[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Rules and Regulations]
[Pages 50816-50879]
[FR Doc No: 2011-19922]

Vol. 76

Tuesday,

No. 158

August 16, 2011

Part II

Environmental Protection Agency

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40 CFR Parts 704, 710, and 711

TSCA Inventory Update Reporting Modifications; Chemical Data Reporting;
Final Rule

Federal Register / Vol. 76 , No. 158 / Tuesday, August 16, 2011 /
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 704, 710, and 711

[EPA-HQ-OPPT-2009-0187; FRL-8872-9]
RIN 2070-AJ43

TSCA Inventory Update Reporting Modifications; Chemical Data
Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending the Toxic Substances Control Act (TSCA)
section 8(a) Inventory Update Reporting (IUR) rule and changing its
name to the Chemical Data Reporting (CDR) rule. The CDR enables EPA to
collect and publish information on the manufacturing, processing, and
use of commercial chemical substances and mixtures (referred to
hereafter as chemical substances) on the TSCA Chemical Substance
Inventory (TSCA Inventory). This includes current information on
chemical substance production volumes, manufacturing sites, and how the
chemical substances are used. This information helps the Agency
determine whether people or the environment are potentially exposed to
reported chemical substances. EPA publishes submitted CDR data that is
not Confidential Business Information (CBI). EPA is amending this rule
to require submission of information that will better address Agency
and public information needs, improve the usability and reliability of
the reported data, and ensure that data are available in a timely
manner. EPA is requiring electronic reporting of CDR information and
modifying reporting requirements, including certain circumstances that
trigger reporting, the specific data to be reported, the reporting
standard for processing and use information, and CBI reporting
procedures.

DATES: This final rule is effective September 15, 2011.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2009-0187. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPPT Docket. The OPPT Docket is
located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg.,
1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading
Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number of the EPA/DC
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
OPPT Docket is<PHONE_NUMBER>. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Chenise Farquharson, Chemical Control Division (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-7768; e-mail address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture
(including manufacture as a byproduct) or import, for commercial
purposes, chemical substances listed on the TSCA Inventory (under TSCA
section 3, ``import'' is included in the definition of manufacture).
Potentially affected entities may include, but are not limited to:
     Chemical substance manufacturers and importers (NAICS
codes 325 and 324110; e.g., chemical substance manufacturing and
processing and petroleum refineries).
     Chemical substance users and processors who, in addition
to manufacturers described in this unit, may manufacture a byproduct
chemical substance (NAICS codes 22, 322, 331, and 3344; e.g.,
utilities, paper manufacturing, primary metal manufacturing, and
semiconductor and other electronic component manufacturing).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

II. Background

A. What action is the agency taking?

    In this action, EPA is promulgating several amendments to the IUR
rule, taking into consideration comments received on the proposed rule
and is changing its name to the CDR rule. The amendments were proposed
in the Federal Register issue of August 13, 2010 (Ref. 1). The
amendments contained in this final rule, as well as the TSCA Inventory
update provisions of 40 CFR part 710, subpart C, unchanged by these
amendments, appear in a new part, 40 CFR part 711. The following is a
brief listing of the primary amendments. These amendments are described
in more detail in Unit III.
    1. EPA is amending 40 CFR 710.59, which appears in the new 40 CFR
part 711 as 40 CFR 711.35, to require electronic reporting of the CDR
data, using an Agency-provided, web-based reporting tool (e-CDRweb) to
submit CDR reports through the Internet to EPA's Central Data Exchange
(CDX). After the final rule's effective date (see DATES), paper
submissions will no longer be accepted.
    2. EPA is adding a new definition section, which appears in the new
40 CFR part 711 as 40 CFR 711.3, revising the definition for
manufacture and site; and making other needed definitional
modifications and additions.
    3. EPA is amending 40 CFR 710.53, which appears in the new 40 CFR
part 711 as 40 CFR 711.20, to change the reporting frequency from every
5 years to every 4 years.
    4. EPA is amending 40 CFR 710.48(a), which appears in the new 40
CFR part 711 as 40 CFR 711.8(a), to modify the method used to determine
whether a manufacturer (including importer) is subject to CDR
reporting. The method will be effective after the 2012 submission
period. Subsequent to 2012, reporting is required if the production
volume of a chemical substance met or exceeded the 25,000 pound (lb)
threshold in any calendar year since the last principal reporting year
(e.g., 2011).

    5. EPA is amending 40 CFR 710.52(c), which appears in the new 40
CFR part 711 as 40 CFR 711.15(b), to replace the 300,000 lb reporting
threshold for processing and use information by phasing in a lower
threshold. For the 2012 submission period, the threshold for reporting
processing and use information is 100,000 lb. In subsequent submission
periods, the reporting threshold will be 25,000 lb.
    6. EPA is amending 40 CFR 710.48(a), which appears in the new 40
CFR part 711 as 40 CFR 711.8(b), to replace the 25,000 lb threshold for
specific chemical substances that are the subject of particular TSCA
rules and/or orders. The new reporting threshold for these chemical
substances is 2,500 lb, which is effective for the 2016 submission
period and subsequent submission periods.
    7. EPA is amending 40 CFR 710.46, which appears in the new 40 CFR
part 711 as 40 CFR 711.6, to make chemical substances for which an
enforceable consent agreement (ECA) to conduct testing has been made
under 40 CFR part 790 ineligible for exemptions, to provide a full
exemption from CDR requirements for water, and to remove polymers,
which are already fully exempt from the partially exempt list of
chemical substances at 40 CFR 710.46(b)(2)(iv), which appears in the
new 40 CFR part 711 as 40 CFR 711.6(b)(2)(iv).
    8. EPA is amending 40 CFR 710.52(c), which appears in the new 40
CFR part 711 as 40 CFR 711.15(b), to modify the reporting requirements
for certain manufacturing data elements. Specifically, manufacturers
(including importers) are required to report:
    a. The name and address belonging to the parent company.
    b. The current Chemical Abstracts (CA) Index Name, as used to list
the chemical substance on the TSCA Inventory, as part of the chemical
identity.
    c. For the 2012 submission period only, the production volume for
calendar year 2010.
    d. The production volume for each of the years since the last
principal reporting year. This requirement will be effective after the
2012 reporting cycle (i.e., for the 2016 submission period and
subsequent submission periods).
    e. The volume of a manufactured (including imported) chemical
substance used at the reporting site.
    f. Whether an imported chemical substance is physically present at
the reporting site.
    g. The volume directly exported and not domestically processed or
used.
    h. When a manufactured chemical substance, such as a byproduct, is
being recycled, remanufactured, reprocessed, or reused.
    9. EPA is replacing the ``readily obtainable'' reporting standard
used for the reporting of processing and use information required by 40
CFR 710.52(c)(4), which appears in the new 40 CFR part 711 as 40 CFR
711.15(b)(4), with the ``known to or reasonably ascertainable by''
reporting standard.
    10. EPA is amending 40 CFR 710.58, which appears in the new 40 CFR
part 711 as 40 CFR 711.30, to require upfront substantiation when
processing and use information required by 40 CFR 710.52(c)(4), which
appears in the new 40 CFR part 711 as 40 CFR 711.15(b)(4), is claimed
as CBI.
    11. EPA will disallow confidentiality claims for processing and use
data elements identified as not ``known to or reasonably ascertainable
by'' (40 CFR 710.52(c)(4)), which appears in the new 40 CFR part 711 as
40 CFR 711.15(b)(4).
    12. EPA is revising the list of industrial function categories for
the reporting of processing and use information. EPA is also amending
40 CFR 710.52(c)(4)(i)(C), which appears in the new 40 CFR part 711 as
40 CFR 711.15(b)(4)(i)(B), to replace the 5-digit NAICS codes with 48
Industrial Sector (IS) codes.
    13. EPA is amending 40 CFR 710.52(c)(4)(ii), which appears in the
new 40 CFR part 711 as 40 CFR 711.15(b)(4)(ii), to revise the list of
consumer and commercial product categories for the reporting of
consumer and commercial use information. EPA is also requiring the
separate reporting for consumer or commercial categories and the
reporting of the number of commercial workers reasonably likely to be
exposed to the subject chemical substance.
    14. EPA is eliminating the gaps in the ranges used to report
concentration in 40 CFR 710.52(c)(3) and (c)(4), which appear in the
new 40 CFR part 711 as 40 CFR 711.15(b)(3) and (b)(4).

B. What is the agency's authority for taking this action?

    EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to
compile and keep current an inventory of chemical substances
manufactured or processed in the United States. This inventory is known
as the TSCA Chemical Substance Inventory (TSCA Inventory). The Agency
maintains the Master Inventory File as the authoritative list of all
the chemical substances reported to EPA for inclusion on the TSCA
Inventory. In 1977, EPA promulgated a rule published in the Federal
Register issue of December 23, 1977 (Ref. 2) under TSCA section 8(a),
15 U.S.C. 2607(a), to compile an inventory of chemical substances in
commerce at that time. In 1986, EPA promulgated the initial IUR rule
under TSCA section 8(a) at 40 CFR part 710, published in the Federal
Register issue of June 12, 1986 (Ref. 3), to facilitate the periodic
updating of information on chemical substances listed on the TSCA
Inventory and to support activities associated with the implementation
of TSCA. In 2003, EPA promulgated extensive amendments to the IUR rule,
published in the Federal Register issue of January 7, 2003 (2003 IUR
Amendments) (Ref. 4), to collect exposure-related information
associated with the manufacturing, processing, and use of eligible
chemical substances and to make certain other changes.
    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. Section 8(a) of TSCA
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,
or that is the subject of an order in effect under TSCA section 5(e),
or that is the subject of relief granted pursuant to a civil action
under TSCA section 5 or 7. The standard for determining whether an
entity qualifies as a small manufacturer for purposes of 40 CFR part
710, which appears in the new 40 CFR part 711, is found at 40 CFR
704.3. Processors are not currently subject to the rules at 40 CFR part
710, which appears in the new 40 CFR part 711.
    This document renames the IUR as CDR and promulgates the CDR as 40
CFR part 711, which includes provisions copied from the existing
regulations in 40 CFR part 710, subpart C, that are not substantively
changed as a part of this rulemaking, and the new provisions in this
final rule. Failure to comply fully with any provision of this final
rule will be a violation of TSCA section 15 and will subject the
violator to the penalties of TSCA sections 16 and 17.

C. What was the TSCA inventory update reporting (IUR) rule prior to
these modifications?

    The IUR rule, as modified by the 2003 IUR Amendments, required U.S.
manufacturers (including importers) of chemical substances listed on
the TSCA Inventory to report the identity of chemical substances
manufactured (including imported) during the reporting year in
quantities of 25,000 lb or greater at any single site they own or
control to EPA every 5 years. IUR data were collected five times prior
to the 2003 IUR Amendments: 1986, 1990, 1994, 1998, and 2002, and one
time after the 2003 IUR Amendments, in 2006. EPA uses the TSCA
Inventory and data reported under the IUR rule to support many TSCA-
related activities and to support a number of EPA and other Federal
health, safety, and environmental protection activities. The Agency
also makes the data available to the public, to the extent possible
given CBI claims.
    Persons manufacturing (including importing) chemical substances
were 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. This exposure-
related information included the physical form and maximum
concentration of the chemical substance and the number of potentially
exposed workers. Several groups of chemical substances were and will
continue to be generally excluded from the reporting requirements:
e.g., polymers, microorganisms, naturally occurring chemical
substances, and certain natural gas substances.
    Manufacturers (including importers) of chemical substances in
larger volumes (i.e., 300,000 lb or greater manufactured (including
imported) during the reporting year at any single site) were required
also to report certain processing and use information for the 2006
submission. This information includes process or use category; NAICS
code; industrial function category; percent production volume
associated with each process or use category; number of use sites;
number of potentially exposed workers; and consumer/commercial
information such as use category, use in or on products intended for
use by children, and maximum concentration.
    The 2006 submission was the first instance where manufacturers
(including importers) of inorganic chemical substances were required to
report under the IUR rule. For the 2006 submission only, inorganic
chemical substances were partially exempted from the IUR rule, and
manufacturers of such chemical substances were required to report the
manufacturing information and not the processing and use information,
regardless of production volume. Under the previous rule, for future
collections (i.e., for 2011 or 2016 collections, etc.), the partial
exemption for inorganic chemical substances would have no longer been
applicable and submitters would have reported in the same manner as was
required for organic chemical substances, including processing and use
information. In addition, starting with the 2006 collection and for
future collections, specifically listed petroleum process streams and
other specifically listed chemical substances were partially exempt,
and manufacturers of such chemical substances were not required to
report processing and use information. These partial exemptions will
continue in subsequent submission periods under the CDR as revised in
this final rule (including the 2012 collection), for as long as the
chemical substances remain on these partial exemption lists 40 CFR
711.6(b)(1) and (b)(2).
    Non-confidential data, including both searchable and separately
downloadable databases, and the 2006 IUR data summary report are
available to the public on the CDR Web site (http://www.epa.gov/iur).

D. Why is the agency amending the IUR rule?

    EPA has modified the IUR rule to meet four primary goals:
    1. To tailor the information collected to better meet the Agency's
overall information needs.
    2. To increase its ability to effectively provide public access to
the information.
    3. To obtain new and updated information relating to potential
exposures to a subset of chemical substances listed on the TSCA
Inventory.
    4. To improve the usefulness of the information reported. EPA
believes that expanding the range of chemical substances for which more
in-depth processing and use information is to be reported and adjusting
the specific reported information, the method and frequency of
collecting the information, and CBI requirements will accomplish these
goals.
    These goals are supported by a policy outlined in TSCA section 2,
which is that ``adequate data should be developed with respect to the
effect of chemical substances and mixtures on health and the
environment and that the development of such data should be the
responsibility of those who manufacture and those who process such
chemical substances and mixtures'' (TSCA section 2(b)(1)).
Modifications to the IUR requirements by the 2003 IUR Amendments
provided many improvements to the data collected through that rule, and
EPA's efforts to use the 2006 IUR data identified areas where further
improvements are needed. The modifications described in this final rule
change some of the reporting requirements in an effort by EPA to ensure
the required information is properly reported and that the information
in the Agency's database reflects the information provided in the IUR
reports; increase the usability of the collected information; increase
the availability of information for the public; and focus reporting on
information that is most needed by the Agency.
    In addition, these changes will enable EPA and other Federal
agencies to improve their risk screening capabilities, enabling them to
better assess and manage risk, and improve public awareness of basic
information about a large number of chemical substances.
    EPA provided reporting software for the 2006 IUR submission period
and encouraged electronic reporting through the Internet, using the
Agency's CDX. EPA's experience with populating the IUR database and
with using the 2006 IUR data provided insight into how well both the
reporting software and submission methods worked. For instance, because
of validations built into the reporting software, electronic
submissions were able to be quickly assimilated into the IUR database.
Other forms of submission required the documents to be scanned in or
hand entered, and resulted in many introduced errors during the data
entry process. Additionally, for the 2006 IUR, certain types of
submissions (e.g., joint submissions) could not be reported
electronically. Other problems, such as incorrect chemical identities,
delayed the inclusion of the data into the database, resulting in the
Agency's inability to begin using the 2006 IUR data and providing
public access in a timely manner. The modifications in this final rule
associated with reporting methods and changes to the reporting software
will better ensure the information reported to the Agency is accurate
and in compliance with the IUR requirements.

    During the development of the 2003 IUR Amendments, the Agency
considered the data accuracy and reliability needed for screening level
exposure analyses and took several steps to ensure the IUR data met
those needs. Screening level data need not be precise, but should be
accurate and reliable enough for the Agency to develop screening level
assessments. The 2003 IUR Amendments supplied exposure-related
information the Agency did not previously possess, recognizing that
industry has a greater knowledge than EPA about its own operations and
the uses of chemical substances it manufactures and sells.
    EPA's extensive use of the 2006 IUR data in the Agency's Existing
Chemicals Program is consistent with how EPA envisioned the data would
be used when the 2003 IUR Amendments were promulgated. In 2007, the
Agency began to develop and post screening-level hazard, exposure, and
risk characterizations for high production volume (HPV) chemical
substances, which are those chemical substances produced nationally at
aggregated volumes of one million lb or more per year. In developing
these characterizations, EPA identified areas where the IUR data
collection can be improved and enhanced. Improvements would allow EPA
to better identify and take follow-up action on chemical substances
that may pose potential risks to human health or the environment.
    During its review of the IUR data, EPA identified numerous examples
of CBI claims where the same or similar information to that claimed as
CBI was already available to the public. In several cases, information
on production volume and uses for a chemical substance or group of
chemical substances was claimed CBI on Form U, while the same or
similar information was submitted voluntarily by the company without
such a claim under the HPV Challenge Program. In those cases, EPA had
previously made the information publicly available through the High
Production Volume Information System (HPVIS) or on EPA's Existing
Chemicals Program Web site. More detailed CBI substantiation
requirements will encourage the correct designation of non-confidential
reported information, thereby facilitating reporting of this
information to the public.
    EPA Administrator Lisa P. Jackson has made it a priority to
strengthen the Agency's chemical management program, including the
development of new regulatory risk management actions, the development
of Chemical Action Plans targeting the Agency's risk management
efforts, requiring the reporting of information needed to understand
chemical substance risks, and increasing public access to information
about chemical substances (Ref. 5). The IUR provides exposure-related
data needed to understand chemical substance risks. The modifications
to the IUR rule will enhance the capabilities of the Agency to ensure
risk management actions are taken on chemical substances which may pose
the greatest concern. More in-depth reporting of the processing and use
data, more careful consideration of the need for confidentiality
claims, and adjustments to the specific data elements are important
aspects of this action. By enhancing the data supplied to the Agency,
EPA expects to more effectively and expeditiously identify and address
potential risks posed by chemical substances and provide improved
access and information to the public.
    An important and anticipated result of this action is that EPA will
receive more publicly available, non-CBI information, therefore
increasing the transparency and public accessibility of the chemical
substance use, and exposure information and ensuring consistency with
the President's policy goals for government reliance on and public
availability of scientific information.
    As part of this action, EPA is also renaming the IUR to CDR. This
name change is intended to better reflect the distinction between this
data collection (which includes exposure-related data) and the TSCA
Inventory itself (which only involves chemical identification
information). Identifying this data collection as ``CDR'' will make it
easier for the public to understand what information is available to
them through the data collection. The name change thereby contributes
to the Agency's current chemicals management program by increasing
transparency and facilitating public access to information about
chemical substances.

E. When is reporting required?

    EPA promulgated a final rule, published in the Federal Register
issue of May 11, 2011 (Ref. 6), to suspend the 2011 submission period.
EPA suspended the submission period to allow additional time to
finalize the proposed modifications, and to provide sufficient time for
companies to comply with the CDR reporting requirements. This action
supersedes the suspension of the 2011 submission period by establishing
a new sequence of submission periods, beginning with a submission
period in 2012. For the 2012 CDR, all information reported to EPA in
response to 40 CFR part 711 must be submitted between February 1, 2012,
and June 30, 2012. Beginning in 2016 and for each subsequent submission
period, the submission period will begin June 1 and end September 30
(40 CFR 711.20).

III. What are the revised requirements of the CDR?

    EPA is making a number of revisions to the IUR, as described in
this unit. The regulatory text of this document describes the full
specific CDR reporting requirements and includes both the modified and
the unmodified portions of the regulatory text (see 40 CFR part 711).
EPA has also developed guidance documents with specific reporting
instructions, questions and answers, and case studies, and intends to
conduct a webinar to help potential CDR submitters become familiar with
the revised reporting form (Form U) and amended reporting requirements.
Guidance documents and information on the webinar are available on the
CDR Web site (http://www.epa.gov/iur).

A. What technical modifications have been made to the regulatory text?

    The Agency is making several technical modification related to
moving the regulatory text to its own part in the CFR. The chemical
substances that are covered by the CDR rule are on the Master Inventory
File, which includes chemical substances from the original TSCA
Inventory compilation and those added subsequently through the notice
requirements of TSCA section 5. Because the CDR rule applies to a list
of chemical substances included on the original TSCA Inventory plus
additional chemical substances added subsequently, and because the
Agency from time to time has modified the CDR rule, the Agency believes
the regulatory text associated with the CDR rule should be in its own
part in the CFR, distinct from both the original TSCA Inventory rules
and from the TSCA section 5 requirements.
    1. Move the IUR regulatory text from 40 CFR part 710, subpart C, to
40 CFR part 711 and eliminate subpart divisions. Subpart C (40 CFR
710.43 to 710.59) of 40 CFR part 710 contains the IUR regulatory text.
EPA is moving all of the subpart C text from 40 CFR part 710 to a new
40 CFR part 711 and adding a new scope and compliance section (40 CFR
711.1).

 Table 1--Distribution Table for 40 CFR Part 710, Subpart C, Regulatory
                                  Text
------------------------------------------------------------------------
          Old CFR citation                     New CFR citation
------------------------------------------------------------------------
40 CFR 710.43                        40 CFR 711.3
40 CFR 710.45                        40 CFR 711.5
40 CFR 710.46                        40 CFR 711.6
40 CFR 710.48                        40 CFR 711.8
40 CFR 710.49                        40 CFR 711.9
40 CFR 710.50                        40 CFR 711.10
40 CFR 710.52                        40 CFR 711.15
40 CFR 710.53                        40 CFR 711.20
40 CFR 710.55                        40 CFR 711.22
40 CFR 710.57                        40 CFR 711.25
40 CFR 710.58                        40 CFR 711.30
40 CFR 710.59                        40 CFR 711.35
------------------------------------------------------------------------

    Because all of the text of subpart C was moved to 40 CFR part 711,
40 CFR part 710 no longer has a subpart C. Neither 40 CFR part 710 nor
40 CFR part 711 have any subparts.
    2. Consolidate definitions. As part of moving the regulatory text
from 40 CFR part 710, subpart C, to 40 CFR part 711, EPA is
consolidating definitions copied from 40 CFR 710.3 and 40 CFR 710.43
into the new 40 CFR 711.3, except where an appropriate definition is
already in place in TSCA section 3 or at 40 CFR 704.3, and an
additional definition of the term in 40 CFR 711.3 was therefore
unnecessarily duplicative. The definitions in TSCA section 3 and at 40
CFR 704.3 are included in 40 CFR 711.3, except insofar as 40 CFR 711.3
provides a modified definition of a term also defined at 40 CFR 704.3.
    The term mixture is defined in both 40 CFR 710.3 and TSCA section
3. For purposes of the CDR rule, EPA is including the definition of
mixture from TSCA section 3 with the definitions at 40 CFR 711.3. The
TSCA mixture definition differs from the definition in 40 CFR 710.3 and
40 CFR 720.3, the regulations used to determine the chemical substances
listed on the TSCA Inventory, in that it does not specifically address
hydrates. A hydrate is a mixture of water and an anhydrous chemical
substance. Because they are mixtures, hydrates are not listed as such
on the TSCA Inventory. For this reason, EPA believes it is superfluous
to include a specific discussion of hydrates in the CDR definition of
mixture. Please see the Instructions for the 2012 TSCA Chemical Data
Reporting (Instructions document) for additional discussion (Ref. 7).
    Unit III.C. contains further discussions about changes to specific
definitions, in relation to the modifications included in this final
rule. A summary of all CDR-related definitions is available in the
docket (Ref. 8).
    3. Remove ``non-isolated intermediate'' definition from 40 CFR
710.3. EPA added a definition to 40 CFR 710.43 for the term non-
isolated intermediate as part of the 2003 IUR Amendments. Subsequently,
as part of the IUR Revisions Rule, published in the Federal Register
issue of December 19, 2005 (Ref. 9), EPA erroneously moved the
definition to 40 CFR 710.3 from 40 CFR 710.43. EPA is removing the
definition from 40 CFR 710.3 as this definition was not associated with
the original TSCA Inventory, and therefore does not belong in 40 CFR
710.3. A definition of this term, codified elsewhere at 40 CFR 704.3,
is included with the CDR definitions at 40 CFR 711.3.
    4. Remove 40 CFR part 710, subpart B. EPA is removing the
regulatory text contained in 40 CFR part 710, subpart B (40 CFR 710.23
to 710.39). This text refers to IUR submission periods of 2002 and
earlier and is obsolete. As noted in 40 CFR 710.1, the Agency expressed
its intent to remove 40 CFR part 710, subpart B, once the 2002 update
was complete.
    5. Remove superfluous text associated with reporting production
volumes. EPA is removing the phrase ``provided that the reported
figures are within 10% of the actual volume'' from the
production volume reporting requirements found in 40 CFR
710.52(c)(3)(iv), which appears in the new 40 CFR part 711 as 40 CFR
711.15(b)(3)(iv). The revised wording would be ``This amount must be
reported to two significant figures of accuracy.'' The phrase that was
removed is superfluous because any number reported accurately to two
significant figures is within 10% of the correct value.
    6. Correct text associated with reporting number of sites and
number of workers. EPA is replacing the phrase ``less than'' with the
phrase ``fewer than'' in the ranges used to report the number of
workers found in the table in 40 CFR 710.52(c)(3)(v), which appears in
the new 40 CFR part 711 as 40 CFR 711.15(b)(3)(vii) and the number of
sites found in the table in 40 CFR 710.52(c)(4)(i)(E), which appears in
the new 40 CFR part 711 as 40 CFR 711.15(b)(4)(i)(E). This change makes
the phrases describing the ranges grammatically correct.

B. What are the changes to the method of submission?

    EPA is requiring the mandatory use of Agency-provided, web-based
reporting tool (e-CDRweb) and CDX to submit the completed Form U to the
Agency. After the final rule's effective date, EPA will no longer
accept paper submissions or electronic media (i.e., as a file on a CD-
ROM) for any CDR submission.
    In order to submit electronically to EPA via CDX, individuals
acting on behalf of the submitter must first register with CDX. CDX
registration is a requirement for all electronic submissions using CDX;
this requirement predates this final rule. EPA has modified the 2006
Electronic Signature Agreement (ESA) Form to identify more clearly the
individual(s) required to sign the ESA Form (Ref. 10). Each CDR
submission must have an authorized official associated with the
submission, who is the person signing the certification statement and
submitting the CDR report via CDX. The authorized official must
complete both an ESA Form and the CDX registration process. Companies
can access the reporting tool upon completion of their CDX
registration. The instruction manual and other guidance materials are
available on EPA's Web site (http://www.epa.gov/iur).

C. What definitions have been modified or added to clarify the
reporting requirements?

    As part of developing the definition section for 40 CFR part 711,
EPA is modifying six definitions associated with the CDR rule and
adding four new definitions. In 40 CFR 704.3 and 40 CFR 710.3, EPA is
also modifying the definition of importer by removing the citation to
19 CFR 1.11.
    1. Manufacture and manufacturer. To improve the information
submitted through the CDR rule, EPA is modifying the definition of
manufacture by including elements from the 40 CFR 720.3 definition for
manufacturer. The Agency is also adding a simple definition for the
term manufacturer to 40 CFR 711.3. In addition to the change to the
definition of manufacture, EPA is adding a paragraph (c) to the
regulation at 40 CFR 711.22 to clarify the reporting relationship
between the contracting company and the toll manufacturer. The
contracting company and the toll manufacturer should confer with each
other to avoid duplicate reporting, and both the contracting company
and the toll manufacturer are liable if no report is made. EPA agreed
with comments that the ``primarily responsible'' language that was
proposed was confusing and needed to be revised. As a result, EPA
modified paragraph (c) of 40 CFR 711.22 to clarify that the contracting
company and the toll manufacturer should determine among themselves who
should submit the required report for the site. EPA also added ``per
site'' in two places in paragraph (c) of 40 CFR 711.22 to

specify that there is supposed to be one report per chemical substance,
per site. See Unit III.C.2., for further discussion of the site for
contract manufacturing situations.
    This final rule defines the term manufacture under the CDR to mean:

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 a complex combination of substances. When a chemical
substance, manufactured other than by import, is:
    (1) 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, then that chemical substance is
co-manufactured by the producing manufacturer and the person
contracting for such production.

    This final rule defines the term manufacturer under the CDR to mean
``a person who manufactures a chemical substance.''
    2. Site. EPA is amending the definition of site to clarify that the
importer's site must be a U.S. address; accommodate manufacturing under
contract; and accommodate portable manufacturing units. See Unit
III.J., for a further discussion of this final rule as it relates to
importers.
    This final rule defines the term site under the CDR to mean:

A contiguous property unit. Property divided only by a public right-
of-way shall be considered one site. More than one plant may be
located on a single site.
    (1) For chemical substances manufactured under contract, i.e.,
by a toll manufacturer, the site is the location where the chemical
substance is physically manufactured.
    (2) The site for an importer who imports a chemical substance
described in 40 CFR 711.5 is the U.S. site of the operating unit
within the person's organization that is directly responsible for
importing the chemical substance. The import site, in some cases,
may be the organization's headquarters in the United States. If
there is no such operating unit or headquarters in the United
States, the site address for the importer is the U.S. address of an
agent acting on behalf of the importer who is authorized to accept
service of process for the importer.
    (3) For portable manufacturing units sent out to different
locations from a single distribution center, the distribution center
shall be considered the site.

    3. Electronic-reporting related definitions. EPA is adding two new
terms, Central Data Exchange (CDX) and e-CDRweb. The Agency is adding
these terms to provide clarity to the requirement for electronic
reporting of CDR data. The term CDX means ``EPA's centralized
electronic document receiving system, or its successors.'' The term e-
CDRweb means the ``electronic, web-based CDR tool provided by EPA for
the completion and submission of the CDR data.''
    4. Processing and use-related definitions. EPA is amending the
definitions of the terms commercial use and consumer use in order to
make them more consistent with the definitions developed
collaboratively by the United States and Canada. See Unit III.G.8.a.,
for further information. While the definitions for these two terms
differ in their precise wording from the Canadian version (to preserve
the use of terminology defined in CDR and related regulations), EPA
does not expect the basic application of these two terms to differ from
the basic application of the Canadian definitions (Ref. 11). The term
commercial use means ``the use of a chemical substance or a mixture
containing a chemical substance (including as part of an article) in a
commercial enterprise providing saleable goods or services.'' Examples
included in the 40 CFR 710.43 definition have been eliminated. The
slightly modified definition of consumer use is ``the use of a chemical
substance or a mixture containing a chemical substance (including as
part of an article) when sold to or made available to consumers for
their use.'' The restrictions associated with where a consumer would
use the product have been removed.
    EPA is adding a definition for the term industrial function. For
the 2006 IUR, EPA defined industrial use and did not define industrial
function. The inclusion of both definitions provides clarity for the
industrial processing and use reporting requirements and makes the
Agency's requirements consistent with those collaboratively developed
with Canada (Ref. 11). Additional discussion of those requirements is
in Unit III.G.7. With this final rule, industrial function means ``the
intended physical or chemical characteristic for which a chemical
substance or mixture is consumed as a reactant; incorporated into a
formulation, mixture, reaction product, or article; repackaged; or
used.''
    5. Principal reporting year and submission period. As described in
Unit II.A., EPA is changing the reporting frequency from every 5 years
to every 4 years and requiring the reporting of production volumes for
each calendar year since the last principal reporting year. EPA is
modifying the terms reporting year and submission period to reflect
these changes.
    The term reporting year is modified to add the term ``principal''
and to replace the word ``information'' with ``manufacturing,
processing and use data.'' These changes are to indicate that the
principal reporting year is the year in which most of the reported data
are based. Under the final rule, the principal reporting year is the
latest complete calendar year preceding the submission period.
Additionally, EPA is removing the reference to ``the calendar year at
5-year intervals thereafter'' and removing the reference to ``calendar
year 2005.'' With these changes, the term principal reporting year is
defined as ``the latest complete calendar year preceding the submission
period.''
    The term submission period is modified by removing the phrase
``generated during the reporting year.'' With this change, the
definition of submission period reflects that data for years in
addition to the principal reporting year would be reported. With this
change, the definition of submission period means ``the period in which
manufacturing, processing, and use data are submitted to EPA.''

D. Has the reporting frequency been changed?

    As proposed, EPA has changed the reporting frequency to every 4
years. The Agency has determined that reporting every 5 years is too
infrequent and believes that returning reporting to every 4 years will
provide data sufficiently current to meet Agency and public needs.
After the 2012 submission period, the next submission period under the
CDR rule will occur in 2016. The submission period will continue to
occur in the year following the principal reporting year.

E. How have the reporting thresholds changed?

    Reporting thresholds are used to determine when CDR reporting is
required for a subject chemical substance at a manufacturing (including
importing) site. EPA has made three changes related to the reporting
thresholds:
     Determination of whether you meet the 25,000 lb threshold.
     Replacement of the 300,000 lb threshold for reporting
information in Part III of Form U.
     Reduction of the 25,000 lb threshold for certain chemical
substances.
    1. Method for determining whether a person is subject to CDR
reporting requirements. For the 2012 submission period, manufacturers
(including importers) are required to report under the CDR rule if they
manufacture

(including import) a chemical substance listed on the TSCA Inventory
during the principal reporting year (i.e., 2011 for the 2012 submission
period); the chemical substance is not otherwise exempt; and the
associated production volume (domestically manufactured plus imported
volumes) at a site met or exceeded 25,000 lb during the principal
reporting year (i.e., 2011 for the 2012 submission period).
    For submission periods subsequent to the 2012 submission period,
the determination of the need to report is based on whether, for any
calendar year since the last principal reporting year, a chemical
substance was manufactured (including imported) at a site in production
volumes of 25,000 lb or greater. For example, for the 2016 submission
period, it would be necessary to examine the annual production volumes
for the calendar years 2012 to 2015 for the site. If the production
volume for a reportable chemical substance were 25,000 lb or greater
for any calendar year during that 4-year period, then it would be
necessary to report the chemical substance, unless it were otherwise
exempt. For instance, a subject chemical substance with production
volumes of 5,000 lb in 2015 and 35,000 lb in 2012 would be reported for
the 2016 CDR. Regardless of the 2015 production volume, in this example
scenario the 2016 CDR submission would contain detailed information
based on the production volume during the 2015 calendar year and
production volume information only for the years 2012 through 2014. See
Unit III.D.1. of the proposed rule (Ref. 1) for further discussion.
    EPA is finalizing this change because of the mounting evidence that
many chemical substances, even larger production volume chemical
substances, often experience wide fluctuations in production volume
from year to year. (See Unit III.D.1. of the proposed rule (Ref. 1).)
This can result in the production volume of a chemical substance
exceeding the threshold for several years, then falling below the
threshold during the CDR principal reporting year. EPA believes that
using production volume reporting for all years since the last
principal reporting year to determine reporting obligations will yield
a much more accurate picture of the chemical substances currently in
commerce, ensuring proper review under EPA's risk screening,
assessment, and management activities and providing better information
to the public. This issue is addressed further in Unit V.C. as well as
in the ``Summary of EPA's Responses to Public Comments Submitted in
Response to Proposed TSCA Inventory Update Reporting Modifications
Rule'' (Responses to Comments document) (Ref. 12).
    2. Replacement of the 300,000 lb threshold for processing and use
information. EPA is replacing the 300,000 lb threshold for processing
and use information by phasing in a lower reporting threshold. For the
2012 CDR, all submitters of non-excluded chemical substances are
required to report processing and use information if they manufactured
(including imported) 100,000 lb or more of a chemical substance in
2011. Subsequent to the 2012 submission period, the reporting threshold
will be 25,000 lb (or 2,500 lb for chemical substances subject to 40
CFR 711.8(b)). EPA is replacing the 300,000 lb reporting threshold in
order to collect information necessary to complete screening-level
exposure characterizations for CDR reportable chemical substances. EPA
is phasing in the lower threshold in order to give chemical
manufacturers time to comply with the modified reporting requirements.
    In order to select a threshold for processing and use reporting,
EPA considered the burden of reporting as well as the Agency's needs
for processing and use information on the maximum number of chemical
substances. As discussed elsewhere in this preamble and other
supporting documents, EPA identified that the processing and use data
received from the 2006 IUR was not sufficient in part because it did
not include information on many HPV and most moderate production volume
(MPV) chemical substances that EPA was trying to assess. Therefore, in
its proposal, EPA proposed lowering the processing and use reporting
threshold from 300,000 lb to 25,000 lb in order to enable the Agency to
collect exposure-related information needed to screen and prioritize
the HPV and MPV chemical substances. EPA received comments suggesting
that the Agency adopt a phased-in approach for reducing the threshold,
similar to the approach used for introducing the requirement for
reporting information for inorganic chemical substances. Manufacturers
reporting for inorganic chemical substances were provided a one-time
partial exemption for those substances for the 2006 IUR, thereby
phasing in reporting. Other commenters suggested that because reporting
of processing and use information for inorganic chemicals was not
required for the 2006 IUR, the industry sector is still inexperienced
with reporting such information and therefore should be given an
opportunity to report under the existing thresholds. Another commenter
suggested that EPA lower the processing and use threshold to 100,000
lb, which is consistent with one of the triggers for the small business
exemption.
    EPA agrees with a phased-in approach because it provides submitters
with an opportunity to become familiar with the reporting requirements,
while at the same time providing much needed and more complete
processing and use information on chemical substances of interest to
the Agency. Future reporting of the processing and use information by
all submitters will provide EPA and others with needed additional
information for those chemical substances with production volumes of
25,000 lb or more at a site. In the future, EPA may find it necessary
to collect information on chemical substances at reporting thresholds
below the thresholds introduced in this action.
    Using the 2006 IUR data, EPA looked at the effect of setting the
processing and use reporting threshold at various levels. Based on this
information, lowering the threshold to 25,000 lb would not have brought
in a significant number of new reporters for the 2012 submission
period, because about 89% of companies and 86% of sites reported at
least one chemical substance with a production volume of 300,000 lb or
more in 2006 (Ref. 13). Therefore, most companies would be expected to
be generally aware of the processing and use reporting requirements
because the company would have reported such information on at least
one chemical substance.
    On a chemical-by-chemical basis, EPA's examination of the 2006 IUR
data revealed that approximately 66% of the individual reports were
above the 300,000 lb threshold, and that these reports covered
approximately 60% of the chemical substances reported for the 2006 IUR.
Lowering the threshold to 25,000 lb would result in processing and use
information on 40% more chemicals and would have greatly informed EPA's
Existing Chemicals Program. As discussed earlier, EPA recognized the
need to allow companies time to become familiar with reporting the
processing and use information, and therefore considered alternate
reporting thresholds for the 2012 CDR. Lowering the threshold to
100,000 lb results in processing and use information on approximately
23% more chemical substances than the 300,000 lb threshold, while
increasing the number of reports by only approximately 18%. EPA
believes that the 100,000 lb threshold, as an interim threshold,
provides an appropriate balance

between increasing the number of chemicals with processing and use
information and increasing the reporting burden on industry. See the
``Economic Analysis for the Final Inventory Update Reporting (IUR)
Modifications Rule'' (Economic Analysis) (Ref. 14) for further
discussion.
    The exposure information is an essential part of developing risk
evaluations and, based on its experience in using this information, the
Agency believes that collecting this exposure information is critical
to its mission of characterizing exposure, identifying potential risks,
and noting uncertainties for these lower production volume chemical
substances. In addition, the lower thresholds will provide the public
with information on a greater number of chemical substances. This issue
is addressed further in Unit V.C.2., as well as in the Responses to
Comments document (Ref. 12).
    3. Reduction of the 25,000 lb threshold for specific regulated
chemical substances. For the 2012 CDR, EPA is maintaining the 25,000 lb
reporting threshold for chemical substances that are the subject of
particular TSCA rules and/or orders. For future CDR collections, EPA is
reducing the threshold (including the threshold for the collection of
processing and use information) to 2,500 lb for those chemical
substances (40 CFR 711.8(b)).
    EPA proposed to eliminate the threshold, which would have required
manufacturers (including importers) of such chemical substances to
report under the CDR rule, regardless of the production volume. A
number of commenters supported the proposal to eliminate the reporting
threshold while others felt the requirement would be overly burdensome,
especially for imported chemical substances or mixtures. In its
proposal, EPA specifically asked for comment on whether a de minimis
production volume threshold should be set for these chemical substances
and how best to set such a de minimis threshold. Some commenters
opposed setting a de minimis threshold and others suggested a variety
of methods for establishing one.
    For many of the reasons identified by commenters (e.g., the expense
and burden of collecting the information, and difficulty in knowing
whether low-concentration chemical substances are present in formulated
mixtures), EPA has decided to set a de minimis threshold and to delay
its implementation. Beginning with the 2016 submission period, the
reporting threshold will be reduced to 2,500 lb for those chemical
substances that are:
     The subject of a rule proposed or promulgated under TSCA
section 5(a)(2), 5(b)(4), or 6,
     The subject of an order issued under TSCA section 5(e) or
5(f), or
     The subject of relief that has been granted under a civil
action under TSCA section 5 or 7.
(40 CFR 711.8(b))
    For the 2016 submission period and submission periods thereafter, a
manufacturer (including importer) of such chemical substances is
required to report manufacturing information on the chemical substances
if they are manufactured (including imported) in volumes of 2,500 lb or
more during any of the years since the last principal reporting year
(e.g., 2011). Information on the processing and use of the chemical
substances must be reported if they were manufactured (including
imported) in volumes of 2,500 lb or more during any of the years since
the last principal reporting year. In addition to the manufacturing,
processing, and use information for the principal reporting year (e.g.,
2015), the production volumes for each year since the last principal
reporting year must also be reported. For the 2016 submission period,
for example, a manufacturer (including importer) must consider the
manufactured or imported volume during the years 2012 through 2015 to
determine the need to report; must report the production volumes for
each year from 2012 to 2015; and must report the full manufacturing,
processing, and use information for 2015.
    Chemical substances that are the subject of these particular TSCA
actions are of demonstrated high interest to the Agency. EPA is
promulgating this change to help reduce the reporting burden for
submitters and to ensure the availability of current information when
the Agency has expressed a concern in the form of regulatory action on
those chemical substances. EPA will use the CDR data associated with
these specific regulated chemical substances to monitor chemical
substance production and compliance with the particular TSCA actions.
In the future, EPA may find it necessary to collect information on
chemical substances at a reporting threshold below the 2,500 lb
threshold introduced in this action. Although the 2,500 lb threshold is
higher than the proposed threshold of zero, the enhanced information
that will be gathered during the 2016 submission period will enable the
Agency and others to more efficiently identify those chemical
substances warranting further, more in-depth review, as well as
chemical substances of lesser concern. See Unit V.C.3., for further
discussion.
    As under the 2006 IUR, if a manufacturer qualifies for the small
manufacturer exemption at 40 CFR 711.9, it is exempt from CDR
reporting. Nothing in this final rule affects the scope of this
exemption at 40 CFR 711.9. However, because the reduction in the
reporting threshold to 2,500 lb is generally applicable to all
manufacturers of the subject chemical substances, for the 2016
submission period and subsequent submission periods, it may affect
small manufacturers to the extent they are non-exempt under 40 CFR
711.9. As under the 2006 IUR, small manufacturers are generally exempt
from CDR reporting but are specifically subject to reporting with
respect to any chemical substance that is the subject of a rule
proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or is the
subject of an order in effect under TSCA section 5(e), or is the
subject of relief that has been granted under a civil action under TSCA
section 5 or 7 (40 CFR 711.9). With the exception of rules proposed or
promulgated under TSCA section 4, the same TSCA actions that make small
manufacturers ineligible for a CDR exemption under 40 CFR 711.9 (with
respect to the particular chemical substance that is the subject of the
action) will also make those small manufacturers subject to the 2,500
lb reporting threshold in the 2016 submission period and subsequent
submission periods (40 CFR 711.8(b)). The proposal or promulgation of a
rule under TSCA section 4 affects the small manufacturer exemption but
it does not affect the applicable reporting threshold under CDR.
    In the proposed rule, EPA specifically sought comment on whether
circumstances triggering an exception to the 25,000 lb reporting
threshold for a chemical substance should include the proposal of
certain rules for the chemical substance, under TSCA section 5(a)(2),
5(b)(4), or 6. EPA explained that such an approach would more closely
parallel the exception language in the introductory paragraph to 40 CFR
711.6 and in 40 CFR 711.9. (See Unit III.D.3. of the proposed rule
(Ref. 1)). Including these types of proposed rules in the list of
triggering circumstances is also more consistent with reporting
obligations under other parts of TSCA, such as 12(b). Among other
situations, reporting under TSCA 12(b) is required when any rule under
TSCA section 5 or 6 is proposed or promulgated. In response to the
comments received, EPA has determined that chemical substances

subject to a rule proposed under TSCA section 5(a)(2), 5(b)(4), or 6
will be excepted from the 25,000 lb reporting threshold, and thus will
be reportable at 2,500 lb beginning with the 2016 CDR. See Unit V.C.3.,
for further discussion.

F. What are the changes to the chemical substances covered by CDR?

    1. Water. EPA is fully exempting all (both naturally occurring and
manufactured) water (Chemical Abstracts Service Registry Number (CASRN)
7732-18-5) (40 CFR 711.6(a)(4)) from reporting under the CDR rule.
    2. Fully exempt polymers removed from partially exempt list.
Polymers are a class of chemical substances for which CDR reporting is
not required (40 CFR 711.6(a)(1)). However, three polymers were
previously listed in the partially exempt list of chemical substances
at 40 CFR 710.46(b)(2)(iv): Starch (CASRN 9005-25-8), dextrin (CASRN
9004-53-9), and maltodextrin (CASRN 9050-36-6). EPA has removed from
the partially exempt list of chemical substances at 40 CFR
711.6(b)(2)(iv) these three chemical substances which, as polymers, are
fully exempt from reporting.
    3. Chemical substances that are the subject of an ECA are
ineligible for exemptions. EPA may enter into an ECA, pursuant to
procedures at 40 CFR part 790, with a manufacturer of a chemical
substance to obtain testing where a consensus exists among EPA,
affected manufacturers and/or processors, and interested members of the
public concerning the need for and scope of testing. Chemical
substances that are the subject of an ECA are now included in the list
of chemical substances that are ineligible for a CDR exemption, in the
introductory paragraph of 40 CFR 711.6, along with the other chemical
substances that are likewise not eligible for a CDR exemption. The
paragraph states that a chemical substance ``is not exempted from any
of the reporting requirements of this part if that substance is the
subject of a rule proposed or promulgated under section 4, 5(a)(2),
5(b)(4), or 6 of the Act, or is the subject of a consent agreement
developed under the procedures of 40 CFR part 790, or is the subject of
an order issued under section 5(e) or 5(f) of the Act, or is the
subject of relief that has been granted under a civil action under
section 5 or 7 of the Act.''

G. What changes have been made to reportable data elements?

    1. Parent company and site identity. Manufacturers (including
importers) are required to report the company name and Dun & Bradstreet
D-U-N-S[reg] ((D&B) number) to identify the company associated with the
plant site, and also to report the site name, address, and D&B number.
If the company associated with the plant site does not have a D&B
number, the manufacturer (including importer) must obtain one for the
company. Likewise, if the plant site does not have a D&B number, the
manufacturer (including importer) must obtain one for the site. EPA
received a variety of questions concerning the correct company name to
report during the 2006 IUR submission period. EPA is now clarifying
what is meant by company name, by requiring at 40 CFR 711.15(b)(2)(ii)
that the company name provided be the U.S. parent company name and
defining ``U.S. parent company,'' at 40 CFR 711.3, to mean ``the
highest level company, located in the United States, that directly owns
at least 50% of the voting stock of the manufacturer.'' As noted in the
proposed rule (Ref. 1), EPA believes that using an approach that is
consistent with the Toxics Release Inventory (TRI) reporting
requirements would be most clear both for reporters and users of the
data. The CDR definition of ``U.S. parent company name'' is consistent
with the use of the term of ``parent company'' in section 5 of the 2009
Toxic Chemical Release Inventory Reporting Forms and Instructions (Ref.
15). The 2006 IUR submissions from different reporting sites contained
varying D&B numbers for parent companies that appeared to be the same
company. In order to better identify when reporting sites are under the
same parent company, EPA is requiring the address as well as the D&B
number of the parent company.
    2. Technical contact. Manufacturers (including importers) are
required to provide a technical contact for their CDR submission. The
technical contact does not have to be a person located at the
manufacturing (including importing) site, but must be a person who can
answer questions EPA may have about the reported chemical substance. In
the proposed rule, EPA had stated that the technical contact should be
a person located at the manufacturing (including importing) site. EPA
has decided, however, to not impose limitations on where the technical
contact can be located. Therefore, companies may use their discretion
in selecting a technical contact or multiple technical contacts, as
provided by the new e-CDRweb tool. Submitters should consider, in
selecting the technical contact, that EPA may have follow-up questions
about a CDR submission, one or more years after the submission date.
    3. Chemical identification. Manufacturers (including importers) are
required to submit the correct chemical identity for each subject
chemical substance.
    a. Chemical name. EPA is requiring the reporting of the Chemical
Abstracts (CA) Index Name currently used to list the chemical substance
on the TSCA Inventory as the chemical name reported for CDR. The
reporting tool will be directly linked to the non-confidential portion
of the TSCA Inventory through the Agency's Substance Registry Services
(SRS) database, which lists all chemical substances on the TSCA
Inventory. This link will enable submitters to select the correct CA
Index Name for their reportable chemical substance(s) from SRS. EPA
believes that using SRS to select the chemical name as currently listed
on the TSCA Inventory will greatly reduce the number of incorrectly
identified chemical substances and allow the data to be released more
quickly to the public. See the discussion in Unit III.G.3.c. regarding
identifying confidential chemical substances. Manufacturers (including
importers) are allowed to supply, as part of a joint submission, an
alternate chemical name, and in the case of importers, a trade name, in
those instances where a supplier will not disclose to the submitter the
specific chemical name of the imported TSCA Inventory chemical
substance or a reactant used to manufacture the TSCA Inventory chemical
substance. In these cases, the manufacturer (including importer) and
the supplier may report the information required in this part in a
joint submission. In order to clarify this requirement, EPA is amending
40 CFR part 711.15(b)(3)(i), to state that the importer must ask the
supplier of the confidential chemical substance to directly provide EPA
with the correct chemical identity, in a joint submission with the
manufacturer. Similarly, in the event a manufacturer submitting a Form
U cannot provide the whole chemical identity because the reportable
chemical substance is manufactured using a reactant having an unknown
specific chemical identity claimed as confidential by its supplier, the
manufacturer must ask that the supplier directly provide to EPA the
correct chemical identity of the confidential reactant in a joint
submission. Nothing in 40 CFR 711.15(b)(3)(i) relieves a manufacturer
(including an importer) of its obligation to report information that it
actually knows or can reasonably ascertain. See Unit III.J.2., for
additional information regarding joint submissions.

Detailed instructions regarding joint submissions are included in the
Instructions document included in the docket (Ref. 7).
    b. Chemical identifying number. As part of the chemical identity,
submitters provide a chemical identifying number associated with the
correct CA Index Name, as described in Unit III.G.3.a. EPA is requiring
that submitters report only the CASRN as a chemical identifying number,
except in the case of confidential chemical substances. In the case of
confidential chemical substances, EPA is requiring that submitters
report only the TSCA Accession Number as a chemical identifying number.
EPA is removing the Premanufacture Notification (PMN) number as an
allowed chemical identifying number because each TSCA Inventory
chemical substance has either (or both) a CASRN or a TSCA Accession
Number, which are likely to be already known to the submitter.
Submitters who, in the past, have reported using the PMN number of a
confidential substance can identify the TSCA Accession Number from SRS
by searching on the PMN number. Those submitters who are not able to
identify the TSCA Accession Number by searching SRS may contact EPA in
writing, if necessary, to learn the TSCA Accession Number assigned when
the Notice of Commencement (NOC) was submitted to the Agency. Specific
information is included in the Instructions document (Ref.7).
    c. Chemical identity for chemical substances listed on the
confidential portion of the TSCA Inventory. In cases where a chemical
substance is listed on the confidential portion of the TSCA Inventory,
submitters are to report the chemical substance's TSCA Accession Number
and generic name, which are listed on the non-confidential portion of
the TSCA Inventory and are included in SRS. In order to continue to
protect the confidentiality of the underlying specific chemical
identification information (i.e., the CASRN and specific chemical
name), the submitter must claim the chemical identity as CBI and
complete the upfront substantiation. Doing so will maintain a
confidentiality claim for the underlying CASRN and specific chemical
name on the confidential portion of the TSCA Inventory (the TSCA
Accession Number and generic chemical name remain non-confidential).
Failure to identify the chemical identity as CBI and complete the
upfront substantiation will waive any CBI claim to the chemical
identity and will result in the transfer of the chemical substance from
the confidential portion of the TSCA Inventory to the non-confidential,
publicly releasable, portion of the TSCA Inventory.
    4. Production volume. Manufacturers (including importers) are
required to report production volume information for each chemical
substance for which they submit a CDR report. EPA has made a number of
changes to the reporting of production volume and associated
information.
    a. Report production volume for each of the years since the last
principal reporting year. In addition to the production volume for the
principal reporting year, EPA is requiring the reporting of production
volume for 2010 for the 2012 submission period and for each of the
years since the last principal reporting year beginning with the 2016
submission period. More specifically, for the 2012 submission period,
manufacturers (including importers) will be required to report the
total annual volume (domestically manufactured and imported volumes in
pounds) of each reportable chemical substance at each site during
calendar year 2010. For submission periods subsequent to the 2012
submission period, manufacturers (including importers) will be required
to report the total annual volume (domestically manufactured and
imported volumes in pounds) of each reportable chemical substance at
each site for each complete calendar year since the last CDR principal
reporting year. For example, for the 2016 submission period,
manufacturers (including importers) of a reportable chemical substance
will report the production volume of that chemical substance for each
of the following calendar years: 2015, 2014, 2013, and 2012.
    EPA had proposed that this requirement begin in full starting with
the current submission period, which would have required submitters to
report production volumes for 2006 through 2010 for the 2012 submission
period. Several commenters supported the proposed change while others
stated that the requirement would be overly burdensome, especially for
the submission period immediately following promulgation of this rule.
Some commenters recommended that EPA delay the implementation of the
requirement until the next reporting cycle to allow companies
sufficient time to prepare for the additional data collection effort.
In response to the comments received, EPA believes its decision to
defer this requirement until the next reporting cycle is warranted in
light of other simultaneous changes to the CDR rule which increase
reporting burden. The Agency also believes the delay will give
companies adequate time to establish systems to collect and compile the
required information.
    For the principal reporting year, e.g., 2011, the domestic
manufacture and the import production volume will continue to be
reported separately on the same report. EPA review and analysis of the
2006 IUR data has revealed that some submitters are erroneously
submitting multiple reports for the same chemical substance, at times
reporting the information associated with domestic manufacturing and
importing in different reports. Submitters should complete only one
report for each chemical substance.
    b. Volume of chemical substance used on-site. EPA is requiring that
submitters report the volume of a manufactured (including imported)
chemical substance used at the reporting site. The requirement to
report the volume used on-site is replacing the requirement to indicate
that the chemical substance is site-limited. Under this final rule,
either domestically manufactured or imported chemical substances can be
reported as used at the reporting site.
    c. Indicate whether imported chemical substances are physically at
the reporting site. EPA is adding a requirement to indicate whether an
imported chemical substance is physically at the reporting site. Often,
the site reporting an imported chemical substance never physically
receives the chemical substance, but instead ships it directly to
another location such as a warehouse, a processing or use site, or a
customer's site.
    d. Report volume exported. EPA is adding a requirement to report
the production volume directly exported and not domestically processed
or used. This will allow EPA to better identify the proportion of the
production volume accounted for by the processing and use reporting,
given that such downstream reporting is not required for directly
exported chemical substances.
    5. Identify whether a chemical substance is to be recycled,
remanufactured, reprocessed, or reused. In the proposed rule, EPA
sought comment on adding a checkbox indicating whether a manufactured
chemical substance was recycled, remanufactured, reprocessed, reused,
or reworked. In response to the comments received, EPA has determined
that the term ``reworked'' may be interpreted and applied too broadly
to provide the type of information that EPA needs to collect and has
removed ``reworked'' from the list of recycling synonyms, but has
chosen to otherwise finalize this reporting requirement as proposed.
Consequently, EPA is adding a

requirement to indicate whether a manufactured chemical substance, such
as a byproduct, is to be recycled, remanufactured, reprocessed, or
reused. Submitters should indicate whether their manufactured chemical
substance, which otherwise would be disposed of as a waste, is being
removed from the waste stream and has a commercial purpose (i.e., it is
being recycled, remanufactured, reprocessed, or reused). Indicating
that a manufactured chemical substance, such as a byproduct, is to be
recycled, remanufactured, reprocessed, or reused does not affect the
reporting requirements associated with any chemical substance
manufactured from the byproduct. See Unit IV.2., for detailed
information on byproduct reporting.
    6. Concentration ranges. EPA is eliminating gaps in the ranges used
to report concentration in 40 CFR 711.15(b)(3) and (b)(4). The ranges
are now:
     Less than 1% by weight.
     At least 1% but less than 30% by weight.
     At least 30% but less than 60% by weight.
     At least 60% but less than 90% by weight.
     At least 90% by weight.
    7. Industrial processing and use information reporting. EPA is
revising the list of industrial function categories and replacing the
NAICS codes with industrial sector categories, as described in Unit
III.G.7.a. and b.
    a. Industrial function categories. EPA is revising the list of
industrial function categories by combining categories that lead to
common exposure scenarios and adding categories where the Agency
believes the existing categories do not adequately describe potential
uses. EPA worked with Environment Canada and Health Canada to develop
the set of categories, which will be used by both the United States and
Canada for inventory reporting (Ref. 11).
    EPA is adding eight new industrial function categories and removing
six existing categories from the previous list; the total number of
industrial function categories has increased to 35. Also, EPA is
renaming several of the industrial function categories to provide a
more informative description of the function of chemical substances
that should be reported in that category. Lastly, EPA is requiring that
if a submitter selects the category ``Other,'' the submitter must
provide its own description of the industrial function of the chemical
substance. EPA is using the industrial function categories listed in
Table 2 of this unit:

       Table 2--Codes for Reporting Industrial Function Categories
------------------------------------------------------------------------
                 Code                               Category
------------------------------------------------------------------------
U001..................................  Abrasives.
U002..................................  Adhesives and sealant chemicals.
U003..................................  Adsorbents and absorbents.
U004..................................  Agricultural chemicals (non-
                                         pesticidal).
U005..................................  Anti-adhesive agents.
U006..................................  Bleaching agents.
U007..................................  Corrosion inhibitors and anti-
                                         scaling agents.
U008..................................  Dyes.
U009..................................  Fillers.
U010..................................  Finishing agents.
U011..................................  Flame retardants.
U012..................................  Fuels and fuel additives.
U013..................................  Functional fluids (closed
                                         systems).
U014..................................  Functional fluids (open
                                         systems).
U015..................................  Intermediates.
U016..................................  Ion exchange agents.
U017..................................  Lubricants and lubricant
                                         additives.
U018..................................  Odor agents.
U019..................................  Oxidizing/reducing agents.
U020..................................  Photosensitive chemicals.
U021..................................  Pigments.
U022..................................  Plasticizers.
U023..................................  Plating agents and surface
                                         treating agents.
U024..................................  Process regulators.
U025..................................  Processing aids, specific to
                                         petroleum production.
U026..................................  Processing aids, not otherwise
                                         listed.
U027..................................  Propellants and blowing agents.
U028..................................  Solids separation agents.
U029..................................  Solvents (for cleaning or
                                         degreasing).
U030..................................  Solvents (which become part of
                                         product formulation or
                                         mixture).
U031..................................  Surface active agents.
U032..................................  Viscosity adjustors.
U033..................................  Laboratory chemicals.
U034..................................  Paint additives and coating
                                         additives not described by
                                         other categories.
U999..................................  Other (specify).
------------------------------------------------------------------------

    b. IS codes. EPA is replacing the 5-digit NAICS codes with 48 IS
codes (Ref. 16). The sectors were adapted from the European Union's
(EU's) ``Guidance on Information Requirements and Chemical Safety
Assessment.'' The IS codes divide the entire range of NAICS codes into
sectors so that there is a sector corresponding to any NAICS code (see
the Instructions document, Ref. 7). The use of the sectors will reduce
the number of unique combinations, thereby increasing the usability of
the data, and also reducing the CDR reporting burden.
    EPA is using the 48 sectors listed in Table 3 of this unit:

                       Table 3--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 clay,
                                         glass, cement, concrete, lime,
                                         gypsum, 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).
------------------------------------------------------------------------

    When the category reported for the IS code is ``Other,'' the
submitter is required to provide a written description of the use of
the chemical substance, which may include the NAICS code.
    8. Consumer and commercial use reporting. EPA is making four
changes to the consumer and commercial information required to be
reported:
     Revising and expanding the list of consumer and commercial
product categories.
     Requiring the provision of a description when the product
category ``Other'' is reported.
     Identifying whether the use is a consumer or a commercial
use, or both.
     Reporting the number of commercial workers reasonably
likely to be exposed while using the reported chemical substance.
    Reporting associated with children's use, the maximum
concentration, and the percent production volume remains unchanged.
    a. Consumer and commercial product categories. EPA is revising the
list of consumer and commercial product categories by combining
categories that lead to common exposure scenarios and adding categories
that were not adequately described in the initial set of categories.
EPA worked with Environment Canada and Health Canada to develop the
categories. Harmonized categories will facilitate consistent reporting
of chemical substance use information by industry in the United States
and Canada (Ref. 11).
    The list includes 33 product categories, including ``Other.''
Examples of new categories which have been added include explosive
materials, building/construction products not covered elsewhere, and
air care products. The glass and ceramic products category had
relatively few 2006 IUR submissions and overlaps with the new
categories, and so has been eliminated. Also, several of the consumer
and commercial product categories have been renamed to better describe
the products that should be

reported in those categories. In addition to revising the overall
product categories, narrower definitions and expanded lists of examples
of products in which the chemical substance would be used will be added
to each category descriptor. The examples were selected to include
items that could have fit into other categories in order to address the
overlap inherent in any product category list. The product categories
were then placed into several broader groupings, e.g., ``Chemicals with
Agriculture and Outdoor Uses'' based on the similarities of products.
EPA believes that the user will find the current groupings easier to
use than the alphabetical listing used for the 2006 IUR. EPA is also
requiring that if a submitter chooses the product category ``Other,''
the submitter must include a text description for the consumer and
commercial product containing the chemical substance.
    EPA is using the consumer and commercial product categories listed
in Table 4 of this unit:

 Table 4--Codes for Reporting Consumer and Commercial Product Categories
------------------------------------------------------------------------
                 Code                               Category
------------------------------------------------------------------------
  Chemical Substances in Furnishing, Cleaning, Treatment Care Products
------------------------------------------------------------------------
C101..................................  Floor Coverings.
C102..................................  Foam Seating and Bedding
                                         Products.
C103..................................  Furniture and Furnishings not
                                         covered elsewhere.
C104..................................  Fabric, Textile, and Leather
                                         Products not covered elsewhere.
C105..................................  Cleaning and Furnishing Care
                                         Products.
C106..................................  Laundry and Dishwashing
                                         Products.
C107..................................  Water Treatment Products.
C108..................................  Personal Care Products.
C109..................................  Air Care Products.
C110..................................  Apparel and Footwear Care
                                         Products.
------------------------------------------------------------------------
    Chemical Substances in Construction, Paint, Electrical, and Metal
                                Products
------------------------------------------------------------------------
C201..................................  Adhesives and Sealants.
C202..................................  Paints and Coatings.
C203..................................  Building/Construction Materials--
                                         Wood and Engineered Wood
                                         Products.
C204..................................  Building/Construction Materials
                                         not covered elsewhere.
C205..................................  Electrical and Electronic
                                         Products.
C206..................................  Metal Products not covered
                                         elsewhere.
C207..................................  Batteries.
------------------------------------------------------------------------
 Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
------------------------------------------------------------------------
C301..................................  Food Packaging.
C302..................................  Paper Products.
C303..................................  Plastic and Rubber Products not
                                         covered elsewhere.
C304..................................  Toys, Playground, and Sporting
                                         Equipment.
C305..................................  Arts, Crafts, and Hobby
                                         Materials.
C306..................................  Ink, Toner, and Colorant
                                         Products.
C307..................................  Photographic Supplies, Film, and
                                         Photochemicals.
------------------------------------------------------------------------
    Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use
                                Products
------------------------------------------------------------------------
C401..................................  Automotive Care Products.
C402..................................  Lubricants and Greases.
C403..................................  Anti-Freeze and De-icing
                                         Products.
C404..................................  Fuels and Related Products.
C405..................................  Explosive Materials.
C406..................................  Agricultural Products (non-
                                         pesticidal).
C407..................................  Lawn and Garden Care Products.
------------------------------------------------------------------------
      Chemical Substances in Products not Described by Other Codes
------------------------------------------------------------------------
C980..................................  Non-TSCA Use.
C909..................................  Other (specify).
------------------------------------------------------------------------

    b. Designation of consumer or commercial use. EPA is requiring
submitters to designate, via a checkbox, whether the indicated product
category is a consumer or a commercial use, or both.
    c. Number of commercial workers reasonably likely to be exposed.
EPA is requiring that submitters report the total number of commercial
workers, including those at sites not under the submitter's control,
that are reasonably likely to be exposed while using the reportable
chemical substance, with respect to each commercial use. The
approximate number of workers should be reported using the same
definitions and ranges used for manufacturing and industrial processing
and use workers required by 40 CFR 711.15(b)(3)(vii) and (b)(4)(i)(F),
respectively. The ranges are:
     Fewer than 10 workers.
     At least 10 but fewer than 25 workers.
     At least 25 but fewer than 50 workers.
     At least 50 but fewer than 100 workers.
     At least 100 but fewer than 500 workers.

     At least 500 but fewer than 1,000 workers.
     At least 1,000 but fewer than 10,000 workers.
     At least 10,000 workers.

H. What changes have been made to the standard for the reporting of
processing and use information?

    In order to collect more complete information regarding industrial
processing and use, and commercial and consumer use of chemical
substances, EPA is, in 40 CFR 711.15(b)(4), replacing the ``readily
obtainable'' reporting standard used for reporting under 40 CFR
710.52(c)(4) with the ``known to or reasonably ascertainable by''
reporting standard set forth under TSCA section 8(a)(2). This is the
same standard that applied to the reporting of information described in
the regulations at 40 CFR 710.52(c)(1), (c)(2), and (c)(3) for the 2006
IUR submission, and this standard continues to apply to the reporting
of such information under 40 CFR 711.15(b)(1), (b)(2), and (b)(3). This
standard covers 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.
    Under the standard, a submitter would therefore prepare its report
about the processing and use of a chemical substance it manufactures
(including imports), without confining its inquiry solely to what is
known to managerial and supervisory employees, but would also be
expected to review information which the manufacturer (including
importer) may have in their possession or control, plus all information
that a reasonable person similarly situated might be expected to
possess, control, or know. The inquiry would be as extensive as a
reasonable person, similarly situated, might be expected to perform.
The standard does not necessarily require that the manufacturer conduct
an exhaustive survey of all employees.
    ``Known to or reasonably ascertainable'' information includes, but
is not limited to, information that may be possessed by employees or
other agents of the company reporting under the CDR rule, including
persons involved in the research, development, manufacturing, or
marketing of a chemical substance and includes knowledge gained through
discussions, symposia, and technical publications. Examples of types of
information that are considered to be in a person's possession or
control, or that a reasonable person similarly situated might be
expected to posses, control, or know, include files maintained by the
submitter, such as marketing studies, sales reports, or customer
surveys; information contained in standard references, such as MSDSs,
that contain use information or concentrations of chemicals in
mixtures; and information from the CASRN and from the D&B number.
    The following hypothetical examples illustrate the anticipated
application of the ``known to or reasonably ascertainable standard,''
in the specific context of the collection of processing and use data
under the CDR. Because the standard applies on a case-by-case basis,
however, these examples cannot substitute for a complete analysis of a
submitter's particular circumstances:
    Company XYZ discovers that it has no knowledge of how a particular
reportable chemical substance (chemical substance 1) is
processed or used by its customers. Company XYZ usually maintains
marketing data documenting customers' use of its chemicals, in line
with the reasonable business practices typical of comparable
manufacturers, but it irrevocably lost these data for chemical
substance 1 due to an inadvertent computer malfunction.
Company XYZ has many customers, but it expects that it could
substantially reconstruct this missing information by briefly
contacting its largest customer and asking that customer how chemical
substance 1 is generally used. Company XYZ contacts this
customer, reports on the basis of the processing and use. data that the
customer was willing to provide. Company XYZ has likely fulfilled its
duties under the reporting standard. Company XYZ would not have
fulfilled its duties under the reporting standard if it had not
endeavored to supplement the information it already knew.
    Company XYZ has never maintained information on how a particular
reportable chemical substance (chemical substance 2) is
processed or used by its customers. However, it is typical for
comparable manufacturers to collect such information as part of their
reasonable business practices. Company XYZ has many customers but it
expects that it could substantially fill this data gap by reviewing the
public Web site of its largest customer. Company XYZ reviews this Web
site, and reports on the basis of the information contained in the Web
site. Company XYZ has likely fulfilled its duties under the reporting
standard. Company XYZ would not have fulfilled its duties under the
reporting standard if it had not endeavored to supplement the
information it already knew.
    Company ABC maintains seasonal marketing data on changes in use
patterns for a particular chemical substance (chemical substance
3). Comparable manufacturers typically only maintain such data
on an annual basis, in line with reasonable business practices. Company
ABC irrevocably loses its summer marketing data for Substance
3, due to an inadvertent computer malfunction. Company ABC
expects that it could substantially reconstruct the missing summer
marketing data by contacting its largest customer and asking the
customer what it used or processed chemical substance 3 for in
the past summer. Nevertheless, instead of attempting to reconstruct the
summer data in this manner, Company ABC reports on the basis of the
processing and use data that it already knows (regarding the winter,
spring, and fall of the year). Company ABC has likely fulfilled its
duties under the reporting standard. Company ABC would not have
fulfilled its duties under the reporting standard if it designated the
information as ``not known or reasonably ascertainable'' simply because
one of the seasonal marketing reports was missing.
    Company ABC has never maintained information on how a particular
reportable chemical substance (chemical substance 4) is
processed or used by its customers. However, it is typical for
comparable manufacturers to collect such information as part of their
reasonable business practices. Company ABC has one major customer and
ten minor customers. Company ABC asks its major customer to supply
information about how chemical substance 4 is processed and
used, but that customer is unwilling to supply this information.
Company ABC reasonably expects that the only remaining way to
substantially fill this data gap would be to send a survey to its ten
minor customers. Company ABC reports that the information is ``not
known or reasonably ascertainable'' to it. Company ABC has likely
fulfilled its duties under the reporting standard.
    EPA would like furthermore to clarify that submitters are not
required to conduct a new or additional customer survey (i.e., to pose
a comprehensive set of identical questions to multiple customers) under
this standard. If particular information cannot be derived or
reasonably estimated from the information available to the company
without conducting further customer surveys, it is not ``known to or
reasonably ascertainable'' to the submitter for purposes of the CDR.
However, to the extent that customer surveys are already in the
submitter's possession or control, and to the extent that reasonable
efforts to analyze or

derive information from already-available customer surveys may inform
processing and use information that is reported, the information is
generally ``known to or reasonably ascertainable.'' See Unit V.E.1.,
and the Responses to Comments document (Ref. 12) for further
discussion. EPA's reporting tool permits submitters to enter or select
``NKRA'' on Form U to address circumstances where the information is
not known to or reasonably ascertainable by the submitter.

I. What changes have been made to requirements for making CBI claims?

    EPA is making several changes to the requirements for claiming
information as confidential. Submitters may claim certain information
reported under the CDR as CBI in accordance with 40 CFR part 2 and CDR
rules at 40 CFR 711.30. Claims of confidentiality may be made for
chemical identity, site identity, and processing and use information,
and submitters must substantiate these claims at the time information
is submitted to EPA. EPA's procedures for handling information claimed
as confidential are set forth at 40 CFR part 2, subpart B. EPA strongly
encourages submitters to review confidentiality claims carefully to
ensure that the information in question falls within the parameters of
TSCA section 14. EPA cautions submitters that they may be subject to
criminal penalties under 18 U.S.C. 1001 if they knowingly and willfully
make a false statement in connection with the assertion of a CBI claim.
CBI claims should be limited to only those data elements the release of
which would likely cause substantial harm to the business' competitive
position. Interested persons are reminded that with regard to chemical
substance use information, EPA is interested in aggregated, general
uses, not detailed uses associated with specific customers.
    To claim information as confidential, a submitter must indicate its
claim by both checking the appropriate box and signing the
certification statement on the reporting form, and may also be required
(depending on the data element) to provide substantiation of the claim
at the time it is made. A submitter must indicate its claims at the
time the information is submitted. If a submitter fails to follow these
procedures, EPA may release the information to the public without
further notice to the submitter. By signing the certification statement
the submitter attests to the secrecy and value of the information for
which confidentiality claims have been asserted.
    1. Chemical identity CBI claims. There is no substantive change to
submitters' ability to make confidentiality claims for chemical
identity in the CDR. As in the past, a submitter may assert a claim of
confidentiality for the identity of the reported chemical substance
only when the chemical substance is listed on the confidential portion
of the TSCA Inventory. Submitters who assert a confidentiality claim
for chemical identity must also provide substantiation for the claim at
time of filing. See 40 CFR 711.30(b).
    However, in response to comments, this final rule includes some
changes to the process that must be used to make this type of CBI
claim. The proposed rule, at 40 CFR 711.15(b)(3)(i), provided that
``[a] submitter under this part may use an EPA-designated TSCA
Accession Number for a confidential chemical substance in lieu of a
CASRN when a CASRN is not known to or reasonably ascertainable by the
submitter.'' In the proposed rule, EPA also noted that up to 5% of the
reports submitted under the 2006 IUR contained chemical identity
problems. EPA therefore proposed to require that submitters report
using the CA Index Name currently used to list the chemical substance
on the TSCA inventory. EPA further indicated that it would include
CASRNs and CA Index Names into the e-CDRweb tool, to the extent
possible without jeopardizing confidentiality claims. EPA believes that
selecting chemical identity from a pre-populated list, rather than
keying in the chemical identity information, will significantly improve
the accuracy and consistency of submitted reports.
    EPA received several comments from industry groups requesting that
the e-CDRweb tool include security safeguards to adequately protect
CBI. In light of the security concerns expressed in public comments,
EPA has decided not to include CASRNs and CA Index Names for chemical
substances on the confidential portion of the TSCA Inventory into the
portions of the e-CDRweb tool that will be publicly accessible.
However, EPA still believes it is important to require that all
chemical identities be selected from a pre-populated list, to avoid
repeating the chemical identity problems experienced with the 2006 IUR.
Therefore, 40 CFR 711.15(a)(3)(i) has been revised in this final rule
to require that submitters who wish to report chemical substances
listed on the confidential portion of the TSCA Inventory use the
chemical substance's TSCA Accession Number and generic name. Requiring
the use of TSCA Accession Numbers and generic names will allow EPA to
adequately protect confidential CASRNs and CA Index Names (by omitting
them from the pre-populated selection list) while still obtaining the
improvements in reporting accuracy it sought in the proposed rule.
    In SRS, a submitter can readily find a cross-reference list that
displays the TSCA Accession Number, generic chemical name, and the PMN
case number (or for an initial TSCA Inventory chemical substance, the
TSCA Inventory reporting form number) for any confidential chemical
substance listed on the TSCA Inventory. Submitters who wish to retain
the CBI claim for the chemical substance identified by the TSCA
Accession Number must assert and substantiate the claim at time of
filing. Submitters who do not wish to retain the CBI claim for the
chemical substance identity, and who wish the chemical substance to be
listed on the public portion of the TSCA Inventory, should not assert a
CBI claim or provide substantiation. Submitters who fail to follow the
required procedures for asserting CBI claims for chemical identity will
waive the claims, and EPA may release the information without further
notice to the submitter. See the regulatory text at 40 CFR 711.30(e).
    2. Upfront substantiation for processing and use information CBI
claims. Under the CDR, a submitter may assert a claim of
confidentiality for data associated with the processing and use of its
chemical substance if the submitter has reason to believe that release
of the information would reveal trade secrets, or confidential
commercial or financial information, as provided by TSCA section 14 and
40 CFR part 2. Under this final rule, EPA is requiring upfront
substantiation for CBI claims for processing and use information.
    In order to submit a claim of confidentiality for processing and
use information data elements, the submitter is required (in addition
to signing the certification statement) to both check the appropriate
box on the reporting form and substantiate the claim in writing, within
the reporting tool, by answering certain questions provided in 40 CFR
711.30(d). EPA revised the substantiation question at 40 CFR
711.30(d)(1)(ii), respecting competitive harm, to include harmful
effect ``to your customer's competitive position.'' Where a submitter
fails to submit substantiation of the processing and use CBI claim in
accordance with the applicable rules (i.e., the submitter does not
provide an answer to all the required questions associated with the

claim on the Form U it submits via e-CDRweb), EPA will consider the
information not subject to a confidentiality claim and may make the
information available to the public without further notice to the
submitter.
    3. Prohibition of confidentiality claims for data elements
identified as ``not known or reasonably ascertainable.'' EPA is
prohibiting claims of confidentiality pertaining to the designation
that information is ``not known or reasonably ascertainable.'' As
described in Unit II.A., for the 2012 and future CDR collections,
submitters will be required to report processing and use information to
the extent that it is known to or reasonably ascertainable by them.
    For the 2006 IUR collection, EPA observed that, on occasion,
processing and use information was claimed as confidential when a
submitter determined that the information was not readily obtainable.
Section 14 of TSCA limits the disclosure of information entitled to
confidential treatment under exemption 4 of the Freedom of Information
Act (FOIA). EPA has considered the NKRA designation and its
relationship to a potential CBI or trade secret claim. Given that a
NKRA assertion is an assertion that no information is available, the
Agency does not believe that the designation conveys trade secret or
confidential commercial or financial information.

J. What changes specifically affect importers?

    1. Importer site address. Submitters report CDR data on chemical
substances that they manufacture domestically and that they import into
the United States. Previously, the regulations defining the site for
importer reporting were found in both the definition for site in 40 CFR
710.3 and in paragraph 40 CFR 710.48(b). EPA is eliminating unnecessary
duplication in the CDR regulation by moving the additional information
regarding the importer site from 40 CFR 710.48(b) into a revised
definition for site at 40 CFR 711.3, as described in Unit III.C.2., and
eliminating 40 CFR 710.48(b).
    In addition, EPA has observed that submitters occasionally use a
foreign address as the site address for the importer. EPA now is
requiring that submitters report a U.S. site address, by modifying the
definition for site to state specifically that the site must be a U.S.
site. The U.S. address of an agent acting on behalf of the importer,
and authorized to accept service of process for the importer, may be
reported as the importer's site address if the operating unit that is
directly responsible for importing the chemical substance and that
controls the import transaction has no U.S. address. The Agency expects
that all importers will have a U.S. site, as defined in the 40 CFR
711.3 definition for site, because, under Customs regulations at 19 CFR
141.18, a non-resident corporation is not permitted to enter
merchandise for consumption unless it has a resident agent in the State
where the port of entry is located, who is authorized to accept service
of process against the corporation.
    2. Joint submissions. For purposes of CDR, submitters are allowed
to report the CDR information jointly with the foreign supplier of a
reportable chemical substance whose chemical identity is unknown to the
importer. Previously, joint submissions could not be made
electronically. EPA is now requiring that submitters use CDX and e-
CDRweb for preparation and submission of joint submissions. See 40 CFR
711.15(b)(3)(i)(C). Therefore, the authorized officials of the jointly
submitting companies will need to register with CDX in order to submit
a joint report to EPA.
    Importers may not know the specific chemical identity of a chemical
substance because the foreign supplier chooses to keep it confidential.
In such a situation, the importer must use e-CDRweb to ask the foreign
supplier to submit the chemical identity information directly to EPA
through a joint report. To submit a joint report, the importer
completes the majority of the required information, and supplies a
trade name or other designation to identify the chemical substance, and
provides contact information for the foreign supplier. The importer
then uses e-CDRweb to contact the foreign supplier and request that the
foreign supplier report the specific chemical identity information
directly to EPA. The importer must submit a copy of such request to
EPA, along with the rest of its CDR submission for the chemical
substance. As a general matter, EPA expects that importers will supply
the information described at 40 CFR 711.15(b)(3)(i)(A), rather than an
``NKRA'' designation, when importers do not know the confidential
chemical identity of a chemical substance they import. EPA believes
that an NKRA designation would generally only be appropriate in the
unlikely event that an importer did not know, and could not reasonably
ascertain, the information needed to link its submission with a
secondary report from the supplier.
    In an acceptable joint submission, the secondary submitter supplies
the chemical identity, as well as its technical contact and company
information, and provides the primary submitter's site information. EPA
will not accept joint submissions that are not submitted electronically
using e-CDRweb and CDX. All information will be saved by the reporting
tool and both submissions will be matched based upon company and
chemical substance information. Once the forms are linked, EPA will
process the joint submission as one report for the reported chemical
substance. See the Instruction document (Ref. 7), for detailed
instructions on submitting a joint report.

IV. What clarifications have been made to reporting requirements?

    1. Clarification of the relationship between company name and site
identity CBI claims. Under the CDR, submitters are able to separately
claim as CBI the company name and site identity associated with a
chemical substance for which they are reporting under the CDR. The
submitter is required to provide an upfront substantiation for CBI
claims for the site identity. EPA believes there is some confusion as
to what is considered confidential when such claims are made, and is
taking this opportunity to provide clarification.
    The CBI claim protects the link between the company and/or site
identity and the particular chemical substance. If the company or site
identity associated with a particular chemical substance is not claimed
as CBI, EPA may make that information available to the public without
further notice to the submitter. EPA will not impute the existence of a
CBI claim for company identity or for site identity from a CBI claim
associated with a different chemical substance.
    Company and site identity CBI claims are separate claims, and in
some cases one type of claim may be justified while the other is not.
Therefore, a submitter is permitted to assert its CBI claim for the
company identity, the site identity, or both the company and site
identity. Such claims must be made for each chemical substance for
which such claims are being made. Because the circumstances for each
chemical substance can vary, the CDR rule does not allow for blanket
claims covering all chemical substances in a site's CDR report.
    Likewise, the submitter must provide separately the required
upfront substantiation for the site identity CBI claims associated with
each chemical substance. For instance, if the submitter is reporting
for five chemical substances and wishes to claim its site information
confidential for three of the five

chemical substances, it must assert the claim and provide separate
upfront substantiation three times, once for each of the three chemical
substances.
    EPA has also observed that submitters sometimes claim only their
company identity, and not their site identity, as confidential. If the
site identity for a particular chemical substance is not claimed as
CBI, or is claimed but not substantiated pursuant to 40 CFR 711.30(c),
EPA may make that information available to the public without further
notice to the submitter. EPA will not impute the existence of a CBI
claim for site identity from a CBI claim for company identity, even if
the company name appears within the site identity information. To help
ensure that submitters consider this issue, the e-CDRweb reporting tool
provides a warning whenever the company identity is claimed as CBI for
a particular chemical substance and the site identity is not also
claimed as CBI for that chemical substance.
    2. Explanation of byproduct reporting. During the 2006 submission
period, EPA received questions about the requirements for reporting
byproducts. The questions included whether byproduct manufacturers
(including importers) were required to report the byproducts under the
IUR rule. Based on those and subsequent inquiries, and from the public
comments from the proposed rule, it is apparent that scope of the CDR
obligation to report byproducts is not well understood by industry. The
scope of byproduct reporting has become a particularly pertinent issue
because (by the terms of the 2003 IUR Amendments) inorganic chemical
substances are now no longer exempt from reporting under CDR, including
(beginning with the 2012 CDR) the information collection requirements
for processing and use information. Inorganic chemical substances are
often recycled, which may trigger the need to report a byproduct
substance that is recycled. In an effort to further clarify reporting
obligations, EPA is providing additional information on byproduct
reporting, including circumstances under which reporting is not
required, in two guidance documents included in the docket for this
final rule (Refs. 7 and 16) and on EPA's Web site at http://www.epa.gov/iur. For purposes of CDR, a byproduct is a chemical
substance produced without a separate commercial intent during the
manufacture, processing, use, or disposal of another chemical substance
or mixture (40 CFR 704.3). Thus, for example, when a chemical substance
or mixture is used for the purpose of manufacturing an article, and
that manufacture results in the production of a different chemical
substance, that different chemical substance is a byproduct for
purposes of the CDR. Chemical substances that are byproducts of the
manufacture, processing, use, or disposal of another chemical substance
or mixture, like any other manufactured chemical substances, are
subject to CDR reporting if they are listed on the TSCA Inventory, are
not otherwise excluded from reporting, and their manufacturer is not
specifically exempted from CDR reporting requirements.
    The 40 CFR 704.3 definition of manufacture for commercial purposes
states that ``[m]anufacture for commercial purposes also applies to
substances that are produced coincidentally during the manufacture,
processing, use, or disposal of another substance or mixture, including
both byproducts that are separated from that other substance or mixture
and impurities that remain in that substance or mixture. Such
byproducts and impurities may, or may not, in themselves have
commercial value. They are nonetheless produced for the purpose of
obtaining a commercial advantage since they are part of the manufacture
of a chemical product for a commercial purpose.'' Thus, byproducts of
the manufacture, processing, use, or disposal of another chemical
substance or mixture for a commercial purpose are themselves both
``manufactured'' and ``manufactured for commercial purposes.'' Also,
considering the overall context of this definition, EPA interprets
``chemical product'' broadly to include any product of the
manufacturing, processing, use, or disposal of another chemical
substance or mixture, other than a byproduct.
    Byproducts that are manufactured (including imported) in volumes of
25,000 lb or more at a single site are potentially subject to CDR
requirements. However, 40 CFR 711.10(c) excludes from reporting those
chemical substances meeting the requirements of 40 CFR 720.30(g) or
(h). Manufacturers (including importers) of byproducts are not required
to report the manufacture (including import) of a byproduct if the
byproduct is not used for commercial purposes. See 40 CFR 720.30(h)(2).
Thus, even where a byproduct is manufactured (including imported) for a
commercial purpose, if the byproduct is not subsequently put to use for
another commercial purpose, the byproduct is excluded from CDR
reporting. Furthermore, if the byproduct's ``only commercial purpose is
for use by public or private organizations that: (1) Burn it as a fuel,
(2) dispose of it as a waste, including in a landfill or for enriching
soil, or (3) extract component chemical substances from it for
commercial purposes,'' 40 CFR 720.30(g), that byproduct is also
excluded from CDR reporting. This exclusion applies only to the
byproduct; it does not apply to the component chemical substances
extracted from the byproduct. The Instructions document (Ref. 7)
includes a decision tree to assist a byproduct manufacturer (including
importer) in its determination of the need to report its byproduct
chemicals.
    Some manufacturers (including importers) of byproducts have
expressed a belief that a chemical substance that is regulated by
another EPA program, such as under the Resource Conservation and
Recovery Act (RCRA), or that is exempt from certain requirements by the
other program based on certain treatments or disposals, should not be
required to be reported for CDR purposes. However, under this final
rule, when such chemical substances have a commercial purpose not
exempted by 40 CFR 720.30(g), the manufacturer (including importer) of
such a chemical substance may have CDR reporting obligations, and is
not relieved of those obligations based on exemptions under other laws.
    Although the need to report for byproduct chemical substances is
not a new requirement, EPA recognizes that there were many comments and
concerns raised about byproduct chemical substances, as stated earlier
in this unit, and that there may be byproduct manufacturers that remain
unsure of their reporting obligations under the CDR. In particular, the
Agency recognizes that this may be an issue for those byproduct
manufacturers who recycle byproducts by sending them off-site to a
recycler. The Agency is committed to helping byproduct manufacturers
report according to the CDR requirements and views the 2012 reporting
cycle as an opportunity for the Agency and byproduct manufacturers to
work together. Among other things, the Agency will use this opportunity
to determine whether additional guidance tailored to these
manufacturers is needed. In addition, EPA intends to provide training
specific to byproduct reporting and to make available Agency personnel
to answer questions on an individual basis.
    EPA also intends to continue to work with industry and the
interested public. EPA encourages recycling. The Agency intends to
examine the collected information related to byproducts, recognizing
the importance of recycling,

to identify whether there are segments of byproduct manufacturing for
which EPA can determine that there is no need for the CDR information
for the 2016 or other future reporting cycles.

V. Public Comments

    EPA carefully considered the comments it received on the proposed
IUR modifications. Major comments are discussed in this unit.
Additional comment summaries and more detailed responses, including
responses to most of the additional issues that EPA requested comment
on, are contained in the Responses to Comments document (Ref. 12).
    As part of this action, EPA is changing the identification of the
regulation from IUR to CDR. Elsewhere in this document, EPA has
retained the use of the term ``IUR'' to reflect historical terminology,
and has used the term ``CDR'' to describe the revised reporting
requirements and future submission periods. However, in order to
enhance understanding of the responses to the public comments, EPA is
retaining the use of the IUR acronym for this unit, even where
referring to revised reporting requirements and future submission
periods. The reader should recognize that where IUR is used to refer to
the 40 CFR part 711 regulations or to future IUR submission periods,
IUR and CDR are synonymous.

A. General Comments

    1. Justification for proposed modifications. Several commenters
supported many of EPA's proposed reporting changes, stating that the
changes will facilitate EPA's ability to track chemical substances used
and made in the United States, which would strengthen EPA's ability to
identify chemical substances for further assessment. They also noted
that the IUR data not only supports activities under EPA authorities,
but is also used by other Federal agencies, the States, and other
interested stakeholders to identify potential chemical substances of
concern. Other commenters expressed the view that EPA has not provided
adequate justification supporting the Agency's need for the IUR data
and has not sufficiently tailored the requested information to meet
EPA's goals. One commenter did not agree that the modifications will