TSCA Inventory Update Reporting Modifications, 49656-49707 [2010-19830]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 156 (Friday, August 13, 2010)]
[Proposed Rules]
[Pages 49656-49707]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19830]



[[Page 49655]]

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

Part IV





Environmental Protection Agency





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



40 CFR Parts 704, 710, and 711



TSCA Inventory Update Reporting Modifications; Proposed Rule

Federal Register / Vol. 75, No. 156 / Friday, August 13, 2010 / 
Proposed Rules

[[Page 49656]]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 704, 710, and 711

[EPA-HQ-OPPT-2009-0187; FRL-8833-5]
RIN 2070-AJ43


TSCA Inventory Update Reporting Modifications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Toxic Substances Control Act (TSCA) Inventory Update 
Reporting (IUR) rule enables EPA to collect and then make public 
critical information on the manufacturing, processing, and use of 
commercial chemicals, including current information on volumes of 
chemical production, manufacturing facility data, and how the chemicals 
are used. This information helps the Agency determine whether chemicals 
may be dangerous to people or the environment. EPA proposes to amend 
the TSCA IUR rule, thereby providing improved information for EPA to 
better identify and, where appropriate, take steps to manage risks 
associated with chemical substances and mixtures (referred to hereafter 
as chemical substances). Additionally, improved information would be 
available for the public. The IUR rule, promulgated under TSCA section 
8(a), requires manufacturers (including importers) of certain chemical 
substances on the TSCA Chemical Substance Inventory (TSCA Inventory) to 
report information about the manufacturing (including import), 
processing, and use of those chemical substances. EPA is proposing to 
require electronic reporting of IUR information and to modify IUR 
reporting requirements, including certain circumstances that trigger 
reporting, the specific data to be reported, the reporting standard for 
processing and use information, and Confidential Business Information 
(CBI) reporting procedures. These modifications would 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.

DATES: Comments must be received on or before October 12, 2010.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2009-0187, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2009-0187. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2009-0187. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be CBI or 
other information whose disclosure is restricted by statute. Do not 
submit information that you consider to be CBI or otherwise protected 
through regulations.gov or e-mail. The regulations.gov website is an 
``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the docket and made available on the Internet. If you submit 
an electronic comment, EPA recommends that you include your name and 
other contact information in the body of your comment and with any disk 
or CD-ROM you submit. If EPA cannot read your comment due to technical 
difficulties and cannot contact you for clarification, EPA may not be 
able to consider your comment. Electronic files should avoid the use of 
special characters, any form of encryption, and be free of any defects 
or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at https://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at https://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Susan Sharkey, Chemical Control Division, (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8789; e-mail address: sharkey.susan @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. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture 
(including manufacture as a byproduct) or import chemical substances 
listed on the TSCA Inventory. Potentially affected entities may 
include, but are not limited to:
      Chemical manufacturers and importers (NAICS codes 325 and 
324110; e.g., chemical manufacturing and processing and petroleum 
refineries).
      Chemical users and processors who 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

[[Page 49657]]

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.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit CBI to EPA through regulations.gov 
or e-mail. Clearly mark the part or all of the information that you 
claim to be CBI. For CBI information in a disk or CD-ROM that you mail 
to EPA, mark the outside of the disk or CD-ROM as CBI and then identify 
electronically within the disk or CD-ROM the specific information that 
is claimed as CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    In this action, EPA is proposing several amendments to the current 
IUR rule requirements, including moving the IUR rule text from 40 CFR 
part 710, subpart C, to a new part, 40 CFR part 711. Where applicable, 
the current regulatory text reference is followed by a parenthetical 
containing the proposed new reference. These amendments are described 
in more detail in Unit III.
     1. EPA is proposing to amend 40 CFR 710.59 (proposed 40 CFR 
711.35) to require electronic reporting of the IUR data, using an 
Agency-provided, web-based reporting software (e-IURweb) to submit IUR 
reports through the Internet to EPA's Central Data Exchange (CDX). 
After the final rule's effective date, paper submissions would no 
longer be accepted.
    2. EPA is proposing to enhance the reported manufacturing data and 
the processing and use data.
    3. EPA is proposing a new definition section in proposed 40 CFR 
711.3, revisions to the definition for manufacture and site, and other 
needed definitional modifications and additions.
    4. EPA is proposing to amend 40 CFR 710.53 (proposed 40 CFR 711.20) 
to change the reporting frequency from every 5 years to every 4 years.
    5. EPA is proposing to amend 40 CFR 710.48(a) (proposed 40 CFR 
711.8(a)) to modify the method used to determine whether a manufacturer 
or importer is subject to IUR reporting. Reporting would be 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., 2005).
    6. EPA is proposing to amend 40 CFR 710.52(c) (proposed 40 CFR 
711.15(c)) to eliminate the 300,000 lb. threshold for processing and 
use information, thereby requiring all reporters of non-excluded 
chemical substances to report information in all parts of the IUR 
reporting form (Form U).
    7. EPA is proposing to amend 40 CFR 710.48(a) (proposed 40 CFR 
711.8(a)) to eliminate the 25,000 lb. threshold for certain chemical 
substances that are the subject of particular TSCA rules and/or orders 
and to require manufacturers (including importers) of such chemical 
substances to report under the IUR rule, regardless of the production 
volume.
    8. EPA is proposing to amend 40 CFR 710.46 (proposed 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 IUR requirements for 
water, and to remove polymers that are already fully exempt from the 
partially exempt list of chemical substances at 40 CFR 710.46(b)(2)(iv) 
(proposed 40 CFR 711.6(b)(2)(iv)).
    9. EPA is proposing to amend 40 CFR 710.52(c) (proposed 40 CFR 
711.15(c)) to modify the reporting requirements of certain 
manufacturing data elements. Specifically, manufacturers (including 
importers) would be required to report:
    i. The name and address belonging to the parent company.
    ii. The current Chemical Abstracts (CA) Index Name, as used to list 
the chemical substance on the TSCA Inventory, as part of the chemical 
identity.
    iii. The production volume for each of the years since the last 
principal reporting year.
    iv. The production volume of a manufactured (including imported) 
chemical substance used at the reporting site.
    v. Whether an imported chemical substance is physically present at 
the reporting site.
    vi. The production volume directly exported and not domestically 
processed or used.
    vii. When a manufactured chemical substance, such as a byproduct, 
is being recycled, remanufactured, reprocessed, reused, or reworked.
    10. EPA is proposing to replace the ``readily obtainable'' 
reporting standard used for the reporting of processing and use 
information required by 40 CFR 710.52(c)(4) (proposed 40 CFR 
711.15(b)(4)) with the ``known to or reasonably ascertainable by'' 
reporting standard.
    11. EPA is proposing to amend 40 CFR 710.58 (proposed 40 CFR 
711.30) to require upfront substantiation when processing and use 
information required by 40 CFR 710.52(c)(4) (proposed 40 CFR 
711.15(b)(4)) is claimed as CBI.
    12. EPA is proposing to disallow confidentiality claims for 
processing and use data elements identified as not ``known to or 
reasonably ascertainable by'' (40 CFR 710.52(c)(4) (proposed 40 CFR 
711.15(b)(4))).
    13. EPA is proposing to revise the list of industrial function 
categories for the reporting of processing and use information. EPA is 
also proposing to amend 40 CFR 710.52(c)(4)(i)(C) (proposed 40 CFR 
711.15(b)(4)(i)(B)) to replace the 5-digit NAICS codes with 48 
Industrial Sectors (IS).
    14. EPA is proposing to amend 40 CFR 710.52(c)(4)(ii) (proposed 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 proposing to require the separate reporting 
for consumer or commercial categories and reporting of the number of 
commercial workers reasonably likely

[[Page 49658]]

to be exposed to the subject chemical substance.
    15. EPA is proposing to eliminate the gaps in the ranges used to 
report concentration in 40 CFR 710.52(c)(3) and(c)(4) (proposed 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. 1) 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. 2) 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 
Amendments) (Ref. 3) 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) 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 
(proposed 40 CFR part 711) is found at 40 CFR 704.3. Processors are not 
currently subject to the rules at 40 CFR part 710 (proposed 40 CFR part 
711).

C. What is the Current TSCA Inventory Update Reporting (IUR) Rule?

    The IUR rule, as modified by the 2003 Amendments, requires U.S. 
manufacturers (including importers) of chemical substances listed on 
the TSCA Inventory to report to EPA every 5 years 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 (see 40 CFR part 710, subpart C). IUR data 
were collected five times prior to the 2003 Amendments: 1986, 1990, 
1994, 1998, and 2002, and one time after the 2003 Amendments, in 2006. 
EPA uses the TSCA Inventory and data reported under the IUR rule to 
support many TSCA-related activities and to provide overall support for 
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 are 
required to report information such as company name, site location and 
other identifying information, production volume of the reportable 
chemical substance, and exposure-related information associated with 
the manufacture of each reportable chemical substance. This exposure-
related information includes the physical form and maximum 
concentration of the chemical substance and the number of potentially 
exposed workers (40 CFR 710.52). Several groups of chemical substances 
are generally excluded from IUR reporting requirements: e.g., polymers, 
microorganisms, naturally occurring chemical substances, and certain 
natural gas substances (40 CFR 710.46).
    Manufacturers (including importers) of chemicals in larger volumes 
(i.e., 300,000 lb. or greater manufactured (including imported) during 
the reporting year at any single site) are required also to report 
certain processing and use information (40 CFR 710.52(c)(4)). 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 chemicals were required to report the 
manufacturing information and not the processing and use information, 
regardless of production volume. A partial exemption means that a 
submitter is exempt from the processing and use reporting requirements 
described in 40 CFR 710.52(c)(4). Under the current rule, for future 
collections (i.e., for 2011 or 2016 IUR collections, etc.), the partial 
exemption for inorganic chemicals will no longer be applicable and 
submitters will report in the same manner as is required for organic 
chemicals, including processing and use information (40 CFR 
710.46(b)(3)). In addition, starting with the 2006 collection and for 
future collections, specifically listed petroleum process streams and 
other specifically listed chemical substances are partially exempt, and 
manufacturers of such chemical substances are not required to report 
processing and use information. These partial exemptions will continue 
in subsequent submission periods (including 2011), for as long as the 
chemical substances remain on these partial exemption lists (40 CFR 
710.46(b)(1) and (b)(2) (proposed 40 CFR 711.6(b)(1) and (b)(2)).
    Non-confidential data, including both searchable and separately 
downloadable databases and a 2006 IUR data summary report are available 
for public use on the IUR website (https://www.epa.gov/iur).

D. Why is the Agency Proposing Changes in the IUR Rule?

    EPA is proposing to modify 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 
comprehensive information is to be reported and adjusting the specific 
reported information, the method and

[[Page 49659]]

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 Amendments provided 
many improvements to the data collected through that rule, and EPA's 
efforts to use the 2006 IUR data have identified areas where further 
improvements are needed. The modifications described in this proposed 
rule would 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.
      Focus reporting on information that is most needed by the 
Agency.
 In addition, these proposed changes will enable EPA and other Federal 
agencies to improve their risk screening capabilities, enabling them to 
better assess and manage risk, and improving 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 incorporation of the data into the database, resulting in 
the Agency's inability to begin using the 2006 IUR data and providing 
public access. The proposed modifications associated with reporting 
methods and changes to the reporting software will better ensure the 
information reported to the Agency is accurate and in compliance with 
the IUR requirements.
    During the development of the 2003 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 amended IUR rule supplies 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 representative of how EPA envisioned the data 
would be used when the 2003 Amendments were promulgated. In 2007, the 
Agency began to develop and post screening-level hazard, exposure, and 
risk characterizations for high production volume (HPV) chemicals, 
which are those chemicals 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 website. Correct designation of reported information as non-
confidential will facilitate 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 risks, and increasing public access to information about 
chemical substances (Ref. 4). The IUR provides exposure-related data 
needed to understand chemical risks. The proposed modifications to the 
IUR rule would 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 
would 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.

III. Modifications Affecting All Manufacturers (Including Importers)

    As discussed in detail in Unit III.C., under this proposed rule, 
sites that manufactured (including imported) a reportable chemical 
substance in quantities of 25,000 lb. or more in any calendar year 
since the last IUR principal reporting year (e.g., 2005) would be 
required to complete all manufacturing (including production volume), 
processing, and use information for the principal reporting year (e.g., 
2010), plus production volume information for all the preceding years 
since the last IUR principal reporting year (e.g., 2006 through 2009, 
for the principal reporting year 2010). Draft detailed instructions for 
completing the IUR submission are available in the docket established 
for this rulemaking (Ref. 5).
    Persons making an IUR submission would be required to use e-IURweb, 
the Agency-provided web-based software designed to complete Form U (the 
IUR reporting form) and submit the information electronically over the 
Internet, through EPA's CDX. The 2011 e-IURweb will be similar in 
format to the 2006 e-IUR downloadable software,

[[Page 49660]]

and will include changes associated with the proposed amendments that 
are finalized, improved validation checks, and other improvements. A 
more detailed description of e-IURweb and the electronic submission 
process is provided in Unit III.B.
    The following discussion describes the proposed changes to the IUR 
rule contained in this proposed rule.

A. Technical Modifications to the Regulatory Text

    Currently, 40 CFR part 710 contains three subparts. Subpart A 
contains regulatory text associated with the original compilation of 
the TSCA Inventory; subpart B contains regulatory text associated with 
the IUR rule covering the update reporting in 2002; and subpart C 
contains the regulatory text associated with the IUR rule for 2006 and 
beyond. The chemical substances that are covered by the IUR 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 IUR 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 IUR rule, the 
Agency believes the regulatory text associated with the IUR rule should 
be in its own section in the CFR, distinct from both the original TSCA 
Inventory rules and from the TSCA section 5 requirements. Where EPA is 
proposing to update the location of existing regulatory provisions, or 
to otherwise update regulatory provisions in a non-substantive fashion 
(e.g., to update cross-references to reflect the movement of referenced 
provisions) EPA does not thereby reopen the substance of such 
provisions for public comment, except where public comment is expressly 
requested.
    1. Moving the IUR regulatory text from 40 CFR part 710, subpart C, 
to 40 CFR part 711 and eliminating subpart divisions. Subpart C of 40 
CFR part 710, 40 CFR 710.43 to 710.59, contains the IUR regulatory 
text. EPA is proposing to move all of the subpart C text from 40 CFR 
part 710 to a new 40 CFR part 711 and would add a new scope and 
compliance section (40 CFR 711.1). Specific sections would be moved as 
follows: 40 CFR 710.43 would become 40 CFR 711.3; 40 CFR 710.45 would 
become 40 CFR 711.5; 40 CFR 710.46 would become 40 CFR 711.6; 40 CFR 
710.48 would become 40 CFR 711.8; 40 CFR 710.49 would become 40 CFR 
711.9; 40 CFR 710.50 would become 40 CFR 711.10; 40 CFR 710.52 would 
become 40 CFR 711.15; 40 CFR 710.53 would become 40 CFR 711.20; 40 CFR 
710.55 would become 40 CFR 711.22; 40 CFR 710.57 would become 40 CFR 
711.25; 40 CFR 710.58 would become 40 CFR 711.30; and 40 CFR 710.59 
would become 40 CFR 711.35. Because all of the text of subpart C would 
be moved to 40 CFR part 711, 40 CFR part 710 would no longer have a 
subpart C. Neither 40 CFR part 710 or 40 CFR part 711 would have any 
subparts.
    2. Consolidation of definitions. As part of moving the regulatory 
text from 40 CFR part 710, subpart C, to 40 CFR part 711, EPA is 
proposing to consolidate definitions copied from 40 CFR 710.3 and those 
currently found at 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 would therefore be unnecessarily duplicative. The definitions in 
TSCA section 3 and at 40 CFR 704.3 would be incorporated into 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 IUR rule, EPA is proposing to incorporate the 
definition of mixture from TSCA section 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. 
While hydrates are not addressed specifically in the definition, a 
hydrate is a mixture of water and an anhydrous chemical substance. As 
with mixtures in general, the individual components of the mixture may 
be separately reportable at the time of their manufacture or import. 
EPA believes, for purposes of the IUR rule, it is not necessary to 
include hydrates separately in the definition of mixture. The Agency 
would continue to include such a discussion in the instructions (Ref. 
5).
    Unit III.C. contains further discussions about changes to specific 
definitions, in relation to the modifications included in this proposed 
rule. A summary of all IUR-related definitions is available in the 
docket (Ref. 6).
    3. Delete 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 Amendments. Subsequently, as part of 
the IUR Revisions Rule published in the Federal Register issue of 
December 19, 2005 (Ref. 7), EPA erroneously moved the definition to 40 
CFR 710.3 from 40 CFR 710.43. EPA is proposing to delete 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, would be 
incorporated into the IUR definitions at proposed 40 CFR 711.3.
    4. Deleting subpart B text. EPA is proposing to delete the 
regulatory text contained in 40 CFR part 710, 40 CFR 710.23 to 710.39 
(subpart B). 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 subpart B once the 2002 update was complete.
    5. Deleting superfluous text associated with reporting production 
volumes. EPA is proposing to delete the phrase ``provided that the 
reported figures are within 10% of the actual volume'' from 
the production volume reporting requirements currently found in 40 CFR 
710.52(c)(3)(iv) (proposed 40 CFR 711.15(b)(3)(iv)). The revised 
wording would be ``This amount must be reported to two significant 
figures of accuracy.'' The deleted phrase is superfluous because any 
number reported accurately to two significant figures is within 10% of 
the correct value.
    6. Correcting text associated with reporting number of sites and 
number of workers. EPA is proposing to replace the phrase ``less than'' 
with the phrase ``fewer than'' in the ranges used to report the number 
of workers currently found in the table in 40 CFR 710.52(c)(3)(v) 
(proposed 40 CFR 711.15(b)(3)(vii)) and the number of sites currently 
found in the table in 40 CFR 710.52(c)(4)(i)(E) (proposed 40 CFR 
711.15(b)(4)(i)(E)). This proposed change would make the phrases 
describing the ranges grammatically correct.

B. Method of Submission

    The upcoming IUR submission period, during which submitters will be 
required to report the IUR information to EPA, will be June 1 to 
September 30, 2011. The Agency will make e-IURweb and associated 
guidance materials available to submitters prior to the start of the 
submission period. Draft instructions are included in the docket for 
this proposed rule.
    EPA is proposing to require the mandatory use of Agency-provided, 
web-based reporting software (e-IURweb) to complete Form U and CDX to 
submit the completed Form U to the

[[Page 49661]]

Agency. Users of CDX are required to register and to submit an 
authorized signature agreement.
    EPA accepted 2006 IUR submissions in several ways. Submissions 
could be completed and delivered electronically via the Internet and 
CDX, or submissions could be completed on paper or electronic media 
(i.e., as a file on a CD-ROM) and delivered by mail or a delivery 
service. Approximately one-third of the submissions were made 
electronically, and EPA was able to immediately process and quickly 
begin to use the information from those electronic submissions. 
Submissions sent as a file on a CD-ROM were printed and, along with 
paper submissions, scanned into an electronic system.
    Due mostly to the time and resources needed to review and correct 
submitter- and scanning-related errors associated with non-electronic 
submissions, EPA required over 2 years to validate and process the data 
from the 2006 IUR. The Agency had to take extra steps in order to 
correct the data during that period, such as accessing the original 
submission instead of the information in the IUR database. In addition, 
EPA released the public database in December 2008 without information 
on approximately 5% of the reported chemical substances due to the high 
error rate experienced with the 2006 IUR data collection and receipt. A 
large number of errors were created through the scanning process and 
required correction by hand, which was very labor intensive. The 
introduced errors included incorrectly scanned chemical identities and 
indications of whether a data element was claimed CBI. An incorrectly 
recorded CBI claim could lead to the inadvertent disclosure of 
confidential information or to the non-release of non-confidential 
information.
    EPA also detected significant errors not related to scanning on a 
substantial number of reporting forms and faced difficulties resolving 
issues pertaining to submissions with incorrect chemical identification 
information. Some of the errors included submitters not specifically 
identifying a chemical substance, providing chemical names and Chemical 
Abstracts Registry Numbers (CASRN) that did not match, or providing a 
CASRN that did not exist. Often, the submitted data did not conform to 
the reporting requirements described and explained in the IUR rule and 
2006 guidance documents.
    The 2006 IUR reporting software provided by the Agency contained a 
validation program designed to identify certain errors prior to 
submission. Sometimes a submitter used the software to prepare a 
submission, but printed the reporting form prior to completing the 
validation check because it was not able to pass the validation. Such 
reports typically contained incomplete or incorrect information, and 
EPA needed to contact the submitter or take other steps to correct the 
data prior to entering it into the database.
    EPA believes the proposed requirement to use e-IURweb to report 
electronically would eliminate problems related to the scanning of 
paper documents, incorrect chemical identities, and other errors 
introduced by the submitter. These errors substantially delayed the 
availability of the IUR information to both internal EPA programs, such 
as the Existing Chemicals Program, and the public.
    1. Updated e-IURweb reporting software. EPA developed e-IUR 
reporting software for use in preparing and submitting reports 
electronically during the 2006 IUR submission period (see https://www.epa.gov/iur/tools/software.html). For the 2011 IUR submission 
period, EPA will provide a free web-based application in place of the 
2006 downloadable software. The 2011 e-IURweb software will feature 
several enhancements over the 2006 e-IUR software. These improvements 
include a sophisticated validation system, which would alert users when 
a required field on the form is either missing information or contains 
certain kinds of potentially incorrect information. Other updates are 
expected to include automated chemical identity checks, automated 
company and site identity checks, and the facilitation of joint 
submissions and amendments.
    2. Require electronic submissions over the Internet. EPA is 
proposing to require that manufacturers (including importers) submit 
their IUR reports to the Agency through CDX via the Internet. EPA would 
require that all submissions be generated using e-IURweb, as described 
in Unit III.B.1. Electronic submissions would ensure that IUR data will 
have completed a basic validation check, could be quickly incorporated 
into a database and ready for immediate Agency use, and would not be 
subject to subsequent data entry errors. Furthermore, EPA believes the 
required use of e-IURweb and CDX would reduce the reporting burden on 
industry by reducing both the cost and the time required to review, 
edit, and transmit data to the Agency. After the final rule's effective 
date, EPA would no longer accept paper submissions or electronic media 
(i.e., as a file on a CD-ROM) for any IUR submission.
    EPA is proposing that submission of IUR data through CDX become 
EPA's required submission method for several reasons. Electronic 
submission enables EPA to notify the submitter that the Agency has 
received its submission, it reduces reporting errors, and it enables 
data to be available for Agency and public use more quickly. During the 
comment period for the renewal of the Information Collection Request 
(ICR), which was published in the Federal Register issue of September 
5, 2008 (Ref. 8), EPA received positive comments regarding the use of 
CDX, the encrypted Internet submission process, and the ability to use 
a secure electronic signature method to submit IUR reports.
    EPA requests comment on whether there are circumstances in which a 
company may not have Internet access to report IUR data electronically.
    3. Electronic signature process. 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 and is not being introduced with this 
proposal. During the 2006 IUR, submitters were required to complete an 
Electronic Signature Agreement (ESA) and to submit the agreement in 
hard copy with a wet ink signature to EPA in order to complete the CDX 
registration (Ref. 9). There was confusion among some submitters 
regarding the correct identity of the individual eligible to register 
for CDX and the individual required to sign the ESA.
    EPA is making changes to the registration process in order to 
address problems identified during the 2006 IUR electronic reporting. 
For 2011 IUR reports, EPA is modifying the 2006 ESA to identify more 
clearly the individual(s) required to sign the agreement. The Agency is 
developing an ESA process similar to that of the New Chemical Program 
electronic submissions (Ref. 10). Each IUR submission must have an 
authorized official associated with the submission, who is the person 
signing the certification statement and submitting the IUR report via 
CDX. The authorized official would need to complete both an ESA and the 
CDX registration process.
    EPA is requesting comment on whether some reporting sites may need 
or desire to have more than one individual complete an ESA, so that 
other individuals could add information to the IUR submission. The 
other individual may be a paid employee of the company, an outside 
consultant for the company, or an authorized representative agent for 
the company. While this individual would not be able to sign the 
certification statement required for the IUR submission, he or

[[Page 49662]]

she would be able to provide additional information, if needed, using 
CDX. For 2006 and prior IUR submissions, submitters were not able to 
provide additional information electronically.
    EPA is considering developing a single ESA and CDX registration 
process that would be applicable to all TSCA programs. EPA believes a 
company or site may want to use the same authorized official for both 
Premanufacture Notice (PMN) submissions and IUR submissions. EPA is 
interested in obtaining comments on this approach. For example, would 
the authorized official responsible for signing both an IUR submission 
and a PMN submission be the same person?

C. Modifications to Selected Definitions

    As part of developing the definition section for 40 CFR part 711, 
EPA is proposing to modify six definitions associated with the IUR rule 
and to add four new definitions. In 40 CFR 704.3 and 40 CFR 710.3, EPA 
is also proposing to modify the definition of importer by removing the 
citation to 19 CFR 1.11. The citation, which would correctly read 19 
CFR 101.1, is not needed for this definition because it does not add 
additional information to the definition of importer.
    1. Manufacture and manufacturer. In order to improve the 
information submitted through the IUR rule, EPA is proposing to modify 
the definition of manufacture by incorporating elements from the 40 CFR 
720.3 definition for manufacturer. The proposed 40 CFR 711.3 definition 
of manufacture would allow persons contracting with a toll manufacturer 
to report the chemical physically manufactured at the toll 
manufacturer's site. Under the proposed definition of site, the site 
information would be the toll manufacturer's site (see Unit III.C.2.). 
Adopting this definition would allow the person contracting for the 
manufacture of a chemical substance to report the information on the 
industrial processing and use of a chemical substance and on the 
consumer and commercial uses of a product containing the chemical 
substance. Information on the uses of a chemical substance is often 
unavailable to a toll manufacturer who produces a chemical substance 
for another person. EPA is proposing to include a modified definition 
of manufacture in 40 CFR 711.3 instead of adopting the definition of 
manufacturer from 40 CFR 720.3 because the IUR rule does not use the 
term manufacturer. In order to avoid any confusion with the definitions 
of these terms found at 40 CFR 704.3, the Agency is also proposing to 
add a simple definition for the term manufacturer to 40 CFR 711.3. In 
addition to the proposed change to the definition of manufacture, EPA 
is proposing to add a paragraph (c) to the proposed regulation at 40 
CFR 711.22 to clarify the reporting relationship between the 
contracting company and the toll manufacturer. The contracting company 
is primarily responsible for the IUR reporting, but in the event the 
contracting company does not report, the toll manufacturer must report. 
Both the contracting company and the toll manufacturer are liable if no 
report is made. Note that the contracting company and the toll 
manufacturer should confer with each other to avoid duplicate 
reporting.
    With this proposal, the term manufacture therefore would be defined 
under the IUR rule 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.
    (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, that chemical substance is jointly 
manufactured by the producing manufacturer and the person contracting 
for such production.''
Also with this proposal, the term manufacturer would be defined under 
the IUR rule to mean ``a person who manufactures a chemical 
substance.''
    2. Site. EPA is proposing to amend the definition of site to:
    i. Clarify that the importer's site must be a U.S. address.
    ii. Accommodate manufacturing under contract.
    iii. Accommodate portable manufacturing units.
See Unit III.I. for a further discussion of this proposal as it relates 
to importers. As described in Unit III.C.1., the proposed 40 CFR 711.3 
definition of manufacture would allow persons contracting with a toll 
manufacturer to report the chemical substance physically manufactured 
at the toll manufacturer's site and the site identification information 
pertaining to the toll manufacturer's site.
    EPA identified the need to accommodate portable manufacturing units 
during the 2006 IUR submission period. Two examples of portable 
manufacturing units are tanks used to manufacture calcium hydroxide 
slurry for use in building construction and road and highway projects, 
and tanks used to mix anhydrous ammonia and water to manufacture 
ammonium hydroxide prior to application to agricultural lands. EPA is 
interested in including chemical substance manufacturing that is, for 
instance, performed by road crews or is occurring at construction sites 
at which chemical substances are mixed on site in such a manner to 
create a different chemical substance, e.g., asphalt emulsifiers. The 
site of physical manufacturing could change on a frequent basis. 
Manufacturers would report the aggregated production volume for all of 
the portable manufacturing units sent out to different locations from a 
single distribution center. The address of the distribution center 
would be reported as the site location. EPA is interested in comments 
on whether the proposed definition addressing portable manufacturing 
units would result in reporting, under the IUR rule, for situations 
similar to those presented as examples.
    With this proposal, the term site would be defined under the IUR 
rule 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.
    (a) For chemical substances manufactured under contract, i.e., by a 
toll manufacturer, the site is the location where the chemical 
substance is physically manufactured.
    (b) 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.
    (c) 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 proposing to 
add two new terms, Central Data Exchange (CDX) and e-IURweb. The Agency 
is adding these terms to provide clarity to the proposed requirement 
for electronic reporting of IUR data. The term CDX means ``EPA's 
centralized electronic

[[Page 49663]]

document receiving system, or its successors, including associated 
instructions for registering to submit electronic documents.'' The new 
definition would make the term consistent with the new PMN definition. 
The term e-IURweb means the ``electronic, web-based IUR software 
provided by EPA for the completion and submission of the IUR data.''
    4. Processing and use-related definitions. EPA is proposing to 
amend 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.F.8. for 
further information. The proposed definitions for these two terms 
differ in wording from the Canadian version to ensure the use of 
terminology defined in IUR and related regulations, and EPA believes 
the basic application of these two terms would not differ from the 
basic application of the Canadian definitions (Ref. 11). The term 
commercial use would mean ``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 would be 
eliminated. The slightly modified definition of consumer use would be 
``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 would be removed.
    EPA is proposing to add 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 would make the Agency's requirements consistent with those 
collaboratively developed with Canada (Ref. 11). Additional discussion 
of those requirements is in Unit III.F.7. With this proposal, 
industrial function would mean ``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 proposing to change the reporting cycle from every 5 
years to every 4 years and to require the reporting of production 
volumes for each calendar year since the last principal reporting year. 
EPA is proposing to modify the terms reporting year and submission 
period to reflect these changes.
    The term reporting year would be 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 current proposal, the principal 
reporting year is the latest complete calendar year preceeding the 
submission period. Additionally, EPA is proposing to remove the 
reference to ``the calendar year at 5-year intervals thereafter'' and 
to remove the reference to ``calendar year 2005.'' With these changes, 
the term principal reporting year would be defined as ``the lastest 
complete calendar year preceding the submission period.''
    The term submission period would be modified by deleting the phrase 
``generated during the reporting year.'' With this change, the 
definition of submission period would reflect that data for years in 
addition to the principal reporting year would be reported. With this 
change, the definition of submission period would mean ``the period in 
which manufacturing, processing, and use data are submitted to EPA.''

D. Modifications to Reporting Thresholds

    Reporting thresholds are used to determine when IUR reporting is 
required for a subject chemical substance at a manufacturing (including 
importing) site. Every person manufacturing (including importing) a 
non-excluded chemical substance at or above the 25,000 lb. threshold is 
required to report information in Parts I and II of Form U. Beginning 
with the 2006 IUR submission period, every person manufacturing 
(including importing) a non-excluded chemical substance at or above the 
300,000 lb. threshold was required to report information in Part III of 
Form U, unless the chemical substance was partially exempt. EPA is 
proposing three changes related to the reporting thresholds:
     Determination of whether you meet the 25,000 lb. 
threshold.
     Elimination of the 300,000 lb. threshold for reporting 
information in Part III of Form U.
     Elimination of the 25,000 lb. threshold for certain 
chemical substances.
    1. Method for determining whether a person is subject to IUR 
reporting requirements. Currently, a 1-year snap shot of manufacturing 
(including importing) is used to determine the need to report for the 
IUR rule. The method used to make the reporting determination involves 
identifying that a person manufactured (including imported) a chemical 
substance listed on the TSCA Inventory during the principal reporting 
year (e.g., 2005 for the 2006 IUR submission period); that the chemical 
substance was not otherwise exempt; and that the associated production 
volume (domestically manufactured plus imported volumes) met or 
exceeded 25,000 lb. for the principal reporting year (e.g., 2005 for 
the 2006 IUR submission period).
    EPA is proposing to modify the method used to determine whether a 
person is subject to IUR reporting. The proposed method would be to 
determine 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. The 
proposed method would be effective after the 2011 IUR submission 
period.
    For example, assume the next submission period occurs in 2015. The 
principal reporting year for the 2011 IUR submission period is calendar 
year 2010. Therefore, for the 2015 IUR submission period, it would be 
necessary to examine the annual production volumes for the years 2011 
to 2014 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 2014 
and 35,000 lb. in 2012 would be reported for the 2015 IUR. Regardless 
of the 2014 production volume, in this example scenario the 2015 IUR 
submission would contain detailed information based on manufacturing 
during the 2014 calendar year and production volume information only 
for the years 2011 through 2013, as described in Unit III.F.4.i.
    EPA is proposing this change because of the mounting evidence that 
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. Consequently, 
previous IUR reporting has resulted in a change of

[[Page 49664]]

approximately 30% in the composition of the chemical substances being 
reported from one submission 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.
    An example of the wide fluctuations in manufacturing volume is 
found in the Agency's HPV Challenge Program (described in Unit 
III.D.1.). In this program, IUR data were used to determine the HPV 
chemical substances, or the chemical substances with nationally 
aggregated production volumes of one million lb. or more. As the HPV 
Challenge Program progressed, the Agency chose not to pursue certain 
chemical substances because new IUR reporting indicated that the 
nationally aggregated production volume had dropped below one million 
lb. However, based on the latest IUR, the production volume for some of 
the chemical substances the Agency was no longer pursuing had risen 
again to exceed one million lb.
    Industry representatives have provided further evidence that 
capturing production volume for only the principal reporting year is 
resulting in the omission of information on chemical substances in 
current production. In comments submitted to the Agency in response to 
other programs, the industry representatives expressed concern that 
short reporting determination periods would drastically misrepresent 
the chemical substances that currently are in commerce. Industry 
representatives 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. Comments 
included statements such as ``A longer time frame is necessary to 
capture the sporadically produced chemicals... As such, a `snapshot' in 
time may not adequately identify the complete inventory 
requirements...'' (Ref. 12). Another commenter agreed a longer 
timeframe to report chemical substances would capture those chemical 
substances that undergo periodic manufacture based upon customer-driven 
demand or other factors (e.g., variation in availability or cost of raw 
materials, cost of substitute materials, etc.) (Ref. 13) or chemical 
substances that are used infrequently and upon request when working 
with suppliers (Ref. 14).
    In light of these comments and EPA's own experiences, the Agency 
believes that using production volume reporting for all years since the 
last principal reporting year to determine reporting obligations would 
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. EPA presents the estimated increase in industry costs 
and burden associated with this proposed amendment in Section 4.4.3 of 
the Economic Analysis (Ref. 15).
    EPA requests comments on alternatives that would provide an equally 
accurate picture of chemical production, and whether 25,000 lb. in any 
1 year is the appropriate reporting threshold. EPA also requests 
comment on whether this change should apply only to certain regulated 
chemical substances (see Unit III.D.3.).
    2. Eliminate 300,000 lb. threshold for processing and use 
information. EPA is proposing to eliminate the 300,000 lb. threshold 
for processing and use information, thereby requiring all reporters of 
non-excluded chemical substances to report information in all parts of 
Form U. EPA is proposing to eliminate this reporting threshold in order 
to collect information necessary to complete screening-level exposure 
characterizations for IUR reportable chemical substances. 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, this change will provide the public with information on a 
greater number of chemical substances. In the 2003 Amendments final 
rule (Ref. 3), EPA acknowledged the value of information for chemical 
substances manufactured in lower volumes and stated that if the Agency 
were to find it necessary in the future, it would collect information 
on chemical substances at reporting thresholds below the thresholds 
that were introduced in that action (i.e., 25,000 lb. and 300,000 lb.).
    The current 300,000 lb. threshold applies to each reportable