## July 20, 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 Rulei 

## 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.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 and 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 und er 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 Intermed iate” Definition from §710.3........................................... 3-2 3.1.4 Delete Subpart B Text...................................................................................................... 3-2 3.1.5 Delete Superfluous Text Associated With Reporting Production Volumes .................... 3-2 3.1.6 Correcting Text Associated With Reporting Number of Sites and Number of Workers.t. 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 Re lated Definitions........................................................................ 3-3 3.2.4 Processing and Use-Related Definitions.......................................................................... 3-4 3.2.5 Principal Reporting Year and Submission Period............................................................ 3-4 3.3 Modifications to Reporting Thresholds ........................................................................................ 3-5 3.3.1 Method for Determining Whether a Manuf acturer is Subject to IUR Reporting Requirements ................................................................................................................... 3-5 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 ............................ 3-6 3.4 Changes to Substances S ubject to the IUR Rule........................................................................... 3-6 3.4.1 Make Chemicals Subject to Enforceable C onsent Agreements (ECAs) Ineligible for Exemptions .....................................................................................................................

. 3-6 3.4.2 Full Exemption for Manufactured Water......................................................................... 3-6 3.4.3 Remove Fully Exempt Polymers from the Partially Exempt List.................................... 3-7 3.5 Modifications to Reportable Data Elements ................................................................................. 3-7 3.5.1 Parent Company and Site Identity ................................................................................... 3-7 3.5.2 Technical Contact ............................................................................................................ 3-7 3.5.3 Chemical Identity............................................................................................................. 3-7 3.5.4 Report Production Volume for Each of the Years since the Last Principal Reporting Year

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

. 3-8 3.6 Concentration Ranges ...........................................................................................................

........ 3-9 3.7 Industrial Processing and U se Information Reporting.................................................................. 3-9 3.7.1 Revise Industrial F unction Categories ............................................................................. 3-9 3.7.2 Revise Industrial Sectors ............................................................................................... 3-10 3.8 Consumer and Commerc ial Use Reporting ................................................................................ 3-10 3.8.1 Revise Consumer and Comme rcial Product Categories ................................................ 3-10 3.8.2 Designation of Consumer or Commercial Use .............................................................. 3-10 3.8.3 Number of Commercial Workers Reasonably Likely To Be Exposed.......................... 3-10 3.9 Changes to Standard for the Reporti ng of Processing and Use Information .............................. 3-11 3.10 Modifications to Confidential Bu siness Informati on (CBI) Claims ........................................... 3-11 3.10.1 Chemical Identity CBI Claims....................................................................................... 3-11 3.10.2 Upfront Substantiation for Processing and Use Information CBI Claims ..................... 3-12 3.10.3 Limitation on Confidentiality Claims for Da ta Elements Identified as “Not Known or Reasonably Ascertainable” ............................................................................................ 3-12 3.11 Method of Submission ...........................................................................................................

..... 3-12 3.11.1 Updated e-IUR Reporting Software............................................................................... 3-13 3.11.2 Require Electronic Submissions over the Internet......................................................... 3-13 3.11.3 Electronic Signature Process.......................................................................................... 3-13 3.12 Modifications Specifically Affecting Importers ......................................................................... 3-14 3.13 Modify Reporting Frequency.....................................................................................................

. 3-15 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) .................................................................. 4-2 4.2.3 Estimates of Baseline 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 Cycles’ Labor Hours (Burden) ..................................... 4-10 4.3 Total Baseline IUR Industry Co mpliance 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. Threshol d 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 .................................................................................................................... 4-23 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 ................................................................................. 4-25 4.4.10 Technical Contact .......................................................................................................... 4-26 4.4.11 Chemical Identity........................................................................................................... 4-26 4.4.12 Report Production Volume for Each of the Years since Last Principal Reporting Year............................................................................................................................. 4-26iv 4.4.13 Volume of Chemical Substance Used On-Site .............................................................. 4-27 4.4.14 Indicate Whether Chemical Is Physically at Reporting Site .......................................... 4-29 4.4.15 Report Production Volume Exported............................................................................. 4-30 4.4.16 Identify Whether a Chemical Is To Be Recycled, Remanufactured, Reprocessed, Reused, or Reworked................................................................................................................... 4-31 4.4.17 Concentration Ranges .................................................................................................... 4-32 4.4.18 Revise Industrial F unction Categories ........................................................................... 4-33 4.4.19 Revise Industrial Sectors ............................................................................................... 4-34 4.4.20 Revise Consumer and Comme rcial 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 Repor ting of Processing and Use Information............ 4-37 4.4.24 Chemical Identity CBI Claims....................................................................................... 4-38 4.4.25 Upfront Substantiation for Processing and Use Information CBI Claims ..................... 4-38 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 and Cost of all Amendments .............................................. 4-45 4.5.1 Modifications that Affect the Number of Reports Submitted........................................ 4-45 4.5.2 Modifications That Aff ect the Reporting Burden.......................................................... 4-48 4.5.3 Amendment that Affects the Reporting Frequency ....................................................... 4-53 4.5.4 Average Cost and Burden per Site................................................................................. 4-53 4.6 Annualized Industry Cost Estimates for all Modifications......................................................... 4-56 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 ................................................................................................................... 5-4 5.4.4 Eliminate the 300,000 lb. Threshol d for Processing and Use Reporting......................... 5-6 5.4.5 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals ............................ 5-7 5.4.6 Make Chemicals Subject to Enforceable C onsent Agreements (ECAs) Ineligible for Exemptions .....................................................................................................................

. 5-8 5.4.7 Full Exemption for Manufactured Water......................................................................... 5-9 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 .......................................................................................................... 5-10 5.4.11 Chemical Identity........................................................................................................... 5-10 5.4.12 Report Production Volume for Each of the Years since Last Principal Reporting Year ... 5- 10v 5.4.13 Volume of Chemical Substance Used On-Site .............................................................. 5-11 5.4.14 Indicate Whether Chemical Is Physically at Reporting Site .......................................... 5-12 5.4.15 Report Production Volume Exported............................................................................. 5-12 5.4.16 Identify Whether Chemical Is To Be Recy cled, Remanufactured, Reprocessed, Reused, or Reworked................................................................................................................... 5-13 5.4.17 Concentration Ranges .................................................................................................... 5-14 5.4.18 Revise Industrial F unction Categories ........................................................................... 5-14 5.4.19 Revise Industrial Sectors ............................................................................................... 5-15 5.4.20 Revise Consumer and Comme rcial 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 Repor ting of Processing and Use Information............ 5-18 5.4.24 Chemical Identity CBI Claims....................................................................................... 5-18 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” ............................................................................................ 5-19 5.4.27 Require Electronic Submissions over the Internet......................................................... 5-19 5.4.28 Updated e-IUR Reporting Software............................................................................... 5-20 5.4.29 Electronic Signature Process.......................................................................................... 5-20 5.4.30 Modifications Specifically Affecting Importers ............................................................ 5-21 5.4.31 Modify Reporting Frequency......................................................................................... 5-21
5.5 Total Agency Cost of All Modifications..................................................................................... 5-22 5.6 Annualized Agency Cost Estimates for All Modifications......................................................... 5-27 6. Social Cost Summary.........................................................................................................

.................. 6-1 7. Impact of the Proposed IUR Rule Modifi cations 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 Clo sely Match the Agency’s Information Needs 7-3 7.2.2 Increase EPA’s Ability to Effectively Provi de Public Access to the Information........... 7-6 7.2.3 Obtain New and Updated Exposure Information............................................................. 7-7 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 ......................................................... 7-13 7.3.2 Other Federal Risk Ma nagement Programs................................................................... 7-14 7.3.3 State and Local Programs .............................................................................................. 7-15 7.3.4 Nongovernmental Organization (NGO) Initiativ es 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).................................................................................................. 9-1vi 9.4 Executive Order 13132 - Federalism ............................................................................................ 9-2 9.5 Executive Order 12898 – Environmental Justice.......................................................................... 9-2 9.6 Executive Order 13045 – Children’s Health................................................................................. 9-2 9.7 Executive Order 13175 – Consultation and Coordi nation with Indian Tribal Governments........ 9-3 9.8 Executive Order 13211 – Energy Supply, Distribution, or Use.................................................... 9-3 9.9 National Technology Transf er 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 Whethe r 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 the Option is Considered by Itself ...............G- 1 G.1.2 Annual Reporting Cost and Burden when the All the Proposed Amendments are Considered ..................................................................................................................... .G- 3 G.1.3 Small Entity Analysis .....................................................................................................G- 5 G.2 Modify Reporting Frequency to a Three-Y ear Cycle ..................................................................G- 6 G.2.1 Three-Year Reporting Cycle Cost when the Option is Considered by Itself..................G- 6 G.2.2 Three-Year Cycle Cost and Burden when the All the Proposed Amendments are Considered ..................................................................................................................... .G- 8 G.2.3 Small Entity Anaylsis ...................................................................................................G- 11 G.3 Change the Threshold for Reporting to 10,000 lb. ....................................................................G- 12 G.3.1 10,000 lb. Reporting Threshold Cost and Burden when the Option is Considered by Itself

............................................................................................................................... .......G- 12 G.3.2 Change the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered ....................................................................................................................G

- 15 G.3.3 Small Entity Analysis ...................................................................................................G- 22 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- 11 H.4 Agency Burden Estimate ......................................................................................................... ..H- 15
H.5 Agency Cost Estimate........................................................................................................... .....H- 18 H.6 Small Entity Analysis .......................................................................................................... ......H- 22vii Appendix I. - Estimated Burden and Cost of a Section 8(a) Rule for Exposure-R elated Data Elements.................................................................................................................................................... I- 1 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- 5 I.5 Agency Cost Estimate........................................................................................................... .........I- 7 I.6 Small Entity Analysis .......................................................................................................... ..........I- 8viii 

## List of Tables

Table 4-1: Derivation of Loaded Wage Rates for the Private Manufacturing Sector (2008$) .................. 4-2 Table 4-2: Baseline First-Cy cle Labor Burden per Form U, in Hours....................................................... 4-4 Table 4-3: Bu rden Percentages Attributed to S ite-Limited Activity and Production Volume Questions.. 4-6 Table 4-4: M ailing Submission Costs (December, 2009).......................................................................... 4-6 Table 4-5: Baseline First-Cy cle Total Cost per Form U (2008$) .............................................................. 4-8 Table 4-6: Baseline Nu mber of Reports and Sites................................................................................

... 4-10 Table 4-7: Weighting Fact ors for Burden Estimates fo r Sites That Have Previously Submitted a Form U 4- 11 Table 4-8: Baseline Future-Cy cle La bor Burden per Report, in Hours ................................................... 4-12 Table 4-9: Baseline Future-Cy cle Total Cost per Report (2008$)........................................................... 4-14 Table 4-10: T otal Baseline Cost and Burd en to Industry (2011 Reporting Cycle).................................. 4-16 Table 4-11: T otal Baseline Cost and Burden to Industry (Future Reporting Cycles).............................. 4-16 Table 4-12: C hange 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: C hange 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: C hange in Industry Burden as a Result of Eliminating the 300,000 lb. Threshold for Downstream Processing and U se Information Reporting................................................................ 4-20 Table 4-15: C hange in Industry Cost as a Result of Eliminating the 300,000 lb. Threshold for Downstream Processing and U se Information Reporting................................................................ 4-21 Table 4-16: C hange in Industry Burden as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals ....................................................................................................................... 4-22 Table 4-17: C hange in Industry Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals ....................................................................................................................... 4-22 Table 4-18: C hange 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: C hange in Industry Burden as a Result of Exempting Manufactured Water from Reporting...

......................................................................................................................................................... 4-25 Table 4-21: C hange in Industry Cost as a Result of Exempting Manufactured Water from Reporting .. 4-25 Table 4-22: C hange in Industry Burden as a Result of Requiring the Reporting of Production Volume in all Non-Principal Reporting Years..............................................................................................

..... 4-27 Table 4-23: C hange in Industry Cost as a Result of Requiring the Reporting of Production Volume in all Non-Principal Reporting Years..................................................................................................

...... 4-27 Table 4-24: C hange in Industry Burden as a Result of Requiring the Reporting of Production Volume Used On-Site...................................................................................................................

................. 4-28 Table 4-25: C hange 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: C hange in Industry Burden as a R esult of Requiring Reporting of Volume Exported ........ 4-30 Table 4-29: C hange in Industry Cost as a Resu lt 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..................................................................... 4-32ix 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: C hange in Industry Burden as a Result of Modifying the Industrial Function Categories... 4-33 Table 4-33: C hange in Industry Cost as a Result of Modifying the Industr ial Function Categories ....... 4-34 Table 4-34: C hange in Industry Burden as a Resu lt of Modifying the Consumer and Commercial Product Categories ........................................................................................................................................ 4-35 Table 4-35: C hange in Industry Cost as a Result of Modifying the Consumer and Commercial Product Categories ........................................................................................................................................ 4-36 Table 4-36: C hange in Industry Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed................................................................................................

.. 4-37 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: C hange in Industry Burden as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI .......................................................................................... 4-38 Table 4-39: C hange in Industry Cost as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI .......................................................................................... 4-39 Table 4-40: C hange in Industry Burden as a Result of Requiring Electronic Submission ...................... 4-40 Table 4-41: C hange in Industry Cost as a Result of Requiring Electronic Submission........................... 4-41 Table 4-42: C hange in Industry Burden as a Result of Requiring CDX Registration for Secondary Submitters ........................................................................................................................................ 4-42 Table 4-43: C hange in Industry Cost as a Result of Requiring CDX Registration for Secondary Submitters

......................................................................................................................................................... 4-43 Table 4-44: C hange in Industry Burden as a Result of Modifying the Reporting Frequency, over a 25- Year Period ....................................................................................................................

.................. 4-44 Table 4-45: C hange in Industry Cost as a Result of Modifying the Reporting Frequency, over a 20-Year Period ............................................................................................................................................... 4-45 Table 4-46: C hange in the Number of Sites a nd Reports Submitted for All Amendments Combined.... 4-47 Table 4-47: C hange in the 2011 Reporting Cycle Burden for All Amendments Combined, by Labor Category........................................................................................................................................... 4-50 Table 4-48: C hange in the Future Reporting Cycle Burden for All Amendments Combined, by Labor Category........................................................................................................................................... 4-51 Table 4-49: T otal Industry Burden for All Amendments Combined....................................................... 4-52 Table 4-50: T otal Industry Cost When All Amendments Are Combined................................................ 4-53 Table 4-51: Average Number of Fu ll and Partial Reports per Site.......................................................... 4-54 Table 4-52: Average Total Burden per Site ......................................................................................

....... 4-55 Table 4-53: Average Total Cost per Site ........................................................................................

......... 4-56 Table 4-54: I ndustry Burden over a Period of 25 Years if All Proposed Amendments Are Implemented.. 4- 57 Table 4-55: I ndustry Cost over a Period of 25 Year s if All Proposed Amendments Are Implemented.. 4-58 Table 5-1: Derivation of L oaded Agency Wage Rates (2008$)................................................................. 5-2 Table 5-2: Derivation of E xtramural Task Costs, per Reporting Cycle..................................................... 5-2 Table 5-3: Total Agency Cost unde r the Current IUR Requirements........................................................ 5-3 Table 5-4: Baseline Agency Burden per Report ...................................................................................

..... 5-4 Table 5-5: Ch ange 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: Ch ange in Agency Cost as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements ................................................................. 5-6 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..............................................................................................................

................ 5-7x 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: C hange in Agency Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals ......................................................................................................................... 5-8 Table 5-11: Change in Age ncy Burden as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions .....................................................................................................................

................... 5-8 Table 5-12: Change in Age ncy Cost as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions .....................................................................................................................

................... 5-8 Table 5-13: C hange in Agency Burden as a Result of a Full Exemption for Manufactured Water........... 5-9 Table 5-14: C hange in Agency Cost as a Result of a Full Exemption for Manufactured Water ............... 5-9 Table 5-15: C hange 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: C hange in Agency Cost as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year ............................................................................................

.... 5-11 Table 5-17: C hange in Agency Burden as a Result of Reporting of Production Volume Used On-Site. 5-11 Table 5-18: C hange in Agency Cost as a Result of Reporting of Production Volume Used On-Site ..... 5-11 Table 5-19: Change in Age ncy Burden as a Resu lt of Indicating Whether an Imported Chemical is Physically On-Site .............................................................................................................

.............. 5-12 Table 5-20: Change in Age ncy Cost as a Result of Indicating Whether an Imported Chemical is Physically On-Site .............................................................................................................

.............. 5-12 Table 5-21: C hange in Agency Burden as a Result of Requiring the Reporting of Export Volume ....... 5-13 Table 5-22: C hange in Agency Cost as a Result of Requiring the Reporting of Export Volume............ 5-13 Table 5-23: Change in Age ncy Burden as a Result of Indicating Whether Chemical is Recycled, Remanufacture, Reprocessed, Reused, or Reworked....................................................................... 5-13 Table 5-24: Change in Age ncy Cost as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed , Reused, or Reworked..................................................................... 5-14 Table 5-25: C hange in Agency Burden as a Resu lt of Revising the Industr ial Function Categories....... 5-14 Table 5-26: C hange in Agency Cost as a Result of Revising the Industrial Function Categories........... 5-15 Table 5-27: C hange in Agency Burden as a Resu lt of Revising the Consumer and Commercial Product Categories ........................................................................................................................................ 5-16 Table 5-28: C hange in Agency Cost as a Result of Revising the Consumer and Commercial Product Categories ........................................................................................................................................ 5-16 Table 5-29: Change in Age ncy Burden as a Resu lt of Designation of Consumer or Commercial Use... 5-17 Table 5-30: C hange in Agency Cost as a Result of Designation of Consum er or Commercial Use ....... 5-17 Table 5-31: C hange 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 Age ncy Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed................................................................................................

.. 5-18 Table 5-33: C hange in Agency Burden as a Result of Requiring Upfront Substantiation for CBI Claims

............................................................ ............................................................... 5-18 Table 5-34: C hange in Agency Cost as a Result of Requiring Upfront Substantiation for CBI Claims.. 5-19 Table 5-35: C hange in Agency Burden as a Result of Requiring Electronic Submission ....................... 5-19 Table 5-36: C hange in Agency Cost as a Result of Requiring Electronic Submission............................ 5-20 Table 5-37: C hange in Agency Burden as a Result of Modifying the Reporting Frequency .................. 5-21 Table 5-38: C hange in Agency Cost as a Result of Modifying the Reporting Frequency....................... 5-22 Table 5-39: C hange in Agency Burden as a Result of All the Proposed IUR Modifications.................. 5-23 Table 5-40: T otal Agency Burden for All Amendments Combined........................................................ 5-24 Table 5-41: T otal 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......................................... 5-26 Table 5-44: Agency Cost per Report when All Amendments Are Combined......................................... 5-26xi Table 5-45: Agency Burden over a Period of 25 Y ears if All Proposed Amendments Are Implemented

........................................................................................................................................................ 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 So ciety If All Modifications Are Implemented ............................ 6-1 Table 6-2: Change in Total Costs to Soci ety if All Modifications Are Implemented ............................... 6-2 Table 8-1: Results of D un & Bradstreet Analysis................................................................................

...... 8-3 Table 8-2: Estimated Nu mber of Small Compan ies under the Proposed IUR Rule Amendments............ 8-4 Table 8-3: Derivation of C ost-to-Sales Ratios for Small Companies under the Proposed IUR Rule Amendments ...................................................................................................................................... 8-5 Table C-1: List of Current and Propo sed Industrial Func tion Categories................................................. C- 1 Table D-1: List of Current and Proposed C onsumer and Commercial Product Categories......................D- 1 Table F-1: Sensitivit y Analysis of Industry Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met ................................................................................................... ....... F- 2 Table F-2: Sensitivit y Analysis of Industry Cost Estimates for Modifying the Method for Determining Whether the Threshold Is Met ................................................................................................... ....... F- 2 Table F-3: Sensitivit y Analysis of Agency Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met ................................................................................................... ....... F- 3 Table F-4: Sensitivit y Analysis of Agency Cost Estimates for Modifying the Method for Determining Whether the Threshold Is Met ................................................................................................... ....... F- 3 Table F-5: Sensitivit y Analysis of Industry Burden Estimates for Reporting Pro duction Volume Used OnSite .................................................................................................................................................... F- 4 Table F-6: Sensitivit y Analysis of Industry Cost Estimates for Reporting Production Volume Used OnSite .................................................................................................................................................... F- 4 Table F-7: Sensitivit y Analysis of Agency Burden Estimates for Reporting Pro duction Volume Used OnSite .................................................................................................................................................... F- 5 Table F-8: Sensitivit y Analysis of Agency Cost Estimates for Reporting Production Volume Used OnSite .................................................................................................................................................... F- 5 Table F-9: Sensitivit y Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category........................................................................................................ F- 6 Table F-10: S ensitivity Analysis of Industry Cost Es timates for Requiring Write-in Text for “Other” as an Industrial Func tion Category ................................................................................................... ......... F- 6 Table F-11: S ensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category........................................................................................................ F- 7 Table F-12: S ensitivity Analysis of Agency Cost Estim ates for Requiring Write-in Text for “Other” as an Industrial Func tion Category ................................................................................................... ......... F- 7 Table F-13: S ensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category .......................................................................... F- 8 Table F-14: S ensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commerc ial Product Category ............................................................................. F- 8 Table F-15: S ensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category .......................................................................... F- 9 Table F-16: S ensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commerc ial Product Category ............................................................................. F- 9 Table F-17: S ensitivity Analysis of Industry Burden Estimates for Requiring Upfront CBI Substantiation ........................................................................................................................................................ F- 10 Table F-18: S ensitivity Analysis of Industry Cost Estimates for Requiring Upfront CBI Substantiation... ........................................................................................................................................................ F- 10 Table F-19: S ensitivity Analysis of Agency Burden Estimates for Requiring Upfront CBI Substantiation ........................................................................................................................................................ F- 11 Table F-20: S ensitivity Analysis of Agency Cost Es timates for Requiring Upfront CBI SubstantiationF- 11xii Table G-1: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data Annually....................................................................................................................... .....................G- 1 Table G-2: Industr y 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- 2 Table G-4: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually....................................................................................................................... .....................G- 3 Table G-5: Industr y Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered ........................................................G- 3 Table G-6: Industr y Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered ........................................................G- 4 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- 4 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- 5 Table G-9: Derivation of C ost-to-Sales Ratios for Small Manufacturers for Collection of Annual Reporting...........................................................................................................................................G- 6 Table G-10: Annual Indus try Burden under the Alternative Option of a Three-Year Reporting Cycle...G- 7 Table G-11: Industr y Cost under the Alternative Option of a Three-Year Reporting Cycle....................G- 7 Table G-12: Burden to the Agency under the Altern ative Option of a Three-Year Reporting Cycle ......G- 8 Table G-13: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle.....................G- 8 Table G-14: Annual Indus try Burden under the Altern ative Option of a Three-Year Reporting Cycle when the All the Proposed Amendm ents are Considered...........................................................................G- 9 Table G-15: Industr y Cost under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered ......................................................................................G- 9 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- 10 Table G-17: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered ..........................................................................................G- 10 Table G-18: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a Three-Year Reporting Cy cle ...............................................................................................................................................G- 12 Table G-19: Nu mber of Reports and Sites in 2002................................................................................ .G- 13 Table G-20: Industr y Burden as a Result of Changi ng the Threshold for Reporting to 10,000 lb. ........G- 13 Table G-21: Industr y Cost as a Result of Changi ng the Threshold for Reporting to 10,000 lb..............G- 14 Table G-22: Change in Burden to the A gency as a Result of Changing the Threshold for Reporting to 10,000 lb. ..................................................................................................................... ...................G- 14 Table G-23: Change in Ag ency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. ...................................................................................................................G- 15 Table G-24: Change in the Number of Sites and Reports Submitted of All Amendments Combined with the 10,000 lb. Reporting Threshold ............................................................................................. ...G- 17 Table G-25: Industr y Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered ..........................................................................................G- 18 Table G-26: Industr y Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered ..........................................................................................G- 19 Table G-27: Industr y Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered ..........................................G- 19 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- 20 Table G-29: Agency Burden as a Result of Lowere d Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered...........................................................................G- 20xiii Table G-30: Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered ....................................................................................G- 21 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- 21 Table G-32: Change in Ag ency 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- 22 Table G-33: Derivation of Cost-to-Sales Ratios fo r Small Manufacturers for a 10,00 0 lb. Reporting Threshold ...................................................................................................................... ..................G- 23 Table H-1: Description of Additional D ata Elements............................................................................. ..H- 1 Table H-2: Change in In dustry Burden to Manufact urers as a Result of Additional Exposure-Related Data Elements .......................................................................................................... .........................H- 8 Table H-3: Schedule of Annual In dustry 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- 9 Table H-5: Schedule of Annual In dustr y Burden to Processors .............................................................H- 10 Table H-6: Change in In dustry Burden to Manuf acturers and Processors as a Result of Additional Exposure-Related Data Elements................................................................................................. ...H- 10 Table H-7: Schedule of Annual Industr y Burden to Manufacturers and Processors if All Proposed Amendments Are Implemented ..................................................................................................... .H- 11 Table H-8: Per-Report Cost for Additiona l Data Elements, based on PMN Burden..............................H- 11 Table H-9: Change in Industry Cost to Manufactur ers as a Result of Additional Exposure-Related Data Elements....................................................................................................................... ...................H- 12 Table H-10: Annual Increase in Industry Cost to Ma nufacturers if All Proposed Amendments Are Implemented (2008$)............................................................................................................ ..........H- 12 Table H-11: Change in Industr y Cost to Processors as a Result of Additional Exposure-Related Data Elements....................................................................................................................... ...................H- 13 Table H-12: Annual Increase in Industry Cost to Processors if All Proposed Amendments Are Implemented (2008$)............................................................................................................ ..........H- 13 Table H-13: Change in In dustry Cost to Manufact urers and Processors as a Result of Additional Exposure-Related Data Elements................................................................................................. ...H- 14 Table H-14: Annualized Increase in Industr y Cost to Manufacturers and Processors if All Amendments Are Implemented (2008$)........................................................................................................ .......H- 14 Table H-15: Change in Agency Burden to Process Ma nufacturer Data as a Result of Additional ExposureRelated Data Elements.......................................................................................................... ..........H- 15 Table H-16: Annual Increase in Agency Burden to Process Manuf acturer Data if All Proposed Amendments Are Implemented ..................................................................................................... .H- 16 Table H-17: Change in Agency Burden to Pro cess Processor Data as a Result of Additional ExposureRelated Data Elements.......................................................................................................... ..........H- 16 Table H-18: Annual Increase in Agency Burden to Process Processor Data if Al l Proposed Amendments Are Implemented ................................................................................................................ ............H- 17 Table H-19: Change in Agency Burden to Pro cess Manufacturer and Processor Data as a Result of Additional Exposure-Rela ted Data Elements..................................................................................H- 17 Table H-20: Annual Increase in Agency Burden to Process Data if All Proposed Amendments Are Implemented .................................................................................................................... ...............H- 18 Table H-21: Change in Agency Cost of Processing Manufacturer Data as a Result of Additional Exposure-Related Data Elements................................................................................................. ...H- 18 Table H-22: Annual Increase in Agency Cost to Pro cess M anufacturer Data if All Proposed Amendments Are Implemented (2008$)........................................................................................................ .......H- 19 Table H-23: Change in Agency Cost to Process Pr ocessor Data as a Result of Additional ExposureRelated Data Elements.......................................................................................................... ..........H- 20xiv Table H-24: Annual Increase in Agency Cost to Pro cess Processor Data if All Proposed Amendments Are Implemented (2008$)............................................................................................................ ..........H- 20 Table H-25: Change in Agency Cost of Processi ng Manufacture and Processor Data as a Result of Additional Exposure-Rela ted Data Elements..................................................................................H- 21 Table H-26: Annual Increase in Agency Cost to Pro cess M anufacturer and Processor Data if All Proposed Amendments Are Implemented (2008$).........................................................................................H- 22 Table H-27. Derivation of Cost-to-Sales Ratios for Sm all Manufacturers for Collection of Ad ditional Data Elements....................................................................................................................... ...................H- 23 Table H-28: Derivation of Cost-to-Sales Ratios for Small Processors for Coll ection of Additional Data Elem ents....................................................................................................................... ...................H- 24 Table I-1: Annual Industr y Burden as a Result of a TSCA Section 8(a) Data Collection......................... I- 3 Table I-2: Schedule of An nual Industr y Burden.................................................................................. ...... I- 3 Table I-3: Per-Report Cost for Additional Data Elements, based on PMN Burden .................................. I- 4 Table I-4: Annual Industr y Cost as a Result of a TSCA Section 8(a) Data Collection ............................. I- 4 Table I-5: Annual Increase in Industry Cost if All Amendments Are Im plemented (2008$)) .................. I- 5 Table I-6: Per-Report Burden for Data Elem ents Similar to Those Included in a TSCA Section 8(a) Data Collection........................................................................................................................................... I- 5 Table I-7: Agency Burden to Process Data as a Result of a TSCA Section 8(a) Data Collection............ I- 6 Table I-8: Schedule of Annual Agency Burden.................................................................................... ..... I- 6 Table I-9: Per-Report Cost for Data Elements Si mila r to Those Included in a TSCA Section 8(a) Data Collection........................................................................................................................................... I- 7 Table I-10: Agency Cost to Process Data as a R esult of the TSCA Section 8(a) Data Collection ........... I- 7 Table I-11: Annual Increase in Agency Cost (2008$) ............................................................................. .. I- 7 Table I-12: Derivation of C ost-to-Sales Ratios fo r Small Manufacturers for Collection of ExposureRelated Data Elements.......................................................................................................... ............. I- 9 Table I-13: Derivation of Cost-to-Sales Ratios for Small Processors for Collec tion of Exposure-Related Data Elements .................................................................................................................................. I- 10xv 

## Executive Summary

The U.S. Environmental Protection Agency (EPA) requires manufacturers (including importers) of certain chemical substances to pe riodically report information 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 Act (TSCA), which requires EPA to compile and keep current a listing of chemicals in commerce in the United States. The data reported under the IUR rule are used to support many EPA and other federal agency 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 in commerce in the United States. For reportable substances a company manufactures or imports in volumes of 25,000 lb. or more at a plant site during the principal reporting year, a s ubmitter is required to prov ide plant site, production volume, and manufacturing information. Sites must also provide processing and use information for chemicals manufactured (including imported) in vo lumes 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 “partia lly exempt,” such as specifically listed petroleum process streams, and listed chemical substances for whic h the IUR information is of low current interest. These chemicals are all referred to as “partially exem pt” from reporting because companies must provide manufacturing information for them but not processing and use information. EPA now is proposing amendments 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),” “ e-IURweb” , and “industrial function”;

• For the reporting cycles subsequent to the 2011 repor ting cycle, add requirement to report whether, 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. reporting threshold for pr ocessing and use information , thereby requiring 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 chem ical’s production volum e for each of the five years since the last principal reporting year;xvi • Require submitters to report separat ely production volume used on-site;

• 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 indicate whether the chemical is to be recycled, remanufactured, reprocessed, reused, or reworked;

• For downstream processing and use information: mo dify 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 submitters to report the to tal 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;

• 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 (CBI);

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

• Require submitters to submit forms electronically us ing the e-IURweb software and EPA’s 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 25 years of the rule, EPA estimates the net present value of the rule m odifications will be $570.41 million in social cost. Annualized costs are expected to be $21.58 million (at a three percent discount rate) and $19.93 million (at a seven percent discount rate). 1 EPA estimates all of the amendments combined would increase the burden to industry by approximately 1.39 million hours to 3.24 million hours, and increase the cost to industry by approximately $91.87 million to $198.84 million in total for the 2011 reporting cycle. EPA estimates in future reporting cycles, the industry burde n will increase by 1.21 million hours to a total of 2.64 million hours, and industry cost will increase by $79.27 million to $162.08 million. EPA further estimates over a 25-year period, industry burden will increase by 8.85 million hours. EPA estimates the net burden to society will increase by 8.85 milli on hours over a 25-year period because EPA will experience a small reduction in burden as a result of the proposed rule. The information gathered will enable the Agency to continue to target educational, regulatory, or enforcement activities to industries or chemicals posing the greatest potential risks and to target programs for population groups 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.1-1 

## 1. Introduction

This report assesses the costs and benefits EPA exp ects to result from its 2010 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 data are available in a timely manner. This chapter provides background information on EPA’s statutory authority for collecting information throug h 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 and 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 in commerce in the United States, thereby providing a listing of chemicals manufactured or processed in the Unite d 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).1-2 chemicals, polymers, microorganisms, and naturall y occurring chemical substances 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 used to support 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 rule, 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.2-1 

## 2. Current IUR Requirements and Affected Entities

2.1 Overview of Current IUR Requi rements
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 restrictions related to confidential business information (CBI), 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 CFR §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 reporting 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 substances. 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 form that must be signed by a company-authorized official, to certify 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 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 chemical2-2 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 can be claimed for each data element reported. Submitters who claim the chemical identity or plant site iden tity 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 Re gulated 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 listed on the TSCA Inventory and regulated under TSCA §8. Manufacturers (including importers) of non-TSCA chem ical 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 manufacturers, primary metal manufacturers, , and semiconductor and other elect ronic component manufacturers (NAICS codes 22, 322, 331, and 3344) also are likely to be subject to the rule. However, companies in any industry are subject to reporting if they manufacture or import listed chemicals at or above the reporting threshold. Companies must review the rule to determ ine whether they are required to report.3-1 

## 3. Changes in Reporting Requirements 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
Currently, 40 CFR part 710 contains three subpart s. Subpart A contains regulatory text associated with the original compilation of the TSCA Inventory; Subpart B contains regulatory text associated with the IUR rule covering the update reporting in 2002; a nd Subpart C contains the regulatory text associated with the IUR rule for 2006 and beyond. The chemic als covered by the IUR rule are on the Master Inventory File, which includes chemicals from the original Inventory compilation and those added subsequently through the notice requirements of section 5 of TSCA. Because the IUR rule applies to a list of chemicals included in the original Inventory plus additional chemicals added subsequently, and because the Agency from time to time has modified the IUR rule, the Ag ency believes the regulatory text associated with the IUR rule should be in its own section in the Code of Federal Regulations (CFR), 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 Subpart 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 40 CFR part 710 to a new 40 CFR part 711 and would add a new Scope and Compliance section (40 CFR 711.1 ). Specific sections would be moved as follows: § 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 § 711.15; § 710.53 would become § 711.20; § 710.55 would become § 711.22; § 710.57 would become § 711.25; § 710.58 would become § 711.30; and § 710.59 would become § 711.35. Because all of the text of Subpart C would be moved to 40 CFR part 711, 40 CFR part 710 would no longer have a Subpart C. Neither part 71 0 nor part 711 would have any subparts.

3.1.2 Consolidation of Definitions As part of moving the regulatory text from 40 CFR part 710, subpart C to 40 CFR part 711, EPA is proposing to consolidate definitions copied from 40 CFR 710.3 and those currently found at 40 CFR 710.43 into the new 40 CFR 711.3, except where an appr opriate definition is already in place in section 3 of TSCA or at 40 CFR 704.3, and an additional definition of the term in 40 CFR 711.3 would therefore be unnecessarily duplicative.. The definitions at §704.3 woul d be incorporated by reference into proposed §711.3, except insofar as proposed §711.3 provides a modifi ed 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, it is not necessary to include hydrates separately in the defin ition of mixture. The Agency would continue to include such a discussion in the Instructions.3-2 3.1.3 Delete “Non-isolated Intermediate” Definition from §710.3

EPA added a definition to 40 CFR 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 m oved the definition to 40 CFR 710.3 from 40 CFR 710.43. EPA is proposing to delete the definition from 40 CFR 710.3 as this definition was not associated with the original Inventory, and therefore does not belong in 40 CFR 710.3. A definition of this term, codified elsewhere at 40 CFR 704.3, would be incorp orated by reference into the IUR definitions at proposed 40 CFR 711.3.

3.1.4 Delete Subpart B Text EPA is proposing to delete the regulatory text c ontained in 40 CFR part 710, §§ 710.23 to 710.39 (subpart B). This text refers to IU R submission periods of 2002 and earlier and is obsolete. As noted in § 710.1, the Agency expressed its intent to remove subpart B once the 2002 update was complete.

3.1.5 Delete Superfluous Text Associated With Reporting Production Volumes EPA is proposing to delete the phrase “provided th at the reported figures are within ±10% of the actual volume” from the production volume reporti ng requirements currently found in 40 CFR 710.52(c)(3)(iv) (proposed 40 CFR711.15(b)(3)(iv)). The revised wording would be, “This amount must be reported to two significant figures of accuracy .” The deleted phrase is superfluous because any number reported accurately to two significant figures is within ten percent of the correct value.

3.1.6 Correcting Text Associated With Reporting Number of Sites and Number of Workers EPA is proposing to replace the phrase “less than” with the phrase “fewer than” in the ranges used to report the number of workers currently found in the table in 40 CFR 710.52(c)(3)(v) (proposed 40 CFR 711.15(b)(3)(vii)) and the number of sites currently found in the table in 40 CFR 710.52(c)(4)(i)(E) (proposed 40 CFR 711.15(b)(4)(i)(E). This propo sed change would make the phrases describing the ranges grammatically correct.



### 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 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 IUR rule does not use the term manufacturer . In order to avoid any confusion with the definitions of these terms f ound at §704.3, the Agency is also proposing to add a3-3 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 §711.22 to clarify the reporting relationship between the contracting company and the toll manufacturer. The contracting company is primarily responsible for the IUR reporting, but in the event the contracting company does not report, the toll manufacturer must report. Both the company and manufacturer are liable if no report is made. Note the contracting company and the toll manufacturer should confer with each other to avoid duplicate reporting 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 substance 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 contracts 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 manufactured by the producing manufacturer and the person contracting for such production.” Also with this proposal, the term manufacturer would be defined under the IUR rule to mean “a person who manufactures a chemical substance.”

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. The proposed 40 CFR 711.3 definition of manufacture would allow persons contracting with a toll manufacturer to report the chemical physically manufac tured at the toll manufacturer’s site and the site identification information pertaining to the toll manufacturer’s site.

EPA identified the need to accommodate porta ble manufacturing units during the 2006 IUR submission period. Two examples of portable manufactu ring units are tanks used to manufacture calcium hydroxide slurry for use in building construction and road and highway projects, and tanks used to mix anhydrous ammonia and water to manufacture ammoni um hydroxide prior to application to agricultural lands. EPA is interested in including chemical ma nufacturing that is, for instance, performed by road crews or is occurring at construction sites at which ch emicals are mixed on site in such a manner to create a different chemical substance, e.g., asphalt emulsifier s. The site of physical manufacturing could change on a frequent basis. Manufacturers would report the a ggregated production volume for all of the portable manufacturing units sent out to different locations from a single distribution center. The address of the distribution center would be reported as the site location.

Under the proposal, the term site would be defined to mean “a contiguous property unit. Property divided only by a public right-of-way shall be consider ed one site. More than one plant may be located on a single site. For substances manufactured under contract, i.e., by a toll manufacturer, the site is the location where the chemical substance is physically manufactured. The site for an importer who imports a chemical substance described in §711.5 is the U.S. site of the operating unit within the person's organization directly responsible for importing the subs tance. The import site, in some cases, may be the organization's headquarters in the United States. If ther e is no such operating unit or headquarters in the United States, the site address for the importer is the U.S. address of an agent acting on behalf of the importer who is authorized to accept service of pro cess 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 e-IURweb. The Agency is adding these terms to provide clarity to the propo sed requirement for electronic reporting of IUR data.3-4 The term CDX means “EPA’s centralized electronic document receiving system, or its successors, including associated instructions for registering to submit electronic documents.” The new definition would make the term c onsistent with the new Premanufacture Notice (PMN) definition. The term eIURweb means the “electronic, web-based 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 the terms c ommercial use and consumer use in order to make them more consistent with the defi nitions developed collaboratively by the United States and Canada. The proposed definitions for these two terms differ in wording from the Canadian version to ensure the use of terminology defined in IUR a nd related regulations, and EPA believes the basic application of these two terms woul d not differ from the basic application of the Canadian definitions. The term c ommercial use would mean “the use of a chemical substance or a mixture containing a chemical substance (including as part of an article ) in a commercial enterprise providing saleable goods or services.” Examples included in the § 710.43 definition would be eliminated. The slightly modified definition of consumer use would be “the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) when sold to or made available to consumers for their use.” The restrictions associated with where a consum er would use the product would be removed.

EPA is proposing to add a definition for the term industrial function. For the 2006 IUR, EPA defined industrial use and did not define industrial function . The inclusion of both definitions provides clarity for the industrial processing and use reporting requireme nts and would make the Agency’s requirements consistent with those collaboratively deve loped with Canada. With this proposal, industrial function would mean “the intended physical or chemical charac teristic for which a chemical substance or mixture is consumed as a reactant; incorporated into a form ulation, mixture, reaction product, or article; repackaged; or used.”

3.2.5 Principal Reporting Year 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.” These changes are to indicate 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 remove the refere nce 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 latest complete calendar year proceeding the submission period and in which manufacturing, processing, and use ac tivities associated with the data reported to EPA during an IUR submission period occur. Production vol ume for manufacturing activities in other years of the reporting cycle may also be reportable during the submission period, but full manufacturing, processing, 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.”3-5 

### 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 IU R submission period, 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, unless th e substance was partially exempt.. EPA is proposing three changes related to the reporting thresholds: (1 ) determination of whether you meet the 25,000 lb. threshold, (2) elimination of the 300,000 lb. thr eshold for reporting information in Part III, and (3) elimination of the 25,000 lb. threshold requirement for certain chemicals.

3.3.1 Method for Determining Whether a Manufacturer i s 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 involves determining that an entity manufactured (including imported) a chemical substance listed on the TSCA Inventory during the principal reporting year (e.g., 2005 for the 2006 IUR reporting cycle); the chemical substance was not otherwise exempt; and the associ ated production volume (domestically manufactured plus imported volumes) met or exceeded the 25,000 lb . threshold for the principal reporting year (e.g., 2005 for the 2006 IUR reporting cycle). EPA is not proposing to change the method for determing whether a manufacturer (including importer) is subject to IUR reporting requirements for the 2011 submission period. EPA is proposing to modify the method used to determine whether a person is subject to IUR reporting for submission periods sub sequent to the 2011 submission period. The proposed method for submission periods subsequent to 2 011 would be to determine whether, for any calendar year since the last principal reporting year, a chemical was manufact ured (including imported) at a site in production volumes of 25,000 lb. or greater. For example, assume the next submission period occurs in 2015. The principal reporting year for the 2011 submission period is calendar year 2010. Therefore, for the 2015 submission period, it would be necessary to examine the annual production volumes for the years 2011 to 2014 for the site. If the production volume for a reporta ble chemical substance were 25,000 lb. or greater for any calendar year during that four-year period, then it would be necessary to report the chemical substance, unless it is otherwise exempt. For instance, a subject chemical with production volumes of 5,000 lb. in 2014 and 35,000 lb. in 2012 would be reported for the 2015 IUR. Regardless of the 2014 production volume, in this example scenario the 2015 IUR submission would contain detailed information based on manufacturing during the 2014 calendar year and produc tion volume information only for the years 2011 through 2013.

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 for all IUR reportable chemicals. The exposure information is an essential part of developing risk ev aluations and, based on its experience in using this information, the Agency believes collecting this ex posure information is critical to its mission of characterizing exposure, identifying potential risks, and noting uncertainties for these lower production volume chemicals. In addition, this change will provide the public with information on a greater number of chemicals. In the 2003 Amendments final rule (68 FR 848, January 7, 2003), EPA acknowledged the value of information for chemical substances manufac tured in lower volumes and stated if the Agency were to find it necessary in the future, it would collect information on chemical substances at reporting thresholds below the thresholds that were introduced in that action (i.e., 25,000 lb. and 300,000 lb.).3-6 The Agency explored setting the threshold for reporting processing and use information at an alternate level between 25,000 lb. and 300,000 lb. fo r this action (EPA, 2008c). However, the need to complete characterizations for chemicals manufactured (including imported) in volumes of 25,000 lb. to 300,000 lb. in any year led the Agency to believe it would be best to eliminate the upper threshold and collect full information for all reported chemicals.

3.3.3 Eliminate the 25,000 lb. Threshold fo r Cer tain 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, regardless 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 ch emicals that are: (1) the subject of a rule 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 agreement (ECA), pursuant to procedures at 40 CFR part 790, with a manufacturer of a chemical substance, to obtain testing where a consensus exists among EPA, affected manufacturers and/or processors, and interested members of the public concerning the need for and scope of testing. Chemicals covered by ECAs ar e of demonstrated high interest to EPA. The Agency has an interest in identifying the manufacturing, pr ocessing, and use of substances under such agreements, and therefore is proposing to require such substances be reported for IU R purposes, regardless of whether the substance otherwise meets the requirements lis ted in 40 CFR §710.46 (proposed 40 CFR §711.6) as an exempt or partially exempt chemical substance. This provision will ensure the availability of current information if EPA has expressed a concern in the 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. 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 ineligible for an IUR ex emption, in the introductory paragraph of 40 CFR 710.46 (proposed 40 CFR 711.6) listing the other chemicals likewise not e ligible for an IUR exemption. The paragraph would state a chemical “is not exempted from any of the repor ting requirements of this part if that substance is the subject of a rule proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent agreement developed under the procedures of 40 CFR Part 790, or is the subject of an order issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of the Act.”

3.4.2 Full Exemption for Manufactured Water Naturally occurring water is excluded from reporting 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)).3-7 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), Dextrin (CASRN 9004-53-9), and Maltodextrin (CASRN 9050-36-6). Improperly including substances meeting the 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 & Bradstreet (D&B) number to identify the company associated with the plant site, and also to report the site name, address, and D&B number. If the company associated w ith the plant site does not have a D&B number, the manufacturer must obtain a D&B number for the company. 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 the comp any name provided be the ultimate domestic parent company name. EPA believes this change will redu ce confusion by making this reporting requirement consistent with the Toxic Release Inventory (T RI) requirements for parent company name. The requirement that the ultimate domestic parent company 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 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. EPA therefore is 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 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 where 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. In these cases, the manufacturer (including importer) and the supplier report the information required in this part in a joint submission (See Section 3.12).3-8 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 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 I nventory substance has either (or both) a CASRN or a TSCA Accession Number, which are likely to be already known to the submitter. Furthermore, the Agency spends considerably more time and effort to access and review reported information identified only 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 vo lume for each year since the last principal reporting year. Thus, for the 2011 IUR submission pe riod, manufacturers (including importers) of a subject chemical who determine they are subject to IUR reporting requirements as described in Section 3.3.1 would report the production volume of that chemical for the following calendar years: 2006, 2007, 2008, 2009, and 2010. Collecting th e production volume for multiple years would provide EPA with more accurate and up-to-date information than what is provided under the current, once-every-five-years snapshot.

3.5.5 Volume of Chemical Substance Used On-Site EPA is proposing to require submitters to report th e volumes of a manufactured (including imported) chemical substance used at the reporting site. The requirement to report the volume used on-site is replacing the requirement to indicate 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 domestically manufact ured chemicals, consumed entirely at the site of manufacture, should be reported as site-limited.

3.5.6 Indicate Whether Imported Chemicals Are Ph ysically 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 Re worked EPA is proposing to add a requirement to indicate via a check-box whether a manufactured chemical, such as a byproduct, is to be recycled, remanufact ured, reprocessed, reused, or reworked. Submitters3-9 would identify 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., it is being recycled, remanufactured, reprocessed, reused, or reworked). EPA believes such information will help the Agency identify where these activities are already occurring, an d can be used to encourage such activities. Collecting information on whether a chemical is being recycled, remanufactured, reprocessed or reused and is not entering the waste stream provides valuable information to EPA and others regarding trends in chemical manufacturing. This information also can be used to help determine the effectiveness of various programs, such as EPA’s Resource Conservation Ch allenge (RCC) Program. EPA launched the RCC in 2002, implementing Congress’ instruction to prevent pollution and conserve natural resources and energy by managing materials more efficiently. The RCC Progr am’s goals include promoting reuse and recycling and reducing chemicals of national concern in products and waste. Indicating a manufactured chemical, such as a byproduct, is to be recycled, remanufactur ed, reprocessed, reused, or reworked does not affect the reporting requirements associated with any substance manufactured from the byproduct.



### 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 ( NAICS) codes. EPA foundthat knowing these two data elements for a chemical substance was useful in sel ecting a scenario characterizing 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 characterizes 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 revise the list of industrial function categories by combining categories leading 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 facilitate the exchange of inform ation between EPA and Canadian agencies and could serve as a model to be used by Mexico in developing an inventory of chemical s ubstances. In addition, the harmonized categories would facilitate c onsistent reporting of chemical use information by industry in the United States and Canada. 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 industrial fu nction categories would increase to 35. Also, EPA is proposing to rename several of the industrial f unction categories to provide a more informative description of the function of the chemical substances that should be reported in that category. Lastly, EPA is proposing to require that if a submitter selects the category “Other,” the submitter must provide its3-10 own description of the industrial function of the chem ical 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 sectors were adapted from the European Union’s (EU’s) “Guidance on information requirements and chemical safety assessment.” The Industrial Sectors chosen divide the entire range of NAICS codes into sector s so there is a sector corresponding to any NAICS code. The Agency believes this change would provid e several benefits. First, the sectors would reduce reporting burden because submitters would not have to look up the NAICS code. Second, it would encourage more complete reporting by using terms al ready familiar to industry. Third, the sectors would reduce the likelihood of errors that result from the se lection of miscellaneous or inappropriate NAICS codes. Fourth, it would reduce the number of codes that could apply to one substance. 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 corresponding to th e actual use of the chemical substance they were 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 leading to common exposure scenarios and adding categories not adequately described in the initial set of categories. EPA worked with Envir onment Canada and Health Canada to develop the proposed categories. The proposed list includes 33 pro duct categories, including “Other.” Examples of new categories thathave been added include explos ive materials, building/construction products not covered elsewhere, and air care products. The glass a nd ceramic products categor y had relatively few IUR submissions in 2006 and overlaps with proposed new categories, and so has been proposed for elimination. Also, several of the consumer and comme rcial product categories would be renamed to better describe the products 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 use or a commercial use, or both

. The Agency’s experience using the 2006 IUR data identified a need to distinguish between potentially exposed consumer and commercial populations. The designation of consumer or commercial use, or both, would allow EPA to complete a better characterization of the potentially exposed populations.

3.8.3 Number of Commercial Workers Reasonably Likely To Be Exposed EPA is proposing to require submitters to report th e 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 workers3-11 would be reported using the same definitions and ranges used for manufacturing and industrial processing and use workers, required by 40 CFR 710.52. The propo sed ranges 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 worker s, and 8) at least 10,000 workers.



### 3.9 Changes to Standard for the Reporting of Processing and Use Information
In order to collect more complete information regarding the industrial processing and industrial, commercial, and consumer use of chemicals, EPA is proposing in § 711.15(c)(4) to replace the “readily obtainable” reporting standard used for reporting under 40 CFR 710.52(c)(4) in 2006 with the “known to or reasonably ascertainable by” reporting standard set forth under TSCA for this type of TSCA reporting. TSCA section 8(a)(2) authorizes EPA to require pers ons to report information “known to or reasonably ascertainable by” the submitter. This is the same st andard that currently applies to the reporting of information described in the regulations at §§ 710.52 (c)(1), (c)(2), and (c)(3), and this standard would continue to apply to the reporting of such informa tion under proposed §§ 711.15(c)(1), (c)(2), and (c)(3). It covers all information in a person’s possession or control, plus all info rmation a reasonable person similarly situated might be expected to possess, control, or know. The “known to or reasonably ascertainable by” reporting standard was the only sta ndard used for IUR reporting purposes prior to the 2006 IUR submission period. EPA is proposing this change to the reporting standard because reporting under the “readily obtainable” reporting standard did not generate suffi ciently complete processing and use information, which limited the usefulness of the 2006 IUR processi ng and use data for screening level reviews. EPA believes the “readily obtainable” reporting standard w as a major reason for the small amount of reporting processing and use data.



### 3.10 Modifications to Confidential Bu siness 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 711.30). 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 the proposed changes 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 im prove 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 711.30(b)). At times a3-12 submitter will assert a claim of confidentiality for the chemical identity of a substance listed on the public portion of the Master Inventory File. Where the identity of a chemical substance is already provided on the public portion of the TSCA Chemical Substances Inventory, which is publicly available from the National Technical Information Service, EPA's we bsite and other sources, EPA believes the identity itself, even assuming it might otherwise be CBI, as well as any information that might be derived from it about processes or portions, has already been disclosed

. EPA is proposing, 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 711.30(e).

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 has reason to believe 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, subm itters made confidentiality claims for 25 to 50 percent of the reported processing and use information. While the Agency does not questionconfidentiality claims are so metimes necessary, it encourages su bmitters to consider carefully whether such claims are in fact necessary before asserting them. The Agency has identified instances in which submitters have claimed the processing and use data as confidential, yet similar if not identical information was found in publicly available sources, such as company websites, published Material Safety Data Sheets (MSDSs), or information submitte d to the Agency and posted on the Agency’s HPVIS website. EPA can take steps to challenge or veri fy confidentiality claims, but the Agency believes companies should limit their CBI claims to those they are capable of adequately substantiating. For the 2006 IUR, submitters were not required to provide upfront 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 writi ng by answering certain questions provided in§ 711.30(d) of the proposed rule. Where a submitter fails to substantiate the processing and use CBI claim in accordance with the applicable rules (i.e., the submitter does not provide an answer to the required questions), EPA would consider the information not subject to a confidentiality claim and may make the information available to the public w ithout further notice to the submitter.

3.10.3 Limitation on Confidentiality Claims for Data Elements Identified as “Not Known or Rea sonably Ascertainable” Under the IUR rule, submitters provide inform ation on the industrial processing and use, and consumer and commercial uses of the IUR reportable chemicals they manufacture (including import). For the 2011 and future IUR collections, EPA is proposing submitters be required to report this information to the extent it is known to or reasonably ascertainable by them. For the 2006 IUR collection, submitters reported the processing and use information to the extent it was readily obtainable, and were permitted to identify when such information was not readily obt ainable by entering “NRO.” EPA has observed, on occasion, processing and use information has been cl aimed as confidential when a submitter determined the information was not readily obtainable.



### 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 the3-13 submissions were made electronically, and EPA was able to immediately process and quickly begin to use the information from those electronic submissions. Submissions sent as a file on a CD 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-IURweb) to complete the IUR Form U and the CDX to submit th e completed Form U to the Agency. CDX users are required to register with CDX and to s ubmit an authorized signature agreement.

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 (http://www.ep a.gov/iur/tools/software.html). For the 2011 submission period, EPA will provide a free, web-ba sed application in place of the 2006 downloadable software. The 2011 e-IURweb software features several enhancements over the 2006 e-IUR software, such as a sophisticated validation system, which woul d 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 submi ssions and amendments.

3.11.2 Require Electronic Submissions over the Internet EPA is proposing to require manufacturers (including importers) to submit their IUR reports to the Agency through CDX via the Internet. EPA would re quire all submissions to be generated using eIURweb reporting software. Electronic submissions would ensure IUR data will have completed a basic validation check, could be incorporated quickly into a database and be ready for immediate Agency use, and would not be subject to s ubsequent data entry errors. Furthermore, EPA believes the required use of e-IURweb and CDX would reduce the reporting burden on industry by reducing both the cost and the time required to review, edit and transmit data to th e Agency. After the final rule’s effective date, EPA would no longer accept paper submissions or electronic media (i.e., as a file on a CD) for any IUR submission.

3.11.3 Electronic Signature Process In order to submit electronically to EPA via C DX, individuals acting on behalf of the submitter must first register with CDX. CDX registration is a requirement for all electronic submissions using CDX and is not being introduced with this proposal. During the 2006 IUR, subm itters were required to complete an electronic signature agreement (ESA) and to submit the agreement in hard copy with a wet ink signature to EPA in order to complete the CDX registration. There was confusion among some submitters regarding the correct identity of the indivi dual eligible to register for CDX and the individual required to sign the ESA.

EPA is making changes to the registration process in order to address problems identified during the 2006 IUR electronic reporting. For 2011 IUR reports, EPA is modifying the 2006 ESA to identify more clearly the individual(s) required to sign the agre ement. The Agency is developing an ESA process similar to that planned for New Chemicals Program electronic submissions. Each IUR submission must have an authorized official associ ated with the submission, who is the person signing the certification statement and submitting the IUR report via CDX. The au thorized official would need to complete both an ESA and the CDX registration process3-14 

### 3.12 Modifications Specifically Affecting Importers
Submitters report IUR data on chemicals they manuf acture domestically and import into the United States. Current IUR regulations require the site respons ible for reporting for imported chemicals to be the site of the operating unit directly responsible fo r importing the substance and controlling the import transaction. In some cases, the import site may be the organization’s headquarters in the United States. The regulations defining the site for importer reporting are found in both the definition for site in §710.3 and in paragraph §710.48(b). EPA is proposing to eliminate unnecessary duplication 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 submitters occasionally use a foreign address as the site address for the importer. EPA now is proposing to require submitters to report a U.S. site address, by modifying the definition for site to state specifically 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 directly responsible for importing th e substance and controls the import transaction has no U.S. address. The Agency expects all importers will have a U.S. site, as defined in the proposed § 711.3 de finition for site because, under Cust oms regulations at §141.18, a nonresident corporation is not permitted to enter merc handise for consumption unless it has a resident agent in the State where the port of entry is located, who is authorized to accept service of process against the corporation. For purposes of IUR, 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 the IUR information is submitted to EPA and may do so by submitting a joint report. To do so, the U.S. importer, as the 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 same, except submitters would be required to use CDX and e-IURweb 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 electronica lly, the primary submitter would use e-IURweb 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) manufactured using a chemical substance made by the secondary submitter. The primary submitter reports only the volume that it used. A secondary submitter would also need to use e-IURweb to identify the need to submit a joint report and would identify itself as a secondary submitte r. It would provide the primary submitter’s company information and its own technical contact information, and would identify the chemical substance(s) in its product, including the percenta ges. This information would be saved by the reporting3-15 tool and both submissions would be matched based upon company and chemical information. Once the forms were 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. EPA often had no way to determine whet her a submission was a “joint” submission, which increased the time required for manual processing of th e data. EPA anticipates the use of the reporting tool would help to make joint 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 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 reporting every five years does not provide data sufficiently current to meet Agency and public needs. 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 annu al reporting. The Agency believes efficiencies are gained with more frequent reporting, both for the submitter and for EPA. With more frequent reporting, companies would be able to establish standard systems and practices to collect the required information.4-1 

## 4. Industry Burden a nd 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 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 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 staff; 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 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 re porting threshold. Each report is submitted for a unique chemical/site combination. The 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 chemicals not falling into one of the categories exempt from reporting; (2) the annual production or import 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 it must s ubmit a Form U, staff must familiarize themselves with the requirements of the rule. Sit es reporting previously must become familiar with new requirements, and sites new to reporting must become familiar with all requirements. This entails reading the rule, understanding the various re porting 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 it must submit a Form U for a chemical and has become familiar with the rule, 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.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”, “Professional 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 outlin ed in EPA, 2002b, fringe benefits are calculated as a percentage of total wages for each category. An additional 17 percent is added to the wages in each category to account for overhead, based 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 cat egories are 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 Employee Compensation Supplementary 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 Analys is for the Amended Inventory Update Ru le: Final Report (EPA, 2002a).

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 whet her it must comply with the IUR rule. Sites that4-3 arerequired to report then must become familiar with the 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 file only one Part I of Form U, regardless of the number of reportable chemicals it manufactures or imports. The in formation required in Part I, such as site and company identification, are common to all chemicals pr oduced 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 maili ng costs, and are calculated per-site. Recordkeeping costs are calculated as per-report costs (so total repor ting and recordkeeping 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; and

• 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 analysis. The economic analysis for the 2005 Amendments assumed a 15 percent reduction in burden for the completion of Part III because submitters no longer were required to report use and dow nstream processing information for exports. 3 Therefore, this 15 percent reduction was applied to all 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 burde n estimates, per site, to

co mplete and submit a Form U (one report for one chemical).

3 In the 2005 economic analysis, EPA estimated 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.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 Burden0.00 0.000.000.00Part I.Site Identification Information(Total Burden for Part I)0.76 0.95 1.05 2.761 Certification0.68 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 0.563.36Chemical Identification Upfront CBI Substantiation 0.26 1.45 0.672.38Plant Site Upfront Substantiation0.12 0.83 0.51 1.46Total Number of Workers0.21 1.43 0.59 2.234-5ClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Maximum 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 0.131.010.28 1.42Industrial Function Category2.11 4.41 2.078.59Function Code0.19 0.94 0.40 1.52Percent of Production Volume1.23 10.00 5.2716.51Total Number of Processing and Use Sites1.57 9.14 3.5214.24Total Number of Potentially Exposed Workers 2.10 15.43 3.8321.362 Consumer and Commercial UseExposure-Related DataDetermination of Applicability 0.140.940.25 1.33Identification of Production Category/Use byChildren0.14 0.84 0.25 1.23Percent of Production Volume0.20 1.26 0.451.91Maximum Concentration by Category0.11 1.36 0.341.81Total 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).4-6 The survey conducted for the economic analysis for the Final TSCA IUR rule 2003 Amendments (EPA, 2002a) estimated a single burden for reporting site-limited activity and production volume. This burden is estimated to be 3.36 hours per 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 burde n equivalent to all four questions combined. To estimate more accurately the burden of several pr oposed amendments, EPA used its best professional judgment and estimated the percent burden each activity contributed 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 site-limited 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

Source: Revised Economic Analysis for the Amende d Inventory Update Rule: Final Report (EPA, 2002a).

4.2.3 Estimates of Baseline Submission (Mailing) Costs As noted above, the baseline scenario in this analysis is the total cost 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 Expe dited 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, 20094-7 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 hours in Section 4.2.2, and the mail-in submission costs derived in Se ction 4.2.3. The burden hours for each occupation category are multiplied by the corresponding wage rate t o calculate the baseline cost per site of completing each section of Form U. EPA estimates the total cost per site of submitting and completing a partial report (Parts I, II, recordkeeping and submission costs) for the first time is $3,188. EPA estimates 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 $7,247, for one chemical. Table 4-5 contains the submission costs by section for first-time submitters, including the costs for com pliance determination, rule familiarization, report preparation, report submission, and recordkeeping costs.4-8Table 4-5: Baseline First-Cycle Total Cost per Form U (2008$)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 Upfront CBI Substantiation $7.40$85.32$53.57$146.29Plant Site Upfront Substantiation$3.42 $48.84 $35.57 $87.97Total Number of Workers$5.98 $84.14 $40.97 $131.094-9Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Maximum 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).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 . Because there is a cost difference between the two types of reports, the total number of reports is br oken down into sites that filed full reports and sites that filed partial 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 because of the low co mpany turnover 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 pu rposes of this analysis, EPA assumes the baseline number of reports submitted will not change from the 2006 submissions. In 2006, a total of 4,085 sites completed 25,896 reports 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 a nd 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 lb. to 25,000 lb., it was not possible for EPA to compare records to determine whether the number of sites and reports submitted for a consistent set of chemicals had changed significantly between the two reporting cycl es. Such an analysis po tentially could provide support for EPA’s assumption the number of sites a nd reports will remain relatively unchanged in the next reporting cycle. Therefore, to the extent changes in the chemical industry unrelated to the proposed IUR rule amendments could affect the number of site and reports submitted, th is analysis may under- or overestimate costs and burden.

4.2.6 Estimates of Future Reporting Cycles’ Labor Hours (Burden) EPA assumes sites that previously have submitted a Form U will incur a reduced 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 the need tobecome familiar with the revised requirements. However, the Agency assu mes 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 efficiencies achieved through th e 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 previously submitted a Form U. The burden estimates for these sit es are weighted to reflect this decreased burden (EPA, 2002a). Table 4-7 contains the weighting f actors for each secti on of the form. Table 4-8 contains the baseline, future reportin g 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 reporti ng cycle costs per report, whic h are calculated using the wage rates in Table 4-1 and the hourl y burden estimates from Table 4-8.4-11 Table 4-7: Weighting Factors for Burden Estimate s for Sites That Have Previously Submitted a Form U

Section of Form U Percent of Initial Burden Incurred 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 Amen ded Inventory Update Rule: Final Report (EPA, 2002a), pp. 3-17.4-12Table 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 Burden0.000.000.000.00Part I.Site Identification Information(Total Burden for Part I)0.69 0.87 1.02 2.581 Certification0.68 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 Upfront CBISubstantiation0.21 1.16 0.61 1.98Plant Site Upfront Substantiation0.10 0.66 0.41 1.174-13ClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Total 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 0.100.81 0.23 1.14Industrial Function Category1.693.531.656.87Function Code0.15 0.75 0.32 1.21Percent of Production Volume0.998.004.2213.21Total Number of Processing and Use Sites1.267.312.8211.39Total Number of Potentially Exposed Workers 1.68 12.343.0617.092Consumer and Commercial Use Exposure-RelatedDataDetermination of Applicability 0.120.75 0.20 1.06Identification of Production Category/Use byChildren0.12 0.67 0.20 0.98Percent of Production Volume0.161.010.361.53Maximum Concentration by Category0.091.090.281.45Total 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.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 Cost for Form U Compliance Determination)$0.00 $147 $0.00 $147Rule Familiarization(Total Cost 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 Cost for Form U Submission)$13.78Mailing Cost$13.78Part I.Site Identification Information(Total Cost 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 Cost 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 Upfront CBISubstantiation$5.92 $68.25 $42.86 $117.03Plant Site Upfront Substantiation$2.73 $39.07 $28.57 $70.37Total Number of Workers$4.78 $67.31 $32.77 $104.874-15Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Maximum 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.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 recordkeeping were estimated on a per-report basis.

Table 4-10 shows the total burden and cost to indus try under the current baseline. The current IUR rule would cost industr y approximately 1.84 milli on hours and $106.97 million during the 2011 reporting cycle.

Table 4-10: Total Baseline Cost and Burden to Industry (2011 Reporting Cycle)
Burden and Cost

for All Part Is, Rule Familiarization,

Compliance Determination and Submission Burden and Cost for All Part IIs and Recordkeeping Burden and Cost for All Part IIIs Total Burden and Cost 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 industr y 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 t he baseline burden estimates found in Table 4-2 and Table 4-5. In all future reporting cycles, EPA esti mated the baseline burden to industry to be approximately 1.43 million hours and $82.82 million.

Table 4-11: Total Baseline Cost and Burden to Industry (Future Reporting Cycles)
Burden and Cost

for all Part Is, Rule Familiarization,

Compliance Determination and Submission Burden and Cost for all Part IIs and Recordkeeping Burden and Cost for all Part IIIs Total Burden and Cost 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 inconsistenc ies and lim itations 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 the number of sites and reports will remain relatively unchanged in the next reporting cycle.4-17 Therefore, to the extent changes in the chemical i ndustry unrelated to the proposed IUR rule amendments could affect the number of site and reports 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 information about each of these proposed amendments. In each of the following se ctions, 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 am endments.

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 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),” “e-IURweb,” 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 community. Therefore, EPA does not expect changes to definitions to impact industry burden or cost.

4.4.3 Method for Determining Whether a Manufacturer i s 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. repor ting threshold during the principal reporting year. EPA is proposing to modify the timeframe for reporti ng, so chemical manufacturers (including importers) will be subject to the IUR rule if a chemical’s production volume has exceeded the threshold in any calendar year since the last principal reporting year. This modification would not take effect until after the first post-amendment reporting cycle (2011); for the first reporting cycle, submitters would still consider production volume for only the principal reporting year. EPA believes this proposed amendment will cause an increase in the numbers of submitters and reports in future reporting cycles. Because data on the production volume of chemicals reportable under the IUR rule during non-principal reporting years curren tly is not available, the actual percentage increase in these numbers is unknown. The Agency, using its best professional judgment, estimates for the purpose of this analysis, the amendment will increase the numb er of submitters and reports in future reporting cycles by approximately five percent. Using an estimated five percent increase over the baseline number of sites and reports (baseline presented in Table 4-6), EPA estimates204 additional s ites will submit reports in future reporting cycles. EPA further estimates those sites will submit an additi onal 854 full reports and 4 41 partial reports, for a total of 1,295 additional reports for 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 th e baseline unit burden estimates as shown in Table 4-2 and Table 4-8, Table 4-12 shows the industry burden estimate as a result of this prop osed amendment. The Agency4-18 estimates the amendment will not cause a change in i ndustry burden during the 2011 reporting cycle, but will generate an increase of approximately 71,700 hours during all future reporting cycles.

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 1,842,934
First Cycle,PostAmendment 33.26 4,085 19.82 25,896 69.92 17,075 1,842,934

Change from the Baseline, First Cycle 0.00 0 0.00 0 0.00 0 0

Future Cycle Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833
Future 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 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 4-13 shows the industry cost estimate as a result of this pr oposed amendm ent. EPA estimates the amendment will not cause a change in industry cost in the first reporting cycle, but will increase costs by $4.14 million in all future reporting cycles.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 $106.97
First Cycle,PostAmendment $2,058 4,085 $1,129 25,896 $4,059 17,075 $106.97

Change from the Baseline, First Cycle $0 0 $0 0 $0 0 $0.00

Future Cycle Baseline $561 4,085 $968 25,896 $3,247 17,075 $82.82
Future 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 corresponding baseline value from the postamendment value.

Limitations of Analysis. To the extent the change in method for determining whether a manufacturer is subject to the IUR reporting requirements causes an increase in numbers of sites and reports submitted that is higher or lower than five percent, this an alysis may under- or overestimate the total burden and cost increase. A sensitivity anal ysis is performed in Appendix F.1. In the pro posal, 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 burd en 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. threshold 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, fo rms with only Part I and Part II completed) is 8,821 (see Table 4-6). However, sev eral of these reports are submitted for partially exempt chemicals. Under the proposed amendment, submitters of partially exempt chemicals 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.4-20 Using the baseline unit burden estimate as shown in Table 4-2 and Table 4-8, Table 4-14 shows the industr y burden estimate as a result of this propo sed amendment. The Agency estimates the amendment will cause an increase in industry burden of approximat ely 573,500 hours during the first reporting cycle, and 458,800 hours during all future reporting cycles.

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 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 4-15 shows the industry cost estimate as a result of this pr oposed amendm ent. EPA estimates the industry cost will increase by $33.3 million in the 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 exposure-related processing and use information would be collected for High Production Volume (HPV) chemi cals. However, the uncertainty that thresholds lower than 300,000 lbs. would capture substantially more of the HPV chemicals, coupled with the need to complete characterizations for chemicals manufactured (including imported) in volumes of 25,000 lb. to 300,000 lb., led the Agency to believe it would be best to eliminate the 300,000 lb. threshold altogether and collect full information for the all reported chemicals

.4-21 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 subtracting the corresponding baseline value from the postamendment value.

Limitations of Analysis. EPA is assuming each partially exempt chemical is produced at four different sites. To the extent 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 fo r Cer tain Regulated Chemicals EPA is proposing to eliminate the 25,000 lb. threshol d for chemicals that are: (1) the subject of a regulation promulgated under 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 manufacturers (including 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 Partial 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. Because the proposed amendment would affect only chemicals s ubject to a promulgated rule, this figure is an overestimate. 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 with CAS numbers, no reports were filed for 652 chemicals, or 88 percen t (EPA, 2009e). EPA also assumes no reports were filed for 88 percent of the 391 chemicals with accession number s, 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 estimatesreports will now be filed for approximately 1,005 additional chemicals for which reports ar e 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 the reports generated by this amendment would be for production volumes lower than 25,000 lb. (therefo re, lower than 300,000 lb.), so, as a result of this amendment alone, submitters would not be re quired to complete Part III (see Section 4.5 for an estimate of the aggregated i mpact of all proposed amen dments). In addition, the Agency is assuming manufacturers (including importers) of these chemical s already would be submitting reports for other4-22 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 completion of Part II as shown 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 the amendment will cause an increase in industry bu rden of approximately 79,600 hours during the first reporting cycle and 68,500 hours during all future reporting cycles.

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 pr oposed 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 manufacturers (including importers) already are submitting reports for these chemicals. That is, to th e extent some portion of these chemicals already are subject to IUR reporting because they are produced in volumes of 25,000 lb. or greater, the Agency is overestimating the number of additional reports it would receive as a resu lt of the amendment. Furthermore, to the extent manufacturers (including importers) of these chemicals do not already submit reports for other chemicals, EPA is underestimating the number of sites would increase from the baseline as a result of this amendment.4-23 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. Manuf acturers (including importers) of these chemicals no longer would be partially ex empt, and so must complete Part III of Form U. 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 showing 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 currently bein g subject to an ongoing ECA. Therefore, only two chemicals would lose the partial exemption under the proposed amendment, and so would need to complete Part III of Form U. In addition, EPA is assuming an additional two chemicals could be under ECAs in future reporting cycles. Therefore, EPA is estimating the proposed amendment would cause submitters of a total of four chemicals to complete Part III of Form U. Based on data from the 2006 IUR reporting cycle, the Agency estimates approximately four sites produce each chemical (EPA, 2008c); therefore, a total of 16 Part IIIs would be submitted fo r the first time for chemicals subject to an ECA. Using the baseline unit burden estimate for completion of Part III as shown in Table 4-2 and Table 4-8, Table 4-18 shows the industry burden estimate as a result of this prop osed amendment. The Agency estimates the amendment will cause an increase in indus try burden of approxim ately 1,100 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 pr oposed amendm ent. EPA estimates the4-24 industry cost will increase by $64,900 during the 2011 reporting cycle and by approximately $52,000 during all future reporting cycles.

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 each of these chemicals is produced at four different sites. To the extent this is not the case, this analysis may over- or underestimate the number of additional Part IIIs. In addition, some of these chemicals may be pr oduced in volumes of 300,000 lb. or greater, and therefore would already be required to submit a full repor t. To the extent this is the case, this analysis overestimates the total number of additional Part IIIs. Finally, to the extent additional chemicals become subject to ECAs in the future, this 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 producing manufactured water only need to comp lete 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). EP A assumes manufactured water is a byproduct of chemical production. Therefore, sites submitting a report 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 in Table 4-2 and Table 4-8, Table 4-20 shows the reduction in i ndustry burden estimate as a result of th is proposed amendment. The Agency estimates the amendment will cause a decrease in industry burden of approximately 850 hours during the first reporting cycle, and 700 hours during all future reporting cycles.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 subtracting the corresponding baseline value from the postamendment value.

The cost savings due to the amendment were determined 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 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 subtracting the corresponding baseline value from the postamendment value.

Limitations of Analysis . EPA is assuming the sites producing manufactured water are also producing other chemicals above the reporting threshold, and w ill continue to submit a Form U, which may not be the case for all sites. In that case, the above estimat e 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 fully exempt from reporting. EPA expects this proposed amendment will not impact industry burden or costs, because these substances curre ntly 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 and EPA assumes it will not change the behavior of the regulated community.

4.4.9 Parent Company and Site Identity EPA is proposing submitters provide the name, address, and D&B number of their ultimate domestic parent company, as well as for the site. This informat ion was required as part of Form U prior to the 2006 amendments, so the 2002 economic analysis, on whic h these burden estimates are based, already included4-26 the cost of providing the information for the ultim ate domestic parent company. The proposed rule will now be consistent with the 2002 analysis, and EPA assumes 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 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 this amendment will not cause an increase in burden.

4.4.11 Chemical Identity EPA is proposing to require IUR submitters to 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 identifying number or, in the case of confidential chemical substances, the accession number. Note 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 all manufacturers (including importers) know or can easily obtain the CA Index Names and CASRN numbers for the chemicals they produce. Therefore, EPA assumes no additional burden will be incurred by requiring submitters to report the CA Index Name and CASRN as the chemical identity instead of whichever 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 submitters to report pr oduction volume for 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 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 there will be an increase in burden as the result of gathering data and reporting production 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 approximately 45 percent of these 3.36 hours (i.e., 1.51 hours) is attributed to gathering production volume information. (See Table 4-3 for an ex planation of this percentage breakdown. ) Therefore, the Agency estimates a site would spend an additional 6.05 hours (i.e., 1.51 x 4) to gather 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 the amendment will cause a total in crease in industry burden of approximately 156,600 hours in the first reporting cycle and 125,300 hours in all future reporting cycles.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 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 4-23 shows the industry cost estimate as a result of this pr oposed amendm ent. EPA estimates the industry cost will increase by $8.77 million in the 2 011 reporting cycle 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 subtracting the corresponding baseline value from the postamendment value.

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

4.4.13 Volume of Chemical Substance Used On-Site Previous Form Us have required submitters to indicate whether a chemical was site-limited, referring to a chemical substance manufactured and/or pro cessed 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 the4-28 necessary information are similar. EPA estimates 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 this information would be reported, under th e amendment. In the data submitted to EPA for the 2006 reporting year, about 14.8 percent of reports in clude 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 not distributed (e ither as the chemical substance itself or in a mixture) outside the plant site for commercial purposes. Therefore, EPA assumes all chemicals used onsite must be chemical intermediates. Accord ing to data from the 2006 IUR database (EPA, 2008c), approximately 24 percent of all reports containing downstream processing and use information included chemicals used as intermediates. Therefore, EPA assumes 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 and 24, to estimate the increase in the 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 th is proposed amendment. The Agency estimates the amendment will cause a total increase in industry burden of approximately 7,600 hours during the first reporting cycle and 6,100 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 pr oposed amendm ent. EPA estimates the total industry cost will increase by $425,400 during the first reporting cycle and $340,300 during all future reporting cycles.4-29 Table 4-25: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume Used On-Site Cost to Report Production Volume Used On-Site (2008$) 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 the burden of reporti ng the production volume used on-site is different from the burden to report the total productio n 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 the percentage of reports containing downstream processing and use information that included chemicals used as intermed iates 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 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 s ubmitter must state whether the site’s chemical is manufactured or imported. The Agency estimates pr oviding this information requires 0.17 hours per report (see Table 4-3). EPA assumes the burden to indicate whether a chemical is physically on-site will be similar to the burden incurred to indicate whether a chemical is manufactured or imported, given the similarity of these activities to identify the necessary information. Table 4-26 shows the industry burden esti mates as a result of this proposed amendment. Th e Agency estimates the amen dment will cause a total increase in industry burden of approximately 4,400 h ours for the 2011 reporting cycle, and 3,500 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.4-30 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 pr oposed amendm ent. EPA estimates the total industry cost will increase by approximately $243,7 00 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 the burden of indicating whether a chemical is physically at the reporting site is different from the burden to report whet her a chemical is manufactured or imported, this analysis may over- or underestimate the burden and cost of this amendment. Furthermore, this requirement may apply only to importers; the number of reports affected, therefore, is 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 the bur den 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 it will ta ke a submitter 1.51 hours to provide the volume exported (see Table 4-3). Using the baseline unit burden esti mate as shown in Table 4-2 and Table 4-8, Table 4-28 shows the industr y burden estimate as a result of this propo sed amendment. The Agency estimates the amendment will increase industry burden by approximately 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.4-31 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 pr oposed amendm ent. EPA estimates 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
Cost 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 the burden of reporting the volume exported is different from the burden to report the total production volume, 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 Re worked 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. 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 t o be approximately 0.17 hours. Using the baseline unit burden estimate as shown in Table 4-2 and Table 4-8, Table 4-30 shows the industr y burden estimates as a result of this proposed amendment. The Agency estimates the amendment will cause a total increase in industry burden of approx imately 4,400 hours in th e first reporting cycle and approximately 3,500 hours during all future reporting cycles.4-32 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 Chemical 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.

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 pr oposed amendm ent. EPA estimates the cost to industry will increase by $243,700 for the 2011 reporting cycle 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 Chemical 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 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 it will have no impact on industry burden or cost.4-33 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 a small additional burden for submitte rs to familiarize themselves with the eight new categories; based on best professional judgment, EPA estimates 15 minutes of technical labor burden. EPA also estimates it would take three minutes of cler ical burden, and six minutes of technical burden to write in the text description if the submitter selects “Other”. According to 2006 IUR data (EPA, 2008a), the response “Other” was selected in 1,206 reports. Us ing its best professional judgment, EPA expects the new categories proposed in the IUR modifications rule will reduce by half the number of submitters selecting “Other” as an industrial function category. Therefore, EPA estimates this amendment would affect 603 reports. Using the baseline unit burden estimates as shown in Table 4-2 and Table 4-8, Table 4-32 shows the industr y burden estimate as a result of this propo sed amendment. The Agency estimates the amendment will cause a total increase in industry burden in the first reporting cycle of approximately 4,400 hours. In future reporting cycles, submitters will 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 pr oposed amendm ent. EPA estimates the industry cost will increase by approximately $255,6 00 in the first reporting cycle and $3,500 in the following reporting years.4-34 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 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 there is no burden for rule familiarization with the new industrial function categories during future reporting cycles. This may not be the case if sites have different employees complete Form U from repor ting year to reporting year, or for sites 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 the burden reduction w ould be negligible and do es 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 leading to common exposure scenarios and adding categories not adequately described in the current set of codes. The resultant proposed list incl udes 34 use categories, including “Other.” Several of the existing consumer and commercial use categories have been renamed to better describe the products that should be reported under that category. EPA anticipates the burden for submitters to familiarize themselves with the new categories will increase the burden for comple ting the consumer and commercial product categories 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 occur only during the first reporting
cy cle. 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 substance also be reported. Using its best professional judgment, EPA estimates it would take three minutes of clerical burden and six minutes of technical burden to write in the text description.4-35 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 the new categories proposed in this rule will reduce by half the number of submitters selecting “Other” as a consumer and commercial product category. Therefore, EPA assumes th is amendment would affect 604 reports. Using the baseline unit burden estimate as shown in Table 4-2 and Table 4-8, Table 4-34 shows the industr y burden estimate as a result of this propo sed amendment. The Agency estimates the amendment will cause a total increase in industry burden of a pproximately 14,400 hours during the first reporting cycle. In future reporting cycles, submitters no longe r will need to familiarize themselves with the new industrial function categories, so the industry burden is estimated at approximately 70 hours to write in text for “Other” responses.

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 20,972First Cycle, PostAmendment 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 16,778Future Cycle, PostAmendment 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 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 4-35 shows the industry cost estimate as a result of this pr oposed amendm ent. EPA estimates the industry cost will increase by approximately $845,600 in the first reporting cycle, and $3,500 during all future reporting cycles.4-36 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 $1,206,177First Cycle, PostAmendment $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 $964,942Future Cycle, PostAmendment $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 ove r- or underestimate. EPA is assuming 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 ere 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 sites submitting a Form U for the first time.

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 the submitter would indicate whether a use is a consumer or commercial use as part of the activity involved in selecting the correct c onsumer 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 this amendment does not cause any additional burden beyond that estimated in Section 4.4.20.

4.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed EPA is proposing to require submitters to report th e total number of commercial workers, including those at sites not under the submitter’s control, reaso nably 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 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 the number of subm itters will not change from th e baseline under this amendment. Using the baseline unit burden estimate as shown in Table 4-2 and Table 4-8, Table 4-36 shows the industr y burden estimate as a result of this propo sed amendment. The Agency estimates the amendment4-37 will cause a total increase in industry burden of a pproximately 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 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 4-37 sh ows the industry cost estimate as a resu lt of this proposed am endment. EPA estimates the industry cost will increase by $21.10 million for th e 2011 reporting cycle, and $16.88 million during all future reporting cycles.

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 subtracting the corresponding baseline value from the postamendment value.

Limitations of Analysis . EPA is assuming burden to report the number of commercial workers reasonably likely to be exposed is equivalent to reporting the number of industrial 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 expo sed than the submitter is aware of. The commercial uses may be difficult for manufacturers (including importers) to identify (see “NRO” discussion responses in Section 3.9); therefore, the number of workers exposed may be even more difficult to identif y.

4.4.23 Changes to the Standard for the Reporting of Processing and Use Information EPA is proposing to eliminate the “not readably obtainable” (NRO) standard and replace it with the more stringent “known to or reasonably ascertainable 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 ascertainab le” information. The proposed rule will now be4-38 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, when a submitter asserts a claim of confidentiality for the chemical identify of a substance listed on the public portion of the Master I nventory File, the Agency may make the information available to the public without further notice to the su bmitter. This will not reveal any data to the public that is actually confidential and will not in cur 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 tota l of 8,133 reports had claimed processing and use information was CBI, with an average of three processing and use information CBI claims per report. EPA estimates the number of reports with processing and use CBI claims will be reduced to 2,928 as a result of the proposed amendment. For the purposes of this analysis, EPA assumes the pe r-item burden 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 and must answer the tw o 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 pe r report, EPA estimates submitters will incur 4.38 additional hours of burden per report as a result of the amendment. Table 4-38 shows the industry burden estimate as a re sult of th is proposed amendment. The Agency estimates the amendment will cause a total increase in in dustry 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 pr oposed amendm ent. EPA estimates the4-39 industry cost will increase by approximately $772,700 in the first reporting 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 the percent reduction in CBI claims for processing and use information will be the same as the percent reduction when upfront substantiation was required for plant site identification. However, to the extent th e actual burden differs, this analysis may over- or underestimate the burden and cost of this amendment.

4.4.26 Limitation on the Confidentiality Claims for Data Elements Identified as “Not Known or Rea sonably 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 this am endment will not impact industry burden because submitters are not being required to do anything additional (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 Submissions over the Internet EPA is proposing to require electronic submissions of all Form Us over the Internet using e-IURweb 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 TSCA section 5 pre-manufacturing notices be submitted electronically. The costs and savings of this IUR amendment will be realized on a per-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 assu mes the burden savings associated with electronic reporting and submission via CDX are due to the reducti on or elimination of clerical/administrative time. The baseline time estimate for clerical burden (approx imately 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 estimate of potential form comp letion 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).4-40 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 CDX, and to complete elec tronic 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 re gistration and electronic signature agreements, to be a total of 0.93 hours of managerial burden and 1.73 hours of technical time per site (EPA, 2009b; EPA, 2004). Based on the e-PMN EA, recordkeeping costs will be halved because of the efficiencies in creating and storing documents electronically (EPA, 2 009b), reducing overall burden per report by three hours. Table 4-40 shows the industry burden estimate as a re sult of th is proposed amendment. The Agency estimates the amendment will cause a total decrease in industry burden of approximately 245,600 hours in the first reporting cycle and 210,200 hours in all future reporting cycles.

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 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 1,842,934
First Cycle,PostAmendment 35.17 4,085 15.27 25,896 61.98 17,075 1,597,358

Change from the Baseline, First Cycle 1.91 0 -4.55 0 -7.94 0 -245,576

Future Cycle Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833
Future Cycle,PostAmendment 11.05 4,085 12.82 25,896 49.58 17,075 1,223,658

Change from the Baseline, Future Cycles 1.98 0 -4.24 0 -6.35 0 -210,175

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 r esult of this proposed amendment. EPA estimates4-41 the industry cost will decrease by $9.02 million during the 2011 reporting cycle and by $8.01 million during all future reporting cycles.

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 Industry Cost (millions

2008$)

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

(e*f) First Cycle, Baseline $2,058 4,085 $1,143 25,896 $4,059 17,075 $107.32
First Cycle,PostAmendment $2,190 4,085 $923 25,896 $3,833 17,075 $98.30

Change from the Baseline, First Cycle $132 0 -$220 0 -$226 0 -$9.02

Future Cycle Baseline $561 4,085 $982 25,896 $3,247 17,075 $83.17
Future Cycle,PostAmendment $695 4,085 $771 25,896 $3,067 17,075 $75.16

Change from the Baseline, Future Cycles $134 0 -$211 0 -$181 0 -$8.01

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 the clerical burden will decrease by percentages similar to the decrease estimated for the e-PMN rule . To the extent any differences exist (given the differences in the two rules), this analysis may over- or underestimate 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. For the 2011 submission period, EPA will provide a free, web-based application in place of the 2006 downloadable software. The updated e-IURweb reporting tool would feature several improved capab ilities over the previous e-IUR reporting tool. 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 Exchange (CDX), 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 agreement, 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 burden4-42 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.

4.4.30 Modifications Specifically 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 still responsible for ensuring 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 in Section 4.4.27, submission costs to register with EPA’s CDX, and complete the Electronic Signature Agree ment forms 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 0.93 hours of managerial burden and 1.73 hours of technical time per site (EPA, 2009b). Based on prev ious IUR submissions, EPA estimates between 10 and 20 sites were importers, and therefore, the same approximate number were s econdary submitters (EPA, 2009h). For this analysis, EPA uses the conser vative upper-bound of 20 secondary submitter sites. Table 4-42 shows the industry burden estimate as a re sult of th is proposed amendment. The Agency estimates the amendment will cause an increase in industry burden of approximately 53.3 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 2.67 20 53.3
Change from the Baseline, First Cycle 2.67 20 53.3

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

Table 4-43 shows the industry cost estimate as a resu lt of this pr oposed am endment. EPA estimates the industry cost will increase by approximately $3, 300 during the 2011 and future reporting cycles.4-43 Table 4-43: Change in Industry Cost as a Result of Requiring CDX Registration for Secondary Submitters
Cost for CDX Registration (per site) (2008$) Number of Sites Industry Cost (2008$)
First Cycle, Baseline $0 0 $0First Cycle, PostAmendment $167 20 $3.347
Change from the Baseline, First Cycle $167 20 $3.347

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

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 industry burden for the principal reporting year will not change, the longer-term industry burden will increase because re porting will become more frequent; therefore, EPA estimated the annual reporting burden to industry over a 25-year period. A 25-year period allows EPA to analyze a set of complete reporting cycles under both the baseline and post-amendment scenarios. Under the baseline, a five-year reporting cycle is used, and the cost of five complete cycles is presented. Under the post-amendment scenario, reporting occurs every four years, and the cost of six complete cycles is presented. (Note the 2011 reporting cycle cove rs a 5-year period, under either scenario). For more information on the distribution of burden over a reporting cycle, see the discussion in Section 4.6.

The baseline industr y burden in the 2011 reporting cycle was calculated in Table 4-10 as 1.84 million hours. As sho wn in Table 4-11, the industry reporting burden in fu t ure reporting cycles is reduced to 1.43 million hours because EPA assumes sites have submitted 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 rep orting cycles – that is, the burden and cost to industry for repor ting cycles after the 2011 cycle, in the absence of the proposed amendments. 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 baseline burden estimates found i n Table 4-2 and Table 4-5, to esti mate in all future reporting cycles, th e baseline burden to industry is approximately 1.43 million hours.

As shown in Table 4-44, EPA estimates the industry burden will increase by 1.43 million hours over a 25-y ear period as a result of this amendment.4-44 Table 4-44: Change in Industry Burden as a Result of Modifying the Reporting Frequency, over a 25-Year Period

Baseline Burden Post-Amendment Burden Change in Burden Reporting Cycle 1 Year(s)
(millions of hours) (millions of hours) (millions of hours)
1 2007 to 2011 1.84 1.84 0.00 2012 to 2016 1.43 -- 2 2012 to 2015 -- 1.43 0.00

2017 to 2021 1.43 -- 3 2016 to 2019 -- 1.43 0.00

2022 to 2026 1.43 -- 4 2020 to 2023 -- 1.43 0.00

2027 to 2031 1.43 -- 5 2024 to 2027 -- 1.43 0.00

6 2028 to 2031 -- 1.43 1.43
Total 7.58 9.01 1.43 Annual Average 0.30 0.36 0.06

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles.

As shown in Table 4-10, the total industry cost in the baseline first reporting cycle is approximately $106.97 m illion, and as shown in Table 4-11, the baseline cost is $82.82 million in all future reporting
cy cles. 4-45 shows the annual industry cost estimate as a result of this amendment. In total, EPA estimates the proposed amendment will increase the co st to industry by $82.82 million over a 25-year period. In the proposal, EPA is requesting comment on increasing the frequency of reporting to annual reporting of all data; biennial re porting; and reporting once every three years, with processing and use data (Part III) reported only in the principal reporti ng year. EPA conducted a preliminary analysis of the cost and burden of increasing the freque ncy of reporting to annua lly, and every three years. The results of the analysis are presented in Appendix G.4-45 Table 4-45: Change in Industry Cost as a Result of Modifying the Reporting Frequency, over a 25- Year Period

Baseline Cost Post-Amendment Cost Change in Cost Reporting Cycle 1 Year(s) (millions of 2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2011 $106.97 $106.97 $0.00
2012 to 2016 $82.82 -- 2 2012 to 2015 -- $82.82 $0.00

2017 to 2021 $82.82 -- 3 2016 to 2019 -- $82.82 $0.00

2022 to 2026 $82.82 -- 4 2020 to 2023 -- $82.82 $0.00

2027 to 2031 $82.82 -- 5 2024 to 2027 -- $82.82 $0.00

6 2028 to 2031 -- $82.82 $82.82
Total $438.24 $521.05 $82.82 Annual Average $17.53 $20.84 $3.31

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles.

Limitations of Analysis . EPA assumes future reporting cycle 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 these reductions in burden do not occur, this analysis may underestimate the burden and cost of the rule amendment.



### 4.5 Total Industry Compliance Burden and Cost of all Amendments
The burdens and costs presented in Section 4.4 are the stand-alone industry compliance burden and cost for each a mendment, 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 affecting the number of reports submitted during a re porting cycle, those affecting the reporting burden, and those affecting the reporting frequency. The impact 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 rule amendments cha nge the number of full and/or partial reports EPA expects to be submitted, based on the specific chemicals they affect. The amendment changing 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 the 300,000 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 following steps describe how the combined effect of the amendments affecting the number of reports was calculated.4-46 Step 1: Sum the affected amendments. Table 4-46 a nd Table 4-47 present the num ber of full and partial reports EPA expects to be submitted as a result of the proposed IUR amendments, in the 2011 reporting cycle and future reporting cycles, respectiv ely. The proposed amendments changing the number of full and/or partial reports expected to be submitted are as follows:

• Elimination of the 300,000 lb. threshold for downstream processing and use reporting: When taken alone, EPA expects this amendment to increase the number of Part IIIs submitted by 8,203 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 chemi cals subject to ECAs ineligible for exemptions: EPA estimated this amendment will increase the number of Part IIIs submitted by 16 reports (see Section 4.4.6).

• Full exempti on for manufactured water: EPA expects this amendment, by itself, will decrease the number of Part IIIs submitted by 43 reports (see Section 4.4.7). Step 2: Consider the effects of the change in method for determining rule ap plicability . 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 in future reporting cycles. Therefore, for future reporting cycles, EPA multiplied the Step 1 results by 1.05, to account for this amendment. Then the Agency added in the numbe r of additional sites and reports estimated for this amendment individually. (In Table 4-46, for the first cycle calculati ons, this step is merely a placeholder and does not cause any change.)

• Method for determining whether a manufacturer is subject to the IUR reporting requirements. When taken by itself, this amendment would gene rate 204 additional submitters in future reporting cycles (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 the baseline number of 17,075) (see Section 4.4.3). Step 3: Consider the eff ect 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. For example, under the fu ture reporting cycle calculations, EPA started with the Step 2 total for Part III reports (9,484), and added the Step 2 total for Part II reports (5,469), minus the number of new Part III reports as a result of making EC As ineligible for exemptions (16) and the number of new Part II reports as a result of changing the met hod of determining whether a manufacturer is subject to reporting requirements (1,295). As shown in Table 4-47, the number of reports with Part III will increase by 13,641 in future reporting cycles. Similar calculations are shown in Table 4-46 for the 2011 reporting c ycle. Step 4: Calculate the number of reports when all 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 equal to the number of partially exempt reports with the five percent increase taken into account (618x1.05 = 649).4-47 Table 4-46: Change in the 2011 Reporting Cycle Nu mber 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 3,975 8,219 Method for Determining Whet her you are Subject to the IUR Reporting Requirements (see Section 4.4.3) -- -- --

STEP 2 TOTAL

-- 3,975 8,219 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 -- -- 3,959

STEP 3 TOTAL (Step 3 + Step 2 Total )

-- 3,975 12,178 Step 4: Calculate the total number of reports by adding the Step 3 Total to the Baseline STEP 4 TOTAL (Baseline + Step 3 Total) 4,085 29,871 29,253

Table 4-47: Change in the Future Cycle 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 Whether you are Subject to 204 1,295 8544-48 the IUR Reporting Requirements (see Section 4.4.3)

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 co mplete a report. As discussed in Section 4.4.27, EPA

assu mes the amendment to require electronic submission over the Internet will eliminate clerical burden used in the preparation of Parts I, II and III of Form U, and the burden for recordkeeping across all wage rate categories will be reduced by half. Table 4-48 contains the total burden by labor category for the 2011 reporting cycle when all the amendments are considered together. Table 4-49 contains the future reporting c ycle burden, by labor category. The step s below describe how the co mbined effect of the amendments affecting the re porting burden was calculated. Step 1: Sum the affected amendments. The amendments affecting the 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 burde n to complete Part II (see Section 4.4.12).

• Report production volu me 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 4-48 presents the per-report total burden of 0.293 hours to reflect 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 burde n 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 whe ther 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 am endment 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 “Other”) (see Section 4.4.18). Table 4-48 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 (fo r submitters selecting “Other”) (see Section 4.4.20). Table 4-48 presents the per-report total burden of 0.84 hours, which reflects 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 complete Part III (see Section 4.4.22).

• Upfront sub stantiation for processing and use information Confidential Business Information claims: This amendment is estimated to require 4.38 additional hours of burden to complete Part III4-49 for all submitters claiming processing and use information as CBI (see Section 4.4.25). Table 4-48 presents the per-report total burden of 0.75 hours, which reflects that only 17 percent of reports are expected to incur additional co sts 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 subtracts 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 ar e 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 technical 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.4-50Table 4-48: 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--1.730.93-0.76 -- -- -0.75 -1.50 -0.75 -2.82 -- -- -10.11 -- --Step 2 Total (Electronic Submission + Step1 Total)-- 1.73 0.93 -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-- 23.23 9.93 -- 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 categories4-51Table 4-49: 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--1.730.93-0.69-- -- -0.75 -1.50 -0.75-2.25-- ---8.09----Step 2 Total (Electronic Submission + Step1 Total)-- 1.73 0.93 -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 2.93 -- 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 categories4-52 Table 4-50 contains the estimated change in the b urden 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 1.39 million hours to 3.24 million hours in total for the 2011 reporting cycle. In future reporting cycles, EPA estimates industry burden will increase by 1. 21 million hours to 2.64 million hours.

Table 4-50: 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 35.17 4,085 22.19 29,871 83.02 29,253 3.24

Change from the Baseline, First Cycle 1.91 0 2.37 3,975 13.10 12,178 1.39

FutureCycle, Baseline 9.08 4,085 17.06 25,896 55.93 17,075.00 1.43

Future Cycle,PostAmendment 11.05 4,289 18.35 31,365 65.63 30,716 2.64

Change from the Baseline, Future Cycles 1.98 204 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 4-51 shows the total industry cost. To calcu late the total ind ustry cost, the burden estimates located in Table 4-48 and Table 4-49 were multiplied by the wage rates found in Table 4-1. The costs were then multiplied by the number of submissions located in Table 4-47. EPA estimates the total industr y cost will increase by approximately $91.87 million to $198.84 million in total for the 2011 reporting cycle. In future reporting cycles, EPA estimates the industry cost will increase by $79.27 million to $162.08 million.4-53 Table 4-51: 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 $2,192 4,085 $1,346 29,871 $5,117 29,253 $198.84

Change from the Baseline, First Cycle $134 0 $216 3,975 $1,058 12,178 $91.87

Future-Cycle, Baseline $561 4,085 $968.39 25,896 $3,247 17,075 $82.82
Future Cycle,PostAmendment $695 4,289 $1,109 31,365 $4,047 30,716 $162.08

Change from the Baseline, Future Cycles $134 204 $141 5,469 $800 13,641 $79.27

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 th e other 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). Thus, an average site submits IUR data for 6.34 chem icals (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 4-52). Table 4-50 contains the total number of reports subm itted and sites when all the amendments are considered together. Under the first and future reporting cycles, an estimated 4.085 and 4,289 sites, resp ectively, submit a total of 29,871 and 31,365 reports; 29,253 and 30,716 of which will be full reports. Ther efore, in the post-amend ment scenario, an average site will submit 7.31 reports comprised of 7.16 full reports and 0.15 partial reports (See Table 4-52). This is a decrea se of 2.01 partial reports per site and an increase of 2.98 full reports per site compared to the baseline.4-54 Table 4-52: 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)

First Cycle, Baseline 4,085 25,896 6.34 17,075 4.18 2.16
Post-Amendment 4,085 29,871 7.31 29,253 7.16 0.15 Change from the Baseline 0 3,975 0.97 12,178 2.98 -2.01 Future Cycle, Baseline 4,085 25,896 6.34 17,075 4.18 2.16 Future Cycle, Post-Amendment 4,289 31,365 7.31 30,716 7.16 0.15 Change from the Baseline, Future Cycles 204 5,469 0.97 13,641 2.98 -2.01 Source: U.S. EPA, Office of Pollution Preventio n and Toxics, Informati on 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 4-53 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 4-52. EPA calculated the baseline from the per-report burden presented in Table 4-2. In t he 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- amendment burden per report is found in Table 4-50. The average burden per site is expected to b e 792 hours in the first reporting cycle and 615 hours in future reporting cycles. This is an increase of 341 hours per site during the first reporting cycle and 264 hours per site in future reporting cycles compared to the baseline.4-55 Table 4-53: 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 35.17 1 22.19 7.31 83.02 7.16 792
Change from the Baseline 1.91 0 2.37 0.97 13.10 2.98 341
Future Cycle, Baseline 9.08 1 17.06 6.34 55.93 4.18 351
Future Cycle,PostAmendment 11.05 1 18.35 7.31 65.63 7.16 615

Change from the Baseline, Future Cycles 1.98 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.

The average baseline and post-amendment scenario costs per site are found in Table 4-54. Baseline cost per report costs is take n from Table 4-5 and Table 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 site. Post-amendment cost per report is derived in Table 4-50 and Table 4-51. The average post-amendment cost per site is calculated to be approxim atly $48,700 in first reporting cycle, and $37, 800 for all future reporting cycles. This is an increase of approximatly $22,500 per site during th e first reporting cycle and $17,500 during future reporting cycles compared to the baseline.4-56 Table 4-54: Average Total Cost per Site
Cost for Submission Compliance Determination, Rule Familiarization, and to Prepare Part I (2008$ 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 $2,192 1 $1,346 7.31 $5,117 7.16 $48,678
Change from the Baseline $134 0 $216 0.97 $1,058 2.98 $22,493
Future Cycle Baseline $561 1 $968 6.34 $3,247 4.18 $20,274
Future Cycle,PostAmendment $695 1 $1,109 7.31 $4,047 7.16 $37,790

Change from the Baseline, Future Cycles $134 0 $141 0.97 $800 2.98 $17,517

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



### 4.6 Annualized Industry Cost Esti mates for all Modific ations
EPA estimated the total burden to industry of all of the proposed amendments over a 25-year period. EPA used a 20-year annualization period in the prev ious economic analyses of the IUR rule (EPA, 2002a and EPA, 2005), but for this report, a 25-year period allows EPA to analyze a set of complete reporting cycles under both the baseline and post-amendment scenarios. While the IUR data submission activity itself occu rs in one reporting year (e.g., 2011), EPA believes rule compliance and data collection activites, and th us, costs and burdens, are incurred over the course of the reporting cycle. Consequently, costs and burdens are presented for a reporting cycle, rather than per year, because EPA cannot precisely predict the annual breakdown of how the costs are actually incurred by each site over a four- or five-year reporting cycle. Industry has indicated to EPA efforts related to rule compliance and data collection are spread out over multiple years. For example, EPA began receiving calls about reporting requirements for 2011 reporting in early 2009, and the Agency has already held conference calls with companies and EPA IT staff to discuss electronic reporting issues. Companies have stated they prefer to set up a system to collect the IUR information during the time the chemicals are being manufactured. Thus, for the 2011 reporting cy cle, EPA has evidence some companies set up their data systems in 2009 to early 2010, are collecting the information in 2010, and will compile and report that information in 2011. Furthermore, as described in section 4.2.2, IUR burden estimates are taken from the 2002 EPA Economic Analysis for the Amended Inventory Update Final Rule and were based on an industry survey conducted by EPA and designed to measure industry effort associated with collecting chemical exposure data under TSCA Section 8. Nowher e in the survey or its cover letter are these burden4-57 estimates discussed as being annual burdens. They are interpreted in the 2002 EA, and in previous IUR ICRs, as being the total burden incurred over the entire reporting cycle. The total industry burden calculated in Table 4-50 included the burden during the first reporting
cy cle. EPA expects during future reporting cycles, 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 fam iliarization and efficiency gains. Table 4-50 also shows the total burden t o industry in future reporting cycles. Table 4-55 shows the burdens associated with each reporting c ycle over a period of 25 years, including the years covered by the next (2011) reporting cycle. Under the baseline, a five-year reporting cycle is used, and the cost of four complete cycles is analyzed. Under the post-amendment scenario, reporting occurs ev ery four years, and the cost of five complete cycles is presented. (Note the 2011 reporting year covers a 5-year period under either scenario). Over a 25-year period, EPA estimates the proposed amendments will increase industry burden by approximately 8.85 million hours.

Table 4-55: Industry Burden over a Period of 25 Years if All Proposed Amendments Are Implemented

Baseline Burden Post-Amendment Burden Change in Burden Reporting Cycle 1 Year(s) (millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 1.84 3.24 1.39 2012 to 2016 1.43 -- 2 2012 to 2015 -- 2.64 1.21

2017 to 2021 1.43 -- 3 2016 to 2019 -- 2.64 1.21

2022 to 2026 1.43 -- 4 2020 to 2023 -- 2.64 1.21

2027 to 2031 1.43 -- 5 2024 to 2027 -- 2.64 1.21

6 2028 to 2031 -- 2.64 2.64
Total 7.58 16.43 8.85 Annual Average 0.30 0.66 0.35

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles.

Table 4-56 presents the annual and annualized costs esti mates of all the proposed amendments. Over a 25-year period, EPA estimates the proposed amendm ents to the IUR rule w ill increase the annualized industry cost by $21.61 million, with a three per cent discount rate, and $19.95 million with a seven percent discount rate.4-58 Table 4-56: Industry Cost over a Period of 25 Year s if All Proposed Amendments Are Implemented

Baseline Cost Post-Amendment Cost Change in Cost Reporting Cycle 1 Year(s) (millions of 2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2011 $106.97 $198.84 $91.87
2012 to 2016 $82.82 -- 2 2012 to 2015 -- $162.08 $79.27

2017 to 2021 $82.82 -- 3 2016 to 2019 -- $162.08 $79.27

2022 to 2026 $82.82 -- 4 2020 to 2023 -- $162.08 $79.27

2027 to 2031 $82.82 -- 5 2024 to 2027 -- $162.08 $79.27

6 2028 to 2031 -- $162.08 $162.08 Total $438.24 $1,009.25 $571.01 Annual Average $17.53 $40.37 $22.84 Annualized @ 3% $16.80 $38.40 $21.61 Annualized @ 7% $15.88 $35.83 $19.95

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles.5-1 

## 5. Agency Burden a nd 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 after 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 the Agency burden will remain the same for all reporting cycles. EPA labor costs are based on annual Federal wage rates published by the Office of Personnel Management for the Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV locality pay area for5-2 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 Agency 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 ca lendar 2008 is from the Office of Personnel Management salary table for WashingtonBaltimore

- 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 Information Collection Request (ICR) supporting statement (EPA, 2008d) estimates these costs. EPA inflated these costs to 2008 dollars from 2007 dollars using an inflation factor developed from data from the BLS Employee Cost Index (ECI) “Professional, scientific, and technical services” group (BLS, 2009). Table 5-2 shows the derivation of the extramural task cost in 2008 dollars. In total, EPA estimates it will spend approximately $204,000 on th ese tasks per reporting cycle.

Table 5-2: Derivation of Extramural Task Costs, per Reporting Cycle
Tasks Performed by Contractor Staff Annual Cost (2007$) 1 Inflation Factor Annual Cost (2008$) 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

1 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.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 Oversig ht 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 burden 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 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 for Part I. 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 (approximately .054 minutes) (See Equation 2). Equation 2: Burden per Data Element = 0.017 hours / 19 = 0.0009 hours5-4 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 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 contains the Agency burden and cost per report by section of Form U. This baseline burden will r emain 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 information about each of the proposed amendments. In each of the following se ctions, 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 am endments.

5.4.1 Technical Modifications to the Regulatory Text EPA is proposing to reorganize certain existing regulatory text and to delete obsolete regulatory text. These amendments do not substantively affect the re gulatory text, so EPA assumes 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),” “e-IURweb,” “indus trial function,” as described in Section 3. These changes are clarifications only; EPA is clarifying in regulatory text what has been previously explained through outreach with the regulated community. Ther efore, EPA assumes these definition changes will not impact Agency burden or cost.

5.4.3 Method for Determining Whether a Manufacturer i s 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. This modification would not take effect until after the first post-amendment reporting cycle (2011); for the first reporting cycle, submitters will still consider production volume only for the principal reporting year. This creates a difference in the number of sites and reports expected in the first cycle versus future cycles. (See Section 4.4.3 for more information.) Therefore, the tables below show esti mated changes in cost and burden for bot h the first and fiture reporting cycles. 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 no change in burden for the first reporting cycle and5-5 a burden increase of 104 hours in future reporting cycles as a result of modifying the method for determining whether the 25,000 lb .reporting 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) First Cycle, Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080
First Cycle, PostAmendment 0.017 4,085 0.042 25,896 0.054 17,075 2,080
Change from the Baseline, First Cycle 0.000 0 0.000 0 0.000 0 0

Future Cycle Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080
Future Cycle, PostAmendment 0.017 4,289 0.042 27,191 0.054 17,929 2,184
Change from the Baseline, Future Cycles 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 a mendment. The Agency estimates no change in cost for the first re porting cycle and a cost increase of approximately $10,800 in future reporting cycles.5-6 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) First Cycle, Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $216,949
First Cycle, PostAmendment $1.78 4,085 $4.40 25,896 $5.61 17,075 $216,949
Change from the Baseline, First Cycle 0.000 0 0.000 0 0.000 0 0

Future Cycle Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $216,949
Future Cycle, Post-Amendment $1.78 4,289 $4.40 27,191 $5.61 17,929 $227,796
Change from the Baseline, Future Cycles $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.

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 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. Eliminating this threshold will increase industr y burden by requiring more sites to complete Part III of Form U (Part III contains the downstream processing and use information). EPA estimates 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 i ncrease 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 subtracting the corresponding baseline value from the postamendment value.

Table 5-8 shows the estimated change in cost to EPA as a result of the proposed a mendment. The Agency estimates a cost increase of approximately $46,000.5-7 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 subtracting the corresponding baseline value from the postamendment value.

5.4.5 Eliminate the 25,000 lb. Threshold fo r Cer tain Regulated Chemicals EPA is proposing to eliminate the 25,000 lb. reporting threshold for chemicals that are: (1) the subject of a regulation promulgated under secti ons 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) th e 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 these categories (EPA, 2006a). Because the proposed amendment would affect only chemicals subject to a pr omulgated rule, this figure is an overestimate. EPA estimated these chemicals are produced at a total of 4,018 sites (see Section 4.4.5 for more details). 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 i ncrease 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 subtracting the corresponding baseline value from the postamendment 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 $17,700.5-8 Table 5-10: Change in Agency Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals
Cost to Process Part II (2008$ 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 subtracting the corresponding baseline value from the postamendment value.

5.4.6 Make Chemicals Subject to Enforceable Consent Agreements (ECAs) Ineligible for Exemptions The Agency is proposing all chemicals subject to enforceable consent agreements be ineligible for exemptions. A total of four chemicals and 16 s ites are affected by this amendment (see Section 4.4.6 for

m ore 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

a mendment.

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 subtracting the corresponding baseline value from the postamendment 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 subtracting the corresponding baseline value from the postamendment value.5-9 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 inform ation.) Table 5-13 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden reduction of two hours as a result of this am endment.

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 subtracti ng 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 $190.

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 subtracting the corresponding baseline value from the postamendment 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), and 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 w ith their plant site on Part I of Form U. EPA is proposing to the company name to be the ultimate domestic parent 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.5-10 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 the technical contact to 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 num ber. Note 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 known already 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 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 estimates a burden increase of 93 hours as a result of this am endment.

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 subtracting the corresponding baseline value from the postamendment 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 $9,700.5-11 Table 5-16: Change in Agency Cost as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year Cost for Processing Production Volume (2008$ 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 subtracting the corresponding baseline value from the postamendment value.

5.4.13 Volume of Chemical Substance Used On-Site Under the current IUR requirements, submitters who 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 there will be a slight increase in the number of submitters who would report product 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 estimates a burden increase of five hours as a result of this am endment.

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.5-12 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 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 estimates a burden increase of 23 hours as a result of this am endment.

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.

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 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 all submitters to provi de the exported chemical volume in Section II of the report. This will add one 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 estimates a burden increase of 23 hours as a result of this am endment.5-13 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 $2,400.

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.

5.4.16 Identify Whether Chemical Is To Be Recycled, Remanufactured, Reprocessed, Reused, or Re worked EPA is proposing to add a checkbox to Form U for submitters to indicate whether a chemical is to be recycled, remanufactured, reprocessed, reused, or rework ed. This will add one 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 estimates a burden increase of 23 hours as a result of this am endment.

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.5-14 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. 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 newcategories, 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 Part 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 estimates a burden increase of 0.54 hours as a result of this am endment.

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 post-5-15 amendment 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.

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 the Agency’s burden to process the industr ial 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 data element 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 estimates a 0.54 hour b urden increase as a result of this amendment.5-16 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 0 918.82PostAmendment 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 subtracti ng the corresponding baseline value from the post-amendment 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.

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
Post-Amendment $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 subtracti ng the corresponding baseline value from the post-amendment 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 expects a burden increase of 15 hours as a result of this

a mendment.5-17 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.

5.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed EPA is proposing to require submitters of reports with processing and use information to provide the number of commercial workers who are reasonably likely to be exposed to a chemical. This amendment adds one data element to Part 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 expects a burden increase of 15 hours as a result of this

a mendment.

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 $1,600.5-18 Table 5-32: Change in Agency Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed Cost per Report (2008$) 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 obt ainable (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 it will not increase the Agency burden or cost.

5.4.24 Chemical Identity CBI Claims EPA is proposing, when a submitter asserts a claim of confidentiality for the chemical identity of a substance listed on the public portion of the Master I nventory 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 711.30(e). Any such action on EPA’s part would be as part of regular and routine use of the data and will not create any additional burden.

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 2,928 reports w ill 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 am endment.

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 $822.5-19 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 for Data Elements Identified as “Not Known or Rea sonably Ascertainable” EPA is proposing to no longer allow CBI claims for data elements identified as “not known or reasonably ascertainable.” EPA expects 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 Submissions over the Internet EPA is proposing to require all Form Us to be s ubmitted to the Agency electronically, via e-IURweb and EPA’s Central Data Excha nge (CDX) over the Internet. EPA expects 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 benefits of the CDX system, EPA’s processing burde n is expected to decrease by 88.6 percent, not including the operating and maintenance and troubles hooting costs 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 estimates a burden decrease of approximately 1,800 hours as a result of th is 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 2,080PostAmendment 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.5-20 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 (including importers) in preparing and submitting reports electronically du ring the 2006 IUR reporting cycle. For the 2011 submission period, EPA will provide a free, web-ba sed application in place of the 2006 downloadable software.The updated e-IURweb reporting tool for the 2011 IUR collection would feature several improved capabilities over the current e-IUR reporting t ool. Although not quantified here, EPA expects updated e-IURweb software will reduce Agency burden to process and correct errors in the form.

5.4.29 Electronic Signature Process In order to submit IUR data electronically to EPA via the Central Data Exchange (CDX), individuals acting on behalf of the submitter must first register wi th CDX. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder”) downloads two forms: the Electronic Signature Agreement and the Verification by Company Authoriz ing Official Form. Registration enables CDX to perform two important functions: authenticate identity, and verify authorization. For authentication of identity, the submitter completes the Electronic Signa ture Agreement form, signs and dates it, has the form notarized, and mails it back to EPA. The Verifi cation of Authorization form 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 curre ntly responsible for data processing, systems development, and contract oversight and manage ment. EPA multiplied the burden estimate of 645 hours5-21 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 processi ng, reviewing, approving, and filing of the electronic signature agreement form is approximately $46,700 during the 2011 reporting cycle.

5.4.30 Modifications Specifically 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 processi ng of the data. EPA anticipates the use of the reporting tool will help to make joint IUR reporting easier for industry. Although not quantified, EPA also anticipates the electronic reporting tool will streamline EPA’s 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 25-
y ear period. In total, EPA estimates the Agency will spend 4,160 more hours over a 25-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

Baseline Burden Post-Amendment Burden Change in Burden Reporting Cycle 1 Year(s)
(Hours) (Hours) (Hours) 1 2007 to 2011 4,160 4,160 0
2012 to 2016 4,160 -- 2 2012 to 2015 -- 4,160 0

2017 to 2021 4,160 -- 3 2016 to 2019 -- 4,160 0

2022 to 2026 4,160 -- 4 2020 to 2023 -- 4,160 0

2027 to 2031 4,160 -- 5 2024 to 2027 -- 4,160 0

6 2028 to 2031 -- 4,160 4160

Total 20,800 24,960 4,160 Annual Average 832 998 166

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles

Table 5-38 contains the 25-year cost estimate as a result of modifying the reporting frequency. The baseline cost estimate is for data en try only and is discussed in Section 5.2. This table includes extramural costs which are incurred by the Agenc y. In total, EPA estimates it will cost the Agency approximately $466,100 to increase the frequency of reporting from a five-year reporting cycle to a four- year reporting5-22 cycle over a 25-year period. EPA estimates the annualized changes in cost would be $17,408 and $15,511 with a three percent and seven percent discount rate, respectively.

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

Baseline Cost Post-Amendment Cost Change in Cost Reporting Cycle 1 Year(s)
(2008$) (2008$) (2008$) 1 2007 to 2011 $466,132.9 $466,132.9 $0.0
2012 to 2016 $466,132.9 -- 2 2012 to 2015 -- $466,132.9 $0.0

2017 to 2021 $466,132.9 -- 3 2016 to 2019 -- $466,132.9 $0.0

2022 to 2026 $466,132.9 -- 4 2020 to 2023 -- $466,132.9 $0.0

2027 to 2031 $466,132.9 -- 5 2024 to 2027 -- $466,132.9 $0.0

6 2028 to 2031 -- $466,132.9 $466,132.9 Total $2,330,664 $2,796,797 $466,133 Annual Average $93,227 $116,533 $23,307 Annualized @ 3% $87,798 $105,206 $17,408 Annualized @ 7% $81,056 $96,567 $15,511

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles



### 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 the proposed electronic submission amendment will decrea se Agency burden by approximately 88.6 percent.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 costs if all the proposed amendments were to be enacted, EPA used the baseline number of reports and sit es taken from the 2006 IUR database (EPA, 2008c) and the baseline per report cost and burden estimates as found in Table 5-4. The change in the number of reports due to the effect of the am endments combined is calculated in Table 4-46 and Table 4-47 for the first and futur e reporting cycles, respectively. EPA added the cost of one additional FTE (2,080 hours) to the baseline hours to account for the additional activities conducted by the GS-13 employee (see Table 5-3) and all e xtramural costs not related to data entry (see Table 5-2). Table 5-40 presents the total Agency burden for all the a mendments combined. In total, EPA estimates the Agency will save 1,721 hours during the first reporting cycle and 1,704 hours in each future reporting cycle. Table 5-41 presents the total Agency cost est i mates; the Agency will save approximately $179,600 in the first reporting cycle and $177,700 in future reporting cycles 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, Remanufactured, 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 -- Electronic Submission -0.015 -0.043 -0.049 Total Change from the Base line with All Amendments -0.015 -0.037 -0.047 Total, All Amendments 0.002 0.006 0.0065-24 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) First-year Baseline 0.017 4,085 0.042 25,896 0.054 17,075 4,160 First year, Post Amendment 0.002 4,085 0.006 29,871 0.006 29,253 2,439
Change from the Baseline, First year -0.015 0 -0.037 3,975 -0.047 12,178 -1,721
Future-cycle Baseline 0.017 4,085 0.042 25,896 0.054 17,075 4,160
Future cycle, Post Amendment 0.002 4,289 0.006 31,365 0.006 30,716 2,456
Change from the Baseline, Future cycles -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) First-year Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133 First year, Post Amendment $0.20 4,085 $0.58 29,871 $0.66 29,253 $286,580 Change from the Baseline, First year -$1.57 $0.00 -$3.82 $3,975 -$4.95 $12,178 -$179,553 Future-cycle Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133 Future cycle, Post Amendment $0.20 4,289 $0.58 31,365 $0.66 30,716 $288,450 Change from the Baseline, Future cycles -1.574 204 -$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 Section 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 elements in each section of the form. For example, the5-25 revised Part I contains 23 data elements, and 4,289 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) and subtracted the fixed burden of 2,080 hours. An example of this calculation can be seen in Equation 3 for Part I.
Equation 3: Burden to Process Part I per Report = (376.5 hours x 0.0241) / 4,289 = 0.002 hours

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, despite35 data elements being 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 0.017 0.002 -0.015
Part II 47 66 19 0.0009 0.00008 -0.0008 0.042 0.006 -0.037
Part III 60 75 15 0.0009 0.00008 -0.0008 0.054 0.006 -0.048 Total (Full Report) 126 161 35 - - 0.113 0.014 -0.099

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 (approximately .0054 minutes) (see Equation 5).
Equation 5: Burden per Data Element = 0.002 hours / 19 = 0.00009 hours

To calculate the cost to EPA, the 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 amendment cost of $288,450 (See Table 5-41). Thus, EPA calculat ed it costs the Agency approximately $0. 09 to process a single data element of Form U. The total Agency cost per report is approximate ly $1.44 in the post- amendment scenario. Table 5-43 contains the Agency cost per report by section of Form U. This baseline burden will remain the same for all reporting cycles.5-26 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

Table 5-44 contains Agency costs per-data elemen t and per-report separated by EPA and contractor staff. Using the values in Table 5-3, EPA estimates in the baseline, approximately 56.4 percent of the variable Agency costs are attributed to EPA st aff ($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 distribution of costs between Agency and contractor staff to change as a result of the proposed rule. Thus, to calculate the post-amendment cost attributed to contractor staff, EPA multiplied the per-report cost and the per-data element cost by 43.6 per cent. The cost to contract staff is approximately $0.63. Similarly, to derive the EPA staff cost of $0.81 per report, th e total per-report cost 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.5-27 

### 5.6 Annualized Agency Cost Esti mates for All Modific ations
Table 5-45 presents the annual Agency burden estimates for data entry and extramural costs over a 25-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 FTE is added to account for all the GS-13 level tasks (s ee Table 5-3), which are not affected by any of the proposed amendm ents. In total, EPA estimates the Agency burden for th e IUR rule will be reduced by 6,079 hours over a 25-year period under the proposed IUR amendments.

Table 5-45: Agency Burden over a Period of 25 Years if All Proposed Amendments Are Implemented

Baseline Burden Post-Amendment Burden Change in Burden Reporting Cycle 1 Year(s) (Hours) (Hours) (Hours)

1 2007 to 2011 4,160 2,439 -1,721 2012 to 2016 4,160 -- 2 2012 to 2015 -- 2,456 -1,704

2017 to 2021 4,160 -- 3 2016 to 2019 -- 2,456 -1,704

2022 to 2026 4,160 -- 4 2020 to 2023 -- 2,456 -1,704

2027 to 2031 4,160 -- 5 2024 to 2027 -- 2,456 -1,704

6 2028 to 2031 -- 2,456 2,456 Total 20,800 14,721 -6,079 Annual Average 832 589 -243

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles

To estimate the per-reporting cycle cost of all the proposed amendments over a 25-year period, EPA used the total baselin e cost estimate in Table 5-3. These costs include th e data entry perform ed by both EPA and contractor staff, and all extramural activities conducted by contractor staff. Under the baseline, EPA estimates the total Agency cost will be $46 6,100 during each reporting cycle. The annualized postamendment cost also includes all extramural costs from Table 5-2 in addition to the data entry and quality control costs.

Table 5-46 contains the annualized cost estimati on. In total, annual post-amendment cost will be $286,600 during the first reporting cycle and thereafter. Over a 25-year period, EPA estimates the Agency will save approximately $601,800. Annualized savings areapproximately $22,800 and $21,400, discounted at three percent and seven percent, respectively.5-28 Table 5-46: Annual and Discounted Total Cost to the Agency of All Modifications

Baseline Cost Post-Amendment Cost Change in Cost Reporting Cycle 1 Year(s) (2008$) (2008$) (2008$)
1 2007 to 2011 $466,133 $286,580 -$179,553
2012 to 2016 $466,133 -- 2 2012 to 2015 -- $288,450 -$177,683

2017 to 2021 $466,133 -- 3 2016 to 2019 -- $288,450 -$177,683

2022 to 2026 $466,133 -- 4 2020 to 2023 -- $288,450 -$177,683

2027 to 2031 $466,133 -- 5 2024 to 2027 -- $288,450 -$177,683

6 2028 to 2031 -- $288,450 $288,450

Total $2,330,664 $1,728,831 -$601,834 Annual Average $93,227 $69,153 -$24,073 Annualized @ 3% $87,798 $65,011 -$22,788 Annualized @ 7% $81,056 $59,643 -$21,414

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles6-1 

## 6. Social Cost Summary

To calculate the total burden to society of th e proposed IUR amendments,, EPA added the total industry burden to the Agency burden savings. Table 6-1 contains the annual burden estimates for the
y ears 2007 through 2031. 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 m illion hours. EPA estimates the proposed IUR rule amendments would increase the industry burden in the first reporting cycle by 1.39 million hours (see Table 4-50) and decrease Agency burden by 1,721 hours (see Table 5-40). The net burden increase is 1.39 million hours. The burden in future reporting c ycles 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. EPA estimates all of the amendments co mbined would increase the burden to society by 8.85 million hours over a 25-year period. This in cludes a burden increase of 8.85 million hours to the affected industry over the 25 years (see Table 4-55), and a burden decrease of 6,079 hours to the Agency (see Table 5-45) over the same period.

As shown in Table 6-1, EPA estimates the total increase in burden as a result of the IUR rule

am endments over a 25-year period will be 8.85 million hours.

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

Baseline Burden Post-Amendment Burden Change in Burden Reporting Cycle 1 Year(s) (Hours) (Hours) (Hours)

1 2007 to 2011 1.85 3.24 1.39 2012 to 2016 1.44 -- 2 2012 to 2015
-- 2.64 1.20
2017 to 2021 1.44 -- 3 2016 to 2019
-- 2.64 1.20

2022 to 2026 1.44 -- 4 2020 to 2023
-- 2.64 1.20 2027 to 2031 1.44 -- 5 2024 to 2027
-- 2.64 1.20
6 2028 to 2031
-- 2.64 2.64
Total 7.60 16.44 8.85 Annual Average 0.29 0.66 0.35

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles

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 $570.41 million over the 25-year period as a result of the proposed IUR amendements. The cost to industry is expected to increase by $571.01 million over this period (see Table 4-56), and the Agency cost is expected to decrease by $601,834 (see Table 5-46). T he annualized cost to society over a 25-year period is $21.58 million and $19.93 million at three percent and seven percent discount rates, respectively.6-2 Table 6-2: Change in Total Costs to Soci ety if All Modifications Are Implemented

Baseline Cost Post-Amendment Cost Change in Cost Reporting

Cycle 1 Year(s) (millions of 2008$) (millions of 2008$) (millions of 2008$)
1 2007 to 2011 $107.43 $199.12 $91.69 2012 to 2016 $83.28 -- 2 2012 to 2015 -- $162.37 $79.09

2017 to 2021 $83.28 -- 3 2016 to 2019 -- $162.37 $79.09

2022 to 2026 $83.28 -- 4 2020 to 2023 -- $162.37 $79.09

2027 to 2031 $83.28 -- 5 2024 to 2027 -- $162.37 $79.09

6 2028 to 2031 -- $162.37 $162.37
Total $440.57 $1,010.98 $570.41 Annual Average $17.62 $40.44 $22.82 Annualized @ 3% $16.88 $38.47 $21.58 Annualized @ 7% $15.96 $35.89 $19.93

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italiciz ed reporting cycles are proposed, four-yea r cycles7-1 

## 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 industry, and IUR data are used in almost all of OPPT’s risk screening and management programs. However, the IUR 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 electr onic reporting using the e-IURweb reporting software, expanding the range of chemicals for which full info rmation would be reported, adjusting the specific reported information, increasing the frequency of collecting the information, and modifying CBI requirements. EPA expects the proposed amendments will reduce many of the current data constraints and, as a result, improve the effectiveness of EPA’s chemical risk management programs. Mostimportantly, the IUR rule amendments will require submitters to provide processing and use exposurerelated information for more chemicals. This add itional information will allow EPA to more accurately assess human and environmental exposures to specifi c chemicals, including the concentrations, frequency, and durations of these exposures. With this additional information, EPA will improve its abilityto screen chemicals 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 chan ges in the use patterns and preferences which would result from the additional information made available under the proposed rule. These data are not readily available, and collecting such data would be cost-p rohibitive. For example, one approach would be to conduct a national willingness-to-pay (WTP) survey of the general public to determine the value the public places on the availability of the information resulting from the proposed 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 supplied through the 2006 IUR.7-2 In addition, EPA’s current screening activities for medium production volume chemicals are hampered further by the fact EPA has only estimates of production volume for many chemicals and must rely on relatively limited public sources of information. This proposed rule will benefit society by filling these information gaps and contributing to better assessment s 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, information 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 involving these subs tances. 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 eval uated. As discussed in Chapter 5. EPA will bear additional costs for collecting and m anaging 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 posing relatively high risks (a nd/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 accruing from the use of the information generated by this proposed ru le 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 data are available in a timely manner. EPA is proposing these amendmen ts to the IUR rule to meet four primary goals: (1) to tailor the informa tion 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. The7-3 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 described 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 the information needed most by the Agency. These proposed changes will enable EPA and other Federal agencies to improve th eir 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. These amendments and th eir 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 company 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 the company name provided to be the ultimate domestic parent company name. EPA believes this change will reduce confusion by making th is reporting requirement 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 appearing 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. Similar to th e proposed change in parent company name, this change also will lead to more accurate inform ation, 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 connected directly 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 as long as he or she rema ins under contract to the company. EPA may raise follow-up questions about an IUR submission possibl y for years after the submission date. EPA is considering allowing multiple technical contacts on a ch emical-by-chemical basis. The benefit of this proposed amendment would be increased clarity, whic h leads to improved accuracy in the information collected, which in turn leads to mo re 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, submitters sometimes supply a name that is somewhat generic or excludes parts of the specific chemical identity distinguishing one substance from another. EPA’s experience in the 2006 IUR was up to five percent of the reports submitted cont ained chemical identity problems serious enough the7-4 Agency was unable to precisely identify the subs tance. These problems resulted in the temporary exclusion of the information associated with the poorly or erroneously identified chemical from the IUR database until the Agency was able to obtain correct and specific chemical identity information from the submitter. EPA believes the requirement to use the su bstance name as currently listed on the Inventory will greatly reduce the number of poorly identified substances. Improved chemical identification ultimately leads to more accurate risk characterizations. EPA is also proposing to allow submitters to report 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 acceptable chemical identifying 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. This proposed amendment would save the Agency considerable time and effort to access and review reported information that h as been identified only 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 in the 2010 principal reporting year 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 woul d provide greater detail than the current “onceevery-five-years” snapshot. For future reporting cycl es, all manufacturers (including importers) who are required to report based on meeting or exceeding the 25,000 lb. threshold in any year since the last principal reporting year will be required to repor t production volume for each of those years. EPA has mounting evidence many chemicals, incl uding larger volume chemicals, are manufactured in volumes that may widely fluctuate from year to year. This can result in the production volume of a chemical exceeding the threshold for several year s, then falling below the threshold during the IUR principal reporting year. Therefore, EPA believes 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 the 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 environm ental exposures; and to determine the costs (and financial impacts) of potential control strategies in economic analyses. Voluntary EPA programs such as Design for the Environment (DfE) and other pollution prevention programs would use the annual production volume data to identify trends and progra m performance. 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 identifiable production trend data. Therefore, proposed amendment would provide information 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 submitters to report th e 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 the chemical is site-l imited. 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 domestically manufact ured chemicals, consumed entirely at the site of manufacture, should be reported as site-limited.7-5 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 consumed at the manufacturing site. For the 2006 IUR, many submitters continued this prac tice and erroneously filed separate reports to indicate a portion of their production volume was site-limited. Filing separat e 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 report simplifi es reporting for such submitters and results in a less complicated database, thereby making the data easier to use. The proposed amendment to require reporting the volume used on-site wouldprovide valu able information related to potential exposures associated with the on-site volumes, therefore providi ng 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 physica lly at the reporting site provides 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. This amendment would allow EPA to better identify the proportion of the production volume accounted for by the use reporting, given downstream reporting is not required for 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 bei ng used for 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. Designation of consumer or commercial use, or both, would allow EPA to co mplete a better characterization for the potentially exposed populations.

Number of Commercial Workers Reasonably Likely To Be Exposed EPA is proposing to require submitters to report th e 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 workers7-6 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 substa nce. Therefore, this amendment would 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 the proposed amendments would result in the Agency receiving more publicly available, non-CBI information. It is therefore important for the Agency to be able to provide public access to the information in a timely manner; requiring all submissions 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 all submissions to be generated usi ng the e-IURweb reporting softwa re. 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-IURweb reporting would provide several be nefits to EPA and industry. EPA believes the required use of eIURweb 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 populated electronically , thus reducing the potential for error when data are entered by hand or when data are entered through a scanning 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 submission or to identify a problem with the submission. Electronic submissions enable data to be available for Agency an d public use more quickly and it eliminates inefficiencies and errors introdu ced 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). For the 2011 submission period, EPA will provide a free web-based application in pl ace of the 2006 downloadable software. The 2011 eIURweb would feature several enhancements over the 2006 e-IUR. These improvements include a sophisticated validation system, which would alert u sers when a required field on the form is either missing information or contains certain kinds of pot entially incorrect information. Other updates are expected to include automated chem ical identity checks, automated comp any and site identity checks, and the facilitation of joint submissions and amendments. Additionally the reporting software would include user-friendly features such as drop-down selections, search able chemical lists, imbedded help files, and an error-checking process to help identify common reporti ng errors before the submission 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-IURweb reporting software, el ectronic 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 IUR reports.7-7 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 chemicals. EPA needs more 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 EPA uses to evaluate and manage chemical risks are described in Section 7.3. The proposed amendments would increase the amount of exposure infor mation collected are de scribed in the following sections.

Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements For the 2011 reporting cycle, reporting for subject chemicals would be required if the production volume in the 2010 principal reporting year only meets or exceeds the 25,000 lb. reporting threshold, which is the current requirement. For the 2016 reporting cycle and future reporting cycles, a site would examine its annual production volumes for each of th e four calendar years since the last principal reporting year. If the production volume for a reportable chemical substance were 25,000 lb. or greater for any calendar year during that four-year period, then th e site would need to report the chemical substance, unless it is otherwise exempt. EPA is proposing this change because of the mountin g evidence many chemical s, even larger volume chemicals, often experience wide fluctuations in manu facturing volume from year to year. This can result in the production volume of chemical exceeding the threshold for several years, then falling below the threshold during the IUR principal reporting year. Con sequently, historical IUR reporting has resulted in a change of approximately 30 percent in the co mposition 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 industry provide comment on whether a three-year reporting cycle was sufficient for deciding whether a chemical they manufactured or imported should remain listed on the TSCA Inventory. Commenters overwhelmingly expressed concern the proposed three-year reporting cycle would drastically misrep resent the chemicals presently in commerce. (See Docket No: EPA-HQ-OPPT-2008-0785.) In submitted comments, companies agreed unanimously that if they were to report for one year only, the reset would inappropriately remove chemical substances from the Inventory. While all commenters felt the three-year reporting cycle was inadequate , a majority of the industry comments suggested reporting should cover a 10-year period. The co mments strongly indicated there were chemicals manufactured or imported only occasionally, and these chemicals would not be captured if the reporting covered too short a period. Therefore, requiring chemical manufacturers (importers) to evaluate production volume for any calendar year since the prev ious 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.7-8 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 if the Agency were to find it necessary in the future, it would collect information on chemical substances at reporting thresholds below the thresholds introduced in that action. The IUR processing and use information is needed now to comp lete the characterizations and prioritizations for those chemicals manufactured (including impor ted) 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 risk evaluations and, based on its experience in using this information, the Agency has c oncluded collecting this information is critical to its mission of characterizing exposure, identifying potential risks, and noting uncertainties for these lower production volume chemicals. Both hazard and exposure information is 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 characterizations needed to develop the evaluations. As with the high-production volume (HPV) chemicals, EPA would th en be able to identify potential risks, note scientific issues and uncertainties, and indicate the in itial priority assigned by the Agency for potential future appropriate action. Therefore, the proposed rule would 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 eliminate the 25,000 lb. threshold for those chemicals that are: (1) the subject of a rule promulgated 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 importer, of such chemical substances would be required to report information on the manufacturing, processing, and use of the chemical substances if it manufactured (including imported) any quantity of these chemical substances during any of the years since the last principal reporting year, including 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 environment or that the substances have “substantial production/7-9 significant or substantial exposure.” Therefore, this proposed amendment would enable EPA 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 manufacturing, processing, and use of substances under such agreements, and therefore is proposing to require such substances to be reported for IUR purpo ses, 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. This proposed amendment would ensure the availa bility of current information if EPA has expressed a concern in the form of an EC A on any substance otherwise excluded from the IUR rule. For example, EPA could use the IUR data asso ciated with these regulated chemicals to monitor chemical production and complia nce 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 “known to or reasonably ascertainable by” the submitter. This is the same standard currently applying to the reporting of info rmation 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 a reasonable person similarly situated might be expected to possess, control, or know. The “known to or reasonably ascertainable by” reporting standard was the only standard used for IUR reporting purposes prior to the 2006 IUR 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 actually was 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.

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.7-10 The Agency’s experience using the 2006 IUR data to develop exposure characterizations has alerted EPA to the fact the IUR processing and use data are in complete and inconsistent. Effective risk screening by EPA depends on the ability to accurately character ize chemical uses and to predict potential exposures. If the information provided does not include these data, EPA must make assumptions about the use of the unreported production volume. Incorrect assumptions may lead EPA to designate an inappropriately high priority level to the chemical, resulting in unnecessar y effort and resource expenditures for both regulated parties and EPA in cases where adequate data woul d have led the Agency to act differently. Therefore, using the reporting standard “known to or reasonably ascertainable by” would result in companies reporting more consistent and complete processing and use information in their IUR reports, and 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 ev ery five years starting with the 2006 IUR rule modifications, to reduce the burden associated with the amended IUR requirements. While the less frequent reporting does reduce burden, the Agency no w has determined 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 cha nge of approximately 30 percent in the chemicals reported from one reporting cycle to the next. Recei ving IUR information more frequently will provide EPA with a more accurate, up-to-date overview of the chemical manufacturing industry, addressing a criticism the Agency has received for relying on outdated information. More timely information will help EPA to better prioritize chemicals for screening, and w ill 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 function categories by combining categories leading 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 would 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 include a text description for the industr ial function category associated with the use of chemical substance.7-11 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 sect ors so any NAICS code has a corresponding Industrial Sector. The Agency believes this change would provid e several benefits. First, it would encourage more complete reporting by using terms already familia r to industry. Second, the industrial sectors would reduce the likelihood of errors resulting from the se lection of miscellaneous or inappropriate NAICS codes. Third, it would reduce the number of c odes 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 classify chemicals because EPA either would need to develop exposure scenarios for each unique combination, or determine which three-code combinations have similar exposure scenarios and can be grouped. 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 leading to common exposure scenarios and adding categories not adequately described in the initial set of categories. EPA worked with Envir onment Canada and Health Canada to develop the proposed categories, which will be adopted by the Un ited States and Canada for reporting of Inventory information. Harmonized categories for reporting the consumer and commercial uses of chemical substances will benefit both EPA and Canadian agency by facilitating the exchange of information and will serve as a model to be used by Mexico in de veloping an Inventory of chemical substances. In addition, the harmonized categories w ill facilitate consistent reporting of chemical use information by industry in the United States and Canada. Additional benefits of expanding the list of consumer and commercial use categories would be to provide persons submitting IUR inform ation with a greater opportunity to characterize the products in which chemical substances they manufacture are u sed, and to reduce the number of uses reported as “Other.” EPA is proposing to require that if a submitter c hooses the category “Other,” the submitter include a text description for the consumer and commercial pr oduct containing the chemical substance. The 2006 IUR reports showed the category “Other” was reporte d with the greatest frequency. A total of 1,206 reports, or 26 percent, out of 4,666 reports cont aining commercial and consumer use information, included “Other.” Although one of EPA’s objectiv es of revising the consumer and commercial product categories is to reduce the reporting frequency of “Other,” EPA believes 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 definitions and expanded lists of examples of products in which the chemical substance would be used were added to each category descriptor. By requiring the submitters to supply a written description for “Other,” this amendment will enable the Agency to evaluate and improve the inclusiveness of future consumer and commercial category lists or descriptions.7-12 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, on occasion, processing and use information has been claimed as confidential even though it was revealed in submissions sent to the Agency in response to the HPV Challenge program and published on the EPA website. In addition, EPA has observed 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 info rmation meant EPA was unable to make available to the public important data or to completely describ e 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 prod uction volume for each industrial processing or use scenario. This amendment decrease in the numbe r of inappropriate CBI claims under the new substantiation requirement, which w ould 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 transparen cy and public accessibility of the chemical risk information, may increase public confidence in EPA’s chemical management program, and is consistent 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 information 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 beneficiary 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 fro m IUR data are discussed in more detail in the following sections.

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.”7-13 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 review of a chemical in a number of ways, including under an Agency program, through a request by th e 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:

• 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 indust ry has a greater knowledge than EPA about its own operations and the uses of chemicals it manufactures 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-Production Volume (HPV) Challenge Program, which makes available to the public screening-level environmental 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 rule 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 screened first to identify those (1 ) requiring additional testing, (2) presenting potentially significant risk management concerns, or (3) currently not requiring further review. While the proposed amendments to the IUR data woul d increase 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 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 the7-14 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 sour ces are outdated and the 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 help EPA determine which chemical substances are on the Master Testing List (MTL). The MTL is a list of chemicals identified by the Agency as having inadequate data for health and/or environmenta l risk assessments. OPPT uses the MTL to establish priorities for chemical testing, keep the public informed, solicit input from industry on specificchemical exposure and risk assessment needs, and to encourage industry to perform testing. More indepth exposure-related manufacturing, processing, a nd use data would 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 facilita ting earlier completion of critical testing needs.

• Screening Information Data Set (SIDS) program. The Organisation for Economic Co-operation and Development’s (OECD) voluntary SIDS program allows OECD member countries to share the burden of testing internationally traded, large production volume chemicals. The United States is responsible for testing 25 percent of the chemical s identified for the program. The information needed is collected by industry sponsors; however, the data elements included may not be consistent across sponsors, and some companies may not participate in developing all of the data elements. Currently collected data and data collected through more in-depth exposure and use data requirements will enable the EPA to meet many key needs for exposur e data and will provide a consistent database of information from manufacturers (including importers). This information will increase the program’s efficiency by helping to identify chemicals requi ring additional testing or assessment while excluding those with low domestic exposure. An improved e xposure database will also improve evaluation of potential risk in the assessment reports prep ared 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 developing realistic approaches for reducing risk.

7.3.2 Other Federal Risk Management Programs Under TSCA section 4, EPA has the authority to require firms to conduct tests of specific chemicals to determine the potential risk posed by these substances. 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 in7-15 the workplace. OSHA will be able to use the IUR data to identify chemicals with large numbers of potentially exposed workers or with uses suggesting gr eater 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 NIOSH uses to determine occupational safety and health in businesses nationwide may be based on out dated information collected under the National Occupational Exposure Survey (NOES). Completed in 1983, NOES collected information such as plant site location, plant site Standard Industrial Cl assification (SIC), information on the plant site’s occupational safety and health programs, occupati onal titles of workers potentially exposed, the number of employees per occupational title, information on pr ocess steps, and trade names of products. NIOSH could use IUR data in place of the NOES data to id entify chemicals with large numbers of potentially exposed workers or with uses suggesting 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 products. 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 scenarios presenting greater potential ri sk. The information 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 governments 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 posing potentially high risks for individua l states or locations within those states. The information added to the IUR includes c ounty data, which will enable states to identify which counties are likely to have specific issues or which counties may have multiple chemicalrisk situations. 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) Initia tiv es 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 manage risks more effectiv ely 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 promote 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 ex ample of one such program that could use this information. The7-16 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 they do not know how their chemicals are used. Non-CBI use informati on 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.8-1 

## 8. Small Entity Analysis

This chapter estimates the impact 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 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 regulatory flexibility analyses to identify the types, and estimat e the numbers, of small entities to which the rule will apply, and describe the rule requi rements to which small entities will be subject and any regulatory alternatives, including exemptions a nd 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; 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 in the following sections..



### 8.1 Select a Relevant Small Entity Definition

The RFA relies on the definition of “small business” 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 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.”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 any company with sales less than or equal to $40 million is small, regardless of production volume. 6 This assumption may tend to overestimate the number of small businesses affected because it includes entities that may not meet all small business requirementsunder TSCA §8(a). Throughout the remainder of this report, 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. Parent company data was available for 3,392 of these sites, 9 with 872 associated parent companies. Information for the remaining companies was unavailable for several reasons. First, these comp anies 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 busin ess 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 companies 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.8-3 above. These results are fairly consistent with the 2002 EA’s estimates 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 EPA estim ate the total number of parent companies in the baseline. One global parent company may submit reports for more than one site. Based on the sample of companies for which the parent company information is available, EPA estimates 3.89 sites per global parent company. Given that 4,188 sites submitted re ports, EPA estimates the number of parent companies for the 2006 IUR reporting baseline is 1,076.

As described in Section 4.5, the proposed amendments are e xpect ed to increase the number of sites reporting by 204. Therefore, EPA estimates 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 companies derived in Table 8-1 to the total number of parent co mpanies EPA expects to be subject to the rule under the proposed amendments. Table 8-2 shows the number of expected small companies, under both definitions.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 manufacturing (including importing) chemicals at or around the 25,000 lb. threshold. Therefore, this method may underestimate the number of small businesses. Furthermore, to the extent the set of companies for which EPA was not able to find data is not statistically similar to the set of companies for which data was available, this analysis may under- or over-estimate the percentage of small companies.



### 8.5 Estimate Cost-to-Sales Rati os for Small Companies
Table 4-51 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 and 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.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 $21,607,475 $19,948,001 $21,607,475 $19,948,001

Annualized Costs per Site $5,289 $4,883 $5,289 $4,883

Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $9,309 $8,594 $10,156 $9,376

Annual Sales per Small Parent Company $412,713,310 $412,713,310 $11,821,104 $11,821,104

Cost-to-Sales Ratio 0.0023% 0.0021% 0.0859% 0.0793%

Number of Companies Potentially Affected 466 280

As shown in Table 8-3, under the employment-based defin ition, a small parent com pany affected by the rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $9,309 at a three percent discount rate, and even lower under a seven 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 are on averag e more than $11.8 million, with annualized costs associated with the proposed amendments of $10.156 or lower. The cost-to- sales ratio for an average small company under the sales-based defin ition would be 0.09 percent or less. Using the highest annual cost shown in Table 8-3, $10,156, a small company would have to have annual sales of less than $1.02 million in order to have a cost-to-sales ratio larger than one percent. As mentioned 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 small enough to have a cost-to-sales ratio greater than one percent generally will be exem pt 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 466 small firms potentially would be affected by this proposed rule under the employme nt-based definition of the term, and 280 small firms potentially would be affected under the sales-based de finition of the term. Base d on costs annualized over a four-year period and average sales data, EPA estimat ed the cost-to-sales ratio of the proposed rule would be 0.002 percent or less under the employme nt-based definition for an average small company subject to the rule, and 0.09 percent or less under the sales-based definition. As noted above, EPA often defines the lower threshold as compliance costs of one percent of sales and the higher threshold as8-6 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. For a company to have a cost-to-sales ratio larger than one percent, company sales would have to be less than $1.02 million. Because the small businesses affected by the proposed rule actually have aver age sales of more than $11 million, and because any potentially affected companies with sales of $1.02 million or less would generally be exempt from reporting obligations under the IUR, small entities w ill not be significantly affected by the proposed amendments to the IUR rule.9-1 

## 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 this regulatory action does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governme nts, in the aggregate, or for the private sector, in any one year. The analysis of the co sts associated with this action is d escribed 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 this rule does not significantly or uniquely affect small governments. This is because only manufacturers (including importers) of chemical substances are affected by the rule. No action is required by small governments that ar e 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 and OMB control num ber 2070-0162. Because this rule involves new or revised information collection activities requiri ng additional OMB approval, EPA has prepared an addendum to the currently approved ICR (EPA, 2010). The Paperwork Reduction Act mandate s federal 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, ma intain, retain, disclose, or provide information to or for a federal agency. This includes the time needed by regulated entities to review instructions and to develop, acquire, install, and use technology and systems to collect, validate, verify, and disclose information. Time taken to adjust existing ways to comply with any previously applicable instructions and requirements and to train personnel to respond to the information collection task is also included. In this section, burden hours for both industry 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 estimates th e propose d rule would impose a total estimated incremental industry burden of 1.39 million hours, in the first reporting cycle, if all proposed9-2 amendments are implemented. The burden for the average site will increase by approximately 341 hours per site to 792 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” are defined in the Executive Order to in clude regulations having “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 this proposed rule does not have federalism implications because it will not have substantial direct effects on the states, on the relatio nship between the national government and the states, or on the distribution of power and responsibilities am ong the various levels of government, as specified in the Order. This rule simply amends the Inventor y Update Reporting rule in several ways to provide information to better address Agency and public info rmation needs, improve the usability and reliability of the reported data, and ensure data are available in a timely manner. Because EPA has no information indicating 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 requiring special consideration by the Agency under EO 12898. The Agency believes the information collected under th is proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risk s associated with the chemicals covered by the rule. Because the IUR rule is an information collection requ irement, the information that will become available through the rule will enable the Agency to target educational, regulatory, or enforcement activities towards industries or chemicals posing the greatest ri sks 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 co mmunities, 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.



### 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 each9-3 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 this 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 and Coordination w ith 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 Su ppl y, 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 Transfer Advancement Act
Section 12(d) of the National Technology Transfer 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.10-1 

## 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 Reporting 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/newchems/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-HQ-OPPT-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, Production10-2 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. EPA, 2010. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1884.05. [Information Collection Request for] Addendum to Partial Update of the TSCA Section 8(b) Inventory Data Base, Production and Site Reports . Washington, DC. July, 2010. 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.A-1 

## Appendix A. 2006 Form UA-2B-1 

## Appendix B. Proposed Revised Form UB-2B-3B-4C-1 

## Appendix C. – Current and Proposed 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.D-1 

## Appendix D. Current and Proposed Consum er 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 MaterialsD-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)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)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 da ta for other amendments meant EPA only was able to estimate the impact broadly, such as a percentage in crease or decrease in the number of submitters caused by the amendment, using the Agency’s best prof essional 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 “Other” as a product function category, (4) requiring write-in text if selecting “Other” as a consumer or commer cial 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 range 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 a report be filed for a chemical only if the chemical’s production volume exceeds the 25,000 lb. threshold in the principal IUR reporting year. EPA is proposing to modify the timeframe for reporting in fulture reporting cycl es subsequent to 2011 so chemical manufacturers (including importers) would be subject to the IUR rule if a chemical’s production volume has met or exceeded the threshold in any calendar year since th e last principal reporting year. The Agency 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 the increas e in cost and bur den to industry using a midpoint estimate of five percent. Using a fi ve percent increase in the number of sites and reports, EPA expects the burden to industry will increase by approximately 72,000 hour s in future reporting cycles (see Table 4-12). Table F-1: contains the results of the sensitivity analysis using a lower bound estimate of a zero percent increase in the num ber of submitters and an upper bound estimate of a ten percent increase. All baseline burden estimates were taken from Table 4-2. The increase in burden to industr y is expected to range from zero hours to aproximately 143,000 hours as a result of modifying the method for determining whether the 25,000 lb. threshold is met in future reporting cycles.F-2 Table F-1: Sensitivity Analysis of Industry Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

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 9.08 4,085 4,085 17.06 25,896 25,896 55.93 17,075 17,075 1,433,833 1,433,833
PostAmendment 9.08 4,085 4,494 17.06 25,896 28,486 55.93 17,075 18,783 1,433,833 1,577,216
Change from the Baseline 0.00 0 409 0.00 0 2,590 0.00 0 1,708 0 143,383

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

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 ind ustry between $0 and $8.28 million. The midpoint cost estimate of $4.14 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 (Future Reporting Cycles Only)

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 $560.77 4,085 4,085 $968.39 25,896 25,896 $3,247.40 17,075 17,075 $82.82 $82.82
PostAmendment $560.77 4,085 4,494 $968.39 25,896 28,486 $3,247.40 17,075 18,783 $82.82 $91.10
Change from the Baseline $0.00 0 409 $0.00 0 2,590 $0.00 0 1,708 $0.00 $8.28

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 amendment were calculated in Section 5.4. With a five percent incre ase 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 increa se in the number reports and an upper bound increase of ten percent, is presented in Table F-3. Baseline Agency burden is tak en from Table 5-4. The proposed amendment is e xpected to increase the Agenc y burden by between zero and 208 hours.F-3 Table F-3: Sensitivity Analysis of Agency Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

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 corresponding baseline value from the post-amendment value.

Table F-4 shows the range in Agency costs as a result of m odifying the method for determining whether the threshold is met. B aseline Agency costs 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.

Table F-4: Sensitivity Analysis of Agency Cost Estimates for Modifying the Method for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

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 corresponding 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 between 14.8 percent of a ll reports (the percentage 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 increase by 7,596 hours (see Table 4-24). Table F-5 shows the burden estimates using the lower and upper bounds for the num ber of repor ts that will contain information on production volume used on-site. The baseline cost per report is taken from Table 4-6. EPA expects the total industr y burden to range from 5,800 to 9,400 hours.F-4 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 Production Volume Used On-Site (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 corresponding 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 esti mate of $0.43 million (see Table 4-25).

Table F-6: Sensitivity Analysis of Industry Cost 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 corresponding baseline value from the post-amendment value.

In Section 5.4.13, EPA calculated the burden to the Agency of requiring the reporting of production volum e used on-site, using 19.4 percent as the estim ated amount of reports listing production volume used on-site is calculated in Section 5.4.13. The resulting burden was 4.51 hours. In Table F-7, EPA calculates the range of bur den estimates to the Agen cy, using a range of 14.8 to 24 percent as the amount of reports listing production volume used on-site. The resulting burden is 3.44 to 5.57 hours per reporting cycle. The baseline burden per report is taken from Table 5-4.F-5 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 Production Volume Used On-Site (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 corresponding 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 c osts 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.

Table F-8: Sensitivity Analysis of Agency Cost 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 corresponding baseline value from the post-amendment value.



### F.3 Modifying Industrial 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 th is analysis for industry burden are found in Table F-9. A 75 percent reduction in the num ber of submitters clai ming “Other” means 25 percent of submitters are now claiming “Other,” and a 25 percent reduction means 75 percent of submitters are now claiming “Other.” The columns in this table and the remaining tables in this Appendix are labeled to reflect the resulting numbers; e.g., they show the lower resulting number in the “Lower Bound” column and the higher resulting number in the “Upper Bound” column.F-6 Baseline burden estimates are taken from Table 4-2 and the baseline numbe r of reports is foun d in Table 4-6. EPA estimates the burden to industry w ill i ncrease by between 4,300 and 4,400 hours.

Table F-9: Sensitivity Analysis of Industry Burden 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 corresponding baseline value from the post-amendment value.

Table F-10 contains the range of cost estimates to industry with a l ower 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. EPA estimates a cost to industry between $253,400 and $257,800, wit h 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 corresponding 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.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 corresponding 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. B aseline costs to EPA are taken from Table 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 leading to common exposure scenarios and adding categories not adequately described in the current set of categories. The resultant proposed lis t includes 33 product categories, including “Other.” Several consumer and commercial product categories have been renamed to better describe the products that should be reported in that category. EPA is al so proposing to require that if the product category “Other” is selected; a descriptor for the consumer and/or commercial product containing the chemical substance also to be reported. According to 2006 IUR data (EPA, 2008c), 1,207 reports listed “Other” as a consumer and/or commercial product category. Based on EPA’s best professional judgment, EPA expects the new categories in the proposed amendmen t will reduce by half the number of submitters selecting “Other” as a consumer and/or commercial pr oduct category. Therefore, this amendment would affect 604 reports. The cost and burden to indust ry with a 50 percent reduction in the number of submitters is found in Section 4.4.20. 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 burdenF-8 estimates are taken from Table 4-2 and the baseline number of reports is found in Table 4-6. EPA esti mates the burden to industry will in crease between 16,000 a nd 16,100 hours.

Table F-13: Sensitivity Analysis of Industry Burden 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 corresponding 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 decrea se 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 midpoint 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 corresponding 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 hours and is calculated in Section 5.4.20. Table F-15 shows the range 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.F-9 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 post-amendment value.

Table F-16 shows the range in costs to EPA as a result of modifying the consumer and commercial product categories. Baselin e 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 CategoryNumber of Reports with "Other" Writein 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 post-amendment 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 processing and use information was CBI, with an av erage 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. The Agency conducted a sensitivity analysis, assu ming the reduction in CBI claims has a lower bound of 84 percent, meaning 16 per cent of submitters make a CBI clai m in Part III, and an upper bound of 44 percent, meaning 56 percent of submitters make a CBI claim in Part III. Table F-17 contains range in bur den increase to industry as a result of the pro posed amendment. The burden is expected to increase by between 5,700 and 19,900 hours.F-10 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 0PostAmendment 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 subtracting 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 num ber of DPU CBI claims and 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 subtracting 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 Section 5.4.25. Table F-19 contains the range of burden esti mates 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.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 0PostAmendment 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. B aseline costs to EPA are taken from Table 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.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 proposed amendments outlined in Chapter 3. The burden and cost for these alternat e regulatory opti ons are described in the following sections.



### G.1 Require Submitters to S ubmit Full Data Annuall y

As an alternative to the amendment described in Section 3.5.4, which would require submitters to report production volum e 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 second scenario estimates the cost and bu rden 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 would 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, after the first reporting cycle. While the Agency is aware that a site’s pr oduction volume may vary yearly, causing the site to meet or exceed the threshold in some years but not in others, EPA believes on average, the total number of sites and reports would remain unchanged from year to year. EPA analyzed the burden and costs over a 25-year period. EPA assumes submitters will become more efficient at reporting data over time, and therefor e incur a smaller burden in future reporting cycles. Future-cycle reporting burden is taken from Table 4-11.

The annual in dustry burden under the baseline and the alternative option is shown in Table G-1. In total, EPA esti mates the industry burden would increase by approximately 22.94 million hours over 25 years (five reporting cycles). Over one future 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

Baseline Burden Post-Alternative Option Burden Change from Baseline Reporting Cycle Years (millions of hours) (millions of hours) (millions of hours)
1 2007 to 2011 1.84 1.84 0.00
2 2012 to 2016 1.43 7.17 5.74 3 2017 to 2021 1.43 7.17 5.74 4 2022 to 2026 1.43 7.17 5.74 5 2027 to 2031 1.43 7.17 5.74
Total 7.58 30.52 22.94 Annual Average 0.30 1.22 0.92G-2 The industry cost under the baseline and this alternative option is shown in Table G-2. EPA estimates the industr y cost would increase by $1.33 billion over a 25-year period. The annualized cost increase ranges from $44.34 million with a seven percent disc ount rate to $49.54 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

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting Cycle Years (2008$ millions) (2008$ millions) (2008$ millions) 1 2007 to 2011 $106.97 $106.97 $0.00 2 2012 to 2016 $82.82 $414.09 $331.27 3 2017 to 2021 $82.82 $414.09 $331.27 4 2022 to 2026 $82.82 $414.09 $331.27
5 2027 to 2031 $82.82 $414.09 $331.27
Total $438.24 $1,763.32 $1,325.08 Annual Average $17.53 $70.53 $53.00
Annualized at 3% $16.80 $66.34 $49.54
Annualized at 7% $15.88 $60.22 $44.34

The baseline burden to EPA during each reporting cycle is two FTEs, or 4,160 hours (see Section 5-2). While the burden for each reporting cycle will not change as a result of this amendment, m ore frequent reporting would increase costs to the Agency. Table G-3 contains the total Agency burden of the annual reporti ng option, over a 25-y ear period. EPA estimates Agency burden would increase by a total of 66,600 hours over a 25-year period (five 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

Baseline Burden Post-Alternative Option Change from Baseline Reporting Cycle Years
(hours) (hours) (hours) 1 2007 to 2011 4,160 4,160 0 2 2012 to 2016 4,160 20,800 16,640 3 2017 to 2021 4,160 20,800 16,640 4 2022 to 2026 4,160 20,800 16,640 5 2027 to 2031 4,160 20,800 16,640 Total 20,800 87,360 66,560 Annual Average 832 3,494 2,662

The annual Agency cost under the baseline and the alternative option is shown in Table G-4, and is taken from Table 5-3. In total, EPA estimates this option would inc rease the Agency cost by approximately $1.86 million over one five-year reporti ng cycle. Over a 25-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.G-3 Table G-4: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting Cycle Years (2008$) (2008$) (2008$)
1 2007 to 2011 $466,133 $466,132 $0.00
2 2012 to 2016 $466,133 $2,330,664 $1,864,532 3 2017 to 2021 $466,133 $2,330,664 $1,864,532
4 2022 to 2026 $466,133 $2,330,664 $1,864,532
5 2027 to 2031 $466,133 $2,330,664 $1,864,532
Total $2,330,664 $9,788,790 $7,458,126 Annual Average $93,227 $391,552 $298,325
Annualized at 3% $87,798 $366,630 $291,617
Annualized at 7% $81,056 $466,133 $359,885

G.1.2 Annual Reporting Cost and Burden when the All the Proposed Amendments are Consid ered 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 re porting cost and burden would be the same as the burden when all the amendments are considered, as shown in Table 4-50. After the first reporting
cy cle, the number of submitters is not expected to change from year to year. The industry burden of annual reporting is shown in Table G-5. The annual reporting option is expected to increase the industr y burden by approximately 39.58 million hours over a 25-year period, for a total industry burden of 56.01 million hours. EPA estimates over one four-year reporting cycle (note under the proposed amendments, a reporting cycle woul d be changed to four years) the industry burden would increase by approximately 7.92 million hours (2.64 million hours x 3 years) compared to the baseline.

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

Baseline Burden Post-Alternative Option Burden Change from Baseline Reporting Cycle Years (millions of hours) (millions of hours) (millions of hours) 1 2007 to 2011 3.24 3.24 0.00 2 2012 to 2015 2.64 10.56 7.92 3 2016 to 2019 2.64 10.56 7.92 4 2020 to 2023 2.64 10.56 7.92 5 2024 to 2027 2.64 10.56 7.92 6 2028 to 2031 2.64 10.56 7.92
Total 16.43 56.01 39.58 Annual Average 0.66 2.24 1.58

The industry baseline cost is taken from Table 4-51. EPA estimates annual reporting would increase industr y cost by approximately $2.43 billion over a 25-year period. The change in annualized cost ranges from $81.39 million with a seven percent discount rate to $90.90 million with a three percent discount rate as shown in Table G-6. Over one four-year reporting cycle, this option would increase industry cost by approximately $486 million ($162.08 x 3 years) compared to the baseline.G-4 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

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting Cycle Years (2008$ millions) (2008$ millions) (2008$ millions) 1 2007 to 2011 $198.84 $198.84 $0.00 2 2012 to 2015 $162.08 $648.33 $486.25 3 2016 to 2019 $162.08 $648.33 $486.25 4 2020 to 2023 $162.08 $648.33 $486.25
5 2024 to 2027 $162.08 $648.33 $486.25 6 2028 to 2031 $162.08 $648.33 $486.25
Total $1,009.25 $3,440.49 $2,431.24 Annual Average $40.37 $137.62 $97.25
Annualized at 3% $38.40 $129.30 $90.90
Annualized at 7% $35.83 $117.22 $81.39

The Agency baseline burden when all the proposed amendments are considered is taken from Table 5-40. T he annual reporting option is expected to increase Agency burden by approximately 36,800 hours when all amendments are considered (see Table G-7). Over a four-year reporting cycle, EPA estimates Agency burden would increase by a pproximately 7,400 hours (2,456 ho urs 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

Baseline Burden Post-Alternative Option Burden Change from Baseline Reporting Cycle Years (millions of hours) (millions of hours) (millions of hours) 1 2007 to 2011 2,439 2,439 0 2 2012 to 2015 2,456 9,826 7,369 3 2016 to 2019 2,456 9,826 7,369 4 2020 to 2023 2,456 9,826 7,369 5 2024 to 2027 2,456 9,826 7,369 6 2028 to 2031 2,456 9,826 7,369 Total 14,721 51,568 36,847 Annual Average 589 2,063 1,474

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 25-year period, Agency cost would inc rease by approximately $4.33 million, with annualized costs increases ranging from approxima tely $205,000 with a seve n percent discount rate to $227,000 with a three percent discount rate. Over one four-year reporting cycle, the Agency cost is expected to increase by $865,000 ($288,450 x 3 years) compared to the baseline.G-5 Table G-8: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting Cycle Years (2008$) (2008$ millions) (2008$ millions) 1 2007 to 2011 $286,580 $286,580 $0 2 2012 to 2015 $288,450 $1,153,800 $865,350 3 2016 to 2019 $288,450 $1,153,800 $865,350 4 2020 to 2023 $288,450 $1,153,800 $865,350 5 2024 to 2027 $288,450 $1,153,800 $865,350 6 2028 to 2031 $288,450 $1,153,800 $865,350 Total $1,728,830 $6,055,580 $4,326,750 Annual Average $69,153 $242,223 $173,070 Annualized at 3% $65,011 $226,783 $161,773 Annualized at 7% $59,642 $204,495 $144,853

G.1.3 Small Entity Analysis The following section provides a pr eliminary assessment of the impact annual Form U submissions may have on small entities by examining the relati onship between the compliance costs and company sales for small companies. This an alysis is based on the methodology described in Chapter 8 of this report. All costs and burdens are estimated under the assumption all the proposed amendments are enacted. EPA estimated in Chapter 8 of this report 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 4-51 shows the annual incremental cost of th e rule to industry. Because th is 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 wer e 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 defin ition, a small parent com pany 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 $39,582. 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, small parent company sales are on average more than$11.8 million, with annualized costs associated with the proposed amendments of $43,181. The cost-tosales ratio for an average small company under the sal es-based definition would be 0.364 percent or less.

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.G-6 Using the highest annual cost shown in Table G-9 of $43,181, a small company would have to have annual sales of less than $4.32 million in order to have a cost-to-sales ratio larger than one percent.

Table G-9: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of Annual Reporting Employment-based Definition Sales-based Definition

Total Incremental Annu al Costs $91,871,064 Total Number of Sites 4,085 Annual costs per site $21,490 Number of sites per small parent company 1.76 1.92 Annualized costs per small parent company $39,582 $43,181 Annual sales per small parent company $412,713,310 $11,821,104 Cost-to-sales ratio 0.010% 0.365% Number of companies potentially affected 466 280



### G.2 Modify Reporting Frequency to a Three-Year Cycle
As an alternative to the proposed amendment described 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 freque nt. However, the Agency assumes no additional reports will be submitted as a result of reducing the length of the reporting cycle. (While the mix of chemicals might change, EPA assumes the total number 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 under this alternative option are shown in Table G-10. The in dustry burden is taken from Table 4-10 for the first reporting cycle and from Table 4-11 for all future reporting c ycles. In total, EPA estimates unde r this option, industry would incur an additional burden of 2.87 million hours over a 20-year period.G-7 Table G-10: Annual Industry Burden under the Alte rnative Option of a Three-Year Reporting Cycle

Baseline Burden Post-Amendment Burden Change in Burden Reporting Cycle 1 Years (millions of hours) (millions of hours) (millions of hours)
1 2007 to 2011 1.84 1.84 0.00 2012 to 2016 1.43 -- 2 2012 to 2014 -- 1.43 0.00
2017 to 2021 1.43 -- 3 2015 to 2017 -- 1.43 0.00
2022 to 2026 1.43 -- 4 2018 to 2020 -- 1.43 0.00
5 2021 to 2023 -- 1.43 1.43 6 2024 to 2026 -- 1.43 1.43 Total 6.14 9.01 2.87 Annual Average 0.31 0.45 0.14

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italicized reporting cycl es are alternative, three -year cycles.

The annual industry cost under the baseline and this alternative option are shown in Table G-11. In total, EPA estim ates this option would increase co sts to industry by $165.64 million over a 20-year period, with annualized costs increases ranging from $6. 96 million with a seven percent discount rate to $7.75 million with a three percent discount rate.

Table G-11: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting Cycle 1 Years (2008$ millions) (2008$ millions) (2008$ millions) 1 2007 to 2011 $106.97 106.97 0.00 2012 to 2016 $82.82 -- 2 2012 to 2014 -- $82.82 0.00
2017 to 2021 $82.82 -- 3 2015 to 2017 -- $82.82 0.00
2022 to 2026 $82.82 -- 4 2018 to 2020 -- $82.82 0.00
5 2021 to 2023 -- $82.82 $82.82 6 2024 to 2026 -- $82.82 $82.82 Total $355.42 $521.05 $165.64 Annual Average $17.77 $26.05 $8.28 Annualized at 3% $17.00 $24.75 $7.75 Annualized at 7% $16.03 $22.99 $6.96

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italicized reporting cycl es are alternative, three -year cycles.

The baseline burden to EPA during reporting y ears is two FTEs or 4,160 hours (see Section 5-2). While the bur den 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 burden the Agency of the proposed option, over a 20-y ear period. During this period, EPA estimates Agency burden would increase by a total of approximately 8,300 hours.G-8 Table G-12: Burden to the Agency under the Alternative Option of a Three-Year Reporting Cycle

Baseline Burden Post-Amendment Burden Change in Burden Reporting Cycle 1 Years (millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 4,160 4,160 0 2012 to 2016 4,160 -- 2 2012 to 2014 -- 4,160 0
2017 to 2021 4,160 -- 3 2015 to 2017 -- 4,160 0
2022 to 2026 4,160 -- 4 2018 to 2020 -- 4,160 0
5 2021 to 2023 -- 4,160 4,160 6 2024 to 2026 -- 4,160 4,160 Total 16,640 24,960 8,320 Annual Average 832 1,248 416

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italicized reporting cycl es are alternative, three -year cycles.

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 this op tion woul d increase Agency costs by $932,300 over a 20-year period with an annual average of $46,600.

Table G-13: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting Cycle 1 Years (2008$) (2008$) (2008$) 1 2007 to 2011 $466,133 $466,133 $0
2012 to 2016 $466,133 -- 2 2012 to 2014 -- $466,133 $0
2017 to 2021 $466,133 -- 3 2015 to 2017 -- $466,133 $0
2022 to 2026 $466,133 -- 4 2018 to 2020 -- $466,133 $0
5 2021 to 2023 -- $466,133 $466,133 6 2024 to 2026 -- $466,133 $466,133
Total $1,864,532 $2,796,797 $932,266 Annual Average $93,227 $139,840 $46,613 Annualized at 3% $87,798 $131,412 $43,614 Annualized at 7% $81,056 $120,247 $39,190

1 The non-italicized reporting cycles are ba seline, five-year cycles, and the italicized reporting cycl es are alternative, three -year cycles.

G.2.2 Three-Year Cycle Cost and Burden when the All the Proposed Amendments are Consid ered 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 alternative option, t he reporting burden for industry would be the same as the combined post amendment burden shown in Table 4-50; however the reporting cycleG-9 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 17 years as a result of increasing the reporting frequency to three years from four years is 2.64 million hours (see Table G-14). This equates to an annual increase in the reporting burden of approximately 0.13 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

Baseline Burden Post-Amendment Burden Change in Burden Reporting Cycle 1 Years (millions of hours) (millions of hours) (millions of hours)
1 2007 to 2011 3.24 3.24 0.00 2012 to 2015 2.64 -- 2 2012 to 2014 -- 2.64 0.00
2016 to 2019 2.64 -- 3 2015 to 2017 -- 2.64 0.00
2020 to 2023 2.64 -- 4 2018 to 2020 -- 2.64 0.00
5 2021 to 2023 -- 2.64 2.64
Total 11.15 13.79 2.64 Annual Average 0.56 0.69 0.13

1 The non-italicized reporting cycles are ba seline, four-year cycles, an d the italicized reporting cycl es are alternative, three -year cycles.

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 17-year period, total costs would increase by $162.08 million, with an annualized increase of $8.93 million at a three percen t discount rate and $8.07 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

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting Cycle 1 Years (2008$ millions) (2008$ millions) (2008$ millions) 1 2007 to 2011 $19.88 $19.88 $0.00
2012 to 2015 $162.08 -- 2 2012 to 2014 -- $162.08 $0.00
2016 to 2019 $162.08 -- 3 2015 to 2017 -- $162.08 $0.00
2020 to 2023 $162.08 -- 4 2018 to 2020 -- $162.08 $0.00
5 2021 to 2023 -- $162.08 $162.08
Total $506.13 $668.21 $162.08 Annual Average $29.77 $39.31 $9.53
Annualized at 3% $38.29 $47.23 $8.93
Annualized at 7% $35.70 $43.76 $8.07

1 The non-italicized reporting cycles are ba seline, four-year cycles, an d the italicized reporting cycl es are alternative, three -year cycles.G-10 The Agency baseline burdens of 2,439 hours (first reporting cycle) and 2,456 (future reporting cycles) when all the proposed amendments are considered together is taken from Table 5-40. The annual reporting option is expected to increase Agency burden by approximately 2,500 hours over 17 years when all amendments 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

Baseline Burden Post-Amendment Burden Change in Burden Reporting Cycle 1 Years (hours) (hours) (hours)

1 2007 to 2011 2,439 2,439 0
2012 to 2015 2,456 -- 2 2012 to 2014 -- 2,456 0

2016 to 2019 2,456 -- 3 2015 to 2017 -- 2,456 0

2020 to 2023 2,456 -- 4 2018 to 2020 -- 2,456 0

5 2021 to 2023 -- 2,456 2,456
Total 9,807 12,264 2,456 Annual Average 577 721 145

1 The non-italicized reporting cycles are ba seline, four-year cycles, an d the italicized reporting cycl es are alternative, three -year cycles.

Table G-17 contains the total Agency cost under a three-year reporting cycle. EPA estimates the Agency cost would increase by approximately $288,500 over a 17-year period. The annualized cost is expected to increase by $15,600 with a three percent discount rate and $14,400 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

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting Cycle 1 Years (2008$) (2008$) (2008$) 1 2007 to 2011 $286,580 $286,580 $0
2012 to 2015 $288,450 -- 2 2012 to 2014 -- $288,450 $0

2016 to 2019 $288,450 -- 3 2015 to 2017 -- $288,450 $0

2020 to 2023 $288,450 -- 4 2018 to 2020 -- $288,450 $0

5 2021 to 2023 -- $288,450 $288,450
Total $1,151,930 $1,440,380 $288,450 Annual Average $67,761 $84,728 $16,968
Annualized at 3% $63,741 $79,637 $15,896
Annualized at 7% $58,612 $72,971 $14,359

1 The non-italicized reporting cycles are ba seline, four-year cycles, an d the italicized reporting cycl es are alternative, three -yearG-11 cycles.

G.2.3 Small Entity Anaylsis The following section provides a preliminary assessment of the impact a three-year reporting cycle may have on small entities by examining the relati onship between the compliance costs and company sales for small companies. This anal ysis is based on the methodology f ound in Chapter 8 of this report and all costs and burdens are estimated under the assumption all the proposed amendments are enacted. EPA estimated 3.89 manufacturing sites per global pa rent company in Chapter 8 of this report; 41.3 percent of global parent companies (466 companie s) are considered small under the SBA employmentbased 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 estimated using data fro m Dun & Bradstreet, as also described in the EA.

Table 4-51 shows the incremental cost to the industry. 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, 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 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 G-18, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $14,096 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 0.0034 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 $32.7 million or lower. The cost-to-sales ratio for an average small company under the sales- based definition would be 0.13 percent or less.

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.G-12 Using the highest annual cost shown in

Table G-18 of $15,378, a small company would have to have annual sales of less than $1.58 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 Incremental Costs of Proposed Other Amendments $91,871,064

Total Annualized Costs $31,533,214 $32,717,404 $31,533,214 $32,717,404

Total Number of Sites 4,085
Annualized Costs per Site $7,719 $8,009 $7,719 $8,009 Number of Sites per Small Parent Company 1.76 1.92
Annualized Costs per Small Parent Company $13,586 $14,096 $14,821 $15,378
Annual Sales per Small Parent Company $412,713,310 $412,713,310 $11,821,104 $11,821,104

Cost-to-Sales Ratio 0.0033% 0.0034% 0.1254% 0.1301% 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 sites to 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 tio n levels. In total, 882 sites, or 19 percent, of all the sites submitting reports data in 2002 produced chemicals in amounts betweenG-13 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 Pollu tion 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 787 addit ional 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 only additional pa rtial reports (Part IIs) will be submitted.

As described in Section 4.2.2, 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 th e baseline unit burden estimates as shown in Table 4-2, Table G-20 shows the industr y burden estimate as a result of this proposed amendment. The Agency estimates the amendment will cause an increase in industr y burden of approximat ely 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 1,842,934PostAmendment 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 the corresponding baseline value from the postamendment value.G-14 The cost of the amendment was calculated using the unit costs shown in Table 4-5. Table G-21 shows the industr y 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 $1,129.4 2 17,075 $4,059.25 $106.97
PostAmendment 4,872 $2,058.18 29,349 $1,129.4 2 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 the corresponding baseline value from the postamendment 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 number of re ports and subm itters will increase the burden to the Agency. While the burden per reporting cycle w ill not change as a result of this amendment, more frequent reporting will increase costs to the Agency. Table G-22 contains the total Agency of the proposed opti on. 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 the corresponding baseline value from the postamendment value.

Table G-23 shows the estimated change in cost to EPA as a re sult of the proposed amendment. The Agency estimates a cost increase of approximately $16,600.G-15 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 the corresponding baseline value from the postamendment value.

G.3.2 Change the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Consid ered 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 been considered. A 10, 00 0 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 this option would affect the proposed a mendment to lower the threshold fo r 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 inform ation would be 10,000 lb. The total number of s ites and reports, when all the proposed amendments and the 10,000 lb. threshold reporting option are considered, is found in Table G-25. To calculate the

num ber of additional submitters and reports, EPA followed the method outlined in Section 4.5.1. While Steps 1 and 2 re main unchanged from what is described in Section 4.5.1, the other steps have been

m odified and an additional step has been added. The cal culations 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

am endments, EPA multiplied the total number of sites calculated in Step 2 (0 in the first reporting cycle and 204 in future reporting cycles) by 1.19 and the numb er of partial reports calcula ted in step 2 (3,975 in the first reporting cycle and 5,469 in future reporting cycles) 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 (8,219 in the first reporting cycle and 9,484 in future reporting cycles), and added the Step 3 total for Part II reports (7,985 in the first reporting cycle and 9,632 in future repor ting cycles), 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 manufactu rer is subject to reporting requirements (0 in theG-16 first reporting cycle and 1,295 in future reporting cycl es) and the number of new Part II reports that will be for EAC chemicals as a result of th e 10,000 lb. threshold (80 in in the first reporting cycle and 86 in future reporting cycles ) . The number of ECA chemicals as a result of the 10,000 lb. threshold in the first reporting cycle is calculated by multiplying the number of ECA chemicals by 1.13. In future reporting cycles, the number of ECA chemicals as a result of the 10,000 lb. threshold is calculated by multiplying the number of ECA chemicals after the five percent h as been taken into account, 649, by 1.13. to calculate the total number of ECA chemicals take into account the five percent. This number, 649, is then multiplied by 1.13. The number of reports with Part III will increase by 16,801 in the first reporting cycle and 17,737 in future reporting cycles. Step 5: Calculate the number of reports when all 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 4,872 Part Is, 33, 854 Part IIs and 33,156 Part IIIs in the first reporting cycle. In future reporting cycles there will be a total of 5,115 Part Is, 35,5 28 Part IIs and 34,812 Part IIIs. The difference between the total number of Part IIs and Part IIIs, 698 reports, is equal to the number of ECA chemicals times 1.13 (618 x 1.13=698). In future cycles, the difference of 735 reports is equal to the number of partially exempt reports with the five and 13 percent increase taken into account ((618 x 1.05) x 1.13)) = 735).

Table G-24: Change in the Number of Sites and Reports Submitted of All Amendments Combined with the 10,000 lb. Reporting Threshold (First Reporting Cycle)

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

-- 3,975 8,219 Method for Determining Whet her you are Subject to the IUR Reporting Requirements (see Section 4.4.3) 0 0 0

STEP 2 TOTAL 0 3,975 8,219 Step 3: Account for 10,000 lb. reporting threshold Step 2 Total Multiplied by 1.19 for sites and 1.13 for reports 0 4,505

--

10,000 lb. threshold reporting threshold (See Section G.3.1) 787 3,453

--

STEP 3 TOTAL(Step 3 + Step 2 Total ) 787 7,985 8,219 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 -- -- 7,826G-17 Modification Number of Sites Number of Reports Number of Reports with Part III subject to reporting requirements STEP4 TOTAL (Step 4 + Step 3 Total ) 787 7,985 16,801 Step 5:Calculate the total number of reports by adding the Step 3 Total to the Baseline STEP 5 TOTAL (Baseline + Step 3 Total) 4,872 33,854 33,156

Table G-25: Change in the Number of Sites and Reports Submitted of All Amendments Combined with the 10,000 lb. Reporting Threshold (Future Reporting Cycles)

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: 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-26. The baseline values are taken from Table 4-50. Lowering the reporting threshold to 10,000 lb. will not increase the i ndustry per-form burden; however it will increase theG-18 number of Form Us submitted. EPA estimates this option would increase the industry burden by 0.44 million hours in the first reporting cycle and by 0. 35 million hours in all future reporting cycles.

Table G-26: 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 (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 35.17 4,085 22.19 29,871 83.02 29,253 3.24
First year, Post Amendment 35.17 4,872 22.19 33,854 83.02 33,156 3.68

Change from the Baseline, First year 0.00 787 0.00 3,983 0.00 3,903 0.44

Future-Cycle Baseline 11.05 4,289 18.35 31,365 65.63 30,716 2.64
Future Cycle, Post Amendment 11.05 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 the corresponding baseline value from the postamendment value.

Baseline costs are taken from Table 4-51. The 10,000 lb. reporting threshold is expected to increase industr y cost by $27.06 million during the first repor ting cycle and by $21.79 million during all future reporting cycles (See Table G-27).G-19 Table G-27: 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 $2,192 4,085 $1,346 29,871 $5,117 29,253 $198.84
First year, Post Amendment $2,192 4,872 $1,346 33,854 $5,117 33,156 $225.89

Change from the Baseline, First year $0 787 $0 3,983 $0 3,903 $27.06

FutureCycle Baseline $695 4,289 $1,109 31,365 $4,047 30,716 $162.08

FutureCycle, PostAmendment $695 5,115 $1,109 35,547 $4,047 34,812 $183.87

Change from the Baseline, Future Cycles $0 826 $0 4,182 $0 4,096 $21.79

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

The annual industry burden over a 25-year period is shown in Table G-28. Over a 25-year period, the total industr y burden will increase by 2.12 million hours when all the proposed amendments are considered.

Table G-28: Industry Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting

Cycle Years (millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 3.24 3.68 0.44 2 2012 to 2015 2.64 2.99 0.35 3 2016 to 2019 2.64 2.99 0.35 4 2020 to 2023 2.64 2.99 0.35 5 2023 to 2027 2.64 2.99 0.35 6 2026 to 2031 2.64 2.99 0.35
Total 16.43 18.64 2.21 Annual Average 0.66 0.75 0.09

Table G-29 shows the annual industry cost over a 25-year period as a result of lowering the reporting threshold. EPA esti mates a 10,000 lb. reporting thr eshold would increase costs by approximately $136.00G-20 million. Annualized costs range from $5.18 million with a three percent discount rate to $4.84 million with a seven percent discount rate.

Table G-29: 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

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting

Cycle Years (2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $198.84 $225.89 $27.06 2 2012 to 2015 $162.08 $183.87 $21.79 3 2016 to 2019 $162.08 $183.87 $21.79 4 2020 to 2023 $162.08 $183.87 $21.79 5 2023 to 2027 $162.08 $183.87 $21.79 6 2026 to 2031 $162.08 $183.87 $21.79
Total $1,009.25 $1,145.25 $136.00 Annual Average $40.37 $45.81 $5.44 Annualized at 3% $38.40 $43.58 $5.18 Annualized at 7% $35.83 $40.66 $4.84

As previously explained in Section G.3.1, the Agency 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-30 contains the Agency burden as a result of lowering the threshold for reporting whe n all the other amendments are consid ered. EPA estimates the Agency burden will increase by 48 hours in the first reporting cycle and 51 hours during each future reporting cycle.

Table G-30: 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 4,085 0.0056 29,871 0.0063 29,253 2,439PostAmendment 0.002 4,872 0.0056 33,854 0.0063 33,156 2,487 Change from the Baseline 0 787 0 3,983 0 3,903 48.29 Future-cycle Baseline 0.002 4,289 0.006 31,365 0.006 30,716 2,456 Future cycle, Post Amendment 0.002 5,115 0.006 35,547 0.006 34,812 2,507 Change from the Baseline, Future cycles 0 826 0 4,182 0 4,096 50.69 Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.G-21 Table G-31 contains the Agency cost as a resu lt of lowering the reporting threshold. Baseline values are tak en from Table 5-41. Lowering the 10,000 lb. thres hold is expected to increase the Agency cost by approximately $5,000 during the first repor ting cyle and $5,300 in future reporting cycles.

Table G-31: 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 $0.203 4,085 $0.58 29,871 $0.66 29,253 $37,396PostAmendment $0.203 4,872 $0.58 33,854 $0.66 33,156 $42,433 Change from the Baseline 0 826 $0.00 4,163 $0.00 4,096 $5,037 Future-cycle Baseline $0.203 4,289 $0.58 31,365 $0.66 30,716 $39,266 Future cycle, Post Amendment $0.203 5,115 $0.58 35,547 $0.66 34,812 $44,554 Change from the Baseline, Future cycles $0.00 826 $0.00 4,182 $0.00 4,096 $5,287 Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.

The annual Agency burden over a 25-year period is shown in Table G-32. Over a 25-year period, the total Agency burden would increase by 302 hours when all the proposed amendments are considered. Table G-32: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered

Baseline Burden Post-Alternative Option Burden Change from Baseline Reporting Cycle Years hours hours Hours 1 2007 to 2011 2,439 2,487 48.29 2 2012 to 2015 2,456 2,507 50.69 3 2016 to 2019 2,456 2,507 50.69 4 2020 to 2023 2,456 2,507 50.69 5 2023 to 2027 2,456 2,507 50.69 6 2026 to 2031 2,456 2,507 50.69 Total 14,720.86 15,022.62 301.76 Annual Average 588.83 600.90 12.07

Table G-33 contains the annual Agency cost over a 25 -year period as a result of lowering the reporting threshold. EPA estimates a 10,000 lb. reporting threshold will increase the Agency cost by approximately $31,500 over 25 years. Annualized increases in costs range from $1,100 with a seven percent discount rate to $1,200 with a three percent discount rate.G-22 Table G-33: 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

Baseline Cost Post-Alternative Option Cost Change from Baseline Reporting Cycle Years (2008$) (2008$) (2008$) 1 2007 to 2011 $37,396 $42,433 $5,037
2 2012 to 2015 $39,266 $44,554 $5,287 3 2016 to 2019 $39,266 $44,554 $5,287
4 2020 to 2023 $39,266 $44,554 $5,287
5 2023 to 2027 $39,266 $44,554 $5,287 6 2026 to 2031 $39,266 $44,554 $5,287
Total $233,727 $265,201 $31,474 Annual Average $9,349 $10,608 $1,259
Annualized at 3% $8,770 $9,951 $1,181
Annualized at 7% $8,020 $9,100 $1,080

G.3.3 Small Entity Analysis The following section provides a preliminary assessment of the impact 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 all the proposed amendments have been 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 16 , and 24.8 percent (280 companies) are considered small under the TSCA sales-based definition 17 . EPA also estimated an average of appr oximately 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-29 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-34, these costs were divided by the total num ber of sites expected to submit data, for the annualized cost 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 G-34 under the employment-based definition, a small parent company affected by the rule on average has s ales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $11,854 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

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.G-23 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 $12,931 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-34 of $12,931 a small company would have to have annual sales of less than $1.29 million in order to have a cost-to-sales ratio larger than one percent.

Table G-34: 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 $27,055,019 Incremental Costs of Proposed Other Amendments $91,871,064

Total Annualized Costs $31,062,459 $32,813,387 $31,062,459 $32,813,387
Total Number of Sites 4,872 Annualized Costs per Site $6,376 $6,735 $6,376 $6,735 Number of Sites per Small Parent Company 1.76 1.92 Annualized Costs per Small Parent Company $11,221 $11,854 $12,241 $12,931
Annual Sales per Small Parent Company $412,713,310 $11,821,104
Cost-to-Sales Ratio 0.0027% 0.0029% 0.1036% 0.1094% Number of Companies Potentially Affected 466 280H-1 

## Appendix H. Additional Exposure-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 descr iptions are as provided in Table H-1: EPA is soliciting comment in the pream ble for the pr oposed IUR rule amendments on the suitability of these data elements for enabling the Agency to develop 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, pressure, physical state, or similar characteristics. Include steps in which the substance is formulated into ge ls, mixtures, suspensi ons, solutions, etc. 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, dr um 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 continuously adding reactan ts 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 produced 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).

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.H-2 Data Element Description

6 Unit operations List the unit operations needed to prod uce the chemical subs tance. Unit operation means a functional step in manufacturin g, processing, or use operation where substances undergo chemical changes, or changes in temperature, pressure, physical state, concentration, purity, or similar characteristics. Examples of unit operations 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 the operation during which workers may be exposed to the chemical substance. Such activities may include charging reactor vessels, sampling for quality control, tran sferring 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 physica l form of the substance at the time of exposure.

11 Maximum concentration For each worker activity, indicate the maxi mum 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 speci fic types of protective equipment and engineering controls that will be employed to protect the worker from potential exposure to the chemical substance, 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 wh ich 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 type (gas or vapor, aqueous or liquid solution, or solid) and media (stack air, fugitive air, surface water, on-site or off-site land or incineration, POTW, or other (specify)) which describes the release stream containing the chemical

.

17 For each release, provide the quantity (in pounds) of chemical substance released: a) directly to the environment; or

18 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.

19 Control technology For each release, describe the type of tec hnology used to control the release of the substance to the environment. Examples of control technologies include carbon filter, scrubber and biological treat ment (primary, secondary, etc.).

20 Efficiency of control technology Indicate the established efficiency of th e control technology in removing or destroying the chemical substance.H-3 Data Element Description

21 Destination of release For aqueous releases containing the chem ical substance, indicate whether release enters a navigable waterway, a public ly-owned treatment works (POTW), or other. Identify the name of the POTW and/or National Pollutant Discharge Elimination System (NPDES) number as ap propriate. For other releases, indicate 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 treatment 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, pressure, physical state, or similar characteristics. Include steps in which the substance is formulated into ge ls, mixtures, suspensi ons, solutions, etc. 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 releases, dr um residues, etc.) and trace amounts of the substance.

24 Processing or use at sites controlled by manufacturer Indicate whether the sites at which the ch emical 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 proce ssed 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 pro cess the chemical subs tance. Unit operation means a functional step in manufacturin g, processing, or use operation where substances undergo chemical changes, or changes in temperature, pressure, physical state, concentration, purity, or similar characteristics. Examples of unit operations include blending, distillation, filtration, and drying.

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 the operation during which workers may be exposed to the chemical substance. Such activities may include charging reactor vessels, sampling for quality control, tran sferring 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 the numbe r of hours per day and the number of days per year during which the worker is engaged in processing or using the chemical substance.H-4 Data Element Description 33 Physical form For each worker activity, indicate the physica l form of the substance at the time of exposure.

34 Maximum concentration For each worker activity, indicate the maxi mum 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 speci fic 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 wh ich 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 type (gas or vapor, aqueous or liquid solution, or solid) and media (stack air, fugitive air, surface water, on-site or off-site land or incineration, POTW, or other (specify)) which describes the release stream containing the chemical.

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 tec hnology used to control the release of the substance to the environment. Examples of control technologies include carbon filter, scrubber and biological treat ment (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 chem ical substance, indicate whether release enters a navigable waterway, a public ly-owned treatment works (POTW), or other. Identify the name of the POTW and/or NPDES # as appropriate. For other releases, indicate whether the release go es to a municipal or hazardous waste landfill, a commercial incinerator, enters the atmosphere, or is otherwise disposed (specify).

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 treatment 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, harden er, plasticizer, filler, etc.

48 Number of potentially exposed commercial workers Indicate the number of workers in commerci al 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.H-5 Data Element Description

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 commercial 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 chemical in the consumer product, e.g., dispersive dye, solvent, stabilizer, harden er, 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 vi a diffusion, evaporation, abrasion, etc., from articles; or chemicals 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.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 the impacts on manufacturers and processors would be different. Manufacturers would be required to complete an integrated Form U, which would be a Form U revi sed to incorporate the new data elements. For the purpose of this analysis, EPA assumes all of the ame ndments currently being proposed also would be included. EPA assumes processors, on the other hand, w ould be required to complete a tailored Form U focusing only on the additional processing and use information. Manufacturers For manufacturers, EPA assumes the numbers of site s and reports that would be affected by the requirement to provide additional exposure-related 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 4-46, a total of 4,0 85 manufacturers are expected to submit 29,871 reports in the first reporting cycle, including both full and partial reports, when all the proposed amendments are considered. As shown in Table 4-47, in future reporti ng cycles a total of 4,289 manufacturers ar e expected to submit a total of 31,365 reports. To the extent any specific chemicals would be exempt from the requirement to provide these additional data elements, the number of manufacturers a nd 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 program are a smaller set than those regulated under the IUR rule, but the TRI data collection activity currently is the most comprehensive information collection EPA administers for chemical processors. Therefore, EPA assumes information on processors who report under TRI is a suitable proxy for pro cessors 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 chem icals 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 TRI submitter indicating 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 any company that both manufactures and processes a chemic al will be considered a manufacturer for the purposes of IUR reporting of the additional data el ements, TRI submitters who indicated they also manufactured or otherwise used a chemical were filtered out of the dataset. The TRI data revealed an average of 137 pr ocessors reported information per TRI chemical. However, the average value is greatly skewed by certain high-volume chemicals processed by a large number of processors. 21 Therefore, EPA chose to use the median number of 15 processors per chemical,

19 The TRI program may collect data on certain chemicals for which IUR re porting is not required. A list of CASRNs for the non-confidential IUR chemicals was foun d at “Non-confidential 2006 IUR Records by Chemical, including Manufacturing, Processing and Use Information” http://cfpub.epa.gov/iurs earch/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.H-7 assuming it to be more representative of the universe of chemical processors who would report under the IUR rule. 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 derived from TRI data, EPA estimates 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 the universe of processors is different under the TRI regulation and IUR rule. Because the sets of chemicals 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 processors estimated here to be an underestimate. Furthermore, “processor” may be defined differently by the two rules; any specific criteria 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 because Form A, the other, simpler, TRI reporting form, does not request information that would identify the submitter as a processor or manufacturer. Form R is used for high-volume chemicals (i.e., those manufactured, pr ocessed, or otherwise used in amounts greater than one million pounds) or for chemicals meeting other sp ecific criteria; as a result, processors of small volumes may not be included, causing the median number to be an underestimate.



### H.2 Industry Burden Estimate
Manufacturers Given the similarity between the additional exposure-related data elements and the exposure data collected under EPA’s New Chemical Program, EPA assu mes 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 “integrated Form U” (that is, a Form U modified to include the additional data elements) by adding the base burden for a full form (estimated in Section 4.5 of this report) to the burden to complete a PMN. EPA assu mes 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 complete 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 the total burden to manufacturers to submit a dditional exposure-related data as part of their IUR

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.H-8 reporting is 2.78 million hours in th e first reporting cycle and 2.33 million hours in all future reporting cycles (See Table H-2: ). This approach is lim ited to the extent 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) 35.17 4,085 22.19 29,871 83. 02 29,253 0.00 0 3.24

Total Manufacturer Burden (First Cycle) Including Additional Data Elements 35.17 4,085 22.19 29,871 83. 02 29,253 93 29,871 6.01

Incremental Increase due to Additional Data Elements (First Cycle) 0.00 0 0.00 0 0.00 0 93.00 29,871 2.78
Manufacturer Burden (Future Cycles) Considering all Proposed Amendments (As Estimated in Table 4-47) 11.05 4,289 18.35 31,365 65.63 30,716 0 0 2.64

Total Manufacturer Burden (Future Cycles) Including Additional Data Elements 11.05 4,289 18.35 31,365 65. 63 30,716 74.4 31,365 4.97

Incremental Increase due to Additional Data Elements (Future Cycles) 0.00 0 0.00 0 0.00 0 74.40 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 additi onal enhanced data elements over a 25-year period. The baseline burden estimates fo r completing Form U after all the proposed amendments are considered is taken from Table 4-55. EPA estimates over a 25-year period, the total burden t o manufacturers for completing Form U, incl uding the additional data elements, would be 30.88 million hours. The data elements add 14.45 million hours to the i ndustry burden over this period.H-9 Table H-3: Schedule of Annual Industry Burden to Manufacturers if All Proposed Amendments Are Implemented

Reporting Cycle Years 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)

1 2007 to 2011 3.24 2.78 6.01
2 2012 to 2015 2.64 2.33 4.97
3 2016 to 2019 2.64 2.33 4.97
4 2020 to 2023 2.64 2.33 4.97
5 2023 to 2027 2.64 2.33 4.97
6 2026 to 2031 2.64 2.33 4.97
Total 16.43 14.45 30.88 Annual Average 0.66 0.58 1.24

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 applicable . For the purpose of this estimation, EPA assumes the burden on processors to complete an IUR form ta ilored to processing and use information would be similar to that of a PMN form alone. Using the number of processors and number of reports as estimated in Section H.1, the total burden to processors to submit exposure-related data elements is estimated to be 8.57 million hours in the first reporting cycle and 6.85 million hours in fu ture reporting cycles, and is shown in Table H-4. This approach is also lim ited to the extent th e data elements requested from processors in any modification to the IUR match the PMN form and the burden it imposes.

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.H-10 Table H-5 contains the annual burden to processors of the additional enhanced data elements over a 25-y ear period. EPA estimates over a 25-year period, the total burden to processors for completing Form U, including the additional data elem ents, would be 42.83 million hours. This burden consists of labor to complete only the additional data elements because processors currently are not required to submit Form U.

Table H-5: Schedule of Annual Industry Burden to Processors

Reporting Cycle Years 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)

1 2007 to 2011 0.00 8.57 8.57 2 2012 to 2015 0.00 6.85 6.85 3 2016 to 2019 0.00 6.85 6.85 4 2020 to 2023 0.00 6.85 6.85 5 2023 to 2027 0.00 6.85 6.85 6 2026 to 2031 0.00 6.85 6.85 Total 0.00 42.83 42.83 Annual Average 0.00 1.71 1.71

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 11.34 million hours in the first reporting cycle and 9.19 million hours all future reporting cycl es. The derivation of these numbers is found in Table H-6.

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 3.24 0.00 3.24
Total Burden (First Cycle) Including Additional Data Elements 6.32 8.57 14.88

Incremental Increase due to Additional Data Elements (First Cycle) 2.78 8.57 11.34
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 25-
y ear 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 over a 25-year period, the total burden to industry for completing Form U, including the additional data el ements, would be 73.70 m illion hours. The additional data elements add 57.27 million hours to the industry burden over this period.H-11 Table H-7: Schedule of Annual Industry Burden to Manufacturers and Processors if All Proposed Amendments Are Implemented

Reporting Cycle Years 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)

1 2007 to 2011 3.24 11.34 14.58 2 2012 to 2015 2.64 9.19 11.82 3 2016 to 2019 2.64 9.19 11.82 4 2020 to 2023 2.64 9.19 11.82 5 2023 to 2027 2.64 9.19 11.82 6 2026 to 2031 2.64 9.19 11.82 Total 16.43 57.27 73.70 Annual Average 0.66 2.29 2.95



### 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 bec ause EPA assumes 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 additional per repor t 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.

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 esti mates the option will cost manufacturers an add itional $169 million during the first reporting cycle and an additional $142 million during all future reporting cycles.H-12 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) $2,192 4,085 $1,346 29, 871 $5,117 29,253 0 0 $198.84

Total Manufacturer Cost (First Cycle) Including Additional Data Elements $2,192 4,085 $1,346 29,871 $5, 117 29,253 $5,673 29,871 $368.31

Incremental Increase due to Additional Data Elements (First Cycle) $0.00 0 $0.00 0 $0.00 $0. 00 $5,673.44 29,871 $169.47
Manufacturer Cost (Future Cycles) Considering all Proposed Amendments (As Estimated in Table 4-48) $695 4,289 $1,109 31,365 $4,047 $30,716 0 0 $162.08

Total Manufacturer Cost (Future Cycles) Including Additional Data Elements $695 4,289 $1,109 31,365 $4,047 30,716 $4,538.75 31,365 $304.44

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 costs 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 4-56. Over a 25-year period, EPA estimat es the annualized cost to manufacturers will be $72 million at a three percent discount rate, a nd $67 million at a seven percent discount rate.

Table H-10: Annual Increase in Industry Cost to Manufacturers if All Proposed Amendments Are Implemented (2008$)

Reporting

Cycle Years 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$)

1 2007 to 2011 $198.84 $169.47 $368.31

2 2012 to 2015 $162.08 $142.36 $304.44

3 2016 to 2019 $162.08 $142.36 $304.44

4 2020 to 2023 $162.08 $142.36 $304.44

5 2023 to 2027 $162.08 $142.36 $304.44

6 2026 to 2031 $162.08 $142.36 $304.44 Total $1,009.25 $881.26 $1,890.51 Annual Average $40.37 $35.25 $75.62
Annualized at 3% $38.40 $33.47 $71.88
Annualized at 7% $35.83 $31.15 $66.98H-13 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 m illion in the first reporting cycle and $418 million in all future reporting cycles.

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 subtracting the corresponding baseline value from the postamendment value.

Table H-12 presents the annual and annualized costs estimates to processors of competing Form U with the additional exposure-relate d data elements. Over a 25-year period, EPA estimates 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$)

Reportng

Cycle Years 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$)

1 2007 to 2011 $0.00 $523.00 $523.00 2 2012 to 2015 $0.00 $418.00 $418.00 3 2016 to 2019 $0.00 $418.00 $418.00
4 2020 to 2023 $0.00 $418.00 $418.00
5 2023 to 2027 $0.00 $418.00 $418.00 6 2026 to 2031 $0.00 $418.00 $418.00
Total $0.00 $2,613.00 $2,613.00 Annual Average $0.00 $104.52 $104.52
Annualized at 3% $0.00 $116.03 $116.03
Annualized at 7% $0.00 $125.45 $125.45H-14 Total estimated industry cost is presented in Table H-13 and is calculated by summing the costs to both m anufactures 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 $692 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 $199 $0 $199
Total Cost (First Cycle) Including Additional Data Elements $368 $523 $891

Incremental Increase due to Additional Data Elements (First Cycle) $169 $523 $692
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 subtracting the corresponding baseline value from the postamendment value.

Table H-14 presents the annual and annualized costs esti mates 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 25-year period, EPA es timates the annualized cost to the industry will be $166 million at a three percent discount rate, and $150 million at a seven percent discount rate.

Table H-14: Annualized Increase in Industry Cost to Manufacturers and Processors if All Amendments Are Implemented (2008$)

Reporting

Cycle Years 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$)

1 2007 to 2011 $198.84 $692.47 $891.31

2 2012 to 2015 $162.08 $560.36 $722.44

3 2016 to 2019 $162.08 $560.36 $722.44

4 2020 to 2023 $162.08 $560.36 $722.44

5 2023 to 2027 $162.08 $560.36 $722.44

6 2026 to 2031 $162.08 $560.36 $722.44 Total $1,009.25 $3,494.26 $4,503.51 Annual Average $40.37 $139.77 $180.14
Annualized at 3% $37.28 $129.14 $166.43
Annualized at 7% $33.48 $116.05 $149.53H-15 

### 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 bu rden of processing the new data elements for manufacturer s, 0.0048 hours. EPA assumes there will be no change in the fixed Agency costs associated with this modification to the 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. EPA does not expect the future reporting cycle burden t o differ from first reporting cycle burden.

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) Burden to Process New Data Elements (hours) Number of Reports (With New Data Elements) Agency Burden (hours)

First Year, Baseline Burden (All Proposed Amendments) 0.0019 4,085 0.0056 29,871 0.0063 29,253 0 0 2,439

First year, With Enhanced Data Elements 0.0019 4,085 0.0056 29,871 0.0063 29,253 0.0048 29,871 2,582

Change, first year 0 0 0 0 0 0 0.0048 29,871 143
Future-cycle Baseline 0.0019 4,289 0.0056 31,365 0.0063 30,716 0 0 2,456
Future cycle, Post Amendment 0.0019 4,289 0.0056 31,365 0.0063 30,716 0.0048 31,365 2,607

Change from the Baseline, Future cycles 0 0 0 0 0 0 0.0048 31,365 150

Table H-16 presents the estimated annual burden to the Agency of processing Form U with the additional exposure-related data elements. Over a 25-y ear period, EPA estimates the total Agency burden to process manufacturer data will be 15,600 hours.H-16 Table H-16: Annual Increase in Agency Burden to Process Manufacturer Data if All Proposed Amendments Are Implemented

Reporting Cycle Years Baseline Form U Burden (When all Amendments are Considered) (hours) Form U Burden with

Enhanced Data Elements

(hours) Total Industry Burden (hours)

1 2007 to 2011 2,439 143 2,582 2 2012 to 2015 2,456 150 2,607 3 2016 to 2019 2,456 150 2,607 4 2020 to 2023 2,456 150 2,607 5 2023 to 2027 2,456 150 2,607 6 2026 to 2031 2,456 150 2,607 Total 14,721 896 15,617 Annual Average 589 36 625

Manufacturers and Processors Combined

Table H-17 shows the estimated burden to the Agency of processi ng 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 t he Agency of processing Form U with the additional exposure-related data elements. Over a 25-y ear period, EPA estimates the total Agency burden to process processor data will be 2,651 hours.H-17 Table H-18: Annual Increase in Agency Burden to Process Processor Data if All Proposed Amendments Are Implemented

Reporting Cycle Years Baseline Form U Burden (When all Amendments are Considered) (hours) Form U Burden with Enhanced Data Elements

(hours) Total Industry Burden (hours)

1 2007 to 2011 0.00 442 442 2 2012 to 2015 0.00 442 442 3 2016 to 2019 0.00 442 442 4 2020 to 2023 0.00 442 442 5 2023 to 2027 0.00 442 442 6 2026 to 2031 0.00 442 442
Total 0.00 2,651 2,651 Annual Average 0.00 106 106

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 592 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 Agency Burden Total Burden of Processing Manufacturer Data (hours) Total Burden of Processing Processor Data (hours) (hours) Burden (First Cycle) Considering all Proposed Amendments 2,439 0 2,439

Total Burden (First Cycle) Including Additional Data Elements 2,582 442 3,024

Incremental Increase due to Additional Data Elements (First Cycle) 143 442 585

Burden (Future Years) Considering all Proposed Amendments 2,456 0 2,456

Total Burden (Future Years) Including Additional Data Elements 2,607 442 3,049

Incremental Increase due to Additional Data Elements (Future Years) 150 442 592

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 25-year period, EPA estimates the total Agency burden to process manufacturer and processor data will be 18,269 hours.H-18 Table H-20: Annual Increase in Agency Burden to Process Data if All Proposed Amendments Are Implemented

Reporting

Cycle Years Baseline Burden (When all Amendments are Considered) Form U Burden with Enhanced Data Elements (hours) Total Agency Burden (hours)

1 2007 to 2011 2,439 585 3,024

2 2012 to 2015 2,456 592 3,049

3 2016 to 2019 2,456 592 3,049
4 2020 to 2023 2,456 592 3,049
5 2023 to 2027 2,456 592 3,049
6 2026 to 2031 2,456 592 3,049 Total 14,721 3,548 18,269 Annual Average 589 142 731



### 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 numb er 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 el ements for manufacturers is approximately $15,100 in the first reporting cycle and $15,800 in future reporting cycles, as shown in Table H-21. This table reflect s both the variable cost to the Agency , which is dependent on th e number of reports, and a fixed cost to the Agency of $249,200 (see Section 5.3) which will not change as a result of including the additional dat a option in the IUR.

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 Burden (millions of 2008$)

First Year, Baseline Cost (All Proposed Amendments) $0.20 4,085 $0.58 29,871 $0.66 29,253 $0.00 0 $241,393

First year, with Enhanced Data Elements $0.20 4,085 $0.58 29,871 $0.66 29,253 $0.51 29,871 $256,481

Change, first year $0.00 0 $0.00 0 $0.00 0 $0.51 29,871 $15,089 Future-Cycle Baseline $0.20 4,289 $0.58 31,365 $0.66 30,716 0.00 0 $243,263
Future-Cycle, Post Amendment $0.20 4,289 $0.58 31,365 $0.66 30,716 0.51 31,365 $259,106H-19 Cost to Process Part I (2008$) 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 Burden (millions of 2008$)

Change from the Baseline, Future Cycles $0.00 0 $0.00 0 $0.00 0 0.51 31,365 $15,843

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 25-year period, EPA estimates the annualized cost to the Agency will be $58,350 at a three percent discount rate, and $53,517 at a seven percent discount rate.

Table H-22: Annual Increase in Agency Cost to Process Manufacturer Data if All Proposed Amendments Are Implemented (2008$)

Reporting Cycle Years Baseline Cost (2008$) PostAlternative Option Cost (2008$) Change from Baseline (2008$)

1 2007 to 2011 $241,393 $15,089 $256,481
2 2012 to 2015 $243,263 $15,843 $259,106
3 2016 to 2019 $243,263 $15,843 $259,106
4 2020 to 2023 $243,263 $15,843 $259,106
5 2023 to 2027 $243,263 $15,843 $259,106
6 2026 to 2031 $243,263 $15,843 $259,106 Total $1,457,707 $94,306 $1,552,013 Annual Average $58,308 $3,772 $62,081
Annualized at 3% $54,812 $3,538 $58,350
Annualized at 7% $50,281 $3,236 $53,517

Manufacturers and Processors Combined Table H-23 shows the Agency cost of processing the processor data. To esti mate 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 the total Ag ency cost to process the processor data is $46,500.H-20 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 Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the postamendment value.

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 25-year period, EPA estimates annualized cost to the Agency will be $10,5 00 at a three percent discount rate, and $9,600 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$)

Reporting

Cycle Years Baseline Cost(2008$ ) PostAlternative

Option Cost(2008$) Change from Baseline(2008$)

1 2007 to 2011 $0 $46,522 $46,522
2 2012 to 2015 $0 $46,522 $46,522
3 2016 to 2019 $0 $46,522 $46,522
4 2020 to 2023 $0 $46,522 $46,522
5 2023 to 2027 $0 $46,522 $46,522
6 2026 to 2031 $0 $46,522 $46,522 Total $0 $279,132 $279,132 Annual Average $0 $11,165 $11,165 Annualized at 3% $0 $10,500 $10,500 Annualized at 7% $0 $9,638 $9,638

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 $61,600 in the first reporting cycle and $62,400 in all future reporting cycles.H-21 Table H-25: Change in Agency Cost of Processing Manufacture and Processor Data as a Result of Additional Exposure-Related Data Elements

Total Agency Burden Total Burden of Processing Manufacturer data (2008$) Total Burden of Processing Processor data (2008$) (2008$) Cost (First Cycle) Considering all Proposed Amendments $241,393 $0 $241,393

Total Cost (First Cycle) Including Additional Data Elements $256,481 $46,522 $303,004

Incremental Increase due to Additional Data Elements (First Cycle) $15,089 $46,522 $61,611

Cost (Future Years) Considering all Proposed Amendments $243,263 $0 $241,393

Total Cost (Future Years) Including Additional Data Elements $259,106 $46,522 $305,629

Incremental Increase due to Additional Data Elements (Future Years) $15,843 $46,522 $62,366

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 25-year period, EPA estimates annualized cost to the Agency will be $68,900 at a three percent discount rate, and $63,200 at a seven percent discount rate.H-22 Table H-26: Annual Increase in Agency Cost to Process Manufacturer and Processor Data if All Proposed Amendments Are Implemented (2008$)

Reporting Cycle Years Baseline Burden (When all Amendments are

Considered)

(2008$) Form U Burden with Enhanced data Elements (2008$) Total Agency Burden (2008$)

1 2007 to 2011 $241,393 $61,611 $303,004
2 2012 to 2015 $243,263 $62,366 $305,629
3 2016 to 2019 $243,263 $62,366 $305,629
4 2020 to 2023 $243,263 $62,366 $305,629
5 2023 to 2027 $243,263 $62,366 $305,629
6 2026 to 2031 $243,263 $62,366 $305,629 Total $1,457,707 $373,440 $1,831,147 Annual Average $58,308 $14,938 $73,246
Annualized at 3% $54,812 $14,039 $68,850
Annualized at 7% $50,281 $12,874 $63,155



### H.6 Small Entity Analysis

As described in Chapter 8 of this economic analysis, EPA assessed th e impact 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

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.H-23 small under either definition were estimated using da ta from Dun & Bradstreet, as also described in Chapter 8.

Table H-13 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 ma in 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, these costs were divided b y 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 pa rent company to arrive at the annualized costs per small parent company. This value was divided by th e 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 s ales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $31,067 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 $33,892 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 $33,892 a small company would have to have annual sales of less than $3.39 million in order to have a cost-to-sales ratio larger than one percent.

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 $169,471,347.15

Incremental Costs of Proposed Other Amendments $91,871,064.30

Total Annualized Costs $68,260,366 $72,108,063 $68,260,366 $72,108,063
Total Number of Sites 4,085 Annualized Costs per Site $16,710 $17,652 $16,710 $17,652 Number of Sites per Small Parent Company 1.76 1.92
Annualized Costs per Small Parent Company $29,410 $31,067 $32,083 $33,892
Annual Sales per Small Parent Company $412,713,310 $11,821,104

Cost-to-Sales Ratio 0.007% 0.008% 0.271% 0.287% Number of Companies Potentially Affected 466 280

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.H-24 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 the chemical processor industry shares many characteristics with the chemical manufacturing in dustry. To the extent th is is not the case, this analysis may over- or underestimate the impact of additional data elements on processors. Specifically, EPA assumes 3.89 manufacturing sites per global parent company. EPA also assumes 41.3 percent of global parent companies are consid ered small under an employment-based definition, and 24.8 percent are considered small under a sales-based de finition. EPA further assumes 1.76 sites per small parent company under the employment-based definiti on, and 1.92 sites per small parent company under the sales-based definition, consistent with manufacturer 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. 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.

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 s ales of more than $412.7 million. 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-basedH-25 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 compliance 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 annua l sales of less than $734,600 in order to have a cost-to-sales ratio larger than one percent.I-1 

## Appendix I. - Estimated Burden and Co st 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 a sec tion 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 sub mitted for each chemical. Therefore, EPA estimates a total of 66 sites will s ubmit 421 reports for the estimated 100 chemicals. To the extent the specific chemicals subject to a secti on 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 compre hensive collection of information EPA administers for chemical processors. Therefore, EPA assumes 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 inI-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 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 toxic chemical as a chemical processing aid. 27 Because EPA assumes any company that both manufactures and processes a chemical will be considered a manufacturer for the purposes of a section 8(a) rule, TRI submitters who indicated they also manufactured or otherwise us ed a chemical were filtered out of the dataset. The TRI data revealed an average of 137 pr ocessors reported information per TRI chemical. However, the average value is greatly skewed by certain high-volume chemicals 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 a total of 1,500 reports will be submitted for an estimated 100 chemicals. According to the TRI data, each processo r processes approximately 2.45 chemicals; therefore, EPA expects a section 8(a) rule to affect 612 sites. This approach is limited to the extent the universe 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 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 ove restimate. Finally, the data used in this analysis was for submissions of TRI Form R only. This w as done because Form A, the other, simpler, TRI reporting form, does not request information that 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 a section 8(a) rule would require electronic submission, so EPA reduced the estimated burden to 93 hours. This reduction is consistent with the assumption in section 4.4.27; all clerical burden will be eliminated because paper filing will not be perm itted with electronic submission.

26 The TRI program may collect data on certain chemicals for which IUR re porting is not required. A list of CASRNs for the non-confidential IUR chemicals was foun d at “Non-confidential 2006 IUR Records by Chemical, including Manufacturing, Processing and Use Information” http://cfpub.epa.gov/iurs earch/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.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). Because each individual collection under the rule would be for a different set of chem icals, EPA assumes 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 the data elem ents 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 25-year period. A 25-year period was used so the burden and co st to the industry are directly comparable to the annual burden presented in Table 4-52 and the annual co st estimates for the proposed amendments to the IUR rule, found in Table 4-53. Table I-2 contains the annual burden to industry over 20 years as a result of a section 8(a) rule and o f completing Form U. Over a 25-year period, EPA estimates the total burden to industry of both the IUR data collection and a sec tion 8(a) collection will be 20.04 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
Baseline Cost (When all Amendments

are Considered) Manufacturer Section 8(a) Cost Processor Section 8(a) Cost Manufacturer and Processor

Section 8(a) Cost Total Cost to Industry (Manufacturer and Processor

+ Baseline) Reporting

Cycle Years

(millions of hours) (millions of hours) (millions of hours) (millions of hours) (millions of hours)
1 2007 to 2011 3.24 0.04 0.14 0.18 3.41
2 2012 to 2015 2.61 0.16 0.56 0.71 3.32
3 2016 to 2019 2.61 0.16 0.56 0.71 3.32
4 2020 to 2023 2.61 0.16 0.56 0.71 3.32
5 2023 to 2027 2.61 0.16 0.56 0.71 3.32
6 2026 to 2031 2.61 0.16 0.56 0.71 3.32
Total 16.29 0.82 2.93 3.75 20.04 Annual Average 0.65 0.03 0.12 0.15 0.80I-4 

### 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 Section 4.4.27) which EPA assumes all clerical burden for preparing and subm itting Form U is eliminated. As shown in Table I-3, EPA estimates the additional per report cost to be $5,6 73.

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) ru le would cost manufacturers $2.39 million and processors $8.51 million each year.

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 i mates 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 25- year period, EPA estimates total annualized cost to the industry will be $46.98 million, with a three percent discount rate, and $43.56 million w ith a seven percent discount rate.I-5 Table I-5: Annual Increase in Industry Cost if All Amendments Are Implemented (2008$)

Baseline Cost

(When all Amendments

are Considered) Manufacturer Section 8(a) Cost Processor Section 8(a) Cost Manufacturer and Processor

Section 8(a) Cost Total Cost to Industry (Manufacturer and Processor

+ Baseline) Reporting

Cycle Years

(2008$ millions) (2008$ millions) (2008$ millions) (2008$ millions) (2008$ millions)
1 2007 to 2011 $198.84 $2.39 $8.51 $10.90 $209.74
2 2012 to 2015 $162.08 $9.56 $34.04 $43.60 $205.68

3 2016 to 2019 $162.08 $9.56 $34.04 $43.60 $205.68

4 2020 to 2023 $162.08 $9.56 $34.04 $43.60 $205.68

5 2023 to 2027 $162.08 $9.56 $34.04 $43.60 $205.68

6 2026 to 2031 $162.08 $9.56 $34.04 $43.60 $205.68 Total $1,009.25 $50.19 $178.71 $228.90 $1,238.15 Annual Average $40.37 $2.01 $7.15 $9.16 $49.53

Annualized at 3% $38.40 $1.88 $6.69 $8.57 $46.98

Annualized at 7% $35.83 $1.70 $6.04 $7.73 $43.56



### I.4 Agency Burden Estimate
For the purposes of this analysis, EPA assumed the Ag ency burden was similar 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 calculate the Agency burden associated with the exposure-related data elements, EPA used the per-data element burde n to EPA after all the proposed amendments are considered, 0.00008 hours, as calculated in Section 5.5. The number of exposure- related data elem ents is 57, as shown in Table H-1. The section 8(a) burden 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 process 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.I-6 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 extra mural costs during all principal reporting and non-principal reporting year s over a 25-year period. The Agency burden for processing Form U is taken from Table 5-42. In total, EPA estimates the Agency burden for the IUR rule and a section 8(a) rule will be 15,0 00 hours over a 25-year period. The to tal burden as a result of a section 8(a) rule will be 240 hours over a 25-year period.

Table I-8: Schedule of Annual Agency Burden

Baseline Cost (When all Amendments

are Considered) Manufacturer Section 8(a) Cost Processor Section 8(a) Cost Manufacturer and Processor

Section 8(a) Cost Total Cost to Industry (Manufacturer and Processor + Baseline) Reporting

Cycle Years

(hours) (hours) (hours) (hours) (hours)

1 2007 to 2011 2,439 2.02 7.20 9.22 2,448
2 2012 to 2015 2,456 10.10 35.98 46.08 2,503
3 2016 to 2019 2,456 10.10 35.98 46.08 2,503
4 2020 to 2023 2,456 10.10 35.98 46.08 2,503
5 2023 to 2027 2,456 10.10 35.98 46.08 2,503
6 2026 to 2031 2,456 10.10 35.98 46.08 2,503 Total 14,721 52.52 187.12 239.64 14,960 Annual Average 589 2.10 7.48 9.59 598I-7 

### 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 estimated 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

Table I-10 shows the Agency cost of processing the processor data. EPA estimates 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 25-year period, EPA estimates total cost to the Agency will be $65,800, with a three percent discount rate, and $60,300 with a seven percent discount rate.

Table I-11: Annual Increase in Agency Cost (2008$)

Baseline Cost (When all Amendments

are Considered) Manufacturer Section 8(a) Cost Processor Section 8(a) Cost Manufacturer and Processor

Section 8(a) Cost Total Cost to Industry (Manufacturer and Processor

+ Baseline) Reporting

Cycle

Years (2008$) (2008$) (2008$) (2008$) (2008$)

1 2007 to 2011 $286,580 $213 $758 $970 $287,550 2 2012 to 2015 $288,450 $1,065 $3,790 $4,855 $293,305 3 2016 to 2019 $288,450 $1,065 $3,790 $4,855 $293,305 4 2020 to 2023 $288,450 $1,065 $3,790 $4,855 $293,305 5 2023 to 2027 $288,450 $1,065 $3,790 $4,855 $293,305I-8 6 2026 to 2031 $288,450 $1,065 $3,790 $4,855 $293,305
Total $1,728,831 $5,538 $19,708 $25,245 $1,754,076 Annual Average $69,153 $222 $788 $1,010 $70,163
Annualized at 3% $65,011 $168 $596 $763 $65,774
Annualized at 7% $59,643 $151 $538 $688 $60,331



### I.6 Small Entity Analysis
The following section provides a preliminary assessment of the impact 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 Chapter 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 shows the cost to manufacturers as a resu lt of a section 8(a) rule. These costs were summed and annualized over four years (the likely timeframe for the rule) at both a three percent and seven percent discount rate. 31 As shown in Table I-12, these costs were divided by the total number of sites eected to submit data, for the annualized costs per s ite. This was multiplied by the number of sites per small parent company to arrive at the annualized cost s 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, under the employment-based definition, a small parent company affected by the rule on average has s ales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $19,443 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 0.005 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 $19,047 or lower. The cost-to-sales ratio for 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.

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.I-9 This approach is limited to the extent the unive rse 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 4I-10 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 the chemical processor industry shares many characteristics with the chemical manufacturing industry su bject to the IUR rule. To the extent this is not the case, this analysis may over- or underestimate th e impact of additional data elements on processors. Specifically, EPA assumes 3.89 manufacturing sites per global parent company. EPA also assumes 41.3 percent of global parent companies are considered small under an employment-based definition, and 24.8 percent are considered small under a sales-based de finition. EPA further assumes 1.76 sites per small parent company under the employment-based definiti on, and 1.92 sites per small parent company under the sales-based definition, consistent with manufacturer 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 re venue for this analysis, so manufacturer revenue was used as a proxy. Therefore, this analysis pr ovides only a preliminary estimate of impacts.

EPA divided the number of expected processor reports (1,500) by the average number of chemicals for which a processor submitted TRI data (2.45) to obtain 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 number of companies potentially affected), under the employment-based definition and sales-based definition, respectively. To calculate cost-to-sal es ratios, EPA followed the same methodology for processors as described above for manufacturers. Results are presented in Table I-13.

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

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 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $6,750 at a seven percent discount rate, and evenI-11 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 compliance 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.