated e-CDRweb prior to the
2020 CDR submission period. EPA anticipates holding a webinar to
introduce the revised e-CDRweb to the regulated community directly
following the finalization of the CDR Revisions rule. During the
webinar, EPA will issue a general invitation to interested parties to
participate in a short testing period of the revised e-CDRweb. EPA will
open the testing period within 4 months after this proposal is
finalized, and currently anticipates that testing will occur in the
February to March 2020 timeframe. Because of resource constraints, the
testing period will be limited to 25 participants. For additional
information, contact the person under FOR FURTHER INFORMATION CONTACT.
Also, information will be posted on the CDR website (https://www.epa.gov/chemical-data-reporting).
D. Why is the Agency taking this action?
EPA is proposing revisions to the CDR rule for three primary
reasons: Align with amendments to TSCA from the Frank R. Lautenberg
Chemical Safety for the 21st Century Act (2016 Amendments), improve the
CDR data collected as necessary to support the implementation of TSCA,
and reduce burden for CDR reporters pursuant to TSCA section 8(a)(5).
The 2016 Amendments to TSCA changed requirements associated with
confidentiality claims, including identifying the data elements
eligible for confidentiality claims and when substantiation of claims
is required. EPA is proposing revisions to the CDR rule to address
these changes.
EPA is proposing to modify the definition for small manufacturers,
as a result of the 2016 Amendments revision of TSCA section 8(a)(3)(C),
which requires EPA, after consultation with the Administrator of the
SBA, to review the adequacy of the standards for determining which
manufacturers and processors qualify as small manufacturers and
processors for purposes of TSCA sections 8(a)(1) and 8(a)(3). EPA
published a determination that revision of the TSCA section 8(a) size
standards for small manufacturers as warranted in a Federal Register
Notice published November 30, 2017 (82 FR 56824). EPA's determination,
supporting documents, and comments received can be found at
regulations.gov under docket number EPA-HQ-OPPT-2016-0675. This
proposed change may reduce burden for some manufacturers
[[Page 17694]]
that would be considered small manufacturers under CDR and other TSCA
section 8(a) rules relying on the small manufacturer definition in 40
CFR part 704.3.
EPA is also proposing to make some changes to the CDR data
reporting so the information collected is tailored to better meet the
Agency's overall information needs and aligned with specific needs for
prioritization and risk evaluation under TSCA section 6. TSCA section 2
specifies that ``adequate information should be developed with respect
to the effect of chemical substances and mixtures on health and the
environment and that the development of such information should be the
responsibility of those who manufacture and those who process such
chemical substances and mixtures'' (TSCA section 2(b)(1)). These
proposed changes include the addition of data elements, such as a site-
specific NAICS code and how much of a chemical is a byproduct;
modification to multi-reporter submission requirements, including
adding a process for jointly reporting co-manufactured chemicals; and
changes to current data elements, such as codes used for reporting
processing and use information. In addition, proposed changes to the
parent company reporting requirements would increase EPA's ability to
protect confidential information while better enabling EPA to make
information publicly available and the addition of a voluntary public
contact would direct inquiries from the public to a designated
individual rather than to the technical contact. These changes would
help to meet the Agency's requirement under TSCA section 26(h), in
carrying out TSCA sections 4, 5, and 6, to make scientific decisions
consistent with the best available science, improve the CDR data
collected as necessary to support the implementation of TSCA, and
improve EPA's ability to effectively provide public access to the
information. Furthermore, these changes would meet the Agency's
objective to obtain new and updated information relating to potential
exposures to a major subset of chemical substances listed on the TSCA
Inventory.
At the same time, EPA is interested in reducing burden on industry
while maintaining the Agency's ability to receive the information it
needs to understand exposure to these chemicals (TSCA section 8(a)(5)).
EPA used experiences from the 2016 CDR submission period, concerns
identified by users of CDR information, and burden-reduction
suggestions made as part of public comment opportunities, including
public comments solicited in conjunction with Executive Order 13777,
Enforcing the Regulatory Reform Agenda (EPA-HQ-OA-2017-0190 and 82 FR
17793, April 13, 2017) and as part of the renewal of the Information
Collection Request (ICR) (EPA-HQ-OPPT-2017-0648 and 83 FR 36928, July
31, 2018). In addition, EPA identified ways to reduce burden
specifically for manufacturers of inorganic byproducts as part of an
extensive negotiated rulemaking effort, which included participation by
all stakeholder groups, and subsequent public comment period in 2017
(EPA-HQ-OPPT-2016-0597 and 82 FR 47423, October 12, 2017). Taking into
account these experiences and stakeholder input, EPA is proposing the
following changes to reduce burden: The new ability to alternatively
report inorganic byproducts within defined metal categories, the
introduction of two new exemptions related to byproducts, a revised
approach to reporting for co-manufactured chemicals, and the
harmonization of function and product codes with those used by other
countries.
Additionally, EPA has received comments that modernizing the CDR
data collection and public access to the database would reduce
reporting burden and facilitate ease of use by reporters and the public
(81 FR 90843; EPA-HQ-OPPT-2016-0597 and Refs. 1, 2, and 3). These
comments were used to develop this proposal and to inform other, non-
regulatory changes that EPA plans to make to the reporting process.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs and benefits of revising CDR
reporting requirements and modifying standards for small manufacturers
in CDR and other TSCA section 8(a) reporting. Some aspects of the
proposal increase burden and cost while other aspects decrease burden
and result in cost savings. Overall, EPA estimates that the combined
impact of all the proposed amendments would decrease the total burden
and result in a cost savings to industry and government reporters.
These analyses, which are available in the docket (Refs. 4 and 5), are
discussed in Units III. and IV. and are briefly summarized here.
1. CDR revisions economic impacts summary. The proposed amendments
are estimated to result in an overall net decrease in burden with
associated cost savings. The estimated changes include increases in
rule familiarization, compliance determination, and form completion.
The future cycle burden and costs or cost savings are listed by type of
change:
For changes to modify or add reportable data elements
(e.g., processing and use codes, NAICS codes, byproduct percentage,
chemical function, public contact, and parent company--discussed in
Units III.B. and III.C.), the incremental burden is expected to
increase by 45,000 hours with an associated cost increase of $3.5
million.
For changes to claiming confidentiality (discussed in Unit
III.A.), the incremental burden is expected to decrease by 340 hours
with an associated cost savings of $0.03 million.
For changes to add byproducts exemptions (discussed in
Unit III.D.), the incremental burden is expected to decrease by 68,000
hours with an associated cost savings of $5.2 million.
For changes to implement consolidated category reporting
for certain inorganic metals (discussed in Unit III.D.), the
incremental burden is expected to decrease by 13,000 hours with an
associated cost savings of $1.0 million.
For changes that affect CDR reporting eligibility
(targeted to certain sites with varying reductions to the number of
chemicals reported per site), the incremental burden is expected to
result in a net decrease by 81,000 hours with associated cost savings
at $6.3 million. There are increases in burden and costs for several
requirements, such as the need to assess whether exemptions apply
(compliance determination) and the need to familiarize oneself with
modifications to the rule (rule familiarization), estimated at 3,000
hours with an associated cost of $0.24 million. However, the changes to
form completion in the aggregate are estimated to result in an overall
net decrease in burden and cost savings due to decreases in the number
of sites reporting and or the number of chemical reports from a site.
These decreases are due to the proposed byproduct exemptions (discussed
in Units III.D.2. and III.D.3.) and consolidated category reporting
(discussed in Unit III.D.1.).
In sum, the overall incremental impacts to industry and government
reporters result in a net decrease in burden and cost savings.
Estimates include rule familiarization, compliance determination, and
CDR form completion (Ref. 4). Note that estimated changes to
recordkeeping burden and cost are negligible and estimated at zero. An
estimated 5,660 sites are expected to report during the next CDR
submission period in 2020. The total incremental burden reduction and
cost savings are estimated at a 36,000 hour reduction and $2.79 million
cost savings. On an annualized basis using a 3 percent and
[[Page 17695]]
a 7 percent discount rate over a 10-year period, the annualized
incremental cost savings is estimated at $0.66 million and $0.65
million per year, respectively (Ref. 4).
2. TSCA section 8(a) small manufacturer definition economic impacts
summary. The proposed modified standards for small manufacturers would
affect TSCA section 8(a) rules, including CDR. These rules use the TSCA
section 8(a) small manufacturer definition to identify the entities
exempted from reporting or for other reduced reporting requirements.
The impact from the proposal is focused on the CDR rule and may impact
whether a site is required to report or the number of chemicals a site
would report. There is no measurable impact to other TSCA section 8(a)
rules either because EPA has not received any chemical reports for the
rule for an extended period of time or because the rule uses a
different definition that is not being changed by this proposal (see
Unit IV.A. for a more detailed discussion). The proposed definition,
discussed in detail in Unit IV., results in a cost savings.
a. Impact of proposed small manufacturer definition. The proposal
is estimated to eliminate reporting entirely for 93 industry sites and
reduce reporting by eliminating the need to report at least one
chemical for additional 129 industry sites (Ref. 5). This reduction in
reporting is in addition to the sites already not reporting because
they meet the current small manufacturer definition.
Under this proposed definition, incremental future cycle burden
reductions and cost savings are estimated at 64,000 hours and $5.0
million, respectively, over a four-year CDR reporting cycle (Ref. 5).
On an annualized basis, using a 3 percent and 7 percent discount rate
over a 10-year period yields net annualized incremental cost savings of
$1.2 million and $1.2 million per year, respectively (Ref. 5). This
proposal also includes a small government exemption (described in this
unit).
b. Impact of proposed small government definition. The following
government entities report under CDR: Seven municipalities, one county-
level public utility district, and one tribal entity. Under the
proposed small government definition, four government entities would be
exempted from the need to report. The burden and cost savings
associated with the exempted entities, in future reporting cycles, are
included in the estimates for the proposed definition with incremental
future cycle burden reduction and cost savings estimated at 500 hours
and $39,000 respectively, over a four-year CDR reporting cycle (Ref.
5).
3. Total economic impacts summary for proposal. The amendments in
this proposal may affect the number of reports submitted during a
submission period and the burden to prepare a report. EPA estimates
that the combined impact of all the proposed amendments would decrease
the total burden and cost to industry associated with CDR reporting.
Tables 1A and 1B present the summaries of burden and cost impacts,
respectively, for the proposed CDR revisions and TSCA section 8(a)
small manufacturer definition update. In the tables, estimates are
presented for the CDR four-year first cycle and in the future cycle. In
the first cycle, higher burdens and costs are incurred, because all
reporters need to familiarize themselves with the changes and may take
longer to complete reporting activities. After the first cycle, and for
future cycles, experienced reporters (85%) are familiar with the
changed requirements. In addition to estimates that cover the four-year
CDR cycle, Tables 1A and 1B present annual estimates. These annual
estimates are the four-year estimates divided by four. EPA acknowledges
that activities may be spread unevenly across the four years. On an
annualized basis, using a 3 percent and 7 percent discount rate over a
10-year period yields a net annualized incremental cost savings of
$1.85 million and $1.83 million per year, respectively, for the overall
proposed rule.
Table 1A--Summary of Economic Impacts, Burden Reductions
----------------------------------------------------------------------------------------------------------------
First cycle Future cycles
---------------------------------------------------------------
Four-year Annual Four-year Annual
Number of cycle ---------------- cycle ---------------
affected sites ---------------- ----------------
Burden Burden Burden Burden
reduction reduction reduction reduction
(hours) (hours) (hours) (hours)
----------------------------------------------------------------------------------------------------------------
CDR Revisions................... 5,660 31,306 7,827 36,005 9,001
8(a) Small Manufacturer 5,627 56,162 14,040 64,295 16,074
Exemption \1\..................
Small Government Exemption \2\.. 33 454 113 504 126
-------------------------------------------------------------------------------
Net Incremental Change...... 5,660 87,922 21,980 100,804 25,201
----------------------------------------------------------------------------------------------------------------
General Note: Annual estimates are based on changes applied evenly across the four-year cycle. However, due to
rounding issues, results may not be readily derived using this table.
Footnotes:
\1\ Under the proposed exemptions, incremental changes represent the net change due to the proposed rule and
therefore include sites and chemical reports that are exempted. Note that sites and reports can be entirely
affected or undergo a split effect, with a portion of the site's chemical reports exempted.
\2\ Four small governments are identified to qualify for the small government exemption under the proposed small
government exemption.
[[Page 17696]]
Table 1B--Summary of Economic Impacts, Cost Savings
----------------------------------------------------------------------------------------------------------------
First cycle Future cycles
---------------------------------------------------------------
Four-year Annual Four-year Annual
Number of cycle ---------------- cycle ---------------
affected sites ---------------- ----------------
Cost savings Cost savings Cost savings Cost savings
(2017$) (2017$) (2017$) (2017$)
----------------------------------------------------------------------------------------------------------------
CDR Revisions................... 5,660 $2,428,630 $607,157 $2,792,871 $698,218
8(a) Small Manufacturer 5,627 4,357,362 1,089,341 4,988,270 1,247,068
Exemption \1\..................
Small Government Exemption \2\.. 33 35,132 8,783 39,025 9,756
-------------------------------------------------------------------------------
Net Incremental Change...... 5,660 6,821,124 1,705,281 7,820,166 1,955,042
----------------------------------------------------------------------------------------------------------------
General Note: Annual estimates are based on changes applied evenly across the four-year cycle. However, due to
rounding issues, results may not be readily derived using this table.
Footnotes:
\1\ Under the proposed exemptions, incremental changes represent the net change due to the proposed rule and
therefore include sites and chemical reports that are exempted. Note that sites and reports can be entirely
affected or undergo a split effect, with a portion of the site's chemical reports exempted.
\2\ Four small governments are identified to qualify for the small government exemption under the proposed small
government exemption.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through regulations.gov
or email. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to EPA, mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.
II. Background
A. What is the Chemical Data Reporting (CDR) rule?
The CDR rule requires U.S. manufacturers of certain chemicals
listed on the TSCA Inventory to report to EPA every four years the
identity of chemical substances manufactured for all years since the
last principal reporting year. For example, for the 2020 submission
period, the principal reporting year is 2019 and the last principal
reporting year for the 2016 submission period was 2015. Reporting
during the 2020 submission period covers the manufacture of chemicals
in 2016, 2017, 2018, and 2019. To help minimize reporting burden,
detailed information is required only for the principal reporting year
(i.e., 2019), including a breakout of the production volume to provide
separate volumes for domestically manufactured and imported amounts.
Generally, reporting is required for substances whose production
volumes are 25,000 pounds or more at any single site during any of the
calendar years since the last principal reporting year. However, a
lower threshold applies for chemical substances that are the subject of
certain TSCA actions (see 40 CFR 711.8(b)). The CDR regulation
generally excludes several groups of chemical substances from its
reporting requirements, e.g., polymers, microorganisms, naturally
occurring chemical substances, certain forms of natural gas, and water
(see 40 CFR 711.5 and 711.6). For the 2016 CDR, EPA received Form U's
from 5,660 sites with an associated 42,464 chemical reports, providing
information on 8,717 unique chemicals.
Persons domestically manufacturing or importing chemical substances
are required to report information such as company name, site location
and other identifying information, production volume of the reportable
chemical substance, and exposure-related information associated with
the manufacture of each reportable chemical substance, including the
physical form and maximum concentration of the chemical substance, the
number of potentially exposed workers at the reporting site and certain
processing and use information (40 CFR 711.15). The processing and use
information that is currently required includes: Process or use
category; NAICS code; industrial function category; percent production
volume associated with each process or use category; number of sites;
number of potentially exposed industrial or commercial workers; and
consumer/commercial information such as use category, use in or on
products intended for use by children, and maximum concentration. Under
CDR, submitters report information to the extent that it is ``known to
or reasonably ascertainable'' (40 CFR 711.15), which means ``all
information in a person's possession or control, plus all information
that a reasonable person similarly situated might be expected to
possess, control, or know'' (40 CFR 711.3, referencing 40 CFR 704.3).
Reported information can be claimed as confidential (40 CFR 711.30).
B. How are the CDR data used by EPA?
EPA uses the data reported pursuant to the CDR rule to support
health, safety, and environmental protection activities related to
chemical manufacturing and use. Manufacturing, processing and use
information about chemicals in commerce helps EPA understand exposure
to these chemicals and screen and prioritize chemicals to identify
potential human health and environmental effects. EPA uses the data
reported under the CDR rule to support many activities under TSCA and
to provide overall support for EPA and other federal, state, local, and
tribal health, safety, and environmental protection activities (Ref. 6
and 83 FR 36928, July 31, 2018 (EPA-HQ-OPPT-2017-0648)).
CDR provides basic exposure-related data which EPA uses in a wide
variety of its activities, from choosing the chemicals EPA will focus
on for prioritization and assessment activities to informing response
actions, such as to hurricanes and other disasters. For example, in
accordance with TSCA section 6(b)(1)(A), EPA is required to consider
``the conditions of use or significant changes in conditions of use of
the chemical substance, and the
[[Page 17697]]
volume or significant changes in the volume of the chemical substance
manufactured or processed.'' CDR provides information directly
pertaining to the conditions of use, such as the number of sites, the
number of workers reasonably likely to be exposed, and how and why the
chemical is used, based on the CDR processing and use information. In
addition, CDR provides the production volume, the production volume
over time, and changes in the volumes under different conditions of
use. Such information is expected to contribute to improved
understanding of the chemical, including during the prioritization
process. For example, EPA used the 2012 and 2016 CDR data to assist in
identifying current uses and production volumes and, inversely, uses
that are no longer ongoing, to help determine the scope of the risk
evaluations for the first 10 chemicals being reviewed under amended
TSCA. EPA grouped uses for these chemicals based on CDR categories such
as industrial, commercial, and consumer use. Additionally, the problem
formulations for the first 10 chemicals, which were published in June
2018, used CDR data to identify the number of sites where exposure may
occur and approximate workers who may be exposed to the chemicals. For
example, in the Problem Formulation of the Risk Evaluation for
Perchloroethylene (Ethene, 1,1,2,2-Tertrachloro), EPA used CDR data to
identify conditions of use for Perchloroethylene (Ref. 7). CDR data
will continue to inform future prioritization, risk evaluation, and
risk management work under TSCA.
For another example, to help prepare EPA and others to respond to
hurricane disasters that occurred in 2018, EPA prepared information
about chemicals expected to be in the affected areas from data sources
such as CDR.
In 2012, EPA published its TSCA Work Plan for Chemical Assessments.
CDR data were used extensively in the development of this Work Plan.
Using CDR data collected during the 2012 CDR submission period, EPA
updated the exposure rankings for the chemicals initially screened as
part of the original Work Plan and, in 2014, published a revised Work
Plan (2014 Work Plan). TSCA requires that at least 50 percent of all
chemical substances undergoing risk evaluation (High-Priority
designations) come from the 2014 Work Plan, until the Work Plan
chemical list is exhausted.
The Interagency Testing Committee (ITC), an independent advisory
committee to the EPA Administrator, uses CDR data when updating the
Priority Testing List (PTL). The ITC designates or recommends chemicals
to the PTL that the Agency may prioritize when requiring testing under
TSCA section 4 or collecting information under TSCA sections 8(a) or
8(d). In making those determinations, production volumes reported to
CDR are used to identify the opportunity for exposure to a particular
chemical.
OECD member countries develop Emission Scenario Documents (ESD).
EPA is an active participant of the OECD Task Force and regularly works
on the development of ESDs that are reviewed by the Task Force and
added to the published series of ESDs. ESDs developed by EPA cover both
occupational exposures and environmental releases due to EPA's review
responsibilities under TSCA. In a separate and related effort, EPA has
regularly developed industry-specific generic scenarios which are
similar to an OECD ESD, as tools to assist in the assessment of the
many types of uses for new chemicals reviewed under TSCA. CDR data are
used to identify the chemicals commonly used in specific industries,
estimate the number of potentially exposed workers, and develop
estimates of exposure and releases that support the development of
these documents and scenarios.
Additional examples of how EPA uses CDR data include use by the
Office of Research and Development to characterize the life cycle of
chemicals for life cycle inventories, to develop conceptual models, and
to develop standardized emission and release estimates from chemical
production. The Office of Water uses CDR data to identify facilities in
specific industry sectors while developing effluent guidelines and to
identify chemicals of interest and their associated processing and use
activities for Effluent Guidelines Annual Review Reports.
C. What are the current standards for small manufacturers and
processors?
In 1988, EPA established the general TSCA section 8(a) small
manufacturer definition for use in other rules issued under TSCA
section 8(a), which are codified at 40 CFR 704.3. These are the current
standards that apply to CDR:
Small manufacturer or importer means a manufacturer or importer
that meets either of the following standards:
1. First standard. A manufacturer or importer of a substance is
small if its total annual sales, when combined with those of its parent
company (if any), are less than $40 million. However, if the annual
production or importation volume of a particular substance at any
individual site owned or controlled by the manufacturer or importer is
greater than 45,400 kilograms (100,000 pounds), the manufacturer or
importer shall not qualify as small for purposes of reporting on the
production or importation of that substance at that site, unless the
manufacturer or importer qualifies as small under standard (2) of this
definition.
2. Second standard. A manufacturer or importer of a substance is
small if its total annual sales, when combined with those of its parent
company (if any), are less than $4 million, regardless of the quantity
of substances produced or imported by that manufacturer or importer.
3. Inflation index. EPA must use the Producer Price Index for
Chemicals and Allied Products, as compiled by the U.S. Bureau of Labor
Statistics, for purposes of determining the need to adjust the total
annual sales values and for determining new sales values when
adjustments are made. EPA may adjust the total annual sales values
whenever the Agency deems it necessary to do so, provided that the
Producer Price Index for Chemicals and Allied Products has changed more
than 20 percent since either the most recent previous change in sales
values or the date of promulgation of the rule (i.e., 40 CFR 704),
whichever is later. EPA shall provide Federal Register notification
when changing the total annual sales values.
Pursuant to authority under TSCA section 8(a)(3)(B), certain TSCA
section 8(a) rules codify slight variations of the general TSCA section
8(a) small manufacturer definition at 40 CFR 704.3 (see, e.g., 40 CFR
704.45). There is no general small processor standard, and EPA is not
proposing one in this action. However, other rules issued under TSCA
section 8(a) establish analogous standards for small processors in
those particular rules. See Unit IV.A. for additional discussion.
III. Detailed Discussion of the Proposed Modifications to CDR
A. Changes to Claiming Confidentiality
EPA is proposing changes to requirements related to claiming CDR
data as confidential to be consistent with the new statutory
requirements in TSCA section 14. TSCA requires the Agency to review and
make determinations regarding the validity of confidential claims for
information submitted to EPA. EPA estimates that this proposed change
would result in a decrease in burden, which is explained in detail in
Table 4-14 in the Economic Analysis (Ref. 4).
[[Page 17698]]
New statutory provisions that are pertinent to reporting under CDR
include the following:
Under TSCA section 14(c)(3), all claims of confidentiality
must be substantiated at the time the information is submitted to EPA,
except for those types of information exempt under TSCA section
14(c)(2).
The submitter must provide a statement supporting the
claim, as described in TSCA section 14(c)(1)(B) and must certify that
the statement is true and correct, as described in TSCA section
14(c)(5).
TSCA section 14(b)(3)(B) limits confidentiality claims for
reported use information that customarily would be shared with the
general public or within an industry or industry sector.
Under TSCA section 14(e)(1)(B), confidentiality claims on
information not described in TSCA section 14(c)(2) expire after ten
years, unless a request for extension is submitted and granted.
The proposed amendments to the CDR rule address these new
provisions, with the exception of the TSCA section 14(e)(1)(B) CBI
expiration provision which while it will impact all TSCA submissions
filed after June 22, 2016 does not distinctively impact the CDR data
collections.
This preamble discussion also includes information about other
provisions of TSCA relating to actions EPA must take, but that do not
impact the regulatory text or require specific submitter actions.
1. Substantiations. EPA interprets TSCA section 14(c)(3) as
requiring substantiations of non-exempt CBI claims at the time the
information claimed as CBI is submitted to EPA (82 FR 6522, January 19,
2017). The Agency is proposing to amend the CDR substantiation
provisions to require substantiation for all confidentiality claims
except for those types of information exempt from substantiation under
TSCA section 14(c)(2), which are described later in this unit.
Submission of substantiations at the time of assertion of
confidentiality enables EPA to fulfill its obligation under TSCA
section 14(g) to review all confidentiality claims for specific
chemical identity, plus a representative subset (comprising at least 25
percent) of all other non-exempt confidentiality claims.
EPA is proposing revisions to the current substantiation questions
in 40 CFR 711.30 and the addition of new substantiation questions to
address data elements which, prior to amended TSCA, did not require
substantiation at the time of submission. The questions are in the
proposed regulatory text at the end of this notice. In addition,
Appendix B of the CDR Revisions EA (Ref. 4) provides a summary of the
questions prior to the 2016 TSCA Amendments and those that are being
proposed in this action (Ref. 4). These questions would facilitate the
Agency's implementation of TSCA section 14 and the requirement to
review and approve, approve in part, deny in part, or fully deny
requests for confidentiality. These CDR-specific questions are designed
to encourage thoughtful consideration of the need for confidential
treatment, improve the consistency of EPA's review of the responses,
and reduce the need for multiple discussions between EPA and the
submitter regarding the substantiations that may otherwise hinder the
Agency's ability to timely fulfill its review obligations under TSCA.
The questions have been carefully drafted to elicit the required
information to allow for a CBI review and determination, without
imposing an unnecessary burden. A set of standard questions, set forth
in proposed 40 CFR 711.30(b), would apply to all non-exempt CBI claims.
These questions generally ask about the impact of disclosure on the
submitter's competitive position, whether the information has been made
available to others, and the controls used to protect the confidential
information. These are similar in concept to questions under the
current CDR at 40 CFR 711.30. Additional questions are targeted to
specific data elements. For chemical substance identity confidentiality
claims, the additional substantiation questions, set forth in proposed
40 CFR 711.30(c), are substantively the same as exist under the current
CDR at 40 CFR 711.30(b). An additional question for company, site, and
technical contact identity is set forth in proposed 40 CFR 711.30(d).
Although substantively the same as exists for site identity
substantiations in the current CDR at 40 CFR 711.30(c), it is newly
applied to company name and technical contact confidentiality claims.
Additional questions for processing and use information are set forth
in proposed 40 CFR 711.30(e) and are substantively the same as exist in
the current CDR at 40 CFR 711.30(d).
a. Exceptions to the substantiation requirements. TSCA section
14(c)(2) identifies certain information that shall not be subject to
substantiation requirements under this rule. This includes:
Specific information describing the processes used in
manufacture or processing of a chemical substance, mixture, or article;
Marketing and sales information;
Information identifying a supplier or customer;
In the case of a mixture, details of the full composition
of the mixture and the respective percentages of constituents;
Specific information regarding the use, function, or
application of a chemical substance or mixture in a process, mixture,
or article;
Specific production or import volumes of the manufacturer
or processor; and
Prior to the date on which a chemical substance is first
offered for commercial distribution, the specific chemical identity of
the chemical substance, including the chemical name, molecular formula,
Chemical Abstracts Service number, and other information that would
identify the specific chemical substance, if the specific chemical
identity was claimed as confidential at the time it was submitted in a
notice under TSCA section 5.
EPA believes that the only data elements collected under CDR that
may be subject to the TSCA section 14(c)(2) limit on substantiation
requirements are: (1) Production volume and (2) supplier information
associated with joint submissions, such as supplier identity and
details of the full composition of a mixture. However, these two data
elements may still be subject to substantiation and CBI review under
the circumstances described in TSCA section 14(f).
i. Regarding production volume. EPA is proposing to not require
substantiation at the time the claim of confidentiality is made for
five production volume data elements (e.g., the volume domestically
manufactured in 2019, the volume imported in 2019, and the total
production volume for each of the three years 2016 through 2018). For
each reported chemical, total production volume is reported for each of
the years since the last principal reporting year, except for the
current principal reporting year when the production volume is reported
as domestically manufactured and imported volumes. As an example, for
the 2020 CDR submission period, production volume is collected for the
calendar years 2016, 2017, and 2018. For calendar year 2019, the
production volume is reported as domestically manufactured and imported
volumes. EPA believes that these five data elements are exactly the
kinds of specific production or import volumes identified in TSCA
section 14(c)(2)(F).
ii. Regarding information associated with a joint submission. Joint
[[Page 17699]]
submissions are necessary under limited circumstances. Currently these
circumstances are: (1) A company imports a chemical or a mixture under
a trade name and the substance identity, or individual components, are
not known to the importer or (2) a manufacturer cannot provide the
entire chemical identity of a chemical substance it manufactures
because the chemical substance is manufactured using a reactant having
an identity that the reactant supplier claims as confidential. In these
circumstances, the supplier has identified that it will not disclose to
the manufacturer (or importer) or does not, itself, know the chemical
identity.
A joint submission is a submission started by a primary submitter,
typically an importer. The primary submitter provides the trade name of
the subject chemical substance or mixture, the name and address of the
supplier, and other information as appropriate. Given the requirements
of amended TSCA, EPA proposes to require that the primary submitter
identify whether the supplier information, including the supplier
identity and chemical substance name (trade name) is confidential.
Substantiation of the confidentiality claims for this information is
not required at the time of submission under the proposed rule because
EPA believes it is exempt from substantiation as ``[i]nformation
identifying a supplier'' under TSCA section 14(c)(2)(C).
The secondary submitter of the joint submission provides their
company name and location, a technical contact, trade name, and
chemical identity(ies) and percentage of each chemical substance in the
composition of the substance or mixture represented by the trade name.
In addition, as explained in Unit III.B.5., EPA proposes to collect the
function of each chemical in the mixture. Given the requirements of
amended TSCA, EPA is proposing to provide the ability for the secondary
submitter to specifically identify whether this information is claimed
as confidential. Except for the percentage composition information,
which is generally exempt from substantiation pursuant to TSCA section
14(c)(2)(D), all other reported data elements are subject to
substantiation at the time the information is submitted.
b. Chemical identity. Only chemical substances listed on the
confidential portion of the TSCA Inventory (the Inventory) can be
claimed as confidential. This provision is not new and is reflected in
the current CDR rule at 40 CFR 711.30(b). Such a confidentiality claim
applies to the specific identity of the chemical substance as it is
listed on the confidential portion of the Inventory. CDR reported
chemical identities, including generic chemical names, that are listed
on the public portion of the Inventory cannot be claimed as
confidential and would be made publicly available. EPA included this
discussion for clarification purposes only and is not proposing any
changes to this approach.
c. Connection between company, site, or technical contact identity
and chemical-specific information. EPA is proposing to require
assertion and substantiation of a claim of confidentiality at the time
of submission, on a chemical-specific basis, for the linkage between
company or technical contact identity and chemical substance
information. This is the same as is currently required under 40 CFR
711.30(c) for site identity, when on a chemical-specific basis, one
must claim the linkage between the site identity and the chemical
substance information as confidential by asserting and substantiating
the claim at the time of submission. There would likely be instances
where a confidentiality claim for a company name would not be
appropriate, but one for site identity or technical contact might be
appropriate.
d. Benefits of proposed changes to CBI substantiation. The reduced
amount of information subject to confidentiality limitations will
facilitate greater interagency and public sharing of data and will
decrease the number of inappropriate or unnecessary claims of
confidentiality, which will increase the transparency and public
accessibility of the CDR. Clarification of which data elements can be
claimed as confidential will improve the consistency of EPA's review of
CBI substantiation information and will decrease the need for multiple
conversations between EPA and reporters about substantiation responses,
thus reducing burden for the Agency and for reporters.
2. Certification. The authorized official submitting
confidentiality claims must certify all claims for confidentiality are
true and correct, and all information submitted to substantiate such
claims is true and correct. As required by TSCA sections 14(c)(1)(B)
and 14(c)(5). EPA combined these requirements into a single
certification statement, which was implemented in the CDR electronic
reporting tool in June 2016. EPA is proposing to codify the language of
the certification statement in the CDR rule (see the proposed
regulatory text for 40 CFR 711.30(h)).
3. Processing and use data not protected from disclosure. TSCA
section 14(b)(3)(B), as amended by the 2016 Amendments, prohibits
confidentiality claims for the following submitted information: ``a
general description of a process used in the manufacture or processing
and industrial, commercial, or consumer functions and uses of a
chemical substance, mixture, or article containing a chemical substance
or mixture, including information specific to an industry or industry
sector that customarily would be shared with the general public or
within an industry or industry sector.''
This statutory provision directly impacts and limits
confidentiality claims for certain CDR processing and use data. Thus,
EPA proposes to codify in the regulatory text that the following data
elements cannot be claimed as confidential because they constitute
general descriptions of processes and uses that customarily would be
shared with the general public or within an industry or industry
sector:
Certain Industrial processing and use data elements. The
data elements which directly relate to how the chemical is used or
processed, i.e., the type of process or use; the industrial sector; and
the industrial function (40 CFR 711.15(b)(4)(i)(A), (B), and (C)).
Certain Consumer and Commercial use data elements. The
data elements which directly relate to how the chemical is used, i.e.,
the product category (Sec. 711.15(b)(4)(ii)(A)); whether the chemical
is used in commercial or consumer products (Sec. 711.15(b)(4)(ii)(B));
whether the chemical is likely to be used in children's products (Sec.
711.15(b)(4)(ii)(C)); and the function of the chemical in the consumer
or commercial product (the function is a proposed data element--see
Unit III.B.5. for additional information).
For the purposes of this proposal, EPA believes that other CDR
processing and use data elements do not offer a ``general description''
and therefore do not fall within the limits of TSCA section
14(b)(3)(B). Under this proposal, submitters may continue to assert
claims of confidentiality for the following processing and use data
elements:
Certain Industrial Processing and use data elements.
Percent production volume, number of sites, and number of workers
(Sec. 711.15(b)(4)(i)(D), (E), and (F)).
Certain Consumer and Commercial use data elements. Percent
production volume, maximum concentration, and number of commercial
workers (Sec. 711.15(b)(4)(ii)(D), (E), and (F)).
[[Page 17700]]
4. Time duration of confidentiality claims. In accordance with TSCA
section 14(e)(1)(B), non-exempt confidentiality claims are initially
protected from disclosure for a period of 10 years from the date of
submission and confidentiality assertion, assuming all other relevant
requirements of the statute are met. Information on confidential
business information under TSCA is available on EPA's website at
https://www.epa.gov/tsca-cbi. One of the proposed new substantiation
questions asks whether the submitter anticipates that the claim's
duration would last less than the 10-year statutory time frame.
Respondents would indicate when the claim would no longer be needed,
and EPA would incorporate the release date into its data system,
enabling the information to be made publicly available at that time.
B. Modifications to Reportable Data Elements
1. Processing and use codes. The CDR rule requires manufacturers to
report industrial, consumer, and commercial processing and use
information for chemical substances manufactured during the principal
reporting year. EPA is proposing multiple changes to the data elements
comprising this processing and use information. Specifically, EPA is
proposing to replace the CDR industrial function and commercial/
consumer product use codes with OECD function, product, and article use
categories and to add OECD function categories for commercial/consumer
products. EPA is listing these codes in the CDR instructions, rather
than codifying them in the CFR, which would enable EPA to limit the
codes to just those considered relevant for CDR reporting, with a
catch-all ``non-TSCA'' code for the OECD codes that do not fit under
TSCA. EPA would then be able to update the Instructions prior to each
CDR submission period to align with any changes to the OECD codes.
EPA did not develop burden estimates associated with replacing the
current CDR codes with ones based on the OECD codes because such an
estimate heavily relies on the e-CDRweb user interface which will
feature burden-reducing guided data entry. The addition of the function
categories for commercial/consumer products is a new data element whose
addition could potentially result in an increase in burden (not
estimated at this time). For additional information, see section
4.1.3.2 in the Economic Analysis (Ref. 4).
The OECD Internationally Harmonized Functional, Product, and
Article Use Categories were developed through the OECD Working Party on
Exposure Assessment (Task Force on Exposure Assessment) under the
leadership of the EPA, based on a review of current functional use and
product categories from the United States, Canada, and the European
Union; bilateral discussions with the European Chemicals Agency (ECHA);
and multiple reviews from task force members. The OECD categories are
described in the document ``Internationally Harmonised Functional,
Product and Article Use Categories'' (referred to herein as the OECD
Category Document) (Ref. 8).
Harmonizing CDR use codes with the OECD codes would expand the
utilization of applicable use and exposure-related information from
international sources to support EPA risk evaluation and risk
assessment activities for new and existing chemicals. Additionally,
this harmonization would provide industry with international uniformity
in use and exposure information reporting, enabling industry to better
streamline their different country-specific reporting requirements.
EPA has received requests to harmonize CDR data categories and
descriptions with other countries to the extent possible. In
particular, industry stakeholder groups such as the American Chemistry
Council have expressed a desire to harmonize with Canadian and OECD
data collections in order to provide common global terminology and
preciseness in risk evaluation (Ref. 9). EPA worked closely with Canada
in the development of the current CDR processing and use codes, and
both EPA and Canada were involved in the development of the OECD
Harmonized codes.
Under CDR, there are two main categories of use codes: Function use
codes and product use codes. The function of a chemical combined with
the type of product that the chemical is used in provides an exposure
scenario with unique characteristics. These exposure scenarios are
necessary for implementation of TSCA for the prioritization of the
chemical and for further consideration for the development of exposure
and risk evaluations.
a. Function codes (industrial and consumer/commercial). EPA
currently requires the reporting of function categories for chemical
substances used in industrial products but does not require the
reporting of a chemical substance's function for commercial/consumer
products. EPA is proposing to require reporting of function use
categories for both industrial and commercial/consumer products and to
adopt the OECD functional use categories.
Function codes are based on the intended physical or chemical
characteristic for when a chemical substance or mixture is consumed as
a reactant; incorporated into a formulation, mixture, reaction product,
or article; repackaged; or used (e.g., as an abrasive, a catalyst, or
an elasticizer). EPA uses information regarding the function of a
chemical substance in combination with the industrial sector and
processing or use operation to identify an exposure scenario or the
type of application in which a chemical would be used (such as solvents
for cleaning and degreasing). Understanding the exposure scenarios or
the type of application of the chemical would inform assessment of the
potential route, duration, frequency and magnitude of exposure.
During screening and risk evaluation activities, EPA evaluates how
the chemical substance is manufactured, processed, distributed in
commerce, used, and disposed of. Currently, CDR requires the reporting
of consumer and commercial product categories but does not require the
reporting of chemical function within the product category. The lack of
functional use information for consumer and commercial applications has
restricted EPA's ability to provide more complete evaluations or more
realistic characterizations of exposure for consumer and commercial
applications; instead, EPA relies in many cases on scenarios using
potentially conservative assumptions. (Ref. 10) The addition of
information on the function of the chemical in combination with the
consumer or commercial product category would improve EPA's ability to
consider exposures to consumers and in commercial applications,
providing a more accurate and real-world understanding of the uses of
chemical substances throughout their life cycle.
As explained in the OECD Category Document, the OECD product and
article use categories are intended to focus on the end-use application
of chemicals within products and articles, rather than upstream
manufacturing and processing. However, the functional use categories
cover the life cycle and describe the specific function that a chemical
provides when used in the formulation of a product or article, or when
used within an industrial process. While the function of a chemical may
be the same across its life cycle, certain functions may only be
appropriate for consideration in an industrial setting,
[[Page 17701]]
while others may be relevant for a consumer or commercial setting.
Adopting the OECD functional use codes would provide greater detail
by expanding the function categories from the 35 codes currently used
by CDR to 117 codes. For example, the broad current CDR category
Adhesives and Sealants corresponds to four categories under the OECD
harmonized codes in this proposal: Adhesion/Cohesion Promoters,
Binders, Flux Agents, and Sealants (Barrier). In this proposed rule,
not all of the OECD harmonized codes would be adopted to CDR because
some are for uses not covered by TSCA (e.g., in the circumstances
where, because of a chemical's particular use, it is not a ``chemical
substance'' under TSCA section 3(2)(B)(vi)). The current CDR codes
contain a catch-all ``non-TSCA code'' for uses that are not covered
under TSCA. Under this proposed rule, EPA would continue to provide the
same non-TSCA code as a blanket code for these applications, such as
for a food or cosmetic (other than soap), when the chemical is
reportable to CDR because the chemical is also used in a way that falls
under the jurisdiction of TSCA. EPA is interested in receiving comments
on whether all of the OECD harmonized codes should be listed so that
the codes are an exact match, even if the uses are not covered by TSCA.
Would the exact match make it easier for submitters to report
information under CDR and other reporting requirements using the OECD
harmonized codes?
EPA is listing these codes in the CDR instructions discussed in
Unit III.B.1. Additional details about the proposed function
categories, how they are related to the OECD functional use categories,
and a crosswalk with the current CDR function codes are in the
supplemental document Technical Support Document: Harmonizing CDR
Functional and Product codes with OECD Functional, Product, and Article
Codes (Ref. 11).
b. Commercial/consumer product codes. CDR currently requires the
reporting of product category codes for manufactured chemical
substances that have consumer or commercial uses. The current product
codes consist of both article and other non-article products; they
correlate to the OECD Product and Article Use Categories described in
the OECD Category document (Ref. 8). The OECD Category document uses
the term ``product'' to mean consumable liquids, aerosols, semi-solids,
or solids that are used a given number of times before they are
depleted and the term ``articles'' to generally mean solids, polymers,
foams, metals, and woods, all of which are always present within indoor
environments for the duration of their useful life, which may be
several years (Ref. 8). These terms were developed for the OECD
Category document because, for the purposes of exposure assessment,
products and articles are treated differently. Formulations,
anticipated use patterns, and available approaches to estimate exposure
are different, and certain chemicals may only be added to articles,
others only used to formulate products, and others could be used for
both. Because of these differences, OECD provides separate lists of
product and article use categories. EPA is proposing to adopt the OECD
codes and to consolidate the separate OECD lists into one list to be
consistent with the current CDR approach of listing the article and
other non-article products in one list of CDR Product Categories.
CDR product categories are broader than the OECD categories. Using
the OECD categories would provide a specificity that would be more
helpful to EPA in carrying out its responsibilities under TSCA. For
example, a broad CDR category is Fuels and Related Products, which,
under the OECD product codes, is divided into three categories: Cooking
and Heating Fuels, Fuel Additives, and Vehicular or Appliance Fuels
(Ref. 11). Under this proposal, the current 33 consumer/commercial
product categories would be replaced by 98 categories. For a listing of
the proposed product categories, see Appendix D of the Instructions for
Reporting (Ref. 12). Under TSCA, the definition of ``chemical
substance'' excludes certain uses such as pesticide, tobacco, food, and
other specifically listed uses. Some of the OECD harmonized product
categories cover the TSCA-excluded uses; those particular codes were
not adopted in CDR. The current CDR codes contain a catch-all ``non-
TSCA code'' for uses that are not covered under TSCA. Under this
proposed rule, EPA would continue to provide the same ``non-TSCA'' code
as a blanket code for these applications. EPA is interested in
receiving comments on whether all of the OECD harmonized codes should
be listed, even if the uses are not covered by TSCA, to make it easier
for submitters to report information under CDR and in response to other
reporting requirements using the OECD harmonized codes. Additional
details about the proposed product categories, how they are related to
the OECD product and article categories, and a crosswalk with the
current CDR product codes are in the supplemental document Technical
Support Document: Harmonizing CDR Functional and Product codes with
OECD Functional, Product, and Article Codes (Ref. 11).
2. NAICS codes for manufacturers. EPA is proposing to require
submitters to report the 6-digit NAICS code that best describes the
manufacturing activities conducted at the reporting site. The NAICS was
developed under the direction and guidance of the Office of Management
and Budget (OMB) as the standard for use by Federal statistical
agencies in classifying business establishments for the collection,
tabulation, presentation, and analysis of statistical data. NAICS is
based on a production-oriented concept, meaning that it groups
establishments into industries according to similarity in the processes
used to produce goods or services (62 FR 17288). Use of the standard
provides uniformity and comparability in the presentation and
understanding of data. EPA estimates that this proposed change would
result in a slight increase in burden, which is explained in detail in
Table 4-11 in the Economic Analysis (Ref. 4).
EPA would use the NAICS code information in its analysis of the
reported manufacturing-related information to better analyze the data
by industry sector. EPA's insight into particular industry sectors has
been limited without this particular data element. For example, during
the 2017 negotiated rulemaking, participants asked EPA to analyze
specific industries to determine if there was overlap in reporting
among different Agency programs and to determine if EPA could trace the
life cycle of some chemical substances from their manufacture through
their use and to their disposal (Refs. 13 and 14). NAICS codes would
have better enabled EPA to fulfill the requests because many other EPA
programs, such as the Toxics Release Inventory (TRI), require the
reporting of NAICS codes. By adding the site's NAICS code as a required
data element for CDR, EPA would be better able to use information from
CDR in conjunction with TRI data to support implementation of TSCA.
Because reporting under CDR is done by the site that is conducting
the manufacturing activity, the site is expected to be sufficiently
knowledgeable to be able to determine the appropriate NAICS code. EPA
believes sites would be able to identify a single NAICS code per site;
however, the Agency is interested in comments on whether the CDR
reporting tool should enable the reporting of multiple NAICS codes
based on each chemical substance, similar to how the technical contact
is reported.
[[Page 17702]]
a. Relationship to processing and use industrial sector codes. For
processing and use information, often conducted at sites other than the
manufacturing site, submitters currently report an industrial sector
(IS) code instead of the NAICS codes. The IS codes divide the entire
range of NAICS codes into sectors such that there is a sector
corresponding to any NAICS code. Initially, submitters reported NAICS
codes when describing the industrial processing and use of their
reported chemicals. In the 2011 Inventory Update Reporting (IUR)
Modifications final rule, EPA replaced the NAICS codes with the
industrial sector codes. (76 FR 50816, August 16, 2011; EPA-HQ-OPPT-
2009-0187-0393). Respondents to the 2006 IUR, the predecessor to the
CDR, submitted 342 unique 5-digit NAICS codes. So many codes made it
difficult for EPA to group chemical substances based on industrial
processing and use scenarios. In all, the 2006 IUR database has 2,330
unique combinations of processing or use codes, NAICS codes, and
industrial function categories. This large number of unique
combinations increased the difficulty and time required by EPA to sort
and classify chemical substances because EPA either would need to
develop exposure scenarios for each unique combination or determine the
three-code combinations that have similar exposure scenarios and can be
grouped. The use of the IS codes for the 2012 and subsequent CDR
reporting cycles has reduced the number of unique combinations, thereby
increasing the usability of the data and reducing the associated
reporting burden.
EPA believes that the manufacturing of chemicals incorporates a
narrower range of NAICS codes than the processing and use of chemicals.
Therefore, identifying the more specific NAICS code for the
manufacturing site is not expected to result in the large number of
combinations experienced in 2006 for the processing and use
information.
b. Improving outreach and reporting assistance. EPA would also use
the NAICS codes to improve outreach and reporting assistance for
manufacturers in specific industry sectors. For the 2016 submission
period, EPA developed industry sector-specific Fact Sheets for the
printed circuit board, metal mining, and electricity-generating sectors
(Refs. 15, 16, and 17). Each Fact Sheet addressed reporting
requirements specific to that industry, including the use of specific
and unique examples designed to better illustrate the sector's
reporting requirements. EPA expects to continue this practice for other
industries, and having NAICS codes available in the CDR dataset would
facilitate expansion of this outreach.
3. Modifying recycled information. Currently, CDR submitters
identify whether their reportable chemical substance is recycled,
remanufactured, reprocessed, reused, or otherwise used for a commercial
purpose instead of being disposed of as a waste or included in a waste
stream. EPA is proposing to modify this data element by removing the
terms ``remanufactured, reprocessed, reused'' as this may be
interpreted and applied too broadly to obtain the information of
interest for this collection. These terms are also not necessarily
synonymous with ``recycle'' in all scenarios. It is EPA's intention
that this data element identify the chemical substances that would
otherwise be disposed of as a waste, and EPA believes the revised
phrase ``recycled or otherwise used for a commercial purpose instead of
being disposed of as a waste or included in a waste stream'' best
describes this intention. This proposed change is also intended to
reduce confusion, and thus burden, and provide greater specificity as
to what this data element requires. For example, the term ``reused''
might cause the site to consider the need to report other chemical
substances that it simply purchased and used if the site found a way to
reuse that substance. Such reporting would be erroneous, because a site
is only required to report a substance that it manufactures, not that
it has merely purchased. However, if a manufactured (including
imported) substance is reused instead of being disposed of as a waste,
then that would be reported. EPA does not anticipate a change in burden
associated with this proposed change. See section 4.1.3 of the Economic
Analysis for additional information (Ref. 4). EPA is soliciting public
comments on modifying this data element to better capture recycling in
CDR.
EPA is soliciting comment on whether submitters should identify the
percentage of total production volume of their chemical substance that
is recycled instead of only designating whether recycling occurred, the
burden associated with providing such an estimate, and any difficulties
industry might encounter in estimating such a percentage (either to the
nearest 10 percent or more accurately). EPA believes that the percent
production volume for a chemical substance that is being recycled or
otherwise used for a commercial purpose instead of being disposed of as
a waste or included in a waste stream would be information relevant to
the exposure profile of a chemical substance and indicates efficiencies
within the chemical manufacturing industry. EPA is interested in the
exposures from these activities. In addition, information about whether
certain types of industries recycle or whether certain types of
chemicals are recycled and if such recycling is increasing or
decreasing provides information about changes in the manufacturing
environment that inform EPA's TSCA activities. Collecting specific
percentages about recycling could give EPA a better understanding of
the recycling reporting universe and provide EPA the opportunity to
grant more targeted reporting exemptions and burden reduction
activities in future reporting cycles.
4. Percent byproduct. EPA is proposing to add the requirement to
report the percent total production volume for a chemical substance
that is a byproduct. EPA believes this data element would provide
information to better understand the manufacturing of byproduct
chemical substances and the impact of current or potential future
exemptions to reporting. EPA is interested in this change in order to
increase transparency by identifying important submitter subpopulations
and their representations in CDR with respect to production volume. EPA
estimates that this proposed change would result in an increase in
burden, which is explained in detail in Table 4-11 in the Economic
Analysis (Ref. 4).
Information about byproduct reporting has been of particular
interest due to requirements of the 2016 amendments to TSCA to conduct
a negotiated rulemaking for manufacturers of inorganic byproducts.
During the deliberations of the negotiated rulemaking committee, EPA
was unable to specifically identify, from the CDR data, chemical
substances manufactured as byproducts or byproduct manufacturers who
would be impacted by changes to the reporting requirements. With the
addition of this data element, EPA will be able to identify those
manufacturers that recycle portions of their substances or only report
to CDR due to their byproduct production. EPA would consequently be
better able to understand a larger spectrum of potential exposure
scenarios, by improving understanding of the connection between
manufacturing and downstream activities for the purposes of substance
life cycle assessments and risk evaluation. In addition, EPA would use
this information to inform future decisions about potential changes to
CDR requirements.
[[Page 17703]]
There are situations where the same chemical substance is
manufactured both as a primary chemical substance and a byproduct.
While this is rare, it is a known occurrence. For example, when
commercial stearic acid is manufactured, it is known to contain
significant amounts of palmitic acid and oleic acid as byproducts. Such
a producer would also be likely to separately manufacture palmitic acid
and/or oleic acid as primary chemical products. In this situation, if
the palmitic acid that is manufactured as a byproduct is used for a
reportable commercial purpose, its volume would be reported along with
the volume of palmitic acid that is separately manufactured at the same
site and its volume would be counted as the byproduct portion when
calculating the percent manufactured as a byproduct. It is important to
recognize that an overproduction of the primary manufactured substance
does not meet the regulatory definition of a byproduct, and thus is not
considered a byproduct for the purposes of CDR, and should not be
counted as such when calculating the percent manufactured for this data
element.
Reporting in percentages. As with other percentage production
volume reporting requirements in the CDR regulation, EPA is proposing
to require that the percentages for the percent byproduct be rounded to
the nearest 10 percent, unless the percentage is less than 5 percent.
EPA would allow the reporting of more specific percent production
volumes. In situations where the percentages account for less than 5
percent of the submitter's total production volume for the reportable
chemical substance, the submitter would not round off to zero if the
production volume attributable to that amount is greater than or equal
to 25,000 lbs. (or in an amount of 2,500 lbs. or more for chemical
substances subject to the rules, orders, or actions described in Sec.
711.8(b)). In such cases, submitters would report the percentage of
production volume attributable to that portion to the nearest 1 percent
of production volume. This exception to the general rounding off rule
is being proposed to differentiate situations where no portion or a
very low portion of the chemical substance is a byproduct, to ensure
that adequate manufacturing information would be reported for the
larger production volume chemical substances. The 25,000 lbs. (or 2,500
lbs.) level was selected for consistency with the current threshold for
reporting under CDR. EPA is interested in receiving comment on whether
reporting the percent production volume to the nearest 10 percent or 1
percent for 5 percent or below is a lower burden than simply reporting
to the nearest 1 percent for any percentage. EPA is interested in the
difficulty that industry might encounter in estimating a percentage
rounded to the nearest ten percent or a more accurate percentage of
byproduct that is produced in the manufacturing process and what
challenges industry may encounter in calculating this estimate. EPA is
also interested in the burden estimate associated with calculating this
data element. EPA is also interested in receiving general comment on
the reporting requirements in this proposed rule, including on the
effort required by a submitter to provide the percent production volume
that is a byproduct.
5. Chemical specific function for imported mixtures. EPA is
proposing to require the secondary submitter of a joint submission to
report the chemical-specific function along with information on
chemical composition of the imported product or mixture. A joint
submission is most typically used when a substance or a mixture is
imported and the supplier does not provide to the importer the specific
chemical identity of the substance or substances that comprise the
mixture. See Unit III.A. for additional information about joint
submissions. Currently, the importer identifies the function of the
imported product. In some circumstances, the function of the imported
product can be correctly applied to the specific chemical substance.
However, in the circumstance where the imported product is a multi-
component mixture, applying the function of the imported product to
each component of the mixture can result in identifying a function for
an individual chemical substance that is not appropriate. For example,
a dye or a fragrance that is part of a cleaning mixture should not be
identified as a cleaner, but rather as a dye or a fragrance. Providing
the appropriate function for the component of the mixture would inform
the assessment process by improving the understanding of the conditions
of use for a chemical (e.g., formulation, use rate, etc.). EPA does not
anticipate a change in burden associated with this proposed change
because the burden associated with reporting the function of the
chemical for the secondary submitter is already captured in the
baseline burden. See section 4.1.3 of the Economic Analysis for
additional information (Ref. 4).
6. Public contact. EPA is proposing to enable the reporting of a
public contact for each CDR submission as a voluntary data element.
Currently, a technical contact familiar with the information provided
in the form is required to be reported. The public contact would be in
addition to the technical contact and would be an individual who may be
contacted by the general public with questions related to the publicly
available information reported by the company under CDR. This person
has been designated by the site or company to handle public inquiries.
The addition of a public contact to handle public inquiries is modeled
after TRI's approach to the public contact, albeit on a voluntary
basis, and would include the contact's name, phone number, and email
address. Because the public contact is intended to be made available to
the public, this voluntary data element would not be able to be claimed
as confidential. EPA is interested in receiving comment on whether it
would be helpful to have a public contact available. EPA estimates that
this proposed change would result in a slight increase in burden, which
is explained in detail in Table 4-11 in the Economic Analysis (Ref. 4).
Difference between public contact and technical contact. Submitters
to CDR are already required to supply, and may claim as confidential, a
technical contact(s) who should be a person able to answer technical
questions about the reported chemical substance(s). Typically, a person
located at the manufacturing site is best able to answer such
questions. The public contact, which would be voluntarily reported, is
intended to be a more general, public-facing company representative who
would be available to answer questions the public might ask the
company.
7. Parent company identity. EPA is proposing three changes
associated with reporting the parent company under CDR: (1) To add the
requirement to report a foreign parent company in addition to reporting
the highest-level U.S. parent company when the ultimate parent company
is located outside of the United States; (2) to remove the definition
of U.S. parent company from 40 CFR 711.3 and replace it with a new
definition for parent company; and (3) to add a requirement for
reporters to report legal name(s) and to follow a naming convention for
providing the parent company name(s), the details of which would be
provided in the CDR Instructions (see 40 CFR 711.35). As a whole, EPA
believes these changes would increase the usefulness of the CDR data by
improving consistency in reporting, better enabling EPA to protect
information claimed as confidential, and reducing the after-reporting
quality control effort for both EPA and
[[Page 17704]]
submitters. EPA estimates that the proposed addition of a foreign
parent company would slightly increase the burden, which is explained
in detail in Table 4-11 in the Economic Analysis (Ref. 4). EPA did not
estimate the burden reduction associated with the reduced need to
contact companies for quality control purposes after data submission.
Currently, sites required to report to CDR must report their U.S.
parent company, which is defined to mean the highest-level company
located in the United States that directly owns at least 50 percent of
the voting stock of the manufacturer (see 40 CFR 711.3). The site must
report its U.S. parent company name, address, and Dun and Bradstreet D-
U-N-S[supreg] (D&B) number (see 40 CFR 711.15(b)(2)(i)).
Proposed change to definition of U.S. parent company. EPA is
proposing to replace the definition of U.S. parent company from 40 CFR
711.3 with a new definition for parent company that includes both U.S.
and foreign parent companies and provides guidelines for different
company structures. In developing this definition, EPA considered
solely using the definition of ``parent company'' already found in 40
CFR 704.3, but decided to propose the specifically listed guidelines in
the regulatory text for clarity and consistency with other programs.
Please review the proposals in the following paragraphs. EPA is
requesting comment on this approach.
Proposed reporting of foreign parent company. In some situations,
the highest-level parent company is outside of the United States. EPA
is proposing that sites also identify the highest-level worldwide
parent company, when applicable, and therefore is also adding the
requirement to report the foreign parent company under 40 CFR 711.15.
Under this proposal, reporters would continue to report their U.S.
parent company, but also report their foreign parent company if the
situation applies.
Including the foreign parent company would increase the ability of
EPA to protect information claimed as confidential. Currently, some
confidential information may be inadvertently disclosed due to
challenges in identifying connections between sites when the parent
companies are outside of the United States. EPA takes such
relationships into account when aggregating confidential information.
By reporting the foreign parent company, EPA would be able to better
identify company groupings for data aggregation and, ultimately,
protection of information claimed as confidential.
This modification would be responsive to industry concerns
expressed during the 2016 CDR submission period with not being able to
report their ``true'' parent company when that company is outside of
the United States. In many cases, sites know the foreign corporation's
name more readily than the U.S. parent company's name.
As opposed to relying exclusively on the foreign parent company
(where applicable), EPA is retaining the U.S. parent company reporting
requirement to allow EPA to align future CDR collections with
historical data; inclusion of the U.S. parent company for 2020
reporting would enable EPA to correlate with past reporting cycles and
potentially to increase consistency in reporting among sites associated
with the same parent company. Including both the U.S. and the foreign
parent companies would provide data users greater flexibility when
combining CDR data with data from other sources, some of which are
limited to only U.S. information.
Application of parent company definition to different situations.
EPA recognizes that there are a variety of ownership situations for
manufacturers reporting under CDR. The scenario-specific information
listed in this document is based on the guidelines included in the
proposed definition and contains additional examples illustrating the
application of the proposed parent company definition and reporting
requirements. The guidelines include how to populate the U.S. and a
foreign parent company data elements. EPA is interested in receiving
comments on whether the guidelines and these examples encompass the
representative range of scenarios for reporting under CDR, and whether
the guidelines included in the proposed definition are sufficient. The
examples are as follows:
(1) If the site is entirely owned by a single U.S. company that is
not owned by another company, then that single company is the U.S.
parent company and there is no foreign parent company.
(2) If the site is entirely owned by a single U.S. company that is,
itself, owned by another U.S.-based company (e.g., it is a division or
subsidiary of a higher-level company), the highest-level company in the
ownership hierarchy is the U.S. parent company. If there is a higher-
level parent company that is outside of the United States, the highest-
level foreign company in the ownership hierarchy is the foreign parent
company.
(3) If the site is owned by more than one company (e.g., company A
owns 40 percent, company B owns 35 percent, and company C owns 25
percent of the site), the highest-level U.S. company with the largest
ownership interest in the site is the U.S. parent company. Under this
scenario, this would be either company A itself (if it doesn't have a
U.S.-based parent company), company A's parent, or, if it exists, a
single parent company that owns both company B and company C, in which
case that single parent company would have the largest ownership
interest. If there is a higher-level foreign company in the site's
ownership hierarchy, that company is the foreign parent company. There
may be the situation where the highest U.S. company is company A's
parent company but a foreign company owns both company B and company C.
In this situation, the foreign parent company would be the highest-
level parent company that owns companies B and C and the U.S. parent
company would be the parent company of company A.
(4) If the site is ultimately owned by a 50:50 joint venture or a
cooperative, the joint venture or cooperative is its own U.S. parent
company. If the site is owned by a U.S. joint venture or cooperative,
the highest level of the joint venture or cooperative is the U.S.
parent company. If the site is owned by a joint venture or cooperative
outside the United States, the highest level of the joint venture or
cooperative outside the United States is the foreign parent company.
(5) If the site is entirely owned by a foreign company (i.e.,
without a U.S.-based subsidiary within the facility's ownership
hierarchy), the highest-level foreign parent company is the facility's
foreign parent company. In this situation, the U.S. parent company
would be the site itself.
(6) If the site is a federally owned, the highest-level federal
agency or department is the U.S. parent company.
(7) If the site is owned by a non-federal public entity, that
entity (such as a municipality, State, or tribe) is the U.S. parent
company.
Proposed use of naming convention. EPA is also proposing to require
sites to follow the CDR instructions regarding standardized conventions
for the naming of a parent company. These naming conventions address
common formatting discrepancies, such as punctuation, capitalization,
and abbreviations (e.g., ``Corp'' for ``Corporation''). The use of
these naming conventions would reduce the number of inconsistencies
with the Parent Company Name data field, and thereby would increase the
reliability and usability of the data and reduce the associated
reporting burden due to the
[[Page 17705]]
Agency's need to request corrections from reporting companies.
C. Changes to Reporting Process for Co-Manufactured Chemicals
EPA is proposing to change the method manufacturers use to report
co-manufactured chemicals. A co-manufacturing relationship occurs when
a chemical substance, manufactured other than by import, is produced
exclusively for another person who contracts for such production. To be
considered a co-manufacture situation, the producing company produces
the chemical substance exclusively for another person (the contracting
company) under contract for that production. If the chemical substance
is produced for other purposes, then the situation fails this first
test of ``co-manufacturing.'' For example, if a company manufactures a
chemical for speculative purposes based on expectations of the market,
the company is not operating in a co-manufacturing situation. In
addition, the other person contracting the manufacture (i.e., the
contracting company) specifies the identity of the chemical substance,
the total amount produced, and the basic technology for the plant
process. This is the second test of ``co-manufacturing.'' To be
considered co-manufacturers, both of these tests must be met. See 40
CFR 711.3 (definition of ``manufacture''). Although this proposed
change reduces co-manufacturer confusion and addresses other industry
concerns, EPA estimates that it would have a minimal impact on the
burden and therefore did not include an estimate in the analysis. See
section 4.1.3.2 in the Economic Analysis for additional information
(Ref. 4).
EPA is avoiding the use of the term toll manufacturer for this
proposal and future guidance to add clarity for the co-manufacturing
situation. In instructions, guidance, and other communication with
submitters, EPA may previously have referred to co-manufacturing as
toll manufacturing, and more specifically to the two parties as the
contracting manufacturer and the toll manufacturer. Because EPA does
not specifically define the term ``toll manufacturer,'' EPA now
believes the use of this term may be open to mis-interpretation and it
would be clearer to use terms associated with the CDR definition of
manufacturer in 40 CFR 711.3. Additionally, EPA believes the chemical
industry often refers to toll manufacturing in a more general manner,
where both of the tests included in the CDR definition for manufacture
are not met. These tests are: (1) The chemical substance is produced
exclusively for another person who contracts for such production, and
(2) that other person specifies the identity of the chemical substance
and controls the total amount produced and the basic technology for the
plant process.
Current reporting requirements. Under the current CDR rule, the
contracting company and the producing company are jointly responsible
for reporting and submitting to CDR. Only one report may be submitted
per reportable chemical and per production site. In order to report,
the contracting company and the producing company must work together
and identify who will submit the report they are both responsible for,
to prevent duplicate reporting and ensure both parties have met their
reporting obligations.
Pursuant to the CDR definition of ``site'' at 40 CFR 711.3, the
site reported is the site of physical manufacture (i.e., the producing
company's site). This is true irrespective of whether it is the
producing company or the contracting company who completes the report.
If both parties fail to report, both the contracting company and
producing company are liable.
The companies must designate a single technical contact for the
specified chemical(s), who can be an employee of either the contracting
company or the producing company (or a consultant). This technical
contact should be knowledgeable about the specific chemical and should
be the best equipped to answer questions about the certain chemical.
Submitters have identified multiple concerns with the current
reporting process for co-manufacturers. Current issues associated with
using this method for reporting include:
The contracting company and producing company are unsure
who should be primarily or solely responsible for CDR reporting and are
concerned regarding the shared liability.
The producing company has information (such as the number
of workers likely to be exposed) that the contracting company does not
have, and the contracting company has information (such as information
about the processing and use of the chemical substance) that the
producing company does not have. However, when currently completing the
CDR chemical report, one company may not be willing to share
information it considers confidential with the other company.
In situations where the producing company is reporting for
additional chemical substances, the current co-reporting requirement
may result in the need to submit multiple CDR reports for the producing
company's site. This created a complicated situation that required
special handling and increased confusion and burden for the submitter.
Proposed reporting methodology. EPA is proposing to change the
reporting mechanism for co-manufacturers by developing a multi-
submitter process, similar to that used by importers, where the
contracting company is the primary submitter and the producing company
is the secondary submitter. When evaluating the co-manufacturing
reporting process, EPA considered industry's desire for a flexible
reporting mechanism and the need to protect the confidential
information of both the contracting company and the producing company.
These considerations were made apparent through documented
correspondence between EPA and reporters to the 2016 CDR who were
either a contracting company or a producing company regarding issues
with the co-manufacturing mechanism. EPA also met with representatives
from reporting companies to discuss the co-manufacturing mechanism and
the challenges related to coordinating a dual effort between the
contracting companies and producing companies during the 2016 reporting
period (Ref. 18).
In response, EPA is proposing a new methodology for the 2020 and
future reporting cycles. Under this new reporting methodology, the
contracting company (as the primary submitter) would have the
responsibility to initiate a co-manufacture report that would prompt
the reporting requirements for the producing company (as the secondary
submitter). The contracting company would start the chemical report for
the co-manufactured chemical, identifying the chemical substance and
the producing company. The contracting company would then initiate the
co-manufacture report using e-CDRweb to send a notification to the
producing company. Additionally, the contracting company is responsible
for completing the volume manufactured (40 CFR 711.15(b)(3)) and the
processing and use-related section (40 CFR 711.15(b)(4)). Upon receipt
of the email, the producing company will have the information needed to
begin its portion of the co-manufacture report, which would include the
manufacturing-related data elements from 40 CFR 711.15(b)(3), including
the production volume.
Although the manufacturing information section includes the
chemical identity field, it is EPA's belief, based on the two tests for
a co-manufacturing situation in which the contracting company specifies
the
[[Page 17706]]
chemical to be manufactured and the process to be used, that the
contracting company would be best situated to complete the chemical
identity field. EPA also believes that both parties should report the
volume manufactured because both are responsible for reporting other
data elements and an associated percent production volume. To ensure
the percent production volume is correctly interpreted by both data
reporters and data users, the basis for that percent production volume
must be known. EPA is interested in receiving comments on whether this
split in the data elements is reflective of the knowledge of each party
in the co-manufacturing relationship.
This improved reporting mechanism would protect the confidentiality
of both the producing company and contracting company by ensuring that
the contracting company would not require any potentially confidential
information from the part of the producing company. This method also
would eliminate confusion between the two involved parties by
designating the contracting company as the primary submitter
responsible for initiating the reporting process. As with current
reporting, both parties would remain liable for reporting the co-
manufactured chemical because each party has a portion of the
information required under CDR. In addition, this co-manufacture
reporting procedure enables the use of one Form U per site, because the
contracting company indicates the producing company's site without
starting a separate Form U and the producing company completes an
independent report for any other, non-co-manufactured chemicals in its
own site report.
Alternative reporting methodologies. EPA considered alternatives to
the proposed approach for reporting in a co-manufacturing situation.
The first alternative would require the producing company (instead of
the contracting company) to initiate the reporting and to be primarily
liable for reporting. In this alternative, the producing company would
initiate reporting via a co-manufacture report and provide the exposure
information from the manufacturing site. Using e-CDRweb, the producing
company would notify the contracting company of the need to provide the
remainder of the information. EPA does not favor this option at this
time because it believes that the contracting company is likely to be
more knowledgeable about the chemical identity and other information
required by CDR and therefore better able to complete the reporting
requirements.
The second alternative would be to retain the current reporting
mechanism (described in Current reporting requirements) where the
contracting company and the producing company are jointly responsible
for reporting and submitting under CDR. This alternative could include
the addition of an indication that the chemical is being co-
manufactured and, for the contracting company, the addition of the
producing company site location. As is currently the case, only one
report may be submitted per reportable chemical and per production
site; therefore, the contracting company and the producing company must
determine who is responsible to submit the one report to prevent
duplicate reporting, and work together to provide a single complete
report.
EPA requests comments on the proposed reporting methodology where
the contracting company is the primary submitter and on the two
alternative reporting scenarios (where the producing company is the
primary submitter or retaining the current reporting mechanism without
a primary or secondary submitter) for improving the reporting process
for co-manufacturing situations. In addition to comments on the general
approaches, EPA is interested in comments on the information that
should be included on each portion of the co-manufacturing report (for
the proposed and first alternative).
Definition of site. EPA is proposing to modify the definition of
site by replacing the term toll manufacturer with the term producing
company. This change would make terminology consistent between the
definitions of site and manufacture.
Relationship of co-manufacturing to imports. As with the current
CDR rule, a co-manufactured chemical substance cannot be an import.
Rather, the chemical substance produced via an arrangement with a
foreign supplier results in an imported chemical substance, and the
U.S. importer alone, as the reporting manufacturer, is responsible for
reporting that substance.
D. Reporting of Byproducts
EPA is proposing three changes that directly impact manufacturers
of byproduct substances, including inorganic byproducts, to: (1) Allow
reporting in metal categories for inorganic byproducts; (2) exempt
specifically listed byproducts that are recycled in a site-limited
manner; and (3) exempt byproducts manufactured in pollution control and
boiler equipment when that equipment is non-integral to the primary
manufacturing process. Byproducts are defined at 40 CFR 704.3 to mean a
chemical substance produced without a separate commercial intent during
the manufacture, processing, use, or disposal of another chemical
substance(s) or mixture(s). In developing these proposals, EPA relied
on information gathered during the negotiated rulemaking process (EPA-
HQ-OPPT-2016-0597 and 81 FR 90843, December 15, 2016) and from other
public comments (EPA-HQ-OA-2017-0190 and 82 FR 17793, April 13, 2017),
with the intent to develop proposals for addressing burden for these
byproduct manufacturers while maintaining the information needed by
EPA, as described in Unit I.C.
1. Alternative reporting in metal compound categories for inorganic
byproducts. EPA is proposing to allow, but not require, CDR reporting
within defined metal compound categories for certain elemental metals
and inorganic metal compounds that are produced as inorganic
byproducts. Manufacturers of these inorganic byproducts would have the
option to combine and report multiple inorganic byproduct metal
substances, that otherwise would be reported individually as listed on
the TSCA Inventory, into one or more specifically-listed categories
(e.g., Chromium & Chromium Compounds).
If the manufacturer has multiple inorganic byproduct chemical
substances to report, they would be able to choose to report some
byproduct substances in categories and other different byproduct
substances as specific substances. However, the manufacturer would not
be able to bifurcate the production volume of the same byproduct
chemical substance and report a portion in a category and another
portion as a specific chemical substance unless the bifurcation is due
to having different metal elements present in the byproduct. Some
substances would be required to be reported as listed on the TSCA
Inventory and not as part of these metal compound categories, because
they are of particular interest to EPA. They are described later in
this unit.
EPA believes this proposed method of reporting in categories would
simplify reporting and ease reporting burden for manufacturers whose
inorganic byproduct metal-containing substances have chemical
compositions that are non-specific and difficult to identify, while
also providing information that meets EPA's needs. Additionally,
because manufacturers would retain the ability to report to CDR by
specific substances contained on the TSCA Inventory (as is currently
required), manufacturers of these byproduct
[[Page 17707]]
substances would have the flexibility to report these substances in the
manner that they prefer.
Inorganic metal substances that are manufactured as products and
not as byproducts would be ineligible to report within a metal category
because these non-byproduct substances are intended products and should
be more easily identifiable by their manufacturers.
EPA has the explicit authority under TSCA section 26(c) to take any
actions authorized or required by TSCA with respect to categories of
chemical substances, and the Agency has experience assessing chemicals
in categories under TSCA. For an example of how EPA could use
information reported in metal compound categories, see the Antimony
Trioxide (ATO) Risk Assessment conducted in 2014 (Ref. 19). Because ATO
is not specifically listed on the TRI, releases reported under the
broader category of antimony compounds were used as a surrogate to
evaluate the potential for aquatic exposures.
The proposed defined inorganic metal compound categories are
designed in part to allow CDR reporting to align more closely with
those chemical substances and compound categories on the 2014 Update to
the TSCA Work Plan for Chemical Assessments.
TRI also uses a similar option of reporting under compound
categories, many of which are metals. EPA recognizes that many
companies report to both statutory programs and is interested in
aligning TRI and CDR to the extent possible and reasonable given the
differing purposes of the two rules.
The proposed CDR metal categories list is comprised of the
following categories from the 2014 Update to the TSCA Work Plan for
Chemical Assessments and from TRI (Refs. 20 and 21). In the future, EPA
may modify, by rulemaking, the metal categories list as more chemicals
are evaluated as part of the existing chemical program:
Antimony & Antimony Compounds
Arsenic & Arsenic Compounds
Barium & Barium Compounds
Beryllium & Beryllium Compounds
Cadmium & Cadmium Compounds
Chromium & Chromium Compounds
Cobalt & Cobalt Compounds
Copper & Copper Compounds
Lead & Lead Compounds
Manganese & Manganese Compounds
Mercury & Mercury Compounds
Molybdenum & Molybdenum Compounds
Nickel & Nickel Compounds
Selenium & Selenium Compounds
Silver & Silver Compounds
Thallium & Thallium Compounds
Vanadium & Vanadium Compounds
Zinc & Zinc Compounds
To better characterize which substances would be reportable within
these metal compound categories, EPA is proposing to use the definition
of inorganic chemical substances that was originally part of the IUR
(51 FR 113, June 12, 1986). For the purposes of this rule, inorganic
substances would be defined to mean those substances that do not
contain carbon or contain carbon only in the form of carbonato [=CO3],
cyano [-CN], cyanato [-OCN], isocyano [-NC], or isocyanato [-NCO]
groups, or the chalcogen analogues of such groups (e.g., thiocarbonato
(=CS3-xOx, where x = 0-2), thiocyanato (-SCN), or isothiocyanato (-
NCS)). It should be noted that EPA does not consider organometallics to
be inorganic chemical substances, and therefore such substances would
not be reportable under metal compound categories. Examples of
organometallic substances listed on the TSCA Inventory are: Ferrocene,
benzoyl- (CASRN 1272-44-2), Plumbane, tetraethyl- (CASRN 78-00-2),
Stannane, tetrabutyl- (CASRN 1461-25-2), Mercury, dimethyl- (CASRN 593-
74-8), and Cobalt, di-.mu.-carbonylhexacarbonyldi-, (Co-Co) (CASRN
10210-68-1).
As an example of how to use this inorganic metal compound category
reporting method, a manufacturer who is domestically producing Copper
chloride, Copper hydroxide, and Copper sulfide as byproduct substances
would have the option to report all of these inorganic byproducts under
a single report of Copper and Copper compounds, aggregating their
volumes. If reporting by category, the manufacturer in this example
would first assess if it meets the threshold for reporting by combining
the production volumes for all three substances (Copper chloride,
Copper hydroxide, and Copper sulfide). If the combined threshold for
any of the years since the last principal reporting year is 25,000 lbs.
or greater, the manufacturer has met the reporting threshold for the
copper compound category (e.g., for 2020 CDR, consider the production
volumes for 2016, 2017, 2018, and 2019), which would prompt the need
for the manufacturer to report for that category of chemicals (Ref.
22).
In terms of reporting, however, EPA is proposing that only the
weight of the parent metal portion of the metal category compound would
be reported (for example, if reporting by categories, 34,000 pounds of
Copper chloride (CuCl2) (CASRN 7447-39-4) would be reported based on
16,072 pounds in the category ``copper and copper compounds'') (Ref.
22). This approach is proposed because it is similar to the methodology
used by TRI (Ref. 23). Although the type of threshold prompting the
need to report would be similar to that for reporting in categories
under TRI, it is important to note that reporting under CDR is for
amounts manufactured (and imported), while reporting under TRI is for
amounts released. It is also important to recognize that this method is
different than reporting under CDR using a TSCA-listed chemical
substance identity.
EPA is interested in obtaining comment on the proposal to allow
reporting of inorganic substances in metal compound categories,
including the methodology for how to report using categories.
Specifically, EPA is interested in receiving comments on deviating from
the standard approach used for CDR of reporting the volume of substance
manufactured and instead using the approach of reporting the weight of
the metal in the compounds when reporting by the metal category. Would
it be more appropriate to report the full weight of the chemical
substance instead of the metal weight? Are submitters likely to report
using this approach?
Exclusions from category reporting. EPA is also proposing to
require various substances to be reported as listed on the TSCA
Inventory and not as part of these metal compound categories. Such
substances are of particular interest to EPA, and would include:
Substances that have been individually identified on the
2014 Update to the TSCA Work Plan for Chemical Assessments (Ref. 20):
specifically, Carbonic acid, barium salt (1:1) (CASRN 513-77-9)
(referred to as Barium carbonate);
Substances that are the subject of certain TSCA actions as
listed in 40 CFR 711.6, including TSCA section 5(a)(2) Significant New
Use Rules (SNURs), TSCA section 5(b)(4) rules, TSCA sections 4, 5(e)
and 5(f) orders, TSCA section 6 rules, TSCA section 4 test rules,
Enforceable Consent Agreements (ECAs) developed under the procedures of
40 CFR part 790, and TSCA section 5 or 7 civil actions. Note that lists
of subject chemicals can be identified using the eCDRweb reporting tool
or separately from EPA's Substance Registry Services (SRS) website
(https://www.epa.gov/srs). Instructions for determining subject
chemicals are provided on the CDR website and in CDR guidance.
Chemical substances undergoing prioritization or risk
evaluation under TSCA section 6. While the current list
[[Page 17708]]
of chemical substances undergoing risk evaluation is comprised of ten
chemicals that are not inorganic metal-containing compounds (Ref. 24),
EPA may initiate risk evaluations for inorganic metal-containing
chemicals in the future, which would exclude those chemical substances
from being able to be reported to CDR under a metal compound category.
For example, consider reporting within the chromium category. There
is a TSCA section 6 action (40 CFR 749.68) that covers several
hexavalent chromium-based water treatment chemicals. Those covered
substances (e.g., Chromic acid (H2Cr2O7), sodium salt (1:2) (CASRN
10588-01-9), Chromic acid (H2CrO4) (CASRN 7738-94-5), and Chromium
trioxide (CrO3) (CASRN 1333-82-0)) would not be reportable within the
chromium category, even if they were manufactured as byproducts.
However, other chromium substances, containing Chromium not in the
hexavalent oxidation state (e.g., Chromium chloride (CrCl3) (CASRN
10025-73-7), Chromium hydroxide (Cr(OH)3) (CASRN 1308-14-1), and
Chromium oxide (Cr2O3) (CASRN 1308-38-9)), if manufactured as byproduct
substances, would be able to be reported within the Chromium compound
category.
2. Specific site-limited recycled byproducts. EPA is proposing to
exempt specifically identified byproducts that are recycled on-site
from two industries. Portland cement manufacturers that produce Flue
dust, portland cement (CASRN 68475-76-3) (referred to as cement kiln
dust), and manufacturers using the Kraft pulping process to produce
Sulfite liquors and Cooking liquors, spent (CASRN 66071-92-9) (often
comprised of what is referred to as black liquor) and Carbonic acid
calcium salt (1:1) (CASRN 471-34-1) (referred to as calcium carbonate)
would, under certain scenarios, be exempted from the need to report
these byproduct substances. These byproducts would be exempted from
reporting only when (1) they are recycled or otherwise used to
manufacture another chemical substance within an enclosed system,
within the same overall manufacturing process, and on the same site as
that byproduct was originally manufactured and (2) when the site is
reporting under CDR the byproduct substance or a different chemical
substance that was manufactured from the byproduct or manufactured in
the same overall manufacturing process.
Based on information provided by these two industries, these
byproduct substances are directly recycled in physically enclosed
systems in a site-limited manner (see definition of ``Site-limited'' at
40 CFR 711.3). For the purposes of CDR, EPA considers an enclosed
system to be a system of equipment directly connected to the production
process that is designed, constructed, and operated in a manner which
prevents emissions, or the release of any chemical substance into the
facility or environment during the production process. Such emissions,
including fugitive emissions, could lead to exposures to workers, the
public, or the environment. For an enclosed system, exposure and
release could only occur due to loss of integrity or failure of the
manufacturing process equipment or control systems.
To meet the EPA enclosed system scenario, any equipment that the
byproduct is present in at any point during the process sequence, such
as tanks, reaction vessels, reactors, processing units (e.g., a drum
filter), and/or connecting lines, must: (1) Be of high structural
integrity and contained on all sides, (2) pose no foreseeable potential
for escape of constituents to the facility or environment during normal
use, and (3) be connected directly by pipeline or similarly enclosed
device to a production process. Also, any transfers or holding steps
occurring in this system must be necessary to the recycle process and
must take place within physically enclosed equipment that meet the
aforementioned criteria. For example, hard piping or completely sealed
(i.e., welded) equipment would meet these criteria if connected
directly to other enclosed equipment, preventing potential releases
including fugitive emissions.
EPA recognizes that there may be some potential for exposures and
releases (e.g., through non-routine cleaning of equipment, or
maintenance operations) associated with such enclosed, site-limited
systems, but believes the potential exposures and releases related to
such systems are less than the potential exposures and releases
associated with recycling systems that are not enclosed. Likewise,
systems that transfer the byproduct to a different site for recycling
or other use are expected to have higher levels of potential exposures
and releases. For example, on-site recycling systems that rely on open
troughs for moving material have an increased opportunity for exposures
due to dusting or splashing as compared to the use of an enclosed pipe
for moving material from one part of the manufacturing process to
another.
Based on 2016 CDR data, the sites reporting under CDR within these
two industries have reported chemicals that are related to these
byproducts because they are subsequently manufactured from the
byproducts or from other substances via the same overall manufacturing
process. EPA therefore would collect exposure-related information about
the manufacturing site for these two industries.
This proposed exemption is only for the volumes of the byproduct
substance, listed at 40 CFR 711.10(c)(2)(i) (as proposed), that are
recycled in a site-limited manner in physically enclosed systems of the
same overall manufacturing process. Volumes that are used for a
commercial purpose distinct from their manufacture as a byproduct
remain reportable. Also, volumes that are removed from the enclosed
systems, such as those that are stored in an open tank or pit, or
stored in any non-connected tank or vessel, are excluded from this
exemption and remain reportable.
Portland cement industry--Cement kiln dust. The Portland Cement
Association (PCA) suggested that EPA should eliminate reporting
requirements for cement kiln dust (CKD) that is temporarily stored
before reintroduction into the Portland cement manufacturing process
(Refs. 25 and 26). PCA suggested that their manufacture and recycling
of cement kiln dust is similar to non-isolated intermediates, which are
currently exempted from the need to report under CDR by 40 CFR
711.10(c)(4)(viii). However, EPA's existing policy with respect to non-
isolated intermediates excludes storage in tanks or other vessels
(e.g., shipping containers) even if the vessels are part of an enclosed
system.
There are circumstances where the cement kiln dust is stored for a
period of time in a tank that is connected in an enclosed system with
the other operating equipment. Because the cement kiln dust is stored,
it cannot meet the requirements of the non-isolated intermediate
exemption and therefore would need to be considered for reporting under
CDR (Refs. 25 and 26).
EPA agrees that, based on the information provided by PCA, relevant
portions of CKD processing meet the definition of enclosed as described
for this proposed exemption; however it does not meet the non-isolated
intermediate exemption. In addition, the recycling operation uses the
CKD to manufacture clinker (which consists of Portland cement), which
is reported under CDR by its component substances and therefore would
supply the Agency with exposure information from a similar production
process. Based on
[[Page 17709]]
CDR data submitted for the most recent principal reporting year (2015),
EPA estimates that approximately 23 million lbs of CKD might meet the
criteria established in this exemption. This is the amount of CKD that
was reported as recycled and used on-site (out of the approximately 1.1
billion lbs total manufactured domestically in 2015).
Kraft pulping cycle--black liquor and calcium carbonate. The
American Forest & Paper Association (AF&PA) provided EPA with extensive
information about the Kraft pulping cycle and chemicals manufactured as
part of that cycle. Most recently, AF&PA and other industry
representatives communicated with EPA by petitioning for full exemption
from CDR for four manufactured Kraft pulping cycle chemicals, by
submitting comments in response to Federal Register notices related to
the negotiated rulemaking, and by meeting with EPA to view and discuss
a video providing an in-depth explanation of the Kraft pulping cycle
(Refs. 27, 28, 29, and 30).
AF&PA identified that the Kraft pulping cycle begins with the
production of black liquor as a byproduct of pulping in the production
of paper, and the black liquor is subsequently used to manufacture
green liquor. Calcium oxide and green liquor are used to manufacture
white liquor, which results in the production of calcium carbonate as a
byproduct. The calcium carbonate is recycled to produce calcium oxide.
From the information provided, EPA believes that both black liquor and
calcium carbonate are byproducts that are recycled in site-limited,
enclosed systems. Based on CDR data submitted for the most recent
principal reporting year (2015), EPA estimates that approximately 382
billion lbs of black liquor and calcium carbonate together might meet
the criteria established in this exemption. This is the amount of black
liquor and calcium carbonate that was reported as recycled and used on-
site (out of the approximately 386 billion lbs total manufactured
domestically in 2015). The other substances in the cycle are
intentionally manufactured substances and would therefore continue to
be reportable under CDR. Because the sites would be reporting these
other substances, their production of black liquor and calcium
carbonate would meet the requirements for this proposed exemption.
Changes to the list of exempted processes and related byproduct
substances. EPA is proposing a petition process for the public to
request changes to the list of exempted manufacturing processes and
related byproduct substances. The initial exempted substances were
selected based on information provided directly to EPA as part of the
negotiated rulemaking-related activities and through other
communications with these industries, as described elsewhere in this
unit. Because there may be other manufacturing processes and related
byproduct substances that meet the criteria for this exemption (as
identified at the beginning of this unit) or EPA's interest in these
byproduct substances may change, EPA may amend the list of byproduct
substances and processes that have been proposed as part of this
exemption. The Agency may do this on its own initiative or in response
to a request from the public, based on EPA's determination of whether
the manufacturing process and related byproduct substance described
meet the criteria explained in this unit.
Any person would be able to request that EPA amend the
manufacturing process and related byproduct substance exempted list.
EPA is proposing to model the procedure to request amendments after the
one described in 40 CFR 711.6(b)(2)(iii) to amend the list of partially
exempted chemical substances for which the processing and use
information is of low current interest. The proposed procedure would
require a written request that identifies the process and byproduct
chemical substance in question, including a written rationale for the
request that provides sufficient specific information, including cites
and relevant documents, to demonstrate to EPA that the byproduct
substance(s) and manufacturing process(es) in question either would or
would not meet the criteria for this exemption.
EPA is proposing to consider the following factors when evaluating
a request to amend the list of exempted manufacturing processes and
related byproduct substances: (1) Whether the byproduct substance is
recycled or otherwise used to manufacture another chemical substance
within an enclosed system, within the same overall manufacturing
process, and on the same site as that byproduct was originally
manufactured; (2) whether the site is reporting under CDR other
chemical substances, in particular a chemical substance other than the
byproduct substance that was manufactured from the byproduct or
manufactured in the same overall manufacturing process; (3) whether EPA
has a current interest in the byproduct substance; and (4) whether the
byproduct substance must have already been reported under CDR or would
be expected to be reported if not exempted by this exemption.
Regarding the second consideration, EPA expects to be able to
ascertain typical exposure scenarios for the process based on
information for other substances that are reported at the facility in
the same or similar manufacturing process. If no other substances are
reported, EPA would not have any exposure-related information about the
manufacturing site.
Regarding the third consideration, EPA may have a current interest
in a byproduct substance that is the subject of a rule proposed or
promulgated under TSCA sections 4, 5(a)(2), 5(b)(4), or 6, or is the
subject of an ECA developed under the procedures of 40 CFR part 790, or
is the subject of an order issued under TSCA sections 4, 5(e) or 5(f),
or is the subject of relief that has been granted under a civil action
under TSCA section 5 or 7. As noted earlier, lists of subject chemicals
can be identified using the eCDRweb reporting tool or separately in
EPA's Substance Registry Services (SRS). Instructions for determining
subject chemicals are provided on the CDR website and in CDR guidance.
EPA may also have a current interest in a byproduct substance that is
undergoing risk evaluation, is being considered for prioritization, or
that has particular uses or attributes that are of interest. This list
is not exhaustive. For example, EPA may have a current interest for
other reasons, including activities under other statutes, such as the
Resource Conservation and Recovery Act (RCRA).
If a request related to a particular byproduct substance and
process is resubmitted, any subsequent request would need to clearly
identify new information contained in the request. EPA may request
other information that it believes necessary to evaluate the request.
EPA would issue a written response to each request within 120 days of
receipt of the request. As needed, the Agency would initiate rulemaking
to revise the list of exempted byproduct substances. To assist EPA in
reaching a decision regarding a particular request prior to a given
principal reporting year, requests would be required to be submitted to
EPA no later than 12 months prior to the start of the next principal
reporting year. EPA is interested in comments that may improve the
proposed process for requesting amendments to the manufacturing process
and related byproduct substance exempted list.
3. Byproducts generated by specified non-integral processes. EPA is
also proposing to exempt byproducts manufactured in certain equipment
via processes that are not integral to the production process. An
integral process
[[Page 17710]]
is the portion of the manufacturing process that is chemically
necessary or provides primary operational support for the production of
the intended product. For the purposes of this exemption, certain
associated processes that are not chemically required to produce the
intended product would be considered non-integral. These may be
required due, for example, to other regulations or the need to generate
heat or electricity on-site, but not specifically necessary for the
manufacture of the intended product. In this proposal, byproducts
manufactured due to the use of pollution control equipment and boilers
that generate heat or electricity on-site, when such equipment is not
part of the main production process, would be exempted from reporting
under CDR.
The site must continue to report chemical substances that are
subsequently manufactured from these byproducts. The production of
byproducts in equipment that is integral to the production processes
remain subject to reporting as well, unless otherwise exempted. For
example, utilities that produce electricity as a product may be using
boilers as part of their production of electricity, and therefore those
boilers are considered equipment integral to the production process.
Thus, byproducts produced by these electric utility boilers would
continue to be subject to reporting. Another example, reverberatory
furnaces, which may function similarly to some boilers, can have a
chemical processing function such as smelting. This and similar
equipment, when used in such scenarios, would be considered integral to
the main production process and any resultant manufactured byproduct
substances would continue to be subject to reporting.
Examples of non-integral pollution control equipment include flue
gas desulfurization and selective catalytic reduction systems. Under
this proposed exemption, if a byproduct substance produced from this
equipment is recycled for a non-exempted commercial purpose, the
byproduct would be exempted from reporting under CDR. However, any
chemical substance manufactured from the otherwise exempted byproduct
would be subject to reporting unless otherwise exempted or the
manufactured volumes are below the reporting threshold. EPA is
interested in receiving comments on other examples of non-integral
pollution control equipment, including descriptions of potential
byproducts that could be produced in such equipment.
In reviewing how the CDR information is used, EPA believes the
information about byproducts produced from the identified non-integral
equipment is generally less critical to be obtained via CDR than
information about byproducts produced from integral equipment for risk
evaluations conducted under TSCA. Release from pollution control
equipment can often be obtained through national inventories such as
TRI. Among other tools, EPA uses generic scenarios, including OECD-
approved Emission Scenario Documents, to develop environmental release
assessments. The generic scenarios can be used in combination with
information from CDR to develop estimates of facility releases. These
Emission Scenario Documents do not include emissions from non-integral
equipment; thus, CDR data from such equipment are generally not needed
to support these environmental release assessments. EPA is interested
in comments that may improve the approach proposed for this exemption.
E. General Regulatory Text Updates
EPA is also proposing to make other general updates to the
regulatory text in 40 CFR part 711 that have been identified subsequent
to the CDR rule's original promulgation in 2011. The general updates to
the regulatory text include removing outdated text, consolidating
byproduct-related exemption text, and simplifying and clarifying
language throughout the regulatory text.
1. Removing outdated regulatory text. EPA is proposing to remove
regulatory text specific to the 2012 CDR submission period. This text
is no longer relevant because the submission period was completed more
than five years ago and all phased-in reporting requirements from the
change from the IUR to CDR have been fully in effect since the 2016
reporting cycle.
2. Consolidating byproduct exemption regulatory text. EPA is
proposing to consolidate regulations regarding byproduct exemptions
that affect reporting under the CDR rule into 40 CFR 711.10, such that
all the CDR reporting exemptions regarding manufacturer activities are
in one place. EPA expects such consolidation would make it easier for
manufacturers to determine whether all or only some of their
manufacturing activities are required to be reported under CDR, or
whether all or some of their manufacturing activities are exempted from
the need to be reported. Specifically, EPA is proposing that new
exemptions proposed in this notice and language from 40 CFR 720.30(g)
and (h) that is currently incorporated by reference would be replicated
in 40 CFR 711.10(c). EPA intends to continue to interpret the
replicated language in the same way as it has been interpreted under
CDR, which for the most part aligns with how it has been interpreted
under the TSCA section 5 Pre-Manufacture Notice (PMN) program. However,
there are differences between the two programs that may result in
different applications of the exemptions covered by this replicated
regulatory text, and listing all exemptions in the CDR regulations
instead of cross-referencing to the PMN regulations would allow for
flexibility in the future as EPA continues to further analyze the CDR
reporting exemptions.
3. Simplifying and clarifying regulatory text. EPA is proposing to
change or add regulatory text to simplify or clarify regulatory
requirements throughout 40 CFR part 711. These proposed changes are in
addition to changes necessary for proposals discussed elsewhere in this
notice, and include revisions to:
40 CFR 711.1(a) to remove the discussion about compiling
and keeping current the TSCA Inventory, including the discussion about
adding new chemicals to the Inventory. This discussion is unnecessary
for an understanding of the scope of the CDR rule.
40 CFR 711.1(c) to include a statement about TSCA section
11 subpoena authority, as a reminder that EPA has this authority for
compliance purposes.
40 CFR 711.3 definitions for e-CDRweb, Manufacture, and
Site for clarification purposes.
40 CFR 711.6(a)(4) to reverse the order of ``certain forms
of natural gas'' and ``water'' for clarification purposes.
40 CFR 711.10 to remove duplicative wording and add
clarity to the requirements.
40 CFR 711.15(a) to add clarity to the reporting
requirements.
40 CFR 711.35(c)(1) to update references.
IV. Detailed Discussion of the Proposed Modifications to Small
Manufacturer Definition and Size Standards
EPA is proposing modifications to the TSCA section 8(a) small
manufacturer size standards, as required, following EPA's determination
on November 30, 2017 that revision to the current size standards is
warranted (82 FR 56824). The proposed standards would apply to small
manufacturers for TSCA section 8(a) rules, including CDR, unless a
different standard is identified in the regulatory text of a particular
rule. EPA
[[Page 17711]]
is also proposing a TSCA section 8(a) definition for small government
entities.
Initially, when TSCA was implemented in the 1970's, EPA took a
case-by-case approach to the definition of small manufacturers and
processors and established individual size standards for each TSCA
section 8(a) rule. EPA then developed a general 8(a) small manufacturer
definition and size standards. These standards, finalized in the
Federal Register of November 16, 1984 (49 FR 45425), have not been
changed, although variations have been used for selected chemical-
specific rules. See Unit II.C. of this action for additional
information, including a description of the current standard.
A. Scope and Content of the Proposed Small Manufacturer Definition
Update
For the TSCA section 8(a) small manufacturer definition update, EPA
is proposing to update the current definition based on inflation. EPA
is interested in public consideration of this approach and is
soliciting comments regarding the extent to which this approach would
reduce the reporting burden for those small manufacturers with fewer
available resources, while ensuring Agency information needs are still
met.
The proposed modification to the TSCA section 8(a) small
manufacturer size standards are based on a number of factors,
including: (1) Information gathered during meetings with the Small
Business Administration, including the Office of Advocacy, regarding
its definition of small business (Ref. 31); (2) preliminary comments
and suggestions from representatives of the chemical industry,
nongovernmental organizations, and state, local, and tribal governments
submitted when EPA published its final determination that a revision to
the standards is warranted (82 FR 56824, November 30, 2017); (3) review
of various alternative exemption criteria; and (4) comments received on
EPA's User Fees for the Administration of the Toxic Substances Control
Act proposed rule (TSCA Fees Rule) (83 FR 8212, February 26, 2018).
Documentation of these meetings, comments, and the analysis can be
found in the dockets for the determination (EPA-HQ-OPPT-2016-0675), the
proposed TSCA Fees Rule (EPA-HQ-OPPT-2016-0401), and this proposal
(EPA-HQ-OPPT-2018-0321).
The proposed definition would be applicable to chemical
manufacturers (including importers), but not to chemical processors.
Because the scope of EPA's analysis of the proposed definition is
focused on impacts to the CDR, in which reporting is required by
manufacturers and not processors, EPA believes it is best to continue
the past practice to develop definitions, as applicable, for small
processors on a rule-by-rule basis. In addition, EPA has reviewed the
existing TSCA section 8(a) rules that contain definitions for small
processors. Because EPA has not received any reports under those rules
for at least ten years, EPA believes that applying this proposed
definition to processors would have no impact (Ref. 32). EPA welcomes
comment on whether the proposed definition should be expanded to
include processors.
All data in this preamble represent impacts to the manufacturing
portion of the chemical industry, as evaluated for the CDR. The
proposed definition is as follows:
Proposed small manufacturer definition: EPA is proposing to base
the update of the current two-standard definition at 40 CFR 704.3 on
inflation by adjusting the sales standard level for the first part from
$40 million to $110 million and for the second part from $4 million to
$11 million. Under this proposal, EPA would use the same definition for
all manufacturers, except for small governments as discussed in this
unit. The impacts of this option are provided in Unit I.E.2. The
definition under this proposal would read:
(1) First standard. A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any), are less than $110 million. However, if
the annual production or importation volume of a particular substance
at any individual site owned or controlled by the manufacturer or
importer is greater than 45,400 kilograms (100,000 pounds), the
manufacturer (including importer) will not qualify as small for
purposes of reporting on the production or importation of that
substance at that site, unless the manufacturer (including importer)
qualifies as small under standard (2) of this definition.
(2) Second standard. A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any), are less than $11 million, regardless
of the quantity of substances produced or imported by that manufacturer
(including importer).
Under CDR, sites that meet the small manufacturer requirements are
exempted from the need to report either for the full site (based on the
second standard) or for particular chemical substances (based on the
first standard), unless the chemical substance the site is
manufacturing (including importing) is the subject of one of certain
TSCA actions: A rule proposed or promulgated under TSCA sections 4,
5(b)(4), or 6, or is the subject of an order in effect under TSCA
section 5(e), or is the subject of relief that has been granted under a
civil action under TSCA sections 5 or 7. As part of this proposal, EPA
is proposing to add TSCA section 4 orders to the list of certain TSCA
actions. The authority to issue section 4 orders was added to TSCA when
the statute was amended in 2016.
The current small manufacturer definition at 40 CFR 704.3 includes
an inflation index to provide direction for determining the need to
update the two standards comprising the definition (see Unit II.C.).
For future inflation adjustments, EPA is proposing to use the Gross
Domestic Product (GDP) deflator, or implicit price deflator, instead of
the Produce Price Index (PPI) for Chemical and Allied Products when
determining the need to adjust the total annual sales values. EPA is
making this proposal because the types of small manufacturers subject
to TSCA section 8(a) reporting requirements are broader than those
defined by the PPI for Chemicals and Allied Products, which covers only
Chemicals and Allied Products. The GDP deflator is less volatile and is
broader than the PPI for Chemicals and Allied Products, and therefore
EPA believes it is a better measure for considering an update to the
revenue size standards in the proposed definition.
EPA estimates that the proposed definition would eliminate
reporting entirely for 93 industry sites and would reduce reporting by
eliminating the need to report at least one chemical for an additional
129 industry sites (Ref. 5). Overall, 888 chemical reports from
industry sites would no longer be submitted to CDR. In sum, the use of
the inflation adjustment definition results in a reduction of 2 percent
of sites, an overall reduction of 2 percent of chemical reports, and a
reduction of 0.07 percent of total volume reported (Ref. 5).
Proposed small governments definition. In addition to the proposed
update to the definition for small manufacturers, EPA is proposing a
definition for small governments. Currently, there is no small
government definition in TSCA section 8(a). During the 2016 CDR
reporting period, EPA became aware that the governments were reporting
under CDR. Examples of governments considered to be manufacturers
include a publicly owned water treatment facility that manufactures
ozone onsite for water treatment, or a municipal landfill that
[[Page 17712]]
captures methane gas to be sold. EPA is proposing a small government
definition to reduce the reporting burden for governments that may lack
necessary resources. EPA proposes to use the same definition for small
governments as the Regulatory Flexibility Act (5 U.S.C. 601(5)): A
small governmental jurisdiction is the government of a city, county,
town, township, village, school district, or special district with a
population of less than 50,000. States and tribal governments are not
considered small governments. EPA is interested in comment on whether
this definition should be changed for TSCA section 8(a) purposes to
also include Tribal governments.
EPA estimates 33 government sites report under CDR in a four-year
cycle. Under the proposed definition of small governments, reporting
would be eliminated entirely for four government sites with an
associated six chemical reports.
Application of standards. The size standards in this proposed rule
would apply to all manufacturers of chemical substances subject to TSCA
section 8(a) reporting and recordkeeping rules, unless the Agency
specifically provides otherwise in a particular TSCA section 8(a) rule.
Rules with different definitions than the current small manufacturer
definition at 40 CFR 704.3 are: the nanoscale rule at 40 CFR 704.20;
certain chemical-specific rules at 40 CFR 704.43 (Chlorinated
Naphthalenes) and 40 CFR 704.102 (Hexachloronorbornadiene); and the
Preliminary Assessment Information Rule (PAIR) at 40 CFR 712. Because
of an inadvertent error there is currently no applicable definition of
``small manufacturer'' in 40 CFR 704.104 (Hexafluoropropylene oxide);
EPA is proposing a correction, as discussed later in this unit.
Nanoscale materials. On January 12, 2017, EPA finalized the TSCA
section 8(a) reporting and recordkeeping rule for nanoscale materials,
which specified a separate small manufacturer definition (82 FR 3641).
The nanoscale materials rule at 40 CFR 704.20 specifies the following
definition: Small manufacturer or processor means any manufacturer or
processor whose total annual sales, when combined with those of its
parent company (if any), are less than $11 million. In November 2017,
when EPA determined that the general TSCA section 8(a) small
manufacturer definition at 40 CFR 704.3 warranted revision, EPA did not
make a determination as to whether the definition in the nanoscale
materials rule warranted revision. After further evaluation and
consideration, EPA has determined that the size standard in the
nanoscale materials rule definition does not warrant revision.
In the process of making this determination, EPA evaluated the
effect of adjusting the small manufacturer size standard for nanoscale
materials for inflation and found that it would cause no measurable
impact on the number of reports received. Furthermore, since the first
reports for nanoscale materials, which would make up a large portion of
reported information, are due within one year after the final effective
date of the rule and before any newly proposed small manufacturer
definition would take effect, EPA does not want to complicate the
process or potentially confuse regulated entities who are in the
process of compiling the required information.
Certain chemical-specific TSCA section 8(a) rules. In addition to
the nanoscale rule, there are eight chemical-specific rules listed in
40 CFR 704 subpart B. Five of those rules refer to the current TSCA
section 8(a) small manufacturer definition listed in 40 CFR 704.3 and
therefore would be impacted by the proposed approach for updating the
standards. These impacted five rules are: Sec. Sec. 704.25 (11-
Aminoundecanoic acid); 704.33 (P-tert-butylbenzoic acid (P-TBBA), p-
tert-butyltoluene (P-TBT) and p-tert-butylbenzaldehyde (P-TBB)); 704.45
(Chlorinated terphenyl); 704.95 (Phosphonic acid, [1,2-ethanediyl-
bis[nitrilobis-(methylene)]]tetrakis- (EDTMPA) and its salts); and
704.175 (4,4'-methylenebis(2-chloroaniline) (MBOCA)). One of the
chemical-specific rules in 40 CFR 704 subpart B, 40 CFR 704.104
(Hexafluoropropylene oxide), only includes a rule-specific small
processor definition and not a small manufacturer definition. Upon
review, EPA finds this to be an inadvertent error. As originally
promulgated, 40 CFR 704.104 included the small manufacturer standard
via the cross reference in 40 CFR 704.104(c)(2) to the exemption
provisions in 40 CFR 704.5 which was lost when the exemptions at 40 CFR
704.5 were amended and the necessary corresponding change was not made
at 40 CFR 704.104(c)(2) (52 FR 41297, October 27, 1987 and 53 FR 51717,
Dec. 22, 1988). As such, EPA is including in this proposal a technical
correction to address this error.
Two of the chemical-specific rules, namely 40 CFR 704.43
(Chlorinated Napthalenes) and 40 CFR 704.102 (Hexachloronorbornadiene)
have their own rule-specific small manufacturer definitions. EPA is not
proposing to change the definitions for these two rules because it has
been over ten years since EPA has received any reports under these
rules. EPA therefore believes a change to the small manufacturer
definitions for these rules would have no impact. However, EPA is
interested in comment on whether the small manufacturer definitions for
these two rules should be changed.
PAIR rule. EPA is proposing to update the current small
manufacturer definition in the PAIR rule at 40 CFR 712.25. EPA
promulgated the TSCA section 8(a) PAIR rule in June 1982, to collect
information to identify, assess and manage human health and
environmental risks from chemical substances, mixtures, and categories
listed on the rule. The 1982 PAIR small manufacturer definition
predates the current 40 CFR 704.3 small manufacturer definition and has
not been updated. It states: A manufacturer is qualified as small if
both of the following criteria are met: (1) Total annual sales taken
together of all sites owned or controlled by the foreign or domestic
parent company were below $30 million for the reporting period; [and]
(2) Total production of the listed substance for the reporting period
was below 45,400 kilograms (100,000 pounds) at the plant site. EPA is
proposing to use the small manufacturer definition in 704.3 for the
PAIR rule.
B. Agency Objectives
Industry compliance with TSCA reporting and recordkeeping
requirements involves the expenditure of time, money, and personnel
resources. These costs have particular impact on companies that have
limited financial and personnel resources, such as smaller firms. Such
manufacturers tend to have fewer administrative personnel and less
capability for data compilation and recordkeeping than larger firms.
However, while recognizing the burdens on smaller firms, EPA is
required to make risk management decisions based on reasonably
available information, such as that collected through CDR. The
information collection authority of TSCA section 8(a) reflects
congressional recognition of EPA's need for sufficient data from the
chemical industry. EPA has concluded that if a firm produces a subject
chemical in substantial quantities, it is inappropriate to exempt that
company from TSCA section 8(a) reporting requirements. Production data
is valuable to EPA as an indicator of chemical exposure and high volume
chemical production reflects a greater potential for environmental
release. For this reason, EPA is maintaining the annual production or
importation
[[Page 17713]]
volume modifier of 100,000 pounds for the first part of the proposed
updated small manufacturer definition.
EPA also has the authority to develop new size standards separate
from the general 8(a) small manufacturer definition in this proposed
rule. Such development would be done in appropriate cases when the
Agency finds that the general TSCA section 8(a) small manufacturer
definition is not suitable for a new specific TSCA section 8(a) rule.
However, when changing the definition for a specific rule, EPA must
follow full notice and comment rulemaking procedures with regard to the
amended definition and size standards.
EPA has an additional objective for the general TSCA section 8(a)
small manufacturer definition and size standards. The standards should
not prevent TSCA section 8(a) rules from providing information that is
representative of firms of different sizes. Large and small firms have
varying amounts of capital available, and therefore may utilize
different production processes, techniques, and equipment. Different
methods of production may cause the potential for chemical exposure to
vary among large and small firms. It is important for the Agency to be
able to monitor these differences. To ensure that EPA would receive
information from a representative portion of manufacturers regulated
under TSCA section 8(a), the structure of the definitions and levels of
the size standards have been designed to allow the Agency to obtain
production, use, and exposure data from a variety of firms.
A final objective for the standards is that they be easily analyzed
and applied by both industry and the Agency. EPA is proposing exemption
criteria that represent readily available data. These data enable
identification of companies which would be likely to qualify for a
small manufacturer exemption. The standards could also be easily
enforced because the selected criteria would enable EPA to monitor
compliance with the exemption.
C. Agency Approach and Methodology
In developing the size standards proposed in this rule, EPA
examined the utility of several possible criteria for ``small'' as
possible measures of chemical exposure potential and the resources
available to manufacturers.
EPA looked at criteria for ``small'' used by other agencies,
reviewed other ``small'' manufacturer definitions used by EPA, and
reexamined criteria used for past rules under TSCA section 8(a), with
specific focus on the recently finalized TSCA section 8(a) nanoscale
materials rule (82 FR 3641, January 12, 2017). EPA considered the
possible utility of parameters that have not been used previously, such
as market share and net profit. EPA also relied on the input of
industry representatives documented in the docket for the final
determination that a revision to the standards is warranted and from
SBA in meetings with EPA staff (82 FR 56824/EPA-HQ-OPPT-2016-0675-0022
and Ref. 31).
No parameter or set of parameters can meet EPA objectives and
requirements perfectly. The various types of parameters considered, and
their possible levels, are only approximations of company resources or
EPA's information needs. EPA reviewed industry comments from the
determination, as well as considerations factored into the development
and evaluation of the original definitions, in selecting standards
which best meet the Agency's requirements. EPA also took into
consideration the comments on the TSCA Fees Rule (83 FR 8212, February
26, 2018), regarding the definition of small manufacturer. The
following unit describes EPA's evaluation of possible alternative
definitions.
D. Evaluation of Alternative Criteria for Small Manufacturer
Definitions and Analysis of Selected Options
In the definitions used in the past by other Federal agencies, as
well as at EPA under TSCA, there is no single definition of a ``small''
business. The definitions and size standards differ according to
context and purpose. Identified broad categories include (1) benefits
distribution, (2) data analysis and reporting, and (3) regulation and
information collection (where flexibility is sought in balance with
program objectives) (Ref. 5).
When establishing its size standards, SBA examines various industry
characteristics such as average firm size, degree of competition within
an industry, start-up costs and entry barriers, and distribution of
firms by size. SBA also evaluates federal market factors including a
small business's share in total industry's receipts. For more details,
please see the ``SBA's Standards Methodology'' white paper, available
at www.sba.gov/size. The SBA size standards are industry-specific
mostly based on either average annual revenue or number of employees,
for reference please see the SBA size standards at 13 CFR 121.202. In
order for an entity to be classified as a small business for federal
contracting and other small business programs, its enterprise level
revenue or number of employees (including all affiliates) shall not
exceed the size standard for the applicable industry. These size
thresholds are determined at the 6-digit North American Industry
Classification System (NAICS) levels. SBA's employee-based size
thresholds range from 100 to 1,500 employees to account for differences
among NAICS codes.
The size standards are intended to reflect the degree of
competition within individual industries. SBA size standards vary by
industry type to reflect the unique competitive characteristics of
different industries. In some cases, SBA uses a revenue standard, or
defines a business size in terms of assets. In other cases, the size
standard is based on the number of employees. Within the chemical
industry, the values assigned to the employment standards vary
considerably among different industry groupings, which are represented
using NAICS codes (Ref. 5).
For purposes of data analysis and reporting, Bureau of the Census
(Census) uses a size standard of employee number at 500 to separate
small businesses into their own subgroup for data reporting. Similarly,
the U.S. Department of Agriculture's (USDA) Economic Research Service
(ERS) identifies small farms at less than $350,000 farm income for
reporting and research purposes. The purpose of these small business
definitions is to identify companies whose paperwork burden can be
lessened without substantial impact on the agencies' information bases
(Ref. 5). Similarly, but to a much greater extent, small business
definitions developed in regulatory contexts involve detailed program-
specific balancing considerations. For example, the Occupational Safety
and Health Administration (OSHA) defines a small business as having 10
employees or fewer for their Fire Protection in Shipyards regulations
(Ref. 5).
Not unlike other federal agencies with similar purposes, EPA has
separate definitions for ``small'' manufacturers, producers,
processors, waste generators, and facilities under different statutes
or regulations, including the National Primary Drinking Water
Regulations, National Pollutant Discharge Elimination System Permit
Regulations, RCRA laws, and the TRI. Each definition was created to
meet individual programmatic needs or statutory requirements; it is
therefore difficult to draw comparisons across the different
definitions. For more information on the different ``small'' entity
definitions used by other federal agencies and EPA, see Tables B-2 and
B-3 in the Economic Analysis (Ref. 5).
[[Page 17714]]
When EPA first established the general TSCA section 8(a) small
manufacturer definition at 40 CFR 704.3 (49 FR 45425, November 16,
1984), EPA considered a number of possible parameters for the size
standards, including: (1) Total annual company profit, (2) total
company assets, (3) total annual company sales, (4) annual chemical
sales, (5) number of company employees, (6) annual production volume
per chemical, and (7) market share. When EPA reevaluated the size
standards (82 FR 56824, November 30, 2017), the Agency considered the
initial parameters again and additionally considered (8) barriers to
entry, (9) start-up or expansion costs, (10) average firm size as a
factor of employment and sales, (11) industry competition and
concentration, (12) growth trends, and (13) technological changes,
which were suggested by SBA's Office of Advocacy during the comment
period and SBA consultation as part of EPA's determination process for
reviewing whether revision to the current size standards for small
manufacturers and processors was warranted (82 FR 56824, November 30,
2017).
To consider these parameters for this proposed rule, EPA explored
SBA's approach to defining small businesses: A manufacturer (including
importer) is defined as small in accordance with the size standards
identified by NAICS codes at 13 CFR 121.201. EPA considered adopting an
SBA-based size-standard in combination with various production volume
modifiers such as 25,000; 50,000; and 100,000 pounds. For example, if
the annual production or importation volume of a particular substance
at any individual site owned or controlled by the manufacturer
(including importer) is greater than 50,000 pounds, the manufacturer
(including importer) would not qualify as small for purposes of
reporting on the production or importation of that substance at that
site.
EPA examined the impact of the various SBA-related definitions and
the inflation adjusted definition on the number of reports, including
by subcategories of particular interest to EPA such as TSCA Work Plan
chemicals and by overall production volume. Details are in Table 2-1 of
the Economic Analysis (Ref. 5). Any of the revised small manufacturing
definitions considered resulted in fewer retained reports. Some of the
definitions resulted in the addition of reports that are currently
exempted. Details are in Tables 5-15 and 5-16 of the Economic Analysis
(Ref. 5).
Comparing the options by the amount of overall production volume
reported provides another insight into the impacts. Under the SBA-based
size standards with production volume modifiers of 50,000 and 100,000
pounds, 38 million and 96 million pounds would be exempted,
respectively. In comparison, under the inflation adjusted option, 13.7
billion pounds would be exempted. When compared to the baseline
production volume, these would result in the retention of reporting on
99.93 percent (inflation adjusted), 99.9998 percent (SBA-based size-
standard with a production-volume modifier of 50,000 pounds) and
99.9995 percent (SBA- based size-standard with a production-volume
modifier of 100,000 pounds). In addition, under the inflation adjusted
option the average report exempted 15.5 million pounds, whereas under
the SBA-based size standards with production volume modifiers of 50,000
and 100,000 pounds, the average report exempted 23,000 pounds and
37,000 pounds, respectively. More details are in Tables 5-15 and 5-16
of the Economic Analysis (Ref. 5).
After analyses, the agency determined that adopting SBA's
definition with the various production volume modifiers would likely
result in loss of information for TSCA implementation, such as
information on TSCA Work Plan chemicals. Given the impacts on losses to
the CDR information necessary for the TSCA program coupled with the
inherently higher complexity of an SBA-based definition (system
involving a mix of revenue and employment bases with levels of size
standards varying according to NAICS), EPA chose to propose the
inflation adjustment option. EPA is, however, interested in comments on
adopting the SBA standard (or an SBA-like standard) for small
manufacturers, with an alternative production volume modifier, instead
of the proposed definition. Details of SBA's standard can be found at
13 CFR 121.201 and on their website (Ref. 33). Details of EPA's
analysis, options considered, and conclusions are summarized in detail
in the Economic Analysis (Ref. 5).
Proposed definition: EPA adjusted the current size standards at 40
CFR 704.3 to account for inflation, resulting in an increase of the
total annual sales from $40 million to $110 million for the first
standard while maintaining the requirement that annual production or
importation volume not exceed 100,000 pounds, and resulting in an
increase of the total annual sales from $4 million to $11 million for
the second standard. This proposed definition would reduce the amount
of information reported under CDR, resulting in a decrease of 2 percent
of chemical reports submitted, 2 percent of sites reporting, and 1.4
percent of total chemicals reported from the baseline conditions of the
current definition. The baseline conditions are described in the
Economic Analysis (Ref. 5). In future cycles, this proposed definition
would reduce overall reporting burden by an estimated -64,295 hours and
result in a $4,988,270 cost savings over a four-year CDR reporting
cycle (Ref. 5). See also Unit I.E.2.
EPA's full analysis of the costs, cost savings, and benefits of
this proposed definition is presented in detail in the Economic
Analysis (Ref. 5). EPA welcomes comments on this proposal and on the
other options and size standards EPA considered for evaluating the
revised definition. In particular, EPA is seeking comments on an
alternative definition for a small manufacturer (e.g., an employment-
based size standard varied by industry or a combination of employment-
based and revenue-based varied by industry, such as the SBA standard
with a 50,000 pound production volume modifier described previously in
this unit of the preamble) which meets EPA's goal to minimize loss of
chemicals and site reporting while maximizing reporting burden
reductions for small businesses. A description on the SBA definition
and a listing of other Federal government definitions for small
business, including the employment-based definition used for the final
TSCA Fees Rule (83 FR 52694, October 17, 2018), is provided in Appendix
B of the Economic Analysis (Ref. 5).
V. Request for Comment
EPA requests comment on all changes and other topics described in
this proposed rule, and the Economic Analyses prepared in support of
this proposed rule (Refs. 4 and 5). EPA encourages all interested
persons to submit comments on the issues identified in this Notice and
to identify any other relevant issues as well. This input will assist
the Agency in developing final rules that successfully addresses
information needs while minimizing potential reporting burdens
associated with the rule. EPA requests that commenters making specific
recommendations include supporting documentation where appropriate.
EPA is also interested in receiving comment on whether reporting
production volumes in ranges instead of to two significant figures
would reduce burden for submitters while continuing to provide the
information needed by EPA for implementation of TSCA. The current
requirement to report to two
[[Page 17715]]
significant figures is, in essence, the reporting of a midpoint of a
range. For example, if reporting 120,000 pounds, the actual production
volume would be between 115,000 and 124,999 pounds. If reporting in
ranges would reduce burden, should the ranges apply to a subset of
reporters (such as inorganic chemicals or byproduct chemical
substances), for lower production volumes only, as is done in TRI,
(such as under 25,000 pounds), or to all? EPA is also interested in how
a reporter would determine the percentage production volume required
for physical form and processing and use information when reporting the
underlying production volume in ranges.
VI. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA (2017). Public Webinar to Obtain Feedback on Improving CDR;
Outreach meeting. Attended by the public, reporters to CDR, and EPA.
Washington, DC. May 1, 2017.
2. EPA (2017). CDR Outreach meeting with Earthjustice and Other
NGOs. Attended by Earthjustice, Safer Chemicals Healthy Families,
Environmental Health Strategy Center, and EPA. Washington, DC. July
17, 2017.
3. EPA (2017). CDR Outreach meeting with Environmental Defense Fund
(EDF). Attended by EDF and EPA. Washington, DC. July 19, 2017.
4. EPA (2018). Economic Analysis for the Proposed Rule on TSCA
Chemical Data Reporting (CDR) Revisions--(RIN 2070-AK33). Office of
Pollution, Prevention, and Toxics. Washington, DC. August 2018.
5. EPA (2018). Economic Analysis for the Proposed Rule on TSCA
Section 8(a) Small Manufacturer Definition Update (RIN 2070-AK33).
Office of Pollution, Prevention, and Toxics. Washington, DC. August
2018.
6. EPA (2017). Chemical Data Reporting (CDR): Importance of Data and
Need for Data on Inorganic Byproducts. August 3, 2017, EPA-HQ-OPPT-
2016-0597-0057.
7. EPA (2018). Problem Formulation of the Risk Evaluation for
Perchloroethylene (Ethene, 1,1,2,2-Tertrachloro). EPA-740-R1-7017.
Office of Pollution, Prevention, and Toxics. Washington, DC. May
2018.
8. Organisation for Economic Co-operation and Development.
``Internationally Harmonised Functional, Product and Article Use
Categories.'' 2017. http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2017)14&doclanguage=en.
Accessed May 18, 2018.
9. American Chemistry Council. Letter from Christina Franz to Cathy
Fehrenbacher, U.S. EPA, September 30, 2015.
10. EPA (2018). OPPT. Email from Nhan Nguyen, Risk Assessment
Division to Susan Sharkey, Existing Chemicals Branch (ECB), Chemical
Control Division (CCD), Subject: CDR Function data element for
consumer/commercial uses. Internal communication. Washington, DC.
August 1, 2018.
11. EPA (2019). OPPT. Technical Support Document: Harmonizing CDR
Functional and Product codes with OECD Functional, Product, and
Article Codes. March 2019.
12. EPA (2019). Instructions for Reporting--2020 TSCA Chemical Data
Reporting--Draft for Public Comment. Washington, DC. March 14, 2019.
13. EPA (2017). Examples: Reporting under CDR, TRI, and RCRA--
Chemical Data Reporting (CDR) Inorganic Byproducts Negotiated
Rulemaking; Presentation. EPA-HQ-OPPT-2016-0597-0030.
14. EPA (2017). Meeting Summary of Public Organizational Planning
Meeting for the Chemical Data Reporting (CDR) Inorganic Byproducts
Negotiated Rulemaking. EPA-HQ-OPPT-2016-0597-0036.
15. EPA (2016). TSCA Chemical Data Reporting Fact Sheet: Byproducts
Reporting for the Printed Circuit Board Industry. https://www.epa.gov/sites/production/files/2016-02/documents/final_cdr_fact_sheet_printed_circuit_board_2_22_16.pdf. Retrieved
August 2, 2016.
16. EPA (2016). TSCA Chemical Data Reporting Fact Sheet: Reporting
Manufactured Chemical Substances from Metal Mining and Related
Activities. https://www.epa.gov/sites/production/files/2016-05/documents/cdr_fact_sheet_metal_mining_5may2016.pdf. Retrieved August
2, 2016.
17. EPA (2016). TSCA Chemical Data Reporting Fact Sheet: Reporting
for Electricity Generating Sites. https://www.epa.gov/sites/production/files/2016-04/documents/cdr_fact_sheet_electric_generating_27apr2016.pdf. Retrieved August
2, 2016.
18. EPA (2018). CDR--Co-Manufacturing and Other Reporting Mechanics;
Internal meeting. Attended by representatives of American Chemistry
Council (ACC) and EPA. Washington, DC. February 12, 2018.
19. EPA (2014). TSCA Work Plan Chemical Risk Assessment--Antimony
Trioxide--CASRN: 1309-64-4. https://www.epa.gov/sites/production/files/2015-09/documents/ato_ra_8-28-14_final.pdf. Retrieved May 31,
2018.
20. EPA (2014). TSCA Work Plan Chemicals. http://www.epa.gov/sites/production/files/2014-02/documents/work_plan_chemicals_web_final.pdf. Retrieved January 30, 2018.
21. EPA (2018). TRI-Listed Chemicals. https://www.epa.gov/sites/production/files/2018-04/ry_2017_tri_chemical_list_4_24_2018.xlsx.
Retrieved July 5, 2018.
22. EPA (2019). CDR Metal Compound Category Reporting Description;
Supporting document. Office of Pollution, Prevention, and Toxics.
Washington, DC. March 2019.
23. EPA (2018). Toxic Chemical Release Inventory Reporting Forms and
Instructions. https://ofmpub.epa.gov/apex/guideme_ext/guideme_ext/guideme/file/ry_2017_rfi.pdf. Retrieved October 3, 2018.
24. EPA (2018). OPPT. First Ten Chemicals for Risk Evaluation,
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca#ten. Accessed August
3, 2018.
25. EPA (2017). Chemical Data Reporting; Requirements for Inorganic
Byproduct Chemical Substances; Notice of Intent to Negotiate;
Comment from PCA. EPA-HQ-OPPT-2016-0597-0019.
26. EPA (2017). Chemical Data Reporting; Requirements for Inorganic
Byproduct Chemical Substances; Notice of Public Meeting;
Cancellation and Public Input Opportunity; Comment from PCA. EPA-HQ-
OPPT-2016-0597-0085.
27. EPA (2006). Response Letter from Jim Willis (Director, Chemical
Control Division) to Dr. John L. Festa (Senior Scientist, AF&PA),
U.S. EPA, October 2006.
28. EPA (2017). Chemical Data Reporting; Requirements for Inorganic
Byproduct Chemical Substances; Notice of Intent to Negotiate;
Comment from AF&PA. EPA-HQ-OPPT-2016-0597-0018.
29. EPA (2017). CDR Outreach Meeting--Overview of CDR Reporting for
Pulping Chemicals; Internal meeting. Attended by representatives of
AF&PA and EPA. Washington, DC. March 30, 2017.
30. EPA (2017). CDR Outreach Meeting--Kraft Chemical Looping Process
Educational Video Presentation; Internal meeting. Attended by
representatives of AF&PA and EPA. Washington, DC. July 13, 2017.
31. EPA (2018). Four Meetings with SBA--updating the Small
Manufacturer Definition; Internal meetings. Attended by
representatives of SBA and EPA. Washington, DC. April 19, May 15,
and September 11, 2018.
32. EPA (2018). Email from Loraine Passe, Chief, Chemical
Information and Testing Branch, CCD to Tyler Lloyd, ECB, CCD,
Subject: Small Manufacturer Update and Small Processor Definition;
Internal communication. Washington, DC. July 16, 2018.
33. SBA. Table of Size Standards. https://www.sba.gov/document/support--table-size-standards. Retrieved March 12, 2019.
34. EPA (2019). Information Collection Request Proposed Addendum to
Chemical Data Reporting under the Toxic Substances Control Act (TSCA
section 8(a)) EPA ICR No. 1884.11; OMB Control Number 2070-0162.
March 2019.
[[Page 17716]]
VII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action is a significant regulatory action that was submitted
to the Office of Management and Budget for review under Executive Order
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011). Any changes made in response to OMB recommendations have been
documented in the docket for this action as required by section
6(a)(3)(E) of Executive Order 12866.
The EPA prepared two economic analyses of the potential costs, cost
savings, and benefits associated with this action. A copy of these
economic analyses, entitled Economic Analysis for the TSCA Chemical
Data Reporting Revisions Rule (Ref. 4) and Economic Analysis for
Proposed Rule on the TSCA Section 8(a) Small Manufacturer Definition
Update (Ref. 5), are available in the docket and is briefly summarized
in Unit I.E.
B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs
The CDR revisions and TSCA section 8(a) small manufacturer
definition update are part of an action that is expected overall to be
a deregulatory action under Executive Order 13771 (82 FR 9339, February
3, 2017).
C. Paperwork Reduction Act (PRA)
For CDR, the information collection requirements in 40 CFR part 711
related to the submission of Form U's are already approved by OMB under
the PRA, 44 U.S.C. 3501 et seq. That information collection request
(ICR) has been assigned EPA ICR No. 1884.11 and OMB Control No. 2070-
0162. Because this proposed rule involves new or revised information
collection activities that require additional OMB approval, EPA has
prepared an addendum to the currently approved ICR (Ref. 34 and 83 FR
36928, July 31, 2018 (EPA-HQ-OPPT-2017-0648). You can find a copy of
the ICR addendum in the docket for this proposed rule (EPA-HQ-OPPT-
2018-0321), and it is briefly summarized here.
The ICR addendum quantifies the burdens associated with the
proposed CDR revisions and TSCA section 8(a) small manufacturer
definition update (RIN 2070-AK33). EPA is proposing revisions to the
CDR rule for three primary reasons: Align with amended TSCA, increase
the usefulness of the CDR data collected, and reduce burden for CDR
reporters pursuant to TSCA section 8(a)(5). The CDR data collection
provides chemical manufacture, processing, and use information that
helps EPA identify what chemicals the public may be exposed to as
consumers or in commercial and industrial settings. The data also help
EPA assess routes of potential exposure to those chemicals.
The PRA mandates that federal agencies estimate the recordkeeping
and reporting burden of a rule. In this context, the term ``burden'' is
interpreted as the total time, effort, or financial resources expended
by individuals to generate, maintain, retain, disclose, or provide
information to or for a federal agency. It includes the time regulated
entities need to review instructions and to develop, acquire, install,
and use technology and systems to collect, validate, verify, and
disclose information. It also includes time taken to adjust existing
ways to comply with any previously applicable instructions and
requirements and to train personnel to respond to the information
collection task.
For CDR, users submit data to EPA using a Form U on a four-year
reporting cycle for the ``principal year'' and for the years since the
previous principal reporting year (currently three years). Completion
of the Form U involves reporting on a per-site basis for each of the
reportable chemicals at that site. Therefore, each site subject to CDR
requirements is considered a respondent that will submit one Form U
(response) on one or more chemicals. Sites are subject to CDR reporting
requirements when annual chemical production volume is at or above
reporting thresholds (typically 25,000 lbs, but 2,500 lb for certain
reporters) in any calendar year in the principal reporting year and the
previous three years. There is one response per respondent, as one Form
U per site accommodates multiple chemical reports in the same
submission. Activities for preparing and submitting a CDR reporting
form include rule familiarization, compliance determination, form
completion, and recordkeeping.
The changes covered by the proposed CDR revisions fall in to the
following categories:
Co-manufacturer reporting;
Modifications and additions to reportable data elements;
Changes to claiming confidentiality; and
Byproduct provisions.
The changes proposed for the TSCA section 8(a) small manufacturer
definition update are as follows:
First standard. A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any) are less than $110 million. However, if
the annual production or importation volume of a particular substance
at any individual site owned or controlled by the manufacturer
(including importer) is greater than 100,000 pounds, the manufacturer
(including importer) will not qualify as small for purposes of
reporting on the production or importation of that substance at that
site, unless the manufacturer (including importer) qualifies as small
under the second standard of this definition.
Second Standard. A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any), are less than $11 million, regardless
of the quantity of substances produced or imported by that manufacturer
(including importer).
These changes are described in further detail in the CDR ICR
Addendum (Ref. 34). Table 2 summarizes the changes to reporting under
this proposed definition.
Table 2--CDR ICR Addendum Summary--Annual Burden and Cost
------------------------------------------------------------------------
------------------------------------------------------------------------
Respondents/affected entities:.... Entities potentially affected by
this ICR include companies
manufacturing (including importing)
chemical substances listed on the
TSCA Inventory and regulated under
TSCA section 8.
Respondent's obligation to Respondents are obligated to report
respond:. to EPA.
Estimated number of respondents:.. 5,660.
Frequency of response:............ The collection occurs every four
years. The next CDR collection will
occur in 2020.
Estimated annual incremental 25,201 hours.
burden:
Estimated annual cost:............ $1,955,042.
------------------------------------------------------------------------
[[Page 17717]]
For TSCA section 8(a) reporting outside of CDR, including the TSCA
section 8(a) Preliminary Assessment Information Rule (PAIR) or any of
the chemical specific TSCA section 8(a) rules, EPA does not estimate
incremental burden and cost either because EPA has not received any
chemical reports under the rule for an extended period of time, or
because the rule uses a different definition that is not being changed
by this proposal.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates and any suggested methods for
minimizing respondent burden to the EPA using the docket identified at
the beginning of this rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs via email to
[email protected], Attention: Desk Officer for EPA. Since OMB
is required to make a decision concerning the ICR between 30 and 60
days after receipt, OMB must receive comments no later than May 28,
2019. EPA will respond to any ICR-related comments in the final rule.
D. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I
certify that this action will not have a significant adverse economic
impact on a substantial number of small entities. The Agency's basis is
briefly summarized here and is detailed in two Economic Analyses (Refs.
4 and 5).
Under RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of this proposed rule on small entities, small
entity is defined as:
1. A small business, as defined by the SBA's regulations at 13 CFR
121.201;
2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000; and
3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and not dominant in its field.
The regulated community does not include small not-for-profit
organizations. Additionally, no small governments are expected to be
adversely affected by the proposed rule; in fact, the proposal creates
an exemption for small governments. Therefore, the focus of the RFA
analysis is on small businesses.
The existing CDR rule, at 40 CFR 711.9, generally exempts from
reporting small businesses, defined at 40 CFR 704.3 as entities with
annual sales of less than $40 million and less than 100,000-pound
production of any given chemical substance at a site; or annual sales
of less than $4 million. Note that under the proposed rule, as under
current regulations, a small business would be ineligible for the
exemption if it produces any chemical substance that is the subject of
a regulation proposed or promulgated under TSCA sections 4, 5(b)(4), or
6; that is the subject of an order in effect under TSCA sections 4 or
5(e); that is subject to a consent agreement under TSCA section 4; or
that is the subject of relief that has been granted pursuant to a civil
action under TSCA sections 5 or 7. A small business may also report
voluntarily.
For purposes of the economic analysis covering the CDR revisions
portion of the proposed rule (Ref. 4), this small manufacturer
exemption is assumed to be unchanged. Conversely, for the TSCA section
8(a) small manufacturer definition update portion of the rule (Ref. 5),
reporting requirements on the Form U are assumed to be unchanged with
changes to the exemption as the focus of the Economic Analysis (Ref.
5). Further discussions in this unit summarize results from each
economic analysis, and then provide the synthesized overall conclusion.
1. CDR revisions. EPA analyzed potential small business impacts
from this proposed rule for purposes of the small entity analysis using
the SBA size standards which are either revenue or employment based,
depending on the industry sector. EPA estimates that 732 small parent
entities would potentially be affected by the CDR revisions portion of
the proposed rule. Based on estimated maximum compliance costs
annualized over a 10-year period and average revenue data for parent
entities, EPA estimates that the cost-to-sales ratio of the proposed
rule would be less than one percent for 728 (99.45 percent) of small
parent entities subject to the rule. An additional two small parent
entities are expected to incur cost impacts between one and three
percent, and two small parent entities are expected to incur cost
impacts above three percent (Ref. 4). Per EPA guidance, even if impacts
are greater than one percent, as long as the number of entities is
fewer than 100 and less than 20 percent of total small entities, the
proposed rule is determined to not result in a significant impact on a
substantial number of small entities. Therefore, EPA concludes that
compliance costs associated with CDR revisions portion of the proposed
rule are not expected to have a significant economic impact on a
substantial number of small entities (no SISNOSE).
2. TSCA section 8(a) small manufacturers definition update. The
TSCA section 8(a) small manufacturer definition update proposed
definition is as follows:
First standard, A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any) are less than $110 million. However, if
the annual production or importation volume of a particular substance
at any individual site owned or controlled by the manufacturer
(including importer) is greater than 100,000 pounds, the manufacturer
or importer will not qualify as small for purposes of reporting on the
production or importation of that substance at that site, unless the
manufacturer (including importer) qualifies as small under the second
standard of this definition.
Second Standard. A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any), are less than $11 million, regardless
of the quantity of substances produced or imported by that manufacturer
(including importer).
Under the proposed definition, the only change from the current
TSCA section 8(a) small manufacturer definition is to increase levels
for revenue size standards. As a result, EPA expects that no currently
exempt small manufacturers would become newly subject to any current
TSCA section 8(a) rules under this proposed definition, because all
manufacturers that are currently exempt would remain exempt under this
proposal. Moreover, the proposed rule would allow exemptions for
certain current reporters, thereby eliminating their reporting burden.
However, a small amount of incremental burden is incurred for rule
familiarization.
As done for the CDR revisions portion of the proposed rule, EPA
analyzed potential small business impacts for purposes of the small
entity analysis using the SBA size standards which are either revenue
or employment based, depending on the industry sector. For the small
manufacturer definition update, EPA estimates that 732 small parent
entities would potentially be affected by the proposed rule. Based on
estimated compliance costs annualized over a 10-year period and average
[[Page 17718]]
revenue data for parent entities, EPA estimates that the cost-to-sales
ratio of the small manufacturer definition update portion of the
proposed rule would be less than 1% for all of these small parent
entities (100 percent) (Ref. 5). Per EPA guidance, if impacts are less
than 1%, a certification that the rule will not result in a significant
(economic) impact on a substantial number of small entities can be made
no matter the number of small entities affected. Therefore, the Agency
concludes that the small manufacturer definition update portion of the
proposed rule would not affect a significant number of small entities
(no SISNOSE). Also note that there are no adverse small entity impacts
to small government entities because under the post-change conditions
all entities defined as small for purposes of small government
assessment are the same entities that are newly eligible to take the
small government exemption and eliminate their CDR reporting burden
entirely.
3. CDR rule overall. Note that the two EAs' analyses cover
overlapping groups, from which results from each analysis can be
synthesized to reach an overall conclusion that the overall compliance
costs associated with the proposed rule would not have a significant
impact on a substantial number of small entities (overall no SISNOSE).
EPA continues to be interested in the potential impacts of this
proposed rule on small entities and welcomes comments on issues related
to such impacts.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and would not
significantly or uniquely affect small governments. According to the
information derived using the 2016 CDR, there are government entities
that report to CDR, including: seven municipalities, one county-level
public utility district, and one tribal entity. However, under the
proposed changes, four of the municipalities would be exempt, with the
remaining entities incurring a minimal average incremental burden and
cost per site at about 3 hours and $262 per year, respectively.
Consequently, impacts would not exceed $100 million for all
governments. Additionally, under the proposed small government
definition, four government entities would be exempt from TSCA section
8(a) reporting requirements (Ref. 5).
In sum, the proposed rule is not expected to result in expenditures
by State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100 million or more (when adjusted annually for
inflation) in any one year. Accordingly, this proposed rule is not
subject to the requirements of sections 202, 203, or 205 of UMRA.
F. Executive Order 13132: Federalism
This action would not have federalism implications. It would not
have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action would not have tribal implications because it is not
expected to have substantial direct effects on tribal governments, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes as specified in Executive Order
13175 (65 FR 67249, November 9, 2000). According to the information
presented in the economic analysis for the TSCA section 8(a) small
manufacturer definition update (Ref. 5), there is one tribal entity
that reported during the 2016 CDR collection. Under the proposed rule,
this entity is estimated to incur a minimal average incremental burden
and cost per site at about 1 hour and $103 per year, respectively.
Consequently, EPA has concluded that the impacts of the proposed rule
would not significantly nor uniquely affect the communities of tribal
governments. Thus, Executive Order 13175 does not apply to this
proposed rule.
H. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997), requires that
federal agencies examine the impacts of each regulatory action on
children for any economically significant regulation (as defined by
Executive Order 12866) that the Agency has reason to believe may
disproportionately affect children. EPA interprets Executive Order
13045 as applying only to those regulatory actions that concern
environmental health or safety risks, such that the analysis required
under section 5-501 of Executive Order 13045 has the potential to
influence the regulation. This action is not subject to Executive Order
13045 because it would not establish an environmental standard intended
to mitigate health or safety risks. Nevertheless, the information
obtained by the reporting required by this proposed rule would be used
to inform the Agency's decision-making process regarding chemical
substances to which children may be disproportionately exposed. This
information would also assist the Agency and others in determining
whether the chemical substances covered in this proposed rule present
potential risks, allowing the Agency and others to take appropriate
action to investigate and mitigate those risks.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
Because this action does not involve any technical standards, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action will not have high and adverse human health or
environmental effects on minority populations, low-income populations,
and/or indigenous peoples as specified in Executive Order 12898 (59 FR
7629, February 16, 1994). The Agency believes that the rule would
improve the information collected under CDR and better assist EPA and
others in determining the potential hazards and risks associated with
the chemical substances covered by the CDR. Because the CDR is an
information collection requirement, the information that would be
improved through the proposed rule would enable the Agency to target
educational, regulatory, or enforcement activities towards industries
or chemical substances that pose the greatest risks and/or to target
programs for geographic areas that are at the highest risk. Thus, the
information to be gathered under the proposed rule would help EPA make
decisions that would benefit potentially at-risk communities, some of
which may be disadvantaged.
[[Page 17719]]
The proposed rule is directed at manufacturers (including
importers) of chemical substances. All consumers of these chemical
products and all workers who come into contact with these chemical
substances could benefit if data regarding the chemical substances'
health and environmental effects were developed. Therefore, it would
not appear that the costs and the benefits of the proposed rule would
be disproportionately distributed across different geographic regions
or among different categories of individuals.
List of Subjects
40 CFR Part 704
Environmental protection, Toxic substances control act, Reporting
and recordkeeping requirements.
40 CFR Part 711
Environmental protection, Toxic substances control act, TSCA
chemical data reporting and recordkeeping requirements.
40 CFR Part 712
Environmental protection, Toxic substances control act, Chemical
information rules.
Dated: April 12, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, EPA proposes to amend 40 CFR parts 704, 711 and 712 as
follows:
PART 704--[AMENDED]
0
1. The authority citation for part 704 to read as follows:
Authority: 15 U.S.C. 2607(a).
0
2. Section 704.3 is amended by:
0
a. Revising the definition of ``small manufacturer or importer''.
0
b. Adding in alphabetical order the definition for ``small
government''.
The additions and revisions read as follows:
Sec. 704.3 Definitions.
* * * * *
Small government means the government of a city, county, town,
township, village, school district, or special district with a
population of less than 50,000.
* * * * *
Small manufacturer means a manufacturer (including importer) that
meets either of the following standards:
(1) First standard. A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any), are less than $110 million. However, if
the annual production or importation volume of a particular substance
at any individual site owned or controlled by the manufacturer or
importer is greater than 45,400 kilograms (100,000 lbs), the
manufacturer (including importer) will not qualify as small for
purposes of reporting on the production or importation of that
substance at that site, unless the manufacturer (including importer)
qualifies as small under standard (2) of this definition.
(2) Second standard. A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any), are less than $11million, regardless of
the quantity of substances produced or imported by that manufacturer
(including importer).
(3) Inflation index. EPA will make use of the Gross Domestic
Product deflators, as compiled by the U.S. Bureau of Labor Statistics,
for purposes of determining the need to adjust the total annual sales
values and for determining new sales values when adjustments are made.
EPA may adjust the total annual sales values whenever the Agency deems
it necessary to do so, provided that the Gross Domestic Product
deflator has changed more than 20 percent since either the most recent
previous change in sales values or the date of promulgation of this
rule, whichever is later. EPA will provide notification in the Federal
Register when changing the total annual sales values.
* * * * *
0
3. Section 704.104 is amended by revising paragraph (c)(2) to read as
follows:
Sec. 704.104 Hexafluoropropylene oxide.
* * * * *
(c) * * *
(2) Persons described in Sec. 704.5 (a) through (f).
* * * * *
PART 711--[AMENDED]
0
4. The authority citation for part 711 continues to read as follows:
Authority: 15 U.S.C. 2607(a).
0
5. Section 711.1 is amended by revising paragraph (a) and (c) to read
as follows:
Sec. 711.1 Scope and compliance.
(a) This part specifies reporting and recordkeeping procedures
under section 8(a) of the Toxic Substances Control Act (TSCA) (15
U.S.C. 2607(a)) for certain manufacturers (including importers) of
chemical substances. TSCA section 8(a) authorizes the EPA Administrator
to require reporting of information necessary for the administration of
TSCA.
* * * * *
(c) TSCA section 15(3) makes it unlawful for any person to fail or
refuse to submit information required under this part. In addition,
TSCA section 15(3) makes it unlawful for any person to fail to keep,
and permit access to, records required by this part. Section 16 of TSCA
provides that any person who violates a provision of TSCA section 15 is
liable to the United States for a civil penalty and may be criminally
prosecuted. Pursuant to TSCA section 17, the Federal Government may
seek judicial relief to compel submission of TSCA section 8(a)
information and to otherwise restrain any violation of TSCA section 15.
(EPA does not intend to concentrate its enforcement efforts on
insignificant clerical errors in reporting.) TSCA section 11 allows for
inspections to assure compliance and the Administrator may by subpoena
require the attendance and testimony of witnesses and the production of
reports, papers, documents, answers to questions, and other information
that the Administrator deems necessary.
* * * * *
0
6. In section 711.3:
0
a. Revise the definition for e-CDRweb;
0
b. Revise the definition for Manufacture;
0
c. Revise paragraph (1) of the definition for Site;
0
d. Remove the definition for U.S. parent company.
0
e. Add alphabetically the definitions for Inorganic chemical substance
and Parent company.
The additions and revisions read as follows:
Sec. 711.3 Definitions.
* * * * *
e-CDRweb means the electronic, web-based tool provided by EPA for
the completion of Form U and submission of the CDR data.
* * * * *
Inorganic chemical substance means any chemical substance which
does not contain carbon or contains carbon only in the form of
carbonato [=CO3], cyano [-CN], cyanato [-OCN], isocyano [-NC], or
isocyanato [-NCO] groups, or the chalcogen analogues of such groups.
* * * * *
Manufacture means to manufacture, produce, or import, for
commercial purposes. Manufacture includes the extraction, for
commercial purposes, of a component chemical substance from a
previously existing chemical substance or complex combination of
chemical substances. A chemical substance is co-
[[Page 17720]]
manufactured by the person who physically does the manufacturing and
the person contracting for such production when that chemical
substance, manufactured other than by import, is:
(1) Produced exclusively for another person who contracts for such
production, and
(2) That other person dictates the specific chemical identity of
the chemical substance and controls the total amount produced and the
basic technology for the manufacturing process.
* * * * *
Parent company means the highest-level company(s) of the site's
ownership hierarchy as of the start of the submission period during
which data are being reported according to the following instructions.
The U.S. parent company is located within the United States while the
foreign parent company is located outside the United States:
(1) If the site is entirely owned by a single U.S. company that is
not owned by another company, that single company is the U.S. parent
company.
(2) If the site is entirely owned by a single U.S. company that is,
itself, owned by another U.S.-based company (e.g., it is a division or
subsidiary of a higher-level company), the highest-level company in the
ownership hierarchy is the United States parent company. If there is a
higher-level parent company that is outside of the United States, the
highest-level foreign company in the ownership hierarchy is the foreign
parent company.
(3) If the site is owned by more than one company (e.g., company A
owns 40 percent, company B owns 35 percent, and company C owns 25
percent), the highest-level U.S. company with the largest ownership
interest in the site is the U.S. parent company. If there is a higher-
level foreign company in the ownership hierarchy, that company is the
foreign parent company.
(4) If the site is owned by a 50:50 joint venture or a cooperative,
the joint venture or cooperative is its own parent company. If the site
is owned by a U.S. joint venture or cooperative, the highest level of
the joint venture or cooperative is the U.S. parent company. If the
site is owned by a joint venture or cooperative outside the United
States, the highest level of the joint venture or cooperative outside
the United States is the foreign parent company.
(5) If the site is entirely owned by a foreign company (i.e.,
without a U.S.-based subsidiary within the site's ownership hierarchy),
the highest-level foreign parent company is the facility's foreign
parent company.
(6) If the site is federally owned, the highest-level federal
agency or department is the U.S. parent company.
(7) If the site is owned by a non-federal public entity, that
entity (such as a municipality, State, or tribe) is the U.S. parent
company.
* * * * *
Sites * * *
(1) For chemical substances manufactured under contract, i.e., by a
co-manufacturer, the site is the location where the chemical substance
is physically manufactured.
* * * * *
0
7. Section 711.6 is amended by revising the section heading, the
introduction paragraph and the first sentence in paragraph (a)(4) to
read as follows.
Sec. 711.6 Chemical substances for which information is not required.
The following groups or categories of chemical substances are
exempted from some or all of the reporting requirements of this part,
with the following exception: A chemical substance described in
paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not
exempted from any of the reporting requirements of this part if that
chemical substance is the subject of a rule proposed or promulgated
under TSCA sections 4, 5(a)(2), 5(b)(4), or 6, or is the subject of an
enforceable consent agreement (ECA) developed under the procedures of
40 CFR part 790, or is the subject of an order issued under TSCA
sections 4, 5(e), or 5(f), or is the subject of relief that has been
granted under a civil action under TSCA sections 5 or 7.
* * * * *
(a) * * *
(4). Water and certain forms of natural gas.
* * * * *
0
8. Section 711.8 is amended by revising paragraph (a) and (b) to read
as follows:
Sec. 711.8 Persons who must report.
* * * * *
(a) Persons subject to recurring reporting--Any person who
manufactured (including imported) for commercial purposes 25,000 lb
(11,340 kg) or more of a chemical substance described in Sec. 711.5 at
any single site owned or controlled by that person during any calendar
year since the last principal reporting year.
* * * * *
(b) Exceptions. Any person who manufactured (including imported)
for commercial purposes any chemical substance that is the subject of a
rule proposed or promulgated under TSCA sections 5(a)(2), 5(b)(4), or
6, or is the subject of an order in effect under TSCA sections 4, 5(e)
or 5(f), or is the subject of relief that has been granted under a
civil action under TSCA sections 5 or 7 is subject to reporting as
described in Sec. 711.8(a), except that the applicable production
volume threshold is 2,500 lb (1,134 kg).
0
9. Section 711.9 is revised to read as follows:
Sec. 711.9 Persons not subject to this part.
A person described in Sec. 711.8 is not subject to the
requirements of this part if that person qualifies as a small
manufacturer or small government as those terms are defined in 40 CFR
704.3. Notwithstanding this exclusion, a person who qualifies as a
small manufacturer or small government is subject to this part with
respect to any chemical substance that is the subject of a rule
proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, or is the
subject of an order in effect under TSCA sections 4 or 5(e), or is the
subject of relief that has been granted under a civil action under TSCA
sections 5 or 7.
0
10. Section 711.10 is revised to read as follows:
Sec. 711.10 Activities for which reporting is not required.
A person described in Sec. 711.8 is not subject to the
requirements of this part with respect to any chemical substance
described in Sec. 711.5, when:
(a) The person manufactured or imported the chemical substance
solely in small quantities for research and development.
(b) The person imported the chemical substance as part of an
article.
(c) The person manufactured the chemical substance in any of the
following manners:
(1) Any byproduct if its only commercial purpose is for use by
public or private organizations that (i) burn it as a fuel, (ii)
dispose of it as a waste, including in a landfill or for enriching
soil, or (iii) extract component chemical substances from it for
commercial purposes. (This exclusion only applies to the byproduct; it
does not apply to the component substances extracted from the
byproduct.)
(2) Byproduct substances listed in subparagraph (i) for the
following manufacturing processes, when recycled or otherwise used
within a site-limited, physically enclosed system that is part of the
same overall manufacturing process from which the byproduct substance
was generated, and when the site is reporting the byproduct or a
different chemical substance that was manufactured from the recycled
[[Page 17721]]
byproduct or manufactured in the same overall manufacturing process:
(i) List of processes and related byproduct substances.
(A) Portland Cement Manufacturing (i.e., CASRN 68475-76-3, Flue
dust, portland cement).
(B) Kraft Pulping Process (i.e., CASRN 66071-92-9, Sulfite liquors
and Cooking liquors, spent; and CASRN 471-34-1, Carbonic acid calcium
salt (1:1)).
(ii) Amendments. EPA may amend the exemptions list in paragraph
(c)(2)(i) of this section on its own initiative or in response to a
request from the public based on EPA's determination of whether the
byproduct substance and process described meet the criteria explained
in paragraph (c)(2) of this section, based on the considerations listed
in paragraph (c)(2)(ii)(B) of this section.
(A) Any person may request that EPA amend the chemical substance
list in paragraph (c)(2)(i) of this section. Your request must be in
writing and must be submitted to the address provided in 40 CFR
700.17(a). Please label your request as follows: Attention: TSCA
Chemical Data Reporting--Byproduct Exemption Request. Requests must
identify the manufacturing process and byproduct chemical substance in
question, as well as its CASRN or other chemical identification number
as identified in Sec. 711.15(b)(3)(i), and must contain a written
rationale for the request that provides sufficient specific
information, addressing the considerations listed in (c)(2)(ii)(B) of
this section, including cites and relevant documents, to demonstrate to
EPA that the byproduct substance and process in question either does or
does not meet the criteria explained in paragraph (c)(2) of this
section. If a request related to a particular byproduct substance and
process is resubmitted, any subsequent request must clearly identify
new information contained in the request. EPA may request other
information that it believes necessary to evaluate the request. EPA
will issue a written response to each request within 120 days of
receipt of the request and will maintain copies of these responses in a
docket that will be established for each reporting cycle.
(B) Considerations. In making its determination of whether this
exemption should apply to a particular manufacturing process and
related byproduct substance, EPA will consider the totality of
information available for the process and related byproduct substance
in question, including but not limited to, one or more of the following
considerations:
(1) Whether the byproduct substance is recycled or otherwise used
to manufacture another chemical substance within an enclosed system,
within the same overall manufacturing process, and on the same site as
that byproduct was originally manufactured.
(2) Whether the site is reporting under CDR other chemical
substances, in particular a chemical substance other than the byproduct
substance that was manufactured from the byproduct or manufactured in
the same overall manufacturing process.
(3) Whether EPA has a current interest in the byproduct substance.
(4) That the byproduct substance must have already been reported
under CDR or would be expected to be reported if not exempted by this
exemption.
(C) As needed, the Agency will initiate rulemaking to make
revisions to the list of substances in paragraph (c)(2)(i) of this
section.
(D) To assist EPA in reaching a decision regarding a particular
request prior to a given principal reporting year, requests must be
submitted to EPA no later than 12 months prior to the start of the next
principal reporting year.
(3) A quantity of the byproduct that is manufactured solely in the
following equipment when it is not integral to the chemical
manufacturing processes of the site:
(i) Pollution control equipment.
(ii) Boilers used to generate heat or electricity for that site.
(4) The chemical substances described in this section: (Although
they are manufactured for commercial purposes under TSCA, they are not
manufactured for distribution in commerce as chemical substances per se
and have no commercial purpose separate from the substance, mixture, or
article of which they are a part.)
(i) Any impurity.
(ii) Any byproduct which is not used for commercial purposes.
(iii) Any chemical substance which results from a chemical reaction
that occurs incidental to exposure of another chemical substance,
mixture, or article to environmental factors such as air, moisture,
microbial organisms, or sunlight.
(iv) Any chemical substance which results from a chemical reaction
that occurs incidental to storage or disposal of another chemical
substance, mixture, or article.
(v) Any chemical substance which results from a chemical reaction
that occurs upon end use of another chemical substance, mixture, or
article such as an adhesive, paint, miscellaneous cleanser or other
housekeeping product, fuel additive, water softening and treatment
agent, photographic film, battery, match, or safety flare, and which is
not itself manufactured or imported for distribution in commerce or for
use as an intermediate.
(vi) Any chemical substance which results from a chemical reaction
that occurs upon use of curable plastic or rubber molding compounds,
inks, drying oils, metal finishing compounds, adhesives, or paints, or
any other chemical substance formed during the manufacture of an
article destined for the marketplace without further chemical change of
the chemical substance except for those chemical changes that occur as
described elsewhere in this paragraph.
(vii) Any chemical substance which results from a chemical reaction
that occurs when (A) a stabilizer, colorant, odorant, antioxidant,
filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor,
antifoamer or defoamer, dispersant, precipitation inhibitor, binder,
emulsifier, deemulsifier, dewatering agent, agglomerating agent,
adhesion promoter, flow modifier, pH neutralizer, sequesterant,
coagulant, flocculant, fire retardant, lubricant, chelating agent, or
quality control reagent functions as intended, or (B) a chemical
substance, which is intended solely to impart a specific physiochemical
characteristic, functions as intended.
(viii) Any nonisolated intermediate.
0
11. Section 711.15 is revised to read as follows.
Sec. 711.15 Reporting information to EPA.
Any person who must report under this part, as described in Sec.
711.8, must submit the information described in this section for each
chemical substance described in Sec. 711.5 that the person
manufactured (including imported) for commercial purposes in an amount
of 25,000 lb (11,340 kg) or more (or in an amount of 2,500 lb (1,134
kg) or more for chemical substances subject to the rules, orders, or
actions described in Sec. 711.8(b)) at any one site during any
calendar year since the last principal reporting year (e.g., for the
2020 submission period, consider calendar years 2016, 2017, 2018, and
2019, because 2015 was the last principal reporting year). The
principal reporting year for each submission period is the previous
calendar year (e.g., the principal reporting year for the 2020
submission period is calendar year 2019). For all submission periods, a
separate report must be submitted for each chemical substance at each
site for which the submitter is required to report. A submitter of
information under
[[Page 17722]]
this part must report information as described in this section to the
extent that such information is known to or reasonably ascertainable by
that person.
(a) Reporting information to EPA. Any person who reports
information to EPA must complete a Form U using the e-CDRweb reporting
tool provided by EPA at the address set forth in Sec. 711.35. The
submission must include all information described in paragraph (b) of
this section. Persons must submit the chemical reports on a separate
single Form U for each site for which the person is required to report.
The e-CDRweb reporting tool is described in the instructions available
from EPA at the website set forth in Sec. 711.35.
(b) Information to be reported. The information described in
paragraphs (b)(1), (b)(2), (b)(3), and (b)(4) of this section must be
reported for each chemical substance manufactured (including imported)
in an amount of 25,000 lb (11,340 kg) or more (or in an amount of 2,500
lb (1,134 kg) or more for chemical substances subject to the rules,
orders, or actions described in Sec. 711.8(b)) at any one site during
any calendar year since the last principal reporting year. The
requirement to report information described in paragraph (b)(4) of this
section is subject to exemption as described in Sec. 711.6. Persons
that elect to report eligible chemical substances in categories must
report as described in Sec. 711.15(b)(3)(i).
(1) A certification statement signed and dated by an authorized
official of the submitter company. The authorized official must certify
that the submitted information has been completed in compliance with
the requirements of this part and that the confidentiality claims made
on the Form U are true and correct. The certification must be signed
and dated by the authorized official for the submitter company, and
provide that person's name, official title, and email address.
(2) Company and site information. The following currently correct
company and site information must be reported for each site at which a
reportable chemical substance is manufactured (including imported)
above the applicable production volume threshold, as described in this
section (see Sec. 711.3 for the ``site'' for importers and special
situations).
(i) The legal name, address, and Dun and Bradstreet D-U-N-S[supreg]
(D&B) number for the highest-level parent company located in the United
States and, if one exists, the highest-level foreign-based parent
company. A submitter under this part must obtain a D&B number for the
parent company if none exists and must report using the standardized
conventions for the naming of a parent company as provided in the CDR
Instructions for Reporting identified in Sec. 711.35.
(ii) The name of a person who will serve as technical contact for
the submitter company who will be able to answer questions about the
information submitted by the company to EPA, and that technical contact
person's full mailing address, telephone number, and email address.
(iii) The legal name and full street address of each site. A
submitter under this part must include the appropriate D&B number for
each site reported, and the county or parish (or other jurisdictional
indicator) in which the site is located. A submitter under this part
must obtain a D&B number for the site reported if none exists. For a
co-manufacturing situation, the contracting company must report both
the site controlling the contract and the producing company's site
information.
(iv) The six-digit NAICS code for the site. A submitter under this
part must include the appropriate six-digit NAICS code for each site
reported.
(3) Chemical-specific information. The following chemical-specific
information must be reported for each reportable chemical substance
manufactured (including imported) above the applicable production
volume threshold, as described in paragraph (b) of this section:
(i) The specific, currently correct CA Index name as used to list
the chemical substance on the TSCA Inventory and the correct
corresponding CASRN for each reportable chemical substance at each
site. Submitters who wish to report chemical substances listed on the
confidential portion of the TSCA Inventory will need to report the
chemical substance using the corresponding TSCA Accession Number that
is listed on the public portion of the Inventory. In addition to
reporting the chemical identifying number itself, submitters must
specify the type of number they are reporting by selecting from among
the codes in Table 3 of this paragraph.
(A) Alternative reporting for some inorganic byproduct chemical
substances. Alternately, a submitter under this part may report an
inorganic byproduct chemical substance using a designated metal
compound category, unless the chemical substance is excluded from
reporting in categories. Metal compound categories are listed in Table
4 of this paragraph. For purposes of determining whether any of the
thresholds specified in Sec. 711.8 are met for a metal compound
category, a submitter must make the threshold determination based on
the total amount of all members of the metal compound category
manufactured at the site.
Excluded substances. Substances excluded from reporting in
categories include barium carbonate (CASRN 513-77-9); chemical
substances subject to the rules, orders, or other TSCA actions
described in Sec. 711.6; and chemicals undergoing risk evaluation
under TSCA section 6, as described on EPA's CDR website at https://www.epa.gov/cdr.
Table 3--Codes To Specify Type of Chemical Identifying Number
------------------------------------------------------------------------
Code Number type
------------------------------------------------------------------------
A............................... TSCA Accession Number.
C............................... Chemical Abstracts Service Registry
Number (CASRN).
M............................... TSCA Metal Compound Category Code.
------------------------------------------------------------------------
Table 4--Metal Compound Categories for Inorganic Byproduct Chemical
Substances Only
------------------------------------------------------------------------
Code Category name
------------------------------------------------------------------------
M01............................. Antimony and Antimony Compounds:
Includes any unique chemical
substance that contains antimony as
part of that chemical's structure.
M02............................. Arsenic and Arsenic Compounds:
Includes any unique chemical
substance that contains arsenic as
part of that chemical's structure.
M03............................. Barium and Barium Compounds: Includes
any unique chemical substance that
contains barium as part of that
chemical's structure.
M04............................. Beryllium and Beryllium Compounds:
Includes any unique chemical
substance that contains beryllium as
part of that chemical's structure.
M05............................. Cadmium and Cadmium Compounds:
Includes any unique chemical
substance that contains cadmium as
part of that chemical's structure.
M06............................. Chromium and Chromium Compounds:
Includes any unique chemical
substance that contains chromium as
part of that chemical's structure.
M07............................. Cobalt and Cobalt Compounds: Includes
any unique chemical substance that
contains cobalt as part of that
chemical's structure.
M08............................. Copper and Copper Compounds: Includes
any unique chemical substance that
contains copper as part of that
chemical's structure.
M09............................. Lead and Lead Compounds: Includes any
unique chemical substance that
contains lead as part of that
chemical's structure.
M10............................. Manganese and Manganese Compounds:
Includes any unique chemical
substance that contains manganese as
part of that chemical's structure.
M11............................. Mercury and Mercury Compounds:
Includes any unique chemical
substance that contains mercury as
part of that chemical's structure.
M12............................. Molybdenum and Molybdenum compounds:
Includes any unique chemical
substance that contains molybdenum as
part of that chemical's structure.
M13............................. Nickel and Nickel Compounds: Includes
any unique chemical substance that
contains nickel as part of that
chemical's structure.
[[Page 17723]]
M14............................. Selenium and Selenium Compounds:
Includes any unique chemical
substance that contains selenium as
part of that chemical's structure.
M15............................. Silver and Silver Compounds: Includes
any unique chemical substance that
contains silver as part of that
chemical's structure.
M16............................. Thallium and Thallium Compounds:
Includes any unique chemical
substance that contains thallium as
part of that chemical's structure.
M17............................. Vanadium and Vanadium compounds:
Includes any unique chemical
substance that contains vanadium as
part of that chemical's structure.
M18............................. Zinc and Zinc Compounds: Includes any
unique chemical substance that
contains zinc as part of that
chemical's structure.
------------------------------------------------------------------------
(B) Joint submissions. (1) If an importer submitting a report
cannot provide the information specified in Sec. 711.15(b)(3)(i)
because it is unknown to the importer and claimed as confidential by
the supplier of the chemical substance or mixture, the importer must
use e-CDRweb to ask the supplier to provide the correct chemical
identity and, in the case of a mixture, chemical function information
directly to EPA in a joint submission. Such request must include
instructions for submitting chemical identity information
electronically, using e-CDRweb and CDX (see Sec. 711.35), and for
clearly referencing the importer's submission. Contact information for
the supplier, a trade name or other designation for the chemical
substance or mixture, and a copy of the request to the supplier must be
included with the importer's submission.
(2) If a manufacturer submitting a report cannot provide the
information specified in Sec. 711.15(b)(3)(i) because the reportable
chemical substance is manufactured using a reactant having a specific
chemical identity that is unknown to the manufacturer and claimed as
confidential by its supplier, the manufacturer must use e-CDRweb to ask
the supplier of the confidential reactant to provide the correct
chemical identity of the confidential reactant directly to EPA in a
joint submission. Such request must include instructions for submitting
chemical identity information electronically using e-CDRweb and CDX
(see Sec. 711.35), and for clearly referencing the manufacturer's
submission. Contact information for the supplier, a trade name or other
designation for the chemical substance, and a copy of the request to
the supplier must be included with the importer's submission.
(3) EPA will only accept joint submissions that are submitted
electronically using e-CDRweb and CDX (see Sec. 711.35) and that
clearly reference the primary submission to which they refer.
(ii) For the principal reporting year only, a statement indicating,
for each reportable chemical substance at each site, whether the
chemical substance is manufactured in the United States, imported into
the United States, or both manufactured in the United States and
imported into the United States.
(iii) For the principal reporting year, the total annual volume (in
pounds) of each reportable chemical substance domestically manufactured
or imported at each site. The total annual domestically manufactured
volume (not including imported volume) and the total annual imported
volume must be separately reported. These amounts must be reported to
two significant figures of accuracy. In addition, the total annual
volume (domestically manufactured plus imported volumes in pounds) of
each reportable chemical substance at each site for each complete
calendar year since the last principal reporting year.
(iv) For the principal reporting year only, the volume used on site
and the volume directly exported of each reportable chemical substance
domestically manufactured or imported at each site. These amounts must
be reported to two significant figures of accuracy.
(v) For the principal reporting year only, a designation
indicating, for each imported reportable chemical substance at each
site, whether the imported chemical substance is physically present at
the reporting site.
(vi) For the principal reporting year only, the percentage, rounded
off to the closest 10 percent, of total production volume of the
reportable chemical substance, for each reportable chemical substance
at each site, that is manufactured as a byproduct at the site. Where
this percentage accounts for less than 5 percent of the total
production volume of the reportable chemical substance, submitters
instead must report the percentage, rounded off to the closest 1
percent.
(vii) For the principal reporting year only, a designation
indicating, for each reportable chemical substance at each site,
whether the chemical substance is being recycled or otherwise used for
a commercial purpose instead of being disposed of as a waste or
included in a waste stream.
(viii) For the principal reporting year only, the total number of
workers reasonably likely to be exposed to each reportable chemical
substance at each site. For each reportable chemical substance at each
site, the submitter must select from among the ranges of workers listed
in Table 5 of this paragraph and report the corresponding code (i.e.,
W1 through W8):
Table 5--Codes for Reporting Number of Workers Reasonably Likely To Be
Exposed
------------------------------------------------------------------------
Code Range
------------------------------------------------------------------------
W1.............................. Fewer than 10 workers.
W2.............................. At least 10 but fewer than 25 workers.
W3.............................. At least 25 but fewer than 50 workers.
W4.............................. At least 50 but fewer than 100
workers.
W5.............................. At least 100 but fewer than 500
workers.
W6.............................. At least 500 but fewer than 1,000
workers.
W7.............................. At least 1,000 but fewer than 10,000
workers.
W8.............................. At least 10,000 workers.
------------------------------------------------------------------------
(ix) For the principal reporting year only, the maximum
concentration, measured by percentage of weight, of each reportable
chemical substance at the time it is sent off-site from each site. If
the chemical substance is site-limited, you must report the maximum
concentration, measured by percentage of weight of the reportable
chemical substance at the time it is reacted on-site to produce a
different chemical substance. This information must be reported
regardless of the physical form(s) in which the chemical substance is
sent off-site/reacted on-site. For each chemical substance at each
site, select the maximum concentration of the chemical substance from
among the ranges listed in Table 6 of this paragraph and report the
corresponding code (i.e., M1 through M5):
Table 6--Codes for Reporting Maximum Concentration of Chemical Substance
------------------------------------------------------------------------
Code Concentration range (percent weight)
------------------------------------------------------------------------
M1.............................. Less than 1 percent by weight.
M2.............................. At least 1 but less than 30 percent by
weight.
M3.............................. At least 30 but less than 60 percent
by weight.
M4.............................. At least 60 but less than 90 percent
by weight.
M5.............................. At least 90 percent by weight.
------------------------------------------------------------------------
(x) For the principal reporting year only, the physical form(s) of
the reportable chemical substance as it is sent off-site from each
site. If the chemical substance is site-limited, you must report the
physical form(s) of the reportable chemical substance at the time it is
reacted on-site to produce a
[[Page 17724]]
different chemical substance. For each chemical substance at each site,
the submitter must report as many physical forms as applicable from
among the physical forms listed in this unit:
(A) Dry powder.
(B) Pellets or large crystals.
(C) Water- or solvent-wet solid.
(D) Other solid.
(E) Gas or vapor.
(F) Liquid.
(xi) For the principal reporting year only, submitters must report
the percentage, rounded off to the closest 10 percent, of total
production volume of the reportable chemical substance, reported in
response to paragraph (b)(3)(iv) of this section, that is associated
with each physical form reported under paragraph (b)(3)(x) of this
section.
(4) Chemical-specific information related to processing and use.
The following chemical-specific information must be reported for each
reportable chemical substance manufactured (including imported) above
the applicable production volume threshold, as described in this
section. Persons subject to paragraph (b)(4) of this section must
report the information described in paragraphs (b)(4)(i) and (b)(4)(ii)
of this section for each reportable chemical substance at sites under
their control and at sites that receive a reportable chemical substance
from the submitter directly or indirectly (including through a broker/
distributor, from a customer of the submitter, etc.). Information
reported in response to this paragraph must be reported for the
principal reporting year only and only to the extent that it is known
to or reasonably ascertainable by the submitter. Information required
to be reported under this paragraph is limited to domestic (i.e.,
within the customs territory of the United States) processing and use
activities. If information responsive to a given data requirement under
this paragraph, including information in the form of an estimate, is
not known or reasonably ascertainable, the submitter is not required to
respond to the requirement.
(i) Industrial processing and use information--(A) A designation
indicating the type of industrial processing or use operation(s) at
each site that receives a reportable chemical substance from the
submitter site directly or indirectly (whether the recipient site(s)
are controlled by the submitter site or not). For each chemical
substance, report the letters which correspond to the appropriate
processing or use operation(s) listed in Table 7 of this paragraph. A
particular designation may need to be reported more than once, to the
extent that a submitter reports more than one sector (under paragraph
(b)(4)(i)(B) of this section) that applies to a given designation under
this paragraph.
Table 7--Codes for Reporting Type of Industrial Processing or Use
Operation
------------------------------------------------------------------------
Designation Operation
------------------------------------------------------------------------
PC............................... Processing as a reactant.
PF............................... Processing--incorporation into
formulation, mixture, or reaction
product.
PA............................... Processing--incorporation into
article.
PK............................... Processing--repackaging.
U................................ Use--non-incorporative activities.
------------------------------------------------------------------------
(B) A code indicating the sector(s) that best describe the
industrial activities associated with each industrial processing or use
operation reported under paragraph (b)(4)(i)(A) of this section. For
each chemical substance, report the code that corresponds to the
appropriate sector(s) listed in Table 8 of this paragraph. A particular
sector code may need to be reported more than once, to the extent that
a submitter reports more than one function code (under paragraph
(b)(4)(i)(C) of this section) that applies to a given sector code under
this paragraph.
Table 8--Codes for Reporting Industrial Sectors
------------------------------------------------------------------------
Code Sector description
------------------------------------------------------------------------
IS1............................. Agriculture, forestry, fishing, and
hunting.
IS2............................. Oil and gas drilling, extraction, and
support activities.
IS3............................. Mining (except oil and gas) and
support activities.
IS4............................. Utilities.
IS5............................. Construction.
IS6............................. Food, beverage, and tobacco product
manufacturing.
IS7............................. Textiles, apparel, and leather
manufacturing.
IS8............................. Wood product manufacturing.
IS9............................. Paper manufacturing.
IS10............................ Printing and related support
activities.
IS11............................ Petroleum refineries.
IS12............................ Asphalt paving, roofing, and coating
materials manufacturing.
IS13............................ Petroleum lubricating oil and grease
manufacturing.
IS14............................ All other petroleum and coal products
manufacturing.
IS15............................ Petrochemical manufacturing.
IS16............................ Industrial gas manufacturing.
IS17............................ Synthetic dye and pigment
manufacturing.
IS18............................ Carbon black manufacturing.
IS19............................ All other basic inorganic chemical
manufacturing.
IS20............................ Cyclic crude and intermediate
manufacturing.
IS21............................ All other basic organic chemical
manufacturing.
IS22............................ Plastics material and resin
manufacturing.
IS23............................ Synthetic rubber manufacturing.
IS24............................ Organic fiber manufacturing.
IS25............................ Pesticide, fertilizer, and other
agricultural chemical manufacturing.
IS26............................ Pharmaceutical and medicine
manufacturing.
IS27............................ Paint and coating manufacturing.
IS28............................ Adhesive manufacturing.
IS29............................ Soap, cleaning compound, and toilet
preparation manufacturing.
IS30............................ Printing ink manufacturing.
IS31............................ Explosives manufacturing.
IS32............................ Custom compounding of purchased
resins.
IS33............................ Photographic film, paper, plate, and
chemical manufacturing.
IS34............................ All other chemical product and
preparation manufacturing.
IS35............................ Plastics product manufacturing.
IS36............................ Rubber product manufacturing.
IS37............................ Non-metallic mineral product
manufacturing (includes cement, clay,
concrete, glass, gypsum, lime, and
other non-metallic mineral product
manufacturing).
IS38............................ Primary metal manufacturing.
IS39............................ Fabricated metal product
manufacturing.
IS40............................ Machinery manufacturing.
IS41............................ Computer and electronic product
manufacturing.
IS42............................ Electrical equipment, appliance, and
component manufacturing.
IS43............................ Transportation equipment
manufacturing.
IS44............................ Furniture and related product
manufacturing.
IS45............................ Miscellaneous manufacturing.
IS46............................ Wholesale and retail trade.
IS47............................ Services.
IS48............................ Other (requires additional
information).
------------------------------------------------------------------------
(C) For each sector reported under paragraph (b)(4)(i)(B) of this
section, function category code(s) as provided in the CDR Instructions
for Reporting identified in Sec. 711.35 must be selected to designate
the function category(ies) that best represents the specific manner in
which the chemical substance is used. A particular function category
may need to be reported more than once, to the extent that a submitter
reports more than one industrial processing or use operation/sector
combination (under paragraphs (b)(4)(i)(A) and (b)(4)(i)(B) of this
section) that applies to a given function category under this
paragraph. If more than 10 unique combinations of industrial processing
or use operations/sector/function categories apply to a chemical
substance, submitters need only report the 10 unique combinations for
the chemical substance that cumulatively represent the largest
percentage of the submitter's production volume for that chemical
substance, measured by weight. If none of the listed function
categories accurately describes a use of a chemical substance, the
category ``Other'' may be used, and must include a description of the
use.
(D) The estimated percentage, rounded off to the closest 10
percent, of total production volume of the reportable chemical
substance associated with each combination of industrial processing or
use operation, sector, and function category. Where a
[[Page 17725]]
particular combination of industrial processing or use operation,
sector, and function category accounts for less than 5 percent of the
submitter's site's total production volume of a reportable chemical
substance, the percentage must not be rounded off to 0 percent if the
production volume attributable to that industrial processing or use
operation, sector, and function category combination is 25,000 lb
(11,340 kg) or more during the reporting year. Instead, in such a case,
submitters must report the percentage, rounded off to the closest 1
percent, of the submitter's site's total production volume of the
reportable chemical substance associated with the particular
combination of industrial processing or use operation, sector, and
function category.
(E) For each combination of industrial processing or use operation,
sector, and function category, the submitter must estimate the number
of sites at which each reportable chemical substance is processed or
used. For each combination associated with each chemical substance, the
submitter must select from among the ranges of sites listed in Table 9
of this paragraph and report the corresponding code (i.e., S1 through
S7):
Table 9--Codes for Reporting Numbers of Sites
------------------------------------------------------------------------
Code Range
------------------------------------------------------------------------
S1.............................. Fewer than 10 sites.
S2.............................. At least 10 but fewer than 25 sites.
S3.............................. At least 25 but fewer than 100 sites.
S4.............................. At least 100 but fewer than 250 sites.
S5.............................. At least 250 but fewer than 1,000
sites.
S6.............................. At least 1,000 but fewer than 10,000
sites.
S7.............................. At least 10,000 sites.
------------------------------------------------------------------------
(F) For each combination of industrial processing or use operation,
sector, and function category, the submitter must estimate the number
of workers reasonably likely to be exposed to each reportable chemical
substance. For each combination associated with each chemical
substance, the submitter must select from among the worker ranges
listed in paragraph (b)(3)(viii) of this section and report the
corresponding code (i.e., W1 though W8).
(ii) Consumer and commercial use information--(A) Using the codes
as provided in the CDR Instructions for Reporting identified in Sec.
711.35, submitters must designate the consumer and commercial product
category or categories that best describe the consumer and commercial
products in which each reportable chemical substance is used (whether
the recipient site(s) are controlled by the submitter site or not). If
more than 10 codes apply to a chemical substance, submitters need only
report the 10 codes for the chemical substance that cumulatively
represent the largest percentage of the submitter's production volume
for that chemical, measured by weight. If none of the listed consumer
and commercial product categories accurately describes the consumer and
commercial products in which each reportable chemical substance is
used, the category ``Other'' may be used, and must include a
description of the use.
(B) for each consumer and commercial product category reported
under paragraph (b)(4)(ii)(A) of this section, code(s) described in
paragraph (b)(4)(i)(C) of this section must be selected to designate
the function category(ies) that best represents the specific manner in
which the chemical substance is used. A particular function category
may need to be reported more than once, to the extent that a submitter
reports more than one consumer or commercial product category (under
paragraphs (b)(4)(ii)(A) of this section) that applies to a given
function category under this paragraph. If none of the listed function
categories accurately describes a use of a chemical substance, the
category ``Other'' may be used, and must include a description of the
use.
(C) An indication, within each consumer and commercial product
category reported under paragraph (b)(4)(ii)(A) of this section,
whether the use is a consumer or a commercial use.
(D) Submitters must determine, within each consumer and commercial
product category reported under paragraph (b)(4)(ii)(A) of this
section, whether any amount of each reportable chemical substance
manufactured (including imported) by the submitter is present in (for
example, a plasticizer chemical substance used to make pacifiers) or on
(for example, as a component in the paint on a toy) any consumer
products intended for use by children age 14 or younger, regardless of
the concentration of the chemical substance remaining in or on the
product. Submitters must select from the following options: The
chemical substance is used in or on any consumer products intended for
use by children, the chemical substance is not used in or on any
consumer products intended for use by children, or information as to
whether the chemical substance is used in or on any consumer products
intended for use by children is not known to or reasonably
ascertainable by the submitter.
(E) The estimated percentage, rounded off to the closest 10
percent, of the submitter's site's total production volume of the
reportable chemical substance associated with each consumer and
commercial product category. Where a particular consumer and commercial
product category accounts for less than 5 percent of the total
production volume of a reportable chemical substance, the percentage
must not be rounded off to 0 percent if the production volume
attributable to that commercial and consumer product category is 25,000
lb (11,340 kg) or more during the reporting year. Instead, in such a
case, submitters must report the percentage, rounded off to the closest
1 percent, of the submitter's site's total production volume of the
reportable chemical substance associated with the particular consumer
and commercial product category.
(F) Where the reportable chemical substance is used in consumer or
commercial products, the estimated typical maximum concentration,
measured by weight, of the chemical substance in each consumer and
commercial product category reported under paragraph (b)(4)(ii)(A) of
this section. For each chemical substance in each commercial and
consumer product category reported under paragraph (b)(4)(ii)(A) of
this section, submitters must select from among the ranges of
concentrations listed in Table 6 in paragraph (b)(3)(ix) of this
section and report the corresponding code (i.e., M1 through M5).
(G) Where the reportable chemical substance is used in a commercial
product, the submitter must estimate the number of commercial workers
reasonably likely to be exposed to each reportable chemical substance.
For each combination associated with each substance, the submitter must
select from among the worker ranges listed in Table 5 in paragraph
(b)(3)(viii) of this section and report the corresponding code (i.e.,
W1 though W8).
0
12. Section 711.20 is revised to read as follows:
Sec. 711.20 When to report.
All information reported to EPA in response to the requirements of
this part must be submitted during an applicable submission period,
which runs from June 1 to September 30 at 4-year intervals, beginning
in 2020. In each submission period, any person described in Sec. 711.8
must report as described in this part.
0
13. Section 711.22 is amended by revising paragraph (c) to read as
follows:
[[Page 17726]]
Sec. 711.22 Duplicative reporting.
* * * * *
(c) Co-manufactured chemicals. This part requires that only one
report per site be submitted on each chemical substance described in
Sec. 711.5. When a company contracts with a producing company to
manufacture a chemical substance, and each party meets the definition
of ``manufacturer'' as set forth in Sec. 711.3, the contracting
company must initiate the required report for that site as the primary
submitter. The contracting company must indicate on the report that
this is a co-manufacturing situation, notify the producing company, and
record the production volume domestically co-manufactured as set forth
in Sec. 711.15(b)(3) and processing and use information set forth in
Sec. 711.15(b)(4). Upon notification by the contracting company, the
producing company must also record the production volume domestically
co-manufactured and complete the rest of the report as prompted by e-
CDRweb.
* * * * *
0
14. Section 711.30 is revised to read as follows.
Sec. 711.30 Confidentiality claims.
(a) Generally. (1) Any person submitting information under this
part may assert a confidentiality claim for that information at the
time it is submitted, except for information described in paragraph
(2).
Any such confidentiality claims must be asserted at the time the
information is submitted. These claims will apply only to the
information submitted with the claim. Instructions for asserting
confidentiality claims are provided in the document identified in Sec.
711.35. Information claimed as confidential in accordance with this
section will be treated and disclosed in accordance with the procedures
in 40 CFR part 2.
(2) Exceptions. Confidentiality claims cannot be made:
(i) For public contact information if voluntarily provided;
(ii) For chemical identities listed on the public portion of the
TSCA Inventory or for chemical category identification when reporting
pursuant to Sec. 711.15(b)(3)(i);
(iii) For processing and use data elements required by Sec.
711.15(b)(4)(i)(A), (B), and (C) and Sec. 711.15(b)(4)(ii)(A), (B),
and (C), or
(iv) When a response is left blank or designated as not known or
reasonably ascertainable.
(3) All confidentiality claims must be substantiated at time of
submission, in accordance with the requirements in subsections (b)
through (f) of this section. Confidentiality claims for the following
data elements are exempt from this substantiation requirement:
(i) Production volume information required pursuant to Sec.
711.15(b)(3)(iii).
(ii) Joint submission information from the primary submitter
including trade name and supplier identification required pursuant to
Sec. 711.15(b)(3)(i)(A), (B), and (C).
(iii) Joint submission information from the secondary submitter
including the percentage of formulation required pursuant to Sec.
711.15(b)(3)(i)(A), (B), and (C).
(4) All confidentiality claims require certification in accordance
with subsection (g) of this section. All asserted confidentiality
claims, whether subject to substantiation and review or not, may only
be asserted consistent with the representations set forth in the
certification described in subsection (h) of this section.
(b) All confidentiality claims requiring substantiation at time of
submission. For each data element claimed as confidential, you must
submit with your report detailed written answers to the following
questions signed and dated by an authorized official.
(1) Will disclosure of the information claimed as confidential
likely cause substantial harm to your business's competitive position?
If you answered yes, explain the substantial harm.
(2) To the extent your business has disclosed the information to
others (both internally and externally), has your business taken
precautions to protect the disclosed information? If yes, please
explain and identify the specific measures or internal controls your
business has taken to protect the information claimed as confidential.
(3) Does any of the information claimed as confidential appear in
any public documents, including (but not limited to) safety data
sheets, advertising or promotional material, professional or trade
publications, or any other media or publications available to the
general public? If you answered yes, explain why the information should
be treated as confidential.
(4) Does any of the information you are claiming as confidential
constitute a trade secret?
(5) Is the claim of confidentiality intended to last less than 10
years (see TSCA section 14(e)(1)(B))? If so, indicate the number of
years (between 1-10 years) or the specific date after which the claim
is withdrawn.
(6) Has EPA, another federal agency, or court made any
confidentiality determination regarding information associated with
this chemical substance? If yes, provide the circumstances associated
with the prior determination, whether the information was found to be
entitled to confidential treatment, the entity that made the decision,
and the date of the determination.
(c) Additional requirements for specific chemical identity. The
specific chemical identity includes the CA Index name and corresponding
CASRN as described in Sec. 711.15(b)(3) of this part, and does not
include generic chemical identities or TSCA Accession Number. Generic
chemical identities and accession numbers may not be claimed as
confidential. A person may assert a claim of confidentiality for the
specific chemical identity of a chemical substance only if the identity
of that chemical substance is treated as confidential in the Master
Inventory File as of the time the report is submitted for that chemical
substance. To assert a claim of confidentiality for the identity of a
reportable chemical substance, you must submit with the report detailed
written answers to the questions from paragraph (b) of this section and
to the following questions signed and dated by an authorized official.
(1) Is this chemical substance publicly known to be in U.S.
commerce by a specific chemical identity or name that is consistent
with its listing on the confidential portion of the TSCA Inventory? If
yes, explain why the chemical identity should still be afforded
confidential status (i.e., the chemical is publicly known only as being
distributed in commerce for research and development purposes). If no,
complete the certification statement:
I certify that on the date referenced, I searched the internet
for the chemical substance identity (i.e., by both chemical
substance name and CASRN). I did not find a reference to this
chemical substance which would indicate the chemical is being
manufactured or imported for a commercial purpose and is available
in the United States by anyone. [provide date].
(2) Does this particular chemical substance leave the site of
manufacture (including import) in any form, e.g., as product, effluent,
emission? If so, what measures have been taken to guard against the
discovery of its identity?
(3) If the chemical substance leaves the site in a product that is
available to the public or your competitors, can the chemical substance
be identified by analysis of the product?
(4) Would disclosure of the specific chemical name release
confidential process information? If yes, please explain?
(d) Company, site, and technical contact identity information. A
[[Page 17727]]
submitter may assert a claim of confidentiality for a site, company, or
technical contact identity only if the linkage of that information to a
reportable chemical substance is confidential and not publicly
available. To assert a claim of confidentiality to protect the link
between the company, site, or technical contact identity and the
chemical substance information, you must submit with the report
detailed written answers to the questions from paragraph (b) of this
section and to the following questions, as applicable, signed and dated
by an authorized official.
(1) Has company, site, or technical contact identity information
been linked with a reportable chemical substance in any public document
or in any other Federal, State, or local reporting scheme? For example,
is the chemical identity linked to a facility in a filing under the
Emergency Planning and Community Right-to-Know Act (EPCRA) section 311,
namely through a Safety Data Sheet (SDS)? If yes, explain why the
information should be treated as confidential.
(e) Additional requirements for processing and use information. A
submitter may assert a claim of confidentiality for each data element
required by Sec. 711.15(b)(4)(i)(D), (E) and (F) and Sec.
711.15(b)(4)(ii)(D), (E) and (F) only if the linkage of the information
with a reportable chemical substance is confidential and not publicly
available. To assert a claim of confidentiality for each data element
required by Sec. 711.15(b)(4) which is potentially eligible for
protection from disclosure, you must submit with the report detailed
written answers to the questions from paragraph (b) of this section and
to the following questions signed and dated by an authorized official:
(1) Is the information claimed as confidential publicly known? For
example, is the information available in advertisements or other
marketing materials, professional journals or other similar materials,
or in non-confidential mandatory or voluntary government filings or
publications? Has your company ever publicly released this information?
If yes, explain why the information should be treated as confidential.
(2) Has your company ever provided this information on the chemical
substance to any person and not asked that it be treated as
confidential? If yes, explain why the information should be treated as
confidential.
(f) Joint Submissions. If a primary submitter asks a secondary
submitter to provide information directly to EPA in a joint submission
under Sec. 711.15(b)(3)(i)(A) and (B), only the primary submitter may
assert a confidentiality claim for the data elements it directly
submits to EPA. The primary submitter must substantiate those claims
not exempt under subparagraph (a)(3)(ii) of this section. The secondary
submitter is responsible for asserting all confidentiality claims for
the data elements it submits directly to EPA and substantiating those
claims not exempt under subparagraph (a)(3)(iii) of this section.
(g) Marking substantiations. If any of the information contained in
the answers to the questions listed in subsections (b) though (e) of
this section is asserted to contain information that itself is
considered to be confidential, you must clearly identify the
information that is claimed confidential by marking the specific
information on each page with a label such as ``confidential business
information,'' ``proprietary,'' or ``trade secret.''
(h) Certification statement for claims. An authorized official of a
person asserting a claim of confidentiality must certify that the
submission complies with the requirements of this part by signing and
dating the following certification statement:
I certify that all claims for confidentiality asserted with this
submission are true and correct, and all information submitted
herein to substantiate such claims is true and correct. Any knowing
and willful misrepresentation is subject to criminal penalty
pursuant to 18 U.S.C. 1001. I further certify that: (1) I have taken
reasonable measures to protect the confidentiality of the
information; (2) I have determined that the information is not
required to be disclosed or otherwise made available to the public
under any other Federal law; (3) I have a reasonable basis to
conclude that disclosure of the information is likely to cause
substantial harm to the competitive position of my company; and (4)
I have a reasonable basis to believe that the information is not
readily discoverable through reverse engineering.
(i) No claim of confidentiality. Information not asserted as
confidential in accordance with the requirements of this section may be
made public without further notice to the submitter.
0
15. Section 711.35 is amended by revising paragraph (c)(1) to read as
follows:
Sec. 711.35 Electronic filing.
* * * * *
(c) * * *
(1) By website. Go to the EPA Chemical Data Reporting internet
homepage at http://www.epa.gov/cdr and follow the appropriate links.
* * * * *
PART 712--[AMENDED]
0
16. The authority citation for part 712 continues to read as follows:
Authority: 15 U.S.C. 2607(a).
0
17. Section 712.25 is amended by revising paragraph (c) to read as
follows:
Sec. 712.25 . Exempt manufacturers and importers.
* * * * *
(c) Persons who qualify as small manufacturers (including
importers) in respect to a specific chemical substance listed in Sec.
712.30 are exempt. However, this exemption does not apply with respect
to any chemical in Sec. 712.30 designated by an asterisk. A
manufacturer is qualified as small and is exempt from submitting a
report under this subpart for a chemical substance manufactured at a
particular plant site if it meets the definition for small manufacturer
in Sec. 704.3.
* * * * *
[FR Doc. 2019-07716 Filed 4-24-19; 8:45 am]
BILLING CODE 6560-50-P