# DRAFT January 14, 2010

—Does not contain TSCA CBI—

Prepared by:

Economic and Policy Analysis Branch Economics, Exposure and Technology Division Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency 1200 Pennsylvania Avenue

Washington, D.C. 20460

_ 

# Economic Analysis for the Proposed Inventory Update Reporting (IUR) Modifications Rule

### i 

## Contributors

The EPA analyst responsible for this report is We ndy Hoffman of the Economic and Policy Analysis Branch; Economics, Exposure and Technology Division; Office of Pollution Prevention and Toxics. Analytical and draft preparation support was provided by Abt Associates, Inc. under EPA Contract No. EP-W-08-010.

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ii 

## Table of Contents

Contributors ................................................................................................................... .............................. i

Table of Contents .............................................................................................................. ..........................ii

List of Tables ................................................................................................................. ...........................viii

Executive Summary .............................................................................................................. .................... xv
1. Introduction................................................................................................................ ..........................1-1 1.1 Statutory Authority ............................................................................................................ ...........1-1 1.2 Regulatory History............................................................................................................. ...........1-1 2. Current IUR Requirements a nd Affected Entities ...........................................................................2-1 2.1 Overview of Current IUR Requirements ......................................................................................2-1 2.2 Overview of the Regulated Community .......................................................................................2-2 3. Changes in Reporting Requirements under the Proposed IUR Modifications Rule .....................3-1 3.1 Technical Modifications to the Regulatory Text ..........................................................................3-1 3.1.1 Move the IUR Regulatory Text from 710 Subpart C to 711 and Eliminate Subpart Divisions ...................................................................................................................... ....3-1 3.1.2 Consolidation of Definitions............................................................................................3-1 3.1.3 Delete “Non-isolated Intermedia te” Definition from §710.3...........................................3-2 3.1.4 Delete Subpart B Text......................................................................................................3-2 3.2 Modifications to Selected Definitions.......................................................................................... .3-2 3.2.1 Manufacture and Manufacturer........................................................................................3-2 3.2.2 Site ........................................................................................................................... ........3-3 3.2.3 Electronic-Reporting Rela ted Definitions........................................................................3-3 3.2.4 Processing and Use-Related Definitions..........................................................................3-3 3.2.5 Principal Reporting Year a nd Submission Period............................................................3-4 3.3 Modifications to Reporting Thresholds ........................................................................................3- 4 3.3.1 Method for Determining Whether a Manuf acturer is Subject to IUR Reporting Requirements ................................................................................................................... 3-4 3.3.2 Eliminate 300,000 lb. Threshold for Processing and Use Information............................3-5 3.3.3 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals ............................3-5 3.4 Changes to Substances Subj ect to the IUR Rule...........................................................................3-5 3.4.1 Make Chemicals Subject to Enforceable C onsent Agreements (ECAs) Ineligible for Exemptions ..................................................................................................................... .3-5 3.4.2 Full Exemption for Manufactured Water.........................................................................3-6 3.4.3 Remove Fully Exempt Polymers from the Partially Exempt List....................................3-6 3.5 Modifications to Reportable Data Elements .................................................................................3-6 3.5.1 Parent Company and Site Identity ...................................................................................3-6 3.5.2 Technical Contact ............................................................................................................3- 6 3.5.3 Chemical Identity.............................................................................................................3 -7 3.5.4 Report Production Volume for Each of the Years since the Last Principal Reporting Year

............................................................................................................................... ..........3-7 3.5.5 Volume of Chemical Substance Used On-Site ................................................................3-7 3.5.6 Indicate Whether Imported Chemicals Are Physically at Reporting Site........................3-8 3.5.7 Report Production Volume Exported...............................................................................3-8 3.5.8 Identify Whether a Chemical Is To Be R ecycled, Remanufactured, Reprocessed, Reused, or Reworked.................................................................................................................... .3-8 3.6 Concentration Ranges ........................................................................................................... ........3-8

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

iii 3.7 Industrial Processing and Use Information Reporting..................................................................3-8 3.7.1 Revise Industrial Func tion Categories .............................................................................3-8 3.7.2 Revise Industrial Sectors .................................................................................................3-9 3.8 Consumer and Commercia l Use Reporting ..................................................................................3-9 3.8.1 Revise Consumer and Commerc ial Product Categories ..................................................3-9 3.8.2 Designation of Consumer or Commercial Use ................................................................3-9 3.8.3 Number of Commercial Workers Reasonably Likely To Be Exposed............................3-9 3.9 Changes to Standard for the Reporting of Processing and Use Information ..............................3-10 3.10 Modifications to Confidential Busi ness Information (CBI) Claims ...........................................3-10 3.10.1 Chemical Identity CBI Claims.......................................................................................3-10 3.10.2 Upfront Substantiation for Processing and Use Information CBI Claims .....................3-11 3.10.3 Limitation on Confidentiality Claims for Da ta Elements Identified as “Not Known or Reasonably Ascertainable” ............................................................................................3-11 3.11 Method of Submission ........................................................................................................... .....3-11 3.11.1 Updated e-IUR Reporting Software...............................................................................3-12 3.11.2 Require Electronic Submissions over the Internet.........................................................3-12 3.11.3 Electronic Signature Process..........................................................................................3-12 3.12 Modifications Specifically Affecting Importers .........................................................................3-13 3.13 Modify Reporting Frequency..................................................................................................... .3-14 4. Industry Burden and Cost Estimates.......................................................................................... .......4-1 4.1 Methodology for Compliance Cost and Burden Analysis ............................................................4-1 4.2 Industry Unit Burden and Cost Estimates.....................................................................................4-2 4.2.1 Estimates of Wage Rates .................................................................................................4-2 4.2.2 Estimates of Baseline Labor Hours (Burden) ..................................................................4-3 4.2.3 Estimates of Submission (Mailing) Costs........................................................................4-6 4.2.4 Estimates of Baseline Cost per Report.............................................................................4-7 4.2.5 Estimates of the Number of Sites and Reports ..............................................................4-10 4.2.6 Estimates of Future Reporting Cy cles’ Labor Hours (Burden) .....................................4-10 4.3 Total Baseline IUR Industry Comp liance Burden and Costs......................................................4-16 4.4 Changes in Industry Burden and Costs Due to the Proposed IUR Modifications Rule..............4-17 4.4.1 Technical Modifications to the Regulatory Text ...........................................................4-17 4.4.2 Modifications to Selected Definitions ...........................................................................4-17 4.4.3 Method for Determining Whether a Manuf acturer is Subject to IUR Reporting Requirements .................................................................................................................4- 17 4.4.4 Eliminate the 300,000 lb. Threshold for Processing and Use Reporting.......................4-19 4.4.5 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals ..........................4-21 4.4.6 Make Chemicals Subject to Enforceable C onsent Agreements (ECAs) Ineligible for Exemptions ....................................................................................................................4 -22 4.4.7 Full Exemption for Manufactured Water.......................................................................4-24 4.4.8 Remove Fully-Exempt Polymers from the Partially-Exempt List.................................4-25 4.4.9 Parent Company and Site Identity .................................................................................4-26 4.4.10 Technical Contact ..........................................................................................................4-26 4.4.11 Chemical Identity...........................................................................................................4-2 6 4.4.12 Report Production Volume for Each of the Years since Last Principal Reporting Year ...4- 26 4.4.13 Volume of Chemical Substance Used On-Site ..............................................................4-27 4.4.14 Indicate Whether Chemical Is Ph ysically at Reporting Site ..........................................4-29 4.4.15 Report Production Volume Exported.............................................................................4-30

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iv 4.4.16 Identify Whether a Chemical Is To Be R ecycled, Remanufactured, Reprocessed, Reused, or Reworked...................................................................................................................4 -31 4.4.17 Concentration Ranges ....................................................................................................4-32 4.4.18 Revise Industrial Func tion Categories ...........................................................................4-32 4.4.19 Revise Industrial Sectors ...............................................................................................4-34 4.4.20 Revise Consumer and Commerc ial Product Categories ................................................4-34 4.4.21 Designation of Consumer or Commercial Use ..............................................................4-36 4.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed..........................4-36 4.4.23 Changes to the Standard for the Reportin g of Processing and Use Information............4-37 4.4.24 Chemical Identity CBI Claims.......................................................................................4-37 4.4.25 Upfront Substantiation for Processing and Use Information CBI Claims .....................4-37 4.4.26 Limitation on the Confidentiality Claims for Data Elements Identified as “Not Known or Reasonably Ascertainable” ............................................................................................4-39 4.4.27 Require Electronic Submissions over the Internet.........................................................4-39 4.4.28 Updated e-IUR Reporting Software...............................................................................4-41 4.4.29 Electronic Signature Process..........................................................................................4-41 4.4.30 Modifications Specifically Affecting Importers ............................................................4-42 4.4.31 Modify Reporting Frequency.........................................................................................4-43 4.5 Total Industry Compliance Burden a nd Cost of all Amendments ..............................................4-45 4.5.1 Modifications that Affect the Number of Reports Submitted........................................4-45 4.5.2 Modifications That Affect the Reporting Burden..........................................................4-46 4.5.3 Amendment that Affects the Reporting Frequency .......................................................4-51 4.5.4 Average Cost and Burden per Site.................................................................................4-51 4.6 Annualized Cost Estimates ...................................................................................................... ...4-53 5. Agency Burden and Cost Estimates ............................................................................................ .......5-1 5.1 Methodology for Agency Burden and Cost ..................................................................................5-1 5.2 Data for Agency Cost Estimates ................................................................................................. ..5-1 5.2.1 Agency Wage Rates.........................................................................................................5-1 5.2.2 Extramural (Contractor) Costs.........................................................................................5-2 5.3 Current Total Agency Burden and Cost........................................................................................5-2 5.4 Changes to Agency Burden and Cost as a Result of the Proposed Modifications........................5-4 5.4.1 Technical Modifications to the Regulatory Text .............................................................5-4 5.4.2 Modifications to Selected Definitions .............................................................................5-4 5.4.3 Method for Determining Whether a Manuf acturer is Subject to IUR Reporting Requirements ................................................................................................................... 5-5 5.4.4 Eliminate the 300,000 lb. Threshold for Processing and Use Reporting.........................5-6 5.4.5 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals ............................5-6 5.4.6 Make Chemicals Subject to Enforceable C onsent Agreements (ECAs) Ineligible for Exemptions ..................................................................................................................... .5-7 5.4.7 Full Exemption for Manufactured Water.........................................................................5-8 5.4.8 Remove Fully-Exempt Polymers from the Partially-Exempt List...................................5-9 5.4.9 Parent Company and Site Identity ...................................................................................5-9 5.4.10 Technical Contact ............................................................................................................5- 9 5.4.11 Chemical Identity.............................................................................................................5 -9 5.4.12 Report Production Volume for Each of the Years since Last Principal Reporting Year .5-9 5.4.13 Volume of Chemical Substance Used On-Site ..............................................................5-10 5.4.14 Indicate Whether Chemical Is Ph ysically at Reporting Site ..........................................5-11 5.4.15 Report Production Volume Exported.............................................................................5-12

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v 5.4.16 Identify Whether Chemical Is To Be Recy cled, Remanufactured, Reprocessed, Reused, or Reworked...................................................................................................................5 -13 5.4.17 Concentration Ranges ....................................................................................................5-13 5.4.18 Revise Industrial Func tion Categories ...........................................................................5-14 5.4.19 Revise Industrial Sectors ...............................................................................................5-15 5.4.20 Revise Consumer and Commerc ial Product Categories ................................................5-15 5.4.21 Designation of Consumer or Commercial Use ..............................................................5-16 5.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed..........................5-17 5.4.23 Changes to the Standard for the Reportin g of Processing and Use Information............5-17 5.4.24 Chemical Identity CBI Claims.......................................................................................5-17 5.4.25 Upfront Substantiation for Processing and Use Information CBI Claims .....................5-18 5.4.26 Limitation on Confidentiality Claims for Da ta Elements Identified as “Not Known or Reasonably Ascertainable” ............................................................................................5-18 5.4.27 Require Electronic Submissions over the Internet.........................................................5-18 5.4.28 Updated e-IUR Reporting Software...............................................................................5-19 5.4.29 Electronic Signature Process..........................................................................................5-19 5.4.30 Modifications Specifically Affecting Importers ............................................................5-20 5.4.31 Modify Reporting Frequency.........................................................................................5-20
5.5 Total Agency Cost of All Modifications.....................................................................................5-22 5.6 Annual Burden and Discounted Total Agen cy Cost of All Modifications .................................5-27 6. Social Cost Summary......................................................................................................... ..................6-1 7. Impact of the Proposed IUR Rule Modifica tions Rule on the Benefits of the IUR........................7-1 7.1 Benefits of Informa tion-Based Policies ........................................................................................7 -1 7.2 Benefits of Individual Proposed Amendments .............................................................................7-2 7.2.1 Tailor Information Collected to More Closel y Match the Agency’s Information Needs 7-3 7.2.2 Increase EPA’s Ability to Effectively Provide Public Access to the Information...........7-6 7.2.3 Obtain New and Updated Exposure Information.............................................................7-6 7.2.4 Improve Utility of Information Reported ......................................................................7-10 7.3 Potential Users of Information Generated by the Proposed IUR Modifications Rule................7-12 7.3.1 EPA Risk-Screening and Management Programs .........................................................7-12 7.3.2 Other Federal Risk Mana gement Programs...................................................................7-14 7.3.3 State and Local Programs ..............................................................................................7-15 7.3.4 Nongovernmental Organization (NGO) Initiatives and Private-Sector Stewardship ....7-15 8. Small Entity Analysis....................................................................................................... ....................8-1 8.1 Select a Relevant Small Entity Definition ....................................................................................8- 1 8.2 Identify Number of Small Companies Reporting in 2006 ............................................................8-2 8.3 Estimate Number of Parent Companies........................................................................................8-3 8.4 Estimate Number of Small Companies.........................................................................................8-3 8.5 Estimate Cost-to-Sales Ratios for Small Companies....................................................................8-4 8.6 Summary........................................................................................................................ ...............8-5 9. Additional Analyses ......................................................................................................... ....................9-1 9.1 Executive Order 12866 .......................................................................................................... .......9-1 9.2 Unfunded Mandates Reform Act (UMRA) ..................................................................................9-1 9.3 Paperwork Reduction Act (PRA).................................................................................................. 9-1 9.4 Executive Order 13132 - Federalism ............................................................................................9 -2 9.5 Executive Order 12898 – Environmental Justice..........................................................................9-2

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vi 9.6 Executive Order 13045 – Children’s Health.................................................................................9-3 9.7 Executive Order 13175 – Consultation and Coordina tion with Indian Tribal Governments........9-3 9.8 Executive Order 13211 – Energy Supply, Distribution, or Use....................................................9-3 9.9 National Technology Transfer Advancement Act ........................................................................9-3

10. References................................................................................................................. ........................10-1 Appendix A. 2006 Form U........................................................................................................ ..............A-1 Appendix B. Proposed Revised Form U............................................................................................ .... B-1 Appendix C. – Current and Proposed Industrial Function Categories .............................................C-1 Appendix D. Current and Proposed Consumer and Commercial Product Categories....................D-1 Appendix E. – Industrial Sectors............................................................................................... ............ E-1 Appendix F. – Sensitivity Analyses............................................................................................. ........... F-1 F.1 Method for Determining Whether the Threshold Is Met ..............................................................F-1 F.2 Reporting Production Volume Used On-Site................................................................................F-3 F.3 Modifying Industrial F unction Categories....................................................................................F-5 F.4 “Other” as a Consumer and/or Commercial Product Category ....................................................F-7
F.5 Upfront CBI Substantiation ..................................................................................................... .....F-9 Appendix G. – Alternative Regulatory Options................................................................................... G-1 G.1 Require Submitters to Subm it Full Data Annually ......................................................................G-1 G.1.1 Annual Reporting Cost and Burden when th e Option is Considered by Itself ...............G-1 G.1.2 Annual Reporting Cost and Burden when the All the Proposed Amendments are Considered ..................................................................................................................... .G-4 G.1.3 Small Entity Analysis .....................................................................................................G-8 G.2 Modify Reporting Frequency to a Three-Year Cycle ..................................................................G-9 G.2.1 Three-Year Reporting Cycle Cost and Burden when the Option is Considered by Itself G9 G.2.2 Three-Year Cycle Cost and Burden when the All the Proposed Amendments are Considered ....................................................................................................................G -12 G.2.3 Small Entity Anaylsis ...................................................................................................G-16 G.3 Change the Threshold for Re porting to 10,000 lb. ....................................................................G-17 G.3.1 10,000 lb. Reporting Threshold Cost and Burden when the Option is Considered by Itself

............................................................................................................................... .......G-17 G.3.2 Change the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered ....................................................................................................................G -19 G.3.3 Small Entity Analysis ...................................................................................................G-26 Appendix H. Additional Exposure-Related Data Elements ................................................................H-1 H.1 Estimated Number of Affected Entities.......................................................................................H-6 H.2 Industry burden estimate....................................................................................................... .......H-7 H.3 Industry cost estimate ......................................................................................................... .......H-13 H.4 Agency burden estimate......................................................................................................... ....H-18
H.5 Agency cost estimate ........................................................................................................... ......H-22 H.6 Small Entity Analysis .......................................................................................................... ......H-27 Appendix I. - Estimated Burden and Cost of a Section 8(a) Rule for Exposure-Related Data Elements....................................................................................................................... ............................. I-1

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vii I.1 Estimated Number of Affected Entities.........................................................................................I -1 I.2 Industry Burden Estimate ....................................................................................................... .......I-2 I.3 Industry Cost Estimate......................................................................................................... ..........I-4 I.4 Agency Burden Estimate ......................................................................................................... ......I-6
I.5 Agency Cost Estimate........................................................................................................... .........I-7 I.6 Small Entity Analysis .......................................................................................................... ..........I-9

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viii 

## List of Tables

Table 4-1: Derivation of Loaded Wage Rates fo r the Private Manufacturing Sector (2008$) ..................4-2 Table 4-2: Baseline First-Cycle Labor Burden per Form U, in Hours.......................................................4-4 Table 4-3: Burden Percentages Attributed to Site -Limited Activity and Production Volume Questions..4-6 Table 4-4: Mailing Submission Costs (December, 2009)..........................................................................4 -6 Table 4-5: Baseline Total Cost per Form U (2008$) .............................................................................. ...4-8 Table 4-6: Baseline Number of Reports and Sites................................................................................ ...4-10 Table 4-7: Weighting Factors for Burden Estimates fo r Sites That Have Previously Submitted a Form U4- 11 Table 4-8: Baseline Future-Cycle Labor Burden per Report, in Hours ...................................................4-12 Table 4-9: Baseline Future-Cycle Total Cost per Report (2008$)...........................................................4-14 Table 4-10: Total Baseline Cost and Burden to Industry (2011 Reporting Cycle)..................................4-16 Table 4-11: Total Baseline Cost and Burden to Industry (Future Reporting Cycles)..............................4-16 Table 4-12: Change in Industry Burden as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements ...............................................................4-18 Table 4-13: Change in Industry Cost as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements ...............................................................4-19 Table 4-14: Change in Industry Burden as a Result of Eliminating the 300,000 lb. Threshold for Downstream Processing and Use Information Reporting................................................................4-20 Table 4-15: Change in Industry Cost as a Result of Eliminating the 300,000 lb. Threshold for Downstream Processing and Use Information Reporting................................................................4-20 Table 4-16: Change in Industry Burden as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals ............................................................................................................ ...........4-22 Table 4-17: Change in Industry Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals ............................................................................................................ ...........4-22 Table 4-18: Change in Industry Burden as Result of Making Chemicals Subject to ECAs Ineligible for Exemptions ..................................................................................................................... .................4-23 Table 4-19: Change in Industry Cost as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions ..................................................................................................................... .................4-24 Table 4-20: Change in Industry Burden as a Result of Exempting Manufactured Water from Reporting..4- 25 Table 4-21: Change in Industry Cost as a Result of Exempting Manufactured Water from Reporting ..4-25 Table 4-22: Change in Industry Burden as a Result of Requiring the Reporting of Production Volume in all Non-Principal Reporting Years.............................................................................................. .....4-27 Table 4-23: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume in all Non-Principal Reporting Years.................................................................................................. ......4-27 Table 4-24: Change in Industry Burden as a Result of Requiring the Reporting of Production Volume Used On-Site................................................................................................................... .................4-28 Table 4-25: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume Used On-Site................................................................................................................... .................4-29 Table 4-26: Change in Industry Burden as a Result of Indicating Whether a Chemical is Physically at Reporting Site ................................................................................................................. .................4-29 Table 4-27: Change in Industry Cost as a Result of Indicating Whether a Chemical is Physically at Reporting Site ................................................................................................................. .................4-30 Table 4-28: Change in Industry Burden as a Resu lt of Requiring Reporting of Volume Exported ........4-30 Table 4-29: Change in Industry Cost as a Result of Requiring Reporting of Volume Exported.............4-31 Table 4-30: Change in Industry Burden as a Resu lt of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reused, or Reworked.....................................................................4-31

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

ix Table 4-31: Change in Industry Cost as a Resu lt of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reused, or Reworked.....................................................................4-32 Table 4-32: Change in Industry Burden as a Result of Modifying the Industrial Function Categories...4-33 Table 4-33: Change in Industry Cost as a Result of Modifying the Industrial Function Categories .......4-33 Table 4-34: Change in Industry Burden as a Resu lt of Modifying the Consumer and Commercial Product Categories ..................................................................................................................... ...................4-35 Table 4-35: Change in Industry Cost as a Result of Modifying the Consumer and Commercial Product Categories ..................................................................................................................... ...................4-35 Table 4-36: Change in Industry Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed................................................................................................ ..4-36 Table 4-37: Change in Industry Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed................................................................................................ ..4-37 Table 4-38: Change in Industry Burden as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI .......................................................................................... 4-38 Table 4-39: Change in Industry Cost as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI .......................................................................................... 4-38 Table 4-40: Change in Industry Burden as a Result of Requiring Electronic Submission ......................4-40 Table 4-41: Change in Industry Cost as a R esult of Requiring Electronic Submission...........................4-41 Table 4-42: Change in Industry Burden as a Result of Requiring CDX Registration for Secondary Submitters ..................................................................................................................... ...................4-42 Table 4-43: Change in Industry Cost as a Result of Requiring CDX Registration for Secondary Submitters

............................................................................................................................... ..........................4-42 Table 4-44: Change in Industry Burden as a Result of Modifying the Reporting Frequency, over a 20- Year Period .................................................................................................................... ..................4-43 Table 4-45: Change in Industry Cost as a Result of Modifying the Reporting Frequency, over a 20-Year Period ......................................................................................................................... ......................4-44 Table 4-46: Change in the Number of Sites and Reports Submitted for All Amendments Combined....4-46 Table 4-47: Change in the 2011 Reporting Cycle Burden for All Amendments Combined, by Labor Category....................................................................................................................... ....................4-48 Table 4-48: Change in the Future Reporting Cycle Burden for All Amendments Combined, by Labor Category....................................................................................................................... ....................4-49 Table 4-49: Total Industry Burden for All Amendments Combined.......................................................4-50 Table 4-50: Total Industry Cost When All Amendments Are Combined................................................4-51 Table 4-51: Average Number of Full and Partial Reports per Site..........................................................4-52 Table 4-52: Average Total Burden per Site ...................................................................................... .......4-52 Table 4-53: Average Total Cost per Site ........................................................................................ .........4-53 Table 4-54: Schedule of Annual Industry Burden if All Proposed Amendments Are Implemented.......4-54 Table 4-55: Annual Increase in Industry Cost if All Amendments Are Implemented (2008$)...............4-55 Table 5-1: Derivation of Loaded Agency Wage Rates (2008$).................................................................5-2 Table 5-2: Derivation of Extramural Task Costs, per Reporting Cycle.....................................................5-2 Table 5-3: Total Agency Cost under the Current IUR Requirements........................................................5-3 Table 5-4: Baseline Agency Burden per Report ................................................................................... .....5-4 Table 5-5: Change in Agency Burden as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements .................................................................5-5 Table 5-6: Change in Agency Cost as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements .................................................................5-5 Table 5-7: Change in Agency Burden as a Result of Eliminating the 300,000 lb. Threshold for Processing and Use Reporting.............................................................................................................. ................5-6 Table 5-8: Change in Agency Cost as a Result of Eliminating the 300,000 lb. Threshold for Processing and Use Reporting.............................................................................................................. ................5-6

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

x Table 5-9: Change in Agency Burden as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals ............................................................................................................ .............5-7 Table 5-10: Change in Agency Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals ............................................................................................................ .............5-7 Table 5-11: Change in Agency Burden as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions ..................................................................................................................... ...................5-8 Table 5-12: Change in Agency Cost as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions ..................................................................................................................... ...................5-8 Table 5-13: Change in Agency Burden as a Result of a Full Exemption for Manufactured Water...........5-8 Table 5-14: Change in Agency Cost as a Result of a Full Exemption for Manufactured Water ...............5-9 Table 5-15: Change in Agency Burden as a Result of Reporting of Production Volume for Each of the Years since Last Prin cipal Reporting Year ...................................................................................... 5-10 Table 5-16: Change in Agency Cost as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year ............................................................................................ ....5-10 Table 5-17: Change in Agency Burden as a Result of Reporting of Production Volume Used On-Site.5-11 Table 5-18: Change in Agency Cost as a Result of Reporting of Production Volume Used On-Site .....5-11 Table 5-19: Change in Agency Burden as a Resu lt of Indicating Whether an Imported Chemical is Physically On-Site ............................................................................................................. ..............5-11 Table 5-20: Change in Agency Cost as a Result of Indicating Whether an Imported Chemical is Physically Pr esent On-Site..................................................................................................... ..........5-12 Table 5-21: Change in Agency Burden as a Result of Requiring the Reporting of Export Volume .......5-12 Table 5-22: Change in Agency Cost as a Result of Requiring the Reporting of Export Volume............5-12 Table 5-23: Change in Agency Burden as a Result of Indicating Whether Chemical is Recycled, Remanufacture, Reprocessed, Reused, or Reworked.......................................................................5-13 Table 5-24: Change in Agency Cost as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reused, or Reworked.....................................................................5-13 Table 5-25: Change in Agency Burden as a Result of Revising the Industrial Function Categories.......5-14 Table 5-26: Change in Agency Cost as a Result of Revising the Industrial Function Categories...........5-14 Table 5-27: Change in Agency Burden as a Resu lt of Revising the Consumer and Commercial Product Categories ..................................................................................................................... ...................5-15 Table 5-28: Change in Agency Cost as a Result of Revising the Consumer and Commercial Product Categories ..................................................................................................................... ...................5-16 Table 5-29: Change in Agency Burden as a Result of Designation of Consumer or Commercial Use...5-16 Table 5-30: Change in Agency Cost as a Result of Designation of Consumer or Commercial Use .......5-16 Table 5-31: Change in Agency Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed................................................................................................ ..5-17 Table 5-32: Change in Agency Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed................................................................................................ ..5-17 Table 5-33: Change in Agency Burden as a Result of Requiring Upfront Substantiation for CBI Claims .5- 18 Table 5-34: Change in Agency Cost as a Result of Requiring Upfront Substantiation for CBI Claims..5-18 Table 5-35: Change in Agency Burden as a Result of Requiring Electronic Submission .......................5-19 Table 5-36: Change in Agency Cost as a Result of Requiring Electronic Submission............................5-19 Table 5-37: Change in Agency Burden as a R esult of Modifying the Re porting Frequency ..................5-20 Table 5-38: Change in Agency Cost as a Result of Modifying the Reporting Frequency.......................5-22 Table 5-39: Change in Agency Burden as a Result of All the Proposed IUR Modifications..................5-23 Table 5-40: Total Agency Burden for All Amendments Combined........................................................5-24 Table 5-41: Total Agency Cost of All Amendments Combined..............................................................5-24 Table 5-42: Agency Burden per Report when All Amendments are Combined .....................................5-25 Table 5-43: Agency Cost per Report When All Amendments are Combined.........................................5-25 Table 5-44: Agency Cost per Report when All Amendments Are Combined.........................................5-26

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xi Table 5-45: Annual Data Entry Burden to the Agency of all Modifications ...........................................5-27 Table 5-46: Annual and Discounted Total Cost to the Agency of All Modifications .............................5-28 Table 6-1: Change in Total Burden to Soci ety If All Modifications Are Implemented ............................6-1 Table 6-2: Change in Total Costs to Societ y if All Modifications Are Implemented ...............................6-2 Table 8-1: Results of D un & Bradstreet Analysis................................................................................ ......8-3 Table 8-2: Estimated Number of Small Compani es under the Proposed IUR Rule Amendments............8-4 Table 8-3: Derivation of Cost-to-Sales Ratios for Small Companies under the Proposed IUR Rule Amendments ..................................................................................................................... .................8-5 Table C-1: List of Current and Propo sed Industrial Functi on Categories................................................. C-1 Table D-1: List of Current and Proposed C onsumer and Commercial Product Categories......................D-1 Table F-1: Sensitivity Analysis of Industry Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met ................................................................................................... ....... F-1 Table F-2: Sensitivity Analysis of Industry Cost Estimates for Modifying the Method for Determining Whether the Threshold Is Met ................................................................................................... ....... F-2 Table F-3: Sensitivity Analysis of Agency Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met ................................................................................................... ....... F-2 Table F-4: Sensitivity Analysis of Agency Cost Estimates for Modifying the Method for Determining Whether the Threshold Is Met ................................................................................................... ....... F-3 Table F-5: Sensitivity Analysis of Industry Burden Estimates for Reporting Pro duction Volume Used OnSite ........................................................................................................................... ......................... F-3 Table F-6: Sensitivity Analysis of Industry Cost Estimates for Reporting Production Volume Used OnSite ........................................................................................................................... ......................... F-4 Table F-7: Sensitivity Analysis of Agency Burden Estimates for Reporting Pro duction Volume Used OnSite ........................................................................................................................... ......................... F-4 Table F-8: Sensitivity Analysis of Agency Cost Estimates for Reporting Production Volume Used OnSite ........................................................................................................................... ......................... F-5 Table F-9: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category................................................................................................ ........ F-6 Table F-10: Sensitivity Analysis of Industry Cost Es timates for Requiring Write-in Text for “Other” as an Industrial Func tion Category ................................................................................................... ......... F-6 Table F-11: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category................................................................................................ ........ F-7 Table F-12: Sensitivity Analysis of Agency Cost Estim ates for Requiring Write-in Text for “Other” as an Industrial Func tion Category ................................................................................................... ......... F-7 Table F-13: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commer cial Product Category .......................................................................... F-8 Table F-14: Sensitivity Analysis of Industry Cost Es timates for Requiring Write-in Text for “Other” as a Consumer and/or Commerc ial Product Category ............................................................................. F-8 Table F-15: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commer cial Product Category .......................................................................... F-9 Table F-16: Sensitivity Analysis of Agency Cost Es timates for Requiring Write-in Text for “Other” as a Consumer and/or Commerc ial Product Category ............................................................................. F-9 Table F-17: Sensitivity Analysis of Industry Burden Estimates for Requiring Upfront CBI Substantiation

............................................................................................................................... ......................... F-10 Table F-18: Sensitivity Analysis of Industry Cost Es timates for Requiring Upfront CBI Substantiation.. F10 Table F-19: Sensitivity Analysis of Agency Burden Estimates for Requiring Upfront CBI Substantiation

............................................................................................................................... ......................... F-11 Table F-20: Sensitivity Analysis of Agency Cost Es timates for Requiring Upfront CBI SubstantiationF-11 Table G-1: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data Annually....................................................................................................................... .....................G-1

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xii Table G-2: Industry Cost under the Alternative Option to Require Submitters to Submit Full Data Annually....................................................................................................................... .....................G-2 Table G-3: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data Annually....................................................................................................................... .....................G-3 Table G-4: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually....................................................................................................................... .....................G-4 Table G-5: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered ........................................................G-5 Table G-6: Industry Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered ........................................................G-5 Table G-7: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered ........................................................G-6 Table G-8: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered ........................................................G-7 Table G-9: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of Annual Reporting...................................................................................................................... .....................G-9 Table G-10: Annual Industry Burden under the Altern ative Option of a Three-Year Reporting Cycle...G-9 Table G-11: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle..................G-10 Table G-12: Burden to the Agency under the Altern ative Option of a Three-Year Reporting Cycle ....G-11 Table G-13: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle...................G-11 Table G-14: Annual Industry Burden under the Altern ative Option of a Three-Year Reporting Cycle when the All the Proposed Amendm ents are Considered.........................................................................G-12 Table G-15: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered ....................................................................................G-13 Table G-16: Agency Burden under the Alternative Opti on of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered ....................................................................................G-14 Table G-17: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered ..........................................................................................G-1 5 Table G-18: Derivation of Cost-to-Sales Ratios fo r Small Manufacturers for a Three-Year Reporting Cycle .......................................................................................................................... .....................G-16 Table G-19: Number of Reports and Sites in 2002................................................................................ .G-17 Table G-20: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. ........G-18 Table G-21: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb..............G-18 Table G-22: Change in Burden to the Agency as a Result of Changing the Threshold for Reporting to 10,000 lb. ..................................................................................................................... ...................G-19Table G-23: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. G19 Table G-24: Change in the Number of Sites and Re ports Submitted of All Amendments Combined with the 10,000 lb. Reporting Threshold ............................................................................................. ...G-20 Table G-25: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered ..........................................................................................G-2 1 Table G-26: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered ..........................................................................................G-2 2 Table G-27: Industry Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered, .........................................G-22 Table G-28: Change in Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. and All Other Amendments when All Pr oposed Amendments are Considered .............................G-23 Table G-29: Agency Burden as a Result of Lowere d Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered...........................................................................G-24 Table G-30: Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered ....................................................................................G-24

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xiii Table G-31: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered ..........................................G-25 Table G-32: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. and All Other Amendments when All Pr oposed Amendments are Considered .............................G-25 Table G-33: Derivation of Cost-to-Sales Ratios fo r Small Manufacturers for a 10,000 lb. Reporting Threshold ...................................................................................................................... ..................G-27 Table H-1: Description of Additional Data Elements............................................................................. ..H-1 Table H-2: Change in Industry Burden to Manufactur ers as a Result of Additional Exposure-Related Data Elements....................................................................................................................... .....................H-8 Table H-3: Schedule of Annual Industry Burden to Manufacturers if All Proposed Amendments Are Implemented .................................................................................................................... .................H-9 Table H-4: Change in Industry Burden to Processo rs as a Result of Additional Exposure-Related Data Elements....................................................................................................................... ...................H-10 Table H-5: Schedule of Annual In dustry Burden to Processors .............................................................H-11 Table H-6: Change in Industry Burden to Manuf acturers and Processors as a Result of Additional Exposure-Related Data Elements................................................................................................. ...H-12 Table H-7: Schedule of Annual Industry Burden to Manufacturers and Processors if All Proposed Amendments Are Implemented ..................................................................................................... .H-13 Table H-8: Per-Report Cost for Additional Data Elements, based on PMN Burden..............................H-14 Table H-9: Change in Industry Cost to Manufactur ers as a Result of Additional Exposure-Related Data Elements....................................................................................................................... ...................H-14 Table H-10: Annual Increase in Industry Cost to Manufacturers if All Proposed Amendments Are Implemented (2008$)............................................................................................................ ..........H-15 Table H-11: Change in Industry Cost to Processors as a Result of Additional Exposure-Related Data Elements....................................................................................................................... ...................H-16 Table H-12: Annual Increase in Industry Cost to Processors if All Proposed Amendments Are Implemented (2008$)............................................................................................................ ..........H-16 Table H-13: Change in Industry Cost to Manufacturers and Processors as a Result of Additional Exposure-Related Data Elements................................................................................................. ...H-17 Table H-14: Annualized Increase in Industry Cost to Manufacturers and Processors if All Amendments Are Implemented (2008$)........................................................................................................ .......H-18 Table H-15: Change in Agency Burden to Process Ma nufacturer Data as a Result of Additional ExposureRelated Data Elements.......................................................................................................... ..........H-19 Table H-16: Annual Increase in Agency Burden to Process Manufacturer Data if All Proposed Amendments Are Implemented ..................................................................................................... .H-19 Table H-17: Change in Agency Burden to Pro cess Processor Data as a Result of Additional ExposureRelated Data Elements.......................................................................................................... ..........H-20 Table H-18: Annual Increase in Agency Burden to Pr ocess Processor Data if All Proposed Amendments Are Implemented ................................................................................................................ ............H-20 Table H-19: Change in Agency Burden to Pro cess Manufacturer and Processor Data as a Result of Additional Exposure-Relate d Data Elements..................................................................................H-21 Table H-20: Annual Increase in Agency Burden to Process Data if All Proposed Amendments Are Implemented .................................................................................................................... ...............H-21 Table H-21: Change in Agency Cost of Processi ng Manufacturer Data as a Result of Additional Exposure-Related Data Elements................................................................................................. ...H-23 Table H-22: Annual Increase in Agency Cost to Pro cess Manufacturer Data if All Proposed Amendments Are Implemented (2008$)........................................................................................................ .......H-24 Table H-23: Change in Agency Cost to Process Pr ocessor Data as a Result of Additional ExposureRelated Data Elements.......................................................................................................... ..........H-24 Table H-24: Annual Increase in Agency Cost to Pro cess Processor Data if All Proposed Amendments Are Implemented (2008$)............................................................................................................ ..........H-25

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xiv Table H-25: Change in Agency Cost of Processi ng Manufacture and Processor Data as a Result of Additional Exposure-Relate d Data Elements..................................................................................H-26 Table H-26: Annual Increase in Agency Cost to Pro cess Manufacturer and Processor Data if All Proposed Amendments Are Implemented (2008$).........................................................................................H-26 Table H-27. Derivation of Cost-to-Sales Ratios for Sm all Manufacturers for Coll ection of Additional Data Elements....................................................................................................................... ...................H-28 Table H-28: Derivation of Cost-to-Sales Ratios for Small Processors for Coll ection of Additional Data Elements....................................................................................................................... ...................H-29 Table I-1: Annual Industry Burden as a Result of a TSCA Section 8(a) Data Collection......................... I-3 Table I-2: Schedule of An nual Industry Burden.................................................................................. ...... I-3 Table I-3: Per-Report Cost for Additional Data Elements, based on PMN Burden .................................. I-4 Table I-4: Annual Industry Cost as a Result of a TSCA Section 8(a) Data Collection ............................. I-5 Table I-5: Annual Increase in Industry Cost if All Amendments Are Impl emented (2008$)) .................. I-5 Table I-6: Per-Report Burden for Data Elements Simila r to Those Included in a TSCA Section 8(a) Data Collection..................................................................................................................... ...................... I-6 Table I-7: Agency Burden to Process Data as a Resu lt of a TSCA Section 8(a) Data Collection............ I-6 Table I-8: Schedule of Annual Agency Burden.................................................................................... ..... I-7 Table I-9: Per-Report Cost for Data Elements Simila r to Those Included in a TSCA Section 8(a) Data Collection..................................................................................................................... ...................... I-7 Table I-10: Agency Cost to Pr ocess Data as a Result of the TSCA S ection 8(a) Data Collection ........... I-8 Table I-11: Annual Increase in Agency Cost (2008$) ............................................................................. .. I-8 Table I-12: Derivation of Cost-to-Sales Ratios fo r Small Manufacturers for Collection of ExposureRelated Data Elements.......................................................................................................... ........... I-10 Table I-13: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of Exposure-Related Data Elements .................................................................................................................. ................ I-11

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xv 

## Executive Summary

The U.S. Environmental Protection Agency (EPA) requires manufacturers and importers of certain chemical substances to periodically report informa tion to the Agency under reporting requirements known as the Inventory Update Reporting (IUR) rule. This information is collected based on EPA’s authority under section 8(a) of the Toxic Substances Control Ac t (TSCA), which required EPA to compile and keep current a listing of chemicals in commerce in the Unite d States. The data reported under the IUR rule are used to support many EPA and other federal agen cy health, safety, and environmental protection activities. Established in 1986, the IUR rule was am ended extensively in 2003, and amended again in 2005. Currently, the IUR rule requires companies to report information every five years on certain chemical substances listed on the TSCA Invent ory, which is a listing of chemicals that are in commerce in the United States. For reportable substances that a comp any manufactures or imports in volumes of 25,000 lb. or more at a plant site during the principal reporti ng year, a submitter is required to provide plant site, production volume, and manufacturing information. Sites must also provide processing and use information for chemicals that are manufactured or im ported in volumes that meet or exceed a 300,000 lb. per year threshold. Submitters do not need to provide this processing and use information for chemicals below the 300,000 lb. threshold, or chemicals that are “partially exempt,” such as specifically listed petroleum process streams, and listed chemical subs tances for which the IUR information is of low current interest. These chemicals are all referre d to as “partially exempt” from reporting because companies must provide manufacturing information for them but not processing and use information. EPA now is proposing ame ndments to the IUR rule to modify the current IUR data reporting process in the following ways:

 Technically modify the regulatory text to move various provisions to other sections, to increase clarity;

 Consolidate the definitions currently found at §710.3 and §710.43 into the proposed §711.3, except where an appropriate definition is already in place in section 3 of TSCA or at §704.3, and delete the definition for “non-isolated intermediate” from §710.3;

 Modify the definitions of “importer,” “manufacture,” “site,” “commercial use,” “consumer use,” “reporting year,” and “submission period” to increase clarity of these definitions and make them consistent with the proposed amendments to IUR requirements and with other regulations;

 Add definitions for “manufacturer,” “Central Data Exchange (CDX),” “electronic IUR (e-IUR),” and “industrial function”;

 Add requirement to report if, for any calendar year since the previous IUR principal reporting year, the subject chemical was manufactured in production volumes of 25,000 lb. or greater per year;

 Eliminate the 300,000 lb. threshold, thereby requir ing all reporters of non-excluded substances to report information in all parts of the IUR reporting form;

 Eliminate the 25,000 lb. reporting threshold for certa in regulated chemicals and require manufacturers (including importers) of such chemicals to repor t under the IUR rule, regardless of the production volume;

 Make chemicals subject to Enforceable Consent Agreements (ECAs) ineligible for exemptions;

 Exempt manufactured water from reporting requirements;

 Remove fully exempt polymers from the partially exempt list;

 Amend reportable data elements such as the comp any identification number, technical contact, and chemical identity;

 Require submitters to report the ch emical’s production volume for each of the five years since last principal reporting year;

 Require submitters to report separat ely production volume used on-site;

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xvi  Require submitters of imported chemicals to indicate whether the chemical is physically at the reporting site;

 Require submitters to report production volume exported;

 Require submitters to identify wh ether the chemical is to be recycled, remanufactured, reprocessed, reused, or reworked;

 For downstream processing and use information: modify the set of industrial function categories; provide industrial sectors instead of NAICS codes; and modify the set of consumer and commercial product categories;

 Require submitters to identify whether a use is a consumer use, a commercial use, or both;

 Require that submitters report the total number of 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;

 Change the reporting standard for processing and use information from “readily obtainable” to “known to or reasonably ascertainable by”;

 Require upfront substantiation for claims that processing and use data are confidential business information;

 Restrict submitters from being able to claim not “known to or reasonably ascertainable by” data as CBI;

 Require submitters to electronically submit forms us ing the e-IUR software and EPA’s Central Data Exchange (CDX); and

 Change frequency of reporting from every five years to every four years. These amendments overall will increase IUR rule reporti ng costs. Over the first 20 years of the rule, EPA estimates that the net present value of the rule modifications will be $501.69 million in social cost. Annualized costs are expected to be $26.25 million (at a three percent discount rate) and $27.84 million (at a seven percent discount rate). 1 

### EPA estimates that all of the amendments combined would increase the burden to industry by approximately 1.56 milli on hours to 3.40 million hours in total for the 2011 reporting cycle. EPA estimates that in future repor ting cycles, the industry burden will increase by 1.21 million hours to a total of 2.64 million hours. EPA fu rther estimates that over a 20-year period, industry burden will increase by 7.81 million hours. EPA estimat es that the net increase in burden to society will increase by 7.81 million hours over a 20-year period, because EPA will e xperience a small reduction in burden as a result of the proposed rule. The informatio n gathered will enable the Agency to continue to target educational, regulatory, or enforcement activ ities to industries or chemi cals that pose the greatest potential risks and to target programs for population groups that are at the highest potential risk. With this better targeted information designed to better meet Agency needs, EPA will improve its ability to screen chemicals to identify whether a dditional risk assessment and management steps are needed. More complete reporting of the processi ng and use data, more careful consideration of confidentiality claims, and adjustments to specific data elements will help provide the needed data. By enhancing the data supplied to Agency risk-screeni ng programs, EPA expects to more effectively and expeditiously reduce the risks posed by chemicals. The more EPA can base its decisions on actual data, rather than on assumptions, the better EPA is able to tailor its risk management decisions to the level of actual risk, whether higher or lower than it would be if based only on assumpti ons. Ultimately, enhancing the risk screening process will have positive conseque nces for human and ecosystem health, and will use EPA’s and society’s resources more efficiently. Additi onal benefits will accrue fr om changes in reporting requirements that will improve consistency and comp atibility with other EPA da tabases. EPA would have an increased ability to anticipate industry trends, part icularly for chemicals for which EPA has concerns.

1 All values are in year 2008 dollars.

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1-1 

## 1. Introduction

This report assesses the costs and benefits EPA exp ects to result from its 2009 proposal to modify the Inventory Update Reporting (IUR) rule. The proposed amendments 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 ma nner. This chapter provides background information on EPA’s statutory authority for collecting information through the IUR rule and a discussion of the regulatory history of the IUR rule.



### 1.1 Statutory Authority
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 Inventor y (the TSCA Inventory). TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate re gulations under which manufacturers and processors of chemical substances and mixtures must maintain such records and submit such information as the Administrator may reasonably require. TSCA section 8(a) 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 chemi cal substance that is the subject of a regulation proposed or promulgated under TSCA sections 4, 5(b)(4), or 6; that is the subject of an order under TSCA section 5(e); or that is the subject of relief that h as been 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 is found at 40 CFR 70 4.3. Processors currently are not subject to the regulations at 40 CFR part 710.



### 1.2 Regulatory History
When Congress passed TSCA, it granted EPA broad authority to collect information on chemical substances to help EPA and others assess the magnitude and extent of human and environmental exposure to chemicals used in commerce. Specifically, under §8 of TSCA (15 U.S.C. 2607), EPA is authorized to promulgate regulations requiring manufacturers a nd processors of chemicals to report manufacturing (including importing), proc essing and use information on various types and classes of chemicals. In 1977, EPA used its authority under TSCA §8 to create the TSCA Chemical Substances Inventory, also known as the TSCA Inventory (42 FR 64572), which currently is codified at 40 CFR part 710 Subpart A. The TSCA Inventory lists all TSCA chemicals that are in commerce in the United States, thereby providing a listing of chemicals manufactured or processed in the United States. All chemicals are included, with the exception of pesticides, tobacco, nuclear material, firearms and ammunition, food and food additives, drugs, and cosmetics, which are not under the juri sdiction of TSCA. Chemicals are added to the TSCA Inventory after a company completes EPA’s New Chemicals review process and files a Notice of Commencement. 2


### In 1986, EPA used its authority under TSCA §8(a) to promulgate regulations requiring chemical manufacturers, including importers, to report data periodically to EPA on certain chemical substances listed in the TSCA Inventory (51 FR 21447). The IU R regulations applicable to the 1986 through 2002 reporting cycles currently are codified at 40 CFR Part 710 Subpart B. These regulations are commonly called the TSCA Inventory Update Repor ting rule, or IUR rule. Under this rule, EPA collected data every four years for organic chemicals produced in vol umes of 10,000 lb. or more per site. (Inorganic

2 Currently, more than 83,000 chemicals are listed on the TSCA Inventory (EPA, 2008a).

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1-2 chemicals, polymers, microorganisms, and naturall y occurring chemical subs tances were generally excluded from reporting.) From 1986 to 1998, an averag e of 9,200 individual chemicals was reported per reporting cycle. The IUR data provided a more up-to-d ate picture of a subset of the TSCA chemicals in commerce, generating data that were used to s upport TSCA risk management activities, as well as to provide support to other EPA and non-EPA program activities. In January 2003, EPA promulgated amendments to the IUR rule, re ferred to in this report as the “2003 Amendments” (68 FR 848). The amended IUR ru le, applicable to the 2006 reporting cycle and beyond, currently is codified at 40 CFR Part 710 Subpart C. The 2003 Amendments required reporting for inorganic chemical substances, added new site and manufacturing data elements, required companies to provide basic additional manufacturing, processing, and use information related to potential chemical exposures, changed the period of co verage from corporate fiscal year to calendar year, and extended the recordkeeping period from four years to five y ears. The 2003 Amendments partially mitigated the industry burden increase by raising the reporting thres hold to 25,000 lb.; creating a partial exemption from reporting processing and use information for inor ganic chemicals for the 2006 IUR collection only, and for specifically-listed petroleum process streams a nd other specifically listed chemical substances for 2006 and future reporting cycles; and by exempting fro m reporting certain natural gas substances. As part of the interagency review of the 2003 Amendments under Executive Order 12866, EPA agreed to propose a subsequent rulemaking to change the reporting fre quency in an effort to further reduce industry reporting burden. In 2005, EPA prom ulgated further modifications to the IUR rule (70 FR 75059) (referred to in this report as the “2005 Amendments”) , which extended the reporting cycle to five years, and made further changes to the rule that reduced industry burden and clarified rule requirements.

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2-1 

## 2. Current IUR Requirements and Affected Entities

2.1 Overview of Curre nt IUR Requirements
The IUR rule requires U.S. manufacturers (incl uding importers) of chemicals listed on the TSCA Inventory to report to EPA every five years the iden tity of chemical substances manufactured (including imported) during the principal reporting year in quantiti es of 25,000 lb. or greater at any single site they own or control (see 40 CFR part 710, subpart C). The principal reporting year is defined as the calendar year in which full manufacturing, processing, and use activities associated with the data reported to EPA during an IUR submission period occur. IUR data was collected last 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 fede ral health, safety, and environmental protection activities. To the extent possible due to restricti ons related to confidential business information, the Agency also makes the data available to the public. Persons manufacturing, including importing, chemic al substances are required to report information related to company, site, and chemical identit y and, for each reportable chemical substance, manufacturing exposure-related information (40 CF R §710.52). The 2006 submission year was the first time information on inorganic chemicals was required to be reported. The IUR rule generally exempts several groups of chemical substances from its repor ting requirements, i.e., 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 or imported during the principal reporting year at any single site) additionally are required to report exposure-related processing and use info rmation (40 CFR §710.52(c)(4)). The IUR rule generally partially exempts specifically-listed petr oleum process streams and other specifically-listed chemical substances, and manufacturers (including im porters) of such substances were not required to report processing and use information for those substa nces. For the 2006 IUR only, inorganic chemicals were partially exempted. Form U, the tool used to collect the IUR informati on, is divided into three parts: Site Identification Information (Part I), Manufacturing Information (Par t II), and Processing and Use Information (Part III). A copy of the 2006 IUR Form U is in Appendix A of this report. An overview of the information collected under the IUR rule in 2006 is as follows:

 Company Reporting Number: An 8-digit alphanumeric number assigned by the submitter to each specific IUR submission (for electronic submissions only).

 Certification statement . A company authorized official must sign the form, certifying that the information provided is complete and accurate.

 Company information . Includes the company name and Dun & Bradstreet number.

 Plant site information . Includes the name, address, and Dun & Bradstreet number for the plant site that is reporting.

 Technical contact information . Includes the name, address, tele phone number, and email address for a technical contact.

 Chemical identification . Includes both the specific chemical name and the Chemical Abstracts Service Registry Number (CASRN), or other id entifying number, of the chemical substance.

 Manufacturing information . Includes an indication of whether the chemical substance is manufactured or imported; whether it is site-limited (w hether it is produced and used at the same site, and does not undergo packaging and shipping); and its manufactured and imported production volumes. Also contains the number of workers invol ved in manufacturing that are reasonably likely to be exposed to the chemical substance, the physical form(s) as the chemical leaves the site (including the percent of the production volume in each form), and the maximum concentration of the chemical

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2-2 as it leaves the site. Codes representing ranges are used to report these data. These data are reported to the extent they are “known to or reasonably ascertainable” by the submitter.

 Industrial processing and use data . Includes the types of process or use for the chemical substance, the related North American Industrial Classification System (NAICS) codes, and the industrial function categories. For each unique combination of process or use/NAICS/function, includes the percentage of production volume, the number of sites, and the number of workers attributable to each processing or use activity reported. These data are reported for up to ten uses with the largest production volume (by weight) for the chemical. The industrial function categories used in the 2006 reporting are listed in Appendix C of this report. These data are reported to the extent they are “readily obtainable by” the submitter.

 Consumer and commercial end-use data. Includes the relevant consumer and commercial product category, the percentage of the production volume in each product category, the maximum concentration of the chemical in each final product, and an indication of whether the chemical is in a product intended for use by children. The consum er and commercial product categories used in the 2006 reporting are listed in Appendix D of this report. These data are reported to the extent they are “readily obtainable by” the submitter.

 Confidential Business Information (CBI) status can be claimed for each data element reported. Submitters who claim the chemical identity or pl ant site identity as CBI must provide upfront substantiation of the need for such confidentiality. 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).



### 2.2 Overview of the Regulated Community
The regulated community for the IUR rule (i.e., those who potentially will be affected by the proposed amendments to the IUR rule) consists of companies manufacturing or importing chemicals in amounts of 25,000 lb. or more annually that are listed on the TSCA Inventory and are regulated under TSCA §8. Manufacturers and importers of non-TSCA chemical substances (such as pesticides, tobacco, nuclear material, firearms and ammunition, food and food additives, drugs, and cosmetics) are not required to report information on those chemicals und er the IUR rule. Some chemical substances might have both TSCA and non-TSCA uses. In that case, th e production associated with the TSCA use must be reported. Companies engaged in chemical manufac turing (NAICS code 325) or petroleum refining (NAICS code 324110) are the most likely to report under the IUR rule. Chemical users and processors who may manufacture a byproduct chemical substance, e.g., utilities, paper manufacturing, primary metal manufacturing, and semiconductor and other electronic component manufacturing (NAICS codes 22, 322, 331, and 3344) are also likely to be subject to the ru le. However, companies in any industry are subject to reporting if they manufacture or import listed chemical s at or above the reporting threshold. Companies must review the rule to determine whether they are required to report.

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3-1 

## 3. Changes in Reporting Re quirements under the Proposed IUR Modifications Rule

The proposed amendments encompass several specific changes to the IUR. Each of these proposed amendments is described below.



### 3.1 Technical Modifications to the Regulatory Text
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 covering the update reporting in 2002 and earlier; and S ubpart C contains the regulatory text associated with the IUR for 2006 and beyond. The chemicals that are covered by the IUR are on the Master Inventory File, which includes chemicals from the original Inventory compilation and those added subsequently through the notice requirements of secti on 5 of TSCA.. Because the IUR rule applies to a list of chemicals included in the original Inventor y plus additional chemical s added subsequently, and because the Agency has modified th e IUR rule, the Agency believes th e regulatory text associated with the IUR rule should be in its own section in the Co de of Federal Regulations, distinct from both the original TSCA Inventory rules and from the TSCA section 5 requirements.

3.1.1 Move the IUR Regulatory Text from 710 Subpa rt C to 711 and Eliminate Subpart Divisions 

### Subpart C of 40 CFR part 710, §710.43 to §710.59, contains the IUR regulatory text. EPA is proposing to move all of the Subpart C text from pa rt 710 to part 711 and w ould add a new Scope and Compliance section (§711.1). Specific sections w ould be moved as follows: §710.43 would become §711.3; §710.45 would become §711.5; §710.46 would become §711.6; §710.48 would become §711.8; §710.49 would become §711.9; §710.50 would become §711.10; §710.52 would become §711.12; §710.53 would become §711.13; §710.55 would become §711.15; §710.57 would become §711.17; §710.58 would become §711.18; and §710.59 would beco me §711.19. Because all of the text of Subpart C would be moved to part 711, part 710 would no long er have a Subpart C. Neither part 710 nor part 711 would have any subparts.

3.1.2 Consolidation of Definitions 

### As part of moving the regulatory text from Part 710 Subpart C to part 711, EPA is proposing to consolidate the definitions currently found at §710.3 and §710.43 into the proposed §711.3, except where an appropriate definition is already in place in section 3 of TSCA or at §704.3, and an additional definition of the term in proposed §711.3 would ther efore be unnecessarily duplicative. The definitions at §704.3 would be incorporated by reference into proposed §711.3, except insofar as proposed §711.3 provides a modified definition of a term also defined at §704.3.

The term mixture is defined in both §710.3 and section 3 of TSCA. For purposes of the IUR rule, EPA is proposing to incorporate the definition of mixture from section 3 of TSCA. The TSCA mixture definition differs from the definition in §710.3 and §720.3, the regulations used to determine the chemicals listed on the 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 i ndividual components of the mixture may be separately reportable at the time of their manufacture or import. EPA believes, for purposes of the IUR rule, that it is not necessary to include hydrates separ ately in the definition of mixture. The Agency will continue to include such a discussion in the Instructions.

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3-2 3.1.3 Delete “Non-isolated Intermediate” Definition from §710.3 

### EPA added a definition to §710.43 for the term non-isolated intermediate as part of the 2003 Amendments (68 FR 848, January 7, 2003). Subse quently, as part of the IUR Revisions Rule (70 FR 75059, December 19, 2005), EPA erroneously moved th e definition to §710.3, ra ther than to §710.43. EPA is proposing to delete the definition from §710.3 as this definition was not associated with the original Inventory, and therefore does not belong in §710.3. A definition of this term, codified elsewhere at §704.3, would be incorporated by reference into the IUR definitions at proposed §711.3.

3.1.4 Delete Subpart B Text 

### EPA is proposing to delete the re gulatory text contained in §710. 23 through §710.39 (subpart B). This text refers to IUR submission periods of 2002 and earlie r and is obsolete. As noted in §710.1, the Agency expressed its intent to remove subpart B once the 2002 update was complete.



### 3.2 Modifications to Selected Definitions
As part of developing the definition section for part 711, EPA is proposing to modify six definitions associated with the IUR rule and to add four ne w definitions. In §704.3 a nd §710.3, EPA is also proposing to modify the citation in the definition of importer by removing the citation to 19 CFR 11.1 to 19 CFR 101.1. 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.

3.2.1 Manufacture and Manufacturer 

### In order to improve the information submitted thr ough the IUR rule, EPA is proposing to modify the definition of manufacture by incorporating elements from the §720.3 definition for manufacturer . The proposed §711.3 definition of manufacture would allow persons contracti ng with a toll manufacturer to report the chemical physically manufactured at the to ll manufacturer’s site. Under the proposed definition of site , the site information would reflect the toll ma nufacturer’s site. Adopting this definition would allow the person contracting for the manufacture of a ch emical substance to report the information on the industrial processing and use of a chemical substa nce and on the consumer and commercial uses of a product containing the chemical substance. Informati on on the uses of a chemical substance is often unavailable to a toll manufacturer who produces a ch emical substance for another person. EPA is proposing to modify the §711 definition of manufacture instead of adopting the definition of manufacturer from §720.3 because the 40 CFR part 711 regulations do not use the term manufacturer . In order to avoid any confusion with the definitions of these terms found at §704.3, the Agency is also proposing to add a simple definition for the term manufacturer to the proposed §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 §711.15 to clarify the reportin g relationship between the contracting company and the toll manufacturer. The contracting company is prim arily responsible for the IUR reporting, but in the event the contracting company does not report, the to ll manufacturer must report. Both the company and manufacturer are liable if no report is made. Under this proposal, the term manufacture therefore would be defined under the IUR rule to mean “to manufacture, produce, or import for commercial pur poses. Manufacture includes the extraction, for commercial purposes, of a component chemical substa nce from a previously existing chemical substance or a complex combination of substances. When a subs tance, manufactured other than by import, is (1) produced exclusively for another person who contract s for such production, and (2) that other person specifies the identity of the substance and controls the total amount produced and the basic technology for the plant process, that substance is jointly manufac tured 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.”

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3-3 3.2.2 Site 

### EPA is proposing to amend the definition of site to (1) clarify that the importer’s site must be a U.S. address, (2) accommodate manufacturing under contr act, and (3) accommodate portable manufacturing units.

Two examples of portable manufacturing units ar e 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 hydroxid e prior to application to agricultural lands. EPA is interested in including chemical manufacturing that is occurring at, for instance, construction sites or road crews at which chemicals are mixed on site in such a manner to create a different chemical substance, e.g., asphalt emulsifiers. The site of ph ysical manufacturing could change on a frequent basis. Manufacturers (including importers) would report th e aggregated production volume for all of the portable manufacturing units sent out to different lo cations from a single distribution center. The address of the distribution center would be reported as the site location.

Under the proposal, the term site would be defined to mean “a contiguous property unit. Property divided only by a public right-of-way would be consid ered one site. More than one plant may be located on a single site. For substances manufactured under cont ract, i.e., by a toll manufacturer, the site is the location where the chemical substance is physically manufactured. The site for a person who imports a chemical substance described in §711.5 is the Unite d States site of the operating unit within the person's organization that is directly responsible for im porting the substance and that controls the import transaction. In some cases, it may be the organization' s headquarters office in the United States. If there is no such operating unit or headquarters in the U.S., th e site address for the importer is the U.S. address of an agent acting on behalf of the importer who is au thorized to accept service of process for the importer. For portable manufacturing units sent out to different locations from a single distribution center, the distribution center shall be considered the site.”

3.2.3 Electronic-Reporting Related Definitions 

### EPA is proposing to add two new terms, Central Data Exchange (CDX) and electronic IUR (e-IUR). 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 regi stering to submit electronic documents.” The new definition would make the term consistent with the new Premanufacture Notice (PMN) definition. The
term e-IUR means the “electronic-IUR software provided by the EPA for the completion and submission of the IUR Form U report.”

3.2.4 Processing and Use-Related Definitions 

### EPA is proposing to amend the definitions of two terms: c ommercial use and consumer use in order to make their basic applications consistent with the definitions developed collaboratively by the United States and Canada. The term c ommercial use would mean “the use of a chemical substance or a mixture containing a chemical substance (including products a nd manufactured items composed of or containing a chemical substance) in a commercial enterprise providing saleable goods or services.” Examples included in the §710.43 definition were eliminated . The slightly modified definition of c onsumer use would mean “the use of a chemical substance that is itself, or as part of a mixture (including as part or all of a product or manufactured item), 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 also proposing to add a definition for the term industrial function. For the 2006 IUR, EPA defined industrial use and did not define industrial function. Th e inclusion of both definitions provides clarity for the industrial processing and use reporti ng requirements, and would make the Agency’s

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3-4 requirements consistent with those developed co llaboratively with Canada. 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.”

3.2.5 Principal Reporting Y ear and Submission Period 

### As described in section 3.13, EPA is proposing to change the reporting cycle from every five years to every four years and to require the reporting of pro duction 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.” EPA is proposing these changes 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 proceeding the submission period. Additionally, EPA is proposing to rem ove 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 calendar year in which manufacturing, processing, and use activities associated with the data to be repor ted to EPA during an IUR submission period occur. Production volume for manufacturing activities in other years of the reporting cycle may also be reportable during the submission peri od, but full manufacturing, pro cessing and use data are reported only for activities during the principal reporting year.”

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. The new definition of submission period would mean “the period in which manufacturing, processing and use data are submitted to EPA.”



### 3.3 Modifications to Reporting Thresholds
Reporting thresholds are used to determine when IU R reporting is required for a subject chemical at a manufacturing (including importing) site. Every person manufacturing (including importing) a nonexcluded substance at or above the 25,000 lb. threshol d is required to report information in Parts I and II of the IUR Form U. Beginning with the 2006 IUR submission year, every person manufacturing (including importing) a non-excluded substance at or above the 300,000 lb. threshold was required to report information in Part III of Form U. EPA is prop osing three changes related to the threshold: (1) how to determine whether you meet the 25,000 lb. threshol d, (2) the elimination of the 300,000 lb. threshold for reporting information in Part III, and (3) the elim ination of the 25,000 lb. threshold requirement for certain chemicals.

3.3.1 Method for Determining Whether a Manufactur er is Subject to IUR Reporting Requirements 

### Currently, a one-year “snapshot” of manufacturing (including importing) is used to determine the need to report for the IUR rule. The method used to make the reporting determination involved identifying that an entity manufactured (or imported) a chemical substance listed on the TSCA Inventory during the principal reporting year (e.g., 2005 for the 2006 IUR reporting cycle); that the chemical substance was not otherwise exempt; and that the associated production volume (domestically manufactured plus imported volumes) met or exceeded th e 25,000 lb. threshold for the principal reporting year (e.g., 2005 for the 2006 IUR reporting cycle). EPA is proposing to modify the method used to de termine whether a manufacturer is subject to IUR reporting if, for any calendar year since the previous principal reporting year, the subject chemical was

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3-5 manufactured (including imported) in production volumes of 25,000 lb. or greater. For the 2011 reporting cycle, a site would examine its annual production volumes for the years 2006 to 2010. If the production volume for a reportable chemical substance was 25,000 lb. or greater for any calendar year during that five-year period, then the site would need to report the chemical substance, unless it is otherwise exempt.

3.3.2 Eliminate 300,000 lb. Threshold for Processing and Use Information 

### EPA is proposing to eliminate the 300,000 lb. thresh old for processing and use information, thereby requiring all reporters of non-exclude d substances to report information in all parts of the IUR Form U. EPA is proposing to eliminate this reporting thres hold in order to collect information necessary to complete screening-level exposure characterizations a nd subsequent risk-based prioritizations for medium production volume (MPV) chemicals. In the preamble to the 2003 Amendments final rule (68 FR 848, January 7, 2003), EPA acknowledged th e 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 threshol ds below the thresholds that were introduced in the action. The IUR processing and use information is presently needed to complete the characterizations and prioritizations for those chemicals manufactured (including imported) in volumes of 25,000 lb. to 300,000 lb. 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 proposal (EPA,2008c). However, the need to complete charact erizations for chemicals manufactured (including imported) in volumes of 25,000 lb. to 300,000 lb. led the Agency to believe that it would be best to eliminate the upper threshold and collect fu ll information for all reported chemicals

3.3.3 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals 

### EPA is proposing to eliminate the 25,000 lb. reportin g threshold for certain chemical substances that are the subject of particular TSCA rules and/or orde rs and to require manufacturers (including importers) of such chemicals to report under the IUR rule, rega rdless of the production volume. This provision will ensure the availability of current information if 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 chem icals that are: (1) the subject of a rule proposed or promulgated under section 5(a)(2), 5(b)(4), or 6 of TSCA; (2) the subject of an order issued under section 5(e) or 5(f) of TSCA; or, (3) the subject of relief that has been granted under a civil action under section 5 or 7 of TSCA.



### 3.4 Changes to Substances Subject to the IUR Rule

3.4.1 Make Chemicals Subject to Enforceable Consent Agreements (ECAs) Ineligible for Exemptions 

### EPA may enter into an enforceable consent agre ement (ECA) 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. Chemicals covered by ECAs are of demonstrated high interest to EPA. The Agency has an in terest in identifying the manufacturing, processing, and use of substances under such agreements, and therefore is proposing to require that such substances be reported for IUR pur poses, regardless of whether the substance otherwise meets the requirements listed in 40 CFR §710.46 ( 40 CFR §711.6) as an exempt or partially exempt chemical substance. This provision will ensure th e availability of current information if EPA has expressed a concern in the form of an ECA on any substance otherwise excluded from the IUR rule. For example, EPA could use the IUR data associated wi th these regulated chemicals to monitor chemical

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3-6 production and compliance with the ag reements. EPA is therefore proposing to make chemical substances that are the subject of an ECA ineligible for IUR exemptions. With this proposal, chemicals that are the subj ect of an ECA would be included in the list of chemicals that are ineligible for an IUR exemption, in the introductory paragraph of 40 CFR 710.46 (proposed 40 CFR 711.6) listing the other chemicals th at are likewise not eligible for an IUR exemption. With this proposed addition, the pa ragraph would state that a chemical “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 unde r a civil action under section 5 or 7 of the Act.”

3.4.2 Full Exemption for Manufactured Water 

### Naturally occurring water is excluded from reporti ng under the IUR rule, but manufactured water, which is not naturally occurring, is a reportable subs tance. EPA is proposing to fully exempt all (both naturally occurring and manufactured) water (CAS RN 7732-18-5) and to remove water from the petroleum streams partial exemption (40 CFR §710.46(b)(1)).

3.4.3 Remove Fully Exempt Polymers from the Partially Exempt List 

### Polymers are a class of chemical substances for which IUR reporting is not required (40 CFR §710.46(a)(1)). However, three polymers are listed in the partially exempt list of chemicals at §710.46(b)(2)(iv): Starch (CASRN 9005-25-8), Dext rin (CASRN 9004-53-9), and Maltodextrin (CASRN 9050-36-6). Improperly including substances that meet th e IUR definition of a polymer in the partially exempt list of chemicals may be confusing to su bmitters and may lead to unnecessary reporting for these substances. EPA is proposing to amend the partially exempt list of chemicals at §710.46(b)(2)(iv) to remove these three chemical substances which, as polymers, are fully exempt from reporting.



### 3.5 Modifications to Reportable Data Elements

3.5.1 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 compan y associated with the plant site, and also to report the site name, address, and D&B number. If the company associated w ith the plant site does not have a D&B number, the manufacturer must obtain a D&B number for the comp any. Likewise, if the plant site does not have a D&B number, the manufacturer must obtain a D&B number for the site. EPA is 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 Inve ntory (TRI) requirements for parent company name. The requirement that the ultimate domestic parent co mpany name be reported under the IUR rule does not affect the determination of small business status, wh ich is not limited to domestic companies. Persons subject to the IUR rule should continue to base sm all business determinations on the ultimate parent company, regardless of whether that company is domestic or foreign.

3.5.2 Technical Contact 

### Manufactures (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 site. Based on EPA’s experience with contacting the reported technical c ontact with follow-up questions concerning 2006 IUR submissions, submitters often provide the names of individuals who are not directly connected to the

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3-7 reporting site, and therefore, are not knowledgeable a bout 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 unde r contract. EPA is therefore requesting comment on whether it should allow reporting of multiple techni cal contacts on a chemical-by-chemical basis.

3.5.3 Chemical Identity



### Chemical Name. EPA is proposing to require reporting of the Chemical Abstracts (CA) Index Name currently used to list the substance in the Inventor y 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 currently 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. Manufacturers (including importers) will be allowed to supply an alternate chemical name, and in the case of importers, a trade name, in those instances wh ere a supplier will not disclose to the submitter the specific chemical name of the imported Inventory substance or a reactant used to manufacture the Inventory substance. Chemical Identifying Number

. As part of the chemical identity, submitters provide a chemical identifying number associated with the correct CA Index Name. For most chemicals, the chemical identifying number is the CASRN correctly corr esponding 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 Inventory and a CASRN does not already exist for th at substance, the submitter currently could report either the associated TSCA Accession or PMN number. EPA is proposing to allow submitte rs to report only the CASRN as a chemical identifying number or, in the case of confidential chemical substances, the accession number. Note that in cases where a CASRN exists for a confidential chemical, it can be re ported instead of the 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 I nventory substance has either (or both) a CASRN or a TSCA Accession Number, which are likely to be al ready known to the submitter. Furthermore, the Agency spends considerably more time and effort to access and review reported information that has only been identified by a PMN case number.

3.5.4 Report Production Volume for Each of the Years since the Last Principal Reporting Year 

### EPA is proposing to require reporting of production volu me for each of the five years since the last principal reporting year. Thus, for the 2011 IUR repor ting cycle, manufacturers (including importers) of a chemical at or above the 25,000 lb. threshold would report the production volume of that chemical for each of the following calendar years: 2006, 2007 , 2008, 2009, and 2010. Co llecting the production volume for multiple years would provide EPA with more accurate and up-to-date information than what is provided under the current five-year reporting cycle.

3.5.5 Volume of Chemical Substance Used On-Site 

### EPA is proposing to require that submitters report the volumes of a manufactured (including imported) chemical substance used at the reporting site. The requirement to report the volume used onsite is replacing the requirement to indicate that the chemical is site-limited. Under this proposal, either domestically manufactured or imported chemicals could be reported as used at the reporting site, whereas, under the current reporting requirements, only domesti cally manufactured chemicals, consumed entirely at the site of manufacture, shoul d be reported as site-limited.

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3-8 3.5.6 Indicate Whether Imported Chemic als Are Physically at Reporting Site 

### EPA is proposing to add a requirement to indicate whether an imported chemical is physically at the reporting site. Often, the site reporting an imported ch emical never physically receives the chemical, 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 is physica lly at the reporting site provides more accurate information for screening-level analyses and other uses of the IUR data.

3.5.7 Report Production Volume Exported 

### EPA is proposing to add a requirement to repor t the production volume directly exported and not domestically processed or used. This would allow EP A to better identify the proportion of the production volume included in the use reporting, given that dow nstream reporting is not required for exported substances.

3.5.8 Identify Whether a Chemical Is To Be Recycled, Remanufactured, Reprocessed, Reused, or Reworked 

### EPA is proposing to add a requirement to indicate via a checkbox when a manufactured chemical, such as a byproduct, is being recycled, remanufactured , reprocessed, reused, or reworked. Submitters will identify that their manufactured chemical, which othe rwise would be disposed of as a waste, is being removed from the waste stream and has a commercial purpose (i.e. recycled, remanufactured, reprocessed, reused, or reworked ). Checking this box does not affect the reporting requirements associated with any substance manufactured from the by product. EPA believes that such information will help the Agency to identi fy where these activities are already occu rring, and can be used to encourage such activities.



### 3.6 Concentration Ranges
EPA is proposing to eliminate gaps in the ranges u sed to report concentration in §710.52(c)(3) and (4) by changing the ranges to: 1) less th an one percent by weight, 2) at least one percent but less than 30 percent by weight, 3) at least 30 percent but less than 60 percent by weight, 4) at least 60 percent but less than 90 percent by weight, and 5) at least 90 percent by weight.



### 3.7 Industrial Processing and Use Information Reporting
In 2003, EPA added industrial processing and use da ta to the information co llected through the IUR rule for chemical substances manuf actured in quantities of 300,000 lb. or greater during the principal reporting year. The industrial processing and use info rmation included industrial function categories and North American Industrial Classification System (NAI CS) codes. EPA found that knowing these two data elements for a chemical substance was useful in selecting a scenario that ch aracterizes the frequency, route, and duration of exposure to a chemical substance during manufacture, processing, and use of the substance. These data are also useful when EPA char acterizes the quantity of the chemical substance in wastes and emissions entering the environment and fo r anticipating the environmental media into which wastes will be released. The Agency now is proposin g to revise the list of industrial function categories and to replace the NAICS codes with industrial sector categories

3.7.1 Revise Industrial Function Categories 

### EPA is proposing to add eight new industrial functio n categories and to delete six existing categories from the current list; the total number of industria l function categories would be 35. Also, EPA has renamed several of the industrial function categori es to provide a more informative description of the function of chemical substances that should be reported in that category. Lastly, EPA is requiring that if a

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3-9 submitter selects the category “Other,” the submitter must provide its own descr iption of the industrial function of the chemical substance. Appendix C lists both the existing and proposed sets of industrial function categories.

3.7.2 Revise Industrial Sectors 

### EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) codes with 48 Industrial Sectors (IS). The IS were developed from the European Union’s, “Guidance on information requirements and chemical safety assessment.” The Industrial Sectors divide the entire range of NAICS codes into sectors so that there is a se ctor corresponding to any NAICS code. The Agency believes this change will provide a number of benefits. Expected bene fits include reducing the reporting burden because submitters do not have to look up NAICS codes, encouraging more complete reporting by using familiar terms, reducing the likelihood of errors which result from selection of miscellaneous NAICS codes, and reducing the number of possibl e responses for correlation of the information. Appendix E of this report provides a list of the proposed industrial sectors. When the category chosen for the Indu strial Sector code is “Other,” a written description of the use of the chemical substance, which may include the NAICS code, also must be provided.



### 3.8 Consumer and Commercial Use Reporting
In the 2003 Amendments, EPA added a reporting requ irement for submitters to include information about the consumer and commercial uses of chemical s they reported under the IUR rule. For the 2006 IUR, manufacturers (including importers) of subject chemicals manufactured in quantities of 300,000 lb. or more during calendar year 2005 were required to select up to ten consum er and commercial product categories from a list of 20 categories that correspond to the actual use of the chemical substance they are reporting.

3.8.1 Revise 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. The proposed list includes 33 product categories, including “Other.” Examples of new categories which have been added in clude explosive materials, building/ construction products not covered elsewhere, and air care products . An example of a deleted category is glass and ceramic products, which had relatively few IUR subm issions in 2006 and which overlaps with new categories. Also, several of the consumer and comme rcial product categories have been renamed to better describe the uses that should be reported in those categories. See Appendix D of this report for a list of the new categories.

3.8.2 Designation of Consumer or Commercial Use 

### EPA is proposing to require submitters to designate via a checkbox whether the use is a consumer or a commercial use, or both

. The Agency’s experience using the 20 06 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.

3.8.3 Number of Commercial Workers Reasonably Likely To Be Exposed 

### EPA is proposing to require that submitters report the total number of workers, including those at sites not under the submitter’s control, that are reasona bly likely to be exposed while using the reportable chemical substance, with respect to each commercia l use. The approximate number of workers would be

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3-10 reported using the same definitions and ranges used for manufacturing and industrial processing and use workers, required by 40 CFR 710.52. The proposed rang es are: 1) fewer than 10 workers, 2) at least 10 but fewer than 25 workers, 3) at least 25 but fewer than 50 workers, 4) at least 50 but fewer than 100 workers, 5) at least 100 but fewer than 500 workers, 6) at least 500 but fewer than 1,000 workers, 7) at least 1,000 but fewer than 10,000 workers, and 8) at least 10,000 workers.



### 3.9 Changes to Standard for the Re porting of Processing and Use Information
In order to collect more complete information re garding both the industrial processing and uses, and consumer and commercial uses of chemicals, EPA is proposing to replace the “readily obtainable” reporting standard that was used for the 2006 IUR with a “known to or reasonably ascertainable by” reporting standard. TSCA section 8(a)(2) authorizes EPA to require persons to report information that is known to or reasonably ascertainable by the submitter. For the purposes of reporting under the IUR rule, a submitter would report information described in the re gulatory text at §710.52(c)(1), (c)(2), and (c)(3) that is known to or reasonably ascertainable by the submitter. This means all information in a person’s possession or control, plus all information that a reasona ble person similarly situated might be expected to possess, control, or know. The “known to or reasonabl y ascertainable by” reporting standard was the only standard used for IUR purposes prior to the 2006 IUR. EPA is proposing this change because reporting unde r the “readily obtainable” reporting standard did not generate sufficiently complete processing and u se information. EPA believes the “readily obtainable” reporting standard limited the usefulness of th e 2006 IUR data for screening level reviews.



### 3.10 Modifications to Confidential Business Information (CBI) Claims
Submitters may currently claim certain informa tion reported under the IUR as confidential business information (CBI) in accordance with 40 CFR part 2 and IUR rules at §710.38 (proposed 40 CFR 711.18). Submitters must assert claims of confidentia lity at the time information is submitted to EPA. EPA’s procedures for handling information claimed as c onfidential are set forth at 40 CFR part 2, subpart B. To claim information as confidential, a submitter must indicate its claim by 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 conf identiality claims have been asserted. EPA expects that the proposed cha nges to the method for claiming information as CBI would reduce the number of unjustifiable CBI claims . 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 di scuss and explain its risk management actions and decisions more clearly.

3.10.1 Chemical Identity CBI Claims 

### Under the IUR, a submitter may assert a claim of c onfidentiality for data associ ated with the identity of the reported chemical substance when the chemical is listed on the confidential portion of the Master Inventory File and when the submitter provides th e required substantiation at the time the submitter makes the confidentiality assertion. See 40 CFR 71 0.58(b) (proposed 40 CFR 711.18(b)). At times a submitter will assert a claim of confidentiality for the ch emical identity of a substance that is listed on the public portion of the Master Inventory File. EPA is proposing that, when this occurs, the Agency may make the information available to the public wit hout further notice to the submitter. See the proposed regulatory text at 40 CFR 711.18(e).

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3-11 3.10.2 Upfront Substantiation for Processing and Use Information CBI Claims 

### Under the IUR rule, a submitter may assert a claim of confidentiality for data associated with the processing and use of its chemical if the submitter ha s reason to believe that release of the information would reveal trade secrets or confidential commercial or financial information, as provided by section 14 of TSCA and 40 CFR part 2. During the 2006 IUR, s ubmitters made confidentiality claims for 25 to 50 percent of the reported processing and use informa tion. While the Agency does not question that confidentiality claims are sometimes necessary, it en courages submitters to consider carefully whether such claims are in fact necessary before asserting them. The Agency has iden tified 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 submitte d to the Agency and posted on the Agency’s HPVIS website. For the 2006 IUR, submitters were not required to provide upfr ont substantiation of CBI claims for processing and use data. In these amendments to the IUR rule, EPA is proposing to require upfront substantiation for CBI claims for this information. Under the proposed rule, in order to submit a claim of confidentiality for processing and use information data elements, the s ubmitter 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 the proposed rule. Where a submitter fails to substantia te the processing and use CBI claim in accordance with the applicable requirements, EPA would consid er the information not subject to a confidentiality claim and may make the information available to th e public without further notice to the submitter.

3.10.3 Limitation on Confidentiality Claims for Data Elements Identified as “Not Known or Reasonably Ascertainable” 

### Under the proposed amendments, submitters would be unable to enter a claim of confidentiality if “not known or reasonably ascertainable” is selected fo r the industrial processing and use or consumer and commercial use information. In the 2006 IUR coll ection, submitters reported the processing and use information to the extent that it was readily obta inable, and were permitted to identify when such information was not readily obtainable by entering “NRO.” EPA has considered the NRO designation and its relationship to a potential CBI or trade secret claim. Given that an NRO assertion is an assertion that no information is available, the Agency does not be lieve 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.



### 3.11 Method of Submission
EPA accepted 2006 IUR submissions in several ways . Submissions could be completed and delivered electronically via the Internet and CDX, or submissi ons could be completed on paper or electronic media (i.e., as a file on a CD) and delivered by mail or a delivery service. Approximately one-third of the submissions were made electronically, and EPA was ab le to immediately process and quickly begin to use the information from those electronic submissions. Subm issions sent as a file on a CD were printed and, along with paper submissions, scanned by EPA into an electronic system. Due mostly to the time and resources needed to review and correct submitter- and scanning-related errors associated with nonelectronic submissions, EPA required more than two years to validate and process the data from the 2006 IUR. EPA is proposing to require the mandatory use of Agency-provided reporting software (e-IUR) to complete the IUR Form U and the Central Data Exch ange (CDX) to submit the completed Form U to the Agency. CDX users are required to register with CDX and to submit an authorized signature agreement.

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3-12 3.11.1 Updated e-IUR Reporting Software 

### EPA developed e-IUR reporting software for use in preparing and submitting reports electronically during the 2006 IUR reporting cycle (see www.epa.gov/iu r). The 2011 e-IUR software features several enhancements over the 2006 e-IUR software, such as 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. For the 2011 e-IUR, EPA also is consider ing a free web-based application in place of, or in addition to, free downloadable software.

3.11.2 Require Electronic Subm issions over the Internet 

### EPA is proposing to require that manufacturers (i ncluding importers) submit their IUR reports to the Agency through CDX via the Internet. EPA would requ ire that all submissions be generated using e-IUR reporting software. Electronic submissions would ensure that IUR data will have completed a basic validation check, could be incorporated quickly into a database and ready for i mmediate Agency use, and would not be subject to subsequent data entry errors. Furthermore, EPA believes the required use of eIUR 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 Agen cy. 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) for any IUR submission.

3.11.3 Electronic Signature Process 

### Each IUR submission must have an authorized official, who is the person signing the certification statement and submitting the IUR report via CDX, asso ciated with the submission. During the 2006 IUR, submitters were required to complete an electr onic 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. For 2011 IUR reports, EPA is modifying the 2006 ESA to id entify more clearly the individual(s) required to sign the agreement. To register in CDX, the CDX re gistrant (also referred to as “Electronic Signature Holder”) would download two forms: the Electroni c Signature Agreement and the Verification of Authorization. For authentication of identity, the re gistrant would complete the ESA, sign and date it, have the form notarized, and mail it to EPA. The Verifi cation of Authorization form requires the signature of an immediate supervisor or witnessing official ve rifying that the registrant is the person who should sign their name in the certification statement box on Form U. Once both forms are received, EPA would activate the registrant’s CDX account and send a notification via email. EPA is requesting comment in this proposal on possible ways to streamline the ESA and CDX registration process, and on allowing multiple individua ls complete an ESA. Reporting sites may need or desire to have more than one individual complete an electronic signature agreement, so that other individuals can add information to an original IUR submission. Persons submitting supplemental information for an IUR submission on behalf of a co mpany would need to register with CDX by signing an ESA and Verification of Supplemental Submitter form. The Verification of Supplemental Submitter form requires the signature of an immediate supe rvisor or witnessing official from the company and anyone he/she authorizes to submit additional informa tion. The company official can have the agreement with an unlimited number of supplemental submitters, but will have to complete a form for each supplemental submitter. Supplemen tal submitters can work with an unlimited number of company officials, but will need an agreement with each compan y official (even if the company officials work at the same company). A supplemental submitter may be a paid employee of the company, an outside consultant for the company, or an authorized repr esentative agent for the compan y. While this individual would not be able to sign the certification statemen t required for the initial IUR submission, he or she would be able to provide additio nal information, if needed, using CDX. For 2006 and prior IUR submissions, submitters were not able to pr ovide additional information electronically.

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### 3.12 Modifications Specifica lly Affecting Importers
Submitters report IUR data on chemicals that they ma nufacture domestically and that they import into the United States. Current IUR regulations require th at the site responsible for reporting for imported chemicals is the site of the operating unit that is di rectly responsible for importing the 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 fo r importer reporting are found in both the definition for site in §710.3 and in paragraph §710.48(b). EPA is proposing to eliminate unnecessary duplica tion in the IUR regulation by moving the additional information regarding the importer s ite from §710.48(b) into a revised definition for site , and eliminating paragraph §710.48(b). In addition, EPA has observed that submitters oc casionally 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 substance and that controls the import transaction h as no U.S. address. The Agency expects that all importers will have a U.S. site, as defined in th e proposed § 711.3 definition for site because, under Customs regulations at §141.18, a non-resident cor poration is not permitted to enter merchandise for consumption unless it has a resident agent in the St ate where the port of entry is located, who is authorized to accept service of process against the corporation. For purposes of IUR, currently submitters are allowe d to report the IUR information jointly with the foreign manufacturer of the chemical. Importers may not know the specific chemical identity of a substance because the foreign supplier chooses to keep it confidential. In such a situation, the importer is still responsible for ensuring that the IUR informatio n is submitted to EPA and may do so by submitting a joint report. To do so, the U.S. importer, as the prim ary submitter, completes the majority of the required information, but supplies a trade name or other desi gnation to identify the chemical substance. In addition, the primary submitter provides technical c ontact 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 a nd company information but provides the primary submitter’s site information. The secondary submitte r should also provide the upfront substantiation required for any confidentiality claims for chemical identity. Under the proposed rule, the process would be the sa me, except that submitters would be required to use CDX and e-IUR for preparation and submission of joint submissions. Previously, joint submissions could not be made electronically. In order to submit el ectronically 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. The secondary submitter (e.g., a foreign supplier or manufacturer) would have to register as someone authorized by the primary submitter’s (e.g., the importer’s) authorized official to send joint submissions to EPA. For joint submissions to be submitted electronically, the primary submitter would use e-IUR to identify the need to submit a joint report and woul d 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 n eed to use e-IUR to identify the need to submit a joint report and would identify itself as a secondary s ubmitter. 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 pe rcentages. This information would be saved by the

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3-14 reporting tool and bot h 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 reporting cycle, EPA set aside joint submissions until both were received and matched. Oftentimes, EPA had no way to determin e 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 jo int IUR reporting easier for industry and streamline EPA processing of the IUR information submitted in the 2011 reporting cycle.



### 3.13 Modify Reporting Frequency

Prior to the 2003 Amendments, the IUR collecti on occurred every four years. EPA reduced the reporting frequency from every four years to every five years starting with the 2006 IUR to reduce the burden associated with the amended IUR. The Agency now has determined that reporting every five years is too infrequent, and is proposing to return to reporting every four years. While the less frequent reporting does reduce burden, EPA now believes that reporting every five years does not provide data sufficiently current to me et Agency and public need s. The Agency has been criticized for using outdated information. EPA, th erefore, is considering increasing the frequency of reporting to every three years, or possibly to annual reporting. The Agency belie ves 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 syst ems and practices to collect the required information.

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## 4. Industry Burden and Cost Estimates

4.1 Methodology for Compliance Cost and Burden Analysis
This chapter analyzes the changes in industry compliance burden and cost associated with the proposed amendments to the IUR rule. EPA calculates the incremental burden and cost, or savings, of the amendments by comparing the burden and cost of complying with the proposed amendments to the burden and cost that industry would incur to comply with current IUR requirements in the 2011 reporting cycle absent the amendments (the baseline). The methodology for estimating the change in industry burden and cost can be summarized as follows:

 Step 1 : Identify the tasks that sites perform to comply with reporting requirements for both the current IUR requirements and the proposed IUR amendments.

 Step 2 : Determine the unit burden and cost for all ac tivities identified in Step 1, based on labor requirements for managerial, technical, and clerical st aff, current wage rates, and other current costs.

 Step 3 : Determine the expected number of sites a nd reports filed under both the current IUR requirements and the proposed IUR amendments.

 Step 4 : Multiply the burden and cost per form by th e number of forms to determine the estimated total burden and cost of compliance for the current IUR and the proposed IUR amendments.

 Step 5 : Subtract the compliance burden and cost afte r the proposed IUR amendments from the burden and cost under the current IUR requirements to calcu late the incremental additional burden and cost or savings attributable to the amendments. A chemical company may own many sites; each of which may manufacture (including import) multiple chemicals. Each site must submit a Form U if it exceeds the 25,000 lb. threshold for at least one chemical that is not exempt from reporting. A site will submit one Form U Part I, and either a full or partial report for each chemical that meets or exceeds the reporting threshold. E ach report is submitted for a unique chemical/site combination. Th e activities under these tasks are as follows:

 Compliance Determination : To determine whether it must submit a Form U, a site must determine whether (1) it manufactures or imports any chemical s that do not fall into one of the categories exempt from reporting; (2) the annual production or im port volume of the chemical is at or above the reporting threshold; and (3) the company meets the small business criteria set forth in the TSCA §8(a) Small Manufacturer Exemption Rule (40 CFR §704.3). For simplicity, the cost for compliance determination is considered to be incurred once per site, and not to vary with the number of chemicals at the site. A portion of the compliance determina tion cost depends on the number of chemicals, but for most chemicals this component of the burden will be extremely small. The majority of the time required for this task involves identifying the re quirements and reviewing information to determine whether the site must submit a Form U.

 Rule Familiarization : Once a site has determined that it must submit a Form U, staff must familiarize themselves with the requirements of the ru le. Sites that reported previously must become familiar with new requirements, and sites new to reporting must become familiar with all requirements. This entails reading the rule, unders tanding the various reporting and administrative requirements, and determining the manner in which the reporting requirements will be met.

 Preparation and Submission of Reports : Once a site has determined that it must submit a Form U for a chemical and has become familiar with the ru le, the required information must be collected and a Form U covering all of the reportable chemicals at that site must be completed, reviewed, and submitted to EPA. This task involves any research necessary to identify the correct information to report, the act of completing Form U (technical a nd clerical burden), managerial review, and any mailing or other submission costs.

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4-2  Recordkeeping : Submitters must keep records supporting their submissions for five years. More information on estimating compliance costs under the current IUR rule can be found in the economic analyses for the 2003 Amendments, Economic Analysis for the Amended Inventory Update Rule (EPA, 2002a) and for the 2005 Amendments, (EPA, 2005).



### 4.2 Industry Unit Burden and Cost Estimates
The industry reporting burden and cost are calculated based on estimates of wage rates, labor hours, and the numbers of sites and reports. This section d escribes the specific data used to develop these estimates.

4.2.1 Estimates of Wage Rates 

### Standard wage rates for managerial, technical, and clerical levels were de veloped from information published by the Bureau of Labor Statistics (BLS) and a method outlined in the document Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b). Average wage data for the three major occupational groups are published quarterly by the BLS in the Employer Costs for Employer Compensation (ECEC) reports. Managerial, technical , and clerical wage rates are taken from the “Management, Business, and Financial”, “Professi onal and Related”, and “Office and Administrative Support” occupational groups respectiv ely. Wage data for the three occupational categories was gathered for manufacturing industries from Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006 – December 2008 (BLS, 2009). Fringe benefits costs, such as health insurance and vacation, for each labor category are taken from the same ECEC series. Following the methodology outlined in (EPA, 2002b), fringe benefits are calculated as a percentage of total wages for each cat egory. An additional 17 percent is added to the wages in each category to account for overhead, base d on information provided by the chemical industry and chemical industry trade associations in the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). The wages for each of the three categories were then multiplied by benefits and overhead factors to estimate loaded , annual salaries in 2008 dollars. Table 4-1 contains the loaded wage rates for the managerial, t echnical and clerical occupation categories.

Table 4-1: Derivation of Loaded Wage Rates fo r the Private Manufacturing Sector (2008$)

Wage 1 Fringe Benefits 1 Fringes as % of Wage Overhead % of Wage 2 Fringe + Overhead Factor Loaded Wages

(a) (b) (c) = (b)/(a) (d) (e)=(1)+(c)+(d) (f) = (a)*(e)
Managerial $43.22 $19.46 48.37% 17% 1.62 $70.03

Technical $35.29 $17.55 47.58% 17% 1.67 $58.84

Clerical $17.22 $8.33 45.03% 17% 1.65 $28.48

Notes: 1 Employer Costs for Empl oyee Compensation Supplemen tary Tables: Historical Data December 2006 – December 2008, US Bureau of Labor Statistics, March 12, 2009 (BLS, 2009).
2 An overhead rate of 17% was estimated based on industry data gathered for the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).

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4-3 4.2.2 Estimates of Baseline Labor Hours (Burden) 

### As mentioned earlier, the reporting tool for the IUR rule is Form U. (See Appendix A for a copy of the current Form U). Each site must determine whethe r it must comply with the IUR rule. Sites that are required to report then must become familiar with th e rule’s reporting requirements. The costs associated with these tasks are calculated per site, and do not vary with the number of chemicals reported by the site. Each reporting site is required to f ile only one Part I of Form U, regardless of the number of reportable chemicals it manufactures or imports. The information required in Part I, such as site and company identification, are common to all chemicals produced at a single site; therefore, this information need only be reported once. For each reportable chemical, a site must prepare and submit Part II and, if applicable, Part III of Form U. For the purpose of this analysis, a “report” can be either a partial report (Parts I and II of Form U) or a full report (Parts I, II, and III of Form U), submitted for one chemical. Submission costs, in the baseline, consist of mailing costs, and are cal culated per-site. Recordkeeping costs are calculated as per-report costs (so that total reporting and recordk eeping costs vary with the number of chemicals reported). In summary, compliance costs are determined as follows:

 Compliance Determination: per-site basis

 Rule Familiarization: per-site basis

 Preparation of Part I: per-site basis

 Preparation of Parts II and III: per report basis

 Submission: per-site basis

 Recordkeeping: per-report basis The baseline estimates of the labor hours required for the various tasks are taken from the economic analyses from the 2002 and 2005 IUR rule Amendm ents (EPA, 2002a and EPA, 2005). An industry survey conducted for the 2002 economic analysis provides estimates of the burden to complete each section and subsection of Form U. Compliance determ ination, rule familiarization, and recordkeeping burdens are also taken from the 2002 economic an alysis. The economic analysis for the 2005 Amendments assumed a 15 percent reduction in burden for the completion of Part III because submitters were no longer required to report use and downstream processing information for exports. 3 

### Therefore, this 15 percent reduction was applied to a ll of the 2002 burden estimates in Part III of the form, to estimate the current baseline. The 2002 economic analysis presents low and high estimates for each burden element; for simplicity, this report uses the midpoints of these ranges. Table 4-2 contains the burden estimates, per site, to complete and submit a Form U (one report for one chemical).

3 In the 2005 economic analysis, EPA es timated that 15 percent of the produc tion volume at an average site is exported. Because processing and use information was no longer required for this percentage of production volume, the effort to collect and report this information would decrease accordingly.***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-4Table 4-2: Baseline First-Cycle Labor Burden per Form U, in HoursClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Compliance Determination(Total Burden for Form U Compliance Determination)0.00 2.50 0.00 2.50Rule Familiarization(Total Burden for Form U Submission)0.00 19.00 9.00 28.00Recordkeeping(Total Burden for Form U Recordkeeping)1.50 3.00 1.50 6.00Submission(Total Burden for Form U Submission)0.00 0.00 0.00 0.00Mailing Burden 0.00 0.000.000.00Part I.Site Identification Information(Total Burden for Part I)0.76 0.95 1.05 2.761 Certification 0.68 0.85 1.01 2.542 Company InformationCompany Name, Technical Contact, Address, D&BNumber, Mailing Address0.04 0.04 0.02 0.103 Plant Site IdentificationPlant Name, D&B Number Address, MailingAddress0.05 0.06 0.02 0.13Part II.Manufacturing Information(Total Burden for Part II)1.55 8.78 3.49 13.821 Chemical Identification2 (Other) Manufacturing InformationSite-Limited, Activity, Production Volume (lb.) 0.52 2.28 0.56 3.36Chemical Identification Up-front CBISubstantiation0.26 1.45 0.67 2.38Plant Site Up-Front Substantiation0.12 0.83 0.51 1.46***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-5ClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Total Number of Workers0.21 1.43 0.59 2.23Maximum Concentration, Physical Form, PercentVolume of Production0.44 2.79 1.07 4.30Part IIIProcessing and Use Information(Total Burden for Part III)7.94 45.31 16.66 69.921 Industrial Processing and Use Exposure-Related DataDetermination of Applicability 0.13 1.01 0.28 1.42Industrial Function Category 2.11 4.41 2.07 8.59Function Code 0.19 0.94 0.40 1.52Percent of Production Volume 1.23 10.00 5.27 16.51Total Number of Processing and Use Sites 1.57 9.14 3.52 14.24Total Number of Potentially Exposed Workers 2.10 15.43 3.83 21.362 Consumer and Commercial UseExposure-Related DataDetermination of Applicability 0.14 0.94 0.25 1.33Identification of Production Category/Use byChildren0.14 0.84 0.25 1.23Percent of Production Volume 0.20 1.26 0.45 1.91Maximum Concentration by Category 0.11 1.36 0.34 1.81Total Burden for Report Preparation and SubmissionPartial Report (Parts I, II, Recordkeeping and SubmissionBurden)3.81 34.23 15.04 53.08Full Report (Parts I, II, III, Recordkeeping and SubmissionBurden)11.74 79.54 31.70 122.99Note:Totals may not sum due to rounding.Source:Revised Economic Analysis for the Amended Inventory Update Rule: Final Report(EPA, 2002a).

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4-6 The survey conducted for the economic analysis for the Final TSCA Inventory Reporting rule 2003 Amendments (EPA, 2002a) estimated a single burden for reporting site-limite d activity and production volume. This burden is estimated to be 3.36 hours pe r site (see Table 4-3) and covers four separate activities:

 Answering a yes/no question to indicate wh ether the volume is site-limited volume;

 Indicating whether the chemical is manufactured or imported;

 Providing the manufactured production volume; and

 Providing the imported production volume. Several of the proposed amendments are expected to create burdens similar to one of the above activities, but none are expected to generate a burden e quivalent to all four questions combined. To more accurately estimate the burden of several proposed amendments, EPA used its best professional judgment and estimated the percent burden each activity cont ributed to the total burden of 3.36 hours. These burdens are found in Table 4-3.

Table 4-3: Burden Percentages Attributed to Site-Limited Activity and Production Volume Questions
Activity Percent of Total Burden Burden (hours)Answering a yes/no question to indicate whether the volume is sitelimited volume 5% 0.17

Indicating whether the chemical is manufactured or imported 5% 0.17 Providing the manufactured production volume 45% 1.51 Providing the imported production volume 45% 1.51
Total 100% 3.36

4.2.3 Estimates of Subm ission (Mailing) Costs 

### As noted above, the baseline scenario in this analysis is the total cost that a site would incur to comply with the current IUR rule, absent any of the proposed amendments. Therefore, the Agency estimated the cost of a mail-in submission of Form U, using data from the United States Postal Service website. Following the mailing requirements outlined in the Economic Analysis of Expedited Significant New Use Rules for 56 Chemical Substances (EPA, 2008b), a mail-in submission is assumed to consist of mailing a document via first class registered mail with a return receipt. The cost is estimated to be $13.78 per report and is itemized in Table 4-4.

Table 4-4: Mailing Submissi on Costs (December, 2009)
USPS Service Cost (2008$) Registered mail, regular, with $0 declared value 1 $10.60 Return receipt, requested at time of mailing (receive by mail) 1 $2.30 Postage, First Class Mail for larger envelopes, up to 1 ounce 2 $0.88 Total $13.78 Source : USPS, 2009

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4-7 4.2.4 Estimates of Baseline Cost per Report 

### EPA estimated the baseline cost to industry of completing and submitting Form U, using the loaded wages rates in Section 4.2.1, the estimated labor hour s in Section 4.2.2, and the mail-in submission costs derived in Section 4.2.3. The burden hours fo r each occupation category are multiplied by the corresponding wage rate to calculate the baseline cost per site of completing each section of Form U. EPA estimates the total cost per site of submitting and co mpleting a partial report (Parts I, II, recordkeeping and submission costs) for the first time is $3,188. EPA estimated the cost to a site of submitting and completing a full report (Parts I, II, III, recordkeeping and submission costs) for the first time is $7,247, for one chemical. Table 4-5 contains the submission costs by section for first-time submitters, including the costs for compliance determination, rule familia rization, report preparation, report submission, and recordkeeping costs.***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-8Table 4-5: Baseline Total Cost per Form U (2008$)Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Compliance Determination(Total Burden for Form U Compliance Determination)$0.00 $147 $0.00 $147Rule Familiarization(Total Burden for Form U Submission)$0.00 $1,118 $630 $1,748Recordkeeping(Total Cost for Form U Recordkeeping)$42.72 $177 $104 $324Submission(Total Cost for Form U Submission)$13.78Mailing Cost$13.78Part I.Site Identification Information(Total Cost for Part I)$21.50 $54.08 $73.53 $149.101 Certification $19.22 $50.01 $70.73 $139.962 Company InformationCompany Name, Contact, Address , D&B Number,Mailing Address$1.00 $2.35 $1.40 $4.753 Plant Site IdentificationPlant Name, D&B Number Address, MailingAddress$1.28 $1.71 $1.40 $4.39Part II.Manufacturing Information(Total Burden for Part II)$44.14 $516.61 $244.40 $805.141 Chemical Identification2 (Other) Manufacturing InformationSite-Limited, Activity, Production Volume (lb.) $14.81 $134.15 $39.22 $188.18Chemical Identification Up-front CBISubstantiation$7.40 $85.32 $53.57 $146.29***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-9Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Plant Site Up-front Substantiation$3.42 $48.84 $35.57 $87.97Total Number of Workers$5.98 $84.14 $40.97 $131.09Maximum Concentration, Physical Form, PercentVolume of Production$12.53 $164.16 $74.93 $251.62Part IIIProcessing and Use Information(Total Cost for Part III)$226.08 $2,666 $1,167 $4,0591 Industrial Processing and Use Exposure-Related DataDetermination of Applicability $3.63 $59.27 $19.94 $82.84Industrial Function Category $60.15 $259.57 $144.64 $464.36Function Code $5.33 $55.01 $27.68 $88.02Percent of Production Volume $35.10 $588.41 $369.34 $992.85Total Number of Processing andUse Sites $44.78 $537.89 $246.72 $829.40Total Number of Potentially Exposed Workers $59.91 $907.74 $268.15 $1,2362 Consumer and Commercial UseExposure-Related DataDetermination of Applicability $4.11 $55.01 $17.56 $76.69Identification of Production Category/Use byChildren$4.11 $49.26 $17.56 $70.64Percent of Production Volume $5.81 $74.02 $31.55 $111.38Maximum Concentration by Category $3.15 $80.02 $24.11 $107.28Total Cost for Report Preparation and SubmissionPartial Report (Parts I, II, Recordkeeping and SubmissionCosts)$108 $2,012 $1,053 $3,188Full Report (Parts I, II, III, Recordkeeping and SubmissionCosts)$334 $4,678 $2,220 $7,247Note:Totals may not sum due to rounding.Source:Revised Economic Analysis for the Amended Inventory Update Rule: Final Report(EPA, 2002a).

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4-10 4.2.5 Estimates of the Number of Sites and Reports 

### The baseline number of reports EPA is expecting, and the number of sites submitting those reports, were calculated based on 2006 IUR submissions to EPA . The total number of reports is broken down into sites that filed full reports and sites that filed partia l reports, because of the difference in cost between the two types of reports. The number of reports EPA is expecting was estimated using data compiled from EPA’s 2006 IUR Database (EPA, 2008c). The database c ontains information collected under the IUR rule for previous reporting cycles and was used to gene rate estimated numbers of expected reports. The Agency assumes that because of the low company tu rnover rate within the chemical manufacturing industry, the baseline number of sites submitting Form U in 2011 will be equivalent to the number of sites submitting Form U in 2006. In addition, for the purp oses of this analysis EPA assumes that the baseline number of reports submitted will not change from the 2006 submissions. In 2006, a total of 4,085 sites completed 25,896 forms as shown in Table 4-6

Table 4-6: Baseline Number of Reports and Sites
Number of Partial Reports Number of Full Reports Total

Number of Sites 568 3,517 4,085
Number of Reports 8,821 17,075 25,896 Source: U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division 2006 IUR Database Statistics for IUR Modifications Rule . Washington, DC. December 17, 2008 (EPA, 2008c).



### Limitations of Analysis . Due to inconsistencies and limitations in the data collected in 2002 and 2006, including the amendment requiring reports for inor ganic chemicals for the first time in 2006 and the change in the reporting threshold from 10,000 to 25,000 lb., it was not possible for EPA to compare records to determine whether there was a significant change in the number of sites and reports submitted for a consistent set of chemicals between the two re porting cycles. Such an analysis potentially could provide support for EPA’s assumption that the number of sites and reports will remain relatively unchanged in the next reporting cycle. Therefore, to the extent that changes in the chemical industry unrelated to the proposed IUR rule amendments coul d affect the number of s ite and reports submitted, this analysis may under- or overestimate costs and burden.

4.2.6 Estimates of Future Reporting Cycles’ Labor Hours (Burden) 

### EPA assumes that sites that previously have submitted a Form U will have less of a burden for processing and submitting Form U in future reporting cycl es. All sites will incur a higher reporting cost in the first reporting cycle after the rule amendments ar e finalized, due to an increase in burden to become familiar with the revised requirements. However, the Agency assumes that unit costs for report preparation and submission in future reporting cycles will be lower than the unit costs attributed to reporting in the first reporting cycle because of e fficiencies achieved through the establishment of compliance processes (EPA, 2002a). Furthermore, after a site’s first reporting cycle, the availability of data from previous reporting cycles and familiarity with reporting requirements will expedite the process for submitters who have previous ly submitted a Form U. The burde n estimates for these sites are weighted to reflect this decreased burden (EPA, 2002a). Table 4-7 contains the weighting factors for each section of the form. Table 4-8 contains the baseline, future reporting cycle, per report burden estimates, which are calculated using the weights in Table 4-7 and the first reporting cycle burden estimates in Table 4-2. Table 4-9 contains the baseline future reporting cycle costs per report, which are calculated using the wage rate in Table 4-1 and the hour ly burden estimates from Table 4-8.

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4-11 Table 4-7: Weighting Factors for Burden Estimate s for Sites That Have Previously Submitted a Form U



### Section of Form U Incurred Percent of Initial Burden 1



### Part I. Site Identification
Certification 100% Section A Company Information 20% Section B Plant Site Identification 20% Section C Technical Contact 20% Part II. Manufacturing Information Section A Chemical Identification 20% Section B (Other) Manufacturing Information 80% Part III. Processing and Use Information

Section A Industrial Processing and Use Exposure Related Data 80%

Section B Industrial Processing and Use Exposure Related Data 80%

1 Weighting factors are from the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a), pp. 3-17.***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-12Table 4-8: Baseline Future-Cycle Labor Burden per Report, in HoursClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Compliance Determination(Total Burden for Form U Compliance Determination)0.00 2.50 0.00 2.50Rule Familiarization(Total Burden for Form U Submission)0.00 2.00 2.00 4.00Recordkeeping(Total Burden for Form U Recordkeeping)1.50 3.00 1.50 6.00Submission(Total Burden for Form U Submission)0.000.000.000.00Mailing Burden 0.000.000.000.00Part I.Site Identification Information(Total Burden for Part I)0.69 0.87 1.02 2.581 Certification 0.68 0.85 1.01 2.542 Company InformationCompany Name, Technical Contact, Address,D&B Number, Mailing Address0.01 0.01 0.00 0.023 Plant Site IdentificationPlant Name, D&B Number Address, MailingAddress0.01 0.01 0.00 0.03Part II.Manufacturing Information(Total Burden for Part II)1.24 7.02 2.79 11.061 Chemical Identification2 (Other) Manufacturing InformationSite Limited, Activity, Production Volume (lbs) 0.42 1.82 0.45 2.69Chemical Identification Up-front CBISubstantiation0.21 1.16 0.61 1.98***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-13ClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Plant Site Up-front Substantiation0.10 0.66 0.41 1.17Total Number of Workers0.17 1.14 0.47 1.78Maximum Concentration, Physical Form, PercentVolume of Production0.35 2.23 0.86 3.44Part IIIProcessing and Use Information(Total Burden for Part III)6.35 36.25 13.33 55.931 Industrial Processing and Use Exposure-Related DataDetermination of Applicability 0.10 0.81 0.23 1.14Industrial Function Category 1.69 3.53 1.65 6.87Function Code 0.15 0.75 0.32 1.21Percent of Production Volume 0.99 8.00 4.22 13.21Total Number of Processing and Use Sites 1.26 7.31 2.82 11.39Total Number of Potentially Exposed Workers 1.68 12.34 3.06 17.092Consumer and Commercial Use Exposure-RelatedDataDetermination of Applicability 0.12 0.75 0.20 1.06Identification of Production Category/Use byChildren0.12 0.67 0.20 0.98Percent of Production Volume 0.16 1.01 0.36 1.53Maximum Concentration by Category 0.09 1.09 0.28 1.45Total Burden for Report Preparation and SubmissionPartial Form (Parts I, II, Recordkeeping and SubmissionBurden)3.43 15.39 7.31 26.14Full Form (Parts I, II, III, Recordkeeping and SubmissionBurden)9.78 51.64 20.64 82.07Note:Totals may not sum due to rounding.***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-14Table 4-9: Baseline Future-CycleTotal Cost per Report (2008$)Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Compliance Determination(Total Burden for Form U Compliance Determination)$0.00 $147 $0.00 $147Rule Familiarization(Total Burden for Form U Submission)$0.00 $118 $140 $258Recordkeeping and Submission Costs(Total Cost for Form U Recordkeeping)$42.72 $176.52 $105.04 $324.28Submission(Total Burden for Form U Submission)$13.78Mailing Cost$13.78Part I.Site Identification Information(Total Burden for Part I)$19.68 $51.19 $71.29 $142.161 Certification $19.22 $50.01 $70.73 $139.962 Company InformationCompany Name, Technical Contact, Address,D&B Number, Mailing Address$0.20 $0.47 $0.28 $0.953 Plant Site IdentificationPlant Name, D&B Number Address, MailingAddress$0.26 $0.71 $0.28 $1.24Part II.Manufacturing Information(Total Burden for Part II)$35.31 $413.29 $195.52 $644.121 Chemical Identification2 (Other) Manufacturing InformationSite Limited, Activity, Production Volume (lbs) $11.85 $107.32 $31.37 $150.54Chemical Identification Up-front CBISubstantiation$5.92 $68.25 $42.86 $117.03***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-15Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Plant Site Up-front Substantiation$2.73 $39.07 $28.57 $70.37Total Number of Workers$4.78 $67.31 $32.77 $104.87Maximum Concentration, Physical Form,Percent Volume of Production$10.02 $131.33 $59.94 $201.30Part IIIProcessing and Use Information(Total Burden for Part III)$180.87 $2,132.97 $933.56 $3,247.401 Industrial Processing and Use Exposure-Related DataDetermination of Applicability $2.90 $47.41 $15.95 $66.27Industrial Function Category $48.12 $207.66 $115.71 $371.49Function Code $4.26 $44.01 $22.14 $70.41Percent of Production Volume $28.08 $470.73 $295.47 $794.28Total Number of Processing andUse Sites$35.82 $430.32 $197.38 $663.52Total Number of PotentiallyExposed Workers$47.93 $726.19 $214.52 $988.642 Consumer and Commercial UseExposure-Related DataDetermination of Applicability $3.29 $44.01 $14.05 $61.35Identification of ProductionCode/Use by Children$3.29 $39.41 $13.81 $56.51Percent of Production Volume $4.65 $59.22 $25.24 $89.10Maximum Concentration byCategory$2.52 $64.02 $19.29 $85.82Total Cost for Report Preparation and SubmissionPartial Form (Parts I, II, Recordkeeping and SubmissionCosts)$97.71 $906 $512 $1,529Full Form (Parts I, II, III, Recordkeeping and SubmissionCosts)$279 $3,039 $1,446 $4,777Note:Totals may not sum due to rounding.

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4-16 

### 4.3 Total Baseline IUR Industry Compliance Burden and Costs
The estimated wage rates, burden hours, and numbe r of sites were combined to estimate the total baseline costs to comply with the current IUR rule in the 2011 reporting cycle. Costs were aggregated either per site or per report, depending on how the costs are incurred. Compliance determination and rule familiarization were estimated on a per-site basis; the costs for completing Part I of Form U were estimated on a per-site basis. The cost of completi ng Parts II and III of Form U were calculated on a perreport basis, and submission and recordk eeping were estimated on a per-report basis. Table 4-10 shows the total burden and cost industry under the current baseline. The current IUR rule would cost industry approximately 1.84 million hours and $106.97 million during the 2011 reporting cycle.

Table 4-10: Total Baseline Cost and Burden to Industry (2011 Reporting Cycle)
Burden for all Part Is, Rule Familiarization,

Compliance Determination and Submission Burden for all Part IIs and Recordkeeping Burden for all Part IIIs Total Burden Under the Current IUR

Requirements

Burden in Hours 135,847 513,259 1,193,829 1,842,934 Cost (2008$) $8,407,651 $29,247,454 $69,311,707 $106,966,812



### Table 4-11 contains the total annual baseline costs to industry for future reporting cycles – that is, the burden and cost to industry for reporting cycles afte r the 2011 cycle, in the absence of the proposed amendments. The baseline for future reporting cycles is different than the baseline for the first reporting cycle due to efficiency gains. EPA assumes costs for report preparation and submission in future reporting cycles will be lower than costs in the first reporti ng cycle because of efficiencies achieved through the establishment of compliance processe s, the availability of data from previous reporting cycles, and familiarity with reporting requirements (EPA, 2002a). The weighting factors found in Table 4-7 were applied to the baseline burden estimates found in Tabl e 4-2 and Table 4-5. In all future reporting cycles, EPA estimated the baseline burden to industry as a pproximately 1.43 million hours and $82.82 million.

Table 4-11: Total Baseline Cost and Burden to Industry (Future Reporting Cycles)
Burden for all Part Is, Rule Familiarization,

Compliance Determination and Submission Burden for all Part IIs and Recordkeeping Burden for all Part IIIs Total Burden Under the Current IUR

Requirements

Burden in Hours 37,088 441,682 955,063 1,433,833 Cost (2008$) $2,290,736 $25,077,449 $55,449,366 $82,817,550



### Limitations of Analysis . As described in Section 4.2.5, due to inconsistencies and limitations in the IUR data collected in 2002 and 2006, it was not possible for EPA to compar e records to determine whether there was a significant change in the number of sites and reports submitted for a consistent set of chemicals between the two reporting cycles. Such an an alysis potentially could provide support for EPA’s assumption that the number of sites and reports will remain relatively unchanged in the next reporting cycle. Therefore, to the extent th at changes in the chemical industry unrelated to the proposed IUR rule

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4-17 amendments could affect the number of site and re ports submitted, the baseline burden and cost may be under- or overestimated.



### 4.4 Changes in Industry Burden and Costs Due to the Proposed IUR Modifications Rule
The expected cost and burden impacts of each of the proposed amendments to the IUR rule are outlined below. See Section 3. for more detailed in formation about each of these proposed amendments. In each of the sections below, the burden estimates for each amendment are calculated independently of the other amendments . See Section 4.5 for an estimate of the aggregated impact of all proposed amendments.

4.4.1 Technical Modifications to the Regulatory Text 

### EPA is proposing to reorganize certain existing rule text and to delete obsolete text. These amendments do not substantively affect the rule text , so EPA assumes that this amendment will not affect industry burden or cost.

4.4.2 Modifications to Selected Definitions 

### EPA is proposing to modify the definitions of “i mporter,” “manufacture,” “site,” “commercial use,” “consumer use,” “reporting year,” and “submission pe riod,” and to add definitions for “manufacturer,” “Central Data Exchange (CDX),” “electronic IUR (e-IUR),” and “industrial function,” as described in Section 3. These changes are clarifications only; EPA is clarifying in rule text what has been previously explained through outreach with the regulated comm unity. Therefore, EPA does not expect changes to definitions to impact industry burden or cost.

4.4.3 Method for Determining Whether a Manufactur er is Subject to IUR Reporting Requirements 

### Under the current IUR rule requirements, a subm itter completes a report only if its chemical production has met or exceeded the 25,000 lb. produc tion threshold during the principal reporting year. EPA is proposing to modify the timeframe for repor ting, so that chemical manufacturers (including importers) will be subject to the IUR rule if a chem ical’s production volume has exceeded the threshold in any calendar year since the last principal reporting year. EPA believes that this proposed amendment will cau se an increase in the numbers of submitters and reports. Because data on the production volume of ch emicals reportable under the IUR rule during nonprincipal reporting years is not currently available, the actual percentage increase in these numbers is unknown. The Agency, using its best professional ju dgment, estimates that for the purpose of this analysis the amendment will increase the number of submitte rs and reports by approximately five percent. Using an estimated five percent increase over th e baseline number of sites and reports (baseline presented in Table 4-6), EPA estimates that 204 ad ditional sites will submit reports. EPA further estimates that those sites will submit an additional 854 full reports and 441 partial reports, for a total of 1,295 additional reports for the 2011 reporting cycle and each future reporting cycle. As described in Section 4.1, sites need to complete Part I of Form U only once, and complete Part II and Part III (as applicable) for each chemical manuf actured or imported. Taking this allocation of activities into consideration, and using the baselin e unit burden estimates as shown above in Table 4-2 and Table 4-8, Table 4-12 shows the industry burde n estimate as a result of this proposed amendment. The Agency estimates that the amendment will gene rate an annual increase in industry burden of approximately 92,150 hours during the 2011 reporting cycle and approximately 71,700 hours during all future reporting cycles.

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4-18 Table 4-12: Change in Industry Burden as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements
Burden for Compliance Determination, Rule Familiarization, Submission and to Prepare

Part I (hours per site) Number of Sites Burden for Recordkeeping and to Prepare Part II (hours per

report) Number of Reports Burden to Prepare Part III (hours

per report) Number of Reports with Part III Industry Burden (hours)

(a) (b) (c) (d) (e) (f) (g) = (a * b)+ (c * d)+(e * f) First Cycle, Baseline 33.26 4,085 19.82 25,896 69.92 17,075 1,842,934First Cycle, PostAmendment 33.26 4,289 19.82 27,191 69.92 17,929 1,935,081
Change from the Baseline, First Cycle 0.00 204 0.00 1,295 0.00 854 92,147
Future Cycle Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833Future Cycle, PostAmendment 9.08 4,289 17.06 27,191 55.93 17,929 1,505,524
Change from the Baseline, Future Cycles 0.00 204 0.00 1,295 0.00 854 71,692

Note: Values in Change from the Baseline rows are calculated by subtracting the corres ponding baseline value from the post-amendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-13 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that the industry cost will increase by $5.35 million in the first reporting cycle and $4.14 million in all future reporting cycles.

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4-19 Table 4-13: Change in Industry Cost as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements
Cost for Compliance Determination, Rule Familiarization, Submission and to Prepare

Part I (2008$ per site) Number of Sites Cost for Recordkeeping and to Prepare Part II (2008$ per

report) Number of Reports Cost to Prepare Part III (2008$

per report) Number of Reports

with Part III Industry Cost (millions

2008$)

(a) (b) (c) (d) (e) (f) (g) = (a * b)+ (c * d)+(e * f) First Cycle, Baseline $2,058 4,085 $1,129 25,896 $4,059 17,075 $106.97First Cycle, PostAmendment $2,058 4,289 $1,129 27,191 $4,059 17,929 $112.32
Change from the Baseline, First Cycle $0 204 $0 1,295 $0 854 $5.35
Future Cycle Baseline $561 4,085 $968 25,896 $3,247 17,075 $82.82Future Cycle, PostAmendment $561 4,289 $968 27,191 $3,247 17,929 $86.96
Change from the Baseline, Future Cycles $0 204 $0 1,295 $0 854 $4.14

Note: Values in Change from the Baseline rows are calculated by subtracting the corre sponding baseline value from the post-amendment value.



### Limitations of Analysis. To the extent that the change in method for determining whether a manufacturer is subject to the IUR reporting requi rements causes an increase in numbers of sites and reports submitted that is higher or lower than five percent, this analysis may under- or overestimate total burden and cost increase. A sensitivity anal ysis is performed in Appendix F.1. In the proposal, EPA also requested comment on returning to the previous, lower reporting threshold of 10,000 lb. Appendix G. contains an analysis of the cost and burden of this lower threshold.

4.4.4 Eliminate the 300,000 lb. Threshold for Processing and Use Reporting 

### EPA is proposing to eliminate the 300,000 lb. thr eshold for processing and use reporting, thereby requiring all reporters of non-exclude d substances to report information in all parts of the IUR Form U. Eliminating this threshold will increase industry burden by requiring more sites to complete Part III of Form U (Part III contains the downstream processing and use information). This proposed amendment affects only the burden and costs associated with completing Part III; it would not cause an increase in the number of sit es submitting reports. The baseline number of partial reports submitted (that is, forms with only Part I and Part II comp leted) is 8,821 (see Table 4-6). However, several of these reports are submitted for partially exempt chemicals. Under the proposed amendment, submitters of partially exempt chemical s still will not be required to submit a Part III. In 2006, EPA received a total of 618 partial reports (EPA, 2009a) on th e 712 partially exempt chemicals (EPA, 2006a) currently on the partially exempt list. Using the baseline unit burden estimate as shown a bove in Table 4-2 and Table 4-8, Table 4-14 shows the industry burden estimate as a result of th is proposed amendment. The Agency estimates that the amendment will cause an increase in industry burde n of approximately 573,5 00 hours during the first reporting cycle, and 458,800 hours during all future reporting cycles.

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4-20 Table 4-14: Change in Industry Burden as a Resu lt of Eliminating the 300,000 lb. Threshold for Downstream Processing and Use Information Reporting Burden per Report (Part III)

(hours) Total Number of Reports with Part III Total Industry Burden (hours) First Cycle, Baseline 69.92 17,075 1,193,829First Cycle, PostAmendment 69.92 25,278 1,767,356
Change from the Baseline, First Cycle 0 8,203 573,527
Future Cycle Baseline 55.93 17,075 955,063Future Cycle, PostAmendment 55.93 25,278 1,413,884

Change from the Baseline, Future Cycles 0 8,203 458,822

Note: Values in Change from the Baseline rows are calculated by subtracti ng the corresponding baseline value from the post-amendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-15 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that the industry cost will increase by $33.3 million in th e 2011 reporting cycle and by $26.64 million in all future reporting cycles. EPA also explored the possibility of lowering the threshold for processing and use reporting to various levels below 300,000 lb., but greater than 25, 000 lb. (e.g., not eliminating the threshold entirely) (EPA, 2008c). The current 300,000 lb. threshold appli es to each chemical produced at each individual reporting site, and was selected with the intention that exposure-related processing and use information would be collected for HPV chemicals. However, th e uncertainty that thresholds lower than 300,000 lbs. would capture substantially more of the HPV ch emicals, coupled with the need to complete characterizations for chemicals ma nufactured (including imported) in volumes of 25,000 lb. to 300,000 lb., led the Agency to believe that it would be best to eliminate the 300,000 lb. threshold altogether and collect full information for the all reported chemicals

. Table 4-15: Change in Industry Cost as a Result of Eliminating the 300,000 lb. Threshold for Downstream Processing and Use Information Reporting Cost per Report (Part III)

(2008$) Number of Reports with Part III Total Industry Cost (millions 2008$)

First Cycle, Baseline $4,059.25 17,075 $69.31First Cycle, PostAmendment $4,059.25 25,278 $102.61
Change from the Baseline, First-Year $0.00 8,203 $33.30

Future Cycle Baseline $3,247.40 17,075 $55.45Future Cycle, PostAmendment $3,247.40 25,278 $82.09
Change from the Baseline, Future Cycles $0.00 8,203 $26.64

Note: Values in Change from the Baseline rows are calculated by subtracti ng the corresponding baseline value from the post-amendment value.

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4-21 Limitations of Analysis. EPA is assuming that each partially exempt chemical is produced at four different sites. To the extent that this is not the case, this analysis may over- or underestimate the number of additional Part IIIs.

4.4.5 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals 

### EPA is proposing to eliminate the 25,000 lb. threshol d for chemicals that are: (1) the subject of a regulation proposed or promulgated und er section 5(a)(2), 5(b)(4), or 6 of the Act; (2) the subject of an order issued under section 5(e) or 5(f) of the Act, or (3) the subject of relief that has been granted under a civil action under section 5 or 7 of the Act. The manu facturers and importers of these chemicals would be required to report under the IUR rule , regardless of the production volume. To determine how many chemicals this proposed amendment would affect, EPA referred to Appendix C of the Instructions for Reporting for the 2006 Partia l Updating of the TSCA Chemical Inventory Database (EPA, 2006a), which lists chemical substances that are the subject of certain TSCA orders, proposed or final TSCA rules, or relief granted under ci vil actions. A count of all the chemical substances, listed by CASRN, that are subject to a regulation pro posed or promulgated under sections 5(a)(2), 5(b)(4), or 6 of the Act, subject of an order issued under section 5(e) or 5(f) of the Act, or the subject of relief that has been granted under a civil action under section 5 or 7 of the Act, identified 1,131 chemicals. CASRN numbers were provided for 740 of these chemicals, and an additional 391 chemicals were listed by accession numbers (EPA, 2006a). Of the 740 chemicals w ith CAS numbers, no reports were filed for 652 chemicals, or 88 percent of chemicals (EPA, 2009e). EPA also assumes that no reports were filed for 88 percent of the 391 chemicals with accession numbers, or 345 chemicals. In addition, Form Us were submitted voluntarily for eight chemicals with produc tion volume levels below the 25,000 lb. threshold during the 2006 reporting cycle (EPA, 2009a). EPA estimates that reports will now be filed for approximately 1,005 additional chemicals for which reports are not currently required (652+345+8 = 1,005). Based on the data provided in the 2006 IUR reporting cycle (EPA, 2008c), on average, each chemical is produced at approximately four sites; therefore, EPA expects 4,018 additional reports (Part IIs) to be submitted for these chemicals. The Agency also assum es that the reports generated by this amendment would be for production volumes lower than 25,000 lb. (t herefore, lower than 300,000 lb.), so, as a result of this amendment alone, submitters would not be required to complete Part III (see Section 4.5 for an estimate of the aggregated impact of all proposed am endments). In addition, the Agency is assuming that manufacturers (including importers) of these chemical s already would be submitting reports for other non-exempt chemicals; so, therefore, the number of sites would not increase from the baseline as a result of this amendment. Using the baseline unit burden estimate for comple tion of Part II as shown above in Table 4-2 and Table 4-8, Table 4-16 presents the estimated increase in industry burden as a result of this proposed amendment. The Agency estimates th at the amendment will cause an increase in industry burden of approximately 79,600 hours during the first reportin g cycle and 68,500 hours during all future reporting cycles.

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4-22 Table 4-16: Change in Industry Burden as a Resu lt of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals Burden for Recordkeeping and to Prepare Part II

(hours per report) Number of Reports Industry Burden (hours)
First Cycle, Baseline 19.82 25,896 513,259 First Cycle, Post-Amendment 19.82 29,914 592,896 Change from the Baseline, First Cycle 0.00 4,018 79,637 Future Cycle Baseline 17.06 25,896 441,682 Future Cycle, Post-Amendment 17.06 29,914 510,213 Change from the Baseline, Future Cycles 0.00 4,018 68,531

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-17 shows the industry cost estimate as a result of this proposed amendment. The cost to industry is expected to increase by $4.54 million during th e 2011 reporting cycle and $3.89 million during all future reporting cycles.

Table 4-17: Change in Industry Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals Cost for Recordkeeping and to Prepare Part II

(2008$ per report) Number of Reports Industry Cost (millions 2008$)
First Cycle, Baseline $1,129 25,896 $29.25 First Cycle, Post-Amendment $1,129 29,914 $33.79 Change from the Baseline, First Cycle $0 4,018 $4.54 Future Cycle Baseline $968 25,896 $25.08 Future Cycle, Post-Amendment $968 29,914 $28.97 Change from the Baseline, Future Cycles $0 4,018 $3.89

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis. The number of additional reports EPA receives as a result of this amendment may be an overestimate to the extent that manuf acturers (including importers) already are submitting reports for these chemicals. That is, to the extent th at some portion of these chemicals already are subject to IUR reporting because they are produced in vol umes of 25,000 lb. or greater, the Agency is overestimating the number of add itional reports it would receive as a result of the amendment. Furthermore, to the extent that manufacturers (i ncluding importers) of these chemicals do not already submit reports for other chemicals, EPA is underestim ating the number of sites that would increase from the baseline as a result of this amendment.

4.4.6 Make Chemicals Subject to Enforceable Consent Agreements (ECAs) Ineligible for Exemptions 

### Chemicals subject to enforceable consent agreements (ECAs) are of demonstrated interest to the Agency. For instance, EPA will use the IUR data associated with th ese regulated chemicals to monitor chemical production and compliance with the agre ements. Therefore, EPA proposes to make these chemicals ineligible for reporting exemptions. Ma nufacturers (including importers) of these chemicals will no longer be partially exempt, and so must complete Part III of Form U.

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4-23 EPA publishes and updates on its website a list of TSCA Section 4 Federal Register Enforceable Consent Agreements ( http://www.epa.gov/oppt/chemtest/pubs/4eca.html ) (EPA, 2009f). Since 1985, the Agency has entered into enforceable consent agreements for 67 chemicals. Six of the 67 chemicals were composite substances developed for the sole purpose of conducting testing unde r ECAs, and were never listed on the TSCA Inventory. Eliminating those six s ubstances leaves a total of 61 chemicals subject to ECAs.

EPA also maintains a table that shows the sunset date and status for chemicals subject to section 4 actions, including ECAs ( http://www.epa.gov/oppt/chemtest/pubs/sunset.html ) (EPA, 2009g). Only two of the 61 chemicals were identified as being subject currently to an ongoing ECA. Therefore, only two chemicals will lose the partial exemption and under the proposed amendment, would need to complete Part III of Form U. In addition, EPA is assuming that an additional two chemicals could be under ECAs in future reporting cycles. Therefore, EPA is estim ating that the proposed amendment would cause a total of four chemicals to complete Part III of Form U. Based on data from the 2006 IUR reporting cycle, the Agency estimates that approximately four sites produ ce each chemical (EPA, 2008c); therefore, a total of 16 Part IIIs would be submitted for the first time for chemicals subject to an ECA. Using the baseline unit burden estimate for comple tion of Part III as shown above in Table 4-2 and Table 4-8, Table 4-18 shows the industry burden estimat e as a result of this proposed amendment. The Agency estimates that the amendmen t will cause an increase in industry burden of approximately 1,110 hours during the first reporting cycle, and 900 hours during all future reporting cycles.

Table 4-18: Change in Industry Burden as Result of Making Chemicals Subject to ECAs Ineligible for Exemptions Burden per Report (Part III)

(hours) Total Number of Reports with Part III Total Industry Burden (hours) First Cycle, Baseline 69.92 17,075 1,193,829
First Cycle, PostAmendment 69.92 17,091 1,194,947
Change from the Baseline, First Cycle 0 16 1,119

Future Cycle Baseline 55.93 17,075 955,063
Future Cycle, PostAmendment 55.93 17,091 955,958
Change from the Baseline, Future Cycles 0 16 895

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-19 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that the industry cost will increase by $64,900 during the 2011 reporting cycle and by approximately $52,000 during all future reporting cycles.

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4-24 Table 4-19: Change in Industry Cost as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions Cost per Report (Part III) (2008$) Number of Reports with Part III Total Industry Cost (2008$) First Cycle, Baseline $4,059 17,075 $69,311,707First Cycle, PostAmendment $4,059 17,091 $69,376,655
Change from the Baseline, First Cycle $0 16 $64,948
Future Cycle Baseline $3,247 17,075 $55,449,366Future Cycle, PostAmendment $3,247 17,091 $55,501,324
Change from the Baseline, Future Cycles $0 16 $51,958

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis . EPA is assuming that each of these chemicals is produced at four different sites. To the extent that this is not the case, th is analysis may over- or underestimate the number of additional Part IIIs. In addition, some of these chemic als may be produced in volumes of 300,000 lb. or greater, and therefore would already be required to subm it a full report. To the extent that this is the case, this analysis overestimates the total number of additio nal Part IIIs. Finally, to the extent that additional chemicals become subject to ECAs in the future, th is analysis may underestimate the total number of additional Part IIIs.

4.4.7 Full Exemption for Manufactured Water 

### Under the current IUR regulations, manufactured wate r is partially exempt from reporting; therefore, facilities that produce manufactured water only need to complete Parts I and II of Form U. The Agency is proposing to grant a full exemption for manufactured wate r. In 2006, a total of 43 partial reports were submitted for manufactured water (EPA , 2008c). EPA assumes that manufactured water is a byproduct of chemical production. Therefore, sites submitting a re port for manufactured water will continue to submit reports for other chemicals. Thus the burden reduc tion for this proposed amendment would be the result of 43 fewer Part IIs being submitted. Using the baseline unit burden estimate as shown a bove in Table 4-2 and Table 4-8, Table 4-20 shows the reduction in industry burden estimate as a result of this proposed amendment. The Agency estimates that the amendment will cau se a decrease in industry burden of approximately 850 hours during the first reporting cycle, and by 700 hours during all future reporting cycles.

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4-25 Table 4-20: Change in Industry Burden as a Result of Exempting Manufactured Water from Reporting
Burden for Recordkeeping and to Prepare Part II (hours per report) Number of Reports Total Industry Burden (hours) First Cycle, Baseline 19.82 25,896 513,259 First Cycle, Post-Amendment 19.82 25,853 512,406 Change from the Baseline, First Cycle 0 -43 -852 Future Cycle Baseline 17.06 25,896 441,682 Future Cycle, Post-Amendment 17.06 25,853 440,949 Change from the Baseline, Future Cycles 0 -43 -733

Note: Values in Change from the Baseline rows are calculated by subtract ing the corresponding baseline value from the post-amendment value.



### The cost savings due to the amendment were determ ined using the unit costs shown in Table 4-5 and Table 4-9. Table 4-21 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that the industry cost will decrease by approximately $48,600 in the first reporting cycle and $41,600 in all future reporting cycles.

Table 4-21: Change in Industry Cost as a Result of Exempting Manufactured Water from Reporting

Cost for Recordkeeping and to Prepare Part II (2008$ per report) Number of Reports Total Industry Cost (2008$)

First Cycle, Baseline $1,129 25,896 $29,247,454 First Cycle, Post-Amendment $1,129 25,853 $29,198,889 Change from the Baseline, First Cycle $0 -43 -$48,565 Future Cycle Baseline $968 25,896 $25,077,449 Future Cycle, Post-Amendment $968 25,853 $25,035,808 Change from the Baseline, Future Cycles $0 -43 -$41,641

Note: Values in Change from the Baseline rows are calculated by subtract ing the corresponding baseline value from the post-amendment value.



### Limitations of Analysis . EPA is assuming that the sites producing manufactured water are also producing other chemicals above the reporting threshol d, and will continue to submit a Form U, which may not be the case for all sites. In that case, the above estimate would underestimate the savings to the industry.

4.4.8 Remove Fully-Exempt Polymers from the Partially-Exempt List 

### EPA is proposing to amend the partially-exempt list of chemicals to remove three chemical substances: Starch (CASRN 9005-25-8), Dextri n (CASRN 9004-53-9), and Maltodextrin (CASRN 9049- 76-7). These chemicals, as polymers, are already full y exempt from reporting. EPA expects that this proposed amendment will not impact industry burden or costs, because these substances currently are fully exempt from reporting and therefore no submitters currently are required to submit reports for them. That is, this amendment is a clarification only an d EPA assumes it will not chan ge the behavior of the regulated community.

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4-26 4.4.9 Parent Company and Site Identity 

### EPA is proposing that submitters provide the na me, address, and D&B number of their ultimate domestic parent company, as well as for the site. This information was required as part of Form U prior to the 2006 amendments, so the 2002 economic analysis , on which these burden estimates are based, already included the cost of providing the information for the ultimate domestic parent company. The proposed rule will now be consistent with the 2002 analys is, and EPA assumes that the burden estimate will not change from the baseline. Furthermore, for companies that already may not have a D&B number, there is no cost to obtain one.

4.4.10 Technical Contact 

### Manufacturers (including importers) are required to provide a technical contact for their IUR submission. EPA is proposing to amend the IUR rule to require that the technical contact be a person who works on-site, and is knowledgeable about the chem ical. Because submitters already are required to identify a technical contact, EPA assumes that this amendment will not cause an increase in burden.

4.4.11 Chemical Identity 

### EPA is proposing to require that IUR submitters report the Chemical Abstracts (CA) Index Name currently used to list the substance in the Inventory. Currently, submitters are required to report a specific chemical name, with no further elaboration in the regulatory text. EPA is also proposing to allow submitters to report only the CASRN as a chemical id entifying number or, in the case of confidential chemical substances, the accession number. Note th at in cases where a CASRN exists for a confidential chemical, it can be reported instead of the 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 Inventory substance has either or both a CASRN or a TSCA Accession Number, which are likely to be already known to the submitter. The Agency assumes that all manufacturers (including importers) know or can easily obtain the CA Index Names and CASRN numbers for the chemicals they produce. Therefore, EPA assumes that no additional burden will be incurred by requiring subm itters to report the CA Index Name and CASRN as the chemical identity instead of whicheve r unique identifier they currently use.

4.4.12 Report Production Volume for Each of the Years since Last Principal Reporting Year 

### EPA is proposing to require that submitters report production volume for each of the five years since the last IUR principal reporting year. Thus, for th e 2011 IUR, manufacturers (including importers) of subject chemicals would report the production volume for the calendar years 2006, 2007, 2008, 2009, and 2010. While sites will still submit data to EPA only in the submission year, EPA assumes that there will be an increase in burden as the result of gathering data and reporting producti on volumes for an additional four years. According to the baseline burden estimate, a site spends approximately 3.36 hours to gather production volume and site-limited activity (see Table 4-3). EPA estimates that approximately 45 percent of these 3.36 hours (i.e., 1.51 hours) is attributed to gathering producti on volume information. (See Table 4-3 for an explanation of this percentage breakdown. ) Therefore, the Agency estimates that a site would spend an additional 6.05 hours (i.e., 1.51 x 4) to ga ther the production volume information for the four additional non-principal reporting years. Table 4-22 shows the increase in industry burden as a result of this proposed amendment. The Agency estimates that the amendment will cause a to tal increase in industry burden of approximately 156,600 hours in the first reporting cycle and 125,300 hours in all future reporting cycles.

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4-27 Table 4-22: Change in Industry Burden as a Result of Requiring the Reporting of Production Volume in all Non-Principal Reporting Years
Burden to

Report Production

Volume (hours per

report) Number of Reports Industry Burden (hours)

First Cycle, Baseline 1.51 25,896 39,155 First Cycle, Post-Amendment 7.56 25,896 195,774 Change from the Baseline, First Cycle 6.05 0 156,619 Future Cycle Baseline 1.21 25,896 31,324 Future Cycle, Post-Amendment 6.05 25,896 156,619 Change from the Baseline, Future Cycles 4.84 0 125,295 Note: Values in Change from the Baseline rows are calculated by subtract ing the corresponding baseline value from the post-amendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-23 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that the industry cost will increase by $8.77 million in the 2011 submission year and $7.02 million in all future reporting cycles.

Table 4-23: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume in all Non-Principal Reporting Years Cost to Report Production

Volume (2008$ per

report) Number of Reports Industry Cost (millions 2008$)

First Cycle, Baseline $84.68 25,896 $2.19 First Cycle, Post-Amendment $423.40 25,896 $10.96 Change from the Baseline, First Cycle $338.72 0 $8.77 Future Cycle Baseline $67.74 25,896 $1.75 Future Cycle, Post-Amendment $338.72 25,896 $8.77 Change from the Baseline, Future Cycles $270.98 0 $7.02 Note: Values in Change from the Baseline rows are calculated by subtr acting the corresponding baseline value from the post-amendment value.



### Limitations of Analysis . This analysis is based on an assumption about the percentage breakdown of burden estimated to gather producti on volume and site-limited activity. To the extent that the actual burden is higher or lower than estimated, this analys is under- or overestimates the burden and cost of this amendment.

4.4.13 Volume of Chemical Substance Used On-Site 

### Previous Form U’s have required s ubmitters to indicate whether a ch emical was site-limited, referring to a chemical substance that is manufactured and/or processed only within a site and not distributed forcommercial purposes as a substance or as part of a mixture or article outside the site. A chemical used offsite is one that does not meet this definition; for ex ample, a chemical produced as an end product. EPA is proposing the removal of the site-l imited data element and requiring submitters to report the production volume used on-site. The Agency expects the burden to the submitter of reporting the production volume used on-site to be similar to the burden to report the total productio n volume, given that the activities to identify the

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4-28 necessary information are similar. EPA estimates that it will take a submitter 1. 51 hours to provide the production volume (see Table 4-3). EPA expects an increase in the number of submitters who would report volume used on-site, due to the way that this information would be reported, unde r the amendment. In the data submitted to EPA for the 2006 reporting year, about 14.8 percent of reports include a site-limited volume (EPA 2008c); therefore, EPA assumes this is the minimum number of reports that would be affected.

Site-limited chemicals are those that are not distribu ted (either as the chemical substance itself or in a mixture) outside the plant site for commercial purpo ses. Therefore, EPA assumes that all chemicals used on-site must be chemical intermediates. Accord ing to data from the 2006 IUR database (EPA, 2008c), approximately 24 percent of all re ports containing downstream pro cessing and use information included chemicals used as intermediates. Therefore, EPA assumes that 24 percent of all reports is the maximum percentage of reports that would be affected. No t all chemicals produced as intermediates are used onsite; they may be shipped for use at another site. EPA used 19.4 percent, which is the midpoint of 14.8 percent and 24 percent, to estimate the increase in th e number of reports with chemicals used on-site, i.e., 5,024 reports. Table 4-24 shows the industry burden estimate as a re sult of this proposed amendment. The Agency estimates that the amendment will cause a total increase in industry burden of approximately 7,596 hours during the first reporting cycle and 6,077 hours during all future reporting cycles.

Table 4-24: Change in Industry Burden as a Result of Requiring the Reporting of Production Volume Used On-Site Burden to Report Production Volume Used On-Site (hours) Number of Reports with ProductionVolume Used OnSite Information Total Industry Burden (hours)
First Cycle, Baseline 0.00 0 0 First Cycle, Post-Amendment 1.51 5,024 7,596 Change from the Baseline, First Cycle 1.51 5,024 7,596 Future Cycle Baseline 0.00 0 0 Future Cycle, Post-Amendment 1.21 5,024 6,077 Change from the Baseline, Future Cycles 1.21 5,024 6,077
Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-25 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that the total industry cost will increase by $425,400 duri ng the first reporting cycle and $340,300 during all future reporting cycles.

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4-29 Table 4-25: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume Used On-Site Cost to Report Production Volume Used On-Site (2008$) Number of Reports with ProductionVolume Used OnSite Information Total Industry Cost (2008$)
First Cycle, Baseline $0.00 0 $0.00 First Cycle, Post-Amendment $84.68 5,024 $425,416 Change from the Baseline, First Cycle $84.68 5,024 $425,416 Future Cycle Baseline $0.00 0 $0.00 Future Cycle, Post-Amendment $67.74 5,024 $340,333 Change from the Baseline, Future Cycles $67.74 5,024 $340,333
Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis . To the extent that the burden of reporting the production volume used onsite is different from the burden to report the to tal production volume, this analysis may over- or underestimate the burden and cost of this amendment. Furthermore, to obtain the maximum number of reports that may be affected, EPA assumes that the percentage of repor ts containing downstream processing and use information that included chemical s used as intermediates would be the same as the percentage of all reports that include chemicals used as intermediates (that is, that the percentage of chemicals used as intermediates is consistent whether a submitter completed Part III or not.) To the extent that this is not the case, the analysis may over- or underestimate the number of reports affected.

4.4.14 Indicate Whether Chemical Is Physically at Reporting Site 

### EPA is proposing to require submitters to indicate wh ether an imported chemical is physically at the reporting site. Under the current IUR requirements, a submitter must state if the site’s chemical is manufactured or imported. The Agency estimates that providing this information requires 0.17 hours per report (see Table 4-3). EPA assumes that the burden to indicate whether a chemical is physically on-site will be similar to the burden incu rred to indicate whether a chemical is manufactured or imported, given the similarity of these activities to identify the n ecessary information. Table 4-26 shows the industry burden estimates as a result of this proposed amendm ent. The Agency estimates that the amendment will cause a total increase in industry burden of approximately 4,351 hours for the 2011 reporting cycle, and 3,480 for all future reporting cycles.

Table 4-26: Change in Industry Burden as a Result of Indicating Whether a Chemical is Physically at Reporting Site
Burden to Indicate Whether Chemical is at the Reporting Site (hours) Number of Reports Industry Burden (hours)

First Cycle, Baseline 0.00 25,896 0 First Cycle, Post-Amendment 0.17 25,896 4,351 Change from the Baseline, First Cycle 0.17 0 4,351 Future Cycle Baseline 0.00 25,896 0 Future Cycle, Post-Amendment 0.13 25,896 3,480 Change from the Baseline, Future Cycles 0.13 0 3,480 Note: Values in Change from the Baseline rows are calculated by subtracti ng the corresponding baseline value from the post-amendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-27 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that

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4-30 the total industry cost will increase by approximately $243,700 in the first reporting cycle and $194,900 in all future reporting cycles.

Table 4-27: Change in Industry Cost as a Result of Indicating Whether a Chemical is Physically at Reporting Site
Cost to Indicate Whether Chemical is Physically at Reporting Site (2008$) Number of Reports Industry Cost (2008$)

First Cycle, Baseline $0.00 25,896 $0 First Cycle, Post-Amendment $9.41 25,896 $243,652 Change from the Baseline, First Cycle $9.41 0 $243,652 Future Cycle Baseline $0.00 25,896 $0 Future Cycle, Post-Amendment $7.53 25,896 $194,921 Change from the Baseline, Future Cycles $7.53 0 $194,921
Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis . To the extent that the burden of indicating whether a chemical is physically at the reporting site is different from the burden to report whether a chemical is manufactured or imported, this analysis may over- or underestimate th e burden and cost of this amendment. Furthermore, this requirement may only apply to im porters; the number of reports affect ed is therefore likely to be an overestimation.

4.4.15 Report Production Volume Exported 

### EPA is proposing to add a requirement for subm itters to report the production volume directly exported and not domestically processed or used. The Agency assumes that the burden to the submitter to report the volume exported would be similar to the burden to report the production volume, given the similarity of the activities. EPA estimates that it will take a submitter 1.51 hours to provid e the volume exported (see Table 4-3). Using the baseline unit burden estimate as shown a bove in Table 4-2 and Table 4-8, Table 4-28 shows the industry burden estimate as a result of th is proposed amendment. The Agency estimates that the amendment will increase industry burden by approxi mately 39,200 hours for the 2011 reporting cycle, and 31,300 hours for all future reporting cycles.

Table 4-28: Change in Industry Burden as a Result of Requiring Reporting of Volume Exported Burden to Report

Export Volume (hours) Number of Reports Industry Burden (hours) First Cycle, Baseline 0.00 25,896 0 First Cycle, Post-Amendment 1.51 25,896 39,155 Change from the Baseline, First Cycle 1.51 0 39,155 Future Cycle Baseline 0.00 25,896 0 Future Cycle, Post-Amendment 1.21 25,896 31,324 Change from the Baseline, Future Cycles 1.21 0 31,324 Note: Values in Change from the Baseline rows are calculated by subtracti ng the corresponding baseline value from the post-amendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-29 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that

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4-31 the industry cost will increase by $2.19 million during the first reporting cycle and $1.75 million during all future reporting cycles.

Table 4-29: Change in Industry Cost as a Result of Requiring Reporting of Volume Exported

Burden to Report

Export Volume (2008$) Number of Reports Industry Cost (millions

2008$) First Cycle, Baseline $0.00 25,896 $0.00 First Cycle, Post-Amendment $84.68 25,896 $2.19 Change from the Baseline, First Cycle $84.68 0 $2.19 Future Cycle Baseline 0 25,896 $0.00 Future Cycle, Post-Amendment $67.74 25,896 $1.75 Change from the Baseline, Future Cycles $67.74 $0.00 $1.75
Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis . To the extent that the burden of reporting the volume exported is different from the burden to report the total production volum e, this analysis may over- or underestimate the burden and cost of this amendment.

4.4.16 Identify Whether a Chemical Is To Be Recycled, Remanufactured, Reprocessed, Reused, or Reworked 

### EPA is proposing to add a requirement to indicate via a checkbox when a manufactured chemical, such as a byproduct, is being recycled, remanufactur ed, reprocessed, reused, or reworked. Given the similarity in activities to research records and identif y the appropriate information, the Agency estimates this activity will generate the same burden as indicati ng whether a chemical is used on-site. As shown in Table 4-3, EPA estimated this burden to be approximately 0.17 hours. Using the baseline unit burden estimate as shown a bove in Table 4-2 and Table 4-8, Table 4-30 shows the industry burden estimates as a result of th is proposed amendment. The Agency estimates that the amendment will cause a total increase in industry burden of approximately 4,400 hours in the first reporting cycle and approximately 3,500 hours during all future reporting cycles.

Table 4-30: Change in Industry Burden as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reused, or Reworked Burden for Completing a

Checkbox to Indicate Whether a Product is Recycled, Rema nufactured,

Reprocessed, Reused, or Reworked (hours) Number of Reports Industry Burden (hours)

First Cycle, Baseline 0.00 25,896 0 First Cycle, Post-Amendment 0.17 25,896 4,351 Change from the Baseline, First Cycle 0.17 0 4,351 Future Cycle Baseline 0.00 25,896 0 Future Cycle, Post-Amendment 0.13 25,896 3,480 Change from the Baseline, Future Cycles 0.13 0 3,480 Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

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4-32 The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-31 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that the cost to industry will increase by $243,700 for the 2011 submission year and $194,900 for all future reporting cycles.

Table 4-31: Change in Industry Cost as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reused, or Reworked Cost for Completing a Checkbox to Indicate Whether a Product is Recycled, Rema nufactured,

Reprocessed, Reused, or Reworked (2008$) Number of Reports Industry Cost (millions

2008$)

First Cycle, Baseline $0.00 25,896 $0 First Cycle, Post-Amendment $9.41 25,896 $243,652 Change from the Baseline, First Cycle $9.41 0 $243,652 Future Cycle Baseline $0.00 25,896 $0 Future Cycle, Post-Amendment $7.53 25,896 $194,921 Change from the Baseline, Future Cycles $7.53 0 $194,921 Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis . To the extent that the burden of indicating whether a chemical is recycled, remanufactured, reprocessed, reused, or reworked is different from the burden to report whether a chemical is site-limited, this analysis may over- or underestimate the burden and cost of this amendment.

4.4.17 Concentration Ranges 

### EPA is proposing to amend the ranges used to report concentration in 710.52(C)(3) and (4) by changing the ranges to: 1) less than one percent by wei ght, 2) at least one percent but less than 30 percent by weight, 3) at least 30 percent but less than 60 percent by weight, 4) at least 60 percent but less than 90 percent by weight, and 5) at least 90 percent by weight. This is a technical correction to eliminate gaps in the ranges as previously listed in the IUR rule. Therefore, EPA assumes that it will have no impact on industry burden or cost.

4.4.18 Revise Industrial Function Categories 

### EPA is proposing to modify the current industrial function categories (found in Part III, Section A of Form U), deleting six current categories and adding eight new categories. In addition, EPA is proposing to require submitters to write in a free-te xt descriptor when they select “Other”. EPA anticipates that there would be a small additio nal burden for submitters to familiarize themselves with the eight new categories; based on best professional judgment, EPA estimates 15 minutes of technical labor burden. EPA also estimates that it w ould take three minutes of clerical burden, and six minutes of technical burden to write in the text descr iption if the submitter selects “Other”. According to 2006 IUR data (EPA, 2008a), the response “Other” was selected in 1,206 reports. Using its best professional judgment, EPA expects that the new categories proposed in the IUR modifications rule will reduce by half the number of submitters selecting “Oth er” as an industrial function category. Therefore, EPA estimates that this ame ndment would affect 603 reports. Using the baseline unit burden estimates as shown above in Table 4-2 and Table 4-8, Table 4-32 shows the industry burden estimate as a result of th is proposed amendment. The Agency estimates that the amendment will cause a total increase in industry bur den in the first reporting cycle of approximately

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4-33 4,400 hours. In future reporting cycles, submitters wi ll no longer need to familiarize themselves with the new industrial function categories, and EPA estimates the industry burden to be approximately 70 hours.

Table 4-32: Change in Industry Burden as a Result of Modifying the Industrial Function Categories

Burden for Rule Familiarization of Additional Categories (hours) Number of Reports with

Function Categories Burden to Write in Text for "Other" (hours) Number of Reports with "Other" as a

Function Category Total Industry Burden (hours)
First Cycle, Baseline 1.52 17,075 0.00 0 25,907First Cycle, PostAmendment 1.77 17,075 0.15 603 30,266
Change from the Baseline, First Cycle 0.25 0 0.15 603 4,359
Future Cycle Baseline 1.21 17,075 0.00 0 20,726Future Cycle, PostAmendment 1.21 17,075 0.12 603 20,798
Change from the Baseline, Future Cycles 0.00 0 0.12 603 72

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-33 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that the industry cost will increase by approximately $255, 600 in the first reporting cycle and $3,500 in the following reporting years.

Table 4-33: Change in Industry Cost as a Result of Modifying the Industrial Function Categories

Cost for Rule Familiarization of Additional Categories

(2008$) Number of Reports with

Industrial Function Categories Cost to Write in Text for "Other" (2008$) Number of Reports with Text for "Other" Total Industry Cost (2008$)

First Cycle, Baseline $88.02 17,075 $0.00 0 $1,502,913First Cycle, PostAmendment $102.73 17,075 $7.31 603 $1,758,490
Change from the Baseline, First Cycle $14.71 0 $7.31 603 $255,577
Future Cycle Baseline $70.41 17,075 $0.00 0 $1,202,331Future Cycle, PostAmendment $70.41 17,075 $5.85 603 $1,205,856
Change from the Baseline, Future Cycles $0.00 0 $5.85 603 $3,525

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis . EPA estimates submitters will use 15 minutes of technical labor burden to become familiar with the new categories; this may be an over- or underestimate. EPA is assuming that the number of submitters selecting “Other” as an industria l function category will be reduced by half; this may be an over- or underestimate. In addition, EPA assumes that there is no burden for rule familiarization with the new industrial function categor ies during future reporting cycles. This may not be

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4-34 the case if sites have different employees complete Form U from reporting year to reporting year, or for chemical companies submitting a Form U for the first time.

4.4.19 Revise Industrial Sectors 

### EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) codes with 48 Industrial Sectors (IS). The industria l sectors are based on those used in the European Union’s REACH program. The Agency believes this change may reduce the reporting burden slightly because submitters would not need to look up NAICS codes, and the new industrial sectors would be more intuitive. However, because the submitter still woul d be required to look up some type of code, EPA assumes that the burden reduction would be ne gligible and does not estimate it here.

4.4.20 Revise Consumer and Commercial Product Categories 

### EPA is proposing to revise the list of consum er and commercial use categories by combining categories that lead to common exposure scenarios and adding categories that were not adequately described in the current set of codes. The resulta nt proposed list includes 34 use categories, including “Other.” Several of the existing consumer and comm ercial use categories have been renamed to better describe the products that should be reported under th at category. EPA anticipates that the burden for submitters to familiarize themselves with the new cat egories will increase the burden for completing the consumer and commercial product cate gories by 0.84 hours. This is the burden for the technical employee to identify the consumer and commercial uses of a product (see Table 4-2). This burden will only occur during the first reporting cycle. EPA is also proposing to require that if the produc t category “Other” is reported, a descriptor for the consumer and commercial use of the chemical subs tance must also be reported. Using its best professional judgment, EPA estimates that it would take three minutes of clerical burden and six minutes of technical burden to write in the text description. According to 2006 IUR data (EPA, 2008c), “Other ” was listed as a consumer or commercial product category in 1,207 reports. Based on best professional judgment, EPA expects that the new categories proposed in this rule will reduce by half the number of submitters selecting “O ther” as a consumer and commercial product category. Therefore, EPA assumes that this amendment w ould affect 604 reports. Using the baseline unit burden estimate as shown a bove in Table 4-2 and Table 4-8, Table 4-34 shows the industry burden estimate as a result of th is proposed amendment. The Agency estimates that the amendment will cause a total increase in industry burden of approximately 14,400 hours during the first reporting cycle. In future reporting cycles, th e submitters will no longer need to familiarize themselves with the new industrial function categories, so the burden to the industry is estimated at approximately 72 hours to write in text for “Other” responses.

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4-35 Table 4-34: Change in Industry Burden as a Result of Modifying the Consumer and Commercial Product Categories
Burden for Rule Familiarization for Additional

Categories

(hours) Number of Reports with

Industrial Function Categories Burden to Write in Text for "Other" (hours) Number of Reports with "Other" as a

Function Category Total Industry Burden (hours) First Cycle, Baseline 1.23 17,075 0.00 0 20,972 First Cycle, Post-Amendment 2.07 17,075 0.15 604 35,359 Change from the Baseline, First Cycle 0.84 0 0.15 604 14,387
Future Cycle Baseline 0.98 17,075 0.00 0 16,778 Future Cycle, Post-Amendment 0.98 17,075 0.12 604 16,850 Change from the Baseline, Future Cycles 0.00 0 0.12 604 72

Note: Values in Change from the Baseline rows are calculated by subtracting the co rresponding baseline value from the post-amendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-35 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that the industry cost will increase by approximately $845, 600 in the first reporting cycle, and $3,500 during all future reporting cycles.

Table 4-35: Change in Industry Cost as a Result of Modifying the Consumer and Commercial Product Categories

Cost for Rule Familiarization for Additional

Categories

(2008$) Number of Reports with Function Categories Cost to Write in Text for "Other" (2008$) Number of Reports

with "Other"

as a Function Category Total Industry

Cost (2008$)

First Cycle, Baseline $70.64 17,075 $0.00 0 $1,206,177 First Cycle, Post-Amendment $119.90 17,075 $7.31 604 $2,051,756 Change from the Baseline, First Cycle $49.26 0 $7.31 604 $845,579 Future Cycle Baseline $56.51 17,075 $0.00 0 $964,942 Future Cycle, Post-Amendment $56.51 17,075 $5.85 604 $968,470 Change from the Baseline, Future Cycles $0.00 0 $5.85 604 $3,528 Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis . EPA estimates submitters will need 0.84 hours of technical labor to become familiar with the new codes; this may be an over- or underestimate. EPA is assuming that the number of submitters selecting “Other” as a consumer and commerci al use code will be reduced by half; this may be an over- or underestimate. In addition, EPA assumes th at there is no burden for rule familiarization with the new use categories during the future reporting cycles. This may not be the case if sites have different employees complete Form U from reporting year to reporting year, or for chemical companies submitting a Form U for the first time.

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4-36 4.4.21 Designation of Consumer or Commercial Use 

### EPA is proposing to require submitters to indicate wh ether the downstream use of their chemical 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 consumers versus commercial populations. The indication of consumer or commercial use will allow EPA to complete a better characterization of the potentially exposed populations. EPA anticipates that the submitter would indicate whet her a use is a consumer or commercial use as part of the activity involved in sel ecting the correct consumer and commercial use categories, as described above. The burden to fill in a checkbox for the corr ect use would be negligible. Therefore, EPA assumes that this amendment does not cause any additional burd en beyond that estimated in section 4.4.20 above.

4.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed 

### EPA is proposing to require that submitters report the total number of workers, including those at sites not under the submitter’s control, that are reasona bly likely to be exposed while using the reportable chemical substance, with respect to each commercial use. EPA would provide a set of ranges of numbers of workers for the submitter to choose from. The Agency expects this reporting burden to be similar to the burden for providing the number of workers that ar e potentially exposed when using the chemical with respect to its industrial use, which is already required, because of the similarity of the required data. This burden is approximately 21.36 hours (see Table 4-2) or $1,236 (See Table 4-5) per report. EPA assumes that the number of submitters will not change from the baseline under this amendment. Using the baseline unit burden estimate as shown a bove in Table 4-2 and Table 4-8, Table 4-36 shows the industry burden estimate as a result of th is proposed amendment. The Agency estimates that the amendment will cause a total increase in industry bur den of approximately 364,700 hours in the first reporting cycle and 291,800 during all future reporting cycles.

Table 4-36: Change in Industry Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed
Burden to Provide the Number of Commercial Workers (hours) Number of Reports Burden (hours)
First Cycle, Baseline 0 17,075 0 First Cycle, Post-Amendment 21.36 17,075 364,731 Change from the Baseline, First Cycle 21.36 0 364,731 Future Cycle Baseline 0 17,075 0 Future Cycle, Post-Amendment 17.09 17,075 291,784 Change from the Baseline, Future Cycles 17.09 0 291,784 Note: Values in Change from the Baseline rows are calculated by subtract ing the corresponding baseline value from the post-amendment value.



### The cost of the amendment was calculated using the unit co sts shown in Table 4-5 and Table 4-9. Table 4-37 shows the industry cost estimate as a resu lt of this proposed am endment. EPA estimates that the industry cost will increase by $21.10 m illion for the 2011 reporting cycle, and $16.88 million during all future reporting cycles.

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4-37 Table 4-37: Change in Industry Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed
Cost to Provide the Number of Commercial Workers (2008$) Number of Reports Cost (millions

2008$) First Cycle, Baseline $0 17,075 $0 First Cycle, Post-Amendment $1,236 17,075 $21.10 Change from the Baseline, First Cycle $1,236 0 $21.10 Future Cycle Baseline $0 17,075 $0 Future Cycle, Post-Amendment $989 17,075 $16.88 Change from the Baseline, Future Cycles $989 0 $16.88
Note: Values in Change from the Baseline rows are calculated by subtract ing the corresponding baseline value from the post-amendment value.



### Limitations of Analysis . EPA is assuming that burden to report the number of commercial workers exposed is equivalent to reporting the number of indus trial workers likely to be exposed. However, this is likely an underestimate of the burden for several reasons. There may be more commercial uses for a product, and more workers exposed than the submitte r is aware of. The commercial uses may be difficult for manufacturers (including importers) to identify (see discussion of “NRO” responses in Section 3.9); therefore, the number of workers exposed may be even more difficult to identify.

4.4.23 Changes to the Standard for the Reporting of Processing and Use Information 

### EPA is proposing to eliminate the “Not Readably Ob tainable (NRO)” standard and replace it with the more stringent “Known to or Reasonably Ascertainab le by” standard. EPA assumes this amendment will increase the reporting burden. However, all burden estim ates in this economic analysis are based on an industry survey conducted for the 2002 IUR EA (EPA , 2002a). At the time of the survey, EPA required the higher reporting standard of “Reasonably Ascertain able” information. The proposed rule will now be consistent with the higher standard of information used by the survey, therefore, the burden estimates will not change.

4.4.24 Chemical Identity CBI Claims 

### EPA is proposing that, when a submitter asserts a clai m of confidentiality for the chemical identify of a substance that is listed on the public portion of the Master Inventory File, the Agency may make the information available to the public w ithout further notice to the submitter. This will not reveal any data to the public that is actually confidential and will not incur any cost or burden on the manufacturer.

4.4.25 Upfront Substantiation for Processing and Use Information CBI Claims 

### EPA is proposing to require an upfront substan tiation when a submitter claims processing and use information as Confidential Business Information ( CBI). Upfront substantiation involves providing a written response to a set of questions provided in the proposed rule, for each individual item to be claimed as CBI. In 2002, when EPA first required upfront substan tiation for claiming the plant site ID as CBI, the Agency saw a 64 percent reduction in the number of CBI claims. The Agency expects the number of processing and use CBI claims to decrease by the sa me amount as a result of this proposed amendment. According to 2006 IUR data (EPA, 2008c), a total of 8,133 reports had claimed that processing and use information was CBI, with an average of three pr ocessing and use information CBI claims per report. EPA estimates that the number of reports with pr ocessing and use CBI claims will be reduced to 2,928 as a result of the proposed amendment.

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4-38 For the purposes of this analysis, EPA assumes th at the burden, per item, to complete this substantiation will be similar to the burden estimated to complete the substantiation questions when a submitter makes a plant site identity CBI claim a nd must answer the two questions in 40 CFR §710.58(c)(1). As shown in Table 4-2 and Table 4-4, this is a burden of 1.46 hours and cost of $87.34 per CBI claim. Assuming an average of three processing and use CBI claims per report, EPA estimates that submitters will incur 4.38 additio nal hours of burden per report as a result of the amendment. Table 4-38 shows the industry burden estimate as a re sult of this proposed amendment. The Agency estimates that the amendment will cau se a total increase in industry burden of approximately 12,800 hours in the first reporting cycle and 10,300 hours in all future reporting cycles.

Table 4-38: Change in Industry Burden as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI
Burden for Upfront CBI Substantiation for CBI Claims in Part III (hours) Number of Reports with Upfront Substantiation for CBI Claims in Part III Industry Burden (hours)

First Cycle, Baseline 0 0 0 First Cycle, Post-Amendment 4.38 2,928 12,824 Change from the Baseline, First Cycle 4.38 2,928 12,824 Future Cycle Baseline 0 0 0 Future Cycle, Post-Amendment 3.50 2,928 10,259 Change from the Baseline, Future Cycles 3.50 2,928 10,259 Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-39 shows the industry cost estimate as a result of this proposed amendm ent. EPA estimates that the industry cost will increase by approximately $772,300 in the first repor ting cycle and $618,100 in future reporting cycles.

Table 4-39: Change in Industry Cost as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI

Cost for Upfront CBI Substantiation for CBI Claims in Part III Number of Reports with Upfront Substantiation for CBI Claims in Part III Industry Cost (2008$)

First Cycle, Baseline $0 0 $0 First Cycle, Post-Amendment $263.90 2,928 $772,678 Change from the Baseline, First Cycle $263.90 2,928 $772,678 Future Cycle Baseline $0 0 $0 Future Cycle, Post-Amendment $211.12 2,928 $618,143 Change from the Baseline, Future Cycles $211.12 2,928 $618,143
Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis . EPA assumes that the percent reduction in CBI claims for processing and use information will be the same as the percent re duction when upfront substantiation was required from plant site identification. However, to the extent that the actual burden differs, this analysis may over- or underestimate the burden and cost of this amendment.

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4-39 4.4.26 Limitation on the Confidentiality Claims fo r Data Elements Identified as “Not Known or Reasonably Ascertainable” 

### Under the proposed rulemaking, IU R submitters would be unable to en ter a claim of confidentiality if “not known or reasonably ascertainable” is selected fo r the industrial processing and use or consumer and commercial use information. EPA assumes that this amendment will not impact industry burden because submitters are not being required to do anything addi tional (e.g., gather information or provide a written response); they are simply prohibited from claiming “ not known or reasonably a scertainable” data items as CBI.

4.4.27 Require Electronic Subm issions over the Internet 

### EPA is proposing to require electronic submissions of all Form Us over the Internet using e-IUR and EPA’s Central Data Exchange (CDX). The Agency’s cost estimates were calculated following the methodology outlined in the economic analysis for th e e-PMN rule (EPA, 2009b), where EPA is requiring that TSCA section 5 pre-manufacturing notices be subm itted electronically. The costs and savings of this IUR amendment will be realized on a pe r-site basis, as well as per report. Following the methodology outlined in the economic analysis for the e-PMN rule (EPA, 2009b) the clerical burden used in the preparation of Parts I, II and III of Form U will be eliminated with this proposed amendment. Specifically, the Agency assumes that the burden savings associated with electronic reporting and submission via CDX are due to the reduction or elimination of clerical/administrative time. The baseline time estimate for clerical burden (approximately six percent of the burden) was assumed to approximate the amount of clerical/administrative time involved in filling out and submitting the paper IUR Form U. This estim ate of potential form completion and submission savings is in line with the estimated savings in switching from paper to electronic submissions as estimated in the Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis of 10 percent (EPA, 2004). The technical burden to gather and organize data, and managerial burden for review and approval, will not change from the baseline. Overall, this proposed amendment would decrease the burden to prepare Parts I, II, and III. In addition, estimates developed in the CROMERR re port were used to develop estimates of burdens to register with EPA’s Central Data Exchange (CDX), and to set up a Pay.gov account and electronic signature agreements. These burdens are incurred on a per-site basis. EPA estimated these costs in the economic analysis for the e-PMN rule, which used CROMERR to develop estimates of burden from CDX registration and electronic signature agreements, to be a total of 1.33 hours of managerial burden and 2.28 hours of technical time per site (EPA, 2009b; EPA, 2 004). Based on the e-PMN EA, recordkeeping costs will be halved 

### because of the efficiencies in creati ng and storing documents electronically (EPA, 2009b)


### , reducing overall burden per report by three hours. Table 4-40 shows the industry burden estimate as a re sult of this proposed amendment. The Agency estimates that the amendment will cau se a total decrease in industry burden of approximately 241,700 hours in the first reporting cycle and 209,600 hours in all future reporting cycles.

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4-40 Table 4-40: Change in Industry Burden as a Result of Requiring Electronic Submission
Burden for

Report, Compliance Determination, Rule Familiarization, Submission and Part I (per site) (hours) Number of Sites Burden for Recordkeeping

and Part II (hours per

report) Number of Reports Burden per Part III (hours) Number of Reports

with Part III

(a) (b) (c) (d) (e) (f) Industry Burden (hours)

(g) = (a*b) + (c*d) +

(e*f)

First Cycle, Baseline 33.26 4,085 19.82 25,896 69.92 17,075 1,842,934
First Cycle,PostAmendment 36.12 4,085 15.27 25,896 61.98 17,075 1,601,239

Change from the Baseline, First Cycle 2.86 0 -4.55 0 -7.94 0 -241,695

Future Cycle Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833
Future Cycle,PostAmendment 11.19 4,085 12.82 25,896 49.58 17,075 1,224,202

Change from the Baseline, Future Cycles 2.11 0 -4.24 0 -6.35 0 -209,631

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### EPA calculated the cost savings of the amendment using the unit costs shown in Table 4-5 and Table 4-9. Table 4-41 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that the industry cost will decrease by $8.77 milli on during the 2011 reporting cycle and by $7.97 million during all future reporting cycles.

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4-41 Table 4-41: Change in Industry Cost as a Result of Requiring Electronic Submission
Cost for Report, Compliance Determination, Rule Familiarization, Submission and Part I (per site) (2008$) Number of Sites Cost for Recordkeeping

and Part II (2008$ per

report) Number of Reports Cost per Part III (2008$) Number of Reports

with Part III

(a) (b) (c) (d) (e) (f) Industry Cost (millions

2008$) (g) = (a  b)+ (c  d)+(e*f)

First Cycle, Baseline $2,058 4,085 $1,143 25,896 $4,059 17,075 $107.32
First Cycle,PostAmendment $2,251 4,085 $923 25,896 $3,833 17,075 $98.55

Change from the Baseline, First Cycle $192 0 -$220 0 -$226 0 -$8.77

Future Cycle Baseline $561 4,085 $982 25,896 $3,247 17,075 $83.17
Future Cycle,PostAmendment $704 4,085 $771 25,896 $3,067 17,075 $75.20

Change from the Baseline, Future Cycles $143 0 -$211 0 -$181 0 -$7.97

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Limitations of Analysis . EPA assumes that the clerical burden will decrease by percentages similar to the decrease estimated for the e-PMN rule. To the extent that any diffe rences exist (given the differences in the two rules), this analysis may over- or unde restimate the burden and cost of this amendment.

4.4.28 Updated e-IUR Reporting Software 

### EPA developed the e-IUR reporting software for use in preparing and submitting reports electronically during the 2006 IUR reporting cycle. The updated reporting tool would feature several improved capabilities over the previous e-IUR reporting to ol. This amendment is not expected to change industry burden, other than as described in Section 4.4.27.

4.4.29 Electronic Signature Process 

### In order to submit Form U electronically via EPA ’s Central Data Excha nge, individuals acting on behalf of the submitter must first register with CDX. This process involves completing an Electronic Signature Agreement form along with a signature and date, having the form notarized, and mailing it back to EPA. The burden of the electronic signature agreem ent, one hour per submission, was included in the burden reduction estimate used in the economic anal ysis for the e-PMN rule (EPA, 2009b). The burden and cost reduction estimates for electronic submission, as shown in Section 4.4.27, include the cost of the electronic signature process because they are based on th e estimates used in the economic analysis for the e-PMN rule.

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4-42 4.4.30 Modifications Specifi cally Affecting Importers 

### For purposes of IUR, importers currently are allowe d to report the IUR information jointly with the foreign manufacturer of the chemical. Importers , or primary submitters, may not know the specific chemical identity of a substance because the forei gn supplier, or secondary submitter, chooses to keep it confidential. In such a situation, the importer is s till responsible for ensuring that the IUR information is submitted to EPA and may do so by submitting a join t report. Overall, the amount of information submitted via Form U for primary and secondary submitters would not change as a result of this proposed amendment, although EPA plans to revise the Fo rm U for joint submitters. Under the proposed amendment, the foreign manufacturer must now regi ster with CDX and submit its report electronically. Previously, joint submissions could not be made electronically. As described above in Section 4.4.27, submission cost s to register with EPA’s Central Data Exchange (CDX), complete the Electronic Signature Agreement forms, and set up a Pay.gov account are incurred on a per-site basis. EPA estimated these costs in the economic analysis for the e-PMN rule to be a total of 1.33 hours of managerial burden and 2.28 hours of technical time per site (EPA, 2009b). Based on previous IUR submissions, EPA estimates that between 10 and 20 sites were importe rs, and therefore, the same approximate number were s econdary submitters (EPA, 2009h). Fo r this analysis, EPA uses the conservative upper-bound of 20 secondary submitter sites. Table 4-42 shows the industry burden estimate as a re sult of this proposed amendment. The Agency estimates that the amendment will cause an increase in industry burden of approximately 72.2 hours in the first reporting cycle. Future reporting cycles are assumed to the similar to the first reporting cycle.

Table 4-42: Change in Industry Burden as a Result of Requiring CDX Registration for Secondary Submitters
Burden for CDX Registration (per site) (hours) Number of Sites Industry Burden (hours) First Cycle, Baseline 0.00 0 0.00First Cycle, PostAmendment 3.61 20 72.2
Change from the Baseline, First Cycle 3.61 20 72.2

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### 4-45 3 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that the industry cost will increase by $4,500 during the 2011 reporting cycle.

Table 4-43: Change in Industry Cost as a Result of Requiring CDX Registration for Secondary Submitters
Cost for CDX Registration (per site) (2008$) Number of Sites Industry Cost (2008$) First Cycle, Baseline $0 0 $0First Cycle, PostAmendment $3.61 20 $4,546
Change from the Baseline, First Cycle $3.61 20 $4,546

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

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4-43 4.4.31 Modify Reporting Frequency 

### The Agency is proposing to modify the IUR reporting cycle from a five-year reporting frequency to a four-year reporting frequency. While the principal reporting year industry burden will not change, the longer-term industry burden will increase because reporting will become more frequent; therefore, EPA estimated the annual reporting burden to industry over a 20-year period. The baseline industry burden in the year 2011 was calculated in Table 4-10 as 1.84 million hours. As shown in Table 4-11, the industry reporting burden in future reporting cycles is reduced to 1.43 million hours because EPA assumes that sites that have subm itted Form U previously incur a lower burden for processing and submitting the Form, as these firms have become more familiar with reporting and may be more efficient at the compliance process. Table 4-11 contains the total annual baseline costs to industry for future reporting cycles – that is, the burden and cost to industry for repor ting cycles after the 2011 cycle, in the absence of the proposed amendmen ts. EPA assumes costs for report preparation and submission in future reporting cycles will be lower than costs in the first reporting cycle because of efficiencies achieved through the establishment of compliance processes, the availability of data from previous reporting cycles, and familiarity with reporting requirements ( EPA, 2002a). The weighting factors found in Table 4-7 were applied to the b aseline burden estimates found in Table 4-2 and Table 4-5, to estimate that in all future reporting cycles, the baseline burden to industry is approximately 1.43 million hours. As shown in Table 4-44, EPA estimates that the industry burden will increase by 1.43 million hours over a 20-year period as a result of this amendment.

Table 4-44: Change in Industry Burden as a Result of Modifying the Reporting Frequency, over a 20-Year Period

Year Baseline Burden (millions of hours) Post-Amendment Burden (millions of hours) Change in Burden (millions of hours) 2011 1.84 1.84 0.00 2012 0.00 0.00 0.00 2013 0.00 0.00 0.00 2014 0.00 0.00 0.00 2015 0.00 1.43 1.43 2016 1.43 0.00 -1.43 2017 0.00 0.00 0.00 2018 0.00 0.00 0.00 2019 0.00 1.43 1.43 2020 0.00 0.00 0.00 2021 1.43 0.00 -1.43 2022 0.00 0.00 0.00 2023 0.00 1.43 1.43 2024 0.00 0.00 0.00 2025 0.00 0.00 0.00 2026 1.43 0.00 -1.43 2027 0.00 1.43 1.43 2028 0.00 0.00 0.00 2029 0.00 0.00 0.00 2030 0.00 0.00 0.00 Total 6.14 7.58 1.43 Annual Average 0.31 0.38 0.07

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4-44 As shown in Table 4-10, the total industry cost in the baseline first reporting cycle is approximately $106.97 million, and as shown in Table 4-11, the base line cost is $82.82 million in all future reporting cycles. 4-45 shows the annual industry cost estim ate as a result of this amendment. In total, EPA estimates that the proposed amendment will increase the cost to industry by $82.82 million over a 20-year period. In the proposal, EPA requested comment on increasi ng the frequency of reporting to annual reporting of all data; biennial repor t; and reporting once every three years, with processing and use data (Part III) reported only in the principal reporting year. EPA conduc ted a preliminary analysis of the cost and burden of increasing the frequency of reporting to annually, and every three years. The results of the analysis are presented in Appendix G.

Table 4-45: Change in Industry Cost as a Result of Modifying the Reporting Frequency, over a 20- Year Period

Year Baseline Cost (millions 2008$) Post-Amendment Cost (millions 2008$) Change in Cost (millions

2008$) 2011 $106.97 $106.97 $0.00 2012 $0.00 $0.00 $0.00
2013 $0.00 $0.00 $0.00
2014 $0.00 $0.00 $0.00
2015 $0.00 $82.82 $82.82
2016 $82.82 $0.00 -$82.82
2017 $0.00 $0.00 $0.00 2018 $0.00 $0.00 $0.00
2019 $0.00 $82.82 $82.82
2020 $0.00 $0.00 $0.00
2021 $82.82 $0.00 -$82.82
2022 $0.00 $0.00 $0.00
2023 $0.00 $82.82 $82.82 2024 $0.00 $0.00 $0.00
2025 $0.00 $0.00 $0.00
2026 $82.82 $0.00 -$82.82
2027 $0.00 $82.82 $82.82
2028 $0.00 $0.00 $0.00
2029 $0.00 $0.00 $0.00 2030 $0.00 $0.00 $0.00 Total $355.42 $438.24 $82.82 Annual Average $17.77 $21.91 $4.14



### Limitations of Analysis . EPA assumes that future reporting cycl e costs will decrease due to efficiency gains and a reduction in the time required for submitte rs to become familiar with the rule and its amendments. To the extent that these reductions in burden do not occur, this analysis may underestimate the burden and cost of the rule amendment.

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4-45 

### 4.5 Total Industry Compliance Burden and Cost of all Amendments
The burdens and costs presented in Section 4.4 ar e the stand-alone industry compliance burden and cost for each amendment, and do not take into acco unt the interaction of amendments (i.e., how the impact of one amendment would affect the burden of another amendment.) For this reason, when calculating the total industry cost of all amendments described in EPA’s proposed rule, the Agency can not simply add the individual changes in burden fo r each proposed amendment, but must consider the affect of one amendment on another. As described be low, amendments fall into three categories: those that affect the number of reports submitted during a re porting cycle; those that affect the reporting burden; and those that affect the reporting frequency. The im pact that each amendment has on the others depends on its category.

4.5.1 Modifications that Affect the Number of Reports Submitted 

### Several of the proposed IUR amendments change the number of full and/or partial reports EPA expects to be submitted, based on the specific chemic als they affect. The ame ndment that changes the method for determining whether a manufacturer is s ubject to the IUR reporting requirements is expected to increase the overall number of repor ts and submitters by five percent; therefore, the combined impact would also increase each of the impacts of the othe r amendments in this category by five percent. Furthermore, the amendment to eliminate 300,0 00 lb. threshold for downstream processing and use reporting would make Part IIIs necessary for all the a dditional Part IIs required by other amendments. The steps below describe how the combined effect of th e amendments affecting the number of reports was calculated. Step 1: Sum the affected amendments. Table 4-46 presents the number of full and partial reports submitted as a result of the proposed IUR amendmen ts. The proposed amendments that change the number of full and/or partial reports e xpected to be submitted are as follows:

 Eliminate 300,000 lb. threshold for do wnstream processing and use reporting: When taken alone, EPA expects this amendment to increase the nu mber of Part IIIs submitted by 8,203 additional reports (see Section 4.4.4).

 Elimination of the 25,000 lb. threshold for certain regulated chemicals: This amendment, by itself, would increase in the number of Part IIs submitted by 4,018, (see Section 4.4.5).

 Make chemicals subject to ECAs ineligible for exemptions: EPA estimated that this amendment will increase the number of Part IIIs submitted by 16 additional reports (see Section 4.4.6).

 Full exemption for manufactured water: EPA expects that this amendment, by itself, will decrease the number of Part IIIs submitted by 43 fewer reports (see Section 4.4.7). Step 2: Consider the effects of the change in method for determining rule applicability . The Agency expects the change in the method for determ ining whether a manufacturer is subject to the IUR reporting requirements to increase the number of report s and submitters by five percent. Therefore, EPA multiplied the Step 1 results by 1.05, to account for this amendment. Then the Agency added in the number of additional sites and reports estim ated for this amendment individually.

 Method for determining whether a manufacturer is subject to the IUR reporting requirements. When taken by itself, this amendment generate d 204 additional submitters (five percent of the baseline number of 4,085), 1,295 additional Part IIs (five percent of the baseline number of 25,896), and 854 additional Part IIIs (five percent of th e baseline number of 17,075) (see Section 4.4.3). Step 3: Consider the effect of eliminating the 300,000 lb. threshold for processing and use reporting (and avoid double-counting). 

### Under this amendment, all submitters of non-exempt chemicals would be required to submit a Part III. Theref ore, the number of Part IIIs must be increased by the increased number of Part IIs, to account for the effect of eliminating the 300,000 lb. threshold for processing and use reporting. EPA started with the Step 2 total for Part III reports (9,484), and added the

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4-46 Step 2 total for Part II reports (5,469), minus the number of new Part III reports as a result of making ECAs ineligible for exemptions (16) and the numbe r of new Part II reports as a result of changing the method of determining whether a manufacturer is s ubject to reporting requirements (1,295). The number of reports with Part III will increase by 13,641. Step 4: Calculate the number of reports when a ll amendments are considered together. The total number of additional reports from Step 2 is added to the number of reports in the baseline to calculate the total number of reports when all th e proposed amendments are consider ed together. There will now be a total of 4,289 Part Is, 31, 365 Part IIs and 30,716 Part IIIs. The difference between the total number of Part IIs and Part IIIs, 649 reports, is equa l to the number of partially exempt reports with the five percent increase taken into account (618x1.05 = 649).

Table 4-46: Change in the Number of Sites and Reports Submitted for All Amendments Combined

Modification Number of Sites Number of Reports Number of Reports with Part III Baseline 4,085 25,896 17,075 Step 1: Sum affected amendments Eliminate 300,000 lb. Threshold for Downstream Processing and Use Reporting (see Section 4.4.6) -- -- 8,203

Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals (see Section 4.4.5) -- 4,018 --

Make Chemicals Subject to ECAs Ineligible for Exemptions (see Section 4.4.6) -- -- 16

Full Exemption for Manufactu red Water (see Section 4.4.7). -- (43) --

STEP 1 TOTAL -- 3,975 8,219 Step 2: Account for change in the me thod for determining whether you are subj ect to the IUR repor ting requirements Step 1 Total Multiplied by 1.05 4,174 8,630 Method for Determining Whet her you are Subject to the IUR Reporting Requirements (see Section 4.4.3) 204 1,295 854

STEP 2 TOTAL 204 5,469 9,484 Step 3: Consider the effect of elimin ating the 300,000 lb. threshold for proce ssing and use reporting (and avoid doublecounting). Step 2 total for Part II reports minus number of new Part III reports as a result of making ECAs ineligible for exemptions and the number of new Part II reports as a result of changing the method of determining whether subject to reporting requirements -- -- 4,158

STEP 3 TOTAL (Step 3 + Step 2 Total ) 204 5,469 13,641 Step 4:Calculate the total number of reports by adding the Step 3 Total to the Baseline STEP 4 TOTAL (Baseline + Step 3 Total) 4,289 31,365 30,716

4.5.2 Modifications That Affect the Reporting Burden 

### Several amendments affect the burden to complete a report. As discussed in Section 4.4.27, EPA assumes that the amendment to require electronic s ubmission over the Internet will eliminate clerical burden used in the preparation of Parts I, II and III of Form U, and that the burden for recordkeeping across all wage rate categories will be reduced by half. Table 4-47 contains the total burden by labor category for the 2011 reporting cycle when all the amendments are considered together. Table 4-48 contains the future reporting cycle burden, by labor category. The steps below describe how the combined effect of the amendments that affected the reporting burden was calculated.

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4-47 Step 1: Sum the affected amendments. The amendments that affect th e reporting burden are as follows:

 Report production volume for each of the years since last report: This amendment is estimated to require 6.05 additional hours of burden to complete Part II (see Section 4.4.12).

 Report production volume used on-site: This amendment is estimated to require 1.51 additional hours of burden to complete Part II (see Section 4.4.13). Table 4-47 presents the per-report total burden of 0.293 hours to reflect that only 24 percent of reports are expected to report volume used on site.

 Indicate whether the chemical is physically at reporting site: This amendment is estimated to require 0.17 additional hours of burden to complete Part II (see Section 4.4.14).

 Report volume exported: This amendment is estimated to requi re 1.51 additional hours of burden to complete Part II (see Section 4.4.15).

 Identify whether a chemical is to be recycled, remanufactured, reprocessed, reused, or reworked: This amendment is estimated to require 0.17 additional hours of burden to complete Part II (see Section 4.4.16).

 Revise industrial function categories: This amendment is estimated to require 0.25 additional hours to complete Part III (for submitters to familiari ze themselves with the new categories), and an additional 0.15 hours (for submitters selecting “Oth er”) (see Section 4.4.18). Table 4-47 presents the per-report total burden of 0.26 hours to reflect that only 3.5 percent of reports are expected to select “Other” and thus incur this additional cost.

 Revise consumer and commercial product categories: This amendment is estimated to require 0.84 additional hours of burden to complete Part III (fo r submitters to familiarize themselves with the new categories), and an additional 0.15 hours (for s ubmitters selecting “Other”) (see Section 4.4.20). Table 4-47 presents the per-report total burden of 0. 84 hours, which reflects that only 3.5 percent of reports are expected to select “Other” and thus incur this additional burden.

 Number of commercial workers reasonably likely to be exposed: This amendment is estimated to require 21.36 additional hours to comp lete Part III (see Section 4.4.22).

 Upfront substantiation for processing and use information CBI claims: This amendment is estimated to require 4.38 additional hours of burden to complete Part III for all submitters that claim processing and use information as CBI (see Section 4.4.25). Table 4-47 presents the per-report total burden of 0.75 hours, which reflects that only 17 pe rcent of reports are expected to incur additional costs because of the amendment.

Step 2: Consider the effect of the amendment to require electronic submission over the Internet. This amendment would eliminate the need for clerical tasks such as typing in formation into Form U, photocopying, and mailing. In Step 2, EPA subtract s the clerical burden for all proposed amendments, eliminating a burden of 0.76 hours per Part I, 2.82 hours per Part II, and 10. 11 hours per Part III. The burden reductions in recordkeeping will be reduced by 50 percent for all wage categories and will not change from what is presented in Section 4.4.27.

Step 3: Calculate the total burden when all amendments are combined. To calculate the total industry burden estimates, EPA added the total from Step 2 to the baseline. In total, the clerical burden will be 0.75 hours per full report with one chemical, the techni cal burden will be 102.83 hours per full report with one chemical, and the managerial burden will be 37.74 hours per full report with one chemical.***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-48Table 4-47: Change in the 2011 Reporting Cycle Burden for All Amendments Combined, by Labor CategoryModificationComplianceDetermination, RuleFamiliarization, andSubmissionBurdenBurden to CompletePart IRecordkeepingBurdenBurden to CompletePart IIBurden to CompletePart IIICTMCTMCTMCTMCTMBaseline-- 21.50 9.00 0.76 0.95 1.05 1.50 3.00 1.50 1.55 8.78 3.49 7.94 45.31 16.66Step 1: Sum the Affected AmendmentsReport production volume for each of theyears since last report-- -- -- -- -- -- -- -- -- 0.936 4.104 1.008 -- -- --Report production volume Used On-Site-- -- -- -- -- -- -- -- -- 0.045 0.199 0.049 -- -- --Indicate whether chemical is physically atreporting site-- -- -- -- -- -- -- -- -- 0.026 0.114 0.028 -- -- --Report the volume exported-- -- -- -- -- -- -- -- --0.234 1.026 0.252-- -- --Identify whether a chemical is to be recycled,remanufactured, reprocessed, reused, orreworked-- -- -- -- -- -- -- -- -- 0.026 0.114 0.028 ------Revise industrialfunction categories-- -- -- -- -- -- -- -- -- -- -- -- 0.003 0.254 0.000Revise commercial and consumer productcategories-- -- -- -- -- -- -- -- -- -- -- -- 0.003 0.841 0.000Number of commercial workers reasonablylikely to be exposed-- -- -- -- -- -- -- -- -- -- -- -- 2.104 15.428 3.829Upfront substantiation for processing and useinformation CBI claims-- -- -- -- -- -- -- -- -- -- -- -- 0.062 0.427 0.262Step 1 Total-- -- -- -- -- -- -- -- -- 1.267 5.557 1.365 2.171 16.949 4.092Step 2:Add the Effect of theElectronic Reporting AmendmentsElectronic Submission-- 2.28 1.33 -0.76 -- -- -0.75 -1.50 -0.75 -2.82 -- -- -10.11 -- --Step 2 Total (Electronic Submission + Step1 Total)-- 2.28 1.33 -0.76 -- -- -0.75 -1.50 -0.75 -1.55 5.56 1.36 -7.94 16.95 4.09Step 3 Total BurdenStep 2 Total + Baseline-- 23.78 10.33 -- 0.95 1.05 0.75 1.50 0.75 -- 14.34 4.85 -- 62.26 20.76Note: C = Clerical; T = Technical; and M = Managerial wage categories***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***4-49Table 4-48: Change in the Future Reporting Cycle Burden for All Amendments Combined, by Labor CategoryModificationComplianceDetermination, RuleFamiliarization, andSubmissionBurdenBurden to CompletePart IRecordkeepingBurdenBurden to CompletePart IIBurden to CompletePart IIICTMCTMCTMCTMCTMBaseline--4.500 2.0000.691 0.870 1.018 1.500 3.000 1.500 1.240 7.024 2.792 6.351 36.251 13.33Step 1: Sum the Affected AmendmentsReport production volume for each of theyears since last report-- -- -- -- -- -- -- -- -- 0.749 3.283 0.806 -- -- --Report production volume used on-site-- -- -- -- -- -- -- -- -- 0.036 0.159 0.039 -- -- --Indicate whether chemical is physically atreporting site-- -- -- -- -- -- -- -- -- 0.021 0.091 0.022 -- -- --Report the volume exported-- -- -- -- -- -- -- -- -- 0.187 0.821 0.202 -- -- --Identify whether a chemical is to be recycled,remanufactured, reprocessed, reused, orreworked-- -- -- -- -- -- -- -- -- 0.021 0.091 0.022 ------Revise industrialfunction categories-- -- -- -- -- -- -- -- -- -- -- -- 0.002 0.003 0.000Revise commercial and consumer productcategories-- -- -- -- -- -- -- -- -- -- -- -- 0.002 0.003 0.000Number of commercial workers reasonablylikely to be exposed-- -- -- -- -- -- -- -- -- -- -- -- 1.683 12.342 3.063Upfront substantiation for processing and useinformation CBI claims-- -- -- -- -- -- -- -- -- -- -- -- 0.049 0.427 0.210Step 1 Total-- -- -- -- -- -- -- -- -- 1.014 4.446 1.092 1.737 12.775 3.273Step 2:Add the Effect of theElectronic Reporting AmendmentsElectronic Submission--1.731.07-0.69-- -- -0.75 -1.50 -0.75-2.25-- ---8.09----Step 2 Total (Electronic Submission + Step1 Total)-- 1.73 1.07 -0.69 -- -- -0.75 -1.50 -0.75 -1.24 4.45 1.09 -6.35 12.77 3.27Step 3 Total BurdenStep 2 Total + Baseline-- 6.23 3.07 -- 0.87 1.02 0.75 1.50 0.75 -- 11.47 3.88 -- 49.03 16.60Note: C = Clerical; T = Technical; and M = Managerial wage categories

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4-50 Table 4-49 contains the estimated change in the burden and the total burden per reporting cycle as a result of the all the proposed IUR amendments during the first reporting cycle. It also presents the burden in future reporting cycles. EPA estimates the tota l industry burden will increase by approximately 1.56 million hours to 3.40 million hours in total for the 20 11 reporting cycle. In future reporting cycles, EPA estimates that industry burden will increase by 1.21 million hours to 2.64 million hours.

Table 4-49: Total Industry Burden for All Amendments Combined
Burden for Compliance Determination, Rule Familiarization,

Submission and to Prepare Part I (hours per site) Number of Sites Burden for Record Keeping

and to Prepare Part II (hours per

report) Number of Reports

(with Part II) Burden to Prepare Part III (hours per

report) Number of Reports (with Part III) Industry Burden (millions of hours)

(a) (b) (c) (d) (e) (f) (g) = (a  b)+ (c  d)+(e  f) First Cycle, Baseline 33.26 4,085 19.82 25,896 69.92 17,075 1.84
First Cycle,PostAmendment 36.12 4,289 22.19 31,365 83.02 30,716 3.40

Change from the Baseline, First Cycle 2.86 204 2.37 5,469 13.10 13,641 1.56

Future-Cycle, Baseline 9.08 4,085 17.06 25,896 55.93 17,075.00 1.43
Future Cycle,PostAmendment 11.19 4,289 18.35 31,365 65.63 30,716 2.64

Change from the Baseline, Future Cycles 2.11 204 1.30 5,469 9.70 13,641 1.21

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 4-50 shows the total industry cost. To calcu late the total industry cost, the burden estimates located in Table 4-47 and Table 4-48 were multiplied by the wage rates found in Table 4-1. The costs were then multiplied by the number of submissions located in Table 4-46. EPA estimates the total industry cost will increase by approximately $102.07 million to $209.04 million in total for the 2011 reporting cycle. In future reporting cycles, EPA estim ates that the industry cost will increase by $79.31 million to $162.12 million.

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4-51 Table 4-50: Total Industry Cost When All Amendments Are Combined
Cost for Compliance Determination, Rule Familiarization,

Submission and to Prepare Part I (2008$ per site) Number of Sites Cost for Record Keeping

and to Prepare Part II (2008$ per

report) Number of Partial Reports

(with Part II) Cost to prepare Part III (2008$

per report) Number of Full Reports (with Part III) Industry Cost (millions

2008$)

(a) (b) (c) (d) (e) (f) (g) = (a  b)+ (c  d)+(e  f) First Cycle, Baseline $2,058 4,085 $1,129 25,896 $4,059 17,075 $106.97
First Cycle,PostAmendment $2,252 4,289 $1,346 31,365 $5,117 30,716 $209.04

Change from the Baseline, First Cycle $194 204 $216 5,469 $1,058 13,641 $102.07

Future-Cycle, Baseline $561 4,085 $968.39 25,896 $3,247 17,075 $82.82
Future Cycle,PostAmendment $704 4,289 $1,109 31,365 $4,047 30,716 $162.12

Change from the Baseline, Future Cycles $143 204 $141 5,469 $800 13,641 $79.31

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

4.5.3 Amendment that Affects the Reporting Frequency 

### This proposed amendment to modify the reporting frequency from every five years to every four years would not change the number of submissions or the submission burden, but would increase the cost to submitters over multiple reporting cycles because subm issions are made more frequently. The effect of this amendment, in combination with the othe r amendments, is shown in Section 4.5.4.

4.5.4 Average Cost and Burden per Site



### Under the baseline, 4,085 sites submit a total of 25,896 reports; 17,075 of these are full reports and the remainder is partial reports (See Table 4-6). T hus, an average site submits IUR data for 6.34 chemicals (25,896 reports divided by 4,085 sites), a nd submits full reports for 4.18 of those chemicals (17,075 reports divided by 4,085 sites) (See Table 4- 51). Table 4-49 contains the total number of reports submitted and sites when all the amendments are cons idered together. An estimated 4,289 sites submit a total of 31,365 reports, 30,716 of which will be full reports. Ther efore, in the post-amendment scenario, an average site will submit 7.31 reports comprised of 7.16 full reports and 0.15 partial reports (See Table 4-51). This is a decrease of 2.01 partial reports pe r site and an increase of 2.98 full reports per site compared to the baseline.

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4-52 Table 4-51: Average Number of Full and Partial Reports per Site

Total Number of Sites Total Number of

Reports Average Number of Reports per Site Total Number of Full Reports Average Number Full Reports per Site Average Number of Partial Reports per Site (a) (b) (c)=(b)/(a) (d) (e)=(d)/(a) (f)=(c)-(e) Baseline 4,085 25,896 6.34 17,075 4.18 2.16
PostAmendment 4,289 31,365 7.31 30,716 7.16 0.15
Change from the Baseline 204 5,469 0.97 13,641 2.98 -2.01

Source: U.S. EPA, Office of Pollution Prevention a nd Toxics, Information Management Division 2006 IUR Database Statistics for IUR Modifications Rule . Washington, DC. December 17, 2008 (EPA, 2008c).
Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 4-52 contains the average total burden per site . Each site will submit only one Part I under both the baseline and post-amendment scen arios. The average numbers of Pa rt IIs and Part IIIs submitted per site are taken from Table 4-51. EPA calculated the baseline from the per-report burden presented in Table 4-2. In the first cycle baseline, the average site’s burden is 451 hours during the first reporting cycle and 351 hours in future reporting cycles. The post-amendmen t burden per report is found in Table 4-49. The average burden per site is expected to be 793 hours in the first reporting cycle and 615 hours in future reporting cycles. This is an increase of 342 hours per site during the first reporting cycle and 264 hours per site in future reporting cycles compared to the baseline.

Table 4-52: Average Total Burden per Site
Burden for Compliance Determination, Rule Familiarization,

Submission and to Prepare Part I (hours per site) Average Number of Part Is per Site Burden for Record Keeping and

to Prepare

Part II (hours per

report) Average Number of Part IIs per

Site Burden for Part III (hours

per report) Average Number of Part IIIs per

Site Total Average Burden per Site (hours)

(a) (b) (c) (d) (e) (f) (g) = (a*b) +(c*d)+(e*f) First Cycle, Baseline 33.26 1 19.82 6.34 69.92 4.18 451

PostAmendment 36.12 1 22.19 7.31 83.02 7.16 793
Change from the Baseline 2.86 0 2.37 0.97 13.10 2.98 342
Future Cycle, Baseline 9.08 1 17.06 6.34 55.93 4.18 351
Future Cycle,PostAmendment 11.19 1 18.35 7.31 65.63 7.16 615

Change from the Baseline, Future Cycles 2.11 0 1.30 0.97 9.70 2.98 264

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

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4-53 The average baseline and post-amendment scenario co st per site are found in Table 4-53. Baseline costs per report costs are taken from Table 4-5 and Ta ble 4-8 and used in calculating the average baseline cost per site. In the first reporting cycle, the averag e baseline cost per site is estimated to be $26,185. Future cycle average baseline cost is estimated to be $20,274 per s ite. Post-amendment costs per report are derived in Table 4-49 and Table 4-50. The average post-amendment cost per site is calculated to be $48,739 in first reporting cycle, and $37,800 for all future reporting cycles. This is an increase of $22,600 per site during the first reporting cycle and $17,500 during future reporting cycles compared to the baseline.

Table 4-53: Average Total Cost per Site
Cost for Submission Compliance Determination, Rule Familiarization, and to Prepare Part I (2008$ per site) Average Number of Part Is per Site Cost for Record Keeping and

to Prepare

Part II (2008$ per

report) Average Number of Part IIs per

Site Cost to Prepare Part III (2008$

per report) Average Number of Part IIIs per

Site Total Average Cost per Site (2008$)

(a) (b) (c) (d) (e) (f) (g) = (a*b) +(c*d)+(e*f) First Cycle, Baseline $2,058 1 $1,129 6.34 $4,059 4.18 $26,185

PostAmendment $2,252 1 $1,346 7.31 $5,117 7.16 $48,739
Change from the Baseline $194 0 $216 0.97 $1,058 2.98 $22,553
Future Cycle Baseline $561 1 $968 6.34 $3,247 4.18 $20,274
Future Cycle,PostAmendment $704 1 $1,109 7.31 $4,047 7.16 $37,800

Change from the Baseline, Future Cycles $143 0 $141 0.97 $800 2.98 $17,526

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### 4.6 Annualized Cost Estimates
EPA estimated the total burden to industry of all of the proposed amendments over a 20-year period. This follows EPA’s practice of using a 20-year annuali zation period in the previous economic analyses of the IUR rule (EPA, 2002a and EPA, 2005). In addition, a 20-year period allows EPA to analyze a set of complete reporting cycles under both the baseline an d post-amendment scenarios. Under the baseline, a five-year reporting cycle is used, and the cost of four complete cycles is analyzed. Under the postamendment scenario, reporting occurs every four years, a nd the cost of five complete cycles is presented. The total industry burden calculated in Table 4- 49 included the burden during the first reporting cycle. EPA expects that during future reporting cy cles, the industry burden will decrease as submitters become more efficient with the data and more fam iliar with the reporting requirements. Section 4.2.6 discusses the burden reductions associated with this rule familiarization and efficiency gains. Table 4-49 also shows the total burden to industry in future reporting cycles. Table 4-54 contains a schedule of the

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4-54 annual burden estimates. Over a 20-year period, EP A estimates that the proposed amendments will increase industry burden by approximately 7.81 million hours.

Table 4-54: Schedule of Annual Industry Burden if All Proposed Amendments Are Implemented

Year Baseline Burden (millions of hours) Post-Amendment Burden (millions of hours) Change from Baseline (millions of hours) 2011 1.84 3.40 1.56 2012 0.00 0.00 0.00 2013 0.00 0.00 0.00 2014 0.00 0.00 0.00 2015 0.00 2.64 2.64 2016 1.43 0.00 -1.43 2017 0.00 0.00 0.00 2018 0.00 0.00 0.00 2019 0.00 2.64 2.64 2020 0.00 0.00 0.00 2021 1.43 0.00 -1.43 2022 0.00 0.00 0.00 2023 0.00 2.64 2.64 2024 0.00 0.00 0.00 2025 0.00 0.00 0.00 2026 1.43 0.00 -1.43 2027 0.00 2.64 2.64 2028 0.00 0.00 0.00 2029 0.00 0.00 0.00 2030 0.00 0.00 0.00 Total 6.14 13.96 7.81 Annual Average 0.31 0.70 0.39



### Table 4-55 presents the annual and annualized costs estimates of all the proposed amendments. Over a 20-year period, EPA estimates that the proposed am endments to the IUR rule will increase industry cost by $26.27 million, with a three percent discount ra te, and $27.86 million with a seven percent discount
rate.

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4-55 Table 4-55: Annual Increase in Industry Cost if All Amendments Are Implemented (2008$)

Year Baseline Cost (millions 2008$) Post-Amendment Cost (millions 2008$) Change from Baseline (millions 2008$) 2011 $106.97 $209.04 $102.07 2012 $0.00 $0.00 $0.00 2013 $0.00 $0.00 $0.00 2014 $0.00 $0.00 $0.00 2015 $0.00 $162.12 $162.12 2016 $82.82 $0.00 -$82.82 2017 $0.00 $0.00 $0.00 2018 $0.00 $0.00 $0.00 2019 $0.00 $162.12 $162.12 2020 $0.00 $0.00 $0.00 2021 $82.82 $0.00 -$82.82 2022 $0.00 $0.00 $0.00 2023 $0.00 $162.12 $162.12 2024 $0.00 $0.00 $0.00 2025 $0.00 $0.00 $0.00 2026 $82.82 $0.00 -$82.82 2027 $0.00 $162.12 $162.12 2028 $0.00 $0.00 $0.00 2029 $0.00 $0.00 $0.00 2030 $0.00 $0.00 $0.00 Total $355.42 $857.53 $502.11 Annual Average $17.77 $42.88 $25.11 Annualized at 3% $19.13 $45.41 $26.27 Annualized at 7% $21.01 $48.87 $27.86

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5-1 

## 5. Agency Burden and Cost Estimates

5.1 Methodology for Agency Burden and Cost
This chapter analyzes the changes in burden and cost to EPA as a result of the proposed amendments to the IUR rule. This chapter calcu lates the incremental cost and burde n changes of the amendments by comparing the Agency costs under the current base line to Agency costs after the proposed rule amendments. The methodology for estimating the change in Agency cost is similar to estimating the change in burden to industry:

 Step 1 : Identify the tasks performed by the Agency under both the current IUR requirements and the proposed IUR rule amendments.

 Step 2 : Determine the unit cost and burden for all activities identified in Step 1.

 Step 3 : Determine the estimated total cost and burden by multiplying the unit cost and burden by the frequency of the activity.

 Step 4 : Subtract the total Agency cost or burden afte r the proposed IUR amendments from the cost or burden under the current IUR rule to calculat e the incremental Agency cost or savings Based on the supporting statement for the 2008 Information Collection Request for the Partial Update of the TSCA Production and Site Reports (EPA 2008d), tasks associated with the costs and burden to the Agency under the IUR rule include:

 Document receipt and tracking;

 Data entry and quality control of data entry;

 Backup systems operation;

 Data processing;

 Systems development;

 Contract oversight and management;

 Publication and printing of forms and materials; and

 Operation of the TSCA Hotline to handle IUR-related calls. Costs related to using the data are not included. Th e one-time costs associated with the requirements of previous IUR amendments are also not considered here.



### 5.2 Data for Agency Cost Estimates

5.2.1 Agency Wage Rates 

### Of the tasks listed above, Agency personnel are respon sible for 1) quality control of data entry; and 2) data processing, systems development, and contract oversight and management. Under the current IUR rule, the Agency is expected to require one FTE at the GS-12 level, per-reporting cycle, to perform quality control of data entry (EPA, 2008d). An additi onal FTE at the GS-13 level is needed to complete data processing, systems development, and contract oversight and management per-reporting cycle (EPA, 2008d). The total baseline burden to the Agency is therefore 4,160 hours under the baseline. EPA assumes that the Agency burd en will remain the same for all reporting cycles.

EPA labor costs are based on annual Federal wa ge rates published by the Office of Personnel Management for the Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV locality pay area for

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5-2 2008 (OPM, 2008). Wages are presented in terms of GS-level and step. Based on previous IUR economics analyses, a Step 3 is assumed for a ll FTEs (EPA, 2002a and EPA , 2005). Following the methodology outlined in Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a), an additional 58 percent is added to the wage rate to account for fringe benefits and overhead costs. Table 5-1 shows the loaded wage rates for Ag ency staff at the GS-12 Step 3, and GS-13 Step 3 levels.

Table 5-1: Derivation of Loaded Agency Wage Rates (2008$)

Pay Grade Annual Salary Overhead and Fringe Benefits % of Wages Overhead and Fringe Benefit Cost Total

GS 12 Step 3 $77,416 58% $44,901 $122,317 GS 13 Step 3 $88,493 58% $51,326 $139,819 Source: The unloaded Federal salary for calendar 2008 is from the Office of Personnel Management salary table for Washington-Baltimore

- Northern Virginia (OPM, 2008).

5.2.2 Extramural (Contractor) Costs 

### In addition to costs incurred by EPA staff, burden is associated with extram ural tasks performed by contractors. These tasks include data receipt, track ing and data entry; backup systems operations and maintenance; printing and publishing forms and ma terials; and managing the TSCA hotline. The 2008 ICR supporting statement (EPA, 2008d) estimates these costs. EPA inflated these costs to 2008 dollars from 2007 dollars using an inflation factor devel oped from data from the BLS Employee Cost Index (ECI) “Professional, scientific, and technical servic es” group (BLS, 2009). Table 5-2 shows the derivation of the extramural task cost in 2008 dollars. In total, EPA estimates that it will spend approximately $204,000 on these tasks per reporting cycle.

Table 5-2: Derivation of Extramural Task Costs, per Reporting Cycle
Tasks Performed by Contractor Staff Annual Cost (2007$)* Inflation Factor Annual Cost (2008$) Document Receipt, Tracking and Data Entry $90,737 1.04 $94,632 Maintaining and Operati ng Back Up Systems $56,711 1.04 $59,145 Printing and Publishing Forms and Materials $5,298 1.04 $5,525 Managing the TSCA Hotline $42,855 1.04 $44,694 Total $195,601 n/a $203,997 *Source: ICR No. 1884.04. [Information Collection Request for] Partial Update of the TSCA Section 8(b) Inventory Data Base, Production and Site Report Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act , September 5, 2008. (EPA, 2008d)



### 5.3 Current Total Agency Burden and Cost

As shown in Table 5-3, EPA calculated the total baseline Agency costs by combining the costs of EPA staff and the extramural tasks performed by contractors.

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5-3 Table 5-3: Total Agency Cost under the Current IUR Requirements

Task Staff Cost per Reporting Cycle (2008$)
VARIABLE COSTS (DEPENDENT ON TH E NUMBER OF REPORTS SUBMITTED)
Quality Control of Data Entry EPA Employee (GS 12 Step 3) $122,317

Document Receipt, Tracking and Data Entry Contractor $94,632

TOTAL VARIABLE COST $216,949

FIXED COSTS
Data Processing, Systems Development, and Contract Oversight and Management EPA Employee (GS 13 Step 3) $139,819

Maintaining and Operating Back Up Systems Contractor $59,145

Printing and Publishing Forms and Materials Contractor $5,525

Managing the TSCA Hotline Contractor $44,694 TOTAL FIXED COST $249,183

TOTAL AGENCY COST $466,133

Note: Totals may not sum due to rounding.



### Previous estimates of Agency costs, on which th e estimates included in this analysis are based, provide only cost estimates, not burden estimates. Therefore, EPA’s per report burden was estimated as described in this section. The EPA GS 13 sta ff’s responsibilities for data processing, systems development, and contract oversight and management task are not strongly tied to the number of reports received, nor are the contractor tasks of maintaining and operating a back-up system and managing the TSCA hotline. However, quality control of data entry, and the document receipt, tracking, and data entry burdens, are dependent upon the numb er of reports received. The combined cost of these activities is $216,949 (See Table 5-3). EPA assumes an Agency burd en of 2,080 hours, accounting for a year of the GS 12’s burden (contractor hours are included as costs to the Agency, not burden.) EPA assumes that 

### it incurs the same cost to perform the data entry and processing for each data element in Form U. To calculate the Agency burden per data elem ent, EPA followed a methodology outlined in the Economic Analysis of the Final Rule to Add Certain Industry Groups to EPCRA Section 313 (EPA, 2007). EPA first calculated the total number of data elements in Form U (126 elements) and the percentage of data elements in each section of the form , and derived a weighted percentage of elements in each section of the form. For example, there are 19 data elements in Part I, and 4,085 sites submit Part I of Form U. These 77,615 data elements (19 x 4,085 = 77,615) account for approximately 3.4 percent of all data elements. Similarly, 52.5 pe rcent of all data elements are in Part II of the form, and 44.1 percent are in Part III. The Agency then multiplied the total burden of IUR processing, 2,080 hours, by the percentage of data elements in a section and di vided by the total number reports submitted for each section. An example of this calculation can be seen in Equation 1 below for Part I.

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5-4 Equation 1: Burden to Process Part I per Report = (2,080 hours x 0.034) / 4,085 = 0.017 hours

The burden per section was then divided by the total number of data items in that section to calculate the burden per item, 0.0009 hour (approxim ately .054 minutes) (See Equation 2). Equation 2: Burden per Data Element = 0.017 hours / 19 = 0.0009 hours

To calculate the cost to EPA, the process describ ed above was repeated; however, instead of using 2,080 hours, EPA used the combined cost for the qua lity control of data entry, and document receipt, tracking, and data entry, which was $216,949. Thus, EPA calculated that it costs the Agency approximately $0.09 to process a single data element of Form U. The total Agency burden per report is approximately 0.113 hours and $11.79. Table 5-4 cont ains the Agency burden and cost per report by section of Form U. This baseline burden will remain the same for all reporting cycles.

Table 5-4: Baseline Agency Burden per Report
Burden per Data Element Total Number of Data Elements Burden (hours) Cost (2008$) Burden (hours) Cost (2008$)
Part I 19 0.0009 $0.09 0.017 $1.78
Part II 47 0.0009 $0.09 0.042 $4.40
Part III 60 0.0009 $0.09 0.054 $5.61 Total (Full Report) 126 - - 0.113 $11.79



### 5.4 Changes to Agency Burden and Cost as a Result of the Proposed Modifications
The estimated cost and burden impacts on the Agency for each of the proposed amendments to the IUR are outlined below. See Section 3. for more in formation about each of the proposed amendments. In each of the sections below, the burden estimates for each amendment are calculated independently of the other amendments . See Section 5.5 for an estimate of the aggregated impact of all proposed amendments.

5.4.1 Technical Modifications to the Regulatory Text 

### EPA is proposing to 

### reorganize certain existing regulato ry text and to delete obsolete regulatory text. These amendments do not substa ntively affect the re gulatory text, so EPA assumes that this amendment will not impact Agency burden or cost.

5.4.2 Modifications to Selected Definitions 

### EPA is proposing to modify the definitions of “i mporter,” “manufacture,” “site,” “commercial use,” “consumer use,” “reporting year,” and “submission pe riod,” and to add definitions for “manufacturer,” “Central Data Exchange (CDX),” “electronic IUR (e -IUR),” “industrial function,” as described in Section 3. These changes are clarifications only; EPA is clar ifying in regulatory text what has been previously explained through outreach with the regulated comm unity. Therefore, EPA assumes that these definition changes will not impact Agency burden or cost.

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5-5 5.4.3 Method for Determining Whether a Manufactur er is Subject to IUR Reporting Requirements 

### EPA is proposing to require reporting if, for any calendar year since the previous IUR principal reporting year, the subject chemical was manufactured or imported in volumes of 25,000 lb. or greater. The Agency estimates this will incr ease the total number of sites and reports by five percent from the baseline. (See Section 4.4.3 for more information.) Table 5-5 shows the estimated Agen cy burden of the proposed ame ndment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden increase of 104 hours as a result of modifying the method for determining whether the 25,000 lb. threshold is met.

Table 5-5: Change in Agency Burden as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements

Burden to

Process Part I Submission

(hours) Number of Sites Burden to Process Part II (hours per

report) Number of Reports

(with Part II) Burden to Process

Part III (hours

per report) Number of Reports

with Part III Agency Burden (hours)

(a) (b) (c) (d) (e) (f) (g) = (a*b)+ (c*d)+(e*f) Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080PostAmendment 0.017 4,289 0.042 27,191 0.054 17,929 2,184
Change from the Baseline 0.000 204 0.000 1,295 0.000 854 104

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-6 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $10,847.

Table 5-6: Change in Agency Cost as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements

Cost to Process Part I Submission

(2008$) Number of Sites Cost to Process Part II (2008$ per

report) Number of Reports

(with Part II) Cost to Process Part III (2008$

per report) Number of Reports

with Part III Agency Burden (2008$)

(a) (b) (c) (d) (e) (f) (g) =(a*b)+(c*d)+(e*f)
Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $216,949

PostAmendment $1.78 4,289 $4.40 27,191 $5.61 17,929 $227,796

Change from the Baseline $0.00 204 $0.00 1,295 $0.00 854 $10,847

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

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5-6 5.4.4 Eliminate the 300,000 lb. Threshold for Processing and Use Reporting 

### EPA is proposing to eliminate the 300,000 lb. thresh old for processing and use information, thereby requiring all submitters of non-excluded substances to re port information in all parts of the IUR Form U. Eliminating this threshold will increase industry burden by requiring more sites to complete Part III of Form U (Part III contains the downstream processi ng and use information). EPA estimates that the number of Part IIIs submitted will increase by 8,203 reports (see Section 4.4.4 for more information). Table 5-7 shows the estimated Agen cy burden of the proposed ame ndment, using the baseline burden estimates found in Table 5-4. The Agency expects a burden increase of 441 hours as a result of this amendment.

Table 5-7: Change in Agency Burden as a Result of Eliminating the 300,000 lb. Threshold for Processing and Use Reporting

Burden to Process Part III (hours per report) Number of Reports Agency Burden (hours)

(a) (b) (c) = (a)*(b)
Baseline 0.05 17,075 919
Post-Amendment 0.05 25,278 1,360 Change from the Baseline 0 8,203 441 Note: Values in Change from the Baseline rows are calculated by subt racting the corresponding baseline value from the post-amendment value.



### Table 5-8 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $46,000.

Table 5-8: Change in Agency Cost as a Result of Eliminating the 300,000 lb. Threshold for Processing and Use Reporting

Cost to Process Part III (2008$ per report) Number of Reports Agency Cost (2008$)

(a) (b) (c) = (a)*(b)
Baseline $5.61 17,075 $95,835
Post-Amendment $5.61 25,278 $141,876 Change from the Baseline $0.00 8,203 $46,040 Note: Values in Change from the Baseline rows are calculated by subt racting the corresponding baseline value from the post-amendment value.

5.4.5 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals 

### EPA is proposing to eliminate the 25,000 lb. threshol d for chemicals that are: (1) the subject of a regulation proposed or promulgated under sections 5(a)(2), 5(b)(4), or 6 of the Act; (2) the subject of an order issued under section 5(e) or 5(f) of the Act, or (3) the subject of relief that has been granted under a civil action under section 5 or 7 of the Act. The manufacturers (including importers) of these chemicals would be required to report under the IUR rule, regardless of the production volume. Approximately 1,131 chemicals fall into th ese categories (EPA, 2006a). EPA estimated these chemicals are produced at a total of 4,018 sites (see Section 4.4.5 for more details).

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5-7 Table 5-9 shows the estimated Agen cy burden of the proposed ame ndment, using the baseline burden estimates found in Table 5-4. The Agency expects a burden increase of 169 hours as a result of the elimination of the 25,000 lb. threshold for certain regulated chemicals.

Table 5-9: Change in Agency Burden as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals
Burden to Process Part II (hours per

report) Number of Reports Agency Burden (hours)

(a) (b) (c) = (a)*(b) Baseline 0.04 25,896 1,092 Post-Amendment 0.04 29,914 1,261 Change from the Baseline 0 4,018 169 Note: Values in Change from the Baseline rows are calculated by subt racting the corresponding baseline value from the post-amendment value.



### Table 5-10 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $17,665.

Table 5-10: Change in Agency Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals

Cost to Process Part II (2008$ per report) Number of Reports Agency Cost (2008$)

(a) (b) (c) = (a)*(b) Baseline $4.40 25,896 $113,853 Post-Amendment $4.40 29,914 $131,518 Change from the Baseline $0.00 4,018 $17,665 Note: Values in Change from the Baseline rows are calculated by subt racting the corresponding baseline value from the post-amendment value.

5.4.6 Make Chemicals Subject to Enforceable Consent Agreements (ECAs) Ineligible for Exemptions 

### The Agency is proposing that all chemicals subject to enforceable consent ag reements be ineligible for exemptions. A total of four chemicals and 16 sit es are affected by this amendment (see Section 4.4.6 for more information). These sites would submit Part III of Form U for these chemicals for the first time in the next submission period. Table 5-11 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency expects a burden increase of one hour as a result of this amendment.

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5-8 Table 5-11: Change in Agency Burden as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions

Burden to Process Part III (hours

per report) Number of Reports Agency Burden (hours)
(a) (b) (c) = (a)*(b) Baseline 0.05 17,075 919 Post-Amendment 0.05 17,091 920 Change from the Baseline 0 16 1 Note: Values in Change from the Baseline rows are calculated by subt racting the corresponding baseline value from the post-amendment value.



### Table 5-12 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $90.

Table 5-12: Change in Agency Cost as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions

Cost to Process Part III (2008$

per report) Number of Reports Agency Cost (2008$)

(a) (b) (c) = (a)*(b) Baseline $5.61 17,075 $95,835 Post-Amendment $5.61 17,091 $97,925 Change from the Baseline $0.00 16 $90 Note: Values in Change from the Baseline rows are calculated by subt racting the corresponding baseline value from the post-amendment value.

5.4.7 Full Exemption for Manufactured Water 

### Under the current IUR regulations, manufactured wate r is partially exempt from reporting; therefore, facilities that produce manufactured water need to co mplete only Parts I and II of Form U. The Agency now is proposing to grant a full exemption for manuf actured water. Thus, the burden reduction for this proposed amendment would be the result of 43 fewer Part IIs being submitted (see section 4.4.7 for more information.) Table 5-13 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estim ates a burden reduction of two hours as a result of this amendment.

Table 5-13: Change in Agency Burden as a Result of a Full Exemption for Manufactured Water
Burden to Process Part II (hours per report) Number of Reports Agency Burden (hours) (a) (b) (c) = (a)*(b) Baseline 0.04 25,896 1,092 Post-Amendment 0.04 25,853 1,090 Change from the Baseline 0 -43 -2 Note: Values in Change from the Baseline rows are calculated by subt racting the corresponding baseline value from the post-amendment value.



### Table 5-14 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost savings of approximately $189.

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5-9 Table 5-14: Change in Agency Cost as a Result of a Full Exemption for Manufactured Water
Cost to Process Part II (2008$ per report) Number of Reports Agency Cost (2008$) (a) (b) (c) = (a)*(b) Baseline $4.40 25,896 $113,853 Post-Amendment $4.40 25,853 $113,664 Change from the Baseline $0.00 -43 -$189 Note: Values in Change from the Baseline rows are calculated by subtr acting the corresponding baseline value from the post-amendment value.

5.4.8 Remove Fully-Exempt Polymers from the Partially-Exempt List 

### EPA is amending the list of partially exempt chemic als to remove three chemical substances (Starch (CASRN 9005-25-8), Dextrin (CASRN 9004-53-9), a nd Maltodextrin (CASRN 9049-76-7)) which, as polymers, are fully exempt from reporting. This will not change the Agen cy burden, because these substances currently are fully exempt from reporti ng, and therefore no add itional reports will be submitted to EPA.

5.4.9 Parent Company and Site Identity 

### Manufacturers (including importers) currently are re quired to report the name and other information to identify the company associated with their plant site on Part I of Form U. EPA is proposing to require that the company name be the ultimate domestic pa rent name. EPA assumes no additional Agency burden for processing the ultimate domestic parent name, compared to the current IUR reporting requirement of the parent company name.

5.4.10 Technical Contact 

### Manufacturers (including importers) are required to provide a technical contact for their IUR submission. EPA is proposing to amend the IUR rule to require that the technical contact be a person who works at the site and is knowledgeable about the ch emical. EPA assumes no additional Agency burden to process the technical contact regardless of the location of the contact.

5.4.11 Chemical Identity 

### EPA is proposing to require the reporting of the Chem ical Abstracts (CA) Index Name currently used to list the substance in the Inventory as the chemic al name reported for IUR. Currently, submitters are required to report a specific chemical name, with no furt her elaboration in the regulatory text. EPA is also proposing to allow submitters to report only the CA SRN as a chemical identifying number or, in the case of confidential chemical substances, the accession numbe r. Note that in cases where a CASRN exists for a confidential chemical, it can be reported instead of the 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 Inventory substan ce has either a CASRN or a TSCA Accession Number or both, which are likely to be already known to the submitter. EPA assumes no additional Agency burden to process a CA Index Name or CASRN, compared to another chemical identity name or number.

5.4.12 Report Production Volume for Each of the Years since Last Principal Reporting Year 

### EPA is proposing to require reporting of a chemic al’s production volume manufactured in each of the five years since the last IUR principal reporting year. Thus, for the 2011 IUR, manufacturers (including importers) of subject chemicals would report the pr oduction volume for the calendar years 2006, 2007, 2008, 2009, and 2010. This amendment will result in four additional data items for EPA to process in Part

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5-10 II of Form U, adding approximately 1.2 minutes (0 .02 hours) of processing burden per form (see Table 5-4). Table 5-15 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency es timates a burden increase of 93 hours as a result of this amendment.

Table 5-15: Change in Agency Burden as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year

Burden for Processing Production Volume (hours per report) Number of Reports Agency Burden (hours)

(a) (b) (c) = (a)*(b) Baseline 0.001 25,896 23 Post-Amendment 0.004 25,896 116 Change from the Baseline 0.004 0 93 Note: Values in Change from the Baseline rows are calculated by subtract ing the corresponding baseline value from the post-amendment value.



### Table 5-16 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $9,700.

Table 5-16: Change in Agency Cost as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year
Cost for Processing Production Volume (2008$ per report) Number of Reports Agency Cost (2008$)

(a) (b) (c) = (a)*(b)
Baseline $0.09 25,896 $2,422
Post-Amendment $0.47 25,896 $12,112 Change from the Baseline $0.37 0 $9,690 Note: Values in Change from the Baseline rows are calculated by subtract ing the corresponding baseline value from the post-amendment value.

5.4.13 Volume of Chemical Substance Used On-Site 

### Under the current IUR requirements, submitters w ho manufacture a chemical exclusively for on-site use are required to indicate this on Form U. The Agen cy is proposing to require submitters to report both production volumes used on- and off-site. EPA expects that there will be a slight increase in the number of submitters who would report pro duct volume used on-site information; about 19.4 percent of all submitters will report the volume used on-site (see Section 5.4.13 for more information). Table 5-17 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estim ates a burden increase of five hours as a result of this amendment.

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5-11 Table 5-17: Change in Agency Burden as a Resu lt of Reporting of Production Volume Used OnSite
Burden to Process Information (hours per

report) Number of Reports Number of Reports with Production Volume Used On-Site Agency Burden (hours)

Baseline 0.042 25,896 0 1,092
Post-Amendment 0.043 25,896 5,024 1,096 Change from the Baseline 0.001 0 5,024 5

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-18 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $470.

Table 5-18: Change in Agency Cost as a Result of Reporting of Production Volume Used On-Site
Cost to Process

Information (2008$ per

report) Number of Reports Number of Reports with Production Volume Used On-Site Agency Cost (2008$)

Baseline $4.40 25,896 0 $113,853

Post-Amendment $4.49 25,896 5,024 $114,323 Change from the Baseline $0.09 0 5,024 $470

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

5.4.14 Indicate Whether Chemical Is Physically at Reporting Site 

### EPA is proposing to require submitters to indicate wh ether an imported chemical is physically at the reporting site. This will add one additiona l data element for EPA to process. Table 5-19 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency es timates a burden increase of 23 hours as a result of this amendment.

Table 5-19: Change in Agency Burden as a Result of Indicating Whether an Imported Chemical is Physically On-Site
Burden to Process Information (hours per report) Number of Reports Agency Burden (hours)
(a) (b) (c) = (a)*(b)
Baseline 0.042 25,896 1,092
Post-Amendment 0.043 25,896 1,115 Change from the Baseline 0.001 0 23

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

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5-12 Table 5-20 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $2,400.

Table 5-20: Change in Agency Cost as a Result of Indicating Whether an Imported Chemical is Physically Present On-Site
Cost to Process

Information (2008$ per report) Number of Reports Agency Cost (2008$)
(a) (b) (c) = (a)*(b)
Baseline $4.40 25,896 $113,853

Post-Amendment $4.49 25,896 $116,275 Change from the Baseline $0.09 0 $2,422

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

5.4.15 Report Production Volume Exported 

### EPA is proposing to require that all submitters provide the exported chemical volume in Section II of the report. This will add one add itional data element to Part II of Form U for EPA to process. Table 5-21 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency es timates a burden increase of 23 hours as a result of this amendment.

Table 5-21: Change in Agency Burden as a Result of Requiring the Reporting of Export Volume

Burden to Process Information (hours per report) Number of Reports Agency Burden (hours)
(a) (b) (c) = (a)*(b)
Baseline 0.042 25,896 1,092
Post-Amendment 0.043 25,896 1,115 Change from the Baseline 0.001 0 23

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-22 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $2,422.

Table 5-22: Change in Agency Cost as a Result of Requiring the Reporting of Export Volume

Cost to Process

Information (2008$ per report) Number of Reports Agency Cost (2008$)
(a) (b) (c) = (a)*(b)
Baseline $4.40 25,896 $113,853

Post-Amendment $4.49 25,896 $116,275 Change from the Baseline $0.09 0 $2,422

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

5-13 5.4.16 Identify Whether Chemical Is To Be Recycled, Remanufactured, Reprocessed, Reused, or Reworked 

### EPA is proposing to add a checkbox to Form U for subm itters to indicate whether a chemical is to be recycled, remanufactured, reprocessed, reused, or rewo rked. This will add one additional data element to Part II of Form U for EPA to process. Table 5-23 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency es timates a burden increase of 23 hours as a result of this amendment.

Table 5-23: Change in Agency Burden as a Result of Indicating Whether Chemical is Recycled, Remanufacture, Reprocessed, Reused, or Reworked
Burden to Process a Checkbox to

Indicate Whether a Product is

Recycled, Rema nufactured, Reprocessed, Reused, or Reworked (hours per report) Number of Reports Agency Burden (hours)

(a) (b) (c) = (a)*(b)

Baseline 0.042 25,896 1,092

Post-Amendment 0.043 25,896 1,115 Change from the Baseline 0.001 0 23

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-24 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $2,400.

Table 5-24: Change in Agency Cost as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reused, or Reworked
Cost to Process a Checkbox to Indicate Whether a Product is

Recycled, Rema nufactured, Reprocessed, Reused, or Reworked (2008$ per report) Number of Reports Agency Cost (2008$)

(a) (b) (c) = (a)*(b)
Baseline $4.40 25,896 $113,853
Post-Amendment $4.49 25,896 $116,275 Change from the Baseline $0.09 0 $2,422

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

5.4.17 Concentration Ranges 

### EPA is proposing to amend the ranges used to repor t chemical concentration in §710.52(C)(3) and (4) by changing the ranges to: 1) less th an one percent by weight, 2) at least one percent but less than 30 percent by weight, 3) at least 30 percent but less than 60 percent by weight, 4) at least 60 percent but less than 90 percent by weight, and 5) at least 90 percent by weight.

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5-14 This is a technical correction to eliminate gaps in the ranges as previously listed in the rule. EPA assumes it will have no impact on Agency burden or cost.

5.4.18 Revise Industrial Function Categories 

### The Agency is revising the industrial function categories, by adding eight additional 

### categories, eliminating six existing categories and requiring submitters to write in text when they claim “Other” as the category. This would add one data element to Pa rt III of Form U for EPA to process. EPA expects the number of submitters who select “Other” to decrease, for a total of 603 submitters expected to write-in this text descriptor (see Section 4.4.18 for more information). Table 5-25 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency es timates a burden increase of 0.54 hours as a result of this amendment.

Table 5-25: Change in Agency Burden as a Result of Revising the Industrial Function Categories
Burden to

Process Function Categories (hours per

report) Number of Reports with

Function Categories Burden toProcess Writein Text for

"Other" (hours) Number of Reports with Text Descriptor for "Other" Burden (hours)

(a) (b) (c) (d) (e) = (a*b)+ (c*d)
Baseline 0.05 17,075 0.000 0 918.82

Post-Amendment 0.05 17,075 0.001 603 919.36 Change from the Baseline 0.00 0 0.001 603 0.54

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-26 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $56.

Table 5-26: Change in Agency Cost as a Result of Revising the Industrial Function Categories
Cost to Process Industrial Function Categories (2008$ per

report) Number of Reports with

Industrial Function Categories Cost to Process Write-in Text for "Other" (2008$) Number of Reports with Text Descriptor for "Other" Cost (2008$)

(a) (b) (c) (d) (e) = (a*b) + (c*d)
Baseline $5.61 17,075 $0.00 0 $95,835

Post-Amendment $5.61 17,075 $0.09 603 $95,892 Change from the Baseline $0.00 0 $0.09 603 $56

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

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5-15 5.4.19 Revise Industrial Sectors 

### EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) codes with 48 Industrial Sectors. This amendment will not change the Agency’s data processing burden. 

### EPA expects that the Agency’s burden to proces s the industrial sectors will remain the same regardless of the code system used.

5.4.20 Revise Consumer and Commercial Product Categories 

### The Agency is proposing to revise the consumer and commercial product categories, by adding 

### 12 new categories and requiring submitters to write in text when they select “Other” as a consumer or commercial product category . EPA expects 604 submitters to write in this text descriptor for “Other” (see Section 4.4.20 for more information), a dding one additional data elem ent to Part III of Form U for EPA to process. Table 5-27 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimat es a 0.54 hour burden increase as a result of this amendment.

Table 5-27: Change in Agency Burden as a Result of Revising the Consumer and Commercial Product Categories
Burden to Process Consumer or Commercial

Product Categories (hours per report) Number of Reports with Consumer or Commercial

Product Categories Burden toProcess Writein Text for

"Other" (hours) Number of Reports with

Write-in Text for "Other" Burden (hours)

(a) (b) (c) (d) (e) = (a)*(b)+ (c)*(d)
Baseline 0.05 17,075 0.000 0 918.82
PostAmendment 0.05 17,075 0.001 604 919.36
Change from the Baseline 0.00 0 0.001 604 0.54

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-28 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $56.

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

5-16 Table 5-28: Change in Agency Cost as a Result of Revising the Consumer and Commercial Product Categories
Cost to Process

Consumer or Commercial

Product Categories (hours per report) Number of Reports with Consumer or Commercial

Product Categories Cost to Writein Text for

"Other" (2008$) Number of Reports with

Write-in Text for "Other" Cost (2008$)

(a) (b) (c) (d) (e) = (a)*(b)+ (c)*(d)
Baseline $5.61 17,075 $0.00 0 $95,835
PostAmendment $5.61 17,075 $0.09 604 $95,892
Change from the Baseline $0.00 0 $0.09 604 $56

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

5.4.21 Designation of Consumer or Commercial Use 

### EPA is proposing to require the identification of whether the downstream use is a consumer or a commercial use, or both, adding one data element to Part III of Form U for EPA to process. Table 5-29 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency expect s a burden increase of 15 hours as a result of this amendment.

Table 5-29: Change in Agency Burden as a Result of Designation of Consumer or Commercial Use Burden per Report (hours) Number of Reports with Part III Burden (hours)
Baseline 0.054 17,075 919
Post-Amendment 0.055 17,075 934 Change from the Baseline 0.001 0 15

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-30 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $1,600.

Table 5-30: Change in Agency Cost as a Result of Designation of Consumer or Commercial Use
Cost per Report (2008$) Number of Reports with Part III Cost (2008$)

Baseline $5.61 17,075 $95,835
Post-Amendment $5.71 17,075 $97,433 Change from the Baseline $0.09 0 $1,597

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

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5-17 5.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed 

### EPA is proposing to require that submitters of re ports with processing and use information provide the number of commercial workers who are reasona bly likely to be exposed to a chemical. This amendment adds one data element to Pa rt III of Form U for EPA to process. Table 5-31 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency expect s a burden increase of 15 hours as a result of this amendment.

Table 5-31: Change in Agency Burden as a Re sult of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed Burden per Report (hours) Number of Reports with Part III Burden (hours)
Baseline 0.054 17,075 919
Post-Amendment 0.055 17,075 934 Change from the Baseline 0.001 0 15

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-32 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $1,600.

Table 5-32: Change in Agency Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed
Cost per Report (2008$) Number of Reports with Part III Cost (2008$)

Baseline $5.61 17,075 $95,835
Post-Amendment $5.71 17,075 $97,433 Change from the Baseline $0.09 0 $1,597

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

5.4.23 Changes to the Standard for the Reporting of Processing and Use Information 

### EPA is proposing to eliminate the “Not Readily Ob tainable (NRO)” standard and replace it with the more stringent “Known to or Reasonably Ascertainable by” standard for reporting of processing and use information. This amendment does not affect the number of submitters or the number of data elements in Form U, and therefore, EPA assumes that it w ill not increase the Agency burden or cost.

5.4.24 Chemical Identity CBI Claims 

### EPA is proposing that, when a submitter asserts a clai m of confidentiality for the chemical identify of a substance that is listed on the public portion of the Master Inventory File, the Agency may make the information available to the public without further notice to the submitter. See the proposed regulatory text at 40 CFR 711.18(e). Any such action on EPA’s pa rt would be as part of regular and routine use of the data and will not create any additional burden.

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5-18 5.4.25 Upfront Substantiation for Processing and Use Information CBI Claims 

### EPA is proposing to require upfront substantiati on for all CBI claims in the processing and use section of Form U. This amendment adds two data elements per item claimed as CBI, to Part III of Form U for EPA to process. EPA expects that 2,928 repor ts will claim processing and use information as CBI, and on average they will make three CBI claims per report (see section 4.4.25 for more information). Table 5-33 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency expects a burden increase of eight hours as a result of this amendment.

Table 5-33: Change in Agency Burden as a Resu lt of Requiring Upfront Substantiation for CBI Claims

Burden per Report (hours) Number of Reports with Part III Burden for Upfront CBI Substantiation for

CBI Claims in Part III Number of Reports with Substantiated CBI Claims in Part III Burden (hours)

Baseline 0.05 17,075 0.000 0 919
Post-Amendment 0.05 17,075 0.003 2,928 927 Change from the Baseline 0.00 0 0.003 2,928 8

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-34 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $822.

Table 5-34: Change in Agency Cost as a Result of Requiring Upfront Substantiation for CBI Claims

Cost per Report (2008$) Number of Reports with Part III Cost for Upfront CBI Substantiation for

CBI Claims in Part III Number of Reports with Substantiated CBI Claims in Part III Cost (2008$)

Baseline $5.61 17,075 $0.00 0 $95,835

Post-Amendment $5.61 17,075 $0.28 2,928 $96,657 Change from the Baseline $0.00 0 $0.28 2,928 $822

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

5.4.26 Limitation on Confidentiality Claims fo r Data Elements Identified as “Not Known or Reasonably Ascertainable” 

### EPA is proposing to no longer allow CBI claims for data elements identified as “not known or reasonably ascertainable.” EPA expects that there will be no change in Agency burden as a result of this proposed amendment because the number of submitte rs and data elements will not change.

5.4.27 Require Electronic Subm issions over the Internet 

### EPA is proposing to require that all Form Us be submitted to the Agency electronically, via e-IUR and EPA’s Central Data Exchange (CDX) over the Internet. EPA expects that mandatory electronic submission will reduce significantly the Agency’s da ta processing time. Based on a study conducted by EPA, “A Business Case Analysis of EPA’s Central Data Exchange” (EPA, 2007) on of the costs and

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5-19 benefits of the CDX system, EPA processing burden is expected to decrease by 88.6 percent, not including the operating and maintenance and troubles hooting costs that are included in the general CDX operating budget. Table 5-35 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency es timates a burden decrease of 1,800 hours as a result of this amendment.

Table 5-35: Change in Agency Burden as a Result of Requiring Electronic Submission Burden per

Report to

Process Part I (hours per site) Number of Sites Burden per Report to

Process Part II (hours per

report) Number of Reports Burden per Report to

Process Part III (hours per site) Number of Sites with Part III Burden (hours)

Baseline 0.017 4,085 0.0422 25,896 0.054 17,075 2,080
PostAmendment 0.002 4,085 0.005 25,896 0.006 17,075 238
Change from the Baseline -0.015 0 -0.0373 0 -0.048 0 -1,842

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table 5-36 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost savings of approximately $192,200.

Table 5-36: Change in Agency Cost as a Result of Requiring Electronic Submission

Cost per Report to

Process Part I (2008$) Number of Sites Cost per Report to

Process Part II (2008$ per

report) Number of Reports Cost per Report to

Process Part III (2008$ per site) Number of Sites with Part III Cost (2008$)

Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $216,949

PostAmendment $0.20 4,085 $0.50 25,896 $0.64 17,075 $24,794

Change from the Baseline -$1.57 0 -$3.89 0 -$4.97 0 -$192,155

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

5.4.28 Updated e-IUR Reporting Software 

### EPA developed the e-IUR reporting software for use by manufacturers and importers in preparing and submitting reports electronically during the 2006 IUR reporting cycle. The updated e-IUR reporting tool for the 2011 IUR collection would feature several improved capabilities over the current e-IUR reporting tool. Although not quantified here, EPA expects that improvements to the e-IUR software will reduce Agency burden to process and co rrect errors in the form.

5.4.29 Electronic Signature Process 

### In order to submit IUR data electronically to EPA via CDX, individuals acting on behalf of the submitter must first register with CDX. To register in CDX, the CDX registrant (also referred to as

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

5-20 “Electronic Signature Holder”) downloads two fo rms: the Electronic Signature Agreement and the Verification by Company Authorizing Official Form. Registration enables CDX to perform two important functions: authenticate identity, and verify authori zation. For authentication of identity, the submitter completes the Electronic Signature Agreement form, signs and dates it, has the form notarized, and mails it back to EPA. The Verification of Authorization fo rm requires the signatures of the authorized company official and anyone he/she authorizes to submit support documents for the company. The storage and processing of these forms is exp ected to generate a small burden for EPA. To estimate the Agency burden of processing, reviewin g, approving, and filing the wet ink copies of these forms, EPA used the burden estimates found in the Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis: Final Rule (EPA, 2004). EPA estimates the burden to receive, process, review, approve, and file wet-ink signature agreements for new submitters or submissions as a result of employee turnover is 0.17 hours per form (EPA, 2004). All 4,0 85 sites will be required to submit new electronic signature agreements in the 2011 submission year. In future reporting cycles, only sites which have not previously registered with CDX or sites with a new authorized company official must submit the electronic signature agreements. EPA expects this nu mber to be negligible. Therefore EPA expects the Agency burden of this amendment to be approxima tely 645 hours (4,085 sites x 0.17 hours per site). The processing, reviewing, approving, and filing of th e electronic signature agreements is expected to be completed by the GS-13 Step-3 employee that is currently responsible for data processing, systems development, and contract oversight and manage ment. EPA multiplied the burden estimate of 645 hours with an hourly wage rate of $67.22. This wage rate was calculated by dividing the annual total loaded wage of the GS-13 Step 3 employee ($139,819) found in Table 5-1 by one FTE of 2,080 hours. Therefore, the total cost to the Agency of processing, reviewing, approving, and filing of the electronic signature agreement form is approximately $46,681 during the 2011 reporting cycle.

5.4.30 Modifications Specifi cally Affecting Importers 

### For purposes of IUR, importers currently are allowe d to report the IUR information jointly with the foreign manufacturer of the chemical. Under the proposed amendment, the foreign manufacturer must now register with CDX and submit its report electroni cally. Previously, joint submissions could not be made electronically. For the 2006 IUR reporting cycle, EPA set aside joint submissions until both were received and matched. Oftentimes, EPA had no way to determin e 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. Although not quantified, EPA also anticipates that the electronic reporting tool will streamline EPA processing of the IUR information submitted in the 2011 reporting cycle, thus reducing Agency burden.

5.4.31 Modify Reporting Frequency 

### EPA is proposing to modify the IUR reporting cycle fr om five years to four years. This will increase the Agency burden because the Agency will receive and process IUR data more frequently. The annual baseline Agency burden is two FTEs, or 4,160 hours. Table 5-37 contains the change in burden over a 20- year period. In total, EPA estimates that the Agen cy will spend 4,160 more hours over a 20-year period as a result of modifying the IUR reporting frequency.

Table 5-37: Change in Agency Burden as a Result of Modifying the Reporting Frequency

Year Baseline Burden ( hours) Post-Amendment Burden (hours) Change in Burden (hours) 2011 4,160 4,160 0 2012 0 0 0 2013 0 0 0

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5-21 2014 0 0 0 2015 0 4,160 4,160 2016 4,160 0 -4,160 2017 0 0 0 2018 0 0 0 2019 0 4,160 4,160 2020 0 0 0 2021 4,160 0 -4,160 2022 0 0 0 2023 0 4,160 4,160 2024 0 0 0 2025 0 0 0 2026 4,160 0 -4,160 2027 0 4,160 4,160 2028 0 0 0 2029 0 0 0 2030 0 0 0 Total 16,640 20,800 4,160 Annual Average 832 1,040 208



### Table 5-38 contains the 20-year cost estimate as a result of modifying the reporting frequency. The baseline cost estimate is for data entry only and is di scussed in Section 5.2. This table includes extramural costs which are incurred by the Agency. In tota l, EPA estimates that it will cost the Agency approximately $466,100 to increase the frequency of reporting from a five-year reporting cycle to a fouryear reporting cycle over a 20-year period. EPA estimat es that the annualized changes in cost would be $22,900 and $22,400 with a three percent and seven percent discount rate, respectively.

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5-22 Table 5-38: Change in Agency Cost as a Result of Modifying the Reporting Frequency

Year Baseline Cost (2008$) Post-Amendment Cost (2008$) Change in Cost (2008$) 2011 $466,133 $466,133 $0 2012 $0 $0 $0 2013 $0 $0 $0 2014 $0 $0 $0 2015 $0 $466,133 $466,133 2016 $466,133 $0 -$466,133 2017 $0 $0 $0 2018 $0 $0 $0 2019 $0 $466,133 $466,133 2020 $0 $0 $0 2021 $466,133 $0 -$466,133 2022 $0 $0 $0 2023 $0 $466,133 $466,133 2024 $0 $0 $0 2025 $0 $0 $0 2026 $466,133 $0 -$466,133 2027 $0 $466,133 $466,133 2028 $0 $0 $0 2029 $0 $0 $0 2030 $0 $0 $0 Total $1,864,532 $2,330,664 $466,133 Annual Average $93,227 $116,533 $23,307 Annualized at 3% $98,818 $121,750 $22,932 Annualized at 7% $106,248 $128,613 $22,365



### 5.5 Total Agency Cost of All Modifications
As EPA did with the industry cost calculations , EPA calculated the cost for each individual amendment as a stand-alone cost, and did not take in to account the effect of individual amendments on the others. For this reason, when calculating the tota l Agency cost, EPA could not simply add the changes in burden for each proposed amendment, but had to consider the interactions among the proposed amendments. For a more detailed discussion of th e interaction among the proposed amendments, see Section 4.5. As shown in Table 5-39, EPA expects that the proposed electronic submission amendment will decrease Agency burden by approximately 88.6 percent.

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5-23 Table 5-39: Change in Agency Burden as a Re sult of All the Proposed IUR Modifications



### To calculate the combined effect on Agency cost s if all the proposed amendments were to be enacted, EPA used t he baseline number of reports and s ites taken from the 2006 IUR database (EPA, 2008c) and the baseline per report cost and burden est imates as found in Table 5-4. The change in the number of reports due to the effect of the amendmen ts combined is calculated in Table 4-46. EPA added the cost of one additional FTE (2,080 hours) to th e baseline hours to account for the additional activities conducted by the GS-13 employee (see Table 5-3) and a ll extramural costs not related to data entry (see Table 5-2). Table 5-40 presents the total Agency burden for all the amendments combined. In total, EPA estimates that the Agency will save 1,704 hours durin g the first reporting cycle. Table 5-41 presents the total Agency cost estimates; the Agency will save approximately $177,700 as a result of the proposed IUR amendments. The baseline and post-amendment co sts both contain the cost of all extramural activities, found in Table 5-2. Option Burden per Part I of Report (hours) Burden per Part II of

Report (hours) Burden per Part III of

Report (hours) Baseline 0.02 0.04 0.05 Production Volume Used On-Site - 0.0002 -- Industrial Function Categories - -- 0.00003 Recycled, Remanufact ured, Reprocessed, Reused, or Reworked - 0.001 --
Whether Chemical is Physi cally at Site - 0.001 -- Exported Volume Reporting - 0.001 -- Consumer/Commercial Product Categories - -- 0.00003 Number of Workers Exposed - -- 0.001 CBI - -- 0.0005 Production Volume in Off-Years - 0.0036 -- e-IUR -0.015 -0.043 -0.049 Total Change from the Baseline with All Amendments -0.015 -0.037 -0.047
Total, All Amendments 0.002 0.006 0.006

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5-24 Table 5-40: Total Agency Burden for All Amendments Combined
Burden

per Report (Part I) (hours) Number of Sites Burden to Process Part II (hours) Number of Reports

(with Part II) Burden to Process Part III (hours) Number of Reports (with Part III) Agency Burden (hours)

(a) (b) (c) (d) (e) (f) (g) = (a  b) +(c  d) +

(e  f)
Baseline 0.017 4,085 0.042 25,896 0.054 17,075 4,160

PostAmendment 0.002 4,289 0.006 31,365 0.006 30,716 2,456

Change from the Baseline -0.015 204 -0.037 5,469 -0.047 13,641 -1,704

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

Table 5-41: Total Agency Cost of All Amendments Combined
Cost per Report (Part I) (2008$) Number of Sites Cost to Process Part II (2008$) Number of Reports

(with Part II) Cost to Process Part III (2008$) Number of Reports (with Part III) Agency Cost (2008$)

(a) (b) (c) (d) (e) (f) (g) = (a  b)+ (c  d) +

(e  f)
Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133

PostAmendment $0.20 4,289 $0.58 31,365 $0.66 30,716 $288,450

Change from the Baseline -$1.57 204 -$3.82 5,469 -$4.95 13,641 -$177,683

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### To calculate the Agency burden per data elem ent, EPA followed the same methodology used to calculate the baseline burden per data element (See S ection 5.3). EPA calculated the total number of data elements in the proposed Form U (146 elements) and th e percentage of data elements in each section of the form, and derived a weighted percentage of elemen ts in each section of the form. For example, there are 23 data elements in the revised Part I, and 4,2 89 sites are expected to submit Part I when all the amendments are considered. These 77,615 data elements (19 x 4,085 = 77,615) account for approximately 2.41 percent of all data elements. Similarly, 41.35 per cent of all data elements are in Part II of the form, and 56.24 percent are in Part III. The Agency then multiplied the total variable burden of IUR processing, 376.5 hours, by the percentage of data elements in a section and divided by the total number reports submitted for each section. To calculate the total variable burden to the Agency, EPA took the total burden estimate of 2,456 hours (Table 5-40 above) and subtracted the fixed burden of 2,080 hours. An example of this calculation can be seen in Equation 3 below for Part I.
Equation 3: Burden to Process Part I per Report = (376.5 hours x 0.0241) / 4,289 = 0.002 hours

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5-25 The burden per section was then divided by the total num ber of data items in that section to calculate the burden per item, 0.00009 hour (approximately .0054 minutes) (See Equation 2).
Equation 4: Burden per Data Element = 0.002 hours / 19 = 0.00009 hours

Table 5-42 contains the total post-amendment burde n to the Agency at the per-report and per-data element level. Because of the electronic submissi on, the Agency burden decreases by .099 hours per report, despite an additional 35 data elements added to Form U.

Table 5-42: Agency Burden per Report when All Amendments are Combined

Number of Data Elements Burden per Data Element (hours) Total Burden per Report (hours) Form

U Section Baseline PostAmendment Change from Baseline Baseline PostAmendment Change from Baseline Baseline PostAmendment Change from Baseline
Part I 19 23 4 0.0009 0.00008 -0.0008 -0.0008 0.017 0.002
Part II 47 66 19 0.0009 0.00008 -0.0008 -0.0008 0.042 0.006
Part III 60 75 15 0.0009 0.00008 -0.0008 -0.0008 0.054 0.006 Total (Full Report) 126 161 35 - - 0.113 0.014



### The burden per section was then divided by the total number of data items in that section to calculate the burden per item, 0.00009 hour (approxi mately .0054 minutes) Equation 5.
Equation 5: Burden per Data Element = 0.002 hours / 19 = 0.00009 hours

To calculate the cost to EPA, th e process described above was repeat ed; however, instead of using the hourly burden, EPA used the combined cost for the quality control of data entry, and document receipt, tracking, and data entry, which was $39,366. This co st was calculated by subtracting the fixed Agency costs, $249,184 (see Table 5-3) from the total post am endment cost of $288,450 (See Table 5-41). Thus, EPA calculated that it costs the Agency approximately $0.09 to process a single data element of Form U. The total Agency cost per report is approximatel y $1.44 in the post- amendment scenario. Table 5-43 contains the Agency cost per report by section of Fo rm U. This baseline burden will remain the same for all reporting cycles.

Table 5-43: Agency Cost per Report When All Amendments are Combined

Number of Data Elements Cost per Data Element (2008$) Total Cost per Report (2008$) Form

U Section Baseline PostAmendment Change from Baseline Baseline PostAmendment Change from Baseline Baseline PostAmendment Change from Baseline
Part I 19 23 4 $0.09 $0.009 -$0.085 $1.78 $0.20 -$1.57
Part II 47 66 19 $0.09 $0.009 -$0.085 $4.40 $0.57 -$3.83
Part III 60 75 15 $0.09 $0.009 -$0.085 $5.61 $0.67 -$4.94 Total (Full Report) 126 161 35 - - $11.79 $1.44 -$10.34

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5-26 Table 5-44 

### contains Agency costs per-data elem ent and per-report separated by EPA and contractor staff. Using the values in Table 5-3, EPA estimates that in the 

### baseline, approximately 56.4 percent of the variable Agency costs are attributed to EPA staff ($122,317/$216,949). The remaining 43.6 percent of data processing costs are incurred by contractor staff ($94,632/$216,949). EPA does not expect the dist ribution of costs be tween Agency and contractor staff to change as a result of the proposed rule. Thus , to calculate the post-amendment costs attributed to contractor staff, EPA multiplied the per-report cost and the per-data element cost by 43.6 percent. The cost to contract staff is approximately $0.63. Similarly, to derive the EPA staff cost of $0.81 per report, the total per-report costs of $1.44 was multiplied by 56.4 percent.

Table 5-44: Agency Cost per Report when All Amendments Are Combined Cost per Data Element (2008$) Total Cost per Report (2008$) 1 Form U Section Agency Staff Cost Contractor Cost Total PostAmendment Cost Agency Staff Cost Contractor Cost Total PostAmendment Cost
Part I $0.005 $0.004 $0.009 $0.11 $0.09 $0.20
Part II $0.005 $0.004 $0.009 $0.32 $0.25 $0.57
Part III $0.005 $0.004 $0.009 $0.37 $0.29 $0.66 Total (Full Report) - - $0.81 $0.63 $1.44

1 Note totals may not sum due to rounding.

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5-27 

### 5.6 Annual Burden and Discounted Total Agency Cost of All Modifications
Table 5-45 presents the annual Agency burden estimat es for data entry and extramural costs over a 20-year period. The annual baseline Agency burden is equivalent to two FTEs, or4,160 hours. The postamendment Agency burden is calculated in Table 5- 40, and an additional FTE is added to account for all the GS-13 level tasks (see Table 5-3), which are not affected by any of the proposed amendments. In total, EPA estimates that the Agency burden for the IUR rule will be reduced by 4,400 hours over a 20- year period under the proposed IUR amendments.

Table 5-45: Annual Data Entry Burden to the Agency of all Modifications

Year Baseline Burden (hours) Post-Amendment Burden (hours) Change from Baseline

2011 4,160 2,456 -1,704 2012 0 0 0 2013 0 0 0 2014 0 0 0 2015 0 2,456 2,456 2016 4,160 0 -4,160 2017 0 0 0 2018 0 0 0 2019 0 2,456 2,456 2020 0 0 0 2021 4,160 0 -4,160 2022 0 0 0 2023 0 2,456 2,456 2024 0 0 0 2025 0 0 0 2026 4,160 0 -4,160 2027 0 2,456 2,456 2028 0 0 0 2029 0 0 0 2030 0 0 0 Total 16,640 12,282 -4,358 Annual Average 832 614 -218



### To estimate the annual cost of all the proposed amendments, EPA used the total baseline cost estimates over a 20-year period in Table 5-3. These costs include the cost of data entry performed by both EPA and contractor staff, and the cost of all extram ural activities conducted by contractor staff. Under the baseline, EPA estimates that the total Agency co st will be $466,100 during each reporting cycle. The annualized post-amendment costs also include all extr amural costs from Table 5-2 in addition to the data entry and quality control costs.

Table 5-46 contains the annualized cost estimation. In total, annual costs will be $288,500 during the first reporting cycle and thereafter. Over a 20-year period, EPA estimates that the Agency will save approximately $422,300. Annualized savings are $23, 500 and $26,700, discounted at three percent and seven percent, respectively.

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5-28 Table 5-46: Annual and Discounted Total Cost to the Agency of All Modifications

Year Baseline Cost (2008$) Post-Amendment Cost (2008$) Change from Baseline

2011 $466,133 $288,450 -$177,683
2012 $0 $0 $0 2013 $0 $0 $0
2014 $0 $0 $0
2015 $0 $288,450 $288,450
2016 $466,133 $0 -$466,133
2017 $0 $0 $0
2018 $0 $0 $0 2019 $0 $288,450 $288,450
2020 $0 $0 $0
2021 $466,133 $0 -$466,133
2022 $0 $0 $0
2023 $0 $288,450 $288,450
2024 $0 $0 $0 2025 $0 $0 $0
2026 $466,133 $0 -$466,133
2027 $0 $288,450 $288,450
2028 $0 $0 $0
2029 $0 $0 $0
2030 $0 $0 $0 Total $1,864,532 $1,442,251 -$422,281 Annual Average $93,227 $72,113 -$21,114

Annualized at 3% $98,818 $75,341 -$23,477

Annualized at 7% $106,248 $79,587 -$26,661

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6-1 

## 6. Social Cost Summary

To calculate the total burden to society, EPA adde d the total industry burden to the Agency burden savings. Table 6-1 below contains the annual burde n estimates for the years 2011 through 2030. The baseline burden for the first reporting cycle is calculated by adding the baseline burden to industry, 1.84 million hours (see Table 4-10), and the baseline burden to EPA, 4,160 hours (see Table 5-3), for a total of 1.85 million hours. EPA estim ates that the proposed IUR rule amendments would increase the industry burden in the first reporting cycle by 1.56 million hours (see Table 4-49) and decrease Agency burden by 1,704 hours (see Table 5-40) . The net burden increase is 1.56 million hours. The burden in future reporting cycles would be less th an for the first reporting cycle. The shift from a five-year cycle to a four-year cycle increases both indu stry and Agency burden. All of these changes are shown in Table 6-1 below. EPA estimates that a ll of the amendments combined would increase the burden to society by 7.81 million hours over a 20-year period. This includes a burden increase of 7.81 million hours to the affected industry over the 20 y ears (see Table 4-54), and a burden decrease of 4,358 hours to the Agency (see Table 5-45) over the same period. As shown in Table 6-1, EPA estimates that the tota l increase in burden as a result of the IUR rule amendments over a 20-year period will be 7.81 million hours.

Table 6-1: Change in Total Burden to So ciety If All Modifications Are Implemented

Year Baseline Burden (millions of hours) Post-Amendment Burden (millions of hours) Change from Baseline (millions of hours)

2011 1.85 3.40 1.56

2012 0.00 0.00 0.00

2013 0.00 0.00 0.00

2014 0.00 0.00 0.00

2015 0.00 2.64 2.64

2016 1.44 0.00 -1.44

2017 0.00 0.00 0.00

2018 0.00 0.00 0.00

2019 0.00 2.64 2.64

2020 0.00 0.00 0.00

2021 1.44 0.00 -1.44

2022 0.00 0.00 0.00

2023 0.00 2.64 2.64

2024 0.00 0.00 0.00

2025 0.00 0.00 0.00

2026 1.44 0.00 -1.44

2027 0.00 2.64 2.64

2028 0.00 0.00 0.00

2029 0.00 0.00 0.00

2030 0.00 0.00 0.00

Total 6.16 13.97 7.81



### Table 6-2 contains the total cost and change in co st to society as a result of the proposed IUR rule amendments. The cost to society is expected to increase by $501.69 million over the 20-year period, for a total cost of $858.97 million. The cost to industry is expected to increase by $502.11 million over this period (see Table 4-45), and the Agency cost is e xpected to decrease by $422,281 (see Table 5-46). The

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6-2 annualized burden to society is $26.25 million and $27.84 million at three percent and seven percent discount rates, respectively.

Table 6-2: Change in Total Costs to Soci ety if All Modifications Are Implemented

Year Baseline Cost (millions 2008$) Post-Amendment Cost (millions 2008$) Change from Baseline (millions 2008$)

2011 $107.43 $209.33 $101.90
2012 $0.00 $0.00 $0.00
2013 $0.00 $0.00 $0.00
2014 $0.00 $0.00 $0.00
2015 $0.00 $162.41 $162.41
2016 $83.28 $0.00 -$83.28
2017 $0.00 $0.00 $0.00
2018 $0.00 $0.00 $0.00
2019 $0.00 $162.41 $162.41
2020 $0.00 $0.00 $0.00
2021 $83.28 $0.00 -$83.28
2022 $0.00 $0.00 $0.00
2023 $0.00 $162.41 $162.41
2024 $0.00 $0.00 $0.00
2025 $0.00 $0.00 $0.00
2026 $83.28 $0.00 -$83.28
2027 $0.00 $162.41 $162.41
2028 $0.00 $0.00 $0.00
2029 $0.00 $0.00 $0.00
2030 $0.00 $0.00 $0.00

Total $357.28 $858.97 $501.69
Annualized at 3% $19.23 $45.48 $26.25

Annualized at 7% $21.11 $48.95 $27.84

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7-1 

## 7. Impact of the Proposed IUR Rule Modifications Rule on the Benefits of the IUR

The IUR rule is one of EPA’s most valuable tool s for meeting the Agency’s mandate under TSCA to manage the risks resulting from chemical production and use in the United States. It is EPA’s most comprehensive source of data on the chemical industr y, and it is used in almost all of OPPT’s risk screening and management programs. However, the IU R data in their current form have numerous limitations, which in turn limit EPA’s eff ectiveness in meeting its mandate under TSCA. In an effort to improve the quality and usefulness of the data the Agency collects under the IUR rule, EPA is proposing a set of IUR amendments. The proposed amendments would improve the completeness and accuracy of the IUR data by requiring elect ronic reporting using the e-IUR reporting software, expand the range of chemicals for which full informa tion would be reported, adjust the specific reported information, increase the frequency of collecting th e information, and modify CBI requirements. EPA expects that the proposed amendments will reduce many of the current data constraints and, as a result, improve the effectiveness of EPA’s chemical risk ma nagement programs. Most importantly, the IUR rule amendments will require submitters to provide processing and use exposur e-related information for more chemicals. This additional information will a llow EPA to more accurately assess human and environmental exposures to specific chemicals, includi ng the concentrations, frequency, and durations of these exposures. With this additional information, EPA will be ab le to screen chemicals better to identify whether additional risk assessment and management steps are needed. More complete reporting of the processing and use data, more careful consider ation of confidentiality claims, and adjustments to specific data elements will help provide the needed data. By en hancing the data supplied to Agency risk-screening programs, EPA expects to more effectively and expe ditiously reduce the risks posed by chemicals. The more EPA can base its decisions on actual data, rather than on assumptions, the better EPA is able to tailor its risk management decisions to the level of act ual risk, whether higher or lower than it would be if based only on assumptions. Ultimately, enhanci ng the risk screening process will have positive consequences for human and ecosystem health, and will use EPA’s and society’s resources more efficiently. Additional benefits will accrue from ch anges in reporting requirements that will improve consistency and compatibility with ot her EPA databases. EPA would be better able to anticipate industry trends, particularly for chemicals for which EPA has concerns, and to measure the effectiveness of Agency programs. The benefits resulting from the proposed IUR rule amendments are discussed qualitatively in this section. Quantification of the benefits of the proposed rule would require more specific information about each user’s use patterns and preferences, and the ch anges in these that would result from the additional information made available under the proposed rule. Th ese data are not readily available, and collecting such data would be cost-prohibitive. For exampl e, one approach would be to conduct a national willingness-to-pay (WTP) survey of the general public to determine the value that the public places on the availability of the information resulting from the propo sed rule. However, such a survey, or a survey to collect similar information, has not been conducted.



### 7.1 Benefits of Information-Based Policies
Improvements in the IUR data would allow EPA and othe rs to use the data more effectively as part of the Agency’s risk screening and prioritization progra ms. Screening chemicals for potential risks is an essential first step in developing and prioritizing risk management activities. Effective risk-screening by EPA depends on the ability to characterize chemical uses accurately and to predict potential exposures. Current screening activities are greatly hampered by the incomplete data supp lied through the 2006 IUR.

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7-2 In addition, EPA’s current screening activities for medium production volume chemicals are further hampered by the fact that EPA has only estimates of production volume for many chemicals and must rely on relatively limited public sources of information. This proposed rule will be nefit society by filling these information gaps and contributing to better asse ssments of potential risks and risk management decisions. The proposed amendments to the IUR rule will incr ease the amount of publicly available data about a chemical’s potential risks, and con sequently are likely to result in (a) a reduction in the costs of risk-based decisions about the chemical, and (b) an improveme nt in the expected outcome of the decisions.

 Reduced cost of risk-based decision making. By making new information about toxic substances available to the public (including EPA and other gove rnment agencies), this proposed rule can replace other information-gathering, management, and dissemination activities related to the regulated chemicals. Once the data are publicly available, in formation users and decision makers will avoid the time and resource costs required to individually perfo rm these activities. In effect, the proposed rule increases the efficiency (and strength) of the decision-making process.

 Improved outcome of decisions. Information-based policies contribute to better decisions by redirecting resources toward their most highly valu ed uses. With incomplete information regarding toxic chemicals, public and private decision makers are unable to make adequate assessments of the benefits and costs of actions that involve these substances. For example, EPA decisions regarding whether, when, and how to target chemicals for fu rther risk assessment can be misdirected if basic risk-screening information is unavailable or inad equate. With more information, EPA can better direct its limited resources toward high-priority risk s. Improved information can therefore help lead to more socially optimal reductions in risks to humans and the environment. The proposed rule amendments will generate both ty pes of benefits. First, it will reduce EPA’s and other decision makers’ reliance on other databases an d information sources that are inadequate for accurately and efficiently characterizing the risks associated with the thousands of chemicals in commerce that need to be evaluate d. As discussed in Chapter 5. EPA will bear additional costs for collecting and managing the new IUR data; however, by providing more reliabl e and complete data on chemical uses and exposures, the rule will also allow EPA to save time and resources in screening chemicals and in developing risk management prioriti es. Furthermore, by requiring data to be submitted electronically, the rule will reduce EPA’s costs of processing the IUR data and result in a better quality database. Second, it will allow EPA to better prioritize its ri sk management activities—to move more quickly in addressing chemicals that pose relatively high risks (and/or relatively low risk-management costs).

A more detailed discussion about the value of in formation-based policies can be found in the economic analysis for the 2003 Amendments (EPA, 2002a ). Specific benefits that accrue from the use of the information generated by this proposed rule are discussed in the following sections.



### 7.2 Benefits of Individual Proposed Amendments
The proposed IUR amendments expa nd the range of chemicals for wh ich full information is to be reported, adjust the specific reported information, increase the frequency of collecting the information, and modify CBI requirements. These proposed amendm ents also 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. EPA is proposing these amendments to the IUR rule to meet four primary goals: (1) to tailor the in formation collected to better meet the Agency’s overall information needs; (2) to increase its ability to effec tively provide public access to the information; (3) to obtain new and updated info rmation relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory; and (4) to improve the usefulness of the information reported. The

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7-3 following sections describe how each of the amendments meets these goals and generates benefits to data

users.
7.2.1 Tailor Information Collected to More Closely Match the Agency’s Information Needs


### EPA’s efforts to use the 2006 IUR data have provided indications of areas where further improvements are needed. Several of the amendments d escribed in this proposed rule would change some of the reporting requirements in an effort by EPA to increase the usability of the collected information and to focus IUR reporting on information that is most needed by the Agen cy. These proposed changes will enable EPA and other Federal agencies to improve their risk screening programs, enabling them to better assess and manage risk, and improving public awareness of basic information about a large number of chemical substances. These amendments and their specific benefits are described below.

Parent Company Name and Site Identity 

### Manufacturers (including importers) are required to report the company name and Dun & Bradstreet (D&B) number to identify the compan y associated with the plant site, and also to report the site name, address, and D&B number. EPA received a variety of questions concerning the correct company name to report during the 2006 IUR reporting cycle. EPA is now clarifying what is meant by company name, by proposing to require that the company name provide d be the ultimate domestic parent company name. EPA believes this change will reduce confusion by ma king this reporting requirem ent consistent with the Toxic Release Inventory (TRI) requirements for parent company name. Reduced confusion leads to more accurate information, which in turn leads to more accurate risk characterizations. Furthermore, the 2006 IUR submissions from di fferent reporting sites contained varying D&B numbers for parent companies that appeared to be th e 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. This too will lead to more accurate information, which will lead to more accurate risk characterizations and small business analyses.

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 site. Based on EPA’s experience with contacting the reported technical c ontact with follow-up questions concerning 2006 IUR submissions, submitters often provide the names of individuals who are not directly connected to the reporting site, and therefore, are not knowledgeable a bout 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 unde r contract to the company. EPA may raise follow-up questions about an IUR submission, possibly years or more after the submission date. EPA is considering allowing multiple technical contacts on a chemical- by-chemical basis. The benefit of this proposed amendment would be increased clarity, which leads to improved accuracy in the information collected, which in turn leads to more accurate risk characterizations.

Chemical Identity 

### EPA is proposing to require the reporting of the Chem ical Abstracts (CA) Index Name currently used to list the substance in the Inventory as the chemic al name reported for IUR. Currently, submitters are required to report a specific chemical name, with no fu rther elaboration in the regulatory text. 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 substance from another. EPA’s experience in the 2006 IUR was that up to five percent of the repor ts submitted contained chemical identity problems serious enough that the Agency was unable to precisel y identify the substance. These problems resulted in

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7-4 the temporary exclusion of the information associated with the poorly or erroneously identified chemical from the IUR database until the Agen cy was able to obtain correct and specific chemical identity information from the submitter. EPA believes the benef it of the requirement to use the substance name as currently listed on the Inventory is that it will grea tly reduce the number of poorly identified substances. Improved chemical identification ultimately lead s to more accurate risk characterizations. EPA is also proposing to allow submitters to re port only the CASRN as a chemical identifying number or, in the case of confidential chemical subs tances, the accession number. EPA is proposing to eliminate the PMN number as an allowed chemical id entifying number because each Inventory substance has either a CASRN or a TSCA Accession Number or both, which are likely to be already known to the submitter. The benefit of this proposed amendment w ould be to save the Agency considerable time and effort to access and review reported information th at has only been identified by a PMN case number.

Report Production Volume for Each of the Years since the Last Principal Reporting Year 

### EPA is proposing to require reporting of production vo lume for each of the years since the last IUR principal reporting year. Thus, for the 2011 IUR repor ting cycle, manufacturers (including importers) of a chemical at or above the 25,000 lb. threshold would report the production volume of that chemical for each of the calendar years: 2006, 2007, 2008, 2009 and 2010. Collecting the production volume for multiple years would provide greater detail than the current “once-every-five-years” snapshot. EPA has mounting evidence that many chemical s, including larger volume chemicals, are manufactured in volumes that may widely fluctuate fro m year to year. This can result in the production volume of a chemical exceeding the threshold for several years, then falling below the threshold during the IUR principal reporting year. Therefore, EPA be lieves that a single snapshot of annual production volume (i.e., taken just once each reporting cycle) does not provide an accurate picture of the chemicals in commerce, and may provide an erroneous view of th e exposure scenarios associated with a particular chemical substance. EPA uses production volume data in several important ways. The data help the Agency to establish trends in chemical manufacturing; to determine the effectiveness of various Agency programs; to estimate the magnitude of consumer, worker, and environmenta l exposures; and in economic analyses to determine the costs (and financial impacts) of potential contro l strategies. Voluntary EPA programs such as Design for the Environment (DfE) and other pollution pr evention programs would use the annual production volume data to identify trends and program perfo rmance. Relying on a single snapshot of annual production volume in each reporting cycle hampers EPA’ s ability to identify the programs and techniques that are most effective, using measurable, readily id entifiable production trend data. Therefore, the benefit of this proposed amendment would be to provide in formation EPA and others need for the assessment of programs and would provide greater accuracy of the volumes of chemicals in commerce than the current one-year snapshot.

Volume of Chemical Substance Used On-Site 

### EPA is proposing to require that submitters re port the volumes of a manufactured or 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 chemic al is site-limited. Under this proposal, either domestically manufactured or imported chemicals could be reported as used at the reporting site, whereas under the current reporting requirements, only domesti cally manufactured chemicals, consumed entirely at the site of manufacture, shoul d be reported as site-limited. EPA is proposing this change to simplify reporting and to collect in formation that better addresses the Agency’s needs. In the past, submitters someti mes erroneously reported their production volume separately to identify the portion of their chemical that was consumed at the manufacturing site. For the 2006 IUR, many submitters c ontinued this practice and erroneously f iled separate reports to indicate that

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7-5 a portion of their production volume was site-limited. F iling separate reports resulted in the need to report separately processing and use information when the combined production volume was 300,000 lb. or greater. Including all production volumes on one repo rt simplifies reporting for such submitters and results in a less complicated database, thereby making the data easier to use. The benefit of the proposed amendment to require reporting the volume used on-site would be to provide valuable information related to potential exposures associated with the on-site vol umes, therefore providing the Agency with better information for exposure assessments and other data analyses.

Indicate Whether Imported Chemicals Ar e Physically at Reporting Site 

### EPA is proposing to add a requirement to indicate whether an imported chemical is physically at the reporting site. Often, the site reporting an imported ch emical never physically receives the chemical, 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 is physically at the reporting site provides the benefit of more accurate information for screening-level analyses and other uses of the IUR data.

Report Volume Exported 

### EPA is proposing to add a requirement to repor t the production volume directly exported and not domestically processed or used. The benefit of this amendment would be to a llow EPA to better identify the proportion of the production volume accounted for by the use reporting, given that downstream reporting is not required fo r exported substances.

Identify Whether Chemical Is To Be Recycled, Remanufactured, Reprocessed, Reused, or Reworked 

### EPA is proposing to add a requirement to indicate via a checkbox whether a manufactured chemical, such as a byproduct, is being recycled, remanufactur ed, reprocessed, reused, or reworked. Submitters would identify that their manufactured chemical, whic h otherwise would be disposed of as a waste, is being removed from the waste stream and is being used in a commercial purpose (i.e. recycled, remanufactured, reprocessed, reused or reworked). Such informat ion will benefit the Agency by identifying where these activities are already occurring, and can be used to encourage such activities. Collecting information on whether a chemical is be ing recycled, remanufactured, reprocessed, reused, or reworked and is not entering the waste stream provid es valuable information to EPA and others regarding trends in chemical manufacturing and can be used to help determine the effectiveness of various programs, such as EPA’s Resource Conservation Challenge (RCC) Program.

Designation of Consumer or Commercial Use 

### EPA is proposing to require submitters to designate via a checkbox whether the use is a consumer or a commercial use, or both. The Agency’s experien ce using the 2006 IUR data identified a need to distinguish between potentially exposed consumer and commercial populations. The benefit of the designation of consumer or commercial use, or bot h, would be to allow EPA to complete a better characterization for the potentially exposed populations.

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. Information on the number of comme rcial 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. Therefore, the benefit of this amendment would be

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7-6 to improve the population characterization, which is important to the development of the overall exposure characterization.

7.2.2 Increase EPA’s Ability to Effectively Provide Public Access to the Information 

### EPA anticipates that the proposed amendments woul d result in receiving more publicly available, non-CBI information. It is therefore important for th e Agency to be able to provide public access to the information in a timely manner; requiring all submissi ons in an electronic format will better enable the Agency to accomplish this.

Require Electronic Submissions over the Internet 

### EPA is proposing to require the mandatory use of EPA’s Central Data Exchange (CDX) through the Internet for manufacturers (including importers) to report IUR information. EPA would require that all submissions be generated using the e-IUR re porting software. EPA would no longer accept paper submissions or electronic media for any IUR submissi on after the effective date of the final rule. The proposed amendment to eliminate paper-based submissions in favor of mandatory e-IUR reporting would provide several bene fits to EPA and industry. EPA believes the required use of e-IUR 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. Data systems into which data were once manually entered would now be filed electronically, thus reducing the pote ntial for error that exists when data are entered by hand or when data is interpreted through a sca nning process. All information sent by submitters via CDX would be transmitted securely to protect CBI. EPA would be able to communicate electronically with submitters, e.g., to confirm receipt of a submis sion or to identify a problem with the submission). Electronic submissions enable data to be availa ble for Agency and public use more quickly and it eliminates inefficiencies and errors that were in troduced in the process to scan paper submissions. EPA developed e-IUR reporting software for use in preparing and submitting reports electronically during the 2006 IUR submission period (see www.ep a.gov/iur). The 2011 e-IUR would feature several enhancements over the 2006 e-IUR. These improveme nts 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 comp any and site identity checks, and the facilitation of joint submissions and amendments. Additionally the repor ting software would include user-friendly features such as drop-down selections, searchable chemical lis ts, imbedded help files, and an error-checking process to help identify common re porting errors before the submi ssion is submitted. All of these applications will increase the accuracy of data and eliminate Agency time in manually performing these checks. Coupled with EPA’s e-IUR reporting software, elec tronic reporting has become the most efficient method of reporting for industry as well as for EPA. During the comment period for the Information Collection Request (ICR) renewal (73 FR 51805, September 5, 2008), 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 reports.

7.2.3 Obtain New and Updated Exposure Information


### The EPA Administrator has announced her intention to increase efforts to assess, prioritize, and take action on existing chemicals, with particular emphasis on protecting children. The Agency is developing a broader, more vigorous approach on existing chemic als, which will utilize the full range of TSCA regulatory tools to reduce or eliminate risks from chemi cals of concern. The IUR rule is one of the tools available for this effort. Through the IUR rule, the Agency collects the information it needs to conduct an initial characterization and screening of potential expo sures associated with chem icals. EPA needs more

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7-7 in-depth exposure-related informati on to fine-tune the screening process, and to better assess, prioritize, and take action on existing chemical s. The various programs and tools that EPA uses to evaluate and manage chemical risks are described in Section 7. 3. The proposed amendments that would increase the amount of exposure information collected are described in the following sections.

Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements 

### EPA is proposing to modify the method used to de termine whether a manufacturer is subject to IUR reporting by requiring reporting if, for any calendar year since the previous IUR principal reporting year, the subject chemical was manufactured (including impo rted) in volumes of 25,000 lb. or greater. For the 2011 reporting cycle, a site would examine its a nnual production volumes for the years 2006 to 2010. If the production volume for a reportable chemical substa nce was 25,000 lb. or greater for any calendar year during that five-year period, then the site would n eed to report the chemical substance, unless it is otherwise exempt. EPA is proposing this change because of the mountin g evidence that many ch emicals, even larger volume chemicals, often experience wide fluctuations in manufacturing volume from year to year. This can result in the production volume of chemical exc eeding the threshold for several years, then falling below the threshold during the IUR principal reporting year. Consequently, historical IUR reporting has resulted in a change of approximately 30 percent in the composition of the chemicals being reported from one reporting cycle to the next. Therefore, the one-year snapshot of production volume does not provide an accurate picture of the chemicals in commerce, and may provide an erroneous view of the exposure scenarios associated with a particular chemical substance. Further evidence that capturing production volume for only the IUR principal reporting year is causing EPA to miss a significant amount of chemi cal production was revealed in the comments the Agency received from the proposed “reset” of the TSCA Inventory. The Federal Register notice of November 21, 2008 (73 FR 70460) requested that industry provide comment on whether a three-year reporting cycle was sufficient for deciding whether a chemical that they manufactured or imported should remain listed on the TSCA Inventory. Commenters ove rwhelmingly expressed concern that the proposed three-year reporting cycle would drastically misrepre sent the chemicals that were presently in commerce. (See Docket No: EPA-HQ-OPPT-2008-0785.) In comments, industry unanimously agreed that if they were to report for one year only, the reset would inappropriately remove chemical substances from the Inve ntory. While all commenters felt that the three-year reporting cycle was inadequate, a majority of the industry comments suggested that reporting should cover a 10-year period. The comments strongly indicated that there were chemicals manufactured or imported only occasionally, and that these chemical s would not be captured if the reporting covered too short a period. Therefore, requiring chemical manufacturers and importers to evaluate production volume for any calendar year since the previous IUR principal reporting year would benefit users of IUR data by yielding a much more accurate picture of the chemicals currently in commerce and properly the subject of EPA’s risk screening, assessment, and management activities.

Eliminate 300,000 lb. Threshold for Processing and Use Information Reporting 

### EPA is proposing to eliminate the 300,000 lb. thresh old for reporting processing and use information, thereby requiring all submitters of non-excluded substa nces to report information in all parts of the IUR Form U. EPA is proposing to eliminate this reporting threshold in order to collect information necessary to complete screening-level exposure characterizati ons and subsequent risk-based prioritizations for medium production volume (MPV) chemicals. In the 200 3 Amendments final rule (68 FR 848, January 7, 2003), EPA acknowledged the value of information fo r 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 th e thresholds that were introduced in that action.

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7-8 The IUR processing and use information is needed now to complete the characterizations and prioritizations for those chemicals manufactured (incl uding imported) in volumes of 25,000 to 300,000 lb. The Agency currently is unable to develop screen ing level risk evaluations for medium and lower production volume chemicals because most of these ch emicals are produced below the volume for which exposure and use information is required under the cu rrent IUR rule (i.e. 300,000 lb. per year). The exposure information is an essential pa rt of developing screening-level ri sk evaluations and, based on its experience in using this information, the Agency has concluded that collecting this information is critical to its mission of characterizing exposur e, identifying potential risks, and noting uncertainties for these lower production volume chemicals. Both hazard and exposure information are needed to develop screening level evaluations. Once the IUR processing and use information is available fo r these medium and lower volume chemicals, EPA would be able to develop the exposure characterizati ons needed to develop the evaluations. As with the HPV chemicals, EPA would then be able to id entify potential risks, note scientific issues and uncertainties, and indicate the initial priority assigned by the Agency for poten tial future appropriate action. Therefore, a benefit of the proposed rule would be to provide this necessary processing and use information for chemicals manufactured or imported in volumes of 25,000 to 300,000 lb.

Eliminate 25,000 lb. Threshold for Certain Regulated Chemicals 

### EPA is proposing to eliminate the 25,000 lb. repo rting threshold for certain regulated chemical substances that are the subject of particular TSCA rules and/or orders and to require manufacturers (including importers) of such chemicals to report under the IUR, regardless of the production volume. Thus, for the 2011 IUR reporting cycle, manufacturers (i ncluding importers) of a chemical at or above the 25,000 lb. threshold would report the production volume of that chemical for each of the calendar years: 2010, 2009, 2008, 2007, and 20 06. This provision will ensure the availability of current information when EPA has expressed a concern in the form of regulator y action on those chemical substances, regardless of the production volume. EPA is proposing to eliminat e the 25,000 lb. threshold for those chemicals that are: (1) the subject of a rule proposed or promulgate d under sections 5(a)(2), 5(b)(4), or 6 of TSCA; (2) the subject of an order issued under section 5(e) or 5(f) of TSCA; or, (3) the subject of relief that has been granted under a civil action under section 5 or 7 of TSCA. Under this proposal, a manufacturer, including im porter, 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 volumes under 25,000 lb. For the 2011 reporting cycle, the manufacturer would need to consider the manuf acture or import during the years 2006 through 2010. Manufacturers (including importers) of these chemicals would report the production volumes for each year from 2006 to 2010, and the full manufacturing, processing, and use information for 2010. Chemicals regulated under TSCA are of demonstrat ed interest to the Agency. EPA has made a determination that such substances either “may pr esent,” “will present,” or “do present” an unreasonable risk to human health and/or the environmen t or that the substances have “substantial production/significant or substantial exposure.” Therefore, the benefit of this proposed amendment is that EPA would be able to use the IUR data associated with these regulated chemicals to monitor chemical production and compliance with the rules.

Making Chemicals Subject to Enforceable Con sent Agreements Inelig ible for Exemptions 

### EPA may enter into an enforceable consent agre ement (ECA) 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. Chemicals covered by ECAs are of demonstrated interest to EPA. The Agency has an inte rest in identifying the

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7-9 manufacturing, processing, and use of substances under such agreements, and therefore is proposing to require that such substances be reported for IUR pur poses, regardless of whether the substance otherwise meets the requirements listed in 40 CFR §710.46 (pro posed §711.6) as an exempt or partially exempt chemical substance. The benefit of this proposed am endment is to ensure the availability of current information if EPA has expressed a concern in the fo rm of an ECA on any substance otherwise excluded from the IUR rule. For example, EPA could use the IUR data associated with these regulated chemicals to monitor chemical production and compliance with the agreements.

Changes to Standard for the Reporting of Processing and Use Information 

### In order to collect more complete informati on regarding the industrial processing and use and commercial and consumer use of chemicals, EPA is proposing to replace the “readily obtainable” reporting standard in the 2006 IUR with the “known to or reasonably ascertainable by” reporting standard for the reporting of processing and use information. TSCA section 8(a)(2) 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 reporti ng of information described in the regulations at 710.52(c)(1), (c)(2), and (c)(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” reporti ng standard was the only standard used for IUR reporting purposes prior to the 2006 IUR reporting cycle. EPA is proposing this change because reporting unde r the “readily obtainable” reporting standard did not generate sufficiently precise processing and use in formation for screening-level reviews. The Agency believes reporting under the “known to or reasonably ascertainable by” standard will generate processing and use information sufficiently precise for screening-level reviews. The 2006 IUR response rate for the processing and u se data captured only a portion of the volume the Agency suspects was actually used for industrial processing and use or commercial and consumer use. Considering only those chemicals meeting the cr iteria to require reporting of processing and use information, only 72 percent of the total volume wa s accounted for in the industrial processing and use data and 22 percent in the commercial and consumer use data. At a minimum, EPA is lacking industrial processing and use data on 28 percent of the expected volume reported, and is lacking consumer and commercial processing and use data on 78 percent of the expected volume reported. 4 

### Because of this low level of reporting, EPA now believes the reporting sta ndard of “not readily obtainable” was too lenient and resulted in an underreporting of th e actual processing and use situation. The Agency’s experience using the 2006 IUR data to develop exposure characterizations has alerted EPA to the fact that the IUR processing and use data are incomplete and inconsistent. Effective risk screening by EPA depends on the ability to accurately ch aracterize chemical uses and to predict potential exposures. If the information provided does not in clude these data, EPA must make assumptions about the use of the unreported production volume. Incorre ct assumptions may lead EPA to designate an inappropriately high priority level to the chem ical, resulting in unnecessary effort and resource expenditures for both regulated parties and EPA in ca ses where adequate data would have led the Agency to act differently.

4 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 (68 FR 861), EPA anticipated that, on an individual report basis, the total percentages of production volumes asso ciated with the industrial pr ocessing or use information may add up to more than 100 percent of the reported production volume. This could happen because the submitter reported on the distribution of a chemical to sites in its co ntrol as well as downstream sites, some of which were not immediate purchasers from the original manufacturing site.

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7-10 Therefore, using the reporting standard “known to or reasonably ascertainable by” would generate the benefit of companies reporting a more consistent and complete processing and use information in their IUR reports, and more efficient use of EPA resources.

Change to Reporting Frequency 

### Prior to the 2003 Amendments, the IUR collecti on occurred every four years. EPA reduced the reporting frequency from every four years to every five years starting with the 2006 IUR to reduce the burden associated with the amended IUR. While the less frequent reporting does reduce burden, the Agency now has determined that reporting every five years does not provide data sufficiently current to meet Agency and public needs, and is proposing to return to reporting every four years. As described above, the Agency has been criticized for using outdated information. Also, a review of the previous reporting under IUR has revealed a change of approximately 30 percent in the chemicals that are reported from one reporting cycle to the next . Receiving IUR information more frequently will provide EPA with a more accurate, up-to-date ove rview of the chemical manufacturing industry, addressing a criticism that the Agency has received fo r relying on outdated information. More timely information will help EPA to better prioritize chemicals for screening, and will lead to more efficient use of EPA resources.

7.2.4 Improve Utility of Information Reported 

### Some of the amendments in the proposed rule woul d change reporting requirements, in an effort by EPA to increase the usability of th e collected information. By incr easing data transparency, increasing international compatibility, or changing the method by which the data is submitted, these proposed changes will ultimately enable EPA and other Federal agencies to improve their risk screening programs, enabling them to better assess and manage risk, and improve public awareness of basic information about a large number of chemical substances.

Industrial Function Categories 

### EPA is proposing to revise the list of industrial f unction categories by combining categories that lead to common exposure scenarios and adding categories wh ere the Agency believes the existing categories do not adequately describe potential uses. EPA worked with Environmen t 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 benefit both EPA and Canadian agen cies by facilitating the exchange of information, and would serve as a model to be used by Mexico in developing an Inventory of chemical substances. In addition, the harmonized categories w ould facilitate consistent reporting of chemical use information by industry in the United States and Canada. Another benefit of revising the list of industrial function categories would be to reduce the number of uses reported as “Other.” EPA is proposing to require that if a submitter chooses the category “Other,” the submitter must include a text description for the indus trial function category associated with the use of chemical substance.

Industrial Sectors 

### EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) codes with 48 Industrial Sectors (IS). The industr ial sectors were adopted from the European Union’s guidance on information requirements and chemical safety assessment. The chosen Industrial Sectors 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 provid e several benefits. First, it would encourage more complete reporting by using terms that are alread y familiar to industry. Second, the industrial sectors

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7-11 would reduce the likelihood of errors that result fro m the selection of miscellaneous or inappropriate NAICS codes. Third, it would reduce the number of codes that could apply to one substance. One of the primary purposes of the IUR data collection is to group together similar data for priority setting exercises and activities. Respondents to th e 2006 IUR submitted 342 unique five-digit NAICS codes, which made it difficult for EPA to group chemicals based on industrial processing and use scenarios. The 2006 IUR database has 2,330 unique co mbinations of processing or use categories, NAICS, and industrial function categories, in all. Th is large number of unique combinations increases the difficulty and time required by EPA to sort and cl assify chemicals because EPA either would need to develop exposure scenarios for each unique combinati on, or determine which th ree-code combinations have similar exposure scenarios and can be grouped. Therefore, anothe r benefit of using the industrial sectors would be to reduce the number of unique comb inations, thereby increasi ng the usability of the data.

Consumer and Commercial Product Categories 

### EPA is proposing to revise the list of consum er and commercial use 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 which will be adopted by the United States and Canada for reporting of Inventory information. Harmonized categories fo r reporting the consumer and commercial uses of chemical substances will benefit both EPA and Cana dian agency by facilitating the exchange of information and will serve as a model to be used by Mexico in developing an Inventory of chemical substances. In addition, the harmonized categories wi ll facilitate consistent reporting of chemical use information by industry in the United States and Canada. Another benefit of expanding the lis t of consumer and commercial use categories would be to provide persons submitting IUR information with a greater opportunity to characterize the products in which chemical substances they manufacture are used and w ould reduce the number of uses reported as “Other.” EPA is proposing to require that if a submitter chooses the category “Other,” the submitter must include a text description for the consumer and comme rcial product containing the chemical substance. The 2006 IUR reports showed that the category “Other ” was reported with the greatest frequency. A total of 1,206 reports, or 26 percent, out of 4,666 reports containing commercial and consumer use information, included “Other.” Although one of EPA’s objectives of revising the consumer and commercial product categories is 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. In addition to revising the overall product categories, narrower definiti ons and expanded lists of examples of products in which the chemical substa nce would be used were added to each category descriptor. By requiring the submitters to supply a written description for “Other,” this amendment will benefit EPA because the Agency will be able to ev aluate and improve the inclusiveness of future consumer and commercial category lists or descriptions.

Upfront Substantiation for Processing and Use Information CBI Claims 

### Under the proposed rule, in order to submit a claim of confidentiality for processing and use information data elements, the s ubmitter 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 the proposed rule. Where a submitter fails to substantia te the processing and use CBI claim in accordance with the applicable rules, EPA may make the informa tion available to the public without further notice to the submitter. EPA has observed that, on occasion, processing and u se information has been claimed as confidential even though it was revealed in submissions sent to the Agency in response to the HPV Challenge program

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7-12 and published on the EPA website. In addition, EPA has observed that some of the processing and use information claimed as confidential appears to be available on submitter’s websites or in published Material Safety Data Sheets (MSDS). The high number of confidentiality claims asserted for the reported 2006 IUR reports on industrial processing and use in formation meant that EPA was unable to make available to the public important data or to comple tely describe the analysis or provide the support information used to reach Agency conclusions. 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. The benefit of this amendment would be a decrease in the number of inappropriate CBI claims under the new substantia tion requirement, which 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. This would increase the transparency and public accessibility of the chemical risk information, may increase public confidence in EPA’s chemical management program, and is consiste nt with the President’s policy goals for government reliance on and public availability of scientific information. 5



### 7.3 Potential Users of Information Generated by the Proposed IUR Modifications Rule
EPA will be the primary user of the informati on generated by the proposed rule amendments, although other public and private organizations, in part icular those with interests in managing chemical risks, will also use the data. The information is exp ected to be applied and disseminated by these users in a number of ways; however, it will serve primarily to reduce the costs of screening and managing chemical risks and to improve risk management decisions. The American publ ic will be the ultimate beneficiaries of the amended IUR. By lowering the co st of decision making in the public sector, the rule will free up resources for other public or private uses. Similar gains will also result from cost savings in private-sector decision making. By improving risk mana gement decisions, the rule will also help to better target risk management activities to the areas where the net benefits (i.e., risk re ductions net of control costs) are expected to be the largest. IUR data users and the benefits they derive from IU R data are discussed in more detail in the sections below.

7.3.1 EPA Risk-Screening and Management Programs 

### EPA’s Office of Pollution Prevention and Toxics (O PPT) has a multifaceted approach to identifying and managing chemical risks. OPPT can initiate the revi ew of a chemical in a number of ways, including due to an Agency program, through a request by the Interagency Testing Committee or because of a request by the public. The Agency has a number of more detailed screening tools, such as the Use Cluster Scoring System (UCSS). Depending on the outcome of these screening processes, the next step may include entering one of EPA’s risk management progr ams. These types of programs and the benefits derived from the processing and use information provided on the IUR Form U are examined in detail in the economic analysis for the 2003 Amendments (EPA, 2002). EPA’s current programs and tools to evaluate and manage chemical risks include:

5 On March 9, 2009, President Obama, writing about Scie ntific Integrity in a Presidential Memorandum for the Heads of Executive Departments and Agencies, wrote: “The pu blic must be able to trust the science and scientific process informing public policy decisions. Political officials should not suppress or alter scientific or technological findings and conclusions. If scientific and technological information is developed and used by the Federal Government, it should ordinarily be made available to the public. To the extent permitted by law, there should be transparency in the preparation, identif ication, and use of scientific and technological information in policymaking.”

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7-13  Risk Screening . OPPT screens chemicals on the TSCA Inventory to identify potential risks and determine whether more detailed assessments s hould be undertaken. With the data currently available, EPA does not have the information needed to effectively and systematically screen some of the chemicals on the Inventory. The amended IUR would supply exposure-related information the Agency does not currently have, recognizing that industry has a greater knowledge than EPA about its own operations and the uses of chemicals it manuf actures and sells. Without this information, EPA would likely: (1) not screen these chemicals, (2) screen them using outdated or anecdotal exposure information, or (3) screen them but rely on expos ure estimates (which are typically conservative) using modeling data. Therefore, data collected as a result of the proposed rule will improve the Agency’s ability to screen chem icals in commerce, allowing the Agency to focus its chemical screening programs and to identify potentially risk y situations earlier than otherwise possible. .

 High Production Volume Chemical Testing. EPA’s major efforts to prioritize existing chemicals began with data collected under the High-Pr oduction Volume (HPV) Challenge Program, which makes available to the public screening-level envi ronmental and health effects information on HPV chemicals produced or imported in the United States in quantities of one million lb. or more per year. At the conclusion of the voluntary HPV Challenge Program, EPA developed the first in a series of test rules to require the testing of high production volume chemicals for which no voluntary agreement was made. EPA finalized its first HPV t est rule, covering 37 chemicals, in 2005. A second HPV rule was proposed in 2008, and a third rule is expected to be proposed in 2009. EPA also plans to develop an initial set of screening-level assessments of medium production volume (MPV) chemicals - those produced or imported in quantiti es above 25,000 lb. and less than one million lb. per year. In developing the test rules, EPA relied heavily on exposure information obtained from the IUR; improving the data collected through the IUR will enhance the quality of information used in decision making for future test rules.

 Existing Chemicals Program . The Existing Chemicals Program conducts detailed analyses of potentially high-risk chemicals and develops strate gies to reduce or eliminate the exposure risks. Chemicals are first screened to identify those that (1) require additional tes ting, (2) present potentially significant risk management concerns, or (3) do not currently require further review. While the proposed amendments to the IUR data would in crease EPA’s ability to screen existing chemicals based on exposure and, ultimately, risk, more in-d epth data similar to the New Chemicals Program data would lead to improved screening and a quicker identification of chemicals with a high priority for follow-up action. This would result in a more appropriate entry into EPA’s chemical management programs. The range of benefits EPA anticipates fro m being able to obtain more accurate and broader use information could be expanded with a greater am ount of in-depth exposure and use information. The improved IUR data would be particularly helpful for screening medium and lower volume chemicals that are not covered by the HPV program.

 Use Cluster Scoring System (UCSS). The UCSS tool identifies potential risks of chemical substances used in similar applications, or “use cluste rs.” This system enables the Agency to view the potential risks of a given chemical substance in th e context of the potential risks presented by related products on the market and allows the Agency to establish regulatory review priorities for those use clusters. However, some of the UCSS data s ources are outdated and estimating methodologies are approximate. More in-depth expos ure-related data could be used to create a database providing additional information that will allow the Agency to provide more accurate screening-level estimates for use clusters and to target Agency programs to areas currently needing attention. The additional exposure-related data would also enable EPA to more easily cond uct broader chemical screening analyses across several industries.

 Master Testing List. IUR data also helps to determine which chemicals substances are on the Master Testing List (MTL). The MTL is a list of chemical s identified by the Agency as having inadequate data for health and/or environm ental risk assessments. OPPT uses the MTL to establish priorities for

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7-14 chemical testing, keep the public informed, solic it input from industry on specific chemical exposure and risk assessment needs, and to encourage industry to perform testing. More in-depth exposurerelated manufacturing, processing, and use data woul d enable EPA to better target testing needs to situations in which potential exposures are known to occur, thereby increasing the efficiency of efforts in these programs and facilitating earlie r completion of critical testing needs.

 Screening Information Data Set (SIDS) program. The voluntary OECD SIDS program allows OECD member countries to share the burden of testing internationally traded, large production volume chemicals. The United States is responsible fo r testing 25 percent of the chemicals identified for the program. The information needed is coll ected by industry sponsors; however, the data elements included may not be cons istent across sponsors, and some companies may not participate in developing all of the data elements. Currently coll ected data and data collected through more in-depth exposure and use data requirements will enable the EPA to meet many key needs for exposure data and will provide a consistent database of info rmation from manufacturers and importers. This information will increase the program’s efficiency by helping to identify chemicals requiring additional testing or assessment while excluding thos e with low domestic exposure. A better exposure database will also improve evaluation of potential risk in the assessment reports prepared at the end of the SIDS process.

 Design for the Environment (DfE) program. EPA’s DfE program incorporates principles and strategies from both the Existing Chemicals Program and the UCSS, by focusing on specific chemical uses and establishing partnerships with industry to develop voluntary long-range plans for risk management. Currently collected IUR data, which woul d be enhanced by data collected through more in-depth exposure and use data requirements, helps to identify use cluster candidates for this program. The more in-depth exposure-related data would al so better enable the initial assessment of exposures and help identify potential substitutes. The data could be used to assist in ranking activities, identifying high-risk areas, and developi ng realistic approaches for reducing risk.

7.3.2 Other Federal Risk Management Programs 

### Under TSCA section 4, EPA has the authority to requ ire firms to conduct tests of specific chemicals to determine the potential risk posed by these substanc es. However, other governmental agencies, such as the Occupational Safety and Health Administrati on (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC), share regulatory authority over chemical substances or products containing them. In the case of NIOSH, the agency compiles summaries of available information and r ecommends exposure limits. Therefore, EPA serves as a conduit for chemical hazard information between the chemical producers and these other agencies. OSHA currently manages occupational exposure to ch emicals by setting a variety of chemical and personal protection standards, by requiring preparation of emergency response and process safety management plans and by requiring provision of health and safety data to workers for chemicals used in the workplace. OSHA will be able to use the IUR da ta to identify chemicals with large numbers of potentially exposed workers or with uses that s uggest greater exposure potential. The information provided by the proposed rule could increase OSHA’s ability to manage chemical hazards, exposures, and risks in occupational settings.

NIOSH will also benefit from the additional e xposure-related information collected under the proposed rule amendments. The exposure information that NIOSH uses to determine occupational safety and health in businesses nationwide may be based on outdated information collected under the National Occupational Exposure Survey (NOES). Completed in 1983, NOES collected information such as plant site location, plant site SIC, information on the pl ant site’s occupational safety and health programs, occupational titles of workers potentially exposed , the number of employees per occupational title, information on process steps, and trade names of products. NIOSH could use IUR data in place of the

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7-15 NOES data to identify chemicals with large numbers of potentially exposed workers or with uses that suggest greater exposure potential. CPSC also could use the new data directly in conducting its exposure and risk assessment activities (e.g. screening consumer products for chemical hazar ds). CPSC obtains risk information to screen chemical hazards from a network of hospital emergency rooms. This information is limited to injuries and illnesses resulting from acute exposures only. Additional data required by the proposed IUR ame ndments would provide a better source of reliable information on the chemicals used in consumer produc ts. CPSC would improve its ability to identify the chemicals used in consumer products and, with c onsideration of hazard data, to identify chemical– consumer use situations presenting greater potential risk. The info rmation could improve CPSC’s ability to meet its program objective of protecting the p ublic from chemical hazards in consumer products.

7.3.3 State and Local Programs 

### IUR data also help state and local authorities with rulemaking, information collection, and voluntary program activities. Because state and local governme nts must address chemicals, use patterns, and exposure scenarios that may be unique or isolated, st ate and local agency access to the enhanced data will assist in identifying situations that pose potentially hi gh risks for individual states or locations within those states. The information added to the IUR incl udes county data, which will enable states to identify which counties are likely to have specific issues or which counties may have multiple chemical problems. The additional data also could be used to assist w ith setting goals, targeting actions, and developing or expanding pollution prevention activities.

7.3.4 Nongovernmental Organization (NGO) Init iatives and Private-Sector Stewardship 

### Many private-sector organizations have a strong inter est in reducing risks and providing leadership in preventing pollution while still maintaining productiv e economic enterprises. These organizations can better meet these objectives by developing a better und erstanding of how chemicals are used in general. This will allow them to more effectively manage ri sks and participate in setting chemical priorities at community, regional, and national levels. The publicly available (non-CBI) information pr ovided by the IUR supports activities typically undertaken by NGOs, such as tracking industry trends, organizing grassroots involvement in risk-based decision making, and conducting outreach and educa tional programs. These organizations could use the new data to identify and establish priorities for risks; to evaluate chemicals and chemical use patterns to determine areas of concern; to identify and prom ote pollution prevention opportunities; and to focus pollution prevention, public outreach, a nd education initiatives and activities. Industry can use the amended IUR information to improve corporate product stewardship programs through access to use information reported by multip le companies. The American Chemistry Council’s Responsible Care Program is one example of a corpor ate product stewardship program that could use this information. Use information supplied through IUR coul d be used to further strengthen this program. The Responsible Care Program requires companies to take responsibility for their products from cradle to grave, which requires an understanding of how their pr oduct is being used not only by their customers, but further down the chain. Despite this private effo rt, some companies have told EPA that they do not know how their chemicals are used. Non-CBI informa tion provided by multiple companies could give an individual company a better understanding of the down stream uses of its products, therefore enabling more effective implementation of the Responsible Care concepts.

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## 8. Small Entity Analysis

This chapter estimates the impact that the proposed amendments to the IUR rule may have on small entities by examining the relationship between th e compliance costs and company sales for small companies. The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, requires regulators to assess the effects of regulations on small entities, including businesses, nonprofit organi zations, and governments. In some instances, agencies also are required to examin e regulatory alternatives that may reduce adverse economic effects on significantly impacted small entities. The RFA requires agencies to prepare an initial and final regulatory flexibility analysis for each rule unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA, however, does not specifically define “a significant economic impact on a substantial number” of small entities. Sections 603 and 604 of the RFA require that regulatory flex ibility analyses identify the types, and estimate the numbers, of small entities to which the rule will apply; and describe th e rule requirements to which small entities will be subject and any regulatory alternatives, including exem ptions and deferral, that would lessen the rule’s burden on small entities. The existing IUR rule, at §710.29, generally exem pts from reporting small businesses, defined at §704.3 as entities with annual sales of less than $40 million and less than 100,000 lb. production of any given chemical at a site; or annual sales of less than $4 million. This exemption is maintained in the proposed amendments. In addition, a small business cu rrently is required to report if it produces any chemical substance that is the subject of a regul ation proposed or promulgated under TSCA sections 4, 5(b)(4), or 6; or that is the subject of an order under TSCA section 5(e); or that is the subject of relief that has been granted pursuant to a civil action under TSCA section 5 or 7. A small business may also report voluntarily. The major steps followed in the analysis are described below.



### 8.1 Select a Relevant Small Entity Definition

The RFA relies on the definition of “small bus iness” found in the Small Business Act, which authorizes the Small Business Administration (SBA) to develop definitions for “small business” for industries in each North American Industry Classifi cation System (NAICS) code. The SBA definitions typically are based upon either a sales or an employment level, depending on the nature of the industry. Companies engaged in chemical manufacturing (NAICS Code 325) or petroleum refining (NAICS Code 324110) are the most likely to report under the IUR ru le. Specifically, entities pote ntially affected by the proposed rule include companies manufacturing or im porting chemicals in amounts of 25,000 lb. or more annually and that are listed on the TSCA Inventory and regulated under TSCA §8. Under 13 CFR part 121, SBA defines small business for the six-digit NAICS industry based on employment thresholds (SBA, 2004). These employee size standards range from 500 employees to 1,500 employees for NAICS Codes 325 and 324110. For example, SBA defines a company in NAICS 325320 (Pesticide and Other Agricultural Chemical Manufacturing) as small if it has fewer than 500 employees. In comparison, a company in NAICS 324110 (Petroleum Refineries) is considered small if it has fewer than 1,500 employees. To obtain an average estimate of the num ber of small companies affected by the proposed rule, EPA chose an employment threshold of 1, 000 employees to determine small business status. Throughout the remainder of this report, this de finition is referred to as the “employment-based definition.”

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8-2 For comparative purposes, EPA also considered an alternative definition based upon sales. Under this definition, a manufacturer or importer is defined as small under 40 CFR 704.3 if it meets either of the following criteria:

 Total annual sales of the company, combined w ith those of any parent company, are below $40 million and annual production volum e or importation volume at the facility is less than or equal to 100,000 lb.; or

 Total annual sales of the company, combined w ith those of any parent company, are below $4 million. Consistent with the methodology used in the 200 2 Economic Analysis for the Amended Inventory Update Final Rule (EPA, 2002) , EPA assumed that any company with sales less than or equal to $40 million is small, regardl ess of production volume. 6 

### This assumption may tend to overestimate the number of small businesses affected because it includes entities th at may not meet all small business requirements under TSCA §8(a). Throughout the remainder of this re port, this definition is referred to as the “salesbased definition.”



### 8.2 Identify Number of Small Companies Reporting in 2006
To identify the percentage of small companies repor ting under the IUR rule, EPA obtained a list of all companies that submitted a Form U during the 2006 reporting cycle (EPA, 2009c). Using the Dun & Bradstreet Number reported by the company, EPA identified the ultimate parent company and obtained sales and employment data for companies for which da ta are available from Dun & Bradstreet Corporate Leads Portal (Dun & Bradstreet, 2009). 7


### During the 2006 reporting cycle, 4,188 8 

### sites submitted reports. Of these, parent company data was available for 3,392 sites 9 

### , with 872 associated parent compan ies. Information for the remaining companies was unavailable for several reasons. First, these companies may be too small to be listed in Dun & Bradstreet. Second, the IUR data used may be out of date because it is based on IUR reporting for 2006 (e.g., some companies may have gone out of business or changed hands since the information was reported). Finally, certain companies may have requested to be removed from, or may have declined to provide information to, Dun & Bradstreet. Using the sales data collected for the companies fo r which data was available, EPA estimated the average sales for the parent co mpanies that are considered small under both definitions. Table 8-1 shows the percentage of parent comp anies from the 2006 IUR reporting which qualified for “small business” status, under both the employment-b ased and the sales-based definitions specified

6 It is important to note that the $40 million level is for parent company sales, not individual site sales.

7 Dun & Bradstreet is a New York-based company that provides business information through a global commercial database. It assigns DUNS numbers to identify businesses around the world. These numbers are required for many U.S. federal government transactions and therefore are widely used and assigned. DUNS numbers are also used frequently in corporate research. Database entries provide legal and trade names, physical and mailing addresses, geographical descriptions, product and industry descriptors, sales and number of employees for three years and associated growth rates, as well as up to 40 vital statis tics about each organization. Whil e the reporting year varied by company, company sales and employment data were retrieved from the database in April 2009.

8 Note that this value (4,188) does not equal the number of sites assumed for the baseline in Table 4-6 (4,085). The data used to prepare Table 4-6 counted only sites submit ting reports for chemicals with production volumes equal to or greater than 25,000 lb. (that is, those sites subject to the rule). The 4,188 sites in this dataset may include submitters who voluntarily submitted reports for chemi cals with production volumes lower than 25,000 lb.

9 This does not include parent companies listed in D&B as having either 0 employees or $0 sales.

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8-3 above. These results are fairly consistent with the 2 002 EA’s estimates that between 21 and 35 percent of the regulated community could be considered small businesses (EPA, 2002a).

Table 8-1: Results of Dun & Bradstreet Analysis Existing Sites (2006 Reporting Cycle) Employment-based Definition Sales-based Definition Number of Global Parent Companies with Data 872 872 Number of Global Parent Companies Considered Small 360 218 Percentage of Global Parent Companies Considered Small 41.3% 25.0% Average Annual Sales of Global Parent Companies Considered Small (2008$) $412,713,310 $11,638,441

Source: Analysis of data from Dun & Bradstreet’s Corporate Leads Portal , April 2009.



### 8.3 Estimate Number of Parent Companies
Incomplete information on global parent companies from Dun & Bradstreet for all of the companies that submitted IUR reports in 2006 required that EPA estimate the total number of parent companies in the baseline. One global parent company may submit re ports for more than one site. Based on the sample of companies for which the parent company informat ion is available, EPA estimates that there are 3.89 sites per global parent company. Given that 4,188 s ites submitted reports, EPA estimates that the number of parent companies for the 2006 IUR reporting baseline is 1,076. As described in Section 4.5, the proposed amendm ents are expected to increase the number of sites reporting by 204. Therefore, EPA estimates that the total number of global parent companies reporting under the revised IUR rule to increase by 52 from the baseline (that is, 52 “new” companies (204÷3.89 = 52)).



### 8.4 Estimate Number of Small Companies
EPA estimated the number of small companies potentially impacted by the proposed IUR amendments by applying the percentage of small comp anies derived in Table 8-1 to the total number of expected parent companies subject to the rule under the proposed amendments. Table 8-2 shows the number of expected small companies, under both definitions.

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8-4 Table 8-2: Estimated Number of Small Comp anies under the Proposed IUR Rule Amendments Employment-based Definition Sales-based Definition Baseline Companies New Companies Baseline Companies New Companies Total Number of Parent Companies 1,076 52 1,076 52 Percent of Parent Companies Considered Small 41.3% 24.8% Number of Parent Companies Considered Small 444 22 267 13 Total Number of Parent Companies Considered Small 466 280



### Limitations of the Analysis: The proposed amendments cause an increase in the number of sites reporting because of changes to the reporting volume thresholds and the timeframe in which the thresholds are applied. These amendments may have a disproportionate effect on smaller companies because they may be the ones that manufacture chem icals at or around the 25,000 lb. threshold. Therefore, this method may underestimate the number of small businesses. Furthermore, to the extent that the set of companies for which EPA was not able to fi nd data is not statistically similar to the set of companies for which data was available, this anal ysis may under- or over-estimate the percentage of companies that are small.



### 8.5 Estimate Cost-to-Sales Ra tios for Small Companies
Table 4-50 shows the total increase in industry costs associated with the proposed amendments, if all proposed amendments are implemented. As described in Section 4, industry costs involve compliance determination, rule familiarization, preparation a nd submission of reports, and recordkeeping. Because these costs would be incurred once every four years under a four-year reporting cycle, these costs were annualized over four years at both a three percent and seven percent discount rate 10 

### . By dividing the annualized costs for the entire industry in the first re porting cycle by the number of expected sites (4,085), EPA obtained the per-site incremental cost. EPA assumes that the per-site cost is the same for each site, regardless of whether a site is small. EPA divided the total number of parent companies co nsidered small (under either definition) by the number of sites associated with these parent compani es to estimate the average number of sites per small parent company. This resulted in an average of approximately 1.76 sites per small company under the employee-based definition of small business and appr oximately 1.92 sites per small company under the sales-based definition. The RFA does not define the terms “significant” or “subs tantial” analytically with regard to the extent of the economic impact and number of small entities affected. However, EPA has often defined the lower threshold as compliance costs of one percent of sales and the higher threshold as compliance costs of three percent of sales to establish whether the level of economic impacts faced by the small entities can be presumed as not significant (U.S. EPA, 2006b). Therefore, to determine the magnitude of any potential adverse impact, EPA compared the average, annualized incremental costs on a per-company basis to the average annual sales for small businesses to develop co st-to-sales ratios. The derivation of these ratios is shown in Table 8-3.

10 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.

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8-5 Table 8-3: Derivation of Cost-to-Sales Ratios for Small Companies under the Proposed IUR Rule Amendments Employment-based Definition Sales-based Definition 3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate Total Annualized Costs $26,660,775 $28,163,588 $26,660,775 $28,163,588

Annualized Costs per Site $6,527 $6,894 $6,527 $6,894

Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $11,512 $12,161 $12,509 $13,214

Annual Sales per Small Parent Company $412,713,310 $412,713,310 $11,821,104 $11,821,104

Cost-to-Sales Ratio 0.0028% 0.0029% 0.1058% 0.1118%

Number of Companies Potentially Affected 466 280



### As shown in Table 8-3, under the employment-based definition, a small parent company affected by the rule has, on average, sales of more than $412.7 m illion. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $12,161 at a seven percent discount rate, and even lower under a three percent discount rate. The cost-to- sales ratio for an average small company under the employment-based definition would be 0.003 percent or less. Under the more conservative sales-based definition, small parent company sales are on averag e more than $11.8 million, with annualized costs associated with the proposed amendments of $13,214 or lower. The cost-to- sales ratio for an average small company under the sales-based defin ition would be 0.11 percent or less. Using the highest annual cost shown in Table 8-3, $12,509, a small company would have to have annual sales of less than $1.25 million in order to have a cost-to-sales ratio larger than one percent. As mentioned above in Section 8. , firms with sales of $4 million or less are generally exempt from IUR reporting because they fall within the applicable definition of “small manufacturer,” regardless of production volume (40 CFR §704.3). Therefore, companies that are small enough to have a cost-to-sales ratio greater than one percent generally will be ex empt from reporting under the proposed IUR rule, and thus will not be significantly affected by the amendments.



### 8.6 Summary
EPA analyzed potential small business impacts from this rule using the SBA employment-based definition and the TSCA sales-based definition. EPA estimates that 466 small firms potentially would be affected by this proposed rule under the employment -based definition of the term, and that 280 small firms potentially would be affected under the sal es-based definition of the term. Based on costs annualized over a four-year period and average sales da ta, EPA estimated that the cost-to-sales ratio of the proposed rule would be 0.003 percent or less under the employment-based definition for an average small company subject to the rule, and 0.11 percen t or less under the sales-based definition. As noted above, EPA often defines the lower threshold as comp liance costs of one percent of sales and the higher

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8-6 threshold as compliance costs of three percent of sal es to establish whether the level of economic impacts faced by the small entities can be presumed as not signi ficant. For a company to have a cost-to-sales ratio larger than one percent, company sales would have to be less than $1.25 million. Because the small businesses affected by the proposed rule actually ha ve average sales of more than $11 million, and because any potentially affected compan ies with sales of $1.25 million or less would generally be exempt from reporting obligations under the IUR, small entities will not be significantly affected by the proposed amendments to the IUR rule.

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## 9. Additional Analyses

9.1 Executive Order 12866

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” under section 3(f) of the Executive Order because it may raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executive Order. Accord ingly, EPA submitted this action to the Office of Management and Budget (OMB) fo r review under Executive Order 12866 and any changes made in response to OMB recommendations have been doc umented in the docket for this action.



### 9.2 Unfunded Mandates Reform Act (UMRA)

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4), EPA has determined that this regulatory action does not contai n a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal gove rnments, in the aggregate, or for the private sector, in any one year. The analysis of the costs associated with this action is described in Unit VII.A. Thus, this rule is not subject to the requirements of sections 202 or 205 of UMRA. In addition, EPA has determined that this ru le does not significantly or uniquely affect small governments. This is because only manufacturers (inc luding importers) of chemical substances are affected by the rule. No action is required by sm all governments that are not chemical manufacturers (including importers). Accordingly, this rule is not subject to the requirements of sections 203 of UMRA.



### 9.3 Paperwork Reduction Act (PRA)
According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq. , an agency may not conduct or sponsor, and a person is not requi red to respond, to a collection of information that requires Office of Management and Budget (OMB) a pproval under the PRA, unless it has been approved by OMB and displays a valid OMB control number. The informatio n collection requirements related to the submission of Form Us are already approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq . That Information Collection Re quest (ICR) document has been assigned EPA ICR number 1884.04 an d OMB control number 2070-0162. This rule does/does not impose any new requirements that require additional OMB approval. The Paperwork Reduction Act mandates that fede ral agencies estimate the recordkeeping and reporting burden of a proposed rule. In this context, the term “burden” is interpreted as the total time, effort, or financial resources expended by people to generate, maintain, retain, disclose, or provide information to or for a federal agency. This incl udes the time needed by regulated entities to review instructions and to develop, acquire , install, and use technology and systems to collect, validate, verify, and disclose information. Time taken to adjust existi ng ways to comply with any previously applicable instructions and requirements and to train personnel to respond to the information collection task is also included. In this section, burden hours for both indu stry respondents and the government are estimated. In this report, total industry burden hours represen t the sum of time spent on reporting and on other administrative activities. Industry respondents will sp end time on the following activities associated with the IUR rule: compliance determination, rule familia rization, preparation and submission of reports, and recordkeeping. As derived in Section 4.5 of this report, EPA estim ates that the proposed rule would impose a total estimated incremental industry burden of 1.56 million hours, if all proposed amendments are

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9-2 implemented. The burden for the average site will in crease by approximately 342 hours per site to 793 hours.



### 9.4 Executive Order 13132 - Federalism

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful a nd timely input by State and local officials in the development of regulatory policies that have federa lism implications.” “Policies that have federalism implications” is defined in the Executive Order to incl ude regulations that have “substantial direct effects on the States, on the relationship between the national gove rnment and the States, or on the distribution of power and responsibilities among the va rious levels of government.” EPA has determined that this pr oposed rule does not have federa lism implications because it will not have substantial direct effects on the states, on th e relationship between the national government and the states, or on the distribution of power and respons ibilities among the various levels of government, as specified in the Order. This rule simply amends th e Inventory Update Reporting rule in several ways to provide information to better address Agency and p ublic information needs, improve the usability and reliability of the reported data, and ensure that data are available in a timely manner. Because EPA has no information to indicate that any state or local government manufactures or processes the chemical substances covered by this action, the proposed rule does not apply directly to states and localities and will not affect state and local governments. Thus, Executive Order 13132 does not apply to the proposed rule.



### 9.5 Executive Order 12898 – Environmental Justice
Executive Order (EO) 12898, entitled Federal Actions to Address Envi ronmental Justice in Minority Populations and Low-Income Populations (59 FR 7629 (Feb. 16, 1994)), establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmen tal justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority po pulations and low-income populations in the United States. The proposed rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities that require sp ecial consideration by the Agency under EO 12898. The Agency believes that the inform ation collected under this proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with the chemicals covered by the rule. Because the IUR rule is an information coll ection requirement, the information that will become available through the rule will enable the Agency to target educational, regulatory, or enforcement activities towards industries or chemicals that pose the greatest risks and/or to target programs for geographic areas that are at the highest risk. Thus, the information to be gathered under the rule will help EPA make decisions that will benefit potentially at-risk communities, some of which may be disadvantaged. The proposed rule is directed at manufacturers or importers of chemicals. All consumers of these chemical products and all workers who come into c ontact with these chemicals could benefit if data regarding the chemicals’ health and environmental ef fects were developed. Therefore, it does not appear that the costs and the benefits of the proposed rule will be disproportionately distributed across different geographic regions or among different categories of individuals.

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### 9.6 Executive Order 13045 – Children’s Health

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), requires that federal agencies examin e the impacts of each regulatory action on children for any economically significant regulation (as defined by Executive Order 12866) that the agency has reason to believe may dispr oportionately affect children. The proposed rule is not subject to EO 13045, because it does not establish an environmental standard intended to mitigate health or safety risks, nor does it otherwise have a disproportionate effect on children. Furthermore, the proposed rule is not economically significant. Neve rtheless, the information obtained by the reporting required by this rule will be used to inform the Agency’s decision-making process regarding chemicals to which children may be disproportiona tely exposed. This information will also assist the Agency and others in determining whether the chemicals in th is proposed rule present potential risks, allowing the Agency and others to take appropriate acti on to investigate and mitigate those risks.



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



### 9.8 Executive Order 13211 – Energy Supply, Distribution, or Use
This action is not a “significant energy action” as defined in Executive Order 13211, entitled Actions Concerning Regulations that Significantly A ffect Energy Supply, Distribution, or Use (66 FR 28355 (May 22, 2001)) because it is not likely to have a significant a dverse effect on the supply, distribution, or use of
energy.



### 9.9 National Technology Tr ansfer Advancement Act
Section 12(d) of the National Technology Tran sfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) di rects EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inco nsistent with applicable law or impractical. Voluntary consensus standards are technical standa rds (e.g., materials specifications, test methods, sampling procedures, and business practices) that ar e developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and a pplicable voluntary consensus standards. This proposed action does not involve technical st andards. Therefore, EPA did not consider the use of any voluntary consensus standards.

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## 10. References

BLS, 2009. U.S. Bureau of Labor Statistics. Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006 – December 2008. March 12, 2009. http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf

. Dun & Bradstreet, 2009. Dun & Bradstreet Corporate Leads Portal. Database searches. April 2009. EPA, 1997. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Final Rule to Add Certain Industry Groups to EPCRA Section 313

. Washington, DC. April 1997. EPA, 2002a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA-HQ-OPPT2002-0054-0260 ). Washington, DC. August 2002

. EPA, 2002b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Wage Rates for Economic Analysis of th e Toxics Release Inventory Program. June 10, 2002. EPA, 2003. U.S. EPA, Office of Pollution Prevention and Toxics. ICR No. 574.12. [Information Collection Request for] Premanufacture Review Reporting and Exemption Requirement for New Chemical Substances and Significant Use Repor ting Requirements for Chemicals Substances

. Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act. Washington, DC. November 25, 2003. EPA, 2004. U.S. EPA. Office of Environmental Information. Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis: Final (EPA-HQ- OEI-2003-0001-0248). November 2004. Washington, DC. http://www.regulations.gov/

. EPA, 2005. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of IUR Modifications Final Rule (EPA-HQ OPPT 2004-0106-0055). Washington, DC. July 2005. EPA, 2006a. U.S. EPA, Office of Pollution Prevention and Toxics. Instructions for Reporting for the 2006 Partial Updating of the TSCA Chemical Inventory Database . Washington, DC. November 2006. 

### http://www.epa.gov/iur/pubs/2006_inst_tsca_cheminv.pdf

. EPA, 2006b. U.S. EPA, Office of Policy, Economics, and Innovation. Final Guidance for EPA Rulewriters: Regulatory Flexibility Act . Washington, DC. November 2006. EPA, 2007. U.S. EPA, Office of Environmental Information. A Business Case Analysis of EPA’s Central Data Exchange . Washington, DC. March 2007. EPA, 2008a. U.S. EPA, Office of Pollution Prevention and Toxics. What is the TSCA Chemical Substance Inventory? 

### http://www.epa.gov/oppt/new chems/pubs/invntory.html . Washington, DC. Updated December 10, 2008. EPA, 2008b U.S. EPA Office of Pollution Prevention and Toxics. Economic and Policy Analysis Branch

. Economic Analysis of Expedited Significant New Use Rules for 56 Chemical Substances (EPA-HQOPPT-2008-0251). October 2008. EPA, 2008c. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. 2006 IUR Database Statistics for IUR Modifications Rule . Washington, DC. December 17, 2008. EPA, 2008d. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1884.04. [Information Collection Request for] Partial Update of the TSCA Section 8(b) Inventory Data Base, Production

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10-2 and Site Report, Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act . Washington, DC. September 5, 2008. EPA, 2009a. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. Chemicals Ineligible for Exemptions under Proposed IUR Modifications Rule. (2006 IUR Database Statistics). Washington, DC. May 12, 2009. EPA, 2009b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch . Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule

. (EPA-HQ-OPPT-2008-0296). Washington, DC. July 13, 2009. EPA, 2009c. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. IUR Company Names and Related Information. . (Database query results). Washington, DC. April 14, 2009. EPA, 2009d. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. 2002 IUR Database Statistics for IUR Modifications Rule . Washington, DC. April 30, 2009. EPA, 2009e. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. Email communication from Darryl Ballard to Wendy Hoffman. Washington, DC. May 19, 2009. EPA, 2009f. U.S. EPA, Office of Pollution Prevention and Toxics. TSCA Section 4 Federal Register Enforceable Consent Agreements. http://www.epa.gov/oppt/chemtest/pubs/4eca.html . Washington, DC. Updated October 1, 2009. EPA, 2009g. U.S. EPA, Office of Pollution Prevention and Toxics, Sunset Dates of Chemicals Subject to Final TSCA Section 4 and Related 12(b) Actions, Modified on September 1, 2009. http://www.epa.gov/oppt/chemtest/pubs/sunset.html . Washington, DC. Updated September 1, 2009. EPA, 2009h. U.S. EPA, Office of Pollution Prevention and Toxics, Chemical Control Division. Memo from Susan Sharkey to Wendy Hoffman. Washington, DC. September 8, 2009. OPM, 2008. Office of Personnel Management, Salary Table 2008-DCB, Washington Baltimore-Northern Virginia, DC-MD-PA-VA-WV. http://www.opm.gov/oca/08tables/pdf/DCB.pdf

. U.S. Postal Service (USPS), 2009. USPS – Prices. http://www.usps.com/prices/ . December 15, 2009.

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A-1 

## Appendix A. 2006 Form U

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A-2

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B-1 

## Appendix B. Proposed Revised Form U

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B-2

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B-3

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C-1 

## Appendix C. – Current and Propo sed Industrial Function Categories

Table C-1: List of Current and Proposed Industrial Function Categories 

### Current IUR Industrial Function Categories Proposed IUR Industrial Function Categories
1. Adsorbents and absorbents 2. Adhesives, binders, and sealants 3. Aerosol Propellants *


### 4. Agricultural chemicals (non-pesticidal) 5. Anti-adhesive agents 6. Bleaching agents 7. Coloring agents, dyes 1 

### 8. Coloring agents, pigments 1 

### 9. Corrosion inhibitors and anti-scaling agents 10. Fillers 11. Fixing agents * 

### 12. Flame retardants 13. Flotation agents *


### 14. Fuels 15. Functional fluids 3 

### 16. Intermediates 17. Lubricants 1 

### 18. Odor agents 2 

### 19. Oxidizing agents 20. pH-regulating agents *


### 21. Photosensitive chemicals 22. Plating agents and surface treating agents 23. Processing aids, not otherwise listed 24. Process regulators, used in vulcanization or polymerization processes 2 

### 25. Process regulators, other than polymerization or vulcanization processes 2 

### 26. Reducing agents 2 

### 27. Solvents (for cleaning and degreasing) 28. Solvents (which become part of product formulation or mixture) 29. Solvents (for chemical manufacture and processing and are not part of product at greater than 1% by weight) * 

### 30. Stabilizers *


### 31. Surface active agents 32. Viscosity adjustors 33. Other 1 

### 1. Abrasives + 

### 2. Adsorbents and absorbents 3. Adhesives and sealant chemicals 4. Agricultural chemicals (non-pesticidal) 5. Anti-adhesive agents 6. Bleaching agents 7. Corrosion inhibitors and anti-scaling agents 8. Dyes 1 

### 9. Fillers 10. Finishing agents + 

### 11. Flame retardants 12. Fuels and fuel additives 13. Functional fluids (closed systems) 3 

### 14. Functional fluids (open systems) 3 

### 15. Intermediates 16. Ion exchange agents + 

### 17. Lubricants and lubricant additives 1 

### 18. Odor agents 19. Oxidizing/reducing agents 2 

### 20. Photosensitive chemicals 21. Pigments 1 

### 22. Plasticizers + 

### 23. Plating agents and surface treating agents 24. Process regulators 2 

### 25. Processing aids, specific to petroleum production + 

### 26. Processing aids, not otherwise listed 27. Propellants and blowing agents + 

### 28. Solids separation agents + 

### 29. Solvents (for cleaning and degreasing) 30. Solvents (which become part of product formulation or mixture) 31. Surface active agents 32. Viscosity adjustors 33. Laboratory chemicals 34. Paint additives and coating additives not described by other categories 35. Other (specify) 1

Notes: 1 A current industrial function category has been renamed under th e proposed amendment, but the definition of the category has n ot changed.
2 Two current industrial function categories have been combined into one category under the proposed rule.
3 A single industrial function category has been divi ded into two categories under the proposed rule.

* Indicates that a current industrial function catego ry is being eliminated under the proposed rule.

+ Indicates that a current function cate gory is added under the proposed rule.

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D-1 

## Appendix D. Current and Proposed 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 current set of categories.

Table D-1: List of Current and Proposed Consumer and Commercial Product Categories 

### Current IUR Consumer and Commercial Product Categories Proposed IUR Consumer and Commercial Product Categories 1. Adhesives and sealants 2. Agricultural products (non-pesticidal) 3. Artists' supplies 4. Automotive care products 5. Electrical and electronic products 6. Fabrics, textiles and apparel 7. Glass and ceramic products 8. Lawn and garden products (non-pesticidal) 9. Leather products 10. Lubricants, greases and fuel additives 11. Metal products 12. Paints and coatings 13. Paper products 14. Photographic supplies 15. Polishes and sanitation goods 16. Rubber and plastic products 17. Soaps and detergents 18. Transportation products 19. Wood and wood furniture 20. Other 21. Not readily obtainable Chemical Substances in Furnishing, Cleaning, Treatment/Care Products 1. Floor Coverings 2. Foam Seating and Bedding Products 3. Furniture and Furnishings not covered elsewhere 4. Fabric, Textile, and L eather Products not covered elsewhere 5. Cleaning and Furnishing Care Products 6. Laundry and Dishwashing Products 7. Water Treatment Products 8. Personal Care Products 9. Air Care Products 10. Apparel and Footwear Care Products Chemical Substances in Construction, Paint, Electrical, and Metal Products 11. Adhesives and Sealants 12. Paints and Coatings 13. Building/Construction Materials - Wood and Engineered Wood Products 14. Building/Construction Materials not covered elsewhere 15. Electrical and Electronic Products 16. Metal Products not covered elsewhere 17. Batteries Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products 18. Food Packaging 19. Paper Products 20. Plastic and Rubber Products not covered elsewhere 21. Toys, Playground, and Sporting Equipment 22. Arts, Crafts, and Hobby Materials 23. Ink, Toner, and Colorant Products 24. Photographic Supplies, Film, and Photochemicals Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products 25. Automotive Care Products 26. Lubricants and Greases 27. Anti-Freeze and De-icing Products 28. Fuels and Related Products 29. Explosive Materials

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D-2 30. Agricultural Products (non-pesticidal) 31. Lawn and Garden Care Products Chemical Substances in Products not Described by Other Categories 32. Non-TSCA Use 33. Other (specify)

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E-1 

## Appendix E. – Industrial Sectors

EPA is proposing to replace the NAICS codes used in the industrial processing and use information section with a new set of Industrial Sectors, deve loped from the European Union’s REACH program.

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 Code Sector Description IS34 All Other Chemical Product and Preparation Manufacturing IS35 Plastics Product Manufacturing IS36 Rubber Product Manufacturing IS37 Nonmetallic Mineral Product Manufacturing (includes clay, glass, cement, concrete, lime, gypsum, and other nonmetallic 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)

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F-1 

## Appendix F. – Sensitivity Analyses

Some of EPA’s proposed amendments to the IU R rule are expected to change the number of submitters, reports, or the number of responses to a sp ecific question on Form U. For several options, data available from the 2006 IUR was used to directly estim ate the number of chemicals or submitters affected by the amendment. For example, the number of submitters who pro duce manufactured water above the threshold is known. However, a lack of available data for other amendments meant that EPA only was able to estimate the impact broadly, such as a per centage increase or decrease in the number of submitters caused by the amendment, using the Agency’s best professional judgment. These amendments include (1) the method for determining whether the threshold is met; (2) reporting production volume used on-site; (3) requiring write-in text if submitter selects “Oth er” as a product function category (4) requiring writein text if selecting “Other” as a consumer or comme rcial use; and, (5) upfront substantiation for all processing and use information CBI claims. In estim ating the cost of these amendments, EPA used a midpoint estimate for the percentage increase or decre ase in the number of submitters, reports filed, or number of submitters answering a specific question. To show the possible range of costs as a result of the proposed amendments more accurately, EPA presents a ra nge of costs in this section, using the lower and upper bounds for the item estimated.



### F.1 Method for Determining Whether the Threshold Is Met
Currently, the IUR rule requires that a report be file d for a chemical only if the chemical’s production volume exceeds the 25,000 lb. threshold in the pr incipal IUR reporting year. EPA expects this will increase the number of sites and reports submitted by between zero and ten percent of the baseline (see Table 4-6). In Section 5.4, the Agency estimated th e increase in cost and burden to industry using a midpoint estimate of five percent. Using a five pe rcent increase in the number of sites and reports, EPA expects the burden to industry will increase by appr oximately 92,000 hours (see Table 4-12). Table F-1: contains the results of the sensitivity analysis usin g a lower bound estimate of a zero percent increase in the number of submitters and an upper bound estimate of a ten pe rcent increase. All baseline burden estimates were taken from Table 4-2. The increase in bur den to industry is expected to range from zero hours to 184,000 hours as a result of modifying the method for determining whether the 25,000 lb. threshold is met.

Table F-1: Sensitivity Analysis of Industry Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met

Number of Sites Number of Reports (with Part II) Number of Reports (with Part III) Industry Burden (hours) Burden to Prepare Part I, Rule Familiarization,

Compliance Determination, and Submission (hours per site) Lower Bound

(0% increase) Upper Bound (10% increase) Burden to Prepare Part II

and Record Keeping (hours

per report) Lower Bound

(0% increase) Upper Bound (10% increase) Burden to Prepare Part III (hours

per report) Lower Bound

(0% increase) Upper Bound

(0% increase) Lower Bound (10% increase) Upper Bound (10% increase)

(a) (b) (b) (c) (d) (d) (e) (f) (f) (g) = (a  b)+ (c  d)+(e  f)
Baseline 33.26 4,085 4,085 19.82 25,896 25,896 69.92 17,075 17,075 1,744,894 1,842,934

PostAmendment 33.26 4,085 4,494 19.82 25,896 28,486 69.92 17,075 18,783 1,744,894 2,027,227
Change from the Baseline 0.00 0 409 0.00 0 2,590 0.00 0 1,708 0 184,293

Note: Values in Change from the Baseline rows are calculated by subtracting the corre sponding baseline value from the post-amendment value.

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F-2 Table F-2 shows the range of cost estimates usi ng a zero percent lower bound and ten percent upper bound increase in the number of reports and submitters as a result of the proposed amendment. All baseline cost estimates are taken from Table 4-5. EPA estimates a cost to industry between $0 and $10.7 million. The midpoint cost estimate of $5.35 million is used in Table 4-13.

Table F-2: Sensitivity Analysis of Industry Cost Estimates for Modifying the Method for Determining Whether the Threshold Is Met

Number of Sites Number of Reports (with Part II) Number of Reports (with Part III) Industry Cost (millions 2008$) Cost to Prepare

Part I, Rule Familiarization,

Compliance Determination and Submission (2008$ per site) Lower Bound

(0% increase) Upper Bound (10% increase) Cost to Prepare Part II

and Record Keeping (2008$

per report) Lower Bound

(0% increase) Upper Bound (10% increase) Cost to Prepare Part III (2008$

per report) Lower Bound

(0% increase) Upper Bound (10% increase) Lower Bound

(0% increase) Upper Bound (10% increase)

(a) (b) (b) (c) (d) (d) (e) (f) (f) (g) = (a  b)+ (c  d)+(e  f)
Baseline $2,058.18 4,085 4,085 $1,129.42 25,896 25,896 $4,059.25 17,075 17,075 $106.97 $106.97
PostAmendment $2,058.18 4,085 4,494 $1,129.42 25,896 28,486 $4,059.25 17,075 18,783 $106.97 $117.66
Change from the Baseline $0.00 0 409 $0.00 0 2,590 $0.00 0 1,708 $0.00 $10.70

Note: Values in Change from the Baseline rows are calculated by subtracting the corre sponding baseline value from the post-amendment value.



### The cost and burden to the Agency of this amendmen t were calculated in Section 5.4. With a five percent increase in the number of reports, the Agency’s burden is expected to increase by 104 hours (see Table 5-5). The range in the burden increase to EPA, using a lower bound zero percent increase in the number reports and an upper bound increase of ten percen t, is presented in Table F-3. Baseline Agency burden is taken from Table 5-4. Th e proposed amendment is expected to increase the Agency burden by between zero and 208 hours.

Table F-3: Sensitivity Analysis of Agency Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met

Number of Sites Number of Reports (with Part II) Number of Reports (with Part III) Industry Burden (hours) Burden

to Process Part I (hours) Lower Bound

(0% increase) Upper Bound (10% increase) Burden to Process Part II (hours) Lower Bound

(0% increase) Upper Bound (10% increase) Burden to Process

Part III (hours) Lower Bound

(0% increase) Upper Bound (10% increase) Lower Bound

(0% increase) Upper Bound (10% increase)

(a) (b) (b) (c) (d) (d) (e) (f) (f) (g) = (a  b)+ (c  d)+(e  f)

Baseline 0.017 4,085 4,085 0.042 25,896 25,896 0.054 17,075 17,075 2,080 2,080
PostAmendment 0.017 4,085 4,494 0.042 25,896 28,486 0.054 17,075 18,783 2,080 2,288
Change from the Baseline 0.000 0 409 0.000 0 2,590 0.000 0 1,708 0 208

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### Table F-4 shows the range in Agency costs as a result of modifying the method for determining whether the threshold is met. Baseline Agency cost s are taken from Table 5-4. The proposed amendment is expected to increase the Agency cost between approximately $0 and $21,700 during the first reporting cycle.

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F-3 Table F-4: Sensitivity Analysis of Agency Cost Estimates for Modifying the Method for Determining Whether the Threshold Is Met

Number of Sites Number of Reports (with Part II) Number of Reports (with Part III) Industry Cost (2008$) Cost

to Process Part I (2008$) Lower Bound

(0% increase) Upper Bound (10% increase) Cost to Process Part II (2008$) Lower Bound

(0% increase) Upper Bound (10% increase) Cost to Process

Part III (2008$) Lower Bound

(0% increase) Upper Bound (10% increase) Lower Bound

(0% increase) Upper Bound (10% increase)
(a) (b) (b) (c) (d) (d) (e) (f) (f) (g) = (a  b)+ (c  d)+(e  f)
Baseline $1.78 4,085 4,085 $4.40 25,896 25,896 $5.61 17,075 17,075 $216,949 $216,949
PostAmendment $1.78 4,085 4,494 $4.40 25,896 28,486 $5.61 17,075 18,783 $216,949 $238,644
Change from the Baseline $0.00 0 409 $0.00 0 2,590 $0.00 0 1,708 $0 $21,695

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### F.2 Reporting Production Volume Used On-Site
The cost to industry of requiring the reporting of production volume used on-site is estimated in Section 4.4.13. EPA estimated that between 14.8 percen t of all reports (the per centage of reports which included a site-limited volume in 2006 reporting (E PA 2008c)) and 24 percent of all reports (the percentage of 2006 reports which claim the chemical s is an intermediate in the downstream use and processing section (EPA, 2008c)) would report produc tion volume used on-site. Therefore, the total number of reports with volume used on-site ranges from 3,833 to 6,215 reports. Using a midpoint of 19.4 percent, industry burden is expected to increas e by 7,596 hours (see Table 4-24). Table F-5 shows the burden estimates using the lower and upper bounds for the number of repor ts that will contain information on production volume used on-site. The baseline cost pe r report is taken from Table 4-6. EPA expects the total industry burden to range from 5,800 to 9,400 hours.

Table F-5: Sensitivity Analysis of Industry Bu rden Estimates for Reporting Production Volume Used On-Site Number of Reports with Production Volume Used On-Site Total Industry Burden (hours) Burden per Report to Report ProductionVolume Used OnSite (hours) Lower Limit (14.8% of all

Reports) Upper Limit (24% of all

Reports) Lower Limit (14.8% of all Reports) Upper Limit (24% of all

Reports)
Baseline 0.00 0 0 0 0
Post-Amendment 1.51 3,833 6,215 5,795 9,397 Change from the Baseline 1.51 3,833 6,215 5,795 9,397

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### Table F-6 contains the range of cost estimates using a 14.8 percent lower bound and 24 percent upper bound increase in the number of reports under the propo sed amendment. All baseline cost estimates are taken from Table 4-5. EPA estimates a cost to industry between $324,500 and $526,300, with a midpoint estimate of $0.43 million (see Table 4-25).

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

F-4 Table F-6: Sensitivity Analysis of Industry Co st Estimates for Reporting Production Volume Used On-Site Number of Reports with Production Volume Used On-Site Total Industry Cost (2008$) Cost per Report to Report Production Volume Used On-Site (2008$) Lower Limit (14.8% of all Reports) Upper Limit (24% of all

Reports) Lower Limit (14.8% of all Reports) Upper Limit (24% of all

Reports)

Baseline $0.00 0 0 $0 $0

Post-Amendment $84.68 3,833 6,215 $324,544 $526,288 Change from the Baseline $84.68 3,833 6,215 $324,544 $526,288

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### The burden to the Agency, 4.51 hours, of requiri ng the reporting of production volume used on-site, where an estimated 19.4 percent of reports list producti on volume is used on-site is calculated in Section 5.4.13. Table F-7 contains the range of burden estim ates to the Agency, 3.44 to 5.57 hours per reporting cycle. The baseline burden per report is taken from Table 5-4.

Table F-7: Sensitivity Analysis of Agency Bu rden Estimates for Reporting Production Volume Used On-Site Number of Reports with Production Volume Used On-Site Burden per Report to Report Production Volume Used On-Site (hours) Burden per Report to Report ProductionVolume Used OnSite (hours) Lower Limit (14.8% of all

Reports) Upper Limit (24% of all

Reports) Lower Limit (14.8% of all Reports) Upper Limit (24% of all

Reports) Baseline 0.000 0 0 0.00 0.00
Post-Amendment 0.001 3,833 6,215 3.44 5.57 Change from the Baseline 0.001 3,833 6,215 3.44 5.57

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### Table F-8 contains the range in costs to EPA as a result of modifying the method for determining whether the threshold is met. Baseline costs to EPA are taken from Table 5-4. The proposed amendment is expected to increase the Agency cost between approximately $359 and $581 during the first reporting cycle.

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F-5 Table F-8: Sensitivity Analysis of Agency Co st Estimates for Reporting Production Volume Used On-Site Number of Reports with Production Volume Used On-Site Cost per Report to Report Production Volume Used On-Site (2008$) Cost per Report to Report Production Volume Used On-Site (2008$) Lower Limit (14.8% of all

Reports) Upper Limit (24% of all

Reports) Lower Limit (14.8% of all Reports) Upper Limit (24% of all

Reports)
Baseline $0.00 0 0 $0.00 $0.00

Post-Amendment $0.09 3,833 6,215 $359 $581 Change from the Baseline $0.09 3,833 6,215 $359 $581

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### F.3 Modifying Industria l Function Categories
EPA is proposing to modify the current industrial function categories (found in Part III, Section A of Form U), by eliminating seven existing categories and adding seven new categories, and requiring submitters to write in a free-text descriptor when they select “Other”. EPA anticipates these actions will reduce the number of submitters selecting “Other” by approximately 50 percent, from 1,206 reports to 603 (EPA, 2008a). The burden increase of 4,400 hour s and cost increase of $260,000 are calculated in Section 4.4.18. The Agency conducted a sensitivity analysis for these estimates, with the decrease in reports selecting “Other” ranging from a 25 percent reduction of the total (905 reports in total) to a 75 percent reduction in total (302 reports in total). The results of this anal ysis for industry burden are found in Table F-9. A 75 percent reduction in the number of submitters claimi ng “Other” means that 25 percent of submitters are now claiming “Other,” and a 25 percent reduction mean s that 75 percent of submitters are now claiming “Other.” The columns in this table and the remaini ng tables in this Appendix are labeled to reflect the resulting numbers; e.g., they show the lower resu lting number in the “Lower Bound” column and the higher resulting number in the “Upper Bound” column.

Baseline burden estimates are taken from Table 4-2 a nd the baseline number of reports is found in Table 4-6. EPA estimates the burden to industry w ill increase by between 4,300 and 4,400 hours.

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F-6 Table F-9: Sensitivity Analysis of Industry Burd en Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category Number of Reports with “Other” Write-in Text Total Industry Burden (hours) Burden for Rule Familiarization

of Additional

Categories

(hours) Number of Reports with Industrial Function Categories Burden for Write-in Text for "Other" (hours) Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Baseline 8.59 17,075 0.00 0 0 146,661 146,661PostAmendment 8.84 17,075 0.15 302 905 150,975 151,066
Change from the Baseline 0.25 0 0.15 302 905 4,314 4,404

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### Table F-10 contains the range of cost estimates to industry with a lower bound estimate of a 75 percent decrease in the number of reports with “O ther” as industrial function categories and an upper bound of a 25 percent decrease in the number of reports with “Other” as industrial function categories. All baseline cost estimates are taken from Table 4-5. EP A estimates a cost to industry between $253,400 and $257,800, with a midpoint estimate of $256,000 (see Table 4-33).

Table F-10: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category
Number of Reports with “Other” Write-in Text Total Industry Cost (2008$) Cost for Rule Familiarization

of Additional

Categories

(2008$) Number of Reports with Industrial Function Categories Cost for Write-in Text for "Other" (2008$) Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Baseline $88.02 17,075 $0.00 0 0 $1,502,913 $1,502,913
PostAmendment $102.73 17,075 $7.31 302 905 $1,756,287 $1,760,693
Change from the Baseline $14.71 0 $7.31 302 905 $253,374 $257,780

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### Using a 50 percent decrease in the number of reports with “Other” selected, the burden to the Agency during a reporting cycle is 0.54 hours and is calculated in Section 5.4.18. Table F-11 contains the range of burden estimates to the Agency, 0.27 hour to 0.81 ho urs per reporting cycle. The baseline Agency burden estimates per report are taken from Table 5-4.

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F-7 Table F-11: Sensitivity Analysis of Agency Burd en Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category Number of Reports with "Other" Write-in Text Total Agency Burden (hours) Burden to

Process Write-in Text for "Other" (hours) Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other")
Baseline 0.000 0 0 0.00 0.00

Post-Amendment 0.001 302 905 0.27 0.81

Change from the Baseline 0.001 302 905 0.27 0.81

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### Table F-12 contains the range in costs to EPA as a result of modifying the industrial function categories. Baseline costs to EPA are taken from Ta ble 5-4. The proposed amendment is expected to increase the Agency cost between approximately $28 and $85 during the first reporting cycle.

Table F-12: Sensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category Number of Reports with "Other" Write-in Text Total Agency Cost (2008$) Cost to Process Write-in Text for "Other" (2008$) Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other")
Baseline $0.00 0 0 $0 $0

Post-Amendment $0.09 302 905 $28 $85

Change from the Baseline $0.09 302 905 $28 $85

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value



### F.4 “Other” as a Consumer and/or Commercial Product Category
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 current set of categories. The r esultant proposed list includes 33 product categories, including “Other.” Several cons umer and commercial product categori es have been renamed to better describe the products that should be reported in that cat egory. EPA is also proposing to require that if the product category “Other” is selected; a descriptor fo r the consumer and/or co mmercial product containing the chemical substance must also be reported. A ccording to 2006 IUR data (EPA, 2008c), 1,207 reports listed “Other” as a consumer and/or commercial pr oduct category. Based on EPA’s best professional judgment, EPA expects that the new categories in the proposed amendment will reduce by half the number of submitters selecting “Other” as a consumer and/or commercial product category. Therefore, this amendment would affect 604 reports. The cost a nd burden to industry with a 50 percent reduction in the number of submitters is found in Section 4.4.20.

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F-8 The Agency conducted a sensitivity analysis for the decrease in reports selecting “Other” ranging from a 25 percent reduction of the total (905 reports in total) to a 75 percent reduction of the total (302 reports in total). The results of this analysis for industry are found in Table F-13. Baseline burden estimates are taken from Table 4-2 and the baseline number of reports is found in Table 4-6. EPA estimates the burden to industry will in crease between 16,000 a nd 16,100 hours.

Table F-13: Sensitivity Analysis of Industry Bu rden Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category
Number of Reports with "Other" Write-in Text Total Industry Burden (hours) Burden for Rule Familiarization

of Additional

Categories

(hours) Number of Reports

with Consumer/ Commercial

Product Categories Burden for Write-in Text for "Other" (hours) Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Baseline 8.59 17,075 0.00 0 0 146,661 146,661PostAmendment 9.52 17,075 0.15 302 905 162,672 162,762
Change from the Baseline 0.94 0 0.15 302 905 16,010 16,101

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### Table F-14 shows the range of cost estimates to industry with a lower bound estimate of a 75 percent decrease in the number of “Other” as a consumer and/or commercial product category and an upper bound of a 25 percent decrease in the number of “Other” as a consumer and/or commercial product categories. All baseline cost estimates are taken from Table 4-5. EPA estimates a cost to industry of between $843,000 and $848,000, with a midpoi nt estimate of $846,000 (see Table 4-35).

Table F-14: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category
Number of Reports with "Other" Write-in Text Total Industry Cost (2008$) Cost for Rule Familiarization

of Additional

Categories

(2008$) Number of Reports

with Consumer/ Commercial

Product Categories Cost for Write-in Text for "Other" (2008$) Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Baseline $70.64 17,075 $0.00 0 0 $1,206,177 $1,206,177
PostAmendment $119.90 17,075 $7.31 302 905 $2,049,551 $2,053,962
Change from the Baseline $49.26 0 $7.31 302 905 $843,374 $847,785

Note: Values in Change from the Baseline rows are calculated by subtracting the correspond ing baseline value from the post-amendment value.



### Using a 50 percent decrease in the number of reports with “Other” selected, the burden to the Agency during each reporting cycle is 0.54 h ours and is calculated in Section 5.4.20. Table F-15 shows the range

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F-9 of burden estimates to the Agency; 0.27 hour to 0.81 hours per reporting cycle. The baseline Agency burden estimates per report are taken from Table 5-4.

Table F-15: Sensitivity Analysis of Agency Burd en Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category Number of Reports with "Other" Write-in Text Total Agency Burden (hours) Burden to

Process Write-in Text for "Other" (hours) Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other")
Baseline 0.000 0 0 0.00 0.00
Post-Amendment 0.001 302 905 0.27 0.81 Change from the Baseline 0.001 302 905 0.27 0.81

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.


### Table F-16 shows the range in costs to EPA as a result of modifying the consumer and commercial product categories. Baseline costs to EPA are taken from Table 5-4. The proposed amendment is expected to increase the Agency cost between $28 and approximately $85 during the first reporting cycle.

Table F-16: Sensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category Number of Reports with "Other" Write-in Text Total Agency Cost (2008$)
Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other") Lower Bound (25% of Submitters Claim "Other") Upper Bound (75% of Submitters Claim "Other")
Baseline 0 0 $0 $0

Post-Amendment 302 905 $28 $85
Change from the Baseline 302 905 $28 $85

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### F.5 Upfront CBI Substantiation
EPA is requiring an upfront substantiation when a submitter claims processing and use information as confidential business information (CBI). In 2002, when EPA first required up front substantiation for claiming plant site IDs as CBI, the Agency saw a 64 percent reduction in the number of CBI claims. The Agency expects the number of DPU CBI claims to decrease by the same amount as a result of this proposed amendment. According to 2006 IUR data (EPA, 2008c), a total of 8, 133 reports had claimed that processing and use information was CBI, with an average of three CBI claims for processing and use information per report. The estimates for industr y cost of $773,000 and burden of 12,800 hours, associated with the 8,133 CBI claims are found in Section 4.4.25.

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F-10 The Agency conducted a sensitivity analysis, assu ming the reduction in CBI claims has a lower bound of 84 percent, meaning that 16 percent of subm itters make a CBI claim in Part III, and an upper bound of 44 percent, meaning that 56 percent of s ubmitters make a CBI claim in Part III. Table F-17 contains range in burden increase to industry as a result of the proposed amendment. The burden is expected to increase by between 5,700 and 19,900 hours.

Table F-17: Sensitivity Analysis of Industr y Burden Estimates for Requiring Upfront CBI Substantiation
Number of Reports with CBI Claims in Part III Industry Burden (hours) Burden for Upfront CBI Substantiation for CBI Claims in Part

III (hours) Lower Limit (16% of Submitters Claim CBI) Upper Limit (56% of Submitters Claim CBI) Lower Limit (16% of Submitters Claim CBI) Upper Limit (56% of Submitters Claim CBI)
Baseline 0.00 8,133 8,133 0 0
PostAmendment 4.38 1,301 4,554 5,700 19,949
Change from the Baseline 4.38 -6,832 -3,579 5,700 19,949

Note: Values in Change from the Baseline rows are calculated by subtr acting the corresponding baseline value from the post-amendment value.


### Table F-18 shows the range of cost estimates to industry, with a lower bound estimate of an 84 percent decrease in the number of DPU CBI claims a nd an upper bound of a 44 percent decrease in the number of DPU CBI claims. All baseline cost estimates are taken from Table 4-5. EPA estimates industry cost of between $343,400 and $1.2 million, with a midpoint estimate of $773,000 (see Table 4-33).

Table F-18: Sensitivity Analysis of Industry Cost Estimates for Requiring Upfront CBI Substantiation Number of Reports with CBI Claims in Part III Industry Cost (2008$) Cost for Upfront CBI Substantiation for CBI Claims in Part

III (2008$) Lower Limit (16% of Submitters Claim CBI) Upper Limit (56% of Submitters Claim CBI) Lower Limit (16% of Submitters Claim CBI) Upper Limit (56% of Submitters Claim CBI)
Baseline $0.00 8,133 8,133 $0 $0

PostAmendment $263.90 1,301 4,554 $343,413 $1,201,944
Change from the Baseline $263.90 -6,832 -3,579 $343,413 $1,201,944

Note: Values in Change from the Baseline rows are calculated by subtr acting the corresponding baseline value from the post-amendment value.


### Using a 64 percent decrease in the number CBI claims, the Agency burden increase during each reporting cycle is calculated as eight hours in Secti on 5.4.25. Table F-19 contains the range of burden estimates to the Agency, which is 3.50 hours to 12 .25 hours per reporting cycle. The baseline Agency burden estimates per report are taken from Table 5-4.

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F-11 Table F-19: Sensitivity Analysis of Agency Burden Estimates for Requiring Upfront CBI Substantiation Number of Reports with CBI Claims in Part III Agency Burden (hours) Burden for Upfront CBI Substantiation for CBI Claims in Part

III (hours) Lower Limit (16% of Submitters Claim CBI) Upper Limit (56% of Submitters Claim CBI) Lower Limit (16% of Submitters Claim CBI) Upper Limit (56% of Submitters Claim CBI)

Baseline 0.00 8,133 8,133 0 0

PostAmendment 0.28 1,301 4,554 3.50 12.25

Change from the Baseline 0.28 -6,832 -3,579 3.50 12.25

Note: Values in Change from the Baseline rows are calculated by subtr acting the corresponding baseline value from the post-amendment value.


### Table F-20 contains the range in costs to EPA as a result of modifying the industrial function categories. Baseline costs to EPA are taken from Ta ble 5-4. The proposed amendment is expected to increase the Agency cost between $365 and $1,278 during the first reporting cycle.

Table F-20: Sensitivity Analysis of Agency Cost Estimates for Requiring Upfront CBI Substantiation Number of Reports with CBI Claims in Part III Agency Cost (2008$) Cost for Upfront CBI Substantiation for CBI Claims in Part III Lower Limit (16% of Submitters Claim CBI) Upper Limit (56% of Submitters Claim CBI) Lower Limit (16% of Submitters Claim CBI) Upper Limit (56% of Submitters Claim CBI)

Baseline $0.00 8,133 8,133 $0 $0
PostAmendment $0.28 1,301 4,554 $365 $1,278
Change from the Baseline $0.28 -6,832 -3,579 $365 $1,278

Note: Values in Change from the Baseline rows are calculated by subtr acting the corresponding baseline value from the post-amendment value.

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G-1 

## Appendix G. – Alternative Regulatory Options

In developing the proposed amendments to the IU R rule, EPA considered other regulatory options as alternatives to some of the proposed amendments. Th ese options are considered both as alternatives to all the proposed amendments, and in addition to the pr oposed amendments outlined in Chapter 3. The burden and cost for these alternate regulatory opti ons are described in the sections below.



### G.1 Require Submitters to Submit Full Data Annually

As an alternative to the amendm ent described in Section 3.5.4, which would require submitters to report production volume for each of the years since the last IUR report, EPA considered an option in which submitters would be required to submit all Form U data for each year they meet or exceed the reporting threshold. EPA calculated the cost and burde n of this option under two different scenarios. The first calculates the cost and burden to the industry an d the Agency without considering the other proposed amendments. The section scenario estimates the cost and burden to all affected entities if all the proposed amendments outlined in Section 3. are enacted.

G.1.1 Annual Reporting Cost and Burden when the Option is Considered by Itself 

### Under this alternative option, EPA estimated the cost to the industry and the Agency of annual reporting when the option is considered by itself, with none of the other proposed amendments considered. The annual reporting cost and burden wo uld be the same as in the baseline burden shown in Table 4-10. The number of submitters is not expected to change from year to year. While the Agency is aware that a site’s production volume may vary yearly, 

### causing the site to meet or exceed the threshold in some years but not in others, EPA be lieves that on average, the total number of sites and reports would remain unchanged from year to year. EPA analyzed the burden and costs over a 20-year period. EPA assumes that submitters will become more efficient at reporting data over time, and theref ore incur a smaller burden in future reporting cycles. Future-cycle reporting burden is taken from Table 4-11. The annual industry burden under the baseline and the alternative option is shown in Table G-1. In total, EPA estimates that the industry burden w ould increase by approximately 22.94 million hours over 20 years (four reporting cycles). Over one five-year reporting cycle, the industry burden is expected to increase by 5.74 million hours (1.43 million hours x 4 years) compared to the baseline.

Table G-1: Industry Burden under the Alternative Op tion to Require Submitters to Submit Full Data Annually

Year Baseline Burden (millions of hours) Post-Alternative Option Burden (millions of hours) Change from Baseline (millions of hours)

2011 1.84 1.84 0.00 2012 0.00 1.43 1.43 2013 0.00 1.43 1.43 2014 0.00 1.43 1.43 2015 0.00 1.43 1.43 2016 1.43 1.43 0.00 2017 0.00 1.43 1.43 2018 0.00 1.43 1.43 2019 0.00 1.43 1.43 2020 0.00 1.43 1.43

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G-2 Year Baseline Burden (millions of hours) Post-Alternative Option Burden (millions of hours) Change from Baseline (millions of hours)

2021 1.43 1.43 0.00 2022 0.00 1.43 1.43 2023 0.00 1.43 1.43 2024 0.00 1.43 1.43 2025 0.00 1.43 1.43 2026 1.43 1.43 0.00 2027 0.00 1.43 1.43 2028 0.00 1.43 1.43 2029 0.00 1.43 1.43 2030 0.00 1.43 1.43 Total 6.14 29.09 22.94 Annual Average 0.31 1.45 1.15



### The industry cost under the baseline and this altern ative option is shown in Table G-2. EPA estimates that the industry cost would increase by $1.33 billi on over a 20-year period. The annualized cost increase ranges from $63.95 million with a seven percent discount rate and $65.26 million with a three percent discount rate. Over one five-year reporting cycle, this option would increase industry cost by approximately $331 million ($82.8 million x 4 years) compared to the baseline.

Table G-2: Industry Cost under the Alternative Opti on to Require Submitters to Submit Full Data Annually

Year Baseline Cost (2008$ millions) Post-Alternative Option Cost (2008$ millions) Change from Baseline (2008$ millions)

2011 $106.97 $106.97 $0.00
2012 $0.00 $82.82 $82.82
2013 $0.00 $82.82 $82.82
2014 $0.00 $82.82 $82.82
2015 $0.00 $82.82 $82.82 2016 $82.82 $82.82 $0.00 2017 $0.00 $82.82 $82.82 2018 $0.00 $82.82 $82.82 2019 $0.00 $82.82 $82.82 2020 $0.00 $82.82 $82.82 2021 $82.82 $82.82 $0.00 2022 $0.00 $82.82 $82.82 2023 $0.00 $82.82 $82.82 2024 $0.00 $82.82 $82.82 2025 $0.00 $82.82 $82.82 2026 $82.82 $82.82 $0.00 2027 $0.00 $82.82 $82.82 2028 $0.00 $82.82 $82.82 2029 $0.00 $82.82 $82.82 2030 $0.00 $82.82 $82.82 Total $355.42 $1,680.50 $1,325.08 Annual Average $17.77 $84.03 $66.25

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G-3 Annualized at 3% $19.13 $84.39 $65.26 Annualized at 7% $21.01 $84.95 $63.94



### The baseline burden to EPA during each reporting cy cle is two FTEs, or 4,160 hours (see Section 5- 2). While the burden for each reporting cycle will not ch ange as a result of this amendment, more frequent reporting would increase costs to the Agency. Table G- 3 contains the total Agency burden of the annual reporting option, over a 20-year pe riod. EPA estimates that Agency burden would increase by a total of 66,600 hours over a 20-year period (four reporting cycles). Over one five-year reporting cycle, the Agency burden would increase by 16, 600 hours (4,160 hours x 4 years) compared to the baseline.

Table G-3: Agency Burden under the Alternative Op tion to Require Submitters to Submit Full Data Annually

Year Baseline Burden (hours) Post-Alternative Option Burden (hours) Change from Baseline (hours)

2011 4,160 4,160 0.00 2012 0.00 4,160 4,160 2013 0.00 4,160 4,160 2014 0.00 4,160 4,160
2015 0.00 4,160 4,160
2016 4,160 4,160 0.00
2017 0.00 4,160 4,160
2018 0.00 4,160 4,160
2019 0.00 4,160 4,160
2020 0.00 4,160 4,160
2021 4,160 4,160 0.00
2022 0.00 4,160 4,160
2023 0.00 4,160 4,160
2024 0.00 4,160 4,160
2025 0.00 4,160 4,160
2026 4,160 4,160 0.00
2027 0.00 4,160 4,160
2028 0.00 4,160 4,160
2029 0.00 4,160 4,160
2030 0.00 4,160 4,160 Total 16,640 83,200 66,560 Annual Average 832 4,160 3,328



### The annual Agency cost under the baseline and the al ternative option is shown in Table G-4, and is taken from Table 5-3. In total, EPA estimates th at this option would increase the Agency cost by approximately $1.86 million over one five-year reporti ng cycle. Over a 20-year period, the annualized Agency cost is expected to increase between $359,900 with a seven percent discount rate, and $367,300 with a three percent discount rate compared to the baseline.

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G-4 Table G-4: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually

Year Baseline Cost (2008$) Post-Alternative Option Cost (2008$) Change from Baseline (2008$) 2011 $466,133 $466,133 $0.00
2012 $0.00 $466,133 $466,133
2013 $0.00 $466,133 $466,133 2014 $0.00 $466,133 $466,133
2015 $0.00 $466,133 $466,133
2016 $466,133 $466,133 $0.00
2017 $0.00 $466,133 $466,133
2018 $0.00 $466,133 $466,133
2019 $0.00 $466,133 $466,133
2020 $0.00 $466,133 $466,133
2021 $466,133 $466,133 $0.00
2022 $0.00 $466,133 $466,133
2023 $0.00 $466,133 $466,133
2024 $0.00 $466,133 $466,133
2025 $0.00 $466,133 $466,133
2026 $466,133 $466,133 $0.00
2027 $0.00 $466,133 $466,133
2028 $0.00 $466,133 $466,133
2029 $0.00 $466,133 $466,133
2030 $0.00 $466,133 $466,133 Total $1,864,532 $9,322,660 $7,458,128 Annual Average $93,227 $466,133 $372,906 Annualized at 3% $98,818 $466,133 $367,315 Annualized at 7% $106,248 $466,133 $359,885

G.1.2 Annual Reporting Cost and Burden when the All the Proposed Amendments are Considered 

### EPA estimated the cost and burden of annual repor ting in addition to the proposed amendments outlined in Chapter 3. Under this alternative, the annual reporting cost and burden would be the same as the burden when all the amendments are considered, as shown in Table 4-49. The number of submitters is not expected to change from year to year. The industry burden of annual reporting is show n in Table G-5. The annual reporting option is expected to increase the industry burden by approxima tely 39.59 million hours over a 20-year period, for a total industry burden of 53.55 million hours. EPA estimates that over one four-year reporting cycle (note that under the proposed amendments, a reporting cycle would be changed to four years) the industry burden would increase by approximately 7.92 million hour s (2.64 million hours x 3 years) compared to the baseline.

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G-5 Table G-5: Industry Burden under the Alternative Op tion to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Year Total Burden When all Proposed

Amendments are Considered (millions of hours) Post-Alternative Option Burden (millions of hours) Total Change in Industry Burden (millions of hours)

2011 3.40 3.40 0.00 2012 0.00 2.64 2.64 2013 0.00 2.64 2.64 2014 0.00 2.64 2.64 2015 2.64 2.64 0.00 2016 0.00 2.64 2.64 2017 0.00 2.64 2.64 2018 0.00 2.64 2.64 2019 2.64 2.64 0.00 2020 0.00 2.64 2.64 2021 0.00 2.64 2.64 2022 0.00 2.64 2.64 2023 2.64 2.64 0.00 2024 0.00 2.64 2.64 2025 0.00 2.64 2.64 2026 0.00 2.64 2.64 2027 2.64 2.64 0.00 2028 0.00 2.64 2.64 2029 0.00 2.64 2.64 2030 0.00 2.64 2.64 Total 13.96 53.55 39.59 Annual Average 0.70 2.68 1.98



### The industry baseline cost is taken from Table 4-50. EPA estimates that annual reporting would increase industry cost by approximately $2.43 billion over a 20-year period. The change in annualized cost ranges from $117 million with a seven percent discount rate to $120 million with a three percent discount rate as shown in Table G-6. Over one f our-year reporting cycle, this option would increase industry cost by approximately $486 million ($ 162.12 x 3 years) compared to the baseline.

Table G-6: Industry Cost under the Alternative Opti on to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Year Total Cost When all Proposed Amendments are Considered (2008$ millions) Post-Alternative Option Cost (2008$ millions) Total Change in Industry Cost (2008$ millions)
2011 $209.04 $209.04 $0.00
2012 $0.00 $162.12 $162.12
2013 $0.00 $162.12 $162.12
2014 $0.00 $162.12 $162.12
2015 $162.12 $162.12 $0.00 2016 $0.00 $162.12 $162.12 2017 $0.00 $162.12 $162.12 2018 $0.00 $162.12 $162.12

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G-6 Year Total Cost When all Proposed Amendments are Considered (2008$ millions) Post-Alternative Option Cost (2008$ millions) Total Change in Industry Cost (2008$ millions)
2019 $162.12 $162.12 $0.00 2020 $0.00 $162.12 $162.12 2021 $0.00 $162.12 $162.12 2022 $0.00 $162.12 $162.12 2023 $162.12 $162.12 $0.00 2024 $0.00 $162.12 $162.12 2025 $0.00 $162.12 $162.12 2026 $0.00 $162.12 $162.12 2027 $162.12 $162.12 $0.00 2028 $0.00 $162.12 $162.12 2029 $0.00 $162.12 $162.12 2030 $0.00 $162.12 $162.12 Total $857.53 $3,289.37 $2,431.84 Annual Average $42.88 $164.47 $121.59 Annualized at 3% $45.41 $165.18 $119.78 Annualized at 7% $48.87 $166.26 $117.39



### The Agency baseline burden when all the proposed amendments are considered is taken from Table 5-40. The annual reporting option is expected to increase Agency burden by approximately 36,840 hours when all amendments are considered (see Table G- 7). Over a four-year reporting cycle, EPA estimates that Agency burden would increase by approximately 7, 400 hours (2,456 hours x 3 years) compared to the baseline.

Table G-7: Agency Burden under the Alternative Op tion to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Year Total Burden When all Proposed Amendments are Considered (hours) Post-Alternative Option Burden (hours) Total Change in Agency Burden (hours)

2011 2,456 2,456 0 2012 0 2,456 2,456 2013 0 2,456 2,456 2014 0 2,456 2,456 2015 2,456 2,456 0 2016 0 2,456 2,456 2017 0 2,456 2,456 2018 0 2,456 2,456 2019 2,456 2,456 0 2020 0 2,456 2,456 2021 0 2,456 2,456 2022 0 2,456 2,456 2023 2,456 2,456 0 2024 0 2,456 2,456 2025 0 2,456 2,456 2026 0 2,456 2,456

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G-7 Year Total Burden When all Proposed Amendments are Considered (hours) Post-Alternative Option Burden (hours) Total Change in Agency Burden (hours)

2027 2,456 2,456 0 2028 0 2,456 2,456 2029 0 2,456 2,456 2030 0 2,456 2,456 Total 12,280 49,120 36,840 Annual Average 614 2,456 1,842



### The baseline Agency cost when all the proposed amendments are enacted is taken from Table 5-41. The total Agency cost under the annual reporting option when all proposed amendments are considered is shown in Table G-8. Over a 20-year period, Agency cost would increase by $4.33 million with annualized costs increases ranging from approximately $209,000 with a seven percent discount rate to $213,000 with a three percent discount rate. Over one four-year repor ting cycle, the Agency cost is expected to increase by $865,000 ($288,450 x 3 years) compared to the baseline.

Table G-8: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Year Total Cost When all Proposed Amendments are Considered (2008$) Post-Alternative Option Cost (2008$) Total Change in Agency Cost (2008$)

2011 $288,450 $288,450 $0
2012 $0.00 $288,450 $288,450
2013 $0.00 $288,450 $288,450
2014 $0.00 $288,450 $288,450
2015 $288,450 $288,450 $0 2016 $0.00 $288,450 $288,450 2017 $0.00 $288,450 $288,450 2018 $0.00 $288,450 $288,450 2019 $288,450 $288,450 $0 2020 $0.00 $288,450 $288,450 2021 $0.00 $288,450 $288,450 2022 $0.00 $288,450 $288,450 2023 $288,450 $288,450 $0 2024 $0.00 $288,450 $288,450 2025 $0.00 $288,450 $288,450 2026 $0.00 $288,450 $288,450 2027 $288,450 $288,450 $0 2028 $0.00 $288,450 $288,450 2029 $0.00 $288,450 $288,450 2030 $0.00 $288,450 $288,450 Total $1,442,250 $5,769,000 $4,326,750 Annual Average $72,113 $288,450 $216,338 Annualized at 3% $75,341 $288,450 $213,109 Annualized at 7% $79,587 $288,450 $208,863

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G-8 G.1.3 Small Entity Analysis 

### The following section provides a preliminary assess ment of the impact that annual Form U submissions may have on small entities by examining the relationship between the compliance costs and company sales for small companies. This analysis is based on the methodology described in Chapter 8 of this report. All costs and burdens are estimated under the assumption that all the proposed amendments are enacted. EPA estimated in Chapter 8 of this report that there are 3.89 manufacturing sites per global parent company; 41.3 percent of global parent companies (466 companies) are considered small under the SBA employment-based definition 11 

### , and 24.8 percent (280 companies) are considered small under the TSCA sales-based definition 12 

### . EPA also estimated an average of approximately 1.76 sites per small company under the employment-based definition of small business, and approximately 1.92 sites per small company under the sales-based definition. EPA estimat ed average annual sales revenue of global parent companies considered small under either definition us ing data from Dun & Bradstreet, as also described in Chapter 8.

Table 4-50 shows the annual incremental cost of th e rule to industry. Because this cost would be incurred once every year under an annual reporting cycle, it was not discounted. As shown in Table G-9 below, these costs were divided by the total number of sites expected to submit data, for the annualized costs per site. This was multiplied by the number of sites per small parent company to arrive at the annualized costs per small parent company. This va lue was divided by the annual sales per small parent company to derive the cost-to-sales ratio. As shown in Table G-9, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 m illion. The annual costs of the proposed IUR rule amendments per small parent company, however, are $41,886. The cost-to-sales ratio for an average small company under the employment-based SBA defin ition would be 0.01 percent or less. Under the more conservative sales-based TSCA definition, smal l parent company sales are on average more than$11.8 million, with annualized costs associated with the proposed amendments of $45,649. The cost-tosales ratio for an average small company under the sal es-based definition would be 0.387 percent or less. Using the highest annual cost shown in Table G-9 of $45,649, a small company would have to have annual sales of less than $4.56 million in order to have a cost-to-sales ratio larger than one percent.

11 Threshold of 1,000 employees.
12 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of an y parent company, are below $4 million.

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G-9 Table G-9: Derivation of Cost-t o-Sales Ratios for Small Manufacturers for Collection of Annual Reporting
Employment-based Definition Sales-based Definition
Total Incremental Annual Costs $102,073,745
Total Number of Sites 4,289 Annual costs per site $23,799 Number of sites per small parent company 1.76 1.92 Annualized costs per small parent company $41,886 $45,694 Annual sales per small parent company $412,713,310 $11,821,104 Cost-to-sales ratio 0.01% 0.387% Number of companies potentially affected 466 280



### G.2 Modify Reporting Frequency to a Three-Year Cycle
As an alternative to the proposed amendment d escribed in Section 3.13, which would modify the reporting frequency to a four-year cycle, the Agen cy considered increasing the reporting frequency to once every three years, if the manufacturer exceeds the production volume threshold in any calendar year of the cycle. EPA estimates the burden of this option on all affected entities, both when the option is considered by itself and when all the proposed amendments are considered.

G.2.1 Three-Year Reporting Cycle Cost and Burden when the Option is Considered by Itself 

### EPA’s analysis of industry burden and cost for this amendment is similar to that described in Section 4.4.31; the burden in any one reporting cycle will no t change, but the longer-term burden to industry will increase because reporting will become more frequent. However, the Agency assumes that no additional reports will be submitted as a result of reducing th e length of the reporting cycle. (While the mix of chemicals might change, EPA assumes that the total numb er of reports will remain relatively static.) To be comparable with the proposed four-year reporting cycle option, costs to industry are calculated over a 20-year period. The annual industry burdens under the baseline and un der this alternative option are shown in Table G-10. The industry burden is taken from Table 4-10 for the first reporting cycle and from Table 4-11 for all future reporting cycles. In total, 

### EPA estimates that under this option, industry would incur an additional burden of 4.30 million hours over a 20-year period.

Table G-10: Annual Industry Burden under the Alte rnative Option of a Three-Year Reporting Cycle

Year Baseline Burden (millions of hours) Post-Amendment Burden (millions of hours) Change from Baseline (millions of hours)

2011 1.84 1.84 0.00 2012 0.00 0.00 0.00 2013 0.00 0.00 0.00 2014 0.00 1.43 1.43 2015 0.00 0.00 0.00 2016 1.43 0.00 -1.43 2017 0.00 1.43 1.43 2018 0.00 0.00 0.00 2019 0.00 0.00 0.00

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G-10 Year Baseline Burden (millions of hours) Post-Amendment Burden (millions of hours) Change from Baseline (millions of hours)

2020 0.00 1.43 1.43 2021 1.43 0.00 -1.43 2022 0.00 0.00 0.00 2023 0.00 1.43 1.43 2024 0.00 0.00 0.00 2025 0.00 0.00 0.00 2026 1.43 1.43 0.00 2027 0.00 0.00 0.00 2028 0.00 0.00 0.00 2029 0.00 1.43 1.43
2030 0.00 0.00 0.00 Total 6.14 10.45 4.30 Annual Average 0.31 0.52 0.22



### The annual industry cost under the baseline and this alternative option are shown in Table G-11. In total, EPA estimates that this option would incr ease costs to industry by $248 million over a 20-year period, with annualized costs increases ranging from $11. 29 million with a seven percent discount rate to $11.90 million with a three percent discount rate.

Table G-11: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle

Year Baseline Cost (2008$ millions) Post-Amendment Cost (2008$ millions) Change from Baseline (2008$ millions)
2011 $106.97 $106.97 $0.00 2012 $0.00 $0.00 $0.00 2013 $0.00 $0.00 $0.00 2014 $0.00 $82.82 $82.82 2015 $0.00 $0.00 $0.00 2016 $82.82 $0.00 -$82.82 2017 $0.00 $82.82 $82.82 2018 $0.00 $0.00 $0.00 2019 $0.00 $0.00 $0.00 2020 $0.00 $82.82 $82.82 2021 $82.82 $0.00 -$82.82 2022 $0.00 $0.00 $0.00 2023 $0.00 $82.82 $82.82 2024 $0.00 $0.00 $0.00 2025 $0.00 $0.00 $0.00 2026 $82.82 $82.82 $0.00 2027 $0.00 $0.00 $0.00 2028 $0.00 $0.00 $0.00 2029 $0.00 $82.82 $82.82 2030 $0.00 $0.00 $0.00 Total $355.42 $603.87 $248.45 Annual Average $17.77 $30.19 $12.42

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G-11 Year Baseline Cost (2008$ millions) Post-Amendment Cost (2008$ millions) Change from Baseline (2008$ millions) Annualized at 3% $19.13 $31.03 $11.90 Annualized at 7% $21.01 $32.30 $11.29



### The baseline burden to EPA during reporting years is two FTEs or 4,160 hours (see Section 5-2). While the burden per reporting year would not change as a result of this alternative option, more frequent reporting would increase costs to the Agency. Table G- 12 contains the total bur den the Agency of the proposed option, over a 20-year period. During this period, EPA estimates that Agency burden would increase by a total of 12,500 hours.

Table G-12: Burden to the Agency under the Alternative Option of a Three-Year Reporting Cycle

Year Baseline Burden (hours) Post-Amendment Burden (hours) Change from Baseline (hours) 2011 4,160 4,160 0.00 2012 0.00 0.00 0.00 2013 0.00 0.00 0.00 2014 0.00 4,160 4,160
2015 0.00 0.00 0.00 2016 4,160 0.00 -4,160 2017 0.00 4,160 4,160 2018 0.00 0.00 0.00
2019 0.00 0.00 0.00
2020 0.00 4,160 4,160 2021 4,160 0.00 -4,160 2022 0.00 0.00 0.00 2023 0.00 4,160 4,160 2024 0.00 0.00 0.00
2025 0.00 0.00 0.00
2026 4,160 4,160 0.00
2027 0.00 0.00 0.00
2028 0.00 0.00 0.00
2029 0.00 4,160 4,160 2030 0.00 0.00 0.00
Total 16,640 29,120 12,480 Annual Average 832 1,456 624



### The annual Agency costs under the baseline and the alternative option are shown in Table G-13, and are taken from Table 5-3. In total, EPA estimates th at this option would increase Agency costs by $1.4 million over a 20-year period with an annual average of $69,920.

Table G-13: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle

Year Baseline Cost (2008$) Post-Amendment Cost (2008$) Change from Baseline (2008$) 2011 $466,133 $466,133 $0.00
2012 $0.00 $0.00 $0.00
2013 $0.00 $0.00 $0.00

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G-12 Year Baseline Cost (2008$) Post-Amendment Cost (2008$) Change from Baseline (2008$) 2014 $0.00 $466,133 $466,133
2015 $0.00 $0.00 $0.00
2016 $466,133 $0.00 $0.00
2017 $0.00 $466,133 $466,133
2018 $0.00 $0.00 $0.00 2019 $0.00 $0.00 $0.00
2020 $0.00 $466,133 $466,133
2021 $466,133 $0.00 -$466,133
2022 $0.00 $0.00 $0.00
2023 $0.00 $466,133 $466,133
2024 $0.00 $0.00 $0.00 2025 $0.00 $0.00 $0.00
2026 $466,133 $466,133 $0.00
2027 $0.00 $0.00 $0.00
2028 $0.00 $0.00 $0.00
2029 $0.00 $466,133 $466,133
2030 $0.00 $0.00 $0.00
Total $1,864,532 $3,262,930 $1,398,399 Annual Average $93,227 $163,147 $69,920 Annualized at 3% $98,818 $165,773 $66,955 Annualized at 7% $106,248 $169,785 $63,537

G.2.2 Three-Year Cycle Cost and Burden when the All the Proposed Amendments are Considered 

### EPA estimated the cost and burden of a three-y ear reporting cycle in addition to the proposed amendments outlined in Chapter 3. Under this alte rnative option, the reporting burden for industry would be the same as the combined post amendment burde n shown in Table 4-49; however the reporting cycle would be shortened from four years to three years. For both industry and the Agency, the post-amendment burden will increase from the baseline because of the increased reporting frequency. The total increase in industry burden over 20 years as a result of increasing the reporting frequency from three to four years is 5.28 million hours (see Tabl e G-14). This equates to an annual increase in the reporting burden of approxim ately 0.26 million hours.

Table G-14: Annual Industry Burden under the Alte rnative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered

Year Total Burden When all Proposed

Amendments are Considered (millions of hours) Post-Alternative Option Burden (millions of hours) Total Change in Industry Burden (millions of hours)

2011 3.40 3.40 0.00 2012 0.00 0.00 0.00 2013 0.00 0.00 0.00 2014 0.00 2.64 2.64 2015 2.64 0.00 -2.64

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G-13 Year Total Burden When all Proposed

Amendments are Considered (millions of hours) Post-Alternative Option Burden (millions of hours) Total Change in Industry Burden (millions of hours)

2016 0.00 0.00 0.00 2017 0.00 2.64 2.64 2018 0.00 0.00 0.00 2019 2.64 0.00 -2.64 2020 0.00 2.64 2.64 2021 0.00 0.00 0.00 2022 0.00 0.00 0.00 2023 2.64 2.64 0.00 2024 0.00 0.00 0.00 2025 0.00 0.00 0.00 2026 0.00 2.64 2.64 2027 2.64 0.00 -2.64 2028 0.00 0.00 0.00 2029 0.00 2.64 2.64
2030 0.00 0.00 0.00 Total 13.96 19.24 5.28 Annual Average 0.70 0.96 0.26



### The industry cost for a three-year reporting cycle is shown in Table G-15. Baseline costs are taken from Table 4-50. Over a 20-year period, total cost s would increase by $324 million, with an annualized increase of $15.31 million at a three percent discount rate and $14.32 million at a seven percent discount
rate.

Table G-15: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered

Year Total Cost When all Proposed Amendments are Considered (2008$ millions) Post-Alternative Option Cost (2008$ millions) Total Change in Industry Cost (2008$ millions)

2011 $209.04 $209.04 $0.00 2012 $0.00 $0.00 $0.00 2013 $0.00 $0.00 $0.00 2014 $0.00 $162.12 $162.12 2015 $162.12 $0.00 -$162.12 2016 $0.00 $0.00 $0.00 2017 $0.00 $162.12 $162.12 2018 $0.00 $0.00 $0.00 2019 $162.12 $0.00 -$162.12 2020 $0.00 $162.12 $162.12 2021 $0.00 $0.00 $0.00 2022 $0.00 $0.00 $0.00 2023 $162.12 $162.12 $0.00 2024 $0.00 $0.00 $0.00

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G-14 Year Total Cost When all Proposed Amendments are Considered (2008$ millions) Post-Alternative Option Cost (2008$ millions) Total Change in Industry Cost (2008$ millions)

2025 $0.00 $0.00 $0.00 2026 $0.00 $162.12 $162.12 2027 $162.12 $0.00 -$162.12 2028 $0.00 $0.00 $0.00 2029 $0.00 $162.12 $162.12
2030 $0.00 $0.00 $0.00 Total $857.53 $1,181.78 $324.25 Annual Average $42.88 $59.09 $16.21 Annualized at 3% $45.41 $60.72 $15.31 Annualized at 7% $48.87 $63.19 $14.32



### The Agency baseline burden of 2,456 hours when all the proposed amendments are considered together is taken from Table 5-40. The annual reporti ng option is expected to increase Agency burden by approximately 4,900 hours when all amendm ents are considered (see Table G-16).

Table G-16: Agency Burden under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered

Year Total Burden When all Proposed

Amendments are Considered (millions of hours) Post-Alternative Option Burden (millions of hours) Total Change in Agency Burden (millions of hours)

2011 2,456 2,456 0 2012 0 0 0 2013 0 0 0 2014 0 2,456 2,456 2015 2,456 0 -2,456 2016 0 0 0 2017 0 2,456 2,456 2018 0 0 0 2019 2,456 0 -2,456 2020 0 2,456 2,456 2021 0 0 0 2022 0 0 0 2023 2,456 2,456 0 2024 0 0 0 2025 0 0 0 2026 0 2,456 2,456 2027 2,456 0 -2,456 2028 0 0 0 2029 0 2,456 2,456 2030 0 0 0 Total 12,280 17,192 4,912

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G-15 Year Total Burden When all Proposed

Amendments are Considered (millions of hours) Post-Alternative Option Burden (millions of hours) Total Change in Agency Burden (millions of hours)

Annual Average 614 860 246



### Table G-17 contains the total Agency cost under a three-year reporting cycle. EPA estimates that the Agency cost would increase by approximately $576,900 over a 20-year period. The annualized cost is expected to increase by $28,800 with a three per cent discount rate and $27,200 with a seven percent discount rate.

Table G-17: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered

Year Total Cost When all Proposed Amendments are Considered

(2008$ ) Post-Alternative Option Cost (2008$) Total Change in Agency Cost (2008$)

2011 $288,450 $288,450 $0.00
2012 $0.00 $0.00 $0.00
2013 $0.00 $0.00 $0.00
2014 $0.00 $288,450 $288,450
2015 $288,450 $0.00 -$288,450 2016 $0.00 $0.00 $0.00 2017 $0.00 $288,450 $288,450 2018 $0.00 $0.00 $0.00 2019 $288,450 $0.00 -$288,450 2020 $0.00 $288,450 $288,450 2021 $0.00 $0.00 $0.00 2022 $0.00 $0.00 $0.00 2023 $288,450 $288,450 $0.00 2024 $0.00 $0.00 $0.00 2025 $0.00 $0.00 $0.00 2026 $0.00 $288,450 $288,450 2027 $288,450 $0.00 -$288,450 2028 $0.00 $0.00 $0.0 2029 $0.00 $288,450 $288,450 2030 $0.00 $0.00 $0.0 Total $1,442,250 $2,019,150 $576,900 Annual Average $72,113 $100,958 $28,845 Annualized at 3% $75,341 $102,583 $27,242 Annualized at 7% $79,587 $105,065 $25,478

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G-16 G.2.3 Small Entity Anaylsis 

### The following section provides a preliminary assessment of the impact that a three-year reporting cycle may have on small entities by examining th e relationship between the compliance costs and company sales for small companies. This analysis is based on the methodology found in Chapter 8 of this report and all costs and burdens are estimated under the assumption that all the proposed amendments are enacted. EPA estimated 3.89 manufacturing sites per gl obal parent company in Chapter 8 of this report; 41.3 percent of global parent companies (466 companies) are considered small under the SBA employment-based definition 13 

### , and 24.8 percent (280 companies) are considered small under the TSCA sales-based definition 14 

### . EPA also estimated an average of approximately 1.76 sites per small company under the employment-based definition of small business, and approximately 1.92 sites per small company under the sales-based definition. Average annual sales revenue of global parent companies considered small under either definition were esti mated using data from Dun & Bradstreet, as also described in the EA.

Table 4-50 shows the incremental cost to the in dustry. Because these costs would be incurred once every three years under a three-year reporting cycle, these costs were summed and annualized over three years at both a three percent and seven percent discount rate 15 

### . As shown in Table G-18 below, these costs were divided by the total number of sites expected to submit data, for the annualized costs per site. This was multiplied by the number of sites per small parent company to arrive at the annualized costs per small parent company. This value was divided by the annua l sales per small parent company to derive the costto-sales ratio. As shown in Table G-18, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 mill ion. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $16,273 at a seven percent discount rate, and even lower under a three percent discount rate. The cost-to- sales ratio for an average small company under the employment-based SBA definition would be 0.0036 per cent or less. Under the more conservative salesbased TSCA definition, small parent company sal es are on average more than $11.8 million, with annualized costs associated with the proposed amendments of $36.4 million or lower. The cost-to-sales ratio for an average small company under the sales- based definition would be 0.14 percent or less. Using the highest annual cost shown in Table G-18 of $16,273, a small company would have to have annual sales of less than $1.63 million in order to have a cost-to-sales ratio larger than one percent.

Table G-18: Derivation of Cost-to-Sales Rati os for Small Manufacturers for a Three-Year Reporting Cycle
Employment-based Definition Sales-based Definition

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate
Total Incremental Cost of Amendments $102,073,745

Total Annualized Costs $35,035,115 $36,350,813 $35,035,115 $36,350,813

Total Number of Sites 4,289

13 Threshold of 1,000 employees.
14 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of an y parent company, are below $4 million.

15 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.

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G-17 Employment-based Definition Sales-based Definition

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate Annualized Costs per Site $8,169 $8,475 $8,169 $8,475 Number of Sites per Small Parent Company 1.76 1.92
Annualized Costs per Small Parent Company $14,377 $14,917 $15,684 $16,273 Annual Sales per Small Parent Company $412,713,310 $11,821,104

Cost-to-Sales Ratio 0.0035% 0.0036% 0.1327% 0.1377% Number of Companies Potentially Affected 466 280



### G.3 Change the Threshold for Reporting to 10,000 lb.
The Agency is also considering an option that would lower the reporting threshold from 25,000 lb. to 10,000 lb. Prior to the amendments to the 2006 IUR rule, EPA required that sites submit a Form U for chemicals produced at 10,000 lb. or greater. The 2006 amendments increased the threshold for reporting to 25,000 lb. This alternative regulatory option would return to the previous threshold for reporting.

G.3.1 10,000 lb. Reporting Threshold Cost and Burden when the Option is Considered by Itself 

### EPA used data from the 2002 reporting cycle (EPA , 2009d) to estimate the additional number of reports that would be submitted unde r the alternative threshold option. The total number of reports and sites reporting at three differe nt production levels (10,000 lb. ≤ P V < 25,000 lb., 25,000 lb. ≤ P V < 300,000 lb., and PV ≥ 300,000 lb.) were analyzed to obtain the total range of reports submitted in 2002. Table G-19 contains the total number of reports and sites at all three produc tion levels. In total, 882 sites, or 19 percent, of all the sites submitting reports da ta in 2002 produced chemicals in amounts between 10,000 lb. and 25,000 lb. Thirteen percent of all reports, or 3,5 95 reports, were submitted in 2002 for chemicals produced between 10,000 lb. and 25,000 lb.

Table G-19: Number of Reports and Sites in 2002

Production Volume Number of Sites Percent of Total Number of Reports Percent of Total 10,000 lb. ≤ P V < 25,000 lb. 882 19% 3,595 13%
25,000 lb. ≤ P V < 300,000 lb. 1,392 30% 8,548 32%

PV ≤ 300,000 lb. 2,304 50% 14,818 55% Total 4,578 100% 26,961 100% Source: U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division 2002 IUR Database Statistics for IUR Modifications Rule . Washington, DC. April 30, 2009 (EPA, 2009d)



### .

To estimate the total number of additional sites subm itting reports as a result of the proposed option, EPA applied the percentage of total sites with pr oduction volumes between 10,000 lb. and 25,000 lb. in 2002 (19 percent), to the total number of sites in 2006; 4,085 (baseline 2006 num bers are presented in Table 4-6). Therefore, the Agency estimates that 787 a dditional sites will submit reports as a result of the proposed amendment. The same methodology was applie d to calculating the additional number of reports; EPA estimates a 13 percent increase in the number of 2006 reports, for a total of 3,453 new reports. Because all reports submitted as a result of the pr oposed amendments will be for production volumes less than 300,000 lb., EPA assumes that only additional partial reports (Part IIs) would be submitted.

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G-18 As described in Section 4.2.2, sites need to comple te Part I of Form U only once, and complete Part II and Part III (as applicable) for each chemical manuf actured (or imported). Ta king this allocation of activities into consideration, and using the baseline unit burden estimates as shown in Table 4-2, Table G-20 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that the amendment will cause an increase in industry burden of approximately 94,600 hours.

Table G-20: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb.

Number of Sites Burden per Part I of Report, Compliance Determination, Rule Familiarization, and Submission Number of Partial Reports Burden per Part II of Report and Recordkeeping Number of Full Reports Burden per Part III of

Report Industry Burden (hours)

(a) (b) (c) (d) (e) (f) (g) = (a*b) + (c*d) + (e*f)
Baseline 4,085 33.26 25,896 19.82 17, 075 69.92 1,842,934
PostAmendment 4,872 33.26 29,349 19.82 17, 075 69.92 1,937,544 Change from the Baseline 787 0 3,453 0 0 0 94,611

1 Baseline unit burden deri vations shown in Table 4.4 Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-ame ndment value.



### The cost of the amendment was calculated using th e unit costs shown in Table 4-5. Table G-21 shows the industry cost estimate as a result of this proposed amendment. The cost to industry is expected to increase by $5.52 million.

Table G-21: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb.

Number of Sites Cost per Part I of Report, Compliance Determination, Rule Familiarization, and Submission (2008$) Number of Partial Reports Cost per Part II of Report and Recordkeeping (2008$) Number of Full Reports Cost per Part III of

Report (2008$) Industry Cost (millions

2008$)

Baseline 4,085 $2,058.18 25,896 $1,129.42 17,075 $4,059.25 $106.97
PostAmendment 4,872 $2,058.18 29,349 $1,129.42 17,075 $4,059.25 $112.49
Change from the Baseline 787 $0.00 3,453 $0.00 0 $0.00 $5.52

Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-ame ndment value.



### The baseline burden to EPA of data processing and entry will not change from the baseline of 2,080 hours (see Section 5-2). However, the increased numbe r of reports and submitters will increase the burden to the Agency. While the burden per reporting cycle w ill not change as a result of this amendment, more

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G-19 frequent reporting will increase costs to the Agency . Table G-22 contains the total Agency of the proposed option. EPA’s burden is expect ed to increase by a total of 159 hours.

Table G-22: Change in Burden to the Agency as a Result of Changing the Threshold for Reporting to 10,000 lb.

Burden to Process Part I

Submission

(hours) Number of Sites Burden to Process Part II (hours per report) Number of Reports (with Part II) Burden to Process Part III (hours

per report) Number of Reports

(with Part III) Agency Burden ( hours)

(a) (b) (c) (d) (e) (f) (g) =(a*b)+(c*d)+(e*(f) Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080PostAmendment 0.017 4,872 0.042 29,349 0.054 17,075 2,239
Change from the Baseline 0.000 787 0.000 3,453 0.000 0 159

Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-ame ndment value.



### Table G-23 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $16,600.

Table G-23: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb.

Cost to Process Part I Submission

(2008$) Number of Sites Cost to Process Part II (2008$ per report) Number of Reports (with Part II) Cost to Process Part III (2008$

per report) Number of Reports

(with Part III) Agency Cost (2008$)

(a) (b) (c) (d) (e) (f) (g) =(a*b)+(c*d)+(e*f)

Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $216,949

PostAmendment $1.78 4,872 $4.40 29,349 $5.61 17,075 $233,529

Change from the Baseline $0.00 787 $0.00 3,453 $0.00 0 $16,580

Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-ame ndment value.

G.3.2 Change the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered 

### EPA estimated the cost and burden of lowering the reporting threshold to 10,000 lb. when all of the proposed amendments outlined in Chapter 3. have b een considered. A 10,000 lb. reporting threshold is expected to increase the number of partial reports submitted by approximately 13 percent and the number sites submitting data by 19 percent (See Table G-19) . In addition, EPA assumes that this option would affect the proposed amendment to lower the th reshold for reporting downstream processing and use information from 300,000 lb. to 25,000 lb. (See Section 3.3.2). Under this option, the threshold for reporting this information would be 10,000 lb. The total number of sites and reports, when all the

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G-20 proposed amendments and the 10,000 lb. threshold re porting option are considered, is found in Table G-24. To calculate the number of additional submitte rs and reports, EPA followed the method outlined in Section 4.5.1. While Steps 1 and 2 remain unchanged from what is described in Section4.5.1, the other steps have been modified and an additional step has been added. The calculations for Steps 3, 4, and 5 are outlined below. Step 3: C onsider the effect of decreasing th e reporting threshold to 10,000 lb. This amendment is expected to increase the number of sites submitting Form U by approximately 19 percent and the number of partial reports by approximately 13 percent (See Table G-19). To estimate this effect on the proposed amendments, EPA multiplied the total number of site calculated in Step 2 (204) by 1.19 and the number of partial reports calculated in step 2 (5,469) by 1.13. EPA then added the additional number of reports and sites calculated in Section G. 3.1, which accounts for the increase from the baseline as a result of this option. The number of Part IIIs submitted is not affected by this step. Step 4: Consider the effect of eliminating the 300,000 lb. threshold for processing and use reporting (and avoid double-counting). 

### Under this amendment, all submitters of non-exempt chemicals would be required to submit a Part III. Theref ore, the number of Part IIIs must be increased by the increased number of Part IIs, to account for the effect of eliminating the 300,000 lb. threshold for processing and use reporting. EPA started with the Step 3 total for Part III reports (9,484), and added the Step 3 total for Part II reports (9,632), minus the number of new Part III reports as a result of making ECAs ineligible for exemptions (16), the number of new Part II reports as a result of changing the method of determining whether a manufacturer is subject to reporting requirements (1,295) and the number of new Part II reports that will be for EAC chemi cals as a result of the 10,000 lb. threshold (86 ) 

### . The number of ECA chemicals as a result of the 10,000 lb. thresh old is calculated by multiplying the number of ECA chemicals after the five percent has been taken into account, 649 by 1.13. The number of reports with Part III will increase by 17,737. Step 5: Calculate the number of reports when a ll amendments are considered together. The total number of additional reports from Step 4 is added to the number of reports in the baseline to calculate the total number of reports when all th e proposed amendments are consider ed together. There will now be a total of 5,115 Part Is, 35, 528 Part IIs and 34,812 Part IIIs. The difference between the total number of Part IIs and Part IIIs, 735 reports, is equa l to the number of partially exempt reports with the five and 13 percent increase taken into account ((618x1.05)x1.13)) = 735).

Table G-24: Change in the Number of Sites and Reports Submitted of All Amendments Combined with the 10,000 lb. Reporting Threshold

Modification Number of Sites Number of Reports Number of Reports with Part III Baseline 4,085 25,896 17,075 Step 1: Sum affected amendments Eliminate 300,000 lb. Threshold for Downstream Processing and Use Reporting (see Section 4.4.6) -- -- 8,203

Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals (see Section 4.4.5) -- 4,018 --

Make Chemicals Subject to ECAs Ineligible for Exemptions (see Section 4.4.6) -- -- 16

Full Exemption for Manufactu red Water (see Section 4.4.7). -- (43) --

STEP 1 TOTAL -- 3,975 8,219 Step 2: Account for change in the me thod for determining whether you are subj ect to the IUR repor ting requirements Step 1 Total Multiplied by 1.05

-- 4,174 8,630 Method for Determining Whether you are Subject to 204 1,295 854

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G-21 the IUR Reporting Requirements (see Section 4.4.3) STEP 2 TOTAL 204 5,469 9,484 Step 3: Account for 10,000 lb. reporting threshold Step 2 Total Multiplied by 1.19 for sites and 1.13 for reports 243 6,179

--

10,000 lb. threshold reporting threshold (See Section G.3.1) 787 3,453

--

STEP 3 TOTAL(Step 3 + Step 2 Total ) 1,030 9,632 9,484 Step 4: Consider the effect of elimin ating the 300,000 lb. threshold for proce ssing and use reporting (and avoid doublecounting). Step 3 total for Part II reports minus number of new Part III reports as a result of making ECAs ineligible for exemptions and the number of new Part II reports as a result of changing the method of determining whether subject to reporting requirements -- -- 8,253

STEP4 TOTAL (Step 4 + Step 3 Total ) 1,030 9,632 17,737 Step 5:Calculate the total number of reports by adding the Step 3 Total to the Baseline STEP 5 TOTAL (Baseline + Step 3 Total) 5,115 35,528 34,812



### EPA estimated the cost to the industry of the 10,000 lb. threshold when all the amendments are considered in Table G-25. The baseline values are taken from Table 4-49. Lowering the reporting threshold to 10,000 lb. will not increase the i ndustry per-form burden; however it will increase the number of Form Us submitted. EPA estimates that this option would increase the industry burden by 0.46 million hours in the first reporting cycle and by 0. 35 million hours in all future reporting cycles.

Table G-25: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered Burden per

Part I of Report and Submission (hours per site ) Number of Sites Burden for Part II and

Record Keeping (hours per

report) Number of Reports (with Part II) Burden for Part III and (hours

per report) Number of Reports

(with Part III) Total Burden (millions of hours)

(a) (b) (c) (d) (e) (f) (g) =(a*b)+(c*d)+(e*(f) First-year Baseline 36.12 4,289 22.19 31,365 83.02 30,716 3.40
First year, Post Amendment 36.12 5,115 22.19 35,547 83.02 34,812 3.86
Change from the Baseline, First year 0.00 826 0.00 4,182 0.00 4,096 0.46

Future-cycle Baseline 11.19 4,289 18.35 31,365 65.63 30,716 2.64
Future cycle, Post Amendment 11.19 5,115 18.35 35,547 65.63 34,812 2.99
Change from the Baseline, Future cycles 0.00 826 0.00 4,182 0.00 4,096 0.35

Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-ame ndment value.

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G-22 Baseline costs are taken from Table 4-50. The 10,0 00 lb. reporting threshold is expected to increase industry cost by $28.45 million during the first repor ting cycle and by $21.80 million during all future reporting cycles (See Table G-26).

Table G-26: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered Cost per Part

I of Report and Submission

(2008$) Number of Sites Cost for Part II and

Record Keeping (2008$) Number of Reports (with Part II) Cost for Part III

and (2008$) Number of Reports

(with Part III) Total Burden (millions of 2008$)

(a) (b) (c) (d) (e) (f) (g) =(a*b)+(c*d)+(e*(f) First-year Baseline $2,252 4,289 $1,346 31,365 $5,117 30,716 $209.04
First year, Post Amendment $2,252 5,115 $1,346 35,547 $5,117 34,812 $237.49

Change from the Baseline, First year $0 826 $0 4,182 $0 4,096 $28.45

Futurecycle Baseline $704 4,289 $1,109 31,365 $4,047 30,716 $162

Future cycle, Post Amendment $704 5,115 $1,109 35,547 $4,047 34,812 $183.92

Change from the Baseline, Future cycles $0 826 $0 4,182 $0 4,096 $21.80

Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-ame ndment value.



### The annual industry burden over a 20-year period is shown in Table G-27. Over a 20-year period, the total Agency burden would increase by 1.88 million hours when all the proposed amendments are considered.

Table G-27: Industry Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered,

Year Current PostAmendment Burden (million hours) Future PostAmendment Burden (million hours) Total Change in Industry Burden (million hours) 2011 3.40 3.86 0.46 2012 0.00 0.00 0.00 2013 0.00 0.00 0.00 2014 0.00 0.00 0.00 2015 2.64 2.99 0.35 2016 0.00 0.00 0.00 2017 0.00 0.00 0.00 2018 0.00 0.00 0.00 2019 2.64 2.99 0.35

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G-23 Year Current PostAmendment Burden (million hours) Future PostAmendment Burden (million hours) Total Change in Industry Burden (million hours) 2020 0.00 0.00 0.00 2021 0.00 0.00 0.00 2022 0.00 0.00 0.00 2023 2.64 2.99 0.35 2024 0.00 0.00 0.00 2025 0.00 0.00 0.00 2026 0.00 0.00 0.00 2027 2.64 2.99 0.35 2028 0.00 0.00 0.00 2029 0.00 0.00 0.00 2030 0.00 0.00 0.00 Total 13.96 15.84 1.88 Annual Average 0.70 0.79 0.09



### Table G-28 shows the annual industry cost over a 20-year period as a result of lowering the reporting threshold. EPA estimates that a 10,000 lb. reportin g threshold would increase costs by approximately $115.64 million. Annualized costs range from $6.13 m illion with a three percent discount rate and $6.60 million with a seven percent discount rate.

Table G-28: Change in Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. and All Other Amendments when All Proposed Amendments are Considered

Year Current PostAmendment Cost (millions 2008$) Future PostAmendment Cost (millions 2008$) Total Change in Industry Cost (millions 2008$)
2011 $209.04 $237.49 $28.45
2012 $0.00 $0.00 $0.00
2013 $0.00 $0.00 $0.00
2014 $0.00 $0.00 $0.00
2015 $162.12 $183.92 $21.80 2016 $0.00 $0.00 $0.00 2017 $0.00 $0.00 $0.00 2018 $0.00 $0.00 $0.00 2019 $162.12 $183.92 $21.80 2020 $0.00 $0.00 $0.00 2021 $0.00 $0.00 $0.00 2022 $0.00 $0.00 $0.00 2023 $162.12 $183.92 $21.80 2024 $0.00 $0.00 $0.00 2025 $0.00 $0.00 $0.00 2026 $0.00 $0.00 $0.00 2027 $162.12 $183.92 $21.80 2028 $0.00 $0.00 $0.00 2029 $0.00 $0.00 $0.00 2030 $0.00 $0.00 $0.00

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G-24 Total $857.53 $973.17 $115.64 Annual Average $42.88 $48.66 $5.78 Annualized at 3% $45.41 $51.53 $6.13 Annualized at 7% $48.87 $55.47 $6.60



### As previously explained in Section G.3.1, the Ag ency burden per-report will not change as a result of lowering the reporting threshold. However, the numbe r of reports and the number of sites submitting reports will increase. Table G-29 contains the Agen cy burden as a result of lowering the threshold for reporting when all the other amendments are consid ered. EPA estimates the Agen cy burden will increase by 51 hours during each reporting cycle.

Table G-29: Agency Burden as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered

Burden to Process Part I

Submission

(hours) Number of Sites Burden to Process Part II (hours per report) Number of Reports (with Part II) Burden to Process Part III (hours

per report) Number of Reports

(with Part III) Agency Burden (hours)

(a) (b) (c) (d) (e) (f) (g) =(a*b)+(c*d)+(e*(f)
Baseline 0.002 4,289 0.006 31,365 0.006 30,716 2,456PostAmendment 0.002 5,115 0.006 35,528 0.006 34,812 2,507
Change from the Baseline 0.000 826 0.000 4163 0.000 4,096 51
Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-ame ndment value.



### Table G-30, contains the Agency cost as a re sult of lowering the reporting threshold. Baseline values are taken from Table 5-41. Lowering the 10,000 lb. threshold is expected to increase the Agency cost by approximately $5,300 per reporting cycle.

Table G-30: Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered

Cost to Process Part I Submission

(2008$) Number of Sites Cost to Process Part II (2008$ per report) Number of Reports (with Part II) Cost to Process Part III (2008$

per report) Number of Reports

(with Part III) Agency Burden (2008$)

(a) (b) (c) (d) (e) (f) (g) =(a*b)+(c*d)+(e*(f)
Baseline $0.20 4,289 $0.58 31,365 $0.66 30,716 $39,266PostAmendment $0.20 5,115 $0.58 35,528 $0.66 34,812 $44,554 Change from the Baseline 0.000 826 $0.00 4,163 $0.00 4,096 $5,287 Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-ame ndment value.

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G-25 The annual Agency burden over a 20-year period is s hown in Table G-31. Over a 20-year period, the total Agency burden would increase by 253 hours over a 20-year period when all the proposed amendments are considered. Table G-31: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered

Year Current PostAmendment Burden (hours) Future PostAmendment Burden (hours) Total Change in Agency Burden (hours) 2011 2,456 2,507 51 2012 0 0 0 2013 0 0 0 2014 0 0 0 2015 2,456 2,507 51
2016 0 0 0
2017 0 0 0
2018 0 0 0
2019 2,456 2,507 51
2020 0 0 0
2021 0 0 0
2022 0 0 0
2023 2,456 2,507 51
2024 0 0 0
2025 0 0 0
2026 0 0 0
2027 2,456 2,507 51
2028 0 0 0
2029 0 0 0
2030 0 0 0
Total 12,282 12,536 253 Annual Average 614 627 13



### Table G-32 contains the annual Agency cost ove r a 20-year period, as a result of lowering the reporting threshold. EPA estimates that a 10,000 lb. reporting threshold will increase the Agency cost by approximately $26,400. Annualized costs range fro m $1,460 with a seven percent discount rate and $1,380 with a three percent discount rate.

Table G-32: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. and All Other Amendments when All Proposed Amendments are Considered

Year Current PostAmendment Cost (2008$ ) Future Post-Amendment Cost (2008$) Total Change In Agency Cost (2008$)
2011 $39,266 $44,554 $5,287
2012 $0 $0 $0
2013 $0 $0 $0
2014 $0 $0 $0
2015 $39,266 $44,554 $5,287 2016 $0 $0 $0

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G-26 2017 $0 $0 $0 2018 $0 $0 $0 2019 $39,266 $44,554 $5,287 2020 $0 $0 $0 2021 $0 $0 $0 2022 $0 $0 $0 2023 $39,266 $44,554 $5,287 2024 $0 $0 $0 2025 $0 $0 $0 2026 $0 $0 $0 2027 $39,266 $44,554 $5,287 2028 $0 $0 $0 2029 $0 $0 $0 2030 $0 $0 $0 Total $196,331 $222,769 $26,437 Annual Average $9,817 $11,138 $1,322 Annualized at 3% $10,256 $11,637 $1,381 Annualized at 7% $10,834 $12,293 $1,459

G.3.3 Small Entity Analysis 

### The following section provides a preliminary assessment of the impact that a 10,000 lb. reporting threshold may have on small entities by examining th e relationship between the compliance costs and company sales for small companies. This analysis is based on the methodology found in Chapter 8 of this report. All costs and burdens are estimated under the assumption that all the proposed amendments have been enacted. EPA estimated 3.89 manufacturing sites per global parent company in Chapter 8 of this report; 41.3 percent of global parent companies ( 466 companies) are considered small under the SBA employment-based definition 16 

### , and 24.8 percent (280 companies) are considered small under the TSCA sales-based definition 17 

### . EPA also estimated an average of approximately 1.76 sites per small company under the employment-based definition of small business, and approximately 1.92 sites per small company under the sales-based definition. Average annual sales revenue of global parent companies considered small under either definition were esti mated using data from Dun & Bradstreet, as also described in Chapter 8. Table G-28 above shows the cost to the industry as a result of annual reporting. Because these costs would be incurred once every four years under a proposed four-year reporting cycle, these costs were summed and annualized over four years at both a three percent and seven percent discount rate 18 

### . As shown in Table G-33 below, these costs were divided by the total number of sites expected to submit data, for the annualized cost per site. This was multiplied by the number of sites per small parent company to

16 Threshold of 1,000 employees.
17 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of an y parent company, are below $4 million.

18 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.

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G-27 arrive at the annualized costs per small parent comp any. This value was divided by the annual sales per small parent company to derive the cost-to-sales ratio. As shown in Table G-33 under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 mill ion. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $12,392 at a seven percent discount rate, and even lower under a three percent discount rate. The cost-to- sales ratio for an average small company under the employment-based SBA definition would be 0.003 per cent or less. Under the more conservative salesbased TSCA definition, small parent company sal es are on average more than $11.8 million, with annualized costs associated with the proposed amendm ents of $13,518 or lower. The cost-to-sales ratio for an average small company under the sales-based definition would be 0.11 percent or less. Using the highest annual cost shown in Table G- 33 of $13,518 a small company would have to have annual sales of less than $1.36 million in order to have a cost-to-sales ratio larger than one percent.

Table G-33: Derivation of Cost -to-Sales Ratios for Small Manufacturers for a 10,000 lb. Reporting Threshold
Employment-based Definition Sales-based Definition

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate Incremental Costs of 10,000 lb. threshold $28,446,723
Incremental Costs of Proposed Other Amendments $102,073,745

Total Annualized Costs $34,090,811 $36,012,441 $34,090,811 $36,012,441

Total Number of Sites 5,115
Annualized Costs per Site $6,665 $7,041 $6,665 $7,041
Number of Sites per Small Parent Company 1.76 1.92
Annualized Costs per Small Parent Company $11,731 $12,392 $12,797 $13,518 Annual Sales per Small Parent Company $412,713,310 $11,821,104

Cost-to-Sales Ratio 0.0028% 0.0030% 0.1083% 0.1144%
Number of Companies Potentially Affected 466 280

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H-1 

## Appendix H. Additional Ex posure-Related Data Elements

EPA is considering the collection of additional expos ure-related data, similar to the data collected under the TSCA section 5 New Chemicals Program, to further enhance the Ag ency’s capabilities in conducting screening-level risk assess ments of chemical substances reported to the TSCA Inventory Update, and would substantially impr ove EPA’s ability to quantify chemi cal risks. The ability to quantify chemical risks would further improve the Agency’s ability to identify and manage those risks. The additional exposure-related data elements and brief descriptions ar e as provided in Table H-1: EPA is soliciting comment in the preamble for the pr oposed IUR rule amendments on the suitability of these data elements for enabling the Agency to de velop more comprehensive and complete screening assessments of the risks that may be encountered in manufacture, processing, and use of chemicals. Additionally, the Agency is interested in whether an y additional data should be collected, and in any other considerations relating to the collection of additio nal data. EPA is also soliciting comment on the best method to collect these data, and whether processors, in addition to manufacturers, should be required to report processing and use data. The Agency is consider ing three approaches to collecting the data. They are: 1) integrating these data elements into the IUR; 2) promulgating a new reporting mechanism under TSCA section 8(a); and, 3) using TSCA section 11(c) subpoena authority to collect these data from known manufacturers (including importers). These additiona l data elements are not included as part of the current proposal; therefore, they are not addressed in the main part of this economic analysis. This Appendix provides a preliminary estimate of the burden and cost of collecting data for these additional data elements under the first approach of integrating the data elements into the IUR rule requirements.

Table H-1: Description of Additional Data Elements
Data Element Description Manufacturing Process Information

1 Description of manufacturing process Provide a process flow diagram which describes the manufacturing operations involving the chemical substance. “Unit operation” means a functional step in which substances undergo chemical changes and/or changes in location, temperature, pr essure, physical state, or similar characteristics. Include steps in which th e substance is formulated into gels, mixtures, suspensions, solutions, et c. and in which the substance is transferred into interim storage or shipping containers. Indicate in the 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 substance.

2 Continuous or batch
process Indicate whether the chemical substance is manufactured in discrete batches or is produced by contin uously adding reactants and removing the reaction product.

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

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

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H-2 Data Element Description

5 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 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.

6 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 substances undergo chemical changes, or changes in temperature, pressure, physical state, concentration, purity, or similar characteristics. Examples of unit oper ations include blending, distillation, filtration, and drying.

7 Storage and shipping containers List the types of containers used to transport or store the chemical substance and their capacity. Examples of containers include 1-liter bottles, 5-gallon pails, 55-gallon drums, 200-pound totes, 5000-gallon tank trucks, and 20,000-gallon railcars. Manufacturing Worker Exposure Information

8 Worker activities Describe each specific activity in th e operation during which workers may be exposed to the chemical substance. Such activities may include charging reactor vessels, sampling for quality cont rol, transferring substances from one container to another, changing filters, filling drums, loading and loading tank cars or trucks, etc. Activities must be described even if workers wear protective equipment.

9 Duration and frequency of worker exposure For each worker activity, enter the maximum duration in hours and number of days per year that any one worker will engage in the activity during a normal work day based on the reported production volume. 10 Physical form For each worker activity, indicate the phy sical form of the substance at the time of exposure.

11 Maximum concentration For each worker activity, indicate th e maximum concentration of the substance in the product at the time of exposure.

12 Personal protective equipment and engineering controls used by workers For each worker activity, identify the sp ecific types of protective equipment and engineering controls that will be employed to protect the worker from potential exposure to the chemical substa nce, i.e. gloves, goggles, protective garment, local ventilation, respirator, etc.

13 Worker monitoring data available Indicate whether monitoring data on occupational exposure of workers is available.

14 Summary of occupational exposure monitoring included Indicate whether a summary of occupational exposure monitoring data is included. Summary should include information on the number of workers involved, number of samples taken, types of samples (area or personal), average and standard deviations of exposure. Manufacturing Releases to the Environment

15 Release source (or release point) For each point of release containing the chemical substance, identify and describe the point in the process description at which the release occurs (e.g. releases due to spillage, residues, separation losses, and other sources from each batch or each day).

16 Media and type of release For each release, indicate the media (air, liquid or aqueous solution, solid) and type of release [stack air, fugitiv e air, surface water, on-site or off-site land or incineration, POTW or other (specify)] of a release stream containing the chemical substance.

17 Quantity of substance released a) directly to the environment or b) into control technology For each release, provide the quantity (in pounds) of chemical substance released: a) directly to the environment; or

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H-3 Data Element Description

18 to the environment b) into control technology to the environment in pounds per day for continuous operation or pounds per batch for batch operations.

19 Control technology For each release, describe the type of technology used to control the release of the substance to the environment. Examples of control technologies include carbon filter, scrubber an d biological treatment (primary, secondary, etc.).

20 Efficiency of control technology Indicate the established efficiency of th e control technology in removing or destroying the chemical substance.

21 Destination of release For aqueous releases containing the chemical substance, indicate whether release enters a navigable waterway , a publicly-owned treatment works (POTW), or other. Identify the name of the POTW and/or NPDES # as appropriate. For other releases, in dicate whether the release goes to a municipal or hazardous waste landfill, a commercial incinerator, enters the atmosphere, or is otherwise disposed (specify).

22 Additional release related information attached Indicate whether a description of the releases, calculations or monitoring data on the quantities of releases, or additional information on control technologies and/or tr eatment is attached. Industrial Processing or Use Activities

23 Description of Processing or Use Provide a process flow diagram which describes the processing or use operation involving the chemical substance. “Unit operation” means a functional step in which substances undergo chemical changes and/or changes in location, temperature, pr essure, physical state, or similar characteristics. Include steps in which th e substance is formulated into gels, mixtures, suspensions, solutions, et c. and in which the 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 releas es, drum residues, etc.) and trace amounts of the substance.

24 Processing or use at sites controlled by manufacturer Indicate whether the sites at which the chemical is processed or used are owned by the manufacturer or others.

25 Continuous or batch
process Indicate whether the industrial process in which the chemical is processed or used is a batch or continuous process.

26 Amount of substance processed per day or per batch Provide the amount of the substance in pounds processed or used per batch for batch operation or processed or used per day for continuous operation, respectively.

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

28 Days of operation per year or number of batches per year If the chemical substance is processed in discrete batches, indicate the number of batches necessary to process 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 process the reported production volume.

29 Unit operations List the unit operations needed to process the chemical substance. Unit operation means a functional step in manufacturing, processing, or use operation where substances undergo chemical changes, or changes in temperature, pressure, physical state, concentration, purity, or similar characteristics. Examples of unit oper ations include blending, distillation, filtration, and drying.

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H-4 Data Element Description

30 Storage and shipping containers used List the types of containers used to transport or store the chemical substance and their capacity. Examples of containers include 1-liter bottles, 5-gallon pails, 55-gallon drums, 5,000-gallon tank trucks, and 20,000-gallon railcars. Industrial Processing or Use Occupational Exposures Information

31 Worker activities Describe each specific activity in th e operation during which workers may be exposed to the chemical substance. Such activities may include charging reactor vessels, sampling for quality cont rol, transferring substances from one container to another, changing filters, filling drums, loading and loading tank cars or trucks, etc. Activities must be described even if workers wear protective equipment.

32 Duration and frequency of worker exposure For each worker activity, provide th e number of hours per day and the number of days per year during which the worker is engaged in processing or using the chemical substance. 33 Physical form For each worker activity, indicate the phy sical form of the substance at the time of exposure.

34 Maximum concentration For each worker activity, indicate th e maximum concentration of the substance in the product at the time of exposure.

35 Personal protective equipment and engineering controls used by workers For each worker activity, identify the sp ecific types of protective equipment and engineering controls that will be employed to protect the worker from potential exposure to the chemical.

36 Worker monitoring data available Indicate whether monitoring data on occupational exposure of workers is available.

37 Summary of occupational exposure monitoring included Indicate whether a summary of occupational exposure monitoring data is included. Summary should include information on the # of workers involved, # of samples taken, types of samples (area or personal), average and standard deviations of exposure. Industrial Processing or Use Releases to the Environment Information

38 Release source (or point) For each point of release containing the chemical substance, identify and describe the point in the process description at which the release occurs (e.g. releases due to spillage, residues, separation losses, and other sources from each batch or each day).

39 Media and type of release For each release, indicate the media (air, liquid or aqueous solution, solid) and type of release [stack air, fugitiv e air, surface water, on-site or off-site land or incineration, POTW or other (specify)] of a release stream containing the chemical substance.

40 For each release, provide the quantity (in pounds) of chemical substance released: a) directly to the environment; or

41 Quantity of substance released a) directly to the environment or b) into control technology to the environment b) into control technology to the environment in pounds per day for continuous operation or pounds per batch for batch operations.

42 Control technology For each release, describe the type of technology used to control the release of the substance to the environment. Examples of control technologies include carbon filter, scrubber an d biological treatment (primary, secondary, etc.).

43 Efficiency of control technology Indicate the established efficiency of th e control technology in removing or destroying the chemical substance.

44 Destination of release For aqueous releases containing the chemical substance, indicate whether release enters a navigable waterway , a publicly-owned treatment works (POTW), or other. Identify the name of the POTW and/or NPDES # as appropriate. For other releases, in dicate whether the release goes to a municipal or hazardous waste landfill, a commercial incinerator, enters the atmosphere, or is otherwise disposed (specify).

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H-5 Data Element Description

45 Additional release related information attached Indicate whether a description of the releases, calculations or monitoring data on the quantities of releases, or additional information on control technologies and/or tr eatment is attached. Commercial Use Occupational Exposure Information

46 Description of commercial use Describe the commercial use(s) of products containing the chemical substance.

47 Function of chemical in commercial product Describe the function of the chemical in the commercial product, e.g., dispersive dye, solvent, stabilizer, hardener, plasticizer, filler, etc.

48 Number of potentially exposed commercial workers Indicate the number of workers in co mmercial establishments who are reasonably likely to be exposed to the chemical substance.

49 Physical form of commercial product Indicate the physical form of the product containing the chemical substance.

50 Method of commercial product application Describe the application method (e.g. sprayed applied via pump sprayer or aerosols, poured or applied manually) of the product containing the chemical substance and whether the commercial use is destructive, contained, dispersive, etc.

51 Duration and frequency of commercial product

use Indicate the duration of use, e.g. 5 minutes or less, 30 minutes or less, 1 hour or less, etc. and frequency of co mmercial use, e.g. used more than once a day, used once a day, used several times a week, etc. Consumer Use and Exposure Information

52 Description of

consumer use Describe the consumer use(s) of products containing the chemical substance.

53 Function of chemical in consumer product Describe the function of the chemi cal in the consumer product, e.g., dispersive dye, solvent, stabilizer, hardener, plasticizer, filler, etc.

54 Number of potentially exposed consumers Indicate the number of consumers reasonably likely to be exposed to the chemical substance.

55 Physical form of consumer product(s) containing the chemical substance Indicate the physical form, e.g., gel, foam, powder, etc. of the consumer product containing the chemical substance.

56 Method of consumer product application Describe the application of the consumer product containing the chemical substance, for example, chemicals in products that will be sprayed via pump sprayer or aerosols; products that are poured, mixed, applied by hand/mechanical device; chemicals that can be released via diffusion, evaporation, abrasion, etc. , from articles; or chemical s that are incorporated into articles with no potential for release, etc.

57 Duration and frequency of consumer product

use Indicate the duration of consumer use, e.g., used for 5 minutes or less, 30 minutes or less, less than 1 hour, etc. and frequency of consumer use, e.g. used more than once a day, used once a day, used several times a week, etc.

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H-6 

### H.1 Estimated Number of Affected Entities

In order to estimate the burden and cost of co llecting the additional data, EPA assumes that the impacts on manufacturers and processors would be different. Manufacturers would be required to complete an integrated Form U, which would be a Fo rm U revised to incorporate the new data elements. For the purpose of this analysis, EPA assumes that all of the amendments currently being proposed also would be included. EPA assumes that processors, on th e other hand, would be required to complete a tailored Form U that focuses only on the additional processing and use information. Manufacturers For manufacturers, EPA assumes that the numbers of sites and reports that would be affected by the requirement to provide additional exposure-relate d data would be the same as the numbers of manufacturing sites and reports as estimated in Section 4. 5 of this report. As shown in Table 4-47, a total of 4,289 manufacturers are expected to submit a tota l of 31,365 reports, including both full and partial reports, when all the proposed amendments are cons idered. To the extent th at any specific chemicals would be exempt from the requirement to provid e these additional data elements, the number of manufacturers and reports may be an overestimate.

Processors The number of processors that may be affected by a requirement to submit the additional data elements was estimated using data from EPA’s Toxi c Release Inventory (TRI) reporting program. Under the TRI program, EPA collects information annually on toxic chemical release s and waste management activities from manufacturers, processors, and users of a set of 581 toxic chemicals and 30 toxic chemical categories. The chemicals regulated under the TRI pr ogram are a smaller set than those regulated under the IUR rule, but the TRI data collection activity currently is the most comprehensive information collection that EPA administers for chemical pro cessors. Therefore, EPA assumes that information on processors who report under TRI is a suitable proxy for processors who may report under an amended IUR rule.

EPA used TRI Form R submission data from th e 2007 TRI Public Data Release for 2002 through 2005 (to be consistent with the time period of the mo st recent IUR reporting cycle). EPA filtered the data to include only IUR chemicals (i.e., the ch emicals listed in the public 2006 IUR database) 19 

### . Processors submitted TRI data on an average of 220 of the IUR ch emicals during each of the four years of interest. For this analysis, EPA counted as a “processor” each TR I submitter that indicated that it processes a toxic chemical as a reactant, as a formulation component, as an article component, for repackaging, or as an impurity; or, that it otherwise uses the chemical as a chemical processing aid. 20 

### Because EPA assumes that any company that both manufac tures and processes a chemical will be considered a manufacturer for the purposes of IUR reporting of the additional data elem ents, TRI submitters who indicated that they also manufactured or otherwise used a chemical were filtered out of the dataset. The TRI data revealed that an average of 137 processors reported inform ation per TRI chemical. However, the average value is greatly skewed by cer tain high-volume chemicals that are processed by a large number of processors. 21 

### Therefore, EPA chose to use the median number of 15 processors per chemical, assuming it to be more representative of the universe of chemical processors who would report under the IUR rule.

19 The TRI program may collect da ta on certain chemicals for which IUR reporting is not required. A list of CASRNs for the nonconfidential IUR chemicals was found at “Non-confidential 2006 IUR Records by Chemical, including Manufacturing, Processing and Use Information” http://cfpub.epa.gov/iu rsearch/index.cfm?s=chem Accessed August 30, 2009.
20 TRI submitters indicate their activities and uses of the toxic chemical at the facility in Part II Section 3 of Form R.

21 For example, an average of 3,240 proces sors per year reported for lead alone.

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H-7 Information was reported for a total of 6,140 chem icals under the IUR rule in 2006. By applying the average number of processors per chemical derive d from TRI data, EPA estimates that a total of 92,100 reports would be submitted by processors as a re sult of this option ( 15 x 6,140 = 92,100). This approach is limited to the extent that th e universe of processors is different under the TRI regulation and IUR rule. Because the sets of chemical s covered under the TRI and IUR rules are different, the median number of processors per chemical may be an over- or underestimate. (EPA attempted to minimize this by filtering the TRI data to only in clude known IUR chemicals, but not all IUR chemicals would be subject to TRI reporting requirements.) Add itionally, the TRI rule applies to facilities included within a specific set of NAICS codes; the IUR rule presently does not limit its applicability to a defined set of NAICS codes. This may cause the number of pr ocessors estimated here to be an underestimate. Furthermore, “processor” may be defined differently by the two rules; any specific criteria that EPA may use to define a “processor” for the purpose of the IUR rule may cause the median number of processors per chemical estimated here to be an overestimate. Finally, the data used in this analysis was for submissions of TRI Form R only. This was done becau se Form A, the other, simpler, TRI reporting form, does not request information that would identify th e submitter as a processor or manufacturer. Form R is used for high-volume chemicals (i.e., those manufac tured, processed, or otherwise used in amounts greater than one million pounds) or for chemicals meeti ng other specific criteria; as a result, processors of small volumes may not be included, causing th e median number to be an under-estimate.



### H.2 Industry burden estimate
Manufacturers Given the similarity between the additional exposur e-related data elements and the exposure data collected under EPA’s New Chemical Program, EPA assu mes that the incremental cost for the additional data elements will be similar to the estimated burden to complete a premanufacture notice (PMN) 22



### . Therefore, EPA calculated the burden to complete an “i ntegrated Form U” (that is, a Form U modified to include the additional data elements) by adding the b ase burden for a full form (estimated in Section 4.5 of this report) to the burden to complete a PMN. EPA assumes that every site will be required to complete the additional exposure information. The burden of completing a paper PMN form w as estimated in the supporting statement for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances , EPA ICR No: 574.12 (EPA,. 2003). According to this source, the total burden to co mplete a PMN form in the first reporting cycle is 107 hours. To be consistent with the proposed amendment to require electronic submission (discussed in Section 4.4.27 of this economic analysis), EPA re duced the estimated burden to 93 hours. Because paper filing would not be permitted under the amendment, all cl erical burden is eliminated. Consistent with the method described in Section 4.2.6 of this report, the future cycle burden was calculated by applying a weighting factor of 80 percent to the first cycle bur den, resulting in an estimated burden of 74.4 hours. Using the numbers of manufacturing sites and reports as estimated in Section 4.5 of this report, EPA estimates that the total burden to manufacturers to s ubmit additional exposure-relate d data as part of their IUR reporting is 2.92 million hours in the first reporting cycle and 2.33 million hours in all future reporting cycles (See Table H-2: below).

22 Anyone who plans to manufacture or import a new chemic al substance for a non-exem pt commercial purpose is required by section 5 of TSCA to provide EPA with noti ce before initiating the activity. This premanufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical.

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H-8 This approach is limited to the extent that the data elements requested in any modification to the IUR match the PMN form and the burden it imposes. Furthermore, the PMN form includes some site and chemical identification data which may overlap with the data provided on IUR Part I; however, this overlap was considered to be minimal.

Table H-2: Change in Industry Burden to Ma nufacturers as a Result of Additional ExposureRelated Data Elements

Burden for Rule Familiarization,

Compliance Determination, Submission and to Prepare Part I (hours per site) Number of Sites Burden for Record Keeping and to Prepare Part II (hours

per report) Number of Reports

(with Part II) Burden to Prepare Part III (hours

per report) Number of Reports

(with Part III) Burden to Complete

New Data elements

(hours

per report) Number of Reports

(with New Data elements) Industry Burden (millions of hours)

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a * b)+ (c * d)+ (e * f)+ (g*h) Manufacturer Burden (First Cycle) Considering all Proposed Amendments (As Estimated in Table 4-47) 36.12 4,289 22.19 31,365 83.02 30,716 0 0 3.40

Total Manufacturer Burden (First Cycle) Including Additional Data Elements 36.12 4,289 22.19 31,365 83. 02 30,716 93 31,365 6.32

Incremental Increase due to Additional Data Elements (First Cycle) 0.00 0 0.00 0 0.00 0 93 31,365 2.92
Manufacturer Burden (Future Cycles) Considering all Proposed Amendments (As Estimated in Table 4-47) 11.19 4,289 18.35 31,365 65.63 30,716 0 0 2.64

Total Manufacturer Burden (Future Cycles) Including Additional Data Elements 11.19 4,289 32.57 31,365 65. 63 30,716 74 31,365 4.97

Incremental Increase due to Additional Data Elements (Future Cycles) 0.00 0.00 14.21 0 0.00 0 74 31,365 2.33

Note: Values in Incrememtal Increase rows are calculated by subtracting the corres ponding baseline value from the post-amendment value.



### Table H-3 contains the annual burden to manufacturer s of the additional enhanced data elements over a 20-year period. The baseline burden estimates fo r completing Form U after all the proposed amendments are considered is taken from Table 4-54. EPA estimates that over a 20-year period, the total burden to manufacturers for completing Form U, incl uding the additional data elements, would be 26.21 million hours. The additional data el ements add 12.25 million additional hours to the industry burden over this period.

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H-9 Table H-3: Schedule of Annual Industry Burden to Manufacturers if All Proposed Amendments Are Implemented

Year Baseline Form U Burden (When all Amendments are Considered) (millions of hours) Burden for Enhanced Data Elements (millions of hours) Total Industry Burden (millions of hours)

2011 3.40 2.92 6.32
2012 0 0 0.00
2013 0 0 0.00
2014 0 0 0.00
2015 2.64 2.33 4.97
2016 0 0 0.00
2017 0 0 0.00

2018 0 0 0.00
2019 2.64 2.33 4.97
2020 0 0 0.00
2021 0 0 0.00
2022 0 0 0.00
2023 2.64 2.33 4.97
2024 0 0 0.00
2025 0 0 0.00
2026 0 0 0.00
2027 2.64 2.33 4.97
2028 0 0 0.00
2029 0 0 0.00
2030 0 0 0.00
Total 13.96 12.25 26.21 Annual Average 0.70 0.61 2.50



### Manufacturers and Processors Combined Because processors would not need to complete manufacturing information on Form U, Section II and other elements of Form U may not be applicab le. For the purpose of this estimation, EPA assumes that the burden on processors to complete an IUR fo rm tailored to processing and use information would be similar to that of a PMN form alone. Using the number of processors and number of repor ts as estimated in Section H.1 above, the total burden to processors to submit exposur e-related data elements is estimat ed to be 8.57 million hours in the first reporting cycle and 6.85 million hours in future reporting cycles, and is shown in Table H-4. This approach is also limited to the extent that the data elements request ed from processors in any modification to the IUR match the PMN form and the burden it imposes.

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H-10 Table H-4: Change in Industry Burden to Pro cessors as a Result of Additional Exposure-Related Data Elements

Burden to Complete Enhanced

Data Elements (hours per

report) Number of Reports

(with Enhanced

Data Elements) Industry Burden (millions of

hours)

Processor Burden (First Cycle) Considering all Proposed Amendments 0 0 0.00
Total Processor Burden (First Cycle) Including Additional Data Elements 93 92,100 8.57 Incremental Increase due to Additional Data Elements (First Cycle) 93 92,100 8.57 Processor Burden (Future Cycles) Considering all Proposed Amendments 0 0 0.00
Total Processor Burden (Future Cycles) Including Additional Data Elements 74 92,100 6.85
Incremental Increase due to Additional Data Elements (Future Cycles) 74 92,100 6.85 Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table H-5 contains the annual burden to processors of the additional enhanced data elements over a 20-year period. EPA estimates that over a 20-year peri od, the total burden to processors for completing Form U, including the additional data elements, w ould be 35.97 million hours. This burden consists of labor to complete only the additional data elements because processors currently are not required to submit Form U.

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H-11 Table H-5: Schedule of Annual Industry Burden to Processors

Year Baseline Form U Burden (When all Amendments are Considered) (millions of hours) Burden for Enhanced Data Elements (millions of hours) Total Industry Burden (millions of hours)

2011 0 8.57 8.57
2012 0 0 0
2013 0 0 0
2014 0 0 0
2015 0 6.85 6.85
2016 0 0 0
2017 0 0 0

2018 0 0 0
2019 0 6.85 6.85
2020 0 0 0
2021 0 0 0
2022 0 0 0
2023 0 6.85 6.85
2024 0 0 0
2025 0 0 0
2026 0 0 0
2027 0 6.85 6.85
2028 0 0 0
2029 0 0 0
2030 0 0 0
Total 0 35.97 35.97 Annual Average 0 1.80 1.80



### The total industry burden to both manufacturers a nd processors if EPA were to require them to provide the additional exposure data is calcula ted by summing the total additional burdens for manufacturers and processors. The result is an estimat ed 11.48 million hours in the first reporting cycle and 9.19 million hours all future reporting cycles. The derivation of these numbers is found in Table H-6 below.

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H-12 Table H-6: Change in Industry Burden to Manufacturers and Processors as a Result of Additional Exposure-Related Data Elements

Total Burden to Manufacturers (millions of hours) Total Burden to Processors (millions of hours) Total Industry Burden (millions of hours) Burden (First Cycle) Considering all Proposed Amendments 3.40 0.00 3.40
Total Burden (First Cycle) Including Additional Data Elements 6.32 8.57 14.88

Incremental Increase due to Additional Data Elements (First Cycle) 2.92 8.57 11.48
Burden (Future Cycles) Considering all Proposed Amendments 2.64 0.00 2.64
Total Burden (Future Cycles) Including Additional Data Elements 4.97 6.85 11.83

Incremental Increase due to Additional Data Elements (Future Cycles) 2.33 6.85 9.19

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table H-7 contains the annual burden to industry of the additional enhanced data elements over a 20- year period. The baseline burden estimates for comple ting Form U after all the proposed amendments are considered is taken from Table 4-52. EPA estimates that over a 20-year period, the total burden to industry for completing Form U, including the additi onal data elements, would be 62.18 million hours. The additional data elements add 48. 23 million additional hours to the i ndustry burden over this period.

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H-13 Table H-7: Schedule of Annual Industry Burden to Manufacturers and Processors if All Proposed Amendments Are Implemented

Year Baseline Form U Burden (When all Amendments are Considered) (millions of hours) Form U Burden with Enhanced Data Elements (millions of hours) Total Industry Burden (millions of hours)

2011 3.40 11.48 14.88 2012 0 0 0.00 2013 0 0 0.00 2014 0 0 0.00 2015 2.64 9.19 11.83 2016 0 0 0.00 2017 0 0 0.00 2018 0 0 0.00 2019 2.64 9.19 11.83 2020 0 0 0.00 2021 0 0 0.00 2022 0 0 0.00 2023 2.64 9.19 11.83 2024 0 0 0.00 2025 0 0 0.00 2026 0 0 0.00 2027 2.64 9.19 11.83 2028 0 0 0.00 2029 0 0 0.00 2030 0 0 0.00
Total 13.96 48.23 62.18 Annual Average 0.70 2.41 3.11



### H.3 Industry cost estimate EPA calculated the per-report cost to industry of the additional data elements by multiplying the managerial and technical burdens found in Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Si gnificant New Use Reporting Requirements for Chemical Substances , EPA ICR No: 574.12 (EPA, 2003) by the wa ge rates for technical and managerial staff described in Section 4.2.1. No clerical cost was calculated because EPA assumes that the proposed electronic submission requirement will eliminate a ll clerical burden for processing and submitting Form U. As shown in Table H-8, EPA estimates the additiona l per report cost to be $5,673 in the first reporting cycle and $4,539 in all future reporting cycles, as a re sult of the requirement to report the additional data.

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H-14 Table H-8: Per-Report Cost for Additional Data Elements, based on PMN Burden
Technical Managerial Total

Burden (hours) Wage Rate (2008$) Cost (2008$) Burden (hours) Wage Rate (2008$) Cost (2008$) Burden (hours) Cost (2008$)

PMN Burden/Cost per Report (First Cycle) 75 $58.84 $4,413 18 $70.03 $1,260 93 $5,673

PMN Burden/Cost per Report (Future Cycles) 60 $58.84 $3,530 14.4 $70.03 $1,008 74.4 $4,539



### Manufacturers

The cost to manufacturers of the additional data elements was derived as shown in Table H-9. EPA estimates the option will cost manufacturers an add itional $178 million during the first reporting cycle and an additional $142 million during all future reporting cycles.

Table H-9: Change in Industry Cost to Manufact urers as a Result of Additional Exposure-Related Data Elements

Cost for Submission, Compliance Determination, Rule Familiarization, and to Prepare Part I (2008$) Number of Sites Cost for Record Keeping and to Prepare Part II (2008$) Number of Reports

(with Part II) Cost to Prepare Part III (2008$) Number of Reports

(with Part III) Cost to Complete

New Data Elements (2008$) Number of Reports

(with New Data Elements) Industry Cost (millions of 2008$)

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a * b) +(c *d)+ (e * f)+(g*h) Manufacturer Cost (First Cycle) Considering all Proposed Amendments (As Estimated in Table 4-48) $2,252 4,289 $1,346 31,365 $5,117 30,716 0 0 $209.4

Total Manufacturer Cost (First Cycle) Including Additional Data Elements $2,252 4,289 $1,346 31,365 $5,117 30,716 $5,673 31,365 $386.99

Incremental Increase due to Additional Data Elements (First Cycle) $0.00 0 $0.00 0 $0.00 0 $5,673 31,365 $177.95
Manufacturer Cost (Future Cycles) Considering all Proposed Amendments (As Estimated in Table 4-48) $704 4,289 $1,109 31,365 $4,047 30,716 0 0 $162.12

Total Manufacturer Cost (Future Cycles) Including Additional Data Elements $704 4,289 $1,109 31,365 $4,047 30,716 $4,539 31,365 $3,304.48

Incremental Increase due to Additional Data Elements (Future Cycles) $0.00 0 $0.00 0 $0.00 0 $4,539 31,365 $142.36

Note: Values in Incremental Increase rows are calculated by subt racting the corresponding baseline va lue from the post-amendment value.



### Table H-10 presents the annual and annualized cost s estimates to manufacturers of competing Form U with the additional exposure-related data elements. The baseline cost estimates for completion of Form U come from Table 4-55. Over a 20-year period, EPA estimates that the annualized cost to manufacturers will be $85 million at a three percent discount rate, and $91 million at a seven percent discount rate.

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H-15 Table H-10: Annual Increase in Industry Cost to Manufacturers if All Proposed Amendments Are Implemented (2008$)

Year Baseline Form U Cost (When all Amendments are Considered) (millions 2008$) Form U Cost for Enhanced Data Elements (millions 2008$) Total Cost To Industry (millions 2008$)

2011 $209 $178 $387
2012 $0 $0 $0
2013 $0 $0 $0
2014 $0 $0 $0
2015 $162 $142 $304
2016 $0 $0 $0
2017 $0 $0 $0
2018 $0 $0 $0
2019 $162 $142 $304
2020 $0 $0 $0
2021 $0 $0 $0
2022 $0 $0 $0
2023 $162 $142 $304
2024 $0 $0 $0
2025 $0 $0 $0
2026 $0 $0 $0
2027 $162 $142 $304
2028 $0 $0 $0
2029 $0 $0 $0
2030 $0 $0 $0 Total $858 $747 $1,605 Annual Average $42.88 $37.37 $80.25 Annualized at 3% $45.41 $39.51 $84.91 Annualized at 7% $48.87 $42.42 $91.29



### Manufacturers and Processors Combined To calculate the cost to processors, EPA multiplied the per report cost ($5,673 in the first reporting cycle and $4,539 during all future reporting cycles) by the total number of reports EPA expects to be submitted by processors, 141,220. As shown in Table H-11, EPA estimates the cost to processors to be $523 million in the first reporting cycle and $41 8 million in all future reporting cycles.

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H-16 Table H-11: Change in Industry Cost to Processors as a Result of Additional Exposure-Related Data Elements

Cost to Prepare New Data Elements

(2008$) Number of Reports (with

New Data Elements) Industry Cost (millions 2008$)

Processor Cost (First Cycle) Considering all Proposed Amendments 0 0 $0
Total Processor Cost (First Cycl e) Including Additional Data Elements $5,673 92,100 $523
Incremental Increase due to Additional Data Elements (First Cycle) $5,673 92,100 $523 Processor Cost (Future Cycles) Considering all Proposed Amendments 0 0 $0
Total Processor Cost (Future Cycl es) Including Additional Data Elements $4,539 92,100 $418
Incremental Increase due to Additional Data Elements (Future Cycles) $4,539 92,100 $418

Note: Values in Incremental Increase rows are calculated by s ubtracting the corresponding baselin e value from the post-amendment value.



### Table H-12 presents the annual and annualized cost s estimates to processors of competing Form U with the additional exposure-relate d data elements. Over a 20-year period, EPA estimates that the annualized cost to processors will be $116 million at a three percent discount rate, and $125 million at a seven percent discount rate.

Table H-12: Annual Increase in Industry Cost to Processors if All Proposed Amendments Are Implemented (2008$)

Year Baseline Form U Cost (When all Amendments are Considered) (millions 2008$) Form U Cost for Enhanced Data Elements (millions 2008$) Total Cost To Industry (millions 2008$)

2011 $0 $523 $523
2012 $0 $0 $0
2013 $0 $0 $0
2014 $0 $0 $0
2015 $0 $418 $418
2016 $0 $0 $0
2017 $0 $0 $0
2018 $0 $0 $0
2019 $0 $418 $418
2020 $0 $0 $0
2021 $0 $0 $0
2022 $0 $0 $0
2023 $0 $418 $418
2024 $0 $0 $0
2025 $0 $0 $0
2026 $0 $0 $0
2027 $0 $418 $418

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

H-17 Year Baseline Form U Cost (When all Amendments are Considered) (millions 2008$) Form U Cost for Enhanced Data Elements (millions 2008$) Total Cost To Industry (millions 2008$)

2028 $0 $0 $0
2029 $0 $0 $0
2030 $0 $0 $0 Total $0 $2,195 $2,195 Annual Average $0 $110 $110 Annualized at 3% $0 $116 $116 Annualized at 7% $0 $125 $125



### Total estimated industry cost is presented in Tabl e H-13 and is calculated by summing the costs to both manufactures and processors. EPA estimates the co st to the industry of the additional exposure elements, if both manufacturers and processor are requir ed to provide the data, will be $700 million in the first reporting cycle and $560 million in all future reporting cycles.

Table H-13: Change in Industry Cost to Manufacturers and Processors as a Result of Additional Exposure-Related Data Elements
Total Cost to Manufacturers (millions 2008$) Total Cost to Processors (millions 2008$) Total Industry Cost (millions 2008$) Cost (First Cycle) Considering all Proposed Amendments $209 $0 $209

Total Cost (First Cycle) Incl uding Additional Data Elements $387 $523 $910 Incremental Increase due to Additional Data Elements (First Cycle) $178 $523 $700
Cost (Future Cycles) Considering all Proposed Amendments $162 $0 $162

Total Cost (Future Cycles) Including Additional Data Elements $304 $418 $722 Incremental Increase due to Additional Data Elements (Future Cycles) $142 $418 $560

Note: Values in Incremental Increase rows are calculated by subt racting the corresponding baseline va lue from the post-amendment value.



### Table H-14 presents the annual and annualized costs estimates to industry of competing Form U with the additional exposure-related data elements. The baseline cost estimates for completion of Form U come from Table 4-53. Over a 20-year period, EPA es timates that the annualized cost to the industry will be $201 million at a three percent discount rate, a nd $216 million at a seven percent discount rate.

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

H-18 Table H-14: Annualized Increase in Industry Cost to Manufacturers and Processors if All Amendments Are Implemented (2008$)

Year Baseline Form U Cost (When all Amendments are considered) (millions 2008$) Form U Burden with Enhanced data Elements (millions 2008$) Total Cost To Industry (millions 2008$)

2011 $209 $701 $910 2012 $0 $0 $0
2013 $0 $0 $0
2014 $0 $0 $0
2015 $162 $560 $722
2016 $0 $0 $0
2017 $0 $0 $0 2018 $0 $0 $0
2019 $162 $560 $722
2020 $0 $0 $0
2021 $0 $0 $0
2022 $0 $0 $0
2023 $162 $560 $722 2024 $0 $0 $0
2025 $0 $0 $0
2026 $0 $0 $0
2027 $162 $560 $722
2028 $0 $0 $0
2029 $0 $0 $0 2030 $0 $0 $0 Total $858 $2,942 $3,800 Annual Average $42.88 $147.12 $190.00 Annualized at 3% $45.41 $155.54 $200.94 Annualized at 7% $48.87 $167.01 $215.88



### H.4 Agency burden estimate
Agency burden for both contractor and EPA staff re lated to document receipt, tracking and data entry quality control of data entry would increase with th e promulgation of additiona l exposure-related data elements. To calculate the additiona l Agency burden associated with th e additional data elements, EPA used the per-data element burden to the EPA after a ll the proposed amendments are considered, 0.00008 hours, as derived in Section 5.5). This burden was multiplied by the number of new data elements, 57 (as listed in Table H-1) to calculate the total per-report burden of pr ocessing the new data elements for manufacturers, 0.0048 hours. EPA assumes that ther e will be no change in the fixed Agency costs associated with this modification to th e IUR rule, as described in Table 5-3. Manufacturers All manufactures are expected to submit the add itional data, increasing the Agency burden by 150 hours for all report years, as estimated in Table H- 15 below. EPA does not expect the future reporting cycle burden to differ from first reporting cycle burden.

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H-19 Table H-15: Change in Agency Burden to Process Manufacturer Data as a Result of Additional Exposure-Related Data Elements

Burden to Process Part I (hours) Number of Sites Burden to Process Part II (hours) Number of Reports

(with Part II) Burden to Process

Part III (hours) Number of Reports

(with Part III) PerReport Burden to Process

New Data Elements (hours) Number of Reports

(with new data elements) Agency Burden (hours)

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a *b)+ (c *d)+ (e * f)+(g*h) Agency Burden Considering all Proposed Amendments (As Estimated in Table 5-40) 0.0019 4,289 0.0056 31,365 0.0063 30,716 0 0 2,456

Total Agency Burden Including Processing Additional Data Elements for Manufacturers 0.0019 4,289 0.0056 31,365 0. 0063 30,716 0.0048 31,365 2,607

Incremental Increase due to Additional Data Elements 0 0 0 0 0 0 0.0048 31,365 150

Note: Values in Incremental Increase rows are calculated by subt racting the corresponding baseline va lue from the post-amendment value.



### Table H-16 presents the estimated annual burden to the Agency of processing Form U with the additional exposure-related data elements. Over a 20- year period, EPA estimates that the total Agency burden to process manufacturer data will be 13,034 hours.

Table H-16: Annual Increase in Agency Burden to Process Manufacturer Data if All Proposed Amendments Are Implemented

Year Baseline Burden (When all Amendments are Considered) (hours) Form U Burden with Enhanced Data Elements (hours) Total Agency Burden (hours)

2011 2,456 150 2,607
2012 0 0 0
2013 0 0 0
2014 0 0 0
2015 2,456 150 2,607
2016 0 0 0
2017 0 0 0
2018 0 0 0
2019 2,456 150 2,607
2020 0 0 0
2021 0 0 0
2022 0 0 0
2023 2,456 150 2,607
2024 0 0 0
2025 0 0 0
2026 0 0 0
2027 2,456 150 2,607
2028 0 0 0

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H-20 Year Baseline Burden (When all Amendments are Considered) (hours) Form U Burden with Enhanced Data Elements (hours) Total Agency Burden (hours)

2029 0 0 0
2030 0 0 0 Total 12,282 752 13,034 Annual Average 614.1 37.62 651.72



### Manufacturers and Processors Combined

Table H-17 shows the estimated burden to the Agency of processing the additional data submitted by processors. As described above, EPA expects to receive a total of 92,100 processor reports. The Agency burden, per-report, to process the additional data el ements is 0.0048 hours, and is the same for both processors and manufactures. Therefore, as shown in Table H-10, the Agency burden to process the processor data is approximately 442 hours for all reporting cycles.

Table H-17: Change in Agency Burden to Process Processor Data as a Result of Additional Exposure-Related Data Elements

Per-Report Burden to Process New Data Elements (hours) Number of Reports (with

New Data Elements) Agency Burden (hours)

Agency Burden to Process Processor Data Considering all Proposed Amendments 0.0000 0 0
Total Agency Burden Including Processing Additional Data Elements for Processors 0.0048 92,100 442

Incremental Increase due to Additional Data Elements 0.0048 92,100 442 Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table H-18 presents the estimated annual burden to the Agency of processing Form U with the additional exposure-related data elements. Over a 20- year period, EPA estimates that the total Agency burden to process processor da ta will be 2,209 hours.

Table H-18: Annual Increase in Agency Burden to Process Processor Data if All Proposed Amendments Are Implemented

Year Baseline Burden (When all Amendments are Considered) (hours) Form U Burden with Enhanced Data Elements (hours) Total Agency Burden (hours)
2011 0 442 442
2012 0 0 0
2013 0 0 0
2014 0 0 0
2015 0 442 442
2016 0 0 0
2017 0 0 0
2018 0 0 0
2019 0 442 442

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H-21 Year Baseline Burden (When all Amendments are Considered) (hours) Form U Burden with Enhanced Data Elements (hours) Total Agency Burden (hours)
2020 0 0 0
2021 0 0 0
2022 0 0 0
2023 0 442 442
2024 0 0 0
2025 0 0 0
2026 0 0 0
2027 0 442 442
2028 0 0 0
2029 0 0 0
2030 0 0 0 Total 0 2,209 2,209 Annual Average 0 110.5 110.5



### Table H-19 presents the burden to EPA of processi ng the additional data elements from both the processors and the manufacturers. This option is exp ected to increase the Agency burden by 593 hours for all reporting cycles.

Table H-19: Change in Agency Burden to Process Manufacturer and Processor Data as a Result of Additional Exposure-Related Data Elements

Total Burden of Processing Manufacturer

data (hours) Total Burden of Processing Processor data (hours) Total Agency Burden (hours)

Burden (First Cycle) Considering all Proposed Amendments 2,456 0 2,456
Total Burden (First Cycle) Including Additional Data Elements 2,607 442 3,049 Incremental Increase due to Additional Data Elements (First Cycle) 151 442 593 Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the postamendment value.



### Table H-20 presents the estimated annual burden to the Agency of processing Form U with the additional exposure-related data el ements from both manufacturers and processors. Over a 20-year period, EPA estimates that the total Agency burden to pr ocess manufacturer and processor data will be 2,962 hours.

Table H-20: Annual Increase in Agency Burden to Process Data if All Proposed Amendments Are Implemented

Year Baseline Burden (When all Amendments are Considered) (hours) Form U Burden with Enhanced data Elements (hours) Total Agency Burden (hours)

2011 2,456 3,049 593
2012 0 0 0
2013 0 0 0

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H-22 Year Baseline Burden (When all Amendments are Considered) (hours) Form U Burden with Enhanced data Elements (hours) Total Agency Burden (hours)

2014 0 0 0
2015 2,456 3,049 593
2016 0 0 0
2017 0 0 0
2018 0 0 0
2019 2,456 3,049 593
2020 0 0 0
2021 0 0 0
2022 0 0 0
2023 2,456 3,049 593
2024 0 0 0
2025 0 0 0
2026 0 0 0
2027 2,456 3,049 593
2028 0 0 0
2029 0 0 0
2030 0 0 0 Total 12,282 15,244 2,962 Annual Average 614 762 148


### H.5 Agency cost estimate The additional exposure data elements are expected to increase the cost to both EPA and contractor staff. To calculate the additional Agency cost associat ed with the additional data elements, EPA used the per-data element cost to the EPA after all the propo sed amendments are considered, $0.009, as derived in Section 5.5). This unit cost was multiplied by the nu mber of new data elements, 57 (as listed in Table H-1) to calculate the total per-report cost of processi ng the new data elements for manufacturers, $0.51. Manufacturers The total cost to EPA of processing these new data elements for manufacturers is approximately $15,800, as shown in Table H-21. This table reflects both the variable cost to the Agency, which is dependent on the number of reports, and a fixed cost to the Agency of $249,200 (see Sec tion 5.3) which will not change as a result of including th e additional data option in the IUR.

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H-23 Table H-21: Change in Agency Cost of Processing Manufacturer Data as a Result of Additional Exposure-Related Data Elements

Cost to Process Part I (2008$) Number of Sites Cost to Process Part II (2008$) Number of Reports

(with Part II) Cost to Process

Part III (2008$) Number of Reports

(with Part III) Cost to Process

New Data Elements (2008$) Number of Reports

(with new data elements) Agency Cost (2008$)

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a * b)+ (c * d)+(e * f)+(g*h) Agency Cost Considering all Proposed Amendments (As Estimated in Table 5.41) $0.20 4,289 $0.58 31,365 $0.66 30,716 $0.00 0 $288,450

Total Agency Cost Including Processing Additional Data Elements for Manufacturers $0.20 4,289 $0.58 31,365 $0.66 30,716 $0.51 31,365 $304,294

Incremental Increase due to Additional Data Elements $0.00 0 $0.00 0 $0.00 0 $0.51 31,365 $15,843

Note: Values in Incremental Increase rows are calculated by subt racting the corresponding baseline va lue from the post-amendment value.



### Table H-22 presents the annual and annualized costs estimates to the Agency of processing manufacturer Form U with the additional exposure-re lated data elements. Over a 20-year period, EPA estimates that the annualized cost to the Agency will be $79,500 at a three percent discount rate, and $84,000 at a seven percent discount rate.

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H-24 Table H-22: Annual Increase in Agency Cost to Process Manufacturer Data if All Proposed Amendments Are Implemented (2008$)

Year Baseline Cost (When all Amendments are Considered) ($2008) Cost ($2008) Total Agency Cost ($2008) 2011 $288,450 $15,843 $304,294
2012 $0 $0 $0
2013 $0 $0 $0
2014 $0 $0 $0
2015 $288,450 $15,843 $304,294
2016 $0 $0 $0
2017 $0 $0 $0
2018 $0 $0 $0
2019 $288,450 $15,843 $304,294
2020 $0 $0 $0
2021 $0 $0 $0
2022 $0 $0 $0
2023 $288,450 $15,843 $304,294
2024 $0 $0 $0
2025 $0 $0 $0
2026 $0 $0 $0
2027 $288,450 $15,843 $304,294
2028 $0 $0 $0
2029 $0 $0 $0
2030 $0 $0 $0 Total $1,442,251 $79,217 $1,521,468 Annual Average $72,112.55 $3,960.84 $76,073.39 Annualized at 3% $75,341 $4,138 $79,479 Annualized at 7% $112,467 $4,371 $83,959



### Manufacturers and Processors Combined Table H-23 shows the Agency cost of processing the processor data. To estimate this cost, EPA multiplied the number of processors derived in Section H.1 (141,220) by the per report cost of processing the additional data, $0.51. EPA estimates that the to tal Agency cost to process the processor data is $46,500.

Table H-23: Change in Agency Cost to Process Processor Data as a Result of Additional Exposure-Related Data Elements
Per-Report Cost to Process New Data Elements

(2008$) Number of Reports (with New Data Elements) Agency Cost (2008$)

Agency Cost to Process Processor Data Considering all Proposed Amendments $0.00 0 $0
Total Agency Cost Including Processing Additional Data Elements for Processors $0.51 92,100 $46,522

Incremental Increase due to Additional Data Elements $0.51 92,100 $46,522

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H-25 Table H-24 presents the annual and annualized costs estimates to the Agency of processing a processor Form U with the additional exposure-rela ted data elements. Over a 20-year period, EPA estimates that annualized cost to the Agency will be $12,200 at a three percent discount rate, and $12,800 at a seven percent discount rate.

Table H-24: Annual Increase in Agency Cost to Process Processor Data if All Proposed Amendments Are Implemented (2008$)

Year Baseline Cost (When all Amendments are Considered) ($2008) Cost ($2008) Total Agency Cost ($2008)
2011 $0 $46,522 $46,522
2012 $0 $0 $0
2013 $0 $0 $0
2014 $0 $0 $0
2015 $0 $46,522 $46,522
2016 $0 $0 $0
2017 $0 $0 $0
2018 $0 $0 $0
2019 $0 $46,522 $46,522
2020 $0 $0 $0
2021 $0 $0 $0
2022 $0 $0 $0
2023 $0 $46,522 $46,522
2024 $0 $0 $0
2025 $0 $0 $0
2026 $0 $0 $0
2027 $0 $46,522 $46,522
2028 $0 $0 $0
2029 $0 $0 $0
2030 $0 $0 $0 Total $0 $232,612 $232,612 Annual Average $0 $11,630.59 $11,630.59 Annualized at 3% $0 $12,151 $12,151 Annualized at 7% $0 $12,836 $12,836



### Table H-25 shows the cost to EPA of processing the additional data elements from both the processors and the manufactures. This option is expect ed to increase the Agency cost by $62,400 for all reporting cycles.

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H-26 Table H-25: Change in Agency Cost of Processing Manufacture and Processor Data as a Result of Additional Exposure-Related Data Elements

Cost to Process New Data Elements (2008$) Number of Reports (with New Data Elements) Agency Cost (2008$)

Cost (First Cycle) Considering all Proposed Amendments $288,450 $0 $288,450
Total Cost (First Cycle) Including Additional Data Elements $304,294 $46,522 $350,816

Incremental Increase due to Additional Data Elements (First Cycle) $15,843 $46,522 $62,366

Note: Values in Incremental Increase rows are calculated by s ubtracting the corresponding baselin e value from the post-amendment value.



### Table H-26 presents the annual and annualized costs estimates to the Agency of processing

manufacturer and processor Form Us with the addition al exposure-related data elements. Over a 20-year period, EPA estimates that annualized cost to the Agen cy will be $91,600 at a three percent discount rate, and $96,800 at a seven percent discount rate.

Table H-26: Annual Increase in Agency Cost to Process Manufacturer and Processor Data if All Proposed Amendments Are Implemented (2008$)

Year Baseline Cost (When all Amendments are Considered) ($2008) Form U Cost with Enhanced data Elements ($2008) Total Agency Cost ($2008)
2011 $288,450 $62,366 $350,816
2012 $0 $0 $0
2013 $0 $0 $0
2014 $0 $0 $0
2015 $288,450 $62,366 $350,816
2016 $0 $0 $0
2017 $0 $0 $0
2018 $0 $0 $0
2019 $288,450 $62,366 $350,816
2020 $0 $0 $0
2021 $0 $0 $0
2022 $0 $0 $0
2023 $288,450 $62,366 $350,816
2024 $0 $0 $0
2025 $0 $0 $0
2026 $0 $0 $0
2027 $288,450 $62,366 $350,816
2028 $0 $0 $0
2029 $0 $0 $0
2030 $0 $0 $0 Total $1,442,250 $311,829 $1,754,079

Annual Average $72,113 $15,591 $87,704 Annualized at 3% $75,341 $16,289 $91,630 Annualized at 7% $112,467 $17,208 $96,795

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H-27 

### H.6 Small Entity Analysis
As described in Chapter 8 of this economic anal ysis, EPA assessed the impact that the proposed amendments to the IUR rule may have on small entities by examining the relationship between the compliance costs and company sales for small companies. EPA performed a similar analysis to determine the impact of the collection of additional e xposure-related data elem ents on small entities. Manufacturers For manufacturers, EPA estimated (in Chapter 8) 3. 89 manufacturing sites per global parent company; 41.3 percent of global parent companies (466 companies) are considered small under the SBA employment-based definition 23 

### , and 24.8 percent (280 companies) are considered small under the TSCA sales-based definition 24 

### . EPA also estimated an average of approximately 1.76 sites per small company under the employment-based definition of small busin ess and approximately 1.92 sites per small company under the sales-based definition. Average annual sales revenue of global parent companies considered small under either definition were estimated using da ta from Dun & Bradstreet, as also described in Chapter 8.

Table H-13 above shows the incremental cost to manufacturers as a result of adding the additional exposure related data elements to Form U. Table 4-48 (in the main text of the report) shows the incremental cost to manufacturers related to the other proposed amendments. Because these costs would be incurred once every four years under a proposed four-year reporting cycle, these costs were summed and annualized over four years at both a three percent and seven percent discount rate 25 

### . As shown in Table H-27 below, these costs were divided by the tota l number of sites expected to submit data, for the annualized costs per site. This was multiplied by the numb er of sites per small parent company to arrive at the annualized costs per small parent company. Th is value was divided by the annual sales per small parent company to derive the cost-to-sales ratio. As shown in Table H-27, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 mill ion. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $31,705 at a seven percent discount rate, and even lower under a three percent discount rate. The cost-to- sales ratio for an average small company under the employment-based SBA definition would be 0.008 per cent or less. Under the more conservative TSCA sales-based definition, small parent company sales are on average more than $11.8 million, with annualized parent company costs associated with the proposed amendments of $34,587 or lower. The cost-to-sales ratio for an average small company under the sales-based definition would be 0.29 percent or less. Using the highest annual cost shown in Table H- 27 of $34,587 a small company would have to have annual sales of less than $3.45 million in order to have a cost-to-sales ratio larger than one percent.

23 Threshold of 1,000 employees.
24 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of an y parent company, are below $4 million.

25 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.

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H-28 Table H-27. Derivation of Cost-to- Sales Ratios for Small Manufacturers for Collection of Additional Data Elements Employment-based Definition Sales-based Definition 3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate Incremental Costs of Enhanced Data Elements $177,947,467

Incremental Costs of Proposed Other Amendments $102,073,744

Total Annualized Costs $73,139,106 $77,261,808 $73,139,106 $77,261,808

Total Number of Sites 4,289

Annualized Costs per Site $17,053 $18,014 $17,053 $18,014

Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $30,013 $31,705 $32,741 $34,587

Annual Sales per Small Parent Company $412,713.310 $11,821,104

Cost-to-Sales Ratio 0.007% 0.008% 0.277% 0.293%

Number of Companies Potentially Affected 466 280



### Processors EPA is limited in its efforts to estimate the impa ct of the collection of additional exposure-related data elements on processors by the availability of data. As described above, EPA used TRI submission data to estimate the number of processors that may be affected by the requirement. However, data provided under the TRI program does not include in formation about a submitter’s parent company or annual revenues. For this screening-level analysis , EPA assumes that the chemical processor industry shares many characteristics with the chemical manufactu ring industry. To the extent that this is not the case, this analysis may over- or underestimate the im pact of additional data elements on processors. Specifically, EPA assumes 3.89 manufacturing sites per global parent company. EPA also assumes that 41.3 percent of global parent companies are cons idered small under an employment-based definition, and 24.8 percent are considered small under a sales-b ased definition. EPA further assumes 1.76 sites per small parent company under the employment-based de finition, and 1.92 sites per small parent company under the sales-based definition, consistent with manuf acturer information. Given the large number of companies identified as processors according to TR I submissions, EPA was unable to examine Dun & Bradstreet data to estimate annual parent company revenue for this analysis. EPA used manufacturer revenue as a proxy, so this analysis provi des only a preliminary estimate of impacts. EPA divided the number of expected processor reports (92,100) by the average number of chemicals for which a processor submitted TRI data (2.45) to obt ain the estimated number of processors (37,592) who would report under an amended IU R rule. EPA divided this number by 3.89 (the number of sites per global parent company) for an estimated 9,664 global parent companies. This number was then multiplied by 41.3 percent and 24.8 percent to estimate the numb er of small global parent companies (the number of companies potentially affected), under the employme nt-based and sales-based definitions, respectively.

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H-29 To calculate cost-to-sales ratios, EPA followed th e same methodology for processors as described above for manufacturers. Results are presented in Table H-28 below.

Table H-28: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of Additional Data Elements Employment-based Definition Sales-based Definition 3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate Incremental Costs of Enhanced Data Elements $522,523,888

Incremental Costs of Proposed Other Amendments $0.00

Total Annualized Costs $136,478,697 $144,171,723 $136,478,697 $144,171,723

Total Number of Sites 37,592

Annualized Costs per Site $3,631 $3,835 $3,631 $3,835

Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $6,390 $6,750 $6,971 $7,364

Annual Sales per Small Parent Company $412,7613,310 $11,821,104

Cost-to-Sales Ratio 0.002% 0.002% 0.059% 0.062%

Number of Companies Potentially Affected 3,990 2,397



### As shown in Table H-28, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 mill ion. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $6,750 at a seven percent discount rate, and even lower under a three percent discount rate. The cost-to- sales ratio for an average small company under the employment-based definition would be 0.002 percent or less. Under the more conservative sales-based definition, small parent company sales on average ar e more than $11.8 million, with annualized costs associated with the proposed amendments of $7,364 or lower. The cost-to-sales ratio for an average small company under the sales-based definition would be 0.062 percent or less. As described in Chapter 8, the Regulatory Flexib ility Act does not define the terms “significant” or “substantial” analytically with regard to extent of economic impact and number of small entities affected. However, EPA typically defines a threshold as comp liance costs of one percent of sales to establish whether the level of economic impacts faced by the small entities can be presumed as not significant (EPA, 2006b). Using the highest annual cost shown in Table H-28, $7,346, a small company would have to have annual sales of less than $734,600 in order to have a cost-to-sales ratio larger than one percent.

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I-1 

## Appendix I. - Estimated Burden and Cost of a Section 8(a) Rule for Exposure-Related Data Elements

EPA is considering the annual collection of exposu re-related data elements for approximately 100 chemicals under a TSCA section 8(a) rulemaking. TSCA section 8(a) gives EPA the authority to require, by rulemaking, manufacturers (including importers) a nd processors of chemical substances to maintain records and/or report such data as EPA may reasonabl y require to carry out the TSCA mandates. Section 8(a) regulations can be tailored to meet unique info rmation needs (e.g., via chemical-specific rules) or information can be obtained via use of “model” or st andardized reporting rules. The Agency is requesting comment on a “model” reporting rule that would enable the Agency to undertake periodic data collection of information similar to that collected under the TSCA section 5 New Chemicals Program. The information would enhance the Agency’s capabilities to conduct screening-level risk assessments of selected chemical substances. Each data collection woul d be specific to a unique set of IUR chemicals for which the information is needed; EPA would request th e information through one or more notices or letter writing actions per year, for an approximate total of 100 chemical substances per year.

The additional data elements are the same as tho se proposed under the option outlined in Appendix H. A brief description of the exposure-rela ted data elements that may be included in such a section 8(a) rule are provided in Table H-1.



### I.1 Estimated Number of Affected Entities For the purpose of this analysis, EPA assumes that a section 8(a) rule would apply to both manufacturers and processors of the subject chemicals. Manufacturers Because the applicability of a section 8(a) rule would be similar to that of the IUR rule (i.e., it would apply to manufacturers or importers of a subject chem ical when produced in volu mes greater than 25,000 lb.), EPA estimated the number of manufacturers wh o would report and the number of reports it expects to be submitted using data from Section 4.2.5 of this report. On average, 0.66 sites submit data under the IUR rule per regulated chemical, and an average of 4.21 full reports are submitted for each chemical. Therefore, EPA estimates that a total of 66 sites w ill submit 421 reports for the estimated 100 chemicals. To the extent that the specific chem icals subject to a section 8(a) rule do not have an average number of manufacturers, this may be an over- or underestimate.

Processors The number of processors that may be affected by a section 8(a) rule was estimated using data from EPA’s Toxic Release Inventory (TRI) reporting program. Under the TRI program, EPA collects information annually on toxic chemical releases and waste management activities from manufacturers, processors, and users of a set of 581 toxic chemical s and 30 toxic chemical categories. The chemicals regulated under the TRI program are a smaller set th an those regulated under the IUR rule, but the TRI data collection activity currently is the most co mprehensive collection of information that EPA administers for chemical processors. Therefore, EPA assumes that information on processors who report under TRI is a suitable proxy for processors who may report under a section 8(a) rule.

EPA used TRI Form R submission data from the 2007 TR I Public Data Release in this analysis. To be consistent with the Economic Analysis for th e Proposed IUR Modifications Rule (from which other data for this analysis is derived), EPA used TRI data for the years 2002 through 2005 (the time period of the most recent IUR reporting cycle), filtered to in clude only IUR chemicals (i.e., the chemicals listed in

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I-2 the public 2006 IUR database) 26 

### . Processors submitted TRI data on an average of 220 of the IUR chemicals during each of the four years of interest. For this analysis, EPA counted as a “processor” each TRI submitter who indicated that it processes a toxic chemical as a reactant, as a formulation component, as an article component, for repackaging, or as an impu rity; or, that it otherwise uses the toxic chemical as a chemical processing aid. 27 

### Because EPA assumes that any company that both manufactures and processes a chemical will be considered a manufact urer for the purposes of a section 8(a) rule, TRI submitters who indicated that they also manufactured or otherwise used a chemical were filtered out of the dataset. The TRI data revealed that an average of 137 processors reported inform ation per TRI chemical. However, the average value is greatly skewed by cer tain high-volume chemicals that are processed by a large number of processors. 28 

### Therefore, EPA chose to use the median number of 15 processors per chemical, assuming it to be more representative of the universe of TSCA chemical processors. Using the median of 15 processors per chemical, EPA expects that a total of 1,500 reports will be submitted for an estimated 100 chemicals. According to the TR I data, each processor processes approximately 2.45 chemicals; therefore, EPA expects a se ction 8(a) rule to affect 612 sites. This approach is limited to the extent that the uni verse of TRI processors is different from that of a section 8(a) rule. Because the set of chemicals covered under the rules is different, the median number of processors per chemical may be an over- or underes timate. Additionally, the TRI rule is applicable to facilities included within a specific set of NAICS codes; a section 8(a) rule may not limit its applicability to a defined set of NAICS codes, which could cause the number of processors estimated here to be an underestimate. Furthermore, “processor” may be defined differently by the two rules; any specific criteria that EPA may use to define a “processor” for the purpose of a section 8(a) rule may cause the median number of processors per chemical estimated here to be an overestimate. Finally, the data used in this analysis was for submissions of TRI Form R only. This was done because Form A, the other, simpler, TRI reporting form, does not request information th at would identify the submitter as a processor or manufacturer. Form R is used for high-volume chemicals (i.e., those manufactured, processed, or otherwise used in amounts greater than one million pounds) or for chemicals meeting other specific criteria; as a result, processors of small volumes may not be included, causing the median number to be an underestimate.



### I.2 Industry Burden Estimate
The section 8(a) rule would require submitters (bot h manufacturers and processors) to provide data similar to the exposure-related da ta elements that are collected under EPA’s New Chemicals Program through a premanufacture notice (PMN) and under the IUR rule. Therefore, the burden associated with a section 8(a) rule is calculated by estim ating the burden to complete a PMN. The burden to complete a paper PMN form w as estimated in the supporting statement for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances , EPA ICR No: 574.12 (EPA, 2003). According to this source, the total burden to complete a PMN form is 107 hours. EPA assumes that a section 8(a) rule would require electronic submissi on, so EPA reduced the estimated burden to 93 hours. This reduction is consiste nt with the assumption in section 4.4.27; that all clerical burden will be eliminated because paper filing will not be permitted with electronic submission.

26 The TRI program may collect da ta on certain chemicals for which IUR reporting is not required. A list of CASRNs for the nonconfidential IUR chemicals was found at “Non-confidential 2006 IUR Records by Chemical, including Manufacturing, Processing and Use Information” http://cfpub.epa.gov/iu rsearch/index.cfm?s=chem Accessed August 30, 2009.
27 TRI submitters indicate their activities and uses of the toxic chemical at the facility in Part II Section 3 of Form R.

28 For example, an average of 3,240 processors reported under TRI per year for lead alone.

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I-3 Using the number of manufacturer reports as estimat ed in Section I-1 of this appendix, the total burden to manufacturers to submit additional exposur e-related data elements as part of their IUR reporting is estimated to be 39,200 hours. Using the number of processor reports as estimated in Section I-1 above, the total burden to processors to submit e xposure-related data elemen ts is estimated to be 139,500 hours (See Table I-1 below). Because each indivi dual collection under the rule would be for a different set of chemicals, EPA assumes that different sites will be submitting reports every year, so the burden would be the same in future individual collections. This approach is limited to the extent that the data elements requested in a section 8(a) rule match the IUR Form U and the PMN form, and the burden they incur.

Table I-1: Annual Industry Burden as a Result of a TSCA Section 8(a) Data Collection

Entity Subject to the Data Collection Burden to Complete Exposure-Related Data Elements (hours per report) Number of Reports Total Burden (hours)

Manufacturers 93 421 39,166
Processors 93 1,500 139,500
Total for Manufacturers and Processors 93 1,921 178,666



### Annual Industry Burden Estimates

EPA estimated the total annual burden and cost to industry of a section 8(a) rule over a 20-year period. A 20-year period was used so that the burden and cost to the industry are directly comparable to the annual burden presented in Table 4-52 and the annua l cost estimates for the proposed amendments to the IUR rule, found in Table 4-53. Table I-2 contai ns the annual burden to industry over 20 years as a result of a section 8(a) rule and of completing Form U. Over a 20-year period, EPA estimates that the total burden to industry of both the IUR data collec tion and a section 8(a) collection will be 17.41 million hours. The section 8(a) rule adds 3.57 million hours to the industry burden during this time period.

Table I-2: Schedule of Annual Industry Burden

Year Baseline Industry Burden (When all Amendments are Considered) (millions of hours) Manufacturer Section 8(a) Burden (millions of hours) Processor Section

8(a) Burden (millions of hours) Manufacturer and Processor

Section 8(a)

Burden (millions of hours) Total Burden To Industry (Manufacturer and Processor + Baseline) (millions of hours)
2011 3.40 0.039 0.140 0.179 3.580
2012 0 0.039 0.140 0.179 0.179
2013 0 0.039 0.140 0.179 0.179
2014 0 0.039 0.140 0.179 0.179
2015 2.61 0.039 0.140 0.179 2.789
2016 0 0.039 0.140 0.179 0.179
2017 0 0.039 0.140 0.179 0.179
2018 0 0.039 0.140 0.179 0.179
2019 2.61 0.039 0.140 0.179 2.789
2020 0 0.039 0.140 0.179 0.179
2021 0 0.039 0.140 0.179 0.179
2022 0 0.039 0.140 0.179 0.179

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

I-4 Year Baseline Industry Burden (When all Amendments are Considered) (millions of hours) Manufacturer Section 8(a) Burden (millions of hours) Processor Section

8(a) Burden (millions of hours) Manufacturer and Processor

Section 8(a)

Burden (millions of hours) Total Burden To Industry (Manufacturer and Processor + Baseline) (millions of hours) 2023 2.61 0.039 0.140 0.179 2.789
2024 0 0.039 0.140 0.179 0.179
2025 0 0.039 0.140 0.179 0.179
2026 0 0.039 0.140 0.179 0.179
2027 2.61 0.039 0.140 0.179 2.789
2028 0 0.039 0.140 0.179 0.179
2029 0 0.039 0.140 0.179 0.179
2030 0 0.039 0.140 0.179 0.179
Total 13.84 0.78 2.79 3.57 17.41 Annual Average 0.69 0.04 0.14 0.18 0.87



### I.3 Industry Cost Estimate
EPA calculated the per-report cost to industry of the additional data elements by multiplying the managerial and technical burdens found in Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Si gnificant New Use Reporting Requirements for Chemical Substances , EPA ICR No: 574.12 (EPA, 2003), by the wage rates for technical and managerial staff described in Section 4.2.1. No clerical cost was calculated because of the proposed electronic submission requirement (see Secti on 4.4.27) which EPA assumes that a ll clerical burden for preparing and submitting Form U is eliminated. As shown in Ta ble I-3, EPA estimates the additional per report cost to be $5,673.

Table I-3: Per-Report Cost for Additional Data Elements, based on PMN Burden
Technical Managerial Total

Burden (hours) Wage Rate (2008$) Cost (2008$) Burden (hours) Wage Rate (2008$) Cost (2008$) Burden (hours) Cost (2008$)

PMN Burden/Cost per Report 75 $58.84 $4,413 18 $70.03 $1,260 93 $5,673



### The cost to manufacturers and processors to submit the exposure-related data elements was derived as shown in Table I-4. EPA estimates the section 8(a) rule would cost manufacturers $2.39 million and processors $8.51 million each year.

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

I-5 Table I-4: Annual Industry Cost as a Result of a TSCA Section 8(a) Data Collection

Entity Subject to the Data Collection Cost to Prepare Exposure-related

Data Elements (2008$) Number of Reports Industry Cost (millions of 2008$)

Manufacturers $5,673 421 $2.39 Processors $5,673 1,500 $8.51
Total for Manufacturers and Processors $5,673 1,921 $10.90



### Annual Industry Cost Estimates Table I-5 presents the annual and annualized cost est imates to industry of completing Form U and a section 8(a) collection. The cost estimates for completion of Form U come from Table 4-53. Over a 20- year period, EPA estimates that total annualized cost to the industry will be $56.31 million, with a three percent discount rate, and $59.77 million w ith a seven percent discount rate.

Table I-5: Annual Increase in Industry Cost if All Amendments Are Implemented (2008$))

Year Baseline Industry Cost (When all Amendments are Considered) (millions 2008$) Manufacturer Section 8(a) Cost (millions 2008$) Processor Section 8(a) Cost (millions 2008$) Manufacturer and Processor

Section 8(a) Cost (millions 2008$) Total Cost to Industry (Manufacturer and Processor

+ Baseline)

(millions

2008$)
2011 $209.04 $2.39 $8.51 $10.90 $219.94

2012 $0.00 $2.39 $8.51 $10.90 $10.90

2013 $0.00 $2.39 $8.51 $10.90 $10.90
2014 $0.00 $2.39 $8.51 $10.90 $10.90

2015 $162.12 $2.39 $8.51 $10.90 $173.02

2016 $0.00 $2.39 $8.51 $10.90 $10.90
2017 $0.00 $2.39 $8.51 $10.90 $10.90

2018 $0.00 $2.39 $8.51 $10.90 $10.90

2019 $162.12 $2.39 $8.51 $10.90 $173.02
2020 $0.00 $2.39 $8.51 $10.90 $10.90

2021 $0.00 $2.39 $8.51 $10.90 $10.90

2022 $0.00 $2.39 $8.51 $10.90 $10.90
2023 $162.12 $2.39 $8.51 $10.90 $173.02

2024 $0.00 $2.39 $8.51 $10.90 $10.90

2025 $0.00 $2.39 $8.51 $10.90 $10.90
2026 $0.00 $2.39 $8.51 $10.90 $10.90

2027 $162.12 $2.39 $8.51 $10.90 $173.02

2028 $0.00 $2.39 $8.51 $10.90 $10.90
2029 $0.00 $2.39 $8.51 $10.90 $10.90

2030 $0.00 $2.39 $8.51 $10.90 $10.90

Total $857.53 $47.77 $170.20 $217.97 $1,075.50 Annual Average $42.88 $2.39 $8.51 $10.90 $53.78

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

I-6 Year Baseline Industry Cost (When all Amendments are Considered) (millions 2008$) Manufacturer Section 8(a) Cost (millions 2008$) Processor Section 8(a) Cost (millions 2008$) Manufacturer and Processor

Section 8(a) Cost (millions 2008$) Total Cost to Industry (Manufacturer and Processor

+ Baseline)

(millions

2008$) Annualized at 3% $45.41 $2.39 $8.51 $10.90 $56.31

Annualized at 7% $48.87 $3.48 $12.39 $15.87 $59.77



### I.4 Agency Burden Estimate
For the purposes of this analysis, EPA assumed that th e Agency burden was simi lar to that associated with the IUR rule, and would include contractor and EPA staff burden related to document receipt, tracking and quality control of data entry. To calcula te the Agency burden asso ciated with the exposurerelated data elements, EPA used the per-data elemen t burden to EPA after all the proposed amendments are considered, 0.00008 hours, as calculated in Section 5.5. The number of exposure-related data elements is 57, as shown in Table H-1. The section 8(a) burd en per-report is estimated as shown in Table I-6.

Table I-6: Per-Report Burden for Data Elements Similar to Those Included in a TSCA Section 8(a) Data Collection

Data Elements Number of Data Elements Per-Data Element Burden (hours) Per-report Burden (hours) Exposure-related Data Elements 57 0.00008 0.0048



### Table I-7 shows the estimated burde n to the Agency of processing the data submitted by chemical manufacturers and processors. As described above, EPA expects a total of 421 manufacturer reports and 1,500 processor reports. The Agency burden to pro cess the exposure-related data elements, per-form, 0.0048 hours, is the same for both processors and manufacturers. Therefore, the Agency burden to process the manufacturer data is 2.02 hours, and fo r processor data, is approximately 7.20 hours.

Table I-7: Agency Burden to Process Data as a Result of a TSCA Section 8(a) Data Collection

Per-Report Burden to Process Exposure-Related Data Elements (hours) Number of Reports Agency Burden (hours)

Agency Burden to Process Manufacturer Data 0.0048 421 2.02 Agency Burden to Process Processor Data 0.0048 1,500 7.20 Total Agency Burden 0.0048 1,921 9.22



### Annual Agency Burden Estimates Table I-8 presents the annual Agency burden estimat es for data entry and extramural costs during all principal reporting and non-principal reporting year s over a 20-year period. The Agency burden for processing Form U is taken from Table 5-42. In total, EPA estimates that the Ag ency burden for the IUR rule and a section 8(a) rule will be 12,464 hours ove r a 20-year period. The total burden as a result of a section 8(a) rule will be 184 hours over a 20-year period.

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

I-7 Table I-8: Schedule of Annual Agency Burden

Year Baseline Agency Burden (When all Amendments are considered)

(hours) Agency Burden to

Process Manufacturer

Section 8(a)

(hours) Agency Burden to Process Processor

Section

8(a) (hours) Agency Burden to

Process Manufacturer and Processor

Section 8(a)

(hours) Total Burden To Agency (Manufacturer and Processor

+ Baseline)

(hours)

2011 2,456 2.02 7.20 9.22 2,465
2012 0 2.02 7.20 9.22 9.22
2013 0 2.02 7.20 9.22 9.22
2014 0 2.02 7.20 9.22 9.22
2015 2,456 2.02 7.20 9.22 2,465
2016 0 2.02 7.20 9.22 9.22
2017 0 2.02 7.20 9.22 9.22
2018 0 2.02 7.20 9.22 9.22
2019 2,456 2.02 7.20 9.22 2,465
2020 0 2.02 7.20 9.22 9.22
2021 0 2.02 7.20 9.22 9.22
2022 0 2.02 7.20 9.22 9.22
2023 2,456 2.02 7.20 9.22 2,465
2024 0 2.02 7.20 9.22 9.22
2025 0 2.02 7.20 9.22 9.22
2026 0 2.02 7.20 9.22 9.22
2027 2,456 2.02 7.20 9.22 2,465
2028 0 2.02 7.20 9.22 9.22
2029 0 2.02 7.20 9.22 9.22
2030 0 2.02 7.20 9.22 9.22 Total 12,282 40 144 184 12,464 Annual Average 614 2.02 7.20 9.22 623



### I.5 Agency Cost Estimate
To calculate the Agency cost associated with pr ocessing the data received from a section 8(a) rule, EPA used the cost per-data element to the EPA estimat ed in the IUR EA, $0.0089 (Section 5.5). This unit cost was multiplied by the number of data elements to calculate the total per-report cost of processing the data elements, as shown in Table I-9.

Table I-9: Per-Report Cost for Data Elements Similar to Those Included in a TSCA Section 8(a) Data Collection

Data Elements Number of Data Elements Per-Data Element Cost (2008$) Per-Report Cost (2008$) Exposure-related Data Elements 57 $0.0089 $0.51

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

I-8 Table I-10 shows the Agency cost of processing th e processor data. EPA estimates that the total Agency cost to process the manufacturer data is $213, and the total cost to the Agency of processing the processor data is $758. The total Agency data processing cost is $970.

Table I-10: Agency Cost to Process Data as a Result of the TSCA Section 8(a) Data Collection
Per-Report Cost to Process Exposure-Related

Data Elements (2008$) Number of Reports Agency Cost (2008$)

Agency Cost to Process Manufacturer Data $0.51 421 $213 Agency Cost to Process Processor Data $0.51 1,500 $758 Total Agency Cost $0.51 1,921 $970



### Annual Agency Cost Estimates Table I-11 presents the estimated annual and annualiz ed costs to the Agency of processing Form U and a section 8(a) data collection. The cost estimates for completion of Form U come from Table 4-53. Over a 20-year period, EPA estimates that total cost to the Agency will be $76,300, with a three percent discount rate, and $80,600 with a seven percent discount rate.

Table I-11: Annual Increase in Agency Cost (2008$)

Year Baseline Agency Cost (When all Amendments are Considered) (2008$) Agency Cost to Process Manufacturer

Section 8(a)

(2008$) Agency Cost to Process Processor

Section

8(a) (2008$) Agency Cost to Process Manufacturer and Processor

Section 8(a)

(2008$) Total Cost To Agency (Manufacturer and Processor

+ Baseline)

(2008$)

2011 $288,450 $213 $758 $970 $289,420
2012 $0 $213 $758 $970 $970
2013 $0 $213 $758 $970 $970
2014 $0 $213 $758 $970 $970
2015 $288,450 $213 $758 $970 $289,420
2016 $0 $213 $758 $970 $970
2017 $0 $213 $758 $970 $970
2018 $0 $213 $758 $970 $970
2019 $288,450 $213 $758 $970 $289,420
2020 $0 $213 $758 $970 $970
2021 $0 $213 $758 $970 $970
2022 $0 $213 $758 $970 $970
2023 $288,450 $213 $758 $970 $289,420
2024 $0 $213 $758 $970 $970
2025 $0 $213 $758 $970 $970
2026 $0 $213 $758 $970 $970
2027 $288,450 $213 $758 $970 $289,420
2028 $0 $213 $758 $970 $970
2029 $0 $213 $758 $970 $970
2030 $0 $213 $758 $970 $970

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

I-9 Year Baseline Agency Cost (When all Amendments are Considered) (2008$) Agency Cost to Process Manufacturer

Section 8(a)

(2008$) Agency Cost to Process Processor

Section

8(a) (2008$) Agency Cost to Process Manufacturer and Processor

Section 8(a)

(2008$) Total Cost To Agency (Manufacturer and Processor

+ Baseline)

(2008$)
Total $1,442,250 $4,253 $15,154 $19,407 $1,461,657 Annual Average $72,113 $213 $758 $970 $73,083 Annualized at 3% $75,341 $213 $758 $970 $76,311 Annualized at 7% $79,587 $213 $758 $970 $80,558



### I.6 Small Entity Analysis
The following section provides a preliminary assessment of the impact that a section 8(a) rule may have on small entities by examining the relationship between the compliance costs and company sales for small companies. This analysis is based on the methodology found in Chap ter 8 of this report. Manufacturers For manufacturers, EPA estimated 3.89 manufacturing s ites per global parent company in Chapter 8; 41.3 percent of global parent companies (466 companies) are considered small under the SBA employment-based definition 29 

### , and 24.8 percent (280 companies) are considered small under the TSCA sales-based definition 30 

### . EPA also estimated an average of approximately 1.76 sites per small company under the employment-based definition of small business, and approximately 1.92 sites per small company under the sales-based definition. Average annual sales revenue of global parent companies considered small under either definition were esti mated using data from Dun & Bradstreet, as also described in Chapter 8.

Table I-4 above shows the cost to manufacturers as a result of a section 8(a) rule. These costs were summed and annualized over four years (the likely ti meframe for the rule) at both a three percent and seven percent discount rate 31 

### . As shown in Table I-12 below, these costs were divided by the total number of sites eected to submit data, for the annualized costs per site. This was multiplied by the number of sites per small parent company to arrive at the annualized costs per small parent company. This value was divided by the annual sales per small parent company to derive the cost-to-sales ratio.

As shown in Table I-12 Error! Reference source not found. , under the employment-based definition, a small parent company affected by the ru le on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule ame ndments per small parent company, however, are $19,443 at a seven percent discount rate, and even lo wer under a three percent discount rate. The cost-tosales ratio for an average small company under th e employment-based SBA definition would be 0.005 percent or less. Under the more conservative sales -based TSCA definition, small parent company sales

29 Threshold of 1,000 employees.
30 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of an y parent company, are below $4 million.

31 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

I-10 are on average more than $11.8 million, with annuali zed costs associated with the proposed amendments of $19,047 or lower. The cost-to-sales ratio fo r an average small company under the sales-based definition would be 0.16% or less. Using the highest annual cost shown in Table I-12 of $19,443, a small company would have to have annual sales of less than $1.94 million in order to have a cost-to-sales ratio larger than one percent. This approach is limited to the extent that the universe of manufacturers identified under the economic analysis for the IUR rule would be similar to the manufacturers subject to a section 8(a) rule.

Table I-12: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of ExposureRelated Data Elements Employment-based Definition Sales-based Definition 3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate Cost of Section 8(a) Rule $2,388,518.53

Total Annualized Costs $623,860 $659,026 $623,860 $659,026

Total Number of Sites 66

Annualized Costs per site $9,391 $9,920 $9,391 $9,920

Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $16,528 $19,443 $18,030 $19,047

Annual Sales per Small Parent Company $412,713,310 $11,821,104

Cost-to-sales Ratio 0.004% 0.005% 0.153% 0.161% Number of Companies Potentially Affected 7 4

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

I-11 Processors To estimate the impact of the collection of expos ure-related data elements on processors, EPA is limited by the availability of data. As described a bove, EPA estimated the number of processors that may be impacted by the requirement using TRI submissi on data. However, data provided under the TRI program does not include information about a s ubmitter’s parent company or annual revenues. For this screening-level analysis, EPA assumes th at the chemical processor industry shares many characteristics with the chemical manufacturing industry su bject to the IUR rule. To the extent that this is not the case, this analysis may over- or underestim ate the impact of additional data elements on processors. Specifically, EPA assumes 3.89 manufacturi ng sites per global parent company. EPA also assumes that 41.3 percent of global parent compan ies are considered small under an employment-based definition, and 24.8 percent are considered small under a sales-based definition. EPA further assumes 1.76 sites per small parent company under the empl oyment-based definition, and 1.92 sites per small parent company under the sales-based definition, cons istent with manufacturer information. Given the large number of companies identified as processors ac cording to TRI submissions, EPA was unable to examine Dun & Bradstreet data to estimate annual parent company revenue for this analysis, so manufacturer revenue was used as a proxy. Therefore, this analysis provides only a preliminary estimate of impacts. EPA divided the number of expected processor repor ts (1,500) by the average number of chemicals for which a processor submitted TRI data (2.45) to obt ain the estimated number of processors (612). EPA divided this number by 3.89 (the number of sites per global parent company) for an estimated 157 global parent companies. This number was then multiplied by 41.3 percent and 24.8 percent to estimate the number of small global parent companies (the numbe r of companies potentially affected), under the employment-based definition and sales-based definition, respectively. To calculate cost-to-sales ratios, EPA followed the same methodology for processors as described above for manufacturers. Results are presented in Table I-13 below.

Table I-13: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of ExposureRelated Data Elements Employment-based Definition Sales-based Definition 3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate Cost of Section 8(a) Rule $8,510,161

Total Annualized Costs $2,222,780 $2,348,074 $2,222,780 $2,348,074

Total Number of Sites 612
Annualized Costs per Site $3,631 $3,835 $3,631 $3,835
Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $6,390 $6,750 $6,971 $7,364

Annual Sales per Small Parent Company $412,713,310 $11,821,000

Cost-to-sales Ratio 0.0015% 0.0016% 0.059% 0.062%
Number of Companies Potentially Affected 65 39

### ***EO 12866 Review DRAFT—Do not Cite, Qu ote or Release During Review***

I-12 As shown in Table I-13, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 mill ion. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $6,750 at a seven percent discount rate, and even lower under a three percent discount rate. The cost-to- sales ratio for an average small company under the employment-based definition would be 0.0016 percent or less. Under the more conservative sales-based definition, small parent company sales are on averag e more than $11.8 million, with annualized costs associated with the proposed amendments of $7,364 or lower. The cost-to-sales ratio for an average small company under the sales-based definition would be 0.062 percent or less. As described in Chapter 8, the Regulatory Flexib ility Act does not define the terms “significant” or “substantial” analytically with regard to extent of economic impact and number of small entities affected. However, EPA typically defines a threshold as comp liance costs of one percent of sales to establish whether the level of economic impacts faced by the small entities can be presumed as not significant (U.S. EPA, 2006b). Using the highest annual cost shown in Table I-13, $7,364, a small company would have to have annual sales of less than $736,400 in or der to have a cost-to-sales ratio larger than one percent.