DRAFT 

January 14, 2010 

—Does not contain TSCA CBI—

Prepared by: 

Economic and Policy Analysis Branch 

Economics, Exposure and Technology Division 

Office of Pollution Prevention and Toxics 

U.S. Environmental Protection Agency 

1200 Pennsylvania Avenue 

Washington, D.C. 20460 

_ 

Economic Analysis for the Proposed Inventory Update 

Reporting (IUR) Modifications Rule
i

Contributors 

The EPA analyst responsible for this report is Wendy 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. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

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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 under the Proposed IUR Modifications Rule .....................3-1

3.1 Technical Modifications to the Regulatory Text ..........................................................................3-1

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

Divisions ..........................................................................................................................3-1

3.1.2 Consolidation of Definitions............................................................................................3-1

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

3.1.4 Delete Subpart B Text......................................................................................................3-2

3.2 Modifications to Selected Definitions...........................................................................................3-2

3.2.1 Manufacture and Manufacturer........................................................................................3-2

3.2.2 Site ...................................................................................................................................3-3

3.2.3 Electronic-Reporting Related Definitions........................................................................3-3

3.2.4 Processing and Use-Related Definitions..........................................................................3-3

3.2.5 Principal Reporting Year and Submission Period............................................................3-4

3.3 Modifications to Reporting Thresholds ........................................................................................3-4

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

Requirements ...................................................................................................................3-4

3.3.2 Eliminate 300,000 lb. Threshold for Processing and Use Information............................3-5

3.3.3 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals ............................3-5

3.4 Changes to Substances Subject to the IUR Rule...........................................................................3-5

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

Exemptions ......................................................................................................................3-5

3.4.2 Full Exemption for Manufactured Water.........................................................................3-6

3.4.3 Remove Fully Exempt Polymers from the Partially Exempt List....................................3-6

3.5 Modifications to Reportable Data Elements .................................................................................3-6

3.5.1 Parent Company and Site Identity ...................................................................................3-6

3.5.2 Technical Contact ............................................................................................................3-6

3.5.3 Chemical Identity.............................................................................................................3-7

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

.........................................................................................................................................3-7

3.5.5 Volume of Chemical Substance Used On-Site ................................................................3-7

3.5.6 Indicate Whether Imported Chemicals Are Physically at Reporting Site........................3-8

3.5.7 Report Production Volume Exported...............................................................................3-8

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

or Reworked.....................................................................................................................3-8

3.6 Concentration Ranges ...................................................................................................................3-8
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3.7 Industrial Processing and Use Information Reporting..................................................................3-8

3.7.1 Revise Industrial Function Categories .............................................................................3-8

3.7.2 Revise Industrial Sectors .................................................................................................3-9

3.8 Consumer and Commercial Use Reporting ..................................................................................3-9

3.8.1 Revise Consumer and Commercial Product Categories ..................................................3-9

3.8.2 Designation of Consumer or Commercial Use ................................................................3-9

3.8.3 Number of Commercial Workers Reasonably Likely To Be Exposed............................3-9

3.9 Changes to Standard for the Reporting of Processing and Use Information ..............................3-10

3.10 Modifications to Confidential Business Information (CBI) Claims ...........................................3-10

3.10.1 Chemical Identity CBI Claims.......................................................................................3-10

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

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

Reasonably Ascertainable” ............................................................................................3-11

3.11 Method of Submission ................................................................................................................3-11

3.11.1 Updated e-IUR Reporting Software...............................................................................3-12

3.11.2 Require Electronic Submissions over the Internet.........................................................3-12

3.11.3 Electronic Signature Process..........................................................................................3-12

3.12 Modifications Specifically Affecting Importers .........................................................................3-13

3.13 Modify Reporting Frequency......................................................................................................3-14

4. Industry Burden and Cost Estimates.................................................................................................4-1

4.1 Methodology for Compliance Cost and Burden Analysis ............................................................4-1

4.2 Industry Unit Burden and Cost Estimates.....................................................................................4-2

4.2.1 Estimates of Wage Rates .................................................................................................4-2

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

4.2.3 Estimates of Submission (Mailing) Costs........................................................................4-6

4.2.4 Estimates of Baseline Cost per Report.............................................................................4-7

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

4.2.6 Estimates of Future Reporting Cycles’ Labor Hours (Burden) .....................................4-10

4.3 Total Baseline IUR Industry Compliance 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 Manufacturer is Subject to IUR Reporting 

Requirements .................................................................................................................4-17

4.4.4 Eliminate the 300,000 lb. Threshold for Processing and Use Reporting.......................4-19

4.4.5 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals ..........................4-21

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

Exemptions ....................................................................................................................4-22

4.4.7 Full Exemption for Manufactured Water.......................................................................4-24

4.4.8 Remove Fully-Exempt Polymers from the Partially-Exempt List.................................4-25

4.4.9 Parent Company and Site Identity .................................................................................4-26

4.4.10 Technical Contact ..........................................................................................................4-26

4.4.11 Chemical Identity...........................................................................................................4-26

4.4.12 Report Production Volume for Each of the Years since Last Principal Reporting Year ...4-

26

4.4.13 Volume of Chemical Substance Used On-Site ..............................................................4-27

4.4.14 Indicate Whether Chemical Is Physically at Reporting Site ..........................................4-29

4.4.15 Report Production Volume Exported.............................................................................4-30
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

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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 Function Categories ...........................................................................4-32

4.4.19 Revise Industrial Sectors ...............................................................................................4-34

4.4.20 Revise Consumer and Commercial 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 Reporting of Processing and Use Information............4-37

4.4.24 Chemical Identity CBI Claims.......................................................................................4-37

4.4.25 Upfront Substantiation for Processing and Use Information CBI Claims .....................4-37

4.4.26 Limitation on the Confidentiality Claims for Data Elements Identified as “Not Known or 

Reasonably Ascertainable” ............................................................................................4-39

4.4.27 Require Electronic Submissions over the Internet.........................................................4-39

4.4.28 Updated e-IUR Reporting Software...............................................................................4-41

4.4.29 Electronic Signature Process..........................................................................................4-41

4.4.30 Modifications Specifically Affecting Importers ............................................................4-42

4.4.31 Modify Reporting Frequency.........................................................................................4-43

4.5 Total Industry Compliance Burden 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 Affect the Reporting Burden..........................................................4-46

4.5.3 Amendment that Affects the Reporting Frequency .......................................................4-51

4.5.4 Average Cost and Burden per Site.................................................................................4-51

4.6 Annualized Cost Estimates .........................................................................................................4-53

5. Agency Burden and Cost Estimates ...................................................................................................5-1

5.1 Methodology for Agency Burden and Cost ..................................................................................5-1

5.2 Data for Agency Cost Estimates ...................................................................................................5-1

5.2.1 Agency Wage Rates.........................................................................................................5-1

5.2.2 Extramural (Contractor) Costs.........................................................................................5-2

5.3 Current Total Agency Burden and Cost........................................................................................5-2

5.4 Changes to Agency Burden and Cost as a Result of the Proposed Modifications........................5-4

5.4.1 Technical Modifications to the Regulatory Text .............................................................5-4

5.4.2 Modifications to Selected Definitions .............................................................................5-4

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

Requirements ...................................................................................................................5-5

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

5.4.5 Eliminate the 25,000 lb. Threshold for Certain Regulated Chemicals ............................5-6

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

Exemptions ......................................................................................................................5-7

5.4.7 Full Exemption for Manufactured Water.........................................................................5-8

5.4.8 Remove Fully-Exempt Polymers from the Partially-Exempt List...................................5-9

5.4.9 Parent Company and Site Identity ...................................................................................5-9

5.4.10 Technical Contact ............................................................................................................5-9

5.4.11 Chemical Identity.............................................................................................................5-9

5.4.12 Report Production Volume for Each of the Years since Last Principal Reporting Year .5-9

5.4.13 Volume of Chemical Substance Used On-Site ..............................................................5-10

5.4.14 Indicate Whether Chemical Is Physically at Reporting Site ..........................................5-11

5.4.15 Report Production Volume Exported.............................................................................5-12
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

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5.4.16 Identify Whether Chemical Is To Be Recycled, Remanufactured, Reprocessed, Reused, 

or Reworked...................................................................................................................5-13

5.4.17 Concentration Ranges ....................................................................................................5-13

5.4.18 Revise Industrial Function Categories ...........................................................................5-14

5.4.19 Revise Industrial Sectors ...............................................................................................5-15

5.4.20 Revise Consumer and Commercial 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 Reporting of Processing and Use Information............5-17

5.4.24 Chemical Identity CBI Claims.......................................................................................5-17

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

5.4.26 Limitation on Confidentiality Claims for Data Elements Identified as “Not Known or 

Reasonably Ascertainable” ............................................................................................5-18

5.4.27 Require Electronic Submissions over the Internet.........................................................5-18

5.4.28 Updated e-IUR Reporting Software...............................................................................5-19

5.4.29 Electronic Signature Process..........................................................................................5-19

5.4.30 Modifications Specifically Affecting Importers ............................................................5-20

5.4.31 Modify Reporting Frequency.........................................................................................5-20

5.5 Total Agency Cost of All Modifications.....................................................................................5-22

5.6 Annual Burden and Discounted Total Agency Cost of All Modifications .................................5-27

6. Social Cost Summary...........................................................................................................................6-1

7. Impact of the Proposed IUR Rule Modifications Rule on the Benefits of the IUR........................7-1

7.1 Benefits of Information-Based Policies ........................................................................................7-1

7.2 Benefits of Individual Proposed Amendments .............................................................................7-2

7.2.1 Tailor Information Collected to More Closely Match the Agency’s Information Needs 7-3

7.2.2 Increase EPA’s Ability to Effectively Provide Public Access to the Information...........7-6

7.2.3 Obtain New and Updated Exposure Information.............................................................7-6

7.2.4 Improve Utility of Information Reported ......................................................................7-10

7.3 Potential Users of Information Generated by the Proposed IUR Modifications Rule................7-12

7.3.1 EPA Risk-Screening and Management Programs .........................................................7-12

7.3.2 Other Federal Risk Management Programs...................................................................7-14

7.3.3 State and Local Programs ..............................................................................................7-15

7.3.4 Nongovernmental Organization (NGO) Initiatives and Private-Sector Stewardship ....7-15

8. Small Entity Analysis...........................................................................................................................8-1

8.1 Select a Relevant Small Entity Definition ....................................................................................8-1

8.2 Identify Number of Small Companies Reporting in 2006 ............................................................8-2

8.3 Estimate Number of Parent Companies........................................................................................8-3

8.4 Estimate Number of Small Companies.........................................................................................8-3

8.5 Estimate Cost-to-Sales Ratios for Small Companies....................................................................8-4

8.6 Summary.......................................................................................................................................8-5

9. Additional Analyses .............................................................................................................................9-1

9.1 Executive Order 12866 .................................................................................................................9-1

9.2 Unfunded Mandates Reform Act (UMRA) ..................................................................................9-1

9.3 Paperwork Reduction Act (PRA)..................................................................................................9-1

9.4 Executive Order 13132 - Federalism ............................................................................................9-2

9.5 Executive Order 12898 – Environmental Justice..........................................................................9-2
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9.6 Executive Order 13045 – Children’s Health.................................................................................9-3

9.7 Executive Order 13175 – Consultation and Coordination with Indian Tribal Governments........9-3

9.8 Executive Order 13211 – Energy Supply, Distribution, or Use....................................................9-3

9.9 National Technology Transfer Advancement Act ........................................................................9-3

10. References.........................................................................................................................................10-1

Appendix A. 2006 Form U......................................................................................................................A-1

Appendix B. Proposed Revised Form U................................................................................................ B-1

Appendix C. – Current and Proposed Industrial Function Categories .............................................C-1

Appendix D. Current and Proposed Consumer and Commercial Product Categories....................D-1

Appendix E. – Industrial Sectors........................................................................................................... E-1

Appendix F. – Sensitivity Analyses........................................................................................................ F-1

F.1 Method for Determining Whether the Threshold Is Met ..............................................................F-1

F.2 Reporting Production Volume Used On-Site................................................................................F-3

F.3 Modifying Industrial Function 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 Submit 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-4

G.1.3 Small Entity Analysis .....................................................................................................G-8

G.2 Modify Reporting Frequency to a Three-Year Cycle ..................................................................G-9

G.2.1 Three-Year Reporting Cycle Cost and Burden when the Option is Considered by Itself G9

G.2.2 Three-Year Cycle Cost and Burden when the All the Proposed Amendments are 

Considered ....................................................................................................................G-12

G.2.3 Small Entity Anaylsis ...................................................................................................G-16

G.3 Change the Threshold for Reporting to 10,000 lb. ....................................................................G-17

G.3.1 10,000 lb. Reporting Threshold Cost and Burden when the Option is Considered by Itself

......................................................................................................................................G-17

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

Considered ....................................................................................................................G-19

G.3.3 Small Entity Analysis ...................................................................................................G-26

Appendix H. Additional Exposure-Related Data Elements ................................................................H-1

H.1 Estimated Number of Affected Entities.......................................................................................H-6

H.2 Industry burden estimate..............................................................................................................H-7

H.3 Industry cost estimate ................................................................................................................H-13

H.4 Agency burden estimate.............................................................................................................H-18

H.5 Agency cost estimate .................................................................................................................H-22

H.6 Small Entity Analysis ................................................................................................................H-27

Appendix I. - Estimated Burden and Cost of a Section 8(a) Rule for Exposure-Related Data 

Elements.................................................................................................................................................... I-1
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I.1 Estimated Number of Affected Entities.........................................................................................I-1

I.2 Industry Burden Estimate ..............................................................................................................I-2

I.3 Industry Cost Estimate...................................................................................................................I-4

I.4 Agency Burden Estimate ...............................................................................................................I-6

I.5 Agency Cost Estimate....................................................................................................................I-7

I.6 Small Entity Analysis ....................................................................................................................I-9
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List of Tables 

Table 4-1: Derivation of Loaded Wage Rates for the Private Manufacturing Sector (2008$) ..................4-2 

Table 4-2: Baseline First-Cycle Labor Burden per Form U, in Hours.......................................................4-4 

Table 4-3: Burden Percentages Attributed to Site-Limited Activity and Production Volume Questions..4-6 

Table 4-4: Mailing Submission Costs (December, 2009)..........................................................................4-6 

Table 4-5: Baseline Total Cost per Form U (2008$) .................................................................................4-8 

Table 4-6: Baseline Number of Reports and Sites...................................................................................4-10 

Table 4-7: Weighting Factors for Burden Estimates for Sites That Have Previously Submitted a Form U4-

11 

Table 4-8: Baseline Future-Cycle Labor Burden per Report, in Hours ...................................................4-12 

Table 4-9: Baseline Future-Cycle Total Cost per Report (2008$)...........................................................4-14 

Table 4-10: Total Baseline Cost and Burden to Industry (2011 Reporting Cycle)..................................4-16 

Table 4-11: Total Baseline Cost and Burden to Industry (Future Reporting Cycles)..............................4-16 

Table 4-12: Change in Industry Burden as a Result of Modifying the Method for Determining Whether a 

Manufacturer is Subject to IUR Reporting Requirements ...............................................................4-18 

Table 4-13: Change in Industry Cost as a Result of Modifying the Method for Determining Whether a 

Manufacturer is Subject to IUR Reporting Requirements ...............................................................4-19 

Table 4-14: Change in Industry Burden as a Result of Eliminating the 300,000 lb. Threshold for 

Downstream Processing and Use Information Reporting................................................................4-20 

Table 4-15: Change in Industry Cost as a Result of Eliminating the 300,000 lb. Threshold for 

Downstream Processing and Use Information Reporting................................................................4-20 

Table 4-16: Change in Industry Burden as a Result of Eliminating the 25,000 lb. Threshold for Certain 

Regulated Chemicals .......................................................................................................................4-22 

Table 4-17: Change in Industry Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain 

Regulated Chemicals .......................................................................................................................4-22 

Table 4-18: Change in Industry Burden as Result of Making Chemicals Subject to ECAs Ineligible for 

Exemptions ......................................................................................................................................4-23 

Table 4-19: Change in Industry Cost as a Result of Making Chemicals Subject to ECAs Ineligible for 

Exemptions ......................................................................................................................................4-24 

Table 4-20: Change in Industry Burden as a Result of Exempting Manufactured Water from Reporting..4-

25 

Table 4-21: Change in Industry Cost as a Result of Exempting Manufactured Water from Reporting ..4-25 

Table 4-22: Change in Industry Burden as a Result of Requiring the Reporting of Production Volume in 

all Non-Principal Reporting Years...................................................................................................4-27 

Table 4-23: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume in all 

Non-Principal Reporting Years........................................................................................................4-27 

Table 4-24: Change in Industry Burden as a Result of Requiring the Reporting of Production Volume 

Used On-Site....................................................................................................................................4-28 

Table 4-25: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume 

Used On-Site....................................................................................................................................4-29 

Table 4-26: Change in Industry Burden as a Result of Indicating Whether a Chemical is Physically at 

Reporting Site ..................................................................................................................................4-29 

Table 4-27: Change in Industry Cost as a Result of Indicating Whether a Chemical is Physically at 

Reporting Site ..................................................................................................................................4-30 

Table 4-28: Change in Industry Burden as a Result of Requiring Reporting of Volume Exported ........4-30 

Table 4-29: Change in Industry Cost as a Result of Requiring Reporting of Volume Exported.............4-31 

Table 4-30: Change in Industry Burden as a Result of Indicating Whether Chemical is Recycled, 

Remanufactured, Reprocessed, Reused, or Reworked.....................................................................4-31 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

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Table 4-31: Change in Industry Cost as a Result of Indicating Whether Chemical is Recycled, 

Remanufactured, Reprocessed, Reused, or Reworked.....................................................................4-32 

Table 4-32: Change in Industry Burden as a Result of Modifying the Industrial Function Categories...4-33 

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

Table 4-34: Change in Industry Burden as a Result of Modifying the Consumer and Commercial Product 

Categories ........................................................................................................................................4-35 

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

Categories ........................................................................................................................................4-35 

Table 4-36: Change in Industry Burden as a Result of Requiring the Number of Commercial Workers 

Reasonably Likely To Be Exposed..................................................................................................4-36 

Table 4-37: Change in Industry Cost as a Result of Requiring the Number of Commercial Workers 

Reasonably Likely To Be Exposed..................................................................................................4-37 

Table 4-38: Change in Industry Burden as a Result of Requiring Upfront Substantiation for Claiming 

Processing and Use Information as CBI ..........................................................................................4-38 

Table 4-39: Change in Industry Cost as a Result of Requiring Upfront Substantiation for Claiming 

Processing and Use Information as CBI ..........................................................................................4-38 

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

Table 4-41: Change in Industry Cost as a Result of Requiring Electronic Submission...........................4-41 

Table 4-42: Change in Industry Burden as a Result of Requiring CDX Registration for Secondary 

Submitters ........................................................................................................................................4-42 

Table 4-43: Change in Industry Cost as a Result of Requiring CDX Registration for Secondary Submitters

.........................................................................................................................................................4-42 

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

Year Period ......................................................................................................................................4-43 

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

Period ...............................................................................................................................................4-44 

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

Table 4-47: Change in the 2011 Reporting Cycle Burden for All Amendments Combined, by Labor 

Category...........................................................................................................................................4-48 

Table 4-48: Change in the Future Reporting Cycle Burden for All Amendments Combined, by Labor 

Category...........................................................................................................................................4-49 

Table 4-49: Total Industry Burden for All Amendments Combined.......................................................4-50 

Table 4-50: Total Industry Cost When All Amendments Are Combined................................................4-51 

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

Table 4-52: Average Total Burden per Site .............................................................................................4-52 

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

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

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

Table 5-1: Derivation of Loaded Agency Wage Rates (2008$).................................................................5-2 

Table 5-2: Derivation of Extramural Task Costs, per Reporting Cycle.....................................................5-2 

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

Table 5-4: Baseline Agency Burden per Report ........................................................................................5-4 

Table 5-5: Change in Agency Burden as a Result of Modifying the Method for Determining Whether a 

Manufacturer is Subject to IUR Reporting Requirements .................................................................5-5 

Table 5-6: Change in Agency Cost as a Result of Modifying the Method for Determining Whether a 

Manufacturer is Subject to IUR Reporting Requirements .................................................................5-5 

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

and Use Reporting..............................................................................................................................5-6 

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

and Use Reporting..............................................................................................................................5-6 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

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Table 5-9: Change in Agency Burden as a Result of Eliminating the 25,000 lb. Threshold for Certain 

Regulated Chemicals .........................................................................................................................5-7 

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

Regulated Chemicals .........................................................................................................................5-7 

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

Exemptions ........................................................................................................................................5-8 

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

Exemptions ........................................................................................................................................5-8 

Table 5-13: Change in Agency Burden as a Result of a Full Exemption for Manufactured Water...........5-8 

Table 5-14: Change in Agency Cost as a Result of a Full Exemption for Manufactured Water ...............5-9 

Table 5-15: Change in Agency Burden as a Result of Reporting of Production Volume for Each of the 

Years since Last Principal Reporting Year ......................................................................................5-10 

Table 5-16: Change in Agency Cost as a Result of Reporting of Production Volume for Each of the Years 

since Last Principal Reporting Year ................................................................................................5-10 

Table 5-17: Change in Agency Burden as a Result of Reporting of Production Volume Used On-Site.5-11 

Table 5-18: Change in Agency Cost as a Result of Reporting of Production Volume Used On-Site .....5-11 

Table 5-19: Change in Agency Burden as a Result of Indicating Whether an Imported Chemical is 

Physically On-Site ...........................................................................................................................5-11 

Table 5-20: Change in Agency Cost as a Result of Indicating Whether an Imported Chemical is 

Physically Present On-Site...............................................................................................................5-12 

Table 5-21: Change in Agency Burden as a Result of Requiring the Reporting of Export Volume .......5-12 

Table 5-22: Change in Agency Cost as a Result of Requiring the Reporting of Export Volume............5-12 

Table 5-23: Change in Agency Burden as a Result of Indicating Whether Chemical is Recycled, 

Remanufacture, Reprocessed, Reused, or Reworked.......................................................................5-13 

Table 5-24: Change in Agency Cost as a Result of Indicating Whether Chemical is Recycled, 

Remanufactured, Reprocessed, Reused, or Reworked.....................................................................5-13 

Table 5-25: Change in Agency Burden as a Result of Revising the Industrial Function Categories.......5-14 

Table 5-26: Change in Agency Cost as a Result of Revising the Industrial Function Categories...........5-14 

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

Categories ........................................................................................................................................5-15 

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

Categories ........................................................................................................................................5-16 

Table 5-29: Change in Agency Burden as a Result of Designation of Consumer or Commercial Use...5-16 

Table 5-30: Change in Agency Cost as a Result of Designation of Consumer or Commercial Use .......5-16 

Table 5-31: Change in Agency Burden as a Result of Requiring the Number of Commercial Workers 

Reasonably Likely To Be Exposed..................................................................................................5-17 

Table 5-32: Change in Agency Cost as a Result of Requiring the Number of Commercial Workers 

Reasonably Likely To Be Exposed..................................................................................................5-17 

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

18 

Table 5-34: Change in Agency Cost as a Result of Requiring Upfront Substantiation for CBI Claims..5-18 

Table 5-35: Change in Agency Burden as a Result of Requiring Electronic Submission .......................5-19 

Table 5-36: Change in Agency Cost as a Result of Requiring Electronic Submission............................5-19 

Table 5-37: Change in Agency Burden as a Result of Modifying the Reporting Frequency ..................5-20 

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

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

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

Table 5-41: Total Agency Cost of All Amendments Combined..............................................................5-24 

Table 5-42: Agency Burden per Report when All Amendments are Combined .....................................5-25 

Table 5-43: Agency Cost per Report When All Amendments are Combined.........................................5-25 

Table 5-44: Agency Cost per Report when All Amendments Are Combined.........................................5-26 
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Table 5-45: Annual Data Entry Burden to the Agency of all Modifications ...........................................5-27 

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

Table 6-1: Change in Total Burden to Society If All Modifications Are Implemented ............................6-1 

Table 6-2: Change in Total Costs to Society if All Modifications Are Implemented ...............................6-2 

Table 8-1: Results of Dun & Bradstreet Analysis......................................................................................8-3 

Table 8-2: Estimated Number of Small Companies under the Proposed IUR Rule Amendments............8-4 

Table 8-3: Derivation of Cost-to-Sales Ratios for Small Companies under the Proposed IUR Rule 

Amendments ......................................................................................................................................8-5 

Table C-1: List of Current and Proposed Industrial Function Categories................................................. C-1 

Table D-1: List of Current and Proposed Consumer and Commercial Product Categories......................D-1 

Table F-1: Sensitivity Analysis of Industry Burden Estimates for Modifying the Method for Determining 

Whether the Threshold Is Met .......................................................................................................... F-1 

Table F-2: Sensitivity Analysis of Industry Cost Estimates for Modifying the Method for Determining 

Whether the Threshold Is Met .......................................................................................................... F-2 

Table F-3: Sensitivity Analysis of Agency Burden Estimates for Modifying the Method for Determining 

Whether the Threshold Is Met .......................................................................................................... F-2 

Table F-4: Sensitivity Analysis of Agency Cost Estimates for Modifying the Method for Determining 

Whether the Threshold Is Met .......................................................................................................... F-3 

Table F-5: Sensitivity Analysis of Industry Burden Estimates for Reporting Production Volume Used OnSite .................................................................................................................................................... F-3 

Table F-6: Sensitivity Analysis of Industry Cost Estimates for Reporting Production Volume Used OnSite .................................................................................................................................................... F-4 

Table F-7: Sensitivity Analysis of Agency Burden Estimates for Reporting Production Volume Used OnSite .................................................................................................................................................... F-4 

Table F-8: Sensitivity Analysis of Agency Cost Estimates for Reporting Production Volume Used OnSite .................................................................................................................................................... F-5 

Table F-9: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as 

an Industrial Function Category........................................................................................................ F-6 

Table F-10: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” as an 

Industrial Function Category ............................................................................................................ F-6 

Table F-11: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as 

an Industrial Function Category........................................................................................................ F-7 

Table F-12: Sensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for “Other” as an 

Industrial Function Category ............................................................................................................ F-7 

Table F-13: Sensitivity 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: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” as a 

Consumer and/or Commercial Product Category ............................................................................. F-8 

Table F-15: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as 

a Consumer and/or Commercial Product Category .......................................................................... F-9 

Table F-16: Sensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for “Other” as a 

Consumer and/or Commercial Product Category ............................................................................. F-9 

Table F-17: Sensitivity Analysis of Industry Burden Estimates for Requiring Upfront CBI Substantiation

........................................................................................................................................................ F-10 

Table F-18: Sensitivity Analysis of Industry Cost Estimates for Requiring Upfront CBI Substantiation.. F10 

Table F-19: Sensitivity Analysis of Agency Burden Estimates for Requiring Upfront CBI Substantiation

........................................................................................................................................................ F-11 

Table F-20: Sensitivity Analysis of Agency Cost Estimates for Requiring Upfront CBI SubstantiationF-11 

Table G-1: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data 

Annually............................................................................................................................................G-1 
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Table G-2: Industry Cost under the Alternative Option to Require Submitters to Submit Full Data 

Annually............................................................................................................................................G-2 

Table G-3: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data 

Annually............................................................................................................................................G-3 

Table G-4: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data 

Annually............................................................................................................................................G-4 

Table G-5: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data 

Annually when all the Proposed Amendments are Considered ........................................................G-5 

Table G-6: Industry Cost under the Alternative Option to Require Submitters to Submit Full Data 

Annually when all the Proposed Amendments are Considered ........................................................G-5 

Table G-7: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data 

Annually when all the Proposed Amendments are Considered ........................................................G-6 

Table G-8: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data 

Annually when all the Proposed Amendments are Considered ........................................................G-7 

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

Reporting...........................................................................................................................................G-9 

Table G-10: Annual Industry Burden under the Alternative Option of a Three-Year Reporting Cycle...G-9 

Table G-11: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle..................G-10 

Table G-12: Burden to the Agency under the Alternative Option of a Three-Year Reporting Cycle ....G-11 

Table G-13: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle...................G-11 

Table G-14: Annual Industry Burden under the Alternative Option of a Three-Year Reporting Cycle when 

the All the Proposed Amendments are Considered.........................................................................G-12 

Table G-15: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle when the All 

the Proposed Amendments are Considered ....................................................................................G-13 

Table G-16: Agency Burden under the Alternative Option of a Three-Year Reporting Cycle when the All 

the Proposed Amendments are Considered ....................................................................................G-14 

Table G-17: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle when the All the 

Proposed Amendments are Considered ..........................................................................................G-15 

Table G-18: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a Three-Year Reporting 

Cycle ...............................................................................................................................................G-16 

Table G-19: Number of Reports and Sites in 2002.................................................................................G-17 

Table G-20: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. ........G-18 

Table G-21: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb..............G-18 

Table G-22: Change in Burden to the Agency as a Result of Changing the Threshold for Reporting to 

10,000 lb. ........................................................................................................................................G-19 

Table G-23: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. G19 

Table G-24: Change in the Number of Sites and Reports Submitted of All Amendments Combined with 

the 10,000 lb. Reporting Threshold ................................................................................................G-20 

Table G-25: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. when All 

Proposed Amendments are Considered ..........................................................................................G-21 

Table G-26: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. when All 

Proposed Amendments are Considered ..........................................................................................G-22 

Table G-27: Industry Burden under the Alternative Option of a Lowered Reporting Threshold and All 

Other Amendments when All Proposed Amendments are Considered, .........................................G-22 

Table G-28: Change in Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. 

and All Other Amendments when All Proposed Amendments are Considered .............................G-23 

Table G-29: Agency Burden as a Result of Lowered Threshold Reporting and All Other Amendments 

when All Proposed Amendments are Considered...........................................................................G-24 

Table G-30: Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments when 

All Proposed Amendments are Considered ....................................................................................G-24 
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Table G-31: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and All 

Other Amendments when All Proposed Amendments are Considered ..........................................G-25 

Table G-32: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. 

and All Other Amendments when All Proposed Amendments are Considered .............................G-25 

Table G-33: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a 10,000 lb. Reporting 

Threshold ........................................................................................................................................G-27 

Table H-1: Description of Additional Data Elements...............................................................................H-1 

Table H-2: Change in Industry Burden to Manufacturers as a Result of Additional Exposure-Related Data 

Elements............................................................................................................................................H-8 

Table H-3: Schedule of Annual Industry Burden to Manufacturers if All Proposed Amendments Are 

Implemented .....................................................................................................................................H-9 

Table H-4: Change in Industry Burden to Processors as a Result of Additional Exposure-Related Data 

Elements..........................................................................................................................................H-10 

Table H-5: Schedule of Annual Industry Burden to Processors .............................................................H-11 

Table H-6: Change in Industry Burden to Manufacturers and Processors as a Result of Additional 

Exposure-Related Data Elements....................................................................................................H-12 

Table H-7: Schedule of Annual Industry Burden to Manufacturers and Processors if All Proposed 

Amendments Are Implemented ......................................................................................................H-13 

Table H-8: Per-Report Cost for Additional Data Elements, based on PMN Burden..............................H-14 

Table H-9: Change in Industry Cost to Manufacturers as a Result of Additional Exposure-Related Data 

Elements..........................................................................................................................................H-14 

Table H-10: Annual Increase in Industry Cost to Manufacturers if All Proposed Amendments Are 

Implemented (2008$)......................................................................................................................H-15 

Table H-11: Change in Industry Cost to Processors as a Result of Additional Exposure-Related Data 

Elements..........................................................................................................................................H-16 

Table H-12: Annual Increase in Industry Cost to Processors if All Proposed Amendments Are 

Implemented (2008$)......................................................................................................................H-16 

Table H-13: Change in Industry Cost to Manufacturers and Processors as a Result of Additional 

Exposure-Related Data Elements....................................................................................................H-17 

Table H-14: Annualized Increase in Industry Cost to Manufacturers and Processors if All Amendments 

Are Implemented (2008$)...............................................................................................................H-18 

Table H-15: Change in Agency Burden to Process Manufacturer Data as a Result of Additional ExposureRelated Data Elements....................................................................................................................H-19 

Table H-16: Annual Increase in Agency Burden to Process Manufacturer Data if All Proposed 

Amendments Are Implemented ......................................................................................................H-19 

Table H-17: Change in Agency Burden to Process Processor Data as a Result of Additional ExposureRelated Data Elements....................................................................................................................H-20 

Table H-18: Annual Increase in Agency Burden to Process Processor Data if All Proposed Amendments 

Are Implemented ............................................................................................................................H-20 

Table H-19: Change in Agency Burden to Process Manufacturer and Processor Data as a Result of 

Additional Exposure-Related Data Elements..................................................................................H-21

Table H-20: Annual Increase in Agency Burden to Process Data if All Proposed Amendments Are 

Implemented ...................................................................................................................................H-21 

Table H-21: Change in Agency Cost of Processing Manufacturer Data as a Result of Additional 

Exposure-Related Data Elements....................................................................................................H-23 

Table H-22: Annual Increase in Agency Cost to Process Manufacturer Data if All Proposed Amendments 

Are Implemented (2008$)...............................................................................................................H-24 

Table H-23: Change in Agency Cost to Process Processor Data as a Result of Additional ExposureRelated Data Elements....................................................................................................................H-24 

Table H-24: Annual Increase in Agency Cost to Process Processor Data if All Proposed Amendments Are 

Implemented (2008$)......................................................................................................................H-25 
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Table H-25: Change in Agency Cost of Processing Manufacture and Processor Data as a Result of 

Additional Exposure-Related Data Elements..................................................................................H-26

Table H-26: Annual Increase in Agency Cost to Process Manufacturer and Processor Data if All Proposed 

Amendments Are Implemented (2008$).........................................................................................H-26

Table H-27. Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of Additional Data 

Elements..........................................................................................................................................H-28 

Table H-28: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of Additional Data 

Elements..........................................................................................................................................H-29 

Table I-1: Annual Industry Burden as a Result of a TSCA Section 8(a) Data Collection......................... I-3 

Table I-2: Schedule of Annual Industry Burden........................................................................................ I-3 

Table I-3: Per-Report Cost for Additional Data Elements, based on PMN Burden .................................. I-4 

Table I-4: Annual Industry Cost as a Result of a TSCA Section 8(a) Data Collection ............................. I-5 

Table I-5: Annual Increase in Industry Cost if All Amendments Are Implemented (2008$)) .................. I-5 

Table I-6: Per-Report Burden for Data Elements Similar to Those Included in a TSCA Section 8(a) Data 

Collection........................................................................................................................................... I-6 

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-7 

Table I-9: Per-Report Cost for Data Elements Similar to Those Included in a TSCA Section 8(a) Data 

Collection........................................................................................................................................... I-7 

Table I-10: Agency Cost to Process Data as a Result of the TSCA Section 8(a) Data Collection ........... I-8 

Table I-11: Annual Increase in Agency Cost (2008$) ............................................................................... I-8 

Table I-12: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of ExposureRelated Data Elements..................................................................................................................... I-10 

Table I-13: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of Exposure-Related 

Data Elements .................................................................................................................................. I-11 
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Executive Summary 

The U.S. Environmental Protection Agency (EPA) requires manufacturers and importers of certain 

chemical substances to periodically 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 required 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 amended 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 Inventory, which is a listing of chemicals that are in commerce in the 

United States. For reportable substances that a company manufactures or imports in volumes of 25,000 lb. 

or more at a plant site during the principal reporting year, a submitter is required to provide plant site, 

production volume, and manufacturing information. Sites must also provide processing and use 

information for chemicals that are manufactured or imported in volumes that meet or exceed a 300,000 lb. 

per year threshold. Submitters do not need to provide this processing and use information for chemicals 

below the 300,000 lb. threshold, or chemicals that are “partially exempt,” such as specifically listed 

petroleum process streams, and listed chemical substances for which the IUR information is of low 

current interest. These chemicals are all referred to as “partially exempt” 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),” “electronic IUR (e-IUR),” and 

“industrial function”; 

 Add requirement to report if, for any calendar year since the previous IUR principal reporting year, 

the subject chemical was manufactured in production volumes of 25,000 lb. or greater per year; 

 Eliminate the 300,000 lb. threshold, thereby 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 certain regulated chemicals and require manufacturers 

(including importers) of such chemicals to report 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 company identification number, technical contact, and 

chemical identity; 

 Require submitters to report the chemical’s production volume for each of the five years since last 

principal reporting year; 

 Require submitters to report separately production volume used on-site; 
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 Require submitters of imported chemicals to indicate whether the chemical is physically at the 

reporting site; 

 Require submitters to report production volume exported; 

 Require submitters to identify whether the chemical is to be recycled, remanufactured, reprocessed, 

reused, or reworked; 

 For downstream processing and use information: modify the set of industrial function categories; 

provide industrial sectors instead of NAICS codes; and modify the set of consumer and commercial 

product categories; 

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

 Require that submitters report the total number of workers, including those at sites not under the 

submitter’s control, that are reasonably likely to be exposed while using the reportable chemical 

substance, with respect to each commercial use; 

 Change the reporting standard for processing and use information from “readily obtainable” to 

“known to or reasonably ascertainable by”; 

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

information; 

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

CBI; 

 Require submitters to electronically submit forms using the e-IUR software and EPA’s Central Data 

Exchange (CDX); and 

 Change frequency of reporting from every five years to every four years. 

These amendments overall will increase IUR rule reporting costs. Over the first 20 years of the rule, 

EPA estimates that the net present value of the rule modifications will be $501.69 million in social cost. 

Annualized costs are expected to be $26.25 million (at a three percent discount rate) and $27.84 million 

(at a seven percent discount rate).1

 EPA estimates that all of the amendments combined would increase 

the burden to industry by approximately 1.56 million hours to 3.40 million hours in total for the 2011 

reporting cycle. EPA estimates that in future reporting cycles, the industry burden will increase by 1.21 

million hours to a total of 2.64 million hours. EPA further estimates that over a 20-year period, industry 

burden will increase by 7.81 million hours. EPA estimates that the net increase in burden to society will 

increase by 7.81 million hours over a 20-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 that pose the greatest 

potential risks and to target programs for population groups that are at the highest potential risk. 

With this better targeted information designed to better meet Agency needs, EPA will improve its 

ability to screen chemicals to identify whether additional risk assessment and management steps are 

needed. More complete reporting of the processing 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-screening 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 assumptions. Ultimately, enhancing 

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 changes in reporting 

requirements that will improve consistency and compatibility with other EPA databases. EPA would have 

an increased ability to anticipate industry trends, particularly for chemicals for which EPA has concerns. 

 

1

 All values are in year 2008 dollars. 
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1. Introduction 

This report assesses the costs and benefits EPA expects to result from its 2009 proposal to modify the 

Inventory Update Reporting (IUR) rule. The proposed amendments would provide information to better 

address Agency and public information needs, improve the usability and reliability of the reported data, 

and ensure that data are available in a timely manner. This chapter provides background information on 

EPA’s statutory authority for collecting information through the IUR rule and a discussion of the 

regulatory history of the IUR rule. 

1.1 Statutory Authority 

EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep current an 

inventory of chemical substances manufactured or processed in the United States. This inventory is 

known as the TSCA Chemical Substance Inventory (the TSCA Inventory). TSCA section 8(a)(1) 

authorizes the EPA Administrator to promulgate regulations 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 chemical 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 has 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 704.3. 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), processing and use information on various types and classes of chemicals. In 1977, 

EPA used its authority under TSCA §8 to create the TSCA Chemical Substances Inventory, also known 

as the TSCA Inventory (42 FR 64572), which currently is codified at 40 CFR part 710 Subpart A. The 

TSCA Inventory lists all TSCA chemicals that are in commerce in the United States, thereby providing a 

listing of chemicals manufactured or processed in the United States. All chemicals are included, with the 

exception of pesticides, tobacco, nuclear material, firearms and ammunition, food and food additives, 

drugs, and cosmetics, which are not under the jurisdiction 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 IUR 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 Reporting rule, or IUR rule. Under this rule, EPA collected data every 

four years for organic chemicals produced in volumes of 10,000 lb. or more per site. (Inorganic 

 

2

 Currently, more than 83,000 chemicals are listed on the TSCA Inventory (EPA, 2008a). 
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1-2

chemicals, polymers, microorganisms, and naturally occurring chemical substances were generally 

excluded from reporting.) From 1986 to 1998, an average of 9,200 individual chemicals was reported per 

reporting cycle. The IUR data provided a more up-to-date picture of a subset of the TSCA chemicals in 

commerce, generating data that were 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, referred 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 coverage from corporate fiscal year to calendar year, and extended the 

recordkeeping period from four years to five years. The 2003 Amendments partially mitigated the 

industry burden increase by raising the reporting threshold to 25,000 lb.; creating a partial exemption 

from reporting processing and use information for inorganic chemicals for the 2006 IUR collection only, 

and for specifically-listed petroleum process streams and other specifically listed chemical substances for 

2006 and future reporting cycles; and by exempting from 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 frequency in an effort to further reduce industry 

reporting burden. In 2005, EPA promulgated further modifications to the IUR rule (70 FR 75059) 

(referred to in this report as the “2005 Amendments”), which extended the reporting cycle to five years, 

and made further changes to the rule that reduced industry burden and clarified rule requirements. 
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2. Current IUR Requirements and Affected Entities 

2.1 Overview of Current IUR Requirements 

The IUR rule requires U.S. manufacturers (including importers) of chemicals listed on the TSCA 

Inventory to report to EPA every five years the identity of chemical substances manufactured (including 

imported) during the principal reporting year in quantities of 25,000 lb. or greater at any single site they 

own or control (see 40 CFR part 710, subpart C). 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 federal health, safety, and environmental protection 

activities. To the extent possible due to restrictions related to confidential business information, the 

Agency also makes the data available to the public. 

Persons manufacturing, including importing, chemical substances are required to report information 

related to company, site, and chemical identity 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 information (40 CFR §710.52(c)(4)). The IUR rule 

generally partially exempts specifically-listed petroleum process streams and other specifically-listed 

chemical substances, and manufacturers (including importers) 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 information, is divided into three parts: Site Identification 

Information (Part I), Manufacturing Information (Part II), and Processing and Use Information (Part III). 

A copy of the 2006 IUR Form U is in Appendix A of this report. An overview of the information 

collected under the IUR rule in 2006 is as follows: 

 Company Reporting Number: An 8-digit alphanumeric number assigned by the submitter to each 

specific IUR submission (for electronic submissions only). 

 Certification statement. A company authorized official must sign the form, certifying that the 

information provided is complete and accurate. 

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

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

that is reporting. 

 Technical contact information. Includes the name, address, telephone 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 identifying number, of the chemical substance. 

 Manufacturing information. Includes an indication of whether the chemical substance is 

manufactured or imported; whether it is site-limited (whether 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 involved in manufacturing that are reasonably likely to 

be exposed to the chemical substance, the physical form(s) as the chemical leaves the site (including 

the percent of the production volume in each form), and the maximum concentration of the chemical 
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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 consumer and commercial product categories used in the 

2006 reporting are listed in Appendix D of this report. These data are reported to the extent they are 

“readily obtainable by” the submitter. 

 Confidential Business Information (CBI) status can be claimed for each data element reported. 

Submitters who claim the chemical identity or plant site identity as CBI must provide upfront 

substantiation of the need for such confidentiality. 

Non-confidential data, including both searchable and separately downloadable databases and a 2006 

IUR data summary report, are available for public use on the IUR website (http://www.epa.gov/iur). 

2.2 Overview of the Regulated Community 

The regulated community for the IUR rule (i.e., those who potentially will be affected by the 

proposed amendments to the IUR rule) consists of companies manufacturing or importing chemicals in 

amounts of 25,000 lb. or more annually that are listed on the TSCA Inventory and are regulated under 

TSCA §8. Manufacturers and importers of non-TSCA chemical substances (such as pesticides, tobacco, 

nuclear material, firearms and ammunition, food and food additives, drugs, and cosmetics) are not 

required to report information on those chemicals under the IUR rule. Some chemical substances might 

have both TSCA and non-TSCA uses. In that case, the production associated with the TSCA use must be 

reported. Companies engaged in chemical manufacturing (NAICS code 325) or petroleum refining 

(NAICS code 324110) are the most likely to report under the IUR rule. Chemical users and processors 

who may manufacture a byproduct chemical substance, e.g., utilities, paper manufacturing, primary metal 

manufacturing, and semiconductor and other electronic component manufacturing (NAICS codes 22, 322, 

331, and 3344) are also likely to be subject to the 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 determine whether they are required to report. 
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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 

40 CFR part 710 contains three subparts. Subpart A contains regulatory text associated with the 

original compilation of the TSCA Inventory; Subpart B contains regulatory text associated with the IUR 

covering the update reporting in 2002 and earlier; and Subpart C contains the regulatory text associated 

with the IUR for 2006 and beyond. The chemicals that are covered by the IUR are on the Master 

Inventory File, which includes chemicals from the original Inventory compilation and those added 

subsequently through the notice requirements of 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 has modified the IUR rule, the Agency believes the regulatory text associated with 

the IUR rule should be in its own section in the Code of Federal Regulations, distinct from both the 

original TSCA Inventory rules and from the TSCA section 5 requirements. 

3.1.1 Move the IUR Regulatory Text from 710 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 part 710 to part 711 and would add a new Scope and 

Compliance section (§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 §711.12; 

§710.53 would become §711.13; §710.55 would become §711.15; §710.57 would become §711.17; 

§710.58 would become §711.18; and §710.59 would become §711.19. Because all of the text of Subpart 

C would be moved to part 711, part 710 would no longer have a Subpart C. Neither part 710 nor part 711 

would have any subparts. 

3.1.2 Consolidation of Definitions 

As part of moving the regulatory text from Part 710 Subpart C to part 711, EPA is proposing to 

consolidate the definitions currently found at §710.3 and §710.43 into the proposed §711.3, except where 

an appropriate definition is already in place in section 3 of TSCA or at §704.3, and an additional 

definition of the term in proposed §711.3 would therefore be unnecessarily duplicative. The definitions at 

§704.3 would be incorporated by reference into proposed §711.3, except insofar as proposed §711.3 

provides a modified definition of a term also defined at §704.3. 

The term mixture is defined in both §710.3 and section 3 of TSCA. For purposes of the IUR rule, 

EPA is proposing to incorporate the definition of mixture from section 3 of TSCA. The TSCA mixture 

definition differs from the definition in §710.3 and §720.3, the regulations used to determine the 

chemicals listed on the Inventory, in that it does not specifically address hydrates. While hydrates are not 

addressed specifically in the definition, a hydrate is a mixture of water and an anhydrous chemical 

substance. As with mixtures in general, the individual components of the mixture may be separately 

reportable at the time of their manufacture or import. EPA believes, for purposes of the IUR rule, that it is 

not necessary to include hydrates separately in the definition of mixture. The Agency will continue to 

include such a discussion in the Instructions. 
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3.1.3 Delete “Non-isolated Intermediate” Definition from §710.3 

EPA added a definition to §710.43 for the term non-isolated intermediate as part of the 2003 

Amendments (68 FR 848, January 7, 2003). Subsequently, as part of the IUR Revisions Rule (70 FR 

75059, December 19, 2005), EPA erroneously moved the definition to §710.3, rather than to §710.43. 

EPA is proposing to delete the definition from §710.3 as this definition was not associated with the 

original Inventory, and therefore does not belong in §710.3. A definition of this term, codified elsewhere 

at §704.3, would be incorporated by reference into the IUR definitions at proposed §711.3. 

3.1.4 Delete Subpart B Text 

EPA is proposing to delete the regulatory text contained in §710.23 through §710.39 (subpart B). This 

text refers to IUR 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. 

3.2 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 new definitions. In §704.3 and §710.3, EPA is also 

proposing to modify the citation in the definition of importer by removing the citation to 19 CFR 11.1 to 

19 CFR 101.1. The citation, which would correctly read 19 CFR 101.1 is not needed for this definition 

because it does not add additional information to the definition of importer. 

3.2.1 Manufacture and Manufacturer 

In order to improve the information submitted through 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 contracting with a toll manufacturer to 

report the chemical physically manufactured at the toll manufacturer’s site. Under the proposed definition 

of site, the site information would reflect the toll manufacturer’s site. Adopting this definition would 

allow the person contracting for the manufacture of a chemical substance to report the information on the 

industrial processing and use of a chemical substance and on the consumer and commercial uses of a 

product containing the chemical substance. Information on the uses of a chemical substance is often 

unavailable to a toll manufacturer who produces a chemical substance for another person. EPA is 

proposing to modify the §711 definition of manufacture instead of adopting the definition of 

manufacturer from §720.3 because the 40 CFR part 711 regulations do not use the term manufacturer. In 

order to avoid any confusion with the definitions of these terms found at §704.3, the Agency is also 

proposing to add a simple definition for the term manufacturer to the proposed §711.3. In addition to the 

proposed change to the definition of manufacture, EPA is proposing to add a paragraph (c) to the 

proposed regulation at §711.15 to clarify the 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. 

 Under this proposal, the term manufacture therefore would be defined under the IUR rule to mean “to 

manufacture, produce, or import for commercial purposes. Manufacture includes the extraction, for 

commercial purposes, of a component chemical substance from a previously existing chemical substance 

or a complex combination of substances. When a substance, manufactured other than by import, is (1) 

produced exclusively for another person who contracts for such production, and (2) that other person 

specifies the identity of the 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.” 
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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 contract, and (3) accommodate portable manufacturing 

units. 

Two examples of portable manufacturing units are tanks used to manufacture calcium hydroxide 

slurry for use in building construction and road and highway projects, and tanks used to mix anhydrous 

ammonia and water to manufacture ammonium hydroxide prior to application to agricultural lands. EPA 

is interested in including chemical manufacturing that is occurring at, for instance, construction sites or 

road crews at which chemicals are mixed on site in such a manner to create a different chemical 

substance, e.g., asphalt emulsifiers. The site of physical manufacturing could change on a frequent basis. 

Manufacturers (including importers) would report the aggregated production volume for all of the 

portable manufacturing units sent out to different locations from a single distribution center. The address 

of the distribution center would be reported as the site location. 

Under the proposal, the term site would be defined to mean “a contiguous property unit. Property 

divided only by a public right-of-way would be considered 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 a person who imports a 

chemical substance described in §711.5 is the United States site of the operating unit within the person's 

organization that is directly responsible for importing the substance and that controls the import 

transaction. In some cases, it may be the organization's headquarters office in the United States. If there is 

no such operating unit or headquarters in the U.S., the site address for the importer is the U.S. address of 

an agent acting on behalf of the importer who is authorized to accept service of process for the importer. 

For portable manufacturing units sent out to different locations from a single distribution center, the 

distribution center shall be considered the site.” 

3.2.3 Electronic-Reporting Related Definitions 

EPA is proposing to add two new terms, Central Data Exchange (CDX) and electronic IUR (e-IUR).

The Agency is adding these terms to provide clarity to the proposed requirement for electronic reporting 

of IUR data. The term CDX means “EPA’s centralized electronic document receiving system, or its 

successors, including associated instructions for registering to submit electronic documents.” The new 

definition would make the term consistent with the new Premanufacture Notice (PMN) definition. The 

term e-IUR means the “electronic-IUR software provided by the EPA for the completion and submission 

of the IUR Form U report.” 

3.2.4 Processing and Use-Related Definitions 

EPA is proposing to amend the definitions of two terms: commercial use and consumer use in order 

to make their basic applications consistent with the definitions developed collaboratively by the United 

States and Canada. The term commercial use would mean “the use of a chemical substance or a mixture 

containing a chemical substance (including products and manufactured items composed of or containing a 

chemical substance) in a commercial enterprise providing saleable goods or services.” Examples included 

in the §710.43 definition were eliminated. The slightly modified definition of consumer use would mean 

“the use of a chemical substance that is itself, or as part of a mixture (including as part or all of a product 

or manufactured item), sold to or made available to consumers for their use.” The restrictions associated 

with where a consumer would use the product would be removed. 

EPA is also proposing to add a definition for the term industrial function. For the 2006 IUR, EPA 

defined industrial use and did not define industrial function. The inclusion of both definitions provides 

clarity for the industrial processing and use reporting requirements, and would make the Agency’s 
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requirements consistent with those developed collaboratively with Canada. With this proposal, industrial 

function would mean “the intended physical or chemical characteristic for which a chemical substance or 

mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product or article; 

repackaged; or used.” 

3.2.5 Principal Reporting 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 production volumes for each calendar year since the last 

principal reporting year. EPA is proposing to modify the terms reporting year and submission period to 

reflect these changes. 

The term reporting year would be modified to add the term principal and to replace the word 

“information” with “manufacturing, processing and use data.” EPA is proposing these changes to 

indicate that the principal reporting year is the year in which most of the reported data are based. Under 

the current proposal, the principal reporting year is the latest complete calendar year proceeding the 

submission period. Additionally, EPA is proposing to remove the reference to “the calendar year at 5-year 

intervals thereafter” and to remove the reference to “calendar year 2005.” With these changes, the term 

principal reporting year would be defined as “the calendar year in which manufacturing, processing, and 

use activities associated with the data to be reported to EPA during an IUR submission period occur. 

Production volume for manufacturing activities in other years of the reporting cycle may also be 

reportable during the submission 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.” 

3.3 Modifications to Reporting Thresholds 

Reporting thresholds are used to determine when IUR 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. threshold is required to report information in Parts I and II 

of the IUR Form U. Beginning with the 2006 IUR submission year, every person manufacturing 

(including importing) a non-excluded substance at or above the 300,000 lb. threshold was required to 

report information in Part III of Form U. EPA is proposing three changes related to the threshold: (1) how 

to determine whether you meet the 25,000 lb. threshold, (2) the elimination of the 300,000 lb. threshold 

for reporting information in Part III, and (3) the elimination of the 25,000 lb. threshold requirement for 

certain chemicals. 

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

Currently, a one-year “snapshot” of manufacturing (including importing) is used to determine the 

need to report for the IUR rule. The method used to make the reporting determination involved 

identifying that an entity manufactured (or imported) a chemical substance listed on the TSCA Inventory 

during the principal reporting year (e.g., 2005 for the 2006 IUR reporting cycle); that the chemical 

substance was not otherwise exempt; and that the associated production volume (domestically 

manufactured plus imported volumes) met or exceeded the 25,000 lb. threshold for the principal reporting 

year (e.g., 2005 for the 2006 IUR reporting cycle). 

EPA is proposing to modify the method used to determine whether a manufacturer is subject to IUR 

reporting if, for any calendar year since the previous principal reporting year, the subject chemical was 
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manufactured (including imported) in production volumes of 25,000 lb. or greater. For the 2011 reporting 

cycle, a site would examine its annual production volumes for the years 2006 to 2010. If the production 

volume for a reportable chemical substance was 25,000 lb. or greater for any calendar year during that 

five-year period, then the site would need to report the chemical substance, unless it is otherwise exempt. 

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

EPA is proposing to eliminate the 300,000 lb. threshold for processing and use information, thereby 

requiring all reporters of non-excluded substances 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 characterizations and subsequent risk-based prioritizations for medium 

production volume (MPV) chemicals. In the preamble to the 2003 Amendments final rule (68 FR 848, 

January 7, 2003), EPA acknowledged the value of information for chemical substances manufactured in 

lower volumes and stated that if the Agency were to find it necessary in the future, it would collect 

information on chemical substances at reporting thresholds below the thresholds that were introduced in 

the action. The IUR processing and use information is presently needed to complete the characterizations 

and prioritizations for those chemicals manufactured (including imported) in volumes of 25,000 lb. to 

300,000 lb. 

 The Agency explored setting the threshold for reporting processing and use information to an 

alternate level between the basic reporting threshold of 25,000 lb. and 300,000 lb. for this proposal 

(EPA,2008c). However, the need to complete characterizations for chemicals manufactured (including 

imported) in volumes of 25,000 lb. to 300,000 lb. led the Agency to believe that it would be best to 

eliminate the upper threshold and collect full information for all reported chemicals 

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

EPA is proposing to eliminate the 25,000 lb. reporting threshold for certain chemical substances that 

are the subject of particular TSCA rules and/or orders and to require manufacturers (including importers) 

of such 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 chemicals that are: (1) the subject of a rule proposed or promulgated 

under section 5(a)(2), 5(b)(4), or 6 of TSCA; (2) the subject of an order issued under section 5(e) or 5(f) 

of TSCA; or, (3) the subject of relief that has been granted under a civil action under section 5 or 7 of 

TSCA. 

3.4 Changes to Substances Subject to the IUR Rule 

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

Exemptions 

EPA may enter into an enforceable consent agreement (ECA) with a manufacturer of a chemical 

substance, to obtain testing where a consensus exists among EPA, affected manufacturers and/or 

processors, and interested members of the public concerning the need for and scope of testing. Chemicals 

covered by ECAs are of demonstrated high interest to EPA. The Agency has an interest in identifying the 

manufacturing, processing, and use of substances under such agreements, and therefore is proposing to 

require that such substances be reported for IUR purposes, regardless of whether the substance otherwise 

meets the requirements listed in 40 CFR §710.46 (40 CFR §711.6) as an exempt or partially exempt 

chemical substance. This provision will ensure the availability of current information if EPA has 

expressed a concern in the form of an ECA on any substance otherwise excluded from the IUR rule. For 

example, EPA could use the IUR data associated with these regulated chemicals to monitor chemical 
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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 subject of an ECA would be included in the list of 

chemicals that are ineligible for an IUR exemption, in the introductory paragraph of 40 CFR 710.46 

(proposed 40 CFR 711.6) listing the other chemicals that are likewise not eligible for an IUR exemption. 

With this proposed addition, the paragraph would state that a chemical “is not exempted from any of the 

reporting requirements of this part if that substance is the subject of a rule proposed or promulgated under 

section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent agreement developed under the 

procedures of 40 CFR Part 790, or is the subject of an order issued under section 5(e) or 5(f) of the Act, or 

is the subject of relief that has been granted 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 substance. EPA is proposing to fully exempt all (both 

naturally occurring and manufactured) water (CASRN 7732-18-5) and to remove water from the 

petroleum streams partial exemption (40 CFR §710.46(b)(1)). 

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 that meet the IUR definition of a polymer in the partially 

exempt list of chemicals may be confusing to submitters and may lead to unnecessary reporting for these 

substances. EPA is proposing to amend the partially exempt list of chemicals at §710.46(b)(2)(iv) to 

remove these three chemical substances which, as polymers, are fully exempt from reporting. 

3.5 Modifications to Reportable Data Elements 

3.5.1 Parent Company and Site Identity 

Manufacturers (including importers) are required to report the company name and Dun and Bradstreet 

(D&B) number to identify the company associated with the plant site, and also to report the site name, 

address, and D&B number. If the company associated with the plant site does not have a D&B number, 

the manufacturer 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 that the company name provided be the ultimate domestic 

parent company name. EPA believes this change will reduce confusion by making this reporting 

requirement consistent with the Toxic Release Inventory (TRI) requirements for parent company name. 

The requirement that the ultimate domestic parent company name be reported under the IUR rule does not 

affect the determination of small business status, which is not limited to domestic companies. Persons 

subject to the IUR rule should continue to base small business determinations on the ultimate parent 

company, regardless of whether that company is domestic or foreign. 

3.5.2 Technical Contact 

Manufactures (including importers) are required to provide a technical contact for their IUR 

submission. The technical contact must be a person who can answer questions EPA may have about the 

reported chemical substance and should be a person located at the manufacturing site. Based on EPA’s 

experience with contacting the reported technical contact with follow-up questions concerning 2006 IUR 

submissions, submitters often provide the names of individuals who are not directly connected to the 
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reporting site, and therefore, are not knowledgeable about either the chemical or the submission. EPA has 

also seen situations where the technical contact is a contracted employee who is able to address 

subsequent concerns only if he or she remains under contract. EPA is therefore requesting comment on 

whether it should allow reporting of multiple technical 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 Inventory as the chemical name reported for IUR. Currently, 

submitters are required to report a specific chemical name, with no further elaboration in the regulatory 

text. The Instructions for Reporting currently state that manufacturers should use CA Index Names or, if 

CA Index Names are not available, manufacturers should use nomenclature that completely and 

accurately describes the chemical substance. 

Manufacturers (including importers) will be allowed to supply an alternate chemical name, and in the 

case of importers, a trade name, in those instances 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.

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 corresponding to the reported CA Index Name. If the 

CASRN number is not available because the chemical substance is listed on the confidential portion of 

the Inventory and a CASRN does not already exist for that substance, the submitter currently could report 

either the associated TSCA Accession or PMN number. 

EPA is proposing to allow submitters to report only the CASRN as a chemical identifying number or, 

in the case of confidential chemical substances, the accession number. Note that in cases where a CASRN 

exists for a confidential chemical, it can be reported instead of the accession number and claimed as 

confidential for purposes of the IUR submission. EPA is proposing to remove the PMN number as an 

allowed chemical identifying number because each Inventory 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 that has only 

been identified by a PMN case number. 

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

EPA is proposing to require reporting of production volume for each of the five years since the last 

principal reporting year. Thus, for the 2011 IUR reporting cycle, manufacturers (including importers) of a 

chemical at or above the 25,000 lb. threshold would report the production volume of that chemical for 

each of the following calendar years: 2006, 2007, 2008, 2009, and 2010. Collecting the production 

volume for multiple years would provide EPA with more accurate and up-to-date information than what 

is provided under the current five-year reporting cycle. 

3.5.5 Volume of Chemical Substance Used On-Site 

EPA is proposing to require that submitters report the volumes of a manufactured (including 

imported) chemical substance used at the reporting site. The requirement to report the volume used onsite is replacing the requirement to indicate that the chemical is site-limited. Under this proposal, either 

domestically manufactured or imported chemicals could be reported as used at the reporting site, whereas, 

under the current reporting requirements, only domestically manufactured chemicals, consumed entirely 

at the site of manufacture, should be reported as site-limited. 
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3.5.6 Indicate Whether Imported Chemicals Are Physically at Reporting Site

EPA is proposing to add a requirement to indicate whether an imported chemical is physically at the 

reporting site. Often, the site reporting an imported chemical never physically receives the chemical, but 

instead ships it directly to another location such as a warehouse, a processing or use site, or a customer’s 

site. Identifying whether the chemical is physically at the reporting site provides 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 report the production volume directly exported and not 

domestically processed or used. This would allow EPA to better identify the proportion of the production 

volume included in the use reporting, given that downstream reporting is not required for exported 

substances. 

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

or Reworked 

EPA is proposing to add a requirement to indicate via a checkbox when a manufactured chemical, 

such as a byproduct, is being recycled, remanufactured, reprocessed, reused, or reworked. Submitters will 

identify that their manufactured chemical, which otherwise would be disposed of as a waste, is being 

removed from the waste stream and has a commercial purpose (i.e. recycled, remanufactured, 

reprocessed, reused, or reworked). Checking this box does not affect the reporting requirements 

associated with any substance manufactured from the byproduct. EPA believes that such information will 

help the Agency to identify where these activities are already occurring, and can be used to encourage 

such activities. 

3.6 Concentration Ranges 

EPA is proposing to eliminate gaps in the ranges used to report concentration in §710.52(c)(3) and (4) 

by changing the ranges to: 1) less than 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 data to the information collected through the IUR 

rule for chemical substances manufactured in quantities of 300,000 lb. or greater during the principal 

reporting year. The industrial processing and use information included industrial function categories and 

North American Industrial Classification System (NAICS) codes. EPA found that knowing these two data 

elements for a chemical substance was useful in selecting a scenario that characterizes the frequency, 

route, and duration of exposure to a chemical substance during manufacture, processing, and use of the 

substance. These data are also useful when EPA characterizes the quantity of the chemical substance in 

wastes and emissions entering the environment and for anticipating the environmental media into which 

wastes will be released. The Agency now is proposing to revise the list of industrial function categories 

and to replace the NAICS codes with industrial sector categories 

3.7.1 Revise Industrial Function Categories 

EPA is proposing to add eight new industrial function categories and to delete six existing categories 

from the current list; the total number of industrial function categories would be 35. Also, EPA has 

renamed several of the industrial function categories to provide a more informative description of the 

function of chemical substances that should be reported in that category. Lastly, EPA is requiring that if a 
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submitter selects the category “Other,” the submitter must provide its own description of the industrial 

function of the chemical substance. Appendix C lists both the existing and proposed sets of industrial 

function categories. 

3.7.2 Revise Industrial Sectors 

EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) 

codes with 48 Industrial Sectors (IS). The IS were developed from the European Union’s, “Guidance on 

information requirements and chemical safety assessment.” The Industrial Sectors divide the entire range 

of NAICS codes into sectors so that there is a sector corresponding to any NAICS code. The Agency 

believes this change will provide a number of benefits. Expected benefits include reducing the reporting 

burden because submitters do not have to look up NAICS codes, encouraging more complete reporting by 

using familiar terms, reducing the likelihood of errors which result from selection of miscellaneous 

NAICS codes, and reducing the number of possible responses for correlation of the information. 

Appendix E of this report provides a list of the proposed industrial sectors. 

When the category chosen for the Industrial 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 requirement for submitters to include information 

about the consumer and commercial uses of chemicals 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 consumer and commercial product 

categories from a list of 20 categories that correspond to the actual use of the chemical substance they are 

reporting. 

3.8.1 Revise Consumer and Commercial Product Categories 

EPA is proposing to revise the list of consumer and commercial product categories by combining 

categories that lead to common exposure scenarios and adding categories that were not adequately 

described in the initial set of categories. EPA worked with Environment Canada and Health Canada to 

develop the proposed categories. The proposed list includes 33 product categories, including “Other.” 

Examples of new categories which have been added include explosive materials, building/ construction 

products not covered elsewhere, and air care products. An example of a deleted category is glass and 

ceramic products, which had relatively few IUR submissions in 2006 and which overlaps with new 

categories. Also, several of the consumer and commercial product categories have been renamed to better 

describe the uses that should be reported in those categories. See Appendix D of this report for a list of 

the new categories. 

3.8.2 Designation of Consumer or Commercial Use 

EPA is proposing to require submitters to designate via a checkbox whether the use is a consumer or 

a commercial use, or both. The Agency’s experience using the 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 that submitters report the total number of workers, including those at 

sites not under the submitter’s control, that are reasonably likely to be exposed while using the reportable 

chemical substance, with respect to each commercial use. The approximate number of workers would be 
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reported using the same definitions and ranges used for manufacturing and industrial processing and use 

workers, required by 40 CFR 710.52. The proposed 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 workers, 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 both the industrial processing and uses, and 

consumer and commercial uses of chemicals, EPA is proposing to replace the “readily obtainable” 

reporting standard that was used for the 2006 IUR with a “known to or reasonably ascertainable by” 

reporting standard. TSCA section 8(a)(2) authorizes EPA to require persons to report information that is 

known to or reasonably ascertainable by the submitter. For the purposes of reporting under the IUR rule, a 

submitter would report information described in the regulatory text at §710.52(c)(1), (c)(2), and (c)(3) 

that is known to or reasonably ascertainable by the submitter. This means all information in a person’s 

possession or control, plus all information that a 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 purposes prior to the 2006 IUR. 

EPA is proposing this change because reporting under the “readily obtainable” reporting standard did 

not generate sufficiently complete processing and use information. EPA believes the “readily obtainable” 

reporting standard limited the usefulness of the 2006 IUR data for screening level reviews. 

3.10 Modifications to Confidential Business Information (CBI) Claims 

Submitters may currently claim certain information reported under the IUR as confidential business 

information (CBI) in accordance with 40 CFR part 2 and IUR rules at §710.38 (proposed 40 CFR 

711.18). Submitters must assert claims of confidentiality at the time information is submitted to EPA. 

EPA’s procedures for handling information claimed as confidential are set forth at 40 CFR part 2, subpart 

B. 

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 confidentiality claims have 

been asserted. EPA expects that 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 improve the timeliness of its public availability. As 

a result, the Agency would be able to publicly discuss and explain its risk management actions and 

decisions more clearly. 

3.10.1 Chemical Identity CBI Claims 

Under the IUR, a submitter may assert a claim of confidentiality for data associated with the identity 

of the reported chemical substance when the chemical is listed on the confidential portion of the Master 

Inventory File and when the submitter provides the required substantiation at the time the submitter 

makes the confidentiality assertion. See 40 CFR 710.58(b) (proposed 40 CFR 711.18(b)). At times a 

submitter will assert a claim of confidentiality for the chemical identity of a substance that is listed on the 

public portion of the Master Inventory File. EPA is proposing that, when this occurs, the Agency may 

make the information available to the public without further notice to the submitter. See the proposed 

regulatory text at 40 CFR 711.18(e). 
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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 that release of the information 

would reveal trade secrets or confidential commercial or financial information, as provided by section 14 

of TSCA and 40 CFR part 2. During the 2006 IUR, submitters made confidentiality claims for 25 to 50 

percent of the reported processing and use information. While the Agency does not question that 

confidentiality claims are sometimes necessary, it encourages submitters to consider carefully whether 

such claims are in fact necessary before asserting them. The Agency has identified instances in which 

submitters have claimed the processing and use data as confidential, yet similar if not identical 

information was found in publicly available sources, such as company websites, published Material 

Safety Data Sheets (MSDSs), or information submitted to the Agency and posted on the Agency’s HPVIS 

website. 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 submitter would be required to both check the appropriate box on the 

reporting form and substantiate the claim in writing by answering certain questions provided in the 

proposed rule. Where a submitter fails to substantiate the processing and use CBI claim in accordance 

with the applicable requirements, EPA would consider the information not subject to a confidentiality 

claim and may make the information available to the public without further notice to the submitter. 

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

Reasonably Ascertainable” 

Under the proposed amendments, submitters would be unable to enter a claim of confidentiality if 

“not known or reasonably ascertainable” is selected for the industrial processing and use or consumer and 

commercial use information. In the 2006 IUR collection, submitters reported the processing and use 

information to the extent that it was readily obtainable, and were permitted to identify when such 

information was not readily obtainable by entering “NRO.” EPA has considered the NRO designation and 

its relationship to a potential CBI or trade secret claim. Given that an NRO assertion is an assertion that 

no information is available, the Agency does not believe that the designation conveys trade secret or 

confidential commercial or financial information. For this reason, EPA is proposing to prohibit claims of 

confidentiality pertaining to the designation that information is not “known to or reasonably 

ascertainable” by the submitter. 

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 submissions could be completed on paper or electronic media 

(i.e., as a file on a CD) and delivered by mail or a delivery service. Approximately one-third of the 

submissions were made electronically, and EPA was 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-IUR) to 

complete the IUR Form U and the Central Data Exchange (CDX) to submit the completed Form U to the 

Agency. CDX users are required to register with CDX and to submit an authorized signature agreement. 
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3.11.1 Updated e-IUR Reporting Software

EPA developed e-IUR reporting software for use in preparing and submitting reports electronically 

during the 2006 IUR reporting cycle (see www.epa.gov/iur). The 2011 e-IUR software features several 

enhancements over the 2006 e-IUR software, such as a sophisticated validation system, which would alert 

users when a required field on the form is either missing information or contains certain kinds of 

potentially incorrect information. Other updates are expected to include automated chemical identity 

checks, automated company and site identity checks, and the facilitation of joint submissions and 

amendments. For the 2011 e-IUR, EPA also is considering a free web-based application in place of, or in 

addition to, free downloadable software. 

3.11.2 Require Electronic Submissions over the Internet 

EPA is proposing to require that manufacturers (including importers) submit their IUR reports to the 

Agency through CDX via the Internet. EPA would require that all submissions be generated using e-IUR 

reporting software. Electronic submissions would ensure that IUR data will have completed a basic 

validation check, could be incorporated quickly into a database and ready for immediate Agency use, and 

would not be subject to subsequent data entry errors. Furthermore, EPA believes the required use of eIUR and CDX would reduce the reporting burden on industry by reducing both the cost and the time 

required to review, edit and transmit data to the 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

Each IUR submission must have an authorized official, who is the person signing the certification 

statement and submitting the IUR report via CDX, associated with the submission. During the 2006 IUR, 

submitters were required to complete an electronic signature agreement (ESA) and to submit the 

agreement in hard copy with a wet ink signature to EPA in order to complete the CDX registration. For 

2011 IUR reports, EPA is modifying the 2006 ESA to identify more clearly the individual(s) required to 

sign the agreement. To register in CDX, the CDX registrant (also referred to as “Electronic Signature 

Holder”) would download two forms: the Electronic Signature Agreement and the Verification of 

Authorization. For authentication of identity, the registrant would complete the ESA, sign and date it, 

have the form notarized, and mail it to EPA. The Verification of Authorization form requires the signature 

of an immediate supervisor or witnessing official verifying that the registrant is the person who should 

sign their name in the certification statement box on Form U. Once both forms are received, EPA would 

activate the registrant’s CDX account and send a notification via email. 

EPA is requesting comment in this proposal on possible ways to streamline the ESA and CDX 

registration process, and on allowing multiple individuals complete an ESA. Reporting sites may need or 

desire to have more than one individual complete an electronic signature agreement, so that other 

individuals can add information to an original IUR submission. Persons submitting supplemental 

information for an IUR submission on behalf of a company would need to register with CDX by signing 

an ESA and Verification of Supplemental Submitter form. The Verification of Supplemental Submitter 

form requires the signature of an immediate supervisor or witnessing official from the company and 

anyone he/she authorizes to submit additional information. The company official can have the agreement 

with an unlimited number of supplemental submitters, but will have to complete a form for each 

supplemental submitter. Supplemental submitters can work with an unlimited number of company 

officials, but will need an agreement with each company official (even if the company officials work at 

the same company). A supplemental submitter may be a paid employee of the company, an outside 

consultant for the company, or an authorized representative agent for the company. While this individual 

would not be able to sign the certification statement required for the initial IUR submission, he or she 

would be able to provide additional information, if needed, using CDX. For 2006 and prior IUR 

submissions, submitters were not able to provide additional information electronically. 
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3.12 Modifications Specifically Affecting Importers 

Submitters report IUR data on chemicals that they manufacture domestically and that they import into 

the United States. Current IUR regulations require that the site responsible for reporting for imported 

chemicals is the site of the operating unit that is directly responsible for importing the substance and that 

controls the import transaction. In some cases, the import site may be the organization’s headquarters in 

the United States. The regulations defining the site 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 site from §710.48(b) into a revised definition for site, and 

eliminating paragraph §710.48(b). 

In addition, EPA has observed that submitters occasionally use a foreign address as the site address 

for the importer. EPA now is proposing to require that submitters report a U.S. site address, by modifying 

the definition for site to state specifically that the site must be a U.S. site. The U.S. address of an agent 

acting on behalf of the importer, and authorized to accept service of process for the importer, may be 

reported as the importer’s site address if the operating unit that is directly responsible for importing the 

substance and that controls the import transaction has no U.S. address. The Agency expects that all 

importers will have a U.S. site, as defined in the proposed § 711.3 definition for site because, under 

Customs regulations at §141.18, a non-resident corporation is not permitted to enter merchandise for 

consumption unless it has a resident agent in the State where the port of entry is located, who is 

authorized to accept service of process against the corporation. 

For purposes of IUR, currently submitters are allowed to report the IUR information jointly with the 

foreign manufacturer of the chemical. Importers may not know the specific chemical identity of a 

substance because the foreign supplier chooses to keep it confidential. In such a situation, the importer is 

still responsible for ensuring that the IUR information is submitted to EPA and may do so by submitting a 

joint report. To do so, the U.S. importer, as the primary submitter, completes the majority of the required 

information, but supplies a trade name or other designation to identify the chemical substance. In 

addition, the primary submitter provides technical contact information for the foreign supplier. The 

primary submitter then contacts the foreign supplier, as the secondary submitter, to notify it of the need to 

report the specific chemical identity information to EPA. In addition to the chemical identity, the 

secondary submitter supplies its technical contact and company information but provides the primary 

submitter’s site information. The secondary submitter 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 that submitters would be required to 

use CDX and e-IUR for preparation and submission of joint submissions. Previously, joint submissions 

could not be made electronically. In order to submit electronically to EPA via CDX, individuals must first 

register with CDX. Therefore, the authorized officials of the jointly submitting companies would need to 

register in order to submit their reports to EPA. The secondary submitter (e.g., a foreign supplier or 

manufacturer) would have to register as someone authorized by the primary submitter’s (e.g., the 

importer’s) authorized official to send joint submissions to EPA. 

For joint submissions to be submitted electronically, the primary submitter would use e-IUR to 

identify the need to submit a joint report and would identify itself as a primary submitter. The primary 

submitter would then complete his or her portion of the report and provide the secondary submitter's 

company information, along with select information on the chemical substance(s) that are manufactured 

using a chemical substance made by the secondary submitter. The primary submitter reports only the 

volume that it used. A secondary submitter would also need to use e-IUR to identify the need to submit a 

joint report and would identify itself as a secondary submitter. It would provide the primary submitter’s 

company information and its own technical contact information, and would identify the chemical 

substance(s) that is in its product, including the percentages. This information would be saved by the 
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reporting tool and both submissions would be matched based upon company and chemical information. 

Once the forms are matched, the joint submission would be ready to be processed by EPA. The Agency is 

currently developing the process to submit joint reports electronically and welcomes any comments 

concerning this process. 

For the 2006 IUR reporting cycle, EPA set aside joint submissions until both were received and 

matched. Oftentimes, EPA had no way to determine whether a submission was a “joint” submission, 

which increased the time required for manual processing of the data. EPA anticipates that the use of the 

reporting tool will help to make joint IUR reporting easier for industry and streamline EPA processing of 

the IUR information submitted in the 2011 reporting cycle. 

3.13 Modify Reporting Frequency 

Prior to the 2003 Amendments, the IUR collection occurred every four years. EPA reduced the 

reporting frequency from every four years to every five years starting with the 2006 IUR to reduce the 

burden associated with the amended IUR. The Agency now has determined that reporting every five years 

is too infrequent, and is proposing to return to reporting every four years. 

While the less frequent reporting does reduce burden, EPA now believes that reporting every five 

years does not provide data sufficiently current to meet Agency and public needs. The Agency has been 

criticized for using outdated information. EPA, therefore, is considering increasing the frequency of 

reporting to every three years, or possibly to annual reporting. The Agency believes that efficiencies are 

gained with more frequent reporting, both for the submitter and for EPA. With more frequent reporting, 

companies would be able to establish standard systems and practices to collect the required information.
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4. Industry Burden and Cost Estimates 

4.1 Methodology for Compliance Cost and Burden Analysis 

This chapter analyzes the changes in industry compliance burden and cost associated with the 

proposed amendments to the IUR rule. EPA calculates the incremental burden and cost, or savings, of the 

amendments by comparing the burden and cost of complying with the proposed amendments to the 

burden and cost that industry would incur to comply with current IUR requirements in the 2011 reporting 

cycle absent the amendments (the baseline). The methodology for estimating the change in industry 

burden and cost can be summarized as follows: 

 Step 1: Identify the tasks that sites perform to comply with reporting requirements for both the 

current IUR requirements and the proposed IUR amendments. 

 Step 2: Determine the unit burden and cost for all activities 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 and reports filed under both the current IUR 

requirements and the proposed IUR amendments. 

 Step 4: Multiply the burden and cost per form by the 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 after the proposed IUR amendments from the burden 

and cost under the current IUR requirements to calculate the incremental additional burden and cost 

or savings attributable to the amendments. 

A chemical company may own many sites; each of which may manufacture (including import) 

multiple chemicals. Each site must submit a Form U if it exceeds the 25,000 lb. threshold for at least one 

chemical that is not exempt from reporting. A site will submit one Form U Part I, and either a full or 

partial report for each chemical that meets or exceeds the reporting threshold. 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 that do not fall 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 determination 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 requirements and reviewing information to determine 

whether the site must submit a Form U. 

 Rule Familiarization: Once a site has determined that it must submit a Form U, staff must 

familiarize themselves with the requirements of the rule. Sites that reported previously must become 

familiar with new requirements, and sites new to reporting must become familiar with all 

requirements. This entails reading the rule, understanding the various reporting and administrative 

requirements, and determining the manner in which the reporting requirements will be met. 

 Preparation and Submission of Reports: Once a site has determined that it must submit a Form U 

for a chemical and has become familiar with the 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 and clerical burden), managerial review, and any 

mailing or other submission costs. 
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 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 describes 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 developed 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 respectively. Wage data for the three occupational categories was gathered 

for manufacturing industries from Employer Costs for Employee Compensation Supplementary Tables: 

Historical Data December 2006 – December 2008 (BLS, 2009).

Fringe benefits costs, such as health insurance and vacation, for each labor category are taken from 

the same ECEC series. Following the methodology outlined in (EPA, 2002b), fringe benefits are 

calculated as a percentage of total wages for each 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 categories were then multiplied 

by benefits and overhead factors to estimate loaded, annual salaries in 2008 dollars. Table 4-1 contains 

the loaded wage rates for the managerial, technical and clerical occupation categories. 

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

Wage1

Fringe 

Benefits1

Fringes as 

% of Wage

Overhead % 

of Wage2

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 Analysis 

for the Amended Inventory Update Rule: Final Report (EPA, 2002a).
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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 whether it must comply with the IUR rule. Sites that are 

required 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 information required in Part I, such as site and company 

identification, are common to all chemicals produced at a single site; therefore, this information need only 

be reported once. For each reportable chemical, a site must prepare and submit Part II and, if applicable, 

Part III of Form U. For the purpose of this analysis, a “report” can be either a partial report (Parts I and II 

of Form U) or a full report (Parts I, II, and III of Form U), submitted for one chemical. Submission costs, 

in the baseline, consist of mailing costs, and are calculated per-site. Recordkeeping costs are calculated as 

per-report costs (so that total reporting 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 

 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 Amendments (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 determination, 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 

were no longer required to report use and downstream 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 burden estimates, per site, to 

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

 

3

 In the 2005 economic analysis, EPA estimated that 15 percent of the production 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. 
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Table 4-2: Baseline First-Cycle Labor Burden per Form U, in Hours 

Clerical 

Burden 

Technical 

Burden 

Managerial 

Burden 

Form U Section and Activity 

(a) (b) (c) 

Compliance Determination (Total Burden for Form U Compliance Determination) 0.00 2.50 0.00 Rule Familiarization  (Total Burden for Form U Submission) 0.00 19.00 9.00 Recordkeeping (Total Burden for Form U Recordkeeping) 1.50 3.00 1.50 Submission (Total Burden for Form U Submission) 0.00 0.00 0.00 

 Mailing Burden 0.00 0.00 0.00 Part I. Site Identification Information (Total Burden for Part I) 0.76 0.95 1.05 1 Certification 0.68 0.85 1.01 2 Company Information 

Company Name, Technical Contact, Address, D&B Number, Mailing Address 0.04 0.04 0.02 

3 Plant Site Identification 

Plant Name, D&B Number Address, Mailing Address 0.05 0.06 0.02 

Part II. Manufacturing Information (Total Burden for Part II) 1.55 8.78 3.49 1 Chemical Identification 2 (Other) Manufacturing Information  Site-Limited, Activity, Production Volume (lb.) 0.52 2.28 0.56 

Chemical Identification Up-front CBI Substantiation 0.26 1.45 0.67 

 Plant Site Up-Front Substantiation 0.12 0.83 0.51 
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Clerical 

Burden 

Technical 

Burden 

Managerial 

Burden 

Form U Section and Activity 

(a) (b) (c) 

 Total Number of Workers 0.21 1.43 0.59 

Maximum Concentration, Physical Form, Percent Volume of Production 0.44 2.79 1.07 

Part III Processing and Use Information (Total Burden for Part III) 7.94 45.31 16.66 1 Industrial Processing and Use Exposure-Related Data  Determination of Applicability 0.13 1.01 0.28  Industrial Function Category 2.11 4.41 2.07  Function Code 0.19 0.94 0.40  Percent of Production Volume 1.23 10.00 5.27  Total Number of Processing and Use Sites 1.57 9.14 3.52  Total Number of Potentially Exposed Workers 2.10 15.43 3.83 2 Consumer and Commercial Use Exposure-Related Data  Determination of Applicability 0.14 0.94 0.25 

Identification of Production Category/Use by Children 0.14 0.84 0.25 

 Percent of Production Volume 0.20 1.26 0.45  Maximum Concentration by Category 0.11 1.36 0.34 Total Burden for Report Preparation and Submission Partial Report (Parts I, II, Recordkeeping and Submission Burden) 3.81 34.23 15.04 Full Report (Parts I, II, III, Recordkeeping and Submission Burden) 11.74 79.54 31.70 Note: Totals may not sum due to rounding. Source: Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).
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The survey conducted for the economic analysis for the Final TSCA Inventory Reporting rule 2003 

Amendments (EPA, 2002a) estimated a single burden for reporting site-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 whether the volume is site-limited volume; 

 Indicating whether the chemical is manufactured or imported; 

 Providing the manufactured production volume; and 

 Providing the imported production volume. 

Several of the proposed amendments are expected to create burdens similar to one of the above 

activities, but none are expected to generate a burden equivalent to all four questions combined. To more 

accurately estimate the burden of several proposed amendments, EPA used its best professional judgment 

and estimated the percent burden each activity 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 sitelimited volume 5% 0.17 

Indicating whether the chemical is manufactured or imported 5% 0.17 

Providing the manufactured production volume 45% 1.51 

Providing the imported production volume 45% 1.51 

Total 100% 3.36 

4.2.3 Estimates of Submission (Mailing) Costs 

As noted above, the baseline scenario in this analysis is the total cost that a site would incur to 

comply with the current IUR rule, absent any of the proposed amendments. Therefore, the Agency 

estimated the cost of a mail-in submission of Form U, using data from the United States Postal Service 

website. Following the mailing requirements outlined in the Economic Analysis of Expedited Significant 

New Use Rules for 56 Chemical Substances (EPA, 2008b), a mail-in submission is assumed to consist of 

mailing a document via first class registered mail with a return receipt. The cost is estimated to be $13.78 

per report and is itemized in Table 4-4. 

Table 4-4: Mailing Submission Costs (December, 2009) 

USPS Service Cost (2008$) 

Registered mail, regular, with $0 declared value1 $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 ounce2 $0.88 

Total $13.78 

Source: USPS, 2009 
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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 Section 4.2.3. The burden hours for each occupation category are multiplied by the 

corresponding wage rate to calculate the baseline cost per site of completing each section of Form U. EPA 

estimates the total cost per site of submitting and completing a partial report (Parts I, II, recordkeeping 

and submission costs) for the first time is $3,188. EPA estimated the cost to a site of submitting and 

completing a full report (Parts I, II, III, recordkeeping and submission costs) for the first time is $7,247, 

for one chemical. Table 4-5 contains the submission costs by section for first-time submitters, including 

the costs for compliance determination, rule familiarization, report preparation, report submission, and 

recordkeeping costs. 
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Table 4-5: Baseline Total Cost per Form U (2008$) 

Clerical Cost Technical Cost Managerial C

Form U Section and Activity (a) (b) (c) 

Compliance Determination (Total Burden for Form U Compliance Determination) $0.00 $147 $0.00 Rule Familiarization  (Total Burden for Form U Submission) $0.00 $1,118 $630 Recordkeeping (Total Cost for Form U Recordkeeping) $42.72 $177 $104 Submission (Total Cost for Form U Submission) 

 Mailing Cost Part I. Site Identification Information (Total Cost for Part I) $21.50 $54.08 $73.53 1 Certification $19.22 $50.01 $70.73 2 Company Information 

Company Name, Contact, Address , D&B Number, Mailing Address $1.00 $2.35 $1.40 

3 Plant Site Identification 

Plant Name, D&B Number Address, Mailing Address $1.28 $1.71 $1.40 

Part II. Manufacturing Information (Total Burden for Part II) $44.14 $516.61 $244.40 1 Chemical Identification 2 (Other) Manufacturing Information  Site-Limited, Activity, Production Volume (lb.) $14.81 $134.15 $39.22 

Chemical Identification Up-front CBI Substantiation $7.40 $85.32 $53.57 
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Clerical Cost Technical Cost Managerial C

Form U Section and Activity (a) (b) (c) 

 Plant Site Up-front Substantiation $3.42 $48.84 $35.57  Total Number of Workers $5.98 $84.14 $40.97 

Maximum Concentration, Physical Form, Percent Volume of Production $12.53 $164.16 $74.93 

Part III Processing and Use Information (Total Cost for Part III) $226.08 $2,666 $1,167 1 Industrial Processing and Use Exposure-Related Data  Determination of Applicability $3.63 $59.27 $19.94  Industrial Function Category $60.15 $259.57 $144.64  Function Code $5.33 $55.01 $27.68  Percent of Production Volume $35.10 $588.41 $369.34  Total Number of Processing and Use Sites $44.78 $537.89 $246.72  Total Number of Potentially Exposed Workers $59.91 $907.74 $268.15 2 Consumer and Commercial Use Exposure-Related Data  Determination of Applicability $4.11 $55.01 $17.56 

Identification of Production Category/Use by Children $4.11 $49.26 $17.56 

 Percent of Production Volume $5.81 $74.02 $31.55  Maximum Concentration by Category $3.15 $80.02 $24.11 Total Cost for Report Preparation and Submission Partial Report (Parts I, II, Recordkeeping and Submission Costs) $108 $2,012 $1,053 Full Report (Parts I, II, III, Recordkeeping and Submission Costs) $334 $4,678 $2,220 Note: Totals may not sum due to rounding. Source: Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).
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4.2.5 Estimates of the Number of Sites and Reports 

The baseline number of reports EPA is expecting, and the number of sites submitting those reports, 

were calculated based on 2006 IUR submissions to EPA. The total number of reports is broken down into 

sites that filed full reports and sites that filed partial reports, because of the difference in cost between the 

two types of reports. The number of reports EPA is expecting was estimated using data compiled from 

EPA’s 2006 IUR Database (EPA, 2008c). The database contains information collected under the IUR rule 

for previous reporting cycles and was used to generate estimated numbers of expected reports. The 

Agency assumes that because of the low company 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 purposes of this analysis EPA assumes that the baseline 

number of reports submitted will not change from the 2006 submissions. In 2006, a total of 4,085 sites 

completed 25,896 forms as shown in Table 4-6 

Table 4-6: Baseline Number of Reports and Sites 

Number of 

 Partial Reports 

Number of 

 Full Reports Total 

Number of Sites 568 3,517 4,085 

Number of Reports 8,821 17,075 25,896 

Source: U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division 

2006 IUR Database Statistics for IUR Modifications Rule. Washington, DC. December 17, 2008 

(EPA, 2008c). 

Limitations of Analysis. Due to inconsistencies and limitations in the data collected in 2002 and 

2006, including the amendment requiring reports for inorganic chemicals for the first time in 2006 and the 

change in the reporting threshold from 10,000 to 25,000 lb., it was not possible for EPA to compare 

records to determine whether there was a significant change in the number of sites and reports submitted 

for a consistent set of chemicals between the two reporting cycles. Such an analysis potentially could 

provide support for EPA’s assumption that the number of sites and reports will remain relatively 

unchanged in the next reporting cycle. Therefore, to the extent that changes in the chemical industry 

unrelated to the proposed IUR rule amendments could affect the number of site and reports submitted, 

this analysis may under- or overestimate costs and burden. 

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

EPA assumes that sites that previously have submitted a Form U will have less of a burden for 

processing and submitting Form U in future reporting cycles. All sites will incur a higher reporting cost in 

the first reporting cycle after the rule amendments are finalized, due to an increase in burden to become 

familiar with the revised requirements. However, the Agency assumes that unit costs for report 

preparation and submission in future reporting cycles will be lower than the unit costs attributed to 

reporting in the first reporting cycle because of efficiencies achieved through the establishment of 

compliance processes (EPA, 2002a). Furthermore, after a site’s first reporting cycle, the availability of 

data from previous reporting cycles and familiarity with reporting requirements will expedite the process 

for submitters who have previously submitted a Form U. The burden estimates for these sites are 

weighted to reflect this decreased burden (EPA, 2002a). Table 4-7 contains the weighting factors for each 

section of the form. Table 4-8 contains the baseline, future reporting cycle, per report burden estimates, 

which are calculated using the weights in Table 4-7 and the first reporting cycle burden estimates in Table 

4-2. Table 4-9 contains the baseline future reporting cycle costs per report, which are calculated using the 

wage rate in Table 4-1 and the hourly burden estimates from Table 4-8. 
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Table 4-7: Weighting Factors for Burden Estimates for Sites That Have Previously Submitted a 

Form U 

Section of Form U Incurred Percent of Initial 

Burden1 

Part I. Site Identification 

 Certification 100% 

Section A Company Information 20% 

Section B Plant Site Identification 20% 

Section C Technical Contact 20% 

Part II. Manufacturing Information 

Section A Chemical Identification 20% 

Section B (Other) Manufacturing Information 80% 

Part III. Processing and Use Information 

Section A Industrial Processing and Use 

Exposure Related Data 80% 

Section B Industrial Processing and Use 

Exposure Related Data 80% 

1

 Weighting factors are from the Revised Economic Analysis for the Amended Inventory Update Rule: 

Final Report (EPA, 2002a), pp. 3-17. 
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Table 4-8: Baseline Future-Cycle Labor Burden per Report, in Hours 

Clerical 

Burden 

Technical 

Burden 

Managerial 

Burden 

Form U Section and Activity 

(a) (b) (c) 

Compliance Determination (Total Burden for Form U Compliance Determination) 0.00 2.50 0.00 Rule Familiarization  (Total Burden for Form U Submission) 0.00 2.00 2.00 Recordkeeping (Total Burden for Form U Recordkeeping) 1.50 3.00 1.50 Submission (Total Burden for Form U Submission) 0.00 0.00 0.00 

 Mailing Burden 0.00 0.00 0.00 Part I. Site Identification Information (Total Burden for Part I) 0.69 0.87 1.02 1 Certification 0.68 0.85 1.01 2 Company Information 

Company Name, Technical Contact, Address, D&B Number, Mailing Address 0.01 0.01 0.00 

3 Plant Site Identification 

Plant Name, D&B Number Address, Mailing Address 0.01 0.01 0.00 

Part II. Manufacturing Information (Total Burden for Part II) 1.24 7.02 2.79 1 Chemical Identification 2 (Other) Manufacturing Information  Site Limited, Activity, Production Volume (lbs) 0.42 1.82 0.45 

Chemical Identification Up-front CBI Substantiation 0.21 1.16 0.61 
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Clerical 

Burden 

Technical 

Burden 

Managerial 

Burden 

Form U Section and Activity 

(a) (b) (c) 

 Plant Site Up-front Substantiation 0.10 0.66 0.41  Total Number of Workers 0.17 1.14 0.47 

Maximum Concentration, Physical Form, Percent Volume of Production 0.35 2.23 0.86 

Part III Processing and Use Information (Total Burden for Part III) 6.35 36.25 13.33 1 Industrial Processing and Use Exposure-Related Data  Determination of Applicability 0.10 0.81 0.23  Industrial Function Category 1.69 3.53 1.65  Function Code 0.15 0.75 0.32  Percent of Production Volume 0.99 8.00 4.22  Total Number of Processing and Use Sites 1.26 7.31 2.82  Total Number of Potentially Exposed Workers 1.68 12.34 3.06 2 Consumer and Commercial Use Exposure-Related Data  Determination of Applicability 0.12 0.75 0.20 

Identification of Production Category/Use by Children 0.12 0.67 0.20 

 Percent of Production Volume 0.16 1.01 0.36  Maximum Concentration by Category 0.09 1.09 0.28 

Total Burden for Report Preparation and Submission 

Partial Form (Parts I, II, Recordkeeping and Submission Burden) 3.43 15.39 7.31 Full Form (Parts I, II, III, Recordkeeping and Submission Burden) 9.78 51.64 20.64 Note: Totals may not sum due to rounding. 
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Table 4-9: Baseline Future-Cycle Total Cost per Report (2008$) 

Clerical Cost Technical Cost Managerial C

Form U Section and Activity (a) (b) (c) 

Compliance Determination (Total Burden for Form U Compliance Determination) $0.00 $147 $0.00 Rule Familiarization  (Total Burden for Form U Submission) $0.00 $118 $140 Recordkeeping and Submission Costs (Total Cost for Form U Recordkeeping) $42.72 $176.52 $105.04 Submission (Total Burden for Form U Submission) 

 Mailing Cost Part I. Site Identification Information (Total Burden for Part I) $19.68 $51.19 $71.29 1 Certification $19.22 $50.01 $70.73 2 Company Information 

Company Name, Technical Contact, Address, D&B Number, Mailing Address $0.20 $0.47 $0.28 

3 Plant Site Identification 

Plant Name, D&B Number Address, Mailing Address $0.26 $0.71 $0.28 

Part II. Manufacturing Information (Total Burden for Part II) $35.31 $413.29 $195.52 1 Chemical Identification 2 (Other) Manufacturing Information  Site Limited, Activity, Production Volume (lbs) $11.85 $107.32 $31.37 

Chemical Identification Up-front CBI Substantiation $5.92 $68.25 $42.86 
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Clerical Cost Technical Cost Managerial C

Form U Section and Activity (a) (b) (c) 

 Plant Site Up-front Substantiation $2.73 $39.07 $28.57  Total Number of Workers $4.78 $67.31 $32.77 

Maximum Concentration, Physical Form, Percent Volume of Production $10.02 $131.33 $59.94 

Part III Processing and Use Information (Total Burden for Part III) $180.87 $2,132.97 $933.56 1 Industrial Processing and Use Exposure-Related Data  Determination of Applicability $2.90 $47.41 $15.95  Industrial Function Category $48.12 $207.66 $115.71  Function Code $4.26 $44.01 $22.14  Percent of Production Volume $28.08 $470.73 $295.47 

Total Number of Processing and Use Sites $35.82 $430.32 $197.38 Total Number of Potentially Exposed Workers $47.93 $726.19 $214.52 

2 Consumer and Commercial Use Exposure-Related Data  Determination of Applicability $3.29 $44.01 $14.05 

Identification of Production Code/Use by Children $3.29 $39.41 $13.81 

 Percent of Production Volume $4.65 $59.22 $25.24 

Maximum Concentration by Category $2.52 $64.02 $19.29 

Total Cost for Report Preparation and Submission 

Partial Form (Parts I, II, Recordkeeping and Submission Costs) $97.71 $906 $512 Full Form (Parts I, II, III, Recordkeeping and Submission Costs) $279 $3,039 $1,446 Note: Totals may not sum due to rounding. 
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4.3 Total Baseline IUR Industry Compliance Burden and Costs 

The estimated wage rates, burden hours, and number 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 completing 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 industry under the current baseline. The current IUR rule 

would cost industry approximately 1.84 million hours and $106.97 million during the 2011 reporting 

cycle. 

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

Burden for all 

Part Is, Rule 

Familiarization, 

Compliance 

Determination 

and Submission 

Burden for all 

Part IIs and 

Recordkeeping 

Burden for all 

Part IIIs 

Total Burden Under 

the Current IUR 

Requirements 

Burden in Hours 135,847 513,259 1,193,829 1,842,934 

Cost (2008$) $8,407,651 $29,247,454 $69,311,707 $106,966,812 

Table 4-11 contains the total annual baseline costs to industry for future reporting cycles – that is, the 

burden and cost to industry for reporting cycles after 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 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 in Table 4-2 and Table 4-5. In all future reporting cycles, 

EPA estimated the baseline burden to industry as approximately 1.43 million hours and $82.82 million. 

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

Burden for all 

Part Is, Rule 

Familiarization, 

Compliance 

Determination 

and Submission 

Burden for all 

Part IIs and 

Recordkeeping 

Burden for all 

Part IIIs 

Total Burden Under 

the Current IUR 

Requirements 

Burden in Hours 37,088 441,682 955,063 1,433,833

Cost (2008$) $2,290,736 $25,077,449 $55,449,366 $82,817,550

Limitations of Analysis. As described in Section 4.2.5, due to inconsistencies and limitations in the 

IUR data collected in 2002 and 2006, it was not possible for EPA to compare records to determine 

whether there was a significant change in the number of sites and reports submitted for a consistent set of 

chemicals between the two reporting cycles. Such an analysis potentially could provide support for EPA’s 

assumption that the number of sites and reports will remain relatively unchanged in the next reporting 

cycle. Therefore, to the extent that changes in the chemical industry unrelated to the proposed IUR rule 
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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 sections below, the burden estimates for each amendment are calculated independently 

of the other amendments. See Section 4.5 for an estimate of the aggregated impact of all proposed 

amendments. 

4.4.1 Technical Modifications to the Regulatory Text 

EPA is proposing to reorganize certain existing rule text and to delete obsolete text. These 

amendments do not substantively affect the rule text, so EPA assumes that this amendment will not affect 

industry burden or cost. 

4.4.2 Modifications to Selected Definitions 

EPA is proposing to modify the definitions of “importer,” “manufacture,” “site,” “commercial use,” 

“consumer use,” “reporting year,” and “submission period,” and to add definitions for “manufacturer,” 

“Central Data Exchange (CDX),” “electronic IUR (e-IUR),” and “industrial function,” as described in 

Section 3. These changes are clarifications only; EPA is clarifying in rule text what has been previously 

explained through outreach with the regulated community. Therefore, EPA does not expect changes to 

definitions to impact industry burden or cost.

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

Under the current IUR rule requirements, a submitter completes a report only if its chemical 

production has met or exceeded the 25,000 lb. production threshold during the principal reporting year. 

EPA is proposing to modify the timeframe for reporting, so that 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. 

EPA believes that this proposed amendment will cause an increase in the numbers of submitters and 

reports. Because data on the production volume of chemicals reportable under the IUR rule during nonprincipal reporting years is not currently available, the actual percentage increase in these numbers is 

unknown. The Agency, using its best professional judgment, estimates that for the purpose of this 

analysis the amendment will increase the number of submitters and reports 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 estimates that 204 additional sites will submit reports. EPA further 

estimates that those sites will submit an additional 854 full reports and 441 partial reports, for a total of 

1,295 additional reports for the 2011 reporting cycle and each future reporting cycle. 

As described in Section 4.1, sites need to complete Part I of Form U only once, and complete Part II 

and Part III (as applicable) for each chemical manufactured or imported. Taking this allocation of 

activities into consideration, and using the baseline unit burden estimates as shown above in Table 4-2 

and Table 4-8, Table 4-12 shows the industry burden estimate as a result of this proposed amendment. 

The Agency estimates that the amendment will generate an annual increase in industry burden of 

approximately 92,150 hours during the 2011 reporting cycle and approximately 71,700 hours during all 

future reporting cycles. 
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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 4,289 19.82 27,191 69.92 17,929 1,935,081 

Change from the 

Baseline, First Cycle 0.00 204 0.00 1,295 0.00 854 92,147 

Future Cycle Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833 

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 post-amendment value. 

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-13 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

the industry cost will increase by $5.35 million in the first reporting cycle and $4.14 million in all future 

reporting cycles. 
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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 4,289 $1,129 27,191 $4,059 17,929 $112.32 

Change from the 

Baseline, First Cycle $0 204 $0 1,295 $0 854 $5.35 

Future Cycle Baseline $561 4,085 $968 25,896 $3,247 17,075 $82.82 

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 post-amendment value.

Limitations of Analysis. To the extent that the change in method for determining whether a 

manufacturer is subject to the IUR reporting requirements causes an increase in numbers of sites and 

reports submitted that is higher or lower than five percent, this analysis may under- or overestimate total 

burden and cost increase. A sensitivity analysis is performed in Appendix F.1. 

In the proposal, EPA also requested comment on returning to the previous, lower reporting threshold 

of 10,000 lb. Appendix G. contains an analysis of the cost and burden of this lower threshold. 

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

EPA is proposing to eliminate the 300,000 lb. threshold for processing and use reporting, thereby 

requiring all reporters of non-excluded 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 sites submitting reports. The baseline number of partial 

reports submitted (that is, forms with only Part I and Part II completed) is 8,821 (see Table 4-6). 

However, several of these reports are submitted for partially exempt chemicals. Under the proposed 

amendment, submitters of partially exempt chemicals still will not be required to submit a Part III. In 

2006, EPA received a total of 618 partial reports (EPA, 2009a) on the 712 partially exempt chemicals 

(EPA, 2006a) currently on the partially exempt list. 

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-14 

shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that 

the amendment will cause an increase in industry burden of approximately 573,500 hours during the first 

reporting cycle, and 458,800 hours during all future reporting cycles. 
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Table 4-14: Change in Industry Burden as a Result 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 1,193,829 

First 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 17,075 955,063 

Future 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 

post-amendment value.

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-15 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

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 applies to each chemical produced at each individual 

reporting site, and was selected with the intention that exposure-related processing and use information 

would be collected for HPV chemicals. However, 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 that it would be best to eliminate the 300,000 lb. threshold altogether and 

collect full information for the all reported chemicals.

Table 4-15: Change in Industry Cost as a Result of Eliminating the 300,000 lb. Threshold for 

Downstream Processing and Use Information Reporting 

Cost per Report 

(Part III) 

(2008$) 

Number of Reports 

with Part III 

Total Industry Cost 

(millions 2008$) 

First Cycle, Baseline $4,059.25 17,075 $69.31 

First 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 $55.45 

Future 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 

post-amendment value.
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Limitations of Analysis. EPA is assuming that each partially exempt chemical is produced at four 

different sites. To the extent that this is not the case, this analysis may over- or underestimate the number 

of additional Part IIIs. 

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

EPA is proposing to eliminate the 25,000 lb. threshold for chemicals that are: (1) the subject of a 

regulation proposed or 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 and importers of these chemicals would be 

required to report under the IUR rule, regardless of the production volume. 

To determine how many chemicals this proposed amendment would affect, EPA referred to Appendix 

C of the Instructions for Reporting for the 2006 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 civil actions. A count of all the chemical substances, 

listed by CASRN, that are subject to a regulation proposed or promulgated under sections 5(a)(2), 5(b)(4), 

or 6 of the Act, subject of an order issued under section 5(e) or 5(f) of the Act, or the subject of relief that 

has been granted under a civil action under section 5 or 7 of the Act, identified 1,131 chemicals. CASRN 

numbers were provided for 740 of these chemicals, and an additional 391 chemicals were listed by 

accession numbers (EPA, 2006a). Of the 740 chemicals with CAS numbers, no reports were filed for 652 

chemicals, or 88 percent of chemicals (EPA, 2009e). EPA also assumes that no reports were filed for 88 

percent of the 391 chemicals with accession numbers, or 345 chemicals. In addition, Form Us were 

submitted voluntarily for eight chemicals with production volume levels below the 25,000 lb. threshold 

during the 2006 reporting cycle (EPA, 2009a). EPA estimates that reports will now be filed for 

approximately 1,005 additional chemicals for which reports are not currently required (652+345+8 = 

1,005). 

Based on the data provided in the 2006 IUR reporting cycle (EPA, 2008c), on average, each chemical 

is produced at approximately four sites; therefore, EPA expects 4,018 additional reports (Part IIs) to be 

submitted for these chemicals. The Agency also assumes that the reports generated by this amendment 

would be for production volumes lower than 25,000 lb. (therefore, lower than 300,000 lb.), so, as a result 

of this amendment alone, submitters would not be required to complete Part III (see Section 4.5 for an 

estimate of the aggregated impact of all proposed amendments). In addition, the Agency is assuming that 

manufacturers (including importers) of these chemicals already would be submitting reports for other 

non-exempt chemicals; so, therefore, the number of sites would not increase from the baseline as a result 

of this amendment. 

Using the baseline unit burden estimate for completion of Part II as shown above in Table 4-2 and 

Table 4-8, Table 4-16 presents the estimated increase in industry burden as a result of this proposed 

amendment. The Agency estimates that the amendment will cause an increase in industry burden of 

approximately 79,600 hours during the first reporting cycle and 68,500 hours during all future reporting 

cycles. 
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Table 4-16: Change in Industry Burden as a Result of Eliminating the 25,000 lb. Threshold for 

Certain Regulated Chemicals 

Burden for Recordkeeping 

and to Prepare Part II 

(hours per report) 

Number of 

Reports 

Industry Burden 

 (hours) 

First Cycle, Baseline 19.82 25,896 513,259 

First Cycle, Post-Amendment 19.82 29,914 592,896 

Change from the Baseline, First Cycle 0.00 4,018 79,637 

Future Cycle Baseline 17.06 25,896 441,682 

Future Cycle, Post-Amendment 17.06 29,914 510,213 

Change from the Baseline, Future 

Cycles 0.00 4,018 68,531 

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

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-17 shows the industry cost estimate as a result of this proposed amendment. The cost to industry 

is expected to increase by $4.54 million during the 2011 reporting cycle and $3.89 million during all 

future reporting cycles. 

Table 4-17: Change in Industry Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain 

Regulated Chemicals 

Cost for Recordkeeping 

and to Prepare Part II 

(2008$ per report) 

Number of 

Reports 

Industry Cost 

(millions 2008$) 

First Cycle, Baseline $1,129 25,896 $29.25 

First Cycle, Post-Amendment $1,129 29,914 $33.79 

Change from the Baseline, First Cycle $0 4,018 $4.54 

Future Cycle Baseline $968 25,896 $25.08 

Future Cycle, Post-Amendment $968 29,914 $28.97 

Change from the Baseline, Future 

Cycles $0 4,018 $3.89 

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

Limitations of Analysis. The number of additional reports EPA receives as a result of this amendment 

may be an overestimate to the extent that manufacturers (including importers) already are submitting 

reports for these chemicals. That is, to the extent that 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 result of the amendment. 

Furthermore, to the extent that manufacturers (including importers) of these chemicals do not already 

submit reports for other chemicals, EPA is underestimating the number of sites that would increase from 

the baseline as a result of this amendment. 

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

Exemptions 

Chemicals subject to enforceable consent agreements (ECAs) are of demonstrated interest to the 

Agency. For instance, EPA will use the IUR data associated with these regulated chemicals to monitor 

chemical production and compliance with the agreements. Therefore, EPA proposes to make these 

chemicals ineligible for reporting exemptions. Manufacturers (including importers) of these chemicals 

will no longer be partially exempt, and so must complete Part III of Form U. 
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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 under ECAs, and were never 

listed on the TSCA Inventory. Eliminating those six substances leaves a total of 61 chemicals subject to 

ECAs. 

EPA also maintains a table that shows the sunset date and status for chemicals subject to section 4 

actions, including ECAs (http://www.epa.gov/oppt/chemtest/pubs/sunset.html) (EPA, 2009g). Only two 

of the 61 chemicals were identified as being subject currently to an ongoing ECA. Therefore, only two 

chemicals will lose the partial exemption and under the proposed amendment, would need to complete 

Part III of Form U. In addition, EPA is assuming that an additional two chemicals could be under ECAs 

in future reporting cycles. Therefore, EPA is estimating that the proposed amendment would cause a total 

of four chemicals to complete Part III of Form U. Based on data from the 2006 IUR reporting cycle, the 

Agency estimates that approximately four sites produce each chemical (EPA, 2008c); therefore, a total of 

16 Part IIIs would be submitted for the first time for chemicals subject to an ECA. 

Using the baseline unit burden estimate for completion of Part III as shown above in Table 4-2 and 

Table 4-8, Table 4-18 shows the industry burden estimate as a result of this proposed amendment. The 

Agency estimates that the amendment will cause an increase in industry burden of approximately 1,110 

hours during the first reporting cycle, and 900 hours during all future reporting cycles. 

Table 4-18: Change in Industry Burden as Result of Making Chemicals Subject to ECAs Ineligible 

for Exemptions 

Burden per Report 

(Part III) 

(hours) 

Total Number of Reports 

with Part III 

Total Industry Burden 

(hours) 

First Cycle, 

Baseline 69.92 17,075 1,193,829 

First Cycle, PostAmendment 69.92 17,091 1,194,947 

Change from the 

Baseline, First 

Cycle 

0 16 1,119 

Future Cycle 

Baseline 55.93 17,075 955,063 

Future Cycle, PostAmendment 55.93 17,091 955,958 

Change from the 

Baseline, Future 

Cycles 

0 16 895 

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

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-19 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

the industry cost will increase by $64,900 during the 2011 reporting cycle and by approximately $52,000 

during all future reporting cycles. 
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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 $69,311,707 

First 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 $55,449,366 

Future Cycle, PostAmendment $3,247 17,091 $55,501,324 

Change from the Baseline, 

Future Cycles $0 16 $51,958 

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

Limitations of Analysis. EPA is assuming that each of these chemicals is produced at four different 

sites. To the extent that this is not the case, this analysis may over- or underestimate the number of 

additional Part IIIs. In addition, some of these chemicals may be produced in volumes of 300,000 lb. or 

greater, and therefore would already be required to submit a full report. To the extent that this is the case, 

this analysis overestimates the total number of additional Part IIIs. Finally, to the extent that 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 water is partially exempt from reporting; therefore, 

facilities that produce manufactured water only need to complete Parts I and II of Form U. The Agency is 

proposing to grant a full exemption for manufactured water. In 2006, a total of 43 partial reports were 

submitted for manufactured water (EPA, 2008c). EPA assumes that manufactured water is a byproduct of 

chemical production. Therefore, sites submitting a report for manufactured water will continue to submit 

reports for other chemicals. Thus the burden reduction for this proposed amendment would be the result 

of 43 fewer Part IIs being submitted. 

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-20 

shows the reduction in industry burden estimate as a result of this proposed amendment. The Agency 

estimates that the amendment will cause a decrease in industry burden of approximately 850 hours during 

the first reporting cycle, and by 700 hours during all future reporting cycles. 
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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 post-amendment 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 that the industry cost will decrease by approximately $48,600 in the first reporting cycle and 

$41,600 in all future reporting cycles. 

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

Cost for 

Recordkeeping and to 

Prepare Part II 

(2008$ per report) 

Number of 

Reports 

Total Industry 

Cost (2008$) 

First Cycle, Baseline $1,129 25,896 $29,247,454 

First Cycle, Post-Amendment $1,129 25,853 $29,198,889 

Change from the Baseline, First Cycle $0 -43 -$48,565 

Future Cycle Baseline $968 25,896 $25,077,449 

Future Cycle, Post-Amendment $968 25,853 $25,035,808 

Change from the Baseline, Future 

Cycles $0 -43 -$41,641 

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

the post-amendment value.

Limitations of Analysis. EPA is assuming that the sites producing manufactured water are also 

producing other chemicals above the reporting threshold, and will continue to submit a Form U, which 

may not be the case for all sites. In that case, the above estimate would underestimate the savings to the 

industry. 

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

EPA is proposing to amend the partially-exempt list of chemicals to remove three chemical 

substances: Starch (CASRN 9005-25-8), Dextrin (CASRN 9004-53-9), and Maltodextrin (CASRN 9049-

76-7). These chemicals, as polymers, are already fully exempt from reporting. EPA expects that this 

proposed amendment will not impact industry burden or costs, because these substances currently are 

fully exempt from reporting and therefore no submitters currently are required to submit reports for them. 

That is, this amendment is a clarification only and EPA assumes it will not change the behavior of the 

regulated community. 
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4.4.9 Parent Company and Site Identity 

EPA is proposing that submitters provide the name, address, and D&B number of their ultimate 

domestic parent company, as well as for the site. This information was required as part of Form U prior to 

the 2006 amendments, so the 2002 economic analysis, on which these burden estimates are based, already 

included the cost of providing the information for the ultimate domestic parent company. The proposed 

rule will now be consistent with the 2002 analysis, and EPA assumes that the burden estimate will not 

change from the baseline. Furthermore, for companies that already may not have a D&B number, there is 

no cost to obtain one. 

4.4.10 Technical Contact 

Manufacturers (including importers) are required to provide a technical contact for their IUR 

submission. EPA is proposing to amend the IUR rule to require that the technical contact be a person who 

works on-site, and is knowledgeable about the chemical. Because submitters already are required to 

identify a technical contact, EPA assumes that this amendment will not cause an increase in burden. 

4.4.11 Chemical Identity 

EPA is proposing to require that IUR submitters report the Chemical Abstracts (CA) Index Name 

currently used to list the substance in the Inventory. Currently, submitters are required to report a specific 

chemical name, with no further elaboration in the regulatory text. EPA is also proposing to allow 

submitters to report only the CASRN as a chemical identifying number or, in the case of confidential 

chemical substances, the accession number. Note that in cases where a CASRN exists for a confidential 

chemical, it can be reported instead of the accession number and claimed as confidential for purposes of 

the IUR submission. EPA is proposing to remove the PMN number as an allowed chemical identifying 

number because each Inventory substance has either or both a CASRN or a TSCA Accession Number, 

which are likely to be already known to the submitter. 

The Agency assumes that all manufacturers (including importers) know or can easily obtain the CA 

Index Names and CASRN numbers for the chemicals they produce. Therefore, EPA assumes that no 

additional burden will be incurred by requiring 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 that submitters report production 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 that 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 that 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 explanation of this percentage breakdown.) Therefore, the Agency estimates that a site would 

spend an additional 6.05 hours (i.e., 1.51 x 4) to 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 that the amendment will cause a total increase in industry burden of approximately 

156,600 hours in the first reporting cycle and 125,300 hours in all future reporting cycles. 
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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 post-amendment value.

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-23 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

the industry cost will increase by $8.77 million in the 2011 submission year and $7.02 million in all 

future reporting cycles. 

Table 4-23: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume 

in all Non-Principal Reporting Years 

Cost to Report 

Production 

Volume 

 (2008$ per 

report) 

Number 

of 

Reports 

Industry Cost 

(millions 2008$) 

First Cycle, Baseline $84.68 25,896 $2.19 

First Cycle, Post-Amendment $423.40 25,896 $10.96 

Change from the Baseline, First Cycle $338.72 0 $8.77 

Future Cycle Baseline $67.74 25,896 $1.75 

Future Cycle, Post-Amendment $338.72 25,896 $8.77 

Change from the Baseline, Future Cycles $270.98 0 $7.02 

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

from the post-amendment value.

Limitations of Analysis. This analysis is based on an assumption about the percentage breakdown of 

burden estimated to gather production volume and site-limited activity. To the extent that the actual 

burden is higher or lower than estimated, this analysis under- or overestimates the burden and cost of this 

amendment. 

4.4.13 Volume of Chemical Substance Used On-Site 

Previous Form U’s have required submitters to indicate whether a chemical was site-limited, referring 

to a chemical substance that is manufactured and/or processed only within a site and not distributed for 

commercial 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 example, a chemical produced as an end product. EPA is 

proposing the removal of the site-limited 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 production volume, given that the activities to identify the 
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necessary information are similar. EPA estimates that it will take a submitter 1.51 hours to provide the 

production volume (see Table 4-3). 

EPA expects an increase in the number of submitters who would report volume used on-site, due to 

the way that this information would be reported, under the amendment. In the data submitted to EPA for 

the 2006 reporting year, about 14.8 percent of reports include a site-limited volume (EPA 2008c); 

therefore, EPA assumes this is the minimum number of reports that would be affected. 

Site-limited chemicals are those that are not distributed (either as the chemical substance itself or in a 

mixture) outside the plant site for commercial purposes. Therefore, EPA assumes that all chemicals used 

on-site must be chemical intermediates. According 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 that 24 percent of all reports is the maximum 

percentage of reports that would be affected. Not all chemicals produced as intermediates are used onsite; they may be shipped for use at another site. EPA used 19.4 percent, which is the midpoint of 14.8 

percent and 24 percent, to estimate the increase in the number of reports with chemicals used on-site, i.e., 

5,024 reports. 

Table 4-24 shows the industry burden estimate as a result of this proposed amendment. The Agency 

estimates that the amendment will cause a total increase in industry burden of approximately 7,596 hours 

during the first reporting cycle and 6,077 hours during all future reporting cycles. 

Table 4-24: Change in Industry Burden as a Result of Requiring the Reporting of Production 

Volume Used On-Site 

Burden to Report 

Production Volume 

Used On-Site 

(hours) 

Number of Reports 

with Production 

Volume Used OnSite Information 

Total Industry 

Burden 

(hours) 

First Cycle, Baseline 0.00 0 0 

First Cycle, Post-Amendment 1.51 5,024 7,596 

Change from the Baseline, First Cycle 1.51 5,024 7,596 

Future Cycle Baseline 0.00 0 0 

Future Cycle, Post-Amendment 1.21 5,024 6,077 

Change from the Baseline, Future Cycles 1.21 5,024 6,077 

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

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-25 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

the total industry cost will increase by $425,400 during the first reporting cycle and $340,300 during all 

future reporting cycles. 
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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 Production 

Volume Used OnSite Information 

Total Industry 

Cost 

(2008$) 

First Cycle, Baseline $0.00 0 $0.00 

First Cycle, Post-Amendment $84.68 5,024 $425,416 

Change from the Baseline, First Cycle $84.68 5,024 $425,416 

Future Cycle Baseline $0.00 0 $0.00 

Future Cycle, Post-Amendment $67.74 5,024 $340,333 

Change from the Baseline, Future Cycles $67.74 5,024 $340,333 

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

Limitations of Analysis. To the extent that the burden of reporting the production volume used onsite is different from the burden to report the total production volume, this analysis may over- or 

underestimate the burden and cost of this amendment. Furthermore, to obtain the maximum number of 

reports that may be affected, EPA assumes that the percentage of reports containing downstream 

processing and use information that included chemicals used as intermediates would be the same as the 

percentage of all reports that include chemicals used as intermediates (that is, that the percentage of 

chemicals used as intermediates is consistent whether a submitter completed Part III or not.) To the extent 

that this is not the case, the analysis may over- or underestimate the number of reports affected. 

4.4.14 Indicate Whether Chemical Is Physically at Reporting Site

EPA is proposing to require submitters to indicate whether an imported chemical is physically at the 

reporting site. Under the current IUR requirements, a submitter must state if the site’s chemical is 

manufactured or imported. The Agency estimates that providing this information requires 0.17 hours per 

report (see Table 4-3). EPA assumes that the burden to indicate whether a chemical is physically on-site 

will be similar to the burden 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 estimates as a result of this proposed amendment. The Agency estimates that the amendment will 

cause a total increase in industry burden of approximately 4,351 hours for the 2011 reporting cycle, and 

3,480 for all future reporting cycles. 

Table 4-26: Change in Industry Burden as a Result of Indicating Whether a Chemical is Physically 

at Reporting Site 

Burden to Indicate 

Whether Chemical is at 

the Reporting Site 

(hours) 

Number of 

Reports 

Industry Burden 

(hours) 

First Cycle, Baseline 0.00 25,896 0 

First Cycle, Post-Amendment 0.17 25,896 4,351 

Change from the Baseline, First Cycle 0.17 0 4,351 

Future Cycle Baseline 0.00 25,896 0 

Future Cycle, Post-Amendment 0.13 25,896 3,480 

Change from the Baseline, Future Cycles 0.13 0 3,480 

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

post-amendment value.

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-27 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 
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the total industry cost will increase by approximately $243,700 in the first reporting cycle and $194,900 

in all future reporting cycles. 

Table 4-27: Change in Industry Cost as a Result of Indicating Whether a Chemical is Physically at 

Reporting Site 

Cost to Indicate 

Whether Chemical is 

Physically at Reporting 

Site (2008$) 

Number of 

Reports 

Industry Cost 

(2008$) 

First Cycle, Baseline $0.00 25,896 $0 

First Cycle, Post-Amendment $9.41 25,896 $243,652 

Change from the Baseline, First Cycle $9.41 0 $243,652 

Future Cycle Baseline $0.00 25,896 $0 

Future Cycle, Post-Amendment $7.53 25,896 $194,921 

Change from the Baseline, Future Cycles $7.53 0 $194,921 

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

Limitations of Analysis. To the extent that the burden of indicating whether a chemical is physically 

at the reporting site is different from the burden to report whether a chemical is manufactured or 

imported, this analysis may over- or underestimate the burden and cost of this amendment. Furthermore, 

this requirement may only apply to importers; the number of reports affected is therefore likely to be an 

overestimation. 

4.4.15 Report Production Volume Exported 

EPA is proposing to add a requirement for submitters to report the production volume directly 

exported and not domestically processed or used. 

The Agency assumes that the burden to the submitter to report the volume exported would be similar 

to the burden to report the production volume, given the similarity of the activities. EPA estimates that it 

will take a submitter 1.51 hours to provide the volume exported (see Table 4-3). 

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-28 

shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that 

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 subtracting the corresponding baseline value from the 

post-amendment value.

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-29 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 
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the industry cost will increase by $2.19 million during the first reporting cycle and $1.75 million during 

all future reporting cycles. 

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

Burden to Report 

Export Volume 

(2008$) 

Number of 

Reports 

Industry 

Cost 

(millions 

2008$) 

First Cycle, Baseline $0.00 25,896 $0.00 

First Cycle, Post-Amendment $84.68 25,896 $2.19 

Change from the Baseline, First Cycle $84.68 0 $2.19 

Future Cycle Baseline 0 25,896 $0.00 

Future Cycle, Post-Amendment $67.74 25,896 $1.75 

Change from the Baseline, Future Cycles $67.74 $0.00 $1.75 

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

Limitations of Analysis. To the extent that the burden of reporting the volume exported is different 

from the burden to report the total production 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 Reworked 

EPA is proposing to add a requirement to indicate via a checkbox when a manufactured chemical, 

such as a byproduct, is being recycled, remanufactured, reprocessed, reused, or reworked. Given the 

similarity in activities to research records and identify the appropriate information, the Agency estimates 

this activity will generate the same burden as indicating whether a chemical is used on-site. As shown in 

Table 4-3, EPA estimated this burden to be approximately 0.17 hours. 

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-30 

shows the industry burden estimates as a result of this proposed amendment. The Agency estimates that 

the amendment will cause a total increase in industry burden of approximately 4,400 hours in the first 

reporting cycle and approximately 3,500 hours during all future reporting cycles. 

Table 4-30: Change in Industry Burden as a Result of Indicating Whether Chemical is Recycled, 

Remanufactured, Reprocessed, Reused, or Reworked 

Burden for Completing a 

Checkbox to Indicate 

Whether a Product is 

Recycled, Remanufactured, 

Reprocessed, Reused, or 

Reworked (hours) 

Number 

of 

Reports 

Industry 

Burden 

(hours) 

First Cycle, Baseline 0.00 25,896 0 

First Cycle, Post-Amendment 0.17 25,896 4,351 

Change from the Baseline, First Cycle 0.17 0 4,351 

Future Cycle Baseline 0.00 25,896 0 

Future Cycle, Post-Amendment 0.13 25,896 3,480 

Change from the Baseline, Future Cycles 0.13 0 3,480 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
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The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-31 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

the cost to industry will increase by $243,700 for the 2011 submission year and $194,900 for all future 

reporting cycles. 

Table 4-31: Change in Industry Cost as a Result of Indicating Whether Chemical is Recycled, 

Remanufactured, Reprocessed, Reused, or Reworked 

 

Cost for Completing a 

Checkbox to Indicate 

Whether a Product is 

Recycled, Remanufactured, 

Reprocessed, Reused, or 

Reworked (2008$) 

Number 

of 

Reports 

Industry Cost 

(millions 

2008$) 

First Cycle, Baseline $0.00 25,896 $0 

First Cycle, Post-Amendment $9.41 25,896 $243,652 

Change from the Baseline, First Cycle $9.41 0 $243,652 

Future Cycle Baseline $0.00 25,896 $0 

Future Cycle, Post-Amendment $7.53 25,896 $194,921 

Change from the Baseline, Future Cycles $7.53 0 $194,921 

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

Limitations of Analysis. To the extent that the burden of indicating whether a chemical is recycled, 

remanufactured, reprocessed, reused, or reworked is different from the burden to report whether a 

chemical is site-limited, this analysis may over- or underestimate the burden and cost of this amendment.

4.4.17 Concentration Ranges 

EPA is proposing to amend the ranges used to report concentration in 710.52(C)(3) and (4) by 

changing the ranges to: 1) less than one percent by 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 IUR rule. 

Therefore, EPA assumes that it will have no impact on industry burden or cost. 

4.4.18 Revise Industrial Function Categories 

EPA is proposing to modify the current industrial function categories (found in Part III, Section A of 

Form U), deleting six current categories and adding eight new categories. In addition, EPA is proposing 

to require submitters to write in a free-text descriptor when they select “Other”. 

EPA anticipates that there would be a small additional burden for submitters to familiarize themselves 

with the eight new categories; based on best professional judgment, EPA estimates 15 minutes of 

technical labor burden. EPA also estimates that it would take three minutes of clerical 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. Using its best 

professional judgment, EPA expects that the new categories proposed in the IUR modifications rule will 

reduce by half the number of submitters selecting “Other” as an industrial function category. Therefore, 

EPA estimates that this amendment would affect 603 reports. 

Using the baseline unit burden estimates as shown above in Table 4-2 and Table 4-8, Table 4-32 

shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that 

the amendment will cause a total increase in industry burden in the first reporting cycle of approximately 
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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 25,907 

First 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 20,726 

Future Cycle, PostAmendment 1.21 17,075 0.12 603 20,798 

Change from the Baseline, 

Future Cycles 0.00 0 0.12 603 72 

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

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-33 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

the industry cost will increase by approximately $255,600 in the first reporting cycle and $3,500 in the 

following reporting years. 

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

Cost for Rule 

Familiarization of 

Additional 

Categories 

(2008$) 

Number of 

Reports with 

Industrial 

Function 

Categories 

Cost to 

Write in 

Text for 

"Other" 

(2008$) 

Number of 

Reports 

with Text for 

"Other" 

Total 

Industry 

Cost (2008$) 

First Cycle, Baseline $88.02 17,075 $0.00 0 $1,502,913 

First 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 $1,202,331 

Future Cycle, PostAmendment $70.41 17,075 $5.85 603 $1,205,856 

Change from the Baseline, 

Future Cycles $0.00 0 $5.85 603 $3,525 

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

Limitations of Analysis. EPA estimates submitters will use 15 minutes of technical labor burden to 

become familiar with the new categories; this may be an over- or underestimate. EPA is assuming that the 

number of submitters selecting “Other” as an industrial function category will be reduced by half; this 

may be an over- or underestimate. In addition, EPA assumes that there is no burden for rule 

familiarization with the new industrial function categories during future reporting cycles. This may not be 
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the case if sites have different employees complete Form U from reporting year to reporting year, or for 

chemical companies submitting a Form U for the first time.

4.4.19 Revise Industrial Sectors 

EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) 

codes with 48 Industrial Sectors (IS). The industrial 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 would be required to look up some type of code, EPA 

assumes that the burden reduction would be negligible and does not estimate it here. 

4.4.20 Revise Consumer and Commercial Product Categories 

EPA is proposing to revise the list of consumer and commercial use categories by combining 

categories that lead to common exposure scenarios and adding categories that were not adequately 

described in the current set of codes. The resultant proposed list includes 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 that the burden for 

submitters to familiarize themselves with the new categories will increase the burden for completing 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 only occur 

during the first reporting cycle. 

EPA is also proposing to require that if the product category “Other” is reported, a descriptor for the 

consumer and commercial use of the chemical substance must also be reported. Using its best 

professional judgment, EPA estimates that it would take three minutes of clerical burden and six minutes 

of technical burden to write in the text description. 

According to 2006 IUR data (EPA, 2008c), “Other” was listed as a consumer or commercial product 

category in 1,207 reports. Based on best professional judgment, EPA expects that the new categories 

proposed in this rule will reduce by half the number of submitters selecting “Other” as a consumer and 

commercial product category. Therefore, EPA assumes that this amendment would affect 604 reports. 

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-34 

shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that 

the amendment will cause a total increase in industry burden of approximately 14,400 hours during the 

first reporting cycle. In future reporting cycles, the submitters will no longer need to familiarize 

themselves with the new industrial function categories, so the burden to the industry is estimated at 

approximately 72 hours to write in text for “Other” responses. 
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Table 4-34: Change in Industry Burden as a Result of Modifying the Consumer and Commercial 

Product Categories 

Burden for Rule 

Familiarization 

for Additional 

Categories 

(hours) 

Number of 

Reports with 

Industrial 

Function 

Categories 

Burden to 

Write in 

Text for 

"Other" 

(hours) 

Number of 

Reports with 

"Other" as a 

Function 

Category 

Total 

Industry 

Burden 

(hours) 

First Cycle, Baseline 1.23 17,075 0.00 0 20,972 

First Cycle, Post-Amendment 2.07 17,075 0.15 604 35,359 

Change from the Baseline, 

First Cycle 0.84 0 0.15 604 14,387 

Future Cycle Baseline 0.98 17,075 0.00 0 16,778 

Future Cycle, Post-Amendment 0.98 17,075 0.12 604 16,850 

Change from the Baseline, 

Future Cycles 0.00 0 0.12 604 72 

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

value.

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-35 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

the industry cost will increase by approximately $845,600 in the first reporting cycle, and $3,500 during 

all future reporting cycles. 

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

Product Categories 

Cost for Rule 

Familiarization 

for Additional 

Categories 

(2008$) 

Number 

of Reports 

with 

Function 

Categories 

Cost to 

Write in 

Text for 

"Other" 

(2008$) 

Number 

of 

Reports 

with 

"Other" 

as a 

Function 

Category 

Total 

Industry 

Cost 

(2008$) 

First Cycle, Baseline $70.64 17,075 $0.00 0 $1,206,177 

First Cycle, Post-Amendment $119.90 17,075 $7.31 604 $2,051,756 

Change from the Baseline, First Cycle $49.26 0 $7.31 604 $845,579 

Future Cycle Baseline $56.51 17,075 $0.00 0 $964,942 

Future Cycle, Post-Amendment $56.51 17,075 $5.85 604 $968,470 

Change from the Baseline, Future Cycles $0.00 0 $5.85 604 $3,528 

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

Limitations of Analysis. EPA estimates submitters will need 0.84 hours of technical labor to become 

familiar with the new codes; this may be an over- or underestimate. EPA is assuming that the number of 

submitters selecting “Other” as a consumer and commercial use code will be reduced by half; this may be 

an over- or underestimate. In addition, EPA assumes that there is no burden for rule familiarization with 

the new use categories during the future reporting cycles. This may not be the case if sites have different 

employees complete Form U from reporting year to reporting year, or for chemical companies submitting 

a Form U for the first time.
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4.4.21 Designation of Consumer or Commercial Use 

EPA is proposing to require submitters to indicate whether the downstream use of their chemical is a 

consumer or a commercial use, or both. The Agency’s experience using the 2006 IUR data identified a 

need to distinguish between potentially exposed consumers versus commercial populations. The 

indication of consumer or commercial use will allow EPA to complete a better characterization of the 

potentially exposed populations. 

EPA anticipates that the submitter would indicate whether a use is a consumer or commercial use as 

part of the activity involved in selecting the correct consumer and commercial use categories, as described 

above. The burden to fill in a checkbox for the correct use would be negligible. Therefore, EPA assumes 

that this amendment does not cause any additional burden beyond that estimated in section 4.4.20 above. 

4.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed 

EPA is proposing to require that submitters report the total number of workers, including those at 

sites not under the submitter’s control, that are reasonably likely to be exposed while using the reportable 

chemical substance, with respect to each commercial use. EPA would provide a set of ranges of numbers 

of workers for the submitter to choose from. The Agency expects this reporting burden to be similar to the 

burden for providing the number of workers that are potentially exposed when using the chemical with 

respect to its industrial use, which is already required, because of the similarity of the required data. This 

burden is approximately 21.36 hours (see Table 4-2) or $1,236 (See Table 4-5) per report. EPA assumes 

that the number of submitters will not change from the baseline under this amendment. 

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-36 

shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that 

the amendment will cause a total increase in industry burden of approximately 364,700 hours in the first 

reporting cycle and 291,800 during all future reporting cycles. 

Table 4-36: Change in Industry Burden as a Result of Requiring the Number of Commercial 

Workers Reasonably Likely To Be Exposed 

 

Burden to Provide the 

Number of Commercial 

Workers (hours) 

Number 

of 

Reports 

Burden 

(hours) 

First Cycle, Baseline 0 17,075 0 

First Cycle, Post-Amendment 21.36 17,075 364,731 

Change from the Baseline, First Cycle 21.36 0 364,731 

Future Cycle Baseline 0 17,075 0 

Future Cycle, Post-Amendment 17.09 17,075 291,784 

Change from the Baseline, Future Cycles 17.09 0 291,784 

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

the post-amendment value.

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-37 shows the industry cost estimate as a result of this proposed amendment. EPA estimates 

that the industry cost will increase by $21.10 million for the 2011 reporting cycle, and $16.88 million 

during all future reporting cycles. 
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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 post-amendment value.

Limitations of Analysis. EPA is assuming that burden to report the number of commercial workers 

exposed is equivalent to reporting the number of 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 exposed than the submitter is aware of. The commercial uses may be difficult 

for manufacturers (including importers) to identify (see discussion of “NRO” responses in Section 3.9); 

therefore, the number of workers exposed may be even more difficult to identify.

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

EPA is proposing to eliminate the “Not Readably 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 estimates 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 Ascertainable” information. The proposed rule will now be 

consistent with the higher standard of information used by the survey, therefore, the burden estimates will 

not change. 

4.4.24 Chemical Identity CBI Claims 

EPA is proposing that, when a submitter asserts a claim of confidentiality for the chemical identify of 

a substance that is listed on the public portion of the Master Inventory File, the Agency may make the 

information available to the public without further notice to the submitter. This will not reveal any data to 

the public that is actually confidential and will not incur any cost or burden on the manufacturer.

4.4.25 Upfront Substantiation for Processing and Use Information CBI Claims 

EPA is proposing to require an upfront substantiation 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 substantiation 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 same amount as a result of this proposed amendment. 

According to 2006 IUR data (EPA, 2008c), a total of 8,133 reports had claimed that processing and use 

information was CBI, with an average of three processing and use information CBI claims per report. 

EPA estimates that the number of reports with processing and use CBI claims will be reduced to 2,928 as 

a result of the proposed amendment. 
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For the purposes of this analysis, EPA assumes that the burden, per item, to complete this 

substantiation will be similar to the burden estimated to complete the substantiation questions when a 

submitter makes a plant site identity CBI claim and must answer the two questions in 40 CFR 

§710.58(c)(1). As shown in Table 4-2 and Table 4-4, this is a burden of 1.46 hours and cost of $87.34 per 

CBI claim. Assuming an average of three processing and use CBI claims per report, EPA estimates that 

submitters will incur 4.38 additional hours of burden per report as a result of the amendment. 

Table 4-38 shows the industry burden estimate as a result of this proposed amendment. The Agency 

estimates that the amendment will cause a total increase in industry burden of approximately 12,800 hours 

in the first reporting cycle and 10,300 hours in all future reporting cycles. 

Table 4-38: Change in Industry Burden as a Result of Requiring Upfront Substantiation for 

Claiming Processing and Use Information as CBI 

Burden for Upfront CBI 

Substantiation for CBI 

Claims in Part III 

(hours) 

Number of Reports 

with Upfront 

Substantiation for 

CBI Claims 

in Part III 

Industry 

Burden 

(hours) 

First Cycle, Baseline 0 0 0 

First Cycle, Post-Amendment 4.38 2,928 12,824 

Change from the Baseline, First Cycle 4.38 2,928 12,824 

Future Cycle Baseline 0 0 0 

Future Cycle, Post-Amendment 3.50 2,928 10,259 

Change from the Baseline, Future Cycles 3.50 2,928 10,259 

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

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. 

Table 4-39 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

the industry cost will increase by approximately $772,300 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 that the percent reduction in CBI claims for processing and 

use information will be the same as the percent reduction when upfront substantiation was required from 

plant site identification. However, to the extent that the actual burden differs, this analysis may over- or 

underestimate the burden and cost of this amendment. 
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4.4.26 Limitation on the Confidentiality Claims for Data Elements Identified as “Not Known or 

Reasonably Ascertainable” 

Under the proposed rulemaking, IUR submitters would be unable to enter a claim of confidentiality if 

“not known or reasonably ascertainable” is selected for the industrial processing and use or consumer and 

commercial use information. EPA assumes that this amendment will not impact industry burden because 

submitters are not being required to do anything additional (e.g., gather information or provide a written 

response); they are simply prohibited from claiming “not known or reasonably ascertainable” 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-IUR and 

EPA’s Central Data Exchange (CDX). The Agency’s cost estimates were calculated following the 

methodology outlined in the economic analysis for the e-PMN rule (EPA, 2009b), where EPA is requiring 

that 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 assumes that the burden savings associated with 

electronic reporting and submission via CDX are due to the reduction or elimination of 

clerical/administrative time. The baseline time estimate for clerical burden (approximately six percent of 

the burden) was assumed to approximate the amount of clerical/administrative time involved in filling out 

and submitting the paper IUR Form U. This estimate of potential form completion and submission 

savings is in line with the estimated savings in switching from paper to electronic submissions as 

estimated in the Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis of 10 percent 

(EPA, 2004). 

The technical burden to gather and organize data, and managerial burden for review and approval, 

will not change from the baseline. Overall, this proposed amendment would decrease the burden to 

prepare Parts I, II, and III. 

In addition, estimates developed in the CROMERR report were used to develop estimates of burdens 

to register with EPA’s Central Data Exchange (CDX), and to set up a Pay.gov account and electronic 

signature agreements. These burdens are incurred on a per-site basis. EPA estimated these costs in the 

economic analysis for the e-PMN rule, which used CROMERR to develop estimates of burden from CDX 

registration and electronic signature agreements, to be a total of 1.33 hours of managerial burden and 2.28 

hours of technical time per site (EPA, 2009b; EPA, 2004). Based on the e-PMN EA, recordkeeping costs 

will be halved because of the efficiencies in creating and storing documents electronically (EPA, 

2009b), reducing overall burden per report by three hours. 

Table 4-40 shows the industry burden estimate as a result of this proposed amendment. The Agency 

estimates that the amendment will cause a total decrease in industry burden of approximately 241,700 

hours in the first reporting cycle and 209,600 hours in all future reporting cycles. 
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Table 4-40: Change in Industry Burden as a Result of Requiring Electronic Submission 

Burden for 

Report, 

Compliance 

Determination, 

Rule 

Familiarization, 

Submission and 

Part I (per site) 

(hours) 

Number 

of Sites 

Burden for 

Recordkeeping 

and Part II 

(hours per 

report) 

Number 

of 

Reports 

Burden per 

Part III 

(hours) 

Number 

of 

Reports 

with 

Part III 

(a) (b) (c) (d) (e) (f) 

Industry 

Burden 

(hours) 

(g) = 

(a*b) + 

(c*d) + 

(e*f) 

First Cycle, 

Baseline 33.26 4,085 19.82 25,896 69.92 17,075 1,842,934 

First Cycle, 

PostAmendment 

36.12 4,085 15.27 25,896 61.98 17,075 1,601,239 

Change from 

the Baseline, 

First Cycle 

2.86 0 -4.55 0 -7.94 0 -241,695 

Future Cycle 

Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833 

Future Cycle, 

PostAmendment 

11.19 4,085 12.82 25,896 49.58 17,075 1,224,202 

Change from 

the Baseline, 

Future 

Cycles 

2.11 0 -4.24 0 -6.35 0 -209,631 

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

EPA calculated the cost savings of the amendment using the unit costs shown in Table 4-5 and Table 

4-9. Table 4-41 shows the industry cost estimate as a result of this proposed amendment. EPA estimates 

that the industry cost will decrease by $8.77 million during the 2011 reporting cycle and by $7.97 million 

during all future reporting cycles. 
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Table 4-41: Change in Industry Cost as a Result of Requiring Electronic Submission 

Cost for 

Report, 

Compliance 

Determination, 

Rule 

Familiarization, 

Submission and 

Part I (per site) 

(2008$) 

Number 

of Sites 

Cost for 

Recordkeeping 

and Part II 

(2008$ per 

report) 

Number 

of 

Reports 

Cost per 

Part III 

(2008$) 

Number 

of 

Reports 

with 

Part III 

(a) (b) (c) (d) (e) (f) 

Industry 

Cost 

(millions 

2008$) 

(g) = (a

b)+ 

(c

d)+(e*f) 

First Cycle, 

Baseline $2,058 4,085 $1,143 25,896 $4,059 17,075 $107.32 

First Cycle, 

PostAmendment 

$2,251 4,085 $923 25,896 $3,833 17,075 $98.55 

Change from 

the Baseline, 

First Cycle 

$192 0 -$220 0 -$226 0 -$8.77 

Future Cycle 

Baseline $561 4,085 $982 25,896 $3,247 17,075 $83.17 

Future Cycle, 

PostAmendment 

$704 4,085 $771 25,896 $3,067 17,075 $75.20 

Change from 

the Baseline, 

Future Cycles 

$143 0 -$211 0 -$181 0 -$7.97 

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

Limitations of Analysis. EPA assumes that the clerical burden will decrease by percentages similar to 

the decrease estimated for the e-PMN rule. To the extent that any 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. The updated reporting tool would feature several 

improved capabilities 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, 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 analysis for the e-PMN rule (EPA, 2009b). The burden 

and cost reduction estimates for electronic submission, as shown in Section 4.4.27, include the cost of the 

electronic signature process because they are based on the estimates used in the economic analysis for the 

e-PMN rule. 
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4-42

4.4.30 Modifications Specifically Affecting Importers 

For purposes of IUR, importers currently are allowed 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 foreign supplier, or secondary submitter, chooses to keep it 

confidential. In such a situation, the importer is still responsible for ensuring that the IUR information is 

submitted to EPA and may do so by submitting a joint report. 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 Form U for joint submitters. Under the proposed 

amendment, the foreign manufacturer must now register with CDX and submit its report electronically. 

Previously, joint submissions could not be made electronically. 

As described above in Section 4.4.27, submission costs to register with EPA’s Central Data Exchange 

(CDX), complete the Electronic Signature Agreement forms, and set up a Pay.gov account are incurred on 

a per-site basis. EPA estimated these costs in the economic analysis for the e-PMN rule to be a total of 

1.33 hours of managerial burden and 2.28 hours of technical time per site (EPA, 2009b). Based on 

previous IUR submissions, EPA estimates that between 10 and 20 sites were importers, and therefore, the 

same approximate number were secondary submitters (EPA, 2009h). For this analysis, EPA uses the 

conservative upper-bound of 20 secondary submitter sites. 

Table 4-42 shows the industry burden estimate as a result of this proposed amendment. The Agency 

estimates that the amendment will cause an increase in industry burden of approximately 72.2 hours in the 

first reporting cycle. Future reporting cycles are assumed to the similar to the first reporting cycle. 

Table 4-42: Change in Industry Burden as a Result of Requiring CDX Registration for Secondary 

Submitters 

Burden for CDX 

Registration (per site) 

(hours)

Number of Sites Industry Burden 

 (hours)

First Cycle, Baseline 0.00 0 0.00 

First Cycle, PostAmendment 3.61 20 72.2 

Change from the 

Baseline, First Cycle 3.61 20 72.2 

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

 4-453 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that 

the industry cost will increase by $4,500 during the 2011 reporting cycle. 

Table 4-43: Change in Industry Cost as a Result of Requiring CDX Registration for Secondary 

Submitters 

Cost for CDX 

Registration (per site) 

(2008$) 

Number of Sites Industry Cost 

(2008$) 

First Cycle, Baseline $0 0 $0 

First Cycle, PostAmendment $3.61 20 $4,546 

Change from the 

Baseline, First Cycle $3.61 20 $4,546 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
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4-43

4.4.31 Modify Reporting Frequency 

The Agency is proposing to modify the IUR reporting cycle from a five-year reporting frequency to a 

four-year reporting frequency. While the principal reporting year industry burden will not change, the 

longer-term industry burden will increase because reporting will become more frequent; therefore, EPA 

estimated the annual reporting burden to industry over a 20-year period. 

The baseline industry burden in the year 2011 was calculated in Table 4-10 as 1.84 million hours. As 

shown in Table 4-11, the industry reporting burden in future reporting cycles is reduced to 1.43 million 

hours because EPA assumes that sites that have 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 reporting cycles – that is, the burden and cost to industry for reporting 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 in Table 4-2 and Table 

4-5, to estimate that in all future reporting cycles, the baseline burden to industry is approximately 1.43 

million hours. 

As shown in Table 4-44, EPA estimates that the industry burden will increase by 1.43 million hours 

over a 20-year period as a result of this amendment. 

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

20-Year Period 

Year Baseline Burden 

(millions of hours) 

Post-Amendment Burden

(millions of hours) 

Change in 

Burden 

(millions of 

hours) 

2011 1.84 1.84 0.00 

2012 0.00 0.00 0.00 

2013 0.00 0.00 0.00 

2014 0.00 0.00 0.00 

2015 0.00 1.43 1.43 

2016 1.43 0.00 -1.43 

2017 0.00 0.00 0.00 

2018 0.00 0.00 0.00 

2019 0.00 1.43 1.43 

2020 0.00 0.00 0.00 

2021 1.43 0.00 -1.43 

2022 0.00 0.00 0.00 

2023 0.00 1.43 1.43 

2024 0.00 0.00 0.00 

2025 0.00 0.00 0.00 

2026 1.43 0.00 -1.43 

2027 0.00 1.43 1.43 

2028 0.00 0.00 0.00 

2029 0.00 0.00 0.00 

2030 0.00 0.00 0.00 

Total 6.14 7.58 1.43 

Annual Average 0.31 0.38 0.07 
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4-44

As shown in Table 4-10, the total industry cost in the baseline first reporting cycle is approximately 

$106.97 million, and as shown in Table 4-11, the baseline cost is $82.82 million in all future reporting 

cycles. 4-45 shows the annual industry cost estimate as a result of this amendment. In total, EPA 

estimates that the proposed amendment will increase the cost to industry by $82.82 million over a 20-year 

period. 

In the proposal, EPA requested comment on increasing the frequency of reporting to annual reporting 

of all data; biennial report; and reporting once every three years, with processing and use data (Part III) 

reported only in the principal reporting year. EPA conducted a preliminary analysis of the cost and burden 

of increasing the frequency of reporting to annually, and every three years. The results of the analysis are 

presented in Appendix G. 

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

Year Period 

Year Baseline Cost 

(millions 2008$) 

Post-Amendment Cost 

(millions 2008$) 

Change in 

Cost 

(millions 

2008$) 

2011 $106.97 $106.97 $0.00 

2012 $0.00 $0.00 $0.00 

2013 $0.00 $0.00 $0.00 

2014 $0.00 $0.00 $0.00 

2015 $0.00 $82.82 $82.82 

2016 $82.82 $0.00 -$82.82 

2017 $0.00 $0.00 $0.00 

2018 $0.00 $0.00 $0.00 

2019 $0.00 $82.82 $82.82 

2020 $0.00 $0.00 $0.00 

2021 $82.82 $0.00 -$82.82 

2022 $0.00 $0.00 $0.00 

2023 $0.00 $82.82 $82.82 

2024 $0.00 $0.00 $0.00 

2025 $0.00 $0.00 $0.00 

2026 $82.82 $0.00 -$82.82 

2027 $0.00 $82.82 $82.82 

2028 $0.00 $0.00 $0.00 

2029 $0.00 $0.00 $0.00 

2030 $0.00 $0.00 $0.00 

Total $355.42 $438.24 $82.82 

Annual Average $17.77 $21.91 $4.14 

Limitations of Analysis. EPA assumes that future reporting cycle costs will decrease due to efficiency 

gains and a reduction in the time required for submitters to become familiar with the rule and its 

amendments. To the extent that these reductions in burden do not occur, this analysis may underestimate 

the burden and cost of the rule amendment. 
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4-45

4.5 Total Industry Compliance Burden and Cost of all Amendments 

The burdens and costs presented in Section 4.4 are the stand-alone industry compliance burden and 

cost for each amendment, and do not take into account 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 for each proposed amendment, but must consider the 

affect of one amendment on another. As described below, amendments fall into three categories: those 

that affect the number of reports submitted during a reporting cycle; those that affect the reporting burden; 

and those that affect the reporting frequency. The impact that each amendment has on the others depends 

on its category. 

4.5.1 Modifications that Affect the Number of Reports Submitted 

Several of the proposed IUR amendments change the number of full and/or partial reports EPA 

expects to be submitted, based on the specific chemicals they affect. The amendment that changes the 

method for determining whether a manufacturer is subject to the IUR reporting requirements is expected 

to increase the overall number of reports and submitters by five percent; therefore, the combined impact 

would also increase each of the impacts of the other amendments in this category by five percent. 

Furthermore, the amendment to eliminate 300,000 lb. threshold for downstream processing and use 

reporting would make Part IIIs necessary for all the additional Part IIs required by other amendments. The 

steps below describe how the combined effect of the amendments affecting the number of reports was 

calculated. 

Step 1: Sum the affected amendments. Table 4-46 presents the number of full and partial reports 

submitted as a result of the proposed IUR amendments. The proposed amendments that change the 

number of full and/or partial reports expected to be submitted are as follows: 

 Eliminate 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 additional 

reports (see Section 4.4.4).

 Elimination of the 25,000 lb. threshold for certain regulated chemicals: This amendment, by 

itself, would increase in the number of Part IIs submitted by 4,018, (see Section 4.4.5). 

 Make chemicals subject to ECAs ineligible for exemptions: EPA estimated that this amendment 

will increase the number of Part IIIs submitted by 16 additional reports (see Section 4.4.6). 

 Full exemption for manufactured water: EPA expects that this amendment, by itself, will decrease 

the number of Part IIIs submitted by 43 fewer reports (see Section 4.4.7). 

Step 2: Consider the effects of the change in method for determining rule applicability. The 

Agency expects the change in the method for determining whether a manufacturer is subject to the IUR 

reporting requirements to increase the number of reports and submitters by five percent. Therefore, EPA 

multiplied the Step 1 results by 1.05, to account for this amendment. Then the Agency added in the 

number of additional sites and reports estimated for this amendment individually. 

 Method for determining whether a manufacturer is subject to the IUR reporting requirements.

When taken by itself, this amendment generated 204 additional submitters (five percent of the 

baseline number of 4,085), 1,295 additional Part IIs (five percent of the baseline number of 25,896), 

and 854 additional Part IIIs (five percent of the baseline number of 17,075) (see Section 4.4.3). 

Step 3: Consider the effect of eliminating the 300,000 lb. threshold for processing and use 

reporting (and avoid double-counting). Under this amendment, all submitters of non-exempt 

chemicals would be required to submit a Part III. Therefore, the number of Part IIIs must be increased by 

the increased number of Part IIs, to account for the effect of eliminating the 300,000 lb. threshold for 

processing and use reporting. EPA started with the Step 2 total for Part III reports (9,484), and added the 
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4-46

Step 2 total for Part II reports (5,469), minus the number of new Part III reports as a result of making 

ECAs ineligible for exemptions (16) and the number of new Part II reports as a result of changing the 

method of determining whether a manufacturer is subject to reporting requirements (1,295). The number 

of reports with Part III will increase by 13,641.

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 the proposed amendments are considered 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). 

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

Modification Number of Sites Number of Reports Number of Reports 

with Part III 

Baseline 4,085 25,896 17,075 

Step 1: Sum affected amendments 

Eliminate 300,000 lb. Threshold for Downstream 

Processing and Use Reporting (see Section 4.4.6) 

-- -- 8,203 

Eliminate the 25,000 lb. Threshold for Certain 

Regulated Chemicals (see Section 4.4.5) 

-- 4,018 -- 

Make Chemicals Subject to ECAs Ineligible for 

Exemptions (see Section 4.4.6) 

-- -- 16 

Full Exemption for Manufactured Water (see Section 

4.4.7). 

-- (43) -- 

STEP 1 TOTAL -- 3,975 8,219 

Step 2: Account for change in the method for determining whether you are subject to the IUR reporting requirements 

Step 1 Total Multiplied by 1.05 4,174 8,630 

Method for Determining Whether you are Subject to 

the IUR Reporting Requirements (see Section 4.4.3) 

204 1,295 854 

STEP 2 TOTAL 204 5,469 9,484 

Step 3: Consider the effect of eliminating the 300,000 lb. threshold for processing and use reporting (and avoid doublecounting). 

Step 2 total for Part II reports minus number of new 

Part III reports as a result of making ECAs ineligible 

for exemptions and the number of new Part II reports as 

a result of changing the method of determining whether 

subject to reporting requirements 

-- -- 4,158 

STEP 3 TOTAL (Step 3 + Step 2 Total ) 204 5,469 13,641 

Step 4:Calculate the total number of reports by adding the Step 3 Total to the Baseline 

STEP 4 TOTAL (Baseline + Step 3 Total) 4,289 31,365 30,716 

4.5.2 Modifications That Affect the Reporting Burden 

Several amendments affect the burden to complete a report. As discussed in Section 4.4.27, EPA 

assumes that the amendment to require electronic submission over the Internet will eliminate clerical 

burden used in the preparation of Parts I, II and III of Form U, and that the burden for recordkeeping 

across all wage rate categories will be reduced by half. Table 4-47 contains the total burden by labor 

category for the 2011 reporting cycle when all the amendments are considered together. Table 4-48 

contains the future reporting cycle burden, by labor category. The steps below describe how the combined 

effect of the amendments that affected the reporting burden was calculated. 
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4-47

Step 1: Sum the affected amendments. The amendments that affect 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 burden to complete Part II (see Section 4.4.12). 

 Report production volume used on-site: This amendment is estimated to require 1.51 additional 

hours of burden to complete Part II (see Section 4.4.13). Table 4-47 presents the per-report total 

burden of 0.293 hours to reflect that only 24 percent of reports are expected to report volume used on 

site. 

 Indicate whether the chemical is physically at reporting site: This amendment is estimated to 

require 0.17 additional hours of burden to complete Part II (see Section 4.4.14).

 Report volume exported: This amendment is estimated to require 1.51 additional hours of burden to 

complete Part II (see Section 4.4.15).

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

reworked: This amendment is estimated to require 0.17 additional hours of burden to complete Part 

II (see Section 4.4.16).

 Revise industrial function categories: This amendment is estimated to require 0.25 additional hours 

to complete Part III (for submitters to familiarize themselves with the new categories), and an 

additional 0.15 hours (for submitters selecting “Other”) (see Section 4.4.18). Table 4-47 presents the 

per-report total burden of 0.26 hours to reflect that only 3.5 percent of reports are expected to select 

“Other” and thus incur this additional cost. 

 Revise consumer and commercial product categories: This amendment is estimated to require 0.84 

additional hours of burden to complete Part III (for submitters to familiarize themselves with the new 

categories), and an additional 0.15 hours (for submitters selecting “Other”) (see Section 4.4.20). 

Table 4-47 presents the per-report total burden of 0.84 hours, which reflects that only 3.5 percent of 

reports are expected to select “Other” and thus incur this additional burden. 

 Number of commercial workers reasonably likely to be exposed: This amendment is estimated to 

require 21.36 additional hours to complete Part III (see Section 4.4.22).

 Upfront substantiation for processing and use information CBI claims: This amendment is 

estimated to require 4.38 additional hours of burden to complete Part III for all submitters that claim 

processing and use information as CBI (see Section 4.4.25). Table 4-47 presents the per-report total 

burden of 0.75 hours, which reflects that only 17 percent of reports are expected to incur additional 

costs because of the amendment. 

Step 2: Consider the effect of the amendment to require electronic submission over the Internet. 

This amendment would eliminate the need for clerical tasks such as typing information 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 are combined. To calculate the total industry 

burden estimates, EPA added the total from Step 2 to the baseline. In total, the clerical burden will be 

0.75 hours per full report with one chemical, the 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. 
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4-48

Table 4-47: Change in the 2011 Reporting Cycle Burden for All Amendments Combined, by Labor C

Modification 

Compliance 

Determination, Rule Familiarization, and 

Submission 

Burden 

Burden to Complete 

Part I 

Recordkeeping 

Burden 

Burden to Complete 

Part II 

C T M C T M C T M C T M 

Baseline -- 21.50 9.00 0.76 0.95 1.05 1.50 3.00 1.50 1.55 8.78 3.49 Step 1: Sum the Affected AmendmentsReport production volume for each of the years 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 at reporting 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, or reworked 

-- -- -- -- -- -- -- -- -- 0.026 0.114 0.028 

Revise industrial function categories -- -- -- -- -- -- -- -- -- -- -- -- Revise commercial and consumer product categories 

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

Number of commercial workers reasonably likely to be exposed 

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

Upfront substantiation for processing and use information CBI claims 

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

Step 1 Total -- -- -- -- -- -- -- -- -- 1.267 5.557 1.365 Step 2:Add the Effect of the Electronic Reporting AmendmentsElectronic Submission -- 2.28 1.33 -0.76 -- -- -0.75 -1.50 -0.75 -2.82 -- -- Step 2 Total (Electronic Submission + Step 1 Total) 

-- 2.28 1.33 -0.76 -- -- -0.75 -1.50 -0.75 -1.55 5.56 1.36 

Step 3 Total BurdenStep 2 Total + Baseline -- 23.78 10.33 -- 0.95 1.05 0.75 1.50 0.75 -- 14.34 4.85 Note: C = Clerical; T = Technical; and M = Managerial wage categories 
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Table 4-48: Change in the Future Reporting Cycle Burden for All Amendments Combined, by Labor Category 

Modification 

Compliance 

Determination, Rule Familiarization, and 

Submission 

Burden 

Burden to Complete 

Part I 

Recordkeeping 

Burden 

Burden to Complete 

Part II 

Burden 

Pa

C T M C T M C T M C T M C 

Baseline -- 4.500 2.000 0.691 0.870 1.018 1.500 3.000 1.500 1.240 7.024 2.792 6.351 3Step 1: Sum the Affected AmendmentsReport production volume for each of the years 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 at reporting 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, or reworked 

-- -- -- -- -- -- -- -- -- 0.021 0.091 0.022 -- 

Revise industrial function categories -- -- -- -- -- -- -- -- -- -- -- -- 0.002 Revise commercial and consumer product categories 

-- -- -- -- -- -- -- -- -- -- -- -- 0.002 

Number of commercial workers reasonably likely to be exposed 

-- -- -- -- -- -- -- -- -- -- -- -- 1.683 1

Upfront substantiation for processing and use information CBI claims 

-- -- -- -- -- -- -- -- -- -- -- -- 0.049 

Step 1 Total -- -- -- -- -- -- -- -- -- 1.014 4.446 1.092 1.737 1Step 2:Add the Effect of the Electronic Reporting AmendmentsElectronic Submission -- 1.73 1.07 -0.69 -- -- -0.75 -1.50 -0.75 -2.25 -- -- -8.09 Step 2 Total (Electronic Submission + Step 1 Total) 

-- 1.73 1.07 -0.69 -- -- -0.75 -1.50 -0.75 -1.24 4.45 1.09 -6.35 

Step 3 Total BurdenStep 2 Total + Baseline -- 6.23 3.07 -- 0.87 1.02 0.75 1.50 0.75 -- 11.47 3.88 -- Note: C = Clerical; T = Technical; and M = Managerial wage categories
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4-50

Table 4-49 contains the estimated change in the burden and the total burden per reporting cycle as a 

result of the all the proposed IUR amendments during the first reporting cycle. It also presents the burden 

in future reporting cycles. EPA estimates the total industry burden will increase by approximately 1.56 

million hours to 3.40 million hours in total for the 2011 reporting cycle. In future reporting cycles, EPA 

estimates that industry burden will increase by 1.21 million hours to 2.64 million hours. 

Table 4-49: Total Industry Burden for All Amendments Combined 

Burden for 

Compliance 

Determination, 

Rule 

Familiarization, 

Submission 

and to 

Prepare Part 

I (hours per 

site) 

Number 

of Sites 

Burden for 

Record 

Keeping 

and to 

Prepare 

Part II 

(hours per 

report) 

Number 

of 

Reports 

(with 

Part II) 

Burden to 

Prepare 

Part III 

(hours per 

report) 

Number of 

Reports 

(with Part 

III) 

Industry 

Burden 

(millions of 

hours) 

(a) (b) (c) (d) (e) (f) 

(g) = (a

b)+ 

(c d)+(ef) 

First Cycle, 

Baseline 33.26 4,085 19.82 25,896 69.92 17,075 1.84 

First Cycle, 

PostAmendment 

36.12 4,289 22.19 31,365 83.02 30,716 3.40 

Change from 

the Baseline, 

First Cycle 

2.86 204 2.37 5,469 13.10 13,641 1.56 

Future-Cycle, 

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

Future Cycle, 

PostAmendment 

11.19 4,289 18.35 31,365 65.63 30,716 2.64 

Change from 

the Baseline, 

Future Cycles 

2.11 204 1.30 5,469 9.70 13,641 1.21 

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

Table 4-50 shows the total industry cost. To calculate the total industry cost, the burden estimates 

located in Table 4-47 and Table 4-48 were multiplied by the wage rates found in Table 4-1. The costs 

were then multiplied by the number of submissions located in Table 4-46. EPA estimates the total 

industry cost will increase by approximately $102.07 million to $209.04 million in total for the 2011 

reporting cycle. In future reporting cycles, EPA estimates that the industry cost will increase by $79.31 

million to $162.12 million.
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Table 4-50: Total Industry Cost When All Amendments Are Combined 

Cost for 

Compliance 

Determination, 

Rule 

Familiarization,

Submission 

and to 

Prepare Part 

I (2008$ per 

site) 

Number 

of Sites 

Cost for 

Record 

Keeping 

and to 

Prepare 

Part II 

(2008$ per 

report) 

Number 

of 

Partial 

Reports 

(with 

Part II) 

Cost to 

prepare 

Part III 

(2008$ 

per 

report) 

Number of 

Full 

Reports 

(with Part 

III) 

Industry 

Cost 

(millions 

2008$) 

(a) (b) (c) (d) (e) (f) 

(g) = (a

b)+ 

(c d)+(ef) 

First Cycle, 

Baseline $2,058 4,085 $1,129 25,896 $4,059 17,075 $106.97 

First Cycle, 

PostAmendment 

$2,252 4,289 $1,346 31,365 $5,117 30,716 $209.04 

Change from 

the Baseline, 

First Cycle 

$194 204 $216 5,469 $1,058 13,641 $102.07 

Future-Cycle, 

Baseline $561 4,085 $968.39 25,896 $3,247 17,075 $82.82 

Future Cycle, 

PostAmendment 

$704 4,289 $1,109 31,365 $4,047 30,716 $162.12 

Change from 

the Baseline, 

Future Cycles 

$143 204 $141 5,469 $800 13,641 $79.31 

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

4.5.3 Amendment that Affects the Reporting Frequency 

This proposed amendment to modify the reporting frequency from every five years to every four 

years would not change the number of submissions or the submission burden, but would increase the cost 

to submitters over multiple reporting cycles because submissions are made more frequently. The effect of 

this amendment, in combination with the 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 

chemicals (25,896 reports divided by 4,085 sites), and submits full reports for 4.18 of those chemicals 

(17,075 reports divided by 4,085 sites) (See Table 4-51). Table 4-49 contains the total number of reports 

submitted and sites when all the amendments are considered together. An estimated 4,289 sites submit a 

total of 31,365 reports, 30,716 of which will be full reports. Therefore, in the post-amendment scenario, 

an average site will submit 7.31 reports comprised of 7.16 full reports and 0.15 partial reports (See Table 

4-51). This is a decrease of 2.01 partial reports per site and an increase of 2.98 full reports per site 

compared to the baseline. 
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4-52

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

Total 

Number 

of Sites 

Total 

Number of 

Reports 

Average 

Number of 

Reports per 

Site 

Total 

Number of 

Full 

Reports 

Average 

Number 

Full Reports 

per Site 

Average 

Number of 

Partial Reports 

per Site 

(a) (b) (c)=(b)/(a) (d) (e)=(d)/(a) (f)=(c)-(e) 

Baseline 4,085 25,896 6.34 17,075 4.18 2.16 

PostAmendment 4,289 31,365 7.31 30,716 7.16 0.15 

Change from 

the Baseline 204 5,469 0.97 13,641 2.98 -2.01 

Source: U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division 2006 IUR Database 

Statistics for IUR Modifications Rule. Washington, DC. December 17, 2008 (EPA, 2008c).

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

Table 4-52 contains the average total burden per site. Each site will submit only one Part I under both 

the baseline and post-amendment scenarios. The average numbers of Part IIs and Part IIIs submitted per 

site are taken from Table 4-51. EPA calculated the baseline from the per-report burden presented in Table 

4-2. In the first cycle baseline, the average site’s burden is 451 hours during the first reporting cycle and 

351 hours in future reporting cycles. The post-amendment burden per report is found in Table 4-49. The 

average burden per site is expected to be 793 hours in the first reporting cycle and 615 hours in future 

reporting cycles. This is an increase of 342 hours per site during the first reporting cycle and 264 hours 

per site in future reporting cycles compared to the baseline. 

Table 4-52: Average Total Burden per Site 

Burden for 

Compliance 

Determination, 

Rule 

Familiarization,

Submission 

and to 

Prepare Part 

I (hours per 

site) 

Average 

Number of 

Part Is per 

Site 

Burden for 

Record 

Keeping and 

to Prepare 

Part II 

(hours per 

report) 

Average 

Number 

of Part 

IIs per 

Site 

Burden 

for 

Part III 

(hours 

per 

report) 

Average 

Number 

of Part 

IIIs per 

Site 

Total 

Average 

Burden per 

Site (hours) 

(a) (b) (c) (d) (e) (f) (g) = (a*b) 

+(c*d)+(e*f) 

First Cycle, 

Baseline 33.26 1 19.82 6.34 69.92 4.18 451 

PostAmendment 36.12 1 22.19 7.31 83.02 7.16 793 

Change from 

the Baseline 2.86 0 2.37 0.97 13.10 2.98 342 

Future Cycle, 

Baseline 9.08 1 17.06 6.34 55.93 4.18 351 

Future Cycle, 

PostAmendment 

11.19 1 18.35 7.31 65.63 7.16 615 

Change from 

the Baseline, 

Future Cycles 

2.11 0 1.30 0.97 9.70 2.98 264 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
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4-53

The average baseline and post-amendment scenario cost per site are found in Table 4-53. Baseline 

costs per report costs are taken from Table 4-5 and Table 4-8 and used in calculating the average baseline 

cost per site. In the first reporting cycle, the average 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 costs per report 

are derived in Table 4-49 and Table 4-50. The average post-amendment cost per site is calculated to be 

$48,739 in first reporting cycle, and $37,800 for all future reporting cycles. This is an increase of $22,600 

per site during the first reporting cycle and $17,500 during future reporting cycles compared to the 

baseline. 

Table 4-53: Average Total Cost per Site 

Cost for 

Submission 

Compliance 

Determination, 

Rule 

Familiarization,

and to 

Prepare Part 

I (2008$ per 

site) 

Average 

Number of 

Part Is per 

Site 

Cost for 

Record 

Keeping and 

to Prepare 

Part II 

(2008$ per 

report) 

Average 

Number 

of Part 

IIs per 

Site 

Cost to 

Prepare 

Part III 

(2008$ 

per 

report) 

Average 

Number 

of Part 

IIIs per 

Site 

Total 

Average 

Cost per 

Site (2008$) 

(a) (b) (c) (d) (e) (f) (g) = (a*b) 

+(c*d)+(e*f) 

First Cycle, 

Baseline $2,058 1 $1,129 6.34 $4,059 4.18 $26,185 

PostAmendment $2,252 1 $1,346 7.31 $5,117 7.16 $48,739 

Change from 

the Baseline $194 0 $216 0.97 $1,058 2.98 $22,553 

Future Cycle 

Baseline $561 1 $968 6.34 $3,247 4.18 $20,274 

Future Cycle, 

PostAmendment 

$704 1 $1,109 7.31 $4,047 7.16 $37,800 

Change from 

the Baseline, 

Future Cycles 

$143 0 $141 0.97 $800 2.98 $17,526 

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

4.6 Annualized Cost Estimates 

EPA estimated the total burden to industry of all of the proposed amendments over a 20-year period. 

This follows EPA’s practice of using a 20-year annualization period in the previous economic analyses of 

the IUR rule (EPA, 2002a and EPA, 2005). In addition, a 20-year period allows EPA to analyze a set of 

complete reporting cycles under both the baseline and post-amendment scenarios. Under the baseline, a 

five-year reporting cycle is used, and the cost of four complete cycles is analyzed. Under the postamendment scenario, reporting occurs every four years, and the cost of five complete cycles is presented. 

The total industry burden calculated in Table 4-49 included the burden during the first reporting 

cycle. EPA expects that during future reporting cycles, the industry burden will decrease as submitters 

become more efficient with the data and more familiar with the reporting requirements. Section 4.2.6 

discusses the burden reductions associated with this rule familiarization and efficiency gains. Table 4-49 

also shows the total burden to industry in future reporting cycles. Table 4-54 contains a schedule of the 
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4-54

annual burden estimates. Over a 20-year period, EPA estimates that the proposed amendments will 

increase industry burden by approximately 7.81 million hours. 

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

Year Baseline Burden 

(millions of hours) 

Post-Amendment 

Burden 

(millions of hours) 

Change from 

Baseline 

(millions of hours) 

2011 1.84 3.40 1.56 

2012 0.00 0.00 0.00 

2013 0.00 0.00 0.00 

2014 0.00 0.00 0.00 

2015 0.00 2.64 2.64 

2016 1.43 0.00 -1.43 

2017 0.00 0.00 0.00 

2018 0.00 0.00 0.00 

2019 0.00 2.64 2.64 

2020 0.00 0.00 0.00 

2021 1.43 0.00 -1.43 

2022 0.00 0.00 0.00 

2023 0.00 2.64 2.64 

2024 0.00 0.00 0.00 

2025 0.00 0.00 0.00 

2026 1.43 0.00 -1.43 

2027 0.00 2.64 2.64 

2028 0.00 0.00 0.00 

2029 0.00 0.00 0.00 

2030 0.00 0.00 0.00 

Total 6.14 13.96 7.81 

Annual Average 0.31 0.70 0.39 

Table 4-55 presents the annual and annualized costs estimates of all the proposed amendments. Over 

a 20-year period, EPA estimates that the proposed amendments to the IUR rule will increase industry cost 

by $26.27 million, with a three percent discount rate, and $27.86 million with a seven percent discount 

rate. 
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4-55

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

Year Baseline Cost 

(millions 2008$) 

Post-Amendment 

Cost 

(millions 2008$) 

Change from 

Baseline 

 (millions 2008$) 

2011 $106.97 $209.04 $102.07 

2012 $0.00 $0.00 $0.00 

2013 $0.00 $0.00 $0.00 

2014 $0.00 $0.00 $0.00 

2015 $0.00 $162.12 $162.12 

2016 $82.82 $0.00 -$82.82 

2017 $0.00 $0.00 $0.00 

2018 $0.00 $0.00 $0.00 

2019 $0.00 $162.12 $162.12 

2020 $0.00 $0.00 $0.00 

2021 $82.82 $0.00 -$82.82 

2022 $0.00 $0.00 $0.00 

2023 $0.00 $162.12 $162.12 

2024 $0.00 $0.00 $0.00 

2025 $0.00 $0.00 $0.00 

2026 $82.82 $0.00 -$82.82 

2027 $0.00 $162.12 $162.12 

2028 $0.00 $0.00 $0.00 

2029 $0.00 $0.00 $0.00 

2030 $0.00 $0.00 $0.00 

Total $355.42 $857.53 $502.11 

Annual Average $17.77 $42.88 $25.11 

Annualized at 3% $19.13 $45.41 $26.27 

Annualized at 7% $21.01 $48.87 $27.86 
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5-1

5. Agency Burden and Cost Estimates 

5.1 Methodology for Agency Burden and Cost 

This chapter analyzes the changes in burden and cost to EPA as a result of the proposed amendments 

to the IUR rule. This chapter calculates the incremental cost and burden changes of the amendments by 

comparing the Agency costs under the current baseline 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 calculate 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. The 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 responsible 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 additional FTE at the GS-13 level is needed to complete 

data processing, systems development, and contract oversight and management per-reporting cycle (EPA, 

2008d). The total baseline burden to the Agency is therefore 4,160 hours under the baseline. EPA 

assumes that the Agency 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 for 
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5-2

2008 (OPM, 2008). Wages are presented in terms of GS-level and step. Based on previous IUR 

economics analyses, a Step 3 is assumed for all 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 calendar 2008 is from the Office of Personnel Management 

salary table for Washington-Baltimore-Northern Virginia (OPM, 2008). 

5.2.2 Extramural (Contractor) Costs 

In addition to costs incurred by EPA staff, burden is associated with extramural tasks performed by 

contractors. These tasks include data receipt, tracking and data entry; backup systems operations and 

maintenance; printing and publishing forms and materials; and managing the TSCA hotline. The 2008 

ICR supporting statement (EPA, 2008d) estimates these costs. EPA inflated these costs to 2008 dollars 

from 2007 dollars using an inflation factor 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 that it will spend approximately 

$204,000 on these tasks per reporting cycle. 

Table 5-2: Derivation of Extramural Task Costs, per Reporting Cycle 

Tasks Performed by Contractor Staff Annual Cost 

(2007$)* 

Inflation 

Factor 

Annual Cost 

(2008$) 

Document Receipt, Tracking and Data Entry $90,737 1.04 $94,632 

Maintaining and Operating Back Up Systems $56,711 1.04 $59,145 

Printing and Publishing Forms and Materials $5,298 1.04 $5,525 

Managing the TSCA Hotline $42,855 1.04 $44,694 

Total $195,601 n/a $203,997 

*Source: ICR No. 1884.04. [Information Collection Request for] Partial Update of the TSCA Section 

8(b) Inventory Data Base, Production and Site Report Supporting Statement for a Request for OMB 

Review under the Paperwork Reduction Act, September 5, 2008. (EPA, 2008d) 

5.3 Current Total Agency Burden and Cost 

As shown in Table 5-3, EPA calculated the total baseline Agency costs by combining the costs of 

EPA staff and the extramural tasks performed by contractors. 
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5-3

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

Task Staff Cost per Reporting Cycle 

(2008$) 

VARIABLE COSTS (DEPENDENT ON THE NUMBER OF REPORTS SUBMITTED)

Quality Control of Data Entry EPA Employee 

(GS 12 Step 3) 

$122,317 

Document Receipt, Tracking and 

Data Entry Contractor $94,632 

TOTAL VARIABLE COST $216,949 

FIXED COSTS

Data Processing, Systems 

Development, and Contract 

Oversight and Management 

EPA Employee 

(GS 13 Step 3) 

$139,819 

Maintaining and Operating Back 

Up Systems Contractor $59,145 

Printing and Publishing Forms and 

Materials Contractor $5,525 

Managing the TSCA Hotline Contractor $44,694 

TOTAL FIXED COST $249,183 

TOTAL AGENCY COST $466,133 

Note: Totals may not sum due to rounding. 

Previous estimates of Agency costs, on which the 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 staff’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 number 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 that it 

incurs the same cost to perform the data entry and processing for each data element in Form U. 

To calculate the Agency burden per data element, 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 percent 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 divided by the total number reports submitted for each 

section. An example of this calculation can be seen in Equation 1 below for Part I. 
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5-4

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

The burden per section was then divided by the total number of data items in that section to calculate 

the burden per item, 0.0009 hour (approximately .054 minutes) (See Equation 2). 

Equation 2: Burden per Data Element = 0.017 hours / 19 = 0.0009 hours 

To calculate the cost to EPA, the process described above was repeated; however, instead of using 

2,080 hours, EPA used the combined cost for the quality control of data entry, and document receipt, 

tracking, and data entry, which was $216,949. Thus, EPA calculated that it costs the Agency 

approximately $0.09 to process a single data element of Form U. The total Agency burden per report is 

approximately 0.113 hours and $11.79. Table 5-4 contains the Agency burden and cost per report by 

section of Form U. This baseline burden will remain the same for all reporting cycles. 

Table 5-4: Baseline Agency Burden per Report 

Number Burden per Data Element Total 

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 sections below, the burden estimates for each amendment are calculated independently 

of the other amendments. See Section 5.5 for an estimate of the aggregated impact of all proposed 

amendments. 

5.4.1 Technical Modifications to the Regulatory Text 

EPA is proposing to reorganize certain existing regulatory text and to delete obsolete 

regulatory text. These amendments do not substantively affect the regulatory text, so EPA 

assumes that this amendment will not impact Agency burden or cost. 

5.4.2 Modifications to Selected Definitions 

EPA is proposing to modify the definitions of “importer,” “manufacture,” “site,” “commercial use,” 

“consumer use,” “reporting year,” and “submission period,” and to add definitions for “manufacturer,” 

“Central Data Exchange (CDX),” “electronic IUR (e-IUR),” “industrial function,” as described in Section 

3. These changes are clarifications only; EPA is clarifying in regulatory text what has been previously 

explained through outreach with the regulated community. Therefore, EPA assumes that these definition 

changes will not impact Agency burden or cost.
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5-5

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

EPA is proposing to require reporting if, for any calendar year since the previous IUR principal 

reporting year, the subject chemical was manufactured or imported in volumes of 25,000 lb. or greater. 

The Agency estimates this will increase the total number of sites and reports by five percent from the 

baseline. (See Section 4.4.3 for more information.) 

Table 5-5 shows the estimated Agency burden of the proposed amendment, using the baseline burden 

estimates found in Table 5-4. The Agency estimates a burden increase of 104 hours as a result of 

modifying the method for determining whether the 25,000 lb. threshold is met. 

Table 5-5: Change in Agency Burden as a Result of Modifying the Method for Determining 

Whether a Manufacturer is Subject to IUR Reporting Requirements 

 

Burden to 

Process 

Part I 

Submission 

(hours)

Number 

of Sites 

Burden to 

Process 

Part II 

(hours per 

report)

Number 

of 

Reports 

(with 

Part II)

Burden 

to 

Process 

Part 

III 

(hours 

per 

report)

Number 

of 

Reports 

with 

Part III

Agency Burden 

 (hours)

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

(c*d)+(e*f)

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080 

PostAmendment 0.017 4,289 0.042 27,191 0.054 17,929 2,184 

Change 

from the 

Baseline 

0.000 204 0.000 1,295 0.000 854 104 

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

Table 5-6 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $10,847. 

Table 5-6: Change in Agency Cost as a Result of Modifying the Method for Determining Whether a 

Manufacturer is Subject to IUR Reporting Requirements 

Cost to 

Process 

Part I 

Submission 

(2008$)

Number 

of Sites 

Cost to 

Process 

Part II 

(2008$ per 

report)

Number 

of 

Reports 

(with 

Part II)

Cost to 

Process 

Part III 

(2008$ 

per 

report)

Number 

of 

Reports 

with 

Part III

Agency Burden 

(2008$)

(a) (b) (c) (d) (e) (f) (g) 

=(a*b)+(c*d)+(e*f)

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

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

Change 

from the 

Baseline 

$0.00 204 $0.00 1,295 $0.00 854 $10,847 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value. 
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5-6

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

EPA is proposing to eliminate the 300,000 lb. threshold for processing and use information, thereby 

requiring all submitters of non-excluded 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). EPA estimates that the 

number of Part IIIs submitted will increase by 8,203 reports (see Section 4.4.4 for more information). 

Table 5-7 shows the estimated Agency burden of the proposed amendment, using the baseline burden 

estimates found in Table 5-4. The Agency expects a burden increase of 441 hours as a result of this 

amendment. 

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

Processing and Use Reporting 

Burden to Process 

Part III 

(hours per report)

Number of 

Reports

Agency Burden 

(hours)

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

Baseline 0.05 17,075 919 

Post-Amendment 0.05 25,278 1,360 

Change from the Baseline 0 8,203 441 

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

value from the post-amendment value.

Table 5-8 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $46,000. 

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

Processing and Use Reporting 

Cost to Process 

Part III 

(2008$ per report)

Number of 

Reports 

Agency Cost 

(2008$) 

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

Baseline $5.61 17,075 $95,835 

Post-Amendment $5.61 25,278 $141,876 

Change from the Baseline $0.00 8,203 $46,040 

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

value from the post-amendment value.

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

EPA is proposing to eliminate the 25,000 lb. threshold for chemicals that are: (1) the subject of a 

regulation proposed or promulgated under sections 5(a)(2), 5(b)(4), or 6 of the Act; (2) the subject of an 

order issued under section 5(e) or 5(f) of the Act, or (3) the subject of relief that has been granted under a 

civil action under section 5 or 7 of the Act. The manufacturers (including importers) of these chemicals 

would be required to report under the IUR rule, regardless of the production volume. 

Approximately 1,131 chemicals fall into these categories (EPA, 2006a). EPA estimated these 

chemicals are produced at a total of 4,018 sites (see Section 4.4.5 for more details). 
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5-7

Table 5-9 shows the estimated Agency burden of the proposed amendment, using the baseline burden 

estimates found in Table 5-4. The Agency expects a burden increase of 169 hours as a result of the 

elimination of the 25,000 lb. threshold for certain regulated chemicals. 

Table 5-9: Change in Agency Burden as a Result of Eliminating the 25,000 lb. Threshold for 

Certain Regulated Chemicals 

Burden to Process 

Part II 

 (hours per 

report) 

Number of 

Reports

Agency Burden 

(hours)

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

Baseline 0.04 25,896 1,092 

Post-Amendment 0.04 29,914 1,261 

Change from the Baseline 0 4,018 169 

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

value from the post-amendment value.

Table 5-10 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $17,665. 

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

Regulated Chemicals 

Cost to Process 

Part II 

(2008$ per report)

Number of 

Reports

Agency Cost 

(2008$)

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

Baseline $4.40 25,896 $113,853 

Post-Amendment $4.40 29,914 $131,518 

Change from the Baseline $0.00 4,018 $17,665 

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

value from the post-amendment value.

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

Exemptions 

The Agency is proposing that all chemicals subject to enforceable consent agreements be ineligible 

for exemptions. A total of four chemicals and 16 sites are affected by this amendment (see Section 4.4.6 

for more information). These sites would submit Part III of Form U for these chemicals for the first time 

in the next submission period. 

Table 5-11 shows the estimated Agency burden of the proposed amendment, using the baseline 

burden estimates found in Table 5-4. The Agency expects a burden increase of one hour as a result of this 

amendment. 
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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 post-amendment value.

Table 5-12 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $90. 

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

for Exemptions 

Cost to Process 

Part III (2008$ 

per report)

Number of 

Reports

Agency Cost 

(2008$)

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

Baseline $5.61 17,075 $95,835 

Post-Amendment $5.61 17,091 $97,925 

Change from the Baseline $0.00 16 $90 

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

value from the post-amendment value.

5.4.7 Full Exemption for Manufactured Water 

Under the current IUR regulations, manufactured water is partially exempt from reporting; therefore, 

facilities that produce manufactured water need to complete only Parts I and II of Form U. The Agency 

now is proposing to grant a full exemption for manufactured water. Thus, the burden reduction for this 

proposed amendment would be the result of 43 fewer Part IIs being submitted (see section 4.4.7 for more 

information.) 

Table 5-13 shows the estimated Agency burden of the proposed amendment, using the baseline 

burden estimates found in Table 5-4. The Agency estimates a burden reduction of two hours as a result of 

this amendment. 

Table 5-13: Change in Agency Burden as a Result of a Full Exemption for Manufactured Water 

Burden to Process 

Part II (hours per 

report)

Number of 

Reports

Agency Burden 

(hours)

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

Baseline 0.04 25,896 1,092 

Post-Amendment 0.04 25,853 1,090 

Change from the Baseline 0 -43 -2

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

value from the post-amendment value.

Table 5-14 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost savings of approximately $189. 
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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 post-amendment value.

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

EPA is amending the list of partially exempt chemicals 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 Agency burden, because these 

substances currently are fully exempt from reporting, and therefore no additional reports will be 

submitted to EPA. 

5.4.9 Parent Company and Site Identity 

Manufacturers (including importers) currently are required to report the name and other information 

to identify the company associated with their plant site on Part I of Form U. EPA is proposing to require 

that the company name be the ultimate domestic 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. 

5.4.10 Technical Contact 

Manufacturers (including importers) are required to provide a technical contact for their IUR 

submission. EPA is proposing to amend the IUR rule to require that the technical contact be a person who 

works at the site and is knowledgeable about the chemical. 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 Chemical Abstracts (CA) Index Name currently used 

to list the substance in the Inventory as the chemical name reported for IUR. Currently, submitters are 

required to report a specific chemical name, with no further elaboration in the regulatory text. 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 that in cases where a CASRN exists for a 

confidential chemical, it can be reported instead of the accession number and claimed as confidential for 

purposes of the IUR submission. EPA is proposing to remove the PMN number as an allowed chemical 

identifying number because each Inventory substance has either a CASRN or a TSCA Accession Number 

or both, which are likely to be already known to the submitter. 

EPA assumes no additional Agency burden to process a CA Index Name or CASRN, compared to 

another chemical identity name or number. 

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

EPA is proposing to require reporting of a chemical’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 production volume for the calendar years 2006, 2007, 

2008, 2009, and 2010. This amendment will result in four additional data items for EPA to process in Part 
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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 amendment. 

Table 5-15: Change in Agency Burden as a Result of Reporting of Production Volume for Each of 

the Years since Last Principal Reporting Year 

Burden for 

Processing 

Production Volume 

(hours per report) 

Number of 

Reports 

Agency 

Burden 

(hours) 

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

Baseline 0.001 25,896 23 

Post-Amendment 0.004 25,896 116 

Change from the Baseline 0.004 0 93 

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

the post-amendment value.

Table 5-16 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $9,700.

Table 5-16: Change in Agency Cost as a Result of Reporting of Production Volume for Each of the 

Years since Last Principal Reporting Year 

Cost for Processing 

Production Volume 

(2008$ per report) 

Number of 

Reports 

Agency Cost 

(2008$) 

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

Baseline $0.09 25,896 $2,422 

Post-Amendment $0.47 25,896 $12,112 

Change from the Baseline $0.37 0 $9,690 

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

the post-amendment value.

5.4.13 Volume of Chemical Substance Used On-Site 

Under the current IUR requirements, submitters who manufacture a chemical exclusively for on-site 

use are required to indicate this on Form U. The Agency is proposing to require submitters to report both 

production volumes used on- and off-site. EPA expects that there will be a slight increase in the number 

of submitters who would report 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 amendment. 
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Table 5-17: Change in Agency Burden as a Result of Reporting of Production Volume Used OnSite 

Burden to 

Process 

Information 

(hours per 

report) 

Number of 

Reports 

Number of Reports 

with Production 

Volume Used On-Site 

Agency Burden 

(hours) 

Baseline 0.042 25,896 0 1,092 

Post-Amendment 0.043 25,896 5,024 1,096 

Change from the 

Baseline 0.001 0 5,024 5 

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

Table 5-18 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $470.

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

Cost to Process 

Information 

(2008$ per 

report) 

Number of 

Reports 

Number of Reports 

with Production 

Volume Used On-Site 

Agency Cost 

(2008$) 

Baseline $4.40 25,896 0 $113,853 

Post-Amendment $4.49 25,896 5,024 $114,323 

Change from the 

Baseline $0.09 0 5,024 $470 

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

5.4.14 Indicate Whether Chemical Is Physically at Reporting Site 

EPA is proposing to require submitters to indicate whether an imported chemical is physically at the 

reporting site. This will add one additional 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 amendment. 

Table 5-19: Change in Agency Burden as a Result of Indicating Whether an Imported Chemical is 

Physically On-Site 

Burden to Process 

Information 

(hours per report)

Number of Reports Agency Burden 

 (hours)

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

Baseline 0.042 25,896 1,092 

Post-Amendment 0.043 25,896 1,115 

Change from the 

Baseline 0.001 0 23 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
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Table 5-20 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $2,400.

Table 5-20: Change in Agency Cost as a Result of Indicating Whether an Imported Chemical is 

Physically Present On-Site 

Cost to Process 

Information 

 (2008$ per report) 

Number of Reports Agency Cost 

 (2008$) 

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

Baseline $4.40 25,896 $113,853 

Post-Amendment $4.49 25,896 $116,275 

Change from the 

Baseline $0.09 0 $2,422 

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

5.4.15 Report Production Volume Exported 

EPA is proposing to require that all submitters provide the exported chemical volume in Section II of 

the report. This will add one additional 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 amendment. 

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

Burden to Process 

Information 

(hours per report) 

Number of Reports Agency Burden 

 (hours) 

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

Baseline 0.042 25,896 1,092 

Post-Amendment 0.043 25,896 1,115 

Change from the 

Baseline 0.001 0 23 

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

Table 5-22 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $2,422. 

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

Cost to Process 

Information 

 (2008$ per report) 

Number of Reports Agency Cost 

 (2008$) 

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

Baseline $4.40 25,896 $113,853 

Post-Amendment $4.49 25,896 $116,275 

Change from the 

Baseline $0.09 0 $2,422 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
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5.4.16 Identify Whether Chemical Is To Be Recycled, Remanufactured, Reprocessed, Reused, or 

Reworked 

EPA is proposing to add a checkbox to Form U for submitters to indicate whether a chemical is to be 

recycled, remanufactured, reprocessed, reused, or reworked. This will add one additional data element to 

Part II of Form U for EPA to process. 

Table 5-23 shows the estimated Agency burden of the proposed amendment, using the baseline 

burden estimates found in Table 5-4. The Agency estimates a burden increase of 23 hours as a result of 

this amendment. 

Table 5-23: Change in Agency Burden as a Result of Indicating Whether Chemical is Recycled, 

Remanufacture, Reprocessed, Reused, or Reworked 

Burden to Process a Checkbox to 

Indicate Whether a Product is 

Recycled, Remanufactured, 

Reprocessed, Reused, or Reworked 

(hours per report) 

Number of Reports Agency Burden 

(hours) 

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

Baseline 0.042 25,896 1,092 

Post-Amendment 0.043 25,896 1,115 

Change from the 

Baseline 0.001 0 23 

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

Table 5-24 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $2,400. 

Table 5-24: Change in Agency Cost as a Result of Indicating Whether Chemical is Recycled, 

Remanufactured, Reprocessed, Reused, or Reworked 

Cost to Process a Checkbox to 

 Indicate Whether a Product is 

Recycled, Remanufactured, 

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 report chemical concentration in §710.52(C)(3) and (4) 

by changing the ranges to: 1) less than one percent by weight, 2) at least one percent but less than 30 

percent by weight, 3) at least 30 percent but less than 60 percent by weight, 4) at least 60 percent but less 

than 90 percent by weight, and 5) at least 90 percent by weight. 
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This is a technical correction to eliminate gaps in the ranges as previously listed in the rule. EPA 

assumes it will have no impact on Agency burden or cost. 

5.4.18 Revise Industrial Function Categories 

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

eliminating six existing categories and requiring submitters to write in text when they claim “Other” as 

the category. This would add one data element to 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 amendment. 

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

Burden to 

Process 

Function 

Categories 

(hours per 

report) 

Number of 

Reports with 

Function 

Categories 

Burden to 

Process Writein Text for 

"Other" 

(hours) 

Number of 

Reports with 

Text 

Descriptor for 

"Other" 

 Burden 

(hours) 

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

(c*d) 

Baseline 0.05 17,075 0.000 0 918.82 

Post-Amendment 0.05 17,075 0.001 603 919.36 

Change from the 

Baseline 0.00 0 0.001 603 0.54 

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

Table 5-26 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $56. 

Table 5-26: Change in Agency Cost as a Result of Revising the Industrial Function Categories 

Cost to 

Process 

Industrial 

Function 

Categories 

(2008$ per 

report) 

Number of 

Reports with 

Industrial 

Function 

Categories 

Cost to Process 

Write-in Text 

for "Other" 

(2008$) 

Number of 

Reports with 

Text 

Descriptor for 

"Other" 

Cost 

(2008$) 

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

(c*d) 

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

Post-Amendment $5.61 17,075 $0.09 603 $95,892 

Change from the 

Baseline $0.00 0 $0.09 603 $56 

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

EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) 

codes with 48 Industrial Sectors. This amendment will not change the Agency’s data processing burden. 

EPA expects that the Agency’s burden to process the industrial sectors will remain the same 

regardless of the code system used.

5.4.20 Revise Consumer and Commercial Product Categories 

The Agency is proposing to revise the consumer and commercial product categories, by adding 12 

new categories and requiring submitters to write in text when they select “Other” as a consumer 

or commercial product category. EPA expects 604 submitters to write in this text descriptor for 

“Other” (see Section 4.4.20 for more information), adding one additional 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 burden increase as a result of this 

amendment. 

Table 5-27: Change in Agency Burden as a Result of Revising the Consumer and Commercial 

Product Categories 

Burden to 

Process 

Consumer or 

Commercial 

Product 

Categories (hours 

per report) 

Number of 

Reports with 

Consumer or 

Commercial 

Product 

Categories 

Burden to 

Process Writein Text for 

"Other" 

(hours) 

Number of 

Reports with 

Write-in 

Text for 

"Other" 

 Burden 

(hours) 

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

(c)*(d) 

Baseline 0.05 17,075 0.000 0 918.82 

PostAmendment 0.05 17,075 0.001 604 919.36 

Change from 

the Baseline 0.00 0 0.001 604 0.54 

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

Table 5-28 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $56. 
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Table 5-28: Change in Agency Cost as a Result of Revising the Consumer and Commercial 

Product Categories 

Cost to Process 

Consumer or 

Commercial 

Product 

Categories (hours 

per report) 

Number of 

Reports with 

Consumer or 

Commercial 

Product 

Categories 

Cost to Writein Text for 

"Other" 

(2008$) 

Number of 

Reports with 

Write-in 

Text for 

"Other" 

Cost 

(2008$) 

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

(c)*(d) 

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

PostAmendment $5.61 17,075 $0.09 604 $95,892 

Change from 

the Baseline $0.00 0 $0.09 604 $56 

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

5.4.21 Designation of Consumer or Commercial Use 

EPA is proposing to require the identification of whether the downstream use is a consumer or a 

commercial use, or both, adding one data element to Part III of Form U for EPA to process. 

Table 5-29 shows the estimated Agency burden of the proposed amendment, using the baseline 

burden estimates found in Table 5-4. The Agency expects a burden increase of 15 hours as a result of this 

amendment. 

Table 5-29: Change in Agency Burden as a Result of Designation of Consumer or Commercial Use 

 Burden per Report 

 (hours) 

Number of Reports 

with Part III 

Burden 

(hours) 

Baseline 0.054 17,075 919 

Post-Amendment 0.055 17,075 934 

Change from the 

Baseline 0.001 0 15 

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

Table 5-30 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $1,600. 

Table 5-30: Change in Agency Cost as a Result of Designation of Consumer or Commercial Use 

 Cost per Report 

 (2008$) 

Number of Reports 

with Part III 

Cost 

(2008$) 

Baseline $5.61 17,075 $95,835 

Post-Amendment $5.71 17,075 $97,433 

Change from the 

Baseline $0.09 0 $1,597 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
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5.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed 

EPA is proposing to require that submitters of reports with processing and use information 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 

amendment. 

Table 5-31: Change in Agency Burden as a Result of Requiring the Number of Commercial 

Workers Reasonably Likely To Be Exposed 

 Burden per Report 

 (hours) 

Number of Reports 

with Part III 

Burden 

(hours) 

Baseline 0.054 17,075 919 

Post-Amendment 0.055 17,075 934 

Change from the 

Baseline 0.001 0 15 

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

Table 5-32 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $1,600. 

Table 5-32: Change in Agency Cost as a Result of Requiring the Number of Commercial Workers 

Reasonably Likely To Be Exposed 

 Cost per Report 

 (2008$) 

Number of Reports 

with Part III 

Cost 

(2008$) 

Baseline $5.61 17,075 $95,835 

Post-Amendment $5.71 17,075 $97,433 

Change from the 

Baseline $0.09 0 $1,597 

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

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

EPA is proposing to eliminate the “Not Readily Obtainable (NRO)” standard and replace it with the 

more stringent “Known to or Reasonably Ascertainable by” standard for reporting of processing and use 

information. This amendment does not affect the number of submitters or the number of data elements in 

Form U, and therefore, EPA assumes that it will not increase the Agency burden or cost. 

5.4.24 Chemical Identity CBI Claims 

EPA is proposing that, when a submitter asserts a claim of confidentiality for the chemical identify of 

a substance that is listed on the public portion of the Master Inventory File, the Agency may make the 

information available to the public without further notice to the submitter. See the proposed regulatory 

text at 40 CFR 711.18(e). Any such action on EPA’s part would be as part of regular and routine use of 

the data and will not create any additional burden. 
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5.4.25 Upfront Substantiation for Processing and Use Information CBI Claims 

EPA is proposing to require upfront substantiation for all CBI claims in the processing and use 

section of Form U. This amendment adds two data elements per item claimed as CBI, to Part III of Form 

U for EPA to process. EPA expects that 2,928 reports will claim processing and use information as CBI, 

and on average they will make three CBI claims per report (see section 4.4.25 for more information). 

Table 5-33 shows the estimated Agency burden of the proposed amendment, using the baseline 

burden estimates found in Table 5-4. The Agency expects a burden increase of eight hours as a result of 

this amendment. 

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

Claims 

Burden per 

Report 

 (hours) 

Number of 

Reports with 

Part III 

Burden for 

Upfront CBI 

Substantiation for 

CBI Claims in 

Part III 

Number of 

Reports with 

Substantiated 

CBI Claims in 

Part III 

Burden 

(hours) 

Baseline 0.05 17,075 0.000 0 919 

Post-Amendment 0.05 17,075 0.003 2,928 927 

Change from the 

Baseline 0.00 0 0.003 2,928 8 

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

Table 5-34 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $822. 

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

 

Cost per 

Report 

 (2008$) 

Number of 

Reports with 

Part III 

Cost for 

 Upfront CBI 

Substantiation for 

CBI Claims in 

Part III 

Number of 

Reports with 

Substantiated 

CBI Claims in 

Part III 

Cost 

(2008$) 

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

Post-Amendment $5.61 17,075 $0.28 2,928 $96,657 

Change from the 

Baseline $0.00 0 $0.28 2,928 $822 

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

5.4.26 Limitation on Confidentiality Claims for Data Elements Identified as “Not Known or 

Reasonably Ascertainable” 

EPA is proposing to no longer allow CBI claims for data elements identified as “not known or 

reasonably ascertainable.” EPA expects that there will be no change in Agency burden as a result of this 

proposed amendment because the number of submitters and data elements will not change. 

5.4.27 Require Electronic Submissions over the Internet 

EPA is proposing to require that all Form Us be submitted to the Agency electronically, via e-IUR 

and EPA’s Central Data Exchange (CDX) over the Internet. EPA expects that mandatory electronic 

submission will reduce significantly the Agency’s data processing time. Based on a study conducted by 

EPA, “A Business Case Analysis of EPA’s Central Data Exchange” (EPA, 2007) on of the costs and 
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benefits of the CDX system, EPA processing burden is expected to decrease by 88.6 percent, not 

including the operating and maintenance and troubleshooting costs that are included in the general CDX 

operating budget. 

Table 5-35 shows the estimated Agency burden of the proposed amendment, using the baseline 

burden estimates found in Table 5-4. The Agency estimates a burden decrease of 1,800 hours as a result 

of this amendment. 

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

Burden per 

Report to 

Process 

Part I 

(hours per 

site) 

Number of 

Sites 

Burden per 

Report to 

Process 

Part II 

(hours per 

report) 

Number of 

Reports 

Burden per 

Report to 

Process 

Part III 

(hours per 

site) 

Number of 

Sites with 

 Part III 

Burden 

(hours) 

Baseline 0.017 4,085 0.0422 25,896 0.054 17,075 2,080 

PostAmendment 0.002 4,085 0.005 25,896 0.006 17,075 238 

Change from 

the Baseline -0.015 0 -0.0373 0 -0.048 0 -1,842 

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

Table 5-36 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost savings of approximately $192,200. 

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

Cost per 

Report to 

Process 

Part I 

(2008$) 

Number of 

Sites 

Cost per 

Report to 

Process 

Part II 

(2008$ per 

report) 

Number of 

Reports 

Cost per 

Report to 

Process 

Part III 

(2008$ per 

site) 

Number of 

Sites with 

 Part III 

Cost 

(2008$) 

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

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

Change from 

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

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

5.4.28 Updated e-IUR Reporting Software 

EPA developed the e-IUR reporting software for use by manufacturers and importers in preparing and 

submitting reports electronically during the 2006 IUR reporting cycle. The updated e-IUR reporting tool 

for the 2011 IUR collection would feature several improved capabilities over the current e-IUR reporting 

tool. Although not quantified here, EPA expects that improvements to the e-IUR software will reduce 

Agency burden to process and correct errors in the form. 

5.4.29 Electronic Signature Process 

In order to submit IUR data electronically to EPA via CDX, individuals acting on behalf of the 

submitter must first register with CDX. To register in CDX, the CDX registrant (also referred to as 
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“Electronic Signature Holder”) downloads two forms: the Electronic Signature Agreement and the 

Verification by Company Authorizing Official Form. Registration enables CDX to perform two important 

functions: authenticate identity, and verify authorization. For authentication of identity, the submitter 

completes the Electronic Signature Agreement form, signs and dates it, has the form notarized, and mails 

it back to EPA. The Verification of Authorization 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 expected to generate a small burden for EPA. To 

estimate the Agency burden of processing, reviewing, 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 4,085 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 number to be negligible. Therefore EPA expects the 

Agency burden of this amendment to be approximately 645 hours (4,085 sites x 0.17 hours per site). 

The processing, reviewing, approving, and filing of the electronic signature agreements is expected to 

be completed by the GS-13 Step-3 employee that is currently responsible for data processing, systems 

development, and contract oversight and management. EPA multiplied the burden estimate of 645 hours 

with an hourly wage rate of $67.22. This wage rate was calculated by dividing the annual total loaded 

wage of the GS-13 Step 3 employee ($139,819) found in Table 5-1 by one FTE of 2,080 hours. Therefore, 

the total cost to the Agency of processing, reviewing, approving, and filing of the electronic signature 

agreement form is approximately $46,681 during the 2011 reporting cycle. 

5.4.30 Modifications Specifically Affecting Importers 

For purposes of IUR, importers currently are allowed 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 electronically. 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 determine whether a submission was a “joint” submission, 

which increased the time required for manual processing of the data. EPA anticipates that the use of the 

reporting tool will help to make joint IUR reporting easier for industry. Although not quantified, EPA 

also anticipates that the electronic reporting tool will streamline EPA processing of the IUR information 

submitted in the 2011 reporting cycle, thus reducing Agency burden. 

5.4.31 Modify Reporting Frequency 

EPA is proposing to modify the IUR reporting cycle from five years to four years. This will increase 

the Agency burden because the Agency will receive and process IUR data more frequently. The annual 

baseline Agency burden is two FTEs, or 4,160 hours. Table 5-37 contains the change in burden over a 20-

year period. In total, EPA estimates that the Agency will spend 4,160 more hours over a 20-year period as 

a result of modifying the IUR reporting frequency. 

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

Year Baseline Burden 

( hours) 

Post-Amendment Burden

(hours) 

Change in Burden 

(hours) 

2011 4,160 4,160 0 

2012 0 0 0 

2013 0 0 0 
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2014 0 0 0 

2015 0 4,160 4,160 

2016 4,160 0 -4,160 

2017 0 0 0 

2018 0 0 0 

2019 0 4,160 4,160 

2020 0 0 0 

2021 4,160 0 -4,160 

2022 0 0 0 

2023 0 4,160 4,160 

2024 0 0 0 

2025 0 0 0 

2026 4,160 0 -4,160 

2027 0 4,160 4,160 

2028 0 0 0 

2029 0 0 0 

2030 0 0 0 

Total 16,640 20,800 4,160 

Annual Average 832 1,040 208 

Table 5-38 contains the 20-year cost estimate as a result of modifying the reporting frequency. The 

baseline cost estimate is for data entry only and is discussed in Section 5.2. This table includes extramural 

costs which are incurred by the Agency. In total, EPA estimates that it will cost the Agency 

approximately $466,100 to increase the frequency of reporting from a five-year reporting cycle to a fouryear reporting cycle over a 20-year period. EPA estimates that the annualized changes in cost would be 

$22,900 and $22,400 with a three percent and seven percent discount rate, respectively. 
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Table 5-38: Change in Agency Cost as a Result of Modifying the Reporting Frequency 

Year Baseline Cost 

(2008$) 

Post-Amendment Cost 

(2008$) 

Change in Cost 

(2008$) 

2011 $466,133 $466,133 $0 

2012 $0 $0 $0 

2013 $0 $0 $0 

2014 $0 $0 $0 

2015 $0 $466,133 $466,133 

2016 $466,133 $0 -$466,133 

2017 $0 $0 $0 

2018 $0 $0 $0 

2019 $0 $466,133 $466,133 

2020 $0 $0 $0 

2021 $466,133 $0 -$466,133 

2022 $0 $0 $0 

2023 $0 $466,133 $466,133 

2024 $0 $0 $0 

2025 $0 $0 $0 

2026 $466,133 $0 -$466,133 

2027 $0 $466,133 $466,133 

2028 $0 $0 $0 

2029 $0 $0 $0 

2030 $0 $0 $0 

Total $1,864,532 $2,330,664 $466,133 

Annual Average $93,227 $116,533 $23,307 

Annualized at 3% $98,818 $121,750 $22,932 

Annualized at 7% $106,248 $128,613 $22,365 

5.5 Total Agency Cost of All Modifications 

As EPA did with the industry cost calculations, EPA calculated the cost for each individual 

amendment as a stand-alone cost, and did not take into account the effect of individual amendments on 

the others. For this reason, when calculating the total 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 the interaction among the proposed amendments, see 

Section 4.5. As shown in Table 5-39, EPA expects that the proposed electronic submission amendment 

will decrease Agency burden by approximately 88.6 percent. 
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Table 5-39: Change in Agency Burden as a Result 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 sites 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 amendments combined is calculated in Table 4-46. 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 extramural costs not related to data entry (see 

Table 5-2). 

Table 5-40 presents the total Agency burden for all the amendments combined. In total, EPA 

estimates that the Agency will save 1,704 hours during the first reporting cycle. Table 5-41 presents the 

total Agency cost estimates; the Agency will save approximately $177,700 as a result of the proposed 

IUR amendments. The baseline and post-amendment costs 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 Physically at Site - 0.001 -- 

Exported Volume Reporting - 0.001 -- 

Consumer/Commercial Product Categories - -- 0.00003 

Number of Workers Exposed - -- 0.001 

CBI - -- 0.0005 

Production Volume in Off-Years - 0.0036 -- 

e-IUR -0.015 -0.043 -0.049 

Total Change from the Baseline with All 

Amendments -0.015 -0.037 -0.047

Total, All Amendments 0.002 0.006 0.006
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Table 5-40: Total Agency Burden for All Amendments Combined 

Burden 

per 

Report 

(Part I) 

(hours) 

Number of 

Sites 

Burden to 

Process 

Part II 

(hours) 

Number 

of 

Reports 

(with 

Part II) 

Burden to 

Process 

Part III 

(hours) 

Number of 

Reports 

(with Part 

III) 

Agency 

Burden 

(hours) 

(a) (b) (c) (d) (e) (f) 

(g) = (ab) 

+(cd) + 

(ef) 

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 4,160 

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

Change 

from the 

Baseline 

-0.015 204 -0.037 5,469 -0.047 13,641 -1,704 

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

Table 5-41: Total Agency Cost of All Amendments Combined 

Cost per 

Report 

(Part I) 

(2008$) 

Number of 

Sites 

Cost to 

Process 

Part II 

(2008$) 

Number 

of 

Reports 

(with 

Part II) 

Cost to 

Process 

Part III 

(2008$) 

Number of 

Reports 

(with Part 

III) 

Agency 

Cost 

(2008$) 

(a) (b) (c) (d) (e) (f) 

(g) = (ab)+ 

(cd) + 

(ef) 

Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133 

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

Change 

from the 

Baseline 

-$1.57 204 -$3.82 5,469 -$4.95 13,641 -$177,683 

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

To calculate the Agency burden per data element, 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 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 23 data elements in the revised Part I, 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 percent of all data elements are in Part II of the form, 

and 56.24 percent are in Part III. The Agency then multiplied the total variable burden of IUR processing, 

376.5 hours, by the percentage of data elements in a section and divided by the total number reports 

submitted for each section. To calculate the total variable burden to the Agency, EPA took the total 

burden estimate of 2,456 hours (Table 5-40 above) and subtracted the fixed burden of 2,080 hours. An 

example of this calculation can be seen in Equation 3 below for Part I. 

Equation 3: Burden to Process Part I per Report = (376.5 hours x 0.0241) / 4,289 = 0.002 hours 
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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 2). 

Equation 4: Burden per Data Element = 0.002 hours / 19 = 0.00009 hours 

Table 5-42 contains the total post-amendment burden to the Agency at the per-report and per-data 

element level. Because of the electronic submission, the Agency burden decreases by .099 hours per 

report, despite an additional 35 data elements added to Form U. 

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

Number of Data Elements Burden per Data Element 

 (hours) 

Total Burden per Report 

Form (hours) 

U 

Section Baseline PostAmendment 

Change 

from 

Baseline 

Baseline PostAmendment 

Change 

from 

Baseline 

Baseline PostAmendment 

Change 

from 

Baseline 

Part I 19 23 4 0.0009 0.00008 -0.0008 -0.0008 0.017 0.002 

Part II 47 66 19 0.0009 0.00008 -0.0008 -0.0008 0.042 0.006 

Part III 60 75 15 0.0009 0.00008 -0.0008 -0.0008 0.054 0.006 

Total 

(Full 

Report) 

126 161 35 - - 0.113 0.014 

The burden per section was then divided by the total number of data items in that section to calculate 

the burden per item, 0.00009 hour (approximately .0054 minutes) 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 repeated; 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 cost 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 calculated that it costs the Agency approximately $0.09 to process a single data element of Form U. 

The total Agency cost per report is approximately $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. 

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 

Form (2008$) 

U 

Section Baseline PostAmendment 

Change 

from 

Baseline 

Baseline PostAmendment 

Change 

from 

Baseline 

Baseline PostAmendment 

Change 

from 

Baseline 

Part I 19 23 4 $0.09 $0.009 -$0.085 $1.78 $0.20 -$1.57 

Part II 47 66 19 $0.09 $0.009 -$0.085 $4.40 $0.57 -$3.83 

Part III 60 75 15 $0.09 $0.009 -$0.085 $5.61 $0.67 -$4.94 

Total 

(Full 

Report) 

126 161 35 - - $11.79 $1.44 -$10.34 
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Table 5-44 contains Agency costs per-data element and per-report separated by EPA and 

contractor staff. Using the values in Table 5-3, EPA estimates that in the baseline, approximately 

56.4 percent of the variable Agency costs are attributed to EPA staff ($122,317/$216,949). The 

remaining 43.6 percent of data processing costs are incurred by contractor staff 

($94,632/$216,949). EPA does not expect the distribution of costs between Agency and 

contractor staff to change as a result of the proposed rule. Thus, to calculate the post-amendment 

costs attributed to contractor staff, EPA multiplied the per-report cost and the per-data element 

cost by 43.6 percent. The cost to contract staff is approximately $0.63. Similarly, to derive the 

EPA staff cost of $0.81 per report, the total per-report costs of $1.44 was multiplied by 56.4 

percent. 

Table 5-44: Agency Cost per Report when All Amendments Are Combined 

Cost per Data Element 

 (2008$) 

Total Cost per Report 

 (2008$)1 

Form U Section Agency 

Staff 

Cost 

Contractor 

Cost 

Total PostAmendment 

Cost 

Agency 

Staff 

Cost 

Contractor 

Cost 

Total PostAmendment 

Cost 

Part I $0.005 $0.004 $0.009 $0.11 $0.09 $0.20 

Part II $0.005 $0.004 $0.009 $0.32 $0.25 $0.57 

Part III $0.005 $0.004 $0.009 $0.37 $0.29 $0.66 

Total (Full Report) - - $0.81 $0.63 $1.44 1

 Note totals may not sum due to rounding. 
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5.6 Annual Burden and Discounted Total Agency Cost of All Modifications 

Table 5-45 presents the annual Agency burden estimates for data entry and extramural costs over a 

20-year period. The annual baseline Agency burden is equivalent to two FTEs, or 4,160 hours. The postamendment Agency burden is calculated in Table 5-40, and an additional FTE is added to account for all 

the GS-13 level tasks (see Table 5-3), which are not affected by any of the proposed amendments. In 

total, EPA estimates that the Agency burden for the IUR rule will be reduced by 4,400 hours over a 20-

year period under the proposed IUR amendments. 

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

Year Baseline Burden 

(hours) 

Post-Amendment 

Burden (hours) Change from Baseline 

2011 4,160 2,456 -1,704 

2012 0 0 0 

2013 0 0 0 

2014 0 0 0 

2015 0 2,456 2,456 

2016 4,160 0 -4,160 

2017 0 0 0 

2018 0 0 0 

2019 0 2,456 2,456 

2020 0 0 0 

2021 4,160 0 -4,160 

2022 0 0 0 

2023 0 2,456 2,456 

2024 0 0 0 

2025 0 0 0 

2026 4,160 0 -4,160 

2027 0 2,456 2,456 

2028 0 0 0 

2029 0 0 0 

2030 0 0 0 

Total 16,640 12,282 -4,358 

Annual 

Average 832 614 -218 

To estimate the annual cost of all the proposed amendments, EPA used the total baseline cost 

estimates over a 20-year period in Table 5-3. These costs include the cost of data entry performed by both 

EPA and contractor staff, and the cost of all extramural activities conducted by contractor staff. Under the 

baseline, EPA estimates that the total Agency cost will be $466,100 during each reporting cycle. The 

annualized post-amendment costs also include all extramural costs from Table 5-2 in addition to the data 

entry and quality control costs. 

Table 5-46 contains the annualized cost estimation. In total, annual costs will be $288,500 during the 

first reporting cycle and thereafter. Over a 20-year period, EPA estimates that the Agency will save 

approximately $422,300. Annualized savings are $23,500 and $26,700, discounted at three percent and 

seven percent, respectively. 
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Table 5-46: Annual and Discounted Total Cost to the Agency of All Modifications 

Year Baseline Cost 

(2008$) 

Post-Amendment 

Cost (2008$) Change from Baseline 

2011 $466,133 $288,450 -$177,683 

2012 $0 $0 $0 

2013 $0 $0 $0 

2014 $0 $0 $0 

2015 $0 $288,450 $288,450 

2016 $466,133 $0 -$466,133 

2017 $0 $0 $0 

2018 $0 $0 $0 

2019 $0 $288,450 $288,450 

2020 $0 $0 $0 

2021 $466,133 $0 -$466,133 

2022 $0 $0 $0 

2023 $0 $288,450 $288,450 

2024 $0 $0 $0 

2025 $0 $0 $0 

2026 $466,133 $0 -$466,133 

2027 $0 $288,450 $288,450 

2028 $0 $0 $0 

2029 $0 $0 $0 

2030 $0 $0 $0 

Total $1,864,532 $1,442,251 -$422,281 

Annual 

Average $93,227 $72,113 -$21,114 

Annualized 

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

Annualized 

at 7% $106,248 $79,587 -$26,661 
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6-1

6. Social Cost Summary 

To calculate the total burden to society, EPA added the total industry burden to the Agency burden 

savings. Table 6-1 below contains the annual burden estimates for the years 2011 through 2030. 

The baseline burden for the first reporting cycle is calculated by adding the baseline burden to 

industry, 1.84 million hours (see Table 4-10), and the baseline burden to EPA, 4,160 hours (see Table 

5-3), for a total of 1.85 million hours. EPA estimates that the proposed IUR rule amendments would 

increase the industry burden in the first reporting cycle by 1.56 million hours (see Table 4-49) and 

decrease Agency burden by 1,704 hours (see Table 5-40). The net burden increase is 1.56 million hours. 

The burden in future reporting cycles would be less than for the first reporting cycle. The shift from a 

five-year cycle to a four-year cycle increases both industry and Agency burden. All of these changes are 

shown in Table 6-1 below. EPA estimates that all of the amendments combined would increase the 

burden to society by 7.81 million hours over a 20-year period. This includes a burden increase of 7.81 

million hours to the affected industry over the 20 years (see Table 4-54), and a burden decrease of 4,358 

hours to the Agency (see Table 5-45) over the same period. 

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

amendments over a 20-year period will be 7.81 million hours. 

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

Year Baseline Burden 

(millions of hours) 

Post-Amendment 

Burden 

(millions of hours) 

Change from Baseline 

(millions of hours) 

2011 1.85 3.40 1.56

2012 0.00 0.00 0.00

2013 0.00 0.00 0.00

2014 0.00 0.00 0.00

2015 0.00 2.64 2.64

2016 1.44 0.00 -1.44

2017 0.00 0.00 0.00

2018 0.00 0.00 0.00

2019 0.00 2.64 2.64

2020 0.00 0.00 0.00

2021 1.44 0.00 -1.44

2022 0.00 0.00 0.00

2023 0.00 2.64 2.64

2024 0.00 0.00 0.00

2025 0.00 0.00 0.00

2026 1.44 0.00 -1.44

2027 0.00 2.64 2.64

2028 0.00 0.00 0.00

2029 0.00 0.00 0.00

2030 0.00 0.00 0.00

Total 6.16 13.97 7.81

Table 6-2 contains the total cost and change in cost to society as a result of the proposed IUR rule 

amendments. The cost to society is expected to increase by $501.69 million over the 20-year period, for a 

total cost of $858.97 million. The cost to industry is expected to increase by $502.11 million over this 

period (see Table 4-45), and the Agency cost is expected to decrease by $422,281 (see Table 5-46). The 
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6-2

annualized burden to society is $26.25 million and $27.84 million at three percent and seven percent 

discount rates, respectively. 

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

Year Baseline Cost 

(millions 2008$) 

Post-Amendment Cost 

(millions 2008$) 

Change from Baseline 

(millions 2008$) 

2011 $107.43 $209.33 $101.90 

2012 $0.00 $0.00 $0.00 

2013 $0.00 $0.00 $0.00 

2014 $0.00 $0.00 $0.00 

2015 $0.00 $162.41 $162.41 

2016 $83.28 $0.00 -$83.28 

2017 $0.00 $0.00 $0.00 

2018 $0.00 $0.00 $0.00 

2019 $0.00 $162.41 $162.41 

2020 $0.00 $0.00 $0.00 

2021 $83.28 $0.00 -$83.28 

2022 $0.00 $0.00 $0.00 

2023 $0.00 $162.41 $162.41 

2024 $0.00 $0.00 $0.00 

2025 $0.00 $0.00 $0.00 

2026 $83.28 $0.00 -$83.28 

2027 $0.00 $162.41 $162.41 

2028 $0.00 $0.00 $0.00 

2029 $0.00 $0.00 $0.00 

2030 $0.00 $0.00 $0.00 

Total $357.28 $858.97 $501.69 

Annualized 

at 3% $19.23 $45.48 $26.25 

Annualized 

at 7% $21.11 $48.95 $27.84 
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7-1

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

of the IUR 

The IUR rule is one of EPA’s most valuable tools 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 it is 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 effectiveness 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 electronic reporting using the e-IUR reporting software, 

expand the range of chemicals for which full information would be reported, adjust the specific reported 

information, increase the frequency of collecting the information, and modify CBI requirements. EPA 

expects that the proposed amendments will reduce many of the current data constraints and, as a result, 

improve the effectiveness of EPA’s chemical risk management programs. Most importantly, the IUR rule 

amendments will require submitters to provide processing and use exposure-related information for more 

chemicals. This additional information will allow EPA to more accurately assess human and 

environmental exposures to specific chemicals, including the concentrations, frequency, and durations of 

these exposures. 

With this additional information, EPA will be able to screen chemicals better to identify whether 

additional risk assessment and management steps are needed. More complete reporting of the processing 

and use data, more careful consideration of confidentiality claims, and adjustments to specific data 

elements will help provide the needed data. By enhancing the data supplied to Agency risk-screening 

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 assumptions. Ultimately, enhancing 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 changes in reporting requirements that will improve 

consistency and compatibility with other 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 changes in these that 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-prohibitive. For example, one approach would be to conduct a national 

willingness-to-pay (WTP) survey of the general public to determine the value that the public places on the 

availability of the information resulting from the 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 others to use the data more effectively as part of 

the Agency’s risk screening and prioritization programs. 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. 
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In addition, EPA’s current screening activities for medium production volume chemicals are further 

hampered by the fact that EPA has only estimates of production volume for many chemicals and must 

rely on relatively limited public sources of information. This proposed rule will benefit society by filling 

these information gaps and contributing to better assessments of potential risks and risk management 

decisions. 

The proposed amendments to the IUR rule will increase the amount of publicly available data about a 

chemical’s potential risks, and consequently are likely to result in (a) a reduction in the costs of risk-based 

decisions about the chemical, and (b) an improvement 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 government 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 perform 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 valued uses. With incomplete information regarding 

toxic chemicals, public and private decision makers are unable to make adequate assessments of the 

benefits and costs of actions that involve these substances. For example, EPA decisions regarding 

whether, when, and how to target chemicals for further risk assessment can be misdirected if basic 

risk-screening information is unavailable or inadequate. With more information, EPA can better 

direct its limited resources toward high-priority risks. 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 types of benefits. First, it will reduce EPA’s and 

other decision makers’ reliance on other databases and information sources that are inadequate for 

accurately and efficiently characterizing the risks associated with the thousands of chemicals in 

commerce that need to be evaluated. As discussed in Chapter 5. EPA will bear additional costs for 

collecting and managing the new IUR data; however, by providing more reliable 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 priorities. 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 risk management activities—to move more quickly in 

addressing chemicals that pose relatively high risks (and/or relatively low risk-management costs). 

A more detailed discussion about the value of information-based policies can be found in the 

economic analysis for the 2003 Amendments (EPA, 2002a). Specific benefits that accrue from the use of 

the information generated by this proposed rule are discussed in the following sections. 

7.2 Benefits of Individual Proposed Amendments 

The proposed IUR amendments expand the range of chemicals for which full information is to be 

reported, adjust the specific reported information, increase the frequency of collecting the information, 

and modify CBI requirements. These proposed amendments also would provide information to better 

address Agency and public information needs, improve the usability and reliability of the reported data, 

and ensure that data are available in a timely manner. EPA is proposing these amendments to the IUR rule 

to meet four primary goals: (1) to tailor the information collected to better meet the Agency’s overall 

information needs; (2) to increase its ability to effectively provide public access to the information; (3) to 

obtain new and updated information relating to potential exposures to a subset of chemical substances 

listed on the TSCA Inventory; and (4) to improve the usefulness of the information reported. The 
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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 information that is most needed by the Agency. These proposed changes 

will enable EPA and other Federal agencies to improve their risk screening programs, enabling them to 

better assess and manage risk, and improving public awareness of basic information about a large number 

of chemical substances. These amendments and their specific benefits are described below. 

Parent Company Name and Site Identity 

Manufacturers (including importers) are required to report the company name and Dun & Bradstreet 

(D&B) number to identify the 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 that the company name provided be the ultimate domestic parent company name. 

EPA believes this change will reduce confusion by making this reporting requirement consistent with the 

Toxic Release Inventory (TRI) requirements for parent company name. Reduced confusion leads to more 

accurate information, which in turn leads to more accurate risk characterizations. 

Furthermore, the 2006 IUR submissions from different reporting sites contained varying D&B 

numbers for parent companies that appeared to be the same company. In order to better identify when 

reporting sites are under the same parent company, EPA is proposing to include the address as well as the 

D&B number of the parent company. This too will lead to more accurate information, which will lead to 

more accurate risk characterizations and small business analyses. 

Technical Contact 

Manufacturers (including importers) are required to provide a technical contact for their IUR 

submission. The technical contact must be a person who can answer questions EPA may have about the 

reported chemical substance and should be a person located at the manufacturing site. Based on EPA’s 

experience with contacting the reported technical contact 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 about either the chemical or the submission. EPA has 

also seen situations where the technical contact is a contracted employee who is able to address 

subsequent concerns only if he or she remains under contract to the company. EPA may raise follow-up 

questions about an IUR submission, possibly years or more after the submission date. EPA is considering 

allowing multiple technical contacts on a chemical-by-chemical basis. The benefit of this proposed 

amendment would be increased clarity, which leads to improved accuracy in the information collected, 

which in turn leads to more accurate risk characterizations. 

Chemical Identity 

EPA is proposing to require the reporting of the Chemical Abstracts (CA) Index Name currently used 

to list the substance in the Inventory as the chemical name reported for IUR. Currently, submitters are 

required to report a specific chemical name, with no further elaboration in the regulatory text. EPA has 

found, however, that submitters sometimes supply a name that is somewhat generic or excludes parts of 

the specific chemical identity that distinguishes one substance from another. EPA’s experience in the 

2006 IUR was that up to five percent of the reports submitted contained chemical identity problems 

serious enough that the Agency was unable to precisely identify the substance. These problems resulted in 
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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 benefit of the requirement to use the substance name as 

currently listed on the Inventory is that it 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 substances, the accession number. EPA is proposing to 

eliminate the PMN number as an allowed 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. The benefit of this proposed amendment would be to save the Agency considerable time and 

effort to access and review reported information that has only been identified by a PMN case number. 

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

EPA is proposing to require reporting of production volume for each of the years since the last IUR 

principal reporting year. Thus, for the 2011 IUR reporting cycle, manufacturers (including importers) of a 

chemical at or above the 25,000 lb. threshold would report the production volume of that chemical for 

each of the calendar years: 2006, 2007, 2008, 2009 and 2010. Collecting the production volume for 

multiple years would provide greater detail than the current “once-every-five-years” snapshot. 

EPA has mounting evidence that many chemicals, including 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 years, then falling below the threshold during 

the IUR principal reporting year. Therefore, EPA believes that a single snapshot of annual production 

volume (i.e., taken just once each reporting cycle) does not provide an accurate picture of the chemicals in 

commerce, and may provide an erroneous view of 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 environmental exposures; and in economic analyses to determine 

the costs (and financial impacts) of potential control strategies. Voluntary EPA programs such as Design 

for the Environment (DfE) and other pollution prevention programs would use the annual production 

volume data to identify trends and program performance. Relying on a single snapshot of annual 

production volume in each reporting cycle hampers EPA’s ability to identify the programs and techniques 

that are most effective, using measurable, readily identifiable production trend data. Therefore, the benefit 

of this proposed amendment would be to 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 that submitters report the volumes of a manufactured or imported 

chemical substance used at the reporting site. The requirement to report the volume used on-site is 

replacing the requirement to indicate that the 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 manufactured chemicals, consumed entirely 

at the site of manufacture, should be reported as site-limited. 

EPA is proposing this change to simplify reporting and to collect information that better addresses the 

Agency’s needs. In the past, submitters sometimes erroneously reported their production volume 

separately to identify the portion of their chemical that was consumed at the manufacturing site. For the 

2006 IUR, many submitters continued this practice and erroneously filed separate reports to indicate that 
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a portion of their production volume was site-limited. Filing separate reports resulted in the need to report 

separately processing and use information when the combined production volume was 300,000 lb. or 

greater. Including all production volumes on one report simplifies reporting for such submitters and 

results in a less complicated database, thereby making the data easier to use. The benefit of the proposed 

amendment to require reporting the volume used on-site would be to provide valuable information related 

to potential exposures associated with the on-site volumes, therefore providing the Agency with better 

information for exposure assessments and other data analyses. 

Indicate Whether Imported Chemicals Are Physically at Reporting Site 

EPA is proposing to add a requirement to indicate whether an imported chemical is physically at the 

reporting site. Often, the site reporting an imported chemical never physically receives the chemical, but 

instead ships it directly to another location such as a warehouse, a processing or use site, or a customer’s 

site. Identifying whether the chemical is physically at the reporting site provides the benefit of more 

accurate information for screening-level analyses and other uses of the IUR data. 

Report Volume Exported 

EPA is proposing to add a requirement to report the production volume directly exported and not 

domestically processed or used. The benefit of this amendment would be to allow EPA to better identify 

the proportion of the production volume accounted for by the use reporting, given that downstream 

reporting is not required for exported 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, remanufactured, reprocessed, reused, or reworked. Submitters 

would identify that their manufactured chemical, which otherwise would be disposed of as a waste, is 

being removed from the waste stream and is being used in a commercial purpose (i.e. recycled, 

remanufactured, reprocessed, reused or reworked). Such information 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 being recycled, remanufactured, reprocessed, reused, or 

reworked and is not entering the waste stream provides valuable information to EPA and others regarding 

trends in chemical 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 experience using the 2006 IUR data identified a need to 

distinguish between potentially exposed consumer and commercial populations. The benefit of the 

designation of consumer or commercial use, or both, would be to allow EPA to complete a better 

characterization for the potentially exposed populations. 

Number of Commercial Workers Reasonably Likely To Be Exposed 

EPA is proposing to require that submitters report the total number of commercial workers, including 

those at sites not under the submitter’s control, that are reasonably likely to be exposed while using the 

reportable chemical substance, with respect to each commercial use. The approximate number of workers 

would be reported using the same definitions and ranges used for manufacturing and industrial processing 

and use workers. Information on the number of commercial workers reasonably likely to be exposed to 

the reportable chemical substance would be used to characterize the commercial population reasonably 

likely to be exposed to the subject chemical substance. Therefore, the benefit of this amendment would be 
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to improve the population characterization, which is important to the development of the overall exposure 

characterization. 

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

EPA anticipates that the proposed amendments would result in 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 that all 

submissions be generated using the e-IUR reporting software. EPA would no longer accept paper 

submissions or electronic media for any IUR submission after the effective date of the final rule. 

The proposed amendment to eliminate paper-based submissions in favor of mandatory e-IUR 

reporting would provide several benefits to EPA and industry. EPA believes the required use of e-IUR 

and CDX would reduce the reporting burden on industry by reducing both the cost and the time required 

to review, edit and transmit data to the Agency. Data systems into which data were once manually entered 

would now be filed electronically, thus reducing the potential for error that exists when data are entered 

by hand or when data is interpreted 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 and public use more quickly and it 

eliminates inefficiencies and errors that were introduced 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.epa.gov/iur). The 2011 e-IUR would feature several 

enhancements over the 2006 e-IUR. These improvements include a sophisticated validation system, 

which would alert users when a required field on the form is either missing information or contains 

certain kinds of potentially incorrect information. Other updates are expected to include automated 

chemical identity checks, automated company and site identity checks, and the facilitation of joint 

submissions and amendments. Additionally the reporting software would include user-friendly features 

such as drop-down selections, searchable chemical lists, imbedded help files, and an error-checking 

process to help identify common reporting 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-IUR reporting software, electronic reporting has become the most efficient 

method of reporting for industry as well as for EPA. During the comment period for the Information 

Collection Request (ICR) renewal (73 FR 51805, September 5, 2008), EPA received positive comments 

regarding the use of CDX, the encrypted internet submission process, and the ability to use a secure 

electronic signature method to submit reports. 

7.2.3 Obtain New and Updated Exposure Information 

The EPA Administrator has announced her intention to increase efforts to assess, prioritize, and take 

action on existing chemicals, with particular emphasis on protecting children. The Agency is developing a 

broader, more vigorous approach on existing chemicals, which will utilize the full range of TSCA 

regulatory tools to reduce or eliminate risks from chemicals 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 exposures associated with chemicals. EPA needs more 
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in-depth exposure-related information to fine-tune the screening process, and to better assess, prioritize, 

and take action on existing chemicals. The various programs and tools that EPA uses to evaluate and 

manage chemical risks are described in Section 7.3. The proposed amendments that would increase the 

amount of exposure information collected are described in the following sections. 

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

EPA is proposing to modify the method used to determine whether a manufacturer is subject to IUR 

reporting by requiring reporting if, for any calendar year since the previous IUR principal reporting year, 

the subject chemical was manufactured (including imported) in volumes of 25,000 lb. or greater. For the 

2011 reporting cycle, a site would examine its annual production volumes for the years 2006 to 2010. If 

the production volume for a reportable chemical substance was 25,000 lb. or greater for any calendar year 

during that five-year period, then the site would need to report the chemical substance, unless it is 

otherwise exempt. 

EPA is proposing this change because of the mounting evidence that many chemicals, even larger 

volume chemicals, often experience wide fluctuations in manufacturing 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. Consequently, historical IUR reporting has 

resulted in a change of approximately 30 percent in the composition of the chemicals being reported from 

one reporting cycle to the next. Therefore, the one-year snapshot of production volume does not provide 

an accurate picture of the chemicals in commerce, and may provide an erroneous view of the exposure 

scenarios associated with a particular chemical substance. 

Further evidence that capturing production volume for only the IUR principal reporting year is 

causing EPA to miss a significant amount of chemical production was revealed in the comments the 

Agency received from the proposed “reset” of the TSCA Inventory. The Federal Register notice of 

November 21, 2008 (73 FR 70460) requested that industry provide comment on whether a three-year 

reporting cycle was sufficient for deciding whether a chemical that they manufactured or imported should 

remain listed on the TSCA Inventory. Commenters overwhelmingly expressed concern that the proposed 

three-year reporting cycle would drastically misrepresent the chemicals that were presently in commerce. 

(See Docket No: EPA-HQ-OPPT-2008-0785.) 

In comments, industry unanimously agreed that if they were to report for one year only, the reset 

would inappropriately remove chemical substances from the Inventory. While all commenters felt that the 

three-year reporting cycle was inadequate, a majority of the industry comments suggested that reporting 

should cover a 10-year period. The comments strongly indicated that there were chemicals manufactured 

or imported only occasionally, and that these chemicals would not be captured if the reporting covered 

too short a period. Therefore, requiring chemical manufacturers and importers to evaluate production 

volume for any calendar year since the previous IUR principal reporting year would benefit users of IUR 

data by yielding a much more accurate picture of the chemicals currently in commerce and properly the 

subject of EPA’s risk screening, assessment, and management activities. 

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

EPA is proposing to eliminate the 300,000 lb. threshold for reporting processing and use information, 

thereby requiring all submitters of non-excluded substances 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 characterizations and subsequent risk-based prioritizations for 

medium production volume (MPV) chemicals. In the 2003 Amendments final rule (68 FR 848, January 7, 

2003), EPA acknowledged the value of information for chemical substances manufactured in lower 

volumes and stated that if the Agency were to find it necessary in the future, it would collect information 

on chemical substances at reporting thresholds below the thresholds that were introduced in that action. 
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The IUR processing and use information is needed now to complete the characterizations and 

prioritizations for those chemicals manufactured (including imported) in volumes of 25,000 to 300,000 lb. 

The Agency currently is unable to develop screening level risk evaluations for medium and lower 

production volume chemicals because most of these chemicals are produced below the volume for which 

exposure and use information is required under the current IUR rule (i.e. 300,000 lb. per year). The 

exposure information is an essential part of developing screening-level risk evaluations and, based on its 

experience in using this information, the Agency has concluded that collecting this information is critical 

to its mission of characterizing exposure, identifying potential risks, and noting uncertainties for these 

lower production volume chemicals. 

Both hazard and exposure information are needed to develop screening level evaluations. Once the 

IUR processing and use information is available for these medium and lower volume chemicals, EPA 

would be able to develop the exposure characterizations needed to develop the evaluations. As with the 

HPV chemicals, EPA would then be able to identify potential risks, note scientific issues and 

uncertainties, and indicate the initial priority assigned by the Agency for potential future appropriate 

action. Therefore, a benefit of the proposed rule would be to provide this necessary processing and use 

information for chemicals manufactured or imported in volumes of 25,000 to 300,000 lb. 

Eliminate 25,000 lb. Threshold for Certain Regulated Chemicals 

EPA is proposing to eliminate the 25,000 lb. reporting 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 (including importers) of a chemical at or above the 

25,000 lb. threshold would report the production volume of that chemical for each of the calendar years: 

2010, 2009, 2008, 2007, and 2006. This provision will ensure the availability of current information when 

EPA has expressed a concern in the form of regulatory action on those chemical substances, regardless of 

the production volume. EPA is proposing to eliminate the 25,000 lb. threshold for those chemicals that 

are: (1) the subject of a rule proposed or 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 manufacture 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 demonstrated interest to the Agency. EPA has made a 

determination that such substances either “may present,” “will present,” or “do present” an unreasonable 

risk to human health and/or the environment or that the substances have “substantial 

production/significant or substantial exposure.” Therefore, the benefit of this proposed amendment is that 

EPA would be able to use the IUR data associated with these regulated chemicals to monitor chemical 

production and compliance with the rules. 

Making Chemicals Subject to Enforceable Consent Agreements Ineligible for Exemptions 

EPA may enter into an enforceable consent agreement (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 interest in identifying the 
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manufacturing, processing, and use of substances under such agreements, and therefore is proposing to 

require that such substances be reported for IUR purposes, regardless of whether the substance otherwise 

meets the requirements listed in 40 CFR §710.46 (proposed §711.6) as an exempt or partially exempt 

chemical substance. The benefit of this proposed amendment is to ensure the availability of current 

information if EPA has expressed a concern in the form of an ECA on any substance otherwise excluded 

from the IUR rule. For example, EPA could use the IUR data associated with these regulated chemicals to 

monitor chemical production and compliance with the agreements. 

Changes to Standard for the Reporting of Processing and Use Information 

In order to collect more complete information regarding the industrial processing and use and 

commercial and consumer use of chemicals, EPA is proposing to replace the “readily obtainable” 

reporting standard in the 2006 IUR with the “known to or reasonably ascertainable by” reporting standard 

for the reporting of processing and use information. TSCA section 8(a)(2) authorizes EPA to require 

persons to report information that is “known to or reasonably ascertainable by” the submitter. This is the 

same standard that currently applies to the reporting of information described in the regulations at 

710.52(c)(1), (c)(2), and (c)(3). It covers all information in a person’s possession or control, plus all 

information that a reasonable person similarly situated might be expected to possess, control, or know. 

The “known to or reasonably ascertainable by” 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 under the “readily obtainable” reporting standard did 

not generate sufficiently precise processing and use information 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 use data captured only a portion of the volume the 

Agency suspects was actually used for industrial processing and use or commercial and consumer use. 

Considering only those chemicals meeting the criteria to require reporting of processing and use 

information, only 72 percent of the total volume was 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 standard of “not readily obtainable” was too lenient 

and resulted in an underreporting of the actual processing and use situation. 

The Agency’s experience using the 2006 IUR data to develop exposure characterizations has alerted 

EPA to the fact that the IUR processing and use data are incomplete and inconsistent. Effective risk 

screening by EPA depends on the ability to accurately characterize 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 unnecessary effort and resource 

expenditures for both regulated parties and EPA in cases where adequate data would have led the Agency 

to act differently. 

 

4

 The Agency believes the percentage of missing processing and use information actually is larger than indicated by 

this analysis. As described in the 2003 Amendments final rule (68 FR 861), EPA anticipated that, on an individual 

report basis, the total percentages of production volumes associated with the industrial processing 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 control as well as downstream sites, some of which were not 

immediate purchasers from the original manufacturing site. 
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Therefore, using the reporting standard “known to or reasonably ascertainable by” would generate the 

benefit of companies reporting a more consistent and complete processing and use information in their 

IUR reports, and more efficient use of EPA resources. 

Change to Reporting Frequency 

Prior to the 2003 Amendments, the IUR collection occurred every four years. EPA reduced the 

reporting frequency from every four years to every five years starting with the 2006 IUR to reduce the 

burden associated with the amended IUR. While the less frequent reporting does reduce burden, the 

Agency now has determined that reporting every five years does not provide data sufficiently current to 

meet Agency and public needs, and is proposing to return to reporting every four years. 

As described above, the Agency has been criticized for using outdated information. Also, a review of 

the previous reporting under IUR has revealed a change of approximately 30 percent in the chemicals that 

are reported from one reporting cycle to the next. Receiving IUR information more frequently will 

provide EPA with a more accurate, up-to-date overview of the chemical manufacturing industry, 

addressing a criticism that the Agency has received for relying on outdated information. More timely 

information will help EPA to better prioritize chemicals for screening, and will lead to more efficient use 

of EPA resources. 

7.2.4 Improve Utility of Information Reported 

Some of the amendments in the proposed rule would change reporting requirements, in an effort by 

EPA to increase the usability of the collected information. By increasing 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 that lead 

to common exposure scenarios and adding categories where the Agency believes the existing categories 

do not adequately describe potential uses. EPA worked with Environment Canada and Health Canada to 

develop the proposed set of categories, which would be used by both the United States and Canada for 

Inventory reporting. Harmonization of the categories for reporting the industrial functions of chemical 

substances would benefit both EPA and Canadian agencies 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 must include a text description for the industrial function category associated with the use of 

chemical substance. 

Industrial Sectors 

EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) 

codes with 48 Industrial Sectors (IS). The industrial sectors were adopted from the European Union’s 

guidance on information requirements and chemical safety assessment. The chosen Industrial Sectors 

divide the entire range of NAICS codes into sectors so that there is a sector corresponding to any NAICS 

code. The Agency believes this change would provide several benefits. First, it would encourage more 

complete reporting by using terms that are already familiar to industry. Second, the industrial sectors 
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would reduce the likelihood of errors that result from the selection of miscellaneous or inappropriate 

NAICS codes. Third, it would reduce the number of codes that could apply to one substance. 

One of the primary purposes of the IUR data collection is to group together similar data for priority 

setting exercises and activities. Respondents to the 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 combinations of processing or use categories, 

NAICS, and industrial function categories, in all. This 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, another benefit of using the industrial 

sectors would be to reduce the number of unique combinations, thereby increasing the usability of the 

data. 

Consumer and Commercial Product Categories 

EPA is proposing to revise the list of consumer and commercial use categories by combining 

categories that lead to common exposure scenarios and adding categories that were not adequately 

described in the initial set of categories. EPA worked with Environment Canada and Health Canada to 

develop the proposed categories which will be adopted by the United States and Canada for reporting of 

Inventory information. Harmonized categories 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 developing an Inventory of chemical 

substances. In addition, the harmonized categories will facilitate consistent reporting of chemical use 

information by industry in the United States and Canada. 

Another benefit of expanding the list of consumer and commercial use categories would be to provide 

persons submitting IUR information with a greater opportunity to characterize the products in which 

chemical substances they manufacture are used and would reduce the number of uses reported as “Other.” 

EPA is proposing to require that if a submitter chooses the category “Other,” the submitter must 

include a text description for the consumer and commercial product containing the chemical substance. 

The 2006 IUR reports showed that the category “Other” was reported with the greatest frequency. A total 

of 1,206 reports, or 26 percent, out of 4,666 reports containing commercial and consumer use 

information, included “Other.” Although one of EPA’s objectives of revising the consumer and 

commercial product categories is to reduce the reporting frequency of “Other,” EPA believes that in many 

cases where “Other” was reported, submitters may not have selected the correct categories for their 

situation. In addition to revising the overall product categories, narrower 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 

benefit EPA because the Agency will be able to evaluate and improve the inclusiveness of future 

consumer and commercial category lists or descriptions. 

Upfront Substantiation for Processing and Use Information CBI Claims 

Under the proposed rule, in order to submit a claim of confidentiality for processing and use 

information data elements, the submitter would be required to both check the appropriate box on the 

reporting form and substantiate the claim in writing by answering certain questions provided in the 

proposed rule. Where a submitter fails to substantiate the processing and use CBI claim in accordance 

with the applicable rules, EPA may make the information available to the public without further notice to 

the submitter. 

EPA has observed that, 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 
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and published on the EPA website. In addition, EPA has observed that some of the processing and use 

information claimed as confidential appears to be available on submitter’s websites or in published 

Material Safety Data Sheets (MSDS). The high number of confidentiality claims asserted for the reported 

2006 IUR reports on industrial processing and use information meant that EPA was unable to make 

available to the public important data or to completely describe the analysis or provide the support 

information used to reach Agency conclusions. This included the number of processing sites, the number 

of potentially exposed industrial workers, and the percent production volume for each industrial 

processing or use scenario. The benefit of this amendment would be a decrease in the number of 

inappropriate CBI claims under the new substantiation requirement, which would improve EPA’s ability 

to make current plant site information available to other Federal agencies and the public because more 

information submitted under IUR could be released publicly. This would increase the transparency and 

public accessibility of the chemical risk information, may increase public confidence in EPA’s chemical 

management program, and is 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 particular those with interests in managing chemical 

risks, will also use the data. The information is expected 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 public will be the ultimate 

beneficiaries of the amended IUR. By lowering the cost 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 management decisions, the rule will also help to better 

target risk management activities to the areas where the net benefits (i.e., risk reductions net of control 

costs) are expected to be the largest. 

IUR data users and the benefits they derive from IUR data are discussed in more detail in the sections 

below. 

7.3.1 EPA Risk-Screening and Management Programs 

EPA’s Office of Pollution Prevention and Toxics (OPPT) has a multifaceted approach to identifying 

and managing chemical risks. OPPT can initiate the review of a chemical in a number of ways, including 

due to an Agency program, through a request by the Interagency Testing Committee or because of a 

request by the public. The Agency has a number of more detailed screening tools, such as the Use Cluster 

Scoring System (UCSS). Depending on the outcome of these screening processes, the next step may 

include entering one of EPA’s risk management programs. These types of programs and the benefits 

derived from the processing and use information provided on the IUR Form U are examined in detail in 

the economic analysis for the 2003 Amendments (EPA, 2002). EPA’s current programs and tools to 

evaluate and manage chemical risks include: 

 

5

 On March 9, 2009, President Obama, writing about Scientific Integrity in a Presidential Memorandum for the 

Heads of Executive Departments and Agencies, wrote: “The public 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, identification, and use of scientific and technological information in policymaking.” 
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 Risk Screening. OPPT screens chemicals on the TSCA Inventory to identify potential risks and 

determine whether more detailed assessments should be undertaken. With the data currently 

available, EPA does not have the information needed to effectively and systematically screen some of 

the chemicals on the Inventory. The amended IUR would supply exposure-related information the 

Agency does not currently have, recognizing that industry has a greater knowledge than EPA about 

its own operations and the uses of chemicals it 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 exposure 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 chemicals in commerce, allowing the Agency to focus its chemical 

screening programs and to identify potentially risky 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 test 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 quantities above 25,000 lb. and less than one million lb. 

per year. In developing the test rules, EPA relied heavily on exposure information obtained from the 

IUR; improving the data collected through the IUR will enhance the quality of information used in 

decision making for future test rules. 

 Existing Chemicals Program. The Existing Chemicals Program conducts detailed analyses of 

potentially high-risk chemicals and develops strategies to reduce or eliminate the exposure risks. 

Chemicals are first screened to identify those that (1) require additional testing, (2) present potentially 

significant risk management concerns, or (3) do not currently require further review. While the 

proposed amendments to the IUR data would increase EPA’s ability to screen existing chemicals 

based on exposure and, ultimately, risk, more in-depth 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 from being able to obtain more accurate and broader 

use information could be expanded with a greater amount of in-depth exposure and use information. 

The improved IUR data would be particularly helpful for screening medium and lower volume 

chemicals that are not covered by the HPV program. 

 Use Cluster Scoring System (UCSS). The UCSS tool identifies potential risks of chemical 

substances used in similar applications, or “use clusters.” This system enables the Agency to view the 

potential risks of a given chemical substance in the 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 sources are outdated and estimating methodologies are 

approximate. More in-depth exposure-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 conduct broader chemical screening 

analyses across several industries. 

 Master Testing List. IUR data also helps to determine which chemicals substances are on the Master 

Testing List (MTL). The MTL is a list of chemicals identified by the Agency as having inadequate 

data for health and/or environmental risk assessments. OPPT uses the MTL to establish priorities for 
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chemical testing, keep the public informed, solicit input from industry on specific chemical exposure 

and risk assessment needs, and to encourage industry to perform testing. More in-depth exposurerelated manufacturing, processing, and use data 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 facilitating earlier completion of critical testing needs. 

 Screening Information Data Set (SIDS) program. The voluntary OECD SIDS program allows 

OECD member countries to share the burden of testing internationally traded, large production 

volume chemicals. The United States is responsible for testing 25 percent of the chemicals 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 exposure data 

and will provide a consistent database of information from manufacturers and importers. This 

information will increase the program’s efficiency by helping to identify chemicals requiring 

additional testing or assessment while excluding those with low domestic exposure. A better exposure 

database will also improve evaluation of potential risk in the assessment reports prepared at the end of 

the SIDS process. 

 Design for the Environment (DfE) program. EPA’s DfE program incorporates principles and 

strategies from both the Existing Chemicals Program and the UCSS, by focusing on specific chemical 

uses and establishing partnerships with industry to develop voluntary long-range plans for risk 

management. Currently collected IUR data, which would 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 also 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 Administration (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 recommends 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 chemicals by setting a variety of chemical and 

personal protection standards, by requiring preparation of emergency response and process safety 

management plans and by requiring provision of health and safety data to workers for chemicals used in 

the workplace. OSHA will be able to use the IUR data to identify chemicals with large numbers of 

potentially exposed workers or with uses that suggest greater exposure potential. The information 

provided by the proposed rule could increase OSHA’s ability to manage chemical hazards, exposures, and 

risks in occupational settings. 

NIOSH will also benefit from the additional exposure-related information collected under the 

proposed rule amendments. The exposure information that NIOSH uses to determine occupational safety 

and health in businesses nationwide may be based on outdated information collected under the National 

Occupational Exposure Survey (NOES). Completed in 1983, NOES collected information such as plant 

site location, plant site SIC, information on the plant site’s occupational safety and health programs, 

occupational titles of workers potentially exposed, the number of employees per occupational title, 

information on process steps, and trade names of products. NIOSH could use IUR data in place of the 
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NOES data to identify chemicals with large numbers of potentially exposed workers or with uses that 

suggest greater exposure potential. 

CPSC also could use the new data directly in conducting its exposure and risk assessment activities 

(e.g. screening consumer products for chemical hazards). 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 amendments 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 consideration of hazard data, to identify chemical–

consumer use situations presenting greater potential risk. The information could improve CPSC’s ability 

to meet its program objective of protecting the public 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, state and local agency access to the enhanced data will 

assist in identifying situations that pose potentially high risks for individual states or locations within 

those states. The information added to the IUR includes county data, which will enable states to identify 

which counties are likely to have specific issues or which counties may have multiple chemical problems. 

The additional data also could be used to assist with setting goals, targeting actions, and developing or 

expanding pollution prevention activities. 

7.3.4 Nongovernmental Organization (NGO) Initiatives and Private-Sector Stewardship 

Many private-sector organizations have a strong interest in reducing risks and providing leadership in 

preventing pollution while still maintaining productive economic enterprises. These organizations can 

better meet these objectives by developing a better understanding of how chemicals are used in general. 

This will allow them to more effectively manage risks and participate in setting chemical priorities at 

community, regional, and national levels. 

The publicly available (non-CBI) information provided 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 educational 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, and education initiatives and activities. 

Industry can use the amended IUR information to improve corporate product stewardship programs 

through access to use information reported by multiple companies. The American Chemistry Council’s 

Responsible Care Program is one example of a corporate product stewardship program that could use this 

information. Use information supplied through IUR could be used to further strengthen this program. The 

Responsible Care Program requires companies to take responsibility for their products from cradle to 

grave, which requires an understanding of how their product is being used not only by their customers, 

but further down the chain. Despite this private effort, some companies have told EPA that they do not 

know how their chemicals are used. Non-CBI information provided by multiple companies could give an 

individual company a better understanding of the downstream uses of its products, therefore enabling 

more effective implementation of the Responsible Care concepts. 
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8. Small Entity Analysis 

This chapter estimates the impact that the proposed amendments to the IUR rule may have on small 

entities by examining the relationship between the 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 organizations, and governments. In some instances, 

agencies also are required to examine regulatory alternatives that may reduce adverse economic effects on 

significantly impacted small entities. The RFA requires agencies to prepare an initial and final regulatory 

flexibility analysis for each rule unless the Agency certifies that the rule will not have a significant 

economic impact on a substantial number of small entities. The RFA, however, does not specifically 

define “a significant economic impact on a substantial number” of small entities. Sections 603 and 604 of 

the RFA require that regulatory flexibility analyses identify the types, and estimate the numbers, of small 

entities to which the rule will apply; and describe the rule requirements to which small entities will be 

subject and any regulatory alternatives, including exemptions and deferral, that would lessen the rule’s 

burden on small entities. 

The existing IUR rule, at §710.29, generally exempts 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 currently is required to report if it produces any 

chemical substance that is the subject of a regulation proposed or promulgated under TSCA sections 4, 

5(b)(4), or 6; or that is the subject of an order under TSCA section 5(e); or that is the subject of relief that 

has been granted pursuant to a civil action under TSCA section 5 or 7. A small business may also report 

voluntarily. 

The major steps followed in the analysis are described below. 

8.1 Select a Relevant Small Entity Definition 

The RFA relies on the definition of “small 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 Classification 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 rule. Specifically, entities potentially affected by the 

proposed rule include companies manufacturing or importing chemicals in amounts of 25,000 lb. or more 

annually and that are listed on the TSCA Inventory and regulated under TSCA §8. Under 13 CFR part 

121, SBA defines small business for the six-digit NAICS industry based on employment thresholds 

(SBA, 2004). These employee size standards range from 500 employees to 1,500 employees for NAICS 

Codes 325 and 324110. For example, SBA defines a company in NAICS 325320 (Pesticide and Other 

Agricultural Chemical Manufacturing) as small if it has fewer than 500 employees. In comparison, a 

company in NAICS 324110 (Petroleum Refineries) is considered small if it has fewer than 1,500 

employees. To obtain an average estimate of the number 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 definition is referred to as the “employment-based 

definition.” 
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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 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 any parent company, are below 

$4 million. 

Consistent with the methodology used in the 2002 Economic Analysis for the Amended Inventory 

Update Final Rule (EPA, 2002) , EPA assumed that any company with sales less than or equal to $40 

million is small, 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 requirements 

under 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 reporting 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 data are available from Dun & Bradstreet Corporate 

Leads Portal (Dun & Bradstreet, 2009).7

During the 2006 reporting cycle, 4,1888

 sites submitted reports. Of these, parent company data was 

available for 3,392 sites9

, with 872 associated parent companies. Information for the remaining 

companies was unavailable for several reasons. First, these companies may be too small to be listed in 

Dun & Bradstreet. Second, the IUR data used may be out of date because it is based on IUR reporting for 

2006 (e.g., some companies may have gone out of business or changed hands since the information was 

reported). Finally, certain companies may have requested to be removed from, or may have declined to 

provide information to, Dun & Bradstreet. 

Using the sales data collected for the companies for which data was available, EPA estimated the 

average sales for the parent companies that are considered small under both definitions. 

Table 8-1 shows the percentage of parent companies from the 2006 IUR reporting which qualified for 

“small business” status, under both the employment-based 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 statistics about each organization. While 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 submitting 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 chemicals with production volumes lower than 25,000 lb. 9

 This does not include parent companies listed in D&B as having either 0 employees or $0 sales. 
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above. These results are fairly consistent with the 2002 EA’s estimates that between 21 and 35 percent of 

the regulated community could be considered small businesses (EPA, 2002a). 

Table 8-1: Results of Dun & Bradstreet Analysis 

Existing Sites 

 (2006 Reporting Cycle)

Employment-based 

Definition 

Sales-based 

 Definition 

Number of Global Parent Companies with Data 872 872 

Number of Global Parent Companies Considered Small 360 218 

Percentage of Global Parent Companies Considered Small 41.3% 25.0% 

Average Annual Sales of Global Parent Companies 

Considered Small (2008$) $412,713,310 $11,638,441 

Source: Analysis of data from Dun & Bradstreet’s Corporate Leads Portal, April 2009. 

8.3 Estimate Number of Parent Companies 

Incomplete information on global parent companies from Dun & Bradstreet for all of the companies 

that submitted IUR reports in 2006 required that EPA estimate the total number of parent companies in 

the baseline. One global parent company may submit reports for more than one site. Based on the sample 

of companies for which the parent company information is available, EPA estimates that there are 3.89 

sites per global parent company. Given that 4,188 sites submitted reports, EPA estimates that the number 

of parent companies for the 2006 IUR reporting baseline is 1,076. 

As described in Section 4.5, the proposed amendments are expected to increase the number of sites 

reporting by 204. Therefore, EPA estimates that the total number of global parent companies reporting 

under the revised IUR rule to increase by 52 from the baseline (that is, 52 “new” companies (204÷3.89 = 

52)). 

8.4 Estimate Number of Small Companies 

EPA estimated the number of small companies potentially impacted by the proposed IUR 

amendments by applying the percentage of small companies derived in Table 8-1 to the total number of 

expected parent companies subject to the rule under the proposed amendments. 

Table 8-2 shows the number of expected small companies, under both definitions. 
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Table 8-2: Estimated Number of Small Companies under the Proposed IUR Rule Amendments 

Employment-based 

Definition 

Sales-based 

 Definition 

Baseline 

Companies 

New 

Companies 

Baseline 

Companies 

New 

Companies 

Total Number of Parent Companies 1,076 52 1,076 52 

Percent of Parent Companies Considered Small 41.3% 24.8% 

Number of Parent Companies Considered 

Small 444 22 267 13 

Total Number of Parent Companies Considered 

Small 466 280 

Limitations of the Analysis: The proposed amendments cause an increase in the number of sites 

reporting because of changes to the reporting volume thresholds and the timeframe in which the 

thresholds are applied. These amendments may have a disproportionate effect on smaller companies 

because they may be the ones that manufacture chemicals at or around the 25,000 lb. threshold. 

Therefore, this method may underestimate the number of small businesses. Furthermore, to the extent that 

the set of companies for which EPA was not able to 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 

companies that are small. 

8.5 Estimate Cost-to-Sales Ratios for Small Companies 

Table 4-50 shows the total increase in industry costs associated with the proposed amendments, if all 

proposed amendments are implemented. As described in Section 4, industry costs involve compliance 

determination, rule familiarization, preparation 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 rate10. By dividing the 

annualized costs for the entire industry in the first reporting 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 considered small (under either definition) by the 

number of sites associated with these parent companies 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 approximately 1.92 sites per small company under the 

sales-based definition. 

The RFA does not define the terms “significant” or “substantial” 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 cost-to-sales ratios. The derivation of these ratios is 

shown in Table 8-3. 

 

10 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 

(OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the 

results to a change in the annualization assumptions. 
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Table 8-3: Derivation of Cost-to-Sales Ratios for Small Companies under the Proposed IUR Rule 

Amendments 

Employment-based Definition Sales-based Definition 

3% Discount 

Rate 

7% Discount 

Rate 

3% Discount 

Rate 

7% Discount 

 Rate 

Total Annualized 

Costs $26,660,775 $28,163,588 $26,660,775 $28,163,588 

Annualized Costs 

per Site $6,527 $6,894 $6,527 $6,894 

Number of Sites 

per Small Parent 

Company 

1.76 1.92 

Annualized Costs 

per Small Parent 

Company 

$11,512 $12,161 $12,509 $13,214 

Annual Sales per 

Small Parent 

Company 

$412,713,310 $412,713,310 $11,821,104 $11,821,104 

Cost-to-Sales 

Ratio 0.0028% 0.0029% 0.1058% 0.1118% 

Number of 

Companies 

Potentially 

Affected 

466 280 

As shown in Table 8-3, under the employment-based definition, a small parent company affected by 

the rule has, on average, sales of more than $412.7 million. The annualized costs of the proposed IUR rule 

amendments per small parent company, however, are $12,161 at a seven percent discount rate, and even 

lower under a three percent discount rate. The cost-to-sales ratio for an average small company under the 

employment-based definition would be 0.003 percent or less. Under the more conservative sales-based 

definition, small parent company sales are on average more than $11.8 million, with annualized costs 

associated with the proposed amendments of $13,214 or lower. The cost-to-sales ratio for an average 

small company under the sales-based definition would be 0.11 percent or less. 

Using the highest annual cost shown in Table 8-3, $12,509, a small company would have to have 

annual sales of less than $1.25 million in order to have a cost-to-sales ratio larger than one percent. As 

mentioned above in Section 8. , firms with sales of $4 million or less are generally exempt from IUR 

reporting because they fall within the applicable definition of “small manufacturer,” regardless of 

production volume (40 CFR §704.3). Therefore, companies that are small enough to have a cost-to-sales 

ratio greater than one percent generally will be exempt from reporting under the proposed IUR rule, and 

thus will not be significantly affected by the amendments. 

8.6 Summary 

EPA analyzed potential small business impacts from this rule using the SBA employment-based 

definition and the TSCA sales-based definition. EPA estimates that 466 small firms potentially would be 

affected by this proposed rule under the employment-based definition of the term, and that 280 small 

firms potentially would be affected under the sales-based definition of the term. Based on costs 

annualized over a four-year period and average sales data, EPA estimated that the cost-to-sales ratio of 

the proposed rule would be 0.003 percent or less under the employment-based definition for an average 

small company subject to the rule, and 0.11 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 
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8-6

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. For a company to have a cost-to-sales ratio 

larger than one percent, company sales would have to be less than $1.25 million. Because the small 

businesses affected by the proposed rule actually have average sales of more than $11 million, and 

because any potentially affected companies with sales of $1.25 million or less would generally be exempt 

from reporting obligations under the IUR, small entities will not be significantly affected by the proposed 

amendments to the IUR rule.
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9-1

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. Accordingly, EPA submitted this action to the Office of 

Management and Budget (OMB) for review under Executive Order 12866 and any changes made in 

response to OMB recommendations have been documented in the docket for this action. 

9.2 Unfunded Mandates Reform Act (UMRA) 

 Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4), EPA has 

determined that this regulatory action does not contain a Federal mandate that may result in expenditures 

of $100 million or more for State, local, and tribal governments, in the aggregate, or for the private sector, 

in any one year. The analysis of the costs associated with this action is described in Unit VII.A. Thus, this 

rule is not subject to the requirements of sections 202 or 205 of UMRA. 

 In addition, EPA has determined that this 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 are not chemical manufacturers 

(including importers). Accordingly, this rule is not subject to the requirements of sections 203 of UMRA. 

9.3 Paperwork Reduction Act (PRA) 

According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., an agency may not conduct 

or sponsor, and a person is not required to respond, to a collection of information that requires Office of 

Management and Budget (OMB) approval under the PRA, unless it has been approved by OMB and 

displays a valid OMB control number. The information 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 Request (ICR) document has been 

assigned EPA ICR number 1884.04 and OMB control number 2070-0162. This rule does/does not 

impose any new requirements that require additional OMB approval. 

The Paperwork Reduction Act mandates that 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, maintain, retain, disclose, or provide 

information to or for a federal agency. This includes the time needed by regulated entities to review 

instructions and to develop, acquire, install, and use technology and systems to collect, validate, verify, 

and disclose information. Time taken to adjust existing ways to comply with any previously applicable 

instructions and requirements and to train personnel to respond to the information collection task is also 

included. In this section, burden hours for both industry respondents and the government are estimated. 

In this report, total industry burden hours represent the sum of time spent on reporting and on other 

administrative activities. Industry respondents will spend time on the following activities associated with 

the IUR rule: compliance determination, rule familiarization, preparation and submission of reports, and 

recordkeeping. 

As derived in Section 4.5 of this report, EPA estimates that the proposed rule would impose a total 

estimated incremental industry burden of 1.56 million hours, if all proposed amendments are 
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9-2

implemented. The burden for the average site will increase by approximately 342 hours per site to 793 

hours. 

9.4 Executive Order 13132 - Federalism 

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to 

develop an accountable process to ensure “meaningful and timely input by State and local officials in the 

development of regulatory policies that have federalism implications.” “Policies that have federalism 

implications” is defined in the Executive Order to include regulations that have “substantial direct effects 

on the States, on the relationship between the national government and the States, or on the distribution of 

power and responsibilities among the various levels of government.” 

EPA has determined that this proposed rule does not have federalism implications because it will not 

have substantial direct effects on the states, on the relationship between the national government and the 

states, or on the distribution of power and responsibilities among the various levels of government, as 

specified in the Order. This rule simply amends the Inventory Update Reporting rule in several ways to 

provide information to better address Agency and public information needs, improve the usability and 

reliability of the reported data, and ensure that data are available in a timely manner. Because EPA has no 

information to indicate that any state or local government manufactures or processes the chemical 

substances covered by this action, the 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 Environmental 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 environmental 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 populations and low-income populations in the United 

States. 

The proposed rule does not have an adverse impact on the environmental and health conditions in 

low-income and minority communities that require special consideration by the Agency under EO 12898.

The Agency believes that the information collected under this proposed rule, if finalized, will assist EPA 

and others in determining the potential hazards and risks associated with the chemicals covered by the 

rule. Because the IUR rule is an information collection requirement, the information that will become 

available through the rule will enable the Agency to target educational, regulatory, or enforcement 

activities towards industries or chemicals that pose the greatest risks and/or to target programs for 

geographic areas that are at the highest risk. Thus, the information to be gathered under the rule will help 

EPA make decisions that will benefit potentially at-risk communities, some of which may be 

disadvantaged. 

The proposed rule is directed at manufacturers or importers of chemicals. All consumers of these 

chemical products and all workers who come into contact with these chemicals could benefit if data 

regarding the chemicals’ health and environmental effects were developed. Therefore, it does not appear 

that the costs and the benefits of the proposed rule will be disproportionately distributed across different 

geographic regions or among different categories of individuals. 
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9-3

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 examine the impacts of each 

regulatory action on children for any economically significant regulation (as defined by Executive Order 

12866) that the agency has reason to believe may disproportionately 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. Nevertheless, 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 disproportionately 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 action to investigate and mitigate those risks.

9.7 Executive Order 13175 – Consultation and Coordination with Indian Tribal 

Governments 

As required by Executive Order 13175, entitled Consultation and Coordination with Indian 

Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this proposed rule does 

not have tribal implications because it will not have any effect on tribal governments, on the relationship 

between the Federal government and the Indian tribes, or on the distribution of power and responsibilities 

between the Federal government and Indian tribes, as specified in the Order. Thus, Executive Order 

13175 does not apply to this rule. 

9.8 Executive Order 13211 – Energy Supply, Distribution, or Use 

This action is not a “significant energy action” as defined in Executive Order 13211, entitled Actions 

Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355 (May 

22, 2001)) because it is not likely to have a significant adverse effect on the supply, distribution, or use of 

energy. 

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) directs EPA to use voluntary consensus standards in 

its regulatory activities unless to do so would be inconsistent with applicable law or impractical. 

Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, 

sampling procedures, and business practices) that are 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 applicable voluntary consensus standards. 

This proposed action does not involve technical standards. Therefore, EPA did not consider the 

use of any voluntary consensus standards. 
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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 the 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-HQOPPT-2008-0251). October 2008. 

EPA, 2008c. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. 

2006 IUR Database Statistics for IUR Modifications Rule. Washington, DC. December 17, 2008. 

EPA, 2008d. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1884.04. [Information 

Collection Request for] Partial Update of the TSCA Section 8(b) Inventory Data Base, Production 
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10-2

and Site Report, Supporting Statement for a Request for OMB Review under the Paperwork 

Reduction Act. Washington, DC. September 5, 2008. 

EPA, 2009a. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. 

Chemicals Ineligible for Exemptions under Proposed IUR Modifications Rule. (2006 IUR Database 

Statistics). Washington, DC. May 12, 2009. 

EPA, 2009b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis 

Branch. Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule. 

(EPA-HQ-OPPT-2008-0296). Washington, DC. July 13, 2009. 

EPA, 2009c. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. 

IUR Company Names and Related Information.. (Database query results). Washington, DC. April 14, 

2009. 

EPA, 2009d. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. 

2002 IUR Database Statistics for IUR Modifications Rule. Washington, DC. April 30, 2009. 

EPA, 2009e. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. 

Email communication from Darryl Ballard to Wendy Hoffman. Washington, DC. May 19, 2009. 

EPA, 2009f. U.S. EPA, Office of Pollution Prevention and Toxics. TSCA Section 4 Federal Register 

Enforceable Consent Agreements. http://www.epa.gov/oppt/chemtest/pubs/4eca.html. Washington, 

DC. Updated October 1, 2009. 

EPA, 2009g. U.S. EPA, Office of Pollution Prevention and Toxics, Sunset Dates of Chemicals Subject to 

Final TSCA Section 4 and Related 12(b) Actions, Modified on September 1, 2009. 

http://www.epa.gov/oppt/chemtest/pubs/sunset.html. Washington, DC. Updated September 1, 2009. 

EPA, 2009h. U.S. EPA, Office of Pollution Prevention and Toxics, Chemical Control Division. Memo 

from Susan Sharkey to Wendy Hoffman. Washington, DC. September 8, 2009. 

OPM, 2008. Office of Personnel Management, Salary Table 2008-DCB, Washington Baltimore-Northern 

Virginia, DC-MD-PA-VA-WV. http://www.opm.gov/oca/08tables/pdf/DCB.pdf. 

U.S. Postal Service (USPS), 2009. USPS – Prices. http://www.usps.com/prices/. December 15, 2009. 
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 A-1

Appendix A. 2006 Form U 
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 A-2
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 B-1

Appendix B. Proposed Revised Form U 
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 B-2
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 B-3
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 C-1

Appendix C. – Current and 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, dyes1 

8. Coloring agents, pigments1

9. Corrosion inhibitors and anti-scaling agents 

10. Fillers 

11. Fixing agents* 

12. Flame retardants 

13. Flotation agents*

 

14. Fuels 

15. Functional fluids3

 

16. Intermediates 

17. Lubricants1

18. Odor agents2

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 processes2

 

25. Process regulators, other than polymerization or 

vulcanization processes2

 

26. Reducing agents2

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. Other1

 

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. Dyes1

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 additives1

18. Odor agents 

19. Oxidizing/reducing agents2

20. Photosensitive chemicals 

21. Pigments1

22. Plasticizers+

23. Plating agents and surface treating agents 

24. Process regulators2

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 the proposed amendment, but the definition of the category has not 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 divided into two categories under the proposed rule. *

 Indicates that a current industrial function category is being eliminated under the proposed rule. + Indicates that a current function category is added under the proposed rule. 
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 D-1

Appendix D. Current and Proposed Consumer and Commercial Product 

Categories 

EPA is proposing to revise the list of consumer and commercial product categories by combining 

categories that lead to common exposure scenarios and adding categories that were not adequately 

described in the current set of categories. 

Table D-1: List of Current and Proposed Consumer and Commercial Product Categories 

Current IUR Consumer and Commercial 

Product Categories 

Proposed IUR Consumer and Commercial 

Product Categories 

1. Adhesives and sealants 

2. Agricultural products (non-pesticidal) 

3. Artists' supplies 

4. Automotive care products 

5. Electrical and electronic products 

6. Fabrics, textiles and apparel 

7. Glass and ceramic products 

8. Lawn and garden products (non-pesticidal) 

9. Leather products 

10. Lubricants, greases and fuel additives 

11. Metal products 

12. Paints and coatings 

13. Paper products 

14. Photographic supplies 

15. Polishes and sanitation goods 

16. Rubber and plastic products 

17. Soaps and detergents 

18. Transportation products 

19. Wood and wood furniture 

20. Other 

21. Not readily obtainable 

Chemical Substances in Furnishing, Cleaning, 

Treatment/Care Products 

1. Floor Coverings 

2. Foam Seating and Bedding Products 

3. Furniture and Furnishings not covered elsewhere 

4. Fabric, Textile, and Leather Products not covered 

elsewhere 

5. Cleaning and Furnishing Care Products 

6. Laundry and Dishwashing Products 

7. Water Treatment Products 

8. Personal Care Products 

9. Air Care Products 

10. Apparel and Footwear Care Products 

Chemical Substances in Construction, Paint, 

Electrical, and Metal Products 

11. Adhesives and Sealants 

12. Paints and Coatings 

13. Building/Construction Materials - Wood and 

Engineered Wood Products 

14. Building/Construction Materials not covered 

elsewhere 

15. Electrical and Electronic Products 

16. Metal Products not covered elsewhere 

17. Batteries 

Chemical Substances in Packaging, Paper, Plastic, 

Toys, Hobby Products 

18. Food Packaging 

19. Paper Products 

20. Plastic and Rubber Products not covered 

elsewhere 

21. Toys, Playground, and Sporting Equipment 

22. Arts, Crafts, and Hobby Materials 

23. Ink, Toner, and Colorant Products 

24. Photographic Supplies, Film, and Photochemicals 

Chemical Substances in Automotive, Fuel, 

Agriculture, Outdoor Use Products 

25. Automotive Care Products 

26. Lubricants and Greases 

27. Anti-Freeze and De-icing Products 

28. Fuels and Related Products 

29. Explosive Materials 
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 D-2

30. Agricultural Products (non-pesticidal) 

31. Lawn and Garden Care Products 

Chemical Substances in Products not Described by 

Other Categories

32. Non-TSCA Use 

33. Other (specify) 
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 E-1

Appendix E. – Industrial Sectors 

EPA is proposing to replace the NAICS codes used in the industrial processing and use information 

section with a new set of Industrial Sectors, developed from the European Union’s REACH program. 

Code Sector Description

IS1 Agriculture, Forestry, Fishing and Hunting 

IS2 Oil and Gas Drilling, Extraction, and 

support activities 

IS3 Mining (except Oil and Gas) and support 

activities 

IS4 Utilities 

IS5 Construction 

IS6 Food, beverage, and tobacco product 

manufacturing 

IS7 Textiles, apparel, and leather 

manufacturing 

IS8 Wood Product Manufacturing 

IS9 Paper Manufacturing 

IS10 Printing and Related Support Activities 

IS11 Petroleum Refineries 

IS12 Asphalt Paving, Roofing, and Coating 

Materials Manufacturing 

IS13 Petroleum Lubricating Oil and Grease 

Manufacturing 

IS14 All other Petroleum and Coal Products 

Manufacturing 

IS15 Petrochemical Manufacturing 

IS16 Industrial Gas Manufacturing 

IS17 Synthetic Dye and Pigment Manufacturing 

IS18 Carbon Black Manufacturing 

IS19 All Other Basic Inorganic Chemical 

Manufacturing 

IS20 Cyclic Crude and Intermediate 

Manufacturing 

IS21 All Other Basic Organic Chemical 

Manufacturing 

IS22 Plastics Material and Resin Manufacturing 

IS23 Synthetic Rubber Manufacturing 

IS24 Organic Fiber Manufacturing 

IS25 Pesticide, Fertilizer, and Other Agricultural 

Chemical Manufacturing 

IS26 Pharmaceutical and Medicine 

Manufacturing 

IS27 Paint and Coating Manufacturing 

IS28 Adhesive Manufacturing 

IS29 Soap, Cleaning Compound, and Toilet 

Preparation Manufacturing 

IS30 Printing Ink Manufacturing 

IS31 Explosives Manufacturing 

IS32 Custom Compounding of Purchased 

Resins 

IS33 Photographic Film, Paper, Plate, and 

Chemical Manufacturing 

Code Sector Description

IS34 All Other Chemical Product and 

Preparation Manufacturing 

IS35 Plastics Product Manufacturing 

IS36 Rubber Product Manufacturing 

IS37 Nonmetallic Mineral Product 

Manufacturing (includes clay, glass, 

cement, concrete, lime, gypsum, and other 

nonmetallic mineral product 

manufacturing) 

IS38 Primary Metal Manufacturing 

IS39 Fabricated Metal Product Manufacturing 

IS40 Machinery Manufacturing 

IS41 Computer and Electronic Product 

Manufacturing 

IS42 Electrical Equipment, Appliance, and 

Component Manufacturing 

IS43 Transportation Equipment Manufacturing 

IS44 Furniture and Related Product 

Manufacturing 

IS45 Miscellaneous Manufacturing 

IS46 Wholesale and Retail Trade 

IS47 Services 

IS48 Other (requires additional information) 
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 F-1

Appendix F. – Sensitivity Analyses 

Some of EPA’s proposed amendments to the IUR rule are expected to change the number of 

submitters, reports, or the number of responses to a specific question on Form U. For several options, data 

available from the 2006 IUR was used to directly estimate the number of chemicals or submitters affected 

by the amendment. For example, the number of submitters who produce manufactured water above the 

threshold is known. However, a lack of available data for other amendments meant that EPA only was 

able to estimate the impact broadly, such as a percentage increase or decrease in the number of submitters 

caused by the amendment, using the Agency’s best professional judgment. These amendments include (1) 

the method for determining whether the threshold is met; (2) reporting production volume used on-site; 

(3) requiring write-in text if submitter selects “Other” as a product function category (4) requiring writein text if selecting “Other” as a consumer or commercial use; and, (5) upfront substantiation for all 

processing and use information CBI claims. In estimating the cost of these amendments, EPA used a 

midpoint estimate for the percentage increase or decrease 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 that 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 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 increase in cost and burden to industry using a 

midpoint estimate of five percent. Using a five percent increase in the number of sites and reports, EPA 

expects the burden to industry will increase by approximately 92,000 hours (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 number 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 industry is expected to range from zero 

hours to 184,000 hours as a result of modifying the method for determining whether the 25,000 lb. 

threshold is met. 

Table F-1: Sensitivity Analysis of Industry Burden Estimates for Modifying the Method for 

Determining Whether the Threshold Is Met 

Number of Sites Number of Reports 

(with Part II) 

Number of Reports 

(with Part III) Burden to Industry Burden (hours) 

Prepare Part I, 

Rule 

Familiarization, 

Compliance 

Determination, 

and Submission 

(hours per site) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Burden 

to 

Prepare 

Part II 

and 

Record 

Keeping 

(hours 

per 

report) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Burden 

to 

Prepare 

Part III 

(hours 

per 

report) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(0% 

increase) 

Lower 

Bound 

(10% 

increase) 

Upper 

Bound 

(10% 

increase) 

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

(c d)+(ef) 

Baseline 33.26 4,085 4,085 19.82 25,896 25,896 69.92 17,075 17,075 1,744,894 1,842,934 

PostAmendment 33.26 4,085 4,494 19.82 25,896 28,486 69.92 17,075 18,783 1,744,894 2,027,227 

Change 

from the 

Baseline 

0.00 0 409 0.00 0 2,590 0.00 0 1,708 0 184,293 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the post-amendment value.
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 F-2

Table F-2 shows the range of cost estimates using a zero percent lower bound and ten percent upper 

bound increase in the number of reports and submitters as a result of the proposed amendment. All 

baseline cost estimates are taken from Table 4-5. EPA estimates a cost to industry between $0 and $10.7 

million. The midpoint cost estimate of $5.35 million is used in Table 4-13. 

Table F-2: Sensitivity Analysis of Industry Cost Estimates for Modifying the Method for 

Determining Whether the Threshold Is Met 

Number of Sites Number of Reports 

(with Part II) 

Number of Reports 

(with Part III) 

Industry Cost Cost to Prepare (millions 2008$) Part I, Rule 

Familiarization, 

Compliance 

Determination 

and Submission 

(2008$ per site) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Cost to 

Prepare 

Part II 

and 

Record 

Keeping 

(2008$ 

per 

report) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Cost to 

Prepare 

Part III 

(2008$ 

per 

report) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

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

(c d)+(ef) 

Baseline $2,058.18 4,085 4,085 $1,129.42 25,896 25,896 $4,059.25 17,075 17,075 $106.97 $106.97 

PostAmendment $2,058.18 4,085 4,494 $1,129.42 25,896 28,486 $4,059.25 17,075 18,783 $106.97 $117.66 

Change 

from the 

Baseline 

$0.00 0 409 $0.00 0 2,590 $0.00 0 1,708 $0.00 $10.70 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding 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 increase in the number of reports, the Agency’s burden is expected to increase by 104 hours (see 

Table 5-5). The range in the burden increase to EPA, using a lower bound zero percent increase in the 

number reports and an upper bound increase of ten percent, is presented in Table F-3. Baseline Agency 

burden is taken from Table 5-4. The proposed amendment is expected to increase the Agency burden by 

between zero and 208 hours. 

Table F-3: Sensitivity Analysis of Agency Burden Estimates for Modifying the Method for 

Determining Whether the Threshold Is Met 

Number of Sites Number of Reports 

(with Part II) 

Number of Reports 

(with Part III) 

Industry Burden 

(hours) Burden 

to 

Process 

Part I 

(hours) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Burden 

to 

Process 

Part II 

(hours) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Burden 

to 

Process 

Part 

III 

(hours) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

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

(cd)+(ef) 

Baseline 0.017 4,085 4,085 0.042 25,896 25,896 0.054 17,075 17,075 2,080 2,080 

PostAmendment 0.017 4,085 4,494 0.042 25,896 28,486 0.054 17,075 18,783 2,080 2,288 

Change 

from the 

Baseline 

0.000 0 409 0.000 0 2,590 0.000 0 1,708 0 208 

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

Table F-4 shows the range in Agency costs as a result of modifying the method for determining 

whether the threshold is met. Baseline Agency 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. 
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Table F-4: Sensitivity Analysis of Agency Cost Estimates for Modifying the Method for 

Determining Whether the Threshold Is Met 

Number of Sites Number of Reports 

(with Part II) 

Number of Reports 

(with Part III) 

Industry Cost 

(2008$) Cost 

to 

Process 

Part I 

(2008$) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Cost to 

Process 

Part II 

(2008$) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Cost to 

Process 

Part 

III 

(2008$) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

Lower 

Bound 

(0% 

increase) 

Upper 

Bound 

(10% 

increase) 

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

(cd)+(ef) 

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

PostAmendment $1.78 4,085 4,494 $4.40 25,896 28,486 $5.61 17,075 18,783 $216,949 $238,644 

Change 

from the 

Baseline 

$0.00 0 409 $0.00 0 2,590 $0.00 0 1,708 $0 $21,695 

Note: Values in Change from the Baseline rows are calculated by subtracting the 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 that between 14.8 percent of all reports (the percentage of reports which 

included a site-limited volume in 2006 reporting (EPA 2008c)) and 24 percent of all reports (the 

percentage of 2006 reports which claim the chemicals is an intermediate in the downstream use and 

processing section (EPA, 2008c)) would report production 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 number of reports 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 industry burden to range from 5,800 to 9,400 hours. 

Table F-5: Sensitivity Analysis of Industry Burden 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 OnSite (hours) 

Lower Limit 

(14.8% of all 

Reports) 

Upper Limit 

(24% of all 

Reports) 

Lower Limit 

(14.8% of 

all Reports) 

Upper Limit 

(24% of all 

Reports) 

Baseline 0.00 0 0 0 0 

Post-Amendment 1.51 3,833 6,215 5,795 9,397 

Change from the 

Baseline 1.51 3,833 6,215 5,795 9,397 

Note: Values in Change from the Baseline rows are calculated by subtracting the 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 proposed amendment. All baseline cost estimates are 

taken from Table 4-5. EPA estimates a cost to industry between $324,500 and $526,300, with a midpoint 

estimate of $0.43 million (see Table 4-25). 
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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 

Cost per Report Total Industry Cost (2008$) 

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.

The burden to the Agency, 4.51 hours, of requiring the reporting of production volume used on-site, 

where an estimated 19.4 percent of reports list production volume is used on-site is calculated in Section 

5.4.13. Table F-7 contains the range of burden estimates to the Agency, 3.44 to 5.57 hours per reporting 

cycle. The baseline burden per report is taken from Table 5-4. 

Table F-7: Sensitivity Analysis of Agency Burden 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 OnSite (hours) 

Lower Limit 

(14.8% of all 

Reports) 

Upper Limit 

(24% of all 

Reports) 

Lower Limit 

(14.8% of 

all Reports) 

Upper Limit 

(24% of all 

Reports) 

Baseline 0.000 0 0 0.00 0.00 

Post-Amendment 0.001 3,833 6,215 3.44 5.57 

Change from the 

Baseline 0.001 3,833 6,215 3.44 5.57 

Note: Values in Change from the Baseline rows are calculated by subtracting the 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 costs to EPA are taken from Table 5-4. The proposed amendment 

is expected to increase the Agency cost between approximately $359 and $581 during the first reporting 

cycle. 
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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 hours and cost increase of $260,000 are calculated in 

Section 4.4.18. 

The Agency conducted a sensitivity analysis for these estimates, with the decrease in reports selecting 

“Other” ranging from a 25 percent reduction of the total (905 reports in total) to a 75 percent reduction in 

total (302 reports in total). The results of this analysis for industry burden are found in Table F-9. A 75 

percent reduction in the number of submitters claiming “Other” means that 25 percent of submitters are 

now claiming “Other,” and a 25 percent reduction means that 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. 

Baseline burden estimates are taken from Table 4-2 and the baseline number of reports is found in 

Table 4-6. EPA estimates the burden to industry will increase by between 4,300 and 4,400 hours. 
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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 0 146,661 146,661 

PostAmendment 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 lower bound estimate of a 75 

percent decrease in the number of reports with “Other” 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, with a midpoint estimate of $256,000 (see Table 4-33). 

Table F-10: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” 

as an Industrial Function Category 

Number of Reports with 

“Other” Write-in Text 

Total Industry Cost 

(2008$) 

 

Cost for Rule 

Familiarization 

of Additional 

Categories 

(2008$) 

Number 

of Reports 

with 

Industrial 

Function 

Categories 

Cost for 

Write-in 

Text for 

"Other" 

(2008$) 

Lower 

Bound 

(25% of 

Submitters

Claim 

"Other") 

Upper 

Bound 

(75% of 

Submitters

Claim 

"Other") 

Lower 

Bound 

(25% of 

Submitters 

Claim 

"Other") 

Upper 

Bound 

(75% of 

Submitters 

Claim 

"Other") 

Baseline $88.02 17,075 $0.00 0 0 $1,502,913 $1,502,913 

PostAmendment $102.73 17,075 $7.31 302 905 $1,756,287 $1,760,693 

Change 

from the 

Baseline 

$14.71 0 $7.31 302 905 $253,374 $257,780 

Note: Values in Change from the Baseline rows are calculated by subtracting the 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 hours per reporting cycle. The baseline Agency burden 

estimates per report are taken from Table 5-4. 
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Table F-11: Sensitivity Analysis of Agency Burden 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. Baseline 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 corresponding baseline value from the post-amendment value

F.4 “Other” as a Consumer and/or Commercial Product Category 

EPA is proposing to revise the list of consumer and commercial product categories by combining 

categories that lead to common exposure scenarios and adding categories that were not adequately 

described in the current set of categories. The resultant proposed list 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 also proposing to require that if the 

product category “Other” is selected; a descriptor for the consumer and/or commercial product containing 

the chemical substance must also 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 that the new categories in the proposed amendment will reduce by half the 

number of submitters selecting “Other” as a consumer and/or commercial product category. Therefore, 

this amendment would affect 604 reports. The cost and burden to industry with a 50 percent reduction in 

the number of submitters is found in Section 4.4.20. 
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 F-8

The Agency conducted a sensitivity analysis for the decrease in reports selecting “Other” ranging 

from a 25 percent reduction of the total (905 reports in total) to a 75 percent reduction of the total (302 

reports in total). The results of this analysis for industry are found in Table F-13. Baseline burden 

estimates are taken from Table 4-2 and the baseline number of reports is found in Table 4-6. EPA 

estimates the burden to industry will increase between 16,000 and 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 0 146,661 146,661 

PostAmendment 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 

decrease in the number of “Other” as a consumer and/or commercial product category and an upper 

bound of a 25 percent decrease in the number of “Other” as a consumer and/or commercial product 

categories. All baseline cost estimates are taken from Table 4-5. EPA estimates a cost to industry of 

between $843,000 and $848,000, with a 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 
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 F-9

of burden estimates to the Agency; 0.27 hour to 0.81 hours per reporting cycle. The baseline Agency 

burden estimates per report are taken from Table 5-4. 

Table F-15: Sensitivity Analysis of Agency 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 Agency Burden Burden to (hours) Process 

Write-in 

Text for 

"Other" 

(hours) 

Lower Bound 

(25% of 

Submitters 

Claim 

"Other") 

Upper Bound 

(75% of 

Submitters 

Claim 

"Other") 

Lower Bound 

(25% of 

Submitters 

Claim 

"Other") 

Upper Bound 

(75% of 

Submitters 

Claim 

"Other") 

Baseline 0.000 0 0 0.00 0.00 

Post-Amendment 0.001 302 905 0.27 0.81 

Change from the 

Baseline 0.001 302 905 0.27 0.81 

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

Table F-16 shows the range in costs to EPA as a result of modifying the consumer and commercial 

product categories. Baseline costs to EPA are taken from Table 5-4. The proposed amendment is expected 

to increase the Agency cost between $28 and approximately $85 during the first reporting cycle. 

Table F-16: Sensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for “Other” 

as a Consumer and/or Commercial Product Category 

Number of Reports with "Other" 

Write-in Text 

Total Agency Cost 

(2008$) 

Lower Bound 

(25% of 

Submitters 

Claim 

"Other") 

Upper Bound 

(75% of 

Submitters 

Claim 

"Other") 

Lower Bound 

(25% of 

Submitters 

Claim 

"Other") 

Upper Bound 

(75% of 

Submitters 

Claim 

"Other") 

Baseline 0 0 $0 $0 

Post-Amendment 302 905 $28 $85 

Change from the 

Baseline 302 905 $28 $85 

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

F.5 Upfront CBI Substantiation 

EPA is requiring an upfront substantiation when a submitter claims processing and use information as 

confidential business information (CBI). In 2002, when EPA first required upfront substantiation for 

claiming plant site IDs as CBI, the Agency saw a 64 percent reduction in the number of CBI claims. The 

Agency expects the number of DPU CBI claims to decrease by the same amount as a result of this 

proposed amendment. According to 2006 IUR data (EPA, 2008c), a total of 8,133 reports had claimed 

that processing and use information was CBI, with an average of three CBI claims for processing and use 

information per report. The estimates for industry cost of $773,000 and burden of 12,800 hours, 

associated with the 8,133 CBI claims are found in Section 4.4.25. 
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The Agency conducted a sensitivity analysis, assuming the reduction in CBI claims has a lower 

bound of 84 percent, meaning that 16 percent of submitters make a CBI claim in Part III, and an upper 

bound of 44 percent, meaning that 56 percent of submitters make a CBI claim in Part III. Table F-17 

contains range in burden increase to industry as a result of the proposed amendment. The burden is 

expected to increase by between 5,700 and 19,900 hours. 

Table F-17: Sensitivity Analysis of Industry Burden Estimates for Requiring Upfront CBI 

Substantiation 

Number of Reports with CBI 

Claims in Part III 

Industry Burden 

 (hours) 

 

Burden for 

Upfront CBI 

Substantiation 

for CBI 

Claims in Part 

III (hours) 

Lower Limit 

 (16% of 

Submitters 

Claim CBI) 

Upper Limit 

(56% of 

Submitters 

Claim CBI) 

Lower Limit 

(16% of 

Submitters 

Claim CBI) 

Upper Limit 

(56% of 

Submitters 

Claim CBI) 

Baseline 0.00 8,133 8,133 0 0 

PostAmendment 4.38 1,301 4,554 5,700 19,949 

Change 

from the 

Baseline 

4.38 -6,832 -3,579 5,700 19,949 

Note: Values in Change from the Baseline rows are calculated by 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 number 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 

estimates to the Agency, which is 3.50 hours to 12.25 hours per reporting cycle. The baseline Agency 

burden estimates per report are taken from Table 5-4. 
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 F-11

Table F-19: Sensitivity Analysis of Agency Burden Estimates for Requiring Upfront CBI 

Substantiation 

Number of Reports with CBI 

Claims in Part III 

Agency Burden 

 (hours) Burden for 

Upfront CBI 

Substantiation 

for CBI 

Claims in Part 

III (hours) 

Lower Limit 

(16% of 

Submitters 

Claim CBI) 

Upper Limit 

(56% of 

Submitters 

Claim CBI) 

Lower Limit 

(16% of 

Submitters 

Claim CBI) 

Upper Limit 

(56% of 

Submitters 

Claim CBI) 

Baseline 0.00 8,133 8,133 0 0 

PostAmendment 0.28 1,301 4,554 3.50 12.25 

Change 

from the 

Baseline 

0.28 -6,832 -3,579 3.50 12.25 

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

value.

Table F-20 contains the range in costs to EPA as a result of modifying the industrial function 

categories. Baseline costs to EPA are taken from 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 subtracting the corresponding baseline value from the post-amendment 

value.
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 G-1

Appendix G. – Alternative Regulatory Options 

In developing the proposed amendments to the IUR rule, EPA considered other regulatory options as 

alternatives to some of the proposed amendments. These 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 alternate regulatory options are described in the sections below. 

G.1 Require Submitters to Submit Full Data Annually 

As an alternative to the amendment described in Section 3.5.4, which would require submitters to 

report production volume for each of the years since the last IUR report, EPA considered an option in 

which submitters would be required to submit all Form U data for each year they meet or exceed the 

reporting threshold. EPA calculated the cost and burden of this option under two different scenarios. The 

first calculates the cost and burden to the industry and the Agency without considering the other proposed 

amendments. The section scenario estimates the cost and burden to all affected entities if all the proposed 

amendments outlined in Section 3. are enacted. 

G.1.1 Annual Reporting Cost and Burden when the Option is Considered by Itself 

Under this alternative option, EPA estimated the cost to the industry and the Agency of annual 

reporting when the option is considered by itself, with none of the other proposed amendments 

considered. The annual reporting cost and burden 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. While the Agency is 

aware that a site’s production volume may vary yearly, causing the site to meet or exceed the 

threshold in some years but not in others, EPA believes that on average, the total number of sites 

and reports would remain unchanged from year to year. 

EPA analyzed the burden and costs over a 20-year period. EPA assumes that submitters will become 

more efficient at reporting data over time, and therefore incur a smaller burden in future reporting cycles. 

Future-cycle reporting burden is taken from Table 4-11. 

The annual industry burden under the baseline and the alternative option is shown in Table G-1. In 

total, EPA estimates that the industry burden would increase by approximately 22.94 million hours over 

20 years (four reporting cycles). Over one five-year reporting cycle, the industry burden is expected to 

increase by 5.74 million hours (1.43 million hours x 4 years) compared to the baseline. 

Table G-1: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data 

Annually 

Year Baseline Burden 

(millions of hours) 

Post-Alternative 

Option Burden 

(millions of hours) 

Change from Baseline 

(millions of hours) 

2011 1.84 1.84 0.00 

2012 0.00 1.43 1.43 

2013 0.00 1.43 1.43 

2014 0.00 1.43 1.43 

2015 0.00 1.43 1.43 

2016 1.43 1.43 0.00 

2017 0.00 1.43 1.43 

2018 0.00 1.43 1.43 

2019 0.00 1.43 1.43 

2020 0.00 1.43 1.43 
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 G-2

Year Baseline Burden 

(millions of hours) 

Post-Alternative 

Option Burden 

(millions of hours) 

Change from Baseline 

(millions of hours) 

2021 1.43 1.43 0.00 

2022 0.00 1.43 1.43 

2023 0.00 1.43 1.43 

2024 0.00 1.43 1.43 

2025 0.00 1.43 1.43 

2026 1.43 1.43 0.00 

2027 0.00 1.43 1.43 

2028 0.00 1.43 1.43 

2029 0.00 1.43 1.43 

2030 0.00 1.43 1.43 

Total 6.14 29.09 22.94

Annual Average 0.31 1.45 1.15

The industry cost under the baseline and this alternative option is shown in Table G-2. EPA estimates 

that the industry cost would increase by $1.33 billion over a 20-year period. The annualized cost increase 

ranges from $63.95 million with a seven percent discount rate and $65.26 million with a three percent 

discount rate. Over one five-year reporting cycle, this option would increase industry cost by 

approximately $331 million ($82.8 million x 4 years) compared to the baseline. 

Table G-2: Industry Cost under the Alternative Option to Require Submitters to Submit Full Data 

Annually 

Year Baseline Cost 

(2008$ millions) 

Post-Alternative 

Option Cost 

(2008$ millions) 

Change from Baseline 

(2008$ millions) 

2011 $106.97 $106.97 $0.00 

2012 $0.00 $82.82 $82.82 

2013 $0.00 $82.82 $82.82 

2014 $0.00 $82.82 $82.82 

2015 $0.00 $82.82 $82.82 

2016 $82.82 $82.82 $0.00

2017 $0.00 $82.82 $82.82

2018 $0.00 $82.82 $82.82

2019 $0.00 $82.82 $82.82

2020 $0.00 $82.82 $82.82

2021 $82.82 $82.82 $0.00

2022 $0.00 $82.82 $82.82

2023 $0.00 $82.82 $82.82

2024 $0.00 $82.82 $82.82

2025 $0.00 $82.82 $82.82

2026 $82.82 $82.82 $0.00

2027 $0.00 $82.82 $82.82

2028 $0.00 $82.82 $82.82

2029 $0.00 $82.82 $82.82

2030 $0.00 $82.82 $82.82

Total $355.42 $1,680.50 $1,325.08 

Annual Average $17.77 $84.03 $66.25 
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 G-3

Annualized at 3% $19.13 $84.39 $65.26 

Annualized at 7% $21.01 $84.95 $63.94 

 

The baseline burden to EPA during each reporting 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, more frequent 

reporting would increase costs to the Agency. Table G-3 contains the total Agency burden of the annual 

reporting option, over a 20-year period. EPA estimates that Agency burden would increase by a total of 

66,600 hours over a 20-year period (four reporting cycles). Over one five-year reporting cycle, the 

Agency burden would increase by 16,600 hours (4,160 hours x 4 years) compared to the baseline. 

Table G-3: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data 

Annually 

Year Baseline Burden 

(hours) 

Post-Alternative 

Option Burden 

(hours) 

Change from Baseline 

(hours) 

2011 4,160 4,160 0.00 

2012 0.00 4,160 4,160 

2013 0.00 4,160 4,160 

2014 0.00 4,160 4,160 

2015 0.00 4,160 4,160 

2016 4,160 4,160 0.00

2017 0.00 4,160 4,160

2018 0.00 4,160 4,160

2019 0.00 4,160 4,160

2020 0.00 4,160 4,160

2021 4,160 4,160 0.00

2022 0.00 4,160 4,160

2023 0.00 4,160 4,160

2024 0.00 4,160 4,160

2025 0.00 4,160 4,160

2026 4,160 4,160 0.00

2027 0.00 4,160 4,160

2028 0.00 4,160 4,160

2029 0.00 4,160 4,160

2030 0.00 4,160 4,160

Total 16,640 83,200 66,560 

Annual Average 832 4,160 3,328 

The annual Agency cost under the baseline and the alternative option is shown in Table G-4, and is 

taken from Table 5-3. In total, EPA estimates that this option would increase the Agency cost by 

approximately $1.86 million over one five-year reporting cycle. Over a 20-year period, the annualized 

Agency cost is expected to increase between $359,900 with a seven percent discount rate, and $367,300 

with a three percent discount rate compared to the baseline. 
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 G-4

Table G-4: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data 

Annually 

Year Baseline Cost 

(2008$) 

Post-Alternative 

Option Cost 

(2008$) 

Change from 

Baseline 

(2008$) 

2011 $466,133 $466,133 $0.00 

2012 $0.00 $466,133 $466,133 

2013 $0.00 $466,133 $466,133 

2014 $0.00 $466,133 $466,133 

2015 $0.00 $466,133 $466,133 

2016 $466,133 $466,133 $0.00

2017 $0.00 $466,133 $466,133

2018 $0.00 $466,133 $466,133

2019 $0.00 $466,133 $466,133

2020 $0.00 $466,133 $466,133

2021 $466,133 $466,133 $0.00

2022 $0.00 $466,133 $466,133

2023 $0.00 $466,133 $466,133

2024 $0.00 $466,133 $466,133

2025 $0.00 $466,133 $466,133

2026 $466,133 $466,133 $0.00

2027 $0.00 $466,133 $466,133

2028 $0.00 $466,133 $466,133

2029 $0.00 $466,133 $466,133

2030 $0.00 $466,133 $466,133

Total $1,864,532 $9,322,660 $7,458,128 

Annual Average $93,227 $466,133 $372,906 

Annualized at 3% $98,818 $466,133 $367,315 

Annualized at 7% $106,248 $466,133 $359,885 

G.1.2 Annual Reporting Cost and Burden when the All the Proposed Amendments are 

Considered 

EPA estimated the cost and burden of annual reporting in addition to the proposed amendments 

outlined in Chapter 3. Under this alternative, the annual reporting cost and burden would be the same as 

the burden when all the amendments are considered, as shown in Table 4-49. The number of submitters is 

not expected to change from year to year. 

The industry burden of annual reporting is shown in Table G-5. The annual reporting option is 

expected to increase the industry burden by approximately 39.59 million hours over a 20-year period, for 

a total industry burden of 53.55 million hours. EPA estimates that over one four-year reporting cycle 

(note that under the proposed amendments, a reporting cycle would be changed to four years) the industry 

burden would increase by approximately 7.92 million hours (2.64 million hours x 3 years) compared to 

the baseline. 
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 G-5

Table G-5: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data 

Annually when all the Proposed Amendments are Considered 

Year 

Total Burden 

When all Proposed 

Amendments are 

Considered 

(millions of hours) 

Post-Alternative Option Burden 

(millions of hours) 

Total Change in 

Industry Burden 

(millions of hours) 

2011 3.40 3.40 0.00 

2012 0.00 2.64 2.64 

2013 0.00 2.64 2.64 

2014 0.00 2.64 2.64 

2015 2.64 2.64 0.00 

2016 0.00 2.64 2.64 

2017 0.00 2.64 2.64 

2018 0.00 2.64 2.64 

2019 2.64 2.64 0.00 

2020 0.00 2.64 2.64 

2021 0.00 2.64 2.64 

2022 0.00 2.64 2.64 

2023 2.64 2.64 0.00 

2024 0.00 2.64 2.64 

2025 0.00 2.64 2.64 

2026 0.00 2.64 2.64 

2027 2.64 2.64 0.00 

2028 0.00 2.64 2.64 

2029 0.00 2.64 2.64 

2030 0.00 2.64 2.64 

Total 13.96 53.55 39.59 

Annual Average 0.70 2.68 1.98 

The industry baseline cost is taken from Table 4-50. EPA estimates that annual reporting would 

increase industry cost by approximately $2.43 billion over a 20-year period. The change in annualized 

cost ranges from $117 million with a seven percent discount rate to $120 million with a three percent 

discount rate as shown in Table G-6. Over one four-year reporting cycle, this option would increase 

industry cost by approximately $486 million ($162.12 x 3 years) compared to the baseline. 

Table G-6: Industry Cost under the Alternative Option to Require Submitters to Submit Full Data 

Annually when all the Proposed Amendments are Considered 

Year 

Total Cost When all Proposed 

Amendments are Considered 

 (2008$ millions) 

Post-Alternative 

 Option Cost 

(2008$ millions) 

Total Change in 

Industry Cost 

(2008$ millions) 

2011 $209.04 $209.04 $0.00 

2012 $0.00 $162.12 $162.12 

2013 $0.00 $162.12 $162.12 

2014 $0.00 $162.12 $162.12 

2015 $162.12 $162.12 $0.00 

2016 $0.00 $162.12 $162.12 

2017 $0.00 $162.12 $162.12 

2018 $0.00 $162.12 $162.12 
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 G-6

Year 

Total Cost When all Proposed 

Amendments are Considered 

 (2008$ millions) 

Post-Alternative 

 Option Cost 

(2008$ millions) 

Total Change in 

Industry Cost 

(2008$ millions) 

2019 $162.12 $162.12 $0.00 

2020 $0.00 $162.12 $162.12 

2021 $0.00 $162.12 $162.12 

2022 $0.00 $162.12 $162.12 

2023 $162.12 $162.12 $0.00 

2024 $0.00 $162.12 $162.12 

2025 $0.00 $162.12 $162.12 

2026 $0.00 $162.12 $162.12 

2027 $162.12 $162.12 $0.00 

2028 $0.00 $162.12 $162.12 

2029 $0.00 $162.12 $162.12 

2030 $0.00 $162.12 $162.12 

Total $857.53 $3,289.37 $2,431.84 

Annual Average $42.88 $164.47 $121.59 

Annualized at 3% $45.41 $165.18 $119.78 

Annualized at 7% $48.87 $166.26 $117.39 

The Agency baseline burden when all the proposed amendments are considered is taken from Table 

5-40. The annual reporting option is expected to increase Agency burden by approximately 36,840 hours 

when all amendments are considered (see Table G-7). Over a four-year reporting cycle, EPA estimates 

that Agency burden would increase by approximately 7,400 hours (2,456 hours x 3 years) compared to 

the baseline. 

Table G-7: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data 

Annually when all the Proposed Amendments are Considered 

Year 

Total Burden 

When all Proposed 

Amendments are Considered 

 (hours) 

Post-Alternative 

 Option Burden 

(hours) 

Total Change in 

Agency Burden 

(hours) 

2011 2,456 2,456 0 

2012 0 2,456 2,456 

2013 0 2,456 2,456 

2014 0 2,456 2,456 

2015 2,456 2,456 0 

2016 0 2,456 2,456 

2017 0 2,456 2,456 

2018 0 2,456 2,456 

2019 2,456 2,456 0 

2020 0 2,456 2,456 

2021 0 2,456 2,456 

2022 0 2,456 2,456 

2023 2,456 2,456 0 

2024 0 2,456 2,456 

2025 0 2,456 2,456 

2026 0 2,456 2,456 
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 G-7

Year 

Total Burden 

When all Proposed 

Amendments are Considered 

 (hours) 

Post-Alternative 

 Option Burden 

(hours) 

Total Change in 

Agency Burden 

(hours) 

2027 2,456 2,456 0 

2028 0 2,456 2,456 

2029 0 2,456 2,456 

2030 0 2,456 2,456 

Total 12,280 49,120 36,840 

Annual Average 614 2,456 1,842 

The baseline Agency cost when all the proposed amendments are enacted is taken from Table 5-41. 

The total Agency cost under the annual reporting option when all proposed amendments are considered is 

shown in Table G-8. Over a 20-year period, Agency cost would increase by $4.33 million with annualized 

costs increases ranging from approximately $209,000 with a seven percent discount rate to $213,000 with 

a three percent discount rate. Over one four-year reporting cycle, the Agency cost is expected to increase 

by $865,000 ($288,450 x 3 years) compared to the baseline. 

Table G-8: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data 

Annually when all the Proposed Amendments are Considered 

Year 

Total Cost 

When all Proposed 

Amendments are Considered 

(2008$) 

Post-Alternative 

Option Cost 

(2008$) 

Total Change in 

Agency Cost 

(2008$) 

2011 $288,450 $288,450 $0 

2012 $0.00 $288,450 $288,450 

2013 $0.00 $288,450 $288,450 

2014 $0.00 $288,450 $288,450 

2015 $288,450 $288,450 $0 

2016 $0.00 $288,450 $288,450 

2017 $0.00 $288,450 $288,450 

2018 $0.00 $288,450 $288,450 

2019 $288,450 $288,450 $0 

2020 $0.00 $288,450 $288,450 

2021 $0.00 $288,450 $288,450 

2022 $0.00 $288,450 $288,450 

2023 $288,450 $288,450 $0 

2024 $0.00 $288,450 $288,450 

2025 $0.00 $288,450 $288,450 

2026 $0.00 $288,450 $288,450 

2027 $288,450 $288,450 $0 

2028 $0.00 $288,450 $288,450 

2029 $0.00 $288,450 $288,450 

2030 $0.00 $288,450 $288,450 

Total $1,442,250 $5,769,000 $4,326,750 

Annual Average $72,113 $288,450 $216,338 

Annualized at 3% $75,341 $288,450 $213,109 

Annualized at 7% $79,587 $288,450 $208,863 
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 G-8

G.1.3 Small Entity Analysis 

The following section provides a preliminary assessment of the impact that annual Form U 

submissions may have on small entities by examining the relationship between the compliance costs and 

company sales for small companies. This analysis is based on the methodology described in Chapter 8 of 

this report. All costs and burdens are estimated under the assumption that all the proposed amendments 

are enacted. 

EPA estimated in Chapter 8 of this report that there are 3.89 manufacturing sites per global parent 

company; 41.3 percent of global parent companies (466 companies) are considered small under the SBA 

employment-based definition11, and 24.8 percent (280 companies) are considered small under the TSCA 

sales-based definition12. 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 estimated average annual sales revenue of global parent 

companies considered small under either definition using data from Dun & Bradstreet, as also described 

in Chapter 8. 

Table 4-50 shows the annual incremental cost of the rule to industry. Because this cost would be 

incurred once every year under an annual reporting cycle, it was not discounted. As shown in Table G-9 

below, these costs were divided by the total number of sites expected to submit data, for the annualized 

costs per site. This was multiplied by the number of sites per small parent company to arrive at the 

annualized costs per small parent company. This value was divided by the annual sales per small parent 

company to derive the cost-to-sales ratio. 

As shown in Table G-9, under the employment-based definition, a small parent company affected by 

the rule on average has sales of more than $412.7 million. The annual costs of the proposed IUR rule 

amendments per small parent company, however, are $41,886. The cost-to-sales ratio for an average 

small company under the employment-based SBA definition 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 $45,649. The cost-tosales ratio for an average small company under the sales-based definition would be 0.387 percent or less. 

Using the highest annual cost shown in Table G-9 of $45,649, a small company would have to have 

annual sales of less than $4.56 million in order to have a cost-to-sales ratio larger than one percent. 

 

11 Threshold of 1,000 employees. 12 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual 

production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of 

the company, combined with those of any parent company, are below $4 million. 
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 G-9

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 Annual Costs $102,073,745 

Total Number of Sites 4,289 

Annual costs per site $23,799 

Number of sites per small parent company 1.76 1.92 

Annualized costs per small parent company $41,886 $45,694 

Annual sales per small parent company $412,713,310 $11,821,104 

Cost-to-sales ratio 0.01% 0.387% 

Number of companies potentially affected 466 280 

G.2 Modify Reporting Frequency to a Three-Year Cycle 

As an alternative to the proposed amendment described in Section 3.13, which would modify the 

reporting frequency to a four-year cycle, the Agency 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 not change, but the longer-term burden to industry will 

increase because reporting will become more frequent. However, the Agency assumes that no additional 

reports will be submitted as a result of reducing the length of the reporting cycle. (While the mix of 

chemicals might change, EPA assumes that 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 industry burden is taken from Table 4-10 for the first reporting cycle and from Table 4-11 for 

all future reporting cycles. In total, EPA estimates that under this option, industry would incur an 

additional burden of 4.30 million hours over a 20-year period. 

Table G-10: Annual Industry Burden under the Alternative Option of a Three-Year Reporting Cycle 

Year 

Baseline 

Burden 

(millions of 

hours) 

Post-Amendment 

Burden 

(millions of hours) 

Change from Baseline 

(millions of hours) 

2011 1.84 1.84 0.00 

2012 0.00 0.00 0.00 

2013 0.00 0.00 0.00 

2014 0.00 1.43 1.43 

2015 0.00 0.00 0.00 

2016 1.43 0.00 -1.43 

2017 0.00 1.43 1.43 

2018 0.00 0.00 0.00 

2019 0.00 0.00 0.00 
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 G-10

Year 

Baseline 

Burden 

(millions of 

hours) 

Post-Amendment 

Burden 

(millions of hours) 

Change from Baseline 

(millions of hours) 

2020 0.00 1.43 1.43 

2021 1.43 0.00 -1.43 

2022 0.00 0.00 0.00 

2023 0.00 1.43 1.43 

2024 0.00 0.00 0.00 

2025 0.00 0.00 0.00 

2026 1.43 1.43 0.00 

2027 0.00 0.00 0.00 

2028 0.00 0.00 0.00 

2029 0.00 1.43 1.43 

2030 0.00 0.00 0.00

Total 6.14 10.45 4.30 

Annual Average 0.31 0.52 0.22 

The annual industry cost under the baseline and this alternative option are shown in Table G-11. In 

total, EPA estimates that this option would increase costs to industry by $248 million over a 20-year 

period, with annualized costs increases ranging from $11.29 million with a seven percent discount rate to 

$11.90 million with a three percent discount rate. 

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

Year Baseline Cost 

(2008$ millions) 

Post-Amendment 

Cost 

(2008$ millions) 

Change from 

Baseline 

(2008$ millions) 

2011 $106.97 $106.97 $0.00 

2012 $0.00 $0.00 $0.00 

2013 $0.00 $0.00 $0.00 

2014 $0.00 $82.82 $82.82 

2015 $0.00 $0.00 $0.00 

2016 $82.82 $0.00 -$82.82 

2017 $0.00 $82.82 $82.82 

2018 $0.00 $0.00 $0.00 

2019 $0.00 $0.00 $0.00 

2020 $0.00 $82.82 $82.82 

2021 $82.82 $0.00 -$82.82 

2022 $0.00 $0.00 $0.00 

2023 $0.00 $82.82 $82.82 

2024 $0.00 $0.00 $0.00 

2025 $0.00 $0.00 $0.00 

2026 $82.82 $82.82 $0.00 

2027 $0.00 $0.00 $0.00 

2028 $0.00 $0.00 $0.00 

2029 $0.00 $82.82 $82.82 

2030 $0.00 $0.00 $0.00 

Total $355.42 $603.87 $248.45 

Annual Average $17.77 $30.19 $12.42 
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 G-11

Year Baseline Cost 

(2008$ millions) 

Post-Amendment 

Cost 

(2008$ millions) 

Change from 

Baseline 

(2008$ millions) 

Annualized at 3% $19.13 $31.03 $11.90 

Annualized at 7% $21.01 $32.30 $11.29 

The baseline burden to EPA during reporting years is two FTEs or 4,160 hours (see Section 5-2). 

While the burden per reporting year would not change as a result of this alternative option, more frequent 

reporting would increase costs to the Agency. Table G-12 contains the total burden the Agency of the 

proposed option, over a 20-year period. During this period, EPA estimates that Agency burden would 

increase by a total of 12,500 hours. 

Table G-12: Burden to the Agency under the Alternative Option of a Three-Year Reporting Cycle 

Year Baseline Burden 

(hours) 

Post-Amendment 

Burden 

 (hours) 

Change from 

Baseline 

(hours) 

2011 4,160 4,160 0.00 

2012 0.00 0.00 0.00 

2013 0.00 0.00 0.00 

2014 0.00 4,160 4,160 

2015 0.00 0.00 0.00 

2016 4,160 0.00 -4,160 

2017 0.00 4,160 4,160 

2018 0.00 0.00 0.00 

2019 0.00 0.00 0.00 

2020 0.00 4,160 4,160 

2021 4,160 0.00 -4,160 

2022 0.00 0.00 0.00 

2023 0.00 4,160 4,160 

2024 0.00 0.00 0.00 

2025 0.00 0.00 0.00 

2026 4,160 4,160 0.00 

2027 0.00 0.00 0.00 

2028 0.00 0.00 0.00 

2029 0.00 4,160 4,160 

2030 0.00 0.00 0.00 

Total 16,640 29,120 12,480 

Annual Average 832 1,456 624 

The annual Agency costs under the baseline and the alternative option are shown in Table G-13, and 

are taken from Table 5-3. In total, EPA estimates that this option would increase Agency costs by $1.4 

million over a 20-year period with an annual average of $69,920. 

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

Year Baseline Cost 

(2008$) 

Post-Amendment Cost 

(2008$) 

Change from 

Baseline 

 (2008$) 

2011 $466,133 $466,133 $0.00

2012 $0.00 $0.00 $0.00

2013 $0.00 $0.00 $0.00
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 G-12

Year Baseline Cost 

(2008$) 

Post-Amendment Cost 

(2008$) 

Change from 

Baseline 

 (2008$) 

2014 $0.00 $466,133 $466,133

2015 $0.00 $0.00 $0.00

2016 $466,133 $0.00 $0.00

2017 $0.00 $466,133 $466,133

2018 $0.00 $0.00 $0.00

2019 $0.00 $0.00 $0.00

2020 $0.00 $466,133 $466,133

2021 $466,133 $0.00 -$466,133

2022 $0.00 $0.00 $0.00

2023 $0.00 $466,133 $466,133

2024 $0.00 $0.00 $0.00

2025 $0.00 $0.00 $0.00

2026 $466,133 $466,133 $0.00

2027 $0.00 $0.00 $0.00

2028 $0.00 $0.00 $0.00

2029 $0.00 $466,133 $466,133

2030 $0.00 $0.00 $0.00

Total $1,864,532 $3,262,930 $1,398,399

Annual Average $93,227 $163,147 $69,920 

Annualized at 3% $98,818 $165,773 $66,955 

Annualized at 7% $106,248 $169,785 $63,537 

G.2.2 Three-Year Cycle Cost and Burden when the All the Proposed Amendments are 

Considered 

EPA estimated the cost and burden of a three-year reporting cycle in addition to the proposed 

amendments outlined in Chapter 3. Under this alternative option, the reporting burden for industry would 

be the same as the combined post amendment burden shown in Table 4-49; however the reporting cycle 

would be shortened from four years to three years. For both industry and the Agency, the post-amendment 

burden will increase from the baseline because of the increased reporting frequency. 

The total increase in industry burden over 20 years as a result of increasing the reporting frequency 

from three to four years is 5.28 million hours (see Table G-14). This equates to an annual increase in the 

reporting burden of approximately 0.26 million hours. 

Table G-14: Annual Industry Burden under the Alternative Option of a Three-Year Reporting Cycle 

when the All the Proposed Amendments are Considered 

Year 

Total Burden 

When all Proposed 

Amendments are 

Considered 

(millions of hours) 

Post-Alternative 

Option Burden 

(millions of hours) 

Total Change in 

Industry Burden 

(millions of hours) 

2011 3.40 3.40 0.00 

2012 0.00 0.00 0.00 

2013 0.00 0.00 0.00 

2014 0.00 2.64 2.64 

2015 2.64 0.00 -2.64 
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 G-13

Year 

Total Burden 

When all Proposed 

Amendments are 

Considered 

(millions of hours) 

Post-Alternative 

Option Burden 

(millions of hours) 

Total Change in 

Industry Burden 

(millions of hours) 

2016 0.00 0.00 0.00 

2017 0.00 2.64 2.64 

2018 0.00 0.00 0.00 

2019 2.64 0.00 -2.64 

2020 0.00 2.64 2.64 

2021 0.00 0.00 0.00 

2022 0.00 0.00 0.00 

2023 2.64 2.64 0.00 

2024 0.00 0.00 0.00 

2025 0.00 0.00 0.00 

2026 0.00 2.64 2.64 

2027 2.64 0.00 -2.64 

2028 0.00 0.00 0.00 

2029 0.00 2.64 2.64 

2030 0.00 0.00 0.00

Total 13.96 19.24 5.28 

Annual Average 0.70 0.96 0.26 

The industry cost for a three-year reporting cycle is shown in Table G-15. Baseline costs are taken 

from Table 4-50. Over a 20-year period, total costs would increase by $324 million, with an annualized 

increase of $15.31 million at a three percent discount rate and $14.32 million at a seven percent discount 

rate. 

Table G-15: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle when the 

All the Proposed Amendments are Considered 

Year 

Total Cost When 

all Proposed 

Amendments are 

Considered 

(2008$ millions) 

Post-Alternative 

Option Cost 

 (2008$ millions) 

Total Change in 

Industry Cost 

(2008$ millions) 

2011 $209.04 $209.04 $0.00 

2012 $0.00 $0.00 $0.00 

2013 $0.00 $0.00 $0.00 

2014 $0.00 $162.12 $162.12 

2015 $162.12 $0.00 -$162.12 

2016 $0.00 $0.00 $0.00 

2017 $0.00 $162.12 $162.12 

2018 $0.00 $0.00 $0.00 

2019 $162.12 $0.00 -$162.12 

2020 $0.00 $162.12 $162.12 

2021 $0.00 $0.00 $0.00 

2022 $0.00 $0.00 $0.00 

2023 $162.12 $162.12 $0.00 

2024 $0.00 $0.00 $0.00 
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 G-14

Year 

Total Cost When 

all Proposed 

Amendments are 

Considered 

(2008$ millions) 

Post-Alternative 

Option Cost 

 (2008$ millions) 

Total Change in 

Industry Cost 

(2008$ millions) 

2025 $0.00 $0.00 $0.00 

2026 $0.00 $162.12 $162.12 

2027 $162.12 $0.00 -$162.12 

2028 $0.00 $0.00 $0.00 

2029 $0.00 $162.12 $162.12 

2030 $0.00 $0.00 $0.00

Total $857.53 $1,181.78 $324.25 

Annual Average $42.88 $59.09 $16.21 

Annualized at 3% $45.41 $60.72 $15.31 

Annualized at 7% $48.87 $63.19 $14.32 

The Agency baseline burden of 2,456 hours when all the proposed amendments are considered 

together is taken from Table 5-40. The annual reporting option is expected to increase Agency burden by 

approximately 4,900 hours 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 

Year 

Total Burden 

When all Proposed 

Amendments are 

Considered 

(millions of hours) 

Post-Alternative 

Option Burden 

(millions of hours) 

Total Change in 

Agency Burden 

(millions of hours) 

2011 2,456 2,456 0 

2012 0 0 0 

2013 0 0 0 

2014 0 2,456 2,456 

2015 2,456 0 -2,456 

2016 0 0 0

2017 0 2,456 2,456

2018 0 0 0

2019 2,456 0 -2,456

2020 0 2,456 2,456

2021 0 0 0

2022 0 0 0 

2023 2,456 2,456 0

2024 0 0 0

2025 0 0 0

2026 0 2,456 2,456

2027 2,456 0 -2,456

2028 0 0 0

2029 0 2,456 2,456

2030 0 0 0

Total 12,280 17,192 4,912 
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 G-15

Year 

Total Burden 

When all Proposed 

Amendments are 

Considered 

(millions of hours) 

Post-Alternative 

Option Burden 

(millions of hours) 

Total Change in 

Agency Burden 

(millions of hours) 

Annual Average 614 860 246 

Table G-17 contains the total Agency cost under a three-year reporting cycle. EPA estimates that the 

Agency cost would increase by approximately $576,900 over a 20-year period. The annualized cost is 

expected to increase by $28,800 with a three percent discount rate and $27,200 with a seven percent 

discount rate. 

Table G-17: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle when the 

All the Proposed Amendments are Considered 

Year 

Total Cost When all 

Proposed 

Amendments are 

Considered 

(2008$ ) 

Post-Alternative 

Option Cost 

(2008$) 

Total Change in 

Agency Cost 

(2008$) 

2011 $288,450 $288,450 $0.00 

2012 $0.00 $0.00 $0.00 

2013 $0.00 $0.00 $0.00 

2014 $0.00 $288,450 $288,450 

2015 $288,450 $0.00 -$288,450 

2016 $0.00 $0.00 $0.00

2017 $0.00 $288,450 $288,450

2018 $0.00 $0.00 $0.00

2019 $288,450 $0.00 -$288,450

2020 $0.00 $288,450 $288,450

2021 $0.00 $0.00 $0.00

2022 $0.00 $0.00 $0.00

2023 $288,450 $288,450 $0.00

2024 $0.00 $0.00 $0.00

2025 $0.00 $0.00 $0.00

2026 $0.00 $288,450 $288,450

2027 $288,450 $0.00 -$288,450

2028 $0.00 $0.00 $0.0

2029 $0.00 $288,450 $288,450

2030 $0.00 $0.00 $0.0

Total $1,442,250 $2,019,150 $576,900 

Annual Average $72,113 $100,958 $28,845 

Annualized at 3% $75,341 $102,583 $27,242 

Annualized at 7% $79,587 $105,065 $25,478 
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 G-16

G.2.3 Small Entity Anaylsis 

The following section provides a preliminary assessment of the impact that a three-year reporting 

cycle may have on small entities by examining 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 and all costs and burdens are estimated under the assumption that all the proposed amendments are 

enacted. EPA estimated 3.89 manufacturing sites per global parent company in Chapter 8 of this report; 

41.3 percent of global parent companies (466 companies) are considered small under the SBA 

employment-based definition13, and 24.8 percent (280 companies) are considered small under the TSCA 

sales-based definition14. 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 from Dun & Bradstreet, as also 

described in the EA. 

Table 4-50 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 rate15. As shown in Table G-18 below, these costs 

were divided by the total number of sites expected to submit data, for the annualized costs per site. This 

was multiplied by the number of sites per small parent company to arrive at the annualized costs per small 

parent company. This value was divided by the annual sales per small parent company to derive the costto-sales ratio. 

As shown in Table G-18, under the employment-based definition, a small parent company affected by 

the rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule 

amendments per small parent company, however, are $16,273 at a seven percent discount rate, and even 

lower under a three percent discount rate. The cost-to-sales ratio for an average small company under the 

employment-based SBA definition would be 0.0036 percent or less. Under the more conservative salesbased TSCA definition, small parent company sales are on average more than $11.8 million, with 

annualized costs associated with the proposed amendments of $36.4 million or lower. The cost-to-sales 

ratio for an average small company under the sales-based definition would be 0.14 percent or less. 

Using the highest annual cost shown in Table G-18 of $16,273, a small company would have to have 

annual sales of less than $1.63 million in order to have a cost-to-sales ratio larger than one percent. 

Table G-18: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a Three-Year 

Reporting Cycle 

Employment-based Definition Sales-based Definition 

 

3% Discount 

Rate 

7% Discount 

Rate 

3% Discount 

Rate 

7% Discount 

Rate 

Total Incremental Cost of Amendments $102,073,745 

Total Annualized Costs $35,035,115 $36,350,813 $35,035,115 $36,350,813 

Total Number of Sites 4,289 

 

13 Threshold of 1,000 employees. 14 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual 

production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of 

the company, combined with those of any parent company, are below $4 million. 

15 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 

(OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the 

results to a change in the annualization assumptions. 
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 G-17

Employment-based Definition Sales-based Definition 

 

3% Discount 

Rate 

7% Discount 

Rate 

3% Discount 

Rate 

7% Discount 

Rate 

Annualized Costs per Site $8,169 $8,475 $8,169 $8,475 

Number of Sites per Small Parent Company 1.76 1.92 

Annualized Costs per Small Parent Company $14,377 $14,917 $15,684 $16,273 

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

Cost-to-Sales Ratio 0.0035% 0.0036% 0.1327% 0.1377% 

Number of Companies Potentially Affected 466 280 

G.3 Change the Threshold for Reporting to 10,000 lb. 

The Agency is also considering an option that would lower the reporting threshold from 25,000 lb. to 

10,000 lb. Prior to the amendments to the 2006 IUR rule, EPA required that sites submit a Form U for 

chemicals produced at 10,000 lb. or greater. The 2006 amendments increased the threshold for reporting 

to 25,000 lb. This alternative regulatory option would return to the previous threshold for reporting. 

G.3.1 10,000 lb. Reporting Threshold Cost and Burden when the Option is Considered by Itself 

EPA used data from the 2002 reporting cycle (EPA, 2009d) to estimate the additional number of 

reports that would be submitted under the alternative threshold option. The total number of reports and 

sites reporting at three different 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 production levels. In total, 882 sites, 

or 19 percent, of all the sites submitting reports data in 2002 produced chemicals in amounts between 

10,000 lb. and 25,000 lb. Thirteen percent of all reports, or 3,595 reports, were submitted in 2002 for 

chemicals produced between 10,000 lb. and 25,000 lb. 

Table G-19: Number of Reports and Sites in 2002 

Production Volume Number of Sites Percent of 

Total 

Number of 

Reports 

Percent of 

Total 

10,000 lb.≤ P V < 

25,000 lb. 882 19% 3,595 13%

25,000 lb.≤ P V < 

300,000 lb. 1,392 30% 8,548 32%

PV ≤ 300,000 lb. 2,304 50% 14,818 55% 

Total 4,578 100% 26,961 100% 

Source: 

U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division 2002 IUR 

Database Statistics for IUR Modifications Rule. Washington, DC. April 30, 2009 (EPA, 2009d).

To estimate the total number of additional sites submitting reports as a result of the proposed option, 

EPA applied the percentage of total sites with production 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 numbers are presented in 

Table 4-6). Therefore, the Agency estimates that 787 additional sites will submit reports as a result of the 

proposed amendment. The same methodology was applied 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 proposed amendments will be for production volumes less 

than 300,000 lb., EPA assumes that only additional partial reports (Part IIs) would be submitted. 
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 G-18

As described in Section 4.2.2, sites need to complete Part I of Form U only once, and complete Part II 

and Part III (as applicable) for each chemical manufactured (or imported). Taking this allocation of 

activities into consideration, and using the baseline unit burden estimates as shown in Table 4-2, Table 

G-20 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates 

that the amendment will cause an increase in industry burden of approximately 94,600 hours. 

Table G-20: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. 

Number of 

Sites 

Burden per 

Part I of 

Report, 

Compliance 

Determination, 

Rule 

Familiarization, 

and Submission 

Number of 

Partial 

Reports 

Burden per 

Part II of 

Report and 

Recordkeeping 

Number of 

Full 

Reports 

Burden per 

Part III of 

Report 

Industry 

Burden 

(hours) 

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

(c*d) + (e*f) 

Baseline 4,085 33.26 25,896 19.82 17,075 69.92 1,842,934 

PostAmendment 4,872 33.26 29,349 19.82 17,075 69.92 1,937,544 

Change 

from the 

Baseline 

787 0 3,453 0 0 0 94,611 

1

 Baseline unit burden derivations shown in Table 4.4 

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

value. 

The cost of the amendment was calculated using the unit costs shown in Table 4-5. Table G-21 shows 

the industry cost estimate as a result of this proposed amendment. The cost to industry is expected to 

increase by $5.52 million. 

Table G-21: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. 

Number 

of Sites 

Cost per Part I 

of Report, 

Compliance 

Determination, 

Rule 

Familiarization, 

and Submission 

(2008$) 

Number of 

Partial 

Reports 

Cost per Part 

II of Report 

and 

Recordkeeping 

(2008$) 

Number of 

Full 

Reports 

Cost per 

Part III of 

Report 

(2008$) 

Industry 

Cost 

(millions 

2008$) 

Baseline 4,085 $2,058.18 25,896 $1,129.42 17,075 $4,059.25 $106.97 

PostAmendment 4,872 $2,058.18 29,349 $1,129.42 17,075 $4,059.25 $112.49 

Change 

from the 

Baseline 

787 $0.00 3,453 $0.00 0 $0.00 $5.52 

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

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 reports and submitters will increase the burden 

to the Agency. While the burden per reporting cycle will not change as a result of this amendment, more 
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 G-19

frequent reporting will increase costs to the Agency. Table G-22 contains the total Agency of the 

proposed option. EPA’s burden is expected 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 2,080 

PostAmendment 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 post-amendment value. 

Table G-23 shows the estimated change in cost to EPA as a result of the proposed amendment. The 

Agency estimates a cost increase of approximately $16,600. 

Table G-23: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 

lb. 

Cost to Process 

Part I 

Submission 

(2008$)

Number of 

Sites 

Cost to 

Process Part 

II (2008$ per 

report)

Number of 

Reports 

(with Part 

II)

Cost to 

Process 

Part III 

(2008$ 

per 

report)

Number 

of 

Reports 

(with 

Part III)

Agency Cost 

(2008$)

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

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

PostAmendment $1.78 4,872 $4.40 29,349 $5.61 17,075 $233,529 

Change from 

the Baseline $0.00 787 $0.00 3,453 $0.00 0 $16,580 

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

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

Considered 

EPA estimated the cost and burden of lowering the reporting threshold to 10,000 lb. when all of the 

proposed amendments outlined in Chapter 3. have been considered. A 10,000 lb. reporting threshold is 

expected to increase the number of partial reports submitted by approximately 13 percent and the number 

sites submitting data by 19 percent (See Table G-19). In addition, EPA assumes that this option would 

affect the proposed amendment to lower the threshold for reporting downstream processing and use 

information from 300,000 lb. to 25,000 lb. (See Section 3.3.2). Under this option, the threshold for 

reporting this information would be 10,000 lb. The total number of sites and reports, when all the 
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 G-20

proposed amendments and the 10,000 lb. threshold reporting option are considered, is found in Table 

G-24. To calculate the number of additional submitters and reports, EPA followed the method outlined in 

Section 4.5.1. While Steps 1 and 2 remain unchanged from what is described in Section4.5.1, the other 

steps have been modified and an additional step has been added. The calculations for Steps 3, 4, and 5 are 

outlined below. 

Step 3: Consider the effect of decreasing the reporting threshold to 10,000 lb. This amendment is 

expected to increase the number of sites submitting Form U by approximately 19 percent and the number 

of partial reports by approximately 13 percent (See Table G-19). To estimate this effect on the proposed 

amendments, EPA multiplied the total number of site calculated in Step 2 (204) by 1.19 and the number 

of partial reports calculated in step 2 (5,469) by 1.13. EPA then added the additional number of reports 

and sites calculated in Section G.3.1, which accounts for the increase from the baseline as a result of this 

option. The number of Part IIIs submitted is not affected by this step. 

Step 4: Consider the effect of eliminating the 300,000 lb. threshold for processing and use 

reporting (and avoid double-counting). Under this amendment, all submitters of non-exempt 

chemicals would be required to submit a Part III. Therefore, the number of Part IIIs must be increased by 

the increased number of Part IIs, to account for the effect of eliminating the 300,000 lb. threshold for 

processing and use reporting. EPA started with the Step 3 total for Part III reports (9,484), and added the 

Step 3 total for Part II reports (9,632), minus the number of new Part III reports as a result of making 

ECAs ineligible for exemptions (16), the number of new Part II reports as a result of changing the method 

of determining whether a manufacturer is subject to reporting requirements (1,295) and the number of 

new Part II reports that will be for EAC chemicals as a result of the 10,000 lb. threshold (86). 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 has been taken into account, 649 by 1.13. The number of reports with Part 

III will increase by 17,737.

Step 5: Calculate the number of reports when 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 the proposed amendments are considered together. There will now be a 

total of 5,115 Part Is, 35,528 Part IIs and 34,812 Part IIIs. The difference between the total number of Part 

IIs and Part IIIs, 735 reports, is equal to the number of partially exempt reports with the five and 13 

percent increase taken into account ((618x1.05)x1.13)) = 735). 

Table G-24: Change in the Number of Sites and Reports Submitted of All Amendments Combined 

with the 10,000 lb. Reporting Threshold 

Modification Number of Sites Number of Reports Number of Reports 

with Part III 

Baseline 4,085 25,896 17,075 

Step 1: Sum affected amendments 

Eliminate 300,000 lb. Threshold for Downstream 

Processing and Use Reporting (see Section 4.4.6) 

-- -- 8,203 

Eliminate the 25,000 lb. Threshold for Certain 

Regulated Chemicals (see Section 4.4.5) 

-- 4,018 -- 

Make Chemicals Subject to ECAs Ineligible for 

Exemptions (see Section 4.4.6) 

-- -- 16 

Full Exemption for Manufactured Water (see Section 

4.4.7). 

-- (43) -- 

STEP 1 TOTAL -- 3,975 8,219 

Step 2: Account for change in the method for determining whether you are subject to the IUR reporting requirements 

Step 1 Total Multiplied by 1.05 -- 4,174 8,630 

Method for Determining Whether you are Subject to 204 1,295 854 
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 G-21

the IUR Reporting Requirements (see Section 4.4.3) 

STEP 2 TOTAL 204 5,469 9,484 

Step 3: Account for 10,000 lb. reporting threshold 

Step 2 Total Multiplied by 1.19 for sites and 1.13 for 

reports

243 6,179 --

10,000 lb. threshold reporting threshold (See Section 

G.3.1)

787 3,453 --

STEP 3 TOTAL(Step 3 + Step 2 Total ) 1,030 9,632 9,484

Step 4: Consider the effect of eliminating the 300,000 lb. threshold for processing and use reporting (and avoid doublecounting). 

Step 3 total for Part II reports minus number of new 

Part III reports as a result of making ECAs ineligible 

for exemptions and the number of new Part II reports as 

a result of changing the method of determining whether 

subject to reporting requirements 

-- -- 8,253 

STEP4 TOTAL (Step 4 + Step 3 Total ) 1,030 9,632 17,737 

Step 5:Calculate the total number of reports by adding the Step 3 Total to the Baseline 

STEP 5 TOTAL (Baseline + Step 3 Total) 5,115 35,528 34,812

EPA estimated the cost to the industry of the 10,000 lb. threshold when all the amendments are 

considered in Table G-25. The baseline values are taken from Table 4-49. Lowering the reporting 

threshold to 10,000 lb. will not increase the industry per-form burden; however it will increase the 

number of Form Us submitted. EPA estimates that this option would increase the industry burden by 0.46 

million hours in the first reporting cycle and by 0.35 million hours in all future reporting cycles. 

Table G-25: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. 

when All Proposed Amendments are Considered 

 

Burden per 

Part I of 

Report and 

Submission 

(hours per 

site )

Number of 

Sites 

Burden for 

Part II and 

Record 

Keeping 

(hours per 

report)

Number of 

Reports 

(with Part 

II)

Burden 

for Part 

III and 

(hours 

per 

report)

Number 

of 

Reports 

(with 

Part III)

Total Burden 

 (millions of hours)

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

First-year 

Baseline 36.12 4,289 22.19 31,365 83.02 30,716 3.40 

First year, Post 

Amendment 36.12 5,115 22.19 35,547 83.02 34,812 3.86 

Change from the 

Baseline, First 

year 

0.00 826 0.00 4,182 0.00 4,096 0.46

Future-cycle 

Baseline 11.19 4,289 18.35 31,365 65.63 30,716 2.64 

Future cycle, Post 

Amendment 11.19 5,115 18.35 35,547 65.63 34,812 2.99 

Change from the 

Baseline, Future 

cycles 

0.00 826 0.00 4,182 0.00 4,096 0.35

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the post-amendment value. 
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Baseline costs are taken from Table 4-50. The 10,000 lb. reporting threshold is expected to increase 

industry cost by $28.45 million during the first reporting cycle and by $21.80 million during all future 

reporting cycles (See Table G-26). 

Table G-26: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. when 

All Proposed Amendments are Considered 

 

Cost per Part 

I of Report 

and 

Submission 

(2008$)

Number of 

Sites 

Cost for 

Part II and 

Record 

Keeping 

(2008$)

Number of 

Reports 

(with Part 

II)

Cost for 

Part III 

and 

(2008$)

Number 

of 

Reports 

(with 

Part III)

Total Burden 

 (millions of 2008$)

(a) (b) (c) (d) (e) (f) (g) 

=(a*b)+(c*d)+(e*(f)

First-year 

Baseline $2,252 4,289 $1,346 31,365 $5,117 30,716 $209.04 

First year, 

Post 

Amendment 

$2,252 5,115 $1,346 35,547 $5,117 34,812 $237.49 

Change 

from the 

Baseline, 

First year 

$0 826 $0 4,182 $0 4,096 $28.45 

Futurecycle 

Baseline 

$704 4,289 $1,109 31,365 $4,047 30,716 $162 

Future 

cycle, Post 

Amendment 

$704 5,115 $1,109 35,547 $4,047 34,812 $183.92 

Change 

from the 

Baseline, 

Future 

cycles 

$0 826 $0 4,182 $0 4,096 $21.80 

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

value. 

The annual industry burden over a 20-year period is shown in Table G-27. Over a 20-year period, the 

total Agency burden would increase by 1.88 million hours when all the proposed amendments are 

considered. 

Table G-27: Industry Burden under the Alternative Option of a Lowered Reporting Threshold and 

All Other Amendments when All Proposed Amendments are Considered, 

Year 

Current PostAmendment Burden 

(million hours) 

Future PostAmendment Burden 

(million hours) 

Total Change in 

Industry Burden 

 (million hours) 

2011 3.40 3.86 0.46 

2012 0.00 0.00 0.00 

2013 0.00 0.00 0.00 

2014 0.00 0.00 0.00 

2015 2.64 2.99 0.35 

2016 0.00 0.00 0.00

2017 0.00 0.00 0.00

2018 0.00 0.00 0.00

2019 2.64 2.99 0.35
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Year 

Current PostAmendment Burden 

(million hours) 

Future PostAmendment Burden 

(million hours) 

Total Change in 

Industry Burden 

 (million hours) 

2020 0.00 0.00 0.00

2021 0.00 0.00 0.00

2022 0.00 0.00 0.00 

2023 2.64 2.99 0.35

2024 0.00 0.00 0.00

2025 0.00 0.00 0.00

2026 0.00 0.00 0.00

2027 2.64 2.99 0.35

2028 0.00 0.00 0.00

2029 0.00 0.00 0.00

2030 0.00 0.00 0.00

Total 13.96 15.84 1.88 

Annual 

Average 0.70 0.79 0.09

Table G-28 shows the annual industry cost over a 20-year period as a result of lowering the reporting 

threshold. EPA estimates that a 10,000 lb. reporting threshold would increase costs by approximately 

$115.64 million. Annualized costs range from $6.13 million with a three percent discount rate and $6.60 

million with a seven percent discount rate. 

Table G-28: Change in Industry Cost as a Result of Changing the Threshold for Reporting to 

10,000 lb. and All Other Amendments when All Proposed Amendments are Considered 

Year 

Current PostAmendment Cost 

(millions 2008$) 

Future PostAmendment Cost 

(millions 2008$) 

Total Change in 

Industry Cost 

 (millions 2008$) 

2011 $209.04 $237.49 $28.45 

2012 $0.00 $0.00 $0.00 

2013 $0.00 $0.00 $0.00 

2014 $0.00 $0.00 $0.00 

2015 $162.12 $183.92 $21.80 

2016 $0.00 $0.00 $0.00

2017 $0.00 $0.00 $0.00

2018 $0.00 $0.00 $0.00

2019 $162.12 $183.92 $21.80

2020 $0.00 $0.00 $0.00

2021 $0.00 $0.00 $0.00

2022 $0.00 $0.00 $0.00

2023 $162.12 $183.92 $21.80

2024 $0.00 $0.00 $0.00

2025 $0.00 $0.00 $0.00

2026 $0.00 $0.00 $0.00

2027 $162.12 $183.92 $21.80

2028 $0.00 $0.00 $0.00

2029 $0.00 $0.00 $0.00

2030 $0.00 $0.00 $0.00
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Total $857.53 $973.17 $115.64 

Annual Average $42.88 $48.66 $5.78 

Annualized at 3% $45.41 $51.53 $6.13 

Annualized at 7% $48.87 $55.47 $6.60 

As previously explained in Section G.3.1, the Agency burden per-report will not change as a result of 

lowering the reporting threshold. However, the number of reports and the number of sites submitting 

reports will increase. Table G-29 contains the Agency burden as a result of lowering the threshold for 

reporting when all the other amendments are considered. EPA estimates the Agency burden will increase 

by 51 hours during each reporting cycle. 

Table G-29: Agency Burden as a Result of Lowered Threshold Reporting and All Other 

Amendments when All Proposed Amendments are Considered 

 

Burden to 

Process Part I 

Submission 

(hours)

Number of 

Sites 

Burden to 

Process Part 

II (hours per 

report)

Number of 

Reports 

(with Part 

II)

Burden 

to 

Process 

Part III 

(hours 

per 

report)

Number 

of 

Reports 

(with 

Part III)

Agency Burden 

 (hours)

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

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

PostAmendment 0.002 5,115 0.006 35,528 0.006 34,812 2,507 

Change from 

the Baseline 0.000 826 0.000 4163 0.000 4,096 51 

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

 Table G-30, contains the Agency cost as a result of lowering the reporting threshold. Baseline 

values are taken from Table 5-41. Lowering the 10,000 lb. threshold is expected to increase the Agency 

cost by approximately $5,300 per reporting cycle. 

Table G-30: Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments 

when All Proposed Amendments are Considered 

 

Cost to Process 

Part I 

Submission 

(2008$)

Number of 

Sites 

Cost to 

Process Part 

II (2008$ per 

report)

Number of 

Reports 

(with Part 

II)

Cost to 

Process 

Part III 

(2008$ 

per 

report)

Number 

of 

Reports 

(with 

Part III)

Agency Burden 

 (2008$)

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

Baseline $0.20 4,289 $0.58 31,365 $0.66 30,716 $39,266 

PostAmendment $0.20 5,115 $0.58 35,528 $0.66 34,812 $44,554 

Change from 

the Baseline 0.000 826 $0.00 4,163 $0.00 4,096 $5,287 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the post-amendment value. 
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The annual Agency burden over a 20-year period is shown in Table G-31. Over a 20-year period, the 

total Agency burden would increase by 253 hours over a 20-year period when all the proposed 

amendments are considered. 

Table G-31: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and 

All Other Amendments when All Proposed Amendments are Considered

Year 

Current PostAmendment Burden 

(hours) 

Future PostAmendment Burden 

(hours) 

Total Change 

in Agency Burden 

 (hours) 

2011 2,456 2,507 51 

2012 0 0 0 

2013 0 0 0 

2014 0 0 0 

2015 2,456 2,507 51 

2016 0 0 0

2017 0 0 0

2018 0 0 0

2019 2,456 2,507 51

2020 0 0 0

2021 0 0 0

2022 0 0 0 

2023 2,456 2,507 51

2024 0 0 0

2025 0 0 0

2026 0 0 0

2027 2,456 2,507 51

2028 0 0 0

2029 0 0 0

2030 0 0 0

Total 12,282 12,536 253 

Annual 

Average 614 627 13 

Table G-32 contains the annual Agency cost over a 20-year period, as a result of lowering the 

reporting threshold. EPA estimates that a 10,000 lb. reporting threshold will increase the Agency cost by 

approximately $26,400. Annualized costs range from $1,460 with a seven percent discount rate and 

$1,380 with a three percent discount rate. 

Table G-32: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 

lb. and All Other Amendments when All Proposed Amendments are Considered 

Year 

Current PostAmendment Cost 

(2008$ ) 

Future Post-Amendment 

Cost 

(2008$) 

Total Change 

In Agency Cost 

(2008$) 

2011 $39,266 $44,554 $5,287 

2012 $0 $0 $0 

2013 $0 $0 $0 

2014 $0 $0 $0 

2015 $39,266 $44,554 $5,287 

2016 $0 $0 $0
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2017 $0 $0 $0

2018 $0 $0 $0

2019 $39,266 $44,554 $5,287

2020 $0 $0 $0

2021 $0 $0 $0

2022 $0 $0 $0

2023 $39,266 $44,554 $5,287

2024 $0 $0 $0

2025 $0 $0 $0

2026 $0 $0 $0

2027 $39,266 $44,554 $5,287

2028 $0 $0 $0

2029 $0 $0 $0

2030 $0 $0 $0

Total $196,331 $222,769 $26,437 

Annual 

Average $9,817 $11,138 $1,322 

Annualized 

at 3% $10,256 $11,637 $1,381 

Annualized 

at 7% $10,834 $12,293 $1,459 

G.3.3 Small Entity Analysis 

The following section provides a preliminary assessment of the impact that a 10,000 lb. reporting 

threshold may have on small entities by examining 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. All costs and burdens are estimated under the assumption that all the proposed amendments have 

been enacted. EPA estimated 3.89 manufacturing sites per global parent company in Chapter 8 of this 

report; 41.3 percent of global parent companies (466 companies) are considered small under the SBA 

employment-based definition16, and 24.8 percent (280 companies) are considered small under the TSCA 

sales-based definition17. 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 from Dun & Bradstreet, as also 

described in Chapter 8. 

Table G-28 above shows the cost to the industry as a result of annual reporting. Because these costs 

would be incurred once every four years under a proposed four-year reporting cycle, these costs were 

summed and annualized over four years at both a three percent and seven percent discount rate18. As 

shown in Table G-33 below, these costs were divided by the total number of sites expected to submit data, 

for the annualized cost per site. This was multiplied by the number of sites per small parent company to 

 

16 Threshold of 1,000 employees. 17 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual 

production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of 

the company, combined with those of any parent company, are below $4 million. 

18 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 

(OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the 

results to a change in the annualization assumptions. 
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arrive at the annualized costs per small parent company. This value was divided by the annual sales per 

small parent company to derive the cost-to-sales ratio. 

As shown in Table G-33 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 $12,392 at a seven percent discount rate, and even 

lower under a three percent discount rate. The cost-to-sales ratio for an average small company under the 

employment-based SBA definition would be 0.003 percent or less. Under the more conservative salesbased TSCA definition, small parent company sales are on average more than $11.8 million, with 

annualized costs associated with the proposed amendments of $13,518 or lower. The cost-to-sales ratio 

for an average small company under the sales-based definition would be 0.11 percent or less. 

 Using the highest annual cost shown in Table G-33 of $13,518 a small company would have to have 

annual sales of less than $1.36 million in order to have a cost-to-sales ratio larger than one percent. 

Table G-33: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a 10,000 lb. Reporting 

Threshold 

Employment-based Definition Sales-based Definition 

 3% Discount Rate 

7% Discount 

Rate 

3% Discount 

Rate 

7% Discount 

Rate 

Incremental Costs of 10,000 lb. threshold $28,446,723 

Incremental Costs of Proposed Other Amendments $102,073,745 

Total Annualized Costs $34,090,811 $36,012,441 $34,090,811 $36,012,441 

Total Number of Sites 5,115 

Annualized Costs per Site $6,665 $7,041 $6,665 $7,041 

Number of Sites per Small Parent Company 1.76 1.92 

Annualized Costs per Small Parent Company $11,731 $12,392 $12,797 $13,518 

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

Cost-to-Sales Ratio 0.0028% 0.0030% 0.1083% 0.1144% 

Number of Companies Potentially Affected 466 280 
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Appendix H. Additional Exposure-Related Data Elements 

EPA is considering the collection of additional exposure-related data, similar to the data collected 

under the TSCA section 5 New Chemicals Program, to further enhance the Agency’s capabilities in 

conducting screening-level risk assessments of chemical substances reported to the TSCA Inventory 

Update, and would substantially improve EPA’s ability to quantify chemical risks. The ability to quantify 

chemical risks would further improve the Agency’s ability to identify and manage those risks. 

The additional exposure-related data elements and brief descriptions are as provided in Table H-1: 

EPA is soliciting comment in the preamble for the proposed 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 any additional data should be collected, and in any other 

considerations relating to the collection of additional 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 considering 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 additional 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 gels, 

mixtures, suspensions, 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, drum residues, etc.) and trace amounts 

of the substance. 

2 Continuous or batch 

process 

Indicate whether the chemical substance is manufactured in discrete batches 

or is produced by continuously adding reactants and removing the reaction 

product. 

3 

Amount of substance 

produced per day or per 

batch 

If the chemical substance is produced in discrete batches, indicate the 

amount of the substance in pounds 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). 
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Data Element Description 

5 

Days of operation per 

year or number of 

batches per year 

If the chemical substance is produced in discrete batches, indicate the 

number of batches necessary to produce the reported production volume; if 

the chemical substance is produced in a continuous process, indicate the 

number of days of operation per year needed to produce the reported 

production volume. 

6 Unit operations 

List the unit operations needed to produce the chemical substance. Unit 

operation means a functional step in manufacturing, processing, or use 

operation where substances undergo chemical changes, or changes in 

temperature, pressure, physical state, concentration, purity, or similar 

characteristics. Examples of unit 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, transferring substances from 

one container to another, changing filters, filling drums, loading and 

loading tank cars or trucks, etc. Activities must be described even if 

workers wear protective equipment. 

9 Duration and frequency 

of worker exposure 

For each worker activity, enter the maximum duration in hours and number 

of days per year that any one worker will engage in the activity during a 

normal work day based on the reported production volume. 

10 Physical form For each worker activity, indicate the physical form of the substance at the 

time of exposure. 

11 Maximum 

concentration 

For each worker activity, indicate the maximum concentration of the 

substance in the product at the time of exposure. 

12 

Personal protective 

equipment and 

engineering controls 

used by workers 

For each worker activity, identify the specific 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 which the release occurs 

(e.g. releases due to spillage, residues, separation losses, and other sources 

from each batch or each day). 

16 Media and type of 

release 

For each release, indicate the media (air, liquid or aqueous solution, solid) 

and type of release [stack air, fugitive air, surface water, on-site or off-site 

land or incineration, POTW or other (specify)] of a release stream 

containing the chemical substance. 

17 

Quantity of substance 

released a) directly to 

the environment or b) 

into control technology 

For each release, provide the quantity (in pounds) of chemical substance 

released: 

a) directly to the environment; or 
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Data Element Description 

18 to the environment b) into control technology to the environment in pounds per day for 

continuous operation or pounds per batch for batch operations. 

19 Control technology 

For each release, describe the type of technology used to control the release 

of the substance to the environment. Examples of control technologies 

include carbon filter, scrubber and biological treatment (primary, 

secondary, etc.). 

20 Efficiency of control 

technology 

Indicate the established efficiency of the control technology in removing or 

destroying the chemical substance. 

21 Destination of release 

For aqueous releases containing the chemical substance, indicate whether 

release enters a navigable waterway, a publicly-owned treatment works 

(POTW), or other. Identify the name of the POTW and/or NPDES # as 

appropriate. For other releases, 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 gels, 

mixtures, suspensions, 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, drum residues, etc.) and trace 

amounts of the substance. 

24 

Processing or use at 

sites controlled by 

manufacturer 

Indicate whether the sites at which the chemical is processed or used are 

owned by the manufacturer or others. 

25 Continuous or batch 

process 

Indicate whether the industrial process in which the chemical is processed 

or used is a batch or continuous process. 

26 

Amount of substance 

processed per day or 

per batch 

Provide the amount of the substance in pounds processed or used per batch 

for batch operation or processed or used per day for continuous operation, 

respectively. 

27 Batch or daily run time 

If the chemical substance is processed in discrete batches, indicate the batch 

time (hours/batch); if the substance is processed in a continuous process, 

indicate the daily run time (hours/day). 

28 

Days of operation per 

year or number of 

batches per year 

If the chemical substance is processed in discrete batches, indicate the 

number of batches necessary to process the reported production volume; if 

the chemical substance is produced in a continuous process, indicate the 

number of days of operation per year needed to process the reported 

production volume. 

29 Unit operations 

List the unit operations needed to process the chemical substance. Unit 

operation means a functional step in manufacturing, processing, or use 

operation where substances undergo chemical changes, or changes in 

temperature, pressure, physical state, concentration, purity, or similar 

characteristics. Examples of unit operations include blending, distillation, 

filtration, and drying. 
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Data Element Description 

30 Storage and shipping 

containers used 

List the types of containers used to transport or store the chemical substance 

and their capacity. Examples of containers include 1-liter bottles, 5-gallon 

pails, 55-gallon drums, 5,000-gallon tank trucks, and 20,000-gallon railcars. 

Industrial Processing or Use Occupational Exposures Information 

31 Worker activities 

Describe each specific activity in the operation during which workers may 

be exposed to the chemical substance. Such activities may include charging 

reactor vessels, sampling for quality control, transferring substances from 

one container to another, changing filters, filling drums, loading and 

loading tank cars or trucks, etc. Activities must be described even if 

workers wear protective equipment. 

32 Duration and frequency 

of worker exposure 

For each worker activity, provide the number of hours per day and the 

number of days per year during which the worker is engaged in processing 

or using the chemical substance. 

33 Physical form For each worker activity, indicate the physical form of the substance at the 

time of exposure. 

34 Maximum 

concentration 

For each worker activity, indicate the maximum concentration of the 

substance in the product at the time of exposure. 

35 

Personal protective 

equipment and 

engineering controls 

used by workers 

For each worker activity, identify the specific types of protective equipment 

and engineering controls that will be employed to protect the worker from 

potential exposure to the chemical. 

36 Worker monitoring data 

available 

Indicate whether monitoring data on occupational exposure of workers is 

available. 

37 

Summary of 

occupational exposure 

monitoring included 

Indicate whether a summary of occupational exposure monitoring data is 

included. Summary should include information on the # of workers 

involved, # of samples taken, types of samples (area or personal), average 

and standard deviations of exposure. 

Industrial Processing or Use Releases to the Environment Information 

38 Release source (or 

point) 

For each point of release containing the chemical substance, identify and 

describe the point in the process description at which the release occurs 

(e.g. releases due to spillage, residues, separation losses, and other sources 

from each batch or each day). 

39 Media and type of 

release 

For each release, indicate the media (air, liquid or aqueous solution, solid) 

and type of release [stack air, fugitive air, surface water, on-site or off-site 

land or incineration, POTW or other (specify)] of a release stream 

containing the chemical substance. 

40 

For each release, provide the quantity (in pounds) of chemical substance 

released: 

a) directly to the environment; or 

41 

Quantity of substance 

released a) directly to 

the environment or b) 

into control technology 

to the environment 

b) into control technology to the environment in pounds per day for 

continuous operation or pounds per batch for batch operations. 

42 Control technology 

For each release, describe the type of technology used to control the release 

of the substance to the environment. Examples of control technologies 

include carbon filter, scrubber and biological treatment (primary, 

secondary, etc.). 

43 Efficiency of control 

technology 

Indicate the established efficiency of the control technology in removing or 

destroying the chemical substance. 

44 Destination of release 

For aqueous releases containing the chemical substance, indicate whether 

release enters a navigable waterway, a publicly-owned treatment works 

(POTW), or other. Identify the name of the POTW and/or NPDES # as 

appropriate. For other releases, indicate whether the release goes to a 

municipal or hazardous waste landfill, a commercial incinerator, enters the 

atmosphere, or is otherwise disposed (specify). 
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Data Element Description 

45 

Additional release 

related information 

attached 

Indicate whether a description of the releases, calculations or monitoring 

data on the quantities of releases, or additional information on control 

technologies and/or 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, hardener, plasticizer, filler, etc. 

48 

Number of potentially 

exposed commercial 

workers 

Indicate the number of workers in commercial establishments who are 

reasonably likely to be exposed to the chemical substance. 

49 Physical form of 

commercial product Indicate the physical form of the product containing the chemical substance. 

50 Method of commercial 

product application 

Describe the application method (e.g. sprayed applied via pump sprayer or 

aerosols, poured or applied manually) of the product containing the 

chemical substance and whether the commercial use is destructive, 

contained, dispersive, etc. 

51 

Duration and frequency 

of commercial product 

use 

Indicate the duration of use, e.g. 5 minutes or less, 30 minutes or less, 1 

hour or less, etc. and frequency of 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, hardener, plasticizer, filler, etc. 

54 Number of potentially 

exposed consumers 

Indicate the number of consumers reasonably likely to be exposed to the 

chemical substance. 

55 

Physical form of 

consumer product(s) 

containing the chemical 

substance 

Indicate the physical form, e.g., gel, foam, powder, etc. of the consumer 

product containing the chemical substance. 

56 Method of consumer 

product application 

Describe the application of the consumer product containing the chemical 

substance, for example, chemicals in products that will be sprayed via pump 

sprayer or aerosols; products that are poured, mixed, applied by 

hand/mechanical device; chemicals that can be released via diffusion, 

evaporation, abrasion, etc., from articles; or 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. 
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 H-6

H.1 Estimated Number of Affected Entities 

 In order to estimate the burden and cost of collecting the additional data, EPA assumes that the 

impacts on manufacturers and processors would be different. Manufacturers would be required to 

complete an integrated Form U, which would be a Form U revised to incorporate the new data elements. 

For the purpose of this analysis, EPA assumes that all of the amendments currently being proposed also 

would be included. EPA assumes that processors, on the other hand, would be required to complete a 

tailored Form U that focuses only on the additional processing and use information. 

Manufacturers 

For manufacturers, EPA assumes that the numbers of sites and reports that would be affected by the 

requirement to provide additional exposure-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 4-47, a total 

of 4,289 manufacturers are expected to submit a total of 31,365 reports, including both full and partial 

reports, when all the proposed amendments are considered. To the extent that any specific chemicals 

would be exempt from the requirement to provide these additional data elements, the number of 

manufacturers and reports may be an overestimate. 

Processors 

The number of processors that may be affected by a requirement to submit the additional data 

elements was estimated using data from EPA’s 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 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 that EPA administers for chemical processors. Therefore, EPA assumes that information on 

processors who report under TRI is a suitable proxy for processors who may report under an amended 

IUR rule. 

EPA used TRI Form R submission data from the 2007 TRI Public Data Release for 2002 through 

2005 (to be consistent with the time period of the most recent IUR reporting cycle). EPA filtered the data 

to include only IUR chemicals (i.e., the chemicals listed in the public 2006 IUR database)19. 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 that indicated that it processes a toxic 

chemical as a reactant, as a formulation component, as an article component, for repackaging, or as an 

impurity; or, that it otherwise uses the chemical as a chemical processing aid.20 Because EPA assumes 

that any company that both manufactures and processes a chemical will be considered a manufacturer for 

the purposes of IUR reporting of the additional data elements, TRI submitters who indicated that they also 

manufactured or otherwise used a chemical were filtered out of the dataset. 

The TRI data revealed that an average of 137 processors reported information per TRI chemical. 

However, the average value is greatly skewed by certain high-volume chemicals that are processed by a 

large number of processors.21 Therefore, EPA chose to use the median number of 15 processors per 

chemical, assuming it to be more representative of the universe of chemical processors who would report 

under the IUR rule. 

 

19 The TRI program may collect data on certain chemicals for which IUR reporting is not required. A list of CASRNs for the nonconfidential IUR chemicals was found at “Non-confidential 2006 IUR Records by Chemical, including Manufacturing, 

Processing and Use Information” http://cfpub.epa.gov/iursearch/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 processors per year reported for lead alone. 
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 H-7

Information was reported for a total of 6,140 chemicals under the IUR rule in 2006. By applying the 

average number of processors per chemical derived from TRI data, EPA estimates that a total of 92,100 

reports would be submitted by processors as a result of this option (15 x 6,140 = 92,100). 

This approach is limited to the extent that 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 include known IUR chemicals, but not all IUR chemicals 

would be subject to TRI reporting requirements.) Additionally, 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 that EPA may 

use to define a “processor” for the purpose of the IUR rule may cause the median number of processors 

per chemical estimated here to be an overestimate. Finally, the data used in this analysis was for 

submissions of TRI Form R only. This was done 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 under-estimate. 

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 assumes that the incremental cost for the additional 

data elements will be similar to the estimated burden to complete a premanufacture notice (PMN)22. 

Therefore, EPA calculated the burden to complete an “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 assumes that every site will be required to complete 

the additional exposure information. 

The burden of completing a paper PMN form was 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 reduced the estimated burden to 93 hours. Because paper 

filing would not be permitted under the amendment, all clerical 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 burden, resulting in an estimated burden of 74.4 hours. 

Using the numbers of manufacturing sites and reports as estimated in Section 4.5 of this report, EPA 

estimates that the total burden to manufacturers to submit additional exposure-related data as part of their 

IUR reporting is 2.92 million hours in the first reporting cycle and 2.33 million hours in all future 

reporting cycles (See Table H-2: below). 

 

22 Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is 

required by section 5 of TSCA to provide EPA with notice before initiating the activity. This premanufacture notice, 

or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical. 
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 H-8

This approach is limited to the extent that the data elements requested in any modification to the IUR 

match the PMN form and the burden it imposes. Furthermore, the PMN form includes some site and 

chemical identification data which may overlap with the data provided on IUR Part I; however, this 

overlap was considered to be minimal. 

Table H-2: Change in Industry Burden to Manufacturers as a Result of Additional ExposureRelated Data Elements 

Burden for 

Rule 

Familiarization, 

Compliance 

Determination, 

Submission and 

to Prepare Part 

I 

(hours per site)

Number 

of Sites 

Burden 

for 

Record 

Keeping 

and to 

Prepare 

Part II 

(hours 

per 

report) 

Number 

of 

Reports 

(with 

Part II) 

Burden 

to 

Prepare 

Part III 

(hours 

per 

report) 

Number 

of 

Reports 

(with 

Part 

III) 

Burden 

to 

Complete 

New 

Data 

elements 

(hours 

per 

report) 

Number 

of 

Reports 

(with 

New 

Data 

elements) 

Industry 

Burden 

(millions 

of 

hours) 

(a) (b) (c) (d) (e) (f) (g) (h) 

(g) = 

(a* b)+ 

(c*d)+ 

(e*f)+ 

(g*h) 

Manufacturer Burden (First Cycle) 

Considering all Proposed Amendments 

(As Estimated in Table 4-47) 

36.12 4,289 22.19 31,365 83.02 30,716 0 0 3.40 

Total Manufacturer Burden (First 

Cycle) Including Additional Data 

Elements 

36.12 4,289 22.19 31,365 83.02 30,716 93 31,365 6.32 

Incremental Increase due to 

Additional Data Elements (First Cycle) 0.00 0 0.00 0 0.00 0 93 31,365 2.92 

Manufacturer Burden (Future Cycles) 

Considering all Proposed Amendments 

(As Estimated in Table 4-47) 

11.19 4,289 18.35 31,365 65.63 30,716 0 0 2.64 

Total Manufacturer Burden (Future 

Cycles) Including Additional Data 

Elements 

11.19 4,289 32.57 31,365 65.63 30,716 74 31,365 4.97 

Incremental Increase due to 

Additional Data Elements (Future 

Cycles) 

0.00 0.00 14.21 0 0.00 0 74 31,365 2.33 

Note: Values in Incrememtal Increase rows are calculated by subtracting the corresponding baseline value from the post-amendment value.

Table H-3 contains the annual burden to manufacturers of the additional enhanced data elements over 

a 20-year period. The baseline burden estimates for completing Form U after all the proposed 

amendments are considered is taken from Table 4-54. EPA estimates that over a 20-year period, the total 

burden to manufacturers for completing Form U, including the additional data elements, would be 26.21 

million hours. The additional data elements add 12.25 million additional hours to the industry burden over 

this period. 
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 H-9

Table H-3: Schedule of Annual Industry Burden to Manufacturers if All Proposed Amendments Are 

Implemented 

Year 

Baseline Form U Burden 

(When all Amendments are Considered) 

(millions of hours) 

Burden for Enhanced 

Data Elements 

(millions of hours) 

Total 

Industry 

Burden 

(millions of 

hours) 

2011 3.40 2.92 6.32 

2012 0 0 0.00 

2013 0 0 0.00 

2014 0 0 0.00 

2015 2.64 2.33 4.97 

2016 0 0 0.00 

2017 0 0 0.00 

2018 0 0 0.00 

2019 2.64 2.33 4.97 

2020 0 0 0.00 

2021 0 0 0.00 

2022 0 0 0.00 

2023 2.64 2.33 4.97 

2024 0 0 0.00 

2025 0 0 0.00 

2026 0 0 0.00 

2027 2.64 2.33 4.97 

2028 0 0 0.00 

2029 0 0 0.00 

2030 0 0 0.00 

Total 13.96 12.25 26.21 

Annual Average 0.70 0.61 2.50 

Manufacturers and Processors Combined 

Because processors would not need to complete manufacturing information on Form U, Section II 

and other elements of Form U may not be applicable. For the purpose of this estimation, EPA assumes 

that the burden on processors to complete an IUR form tailored 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 above, 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 future reporting cycles, and is shown in Table H-4. 

This approach is also limited to the extent that the data elements requested from processors in any 

modification to the IUR match the PMN form and the burden it imposes. 
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 H-10

Table H-4: Change in Industry Burden to Processors as a Result of Additional Exposure-Related 

Data Elements 

 

Burden to 

Complete 

Enhanced 

Data 

Elements 

 (hours per 

report) 

Number 

of 

Reports 

(with 

Enhanced 

Data 

Elements) 

Industry 

Burden 

(millions of 

hours) 

Processor Burden (First Cycle) 

Considering all Proposed Amendments 0 0 0.00 

Total Processor Burden (First Cycle) Including Additional Data Elements 93 92,100 8.57 

Incremental Increase due to Additional Data Elements (First Cycle) 93 92,100 8.57 

Processor Burden (Future Cycles) 

Considering all Proposed Amendments 0 0 0.00 

Total Processor Burden (Future Cycles) Including Additional Data 

Elements 74 92,100 6.85 

Incremental Increase due to Additional Data Elements (Future Cycles) 74 92,100 6.85 

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

Table H-5 contains the annual burden to processors of the additional enhanced data elements over a 

20-year period. EPA estimates that over a 20-year period, the total burden to processors for completing 

Form U, including the additional data elements, would be 35.97 million hours. This burden consists of 

labor to complete only the additional data elements because processors currently are not required to 

submit Form U. 
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 H-11

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

Year 

Baseline Form U Burden 

(When all Amendments are Considered) 

(millions of hours) 

Burden for 

Enhanced Data 

Elements (millions 

of hours) 

Total 

Industry 

Burden 

(millions of 

hours) 

2011 0 8.57 8.57 

2012 0 0 0 

2013 0 0 0 

2014 0 0 0 

2015 0 6.85 6.85 

2016 0 0 0 

2017 0 0 0 

2018 0 0 0 

2019 0 6.85 6.85 

2020 0 0 0 

2021 0 0 0 

2022 0 0 0 

2023 0 6.85 6.85 

2024 0 0 0 

2025 0 0 0 

2026 0 0 0 

2027 0 6.85 6.85 

2028 0 0 0 

2029 0 0 0 

2030 0 0 0 

Total 0 35.97 35.97 

Annual Average 0 1.80 1.80 

The total industry burden to both manufacturers and processors if EPA were to require them to 

provide the additional exposure data is calculated by summing the total additional burdens for 

manufacturers and processors. The result is an estimated 11.48 million hours in the first reporting cycle 

and 9.19 million hours all future reporting cycles. The derivation of these numbers is found in Table H-6 

below. 
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 H-12

Table H-6: Change in Industry Burden to Manufacturers and Processors as a Result of Additional 

Exposure-Related Data Elements 

 

Total Burden to 

Manufacturers 

(millions of hours) 

Total Burden to 

Processors 

(millions of 

hours) 

Total Industry 

Burden 

(millions of 

hours) 

Burden (First Cycle) 

Considering all Proposed Amendments 3.40 0.00 3.40 

Total Burden (First Cycle) Including Additional 

Data Elements 6.32 8.57 14.88 

Incremental Increase due to Additional Data 

Elements (First Cycle) 2.92 8.57 11.48 

Burden (Future Cycles) 

Considering all Proposed Amendments 2.64 0.00 2.64 

Total Burden (Future Cycles) Including 

Additional Data Elements 4.97 6.85 11.83 

Incremental Increase due to Additional Data 

Elements (Future Cycles) 2.33 6.85 9.19 

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

Table H-7 contains the annual burden to industry of the additional enhanced data elements over a 20-

year period. The baseline burden estimates for completing Form U after all the proposed amendments are 

considered is taken from Table 4-52. EPA estimates that over a 20-year period, the total burden to 

industry for completing Form U, including the additional data elements, would be 62.18 million hours. 

The additional data elements add 48.23 million additional hours to the industry burden over this period. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-13

Table H-7: Schedule of Annual Industry Burden to Manufacturers and Processors if All Proposed 

Amendments Are Implemented 

Year 

Baseline Form U Burden 

(When all Amendments are Considered)

(millions of hours) 

Form U Burden with 

Enhanced Data 

Elements 

 (millions of hours) 

Total Industry Burden 

(millions of hours) 

2011 3.40 11.48 14.88 

2012 0 0 0.00 

2013 0 0 0.00 

2014 0 0 0.00 

2015 2.64 9.19 11.83 

2016 0 0 0.00 

2017 0 0 0.00 

2018 0 0 0.00 

2019 2.64 9.19 11.83 

2020 0 0 0.00 

2021 0 0 0.00 

2022 0 0 0.00 

2023 2.64 9.19 11.83 

2024 0 0 0.00 

2025 0 0 0.00 

2026 0 0 0.00 

2027 2.64 9.19 11.83 

2028 0 0 0.00 

2029 0 0 0.00 

2030 0 0 0.00 

Total 13.96 48.23 62.18 

Annual Average 0.70 2.41 3.11 

H.3 Industry cost estimate 

EPA calculated the per-report cost to industry of the additional data elements by multiplying the 

managerial and technical burdens found in Premanufacture Review Reporting and Exemption 

Requirements for New Chemical Substances and Significant 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 EPA assumes that the proposed 

electronic submission requirement will eliminate all clerical burden for processing and submitting Form 

U. As shown in Table H-8, EPA estimates the additional per report cost to be $5,673 in the first reporting 

cycle and $4,539 in all future reporting cycles, as a result of the requirement to report the additional data. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-14

Table H-8: Per-Report Cost for Additional Data Elements, based on PMN Burden 

Technical Managerial Total 

Burden 

(hours) 

Wage 

Rate 

(2008$) 

Cost 

(2008$) 

Burden 

(hours) 

Wage 

Rate 

(2008$) 

Cost 

(2008$) 

Burden 

(hours) 

Cost 

(2008$) 

PMN Burden/Cost 

per Report 

(First Cycle) 

75 $58.84 $4,413 18 $70.03 $1,260 93 $5,673 

PMN Burden/Cost 

per Report 

(Future Cycles) 

60 $58.84 $3,530 14.4 $70.03 $1,008 74.4 $4,539 

Manufacturers 

The cost to manufacturers of the additional data elements was derived as shown in Table H-9. EPA 

estimates the option will cost manufacturers an additional $178 million during the first reporting cycle 

and an additional $142 million during all future reporting cycles. 

Table H-9: Change in Industry Cost to Manufacturers as a Result of Additional Exposure-Related 

Data Elements 

Cost for 

Submission, 

Compliance 

Determination, 

Rule 

Familiarization, 

and to Prepare 

Part I 

(2008$) 

Number 

of Sites 

Cost for 

Record 

Keeping 

and to 

Prepare 

Part II 

(2008$) 

Number 

of 

Reports 

(with 

Part II) 

Cost to 

Prepare 

Part III 

(2008$) 

Number 

of 

Reports 

(with 

Part 

III) 

Cost to 

Complete 

New 

Data 

Elements 

(2008$) 

Number 

of 

Reports 

(with 

New Data 

Elements) 

Industry 

Cost 

(millions 

of 2008$) 

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a* b) 

+(c*d)+ 

(e*f)+(g*h) 

Manufacturer Cost (First Cycle) 

Considering all Proposed Amendments 

(As Estimated in Table 4-48) 

$2,252 4,289 $1,346 31,365 $5,117 30,716 0 0 $209.4 

Total Manufacturer Cost (First Cycle) 

Including Additional Data Elements $2,252 4,289 $1,346 31,365 $5,117 30,716 $5,673 31,365 $386.99 

Incremental Increase due to 

Additional Data Elements (First Cycle) $0.00 0 $0.00 0 $0.00 0 $5,673 31,365 $177.95 

Manufacturer Cost (Future Cycles) 

Considering all Proposed Amendments 

(As Estimated in Table 4-48) 

$704 4,289 $1,109 31,365 $4,047 30,716 0 0 $162.12 

Total Manufacturer Cost (Future 

Cycles) Including Additional Data 

Elements 

$704 4,289 $1,109 31,365 $4,047 30,716 $4,539 31,365 $3,304.48 

Incremental Increase due to 

Additional Data Elements (Future 

Cycles) 

$0.00 0 $0.00 0 $0.00 0 $4,539 31,365 $142.36 

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value 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 4-55. Over a 20-year period, EPA estimates that the annualized cost to manufacturers 

will be $85 million at a three percent discount rate, and $91 million at a seven percent discount rate. 
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 H-15

Table H-10: Annual Increase in Industry Cost to Manufacturers if All Proposed Amendments Are 

Implemented (2008$) 

Year 

Baseline Form U Cost 

(When all 

Amendments are 

Considered) 

(millions 2008$) 

Form U Cost for 

Enhanced Data 

Elements 

 (millions 2008$) 

Total Cost To Industry 

(millions 2008$) 

2011 $209 $178 $387 

2012 $0 $0 $0 

2013 $0 $0 $0 

2014 $0 $0 $0 

2015 $162 $142 $304 

2016 $0 $0 $0 

2017 $0 $0 $0 

2018 $0 $0 $0 

2019 $162 $142 $304 

2020 $0 $0 $0 

2021 $0 $0 $0 

2022 $0 $0 $0 

2023 $162 $142 $304 

2024 $0 $0 $0 

2025 $0 $0 $0 

2026 $0 $0 $0 

2027 $162 $142 $304 

2028 $0 $0 $0 

2029 $0 $0 $0 

2030 $0 $0 $0 

Total $858 $747 $1,605 

Annual Average $42.88 $37.37 $80.25 

Annualized at 3% $45.41 $39.51 $84.91 

Annualized at 7% $48.87 $42.42 $91.29 

Manufacturers and Processors Combined 

To calculate the cost to processors, EPA multiplied the per report cost ($5,673 in the first reporting 

cycle and $4,539 during all future reporting cycles) by the total number of reports EPA expects to be 

submitted by processors, 141,220. As shown in Table H-11, EPA estimates the cost to processors to be 

$523 million in the first reporting cycle and $418 million in all future reporting cycles. 
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 H-16

Table H-11: Change in Industry Cost to Processors as a Result of Additional Exposure-Related 

Data Elements 

 

Cost to 

Prepare New 

Data 

Elements 

(2008$) 

Number of 

Reports (with 

New Data 

Elements) 

Industry Cost 

(millions 2008$) 

Processor Cost (First Cycle) 

Considering all Proposed Amendments 0 0 $0 

Total Processor Cost (First Cycle) 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 Cycles) 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 post-amendment 

value.

Table H-12 presents the annual and annualized costs estimates to processors of competing Form U 

with the additional exposure-related data elements. Over a 20-year period, EPA estimates that the 

annualized cost to processors will be $116 million at a three percent discount rate, and $125 million at a 

seven percent discount rate. 

Table H-12: Annual Increase in Industry Cost to Processors if All Proposed Amendments Are 

Implemented (2008$) 

Year 

Baseline Form U Cost 

(When all 

Amendments are 

Considered) 

(millions 2008$) 

Form U Cost for 

Enhanced Data 

Elements 

(millions 2008$) 

Total Cost To Industry 

(millions 2008$) 

2011 $0 $523 $523 

2012 $0 $0 $0 

2013 $0 $0 $0 

2014 $0 $0 $0 

2015 $0 $418 $418 

2016 $0 $0 $0 

2017 $0 $0 $0 

2018 $0 $0 $0 

2019 $0 $418 $418 

2020 $0 $0 $0 

2021 $0 $0 $0 

2022 $0 $0 $0 

2023 $0 $418 $418 

2024 $0 $0 $0 

2025 $0 $0 $0 

2026 $0 $0 $0 

2027 $0 $418 $418 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-17

Year 

Baseline Form U Cost 

(When all 

Amendments are 

Considered) 

(millions 2008$) 

Form U Cost for 

Enhanced Data 

Elements 

(millions 2008$) 

Total Cost To Industry 

(millions 2008$) 

2028 $0 $0 $0 

2029 $0 $0 $0 

2030 $0 $0 $0 

Total $0 $2,195 $2,195 

Annual Average $0 $110 $110 

Annualized at 3% $0 $116 $116 

Annualized at 7% $0 $125 $125 

Total estimated industry cost is presented in Table H-13 and is calculated by summing the costs to 

both manufactures and processors. EPA estimates the cost to the industry of the additional exposure 

elements, if both manufacturers and processor are required to provide the data, will be $700 million in the 

first reporting cycle and $560 million in all future reporting cycles. 

Table H-13: Change in Industry Cost to Manufacturers and Processors as a Result of Additional 

Exposure-Related Data Elements 

 

Total Cost to 

Manufacturers 

(millions 2008$) 

Total Cost to 

Processors 

(millions 2008$) 

Total Industry 

Cost 

(millions 2008$) 

Cost (First Cycle) 

Considering all Proposed Amendments $209 $0 $209 

Total Cost (First Cycle) Including Additional Data Elements $387 $523 $910 

Incremental Increase due to Additional Data Elements (First 

Cycle) $178 $523 $700 

Cost (Future Cycles) 

Considering all Proposed Amendments $162 $0 $162 

Total Cost (Future Cycles) Including Additional Data Elements $304 $418 $722 

Incremental Increase due to Additional Data Elements (Future 

Cycles) $142 $418 $560 

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post-amendment value.

Table H-14 presents the annual and annualized costs estimates to industry of competing Form U with 

the additional exposure-related data elements. The baseline cost estimates for completion of Form U 

come from Table 4-53. Over a 20-year period, EPA estimates that the annualized cost to the industry will 

be $201 million at a three percent discount rate, and $216 million at a seven percent discount rate. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-18

Table H-14: Annualized Increase in Industry Cost to Manufacturers and Processors if All 

Amendments Are Implemented (2008$) 

Year 

Baseline Form U Cost 

(When all Amendments are considered)

(millions 2008$) 

Form U Burden 

with Enhanced 

data Elements 

(millions 2008$) 

Total Cost To 

Industry 

(millions 2008$) 

2011 $209 $701 $910 

2012 $0 $0 $0 

2013 $0 $0 $0 

2014 $0 $0 $0 

2015 $162 $560 $722 

2016 $0 $0 $0 

2017 $0 $0 $0 

2018 $0 $0 $0 

2019 $162 $560 $722 

2020 $0 $0 $0 

2021 $0 $0 $0 

2022 $0 $0 $0 

2023 $162 $560 $722 

2024 $0 $0 $0 

2025 $0 $0 $0 

2026 $0 $0 $0 

2027 $162 $560 $722 

2028 $0 $0 $0 

2029 $0 $0 $0 

2030 $0 $0 $0 

Total $858 $2,942 $3,800 

Annual Average $42.88 $147.12 $190.00 

Annualized at 3% $45.41 $155.54 $200.94 

Annualized at 7% $48.87 $167.01 $215.88 

H.4 Agency burden estimate 

Agency burden for both contractor and EPA staff related to document receipt, tracking and data entry 

quality control of data entry would increase with the promulgation of additional exposure-related data 

elements. To calculate the additional Agency burden associated with the additional data elements, EPA 

used the per-data element burden to the EPA after all the proposed amendments are considered, 0.00008 

hours, as derived in Section 5.5). This burden was multiplied by the number of new data elements, 57 (as 

listed in Table H-1) to calculate the total per-report burden of processing the new data elements for 

manufacturers, 0.0048 hours. EPA assumes that 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 additional data, increasing the Agency burden by 150 

hours for all report years, as estimated in Table H-15 below. EPA does not expect the future reporting 

cycle burden to differ from first reporting cycle burden. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-19

Table H-15: Change in Agency Burden to Process Manufacturer Data as a Result of Additional 

Exposure-Related Data Elements 

Burden 

to 

Process 

Part I 

(hours) 

Number 

of Sites 

Burden 

to 

Process 

Part II 

(hours) 

Number 

of 

Reports 

(with 

Part II) 

Burden 

to 

Process 

Part 

III 

(hours) 

Number 

of 

Reports 

(with 

Part 

III) 

PerReport 

Burden 

to 

Process 

New 

Data 

Elements 

(hours) 

Number 

of 

Reports 

(with 

new data 

elements) 

Agency 

Burden 

(hours) 

(a) (b) (c) (d) (e) (f) (g) (h) 

(g) = 

(a*b)+

(c*d)+ 

(e*f)+(g*h) 

Agency Burden 

Considering all Proposed Amendments 

(As Estimated in Table 5-40) 

0.0019 4,289 0.0056 31,365 0.0063 30,716 0 0 2,456 

Total Agency Burden Including 

Processing Additional Data Elements 

for Manufacturers 

0.0019 4,289 0.0056 31,365 0.0063 30,716 0.0048 31,365 2,607 

Incremental Increase due to 

Additional Data Elements 0 0 0 0 0 0 0.0048 31,365 150 

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post-amendment value.

Table H-16 presents the estimated annual burden to the Agency of processing Form U with the 

additional exposure-related data elements. Over a 20-year period, EPA estimates that the total Agency 

burden to process manufacturer data will be 13,034 hours. 

Table H-16: Annual Increase in Agency Burden to Process Manufacturer Data if All Proposed 

Amendments Are Implemented 

Year 

Baseline Burden 

(When all Amendments are Considered) 

(hours) 

Form U Burden 

with Enhanced 

Data Elements 

(hours) 

Total Agency 

Burden 

(hours) 

2011 2,456 150 2,607 

2012 0 0 0 

2013 0 0 0 

2014 0 0 0 

2015 2,456 150 2,607 

2016 0 0 0 

2017 0 0 0 

2018 0 0 0 

2019 2,456 150 2,607 

2020 0 0 0 

2021 0 0 0 

2022 0 0 0 

2023 2,456 150 2,607 

2024 0 0 0 

2025 0 0 0 

2026 0 0 0 

2027 2,456 150 2,607 

2028 0 0 0 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-20

Year 

Baseline Burden 

(When all Amendments are Considered) 

(hours) 

Form U Burden 

with Enhanced 

Data Elements 

(hours) 

Total Agency 

Burden 

(hours) 

2029 0 0 0 

2030 0 0 0 

Total 12,282 752 13,034 

Annual Average 614.1 37.62 651.72 

Manufacturers and Processors Combined 

Table H-17 shows the estimated burden to the Agency of processing the additional data submitted by 

processors. As described above, EPA expects to receive a total of 92,100 processor reports. The Agency 

burden, per-report, to process the additional data elements is 0.0048 hours, and is the same for both 

processors and manufactures. Therefore, as shown in Table H-10, the Agency burden to process the 

processor data is approximately 442 hours for all reporting cycles. 

Table H-17: Change in Agency Burden to Process Processor Data as a Result of Additional 

Exposure-Related Data Elements 

 

Per-Report 

Burden to Process 

New Data 

Elements (hours) 

Number of 

Reports (with 

New Data 

Elements) 

Agency Burden 

(hours) 

Agency Burden to Process Processor Data 

Considering all Proposed Amendments 0.0000 0 0 

Total Agency Burden Including Processing Additional Data 

Elements for Processors 0.0048 92,100 442 

Incremental Increase due to Additional Data Elements 0.0048 92,100 442 

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

Table H-18 presents the estimated annual burden to the Agency of processing Form U with the 

additional exposure-related data elements. Over a 20-year period, EPA estimates that the total Agency 

burden to process processor data will be 2,209 hours. 

Table H-18: Annual Increase in Agency Burden to Process Processor Data if All Proposed 

Amendments Are Implemented 

Year 

Baseline Burden 

(When all Amendments are Considered) 

(hours) 

Form U Burden with 

Enhanced Data 

Elements (hours) 

Total Agency 

Burden 

(hours) 

2011 0 442 442 

2012 0 0 0 

2013 0 0 0 

2014 0 0 0 

2015 0 442 442 

2016 0 0 0 

2017 0 0 0 

2018 0 0 0 

2019 0 442 442 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-21

Year 

Baseline Burden 

(When all Amendments are Considered) 

(hours) 

Form U Burden with 

Enhanced Data 

Elements (hours) 

Total Agency 

Burden 

(hours) 

2020 0 0 0 

2021 0 0 0 

2022 0 0 0 

2023 0 442 442 

2024 0 0 0 

2025 0 0 0 

2026 0 0 0 

2027 0 442 442 

2028 0 0 0 

2029 0 0 0 

2030 0 0 0 

Total 0 2,209 2,209 

Annual Average 0 110.5 110.5 

Table H-19 presents the burden to EPA of processing the additional data elements from both the 

processors and the manufacturers. This option is expected to increase the Agency burden by 593 hours for 

all reporting cycles. 

Table H-19: Change in Agency Burden to Process Manufacturer and Processor Data as a Result of 

Additional Exposure-Related Data Elements 

 

Total Burden 

of Processing 

Manufacturer 

data (hours) 

Total 

Burden of 

Processing 

Processor 

data 

(hours) 

Total 

Agency 

Burden 

(hours) 

Burden (First Cycle) 

Considering all Proposed Amendments 2,456 0 2,456 

Total Burden (First Cycle) Including Additional Data Elements 2,607 442 3,049 

Incremental Increase due to Additional Data Elements (First Cycle) 151 442 593 

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

Table H-20 presents the estimated annual burden to the Agency of processing Form U with the 

additional exposure-related data elements from both manufacturers and processors. Over a 20-year period, 

EPA estimates that the total Agency burden to process manufacturer and processor data will be 2,962 

hours. 

Table H-20: Annual Increase in Agency Burden to Process Data if All Proposed Amendments Are 

Implemented 

Year 

Baseline Burden 

(When all Amendments are Considered) 

(hours) 

Form U Burden 

with Enhanced 

data Elements 

(hours) 

Total Agency 

Burden 

(hours) 

2011 2,456 3,049 593 

2012 0 0 0 

2013 0 0 0 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-22

Year 

Baseline Burden 

(When all Amendments are Considered) 

(hours) 

Form U Burden 

with Enhanced 

data Elements 

(hours) 

Total Agency 

Burden 

(hours) 

2014 0 0 0 

2015 2,456 3,049 593 

2016 0 0 0 

2017 0 0 0 

2018 0 0 0 

2019 2,456 3,049 593 

2020 0 0 0 

2021 0 0 0 

2022 0 0 0 

2023 2,456 3,049 593 

2024 0 0 0 

2025 0 0 0 

2026 0 0 0 

2027 2,456 3,049 593 

2028 0 0 0 

2029 0 0 0 

2030 0 0 0 

Total 12,282 15,244 2,962 

Annual Average 614 762 148

H.5 Agency cost estimate 

The additional exposure data elements are expected to increase the cost to both EPA and contractor 

staff. To calculate the additional Agency cost associated with the additional data elements, EPA used the 

per-data element cost to the EPA after all the proposed amendments are considered, $0.009, as derived in 

Section 5.5). This unit cost was multiplied by the number of new data elements, 57 (as listed in Table 

H-1) to calculate the total per-report cost of processing the new data elements for manufacturers, $0.51. 

Manufacturers 

The total cost to EPA of processing these new data elements for manufacturers is approximately 

$15,800, as shown in Table H-21. This table reflects both the variable cost to the Agency, which is 

dependent on the number of reports, and a fixed cost to the Agency of $249,200 (see Section 5.3) which 

will not change as a result of including the additional data option in the IUR. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-23

Table H-21: Change in Agency Cost of Processing Manufacturer Data as a Result of Additional 

Exposure-Related Data Elements 

Cost to 

Process 

Part I 

(2008$) 

Number 

of Sites 

Cost to 

Process 

Part II 

(2008$) 

Number 

of 

Reports 

(with 

Part II) 

Cost to 

Process 

Part 

III 

(2008$) 

Number 

of 

Reports 

(with 

Part 

III) 

Cost to 

Process 

New 

Data 

Elements 

(2008$) 

Number 

of 

Reports 

(with 

new data 

elements) 

Agency Cost 

(2008$) 

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a* b)+ 

(c*d)+(e*f)+(g*h) 

Agency Cost 

Considering all Proposed Amendments 

(As Estimated in Table 5.41) 

$0.20 4,289 $0.58 31,365 $0.66 30,716 $0.00 0 $288,450 

Total Agency Cost Including 

Processing Additional Data Elements 

for Manufacturers 

$0.20 4,289 $0.58 31,365 $0.66 30,716 $0.51 31,365 $304,294 

Incremental Increase due to 

Additional Data Elements $0.00 0 $0.00 0 $0.00 0 $0.51 31,365 $15,843 

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post-amendment value.

Table H-22 presents the annual and annualized costs estimates to the Agency of processing 

manufacturer Form U with the additional exposure-related data elements. Over a 20-year period, EPA 

estimates that the annualized cost to the Agency will be $79,500 at a three percent discount rate, and 

$84,000 at a seven percent discount rate. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-24

Table H-22: Annual Increase in Agency Cost to Process Manufacturer Data if All Proposed 

Amendments Are Implemented (2008$)

Year 

Baseline Cost 

(When all Amendments are Considered) 

($2008) 

Cost 

($2008) 

Total Agency 

Cost 

 ($2008) 

2011 $288,450 $15,843 $304,294 

2012 $0 $0 $0 

2013 $0 $0 $0 

2014 $0 $0 $0 

2015 $288,450 $15,843 $304,294 

2016 $0 $0 $0 

2017 $0 $0 $0 

2018 $0 $0 $0 

2019 $288,450 $15,843 $304,294 

2020 $0 $0 $0 

2021 $0 $0 $0 

2022 $0 $0 $0 

2023 $288,450 $15,843 $304,294 

2024 $0 $0 $0 

2025 $0 $0 $0 

2026 $0 $0 $0 

2027 $288,450 $15,843 $304,294 

2028 $0 $0 $0 

2029 $0 $0 $0 

2030 $0 $0 $0 

Total $1,442,251 $79,217 $1,521,468 

Annual Average $72,112.55 $3,960.84 $76,073.39 

Annualized at 3% $75,341 $4,138 $79,479 

Annualized at 7% $112,467 $4,371 $83,959 

Manufacturers and Processors Combined 

Table H-23 shows the Agency cost of processing the processor data. To estimate this cost, EPA 

multiplied the number of processors derived in Section H.1 (141,220) by the per report cost of processing 

the additional data, $0.51. EPA estimates that the total Agency cost to process the processor data is 

$46,500. 

Table H-23: Change in Agency Cost to Process Processor Data as a Result of Additional 

Exposure-Related Data Elements 

 

Per-Report Cost to 

Process New Data 

Elements 

(2008$) 

Number of 

Reports 

(with New 

Data 

Elements) 

Agency Cost 

(2008$) 

Agency Cost to Process Processor Data 

Considering all Proposed Amendments $0.00 0 $0 

Total Agency Cost Including Processing Additional Data 

Elements for Processors $0.51 92,100 $46,522 

Incremental Increase due to Additional Data Elements $0.51 92,100 $46,522 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-25

Table H-24 presents the annual and annualized costs estimates to the Agency of processing a 

processor Form U with the additional exposure-related data elements. Over a 20-year period, EPA 

estimates that annualized cost to the Agency will be $12,200 at a three percent discount rate, and $12,800 

at a seven percent discount rate. 

Table H-24: Annual Increase in Agency Cost to Process Processor Data if All Proposed 

Amendments Are Implemented (2008$)

Year 

Baseline Cost 

(When all Amendments are Considered) 

($2008) 

Cost 

 ($2008) 

Total Agency 

Cost 

($2008) 

2011 $0 $46,522 $46,522 

2012 $0 $0 $0 

2013 $0 $0 $0 

2014 $0 $0 $0 

2015 $0 $46,522 $46,522 

2016 $0 $0 $0 

2017 $0 $0 $0 

2018 $0 $0 $0 

2019 $0 $46,522 $46,522 

2020 $0 $0 $0 

2021 $0 $0 $0 

2022 $0 $0 $0 

2023 $0 $46,522 $46,522 

2024 $0 $0 $0 

2025 $0 $0 $0 

2026 $0 $0 $0 

2027 $0 $46,522 $46,522 

2028 $0 $0 $0 

2029 $0 $0 $0 

2030 $0 $0 $0 

Total $0 $232,612 $232,612 

Annual Average $0 $11,630.59 $11,630.59 

Annualized at 3% $0 $12,151 $12,151 

Annualized at 7% $0 $12,836 $12,836 

Table H-25 shows the cost to EPA of processing the additional data elements from both the 

processors and the manufactures. This option is expected to increase the Agency cost by $62,400 for all 

reporting cycles. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-26

Table H-25: Change in Agency Cost of Processing Manufacture and Processor Data as a Result of 

Additional Exposure-Related Data Elements 

 

Cost to Process New 

Data Elements 

(2008$) 

Number of 

Reports 

(with New Data 

Elements) 

Agency Cost 

(2008$) 

Cost (First Cycle) 

Considering all Proposed Amendments $288,450 $0 $288,450 

Total Cost (First Cycle) Including Additional Data 

Elements $304,294 $46,522 $350,816 

Incremental Increase due to Additional Data Elements 

(First Cycle) $15,843 $46,522 $62,366 

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post-amendment 

value.

Table H-26 presents the annual and annualized costs estimates to the Agency of processing 

manufacturer and processor Form Us with the additional exposure-related data elements. Over a 20-year 

period, EPA estimates that annualized cost to the Agency will be $91,600 at a three percent discount rate, 

and $96,800 at a seven percent discount rate. 

Table H-26: Annual Increase in Agency Cost to Process Manufacturer and Processor Data if All 

Proposed Amendments Are Implemented (2008$)

Year 

Baseline Cost 

(When all Amendments are Considered) 

($2008) 

Form U Cost with 

Enhanced data 

Elements ($2008) 

Total Agency 

Cost 

($2008) 

2011 $288,450 $62,366 $350,816 

2012 $0 $0 $0 

2013 $0 $0 $0 

2014 $0 $0 $0 

2015 $288,450 $62,366 $350,816 

2016 $0 $0 $0 

2017 $0 $0 $0 

2018 $0 $0 $0 

2019 $288,450 $62,366 $350,816 

2020 $0 $0 $0 

2021 $0 $0 $0 

2022 $0 $0 $0 

2023 $288,450 $62,366 $350,816 

2024 $0 $0 $0 

2025 $0 $0 $0 

2026 $0 $0 $0 

2027 $288,450 $62,366 $350,816 

2028 $0 $0 $0 

2029 $0 $0 $0 

2030 $0 $0 $0 

Total $1,442,250 $311,829 $1,754,079

Annual Average $72,113 $15,591 $87,704 

Annualized at 3% $75,341 $16,289 $91,630 

Annualized at 7% $112,467 $17,208 $96,795 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-27

H.6 Small Entity Analysis 

As described in Chapter 8 of this economic analysis, EPA assessed the impact that the proposed 

amendments to the IUR rule may have on small entities by examining the relationship between the 

compliance costs and company sales for small companies. EPA performed a similar analysis to determine 

the impact of the collection of additional exposure-related data elements 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 definition23, and 24.8 percent (280 companies) are considered small under the TSCA 

sales-based definition24. 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 from Dun & Bradstreet, as also described in 

Chapter 8. 

Table H-13 above shows the incremental cost to manufacturers as a result of adding the additional 

exposure related data elements to Form U. Table 4-48 (in the main text of the report) shows the 

incremental cost to manufacturers related to the other proposed amendments. Because these costs would 

be incurred once every four years under a proposed four-year reporting cycle, these costs were summed 

and annualized over four years at both a three percent and seven percent discount rate25. As shown in 

Table H-27 below, these costs were divided by the total number of sites expected to submit data, for the 

annualized costs per site. This was multiplied by the number of sites per small parent company to arrive at 

the annualized costs per small parent company. This value was divided by the annual sales per small 

parent company to derive the cost-to-sales ratio. 

As shown in Table H-27, under the employment-based definition, a small parent company affected by 

the rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule 

amendments per small parent company, however, are $31,705 at a seven percent discount rate, and even 

lower under a three percent discount rate. The cost-to-sales ratio for an average small company under the 

employment-based SBA definition would be 0.008 percent or less. Under the more conservative TSCA 

sales-based definition, small parent company sales are on average more than $11.8 million, with 

annualized parent company costs associated with the proposed amendments of $34,587 or lower. The 

cost-to-sales ratio for an average small company under the sales-based definition would be 0.29 percent or 

less. 

Using the highest annual cost shown in Table H-27 of $34,587 a small company would have to have 

annual sales of less than $3.45 million in order to have a cost-to-sales ratio larger than one percent. 

 

23 Threshold of 1,000 employees. 24 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual 

production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of 

the company, combined with those of any parent company, are below $4 million. 

25 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 

(OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the 

results to a change in the annualization assumptions. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-28

Table H-27. Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of Additional 

Data Elements 

Employment-based Definition Sales-based Definition 

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate 

Incremental Costs 

of Enhanced Data 

Elements 

$177,947,467 

Incremental Costs 

of Proposed Other 

Amendments 

$102,073,744 

Total Annualized 

Costs $73,139,106 $77,261,808 $73,139,106 $77,261,808

Total Number of 

Sites 4,289 

Annualized Costs 

per Site $17,053 $18,014 $17,053 $18,014

Number of Sites 

per Small Parent 

Company 

1.76 1.92 

Annualized Costs 

per Small Parent 

Company 

$30,013 $31,705 $32,741 $34,587 

Annual Sales per 

Small Parent 

Company 

$412,713.310 $11,821,104 

Cost-to-Sales Ratio 0.007% 0.008% 0.277% 0.293% 

Number of 

Companies 

Potentially Affected 

466 280 

Processors 

EPA is limited in its efforts to estimate the impact 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 information about a submitter’s parent company or 

annual revenues. For this screening-level analysis, EPA assumes that the chemical processor industry 

shares many characteristics with the chemical manufacturing industry. To the extent that this 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 

that 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 definition. EPA further assumes 1.76 sites per 

small parent company under the employment-based definition, 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 TRI 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 provides 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 obtain the estimated number of processors (37,592) 

who would report under an amended IUR 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 number of small global parent companies (the number of 

companies potentially affected), under the employment-based and sales-based definitions, respectively. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 H-29

To calculate cost-to-sales ratios, EPA followed the same methodology for processors as described above 

for manufacturers. Results are presented in Table H-28 below. 

Table H-28: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of Additional 

Data Elements 

Employment-based Definition Sales-based Definition 

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate 

Incremental Costs 

of Enhanced Data 

Elements 

$522,523,888 

Incremental Costs 

of Proposed Other 

Amendments 

$0.00 

Total Annualized 

Costs $136,478,697 $144,171,723 $136,478,697 $144,171,723 

Total Number of 

Sites 37,592 

Annualized Costs 

per Site $3,631 $3,835 $3,631 $3,835 

Number of Sites 

per Small Parent 

Company 

1.76 1.92 

Annualized Costs 

per Small Parent 

Company 

$6,390 $6,750 $6,971 $7,364 

Annual Sales per 

Small Parent 

Company 

$412,7613,310 $11,821,104 

Cost-to-Sales Ratio 0.002% 0.002% 0.059% 0.062% 

Number of 

Companies 

Potentially Affected 

3,990 2,397 

As shown in Table H-28, under the employment-based definition, a small parent company affected by 

the rule on average has sales of more than $412.7 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-based 

definition, small parent company sales on average are 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 Flexibility 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 annual sales of less than $734,600 in order to have a cost-to-sales ratio larger than one percent. 
***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review*** 

 I-1

Appendix I. - Estimated Burden and Cost of a Section 8(a) Rule for 

Exposure-Related Data Elements 

EPA is considering the annual collection of exposure-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) and processors of chemical substances to maintain 

records and/or report such data as EPA may reasonably require to carry out the TSCA mandates. Section 

8(a) regulations can be tailored to meet unique information needs (e.g., via chemical-specific rules) or 

information can be obtained via use of “model” or standardized 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 would be specific to a unique set of IUR chemicals for 

which the information is needed; EPA would request the 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 those proposed under the option outlined in Appendix H. 

A brief description of the exposure-related data elements that may be included in such a section 8(a) rule 

are provided in Table H-1. 

I.1 Estimated Number of Affected Entities 

For the purpose of this analysis, EPA assumes that a section 8(a) rule would apply to both 

manufacturers and processors of the subject chemicals. 

Manufacturers 

Because the applicability of a section 8(a) rule would be similar to that of the IUR rule (i.e., it would 

apply to manufacturers or importers of a subject chemical when produced in volumes greater than 25,000 

lb.), EPA estimated the number of manufacturers who would report and the number of reports it expects 

to be submitted using data from Section 4.2.5 of this report. On average, 0.66 sites submit data under the 

IUR rule per regulated chemical, and an average of 4.21 full reports are submitted for each chemical. 

Therefore, EPA estimates that a total of 66 sites will submit 421 reports for the estimated 100 chemicals. 

To the extent that the specific chemicals subject to a section 8(a) rule do not have an average number of 

manufacturers, this may be an over- or underestimate. 

Processors 

The number of processors that may be affected by a section 8(a) rule was estimated using data from 

EPA’s Toxic Release Inventory (TRI) reporting program. Under the TRI program, EPA collects 

information annually on toxic chemical releases and waste management activities from manufacturers, 

processors, and users of a set of 581 toxic 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 collection of information that EPA 

administers for chemical processors. Therefore, EPA assumes that information on processors who report 

under TRI is a suitable proxy for processors who may report under a section 8(a) rule. 

EPA used TRI Form R submission data from the 2007 TRI Public Data Release in this analysis. To 

be consistent with the Economic Analysis for the 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 include only IUR chemicals (i.e., the chemicals listed in 
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the public 2006 IUR database)26. Processors submitted TRI data on an average of 220 of the IUR 

chemicals during each of the four years of interest. For this analysis, EPA counted as a “processor” each 

TRI submitter who indicated that it processes a toxic chemical as a reactant, as a formulation component, 

as an article component, for repackaging, or as an impurity; or, that it otherwise uses the toxic chemical as 

a chemical processing aid.27 Because EPA assumes that any company that both manufactures and 

processes a chemical will be considered a manufacturer for the purposes of a section 8(a) rule, TRI 

submitters who indicated that they also manufactured or otherwise used a chemical were filtered out of 

the dataset. 

The TRI data revealed that an average of 137 processors reported information per TRI chemical. 

However, the average value is greatly skewed by certain high-volume chemicals that are processed by a 

large number of processors.28 Therefore, EPA chose to use the median number of 15 processors per 

chemical, assuming it to be more representative of the universe of TSCA chemical processors. Using the 

median of 15 processors per chemical, EPA expects that a total of 1,500 reports will be submitted for an 

estimated 100 chemicals. According to the TRI data, each processor processes approximately 2.45 

chemicals; therefore, EPA expects a section 8(a) rule to affect 612 sites. 

This approach is limited to the extent that 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 underestimate. Additionally, the TRI rule is applicable to 

facilities included within a specific set of NAICS codes; a section 8(a) rule may not limit its applicability 

to a defined set of NAICS codes, which could cause the number of processors estimated here to be an 

underestimate. Furthermore, “processor” may be defined differently by the two rules; any specific criteria 

that EPA may use to define a “processor” for the purpose of a section 8(a) rule may cause the median 

number of processors per chemical estimated here to be an overestimate. Finally, the data used in this 

analysis was for submissions of TRI Form R only. This was done because Form A, the other, simpler, 

TRI reporting form, does not request information 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 (both manufacturers and processors) to provide data 

similar to the exposure-related data 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 estimating the burden to complete a PMN. 

The burden to complete a paper PMN form was estimated in the supporting statement for 

Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and 

Significant New Use Reporting Requirements for Chemical Substances, EPA ICR No: 574.12 (EPA, 

2003). According to this source, the total burden to complete a PMN form is 107 hours. EPA assumes that 

a section 8(a) rule would require electronic submission, so EPA reduced the estimated burden to 93 hours. 

This reduction is consistent with the assumption in section 4.4.27; that all clerical burden will be 

eliminated because paper filing will not be permitted with electronic submission. 

 

26 The TRI program may collect data on certain chemicals for which IUR reporting is not required. A list of CASRNs for the nonconfidential IUR chemicals was found at “Non-confidential 2006 IUR Records by Chemical, including Manufacturing, 

Processing and Use Information” http://cfpub.epa.gov/iursearch/index.cfm?s=chem Accessed August 30, 2009. 27 TRI submitters indicate their activities and uses of the toxic chemical at the facility in Part II Section 3 of Form R.

28 For example, an average of 3,240 processors reported under TRI per year for lead alone. 
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Using the number of manufacturer reports as estimated in Section I-1 of this appendix, the total 

burden to manufacturers to submit additional exposure-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 exposure-related data elements is estimated to be 

139,500 hours (See Table I-1 below). Because each individual collection under the rule would be for a 

different set of chemicals, EPA assumes that different sites will be submitting reports every year, so the 

burden would be the same in future individual collections. 

This approach is limited to the extent that the data elements requested in a section 8(a) rule match the 

IUR Form U and the PMN form, and the burden they incur. 

Table I-1: Annual Industry Burden as a Result of a TSCA Section 8(a) Data Collection 

Entity Subject to the Data Collection 

Burden to Complete 

Exposure-Related Data 

Elements (hours per report) 

Number 

of 

Reports 

Total Burden 

 (hours) 

Manufacturers 93 421 39,166 

Processors 93 1,500 139,500 

Total for Manufacturers and Processors 93 1,921 178,666 

Annual Industry Burden Estimates 

EPA estimated the total annual burden and cost to industry of a section 8(a) rule over a 20-year 

period. A 20-year period was used so that the burden and cost to the industry are directly comparable to 

the annual burden presented in Table 4-52 and the annual cost 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 of completing Form U. Over a 20-year period, EPA estimates that the 

total burden to industry of both the IUR data collection and a section 8(a) collection will be 17.41 million 

hours. The section 8(a) rule adds 3.57 million hours to the industry burden during this time period. 

Table I-2: Schedule of Annual Industry Burden 

Year 

Baseline Industry 

Burden 

(When all 

Amendments are 

Considered) 

(millions of hours) 

Manufacturer 

Section 8(a) Burden 

(millions of hours) 

Processor 

Section 

8(a) 

Burden 

(millions 

of hours) 

Manufacturer 

and Processor 

Section 8(a) 

Burden 

(millions of 

hours) 

Total Burden 

To Industry 

(Manufacturer 

and Processor + 

Baseline) 

(millions of 

hours) 

2011 3.40 0.039 0.140 0.179 3.580 

2012 0 0.039 0.140 0.179 0.179 

2013 0 0.039 0.140 0.179 0.179 

2014 0 0.039 0.140 0.179 0.179 

2015 2.61 0.039 0.140 0.179 2.789 

2016 0 0.039 0.140 0.179 0.179 

2017 0 0.039 0.140 0.179 0.179 

2018 0 0.039 0.140 0.179 0.179 

2019 2.61 0.039 0.140 0.179 2.789 

2020 0 0.039 0.140 0.179 0.179 

2021 0 0.039 0.140 0.179 0.179 

2022 0 0.039 0.140 0.179 0.179 
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Year 

Baseline Industry 

Burden 

(When all 

Amendments are 

Considered) 

(millions of hours) 

Manufacturer 

Section 8(a) Burden 

(millions of hours) 

Processor 

Section 

8(a) 

Burden 

(millions 

of hours) 

Manufacturer 

and Processor 

Section 8(a) 

Burden 

(millions of 

hours) 

Total Burden 

To Industry 

(Manufacturer 

and Processor + 

Baseline) 

(millions of 

hours) 

2023 2.61 0.039 0.140 0.179 2.789 

2024 0 0.039 0.140 0.179 0.179 

2025 0 0.039 0.140 0.179 0.179 

2026 0 0.039 0.140 0.179 0.179 

2027 2.61 0.039 0.140 0.179 2.789 

2028 0 0.039 0.140 0.179 0.179 

2029 0 0.039 0.140 0.179 0.179 

2030 0 0.039 0.140 0.179 0.179 

Total 13.84 0.78 2.79 3.57 17.41 

Annual 

Average 0.69 0.04 0.14 0.18 0.87 

I.3 Industry Cost Estimate 

EPA calculated the per-report cost to industry of the additional data elements by multiplying the 

managerial and technical burdens found in Premanufacture Review Reporting and Exemption 

Requirements for New Chemical Substances and Significant 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 that all clerical burden for preparing 

and submitting Form U is eliminated. As shown in Table I-3, EPA estimates the additional per report cost 

to be $5,673. 

Table I-3: Per-Report Cost for Additional Data Elements, based on PMN Burden 

Technical Managerial Total 

Burden 

(hours) 

Wage 

Rate 

(2008$) 

Cost 

(2008$) 

Burden 

(hours) 

Wage 

Rate 

(2008$) 

Cost 

(2008$) 

Burden 

(hours) 

Cost 

(2008$) 

PMN Burden/Cost 

per Report 75 $58.84 $4,413 18 $70.03 $1,260 93 $5,673 

The cost to manufacturers and processors to submit the exposure-related data elements was derived as 

shown in Table I-4. EPA estimates the section 8(a) rule would cost manufacturers $2.39 million and 

processors $8.51 million each year. 
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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 estimates to industry of completing Form U and a 

section 8(a) collection. The cost estimates for completion of Form U come from Table 4-53. Over a 20-

year period, EPA estimates that total annualized cost to the industry will be $56.31 million, with a three 

percent discount rate, and $59.77 million with a seven percent discount rate. 

Table I-5: Annual Increase in Industry Cost if All Amendments Are Implemented (2008$)) 

Year 

Baseline Industry Cost 

(When all Amendments 

are Considered) 

(millions 2008$) 

Manufacturer 

Section 8(a) Cost 

(millions 2008$) 

Processor 

Section 8(a) 

Cost (millions 

2008$) 

Manufacturer 

and Processor 

Section 8(a) 

Cost (millions 

2008$) 

Total Cost to 

Industry 

(Manufacturer 

and Processor 

+ Baseline) 

(millions 

2008$) 

2011 $209.04 $2.39 $8.51 $10.90 $219.94 

2012 $0.00 $2.39 $8.51 $10.90 $10.90 

2013 $0.00 $2.39 $8.51 $10.90 $10.90 

2014 $0.00 $2.39 $8.51 $10.90 $10.90 

2015 $162.12 $2.39 $8.51 $10.90 $173.02 

2016 $0.00 $2.39 $8.51 $10.90 $10.90 

2017 $0.00 $2.39 $8.51 $10.90 $10.90 

2018 $0.00 $2.39 $8.51 $10.90 $10.90 

2019 $162.12 $2.39 $8.51 $10.90 $173.02 

2020 $0.00 $2.39 $8.51 $10.90 $10.90 

2021 $0.00 $2.39 $8.51 $10.90 $10.90 

2022 $0.00 $2.39 $8.51 $10.90 $10.90 

2023 $162.12 $2.39 $8.51 $10.90 $173.02 

2024 $0.00 $2.39 $8.51 $10.90 $10.90 

2025 $0.00 $2.39 $8.51 $10.90 $10.90 

2026 $0.00 $2.39 $8.51 $10.90 $10.90 

2027 $162.12 $2.39 $8.51 $10.90 $173.02 

2028 $0.00 $2.39 $8.51 $10.90 $10.90 

2029 $0.00 $2.39 $8.51 $10.90 $10.90 

2030 $0.00 $2.39 $8.51 $10.90 $10.90 

Total $857.53 $47.77 $170.20 $217.97 $1,075.50 

Annual 

Average $42.88 $2.39 $8.51 $10.90 $53.78 
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Year 

Baseline Industry Cost 

(When all Amendments 

are Considered) 

(millions 2008$) 

Manufacturer 

Section 8(a) Cost 

(millions 2008$) 

Processor 

Section 8(a) 

Cost (millions 

2008$) 

Manufacturer 

and Processor 

Section 8(a) 

Cost (millions 

2008$) 

Total Cost to 

Industry 

(Manufacturer 

and Processor 

+ Baseline) 

(millions 

2008$) 

Annualized at 

3% $45.41 $2.39 $8.51 $10.90 $56.31 

Annualized at 

7% $48.87 $3.48 $12.39 $15.87 $59.77 

I.4 Agency Burden Estimate 

For the purposes of this analysis, EPA assumed that the Agency 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 exposurerelated data elements, EPA used the per-data element burden to EPA after all the proposed amendments 

are considered, 0.00008 hours, as calculated in Section 5.5. The number of exposure-related data elements 

is 57, as shown in Table H-1. The section 8(a) 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 burden 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 for processor data, is approximately 7.20 hours. 

Table I-7: Agency Burden to Process Data as a Result of a TSCA Section 8(a) Data Collection 

 

Per-Report Burden to 

Process 

Exposure-Related 

 Data Elements (hours) 

Number of 

Reports 

Agency Burden 

(hours) 

Agency Burden to Process Manufacturer 

Data 

0.0048 421 2.02 

Agency Burden to Process Processor Data 0.0048 1,500 7.20 

Total Agency Burden 0.0048 1,921 9.22 

Annual Agency Burden Estimates 

Table I-8 presents the annual Agency burden estimates for data entry and extramural costs during all 

principal reporting and non-principal reporting years over a 20-year period. The Agency burden for 

processing Form U is taken from Table 5-42. In total, EPA estimates that the Agency burden for the IUR 

rule and a section 8(a) rule will be 12,464 hours over a 20-year period. The total burden as a result of a 

section 8(a) rule will be 184 hours over a 20-year period. 
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Table I-8: Schedule of Annual Agency Burden 

Year 

Baseline Agency Burden 

(When all Amendments are 

considered) 

(hours) 

Agency 

Burden to 

Process 

Manufacturer 

Section 8(a) 

(hours) 

Agency 

Burden 

to 

Process 

Processor 

Section 

8(a) 

(hours) 

Agency 

Burden to 

Process 

Manufacturer 

and Processor 

Section 8(a) 

(hours) 

Total Burden 

To Agency 

(Manufacturer 

and Processor 

+ Baseline) 

(hours) 

2011 2,456 2.02 7.20 9.22 2,465 

2012 0 2.02 7.20 9.22 9.22 

2013 0 2.02 7.20 9.22 9.22 

2014 0 2.02 7.20 9.22 9.22 

2015 2,456 2.02 7.20 9.22 2,465 

2016 0 2.02 7.20 9.22 9.22 

2017 0 2.02 7.20 9.22 9.22 

2018 0 2.02 7.20 9.22 9.22 

2019 2,456 2.02 7.20 9.22 2,465 

2020 0 2.02 7.20 9.22 9.22 

2021 0 2.02 7.20 9.22 9.22 

2022 0 2.02 7.20 9.22 9.22 

2023 2,456 2.02 7.20 9.22 2,465 

2024 0 2.02 7.20 9.22 9.22 

2025 0 2.02 7.20 9.22 9.22 

2026 0 2.02 7.20 9.22 9.22 

2027 2,456 2.02 7.20 9.22 2,465 

2028 0 2.02 7.20 9.22 9.22 

2029 0 2.02 7.20 9.22 9.22 

2030 0 2.02 7.20 9.22 9.22 

Total 12,282 40 144 184 12,464 

Annual 

Average 614 2.02 7.20 9.22 623 

I.5 Agency Cost Estimate 

To calculate the Agency cost associated with processing 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 
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Table I-10 shows the Agency cost of processing the processor data. EPA estimates that the total 

Agency cost to process the manufacturer data is $213, and the total cost to the Agency of processing the 

processor data is $758. The total Agency data processing cost is $970. 

Table I-10: Agency Cost to Process Data as a Result of the TSCA Section 8(a) Data Collection 

 

Per-Report Cost to Process 

Exposure-Related 

 Data Elements 

(2008$) 

Number of 

Reports 

Agency 

Cost 

(2008$) 

Agency Cost to Process Manufacturer Data $0.51 421 $213

Agency Cost to Process Processor Data $0.51 1,500 $758

Total Agency Cost $0.51 1,921 $970 

Annual Agency Cost Estimates

Table I-11 presents the estimated annual and annualized costs to the Agency of processing Form U 

and a section 8(a) data collection. The cost estimates for completion of Form U come from Table 4-53. 

Over a 20-year period, EPA estimates that total cost to the Agency will be $76,300, with a three percent 

discount rate, and $80,600 with a seven percent discount rate. 

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

Year 

Baseline Agency Cost 

(When all Amendments are 

Considered) 

(2008$) 

Agency Cost 

to Process 

Manufacturer 

Section 8(a) 

(2008$) 

Agency 

Cost to 

Process 

Processor 

Section 

8(a) 

(2008$) 

Agency Cost 

to Process 

Manufacturer 

and Processor 

Section 8(a) 

(2008$) 

Total Cost To 

Agency 

(Manufacturer 

and Processor 

+ Baseline) 

(2008$) 

2011 $288,450 $213 $758 $970 $289,420 

2012 $0 $213 $758 $970 $970 

2013 $0 $213 $758 $970 $970 

2014 $0 $213 $758 $970 $970 

2015 $288,450 $213 $758 $970 $289,420 

2016 $0 $213 $758 $970 $970 

2017 $0 $213 $758 $970 $970 

2018 $0 $213 $758 $970 $970 

2019 $288,450 $213 $758 $970 $289,420 

2020 $0 $213 $758 $970 $970 

2021 $0 $213 $758 $970 $970 

2022 $0 $213 $758 $970 $970 

2023 $288,450 $213 $758 $970 $289,420 

2024 $0 $213 $758 $970 $970 

2025 $0 $213 $758 $970 $970 

2026 $0 $213 $758 $970 $970 

2027 $288,450 $213 $758 $970 $289,420 

2028 $0 $213 $758 $970 $970 

2029 $0 $213 $758 $970 $970 

2030 $0 $213 $758 $970 $970 
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Year 

Baseline Agency Cost 

(When all Amendments are 

Considered) 

(2008$) 

Agency Cost 

to Process 

Manufacturer 

Section 8(a) 

(2008$) 

Agency 

Cost to 

Process 

Processor 

Section 

8(a) 

(2008$) 

Agency Cost 

to Process 

Manufacturer 

and Processor 

Section 8(a) 

(2008$) 

Total Cost To 

Agency 

(Manufacturer 

and Processor 

+ Baseline) 

(2008$) 

Total $1,442,250 $4,253 $15,154 $19,407 $1,461,657 

Annual 

Average $72,113 $213 $758 $970 $73,083 

Annualized at 

3% $75,341 $213 $758 $970 $76,311 

Annualized at 

7% $79,587 $213 $758 $970 $80,558 

I.6 Small Entity Analysis 

The following section provides a preliminary assessment of the impact that a section 8(a) rule may 

have on small entities by examining the relationship between the compliance costs and company sales for 

small companies. This analysis is based on the methodology found in Chapter 8 of this report. 

Manufacturers 

For manufacturers, EPA estimated 3.89 manufacturing sites per global parent company in Chapter 8; 

41.3 percent of global parent companies (466 companies) are considered small under the SBA 

employment-based definition29, and 24.8 percent (280 companies) are considered small under the TSCA 

sales-based definition30. 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 from Dun & Bradstreet, as also 

described in Chapter 8. 

Table I-4 above shows the cost to manufacturers as a result of a section 8(a) rule. These costs were 

summed and annualized over four years (the likely timeframe for the rule) at both a three percent and 

seven percent discount rate31. As shown in Table I-12 below, these costs were divided by the total number 

of sites eected to submit data, for the annualized costs per site. This was multiplied by the number of sites 

per small parent company to arrive at the annualized costs per small parent company. This value was 

divided by the annual sales per small parent company to derive the cost-to-sales ratio. 

As shown in Table I-12Error! Reference source not found., 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 

$19,443 at a seven percent discount rate, and even lower under a three percent discount rate. The cost-tosales ratio for an average small company under the employment-based SBA definition would be 0.005 

percent or less. Under the more conservative sales-based TSCA definition, small parent company sales 

 

29 Threshold of 1,000 employees. 30 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual 

production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of 

the company, combined with those of any 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. 
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are on average more than $11.8 million, with annualized costs associated with the proposed amendments 

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. 

This approach is limited to the extent that the universe of manufacturers identified under the 

economic analysis for the IUR rule would be similar to the manufacturers subject to a section 8(a) rule. 

Table I-12: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of ExposureRelated Data Elements 

Employment-based Definition Sales-based Definition 

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate 

Cost of Section 8(a) 

Rule $2,388,518.53 

Total Annualized 

Costs $623,860 $659,026 $623,860 $659,026 

Total Number of 

Sites 66 

Annualized Costs 

per site $9,391 $9,920 $9,391 $9,920 

Number of Sites 

per Small Parent 

Company 

1.76 1.92 

Annualized Costs 

per Small Parent 

Company 

$16,528 $19,443 $18,030 $19,047 

Annual Sales per 

Small Parent 

Company 

$412,713,310 $11,821,104 

Cost-to-sales Ratio 0.004% 0.005% 0.153% 0.161% 

Number of 

Companies 

Potentially Affected 

7 4 
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Processors 

To estimate the impact of the collection of exposure-related data elements on processors, EPA is 

limited by the availability of data. As described above, EPA estimated the number of processors that may 

be impacted by the requirement using TRI submission data. However, data provided under the TRI 

program does not include information about a submitter’s parent company or annual revenues. 

For this screening-level analysis, EPA assumes that the chemical processor industry shares many 

characteristics with the chemical manufacturing industry subject to the IUR rule. To the extent that this 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 that 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 definition. EPA further assumes 

1.76 sites per small parent company under the employment-based definition, 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 TRI submissions, EPA was unable to 

examine Dun & Bradstreet data to estimate annual parent company revenue for this analysis, so 

manufacturer revenue was used as a proxy. Therefore, this analysis provides only a preliminary estimate 

of impacts. 

EPA divided the number of expected processor 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-sales ratios, 

EPA followed the same methodology for processors as described above for manufacturers. Results are 

presented in Table I-13 below. 

Table I-13: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of ExposureRelated Data Elements 

Employment-based Definition Sales-based Definition 

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate 

Cost of Section 8(a) 

Rule $8,510,161 

Total Annualized 

Costs $2,222,780 $2,348,074 $2,222,780 $2,348,074 

Total Number of 

Sites 612 

Annualized Costs per 

Site $3,631 $3,835 $3,631 $3,835 

Number of Sites per 

Small Parent 

Company 

1.76 1.92 

Annualized Costs per 

Small Parent 

Company 

$6,390 $6,750 $6,971 $7,364 

Annual Sales per 

Small Parent 

Company 

$412,713,310 $11,821,000 

Cost-to-sales Ratio 0.0015% 0.0016% 0.059% 0.062% 

Number of 

Companies 

Potentially Affected 

65 39 
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 I-12

As shown in Table I-13, under the employment-based definition, a small parent company affected by 

the rule on average has sales of more than $412.7 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 0.0016 percent or less. Under the more conservative sales-based 

definition, small parent company sales are on average 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 Flexibility 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 order to have a cost-to-sales ratio larger than one 

percent.