TSCA Inventory Update Reporting Modifications

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

:

http://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

http://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

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, will be publicly available only in hard copy. Publicly available docket materials are available electronically 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

: 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

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

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 (

http://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

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,

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

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

http://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

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

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

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 chemical substance manufactured (including imported) at each individual reporting site and was selected with the intention that exposure-related processing and use information would be collected for HPV chemical substances. When EPA promulgated the 2003 Amendments, the Agency believed a 300,000 lb. per year site-specific reporting threshold would capture sufficient exposure-related information for substantially all HPV chemical substances. However, based on the 2006 data, approximately 23% of the reports submitted for known HPV chemical substances had reported production volumes below the 300,000 lb. threshold, and consequently did not contain exposure-related processing and use information. Therefore, EPA believes that the 300,000 lb. threshold was too high to provide sufficient processing and use data for the HPV chemical substances. The Agency explored setting the threshold for reporting processing and use information to an alternate level between the basic reporting threshold of 25,000 lb. and 300,000 lb. for this action, and requests comment on alternate levels. However, the need to complete characterizations for chemical substances manufactured (including imported) in volumes of 25,000 lb. to 300,000 lb. in any year led the Agency to believe that it would be best to eliminate the upper threshold and collect full information for all reported chemical substances. EPA presents the estimated increase in industry costs and burden associated with this proposed amendment in Section 4.4.4 of the Economic Analysis (Ref. 15).

3.

Elimination of the 25,000 lb. threshold for certain regulated chemical substances

. EPA is proposing to eliminate the 25,000 lb. reporting 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. This provision will ensure the availability of current information when EPA has expressed a concern in the form of regulatory action on those chemical substances, regardless of the production volume. EPA is proposing to eliminate the 25,000 lb. threshold for those chemical substances that are:

• The subject of a rule 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.

Under this proposal, for the 2011 IUR submission cycle, a manufacturer, including importer, of such chemical substances would be required to report information on the manufacturing, processing, and use of the chemical substances if it manufactured (including imported) any quantity of these

chemical substances during the principal reporting year (i.e., 2010) and would report the production volumes for each year from 2006 to 2010 and the full manufacturing, processing, and use information for 2010. For subsequent IUR submission cycles, a manufacturer, including importer, of such chemical substances would be required to report information on the manufacturing, processing, and use of the chemical substances if it manufactured (including imported) any quantity of these chemical substances during any of the years since the last principal reporting year, including quantities under 25,000 lb. For 2015 reporting, the manufacturer would need to consider the manufacture or import during the years 2011 through 2014; would report the production volumes for each year from 2011 to 2014; and would report the full manufacturing, processing, and use information for 2014.

Chemical substances that are the subject of particular TSCA rules and/or orders are of demonstrated high interest to the Agency. EPA will use the IUR data associated with these regulated chemical substances to monitor chemical substance production and compliance with the rules.

EPA requests comment on whether these chemical substances should include those that are the subject of a rule proposed under TSCA section 5(a)(2), 5(b)(4), or 6, thereby more closely paralleling the exception language in the introductory paragraph to 40 CFR 710.46 (proposed 40 CFR 711.6) and in 40 CFR 710.49 (proposed 40 CFR 711.9).

EPA presents the estimated increase in industry costs and burden associated with this proposed amendment in Section 4.4.5 of the Economic Analysis (Ref. 15).

EPA requests comment on whether a de minimus production volume threshold should be set for these chemical substances. EPA also requests comment on how best to set such a de minimus threshold.

E. Changes to Chemical Substances Covered by IUR

1.

Water

. Naturally occurring water is excluded from reporting under the IUR rule, but manufactured water, which is not naturally occurring, is a reportable chemical substance. EPA is proposing to fully exempt all (both naturally occurring and manufactured) water (CASRN 7732-18-5) and to remove water from the petroleum streams partial exemption (40 CFR 710.46(b)(1)).

EPA received approximately 43 IUR reports for water during the 2006 submission period. Therefore, this proposed exemption would likely result in a burden reduction for IUR submitters.

2.

Remove fully exempt polymers from partially exempt list

. Polymers are a class of chemical substances for which IUR reporting is not required (40 CFR 710.46(a)(1)) (proposed 40 CFR 711.6(a)(1)). However, three polymers are 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). Improperly including chemical substances that meet the IUR definition of a polymer in the partially exempt list of chemical substances may be confusing to submitters and may lead to unnecessary reporting for these chemical substances. EPA is proposing to amend the partially exempt list of chemical substances at 40 CFR 710.46(b)(2)(iv) (proposed 40 CFR 711.6(b)(2)(iv)) to remove these three chemical substances which, as polymers, are fully exempt from reporting.

3.

Making chemical substances that are the subject of an Enforceable Consent Agreement (ECA) 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 covered by ECAs are of demonstrated high interest to EPA. The Agency has an interest in identifying the manufacturing, processing, and use of chemical substances under such agreements, and therefore is proposing to require that such chemical substances be reported for IUR purposes, regardless of whether the chemical substance otherwise meets the requirements listed in 40 CFR 710.46 (proposed 40 CFR 711.6) as an exempt or partially exempt chemical substance. This provision will ensure the availability of current information if EPA has expressed a concern in the form of an ECA on any chemical substance otherwise excluded from the IUR rule. EPA is therefore proposing to make chemical substances that are the subject of an ECA ineligible for IUR exemptions.

With this proposal, chemical substances that are the subject of an ECA would be included in the list of chemical substances that are ineligible for an IUR exemption, in the introductory paragraph of 40 CFR 710.46 (proposed 40 CFR 711.6) listing the other chemical substances that are likewise not eligible for an IUR exemption. The paragraph would state 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.”

F. Modifications to Reportable Data Elements

1.

Parent company and site identity

. Manufacturers (including importers) are required to report the company name and Dun and Bradstreet (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 a D&B number for the company. Likewise, if the plant site does not have a D&B number, the manufacturer (including importer) must obtain a D&B number 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 proposing to require that the company name provided be the ultimate domestic parent company name. EPA believes this change will reduce confusion by making this reporting requirement consistent with the Toxic Release Inventory (TRI) requirements for parent company name. The requirement that the ultimate domestic parent company name be reported does not affect the determination of small business status, which is not limited to domestic companies. Persons covered by the IUR rule should continue to base small business determinations on the ultimate parent company, regardless of whether that company is domestic or foreign.

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 proposing to include 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 IUR submission. The technical contact must be a person who can answer questions

EPA may have about the reported chemical substance and should be a person located at the manufacturing (including importing) site. Based on EPA’s experience with contacting the reported technical contact with follow-up questions concerning 2006 IUR submissions, reporters often provide the names of individuals who are not directly connected to the reporting site, and therefore, are not knowledgeable about either the chemical or the submission. EPA has also seen situations where the technical contact is a contracted employee who is able to address subsequent concerns only if he or she remains under contract. Note that EPA may raise follow-up questions about an IUR submission, possibly years after the submission date. EPA is interested in any comments or suggestions regarding how to better identify the technical contact.

EPA is considering allowing multiple technical contacts on a chemical-by-chemical basis. The e-IURweb reporting software would allow the identification of several names associated with a submission. EPA is interested in any comment or suggestions regarding this consideration.

3. Chemical identity

. Manufacturers (including importers) are required to submit the correct chemical identity for each subject chemical substance. For the 2006 IUR, the correct chemical identity included a specific chemical name and a corresponding identifying number. The identifying number could be the CASRN, the TSCA Accession Number, or the number assigned to the chemical’s PMN number.

i.

Chemical name

. EPA is proposing to require the reporting of the CA Index Name currently used to list the chemical substance on the TSCA Inventory as the chemical name reported for IUR. Currently submitters are required to report a specific chemical name, with no further elaboration in the regulatory text. The Instructions for Reporting presently state that manufacturers should use CA Index Names or, if CA Index Names are not available, manufacturers should use nomenclature that completely and accurately describes the chemical substance.

EPA has found, however, that submitters sometimes supply a name that is somewhat generic or excludes parts of the specific chemical identity that distinguishes one chemical substance from another. EPA’s experience from the 2006 IUR was that up to 5% of the reports submitted contained chemical identity problems serious enough that the Agency was unable to precisely identify the chemical substance. These problems resulted in the temporary exclusion of the information associated with the poorly or erroneously identified chemical substance from the IUR database until the Agency was able to obtain correct and specific chemical identity information from the submitter. EPA believes the requirement to use the chemical name as currently listed on the TSCA Inventory will greatly reduce the number of poorly identified chemical substances. EPA intends to include the CASRN and CA Index Names as part of e-IURweb, to the extent possible without jeopardizing confidentiality claims.

Manufacturers (including importers) will be allowed to supply 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 report the information required in this part in a joint submission. In order to clarify this requirement, EPA is proposing an amendment to 40 CFR 710.52(c)(3)(i) (proposed 40 CFR 711.15(b)(3)(i)) to state that the importer must have the supplier of the confidential chemical substance directly provide EPA with the correct chemical identity, in a joint submission with the manufacturer. Furthermore, in the event the manufacturer submitting a report cannot provide the whole chemical identity because the reportable chemical substance is manufactured using a reactant having a specific chemical identity claimed as confidential by its supplier, the manufacturer must submit a report directly to EPA containing all other information known to or reasonably ascertainable by the manufacturer about the chemical identity of the reported chemical substance and must ensure that the supplier directly provides to EPA the correct chemical identity of the confidential reactant in a joint submission. See Unit III.I. for additional information regarding joint submissions. Detailed draft instructions regarding joint submissions are included in the draft Instructions included in the docket (Ref. 5). EPA is interested in any comments regarding the procedure under consideration.

ii.

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.F.3. For most chemical substances, the chemical identifying number is the CASRN correctly corresponding to the reported CA Index Name. If the CASRN number is not available because the chemical substance is listed on the confidential portion of the TSCA Inventory and a CASRN does not already exist for that substance, the submitter could report either the associated TSCA Accession Number or PMN number.

EPA is proposing to allow submitters to report only the CASRN as a chemical identifying number or, in the case of confidential chemical substances, the TSCA Accession Number. Note that in cases where a CASRN exists for a confidential chemical, it can be reported instead of the TSCA Accession Number and claimed as confidential for purposes of the IUR submission. EPA is proposing to remove the 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. Furthermore, the Agency has to spend considerably more time and effort to access and review reported information that has been identified only by a PMN number.

Submitters who, in the past, have reported using the PMN number of a confidential substance may contact EPA, if necessary, to learn the TSCA Accession Number assigned when the Notice of Commencement (NOC) was submitted to the Agency.

4.

Production volume

. Manufacturers (including importers) are required to report production volume information for each chemical substance for which they submit an IUR report. For the 2006 IUR, production volume information consisted of the manufactured production volume; the imported production volume; an indication of whether the chemical substance was manufactured, imported, or both; and an indication of whether the chemical substance was site-limited. In instances where a single site both domestically manufactures and imports the same chemical substance, the site was to report the domestically manufactured and imported production volumes separately on one report. The combined total production volume was then used as the basis for determining the percentage of production volume in other areas of the report, such as for the physical form, the industrial process or use, or the consumer or commercial use.

EPA is proposing a number of changes to the reporting of production volume and associated information. The Agency believes these changes would improve the usefulness of the information for EPA and others, and would provide

clarity for the reporting obligations of the submitter.

i.

Report production volume for each of the years since the last principal reporting year

. EPA is proposing to require reporting of production volume for each of the 5 years since the last IUR principal reporting year. Thus, for the 2011 IUR submission period, manufacturers (including importers) of a chemical at or above the 25,000 lb. threshold would report the production volume of that chemical substance for each of the following calendar years: 2010, 2009, 2008, 2007, and 2006. This change would provide information EPA and others need as stated in Unit III.D. Collecting the production volume for multiple years would provide greater detail than the current once-every-five-years snapshot.

For the principal reporting year, e.g., 2010, the domestic manufacture and the import production volume would 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. The submitter should complete only one report for each chemical substance.

EPA uses production volume data in several important ways. The data help the Agency to establish trends in chemical substance manufacturing; to determine the effectiveness of various Agency and other programs; to estimate the magnitude of consumer, worker, and environmental exposures; and to determine the costs (and financial impacts) of potential control strategies in economic analyses. As discussed in Unit III.D.2., the collection of annual production volume data would allow EPA to identify more consistently the HPV chemical substances. Voluntary EPA programs such as Design for the Environment (DfE) and other pollution prevention programs would use the annual production volume data to identify trends and program performance. Relying on a single snapshot of annual production volume in each reporting determination period hampers EPA’s ability to identify the programs and techniques that are most effective, using measurable, readily identifiable production trend data.

Unit V. contains a series of requests for comments on additional ideas under consideration by the Agency. One of the ideas concerns the collection of more than just the production volume since the last principal reporting year. The Agency is interested in comments on this matter. Please see Unit V. for additional discussion.

ii.

Volume of chemical substance used on-site

. EPA is proposing to require 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 proposal, either domestically manufactured or imported chemical substances could be reported as used at the reporting site, whereas, under the current reporting requirements, only domestically manufactured chemical substances, consumed entirely at the site of manufacture, should be reported as site-limited.

EPA is proposing this change to simplify reporting and to collect information that better addresses the Agency’s needs. In the past, submitters sometimes incorrectly reported their production volume separately to identify the portion of their chemical substance that was consumed at the site of manufacture. For the 2006 IUR, many submitters continued this practice and erroneously filed separate reports to identify that a portion of their production volume was site-limited. Filing separate reports resulted in the need to report processing and use information separately when the combined production volume was 300,000 lb. or greater. Reporting all production volumes on one report simplifies reporting for such submitters and results in a less complicated database, thereby making the data easier to use. In addition, 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 and other data analyses.

iii.

Indicate whether imported chemical substances are physically at reporting site

. EPA is proposing to add 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. Identifying whether the chemical substance is physically at the reporting site provides more accurate information for screening-level analyses and other uses of the IUR data.

iv.

Report volume exported

. EPA is proposing to add a requirement to report the production volume directly exported and not domestically processed or used. This would allow EPA to better identify the proportion of the production volume accounted for by the use reporting, given that downstream reporting is not required for exported chemical substances.

5.

Identify whether a chemical substance is to be recycled, remanufactured, reprocessed, reused, or reworked

. EPA is proposing to add a requirement to indicate (via a check-box) whether a manufactured chemical substance, such as a byproduct, is to be recycled, remanufactured, reprocessed, reused, or reworked. Submitters would identify that 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, reused, or reworked). EPA believes that such information will help the Agency to identify where these activities are already occurring, and can be used to encourage such activities. Collecting information on whether a chemical substance is being recycled, remanufactured, reprocessed, reused, or reworked and is not entering the waste stream provides valuable information to EPA and others regarding trends in chemical substance manufacturing. This information also can be used to help determine the effectiveness of various programs, such as EPA’s Resource Conservation Challenge (RCC) Program. EPA launched the RCC Program in 2002, implementing Congress’ instruction to prevent pollution and conserve natural resources and energy by managing materials more efficiently. The RCC Program’s goals include promoting reuse and recycling and reducing chemicals of national concern in products and waste. Indicating that a manufactured chemical, such as a byproduct, is to be recycled, remanufactured, reprocessed, reused, or reworked does not affect the reporting requirements associated with any chemical substance manufactured from the byproduct. See Unit IV.B. for detailed information on byproduct reporting.

6.

Concentration ranges

. EPA is proposing to eliminate gaps in the ranges used to report concentration in 40 CFR 710.52(c)(3) and (4) (proposed 40 CFR 711.15(b)(3) and (4)). The current ranges result in gaps between 30 and 31% and 60 and 61%. The proposed ranges would be:

• 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

. In 2003, EPA added industrial processing and use data to the information collected through the IUR rule for chemical substances manufactured in quantities of 300,000 lb. or greater during the principal reporting year. The industrial processing and use information included industrial function categories and NAICS codes. EPA found that knowing these two data elements for a chemical substance was useful in selecting a scenario that characterizes the frequency, route, and duration of exposure to a chemical substance during manufacture, processing, and use of the chemical substance. These data are also useful when EPA characterizes the quantity of the chemical substance in wastes and emissions entering the environment and for anticipating the environmental media into which wastes will be released. The Agency is proposing to revise the list of industrial function categories and to replace the NAICS codes with industrial sector categories, as described in sections i. and ii.

i.

Industrial function categories

. EPA is proposing to revise 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 proposed set of categories, which would be used by both the United States and Canada for inventory reporting. Harmonization of the categories for reporting the industrial functions of chemical substances would facilitate the exchange of information between EPA and Canadian agencies and could serve as a model to be used by Mexico in developing an inventory of chemical substances. In addition, the harmonized categories would facilitate consistent reporting of chemical use information by industry in the United States and Canada (Ref. 11).

EPA is proposing to add eight new industrial function categories and to delete six existing categories from the current list; the total number of industrial function categories would increase to 35. Also, EPA is proposing to rename 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 proposing to require 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 proposing the industrial function categories listed in Table 1 of this unit:

Table 1.—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)

ii.

Industrial sectors

. EPA is proposing to replace the 5-digit NAICS codes with 48 IS codes. 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. The Agency believes this change would provide several benefits. First, the sectors would reduce reporting burden because submitters would not have to look up the NAICS code. Second, it would encourage more complete reporting by using terms that are already familiar to industry. Third, the sectors would reduce the likelihood of errors that result from the selection of miscellaneous or inappropriate NAICS codes. Fourth, it would reduce the number of codes that could apply to one chemical substance. Table 2 of this unit lists the proposed sectors. The rationale for selecting the sectors and the link between the sectors and the NAICS system is further described in “Inventory Update Reporting (IUR) Technical Support Document—Replacement of 5-digit NAICS Codes with Industrial Sector Codes” (Ref. 16).

One of the primary purposes of the IUR data collection is to group together similar data for priority setting exercises and activities. Respondents to the 2006 IUR submitted 342 unique 5-digit NAICS codes, which made it difficult for EPA to group chemical substances

based on industrial processing and use scenarios. The 2006 IUR database has 2,330 unique combinations of processing or use code, NAICS code, and industrial function category, in all. This large number of unique combinations increases the difficulty and time required by EPA to sort and classify chemical substances because EPA either would need to develop exposure scenarios for each unique combination, or determine which three-code combinations have similar exposure scenarios and can be grouped. The use of the sectors would reduce the number of unique combinations, thereby increasing the usability of the data, and also reducing the IUR reporting burden.

EPA is proposing the 48 sectors listed in Table 2 of this unit:

Table 2.—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 chosen for the IS code is “Other,” a written description of the use of the chemical substance, which may include the NAICS code, would also need to be provided.

8. Consumer and commercial use reporting. In the 2003 Amendments, EPA added a reporting requirement for submitters to include information about the consumer and commercial uses of chemical substances they reported under the IUR rule. For the 2006 IUR, manufacturers (including importers) of subject chemical substances manufactured (including imported) in quantities of 300,000 lb. or more during calendar year 2005 were required to select up to 10 consumer and commercial product categories from a list of 20 categories that correspond to the actual use of the chemical substance they are reporting. For each category, submitters also were required to indicate whether the chemical substance was used in a product intended for use by children, to report the maximum concentration of the chemical substance in the product category, and to report the percentage of total production volume associated with the product category.

EPA is using the information provided by the 2006 IUR reports in the Existing Chemicals Program. While the Agency found that the information was useful in identifying when consumers and commercial users and children are potentially exposed populations, EPA also found that the data had significant limitations concerning the product categories and identification of potentially exposed populations. The Agency believes the limitations stem from two characteristics of the data:

• The lack of specificity in the product categories.

• The inability to distinguish between consumer and commercial uses.

In addition, because 29% of the reported categories were for the category “Other,” EPA was constrained in its ability to characterize use and exposure scenarios. Also, consumer and commercial uses affect very different populations. The reported information was not useful in differentiating these populations when characterizing potential exposures.

To address these issues, EPA is proposing four changes to the consumer and commercial information required to be reported:

• A revised and expanded list of consumer and commercial product categories.

• The additional requirement to provide a description when the product category “Other” is selected.

• The identification of whether the use is a consumer or a commercial use, or both.

• The number of commercial workers reasonably likely to be exposed while using the reportable chemical substance.

Reporting associated with children’s use, the maximum concentration, and the percent production volume would remain unchanged.

i.

Consumer and commercial product categories

. EPA is proposing to revise 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 proposed categories. Harmonized categories for reporting the consumer and commercial uses of chemical substances would facilitate the exchange of information between EPA and Canadian agencies and would serve as a model to be used by Mexico in developing an inventory of chemical substances. In addition, the harmonized categories would facilitate consistent reporting of chemical substance use information by industry in the United States and Canada (Ref. 11).

During the development of the revised product category list, EPA and Canada considered existing product category schemes, such as the NAICS and Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) categories, but found them to be either too detailed or not right for the task at hand. The NAICS categories are defined for manufacturing processes, not for consumer and commercial products, and therefore did not address the situations of interest. The REACH Program collects detailed information on the use of chemical substances in consumer and commercial products sold in the EU; all of the codes used by REACH are represented in the harmonized industrial function and consumer and commercial codes.

The proposed 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 IUR submissions in 2006 and overlaps with proposed new categories, and so has been proposed for elimination. Also, several of the consumer and commercial product categories would be renamed to better describe the products that should be reported in those categories.

EPA believes that expanding the list of consumer and commercial product categories would provide persons submitting IUR information with a greater opportunity to characterize the product in which chemical substances they manufacture are used and would reduce the number of uses reported as “Other.”

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 would 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 would find the proposed groupings easier to use than the alphabetical listing used for the 2006 IUR.

EPA is also proposing to require 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. In the 2006 IUR reports, the category “Other” was reported with the greatest frequency, with 1,206 out of a total number of 4,157 reports containing consumer and commercial use information, resulting in a reporting rate of 29% for the category. Although one of EPA’s objectives in revising the consumer and commercial product categories was to reduce the reporting frequency of “Other,” EPA believes that in many cases where “Other” was reported, submitters may not have selected the correct categories for their situation. By requiring the submitters to supply a written description for “Other,” EPA would be able to evaluate and improve the inclusiveness of future consumer and commercial category lists or descriptions. In addition, the descriptor information would be more useful than simply the selection of “Other” for EPA’s Existing Chemicals and other programs.

EPA is proposing the consumer and commercial product categories listed in Table 3 of this unit:

Table 3.—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)

ii.

Designation of consumer or commercial use

. EPA is proposing to require submitters to designate, via a checkbox, whether the indicated product category is a consumer or a commercial use, or both. The Agency’s experience using the 2006 IUR data identified a need to distinguish between potentially exposed consumer and commercial populations. The designation of consumer or commercial use, or both, would allow EPA to complete a better characterization of the potentially exposed populations.

iii.

Number of commercial workers reasonably likely to be exposed

. EPA is proposing to require 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 would be reported using the same definitions and ranges used for manufacturing and industrial processing and use workers required by 40 CFR 710.52(c)(3)(v) and (4)(i)(F) (proposed 40 CFR 711.15(b)(3)(vii) and (4)(i)(F)), respectively. The ranges are:

• Fewer than 10 workers.

• At least 10 but fewer than 25 workers.

• At least 25 but fewer than 50 workers.

• At least 50 but fewer than 100 workers.

• At least 100 but fewer than 500 workers.

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

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

• At least 10,000 workers.

Information on the number of commercial workers reasonably likely to be exposed to the reportable chemical substance would be used to characterize the commercial population reasonably likely to be exposed to the subject chemical substance. The population characterization is important to the development of the overall exposure characterization.

EPA requests comment on the ability of submitters to provide this data with reasonable accuracy for each commercial use to which a chemical substance may be applied. Do submitters have sufficient information about the work practices of eventual commercial users to estimate this number? Note that the ranges proposed for commercial workers are the same as those ranges used for reporting manufacturing and industrial workers. Are these ranges also applicable to commercial workers?

G. Changes to Standard for the Reporting of Processing and Use Information

In order to collect more complete information regarding the industrial processing and industrial, commercial, and consumer use of chemicals, EPA is proposing in 40 CFR 711.15(b)(4) to replace the “readily obtainable” reporting standard used for reporting under 40 CFR 710.52(c)(4) in 2006 with the “known to or reasonably ascertainable by” reporting standard set forth under TSCA for this type of TSCA reporting. Section 8(a)(2) of TSCA authorizes EPA to require persons to report information that is “known to or reasonably ascertainable by” the submitter. This is the same standard that currently applies to the reporting of information described in the regulations at 40 CFR 710.52(c)(1), (c)(2), and (c)(3), and this standard would continue to apply to the reporting of such information under proposed 40 CFR 40 CFR 711.15(b)(1), (b)(2), and (b)(3). It 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. The “known to or reasonably ascertainable by” reporting standard was the only standard used for IUR reporting purposes prior to the 2006 IUR submission period.

The 2006 IUR response rate for the processing and use information did not capture a sufficiently large portion of the production volume that the Agency believes actually was used for either industrial processing and use or consumer and commercial use. Thirty percent of the reports submitted for the 2006 IUR met the requirements (based on type of chemical and production volume) to trigger reporting of processing and use information. Of those, almost 13% contained no industrial processing and use information and almost half contained no commercial or consumer use information. For the reports that did contain some processing and use information, the portion of the production volume for which some information was reported is detailed in Table 4 of this unit. Note that a Form U submission contains one or more reports; each report is for a single chemical at a single site.

Table 4.—Percentage of Reports Providing Production Volume Information Related to Processing and Use of Chemicals Reported for the 2006 IUR

Extent of Processing and/or Use Information Provided Based on Production Volume

Reporting

Industrial Processing and Use

(% of reports*)

Consumer and

Commercial Use (% of reports*)

No processing and use information reported

13

46

Processing and/or use information provided, but the associated % PV information reported as zero, NRO, or left blank

6

12

% PV associated with the reported processing and/or use information accounted for more than 0% but less than 50% of the manufactured (including imported) production volume

4

7

% PV associated with the reported processing and/or use information accounted for 50% but less than 100% of the manufactured (including imported) production volume

65

32

% PV associated with the reported processing and/or use information accounted for 100% or more of the manufactured (including imported) production volume

12

3

* The percentage is calculated as a fraction of the total number of reports that triggered the need to report processing and use information.

The Agency believes the percentage of missing processing and use information actually is larger than indicated by this analysis. As described in the 2003 Amendments final rule (Ref. 3), EPA anticipated that, on an individual report basis, the total percentages of production volumes associated with the industrial processing or use information may add up to more than 100% of the reported production volume. This could happen because the submitter reported on the distribution of a chemical substance to sites in its control as well as downstream sites, some of which were not immediate purchasers from the original manufacturing site. For example, consider the scenario where a certain volume of a reported chemical substance is reported as processed by a repackager, sent to another site that adds the chemical substance to a mixture, and then sent to a combination of industrial and commercial users. If the repackaged volume were 100% of the production volume, the total volume reported for the different processing and use scenarios could equal 300% of the production volume. EPA expected and anticipated this type of reporting, as each instance of processing or using the chemical substance created a different exposure scenario. As indicated in Table 4 of this unit, only 12% of the reports contained processing and use information that equaled or exceeded the production volume for their chemical substance. EPA expected this percentage to be significantly larger.

Focusing on the industrial processing and use information, a complete use scenario is comprised of 3 of the IUR data elements: The type of process or use, the NAICS codes, and the industrial function code. A report could contain up to 10 unique combinations of these 3 data elements (i.e., use scenarios). For the reports required to include processing and use information in 2006, submitters reported an average of slightly more than 2 use scenarios. For each unique combination of these 3 data elements, the manufacturer reports the percent production volume, the number of sites, and the number of reasonably likely to be exposed workers associated with the use scenario. In 2006, only about half of the reported use scenarios also included information for the number of sites, the number of workers, and a production volume that was greater than zero.

Reports for consumer and commercial use information included a product category, and, for that category, whether the chemical substance is used in products intended for children, the percent production volume, and the maximum concentration. A report could contain up to ten product categories. For the reports that were required to include processing and use information in 2006, submitters reported an average of slightly less than one product category. Much of the consumer and commercial information contained data elements reported as not readily obtainable (NRO) or were left blank. Specifically, 14% of product category information, 24% of children’s information, and 40% of the maximum concentration were either reported as NRO or left blank. Overall, fewer than half of the consumer and commercial records (i.e., the individually reported product categories and associated information) contained complete data (e.g., where none of the data elements contained information reported as zero, NRO, or were left blank).

This low reporting rate also occurred on an individual chemical substance basis; 2006 IUR submitters did not report processing and use information even though they were required to report such information. This happened for 20% of the chemical substances for which the criteria for reporting processing and use information were met. For those chemical substances, EPA has no processing or use information reported through the IUR rule.

EPA is proposing this change to the reporting standard because reporting under the “readily obtainable” reporting standard did not generate sufficiently complete processing and use information, which limited the usefulness of the 2006 IUR processing and use data for screening level reviews. EPA believes the “readily obtainable” reporting standard was a major reason for the small amount of reporting processing and use data.

For over 30 years, the Agency’s New Chemicals Program has successfully applied the “known to or reasonably ascertainable by” reporting standard. (See 40 CFR 720.45) Companies have used this standard to report to EPA information about how their chemical substances are processed and used by submitting more than 30,000 TSCA section 5 PMNs. Because of this experience, EPA believes that companies routinely have more information about how their chemical substances are processed and used than is reflected in the 2006 IUR data. PMNs routinely include extensive, detailed information on how a company’s customers and others outside the company’s control will process and use its chemical substances. EPA believes that the reporting under the Agency’s New Chemical program indicates that companies generally do know the intended ultimate uses, as well as the intervening processing steps, for their products. In addition, EPA’s experience

in the New Chemicals Program indicates that this reporting standard generates information sufficient for screening-level reviews. Therefore, the Agency believes that using this standard for reporting of IUR industrial processing and industrial, consumer, and commercial use information will improve reporting rates and assist EPA’s efforts to characterize chemical substance uses and to predict potential exposure to these chemical substances.

The Agency’s experience using the 2006 IUR data to develop exposure characterizations, coupled with the limited data EPA was able to publicly release, highlighted the incompleteness of the data and lead the Agency to determine that the data are insufficient, even for screening level purposes. Examples of documents using EPA’s exposure characterizations can be found on the Agency’s website, at

http://iaspub.epa.gov/oppthpv/existchem_hpv_prioritizations.INDEX_HTML

. Effective risk screening by EPA depends on the ability to accurately characterize chemical substance uses and to predict potential exposures. As described in Unit II.D., these data are used by EPA to prioritize work on existing chemicals. If the information provided does not include these data, EPA must make assumptions about the use of the unreported production volume. Incorrect assumptions may lead EPA to designate an inappropriately high or low priority level for the chemical substance, resulting in unnecessary effort and resource expenditures for both regulated parties and EPA in cases where more complete data would have led the Agency to act differently.

For the foregoing reasons, EPA believes that using the reporting standard “known to or reasonably ascertainable by” would result in companies reporting more consistent and complete processing and use information in their IUR reports, and that the information reported would better enable EPA to develop the exposure characterizations needed for the Agency’s screening of existing chemical substances. EPA requests comment on whether and how this change will affect submitter behavior and the degree to which the quality of submissions will be improved.

H. Amendments to Requirements Concerning CBI

Submitters may currently claim certain information reported under the IUR as CBI in accordance with 40 CFR part 2 and IUR rules at 40 CFR 710.38 (proposed 40 CFR 711.30). Submitters must assert claims of confidentiality 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. 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. 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.

EPA expects that reducing the number of CBI claims would increase the amount of information available to the public and improve the timeliness of its public availability. As a result, the Agency would be able to publicly discuss and explain its risk management actions and decisions more clearly. Currently, much of the factual and data support for Agency decisions is claimed as CBI, which complicates the creation of publicly available documents. The public would be better informed and better able to understand and provide meaningful comment on Agency actions if less information were unnecessarily or inappropriately claimed as CBI. The Agency would also be able to provide other public and private organizations and individuals with better information for making their own decisions. Thus, EPA is proposing the changes described in Unit III.H.1., H.2., and H.3. with the belief that the proposed changes would reduce the number of unjustifiable CBI claims without hindering legitimate CBI claims.

1.

Chemical identity CBI claims

. Under the IUR, a submitter may assert a claim of confidentiality for data associated with the identity of the reported chemical substance when the chemical is listed on the confidential portion of the TSCA Inventory and when the submitter provides the required substantiation at the time the submitter makes the confidentiality assertion. See 40 CFR 710.58(b) (proposed 40 CFR 711.30(b)). At times a submitter will assert a claim of confidentiality for the chemical identity of a chemical substance that is listed on the public portion of the TSCA Inventory. Where the identity of a chemical substance is already contained on the public portion of the TSCA Inventory, which is publicly available from EPA’s website (

http://www.epa.gov/opptintr/newchems/pubs/invntory.htm#files

), EPA believes that the identity itself, even assuming it might otherwise be CBI, as well as any information that might be derived from it about processes or portions, has already been disclosed. EPA is proposing that, when this occurs, the Agency may make the information available to the public without further notice to the submitter. See the proposed regulatory text at 40 CFR 711.30(e).

This action is part of a broader effort to increase transparency and provide more valuable information to the public by identifying programs where non-CBI may have been claimed and treated as CBI in the past. See the

Federal Register

issue of January 21, 2010 for a similar change concerning CBI claims of certain chemical identities submitted under TSCA section 8(e) (Ref. 17).

2.

Upfront substantiation for processing and use information CBI claims

. Under the IUR, 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. During the 2006 IUR, submitters made confidentiality claims ranging from 25% (when considering individual data elements) to 50% (when considering data elements combined into use scenarios) of the reported processing and use information. While the Agency does not question that confidentiality claims are sometimes necessary, it encourages submitters to consider carefully whether such claims are in fact necessary before asserting them. The Agency has identified instances in which submitters have claimed the processing and use data as confidential, yet similar if not identical information was found in publicly available sources, such as company websites, published Material Safety Data Sheets (MSDSs), or information submitted to the Agency and posted on the Agency’s HPVIS website (see Unit II.D. for more discussion). EPA can take

steps to challenge or verify confidentiality claims, but the Agency believes companies should limit their CBI claims to those that they are capable of adequately substantiating.

For the 2006 IUR reports, submitters were not required to provide upfront substantiation of CBI claims for processing and use data. In these proposed modifications to the IUR rule, EPA would require upfront substantiation for CBI claims for this information.

EPA believes that many of the CBI claims for processing and use data are inappropriate and that the new substantiation requirement would reduce the occurrence of unnecessary claims. The high number of confidentiality claims asserted for the reported 2006 IUR reports on industrial processing and use information impeded the release of important data. This included the number of processing sites, the number of potentially exposed industrial workers, and the percent production volume for each industrial processing or use scenario (Ref. 18). A decrease in the number of inappropriate CBI claims under the new substantiation requirement would improve EPA’s ability to make current plant site information available to other Federal agencies and the public because more information submitted under IUR could be released publicly.

Under this proposed rule, in order to submit a claim of confidentiality for processing and use information data elements, the submitter would be required to both check the appropriate box on the reporting form and substantiate the claim in writing by answering certain questions provided in 40 CFR 711.30(d) of the proposed rule. Where a submitter fails to substantiate the processing and use CBI claim in accordance with the applicable rules (i.e., the submitter does not provide an answer to the required questions), EPA would 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.

Limitation on confidentiality claims for data elements identified as “not known or reasonably ascertainable.”

Under the IUR rule, submitters provide information on the industrial processing and use and consumer and commercial use of the IUR reportable chemical substances they manufacture (including import). As described in Unit II.A., for the 2011 and future IUR collections, EPA is proposing that submitters be required to report this information to the extent that it is known to or reasonably ascertainable by them. For the 2006 IUR collection, submitters reported the processing and use information to the extent that it was readily obtainable, and were permitted to identify when such information was not readily obtainable by entering “NRO.” EPA has observed that, on occasion, processing and use information has been 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 NRO designation and its relationship to a potential CBI or trade secret claim. Given that a NRO 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. For this reason, EPA is proposing to prohibit claims of confidentiality pertaining to the designation that information is not “known to or reasonably ascertainable by” the submitter. EPA solicits comment on this issue.

I. Modifications Specifically Affecting Importers

Submitters report IUR data on chemical substances that they manufacture domestically and that they import into the United States. Current IUR regulations provide that the site responsible for reporting for imported chemical substances is the site of the operating unit that is directly responsible for importing the chemical substance and that controls the import transaction. In some cases, the import site may be the organization’s headquarters in the United States. The regulations defining the site for importer reporting is found in both the definition for site in 40 CFR 710.3 and in paragraph 40 CFR 710.48(b).

EPA is proposing to eliminate unnecessary duplication in the IUR regulation by moving the additional information regarding the importer site from 40 CFR 710.48(b) into a revised definition for site, 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 proposing to require 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 proposed 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.

For purposes of IUR, submitters are currently allowed to report the IUR information jointly with the foreign manufacturer of the chemical substance. 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 is still responsible for ensuring that the IUR information is submitted to EPA and may do so by submitting a joint report. To do so, the U.S. importer, as the primary submitter, completes the majority of the required information, but supplies a trade name or other designation to identify the chemical substance. In addition, the primary submitter provides technical contact information for the foreign supplier. The primary submitter then contacts the foreign supplier, as the secondary submitter, to notify it of the need to report the specific chemical identity information to EPA. In addition to the chemical identity, the secondary submitter supplies its technical contact and company information but provides the primary submitter’s site information.

Under this proposed rule, the process would be the same, except that submitters would be required to use CDX and e-IURweb for preparation and submission of joint submissions. See proposed 40 CFR 711.15(b)(3)(i)(A). Previously, joint submissions could not be made electronically. In order to submit electronically to EPA via CDX, individuals must first register with CDX. Therefore, the authorized officials of the jointly submitting companies would need to register in order to submit their reports to EPA.

For joint submissions to be submitted electronically, the primary submitter would use e-IURweb to identify the need to submit a joint report and would identify itself as a primary submitter. The primary submitter would then complete his or her portion of the report and provide the secondary submitter's

company information, along with select information on the chemical substance(s) that are manufactured using a chemical substance made by the secondary submitter. The primary submitter reports only the volume that it used. A secondary submitter would also need to use e-IURweb to identify the need to submit a joint report and would identify itself as a secondary submitter. It would provide the primary submitter’s company information and its own technical contact information, and would identify the chemical substance(s) that is in its product, including the percentages. This information would be saved by the reporting tool and both submissions would be matched based upon company and chemical information. Once the forms are matched, the joint submission would be ready to be processed by EPA. The Agency is currently developing the process to submit joint reports electronically and welcomes any comments concerning this process.

For the 2006 IUR submission period, EPA set aside joint submissions until both reports were received and matched. Oftentimes, EPA had no way to determine whether a submission was a “joint” submission, which increased the time required for manual processing of the data. EPA anticipates that the use of the reporting tool will help to make joint IUR reporting easier for industry and streamline EPA processing of the IUR information submitted in the 2011 submission period.

J. Change to Reporting Frequency

Prior to the 2003 Amendments, the IUR collection occurred every 4 years. EPA reduced the reporting frequency from every 4 years to every 5 years starting with the 2006 IUR to reduce the burden associated with the amended IUR rule. For the reasons described in this section, the Agency has determined that reporting every 5 years is too infrequent, and now is proposing to return to reporting every 4 years.

As described in Unit III.D.1., a review of the previous reporting under IUR has revealed an approximately 30% change in the chemicals that are reported from one submission period to the next. While the less frequent reporting does reduce burden, EPA now believes that reporting every 5 years does not provide data sufficiently current to meet Agency and public needs. As described in Unit V.4.i., the Agency has been criticized for using outdated information. For instance, in its “Across the Pont” publication, the Environmental Defense Fund (EDF) stated “Given the dynamic nature of the chemical market, both from year to year and between 2005 and the present, some of the data we report here on chemicals, their production/import volumes and their associated companies may well have changed.” (See

http://www.edf.org/document/8538_Across_Pond_Report.pdf

). EPA, therefore, also is considering increasing the frequency of reporting to every 3 years, or possibly to annual reporting. The Agency believes that efficiencies are gained with more frequent reporting, both for the submitter and for EPA. With more frequent reporting, companies would be able to establish standard systems and practices to collect the required information. For instance, for annual reporting the Agency estimates that submitters would reduce the burden for each reporting cycle by approximately 20%. (See Chapter 4 of the Economic Analysis, Ref. 15). EPA invites comment on the proposed return to 4-year reporting intervals, and also on more frequent reporting (i.e., every 3 years, biennial, or annual reporting). Further information is provided in Question 4.i. under Unit V., and the various reporting frequency alternatives are analyzed in the Economic Analysis. (See Chapter 4 and Appendix G of the Economic Analysis, Ref. 15)

IV. Clarifications to Reporting Requirements

A. Clarification of the Relationship Between Company Name and Site Identity CBI Claims

Under the IUR, submitters are able to claim as CBI both the company name and site identity associated with a chemical substance for which they are reporting under the IUR. 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 e-IURweb reporting software does not allow for blanket CBI claims for company and site identity information, since those are separate claims and in some cases one type of claim may be justified while the other is not. Rather, a submitter is permitted to assert its CBI claim for the company identity, the site identity, or both the company and site identity associated with each chemical substance for which they are submitting an IUR report. In addition, the submitter must provide separately the required upfront substantiation for the site identity CBI claims associated with each chemical substance. For instance, if the submitter is reporting for five chemical substances and wishes to claim its site information confidential for three of the five chemical substances, it must assert the claim and provide separate upfront substantiation three times, once for each of the three chemical substances. 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.

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 710.58(c) (proposed 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, EPA plans to modify the e-IURweb reporting software so that it will provide 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.

B. Explanation of Byproduct Reporting

During the 2006 submission period, EPA received questions about the requirements for reporting byproducts, including whether byproduct manufacturers (including importers) were required to report the byproducts under the IUR rule. These included some questions involving a manufacturer (including importer) that uses a chemical substance in the production of an article. Such manufacturing may produce a byproduct chemical substance that is chemically different from the starting chemical substance; the manufacturer therefore may incur reporting obligations under the IUR rule for that byproduct. The Small Business Administration (SBA) also communicated with EPA about related issues and questions, including ideas on how they could be potentially addressed (Ref. 19). Generally, the concerns included how to identify byproduct chemical substances, especially when such chemical substances were complex and variable mixtures; concerns about

the manufacturer's ability to determine the recycler's use of the byproduct; and identify the need to report, especially when the manufacturer does not consider itself a chemical substance manufacturer. In light of these and similar questions, EPA is providing additional information on byproduct reporting, including circumstances under which reporting is not required, in the draft instruction manual and in other guidance materials included in the docket for this proposed rule (Refs. 5, 20, and 21) in an effort to further clarify reporting obligations.

For purposes of IUR, 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 IUR. 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 IUR reporting if they are manufactured, are listed in the TSCA Inventory, are not otherwise excluded from reporting, and their manufacturer is not specifically exempted from IUR reporting requirements.

For purposes of IUR, a byproduct is “manufactured” only if it is “manufactured for commercial purposes.” See TSCA section 8(f). 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.”

As with all manufactured chemical substances, IUR information on byproducts is of interest to the EPA because such exposure-related information is not otherwise available, and it is necessary for the Agency to manage risks associated with these chemical substances, to fulfill its mandate of protecting human health and the environment. EPA does not believe byproducts inherently pose lower exposures or risks than other manufactured chemical substances.

Byproducts that are manufactured (including imported) in volumes of 25,000 lb. or more at a single site are potentially subject to IUR requirements. However, 40 CFR 710.50(c) (proposed 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 IUR 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 IUR reporting. This exclusion applies only to the byproduct; it does not apply to the component chemical substances extracted from the byproduct.

Some manufacturers (including importers) of byproducts have expressed a belief that a chemical substance that is regulated by another EPA program, such as 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 IUR purposes. However, when such chemical substances have a commercial purpose not exempted by 40 CFR 710.50(c) (proposed 40 CFR 711.10(c)), the manufacturer (including importer) of such a chemical substance does need to consider IUR requirements.

EPA requests comment on the draft guidance documents included in the docket for this proposed rule and on how best to inform companies that may not consider themselves to be manufacturers (including importers) of chemical substances of their potential need to report. In addition, EPA requests comment on how the substantive modifications of the IUR described in this proposed rule could be further modified to minimize reporting burden and costs for byproduct manufacturers (including importers) and recyclers, while still collecting the exposure-related information needed to fulfill EPA's mandate.

V. Request for Comment

EPA requests comment on all substantive modifications of the IUR described in this proposed rule, all available alternatives that bear on such modifications, and the Economic Analysis prepared in support of this proposed rule (Ref. 15). Following is a list of additional issues on which the Agency is specifically requesting public comment. EPA encourages all interested persons to submit comments on these issues, and to identify any other relevant issues as well. This input will assist the Agency in developing a final rule that successfully addresses information needs while minimizing potential reporting burdens associated with the rule. EPA requests that commenters making specific recommendations include supporting documentation where appropriate.

1. EPA anticipates promulgating a final rule by the spring of 2011. Recognizing that this would be shortly before the next scheduled submission period (scheduled to run from June 1, 2011 through September 30, 2011), EPA solicits comment on the transition to new IUR requirements. Specifically, EPA would conduct the 2011 reporting based on the full set of data elements specified in this proposed rule (if finalized as proposed). Further reporting cycles would then recur every 4 years (or other interval as specified in the final rule), along the same lines and with the addition of determining compliance obligations based on manufacturing and import volume from the calendar years since the previous principal reporting year (e.g., reporting in 2015 information based on years 2011, 2012, 2013, and 2014). EPA is also considering changing the existing 2011 submission period to another 4-month period later in 2011.

2. As discussed in Unit II.D., EPA is increasing its emphasis on assessing, prioritizing, and taking action on existing chemical substances that pose unreasonable risks, with particular emphasis on protecting children. EPA is interested in receiving comments regarding how to use IUR data, including how to amend the rule, to best assist in this effort. Similarly, EPA seeks comment on how to tailor more

narrowly the substantive modifications to the IUR contained in this proposal so as to avoid gathering information which EPA or the public would not be able to use.

3. Through the IUR, EPA collects information on chemical substances for which the Agency is most likely to have an interest. Accordingly, to minimize reporting burdens, EPA developed exemptions from the IUR. From time to time, EPA adjusts these reporting exemptions in order to address its chemical substance management program needs.

In response to public comments received in response to the 1985 proposed IUR rule (Ref. 22), EPA established certain exclusions from these exemptions (Ref. 23). The exclusions were to ensure the Agency receives IUR information on chemical substances that are of interest to the Agency. The introductory paragraph to 40 CFR 710.46 (proposed 40 CFR 711.6) identifies that chemical substances that are the subject of proposed or promulgated TSCA section 4, 5(a)(2), 5(b)(4), or 6 rules are excluded from the chemical substance exemptions listed in the section. The introductory paragraph to 40 CFR 710.49 (proposed 40 CFR 711.9) identifies that small manufacturers of chemical substances that are the subject of proposed or promulgated TSCA section 4, 5(b)(4), or 6 rules are excluded from the small manufacturer exemption listed in the section.

As identified in Unit II.D., EPA's Administrator has made it a priority to strengthen the Agency's chemical management program. EPA uses IUR information on proposed rule chemical substances to inform final regulations, especially with respect to accurately responding to public comments; to determine the need for actions supplementing proposed rules, such as voluntary programs; to provide up-to-date, definitive identities of companies manufacturing (including importing) chemical substances potentially subject to a final rule; and to provide up-to-date, accurate information to the public about chemical substances for which the Agency has expressed an interest. For example, five chemical substances were excluded from the final OSHA dermal test rule published in the

Federal Register

issue of April 6, 2004 (Ref. 24) because IUR data collected indicated that there was no longer substantial production.

EPA is interested in receiving comments on whether EPA should continue to include chemical substances that are the subject of proposed rules in the list of exclusions at 40 CFR 710.46 (proposed 40 CFR 711.6) and 40 CFR 710.49 (proposed 40 CFR 711.9). If the proposed rule exclusion were no longer available, should EPA consider removing some or all of the reporting exemptions? This would allow EPA to obtain information on those chemical substances for which it is considering analysis or regulation, but which would otherwise be exempt. EPA also is interested in receiving comments on whether the Agency should: Add new exclusions to reporting exemptions; entirely eliminate certain reporting exemptions under circumstances other than those described in this unit; or leave the exclusions from the reporting exemptions unchanged.

4. The proposals discussed in Unit III.D.1. would result in a site reporting data on subject chemical substances exceeding the 25,000 lb. threshold for any calendar year since the last principal reporting year. The site would report manufacturing (including production volume), processing, and use information for the principal reporting year (e.g., 2010), as well as production volume information for all the years since the last IUR principal reporting year (i.e., 2006 through 2009, for principal reporting year 2010). In developing this proposal, EPA considered several other reporting options and is seeking comment on these options, which are described in Unit V.4.i.-4.iii.

i. EPA is proposing to return the reporting frequency to 4 years and is considering further increasing the frequency to every 3 years, biennially, or annually. (See Ref. 15 for burden and cost information.) More frequent reporting provides more current data. Eliminating the 5-year wait for current information would address concerns that IUR data are outdated and therefore less useful than if it were more current. EPA is particularly interested in the annual reporting option for several reasons. Annual reporting would enable EPA to better analyze trends, including ascertaining which chemical substances are manufactured on a consistent basis, which chemical substances have wide variations from year to year, and which chemical substances are increasing or decreasing in volume. Trend analyses measure the success of programs and can be used to proactively identify developing issues and generally provide a greater insight into the chemical industry. Obtaining this information annually, instead of the proposed option of reporting 4 years of production volume at one time, would allow for closer monitoring of trends and the more timely feedback on the success of programs than would be possible under the proposed option, although if processing and use data changes little year-on-year, it could significantly raise the burden of the IUR on submitters without providing EPA or the public with information benefits. In addition, annual reporting would provide the opportunity to tie-in more closely or actually integrate IUR reporting with the already-required annual TRI reporting.

ii. EPA requests comment on whether the reporting frequency should remain 5 years and whether the proposed requirement for annual production data resolves concerns that IUR data are outdated for its intended purpose. What is the marginal value of processing and use data gathered every 4 years versus every 5 years?

iii. EPA is also interested in comments regarding changing the reporting threshold from 25,000 lb. to 10,000 lb., but is not including this change in the regulatory text accompanying this proposal. (See Ref. 15 for burden and cost information.) Prior to the 2006 IUR, the threshold for determining the need to report was 10,000 lb., therefore this change in the reporting threshold would be a return to the status quo for the IUR. The Agency is interested in collecting information on chemical substances with nationally aggregated production volumes of 25,000 lb. or higher. Because chemical substances are often manufactured (including imported) at more that one site, chemical substances with site-specific production volumes that fall below the 25,000 lb. reporting threshold and therefore would not be reported for IUR may have aggregated production volumes of 25,000 lb. or greater. Are there other thresholds (higher or lower) that might be appropriate?

5. EPA requests comment on the draft economic analysis to evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.

6. EPA requests comment on the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

7. EPA requests comment on how the substantive proposed revisions to the IUR could be further modified to enhance the quality, utility, and clarity of the information to be collected.

8. EPA requests comment on how best to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of

information technology, e.g., permitting electronic submission of responses.

9. EPA is considering collecting additional exposure-related data, similar to those collected under TSCA section 5 (New Chemicals Program), to enhance the Agency’s capabilities in conducting screening-level exposure assessments of chemical substances reported to the IUR.

EPA, through its experience in using the IUR exposure-related and use information, has learned that the current IUR data are not sufficient for determining quantitative estimates of releases of and exposures to chemical substances. As a result of the available 2006 IUR data, EPA could develop only qualitative exposure characterizations with relative ranking of low, medium, or high for characterizing potential exposures to various populations. While the usefulness of these data was limited because data were only partially reported (see Unit III.G.), it was also limited because the specific data elements, as included in the 2006 IUR, were not detailed and comprehensive enough to enable EPA to generate a more robust estimate. For instance, the function and use categories used for processing and use information were broad, and the reported production volume information was insufficient to identify the volumes of chemical substance used at the manufacturing site or domestically processed or used. The Agency believes the proposed rule text changes will improve its ability to identify and manage risks associated with existing chemical substances, but also believes that supplementary, more in-depth exposure-related information (i.e., beyond the elements in the regulatory text of this proposed rule) would substantially improve EPA’s ability to quantify chemical risks. The ability to quantify chemical risks would further improve the Agency’s ability to identify and manage those risks. EPA therefore believes that, while the changes included in the proposed regulatory text address the limitations associated with qualitative characterizations, further changes would be needed to enable the more quantitative estimates.

If additional data identified in Table 5 of this unit were to be reported, EPA could use currently available assessment tools and methodologies to develop screening-level estimates of chemical substance environmental releases and concentrations to various environmental media (including air, water, and land) and exposures to the potentially exposed populations (such as workers, consumers, children, and the general population). Examples of the tools and methodologies include the Agency's Chemical Screening Tool For Exposures & Environmental Releases (ChemSTEER) (Ref. 25) and Exposure and Fate Assessment Screening Tool (EFAST) (Ref. 26). The Agency anticipates that the improved screening-level exposure assessments would be similar to what is developed for new chemical substances submitted to the Agency for review to identify chemicals of concern and potential risk management. The PMN Program Form 7710-25 (available at:

http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm

) (Ref. 27) was used to develop the additional potential exposure-related data elements and their brief descriptions listed in Table 5 of this unit:

Table 5.—Additional Exposure-Related Data Elements Under Consideration by EPA for IUR

Manufacturing Process

Description of manufacturing process

Provide a process flow diagram which describes the manufacturing operations involving the chemical substance. “Manufacturing operation” means a functional step in which chemical substances undergo chemical changes and/or changes in location, temperature, pressure, physical state, or similar characteristics. Include steps in which the chemical chemical substance is formulated into gels, mixtures, suspensions, solutions, etc. and in which the chemical substance is transferred into interim storage or shipping containers. Indicate in your diagram the entry and exit points of the chemical substance. Number all points from which the chemical substance will be released to the environment or to control equipment, including small or intermittent releases (e.g. some cleaning releases, drum residues, etc.) and trace amounts of the chemical substance.

Continuous or batch process

Indicate whether the chemical substance is manufactured in discrete batches or is produced by continuously adding reactants and removing the reaction product.

Amount of chemical substance produced per day or per batch

If the chemical substance is produced in discrete batches, indicate the amount of the chemical substance in pounds produced in each batch; if the chemical substance is produced in a continuous process, indicate the amount of chemical substance in pounds manufactured each day.

Batch or daily run time

If the chemical substance is produced in discrete batches, indicate the batch time (hours/batch); if the chemical substance is produced in a continuous process, indicate the daily run time (hours/day).

Days of operation per year or number of batches per year

If the chemical substance is produced in discrete batches, indicate the number of batches per year necessary to produce the reported production volume; if the chemical substance is produced in a continuous process, indicate the number of days of operation per year needed to produce the reported production volume.

Unit operations

List the unit operations needed to produce the chemical substance. Unit operation means a functional step in manufacturing, processing, or use operation where chemical substances underg

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