```

[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 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 (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 (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.

[[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 (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).

[[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 (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

[[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 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.

[[Page 50825]]

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

[[Page 50826]]

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:

[[Page 50827]]

                       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

[[Page 50828]]

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.

[[Page 50829]]

     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

[[Page 50830]]

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

[[Page 50831]]

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

[[Page 50832]]

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,

[[Page 50833]]

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 
increase the ``usability of collected information'' or ``focus 
reporting'' on what is ``most needed'' by EPA. Another commenter 
mentioned that the Agency does not explain how the existing IUR fails 
to meet these goals or why an IUR expansion is needed to carry out its 
Congressionally mandated TSCA duties. Additionally, commenters 
suggested that EPA should clearly indicate how the IUR data will be 
utilized in programs that systematically review hazard and exposure of 
existing chemicals.
    EPA has an obligation under TSCA to protect human health and the 
environment from unreasonable risks associated with chemical substances 
under its jurisdiction. EPA is amending the IUR rule to improve and 
enhance data reporting requirements under IUR reporting beyond that 
required during the 2006 submission period. There were problems 
associated with many 2006 IUR data submissions that severely limited 
EPA's ability to screen chemical substances for exposure and risks and 
to make data available to the public. These problems included the fact 
that many submissions were incomplete or improperly completed, 
contained invalid chemical identities, and/or inappropriately or 
incorrectly claimed certain data elements as CBI. EPA anticipates that 
this final rule will
    a. Ensure the required information is properly reported and that 
the information in the Agency's database reflects the information 
provided in the IUR reports.
    b. Increase the usability of the collected information.
    c. Increase the availability of information for the public.
    d. Focus reporting on information that is most needed by the 
Agency.
    Additionally, EPA believes that the modifications in this final 
rule will supply manufacturing, and processing and use information the 
Agency did not previously possess and should be accurate and reliable 
enough to develop screening level assessments.
    Data collected under the IUR will be used in a wide variety of 
programs fundamental to fulfilling the Agency's TSCA statutory mandate. 
EPA believes that the IUR data is the most basic data set that will 
give EPA and the public an understanding of the volume of chemical 
substances produced or imported into the United States, how the 
chemical substances are or may be used, and the types of exposures 
(occupational, consumer, environmental, etc.) potentially associated 
with the chemical substances. Many chemical substances are exempted 
from reporting under the IUR rule, which further tailors IUR 
requirements to EPA's information needs. Data about production volume, 
exposures, and/or environmental releases are required to make some of 
the findings necessary to require testing under TCSA section 4, and 
helps EPA to prioritize chemical substances for further data gathering 
or risk management action. For example, data supplied by the IUR have 
supported a series of test rules in the HPV Challenge Program, which 
were implemented to generate health and environmental effects data on 
HPV chemical substances for risk assessment purposes. The IUR supported 
these test rules by providing production volume and exposure 
information needed to make the findings for these test rules. Without 
the IUR information, EPA might not have been able to make these 
findings. The Agency anticipates that the data collected under the 2012 
IUR will better support the development of test rules.
    The Agency's Existing Chemicals Program will use the IUR data to 
assess whether the Agency needs additional data about the hazards or 
exposures to a particular chemical substance under TSCA sections 4 or 
8, and may use IUR data to inform risk management actions such as those 
identified in TSCA sections 5 and 6. 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. EPA used the 2006 IUR data together with other 
available information in developing Action Plans on chemical substances 
beginning in 2009, and noted the limitations inherent in those data. 
Any future program is expected to be similar in analytical approach 
regarding the use of screening-level hazard and screening-level 
exposure data to develop risk prioritizations. EPA's future Existing 
Chemicals Program will build on the experience of this past program, 
and the modified IUR data collected during the 2012 and future 
submission periods will enable the Agency to further enhance its 
program. More detailed discussions are in the Responses to Comments 
document (Ref. 12).
    2. Transitioning to 2012. Commenters stated the new requirements 
are overly burdensome and unrealistic considering the time constraints. 
Commenters supported delaying the submission period in a variety of 
ways, including:
    a. Extending by several months and delaying the implementation of 
changes until the next submission period,
    b. Delaying the submission period until 9 to 12 months following 
the promulgation of the final rule, or
    c. Moving the submission period to 2012 and changing the principal 
reporting year to 2011.
    In light of these comments, to provide sufficient time for 
companies to comply with the amended reporting requirements, and to 
finalize the

[[Page 50834]]

proposed modifications, EPA promulgated a final rule (Ref. 6) to 
suspend the 2011 submission period. In this final rule, EPA supersedes 
the suspension of the submission period by establishing a new sequence 
of submission period, beginning with one from February 1, 2012, through 
June 30, 2012. EPA believes that the timing of the 2012 submission 
period provides companies sufficient time to collect and submit the 
required data, and that steps taken by the Agency have provided and 
will provide the opportunity for companies to gain an understanding of 
the submission process and to prepare their internal electronic systems 
as needed. For example, EPA was asked by several companies and trade 
organizations to provide an overview of the reporting tool. 
Acknowledging that companies were concerned about the time needed to 
develop their internal databases to collect the required information, 
on November 30, 2010, the Agency held an informational workshop and 
webinar to help companies develop a better understanding of the CDX 
registration process and the e-CDRweb electronic reporting tool. A 
recording of the workshop and a summary of the questions and answers is 
available on the IUR Web site (http://www.epa.gov/iur). EPA used 
stakeholders' comments from the workshop to help ensure the tool would 
address the needs of the submitters. In addition, the Agency plans to 
provide an opportunity, prior to finalization of the e-CDRweb, for 
stakeholders to test a pre-release version of the tool. EPA plans to 
conduct a training webinar shortly after the publication of this final 
rule to provide detailed instructions on the reporting requirements and 
on using e-CDRweb to complete and submit Form U. Finally, to the extent 
that the timing of the next submission period actually presents a 
substantial obstacle to the submission of any particular data element, 
notwithstanding EPA's efforts to familiarize submitters with the draft 
and final reporting tool, and EPA's post-promulgation efforts to 
familiarize submitters with the reporting requirements, the IUR 
reporting standard of ``known to or reasonably ascertainable'' 
addresses such circumstances without the need for a delay in 
implementation (see Unit V.E.1.).
    One commenter suggested that EPA continue under the old IUR rule 
for this submission period. The Agency does not agree that it should 
continue under the IUR rule in effect for the 2006 submission period; 
however, the Agency recognizes that additional time may be necessary 
for many submitters to become familiar with the updated IUR reporting 
requirements and develop processes for collecting the information. 
Therefore, the Agency will be phasing in certain requirements so that 
the scope of exposure-related information to be collected will be 
increased for the 2012 IUR data collection and then further increased 
for the 2016 data collection and subsequent reporting years. As 
mentioned by one commenter, the ``IUR rule is one of the very few means 
by which the federal government can obtain and provide public access to 
robust information on the identity, production, processing and use of'' 
chemical substances (Ref. 17). In order to fulfill the EPA 
Administrator's goal of enhancing EPA's TSCA chemical management 
program, EPA needs to begin collecting some of the new and updated 
information in the 2012 submission period. As described on EPA's Web 
site (http://www.epa.gov/opptintr/existingchemicals/pubs/enhanchems.html), EPA's comprehensive approach to enhancing the 
Agency's current chemicals management program includes obtaining 
information needed to understand chemical substance risks and 
increasing transparency and public access to information about chemical 
substances. The changes to the IUR are specifically identified as a key 
component for these aspects of the enhanced program, including required 
electronic reporting and the expanded manufacturing, processing and use 
information. For example, the expansion of reporting processing and use 
information for all chemical substances addresses the identified lack 
or insufficiency of such information for most chemical substances--
including HPV chemical substances. EPA's efforts to understand and 
prioritize chemical substances based on risk, using the 2006 IUR data, 
were instrumental in identifying the needed changes to the IUR 
requirements. These included:
     EPA's Risk-Based Prioritization (RBP) process was 
developed to take the hazard data assembled for HPV chemical substances 
under EPA's HPV Challenge Program to conduct screening-level hazard 
assessments and use the 2006 IUR data to develop screening-level 
exposure assessments, with the goal of using the two types of 
assessments to develop screening-level risk prioritizations for the HPV 
chemical substances with fairly complete Screening Information Data 
Sets (SIDS). EPA quickly discovered that while the hazard data allowed 
EPA to make a screening-level conclusion about hazard, the 2006 IUR 
data rarely provided sufficient information for EPA to reach a 
screening-level conclusion about exposure.
     EPA discovered with the 2006 IUR that a larger than 
expected portion of HPV chemical substance manufacturers produced below 
the 300,000 lb threshold at individual sites, resulting in many 
submitters not being required to provide processing and use information 
for those volumes. In some cases, all of the reporters fell below the 
threshold.
     For MPV chemical substances, with national production 
volumes between 25,000 and one million lbs, even fewer individual sites 
reported production volumes over the 300,000 lb threshold. Although EPA 
desired to include these chemical substances in its risk-based 
prioritization process, the screening-level exposure information was 
not available.
     For those chemical substances for which EPA had some 
processing and use data, the Agency had difficulty evaluating exposure 
for commercial workers and consumers because the 2006 IUR data did not 
differentiate between these populations. The separation of these 
populations for future IUR collections, and including other information 
such as that related to children's use of the chemical substances, will 
help EPA better identify potential risks to more targeted populations.
    These examples illustrate several obstacles EPA encountered in 
understanding chemical substance risks, which stemmed from the scope of 
the 2006 IUR data collection. They also illustrate how the revised IUR 
data collection will increase the Agency's ability to understand 
exposure concerns so that EPA will be better able to identify steps 
needed to manage risks associated with chemical substances. Not only 
will the revised IUR data collection provide information that would 
have been helpful for past programs, it is directly applicable to the 
Agency's current and future programs. EPA will be able to use the 2012 
IUR data to identify additional chemical substances for its Chemical 
Action Plan program, will also be able to identify if any of the 
current Action Plans may need to be revised, and will be able to 
develop other aspects of the enhanced existing chemical substance 
management program that are associated with understanding chemical 
substance risk.
    In addition, requiring the use of electronic reporting will ensure 
that data are available in a timely manner and will reduce data entry 
errors,

[[Page 50835]]

thereby increasing the usability and reliability of the data for EPA 
and other Federal agencies. It will also help to fulfill the EPA 
Administrator's commitment to increase public access to information on 
chemical substances.
    3. EPA's use of IUR data. The Agency received comments related to 
how IUR data can best be used to assist in assessing, prioritizing, and 
taking action on chemical substances that pose unreasonable risks. 
Commenters stated that the current IUR was sufficient for EPA to use as 
a screening tool for the prioritization of chemical substances in 
commerce, and that EPA should use the Agency's wide variety of 
regulatory tools and authorities to collect more detailed information. 
Commenters also expressed interest in providing input on using the IUR 
and the Agency's prioritization process.
    EPA disagrees that the current IUR is sufficient for its purposes. 
Between August 2007 and mid-2009, EPA developed screening-level hazard, 
exposure, and risk characterizations for some chemical substances 
produced or imported in quantities of 25,000 lbs or greater a year. 
Based on those characterizations, EPA developed either an RBP or a 
hazard-based prioritization (HBP) for individual chemical substances or 
a group of chemical substances that were similar in some way, e.g., 
structure, properties, toxicity. Those prioritizations did not 
constitute definitive determinations regarding hazard, risk, or the 
sufficiency of available information for any regulatory purpose, but 
were rather initial evaluations of data and understanding currently 
available to EPA. EPA's experience using the IUR information to develop 
the prioritizations was that the 2006 IUR data were not sufficient to 
provide the needed exposure-related information. When EPA was 
developing RBPs for its HPV chemical substances, it needed both hazard 
and exposure screening-level information. Lacking sufficient exposure 
information, EPA found it necessary in many cases to make assumptions 
about exposure and the resulting prioritization decision was primarily 
hazard-based, as opposed to risk-based, as evidenced by statements in 
many of the RBP as well as HBP documents that EPA developed (available 
on-line at http://iaspub.epa.gov/oppthpv/existchem_hpv_prioritizations.INDEX_HTML) that further information on exposure was 
needed to confirm the prioritization. Thus the exposure information 
provided in the 2006 IUR reporting did not provide EPA with sufficient 
information to prioritize chemical substances for which it generally 
possessed a base set of hazard data. Therefore, for some of the RBPs 
the next steps indicated that additional exposure information would be 
necessary to validate the prioritizations before determining whether 
any further action was needed. In developing these characterizations, 
EPA identified areas where the IUR data collection should be improved 
and enhanced. These improvements, which are reflected in the 
modifications to the reporting requirements in the current rule, will 
allow EPA to better prioritize chemical substances for further 
assessment as well as make appropriate risk management decisions for 
follow-up action on chemical substances that may pose potential risks 
to human health or the environment.
    EPA is considering using other regulatory tools and authorities to 
collect more in-depth information, but believes the IUR is the correct 
mechanism for the data collection finalized in this document. EPA also 
is considering ways to obtain public input on its use of the IUR data 
and its chemical substance prioritization process, as suggested by the 
commenters.
    4. Canada's prioritization approach. Some commenters recommended 
that EPA adopt Canada's prioritization approach. EPA assumes that the 
commenters were referring to the Domestic Substances List (DSL) 
Categorization that Canada completed in 2006. The DSL Categorization 
was a statutorily mandated risk-based prioritization which required 
review of both hazard and exposure information for 23,000 chemical 
substances in a very short period of time. Health Canada was required 
to identify chemical substances presenting human health hazards as well 
as the greatest potential for exposure to Canadians. Even though 
categorization was a legally mandated process with a deadline for 
consideration of all chemical substances on the DSL, Health Canada felt 
that production volume alone was not a sufficient surrogate for 
exposure. In order to move beyond production volume, Health Canada 
sought additional information, including some of the types of data that 
EPA is requiring for the 2012 reporting period (Ref. 18). Based on its 
review of hazard and IUR data collected on HPV and MPV chemical 
substances, EPA also believes that using large production volume as the 
sole surrogate for exposure is not sufficient to identify chemical 
substances of highest concern. Some of the risk-based prioritizations 
of HPV chemical substances resulted in low priority decisions for the 
HPV chemical substances that were low hazard, used in closed systems 
and consumed as intermediates. On the other hand, some of the MPV 
chemical substances were identified as potentially high or medium 
priority, because they had high or medium hazard and would present high 
or medium risk concerns if they had widespread exposure or dispersive 
uses. The only way for the Agency to move from prioritizations based 
primarily on hazard to truly risk-based prioritization is for it to 
receive regularly updated information on exposure and use for chemical 
substances being made and used in the United States. The chemical 
substance manufacturing industry has indicated in several ways, 
including in comments on the proposed rule, that it supports risk-based 
as opposed to hazard-based prioritization. A commenter also noted that 
industry strongly supports risk-based decisions and for that reason 
needs to provide robust production, processing, and use data.

B. Comments on Electronic Reporting

    EPA received various comments on the proposed requirement to use 
the reporting tool, e-CDRweb, to submit all IUR submissions. In 
general, comments were submitted on the reporting tool phasing-in 
electronic reporting registering with CDX, and electronic signatures. 
See section B. in the Responses to Comments document (Ref. 12) for 
further discussion on electronic reporting.
    1. Comments on the reporting tool and phasing-in electronic 
reporting. In general, commenters supported electronic reporting. Some 
commenters suggested that the Agency develop a phased-in process for 
electronic reporting, in order to provide more time for companies to 
become familiar with the new format and to develop their own data 
systems. Some commenters wanted to be able to upload data via an XML 
file into the web-based tool. The requirement to use electronic 
submissions over the Internet was a concern for some commenters. EPA, 
based on its experience collecting and managing the 2006 IUR reports, 
has concluded that mandatory electronic reporting is a critical next 
step for collection of the 2012 data. Optional electronic reporting for 
the 2006 IUR provided the Agency with experience relating to both 
industry and Agency needs, and the Agency has applied this experience 
in the course of developing the 2012 electronic reporting tool (e-
CDRweb). For example, the use of a web-based tool for the 2012 IUR will 
eliminate many of the software compatibility and firewall setting 
issues that were encountered during the 2006

[[Page 50836]]

submission period. In addition, e-CDRweb utilizes other Agency systems, 
such as SRS, enabling the submitter to readily select the chemical 
identity in the correct format, thereby eliminating problems relating 
to the previous need to type or write in the chemical name. With these 
enhancements, EPA believes the use of e-CDRweb will substantially 
reduce error rates and burden; consequently, EPA does not believe it is 
necessary to have another optional electronic reporting period.
    In addition, the Agency's CDX service is increasingly being used by 
a variety of programs, as the Agency moves toward comprehensive 
electronic reporting. EPA is continually looking for ways to improve 
CDX, to better address submitter and Agency needs. For example, EPA has 
developed an eTSCA registration for CDX which, when fully implemented, 
will eliminate the need to register separately to use the e-CDRweb and 
ePMN systems. ePMN registrations using the current eTSCA will be 
acceptable e-CDRweb registrations.
    The Agency believes that commenters' concerns regarding mandatory 
use of the new electronic reporting tool reflect a lack of 
understanding of the tool's capabilities and enhancements. The 
reporting tool provides the ability to submit data in an XML format and 
includes enhancements to CDX that are designed to allow for multi-user 
capabilities and otherwise facilitate electronic reporting. EPA has 
provided training opportunities and guidance materials to facilitate 
electronic reporting, as well as testing opportunities, to alleviate 
particular commenters' concerns. For example, the Agency held an 
informational workshop and webinar on November 30, 2010. The workshop 
was designed to help companies develop a better understanding of the 
CDX registration process and the e-CDRweb electronic reporting tool. 
The workshop, which was recorded live as a webinar, was posted to the 
IUR Web site at http://www.epa.gov/iur along with accompanying slides, 
a question and answer document, and a draft XML schema. In addition, 
EPA plans to invite several companies to test e-CDRweb to identify 
areas needing improvements. The comments and concerns of industry 
representatives will be taken into consideration as EPA further 
develops the reporting tool. EPA also intends to hold further training 
and outreach sessions at which industry representatives may express 
remaining questions and concerns regarding the operation of the e-
CDRweb tool, which EPA will address. Additionally, EPA has published a 
revised Instructions document (Ref. 7) explaining the reporting 
requirements and how to complete Form U using the reporting tool.
    Electronic reporting was first offered as an option for the 2006 
IUR. As explained in the preamble to the proposed rule and the 
Responses to Comments document, there were many problems, errors, and 
delays associated with paper submissions of the 2006 IUR data, which 
make the continued use of paper reporting highly inefficient and 
therefore undesirable. In light of the substantial disadvantages 
associated with allowing paper submissions, and the reporting tool 
improvements and training opportunities outlined in this unit (and 
explained in greater detail in the proposed rule and the Responses to 
Comments document), EPA does not believe it is reasonable to phase in 
electronic reporting over another reporting period and is confident 
that submitters will be able to successfully use the e-CDRweb tool to 
electronically report under the CDR rule in 2012.
    2. Comments on registering with CDX and providing electronic 
signatures. Commenters thought the modified ESA Form, in particular the 
need for multiple notarized signatures, was burdensome and unnecessary. 
Commenters stated that there should be more than one individual with an 
electronic signature and that multiple persons may need to be able to 
input and submit IUR data for a company's U.S. sites. The commenters 
noted that the actual preparer/drafter would rarely be the signatory. 
Another respondent noted that companies should be allowed, but not 
required, to have the same authorized official for the PMN and IUR 
submission.
    EPA understands and is cognizant of the concerns presented by 
industry regarding the revised ESA Form. An ESA Form is required for 
CDX registration and is necessary to submit electronic data to EPA. 
Regarding the prior need for multiple notarized signatures, EPA has 
determined that requiring a notarized signature as part of the ESA Form 
is no longer necessary. EPA is also exploring an approach to eliminate 
the need for an individual to register multiple times with CDX to 
submit to various TSCA programs. As with PMN electronic submissions, 
multiple people from the same site or company are able to register with 
CDX and participate in completing the site's Form U. Although one 
individual will be designated as an authorized official who will sign 
and submit the completed Form U, the e-CDRweb tool allows for more than 
one individual to edit a submission. Ultimately, EPA's goal is to 
provide one ESA Form across all TSCA programs and is exploring the 
reuse of electronic signatures issued under the New Chemicals Program, 
as well as other EPA programs.

C. Comments on Reporting Thresholds

    1. Method for determining whether you must report. EPA proposed to 
modify the method used to determine whether a person is subject to IUR 
reporting. The new method requires persons to report under the IUR if 
they manufactured (including imported) 25,000 lb or more of a chemical 
substance at any single site in any calendar year since the last 
principal reporting year. This method becomes effective after the 2012 
submission period. (Note: There is also a lowered production volume 
threshold for certain chemical substances, effective after the 2012 
submission period. See 40 CFR 711.8(b).) Several commenters believed 
the change is appropriate and should be implemented for the submission 
period following the upcoming submission period (i.e., in the 
submission period following the 2011 submission period described in the 
proposed rule). They noted that the new requirement is essential to 
effectively capture the substantial year-to-year fluctuation in 
production/import volumes that was missed in past IUR reporting cycles, 
thereby skewing the picture of how many and which chemical substances 
are actually in commerce at a given time and what levels of production 
or import. One commenter went further to say that the modification 
would eliminate gaps and uncertainties in the information collected 
under the current IUR that result from infrequent collections and 
reporting of data. Another said that this will keep manufacturers from 
disguising their actual output by producing certain specialty chemical 
substances only in years that are not currently subject to IUR 
reporting. Two commenters supported the change but opposed the proposal 
to delay implementation until after the 2011 submission period 
described in the proposed rule, because it would further delay the 
ability to obtain accurate annual production information.
    In contrast, others had mixed opinions or did not think the change 
was needed. Some commenters felt that unless the value of collecting 
and analyzing historical data could be clearly demonstrated such that 
the resource for the Agency and regulatory community can be justified, 
EPA should retain the mechanism whereby the need to report is based on 
consideration of a single reporting year. Some commenters stated that 
EPA had not shown special

[[Page 50837]]

utility for the information generated. Another commenter believes that 
there is no significant incremental benefit to require reporting from 
companies that produce or import less than 25,000 lb of a reportable 
chemical substance for 4 out of 5 years. The Agency realizes that the 
new multi-year consideration of production volume will increase 
reporting burden on industry, but believes that there is sufficient 
evidence that wide fluctuations in production volumes from year to year 
indicate the past IUR reporting was not accurately characterizing the 
chemical production. As EPA noted in the proposed rule, production 
volumes of chemical substances vacillating above and below reporting 
thresholds in different IUR reporting periods resulted in a change of 
approximately 30% in the composition of the chemical substances being 
reported from one IUR reporting period to the next. For example, EPA 
prepared a prioritization document for the butenedioic acid dialkyl 
esters cluster, which consists of 10 butenedioic acid dialkyl esters, 
seven of which were MPVs and three HPVs in 2006 (Ref. 19). Three of the 
chemical substances have had fluctuating production volumes above and 
below one million lb. In 1990 and 1994 when the HPV Challenge Program 
was being developed, the chemical substances identified by CASRNs 
68921-51-7, 141-05-9, and 624-48-6 had production volumes below one 
million lb and so were not included in the HPV Challenge Program for 
completion of SIDS datasets. In 1998 and 2006, CASRN 68921-51-7's 
production volumes have been above one million lb, making it an HPV in 
those years. In 2002, CASRNs 141-05-9 and 624-48-6 had production 
volumes above one million lb. In part because of their fluctuating 
production volumes, neither SIDS datasets nor consistent exposure and 
use information were available for these chemical substances and so 
they were included in a cluster for an HBP as opposed to an RBP. One 
commenter also submitted an analysis of the degree of fluctuation of 
chemical substances and production volumes in the 2002 and 2006 IUR 
reporting years. This analysis found that about 32% of the organic 
chemical substances reported in 2002, including 400 HPVs, were not 
reported for 2006 and that about 26% of the chemical substances 
reported in 2006, including more than 200 organic HPVs, were not 
reported in 2002.
    In addition, in comments submitted to the Agency in response to 
other programs, industry representatives expressed concern that short 
reporting determination periods would drastically misrepresent the 
chemical substances that currently are in commerce. They stated they 
manufactured or imported some chemical substances only occasionally, 
and that these chemical substances would not be captured if the 
reporting covered too short a period. The proposed rule provides a more 
detailed discussion of these comments (Ref. 1).
    EPA believes that most sites will be able to gather production 
volume information without a substantial effort. In many instances, 
production volumes for recent past years are tracked under standard 
business practices. For example, EPA believes it is standard business 
practice for a company to furnish records of recent operations in the 
case of a proposed sale or merger, and that companies therefore 
typically retain such records so as to be prepared for such 
eventualities. EPA also notes that in the case that prior years' 
production volume information is not known to or reasonably 
ascertainable by the submitter (EPA expects that such cases would be 
extremely rare), those data would not be subject to reporting under the 
IUR and therefore would not trigger an obligation to report. 
Furthermore, persons who have submitted a PMN to the Agency's New 
Chemicals Program are required to maintain records of production volume 
for the first 3 years of production or import and in certain 
circumstances, including but not limited to the names and addresses of 
any person to whom the chemical substance is distributed. They must be 
maintained for 5 years from the date of commencement of manufacture or 
import (See 40 CFR 720.78). EPA expects that many companies would also 
track production volumes for planning, marketing, and sales projection 
purposes. Several types of TSCA actions, such as TSCA section 5(a)(2) 
SNURs and TSCA section 5(e) orders also require that production volume 
records be kept for 5 years for certain chemical substances, and 
several commenters indicated that they archived these records.
    2. Elimination of the 300,000 lb threshold. The Agency received a 
substantial number of comments on the proposed elimination of the 
300,000 lb threshold for reporting processing and use information. 
Comments submitted on various topics are described in this unit.
    a. Increased numbers of covered chemical substances. Commenters 
asserted that the inclusion of inorganic chemical substances, coupled 
with the threshold change for processing and use information, will 
result in a substantial increase in the amount of data being submitted 
to the Agency. Commenters felt that EPA staff will need significant 
time to compile, review, and analyze the data submitted. One commenter 
suggested the Agency use a phased-in approach to adequately collect and 
process the increased information.
    In response to these comments and comments received during 
interagency review, EPA decided to phase in the eventual elimination of 
the 300,000 lb threshold as a separate reporting threshold. For the 
2012 submission period, 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. For subsequent submission periods, the reporting 
threshold for processing and use information will be the same as for 
other types of information: 25,000 lb (or 2,500 lb for chemicals 
subject to 40 CFR 711.8(b)). Thus, there will be no separate threshold 
for the reporting of production and use information after 2012--the 
applicable reporting threshold will be the same as for other types of 
information. EPA believes this is a reasonable approach because it 
provides new submitters with an opportunity to become familiar with the 
reporting requirements, and provides much needed processing and use 
information on additional chemical substances. Future full reporting of 
exposure-related information 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. While it is true that the 
amount of data in the IUR reports is expected to increase substantially 
in the 2012 and subsequent submission periods, EPA is better prepared 
now than it was for the 2006 IUR to compile, review, and analyze the 
anticipated increase of data. With the new e-CDRweb electronic tool, 
large amounts of data will be able to be submitted with less difficulty 
on the part of the submitter, and will be more readily organized, 
analyzed, and made available to the public by the Agency. In addition, 
the use of SRS for identifying chemical substances and validation 
process built into the e-CDRweb tool will eliminate most or all of the 
problems EPA had with missing information (which necessitated phone 
calls and e-mails to submitters), and manual entry of data, which was 
time-consuming and resulted in many mistakes. Given the requirement for 
mandatory electronic submissions and the corresponding improvements to 
the

[[Page 50838]]

e-CDRweb tool, the Agency is confident that the increase in data 
submissions will be easily managed for the 2012 submission period and 
the next, and both EPA and the public will quickly have a useable set 
of exposure-related IUR data.
    b. Reporting burden. Numerous commenters were concerned about the 
increased reporting burden, particularly for smaller companies, and the 
complexity of Form U, Part III. One commenter stated that EPA should 
assess the benefits of the additional reporting requirements to 
establish a cost justification of the proposal. Other commenters were 
concerned that the lowered threshold would increase the number of 
imported mixtures and that it would be difficult to calculate and 
aggregate across products for lower volume chemical substances.
    EPA analyzed the potential impacts of this requirement to all 
submitters, including potential burden to small businesses, in the 
Economic Analysis (Ref. 14). EPA recognizes that reducing the reporting 
threshold for processing and use information increases the reporting 
burden; however, phasing in the lower threshold reduces the burden for 
this reporting cycle and the cost to industry will decrease in all 
future reporting cycles. EPA disagrees with comments suggesting that 
the requirement may have a disproportionate effect on smaller companies 
(commenters suggested that smaller companies are more likely to 
manufacture below the 300,000 lb threshold that is eventually being 
eliminated). The quantity of a chemical substance that is manufactured 
(including imported) at a site is not necessarily dependent on the 
number of employees, which is the criteria by which a company is 
considered to be small. For example, a highly automated facility could 
produce large volumes of a chemical substance with a relatively small 
number of employees. Additionally, as noted in the Economic Analysis 
(Ref. 14), the Agency determined that because the small businesses 
affected by this final rule actually have average sales of more than 
$11 million, and because any potentially affected companies with sales 
of $0.81 million or less (the level at which the cost-to-sales ratio of 
the final rule would exceed 1%) would generally be exempt from 
reporting obligations under the IUR, small entities will not be 
significantly affected by this final rule.
    EPA recognizes that, with the reduction and eventual elimination of 
the 300,000 lb threshold, importers may face an increase in burden to 
identify more component chemical substances contained within more 
imported mixtures. However, EPA believes that due to the deferral of 
the threshold reduction until the 2012 submission period (which 
involves reporting on the processing and use of imports occurring in 
2011) and the deferral of the threshold elimination until the 2016 
submission period (which includes reporting on the processing and use 
of imports occurring in 2015), importers will have had sufficient time 
to conduct an inquiry as to the specific chemical substances they 
import in mixtures. Furthermore, the inquiry need only be as extensive 
as a reasonable person, similarly situated, might be expected to 
perform.
    EPA has several reasons to expect that importers have a reasonable 
awareness of the component chemical substances contained within 
imported mixtures. Importers have long been responsible for certifying 
that their imported chemical substances, including those chemical 
substances present as part of mixtures, are in compliance with TSCA 
(See 19 CFR 12.119). Furthermore, importers have long been required to 
provide chemical-specific information as to the constituents of 
imported mixtures under the IUR (see the definition of importer at 40 
CFR 704.3 and the note at 40 CFR 710.4(c)(2)) and under the PMN program 
(40 CFR 720.30(b)). Furthermore, importers are often required to report 
chemical-specific information regarding imported mixtures under other 
EPA-administered statutes, such as the Emergency Planning and Community 
Right-To-Know Act (EPCRA) and RCRA. While reporting under the IUR 
differs in many significant respects from reporting under the EPCRA and 
RCRA programs, in all cases the importer is required to know the 
identity of the chemical substances they import. EPA notes that one 
commenter described, in detail, its practice of accounting for 
component chemical substances in imported mixtures. The commenter 
stated that ``[w]ith the advent of the [Registration, Evaluation, 
Authorisation and Restriction of Chemicals] REACH we recently 
implemented an application that is capable of tracking volumes of 
individual substances in mixtures and summing them up over a period of 
time. The system automatically looks at the current formulation of any 
product that is crossing a border and adds the volume of each component 
to the cumulative total for that substance'' (Ref. 20). Finally, EPA 
notes that a chemical substance that is imported solely in small 
quantities for research and development, as an impurity, as part of an 
article, or in certain other forms, see 40 CFR 720.30(g) and (h), is 
not subject to the IUR reporting requirements. See 40 CFR 711.10.
    c. Justification for data. Several commenters strongly supported 
EPA's proposed change, stating that the information is essential for 
the completion of prioritizations for IUR reportable chemical 
substances; is critical for evaluating the potential for release of and 
exposure to chemical substances in commerce; and that the information 
requested is basic, screening-level data that should be required for 
all reported chemical substances. Additional commenters generally 
supported the change, but wanted it to take effect after the 2011 
reporting cycle. Other commenters had concerns about the value of the 
information that is reported in Part III of Form U. One commenter 
stated that EPA has not made public documentation of the past use of 
this information to address screening and prioritization of chemical 
substances. Another commenter believes that EPA should provide more 
specificity on its needs and explain why other, more tailored, options 
do not provide the necessary data. EPA's information needs have changed 
since the last major amendment of the IUR rule in 2003. Production 
volume changes from year to year, so chemical substances can easily 
fluctuate above and below a relatively high reporting threshold, such 
as the previous 300,000 lb threshold for reporting processing and use, 
making it difficult for EPA to collect regular exposure information on 
many chemical substances. Requiring the reporting of processing and use 
information on an expanded list of chemical substances will assist the 
Agency and others in screening potential exposures and risks resulting 
from industrial chemical substance operations and commercial and 
consumer uses of chemical substances. The information will also help to 
provide an accurate and readily available source of, as noted in Unit 
V.A.1., basic exposure-related information for a subset of chemical 
substances listed on the TSCA Inventory. Furthermore, collection of 
this data is consistent with the EPA Administrator's strong commitment 
to provide the public with more information on a greater number of 
chemical substances.
    As EPA discusses in this unit and elsewhere, the 2006 IUR 
information did not provide sufficient useable exposure-related data 
for EPA's screening level assessments. If EPA delayed reducing the 
processing and use

[[Page 50839]]

reporting threshold until the 2016 submission period, EPA would have to 
wait several more years before more useful exposure-related information 
is received for chemical substances for which EPA has already 
determined are currently in need of such information. With the phased-
in approach, EPA will be able to collect much needed processing and use 
information on additional chemical substances during the 2012 
submission period. Requiring full reporting for all chemical substances 
in subsequent reporting cycles (i.e., eliminating the separate, higher, 
threshold for production and use information) provides EPA with the 
exposure-related information needed to continue efforts begun with the 
2012 data. For example, the data reported in 2006 did not provide an 
adequate amount of exposure-related information, especially for HPV 
chemical substances. When attempting to use the 2006 IUR data for its 
screening level exposure assessments, EPA found that numerous chemical 
substances previously identified as HPVs were reported in amounts 
classifying them as MPV chemical substances, below the 300,000 lb cut 
off, and thus processing and use information was not provided for 
chemical substances for which EPA had a relatively complete hazard data 
set from the HPV Challenge Program. For example, an RBP was prepared 
for the chlorobenzenes category, which consisted of four chlorobenzenes 
sponsored under the HPV Challenge Program (Ref. 21). Only one of the 
four chemical substances, 1,3-dichlorobenzene (CASRN 541-73-1), was 
considered high priority; however, because it was an MPV chemical 
substance in 2006, no exposure and use data was available from the IUR 
reporting, so the high priority determination was based on high human 
health hazard and assumptions made about exposure.
    The 2006 IUR data did not provide sufficient information on MPV 
chemical substances for use by the Agency's Existing Chemicals Program. 
Screening chemical substance risks generally requires a combination of 
both hazard and exposure information. Because most MPV chemical 
substances were produced below the 300,000 lb reporting threshold, EPA 
did not have exposure information available from the 2006 IUR and 
therefore, developed hazard based prioritizations which were supported 
by a screening level hazard characterization and consideration of very 
limited exposure and use data. The lack of information on exposure and 
use was especially problematic in those instances where the screening 
level hazard characterization identified either a medium or high 
hazard. Basic hazard data is easier to find in existing databases; 
however, specific exposure data is needed to make a priority 
determination risk-based. EPA believes that the lowering of the 
reporting threshold will provide more exposure-related information on a 
greater number of MPV chemical substances. EPA disagrees with the 
comment that it has not made public documentation of the past use of 
processing and use information to address screening and prioritization 
of chemical substances. As discussed in Unit V.A.3., EPA used 2006 IUR 
data starting in 2007 in its development of RBPs and HBPs which it has 
made available on its Web site. More recently, the Existing Chemicals 
Program used the IUR database when developing the Chemical Action 
Plans. For some Action Plan chemical substances, the 2006 IUR data were 
not sufficiently complete to be useful. An example is the Action Plan 
for Dyes Derived from Benzidine and Its Congeners, where the chemical 
substances of concern are known or reasonably anticipated human 
carcinogens; however, those listed were produced in amounts below the 
300,000 lb threshold and so little exposure data was reported. Based on 
IUR data from prior reporting periods, some of the other dyes had been 
reported in the 10,000 to 25,000 lb range, but there was no 2006 IUR 
data available to determine whether these chemical substances were 
still being used in amounts beyond the small amounts used as analytical 
reagents. The Action Plans are available on EPA's Web site at http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html. By 
lowering the reporting threshold for processing and use information to 
25,000 lb in 2016, EPA is increasing consistency for the IUR with 
reporting requirements of the TRI program. Under the TRI program, 
chemical substances that are not chemical substances of special concern 
listed at 40 CFR 372.28 (e.g., mercury, lead) are required to be 
reported if they are manufactured or processed in volumes of 25,000 lb 
or more annually or otherwise used in volumes of 10,000 lb or more 
annually. Though the chemical substances on the TRI list of toxic 
chemicals may be different from those reported under the IUR, an 
analysis showed that over 80% of the sites that reported under the 2006 
IUR also reported under TRI in 2006. Given that there is some overlap 
in the companies that report and the information collected on 
activities and uses of chemical substances under both programs, EPA 
believes that many companies are already accustomed to reporting on 
lower volume chemical substances.
    d. Lack of data for chemical substances. Several commenters noted 
that the 2010 reporting year will be over by the time the rule is 
finalized, and companies would not have had the opportunity to 
establish systems for collecting the information for chemical 
substances in the 25,000 to 300,000 lb range. Other commenters asserted 
that EPA was seeking data that are limited or unavailable because 
manufacturers do not know how their downstream customers use their 
chemical substances. Another commenter asserted that the lowered 
threshold will not enhance the quality or integrity of the resulting 
IUR data due to uncertainties in making estimates. EPA recognizes that 
submitters may not always have detailed information about how the 
chemical substance(s) they manufacture (including import) are used. As 
a result, submitters will be required only to report this information 
to the extent that it is known or can be reasonably ascertained. Based 
on its experience with the New Chemicals Program, discussions with 
industry about voluntary risk management programs, and industry's 
various self-regulation initiatives, the Agency believes that most 
submitters have at least some basic information about downstream uses, 
such as the information that is required by the IUR rule. EPA does not 
anticipate that the quality of the data collected in 2012 will 
significantly decrease due to the timing of the amendment to the 
reporting threshold. As mentioned earlier, EPA published a final rule 
(Ref. 6) to suspend the 2011 submission period to provide sufficient 
time for companies to comply with the updated IUR reporting 
requirements. This final rule was published in advance of the 2012 
submission period, which is February 1, 2012, to June 30, 2012. For 
these reasons, companies should have the opportunity to establish 
systems for collecting the information on their reportable chemical 
substances. Furthermore, many of the reporting elements are the same as 
in past IUR reporting periods, and EPA notes that this final rule 
affords sufficient flexibility to account for those circumstances in 
which information is truly unknown and not reasonably ascertainable. 
The Agency believes that the data will be of sufficient reliability for 
use by the Agency and others for

[[Page 50840]]

purposes such as screening-level risk assessments and prioritization.
    3. Eliminate 25,000 lb threshold for specific regulated chemical 
substances. EPA proposed to eliminate the 25,000 lb reporting threshold 
for chemical substances subject to particular TSCA rules and/or orders 
and to require manufacturers (including importers) of such chemical 
substances to report under the IUR, regardless of the production 
volume. Comments submitted on various topics are described in this 
unit.
    a. Burden. One commenter stated that companies not expecting this 
significant change will be unprepared to gather required information. 
Several commenters expressed the view that the requirement will 
increase the burden upon industry without any real benefit to the 
environment and will create a situation where manufacturers (including 
importers) are responsible for knowing all byproducts of their process, 
no matter how small. Others felt that enacting this requirement without 
a de minimis concentration threshold would add an unnecessary 
additional layer of complexity to IUR analysis and would result in each 
reporting entity responsible for a far greater number of Form U 
submittals.
    The Agency believes it is likely that recordkeeping practices were 
already in place for a company to track the volumes of the chemical 
substances it is manufacturing (including importing). In response to 
commenters, EPA decided to take two steps to limit the burden increase 
associated with IUR reporting for the specific regulated chemical 
substances. As a result, EPA is reducing the reporting threshold for 
these chemical substances to 2,500 lb, instead of entirely eliminating 
the reporting threshold. In addition, EPA is phasing in this change to 
the IUR; it will not affect IUR submissions until the 2016 submission 
period (i.e., it applies to the submission in 2016, of records of 
production occurring between 2012 and 2015). EPA believes this should 
help to reduce the reporting burden for submitters because it provides 
sufficient time for companies to put in place recordkeeping procedures 
to collect and report the required data for situations where the 
recordkeeping procedures do not already exist. The burden of reporting 
will also be greatly diminished by the use of the reporting tool. The 
Economic Analysis contains EPA's analysis of the burden associated with 
this reporting (Ref. 14).
    EPA disagrees that the increased burden will not yield any real 
benefits. Chemical substances that are the subject of particular TSCA 
rules and/or orders are of demonstrated high interest to the Agency. 
Receipt of up-to-date exposure and use information on these chemical 
substances, produced at 2,500 lb or more, will help EPA as it develops 
risk management strategies for those chemical substances subject to 
proposed rules. Additionally, EPA will use the 2016 IUR data as it 
monitors chemical substance production and compliance with the rules. 
The new requirement will also contribute to the EPA Administrator's 
commitment to increase the availability of chemical substance 
information to the public.
    b. Imports and mixtures. Commenters thought this requirement will 
be difficult to meet in practice, particularly for imported chemical 
substances or mixtures. One commenter felt the requirement would create 
a needle-in-a-haystack situation in which a company would need to 
examine all chemical substances and/or mixtures imported, regardless of 
the concentration of the chemical substance or volume of the import. 
Other commenters believed that importers would have great difficulty 
knowing that low-concentration ingredients are present in formulated 
mixtures, especially when they are not subject to inclusion on a label 
or Material Safety Data Sheets (MSDS). EPA recognizes that eliminating 
the 25,000 lb reporting threshold may, in some instances, make it more 
difficult for importers to determine the production information for 
component chemical substances in imported products. Consequently, the 
reporting threshold will be 2,500 lb, instead of zero, and will be 
phased in to begin with the 2016 IUR. The IUR also includes a number of 
exemptions that address the ``needle-in-a-haystack'' concern expressed 
by the commenter. IUR reporting is not required for a chemical 
substance that is imported solely in small quantities for research and 
development, as an impurity, as part of an article, or in certain other 
forms. See 40 CFR 711.10, 40 CFR 720.30(g) and (h). Furthermore, 
companies should be accustomed to reporting chemical-specific 
information to EPA because the Agency has always sought information on 
individual chemical substances in mixtures under the IUR and other TSCA 
regulations. For example, TSCA section 13 requires chemical importers 
to certify that the chemical substance or mixture it is importing is 
not being imported in violation of TSCA; an importer must, therefore, 
have knowledge of the regulatory status of the chemical substances it 
is importing. If an importer does not know, or can't reasonably 
ascertain that a particular chemical substance is present in a mixture, 
it is not required to report the chemical substance. If an MSDS makes 
no mention of the presence of an ingredient, and the importer does not 
otherwise know that the ingredient is present, EPA would generally 
agree that the importer does not know, and cannot reasonably ascertain 
that it is importing that ingredient. Therefore, no IUR report for that 
ingredient would be required. In addition, manufacturers (including 
importers) are not required to report impurities.
    If an importer does not know and cannot reasonably ascertain that a 
particular chemical substance is present in an imported mixture, it is 
not required to report the chemical substance under the IUR. Importers 
of mixtures with constituents of proprietary or otherwise unknown 
chemical identity should ask the supplier for the chemical identity to 
help determine whether an IUR report must be completed. If an importer 
knows that it is importing a particular chemical substance above the 
relevant threshold, but does not know the chemical identity because the 
supplier is unwilling to share the chemical identity with the importer, 
it is sufficient for the importer to follow the procedures in 40 CFR 
711.15(b)(3)(i)(A), requesting that the foreign supplier provide the 
chemical identity directly to EPA in a joint submission.
    The IUR reporting related to mixtures and UVCB chemical substances 
(chemical substances that are of Unknown or Variable composition, 
Complex reaction products, or Biological materials) requires careful 
consideration by submitters. Whenever a submitter has manufactured or 
imported a combination of several chemical substances, the submitter 
must first determine whether for TSCA purposes it is a mixture or a 
single UVCB chemical substance. A mixture is any combination of 
chemical substances that meets the statutory definition of ``mixture'' 
at TSCA section 3(8). Mixtures are not reported to IUR--rather the 
mixture's component chemical substances, the chemical substances that 
make it up, are potentially subject to reporting, as described in this 
unit. A UVCB chemical substance is an indefinite combination of 
chemical substances, that does not meet the statutory definition of 
``mixture'' at TSCA section 3(8), whose number and individual 
identities and/or composition are not precisely or completely known. A 
UVCB combination of chemical substances is subject to reporting under 
IUR and is

[[Page 50841]]

considered a single chemical substance. Generally, the determination of 
whether a combination of chemical substances is a mixture or a UVCB 
chemical substance is made by the time that chemical substance has been 
commercialized and, as such, would be clear early in the IUR process. 
The following discussion is presented with this generality in mind.
     If you imported a mixture, you will need to report the 
individual chemical components of the mixture to the extent that your 
total volume for the individual chemical substance triggers reporting 
(i.e., generally to the extent that such volume reaches the 25,000 lb 
threshold).
     If you domestically manufactured a mixture, you will need 
to determine whether any chemical substances were formed from a 
chemical reaction that occurred as part of manufacturing the mixture. 
If a chemical reaction has occurred, a chemical substance formed from 
the chemical reaction may be subject to reporting, based on its 
production volume or the applicability of other exemptions. If a 
chemical reaction has not occurred, you have not manufactured any 
reportable chemical substances in the production of the mixture. In 
such a case, the production of the mixture has not triggered any IUR 
reporting requirement.
     Domestic manufacturers and importers should also consider 
whether the combination of chemicals they have domestically 
manufactured or imported (respectively) should be chemically identified 
for TSCA purposes as a single UVCB chemical substance instead of a 
mixture.
    EPA has developed two inventory nomenclature guidance documents 
related to the mixture-UVCB determination titled:
    i. ``Toxic Substances Control Act Inventory Representation For 
Chemical Substances Of Unknown Or Variable Composition, Complex 
Reaction Products And Biological Materials: UVCB Substances'' available 
on-line at http://www.epa.gov/oppt/newchems/pubs/uvcb.txt.
    ii. ``Toxic Substances Control Act Inventory Representation For 
Combinations Of Two Or More Substances: Complex Reaction Products'' 
available on-line at http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt.
    c. List of subject chemical substances. Commenters suggested that 
EPA provide an up-to-date list of the chemical substances impacted at 
the beginning of the information collection year to ensure more 
accurate and complete reporting. EPA provides just such a list. It is 
titled ``Chemical Substances that are the Subject of Certain TSCA 
Orders, Proposed or Final TSCA Rules, or Relief Granted under Civil 
Actions.'' It can be found in Appendix B of the Instructions document 
(Ref. 7). The pertinent chemicals are listed both by CASRNs (for non-
confidential chemical substances) or by TSCA Accession Numbers (for 
confidential substances) that are the subject of a rule. The 
Instructions document, which was updated for the 2012 IUR reporting, is 
available in the docket for this final rule and on EPA's IUR Web site 
at http://www.epa.gov/iur. This list is intended to be a helpful 
information resource, but it is not legally determinative of the status 
of any particular chemical substance.
    d. Reporting for chemical substances subject to a proposed rule. 
Some commenters supported EPA's suggestion to eliminate the 25,000 lb 
threshold for certain chemical substances that are the subject of a 
rule proposed under TSCA section 5(a)(2), 5(b)(4), or 6. Another 
commenter believed it was inappropriate to impose expanded reporting 
requirements on chemical substances subject to proposed rules which 
might not be finalized. The Agency generally agrees with the commenters 
who stated that if chemical substances that would typically be exempted 
from reporting are subject of a rule proposed under TSCA section 
5(a)(2), 5(b)(4) or 6, the chemical substances should be reported 
despite the lower volumes produced. However, as discussed in Unit 
III.E.3., EPA has decided to reduce the reporting threshold for these 
chemical substances to 2,500 lb, instead of entirely eliminating the 
reporting threshold. In addition, EPA is phasing in this change to the 
IUR; it will not affect IUR submissions until the 2016 submission 
period.
    The Agency disagrees with the commenter who argued that the change 
to the 25,000 lb reporting threshold (at 40 CFR 711.8(b), promulgated 
under TSCA section 8(a)) should not be triggered by the mere issuance 
of a proposed rule for a chemical. The latter commenter suggested that 
it would be inappropriate to collect more detailed information on such 
a chemical substance until the proposed rule had been fully vetted and 
analyzed, noting that finalization can often take a number of years. 
However, EPA believes that the issuance of one of the proposed rules 
described in this unit represents an appropriate circumstance to 
trigger enhanced information collection under the IUR. EPA issues a 
proposed rule under TSCA section 5, or 6 only after making proposed 
findings under TSCA section 6 that a chemical substance or some 
specified use of a chemical substance presents some level of concern. 
Precisely because potential concerns about the chemical substance would 
be under review and because there might be an opportunity for a fuller 
IUR dataset to help inform that analysis and the development of risk 
management actions, EPA believes it is appropriate for the reduction of 
the 25,000 lb reporting threshold to be triggered when a rule is 
proposed. Furthermore, those chemical substances that are the subject 
of a rule proposed under TSCA sections 5(a)(2), 5(b)(4), or 6 are of 
demonstrated high interest to the Agency. In an effort to better 
understand the extent of manufacture, use, and potential exposure to 
such chemical substances, EPA believes it is appropriate to reduce the 
25,000 lb threshold and require reporting on these chemical substances 
during the 2016 reporting cycle if they are manufactured (including 
imported) in volumes of 2,500 lb or more.
    e. De minimis threshold volume. EPA asked for comment on whether a 
de minimis production volume threshold should be set for these chemical 
substances. Several commenters supported the concept of a de minimis 
threshold, although one of the commenters indicated that it would be 
difficult to choose an appropriate level to decrease the reporting 
burden due to the difficulty associated with definitively identifying a 
production volume level below which there are not chemicals of 
interest. A few of these commenters supported setting a de minimis 
threshold of 2,500 lb, as this is 10% of the 25,000 lb reporting 
threshold and is similar to the de minimis under the EU's REACH 
regulations. One commenter thought a de minimis volume should be set on 
a chemical-by-chemical basis for chemicals for which EPA needs specific 
information. Some commenters opposed setting a de minimis threshold, 
either because they felt that there should be no reporting threshold or 
they felt that the threshold should remain at 25,000 lb. One commenter 
specifically opposed a de minimis threshold for any persistent, 
bioaccumulative and toxic (PBT) chemical substances.
    EPA agrees with some commenters who noted that a 2,500 lb threshold 
would provide sufficient data for the Agency to monitor production and 
compliance with certain proposed or promulgated rules and/or relief 
granted pursuant to actions. Therefore, the Agency has decided to lower 
the reporting threshold to 2,500 lb, instead of zero, beginning with 
the 2016 IUR.

[[Page 50842]]

EPA believes that, at this time, the 2,500 lb threshold is a reasonable 
de minimis threshold that is low enough to help decrease the burden on 
submitters, yet will provide much needed data on chemical substances of 
known concern to the Agency. The reduced threshold is essential to 
ensuring that information is available on chemical substances that 
could pose health or environmental concerns at levels of production or 
import below the 25,000 lb threshold. In the future, EPA may find it 
necessary to collect information on these chemical substances at a 
reporting threshold below the 2,500 lb threshold introduced in this 
action.
    EPA also believes that the regulated community should be 
sufficiently familiar with the 2,500 lb threshold as it is similar to 
the threshold that is used under the EU's REACH regulations to submit 
registration dossiers. Under REACH, a person who manufactures or 
imports a chemical substance in quantities of 1 tonne (metric tonne 
(mt) or if converted to pounds, about 2,205 lb) or more per year within 
the European Economic Area (EEA) must register the chemical substance 
(Ref. 22).
    EPA believes that setting a de minimis threshold on a chemical-by-
chemical basis or special thresholds for PBTs or carcinogens would 
require more time and resources than are presently available. The 
Agency recognizes that because of this de minimis threshold, there may 
be some chemical substances for which the Agency will have an interest 
in the IUR data (e.g., for evaluating potential exposures), but for 
which IUR data are not reported because production volume is below 
2,500 lb per site. However, EPA believes the 2,500 lb threshold will be 
sufficient for most circumstances. To address any future need for 
additional exposure-related information respecting chemical substances 
with per-site production volume below 2,500 lb, EPA may propose to 
amend the IUR further in the future, or may evaluate whether other 
action under TSCA would be appropriate.

D. Comments on Specific Data Elements

    1. Parent company and site identity. Two comments were received in 
support of using the company name, address, and D&B number for 
reporting purposes, and clarifying the meaning of ``company name.'' 
Respecting the clarification, one commenter suggested that the word 
``ultimate'' be removed from the phrase ``ultimate domestic parent 
company'' and that instead companies should be allowed to name their 
domestic company, as is understood within their particular corporate 
organization. The commenter also noted that the intended clarification 
was not reflected in the actual regulatory text at proposed 40 CFR 
711.15(b)(2)(i), which only referred to ``parent company name.''
    During the 2006 submission period, submitters indicated that 
further clarification was needed to identify the correct company name 
for reporting purposes. Based on these previous comments, EPA has 
determined that the parent company's name, address, and D&B number is 
necessary to provide clarity as to which company name to use for 
reporting under the IUR. EPA agrees that further specification of 
``company name'' is appropriate, and that the appropriate name for 
reporting should be clearly identified in the rule, but disagrees that 
``domestic parent company name'' is sufficiently specific. As noted in 
the proposed rule (Ref. 1), EPA believes that using an approach that is 
consistent with the TRI reporting requirements would be most clear both 
for reporters and users of the data. EPA is therefore amending 40 CFR 
711.15(b)(2)(i) to refer to ``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.'' The IUR 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). EPA provides 
further clarification regarding the correct domestic (U.S.) parent 
company name in the Instructions document (Ref. 7).
    2. Technical contact. EPA requested comment on requiring that the 
technical contact be a person knowledgeable about the reported chemical 
substance and be located at the manufacturing (including importing) 
site. Several commenters stated that companies should be able to use 
their discretion in identifying the most appropriate contact or 
contacts. They believe that the technical contact need not be 
physically located at the reporting site, and that information may be 
more reasonably generated by a corporate contact rather than a 
technical contact at the production site. Some commenters said that the 
technical contact should be an employee of the submitting company.
    EPA agrees with commenters who stated that companies should use 
their discretion in selecting a technical contact or multiple technical 
contacts, as permitted by the new e-CDRweb tool. However, EPA believes 
that a technical contact must be someone who can answer detailed 
follow-up questions that EPA may have regarding the submission. EPA has 
found that technical contacts not at the reporting site generally are 
less knowledgeable about the submission or chemical substance and 
therefore may not be able to discuss follow-up questions. Also, it has 
been EPA's general experience that short-term contractors have not been 
suitable technical contacts, because they may no longer be under 
contract with the submitting company when EPA contacts them a year or 
more after the submission is made.
    3. Correct chemical name--a. Comments on imported chemical 
substances and joint submissions. EPA received several comments 
regarding its proposal to require that importers ensure that their 
supplier completes the joint reporting of the CA Index Name currently 
used to list the chemical substance on the TSCA Inventory. The comments 
indicated that it would be difficult for an importer to require that 
another party complete a joint submission because foreign suppliers are 
not subject to the same Federal regulations as U.S. companies, 
compliance with U.S. regulations is not their top priority, and in some 
cases they are slow to comply.
    EPA agrees with the commenters that its proposed joint submission 
procedures for importers, which required the importer to ensure that a 
foreign supplier prepared a secondary submission on its behalf, 
presented implementation difficulties. This is because, as the 
commenters suggested, the foreign supplier may not be subject to any 
direct legal obligation to provide the information to EPA. The Agency 
also notes that this issue extends to the regulations at 40 CFR 
711.15(b)(3)(i)(B), as there may be circumstances in which the 
manufacture of a chemical substance is reportable under the IUR, yet 
the supplier of a reactant used in manufacturing that chemical 
substance would not have an independent legal obligation to report the 
chemical identity of the reactant under the IUR.
    Therefore, the Agency has modified the requirements at 40 CFR 
711.15(b)(3)(i) to reflect the primary submitter's underlying 
obligation to provide what it knows or can reasonably ascertain 
respecting the identity of a chemical substance subject to reporting. 
The joint submission requirement is no longer to ensure that suppliers 
provide secondary submissions to EPA, but to properly ask that they do 
so. Consistent with 40 CFR 711.15(b)(3)(i), a request for a secondary 
submission to EPA must

[[Page 50843]]

be prepared using e-CDRweb, include instructions for electronically 
submitting the information to EPA, and explain how to provide a clear 
reference to the primary submission. Documentation of the request to 
the supplier must be submitted to EPA along with the rest of the 
primary submission.
    Finally, EPA has also modified the requirements to more clearly 
reflect, see proposed rule (Ref. 1), that they only apply in cases 
where a supplier will not reveal the pertinent chemical identity 
information to the submitter. In the event that a manufacturer 
(including importer) actually knows the chemical identity of a chemical 
substance subject to IUR reporting, the manufacturer must provide that 
information irrespective of a supplier's confidentiality claims. EPA 
has modified the substantiation question at 40 CFR 711.30(b)(1)(i) to 
include information about harm to the submitter's competitive position 
``or to your supplier's competitive position.''
    b. Comments on reporting International Union of Pure and Applied 
Chemistry (IUPAC) names as an alternate. A commenter recommended 
allowing IUPAC names as a substitute for CA Index Names for discrete 
chemical substances, because the IUPAC nomenclature provides the exact 
chemical structure and because the commenter was concerned that 
submitters would be required to go through a particular fee-based 
service to obtain CA Index Names for chemical substances.
    The Agency disagrees that IUPAC names should be allowed as a 
substitute for CA Index Names in reporting discrete chemical substances 
for the IUR. Chemical substances are listed on the TSCA Inventory using 
CA Index Names, and only chemical substances listed on the TSCA 
Inventory are to be reported for IUR. The requirement for using CA 
Index names is directly related to positively identifying the listed 
TSCA Inventory chemical substance. Using a different nomenclature for 
the purposes of reporting for IUR could create confusion, both for 
industry and for EPA.
    Additionally, there will generally be no need for submitters to use 
a fee-based service to obtain the CA Index Name and corresponding CASRN 
for IUR reporting purposes. As part of the electronic reporting process 
for the IUR, submitters will be able to easily connect electronically 
from the IUR reporting tool directly to the Agency's SRS database in 
order to obtain CA Index Names and corresponding CASRNs for all of 
their non-confidential chemical substances on the TSCA Inventory. These 
data can then be electronically copied back to the IUR reporting tool.
    4. Chemical identifying number. Some commenters were opposed to 
removing the PMN number as an allowed identifying number, suggesting 
that the Agency might be inundated with requests for TSCA Accession 
Numbers, and that for historical products, this may pose an extra 
burden for both industry and EPA. It was suggested that the Agency 
provide a cross-reference list of PMN numbers to TSCA Accession Numbers 
so that the information can be easily obtained without additional 
burden on industry and the Agency.
    The Agency has added PMN numbers to the SRS listing to provide a 
cross-reference list, as suggested by the commenters. The e-CDRweb 
reporting tool allows the user to search SRS using the PMN number in 
order to populate the IUR report with the pertinent chemical 
identification information for confidential chemical substances listed 
on the TSCA Inventory.
    There are certain circumstances where a submitter occasionally may 
not be sure of the particular PMN case number and TSCA Accession Number 
the Agency has assigned to one of its confidential substances, such 
that the submitter would not be able to definitely determine this 
solely from searching in the SRS. This could happen, for example, if 
the chemical substance were originally reported as part of a 
consolidated PMN and the submitter did not learn from EPA which 
particular case number in the consolidated PMN number sequence 
corresponds to which of the several reported confidential substances. 
This could also happen if a certain PMN represented a mixture of two or 
more confidential substances, such that multiple TSCA Accession Numbers 
were assigned to the different substances reported in that single PMN, 
and the submitter didn't already request the particular TSCA Accession 
Numbers from EPA for the individual chemical substances comprising that 
multi-component type of PMN. In such circumstances, a submitter should 
contact EPA in writing, well before initiating IUR reporting, to obtain 
the required TSCA Accession Numbers from the Agency. The Agency will 
respond to such inquiries in as timely a manner as possible. It is the 
responsibility of the submitter to contact EPA for such information in 
sufficient time to allow for the Agency to respond.
    5. Production volume--a. Report production volume for each year. 
EPA requested comment on the requirement to report production volume 
for each of the 5 years since the last IUR principal reporting year. 
Comments submitted on various topics are described in this unit.
    i. Insufficient time to collect data. Most commenters stated that 
companies were prepared to compile and report the required information 
for the 2010 reporting year; some companies indicated, however, that 
they had not established systems to collect and compile information for 
2006-2009. Several commenters recommended that EPA delay the 
implementation of the reporting requirement until the next reporting 
cycle to allow companies sufficient time to prepare for the additional 
data collection effort. One commenter was concerned that the short 
period of time given by EPA to collect the information will result in 
significantly decreased data quality and reliability. Another commenter 
said that most companies archive data after 18-24 months. Some found it 
confusing that the threshold to determine the need to report in one 
submission period would change to include production data from previous 
years, but that the reporting of production data from previous years 
would take effect in an earlier submission period.
    EPA acknowledges the possibility that certain information 
respecting past production volume, for the years between 2006 and 2009, 
might not be known or reasonably ascertainable to a submitter in 2012. 
While submitters are free to designate as ``not known or reasonably 
ascertainable'' any information that has indeed passed out of the scope 
of reporting due to the passage of time, EPA has determined it is 
nevertheless appropriate to reduce the extent to which submitters will 
need to resort to such designations, and to focus on more recent 
production. EPA believes that phasing in the reporting of past 
production volumes as follows will both improve the quality of the 
information collected and reduce the burden of collecting it.
    Based on the comments received, EPA is requiring that for the 2012 
submission period, manufacturers (including importers) report the total 
annual volume (domestically manufactured and imported volumes in 
pounds) of each reportable chemical substance at each site during the 
calendar years 2010 and 2011. For submission periods subsequent to the 
2012 submission period, 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 principal reporting year are required to be reported. EPA 
believes its decision to require the reporting of 2010 production 
volumes in

[[Page 50844]]

a 2012 submission period is consistent with the comments noting that 
companies were prepared to report 2010 data and that the Agency's 
decision to phase in reporting for each complete calendar year since 
the last principal reporting year is warranted in light of other 
simultaneous changes to the IUR rule which increased reporting burden. 
The Agency also believes the delay to report the production volume for 
each year since the last principal reporting year will give companies 
adequate time to establish systems to collect and compile the required 
information.
    ii. Reporting burden. Several commenters stated that the 
requirement is overly burdensome, especially for chemical substance 
importers and manufacturers who (according to the commenters) will need 
to analyze all products to track the volumes of all component 
chemicals. Another commenter acknowledges that, while the burden of 
reporting the data for each principal reporting year was minor, the 
information would be of little value to the Agency. On the other hand, 
one commenter stated that this requirement could increase the burden by 
at least three fold. Another commenter said that in some cases, 
businesses have no need to capture past production volumes. One 
commenter asserted that many companies will consider the production 
volume in every year to be CBI and will take the necessary steps to 
request CBI coverage of this information. The commenter acknowledged 
that the information will still be available to EPA for consideration, 
but was concerned that the burden on EPA of keeping the information 
confidential will increase substantially due to the potential number of 
CBI claims.
    EPA's burden estimates represent the average burden across all 
sites for providing production volumes. As such, commenters should be 
aware that their particular circumstance may not be average and, 
therefore, the estimate may not accurately reflect their own individual 
circumstances. However, EPA is confident that the estimate does reflect 
the average burden across all sites and encompass the range of burdens 
faced by submitters.
    In addition, some comments identified a misunderstanding of the 
reporting requirements with respect to byproducts. As described 
elsewhere in this unit, accounting for the manufacture of a byproduct 
does not necessarily entail accounting for each individual component 
chemical substance in the byproduct. See the more detailed discussion 
of issues related to byproducts in section F.3. of the Responses to 
Comments document (Ref. 12). The Agency does expect that the reporting 
burden will decrease in reporting cycles beyond 2016, as submitters put 
additional recordkeeping procedures into practice.
    As with any data element, CBI claims should only be made when 
warranted. While more CBI claims may increase EPA's burden slightly, 
the Economic Analysis estimates the amendments will save EPA 
approximately $68,000 in the first reporting year and $175,000 in 
subsequent reporting cycles through efficiencies from electronic 
reporting (Ref. 14). CBI claims on production volumes are unlikely to 
create any significant burden beyond what is estimated in the Economic 
Analysis. CBI claims do, however, prevent valuable information about 
chemical substance manufacture (including import) from becoming 
publicly available.
    iii. Retroactive reporting. Several commenters expressed concerns 
asserting that EPA retroactively is requiring historical data and that 
the requirement for past production information was beyond the scope of 
EPA's TSCA authority for IUR reporting. Another commenter said it was 
not feasible to accurately produce this historical data for the many 
byproducts that companies produce and send for recycling, primarily 
because manufacturers did not know they needed to have such data 
gathering mechanisms in place.
    EPA disagrees with commenters' suggestion that requiring reporting 
information on past production constitutes an imposition of retroactive 
reporting requirements. This is because the final rule does not 
establish a new legal requirement to have taken some particular 
recordkeeping action in the past. Instead, it holds submitters to a 
prospective standard of reasonableness. To the extent that a particular 
piece of information about the past is indeed not known or reasonably 
ascertainable at the time that a person is obligated to make a 
submission (either because of the timing of a change in the reporting 
requirements or for some other reason), the submitter may simply 
indicate that the information is ``not known or reasonably 
ascertainable.''
    iv. Alternate approaches. A few commenters suggested that burden 
would be reduced if companies reported in ranges or provided best 
estimates. Other commenters suggested that reporting be limited to a 
subset of industries or chemical substances, based on criteria to focus 
on data collection and evaluation activities that are more valuable to 
the Agency. Examples of criteria include substances with a history of 
fluctuations in chemical substance manufacture and import practices or 
substances that are considered hazardous.
    EPA disagrees that reporting production volume in ranges or 
estimates would provide data of comparable value. Though EPA requires 
some of the IUR information to be reported in specified ranges, EPA 
sees little value in allowing submitters to report the production 
volumes in ranges. Similarly, EPA sees little value in allowing 
submitters to provide estimates that do not reflect all information 
known or reasonably ascertainable. EPA believes that a higher level of 
confidence in data accuracy will be achieved by requiring specific 
numeric data that reflect all information known or reasonably 
ascertainable to the submitter. It is important to note that EPA is 
interested in use and other exposure-related data on all chemical 
substances that are not exempted from IUR reporting, and manufacturing 
exposure-related data on partially exempted chemical substances. 
Especially since there is a multi-year gap between IUR submission 
periods, the mere fact that a chemical substance is not known to be 
hazardous at this time does not mean that EPA is not interested in 
exposures and uses of that chemical substance. Under a contrary policy, 
EPA would potentially need to wait several years before obtaining the 
basic exposure information necessary to determine whether a hazardous 
chemical substance may present an unreasonable risk (since the 
collection of screening-level exposure information would not be 
triggered until hazard data had been assessed). In summary, after 
considering the suggestions, EPA believes its decision to collect 
multi-year production volume starting with the 2016 IUR submission 
period is still sound.
    EPA disagrees with the suggestion that reporting be limited to a 
subset of industries or chemical substances. The IUR data are used 
extensively in the Agency's screening and prioritization process. As 
such, identifying a list of chemicals or industries prior to screening 
would not provide EPA with the data needed for its programs and defeats 
the purpose of collecting the data. EPA does not believe it practicable 
to provide a definitive list of chemical substances with a ``known 
history of fluctuations.'' The Agency does not have such a list, and 
believes that because year to year fluctuation could be caused by such 
a wide variety of circumstances, including circumstances such as 
economic changes and manufacturing practices, that

[[Page 50845]]

developing and maintaining such a list is not only not practicable, but 
confining that list to substances with a ``history'' of fluctuations 
would not capture the industry variability that EPA is seeking.
    b. Volume of chemical substances used on site. One commenter stated 
that this data element was essential to improving accuracy and utility 
of the reported production volume and two commenters stated they 
thought there was no value in this data element and that the Agency 
should retain the site-limited check box because, the commenters 
stated, it was more informative for screening-level risk assessment. 
Five commenters expressed confusion about the requirements of reporting 
this data element. Specific concerns included a concern about 
duplicative reporting for this data element and the industrial 
processing and use information for chemical substances used on-site; 
whether this applied to chemicals used in synthesis or also to 
chemicals that were repackaged; and the need to identify the amount of 
a chemical substance present on site during a specific time period.
    EPA agrees with the commenter who felt that reporting volumes of 
chemical substance used at a site will increase the accuracy and 
utility of the IUR reporting information. Reporting the volume used on-
site provides valuable information related to potential exposures 
associated with the on-site volumes, providing the Agency with better 
information for exposure assessments. The usefulness of this IUR data 
element has been demonstrated by EPA's use of similar data in the New 
Chemicals Program. PMNs for new chemical substances submitted to EPA 
under TSCA section 5 require many of the same exposure-related data 
elements that will be reported under the IUR. Exposure-related data in 
PMNs include estimates of production volume, categories of use, percent 
production volume in the categories of use, maximum numbers of workers 
exposed, and concentrations and physical forms of the chemical 
substance. EPA uses these exposure-related data to generate screening-
level risk assessments for regulatory decisionmaking under TSCA section 
5. The reporting obligation and the phrase ``site use'' applies to all 
nonexempt substances produced for commercial purposes that are on the 
TSCA Inventory.
    Some of the commenters have misunderstood this data element, which 
provides more detailed and clearer information than did the previous 
site-limited check box. Previously, submitters checked a box to 
indicate that a reported chemical substance was site limited--in other 
words, that it was both manufactured and used on the site. Some 
submitters misreported, identifying an imported chemical substance as 
site-limited (a situation that is not possible because the imported 
chemical substance, by definition, is brought onto the site from 
outside of the United States, and therefore is not physically 
manufactured and used at the reporting site) or reporting the same 
substance twice, once for the volume that is site limited and once for 
the volume that is sent off site. Because of this confusion, EPA 
replaced the site-limited check box with reporting the volume of the 
chemical substance production volume reported on the form that is used 
on the site. For example, if 50,000 lb of a chemical substance was 
manufactured and used on the same site, the submitter would report 
50,000 lb for domestically manufactured and 50,000 lb for the volume 
used on-site. If 70,000 lb of a chemical substance was manufactured, 
25,000 lb was used on-site and 45,000 lb was shipped to a different 
site, the submitter would report 70,000 lb for domestically 
manufactured and 25,000 lb for the volume used on-site. If a site 
imported 30,000 lb and used it at the import site, the submitter would 
report 30,000 lb for imported production volume and 30,000 lb for the 
volume used on-site. If a site imported 100,000 lb and shipped it to an 
alternate site, the submitter would report 100,000 lb for imported 
production volume and 0 lb for the volume used on-site. As these 
examples illustrate, the submitter is not identifying the amount of a 
chemical substance on-site during a particular time period, but rather 
that amount of a chemical substance that is manufactured (including 
imported) and used at the same site.
    Commenters also asked for clarification regarding the activities 
considered to be ``used at the reporting site.'' For a domestically 
manufactured substance, if the volume would have been considered to be 
site-limited, then the chemical substance is used on site. If the 
chemical substance is domestically manufactured, temporarily stored, 
and then packaged for shipment off of the site, that volume would not 
be considered ``used at the reporting site.'' For an imported 
substance, any use at the importing site (e.g., consumed in a reaction 
or cross-linked or cured in an article) would be considered ``used at 
the reporting site.''
    EPA does not believe reporting the portion of the production volume 
that is both manufactured and used on site will result in duplicative 
reporting. Even with the previous site-limited check box, submitters 
provided information about the use of a chemical substance in both the 
manufacturing and industrial processing and use sections of the Form U. 
The information reported under the manufacturing section identifies 
that this substance is processed or used at that particular site and 
reports the number of workers associated with the manufacture of that 
substance. In the same report, the information reported under the 
industrial processing and use section provides more details about how 
the chemical substance is processed or used and, in the event that a 
substance has a use identified by the same combination of use, 
function, and NAICS code by another site, the production volumes, 
sites, and workers would be combined with the information describing 
the other sites' processing or uses.
    c. Report volume exported. The majority of the comments against 
reporting the volume directly exported stated that capturing the 
volumes for each chemical substance in each exported product was 
difficult and burdensome. These comments indicated a misunderstanding 
of the reporting requirement, and EPA believes that a better 
understanding will eliminate those concerns. For the chemical substance 
that was manufactured and is being reported, the submitter is to report 
the volume of that chemical substance that is directly exported. If the 
chemical substance is processed in any way (e.g., combined with other 
chemical substances to form a mixture), the chemical substance is not 
directly exported. Also, if a chemical substance is sent to a 
distributor who then exports it, the chemical substance is not directly 
exported. In both of these examples, the manufacturer would instead 
report either the processing to form a mixture or the transfer to a 
distributor under the processing and use portion of the IUR reporting 
form. ``Directly Exported'' and ``Domestically Processed or Used'' are 
mutually exclusive designations; only one designation applies to any 
particular portion of the production volume.
    6. Identify whether a chemical substance is to be recycled, 
remanufactured, reprocessed, reused, or reworked. EPA received several 
comments on the proposal to add a checkbox indicating whether a 
manufactured chemical substance was or is expected to be recycled, 
including remanufactured, reprocessed, reused, or reworked. Some 
commenters were supportive of adding this reporting element, but 
several of the commenters were concerned that the term ``recycle''

[[Page 50846]]

has been difficult to define in other programs, indicated confusion 
about EPA's purpose in including the checkbox, and expressed doubt that 
this data element would yield useful information.
    EPA intends that this checkbox would be used by manufacturers to 
indicate whether a chemical substance they manufactured, such as a 
byproduct, which might otherwise be disposed of as waste, was or is 
expected to be recycled. EPA also included the terms remanufactured, 
reprocessed, reused, or reworked, intending to capture a broad array of 
similar, and perhaps synonymous, activities by which a substance (that 
would otherwise be disposed of as waste) may be put to use. EPA is 
interested in the exposures from these activities, and believes that 
having more information about which chemical substances are being 
recycled will help the Agency to refine future IUR reporting 
requirements (e.g., if EPA knows enough about exposures to a chemical 
substance from an on-site recycling use, EPA could consider an 
exemption in the future).
    EPA also believes that this information would help the Agency to 
identify where this activity is already occurring, and could be used to 
recognize companies, industries, and sectors that are using ``green'' 
practices. This information would also help to identify sectors where 
recycling is not occurring, providing useful data to measure the 
effectiveness of various EPA programs, such as the Resource 
Conservation Challenge (RCC) Program, and informing other Agency 
efforts to encourage practices that reduce waste. EPA disagrees that a 
precise definition of ``recycle'' is needed to make this data element 
useful for the purposes that EPA has identified. Submitters should 
simply indicate, to the extent that they know or can reasonably 
ascertain, whether the reported volume of the chemical substance that 
they manufactured, which would otherwise be disposed of as waste, was 
or is expected to be recycled, remanufactured, reprocessed, or reused, 
as those terms are understood by the submitter.
    One commenter indicated that many chemical substances are 
``reworked'' in many industrial processes, at least at some point, so 
this box would be checked so often that it would provide little 
meaningful data. EPA agrees that the term may be interpreted and 
applied too broadly to provide the type of information that EPA is 
trying to collect, so has removed ``reworked'' from the list of 
recycling synonyms. Two commenters expressed concern that revealing 
whether a chemical substance they manufactured was recycled would 
reveal CBI. In such a situation, the submitter will be able to claim 
the information as confidential. Another commenter suggested that EPA 
collect information about recycling under a separate rulemaking. EPA 
disagrees that this would be an efficient way to collect the desired 
information. A separate rulemaking for one ``yes or no'' data element 
would be extremely inefficient and needlessly time-consuming for both 
the Agency and industry, particularly when the IUR rule already 
provides a suitable vehicle to collect chemical substance 
manufacturing, processing, and use information.
    7. Industrial processing and use information--a. Industrial 
function categories. The Agency received several comments regarding 
revising the list of industrial function categories for processing and 
use information. Some commenters were in favor of the changes and 
supported EPA's efforts to work collaboratively with Canada to align 
the categories. Other commenters said that this would require 
additional effort by the regulated community to assign the new codes, 
and a clear explanation of the changes with the reporting instructions, 
e.g., a ``read across'' of old and new codes, including additional 
definitions to ensure that activities are consistently coded across 
companies. Commenters stated that providing a description for ``other'' 
will be challenging, may not provide useful information (e.g., due to 
lack of information from the downstream customers), and would require 
additional burden to report. One commenter felt that the list of 
Industrial Function Category (IFC) codes is too limited for inorganic 
chemical substances, and suggested that the Agency add an IFC code for 
``Solid Manufacturing Materials.'' The comment stated that such a code 
would alleviate the need to address many industrial uses in the 
``other'' category, thereby reducing reporting burden.
    EPA agrees with the commenters that a table indicating the 
relationship between the 2006 IFC codes and the new 2012 IFC codes 
would be useful, along with clear definitions for each code. Such 
information is contained in the 2012 IUR Instructions document (Ref. 
7).
    EPA also recognizes that the requirement to report a description 
when the submitter selects the IFC code ``Other'' may be more 
burdensome than for the other IFC codes, but expects any increase to be 
minor. The descriptive information is essential to enable users of the 
data to estimate potential exposures associated with the overall 
processing or use of the chemical substance, of which the function is 
an important component. The Agency's experience with the 2006 IUR data 
was that the category of ``Other,'' with no further description, was 
insufficient for the data to be of much use.
    EPA disagrees with the suggestion to include a ``Solid 
Manufacturing Materials'' IFC code and believes such a code will not 
accurately describe the industrial function of the chemical substance. 
In addition, EPA believes the proposed list of IFC codes covers the 
majority of the industrial functions. This belief is based on the past 
experience of both the U.S. 2006 IUR and Canadian reporting. However, 
EPA does recognize that it did not collect such information for 
inorganic chemical substances in the past, and therefore will use the 
written description for ``Other'' to help evaluate and improve the 
inclusiveness of future IFC codes, including those applicable to 
inorganic chemical substances.
    b. IS codes. EPA proposed to replace the 5-digit NAICS code with a 
new code, Industrial Sector (IS), to describe the industrial setting. 
Some commenters were in favor of this change, noting that using code 
harmonized with Canadian codes would be helpful to both industry and 
data users. Other commenters stated that many companies have already 
begun the process of data collection based on the former system, which 
has precedent. The commenters believe NAICS codes are the 
classification system with which industry and regulators are most 
familiar, and in some cases, the IS codes are less descriptive than the 
NAICS codes. Commenters also asserted that the Agency should recognize 
that these changes will result in increased reporting burden and time.
    EPA disagrees with the commenters that the use of IS codes in place 
of the NAICS codes will present increased burden on industry. The IS 
codes simply group together similar NAICS codes while still providing 
the sufficient differentiation needed to differentiate overall 
industrial processing and use scenarios. The IS codes span the entire 
range of NAICS codes and can be translated from known NAICS codes. Both 
the e-CDRweb reporting tool and the 2012 IUR Instructions document 
(Ref. 7) contain cross-walk tables for submitters to use to determine 
the proper IS code, based on the NAICS code information they may 
already have collected.
    Information on the Agency's development of the IS codes is 
described in the technical support

[[Page 50847]]

document ``Inventory Update Reporting (IUR) Technical Support 
Document--Replacement of 5-digit NAICS Codes with Industrial Sector 
(IS) Codes'' (Ref. 16). In developing the IS codes, EPA considered the 
level of detail required for developing use and exposure scenarios, the 
number of 2006 IUR submissions using the code, the code definition, and 
the level of difficulty required in reporting more detailed codes. 
Submissions to the 2006 IUR reported over 340 unique 5-digit NAICS 
codes. In the 2006 IUR, the three-code combination of processing and 
use (P/U) code, NAICS code, and IFC codes resulted in a large number of 
possible exposure scenarios that could be reported. Although not all of 
the NAICS codes are applicable to chemical substance manufacturing and 
processing, the 2006 IUR database has over 2,300 unique combinations of 
P/U, NAICS, and IFC. Many of the NAICS codes reported are from similar 
industries that would have similar exposure scenarios.
    EPA agrees that the new IS codes are less descriptive than NAICS 
codes, but believes the reduction in specificity will not adversely 
affect, and will actually improve, the Agency's ability to use the 
processing and use data for screening-level purposes. The large number 
of unique combinations increases the difficulty and time required to 
sort and classify chemical substances since EPA would either need to 
develop exposure scenarios for each unique combination or determine 
which three-code combinations have similar exposure scenarios and can 
be grouped together. By replacing the NAICS codes with the IS code, the 
number of potential three-code combinations is reduced from in excess 
of 100,000 possible combinations to 7,920 combinations. Based on 
information collected from the last reporting cycle the number of 
combinations actually reported would be significantly less. 
Additionally, the IS codes will more closely align to the EU Sector of 
Use codes which will allow EPA to compare U.S. data with that collected 
by the European Union.
    8. Consumer and commercial use--a. Consumer and commercial product 
categories. Many commenters supported revising the list of consumer and 
commercial product categories for consumer and commercial use 
information. Those commenters stated that harmonizing codes with 
Canada, revising the product categories, and requiring descriptive 
information when the ``Other'' category is reported are essential to 
improving the consumer and commercial data. The commenters stated also 
that these changes will provide a better understanding of how chemical 
substances are used in downstream products and will help facilitate 
consistent reporting of chemical substance use information in the 
United States and Canada. Other commenters wanted more explanation as 
to why the categories are being revised and requested that the Agency 
provide more descriptive information for each product category, 
including a table identifying how the new categories relate to the 
previous categories. Some commenters stated that providing a 
description for the category ``Other'' will be challenging and may not 
provide useful information. One commenter stated that the Agency should 
not further complicated downstream reporting, noting that was already 
challenging to choose the top ten categories for substances with a 
large number of uses.
    EPA appreciates the support for the harmonized consumer and 
commercial product categories, and agrees that the changes finalized in 
this rule will improve the IUR data. As described in Unit III.G.8.a., 
information from data collected during the 2006 IUR and from Canada was 
used to develop a more useable listing of product categories. EPA 
eliminated categories for which few chemical substances were reported, 
added categories identified as needed, and eliminated overlap in 
categories. In addition, some categories were renamed to better match 
their definitions, other categories descriptors were improved, and 
categories were grouped to allow for easier identification. EPA 
believes these changes will make reporting easier for the submitter, 
and does not agree that these changes result in more complicated 
reporting. The Agency is providing more detailed descriptive 
information in the 2012 IUR Instructions document (Ref. 7) and other 
guidance materials.
    EPA recognizes that the requirement to report a description when 
the submitter selects the product code ``Other'' may be more burdensome 
than for the other product codes, but expects any increase to be minor. 
The descriptive information is essential to enable users of the data to 
estimate potential exposures associated with the consumer or commercial 
use of the chemical substance. The Agency's experience with the 2006 
IUR data was that the category of ``Other,'' with no further 
description, was insufficient for the data to be of much use.
    b. Designation of consumer or commercial use. Commenters had mixed 
viewpoints regarding the need to designate whether the indicated 
product category is consumer use, commercial use, or both. One 
commenter strongly in support of making this designation stated that 
such distinctions are critical to EPA's ability to assess exposure at 
even the most basic level. Others did not oppose the added designation, 
but did ask for further clarification between consumer and commercial 
uses. Commenters opposing the added designation stated that they were 
too removed from the consumer and commercial uses to have a clear 
understanding of the uses at that level of distinction, especially for 
commodity chemical substances with a large number of uses. One 
commenter said suppliers to formulated products were less likely to 
know the distinction because of the confidentiality of the downstream 
user formulations.
    The intent of the consumer and commercial use data element is to 
clearly identify the exposed populations. These two populations (i.e., 
consumers and commercial workers) are very different from each other, 
and the ability to distinguish uses between the two enables better 
exposure-based screening of chemical substances. EPA recognizes that 
submitters may not always have detailed information about how the 
chemical substance(s) they make are used and to what extent they are 
used. However, EPA believes a manufacturer generally has a certain 
awareness of the downstream uses of chemical substances it manufactures 
and sells, even if it does not control its customers' sites, and can 
report this information, based on what is known to or reasonably 
ascertainable by the submitter.
    c. Number of commercial workers. Commenters strongly opposed EPA's 
proposal to require that submitters report the number of commercial 
workers reasonably likely to be exposed while using a product 
containing a reportable substance. Most commenters indicated that they 
do not have sufficient information about the work practices of eventual 
commercial users to estimate this number, that such information is not 
typically shared upstream, and that any such data EPA received would 
be, at best, an educated guess. It was suggested that the Agency rely 
on worker statistics from the Bureau of Labor Statistics as it conducts 
risk assessments, or gather additional data under a separate TSCA 
section 8(a) rule.
    EPA is requiring this information to better assess the size of the 
commercial population in screening risk assessments. In the past, the 
Agency has used the Bureau of Labor Statistics for general workers 
statistics to conduct

[[Page 50848]]

chemical-specific risk assessments; however, these worker statistics, 
which are industry-specific, overestimate the exposures associated with 
a chemical substance because a chemical substance is likely to be used 
by only a portion of the industry. Identifying chemical-specific worker 
populations for downstream activities will fill this gap for the 
Agency. The knowledge of a chemical substance's uses in industry and 
the respective commercial population potentially affected by their uses 
provides the Agency a more complete picture of the potential risks 
associated with a chemical substance.
    EPA recognizes that submitters may not always have detailed 
information about how the chemical substance(s) they manufacture are 
used and to what extent they are used in commercial enterprises. 
However, EPA believes that a manufacturer generally has a certain 
awareness of downstream uses of chemical substances it manufactures and 
sells, even if it does not control its customers' sites. Based on its 
experience with the PMN program, many stakeholder meetings, discussions 
about voluntary risk management programs, and industry's various self-
regulation initiatives, the Agency believes that most submitters can 
report on downstream uses, including the information that would be 
reported under IUR, based on what is known to or reasonably 
ascertainable by the submitter. To reduce the burden in reporting, the 
IUR provides that the number of commercial workers need only be 
reported in ranges, and the ranges are the same as for manufacturing 
and industrial workers. Reporting in ranges will lessen the reporting 
burden when the precise number of workers for multiple end uses is not 
known. Although this may result in some uncertainty in the data 
reported, the chemical substance manufacturer or importer has fulfilled 
his obligation by providing information to the extent it is known or 
reasonably ascertainable. EPA believes that the data will be 
sufficiently reliable for the Agency and others to use for screening-
level risk assessments and prioritization.

E. Definitions and Clarification Requests

    1. Changing the reporting standard for processing and use 
information to ``known to or reasonably ascertainable.'' A number of 
commenters requested further clarification (beyond that offered in 
section 4.0 of the Instructions document (Ref. 7)) of the scope of pre-
reporting inquiry that would be required under the ``known to or 
reasonably ascertainable by'' reporting standard. Specifically, the 
commenters requested further clarification of how this reporting 
standard would apply in the case of information reported under 40 CFR 
711.15(b)(4) (``specific information related to processing and use''). 
The commenters also expressed some confusion about how this standard 
would differ from the ``readily obtainable'' standard, previously 
applicable to such reporting, and whether the change of standard 
indicates that ``extensive file searches and customer surveys'' would 
now be expected of submitters. Other commenters from the chemical 
industry expressed their understanding that the change in reporting 
standard only altered the level of diligence with which submitters must 
search for information within their own organization. They requested 
confirmation that, as under the ``not readily obtainable'' standard, 
submitters would not be required to conduct customer surveys in order 
to assemble data for purposes of IUR.
    The term known to or reasonably ascertainable by is defined at 40 
CFR 704.3. It means ``all information in a person's possession or 
control, plus all information that a reasonable person similarly 
situated might be expected to possess, control, or know.'' By contrast, 
``readily obtainable'' information does not even cover all the 
information in a submitter's possession or control. As defined for the 
2006 IUR, it was limited to what was known by certain ``management and 
supervisory employees of the submitter'' (Ref. 4, p. 879).
    Under the ``known to'' portion of the ``known to or reasonably 
ascertainable by'' standard, a submitter would therefore ascertain what 
it knows 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 other information which the manufacturer 
(including importer) may have in its possession. In response to 
comments regarding the level of diligence with which submitters must 
search for information within their organization, this standard 
requires that submitters conduct a reasonable inquiry within the full 
scope of their organization (not just the information known to 
managerial or supervisory employees). The inquiry would be as extensive 
as a reasonable person, similarly situated, might be expected to 
perform within the organization. Information derived from customer 
surveys or other customer contacts, like any other information, would 
be ``known to'' the submitter if it is available after a reasonable 
inquiry within the organization. The standard does not necessarily 
require that the manufacturer conduct an exhaustive survey of all 
employees.
    EPA agrees that further clarification would be useful regarding 
what is ``reasonably ascertainable'' to submitters about processing and 
use information because this component of the reporting standard 
potentially may require submitters to obtain information previously 
unknown to them, for the purposes of reporting. This circumstance could 
arise if a submitter knows less than that what is reasonably 
ascertainable to it. EPA is therefore offering the following further 
guidance regarding the interpretation of this term.
    For many of the reasons identified by industry commenters (e.g., 
the expense and burden of surveying customers, and uncertainty as to 
the extent to which customers will respond to such surveys), EPA agrees 
that if particular information cannot be derived or reasonably 
estimated without conducting further customer surveys (i.e., without 
sending a comprehensive set of identical questions to multiple 
customers), it would not be ``reasonably ascertainable'' to the 
submitter. Thus there is not a need to conduct new customer surveys for 
purposes of the IUR. However, to the extent that customer surveys are 
already in the submitter's possession or control, and to the extent 
that reasonable efforts to locate or analyze those surveys may result 
in additional processing and use information (or reasonable estimates 
of such information), the information is generally ``reasonably 
ascertainable.'' Also, as illustrated by the examples in Unit III.H., 
inquiry under the ``reasonably ascertainable'' standard may entail 
inquiries outside the organization to fill gaps in the submitter's 
knowledge. Further examples of actions that would meet the ``known to 
or reasonably ascertainable by'' reporting standard are provided in 
Unit III.H.
    A number of commenters objected to the ``known to or reasonably 
ascertainable by'' standard on the grounds that it was subjective or 
too vague to be appropriately applied to the collection of processing 
and use information outside of the submitter's direct control. Other 
commenters objected to the standard's reference to what a reasonable 
person similarly situated ``might'' be expected to possess, control, or 
know. They suggested that the standard be amended to what a reasonable 
person ``should'' be expected to know.

[[Page 50849]]

    EPA does not agree that the ``known to or reasonably 
ascertainable'' standard is subjective or excessively vague. The 
standard is set forth in EPA's statutory authority to collect 
information under TSCA section 8(a), and EPA's definition is consistent 
with Congressional intent to establish an objective standard: ``The 
conferees intend that the `reasonably ascertainable' standard be an 
objective rather than a subjective one. Thus, the manufacturer or 
processor must provide information of which a reasonable person 
similarly situated might be expected to have knowledge'' (Ref. 23, p. 
80). Thus, whether a particular level of diligence meets this standard 
does not depend on the submitter's subjective view of what seems a 
reasonable person ``should'' be expected to know. It turns on an 
objective question: The level of diligence that a reasonable person, 
similarly situated, might expect to undertake. EPA believes it is 
appropriate to define the standard consistently for all persons 
reporting under TSCA section 8(a), and that the existing definition 
appropriately reflects Congressional intent. Finally, EPA does not 
think the standard of objective reasonableness will be unfamiliar to 
submitters. It is included into a wide variety of legal standards under 
State and Federal law, and in the 2006 IUR it applied to all aspects of 
the information collection other than processing and use information.
    2. Clarifications to byproduct reporting--a. Concern that new 
byproduct reporting requirements are being added. In general, some 
commenters asserted that EPA's explanation of the IUR byproduct-related 
reporting requirements reflect new requirements, inconsistent with 
current byproduct exemptions.
    EPA is clarifying, not enlarging, the reporting requirements for 
byproducts, which have been in place for decades. The definitions of 
byproduct and manufacture for commercial purposes (referencing 
byproducts) at 40 CFR 704.3 have been in place since 1983 (Ref. 24), 
and have been applicable to the IUR since the IUR's inception in 1986 
(Ref. 3, p. 21447 (incorporating definitions from 40 CFR 704.3)). The 
reporting exemptions for byproducts at 40 CFR 720.30(g) and (h) (cross-
referenced at 40 CFR 711.10) have also been in place since 1983 (Ref. 
25), and have also been applicable to the IUR since the IUR's inception 
(Ref. 3, p. 21447). While this final rule is modifying the definition 
of manufacture, the pertinent portion of the revised definition 
(providing that manufacture includes ``the extraction, for commercial 
purposes, of a component chemical substance from a previously existing 
chemical substance or complex combination of chemical substances'') is 
consolidated from materially identical language found in the previously 
applicable definitions of manufacture and manufacturer at 40 CFR 704.3. 
This specification of the scope of ``manufacture'' has been in force 
for IUR purposes since 1988. (See Ref. 3, p. 21447 (1986 incorporation 
of definitions from 40 CFR 704.3 into the IUR) and Ref. 26, p. 51716 
(1988 revision to 40 CFR 704.3)).
    In 1983, EPA promulgated a rule that made clear (for subsequent IUR 
and PMN purposes) that the reporting exemption for the manufacture of 
byproducts is only potentially applicable to the manufacture of the 
byproduct and would in no case apply to the manufacture of component 
substances extracted from the byproduct. 40 CFR 720.30(g)(3). 
Furthermore, it has been the Agency's position since at least 1991 
that, in order for byproduct manufacture to qualify for the 40 CFR 
720.30(g)(3) exemption, ``the component to be extracted must be already 
existing as a distinct chemical substance in the waste stream'' (Ref. 
27). When the chemical substance present in the byproduct and the 
chemical substance extracted from the byproduct are distinct chemical 
substances, neither the manufacture of the byproduct nor the 
manufacture of the extracted chemical substance qualify for the 40 CFR 
720.30(g)(3) exemption. See also the discussion in Unit IV.2. The 
guidance docketed with this final rule, which explains existing 
byproducts reporting requirements under the IUR, is consistent with 
past guidance issued in connection with the IUR and TSCA New Chemicals 
Program. For example: In a 2002 response to public comments on a 
previous proposed amendment to the TSCA Inventory Update Rule (Ref. 4), 
EPA explained that ``distillation, extraction, refining, and similar 
activities may result in the manufacture of a chemical substance.'' In 
a 2006 letter to the Aluminum Association, EPA described a circumstance 
in which the extraction of aluminum from aluminum dross byproduct 
constituted the reportable manufacture of aluminum, while cautioning 
that if the aluminum is ``chemically changed during the extraction 
process,'' then not only the extracted aluminum but also the dross 
byproduct would be reportable under the IUR (Ref. 28). In 2008, EPA 
provided similar guidance by letter to the Association Connecting 
Electronics Industries (IPC), another trade group (Ref. 29).
    Due to the 2003 expansion of the IUR reporting requirements to 
inorganic chemical substances, many companies have recently become 
aware of their status as chemical substance manufacturers when they 
recycle their waste materials. Instead of disposing of those waste 
materials, the manufacturers return them to commerce by recycling the 
materials--either themselves or through a third party. Recycling may be 
beneficial for many reasons: It conserves resources, may reduce the 
expense of purchasing new raw or starting materials, may reduce the 
reliance of the United States on foreign suppliers of raw materials, 
reduces the need for landfill or other disposal sites, and returns a 
waste to commerce. However, many recycling activities fit the TSCA and 
IUR rule definition of manufacture, and are likely to be considered 
``manufacture for a commercial purpose.'' EPA has finalized the draft 
IUR guidance documents that were published with the proposed rule. 
These documents include examples of many common manufacturing scenarios 
to assist individuals in determining whether their company is 
manufacturing a chemical substance that needs to be reported under the 
IUR (Refs. 7 and 30).
    b. Concerns about the IUR byproduct reporting requirements, in 
relation to RCRA and the Toxics Release Inventory. Some commenters 
asserted that byproducts should be regulated, if at all, under RCRA 
and/or reported under TRI, and should not be subject to IUR reporting 
requirements. One commenter suggested that EPA revisit the entire issue 
of the management of recycled materials to determine the appropriate 
roles for the TSCA and RCRA programs. Some commenters also asserted 
that reporting under IUR presents a disincentive for recycling.
    In broad terms, the purpose of TSCA sections 8 (governing the IUR) 
and 5 (governing PMN reporting) is to understand the universe of 
chemical substances in commerce in the United States. (TSCA section 5 
also provides EPA with the ability to control for risks of new chemical 
substances before they are placed into commerce.) The IUR requires 
reporting of manufacture, processing, and use information for chemical 
substances in commerce, and exemptions exist for those substances or 
manufacturing activities for which EPA has a low current interest. With 
limited exception, such as those included in 40 CFR 720.30, all 
chemical substances in commerce in the United States are to be listed 
on the TSCA Inventory; companies can trigger the addition of a chemical 
substance to the TSCA

[[Page 50850]]

Inventory by filing a PMN and meeting certain other requirements.
    RCRA is focused on waste--it is concerned with the generation, 
transportation, treatment, storage, and disposal of hazardous wastes 
and the management of non-hazardous solid wastes. RCRA is also focused 
on waste minimization, phasing out land disposal of hazardous waste, 
corrective action for releases, and recycling. EPA notes that while 
RCRA or other statutes may exempt a certain chemical substance from 
reporting requirements based on certain treatments or disposals, RCRA 
exemptions in most cases are not relevant to TSCA reporting 
obligations. It is important to note that finding a commercial use for 
a substance previously treated as a waste under RCRA can relieve the 
manufacturer of that substance from some RCRA requirements, but may 
then subject that manufacturer to TSCA reporting requirements. Also 
note that 40 CFR 720.30(g) provides IUR exemptions for certain uses of 
byproducts. In certain circumstances, reporting under both RCRA and 
TSCA may be required. As noted earlier, the purposes for reporting 
under RCRA and the TSCA IUR are different, and therefore the required 
data sets are different. While the data sets are not duplicative, EPA 
recognizes that there may be limited circumstances where particular 
elements of the data sets overlap. EPA strives to reduce such overlap, 
while ensuring that it is administratively feasible to collect and 
collate the data that are needed for TSCA purposes. The TSCA program is 
continuing its work with the RCRA program to maintain coordination 
between the two programs. It is important to note that the application 
of RCRA regulations varies state-by-state, and recent changes to RCRA 
regulations have not been adopted by all states. Therefore the overlap 
between RCRA reporting and IUR reporting may vary depending upon the 
state in which a submitter's site is located.
    A similar situation exists for some sites that meet the 
requirements to report under both TRI and IUR. The TRI program goal is 
to provide communities with information about toxic chemical substance 
releases and waste management, and the TRI reporting requirements are 
designed to address that goal. Because the IUR program goals differ, 
the specific information collected under each program is not the same. 
Where a person must report for both for the same site, EPA and the 
public will have a broader picture of the exposure scenarios at that 
site, including environmental releases from that site; while the two 
information collections may be complementary, neither is an adequate 
substitute for the other. A more in-depth discussion is provided in the 
Responses to Comments document (Ref. 12).
    EPA believes that commenters' concern that reporting under IUR 
would be a disincentive to recycle reflects certain misunderstandings 
of the IUR requirements. The Agency expects that revised byproduct 
guidance materials, as well as EPA's responses to the comments 
concerning, for instance, byproduct chemical identification 
requirements, will help to alleviate the majority of those concerns. 
EPA believes that many factors play into whether a company chooses to 
recycle, including the value of the recovered materials, the expense of 
disposal, desire to maintain or build a ``green'' reputation, technical 
limitations or flexibility, state and local requirements or incentives, 
and the incentives offered or requirements imposed by other federal 
laws (such as RCRA). EPA strongly believes that the benefits of 
recycling usually outweigh the burden associated with IUR reporting for 
these materials, and, just as with any other chemical substance whose 
manufacture must be reported under the IUR, production volume, worker 
exposure and other IUR data collected on byproduct chemical substances 
support the Agency's mandate to protect human health and the 
environment.
    c. Concerns about how to identify the byproduct chemical substance 
and with reporting both the byproduct and a chemical substance 
extracted from the byproduct. Commenters stated that it is very 
difficult to identify the chemical substances in a byproduct mixture, 
and that the mixture can vary over time, depending upon the specific 
manufacturing situation. Commenters also argued that there would be 
duplicative reporting by the byproduct manufacturer and the recycler/
processor who extracted a component chemical substance from the 
byproduct mixture.
    The comments reflect a misperception that characterizing the 
identity of complex chemical substances, as are found in or comprise 
many byproducts, necessarily involves a detailed analysis of the 
``individual components of the chemical substance.'' In reality, a 
byproduct may be listed on the TSCA Inventory as a single chemical 
substance that represents, for TSCA purposes, what may be a complex 
composition of chemical substances. In this way, the chemical identity 
of a byproduct may represent a chemical substance process stream. 
Complex chemical substances are listed (or can be listed) on the TSCA 
Inventory as chemical substances of Unknown or Variable composition, 
Complex reaction products and Biological materials (``UVCB'' chemical 
substances). As described by the commenters, the byproduct ``mixture'' 
is often complex and varies over time, making the identification of the 
individual components a very difficult task. This description itself 
indicates that the proper identification of such a reaction product is 
as a UVCB chemical substance. As stated in EPA's on-line guidance, 
``Each combination of substances resulting from a reaction is 
considered by the Agency to be either (1) a mixture, composed of two or 
more well-defined chemical substances to be named and listed 
separately, or (2) a reaction product, to be listed as a single 
chemical substance, using one name that collectively describes the 
products, or, failing that, the reactants used to make the products.'' 
(See http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt.) Situations 
may exist where the byproduct substance is actually a mixture, but as 
further described in the aforementioned guidance, ``A combination of 
products resulting from a chemical reaction is considered a mixture 
provided that all of the component product substances are unambiguously 
identified and are represented as forming each time the reaction is 
run.''
    UVCB chemical substances in some cases include a TSCA Inventory 
definition to further describe the chemical substance. Here is one 
example from EPA's on-line guidance (see http://www.epa.gov/oppt/newchems/pubs/uvcb.txt):

Dust, iron-ore, sinter
CASRN 69012-53-9
Definition: Dust generated during the making, breaking and handling of 
sinter which is recovered through the use of pollution abatement 
equipment.

    A byproduct manufacturer, therefore, would potentially report the 
UVCB name for the byproduct composition, while the subsequent recycler 
of the byproduct would potentially report the specific chemical 
identity of the chemical substance they chemically manufacture from the 
byproduct. EPA does not agree that such reporting is duplicative, 
because reporting will fall into one of following two scenarios. If the 
chemical substance manufactured from the UVCB byproduct is already 
present as a constituent of the UVCB byproduct, then the byproduct 
manufacturer need not report the byproduct that is sent for such 
processing/recycling. If the chemical substance manufactured from the 
UVCB

[[Page 50851]]

byproduct is distinct from any chemical substance present in the UVCB 
byproduct as a constituent, then the separate reporting by the 
byproduct manufacturer and the processor/recycler reflects a change in 
chemical composition. Either way, there is no duplication of reporting 
between the manufacturer of the UVCB byproduct and the processor/
recycler. As a general matter, if there is to be appropriate 
stewardship of potential chemical substance risks, EPA believes that 
chemical substance manufacturers, processors, and users should know and 
understand the identities of chemical substances they handle.
    Some commenters stated that many byproduct mixtures in the metals 
industry are processed to recover the metal values and indicated that 
the metal value should be considered a component chemical substance 
(i.e., that if Nickel (II) hydroxide (Ni(OH)2) is present in 
a byproduct mixture, then the elemental substance Nickel (Ni) should be 
considered the component chemical substance). EPA disagrees with this 
statement. (See Ref. 27 for a precedent from a 1991 prenotice 
communication.) Under TSCA, Ni(OH)2 and elemental Ni are two 
different chemical substances, with separate listings on the TSCA 
Inventory. If the byproduct contains Ni(OH)2 but not 
elemental Ni, only Ni(OH)2 is considered a component 
chemical substance of the byproduct. The manufacture of elemental Ni 
from either the Ni(OH)2--bearing byproduct (or 
Ni(OH)2 itself) results in a potential need to report under 
IUR. That is, if the extracted component substance is an oxide and used 
as an intermediate to form an elemental metal, then both the oxide and 
elemental metal are subject to reporting by their manufacturer(s). Note 
that information pertaining to manufacture of a chemical substance need 
only be reported to the extent that the information is known to or 
reasonably ascertainable by the submitter.
    A second example of a metal-containing byproduct is:

Electrolytes, copper-manufg., spent
CASRN 69012-54-0
Definition: Spent copper sulfate electrolyte consisting of copper 
sulfate and sulfuric acid resulting from the electrolytic refining of 
copper.

    This spent material is a UVCB chemical substance that is likely to 
be recycled. If the only commercial purpose for this spent material is 
to extract the component chemical substance copper sulfate, then the 
manufacture of the spent material is exempted from reporting (but the 
manufacture of the copper sulfate [via extraction from the byproduct] 
is subject to reporting). On the other hand, if the spent material is 
used directly to manufacture elemental copper, then both the spent 
material and the elemental copper are subject to reporting under the 
IUR by their respective manufacturers, because elemental copper is not 
a component chemical substance in the spent material byproduct.
    d. Concerns regarding determining when a byproduct is manufactured. 
Commenters stated that clarification is needed regarding purification 
and extraction and when a chemical substance is considered manufactured 
versus purified. Commenters asserted that where there is no change in 
chemical identity, only a change in purity, a chemical substance should 
not be considered manufactured, regardless of the method of 
purification.
    Much of the commenters' confusion regarding the differences between 
purification and extraction appears to concern whether extraction or 
purification involves a change in chemical identity; the potential for 
a change in chemical identity is closely linked with the proper 
identification of the manufactured substance, as described in the 
previous comment response. Where there is no change in chemical 
identity but rather just a change in purity (an impure chemical 
substance correctly identified for TSCA purposes as ``chemical 
substance A,'' for example, undergoing purification to a more pure form 
of ``chemical substance A''), the Agency agrees with the commenter 
that, for purposes of IUR, the chemical substance is not being 
manufactured. The chemical substance that appears on the TSCA Inventory 
may actually represent a category consisting of the same chemical 
substance in various degrees of purity. For example, if a company 
manufactures a specific, discrete chemical substance at 90% purity and 
it is correctly identified as that discrete substance (not having a 
UVCB name), then increasing the purity of the chemical substance (such 
that it retains its chemical identity) is considered purification and, 
for purposes of IUR, such purification is not considered manufacture.
    Note, however, that the extraction of component chemical substances 
from certain complex byproduct mixtures or process streams (i.e., UVCB 
chemical substances), is not considered purification, because the 
complex byproduct mixture and the extracted substance do not have the 
same chemical identity. For example, a manufacturing process involving 
the use of solvent A results in the manufacture of a spent solvent. As 
a variable, complex mixture of solvent A, finished product, unreacted 
reactants, individual byproduct substances, and other impurities, the 
spent solvent is considered to be a UVCB chemical substance. It is not 
unusual for the manufacturer to extract solvent A from this UVCB 
chemical substance. In such a case, the extracted solvent A is 
considered to be manufactured, and therefore is reportable for purposes 
of IUR. When the spent solvent is a byproduct whose only commercial 
purpose is the extraction of a component chemical substance, solvent A, 
the byproduct exemption at 40 CFR 720.30(g)(3) can be applied and the 
spent solvent byproduct does not need to be reported. The extracted 
solvent A is nevertheless reportable for purposes of IUR.
    3. Definitions of ``manufacture'' and ``manufacturer.'' EPA 
received several comments on the definition of manufacture, asserting 
that the definition of manufacture included in the proposed rule was 
inconsistent with past definitions, over-broad, and confusing.
    EPA disagrees, except with respect to minor typographical errors 
noted in this unit. EPA consolidated existing definitions into a single 
manufacture definition to reduce confusion. EPA also added a very short 
clarifying definition that ``a manufacturer is a person who 
manufactures a chemical substance,'' to direct the reader to the 
relevant language in the definition of manufacture, and to avoid 
confusion with an existing definition of manufacturer in 40 CFR 704.3. 
The definition of manufacture is consistent with established regulatory 
and statutory definitions, and is sufficiently flexible to accommodate 
the actual allocation of knowledge between toll manufacturers and 
contracting companies. EPA has separately addressed the comments 
received relating to the extraction of component chemical substances. 
(See the discussion on reporting byproducts and recycling in this 
unit.)
    The first part of the definition of manufacture in this final rule 
is as follows: ``Manufacture means to manufacture, produce, or import, 
for commercial purposes. Manufacture includes the extraction, for 
commercial purposes, of a component chemical substance from a 
previously existing chemical substance or complex combination of 
substances.'' It is similar to the definitions of manufacture and

[[Page 50852]]

manufacturer used for past IUR reporting (Ref. 31). For example, the 
definition of manufacturer in effect for the 2006 IUR reporting period 
is in 40 CFR 704.3: ``Manufacturer means a person who imports, 
produces, or manufactures a chemical substance. A person who extracts a 
component chemical substance from a previously existing chemical 
substance or a complex combination of substances is a manufacturer of 
that component chemical substance.'' The two similar definitions of 
manufacture in effect for the 2006 IUR reporting period were found in 
40 CFR 710.3 (``to manufacture, produce, or import for commercial 
purposes,'' and 40 CFR 704.3 (``to manufacture for commercial 
purposes''). The 40 CFR part 711 definition of manufacture is also 
consistent with the established definition of manufacturer used for 
purposes of PMN reporting, at 40 CFR 720.3. Existing 40 CFR 704.3, 
which was not modified in this final rule, also includes a definition 
of manufacture: ``Manufacture means to manufacture for commercial 
purposes,'' and a definition of ``manufacture for commercial purposes'' 
that makes clear that byproducts produced during manufacturer are also 
``manufactured for a commercial purpose.''
    The definition of manufacture in this final rule is also similar to 
and consistent with TSCA's definition of manufacture at TSCA section 3: 
`` `manufacture' means to import in the customs territory of the United 
States, produce, or manufacture,'' and TSCA section 8: ``For purposes 
of this section, the term `manufacture' * * * mean[s] manufacture * * * 
for commercial purposes.'' Finally, EPA disagrees with one commenter's 
suggestion that a new definition of produce is necessary to clarify 
that production involves a chemical substance that is ``chemically 
different'' from the chemical substance in the starting materials. 
``Chemically different'' is itself an undefined term, so it would not 
bring additional clarity to a new definition of ``produce.'' 
Furthermore, the difference between one chemical substance and another 
(and hence, the question of whether a chemical substance is being 
produced) already has a basis in the statutory definition of chemical 
substance at TSCA section 3(2), and in the differences between the 
entries of the TSCA Inventory.
    The second part of the definition, as noted in the preamble to the 
proposed rule, adds an explanation, derived from the definition of 
manufacturer in 40 CFR part 720, of the conditions under which a 
contract manufacturer would be considered to ``manufacture,'' and 
therefore be responsible for IUR reporting. Persons contracting with a 
toll manufacturer and toll manufacturers are now considered to be co-
manufacturers of what is produced at the toll manufacturer's site. 
Consistent with 40 CFR 711.22(c), such parties should coordinate 
amongst themselves to submit a single report, rather than duplicative 
individual reports, respecting what they have co-manufactured. The 
joint submission mechanism, under 40 CFR 711.15(b)(3)(i), is not 
available to co-manufacturers. The joint submission mechanism addresses 
distinct circumstances: Those in which one party is the manufacturer/
importer, and a second party (not a manufacturer of the chemical 
substance in question) possesses confidential information needed to 
determine the chemical identity of what the first party has 
manufactured/imported. In the final rule, EPA uses the term co-
manufactured rather than the proposed term jointly manufactured. This 
change of terminology is intended to avoid confusion between the 
reporting provisions at 40 CFR 711.22(c) and those at 40 CFR 
711.15(b)(3)(i).
    EPA notes that one change to the definition of manufacture was made 
to correct a typographical error in the definition as proposed and to 
address a comment that the definition used confusing syntax. The words 
``and'' and ``then'' were added to make clear that the conditions in 
paragraph (1), and the conditions in paragraph (2) (up to the comma), 
must both be satisfied before a chemical substance will be considered 
``co-manufactured'' by the producing manufacturer (i.e., the toll 
manufacturer) and the person contracting for such production (i.e., the 
contracting company).
    Several commenters suggested that the toll manufacturer should be 
primarily or solely responsible for IUR reporting, or expressed concern 
that the rule would compel contracting companies to submit information 
on behalf of toll manufacturers. Another commenter supported the 
assignment of responsibility as proposed. Some commenters also 
suggested that EPA should ``acknowledge the complexity of contractual 
mechanisms and not offer a blanket, `one size fits all' requirement for 
reporting responsibilities.''
    EPA agrees that a diversity of contractual arrangements may exist, 
and notes that there was nothing in the proposed rule to prevent toll 
and contracting manufacturers from sharing information and agreeing 
between themselves that one or the other will undertake all or a 
portion of the work associated with IUR reporting for a given chemical 
substance, though comments indicated that there was some confusion 
caused by EPA's assignment of ``primary'' responsibility for reporting 
to the contracting manufacturer (see 40 CFR 711.22(c)). EPA expects 
that in most instances, a person that contracts with a toll 
manufacturer will generally know more about the particular chemical 
substances, and will usually be a better position to report on 
industrial processing and use of a chemical substance, and on 
commercial and consumer uses of products containing the chemical 
substance. Similarly, EPA expects that the toll manufacturer will 
generally be in a better position to report on the number of workers 
and other information about their plant. In light of the contracting 
company's control over the ``total amount produced and the basic 
technology for the plant process,'' and based on EPA's expectations of 
the relative knowledge of the contracting company, EPA initially 
indicated, in proposed 40 CFR 711.22(c), that the contracting company 
would be ``primarily responsible'' for IUR reporting. However, given 
the confusion introduced by indicating that one party or the other is 
``primarily'' responsible for reporting, and not wishing to interfere 
in contractual agreements to the contrary, EPA has decided not to 
allocate ``primary'' responsibility to either party in the final rule. 
Conforming changes have been made to 40 CFR 711.22(c) in this final 
rule. However, the enforceability of the final rule requires EPA to 
specify the persons who are legally responsible for reporting. In 
fairness, EPA has chosen to make both parties responsible for reporting 
on the chemical substances they have co-manufactured, as specified in 
the proposed rule.
    4. Definition of ``site.'' Several commenters asserted that the 
proposed revision to the definition of ``site'' would force different 
companies that are at the same site to report together. EPA disagrees 
with this assertion. In the proposed rule, EPA added explanations to 
accommodate manufacturing under contract and for portable manufacturing 
units, and clarified that an importer's site must be a U.S. address. 
The definition of site used in the past, at 40 CFR 710.3, was not 
otherwise significantly changed. The old definition states that ``Site 
means a contiguous property unit. Property divided only by a public 
right-of-way will be considered one site. There may be more than one 
manufacturing plant

[[Page 50853]]

on a single site. * * *'' This portion of the definition was retained, 
with slight wording change (``More than one plant may be located on a 
single site.''), in the proposed rule.
    The statement ``More than one plant may be located on a single 
site'' is meant to guide companies that have multiple plants at one 
site to sum production volumes and other IUR-reportable data across all 
of their plants at one site and produce one report for each reportable 
substance at each site (not at each plant). The definition does not 
require different companies located at the same site to report 
together.
    5. Processing and use-related definitions. EPA received comments in 
favor of the amended definitions for commercial use and consumer use. 
However, a commenter indicated that the definitions of ``industrial,'' 
``commercial,'' ``function,'' and ``use,'' were unclear and referred to 
problems in reporting both product- and substance-level information. 
EPA appreciates the support for amending the terms commercial use and 
consumer use to harmonize the definitions developed by the United 
States and Canada.
    EPA feels the terms ``industrial'' and ``commercial'' are 
adequately defined. To clarify, EPA defines industrial function as 
``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.'' This definition can be found in the ``IUR Modifications Rule: 
Development of Definitions for Proposed 40 CFR 711.3'' (Ref. 8). EPA 
also notes that the terms use, industrial use, consumer use, and 
commercial use have already been in use for IUR and were previously 
defined in 40 CFR 710.43 (relocated in this final rule to 40 CFR 
711.3).

F. Confidential Business Information

    1. Release of information not validly claimed as CBI. The Agency 
received comments about the proposed change to make information claimed 
as CBI available to the public without further notice to the submitter, 
in the circumstance that the required substantiation is not submitted 
with the claim. Opponents of the change are concerned that a reporting 
error could result in public release of legitimate CBI. They suggested 
notifying the submitter if further substantiation is needed prior to 
releasing data to the public. The commenters are in favor of a warning 
system that would allow submitters time to provide additional 
substantiation on CBI claims before the Agency determines the data is 
non-CBI and releases it as public information.
    There are three situations during which the Agency will release IUR 
information claimed as CBI without further notice to the submitter. 
First is the circumstance that a CBI claim is made for the identity of 
a chemical substance already listed on the non-confidential portion of 
the Master Inventory File. Any such CBI claims were invalid under the 
previous IUR regulations (applicable to the 2006 and earlier submission 
periods).
    The second is the circumstance that a submission lacks the 
certification required under 40 CFR 711.15(b)(1). 40 CFR 711.15(b)(1) 
requires a certification stating that the submitted information has 
been completed in compliance with the requirements of this part and 
that the confidentiality claims made on the Form U are true and 
correct. The certification must be signed and dated by the authorized 
official for the submitter company, and provide that person's name, 
official title, and e-mail address. Consistent with this regulatory 
provision, the e-CDRweb tool is designed to entirely block the 
submission of a Form U lacking an appropriate certification.
    The third is the circumstance that a particular CBI claim is not 
accompanied by upfront substantiation required under 40 CFR 711.30(b), 
(c), or (d) (e.g., upfront substantiation of processing and use 
information). The e-CDRweb reporting tool is designed to protect 
against a company not providing an upfront substantiation. When a CBI 
claim is made and substantiation is required, the reporting tool will 
open the substantiation question page. Should the submitter choose not 
to complete the substantiation at that time, or to only partially 
complete it, the validation portion of the tool will again alert the 
submitter to the need for substantiation. The tool also includes 
warnings that information with unsubstantiated CBI claims will be 
released without further notice to the submitter. EPA believes these 
reminders provide sufficient notice to the submitter of the need to 
substantiate these claims.
    2. Upfront substantiation for processing and use information. The 
Agency received comments both for and against the proposed upfront 
substantiation requirement when processing and use information is 
claimed as confidential. Commenters opposing the proposed change 
explained that processing and use information is often considered 
confidential by customers to protect their competitive positions in the 
market. Commenters voiced concern that the proposed change will impact 
their ability to remain competitive or will reduce innovation. These 
commenters were concerned that the manufacturers of the chemical 
substances would not correctly identify CBI associated with downstream 
uses, and that confidentiality agreements between the chemical 
substance manufacturer and the downstream users would not provide 
sufficient substantiation for the processing and use information. The 
Agency believes that the processing and use information in the publicly 
released IUR reports is sufficiently agglomerated to address these 
concerns. However, the Agency also recognizes that there are 
circumstances when the release of information about a particular use 
could harm the competitive position of the submitter's customer. 
Therefore, EPA has modified the substantiation question at proposed 40 
CFR 711.30(d)(1)(ii) to include information about harm to the 
submitter's competitive position ``or to your customer's competitive 
position.'' EPA also notes that under its confidentiality regulations, 
the Agency normally solicits input from all affected businesses when 
making a final confidentiality determination respecting information 
claimed as CBI.
    Some commenters stated that providing written explanations for 
multiple scenarios would be burdensome. Another commenter argued, 
however, that requiring such explanations will help to limit CBI claims 
to information that in fact warrants protection as a legitimate trade 
secret. The commenter asserted that the frequency with which site 
information was claimed as CBI dropped from 28% to 7% after EPA added 
an upfront substantiation requirement for that data element, and 
suggested that the drop represented an elimination of ``excessive'' 
trade secrecy claims.
    The Agency recognizes that there is a burden associated with 
providing written explanations. However, based on the significant 
number of CBI claims for processing and use information in the last 
information collection, EPA believes that allowing submitters to assert 
CBI claims merely by checking a box encourages submitters to assert 
such claims without sufficiently considering whether there is a basis 
for the claim. While EPA believes that such claims are appropriate 
under certain circumstances, the Agency wants to ensure that all such 
claims are carefully considered and only information that is truly 
confidential, the release of which

[[Page 50854]]

would substantially injure the competitive position of the submitter, 
is claimed as CBI. A substantiation requirement for such claims helps 
ensure that this consideration takes place.
    3. Prohibition of confidentiality claims for data elements 
designated as ``not known or reasonably ascertainable.'' Commenters 
agreed with prohibiting CBI claims for processing and use information 
when designated as ``not known or reasonably ascertainable.'' The 
primary reason cited by supporters was that the proposed change will 
reduce the potential for unwarranted CBI claims.

G. Administrative Comments

    1. Changes to reporting frequency. The Agency received comments 
regarding the proposed change to increase the IUR reporting frequency 
from every 5 years to every 4 years. Some commenters suggested a change 
to the reporting frequency would still present a burden to industry and 
that EPA has not provided adequate justification to warrant or support 
any increase in the reporting frequency. Other commenters expressed 
support for the return to the reporting frequency of every 4 years but 
some felt that to increase the frequency further would be problematic. 
Additional commenters suggesting even more frequent reporting cycles 
and these comments are addressed in more detail in the Responses to 
Comments document (Ref. 12).
    In the 2003 IUR Amendments, EPA changed its reporting requirement 
from every 4 years to every 5 years to lessen the burden associated 
with complying with the amendments. However, EPA has decided to return 
to the reporting frequency of every 4 years, in order to better meet 
Agency needs. EPA has determined that reporting every 5 years is too 
infrequent, and does not provide enough data to sufficiently cover the 
Agency's and public's needs. As discussed in Unit III.D.1. of the 
proposed rule, many chemical substances, even larger volume chemical 
substances, often experience wide fluctuations in manufacturing volume 
from year to year. This can result in the production volume of a 
chemical substance exceeding the threshold for several years, then 
falling below the threshold during the IUR principal reporting year. A 
review of the previous reporting under the IUR indicates an 
approximately 30% change in the chemical substances that are reported 
from one reporting period to the next. Therefore, the 1-year snapshot 
of production volume does not provide an accurate picture of the 
chemical substances in commerce, and may provide an erroneous view of 
the exposure scenarios associated with a particular chemical substance. 
In addition, EPA has been criticized for using outdated information, 
which will be remedied with more frequent reporting. As such, EPA has 
determined that the value gained through obtaining more current and 
useful data is essential to fulfilling the Agency's statutory 
obligations under TSCA, and outweighs the incremental burden to 
submitters.
    2. Remove superfluous text regarding production volume. The Agency 
received comments on the proposal to remove superfluous text associated 
with reporting production volumes, in particular the  10% 
standard of precision. All commenters opposed changing the current 
language. Several commenters indicated that reporting accurately to two 
significant figures is not equivalent to reporting to a precision of 
 10%. One commenter indicated that, if reporting to two 
significant figures, at higher production volumes there would be a 
narrower allowable range of variation.
    EPA is replacing ``provided that the reported figures are within 
 10% of the actual volume'' currently found in 40 CFR 
710.52(c)(3)(iv) with ``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. EPA recognizes some commenters' 
concern that this will result in a sliding precision scale between 1% 
and 10% that is solely based on the reported digits. However, EPA 
believes that reporting to two significant figures will maintain a 
balance between data needs for exposure screening and the industry 
burden associated with data collection. In the 2006 IUR data 
collection, nearly all manufacturers reported production volumes in 
greater precision (i.e., more significant figures) than is required for 
2012 reporting. Based on years of experience assessing chemical 
substance risks through programs such as the New Chemicals Program, the 
Agency believes requiring reporting to two or more significant figures 
is appropriate to facilitate the Agency's initial exposure screens of 
chemical substances, and to prioritize and make basic risk management 
decisions about those chemical substances of greatest concern. Those 
decisions then can prompt more detailed assessments as necessary.

H. Economic Impact Estimates

    1. General burden comments. The Agency received a number of 
comments expressing concerns about the Economic Analysis (Ref. 14); the 
majority of which suggest that the Agency has significantly 
underestimated the effort required to collect, organize, verify and 
report IUR data. Commenters disagreed with EPA's burden estimates for 
several proposed modifications to the rule, including the retroactive 
reporting of production volumes, reporting on imported mixtures, 
mandatory electronic submission, the lowering of the threshold for 
downstream processing and use information, the change in the standard 
of reporting from ``readily obtainable'' to ``known to or reasonably 
ascertainable by,'' and the change in the reporting cycle from every 5 
to every 4 years. Several commenters asserted that the reporting burden 
will increase to between two and six times the burden for reporting in 
2006. However, few commenters provided specific reasons for why they 
believe that the Agency's estimates were low, and no commenters 
provided any analytical basis for revising EPA's estimates or 
substantiated their alternative estimates. The Agency has used the best 
available data to estimate the burden associated with the modifications 
to the IUR rule, and disagrees with the commenters. The burden 
estimates presented in the economic analysis are reasonable estimates 
for the average IUR submitter.
    a. Identification of affected entities. In general, commenters 
stated that the Economic Analysis (Ref. 14) does not identify all 
affected entities, and EPA has inaccurately assumed that the proposed 
rule will affect only chemical substance manufacturers. Another 
commenter noted that a wide range of industries manufacture byproducts, 
so to accurately estimate the burden of the proposed rule, EPA must 
identify all affected industries and facilities. The commenter further 
stated that byproducts sent for recycling are new chemical substances 
reportable under the IUR rule and the Economic Analysis fails to 
identify these manufacturers.
    The Economic Analysis assumes that all companies manufacturing 
(including importing) chemical substances annually in amounts of 25,000 
lb or greater that are listed on the TSCA Inventory will report under 
this rule. Chemical substance users and processors who may manufacture 
a byproduct chemical substance for a commercial purpose, e.g., 
utilities, paper manufacturers, primary metal manufacturers, and 
semiconductor and other electronic component

[[Page 50855]]

manufacturers (NAICS codes 22, 322, 331, and 3344), are considered to 
be chemical substance manufacturers for the purposes of the IUR rule. 
Sites that manufactured a byproduct in a volume above the 25,000 lb 
threshold during the 2006 submission period were required to report 
under IUR, and therefore are included in the 2006 baseline estimates.
    b. Total industry compliance determination burden. Commenters made 
a number of specific points regarding the compliance determination 
burden. According to one commenter, provisions requiring reporting of 
more data for many chemical substances, replacing NAICS codes with EU 
IS codes, and requiring upfront substantiation for CBI claims for Part 
III, Form U, information will contribute to the increased effort 
required to report.
    EPA disagrees that the Economic Analysis underestimates the 
reporting costs and burdens of this final rule amendments as asserted 
by the commenters. EPA does agree that many of the amended rule 
requirements, including provisions requiring reporting of more data for 
many chemical substances, replacing NAICS codes with Industrial Sector 
codes, and requiring upfront substantiation for CBI claims for Part 
III, Form U, information, will cause an increase in burden and cost. 
While EPA does state throughout the Economic Analysis that the burdens 
and costs may be overestimated, the analysis also says that they may be 
underestimated. The statements regarding limitations of the study serve 
to make the analysis more transparent. EPA does not have the ability to 
take into account the effects of individual company circumstances 
concerning downsizing, growth, mergers and acquisitions, on estimates 
of reporting burden and cost, as mentioned by one commenter.
    Several commenters asserted that EPA underestimated the burden 
associated with IUR compliance determination by estimating the burden 
on a per-report basis. According to the comments, this methodology does 
not capture the burden associated with tracking, screening, and keeping 
records for chemical substances that ultimately are not required to be 
reported to IUR because they are manufactured or imported in quantities 
below the reporting threshold.
    Compliance determination occurs on a per-site basis and is based on 
a manufacturer (including importer) determining that it manufactures at 
least one chemical substance at or above the threshold, thus 
necessitating that the site complete and submit a Form U. The Economic 
Analysis assumes all sites that report to the IUR incur the same 
average cost for compliance determination regardless of the number of 
chemical substances reported. EPA expects that it is standard company 
practice to track and maintain records of production volumes for all 
chemical substances manufactured at a given site. Therefore, EPA 
expects that the burden associated with compliance determination should 
not be substantial. The commenters appear to have misinterpreted EPA's 
compliance determination burden to include the burden of actually 
reporting for the chemical substances subject to the IUR, but this is 
not the case. See section 4.2.2 of the Economic Analysis (Ref. 14) for 
further clarification.
    Finally, EPA notes that the IUR does not require submitters to 
retain documentation showing that particular chemical substances did 
not need to be included in a given year's report. In addition, once a 
submitter has made a compliance determination that it has reporting 
obligations under the IUR, it can rely on production volume information 
already reasonably available, in the ordinary course of business, to 
determine that particular chemical substances do not need to be 
reported under the IUR. For this reason, EPA believes it is 
unreasonable to attribute to the rule the costs of tracking, screening, 
and keeping records of the various production volumes of chemical 
substances that ultimately are not required to be reported to IUR 
because they are below the reporting threshold.
    c. Underlying assumptions and data: Baseline costs. Commenters 
questioned the baseline number of reports EPA used in calculating 
baseline costs. One commenter questioned whether EPA's estimate 
included inorganic substances. Another commenter questioned whether EPA 
has adjusted the baseline estimates to account for new manufacturing 
facilities that never previously reported under the IUR rule, the 
elimination the 300,000 lb threshold for processing and use data, and 
the change in the method of determining the eligibility to report.
    The 2006 IUR submission data provide the best estimate for the 
number of reports that would be submitted under the baseline scenario. 
The baseline scenario in the Economic Analysis assumes no changes have 
been made to the 2006 reporting requirements. This cost is used as a 
basis on which to calculate the incremental cost of the rule. 
Therefore, in the baseline, the number of reports should not be 
adjusted to account for any proposed modifications. The Economic 
Analysis does estimate the additional number of Part III of Form U 
reports that will be submitted as a result of this final rule, 
including the elimination of the 300,000 lb threshold (see section 
4.4.4 of the Economic Analysis (Ref. 14)), as well as the additional 
number of reports submitted as a result of the change in the method of 
determining the eligibility to report (see section 4.4.3 of the 
Economic Analysis (Ref. 14)). In addition, the Economic Analysis 
accounts for rule familiarization costs for any new companies 
submitting data (see section 4.2.2 of the Economic Analysis (Ref. 14)). 
The 2006 data do include reports for inorganic chemical substances, 
because while inorganic chemical substance manufacturers were exempt 
from submitting downstream processing and use information in the 2006 
submission period, they were required to submit Parts I and II of Form 
U, and therefore are included in the baseline number of reports.

I. Request for Comment on Additional Issues

    EPA requested comment on several additional topics in Unit V. of 
the proposed rule (Ref. 1, p. 49676). The comment summaries and 
responses to these issues are contained in the Responses to Comments 
document (Ref. 12).

VI. References

    As indicated under ADDRESSES, a docket has been established for 
this rulemaking under docket ID number EPA-HQ-OPPT-2009-0187. The 
following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA in developing this final rule, 
including documents that are referenced within the documents that are 
included in the docket, even if the referenced document is not 
physically located in the docket. For assistance in locating these 
other documents, please consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.

1. EPA. TSCA Inventory Update Reporting Modifications; Proposed 
Rule. Federal Register (75 FR 49656, August 13, 2010) (FRL-8833-5).
2. EPA. Inventory Reporting Regulations; Final Rule. Federal 
Register (42 FR 64572, December 23, 1977) (FRL-817-1).
3. EPA. Partial Updating of TSCA Inventory Data Base; Production and 
Site Reports; Final Rule. Federal Register (51 FR 21438, June 12, 
1986) (FRL-2973-3).
4. EPA. TSCA Inventory Update Rule Amendments; Final Rule. Federal 
Register (68 FR 848, January 7, 2003) (FRL-6767-4).

[[Page 50856]]

5. EPA. OPPT. Enhancing EPA's Chemical Management Program. Available 
on-line at http://www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html.
6. EPA. TSCA Inventory Update Reporting Modifications; Submission 
Period Suspension; Final Rule. Federal Register (76 FR 27271, May 
11, 2011) (FRL-8874-2).
7. EPA. Instructions for the 2012 TSCA Chemical Data Reporting. July 
2011. Also available on-line at http://www.epa.gov/cdr.
8. EPA. OPPT. IUR Modifications Rule: Development of Definitions for 
Proposed 40 CFR 711.3. July 8, 2010.
9. EPA. TSCA Inventory Update Reporting Revisions; Final Rule. 
Federal Register (70 FR 75059, December 19, 2005) (FRL-7743-9).
10. EPA. OPPT. Electronic Signature Agreement. August 2009.
11. EPA/Environment Canada/Health Canada, Overview of Harmonized 
U.S.-Canada Industrial Function and Consumer and Commercial Product 
Codes for Chemical Inventory Reporting. November 2009.
12. EPA. OPPT. Summary of EPA's Responses to Public Comments 
Submitted in Response to Proposed TSCA Inventory Update Reporting 
Modifications Rule.
13. EPA. OPPT. 2006 IUR Database Statistics for the IUR 
Modifications Rule. December 17, 2008.
14. EPA. OPPT. Economics, Exposure and Technology Division (EETD). 
Economic Analysis for the Final Inventory Update Reporting (IUR) 
Modifications Rule. July 2011.
15. EPA. Toxic Chemical Release Inventory Reporting Forms and 
Instructions. October 2009. Available on-line at http://www.epa.gov/tri/report/rfi/ry2009rfi121709.pdf.
16. EPA. OPPT. EETD. Inventory Update Reporting (IUR) Technical 
Support Document--Replacement of 5-digit NAICS Codes with Industrial 
Sector (IS) Codes. October 2009.
17. Environmental Defense Fund, Letter to Docket ID Number EPA-HQ-
OPPT-2009-0187 (on behalf of 32 organizations), from Richard 
Denison, PhD, October 12, 2010.
18. Proposal for Priority Setting for Existing Substances on the 
Domestic Substances List under the Canadian Environmental Protection 
Act, 1999. Greatest Potential for Human Exposure. Canada, 2003.
19. EPA. OPPT. Screening-Level Hazard Characterization and 
Prioritization Document. March 2009. Available on-line at http://www.epa.gov/chemrtk/hpvis/rbp/Butenedioic%20Acid%20Dialkyl%20Esters_HBP_March%202009.pdf.
20. NOVA Chemicals, Letter to Docket ID No. EPA-HQ-OPPT-2009-0187, 
from Linda Santry. October 7, 2010.
21. EPA. OPPT. Initial Risk-Based Prioritization of High Production 
Volume (HPV) Chemicals. April 2009. Available on-line at http://www.epa.gov/chemrtk/hpvis/rbp/Category_Chlorobenzenes_Web_April%202009.pdf.
22. European Commission. REACH. January 2011. Available on-line at 
http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm.
23. H.R. Rep. 94-1679, 94th Congress, 2d Session (1976), reprinted 
in Environmental and Natural Resources Policy Division of the 
Library of Congress, 94th Congress, 2d Session, A Legislative 
History of the Toxic Substances Control Act, (Committee Print 1976) 
(Legislative History, pp. 667-721).
24. EPA. Recordkeeping and Reporting Requirements; Recodification; 
Final Rule. Federal Register (48 FR 23420, May 25, 1983) (FRL-2370-
70).
25. EPA. Premanufacture Notification; Premanufacture Notice 
Requirements and Review Procedures; Final Rule. Federal Register (48 
FR 21722, May 13, 1983) (FRL 2998-5).
26. EPA. Comprehensive Assessment Information Rule; Final Rule. 
Federal Register (53 FR 51698, December 22, 1988) (FRL-3368-1).
27. Prenotice Communication Letter from Mary E. Cushmac, EPA. July 
29, 1991.
28. Letter from Susan Sharkey, EPA, to Robert P. Strieter, The 
Aluminum Association. October 24, 2006.
29. Letter from Charles M. Auer, EPA, to Fern Abrams, IPC. August 
27, 2008.
30. EPA. OPPT. Q&A Document: Recycling and the TSCA Chemical 
Substance Inventory--Premanufacture Notification and Chemical Data 
Reporting Requirements. May 2011.
31. EPA. Table of Comparison of 2012 CDR v 2006 IUR Definitions. 
February 9, 2011.
32. EPA. Agency Information Collection Activities; Final Collection; 
Partial Update of the TSCA Section 8(b) Inventory Data Base, 
Production and Site Reports; EPA ICR No. 1884.05, OMB Control No. 
2070-0162.

VII. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993), this action has been 
designated a ``significant regulatory action'' by the Office of 
Management and Budget (OMB). Accordingly, EPA submitted this action to 
OMB for review under Executive Order 12866 and any changes made in 
response to OMB recommendations have been documented in the docket for 
this action.
    In addition, EPA has prepared an economic analysis of the potential 
impacts associated with this action. A copy of this Economic Analysis 
(Ref. 14) is available in the docket and is briefly summarized in this 
unit. The Agency, in promulgating this final rule, is required under 
TSCA to consider the potential costs and benefits associated with IUR. 
The analysis was therefore used by the decisionmakers to help in the 
selection of the final rule requirements presented in this document.
    The amendments in this final rule affect the number of reports 
submitted during a submission period, the burden to prepare a report, 
and the reporting frequency. EPA estimates that the combined impact of 
all the amendments will increase the total burden and cost to industry 
associated with IUR reporting.
    In its Economic Analysis, EPA estimated industry cost and burden on 
a per-report and a per-site basis and at the industry level. Industry 
cost and burden are incurred by performing activities to comply with 
the amendments, including compliance determination, rule 
familiarization, preparation and submission of reports, and 
recordkeeping.
    On a per-report basis, EPA estimated incremental increases of 0.47 
hours and $118 for a site to complete a partial report for 1 chemical 
substance and 13.57 hours and $1,176 to complete a full report for 1 
chemical substance, in the first reporting cycle after the effective 
date of the final rule amendments. A partial report includes Parts I 
and II of Form U. A full report includes Parts I, II, and III of Form 
U. For future reporting cycles, EPA estimated incremental increases of 
2.26 hours and $212 for a site to complete a partial report for 1 
chemical substance and 11.96 hours and $1,012 to complete a full report 
for 1 chemical substance.
    As a result of the amendments, EPA estimates that the average site 
will submit approximately 0.90 and 2.01 fewer partial reports in the 
first reporting cycle and future reporting cycles, respectively. An 
increase in full reports per site of 0.89 in the first reporting period 
and 2.88 in future reporting periods is expected. For the average site, 
this will increase the burden by 121 hours during the first reporting 
cycle and 249 hours for all subsequent reporting cycles. EPA estimates 
that the average site will incur a net cost increase of $9,000 during 
the first reporting cycle and $16,551 during all future reporting 
cycles.
    At the industry level for all sites submitting a Form U, EPA 
estimates a net total burden increase of 0.50 million hours in the 
first reporting cycle, and 1.14 million hours for all subsequent 
reporting cycles. EPA estimates a net cost increase of $36.76 million 
in the first reporting cycle of the final rule, and $75.12 million in 
all subsequent reporting cycles.

[[Page 50857]]

    EPA estimates that the Agency will experience a reduction in both 
burden and cost to administer the IUR rule as a result of the 
amendments. Specifically, EPA expects to experience a net burden 
reduction of 940 hours in the first reporting cycle and 1,678 in 
subsequent reporting cycles. The Agency estimates it will experience a 
net savings of approximately $68,000 during the first reporting cycle 
and $175,000 in subsequent reporting cycles. This information will be 
reflected in the ICR that is submitted every 3 years to OMB under the 
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.
    EPA believes that this final rule represents an appropriate balance 
between the burden placed on industry to provide information and the 
Agency's need for that information to fill its statutory obligations 
and fulfill its mission under TSCA and, as part of that mission, to 
provide information needed by other agencies (OSHA, NIOSH, CPSC, etc.).

B. Paperwork Reduction Act

    The information collection requirements in 40 CFR part 710 related 
to the submission of Form Us are already approved by OMB under PRA. 
That ICR has been assigned EPA ICR No. 1884 and OMB control no. 2070-
0162. Because this final rule involves new or revised information 
collection activities that require additional OMB approval, EPA has 
prepared an addendum to the currently approved ICR (Ref. 32). An agency 
may not conduct or sponsor, and a person is not required to respond to 
an information collection request subject to PRA, unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and included on any related 
collection instrument (e.g., on the form or survey).
    Under PRA, the term ``burden'' is interpreted as the total time, 
effort, or financial resources expended by people to generate, 
maintain, retain, disclose, or provide information to or for a Federal 
agency. This includes the time needed by regulated entities to review 
instructions and to develop, acquire, install, and use technology and 
systems to collect, validate, verify, and disclose information. Time 
taken to adjust existing ways to comply with any previously applicable 
instructions and requirements and to train personnel to respond to the 
information collection task is also included. In this analysis, total 
industry burden hours represent the sum of time spent on reporting and 
on other administrative activities. Industry will spend time on the 
following activities associated with the IUR rule: Compliance 
determination, rule familiarization, preparation and submission of 
reports, and recordkeeping.
    As presented in the Economic Analysis (Ref. 14) and the addendum 
ICR (Ref. 32), EPA estimates that the final rule would generate a total 
incremental industry burden of 0.50 million hours in the first 
reporting cycle. The burden for a site to complete a full IUR report 
for one chemical substance in the first reporting cycle is estimated to 
be 136.57 hours, which is an incremental burden increase of 13.57 hours 
over the current estimated burden. The burden for a site to complete a 
partial IUR report for one chemical substance in the first reporting 
cycle is estimated to be 53.55 hours, which is an incremental burden 
increase of 0.47 hours over the current estimated burden. For future 
reporting cycles, EPA estimates that the final rule would create a 
total incremental industry burden of 1.14 million hours. The burden to 
complete a full report is estimated to be 94.01 hours, which is an 
incremental increase of 11.94 hours over the current estimated future 
burden. The burden for a partial report is estimated to be 28.38 hours, 
which is an incremental increase of 2.24 hours over the current 
estimate.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this action 
will not have a significant adverse economic impact on a substantial 
number of small entities. The Agency's basis is briefly summarized here 
and is detailed in the Economic Analysis (Ref. 14).
    Under RFA, small entities include small businesses, small 
organizations, and small governmental jurisdictions. For purposes of 
assessing the impacts of this final rule on small entities, small 
entity is defined as:
    1. A small business, as defined by the SBA's regulations at 13 CFR 
121.201. The SBA definitions typically are based upon either a sales or 
an employment level, depending on the nature of the industry. Companies 
engaged in chemical substance manufacturing (NAICS code 325) or 
petroleum refining (NAICS code 324110) are the most likely to report 
under the IUR rule. These employee size standards range from 500 
employees to 1,500 employees for NAICS codes 325 and 324110.
    2. A small governmental jurisdiction that is a government of a 
city, county, town, school district, or special district with a 
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which 
is independently owned and operated and is not dominant in its field.
    Since the regulated community does not include small governmental 
jurisdictions or small not-for-profit organizations, the analysis 
focuses on small businesses.
    The existing IUR rule, at 40 CFR 710.49, generally exempts from 
reporting small businesses, defined at 40 CFR 704.3 as entities with 
annual sales of less than $40 million and less than 100,000 lb 
production of any given chemical substance at a site; or annual sales 
of less than $4 million. This exemption is maintained in this final 
rule. A small business would be required to report under the final 
rule, however, if it produces any chemical substance that is the 
subject of a regulation proposed or promulgated under TSCA section 4, 
5(b)(4), or 6, or that is the subject of an order under TSCA section 
5(e), or that is the subject of relief that has been granted pursuant 
to a civil action under TSCA section 5 or 7 (40 CFR 711.9 and TSCA 
section 8(a)(3)(A)(ii)). A small business may also report voluntarily.
    EPA analyzed potential small business impacts from this final rule 
using both the SBA employee size standards and the TSCA sales-based 
definition of small business. EPA estimates that 466 small firms 
potentially would be affected by this final rule using the employment-
based definition, and 280 small firms potentially would be affected 
using the sales-based definition. Based on costs annualized over a 4-
year period and average sales data for the parent companies, EPA 
estimated that the cost-to-sales ratio of the final rule would be less 
than 0.1% for an average small company subject to the rule. For a 
company to have a cost-to-sales ratio larger than 1%, company sales 
would have to be less than $0.81 million. Because the small businesses 
affected by the final rule have average sales of more than $412.7 
million under the employment-based definition, and $116 million under 
the sales-based definition, small entities will not be affected by the 
amendments to the IUR rule at a cost-to-sales ratio of greater than 1% 
(Ref. 14).

D. Unfunded Mandates Reform Act

    This action does not contain any Federal mandates for State, local, 
or Tribal governments or the private sector under the provisions of 
Title II of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-
1538. EPA has determined that this regulatory action

[[Page 50858]]

will not result in annual expenditures of $100 million or more for 
State, local, and Tribal governments, in the aggregate, or for the 
private sector. The costs associated with this action are briefly 
described in Unit V.A., and is contained in the Economic Analysis (Ref. 
14).
    Based on EPA's past experience, State, local, and Tribal 
governments have not been affected by this reporting requirement, and 
EPA does not have any reason to believe that any State, local, or 
Tribal government will be affected by this final rule. As such, EPA has 
determined that this final rule does not impose any enforceable duty, 
contain any unfunded mandate, or otherwise have any effect on small 
governments. Accordingly, this final rule is not subject to the 
requirements of sections 202, 203, or 205 of UMRA.

E. Executive Order 13132

    Pursuant to Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999), EPA has determined that this final rule does 
not have federalism implications because it will not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in the Executive Order. This final rule simply amends the IUR rule in 
several ways to provide information to 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. 
Because EPA has no information to indicate that any State or local 
government manufactures or processes the chemical substances covered by 
this action, the final rule does not apply directly to States and 
localities and will not affect State and local governments. Thus, 
Executive Order 13132 does not apply to the final rule.

F. Executive Order 13175

    As required by Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), EPA has determined that this final rule does not have Tribal 
implications because it will not have any effect on Tribal governments, 
on the relationship between the Federal Government and the Indian 
Tribes, or on the distribution of power and responsibilities between 
the Federal Government and Indian Tribes, as specified in the Order. 
Thus, Executive Order 13175 does not apply to this final rule.

G. Executive Order 13045

    EPA interprets Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997), as applying only to those regulatory actions 
that concern health or safety risks, such that the analysis required 
under section 5-501 of Executive Order 13045 has the potential to 
influence the regulation. This action is not subject to Executive Order 
13045 because it does not establish an environmental standard intended 
to mitigate health or safety risks. Nevertheless, the information 
obtained by the reporting required by this final rule will be used to 
inform the Agency's decisionmaking process regarding chemical 
substances to which children may be disproportionately exposed. This 
information will also assist the Agency and others in determining 
whether the chemical substances in this final rule present potential 
risks, allowing the Agency and others to take appropriate action to 
investigate and mitigate those risks.

H. Executive Order 13211

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211, entitled ``Actions Concerning Regulations that 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001), because it is not likely to have a significant 
adverse effect on the supply, distribution, or use of energy as 
described in the Executive Order.

I. National Technology Transfer and Advancement Act

    Since this action does not involve any technical standards, section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does 
not apply to this action.

J. Executive Order 12898

    The final rule does not have an adverse impact on the environmental 
and health conditions in low-income and minority communities that 
require special consideration by the Agency under Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994). The Agency believes that the information collected under 
this final rule will assist EPA and others in determining the potential 
hazards and risks associated with the chemical substances covered by 
the final rule. Because the IUR rule is an information collection 
requirement, the information that will become available through the 
rule will enable the Agency to target educational, regulatory, or 
enforcement activities towards industries or chemical substances that 
pose the greatest risks and/or to target programs for geographic areas 
that are at the highest risk. Thus, the information to be gathered 
under the final rule will help EPA make decisions that will benefit 
potentially at-risk communities, some of which may be disadvantaged.
    The final rule is directed at manufacturers (including importers) 
of chemical substances. All consumers of these chemical products and 
all workers who come into contact with these chemical substances could 
benefit if data regarding the chemical substances' health and 
environmental effects were developed. Therefore, it does not appear 
that the costs and the benefits of the final rule will be 
disproportionately distributed across different geographic regions or 
among different categories of individuals.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of the rule in the Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 704, 710, and 711

    Environmental protection, Chemicals, Confidential Business 
Information (CBI), Hazardous materials, Importer, Manufacturer, 
Reporting and recordkeeping requirements.

    Dated: August 1, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
    Therefore, 40 CFR chapter I is amended as follows:

PART 704--[AMENDED]

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

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

Sec.  14;704.3  [Amended]

0
2. In Sec.  14;704.3, remove the phrase ``(as defined in 19 CFR 1.11)'' 
in

[[Page 50859]]

paragraph (1)(ii) of the definition importer.

PART 710--COMPILATION OF THE TSCA CHEMICAL SUBSTANCE INVENTORY

0
3. The authority citation for part 710 continues to read as follows:

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

0
4. Revise the heading for part 710 to read as set forth above.
0
5. Remove the heading ``Subpart A--General Provisions.''
0
6. Revise paragraph (b) of Sec.  14;710.1 to read as follows:

Sec.  14;710.1  Scope and compliance.

* * * * *
    (b) This part applies to the activities associated with the 
compilation of the TSCA Chemical Substance Inventory (TSCA Inventory) 
and the update of information on a subset of the chemical substances 
included on the TSCA Inventory.
* * * * *

0
7. Section 710.3 is amended as follows:
0
i. Revise the introductory text.
0
ii. Remove the phrase ``(as defined in 19 CFR 1.11)'' in paragraph (2) 
of the definition importer.
0
iii. Remove the definition non-isolated intermediate.
    The revision reads as follows:

Sec.  14;710.3  Definitions.

    For purposes of this part:
* * * * *

Subpart B (Sec. Sec.  14;710.23-710.39) [Removed]

0
8. Remove subpart B, consisting of Sec. Sec.  14;710.23-710.39.

Subpart C (Sec. Sec.  14;710.43-710.59) [Removed]

0
9. Remove subpart C, consisting of Sec. Sec.  14;710.43-710.59.

0
10. Add new part 711 to subchapter R to read as follows:

PART 711--TSCA CHEMICAL DATA REPORTING REQUIREMENTS

Sec.
711.1 Scope and compliance.
711.3 Definitions.
711.5 Chemical substances for which information must be reported.
711.6 Chemical substances for which information is not required.
711.8 Persons who must report.
711.9 Persons not subject to this part.
711.10 Activities for which reporting is not required.
711.15 Reporting information to EPA.
711.20 When to report.
711.22 Duplicative reporting.
711.25 Recordkeeping requirements.
711.30 Confidentiality claims.
711.35 Electronic filing.

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

Sec.  711.1  Scope and compliance.

    (a) This part specifies reporting and recordkeeping procedures 
under section 8(a) of the Toxic Substances Control Act (TSCA) (15 
U.S.C. 2607(a)) for certain manufacturers (including importers) of 
chemical substances. Section 8(a) of TSCA authorizes the EPA 
Administrator to require reporting of information necessary for 
administration of TSCA, including issuing regulations for the purpose 
of compiling and keeping current the TSCA Chemical Substance Inventory 
(TSCA Inventory) as required by TSCA section 8(b). In accordance with 
TSCA section 8(b), EPA amends the TSCA Inventory to include new 
chemical substances manufactured (including imported) in the United 
States and reported under TSCA section 5(a)(1). EPA also revises the 
categories of chemical substances and makes other amendments as 
appropriate.
    (b) This part applies to the activities associated with the 
periodic update of information on a subset of the chemical substances 
included on the TSCA Inventory.
    (c) Section 15(3) of TSCA makes it unlawful for any person to fail 
or refuse to submit information required under this part. In addition, 
TSCA section 15(3) makes it unlawful for any person to fail to keep, 
and permit access to, records required by this part. Section 16 of TSCA 
provides that any person who violates a provision of TSCA section 15 is 
liable to the United States for a civil penalty and may be criminally 
prosecuted. Pursuant to TSCA section 17, the Federal Government may 
seek judicial relief to compel submission of TSCA section 8(a) 
information and to otherwise restrain any violation of TSCA section 15. 
(EPA does not intend to concentrate its enforcement efforts on 
insignificant clerical errors in reporting.)
    (d) Each person who reports under this part must maintain records 
that document information reported under this part and, in accordance 
with TSCA, permit access to, and the copying of, such records by EPA 
officials.

Sec.  711.3  Definitions.

    The definitions in this section and the definitions in TSCA section 
3 apply to this part. In addition, the definitions in 40 CFR 704.3 also 
apply to this part, except the definitions manufacture and manufacturer 
in 40 CFR 704.3.
    CDX or Central Data Exchange means EPA's centralized electronic 
document receiving system, or its successors.
    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.
    Consumer use means 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.
    e-CDRweb means the electronic, web-based tool provided by EPA for 
the completion and submission of the CDR data.
    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.
    Industrial use means use at a site at which one or more chemical 
substances or mixtures are manufactured (including imported) or 
processed.
    Intended for use by children means the chemical substance or 
mixture is used in or on a product that is specifically intended for 
use by children age 14 or younger. A chemical substance or mixture is 
intended for use by children when the submitter answers ``yes'' to at 
least one of the following questions for the product into which the 
submitter's chemical substance or mixture is incorporated:
    (1) Is the product commonly recognized (i.e., by a reasonable 
person) as being intended for children age 14 or younger?
    (2) Does the manufacturer of the product state through product 
labeling or other written materials that the product is intended for or 
will be used by children age 14 or younger?
    (3) Is the advertising, promotion, or marketing of the product 
aimed at children age 14 or younger?
    Manufacture means to manufacture, produce, or import, for 
commercial purposes. Manufacture includes the extraction, for 
commercial purposes, of a component chemical substance from a 
previously existing chemical substance or complex combination of 
chemical substances. 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

[[Page 50860]]

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.
    Manufacturer means a person who manufactures a chemical substance.
    Master Inventory File means EPA's comprehensive list of chemical 
substances which constitutes the TSCA Inventory compiled under TSCA 
section 8(b). It includes chemical substances reported under 40 CFR 
part 710 and substances reported under 40 CFR part 720 for which a 
Notice of Commencement of Manufacture or Import has been received under 
40 CFR 720.120.
    Principal reporting year means the latest complete calendar year 
preceding the submission period.
    Reasonably likely to be exposed means an exposure to a chemical 
substance which, under foreseeable conditions of manufacture (including 
import), processing, distribution in commerce, or use of the chemical 
substance, is more likely to occur than not to occur. Such exposures 
would normally include, but would not be limited to, activities such as 
charging reactor vessels, drumming, bulk loading, cleaning equipment, 
maintenance operations, materials handling and transfers, and 
analytical operations. Covered exposures include exposures through any 
route of entry (inhalation, ingestion, skin contact, absorption, etc.), 
but excludes accidental or theoretical exposures.
    Repackaging means the physical transfer of a chemical substance or 
mixture, as is, from one container to another container or containers 
in preparation for distribution of the chemical substance or mixture in 
commerce.
    Reportable chemical substance means a chemical substance described 
in Sec.  14;711.5.
    Site means a contiguous property unit. Property divided only by a 
public right-of-way shall be considered one site. More than one 
manufacturing 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 Sec.  14;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 to different locations 
from a single distribution center, the distribution center shall be 
considered the site.
    Site-limited means a chemical substance is manufactured and 
processed only within a site and is not distributed for commercial 
purposes as a chemical substance or as part of a mixture or article 
outside the site. Imported chemical substances are never site-limited. 
Although a site-limited chemical substance is not distributed for 
commercial purposes outside the site at which it is manufactured and 
processed, the chemical substance is considered to have been 
manufactured and processed for commercial purposes.
    Submission period means the period in which the manufacturing, 
processing, and use data are submitted to EPA.
    U.S. parent company means the highest level company, located in the 
United States, that directly owns at least 50% of the voting stock of 
the manufacturer.
    Use means any utilization of a chemical substance or mixture that 
is not otherwise covered by the terms manufacture or process. 
Relabeling or redistributing a container holding a chemical substance 
or mixture where no repackaging of the chemical substance or mixture 
occurs does not constitute use or processing of the chemical substance 
or mixture.

Sec.  711.5  Chemical substances for which information must be 
reported.

    Any chemical substance that is in the Master Inventory File at the 
beginning of a submission period described in Sec.  14;711.20, unless 
the chemical substance is specifically excluded by Sec.  14;711.6.

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

    The following groups or categories of chemical substances are 
exempted from some or all of the reporting requirements of this part, 
with the following exception: A chemical substance described in 
paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not 
exempted from any of the reporting requirements of this part if that 
chemical substance is the subject of a rule proposed or promulgated 
under TSCA section 4, 5(a)(2), 5(b)(4), or 6, or is the subject of an 
enforceable consent agreement (ECA) developed under the procedures of 
40 CFR part 790, or is the subject of an order issued under TSCA 
section 5(e) or 5(f), or is the subject of relief that has been granted 
under a civil action under TSCA section 5 or 7.
    (a) Full exemptions. The following categories of chemical 
substances are exempted from the reporting requirements of this part.
    (1) Polymers--(i) Any chemical substance described with the word 
fragments ``*polym,'' ``*alkyd,'' or ``*oxylated'' in the Chemical 
Abstracts (CA) Index Name in the Master Inventory File, where the 
asterisk (*) in the listed word fragments indicates that any sets of 
characters may precede, or follow, the character string defined.
    (ii) Any chemical substance that is identified in the Master 
Inventory File as an enzyme, lignin, a polysaccharide (cellulose, gum, 
starch), a protein (albumin, casein, gelatin, gluten, hemoglobin), 
rubber, siloxane and silicone, or silsesquioxane.
    (iii) This exclusion does not apply to a polymeric substance that 
has been depolymerized, hydrolyzed, or otherwise chemically modified, 
except in cases where the intended product of this reaction is totally 
polymeric in structure.
    (2) Microorganisms. Any combination of chemical substances that is 
a living organism, and that meets the definition of microorganism at 40 
CFR 725.3. Any chemical substance produced from a living microorganism 
is reportable under this part unless otherwise excluded.
    (3) Naturally occurring chemical substances. Any naturally 
occurring chemical substance, as described in 40 CFR 710.4(b). The 
applicability of this exclusion is determined in each case by the 
specific activities of the person who manufactures the chemical 
substance in question. Some chemical substances can be manufactured 
both as described in 40 CFR 710.4(b) and by means other than those 
described in 40 CFR 710.4(b). If a person described in Sec.  14;711.8 
manufactures a chemical substance by means other than those described 
in 40 CFR 710.4(b), the person must report regardless of whether the 
chemical substance also could have been produced as described in 40 CFR 
710.4(b). Any chemical substance that is produced from such a naturally 
occurring chemical substance described in 40 CFR 710.4(b) is reportable 
unless otherwise excluded.
    (4) Certain forms of natural gas and water. Chemical substances 
with the following Chemical Abstracts Service Registry Number (CASRN): 
CASRN 7732-18-5, water; CASRN 8006-14-2, natural gas; CASRN 8006-61-9,

[[Page 50861]]

gasoline, natural; CASRN 64741-48-6, natural gas (petroleum), raw liq. 
mix; CASRN 68410-63-9, natural gas, dried; CASRN 68425-31-0, gasoline 
(natural gas), natural; and CASRN 68919-39-1, natural gas condensates.
    (b) Partial exemptions. The following groups of chemical substances 
are partially exempted from the reporting requirements of this part 
(i.e., the information described in Sec.  14;711.15(b)(4) need not be 
reported for these chemical substances). Such chemical substances are 
not excluded from the other reporting requirements under this part.
    (1) Petroleum process streams. EPA has designated the chemical 
substances listed in Table 1 of this paragraph by CASRN, as partially 
exempt from reporting under the IUR.

     Table 1--CASRNs of Partially Exempt Chemical Substances Termed
``Petroleum Process Streams'' for Purposes of Inventory Update Reporting
------------------------------------------------------------------------
                 CASRN                               Product
------------------------------------------------------------------------
8002-05-9.............................  Petroleum.
8002-74-2.............................  Paraffin waxes and hydrocarbon
                                         waxes.
8006-20-0.............................  Fuel gases, low and medium
                                         B.T.U.
8008-20-6.............................  Kerosine (petroleum).
8009-03-8.............................  Petrolatum.
8012-95-1.............................  Paraffin oils.
8030-30-6.............................  Naphtha.
8032-32-4.............................  Ligroine.
8042-47-5.............................  White mineral oil (petroleum).
8052-41-3.............................  Stoddard solvent.
8052-42-4.............................  Asphalt.
61789-60-4............................  Pitch.
63231-60-7............................  Paraffin waxes and hydrocarbon
                                         waxes, microcryst.
64741-41-9............................  Naphtha (petroleum), heavy
                                         straight-run.
64741-42-0............................  Naphtha (petroleum), full-range
                                         straight-run.
64741-43-1............................  Gas oils (petroleum), straight-
                                         run.
64741-44-2............................  Distillates (petroleum),
                                         straight-run middle.
64741-45-3............................  Residues (petroleum), atm.
                                         tower.
64741-46-4............................  Naphtha (petroleum), light
                                         straight-run.
64741-47-5............................  Natural gas condensates
                                         (petroleum).
64741-49-7............................  Condensates (petroleum), vacuum
                                         tower.
64741-50-0............................  Distillates (petroleum), light
                                         paraffinic.
64741-51-1............................  Distillates (petroleum), heavy
                                         paraffinic.
64741-52-2............................  Distillates (petroleum), light
                                         naphthenic.
64741-53-3............................  Distillates (petroleum), heavy
                                         naphthenic.
64741-54-4............................  Naphtha (petroleum), heavy
                                         catalytic cracked.
64741-55-5............................  Naphtha (petroleum), light
                                         catalytic cracked.
64741-56-6............................  Residues (petroleum), vacuum.
64741-57-7............................  Gas oils (petroleum), heavy
                                         vacuum.
64741-58-8............................  Gas oils (petroleum), light
                                         vacuum.
64741-59-9............................  Distillates (petroleum), light
                                         catalytic cracked.
64741-60-2............................  Distillates (petroleum),
                                         intermediate catalytic cracked.
64741-61-3............................  Distillates (petroleum), heavy
                                         catalytic cracked.
64741-62-4............................  Clarified oils (petroleum),
                                         catalytic cracked.
64741-63-5............................  Naphtha (petroleum), light
                                         catalytic reformed.
64741-64-6............................  Naphtha (petroleum), full-range
                                         alkylate.
64741-65-7............................  Naphtha (petroleum), heavy
                                         alkylate.
64741-66-8............................  Naphtha (petroleum), light
                                         alkylate.
64741-67-9............................  Residues (petroleum), catalytic
                                         reformer fractionator.
64741-68-0............................  Naphtha (petroleum), heavy
                                         catalytic reformed.
64741-69-1............................  Naphtha (petroleum), light
                                         hydrocracked.
64741-70-4............................  Naphtha (petroleum),
                                         isomerization.
64741-73-7............................  Distillates (petroleum),
                                         alkylate.
64741-74-8............................  Naphtha (petroleum), light
                                         thermal cracked.
64741-75-9............................  Residues (petroleum),
                                         hydrocracked.
64741-76-0............................  Distillates (petroleum), heavy
                                         hydrocracked.
64741-77-1............................  Distillates (petroleum), light
                                         hydrocracked.
64741-78-2............................  Naphtha (petroleum), heavy
                                         hydrocracked.
64741-79-3............................  Coke (petroleum).
64741-80-6............................  Residues (petroleum), thermal
                                         cracked.
64741-81-7............................  Distillates (petroleum), heavy
                                         thermal cracked.
64741-82-8............................  Distillates (petroleum), light
                                         thermal cracked.
64741-83-9............................  Naphtha (petroleum), heavy
                                         thermal cracked.
64741-84-0............................  Naphtha (petroleum), solvent-
                                         refined light.
64741-85-1............................  Raffinates (petroleum), sorption
                                         process.
64741-86-2............................  Distillates (petroleum),
                                         sweetened middle.
64741-87-3............................  Naphtha (petroleum), sweetened.
64741-88-4............................  Distillates (petroleum), solvent-
                                         refined heavy paraffinic.
64741-89-5............................  Distillates (petroleum), solvent-
                                         refined light paraffinic.
64741-90-8............................  Gas oils (petroleum), solvent-
                                         refined.
64741-91-9............................  Distillates (petroleum), solvent-
                                         refined middle.

[[Page 50862]]

 
64741-92-0............................  Naphtha (petroleum), solvent-
                                         refined heavy.
64741-95-3............................  Residual oils (petroleum),
                                         solvent deasphalted.
64741-96-4............................  Distillates (petroleum), solvent-
                                         refined heavy naphthenic.
64741-97-5............................  Distillates (petroleum), solvent-
                                         refined light naphthenic.
64741-98-6............................  Extracts (petroleum), heavy
                                         naphtha solvent.
64741-99-7............................  Extracts (petroleum), light
                                         naphtha solvent.
64742-01-4............................  Residual oils (petroleum),
                                         solvent-refined.
64742-03-6............................  Extracts (petroleum), light
                                         naphthenic distillate solvent.
64742-04-7............................  Extracts (petroleum), heavy
                                         paraffinic distillate solvent.
64742-05-8............................  Extracts (petroleum), light
                                         paraffinic distillate solvent.
64742-06-9............................  Extracts (petroleum), middle
                                         distillate solvent.
64742-07-0............................  Raffinates (petroleum), residual
                                         oil decarbonization.
64742-08-1............................  Raffinates (petroleum), heavy
                                         naphthenic distillate
                                         decarbonization.
64742-09-2............................  Raffinates (petroleum), heavy
                                         paraffinic distillate
                                         decarbonization.
64742-10-5............................  Extracts (petroleum), residual
                                         oil solvent.
64742-11-6............................  Extracts (petroleum), heavy
                                         naphthenic distillate solvent.
64742-12-7............................  Gas oils (petroleum), acid-
                                         treated.
64742-13-8............................  Distillates (petroleum), acid-
                                         treated middle.
64742-14-9............................  Distillates (petroleum), acid-
                                         treated light.
64742-15-0............................  Naphtha (petroleum), acid-
                                         treated.
64742-16-1............................  Petroleum resins.
64742-18-3............................  Distillates (petroleum), acid-
                                         treated heavy naphthenic.
64742-19-4............................  Distillates (petroleum), acid-
                                         treated light naphthenic.
64742-20-7............................  Distillates (petroleum), acid-
                                         treated heavy paraffinic.
64742-21-8............................  Distillates (petroleum), acid-
                                         treated light paraffinic.
64742-22-9............................  Naphtha (petroleum), chemically
                                         neutralized heavy.
64742-23-0............................  Naphtha (petroleum), chemically
                                         neutralized light.
64742-24-1............................  Sludges (petroleum), acid.
64742-25-2............................  Lubricating oils (petroleum),
                                         acid-treated spent.
64742-26-3............................  Hydrocarbon waxes (petroleum),
                                         acid-treated.
64742-27-4............................  Distillates (petroleum),
                                         chemically neutralized heavy
                                         paraffinic.
64742-28-5............................  Distillates (petroleum),
                                         chemically neutralized light
                                         paraffinic.
64742-29-6............................  Gas oils (petroleum), chemically
                                         neutralized.
64742-30-9............................  Distillates (petroleum),
                                         chemically neutralized middle.
64742-31-0............................  Distillates (petroleum),
                                         chemically neutralized light.
64742-32-1............................  Lubricating oils (petroleum),
                                         chemically neutralized spent.
64742-33-2............................  Hydrocarbon waxes (petroleum),
                                         chemically neutralized.
64742-34-3............................  Distillates (petroleum),
                                         chemically neutralized heavy
                                         naphthenic.
64742-35-4............................  Distillates (petroleum),
                                         chemically neutralized light
                                         naphthenic.
64742-36-5............................  Distillates (petroleum), clay-
                                         treated heavy paraffinic.
64742-37-6............................  Distillates (petroleum), clay-
                                         treated light paraffinic.
64742-38-7............................  Distillates (petroleum), clay-
                                         treated middle.
64742-39-8............................  Neutralizing agents (petroleum),
                                         spent sodium carbonate.
64742-40-1............................  Neutralizing agents (petroleum),
                                         spent sodium hydroxide.
64742-41-2............................  Residual oils (petroleum), clay-
                                         treated.
64742-42-3............................  Hydrocarbon waxes (petroleum),
                                         clay-treated microcryst.
64742-43-4............................  Paraffin waxes (petroleum), clay-
                                         treated.
64742-44-5............................  Distillates (petroleum), clay-
                                         treated heavy naphthenic.
64742-45-6............................  Distillates (petroleum), clay-
                                         treated light naphthenic.
64742-46-7............................  Distillates (petroleum),
                                         hydrotreated middle.
64742-47-8............................  Distillates (petroleum),
                                         hydrotreated light.
64742-48-9............................  Naphtha (petroleum),
                                         hydrotreated heavy.
64742-49-0............................  Naphtha (petroleum),
                                         hydrotreated light.
64742-50-3............................  Lubricating oils (petroleum),
                                         clay-treated spent.
64742-51-4............................  Paraffin waxes (petroleum),
                                         hydrotreated.
64742-52-5............................  Distillates (petroleum),
                                         hydrotreated heavy naphthenic.
64742-53-6............................  Distillates (petroleum),
                                         hydrotreated light naphthenic.
64742-54-7............................  Distillates (petroleum),
                                         hydrotreated heavy paraffinic.
64742-55-8............................  Distillates (petroleum),
                                         hydrotreated light paraffinic.
64742-56-9............................  Distillates (petroleum), solvent-
                                         dewaxed light paraffinic.
64742-57-0............................  Residual oils (petroleum),
                                         hydrotreated.
64742-58-1............................  Lubricating oils (petroleum),
                                         hydrotreated spent.
64742-59-2............................  Gas oils (petroleum),
                                         hydrotreated vacuum.
64742-60-5............................  Hydrocarbon waxes (petroleum),
                                         hydrotreated microcryst.
64742-61-6............................  Slack wax (petroleum).
64742-62-7............................  Residual oils (petroleum),
                                         solvent-dewaxed.
64742-63-8............................  Distillates (petroleum), solvent-
                                         dewaxed heavy naphthenic.
64742-64-9............................  Distillates (petroleum), solvent-
                                         dewaxed light naphthenic.
64742-65-0............................  Distillates (petroleum), solvent-
                                         dewaxed heavy paraffinic.
64742-67-2............................  Foots oil (petroleum).
64742-68-3............................  Naphthenic oils (petroleum),
                                         catalytic dewaxed heavy.

[[Page 50863]]

 
64742-69-4............................  Naphthenic oils (petroleum),
                                         catalytic dewaxed light.
64742-70-7............................  Paraffin oils (petroleum),
                                         catalytic dewaxed heavy.
64742-71-8............................  Paraffin oils (petroleum),
                                         catalytic dewaxed light.
64742-72-9............................  Distillates (petroleum),
                                         catalytic dewaxed middle.
64742-73-0............................  Naphtha (petroleum),
                                         hydrodesulfurized light.
64742-75-2............................  Naphthenic oils (petroleum),
                                         complex dewaxed heavy.
64742-76-3............................  Naphthenic oils (petroleum),
                                         complex dewaxed light.
64742-78-5............................  Residues (petroleum),
                                         hydrodesulfurized atmospheric
                                         tower.
64742-79-6............................  Gas oils (petroleum),
                                         hydrodesulfurized.
64742-80-9............................  Distillates (petroleum),
                                         hydrodesulfurized middle.
64742-81-0............................  Kerosine (petroleum),
                                         hydrodesulfurized.
64742-82-1............................  Naphtha (petroleum),
                                         hydrodesulfurized heavy.
64742-83-2............................  Naphtha (petroleum), light steam-
                                         cracked.
64742-85-4............................  Residues (petroleum),
                                         hydrodesulfurized vacuum.
64742-86-5............................  Gas oils (petroleum),
                                         hydrodesulfurized heavy vacuum.
64742-87-6............................  Gas oils (petroleum),
                                         hydrodesulfurized light vacuum.
64742-88-7............................  Solvent naphtha (petroleum),
                                         medium aliph.
64742-89-8............................  Solvent naphtha (petroleum),
                                         light aliph.
64742-90-1............................  Residues (petroleum), steam-
                                         cracked.
64742-91-2............................  Distillates (petroleum), steam-
                                         cracked.
64742-92-3............................  Petroleum resins, oxidized.
64742-93-4............................  Asphalt, oxidized.
64742-94-5............................  Solvent naphtha (petroleum),
                                         heavy arom.
64742-95-6............................  Solvent naphtha (petroleum),
                                         light arom.
64742-96-7............................  Solvent naphtha (petroleum),
                                         heavy aliph.
64742-97-8............................  Distillates (petroleum),
                                         oxidized heavy.
64742-98-9............................  Distillates (petroleum),
                                         oxidized light.
64742-99-0............................  Residual oils (petroleum),
                                         oxidized.
64743-00-6............................  Hydrocarbon waxes (petroleum),
                                         oxidized.
64743-01-7............................  Petrolatum (petroleum),
                                         oxidized.
64743-02-8............................  Alkenes, C > 10 .alpha.-.
64743-03-9............................  Phenols (petroleum).
64743-04-0............................  Coke (petroleum), recovery.
64743-05-1............................  Coke (petroleum), calcined.
64743-06-2............................  Extracts (petroleum), gas oil
                                         solvent.
64743-07-3............................  Sludges (petroleum), chemically
                                         neutralized.
64754-89-8............................  Naphthenic acids (petroleum),
                                         crude.
64771-71-7............................  Paraffins (petroleum), normal C
                                         > 10.
64771-72-8............................  Paraffins (petroleum), normal C5-
                                         20.
67254-74-4............................  Naphthenic oils.
67674-12-8............................  Residual oils (petroleum),
                                         oxidized, compounds with
                                         triethanolamine.
67674-13-9............................  Petrolatum (petroleum),
                                         oxidized, partially
                                         deacidified.
67674-15-1............................  Petrolatum (petroleum),
                                         oxidized, Me ester.
67674-16-2............................  Hydrocarbon waxes (petroleum),
                                         oxidized, partially
                                         deacidified.
67674-17-3............................  Distillates (petroleum),
                                         oxidized light, compounds with
                                         triethanolamine.
67674-18-4............................  Distillates (petroleum),
                                         oxidized light, Bu esters.
67891-79-6............................  Distillates (petroleum), heavy
                                         arom.
67891-80-9............................  Distillates (petroleum), light
                                         arom.
67891-81-0............................  Distillates (petroleum),
                                         oxidized light, potassium
                                         salts.
67891-82-1............................  Hydrocarbon waxes (petroleum),
                                         oxidized, compounds with
                                         ethanolamine.
67891-83-2............................  Hydrocarbon waxes (petroleum),
                                         oxidized, compounds with
                                         isopropanolamine.
67891-85-4............................  Hydrocarbon waxes (petroleum),
                                         oxidized, compounds with
                                         triisopropanolamine.
67891-86-5............................  Hydrocarbon waxes (petroleum),
                                         oxidized, compds. with
                                         diisopropanolamine.
68131-05-5............................  Hydrocarbon oils, process
                                         blends.
68131-49-7............................  Aromatic hydrocarbons, C6-10,
                                         acid-treated, neutralized.
68131-75-9............................  Gases (petroleum), C3-4.
68153-22-0............................  Paraffin waxes and Hydrocarbon
                                         waxes, oxidized.
68187-57-5............................  Pitch, coal tar-petroleum.
68187-58-6............................  Pitch, petroleum, arom.
68187-60-0............................  Hydrocarbons, C4, ethane-propane-
                                         cracked.
68307-98-2............................  Tail gas (petroleum), catalytic
                                         cracked distillate and
                                         catalytic cracked naphtha
                                         fractionation absorber.
68307-99-3............................  Tail gas (petroleum), catalytic
                                         polymn. naphtha fractionation
                                         stabilizer.
68308-00-9............................  Tail gas (petroleum), catalytic
                                         reformed naphtha fractionation
                                         stabilizer, hydrogen sulfide-
                                         free.
68308-01-0............................  Tail gas (petroleum), cracked
                                         distillate hydrotreater
                                         stripper.
68308-02-1............................  Tail gas (petroleum), distn.,
                                         hydrogen sulfide-free.
68308-03-2............................  Tail gas (petroleum), gas oil
                                         catalytic cracking absorber.
68308-04-3............................  Tail gas (petroleum), gas
                                         recovery plant.
68308-05-4............................  Tail gas (petroleum), gas
                                         recovery plant deethanizer.
68308-06-5............................  Tail gas (petroleum),
                                         hydrodesulfurized distillate
                                         and hydrodesulfurized naphtha
                                         fractionator, acid-free.
68308-07-6............................  Tail gas (petroleum),
                                         hydrodesulfurized vacuum gas
                                         oil stripper, hydrogen sulfide-
                                         free.
68308-08-7............................  Tail gas (petroleum), isomerized
                                         naphtha fractionation
                                         stabilizer.

[[Page 50864]]

 
68308-09-8............................  Tail gas (petroleum), light
                                         straight-run naphtha
                                         stabilizer, hydrogen sulfide-
                                         free.
68308-10-1............................  Tail gas (petroleum), straight-
                                         run distillate
                                         hydrodesulfurizer, hydrogen
                                         sulfide-free.
68308-11-2............................  Tail gas (petroleum), propane-
                                         propylene alkylation feed prep
                                         deethanizer.
68308-12-3............................  Tail gas (petroleum), vacuum gas
                                         oil hydrodesulfurizer, hydrogen
                                         sulfide-free.
68308-27-0............................  Fuel gases, refinery.
68333-22-2............................  Residues (petroleum),
                                         atmospheric.
68333-23-3............................  Naphtha (petroleum), heavy
                                         coker.
68333-24-4............................  Hydrocarbon waxes (petroleum),
                                         oxidized, compds. with
                                         triethanolamine.
68333-25-5............................  Distillates (petroleum),
                                         hydrodesulfurized light
                                         catalytic cracked.
68333-26-6............................  Clarified oils (petroleum),
                                         hydrodesulfurized catalytic
                                         cracked.
68333-27-7............................  Distillates (petroleum),
                                         hydrodesulfurized intermediate
                                         catalytic cracked.
68333-28-8............................  Distillates (petroleum),
                                         hydrodesulfurized heavy
                                         catalytic cracked.
68333-29-9............................  Residues (petroleum), light
                                         naphtha solvent extracts.
68333-30-2............................  Distillates (petroleum),
                                         oxidized heavy thermal cracked.
68333-81-3............................  Alkanes, C4-12.
68333-88-0............................  Aromatic hydrocarbons, C9-17.
68334-30-5............................  Fuels, diesel.
68409-99-4............................  Gases (petroleum), catalytic
                                         cracked overheads.
68410-00-4............................  Distillates (petroleum), crude
                                         oil.
68410-05-9............................  Distillates (petroleum),
                                         straight-run light.
68410-12-8............................  Distillates (petroleum), steam-
                                         cracked, C5-10 fraction, high-
                                         temperature stripping products
                                         with light steam-cracked
                                         petroleum naphtha C5 fraction
                                         polymers.
68410-71-9............................  Raffinates (petroleum),
                                         catalytic reformer ethylene
                                         glycol-water countercurrent
                                         exts.
68410-96-8............................  Distillates (petroleum),
                                         hydrotreated middle,
                                         intermediate boiling.
68410-97-9............................  Distillates (petroleum), light
                                         distillate hydrotreating
                                         process, low-boiling.
68410-98-0............................  Distillates (petroleum),
                                         hydrotreated heavy naphtha,
                                         deisohexanizer overheads.
68411-00-7............................  Alkenes, C > 8.
68425-29-6............................  Distillates (petroleum), naphtha-
                                         raffinate pyrolyzate-derived,
                                         gasoline-blending.
68425-33-2............................  Petrolatum (petroleum),
                                         oxidized, barium salt.
68425-34-3............................  Petrolatum (petroleum),
                                         oxidized, calcium salt.
68425-35-4............................  Raffinates (petroleum),
                                         reformer, Lurgi unit-sepd.
68425-39-8............................  Alkenes, C > 10 .alpha.-,
                                         oxidized.
68441-09-8............................  Hydrocarbon waxes (petroleum),
                                         clay-treated microcryst.,
                                         contg. polyethylene, oxidized.
68459-78-9............................  Alkenes, C18-24 .alpha.-,
                                         dimers.
68475-57-0............................  Alkanes, C1-2.
68475-58-1............................  Alkanes, C2-3.
68475-59-2............................  Alkanes, C3-4.
68475-60-5............................  Alkanes, C4-5.
68475-61-6............................  Alkenes, C5, naphtha-raffinate
                                         pyrolyzate-derived.
68475-70-7............................  Aromatic hydrocarbons, C6-8,
                                         naphtha-raffinate pyrolyzate-
                                         derived.
68475-79-6............................  Distillates (petroleum),
                                         catalytic reformed
                                         depentanizer.
68475-80-9............................  Distillates (petroleum), light
                                         steam-cracked naphtha.
68476-26-6............................  Fuel gases.
68476-27-7............................  Fuel gases, amine system
                                         residues.
68476-28-8............................  Fuel gases, C6-8 catalytic
                                         reformer.
68476-29-9............................  Fuel gases, crude oil
                                         distillates.
68476-30-2............................  Fuel oil, no. 2.
68476-31-3............................  Fuel oil, no. 4.
68476-32-4............................  Fuel oil, residues-straight-run
                                         gas oils, high-sulfur.
68476-33-5............................  Fuel oil, residual.
68476-34-6............................  Fuels, diesel, no. 2.
68476-39-1............................  Hydrocarbons, aliph.-arom.-C4-5-
                                         olefinic.
68476-40-4............................  Hydrocarbons, C3-4.
68476-42-6............................  Hydrocarbons, C4-5.
68476-43-7............................  Hydrocarbons, C4-6, C5-rich.
68476-44-8............................  Hydrocarbons, C > 3.
68476-45-9............................  Hydrocarbons, C5-10 arom. conc.,
                                         ethylene-manuf.-by-product.
68476-46-0............................  Hydrocarbons, C3-11, catalytic
                                         cracker distillates.
68476-47-1............................  Hydrocarbons, C2-6, C6-8
                                         catalytic reformer.
68476-49-3............................  Hydrocarbons, C2-4, C3-rich.
68476-50-6............................  Hydrocarbons, C >= 5, C5-6-rich.
68476-52-8............................  Hydrocarbons, C4, ethylene-
                                         manuf.-by-product.
68476-53-9............................  Hydrocarbons, C >= 20, petroleum
                                         wastes.
68476-54-0............................  Hydrocarbons, C3-5, polymn. unit
                                         feed.
68476-55-1............................  Hydrocarbons, C5-rich.
68476-56-2............................  Hydrocarbons, cyclic C5 and C6.
68476-77-7............................  Lubricating oils, refined used.
68476-81-3............................  Paraffin waxes and Hydrocarbon
                                         waxes, oxidized, calcium salts.
68476-84-6............................  Petroleum products, gases,
                                         inorg.
68476-85-7............................  Petroleum gases, liquefied.
68476-86-8............................  Petroleum gases, liquefied,
                                         sweetened.

[[Page 50865]]

 
68477-25-8............................  Waste gases, vent gas, C1-6.
68477-26-9............................  Wastes, petroleum.
68477-29-2............................  Distillates (petroleum),
                                         catalytic reformer fractionator
                                         residue, high-boiling.
68477-30-5............................  Distillates (petroleum),
                                         catalytic reformer fractionator
                                         residue, intermediate-boiling.
68477-31-6............................  Distillates (petroleum),
                                         catalytic reformer fractionator
                                         residue, low-boiling.
68477-33-8............................  Gases (petroleum), C3-4,
                                         isobutane-rich.
68477-34-9............................  Distillates (petroleum), C3-5, 2-
                                         methyl-2-butene-rich.
68477-35-0............................  Distillates (petroleum), C3-6,
                                         piperylene-rich.
68477-36-1............................  Distillates (petroleum), cracked
                                         steam-cracked, C5-18 fraction.
68477-38-3............................  Distillates (petroleum), cracked
                                         steam-cracked petroleum
                                         distillates.
68477-39-4............................  Distillates (petroleum), cracked
                                         stripped steam-cracked
                                         petroleum distillates, C8-10
                                         fraction.
68477-40-7............................  Distillates (petroleum), cracked
                                         stripped steam-cracked
                                         petroleum distillates, C10-12
                                         fraction.
68477-41-8............................  Gases (petroleum), extractive,
                                         C3-5, butadiene-butene-rich.
68477-42-9............................  Gases (petroleum), extractive,
                                         C3-5, butene-isobutylene-rich.
68477-44-1............................  Distillates (petroleum), heavy
                                         naphthenic, mixed with steam-
                                         cracked petroleum distillates
                                         C5-12 fraction.
68477-47-4............................  Distillates (petroleum), mixed
                                         heavy olefin vacuum, heart-cut.
68477-48-5............................  Distillates (petroleum), mixed
                                         heavy olefin vacuum, low-
                                         boiling.
68477-53-2............................  Distillates (petroleum), steam-
                                         cracked, C5-12 fraction.
68477-54-3............................  Distillates (petroleum), steam-
                                         cracked, C8-12 fraction.
68477-55-4............................  Distillates (petroleum), steam-
                                         cracked, C5-10 fraction, mixed
                                         with light steam-cracked
                                         petroleum naphtha C5 fraction.
68477-58-7............................  Distillates (petroleum), steam-
                                         cracked petroleum distillates,
                                         C5-18 fraction.
68477-59-8............................  Distillates (petroleum), steam-
                                         cracked petroleum distillates
                                         cyclopentadiene conc.
68477-60-1............................  Extracts (petroleum), cold-acid.
68477-61-2............................  Extracts (petroleum), cold-acid,
                                         C4-6.
68477-62-3............................  Extracts (petroleum), cold-acid,
                                         C3-5, butene-rich.
68477-63-4............................  Extracts (petroleum), reformer
                                         recycle.
68477-64-5............................  Gases (petroleum), acetylene
                                         manuf. off.
68477-65-6............................  Gases (petroleum), amine system
                                         feed.
68477-66-7............................  Gases (petroleum), benzene unit
                                         hydrodesulfurizer off.
68477-67-8............................  Gases (petroleum), benzene unit
                                         recycle, hydrogen-rich.
68477-68-9............................  Gases (petroleum), blend oil,
                                         hydrogen-nitrogen-rich.
68477-69-0............................  Gases (petroleum), butane
                                         splitter overheads.
68477-70-3............................  Gases (petroleum), C2-3.
68477-71-4............................  Gases (petroleum), catalytic-
                                         cracked gas oil depropanizer
                                         bottoms, C4-rich acid-free.
68477-72-5............................  Gases (petroleum), catalytic-
                                         cracked naphtha debutanizer
                                         bottoms, C3-5-rich.
68477-73-6............................  Gases (petroleum), catalytic
                                         cracked naphtha depropanizer
                                         overhead, C3-rich acid-free.
68477-74-7............................  Gases (petroleum), catalytic
                                         cracker.
68477-75-8............................  Gases (petroleum), catalytic
                                         cracker, C1-5-rich.
68477-76-9............................  Gases (petroleum), catalytic
                                         polymd. naphtha stabilizer
                                         overhead, C2-4-rich.
68477-77-0............................  Gases (petroleum), catalytic
                                         reformed naphtha stripper
                                         overheads.
68477-79-2............................  Gases (petroleum), catalytic
                                         reformer, C1-4-rich.
68477-80-5............................  Gases (petroleum), C6-8
                                         catalytic reformer recycle.
68477-81-6............................  Gases (petroleum), C6-8
                                         catalytic reformer.
68477-82-7............................  Gases (petroleum), C6-8
                                         catalytic reformer recycle,
                                         hydrogen-rich.
68477-83-8............................  Gases (petroleum), C3-5 olefinic-
                                         paraffinic alkylation feed.
68477-84-9............................  Gases (petroleum), C2-return
                                         stream.
68477-85-0............................  Gases (petroleum), C4-rich.
68477-86-1............................  Gases (petroleum), deethanizer
                                         overheads.
68477-87-2............................  Gases (petroleum),
                                         deisobutanizer tower overheads.
68477-88-3............................  Gases (petroleum), deethanizer
                                         overheads, C3-rich.
68477-89-4............................  Distillates (petroleum),
                                         depentanizer overheads.
68477-90-7............................  Gases (petroleum), depropanizer
                                         dry, propene-rich.
68477-91-8............................  Gases (petroleum), depropanizer
                                         overheads.
68477-92-9............................  Gases (petroleum), dry sour, gas-
                                         concentration concn.-unit-off.
68477-93-0............................  Gases (petroleum), gas concn.
                                         reabsorber distn.
68477-94-1............................  Gases (petroleum), gas recovery
                                         plant depropanizer overheads.
68477-95-2............................  Gases (petroleum), Girbatol unit
                                         feed.
68477-96-3............................  Gases (petroleum), hydrogen
                                         absorber off.
68477-97-4............................  Gases (petroleum), hydrogen-
                                         rich.
68477-98-5............................  Gases (petroleum), hydrotreater
                                         blend oil recycle, hydrogen-
                                         nitrogen rich.
68477-99-6............................  Gases (petroleum), isomerized
                                         naphtha fractionater, C4-rich,
                                         hydrogen sulfide-free.
68478-00-2............................  Gases (petroleum), recycle,
                                         hydrogen-rich.
68478-01-3............................  Gases (petroleum), reformer make-
                                         up, hydrogen-rich.
68478-02-4............................  Gases (petroleum), reforming
                                         hydrotreater.
68478-03-5............................  Gases (petroleum), reforming
                                         hydrotreater, hydrogen-methane-
                                         rich.
68478-04-6............................  Gases (petroleum), reforming
                                         hydrotreater make-up, hydrogen-
                                         rich.
68478-05-7............................  Gases (petroleum), thermal
                                         cracking distn.
68478-08-0............................  Naphtha (petroleum), light steam-
                                         cracked, C5-fraction, oligomer
                                         conc.
68478-10-4............................  Naphtha (petroleum), light steam-
                                         cracked, debenzenized, C8-16-
                                         cycloalkadiene conc.
68478-12-6............................  Residues (petroleum), butane
                                         splitter bottoms.
68478-13-7............................  Residues (petroleum), catalytic
                                         reformer fractionator residue
                                         distn.

[[Page 50866]]

 
68478-15-9............................  Residues (petroleum), C6-8
                                         catalytic reformer.
68478-16-0............................  Residual oils (petroleum),
                                         deisobutanizer tower.
68478-17-1............................  Residues (petroleum), heavy
                                         coker gas oil and vacuum gas
                                         oil.
68478-18-2............................  Residues (petroleum), heavy
                                         olefin vacuum.
68478-19-3............................  Residual oils (petroleum),
                                         propene purifn. splitter.
68478-20-6............................  Residues (petroleum), steam-
                                         cracked petroleum distillates
                                         cyclopentadiene conc., C4-
                                         cyclopentadiene-free.
68478-22-8............................  Tail gas (petroleum), catalytic
                                         cracked naphtha stabilization
                                         absorber.
68478-24-0............................  Tail gas (petroleum), catalytic
                                         cracker, catalytic reformer and
                                         hydrodesulfurizer combined
                                         fractionater.
68478-25-1............................  Tail gas (petroleum), catalytic
                                         cracker refractionation
                                         absorber.
68478-26-2............................  Tail gas (petroleum), catalytic
                                         reformed naphtha fractionation
                                         stabilizer.
68478-27-3............................  Tail gas (petroleum), catalytic
                                         reformed naphtha separator.
68478-28-4............................  Tail gas (petroleum), catalytic
                                         reformed naphtha stabilizer.
68478-29-5............................  Tail gas (petroleum), cracked
                                         distillate hydrotreater
                                         separator.
68478-30-8............................  Tail gas (petroleum),
                                         hydrodesulfurized straight-run
                                         naphtha separator.
68478-31-9............................  Tail gas (petroleum), isomerized
                                         naphtha fractionates, hydrogen
                                         sulfide-free.
68478-32-0............................  Tail gas (petroleum), saturate
                                         gas plant mixed stream, C4-
                                         rich.
68478-33-1............................  Tail gas (petroleum), saturate
                                         gas recovery plant, C1-2-rich.
68478-34-2............................  Tail gas (petroleum), vacuum
                                         residues thermal cracker.
68512-61-8............................  Residues (petroleum), heavy
                                         coker and light vacuum.
68512-62-9............................  Residues (petroleum), light
                                         vacuum.
68512-78-7............................  Solvent naphtha (petroleum),
                                         light arom., hydrotreated.
68512-91-4............................  Hydrocarbons, C3-4-rich,
                                         petroleum distillates.
68513-02-0............................  Naphtha (petroleum), full-range
                                         coker.
68513-03-1............................  Naphtha (petroleum), light
                                         catalytic reformed, arom.-free.
68513-11-1............................  Fuel gases, hydrotreater
                                         fractionation, scrubbed.
68513-12-2............................  Fuel gases, saturate gas unit
                                         fractionater-absorber
                                         overheads.
68513-13-3............................  Fuel gases, thermal cracked
                                         catalytic cracking residue.
68513-14-4............................  Gases (petroleum), catalytic
                                         reformed straight-run naphtha
                                         stabilizer overheads.
68513-15-5............................  Gases (petroleum), full-range
                                         straight-run naphtha
                                         dehexanizer off.
68513-16-6............................  Gases (petroleum), hydrocracking
                                         depropanizer off, hydrocarbon-
                                         rich.
68513-17-7............................  Gases (petroleum), light
                                         straight-run naphtha stabilizer
                                         off.
68513-18-8............................  Gases (petroleum), reformer
                                         effluent high-pressure flash
                                         drum off.
68513-19-9............................  Gases (petroleum), reformer
                                         effluent low-pressure flash
                                         drum off.
68513-62-2............................  Disulfides, C5-12-alkyl.
68513-63-3............................  Distillates (petroleum),
                                         catalytic reformed straight-run
                                         naphtha overheads.
68513-65-5............................  Butane, branched and linear.
68513-66-6............................  Residues (petroleum), alkylation
                                         splitter, C4-rich.
68513-67-7............................  Residues (petroleum),
                                         cyclooctadiene bottoms.
68513-68-8............................  Residues (petroleum),
                                         deethanizer tower.
68513-69-9............................  Residues (petroleum), steam-
                                         cracked light.
68513-74-6............................  Waste gases, ethylene oxide
                                         absorber-reactor.
68514-15-8............................  Gasoline, vapor-recovery.
68514-29-4............................  Hydrocarbons, amylene feed
                                         debutanizer overheads non-
                                         extractable raffinates.
68514-31-8............................  Hydrocarbons, C1-4.
68514-32-9............................  Hydrocarbons, C10 and C12,
                                         olefin-rich.
68514-33-0............................  Hydrocarbons, C12 and C14,
                                         olefin-rich.
68514-34-1............................  Hydrocarbons, C9-14, ethylene-
                                         manuf.-by-product.
68514-35-2............................  Hydrocarbons, C14-30, olefin-
                                         rich.
68514-36-3............................  Hydrocarbons, C1-4, sweetened.
68514-37-4............................  Hydrocarbons, C4-5-unsatd.
68514-38-5............................  Hydrocarbons, C4-10-unsatd.
68514-39-6............................  Naphtha (petroleum), light steam-
                                         cracked, isoprene-rich.
68514-79-4............................  Petroleum products, hydrofiner-
                                         powerformer reformates.
68515-25-3............................  Benzene, C1-9-alkyl derivs.
68515-26-4............................  Benzene, di-C12-14-alkyl derivs.
68515-27-5............................  Benzene, di-C10-14-alkyl
                                         derivs., fractionation
                                         overheads, heavy ends.
68515-28-6............................  Benzene, di-C10-14-alkyl
                                         derivs., fractionation
                                         overheads, light ends.
68515-29-7............................  Benzene, di-C10-14-alkyl
                                         derivs., fractionation
                                         overheads, middle cut.
68515-30-0............................  Benzene, mono-C20-48-alkyl
                                         derivs.
68515-32-2............................  Benzene, mono-C12-14-alkyl
                                         derivs., fractionation bottoms.
68515-33-3............................  Benzene, mono-C10-12-alkyl
                                         derivs., fractionation bottoms,
                                         heavy ends.
68515-34-4............................  Benzene, mono-C12-14-alkyl
                                         derivs., fractionation bottoms,
                                         heavy ends.
68515-35-5............................  Benzene, mono-C10-12-alkyl
                                         derivs., fractionation bottoms,
                                         light ends.
68515-36-6............................  Benzene, mono-C12-14-alkyl
                                         derivs., fractionation bottoms,
                                         light ends.
68516-20-1............................  Naphtha (petroleum), steam-
                                         cracked middle arom.
68526-52-3............................  Alkenes, C6.
68526-53-4............................  Alkenes, C6-8, C7-rich.
68526-54-5............................  Alkenes, C7-9, C8-rich.
68526-55-6............................  Alkenes, C8-10, C9-rich.
68526-56-7............................  Alkenes, C9-11, C10-rich.
68526-57-8............................  Alkenes, C10-12, C11-rich.

[[Page 50867]]

 
68526-58-9............................  Alkenes, C11-13, C12-rich.
68526-77-2............................  Aromatic hydrocarbons, ethane
                                         cracking scrubber effluent and
                                         flare drum.
68526-99-8............................  Alkenes, C6-9 .alpha.-.
68527-00-4............................  Alkenes, C8-9 .alpha.-.
68527-11-7............................  Alkenes, C5.
68527-13-9............................  Gases (petroleum), acid,
                                         ethanolamine scrubber.
68527-14-0............................  Gases (petroleum), methane-rich
                                         off.
68527-15-1............................  Gases (petroleum), oil refinery
                                         gas distn. off.
68527-16-2............................  Hydrocarbons, C1-3.
68527-18-4............................  Gas oils (petroleum), steam-
                                         cracked.
68527-19-5............................  Hydrocarbons, C1-4, debutanizer
                                         fraction.
68527-21-9............................  Naphtha (petroleum), clay-
                                         treated full-range straight-
                                         run.
68527-22-0............................  Naphtha (petroleum), clay-
                                         treated light straight-run.
68527-23-1............................  Naphtha (petroleum), light steam-
                                         cracked arom.
68527-26-4............................  Naphtha (petroleum), light steam-
                                         cracked, debenzenized.
68527-27-5............................  Naphtha (petroleum), full-range
                                         alkylate, butane-contg.
68553-00-4............................  Fuel oil, no. 6.
68553-14-0............................  Hydrocarbons, C8-11.
68602-79-9............................  Distillates (petroleum), benzene
                                         unit hydrotreater dipentanizer
                                         overheads.
68602-81-3............................  Distillates, hydrocarbon resin
                                         prodn. higher boiling.
68602-82-4............................  Gases (petroleum), benzene unit
                                         hydrotreater depentenizer
                                         overheads.
68602-83-5............................  Gases (petroleum), C1-5, wet.
68602-84-6............................  Gases (petroleum), secondary
                                         absorber off, fluidized
                                         catalytic cracker overheads
                                         fractionater.
68602-96-0............................  Distillates (petroleum),
                                         oxidized light, strong acid
                                         components, compds. with
                                         diethanolamine.
68602-97-1............................  Distillates (petroleum),
                                         oxidized light, strong acid
                                         components, sodium salts.
68602-98-2............................  Distillates (petroleum),
                                         oxidized light, strong acid
                                         components.
68602-99-3............................  Distillates (petroleum),
                                         oxidized light, strong acid-
                                         free.
68603-00-9............................  Distillates (petroleum), thermal
                                         cracked naphtha and gas oil.
68603-01-0............................  Distillates (petroleum), thermal
                                         cracked naphtha and gas oil, C5-
                                         dimer-contg.
68603-02-1............................  Distillates (petroleum), thermal
                                         cracked naphtha and gas oil,
                                         dimerized.
68603-03-2............................  Distillates (petroleum), thermal
                                         cracked naphtha and gas oil,
                                         extractive.
68603-08-7............................  Naphtha (petroleum), arom.-
                                         contg.
68603-09-8............................  Hydrocarbon waxes (petroleum),
                                         oxidized, calcium salts.
68603-10-1............................  Hydrocarbon waxes (petroleum),
                                         oxidized, Me esters, barium
                                         salts.
68603-11-2............................  Hydrocarbon waxes (petroleum),
                                         oxidized, Me esters, calcium
                                         salts.
68603-12-3............................  Hydrocarbon waxes (petroleum),
                                         oxidized, Me esters, sodium
                                         salts.
68603-13-4............................  Petrolatum (petroleum),
                                         oxidized, ester with sorbitol.
68603-14-5............................  Residual oils (petroleum),
                                         oxidized, calcium salts.
68603-31-6............................  Alkenes, C10, tert-amylene
                                         concentrator by-product.
68603-32-7............................  Alkenes, C15-20 .alpha.-,
                                         isomerized.
68606-09-7............................  Fuel gases, expander off.
68606-10-0............................  Gasoline, pyrolysis, debutanizer
                                         bottoms.
68606-11-1............................  Gasoline, straight-run, topping-
                                         plant.
68606-24-6............................  Hydrocarbons, C4, butene
                                         concentrator by-product.
68606-25-7............................  Hydrocarbons, C2-4.
68606-26-8............................  Hydrocarbons, C3.
68606-27-9............................  Gases (petroleum), alkylation
                                         feed.
68606-28-0............................  Hydrocarbons, C5 and C10-aliph.
                                         and C6-8-arom.
68606-31-5............................  Hydrocarbons, C3-5, butadiene
                                         purification (purifn.) by-
                                         product.
68606-34-8............................  Gases (petroleum), depropanizer
                                         bottoms fractionation off.
68606-36-0............................  Hydrocarbons, C5-unsatd. rich,
                                         isoprene purifn. by-product.
68607-11-4............................  Petroleum products, refinery
                                         gases.
68607-30-7............................  Residues (petroleum), topping
                                         plant, low-sulfur.
68608-56-0............................  Waste gases, from carbon black
                                         manuf.
68647-60-9............................  Hydrocarbons, C > 4.
68647-61-0............................  Hydrocarbons, C4-5, tert-amylene
                                         concentrator by-product.
68647-62-1............................  Hydrocarbons, C4-5, butene
                                         concentrator by-product, sour.
68650-36-2............................  Aromatic hydrocarbons, C8, o-
                                         xylene-lean.
68650-37-3............................  Paraffin waxes (petroleum),
                                         oxidized, sodium salts.
68782-97-8............................  Distillates (petroleum),
                                         hydrofined lubricating-oil.
68782-98-9............................  Extracts (petroleum), clarified
                                         oil solvent, condensed-ring-
                                         arom.-contg.
68782-99-0............................  Extracts (petroleum), heavy
                                         clarified oil solvent,
                                         condensed-ring-arom.-contg.
68783-00-6............................  Extracts (petroleum), heavy
                                         naphthenic distillate solvent,
                                         arom. conc.
68783-01-7............................  Extracts (petroleum), heavy
                                         naphthenic distillate solvent,
                                         paraffinic conc.
68783-02-8............................  Extracts (petroleum),
                                         intermediate clarified oil
                                         solvent, condensed-ring-arom.-
                                         contg.
68783-04-0............................  Extracts (petroleum), solvent-
                                         refined heavy paraffinic
                                         distillate solvent.
68783-05-1............................  Gases (petroleum), ammonia-
                                         hydrogen sulfide, water-satd.
68783-06-2............................  Gases (petroleum), hydrocracking
                                         low-pressure separator.
68783-07-3............................  Gases (petroleum), refinery
                                         blend.
68783-08-4............................  Gas oils (petroleum), heavy
                                         atmospheric.
68783-09-5............................  Naphtha (petroleum), catalytic
                                         cracked light distd.

[[Page 50868]]

 
68783-12-0............................  Naphtha (petroleum),
                                         unsweetened.
68783-13-1............................  Residues (petroleum), coker
                                         scrubber, condensed-ring-arom.-
                                         contg.
68783-15-3............................  Alkenes, C6-7 .alpha.-.
68783-61-9............................  Fuel gases, refinery, sweetened.
68783-62-0............................  Fuel gases, refinery,
                                         unsweetened.
68783-64-2............................  Gases (petroleum), catalytic
                                         cracking.
68783-65-3............................  Gases (petroleum), C2-4,
                                         sweetened.
68783-66-4............................  Naphtha (petroleum), light,
                                         sweetened.
68814-47-1............................  Waste gases, refinery vent.
68814-67-5............................  Gases (petroleum), refinery.
68814-87-9............................  Distillates (petroleum), full-
                                         range straight-run middle.
68814-89-1............................  Extracts (petroleum), heavy
                                         paraffinic distillates, solvent-
                                         deasphalted.
68814-90-4............................  Gases (petroleum), platformer
                                         products separator off.
68814-91-5............................  Alkenes, C5-9 .alpha.-.
68855-57-2............................  Alkenes, C6-12 .alpha.-.
68855-58-3............................  Alkenes, C10-16 .alpha.-.
68855-59-4............................  Alkenes, C14-18 .alpha.-.
68855-60-7............................  Alkenes, C14-20 .alpha.-.
68911-58-0............................  Gases (petroleum), hydrotreated
                                         sour kerosine depentanizer
                                         stabilizer off.
68911-59-1............................  Gases (petroleum), hydrotreated
                                         sour kerosine flash drum.
68915-96-8............................  Distillates (petroleum), heavy
                                         straight-run.
68915-97-9............................  Gas oils (petroleum), straight-
                                         run, high-boiling.
68918-69-4............................  Petrolatum (petroleum),
                                         oxidized, zinc salt.
68918-73-0............................  Residues (petroleum), clay-
                                         treating filter wash.
68918-93-4............................  Paraffin waxes and Hydrocarbon
                                         waxes, oxidized, alkali metal
                                         salts.
68918-98-9............................  Fuel gases, refinery, hydrogen
                                         sulfide-free.
68918-99-0............................  Gases (petroleum), crude oil
                                         fractionation off.
68919-00-6............................  Gases (petroleum), dehexanizer
                                         off.
68919-01-7............................  Gases (petroleum), distillate
                                         unifiner desulfurization
                                         stripper off.
68919-02-8............................  Gases (petroleum), fluidized
                                         catalytic cracker fractionation
                                         off.
68919-03-9............................  Gases (petroleum), fluidized
                                         catalytic cracker scrubbing
                                         secondary absorber off.
68919-04-0............................  Gases (petroleum), heavy
                                         distillate hydrotreater
                                         desulfurization stripper off.
68919-05-1............................  Gases (petroleum), light
                                         straight run gasoline
                                         fractionation stabilizer off.
68919-06-2............................  Gases (petroleum), naphtha
                                         unifiner desulfurization
                                         stripper off.
68919-07-3............................  Gases (petroleum), platformer
                                         stabilizer off, light ends
                                         fractionation.
68919-08-4............................  Gases (petroleum), preflash
                                         tower off, crude distn.
68919-09-5............................  Gases (petroleum), straight-run
                                         naphtha catalytic reforming
                                         off.
68919-10-8............................  Gases (petroleum), straight-run
                                         stabilizer off.
68919-11-9............................  Gases (petroleum), tar stripper
                                         off.
68919-12-0............................  Gases (petroleum), unifiner
                                         stripper off.
68919-15-3............................  Hydrocarbons, C6-12, benzene-
                                         recovery.
68919-16-4............................  Hydrocarbons, catalytic
                                         alkylation, by-products, C3-6.
68919-17-5............................  Hydrocarbons, C12-20, catalytic
                                         alkylation by-products.
68919-19-7............................  Gases (petroleum), fluidized
                                         catalytic cracker splitter
                                         residues.
68919-20-0............................  Gases (petroleum), fluidized
                                         catalytic cracker splitter
                                         overheads.
68919-37-9............................  Naphtha (petroleum), full-range
                                         reformed.
68920-06-9............................  Hydrocarbons, C7-9.
68920-07-0............................  Hydrocarbons, C  25, hydrotreated bright stock-
                                         based.
72623-84-8............................  Lubricating oils (petroleum),
                                         C15-30, hydrotreated neutral
                                         oil-based, contg. solvent
                                         deasphalted residual oil.
72623-85-9............................  Lubricating oils (petroleum),
                                         C20-50, hydrotreated neutral
                                         oil-based, high-viscosity.
72623-86-0............................  Lubricating oils (petroleum),
                                         C15-30, hydrotreated neutral
                                         oil-based.
72623-87-1............................  Lubricating oils (petroleum),
                                         C20-50, hydrotreated neutral
                                         oil-based.
73138-65-5............................  Hydrocarbon waxes (petroleum),
                                         oxidized, magnesium salts.
92045-43-7............................  Lubricating oils (petroleum),
                                         hydrocracked non-arom. solvent
                                         deparaffined.
92045-58-4............................  Naphtha (petroleum),
                                         isomerization, C6-fraction.
92062-09-4............................  Slack wax (petroleum),
                                         hydrotreated.
93762-80-2............................  Alkenes, C15-18.
98859-55-3............................  Distillates (petroleum),
                                         oxidized heavy, compds. with
                                         diethanolamine.
98859-56-4............................  Distillates (petroleum),
                                         oxidized heavy, sodium salts.
101316-73-8...........................  Lubricating oils (petroleum),
                                         used, non-catalytically
                                         refined.
164907-78-2...........................  Extracts (petroleum), asphaltene-
                                         low vacuum residue solvent.
164907-79-3...........................  Residues (petroleum), vacuum,
                                         asphaltene-low.
178603-63-9...........................  Gas oils (petroleum), vacuum,
                                         hydrocracked, hydroisomerized,
                                         hydrogenated, C10-25.
178603-64-0...........................  Gas oils (petroleum), vacuum,
                                         hydrocracked, hydroisomerized,
                                         hydrogenated, C15-30, branched
                                         and cyclic.
178603-65-1...........................  Gas oils (petroleum), vacuum,
                                         hydrocracked, hydroisomerized,
                                         hydrogenated, C20-40, branched
                                         and cyclic.
178603-66-2...........................  Gas oils (petroleum), vacuum,
                                         hydrocracked, hydroisomerized,
                                         hydrogenated, C25-55, branched
                                         and cyclic.
212210-93-0...........................  Solvent naphtha (petroleum),
                                         heavy arom., distn. residues.
221120-39-4...........................  Distillates (petroleum), cracked
                                         steam-cracked, C5-12 fraction.
445411-73-4...........................  Gas oils (petroleum), vacuum,
                                         hydrocracked, hydroisomerized,
                                         hydrogenated, C10-25, branched
                                         and cyclic
------------------------------------------------------------------------

     (2) Specific exempted chemical substances--(i) Exemption. EPA has 
determined that, at this time, the information in Sec.  711.15(b)(4) 
associated with the chemical substances listed in paragraph (b)(2)(iv) 
of this section is of low current interest.
    (ii) Considerations. In making its determination of whether this 
partial exemption should apply to a particular chemical substance, EPA 
will consider the totality of information available for the chemical 
substance in question, including but not limited to, one or more of the 
following considerations:
    (A) Whether the chemical substance qualifies or has qualified in 
past IUR collections for the reporting of the information described in 
Sec.  711.15(b)(4).

[[Page 50870]]

    (B) The chemical substance's chemical and physical properties or 
potential for persistence, bioaccumulation, health effects, or 
environmental effects (considered independently or together).
    (C) The information needs of EPA, other Federal agencies, Tribes, 
States, and local governments, as well as members of the public.
    (D) The availability of other complementary risk screening 
information.
    (E) The availability of comparable processing and use information.
    (F) Whether the potential risks of the chemical substance are 
adequately managed.
    (iii) Amendments. EPA may amend the chemical substance list in 
paragraph (b)(2)(iv) of this section on its own initiative or in 
response to a request from the public based on EPA's determination of 
whether the information in Sec.  711.15(b)(4) is of low interest.
    (A) Any person may request that EPA amend the chemical substance 
list in Table 2 in paragraph (b)(2)(iv) of this section. Your request 
must be in writing and must be submitted to the following address: OPPT 
IUR Submission Coordinator (7407M), Attention: Inventory Update 
Reporting, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. Requests must identify the chemical substance in question, as 
well as its CASRN or other chemical identification number as identified 
in Sec.  711.15(b)(3)(i), and must contain a written rationale for the 
request that provides sufficient specific information, addressing the 
considerations listed in Sec.  711.6(b)(2)(ii), including cites and 
relevant documents, to demonstrate to EPA that the collection of the 
information in Sec.  711.15(b)(4) for the chemical substance in 
question either is or is not of low current interest. If a request 
related to a particular chemical substance is resubmitted, any 
subsequent request must clearly identify new information contained in 
the request. EPA may request other information that it believes 
necessary to evaluate the request. EPA will issue a written response to 
each request within 120 days of receipt of the request, and will 
maintain copies of these responses in a docket that will be established 
for each reporting cycle.
    (B) As needed, the Agency will initiate rulemaking to make 
revisions to Table 2 in paragraph (b)(2)(iv) of this section.
    (C) To assist EPA in reaching a decision regarding a particular 
request prior to a given principal reporting year, requests must be 
submitted to EPA no later than 12 months prior to the start of the next 
principal reporting year.
    (iv) List of chemical substances. EPA has designated the chemical 
substances listed in Table 2 of this paragraph by CASRN, as partially 
exempt from reporting under the IUR.

         Table 2--CASRN of Partially Exempt Chemical Substances
------------------------------------------------------------------------
                 CASRN                               Chemical
------------------------------------------------------------------------
50-70-4................................  D-glucitol.
50-81-7................................  L-ascorbic acid.
50-99-7................................  D-glucose.
56-81-5................................  1,2,3-Propanetriol.
56-87-1................................  L-lysine.
57-50-1................................  .alpha.-D-Glucopyranoside,
                                          .beta.-D-fructofuranosyl.
58-95-7................................  2H-1-Benzopyran-6-ol, 3,4-
                                          dihydro-2,5,7,8-tetramethyl-2-
                                          [(4R,8R)-4,8,12-
                                          trimethyltridecyl]-, acetate,
                                          (2R)-.
59-02-9................................  2H-1-Benzopyran-6-ol, 3,4-
                                          dihydro-2,5,7,8-tetramethyl-2-
                                          [(4R,8R)-4,8,12-
                                          trimethyltridecyl]-, (2R)-.
59-51-8................................  Methionine.
69-65-8................................  D-mannitol.
87-79-6................................  L-sorbose.
87-99-0................................  Xylitol.
96-10-6................................  Aluminum, chlorodiethyl-.
97-93-8................................  Aluminum, triethyl-.
100-99-2...............................  Aluminum, tris(2-methylpropyl)-
                                          .
123-94-4...............................  Octadecanoic acid, 2,3-
                                          dihydroxypropyl ester.
124-38-9...............................  Carbon dioxide.
137-08-6...............................  .beta.-Alanine, N-[(2R)-2,4-
                                          dihydroxy-3,3-dimethyl-1-
                                          oxobutyl]-, calcium alt (2:1).
142-47-2...............................  L-glutamic acid, monosodium
                                          salt.
150-30-1...............................  Phenylalanine.
563-43-9...............................  Aluminum, dichloroethyl-.
1070-00-4..............................  Aluminum, trioctyl-.
1116-70-7..............................  Aluminum, tributyl-.
1116-73-0..............................  Aluminum, trihexyl-.
1191-15-7..............................  Aluminum, hydrobis(2-
                                          methylpropyl)-.
1317-65-3..............................  Limestone.
1333-74-0..............................  Hydrogen.
1592-23-0..............................  Octadecanoic acid, calcium
                                          salt.
7440-37-1..............................  Argon.
7440-44-0..............................  Carbon.
7727-37-9..............................  Nitrogen.
7782-42-5..............................  Graphite.
7782-44-7..............................  Oxygen.
8001-21-6..............................  Sunflower oil.
8001-22-7..............................  Soybean oil.
8001-23-8..............................  Safflower oil.
8001-26-1..............................  Linseed oil.
8001-29-4..............................  Cottonseed oil.
8001-30-7..............................  Corn oil.
8001-31-8..............................  Coconut oil.
8001-78-3..............................  Castor oil, hydrogenated.
8001-79-4..............................  Castor oil.

[[Page 50871]]

 
8002-03-7..............................  Peanut oil.
8002-13-9..............................  Rape oil.
8002-43-5..............................  Lecithins.
8002-75-3..............................  Palm oil.
8006-54-0..............................  Lanolin.
8016-28-2..............................  Lard, oil.
8016-70-4..............................  Soybean oil, hydrogenated.
8021-99-6..............................  Charcoal, bone.
8029-43-4..............................  Syrups, hydrolyzed starch.
11103-57-4.............................  Vitamin A.
12075-68-2.............................  Aluminum, di-.mu.-
                                          chlorochlorotriethyldi-.
12542-85-7.............................  Aluminum, trichlorotrimethyldi-
                                          .
16291-96-6.............................  Charcoal.
26836-47-5.............................  D-glucitol, monooctadecanoate.
61789-44-4.............................  Fatty acids, castor-oil.
61789-97-7.............................  Tallow.
61789-99-9.............................  Lard.
64147-40-6.............................  Castor oil, dehydrated.
64755-01-7.............................  Fatty acids, tallow, calcium
                                          salts.
65996-63-6.............................  Starch, acid-hydrolyzed.
65996-64-7.............................  Starch, enzyme-hydrolyzed.
67701-01-3.............................  Fatty acids, C12-18.
68002-85-7.............................  Fatty acids, C14-22 and C16-22-
                                          unsatd.
68131-37-3.............................  Syrups, hydrolyzed starch,
                                          dehydrated.
68188-81-8.............................  Grease, poultry.
68308-36-1.............................  Soybean meal.
68308-54-3.............................  Glycerides, tallow mono-, di-
                                          and tri-, hydrogenated.
68334-00-9.............................  Cottonseed oil, hydrogenated.
68334-28-1.............................  Fats and glyceridic oils,
                                          vegetable, hydrogenated.
68409-76-7.............................  Bone meal, steamed.
68424-45-3.............................  Fatty acids, linseed-oil.
68424-61-3.............................  Glycerides, C16-18 and C18-
                                          unsatd. mono- and di-.
68425-17-2.............................  Syrups, hydrolyzed starch,
                                          hydrogenated.
68439-86-1.............................  Bone, ash.
68442-69-3.............................  Benzene, mono-C10-14-alkyl
                                          derivs.
68476-78-8.............................  Molasses.
68514-27-2.............................  Grease, catch basin.
68514-74-9.............................  Palm oil, hydrogenated.
68525-87-1.............................  Corn oil, hydrogenated.
68648-87-3.............................  Benzene, C10-16-alkyl derivs.
68918-42-3.............................  Soaps, stocks, soya.
68952-94-3.............................  Soaps, stocks, vegetable-oil.
68956-68-3.............................  Fats and glyceridic oils,
                                          vegetable.
68989-98-0.............................  Fats and glyceridic oils,
                                          vegetable, residues.
73138-67-7.............................  Lard, hydrogenated.
120962-03-0............................  Canola oil.
129813-58-7............................  Benzene, mono-C10-13-alkyl
                                          derivs.
129813-59-8............................  Benzene, mono-C12-14-alkyl
                                          derivs.
129813-60-1............................  Benzene, mono-C14-16-alkyl
                                          derivs.
------------------------------------------------------------------------

Sec.  14;711.8  Persons who must report.

    Except as provided in Sec. Sec.  711.9 and 711.10, the following 
persons are subject to the requirements of this part. Persons must 
determine whether they must report under this section for each chemical 
substance that they manufacture (including import) at an individual 
site.
    (a) Persons subject to recurring reporting--(1) For the 2012 
submission period, any person who manufactured (including imported) for 
commercial purposes 25,000 lb (11,340 kilogram (kg)) or more of a 
chemical substance described in Sec.  711.5 at any single site owned or 
controlled by that person during the principal reporting year (i.e., 
calendar year 2011) is subject to reporting.
    (2) For the submission periods subsequent to the 2012 submission 
period, any person who manufactured (including imported) for commercial 
purposes 25,000 lb (11,340 kg) or more of a chemical substance 
described in Sec.  711.5 at any single site owned or controlled by that 
person during any calendar year since the last principal reporting year 
(e.g., for the 2016 submission period, consider calendar years 2012, 
2013, 2014, and 2015, given that 2011 was the last principal reporting 
year).
    (b) Exceptions. For the 2016 submission period and subsequent 
submission periods, any person who manufactured (including imported) 
for commercial purposes any chemical substance that is the subject of a 
rule proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 6, 
or is the subject of an order in effect under TSCA section 5(e) or 
5(f), or is the subject of relief that has been granted under a civil 
action under TSCA section 5 or 7 is subject to reporting as described 
in Sec.  711.8(a), except that the applicable production volume 
threshold is 2,500 lb (1,134 kg).

Sec.  14;711.9  Persons not subject to this part.

    A person described in Sec.  711.8 is not subject to the 
requirements of this part

[[Page 50872]]

if that person qualifies as a small manufacturer as that term is 
defined in 40 CFR 704.3. Notwithstanding this exclusion, a person who 
qualifies as a small manufacturer is subject to this part 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.

Sec.  14;711.10  Activities for which reporting is not required.

    A person described in Sec.  711.8 is not subject to the 
requirements of this part with respect to any chemical substance 
described in Sec.  711.5 that the person solely manufactured or 
imported under the following circumstances:
    (a) The person manufactured or imported the chemical substance 
described in Sec.  711.5 solely in small quantities for research and 
development.
    (b) The person imported the chemical substance described in Sec.  
711.5 as part of an article.
    (c) The person manufactured the chemical substance described in 
Sec.  711.5 in a manner described in 40 CFR 720.30(g) or (h).

Sec.  14;711.15  Reporting information to EPA.

    For the 2012 submission period, any person who must report under 
this part, as described in Sec.  711.8, must submit the information 
described in this section for each chemical substance described in 
Sec.  711.5 that the person manufactured (including imported) for 
commercial purposes in an amount of 25,000 lb (11,340 kg) or more at 
any one site during the principal reporting year (i.e., calendar year 
2011). For the submission periods subsequent to the 2012 submission 
period, any person who must report under this part, as described in 
Sec.  711.8, must submit the information described in this section for 
each chemical substance described in Sec.  711.5 that the person 
manufactured (including imported) for commercial purposes in an amount 
of 25,000 lb (11,340 kg) or more (or in an amount of 2,500 lb (1,134 
kg) or more for chemical substances subject to the rules, orders, or 
actions described in Sec.  711.8(b)) at any one site during any 
calendar year since the last principal reporting year (e.g., for the 
2016 submission period, consider calendar years 2012, 2013, 2014, and 
2015, because 2011 was the last principal reporting year). The 
principal reporting year for each submission period is the previous 
calendar year (e.g., the principal reporting year for the 2016 
submission period is calendar year 2015). For all submission periods, a 
separate report must be submitted for each chemical substance at each 
site for which the submitter is required to report. A submitter of 
information under this part must report information as described in 
this section to the extent that such information is known to or 
reasonably ascertainable by that person.
    (a) Reporting information to EPA. Any person who reports 
information to EPA must do so using the e-CDRweb reporting tool 
provided by EPA at the address set forth in Sec.  711.35. The 
submission must include all information described in paragraph (b) of 
this section. Persons must submit a separate Form U for each site for 
which the person is required to report. The e-CDRweb reporting tool is 
described in the instructions available from EPA at the Web site set 
forth in Sec.  711.35.
    (b) Information to be reported. For the 2012 submission period, 
manufacturers (including importers) of a reportable chemical substance 
in an amount of 25,000 lb (11,340 kg) or more at a site during the 
principal reporting year (i.e., 2011) must report the information 
described in paragraphs (b)(1), (b)(2), and (b)(3) of this section. For 
the 2012 submission period, manufacturers (including importers) of a 
reportable chemical substance in an amount of 100,000 lb (45,359 kg) or 
more at a site during the principal reporting year (i.e., 2011) must 
additionally report the information described in paragraph (b)(4) of 
this section. For submission periods subsequent to the 2012 submission 
period, the information described in paragraphs (b)(1), (b)(2), (b)(3), 
and (b)(4) of this section must be reported for each chemical substance 
manufactured (including imported) in an amount of 25,000 lb (11,340 kg) 
or more (or in an amount of 2,500 lb (1,134 kg) or more for chemical 
substances subject to the rules, orders, or actions described in Sec.  
711.8(b)) at any one site during any calendar year since the last 
principal reporting year. The requirement to report information 
described in paragraph (b)(4) of this section is subject to exemption 
as described in Sec.  711.6.
    (1) A certification statement signed and dated by an authorized 
official of the submitter company. The authorized official must certify 
that the submitted information has been completed in compliance with 
the requirements of this part and that the confidentiality claims made 
on the Form U are true and correct. The certification must be signed 
and dated by the authorized official for the submitter company, and 
provide that person's name, official title, and e-mail address.
    (2) Company and plant site information. The following currently 
correct company and plant site information must be reported for each 
site at which a reportable chemical substance is manufactured 
(including imported) above the applicable production volume threshold, 
as described in this section (see Sec.  711.3 for the ``site'' for 
importers):
    (i) The U.S. parent company name, address, and Dun and Bradstreet 
D-U-N-S[supreg] (D&B) number. A submitter under this part must obtain a 
D&B number for the U.S. parent company if none exists.
    (ii) The name of a person who will serve as technical contact for 
the submitter company, and who will be able to answer questions about 
the information submitted by the company to EPA, the contact person's 
full mailing address, telephone number, and e-mail address.
    (iii) The name and full street address of each site. A submitter 
under this part must include the appropriate D&B number for each plant 
site reported, and the county or parish (or other jurisdictional 
indicator) in which the plant site is located. A submitter under this 
part must obtain a D&B number for the site reported if none exists.
    (3) Chemical-specific information. The following chemical-specific 
information must be reported for each reportable chemical substance 
manufactured (including imported) above the applicable production 
volume threshold, as described in paragraph (b) of this section:
    (i) The specific, currently correct CA Index name as used to list 
the chemical substance on the TSCA Inventory and the correct 
corresponding CASRN for each reportable chemical substance at each 
site. A submitter under this part may use an EPA-designated TSCA 
Accession Number for a chemical substance in lieu of a CASRN when a 
CASRN is not known to or reasonably ascertainable by the submitter. 
Submitters who wish to report chemical substances listed on the 
confidential portion of the TSCA Inventory will need to report the 
chemical substance using a TSCA Accession Number.
    In addition to reporting the number itself, submitters must specify 
the type of number they are reporting by selecting from among the codes 
in Table 3 of this paragraph.

[[Page 50873]]

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

     (A) If an importer submitting a report cannot provide the 
information specified in Sec.  711.15(b)(3)(i) because it is unknown to 
the importer and claimed as confidential by the supplier of the 
chemical substance or mixture, the importer must use e-CDRweb to ask 
the supplier to provide the correct chemical identity information 
directly to EPA in a joint submission. Such request must include 
instructions for submitting chemical identity information 
electronically, using e-CDRweb and CDX (see Sec.  711.35), and for 
clearly referencing the importer's submission. Contact information for 
the supplier, a trade name or other designation for the chemical 
substance or mixture, and a copy of the request to the supplier must be 
included with the importer's submission respecting the chemical 
substance.
    (B) If a manufacturer submitting a report cannot provide the 
information specified in Sec.  711.15(b)(3)(i) because the reportable 
chemical substance is manufactured using a reactant having a specific 
chemical identity that is unknown to the manufacturer and claimed as 
confidential by its supplier, the manufacturer must use e-CDRweb to ask 
the supplier of the confidential reactant to provide the correct 
chemical identity of the confidential reactant directly to EPA in a 
joint submission. Such request must include instructions for submitting 
chemical identity information electronically using e-CDRweb and CDX 
(see Sec.  711.35), and for clearly referencing the manufacturer's 
submission. Contact information for the supplier, a trade name or other 
designation for the chemical substance, and a copy of the request to 
the supplier must be included with the importer's submission respecting 
the chemical substance.
    (C) EPA will only accept joint submissions that are submitted 
electronically using e-CDRweb and CDX (see Sec.  711.35) and that 
clearly reference the primary submission to which they refer.
    (ii) For the principal reporting year only, a statement indicating, 
for each reportable chemical substance at each site, whether the 
chemical substance is manufactured in the United States, imported into 
the United States, or both manufactured in the United States and 
imported into the United States.
    (iii) For the principal reporting year, the total annual volume (in 
pounds) of each reportable chemical substance domestically manufactured 
or imported at each site. The total annual domestically manufactured 
volume (not including imported volume) and the total annual imported 
volume must be separately reported. These amounts must be reported to 
two significant figures of accuracy. In addition, for the 2012 
submission period only, the total annual volume (domestically 
manufactured plus imported volumes in pounds) of each reportable 
chemical substance at each site during calendar year 2010. In addition, 
for submission periods subsequent to the 2012 submission period, the 
total annual volume (domestically manufactured plus imported volumes in 
pounds) of each reportable chemical substance at each site for each 
complete calendar year since the last principal reporting year.
    (iv) For the principal reporting year only, the volume used on site 
and the volume directly exported of each reportable chemical substance 
domestically manufactured or imported at each site. These amounts must 
be reported to two significant figures of accuracy.
    (v) For the principal reporting year only, a designation 
indicating, for each imported reportable chemical substance at each 
site, whether the imported chemical substance is physically present at 
the reporting site.
    (vi) For the principal reporting year only, a designation 
indicating, for each reportable chemical substance at each site, 
whether the chemical substance is being recycled, remanufactured, 
reprocessed, reused, or otherwise used for a commercial purpose instead 
of being disposed of as a waste or included in a waste stream.
    (vii) For the principal reporting year only, the total number of 
workers reasonably likely to be exposed to each reportable chemical 
substance at each site. For each reportable chemical substance at each 
site, the submitter must select from among the ranges of workers listed 
in Table 4 of this paragraph and report the corresponding code (i.e., 
W1 through W8):

 Table 4--Codes for Reporting Number of Workers Reasonably Likely To Be
                                 Exposed
------------------------------------------------------------------------
               Code                                 Range
------------------------------------------------------------------------
W1................................  Fewer than 10 workers.
W2................................  At least 10 but fewer than 25
                                     workers.
W3................................  At least 25 but fewer than 50
                                     workers.
W4................................  At least 50 but fewer than 100
                                     workers.
W5................................  At least 100 but fewer than 500
                                     workers.
W6................................  At least 500 but fewer than 1,000
                                     workers.
W7................................  At least 1,000 but fewer than 10,000
                                     workers.
W8................................  At least 10,000 workers.
------------------------------------------------------------------------

     (viii) For the principal reporting year only, the maximum 
concentration, measured by percentage of weight, of each reportable 
chemical substance at the time it is sent off-site from each site. If 
the chemical substance is site-limited, you must report the maximum 
concentration, measured by percentage of weight of the reportable 
chemical substance at the time it is reacted on-site to produce a 
different chemical substance. This information must be reported 
regardless of the physical form(s) in which the chemical substance is 
sent off-site/reacted on-site. For each chemical substance at each 
site, select the maximum concentration of the chemical substance from 
among the ranges listed in Table 5 of this paragraph and report the 
corresponding code (i.e., M1 through M5):

Table 5--Codes for Reporting Maximum Concentration of Chemical Substance
------------------------------------------------------------------------
               Code                    Concentration range (% weight)
------------------------------------------------------------------------
M1................................  Less than 1% by weight.
M2................................  At least 1 but less than 30% by
                                     weight.
M3................................  At least 30 but less than 60% by
                                     weight.
M4................................  At least 60 but less than 90% by
                                     weight.
M5................................  At least 90% by weight.
------------------------------------------------------------------------

     (ix) For the principal reporting year only, the physical form(s) 
of the reportable chemical substance as it is sent off-site from each 
site. If the chemical substance is site-limited, you must report the 
physical form(s) of the reportable chemical substance at the time it is 
reacted on-site to produce a different chemical substance. For each 
chemical substance at each site, the submitter must report as many 
physical forms as applicable from among the physical forms listed in 
this unit:

[[Page 50874]]

    (A) Dry powder.
    (B) Pellets or large crystals.
    (C) Water- or solvent-wet solid.
    (D) Other solid.
    (E) Gas or vapor.
    (F) Liquid.
    (x) For the principal reporting year only, submitters must report 
the percentage, rounded off to the closest 10%, of total production 
volume of the reportable chemical substance, reported in response to 
paragraph (b)(3)(iii) of this section, that is associated with each 
physical form reported under paragraph (b)(3)(ix) of this section.
    (4) Chemical-specific information related to processing and use. 
The following chemical-specific information must be reported for each 
reportable chemical substance manufactured (including imported) above 
the applicable production volume threshold, as described in this 
section. Persons subject to paragraph (b)(4) of this section must 
report the information described in paragraphs (b)(4)(i) and (b)(4)(ii) 
of this section for each reportable chemical substance at sites under 
their control and at sites that receive a reportable chemical substance 
from the submitter directly or indirectly (including through a broker/
distributor, from a customer of the submitter, etc.). Information 
reported in response to this paragraph must be reported for the 
principal reporting year only and only to the extent that it is known 
to or reasonably ascertainable by the submitter. Information required 
to be reported under this paragraph is limited to domestic (i.e., 
within the customs territory of the United States) processing and use 
activities. If information responsive to a given data requirement under 
this paragraph, including information in the form of an estimate, is 
not known or reasonably ascertainable, the submitter is not required to 
respond to the requirement.
    (i) Industrial processing and use information--(A) A designation 
indicating the type of industrial processing or use operation(s) at 
each site that receives a reportable chemical substance from the 
submitter site directly or indirectly (whether the recipient site(s) 
are controlled by the submitter site or not). For each chemical 
substance, report the letters which correspond to the appropriate 
processing or use operation(s) listed in Table 6 of this paragraph. A 
particular designation may need to be reported more than once, to the 
extent that a submitter reports more than one sector (under paragraph 
(b)(4)(i)(B) of this section) that applies to a given designation under 
this paragraph.

    Table 6--Codes for Reporting Type of Industrial Processing or Use
                                Operation
------------------------------------------------------------------------
           Designation                           Operation
------------------------------------------------------------------------
PC..............................  Processing as a reactant.
PF..............................  Processing--incorporation into
                                   formulation, mixture, or reaction
                                   product.
PA..............................  Processing--incorporation into
                                   article.
PK..............................  Processing--repackaging.
U...............................  Use--non-incorporative activities.
------------------------------------------------------------------------

     (B) A code indicating the sector(s) that best describe the 
industrial activities associated with each industrial processing or use 
operation reported under paragraph (b)(4)(i)(A) of this section. For 
each chemical substance, report the code that corresponds to the 
appropriate sector(s) listed in Table 7 of this paragraph. A particular 
sector code may need to be reported more than once, to the extent that 
a submitter reports more than one industrial function code (under 
paragraph (b)(4)(i)(C) of this section) that applies to a given sector 
code under this paragraph.

             Table 7--Codes for Reporting Industrial Sectors
------------------------------------------------------------------------
                 Code                          Sector description
------------------------------------------------------------------------
IS1...................................  Agriculture, forestry, fishing,
                                         and hunting.
IS2...................................  Oil and gas drilling,
                                         extraction, and support
                                         activities.
IS3...................................  Mining (except oil and gas) and
                                         support activities.
IS4...................................  Utilities.
IS5...................................  Construction.
IS6...................................  Food, beverage, and tobacco
                                         product manufacturing.
IS7...................................  Textiles, apparel, and leather
                                         manufacturing.
IS8...................................  Wood product manufacturing.
IS9...................................  Paper manufacturing.
IS10..................................  Printing and related support
                                         activities.
IS11..................................  Petroleum refineries.
IS12..................................  Asphalt paving, roofing, and
                                         coating materials
                                         manufacturing.
IS13..................................  Petroleum lubricating oil and
                                         grease manufacturing.
IS14..................................  All other petroleum and coal
                                         products manufacturing.
IS15..................................  Petrochemical manufacturing.
IS16..................................  Industrial gas manufacturing.
IS17..................................  Synthetic dye and pigment
                                         manufacturing.
IS18..................................  Carbon black manufacturing.
IS19..................................  All other basic inorganic
                                         chemical manufacturing.
IS20..................................  Cyclic crude and intermediate
                                         manufacturing.
IS21..................................  All other basic organic chemical
                                         manufacturing.
IS22..................................  Plastics material and resin
                                         manufacturing.
IS23..................................  Synthetic rubber manufacturing.
IS24..................................  Organic fiber manufacturing.
IS25..................................  Pesticide, fertilizer, and other
                                         agricultural chemical
                                         manufacturing.
IS26..................................  Pharmaceutical and medicine
                                         manufacturing.
IS27..................................  Paint and coating manufacturing.
IS28..................................  Adhesive manufacturing.
IS29..................................  Soap, cleaning compound, and
                                         toilet preparation
                                         manufacturing.
IS30..................................  Printing ink manufacturing.
IS31..................................  Explosives manufacturing.
IS32..................................  Custom compounding of purchased
                                         resins.
IS33..................................  Photographic film, paper, plate,
                                         and chemical manufacturing.
IS34..................................  All other chemical product and
                                         preparation manufacturing.

[[Page 50875]]

 
IS35..................................  Plastics product manufacturing.
IS36..................................  Rubber product manufacturing.
IS37..................................  Non-metallic mineral product
                                         manufacturing (includes cement,
                                         clay, concrete, glass, gypsum,
                                         lime, and other non-metallic
                                         mineral product manufacturing).
IS38..................................  Primary metal manufacturing.
IS39..................................  Fabricated metal product
                                         manufacturing.
IS40..................................  Machinery manufacturing.
IS41..................................  Computer and electronic product
                                         manufacturing.
IS42..................................  Electrical equipment, appliance,
                                         and component manufacturing.
IS43..................................  Transportation equipment
                                         manufacturing.
IS44..................................  Furniture and related product
                                         manufacturing.
IS45..................................  Miscellaneous manufacturing.
IS46..................................  Wholesale and retail trade.
IS47..................................  Services.
IS48..................................  Other (requires additional
                                         information).
------------------------------------------------------------------------

     (C) For each sector reported under paragraph (b)(4)(i)(B) of this 
section, code(s) from Table 8 of this paragraph must be selected to 
designate the industrial function category(ies) that best represents 
the specific manner in which the chemical substance is used. A 
particular industrial function category may need to be reported more 
than once, to the extent that a submitter reports more than one 
industrial processing or use operation/sector combination (under 
paragraphs (b)(4)(i)(A) and (b)(4)(i)(B) of this section) that applies 
to a given industrial function category under this paragraph. If more 
than 10 unique combinations of industrial processing or use operations/
sector/industrial function categories apply to a chemical substance, 
submitters need only report the 10 unique combinations for the chemical 
substance that cumulatively represent the largest percentage of the 
submitter's production volume for that chemical substance, measured by 
weight. If none of the listed industrial function categories accurately 
describes a use of a chemical substance, the category ``Other'' may be 
used, and must include a description of the use.

       Table 8--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).
------------------------------------------------------------------------

[[Page 50876]]

     (D) The estimated percentage, rounded off to the closest 10%, of 
total production volume of the reportable chemical substance associated 
with each combination of industrial processing or use operation, 
sector, and industrial function category. Where a particular 
combination of industrial processing or use operation, sector, and 
industrial function category accounts for less than 5% of the 
submitter's site's total production volume of a reportable chemical 
substance, the percentage must not be rounded off to 0% if the 
production volume attributable to that industrial processing or use 
operation, sector, and industrial function category combination is 
25,000 lb (11,340 kg) or more during the reporting year. Instead, in 
such a case, submitters must report the percentage, rounded off to the 
closest 1%, of the submitter's site's total production volume of the 
reportable chemical substance associated with the particular 
combination of industrial processing or use operation, sector, and 
industrial function category.
    (E) For each combination of industrial processing or use operation, 
sector, and industrial function category, the submitter must estimate 
the number of sites at which each reportable chemical substance is 
processed or used. For each combination associated with each chemical 
substance, the submitter must select from among the ranges of sites 
listed in Table 9 of this paragraph and report the corresponding code 
(i.e., S1 through S7):

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

    (F) For each combination of industrial processing or use operation, 
sector, and industrial function category, the submitter must estimate 
the number of workers reasonably likely to be exposed to each 
reportable chemical substance. For each combination associated with 
each chemical substance, the submitter must select from among the 
worker ranges listed in paragraph (b)(3)(ii) of this section and report 
the corresponding code (i.e., W1 though W8).
    (ii) Consumer and commercial use information--(A) Using the codes 
listed in Table 10 of this paragraph, submitters must designate the 
consumer and commercial product category or categories that best 
describe the consumer and commercial products in which each reportable 
chemical substance is used (whether the recipient site(s) are 
controlled by the submitter site or not). If more than 10 codes apply 
to a chemical substance, submitters need only report the 10 codes for 
the chemical substance that cumulatively represent the largest 
percentage of the submitter's production volume for that chemical, 
measured by weight. If none of the listed consumer and commercial 
product categories accurately describes the consumer and commercial 
products in which each reportable chemical substance is used, the 
category ``Other'' may be used, and must include a description of the 
use.

Table 10--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.

[[Page 50877]]

 
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) An indication, within each consumer and commercial product 
category reported under paragraph (b)(4)(ii)(A) of this section, 
whether the use is a consumer or a commercial use.
    (C) Submitters must determine, within each consumer and commercial 
product category reported under paragraph (b)(4)(ii)(A) of this 
section, whether any amount of each reportable chemical substance 
manufactured (including imported) by the submitter is present in (for 
example, a plasticizer chemical substance used to make pacifiers) or on 
(for example, as a component in the paint on a toy) any consumer 
products intended for use by children age 14 or younger, regardless of 
the concentration of the chemical substance remaining in or on the 
product. Submitters must select from the following options: The 
chemical substance is used in or on any consumer products intended for 
use by children, the chemical substance is not used in or on any 
consumer products intended for use by children, or information as to 
whether the chemical substance is used in or on any consumer products 
intended for use by children is not known to or reasonably 
ascertainable by the submitter.
    (D) The estimated percentage, rounded off to the closest 10%, of 
the submitter's site's total production volume of the reportable 
chemical substance associated with each consumer and commercial product 
category. Where a particular consumer and commercial product category 
accounts for less than 5% of the total production volume of a 
reportable chemical substance, the percentage must not be rounded off 
to 0% if the production volume attributable to that commercial and 
consumer product category is 25,000 lb (11,340 kg) or more during the 
reporting year. Instead, in such a case, submitters must report the 
percentage, rounded off to the closest 1%, of the submitter's site's 
total production volume of the reportable chemical substance associated 
with the particular consumer and commercial product category.
    (E) Where the reportable chemical substance is used in consumer or 
commercial products, the estimated typical maximum concentration, 
measured by weight, of the chemical substance in each consumer and 
commercial product category reported under paragraph (b)(4)(ii)(A) of 
this section. For each chemical substance in each commercial and 
consumer product category reported under paragraph (b)(4)(ii)(A) of 
this section, submitters must select from among the ranges of 
concentrations listed in Table 5 in paragraph (b)(3)(viii) of this 
section and report the corresponding code (i.e., M1 through M5).
    (F) Where the reportable chemical substance is used in a commercial 
product, the submitter must estimate the number of commercial workers 
reasonably likely to be exposed to each reportable chemical substance. 
For each combination associated with each substance, the submitter must 
select from among the worker ranges listed in Table 4 in paragraph 
(b)(3)(vii) of this section and report the corresponding code (i.e., W1 
though W8).

Sec.  711.20  When to report.

    All information reported to EPA in response to the requirements of 
this part must be submitted during an applicable submission period. For 
the 2012 IUR, the submission period is from February 1, 2012 to June 
30, 2012. Subsequent recurring submission periods are from June 1 to 
September 30 at 4-year intervals, beginning in 2016. In each submission 
period, any person described in Sec.  711.8 must report as described in 
this part.

Sec.  711.22  Duplicative reporting.

    (a) With regard to TSCA section 8(a) rules. Any person subject to 
the requirements of this part who previously has complied with 
reporting requirements of a rule under TSCA section 8(a) by submitting 
the information described in Sec.  711.15 for a chemical substance 
described in Sec.  711.5 to EPA, and has done so within 1 year of the 
start of a submission period described in Sec.  711.20, is not required 
to report again on the manufacture of that chemical substance at that 
site during that submission period.
    (b) With regard to importers. This part requires that only one 
report be submitted on each import transaction involving a chemical 
substance described in Sec.  711.5. When two or more persons are 
involved in a particular import transaction and each person meets the 
Agency's definition of ``importer'' as set forth in 40 CFR 704.3, they 
may determine among themselves who should submit the required report; 
if no report is submitted as required under this part, EPA will hold 
each such person liable for failure to report.
    (c) Toll manufacturers and persons contracting with a toll 
manufacturer. This part requires that only one report per site be 
submitted on each chemical substance described in Sec.  711.5. When a 
company contracts with a toll

[[Page 50878]]

manufacturer to manufacture a chemical substance, and each party meets 
the Agency's definition of ``manufacturer'' as set forth in Sec.  
711.3, they may determine among themselves who should submit the 
required report for that site. However, both the contracting company 
and the toll manufacturer are liable if no report is made.

Sec.  711.25  Recordkeeping requirements.

    Each person who is subject to the reporting requirements of this 
part must retain records that document any information reported to EPA. 
Records relevant to reporting during a submission period must be 
retained for a period of 5 years beginning on the last day of the 
submission period. Submitters are encouraged to retain their records 
longer than 5 years to ensure that past records are available as a 
reference when new submissions are being generated.

Sec.  711.30  Confidentiality claims.

    (a) Confidentiality claims. Any person submitting information under 
this part may assert a business confidentiality claim for the 
information at the time it is submitted. Any such confidentiality 
claims must be made at the time the information is submitted. 
Confidentiality claims cannot be made when a response is left blank or 
designated as not known or reasonably ascertainable. These claims will 
apply only to the information submitted with the claim. New 
confidentiality claims, if appropriate, must be asserted with regard to 
information submitted during a different submission period. Guidance 
for asserting confidentiality claims is provided in the instructions 
identified in Sec.  711.35. Information claimed as confidential in 
accordance with this section will be treated and disclosed in 
accordance with the procedures in 40 CFR part 2.
    (b) Chemical identity. A person may assert a claim of 
confidentiality for the chemical identity of a specific chemical 
substance only if the identity of that chemical substance is treated as 
confidential in the Master Inventory File as of the time the report is 
submitted for that chemical substance under this part. The following 
steps must be taken to assert a claim of confidentiality for the 
identity of a reportable chemical substance:
    (1) The submitter must submit with the report detailed written 
answers to the following questions signed and dated by an authorized 
official.
    (i) What harmful effects to your competitive position, if any, or 
to your supplier's competitive position, do you think would result from 
the identity of the chemical substance being disclosed in connection 
with reporting under this part? How could a competitor use such 
information? Would the effects of disclosure be substantial? What is 
the causal relationship between the disclosure and the harmful effects?
    (ii) How long should confidential treatment be given? Until a 
specific date, the occurrence of a specific event, or permanently? Why?
    (iii) Has the chemical substance been patented? If so, have you 
granted licenses to others with respect to the patent as it applies to 
the chemical substance? If the chemical substance has been patented and 
therefore disclosed through the patent, why should it be treated as 
confidential?
    (iv) Has the identity of the chemical substance been kept 
confidential to the extent that your competitors do not know it is 
being manufactured or imported for a commercial purpose by anyone?
    (v) Is the fact that the chemical substance is being manufactured 
(including imported) for a commercial purpose available to the public, 
for example in technical journals, libraries, or State, local, or 
Federal agency public files?
    (vi) What measures have been taken to prevent undesired disclosure 
of the fact that the chemical substance is being manufactured 
(including imported) for a commercial purpose?
    (vii) To what extent has the fact that this chemical substance is 
manufactured (including imported) for commercial purposes been revealed 
to others? What precautions have been taken regarding these 
disclosures? Have there been public disclosures or disclosures to 
competitors?
    (viii) Does this particular chemical substance leave the site of 
manufacture (including import) in any form, e.g., as product, effluent, 
emission? If so, what measures have been taken to guard against the 
discovery of its identity?
    (ix) If the chemical substance leaves the site in a product that is 
available to the public or your competitors, can the chemical substance 
be identified by analysis of the product?
    (x) For what purpose do you manufacture (including import) the 
chemical substance?
    (xi) Has EPA, another Federal agency, or any Federal court made any 
pertinent confidentiality determinations regarding this chemical 
substance? If so, please attach copies of such determinations.
    (2) If any of the information contained in the answers to the 
questions listed in paragraph (b)(1) of this section is asserted to 
contain confidential business information (CBI), the submitter must 
clearly identify the information that is claimed confidential by 
marking the specific information on each page with a label such as 
``confidential business information,'' ``proprietary,'' or ``trade 
secret.''
    (c) Site identity. A submitter may assert a claim of 
confidentiality for a site only if the linkage of the site with a 
reportable chemical substance is confidential and not publicly 
available. The following steps must be taken to assert a claim of 
confidentiality for a site identity:
    (1) The submitter must submit with the report detailed written 
answers to the following questions signed and dated by an authorized 
official:
    (i) Has site information been linked with a chemical identity in 
any other Federal, State, or local reporting scheme? For example, is 
the chemical identity linked to a facility in a filing under the 
Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, 
namely through a Material Safety Data Sheet (MSDS)? If so, identify all 
such schemes. Was the linkage claimed as confidential in any of these 
instances?
    (ii) What harmful effect, if any, to your competitive position do 
you think would result from the identity of the site and the chemical 
substance being disclosed in connection with reporting under this part? 
How could a competitor use such information? Would the effects of 
disclosure be substantial? What is the causal relationship between the 
disclosure and the harmful effects?
    (2) If any of the information contained in the answers to the 
questions listed in paragraph (c)(1) of this section is asserted to 
contain CBI, the submitter must clearly identify the information that 
is claimed confidential by marking the specific information on each 
page with a label such as ``confidential business information,'' 
``proprietary,'' or ``trade secret.''
    (d) Processing and use information. A submitter may assert a claim 
of confidentiality for each data element required by Sec.  711.15(b)(4) 
only if the linkage of the information with a reportable chemical 
substance is confidential and not publicly available. The following 
steps must be taken to assert a claim of confidentiality for each data 
element, individually, required by Sec.  711.15(b)(4):
    (1) The submitter must submit with the report detailed written 
answers to the following questions signed and dated by an authorized 
official:
    (i) Is the identified use of this chemical substance publicly 
known? For example, is information on the use available in 
advertisements or other

[[Page 50879]]

marketing materials, professional journals or other similar materials, 
or in non-confidential mandatory or voluntary government filings or 
publications? Has your company ever provided use information on the 
chemical substance that was not claimed as confidential?
    (ii) What harmful effect, if any, to your competitive position or 
to your customer's competitive position do you think would result from 
the information reported as required by Sec.  711.15(b)(4) and the 
chemical substance being disclosed in connection with reporting under 
this part? How could a competitor use such information? Would the 
effects of disclosure be substantial? What is the causal relationship 
between the disclosure and the substantial harmful effects?
    (2) If any of the information contained in the answers to the 
questions listed in paragraph (d)(1) of this section is asserted to 
contain CBI, the submitter must clearly identify the information that 
is claimed confidential by marking the specific information on each 
page with a label such as ``confidential business information,'' 
``proprietary,'' or ``trade secret.''
    (e) No claim of confidentiality. If no claim of confidentiality is 
indicated on Form U submitted to EPA under this part; if Form U lacks 
the certification required by Sec.  711.15(b)(1); if confidentiality 
claim substantiation required under paragraphs (b), (c), and (d) of 
this section is not submitted with Form U; or if the identity of a 
chemical substance listed on the non-confidential portion of the Master 
Inventory File is claimed as confidential, EPA may make the information 
available to the public without further notice to the submitter.

Sec.  711.35  Electronic filing.

    (a) You must use e-CDRweb to complete and submit Form U (EPA Form 
7740-8). Submissions may only be made as set forth in this section.
    (b) Submissions must be sent electronically to EPA via CDX.
    (c) Access e-CDRweb and instructions, as follows:
    (1) By Web site. Go to the EPA Inventory Update Reporting Internet 
homepage at http://www.epa.gov/iur and follow the appropriate links.
    (2) By phone or e-mail. Contact the EPA TSCA Hotline at (202) 554-
1404 or TSCA-Hotline@epa.gov for a CD-ROM containing the instructions.

[FR Doc. 2011-19922 Filed 8-15-11; 8:45 am]
BILLING CODE 6560-50-P
```