TSCA Inventory Update Reporting Modifications; Chemical Data Reporting, 50816-50879 [2011-19922]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Rules and Regulations]
[Pages 50816-50879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19922]



[[Page 50815]]

Vol. 76

Tuesday,

No. 158

August 16, 2011

Part II





Environmental Protection Agency





-----------------------------------------------------------------------





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

[[Page 50816]]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://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 (202) 566-1744, and the telephone number for the 
OPPT Docket is (202) 566-0280. 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: farquharson.chenise@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.

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).

[[Page 50817]]

    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.

[[Page 50818]]

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 (https://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.

[[Page 50819]]

    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 (https://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).

[[Page 50820]]



 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 (https://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

[[Page 50821]]

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

[[Page 50822]]

(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

[[Page 50823]]

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

[[Page 50824]]

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 discr