June 30, 2011

—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

rr

_ 

Economic Analysis for the Final Inventory Update 

Reporting (IUR) Modifications Rule
i

Contributors

The EPA analysts responsible for this report are Wendy Hoffman and Lynne Blake-Hedges of the 

Economic and Policy Analysis Branch; Economics, Exposure and Technology Division; Office of

Pollution Prevention and Toxics. Analytical and draft preparation support was provided by Abt 

Associates Inc. under EPA Contract No. EP-W-08-010.
ii

Table of Contents

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

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

List of Tables.............................................................................................................................................vii

Executive Summary................................................................................................................................. xiv

1. Introduction..........................................................................................................................................1-1

1.1 Statutory Authority .......................................................................................................................1-1

1.2 Regulatory History........................................................................................................................1-1

2. IUR Requirements and Affected Entities ..........................................................................................2-1

2.1 Overview of IUR Requirements ...................................................................................................2-1

2.2 Overview of the Regulated Community .......................................................................................2-2

3. Changes in Reporting Requirements under the Final 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 Remove “Non-isolated Intermediate” Definition from §710.3........................................3-2

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

3.1.5 Remove Superfluous Text Associated With Reporting Production Volumes .................3-2

3.1.6 Correct Text Associated With Reporting Number of Sites and Number of Workers......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 Replacing the 300,000 lb Threshold for Processing and Use Information ......................3-5

3.3.3 Reducing the 25,000 lb Threshold for Specific Regulated Chemical Substances...........3-5

3.4 Changes to Chemical Substances Subject to the IUR Rule ..........................................................3-6

3.4.1 Make Chemical Substances Subject to Enforceable Consent Agreements (ECAs) 

Ineligible for Exemptions ................................................................................................3-6

3.4.2 Full Exemption for Manufactured Water.........................................................................3-7

3.4.3 Remove Fully Exempt Polymers from the Partially Exempt List....................................3-7

3.5 Modifications to Reportable Data Elements.................................................................................3-7

3.5.1 Parent Company and Site Identity ...................................................................................3-7

3.5.2 Technical Contact ............................................................................................................3-7

3.5.3 Chemical Identity.............................................................................................................3-8

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

.........................................................................................................................................3-9

3.5.5 Volume of Chemical Substance Used On-Site ................................................................3-9

3.5.6 Indicate Whether Imported Chemical Substances Are Physically at Reporting Site.......3-9

3.5.7 Report Production Volume Exported...............................................................................3-9

3.5.8 Identify Whether a Chemical Substance is to be Recycled, Remanufactured, Reprocessed, 

or Reused .......................................................................................................................3-10
iii

3.6 Concentration Ranges.................................................................................................................3-10

3.7 Industrial Processing and Use Information Reporting................................................................3-10

3.7.1 Revise Industrial Function Categories...........................................................................3-10

3.7.2 Industrial Sectors ...........................................................................................................3-11

3.8 Consumer and Commercial Use Reporting ................................................................................3-11

3.8.1 Revise Consumer and Commercial Product Categories................................................3-11

3.8.2 Designation of Consumer or Commercial Use ..............................................................3-12

3.8.3 Number of Commercial Workers Reasonably Likely To Be Exposed..........................3-12

3.9 Changes to Standard for the Reporting of Processing and Use Information ..............................3-12

3.10 Modifications to Confidential Business Information (CBI) Claims ...........................................3-12

3.10.1 Chemical Identity CBI Claims.......................................................................................3-13

3.10.2 Upfront Substantiation for Processing and Use Information CBI Claims.....................3-13

3.10.3 Prohibition of Confidentiality Claims for Data Elements Identified as “Not Known or 

Reasonably Ascertainable” ............................................................................................3-14

3.11 Method of Submission ................................................................................................................3-14

3.11.1 Updated e-IUR Reporting Tool .....................................................................................3-14

3.11.2 Require Electronic Submissions over the Internet.........................................................3-15

3.11.3 Electronic Signature Process..........................................................................................3-15

3.12 Modifications Specifically Affecting Importers.........................................................................3-15

3.13 Modify Reporting Frequency......................................................................................................3-16

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 Baseline Submission (Mailing) Costs.........................................................4-7

4.2.4 Estimates of Baseline Cost per Report.............................................................................4-8

4.2.5 Estimates of the Number of Sites and Reports ..............................................................4-11

4.2.6 Estimates of Future Reporting Cycles’ Labor Hours (Burden) .....................................4-11

4.3 Total Baseline IUR Industry Compliance Burden and Costs......................................................4-17

4.4 Changes in Industry Burden and Costs Due to the Final IUR Modifications Rule ....................4-18

4.4.1 Technical Modifications to the Regulatory Text ...........................................................4-18

4.4.2 Modifications to Selected Definitions ...........................................................................4-18

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

Requirements.................................................................................................................4-18

4.4.4 Replace the 300,000 lb Threshold for Processing and Use Reporting...........................4-20

4.4.5 Reducing the 25,000 lb Threshold for Specific Regulated Chemical Substances.........4-22

4.4.6 Make Chemical Substances Subject to Enforceable Consent Agreements (ECAs) 

Ineligible for Exemptions ..............................................................................................4-24

4.4.7 Full Exemption for Manufactured Water.......................................................................4-26

4.4.8 Remove Fully-Exempt Polymers from the Partially-Exempt List.................................4-27

4.4.9 Parent Company and Site Identity .................................................................................4-28

4.4.10 Technical Contact ..........................................................................................................4-28

4.4.11 Chemical Identity...........................................................................................................4-28

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

29

4.4.13 Volume of Chemical Substance Used On-Site ..............................................................4-31

4.4.14 Indicate Whether Chemical Substance Is Physically at Reporting Site.........................4-32

4.4.15 Report Production Volume Exported.............................................................................4-34
iv

4.4.16 Identify Whether a Chemical Substance is to be Recycled, Remanufactured, Reprocessed, 

or Reused .......................................................................................................................4-35

4.4.17 Concentration Ranges....................................................................................................4-36

4.4.18 Revise Industrial Function Categories...........................................................................4-36

4.4.19 Replace NAICS Codes with Industrial Sectors..............................................................4-38

4.4.20 Revise Consumer and Commercial Product Categories................................................4-38

4.4.21 Designation of Consumer or Commercial Use ..............................................................4-40

4.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed..........................4-40

4.4.23 Changes to the Standard for the Reporting of Processing and Use Information............4-41

4.4.24 Chemical Identity CBI Claims.......................................................................................4-41

4.4.25 Upfront Substantiation for Processing and Use Information CBI Claims.....................4-41

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

Reasonably Ascertainable” ............................................................................................4-43

4.4.27 Require Electronic Submissions over the Internet.........................................................4-43

4.4.28 Updated e-IUR Reporting Software...............................................................................4-45

4.4.29 Electronic Signature Process..........................................................................................4-45

4.4.30 Modifications Specifically Affecting Importers............................................................4-46

4.4.31 Modify Reporting Frequency.........................................................................................4-47

4.5 Total Industry Compliance Burden and Cost of all Amendments..............................................4-49

4.5.1 Modifications that Affect the Number of Reports Submitted........................................4-49

4.5.2 Modifications That Affect the Reporting Burden..........................................................4-52

4.5.3 Amendment that Affects the Reporting Frequency .......................................................4-58

4.5.4 Average Cost and Burden per Site.................................................................................4-58

4.6 Annualized Industry Cost Estimates for all Modifications.........................................................4-60

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

5.4.5 Reduce the 25,000 lb Threshold for Specific Regulated Chemical Substances ..............5-7

5.4.6 Make Chemical Substances Subject to Enforceable Consent Agreements (ECAs) 

Ineligible for Exemptions ................................................................................................5-9

5.4.7 Full Exemption for Manufactured Water.........................................................................5-9

5.4.8 Remove Fully-Exempt Polymers from the Partially-Exempt List.................................5-10

5.4.9 Parent Company and Site Identity .................................................................................5-10

5.4.10 Technical Contact ..........................................................................................................5-10

5.4.11 Chemical Identity...........................................................................................................5-11

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

12

5.4.13 Volume of Chemical Substance Used On-Site ..............................................................5-13

5.4.14 Indicate Whether an Imported Chemical Substance Is Physically at the Reporting Site...5-

14

5.4.15 Report Production Volume Exported.............................................................................5-15
v

5.4.16 Identify Whether Chemical Substance is to be Recycled, Remanufactured, Reprocessed, 

or Reused .......................................................................................................................5-15

5.4.17 Concentration Ranges....................................................................................................5-16

5.4.18 Revise Industrial Function Categories...........................................................................5-16

5.4.19 Replace NAICS Codes with Industrial Sectors..............................................................5-17

5.4.20 Revise Consumer and Commercial Product Categories................................................5-17

5.4.21 Designation of Consumer or Commercial Use ..............................................................5-19

5.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed..........................5-19

5.4.23 Changes to the Standard for the Reporting of Processing and Use Information............5-20

5.4.24 Chemical Identity CBI Claims.......................................................................................5-20

5.4.25 Upfront Substantiation for Processing and Use Information CBI Claims.....................5-20

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

Reasonably Ascertainable” ............................................................................................5-21

5.4.27 Require Electronic Submissions over the Internet.........................................................5-21

5.4.28 Updated e-IURweb Reporting Software........................................................................5-22

5.4.29 Electronic Signature Process..........................................................................................5-22

5.4.30 Modifications Specifically Affecting Importers............................................................5-23

5.4.31 Modify Reporting Frequency.........................................................................................5-23

5.5 Total Agency Cost of All Modifications.....................................................................................5-25

5.6 Annualized Agency Cost Estimates for All Modifications...........................................................5-1

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

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

7.1 Benefits of Information-Based Policies........................................................................................7-2

7.2 Benefits of Individual Amendments.............................................................................................7-3

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...........7-7

7.2.3 Obtain New and Updated Exposure Information.............................................................7-8

7.2.4 Improve Utility of Information Reported ......................................................................7-12

7.3 Potential Users of Information Generated by the IUR Modifications Rule................................7-14

7.3.1 EPA Risk-Screening and Management Programs .........................................................7-15

7.3.2 Other Federal Risk Management Programs...................................................................7-18

7.3.3 State and Local Programs ..............................................................................................7-18

7.3.4 Nongovernmental Organization (NGO) Initiatives and Private-Sector Stewardship ....7-19

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.......................................................................................................................................8-6

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

9.6 Executive Order 13045 – Children’s Health.................................................................................9-3

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

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. – Current and Revised Industrial Function Categories................................................A-1

Appendix B. Current and Revised Consumer and Commercial Product Categories ......................B-1

Appendix C. Industrial Sectors..............................................................................................................C-1

Appendix D. Sensitivity Analyses..........................................................................................................D-1

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

D.2 Reporting Production Volume Used On-Site...............................................................................D-4

D.3 Revising Industrial Function Categories......................................................................................D-5

D.4 “Other” as a Consumer and/or Commercial Product Category ...................................................D-8

D.5 Upfront CBI Substantiation .......................................................................................................D-10

Appendix E. Alternative Regulatory Options ......................................................................................E-1

E.1 Require Submitters to Submit Full Data Annually ...................................................................... E-1

E.1.1 Annual Reporting Cost and Burden when the Option is Considered by Itself ............... E-1

E.1.2 Annual Reporting Cost and Burden when the All the Proposed Amendments are 

Considered ...................................................................................................................... E-3

E.1.3 Small Entity Analysis ..................................................................................................... E-5

E.2 Modify Reporting Frequency to a Three-Year Cycle .................................................................. E-6

E.2.1 Three-Year Reporting Cycle Cost and Burden when the Option is Considered by Itself E6

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

Considered ...................................................................................................................... E-9

E.2.3 Small Entity Analysis ................................................................................................... E-11

E.3 Change the Threshold for Reporting to 10,000 lb ..................................................................... E-12

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

...................................................................................................................................... E-13

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

Considered .................................................................................................................... E-15

E.3.3 Small Entity Analysis ................................................................................................... E-24

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

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

F.2 Industry Burden Estimate .............................................................................................................F-7

F.3 Industry Cost Estimate................................................................................................................F-11

F.4 Agency Burden Estimate ............................................................................................................F-15

F.5 Agency Cost Estimate.................................................................................................................F-19

F.6 Small Entity Analysis .................................................................................................................F-23

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

Elements...................................................................................................................................................G-1

G.1 Estimated Number of Affected Entities.......................................................................................G-1

G.2 Industry Burden Estimate ............................................................................................................G-2

G.3 Industry Cost Estimate.................................................................................................................G-4

G.4 Agency Burden Estimate .............................................................................................................G-5

G.5 Agency Cost Estimate..................................................................................................................G-7

G.6 Small Entity Analysis ..................................................................................................................G-8
vii

List of Tables

Table ES- 1 Summary of the Costs and Benefits Associated with the IUR Rule .....................................xvii

Table 4-1: Derivation of Loaded Wage Rates for the Private Manufacturing Sector (2008$) ..................4-3

Table 4-2: Baseline First-Cycle Labor Burden per Form U, in Hours.......................................................4-5

Table 4-3: Burden Percentages Attributed to Site-Limited Activity and Production Volume Questions .4-7

Table 4-4: Mailing Submission Costs (December, 2009)..........................................................................4-8

Table 4-5: Baseline First-Cycle Total Cost per Form U (2008$) ..............................................................4-9

Table 4-6: Baseline Number of Reports and Sites...................................................................................4-11

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

12

Table 4-8: Baseline Future-Cycle Labor Burden per Report, in Hours...................................................4-13

Table 4-9: Baseline Future-Cycle Total Cost per Report (2008$)...........................................................4-15

Table 4-10: Total Baseline Cost and Burden to Industry (2012 Reporting Cycle)..................................4-17

Table 4-11: Total Baseline Cost and Burden to Industry (Future Reporting Cycles)..............................4-17

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...............................................................4-19

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

Manufacturer is Subject to IUR Reporting Requirements...............................................................4-20

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

Downstream Processing and Use Information Reporting................................................................4-21

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

Processing and Use Information Reporting .....................................................................................4-22

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

Regulated Chemical Substances ......................................................................................................4-23

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

Regulated Chemical Substances ......................................................................................................4-24

Table 4-18: Change in Industry Burden as Result of Making Chemical Substances Subject to ECAs 

Ineligible for Exemptions.................................................................................................................4-25

Table 4-19: Change in Industry Cost as a Result of Making Chemical Substances Subject to ECAs 

Ineligible for Exemptions.................................................................................................................4-26

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

27

Table 4-21: Change in Industry Cost as a Result of Exempting Manufactured Water from Reporting ..4-27

Table 4-22: Change in Industry Burden as a Result of Accession Number Requests .............................4-29

Table 4-23: Change in Industry Cost as a Result of Accession Number Requests..................................4-29

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

all Non-Principal Reporting Years...................................................................................................4-30

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

Non-Principal Reporting Years........................................................................................................4-30

Table 4-26: Change in Industry Burden as a Result of Requiring the Reporting of Production Volume 

Used On-Site....................................................................................................................................4-32

Table 4-27: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume 

Used On-Site....................................................................................................................................4-32

Table 4-28: Change in Industry Burden as a Result of Indicating Whether a Chemical Substance is 

Physically at the Reporting Site .......................................................................................................4-33

Table 4-29: Change in Industry Cost as a Result of Indicating Whether a Chemical Substance is 

Physically at the Reporting Site .......................................................................................................4-33

Table 4-30: Change in Industry Burden as a Result of Requiring Reporting of Volume Exported ........4-34

Table 4-31: Change in Industry Cost as a Result of Requiring Reporting of Volume Exported.............4-34
viii

Table 4-32: Change in Industry Burden as a Result of Indicating Whether Chemical Substance is to be 

Recycled, Remanufactured, Reprocessed, or Reused ......................................................................4-35

Table 4-33: Change in Industry Cost as a Result of Indicating Whether Chemical Substance is to be 

Recycled, Remanufactured, Reprocessed, or Reused ......................................................................4-36

Table 4-34: Change in Industry Burden as a Result of Revising the Industrial Function Categories......4-37

Table 4-35: Change in Industry Cost as a Result of Revising the Industrial Function Categories..........4-37

Table 4-36: Change in Industry Burden as a Result of Revising the Consumer and Commercial Product 

Categories ........................................................................................................................................4-39

Table 4-37: Change in Industry Cost as a Result of Revising the Consumer and Commercial Product 

Categories ........................................................................................................................................4-39

Table 4-38: Change in Industry Burden as a Result of Requiring the Number of Commercial Workers 

Reasonably Likely To Be Exposed..................................................................................................4-40

Table 4-39: Change in Industry Cost as a Result of Requiring the Number of Commercial Workers 

Reasonably Likely To Be Exposed..................................................................................................4-41

Table 4-40: Change in Industry Burden as a Result of Requiring Upfront Substantiation for Claiming 

Processing and Use Information as CBI ..........................................................................................4-42

Table 4-41: Change in Industry Cost as a Result of Requiring Upfront Substantiation for Claiming 

Processing and Use Information as CBI ..........................................................................................4-43

Table 4-42: Change in Industry Burden as a Result of Requiring Electronic Submission ......................4-44

Table 4-43: Change in Industry Cost as a Result of Requiring Electronic Submission...........................4-45

Table 4-44: Change in Industry Burden as a Result of Requiring CDX Registration for Secondary 

Submitters........................................................................................................................................4-46

Table 4-45: Change in Industry Cost as a Result of Requiring CDX Registration for Secondary Submitters

.........................................................................................................................................................4-46

Table 4-46: Change in Industry Burden as a Result of Modifying the Reporting Frequency, over a 26-

Year Period ......................................................................................................................................4-48

Table 4-47: Change in Industry Cost as a Result of Modifying the Reporting Frequency, over a 26-Year 

Period ...............................................................................................................................................4-49

Table 4-48: Change in the Number of Sites and Reports Submitted for All Amendments Combined (First 

Reporting Cycle)..............................................................................................................................4-51

Table 4-49: Change in the Number of Sites and Reports Submitted for All Amendments Combined 

(Future Cycles).................................................................................................................................4-52

Table 4-50: Change in the First Year Reporting Cycle Burden for All Amendments Combined, by Labor 

Category...........................................................................................................................................4-55

Table 4-51: Change in the Future Reporting Cycle Burden for All Amendments Combined, by Labor 

Category...........................................................................................................................................4-55

Table 4-52: Total Industry Burden for All Amendments Combined.......................................................4-57

Table 4-53: Total Industry Cost When All Amendments Are Combined................................................4-58

Table 4-54: Average Number of Full and Partial Reports per Site..........................................................4-59

Table 4-55: Average Total Burden per Site .............................................................................................4-59

Table 4-56: Average Total Cost per Site .................................................................................................4-60

Table 4-57: Industry Burden over a Period of 26 Years if All Amendments Are Implemented .............4-61

Table 4-58: Industry Cost over a Period of 26 Years if All Amendments Are Implemented..................4-62

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.................................................................5-6
ix

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

and Use Reporting..............................................................................................................................5-7

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

Use Reporting ....................................................................................................................................5-7

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

Regulated Chemical Substances (Future Cycles Only) .....................................................................5-8

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

Regulated Chemical Substances (Future Cycles Only) .....................................................................5-8

Table 5-11: Change in Agency Burden as a Result of Making Chemical Substances Subject to ECAs 

Ineligible for Exemptions...................................................................................................................5-9

Table 5-12: Change in Agency Cost as a Result of Making Chemical Substances Subject to ECAs 

Ineligible for Exemptions...................................................................................................................5-9

Table 5-13: Change in Agency Burden as a Result of a Full Exemption for Manufactured Water.........5-10

Table 5-14: Change in Agency Cost as a Result of a Full Exemption for Manufactured Water.............5-10

Table 5-15: Change in Agency Burden as a Result of Accession Nnumber Requests............................5-11

Table 5-16: Change in Agency Cost as a Result of Accession Number Requests...................................5-12

Table 5-17: Change in Agency Burden as a Result of Reporting of Production Volume for Each of the 

Years since Last Principal Reporting Year......................................................................................5-12

Table 5-18: Change in Agency Cost as a Result of Reporting of Production Volume for Each of the Years 

since Last Principal Reporting Year ................................................................................................5-13

Table 5-19: Change in Agency Burden as a Result of Reporting of Production Volume Used On-Site.5-13

Table 5-20: Change in Agency Cost as a Result of Reporting of Production Volume Used On-Site .....5-14

Table 5-21: Change in Agency Burden as a Result of Indicating Whether an Imported Chemical 

Substance is Physically at the Reporting Site ..................................................................................5-14

Table 5-22: Change in Agency Cost as a Result of Indicating Whether an Imported Chemical Substance is 

Physically at the Reporting Site .......................................................................................................5-14

Table 5-23: Change in Agency Burden as a Result of Requiring the Reporting of Export Volume .......5-15

Table 5-24: Change in Agency Cost as a Result of Requiring the Reporting of Export Volume............5-15

Table 5-25: Change in Agency Burden as a Result of Indicating Whether Chemical Substance is to be 

Recycled, Remanufacture, Reprocessed, or Reused ........................................................................5-16

Table 5-26: Change in Agency Cost as a Result of Indicating Whether Chemical Substance is to be 

Recycled, Remanufactured, Reprocessed, or Reused ......................................................................5-16

Table 5-27: Change in Agency Burden as a Result of Revising the Industrial Function Categories ......5-17

Table 5-28: Change in Agency Cost as a Result of Revising the Industrial Function Categories...........5-17

Table 5-29: Change in Agency Burden as a Result of Revising the Consumer and Commercial Product 

Categories ........................................................................................................................................5-18

Table 5-30: Change in Agency Cost as a Result of Revising the Consumer and Commercial Product 

Categories ........................................................................................................................................5-18

Table 5-31: Change in Agency Burden as a Result of Designation of Consumer or Commercial Use...5-19

Table 5-32: Change in Agency Cost as a Result of Designation of Consumer or Commercial Use .......5-19

Table 5-33: Change in Agency Burden as a Result of Requiring the Number of Commercial Workers 

Reasonably Likely To Be Exposed..................................................................................................5-19

Table 5-34: Change in Agency Cost as a Result of Requiring the Number of Commercial Workers 

Reasonably Likely To Be Exposed..................................................................................................5-20

Table 5-35: Change in Agency Burden as a Result of Requiring Upfront Substantiation for CBI Claims.5-

20

Table 5-36: Change in Agency Cost as a Result of Requiring Upfront Substantiation for CBI Claims .5-21

Table 5-37: Change in Agency Burden as a Result of Requiring Electronic Submission .......................5-22

Table 5-38: Change in Agency Cost as a Result of Requiring Electronic Submission ...........................5-22

Table 5-39: Change in Agency Burden as a Result of Modifying the Reporting Frequency ..................5-24

Table 5-40: Change in Agency Cost as a Result of Modifying the Reporting Frequency.......................5-24
x

Table 5-41: Change in Agency Burden as a Result of All the IUR Modifications (First Reporting Cycle)5-

26

Table 5-42: Change in Agency Burden as a Result of All the IUR Modifications (Future Reporting 

Cycles) .............................................................................................................................................5-26

Table 5-43: Total Agency Burden for All Amendments Combined........................................................5-27

Table 5-44: Total Agency Cost of All Amendments Combined..............................................................5-28

Table 5-45: Agency Burden per Report when All Amendments are Combined (First Cycle) ................5-30

Table 5-46: Agency Burden per Report when All Amendments are Combined (Future Cycles)............5-30

Table 5-47: Agency Cost per Report When All Amendments are Combined (First Reporting Cycle)...5-32

Table 5-48: Agency Cost per Report When All Amendments are Combined (Future Reporting Cycles) ..5-

32

Table 5-49: Agency Cost per Report when All Amendments are Combined............................................5-0

Table 5-50: Agency Burden over a Period of 26 Years if All Amendments are Implemented .................5-1

Table 5-51: Annual and Discounted Total Cost to the Agency of All Modifications................................5-2

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 IUR Rule Amendments............................8-4

Table 8-3: Derivation of Cost-to-Sales Ratios for Small Companies under the IUR Rule Amendments .8-5

Table A-1: List of Current and Revised Industrial Function Categories ..................................................A-1

Table B-1: List of Current and Revised Consumer and Commercial Product Categories........................B-1

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

Whether the Threshold Is Met (Future Reporting Cycles Only).......................................................D-2

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

Whether the Threshold Is Met (Future Reporting Cycles Only).......................................................D-2

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

Whether the Threshold Is Met (Future Reporting Cycles Only).......................................................D-3

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

Whether the Threshold Is Met (Future Reporting Cycles Only).......................................................D-3

Table D-5: Sensitivity Analysis of Industry Burden Estimates for Reporting Production Volume Used OnSite ....................................................................................................................................................D-4

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

Table D-7: Sensitivity Analysis of Agency Burden Estimates for Reporting Production Volume Used OnSite ....................................................................................................................................................D-5

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

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

an Industrial Function Category........................................................................................................D-6

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

Industrial Function Category ............................................................................................................D-7

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

an Industrial Function Category........................................................................................................D-7

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

Industrial Function Category ............................................................................................................D-8

Table D-13: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as 

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

Table D-14: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” as a 

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

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

a Consumer and/or Commercial Product Category ........................................................................D-10
xi

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

Consumer and/or Commercial Product Category ...........................................................................D-10

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

........................................................................................................................................................D-11

Table D-18: Sensitivity Analysis of Industry Cost Estimates for Requiring Upfront CBI Substantiation .D11

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

........................................................................................................................................................D-12

Table D-20: Sensitivity Analysis of Agency Cost Estimates for Requiring Upfront CBI Substantiation..12

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

Annually............................................................................................................................................ E-1

Table E-2: Industry Cost under the Alternative Option to Require Submitters to Submit Full Data 

Annually............................................................................................................................................ E-2

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

Annually............................................................................................................................................ E-2

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

Annually............................................................................................................................................ E-3

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

Annually when all the Proposed Amendments are Considered ........................................................ E-3

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

Annually when all the Proposed Amendments are Considered ........................................................ E-4

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

Annually when all the Proposed Amendments are Considered ........................................................ E-4

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

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

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

Reporting........................................................................................................................................... E-6

Table E-10: Annual Industry Burden under the Alternative Option of a Three-Year Reporting Cycle ... E-7

Table E-11: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle .................... E-7

Table E-12: Burden to the Agency under the Alternative Option of a Three-Year Reporting Cycle....... E-8

Table E-13: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle ..................... E-8

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

the All the Proposed Amendments are Considered........................................................................... E-9

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

Proposed Amendments are Considered .......................................................................................... E-10

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

the Proposed Amendments are Considered..................................................................................... E-10

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

Proposed Amendments are Considered .......................................................................................... E-11

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

Cycle ............................................................................................................................................... E-12

Table E-19: Number of Reports and Sites in 2002 ................................................................................. E-13

Table E-20: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb.......... E-14

Table E-21: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb .............. E-14

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

10,000 lb ......................................................................................................................................... E-15

Table E-23: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb.. E15

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

the 10,000 lb Reporting Threshold (First Reporting Cycle) ........................................................... E-17
xii

Table E-25: Change in the Number of Sites and Reports Submitted of All Amendments Combined with 

the 10,000 lb Reporting Threshold (Future Reporting Cycles)....................................................... E-18

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

Proposed Amendments are Considered .......................................................................................... E-19

Table E-27: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb when All 

Proposed Amendments are Considered .......................................................................................... E-20

Table E-28: Industry Burden under the Alternative Option of a Lowered Reporting Threshold and All 

Other Amendments when All Proposed Amendments are Considered .......................................... E-20

Table E-29: Change in Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb 

and All Other Amendments when All Proposed Amendments are Considered.............................. E-21

Table E-30: Agency Burden as a Result of Lowered Threshold Reporting and All Other Amendments 

when All Proposed Amendments are Considered........................................................................... E-22

Table E-31: Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments when 

All Proposed Amendments are Considered .................................................................................... E-23

Table E-32: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and All 

Other Amendments when All Proposed Amendments are Considered .......................................... E-23

Table E-33: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb and 

All Other Amendments when All Proposed Amendments are Considered .................................... E-24

Table E-34: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a 10,000 lb Reporting 

Threshold ........................................................................................................................................ E-25

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

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

Elements............................................................................................................................................ F-8

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

Implemented ..................................................................................................................................... F-9

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

Elements............................................................................................................................................ F-9

Table F-5: Schedule of Annual Industry Burden to Processors.............................................................. F-10

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

Exposure-Related Data Elements.................................................................................................... F-10

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

Amendments Are Implemented ...................................................................................................... F-11

Table F-8: Per-Report Cost for Additional Data Elements, based on PMN Burden .............................. F-11

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

Elements.......................................................................................................................................... F-12

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

Implemented (2008$)...................................................................................................................... F-13

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

Elements.......................................................................................................................................... F-13

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

Implemented (2008$)...................................................................................................................... F-14

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

Exposure-Related Data Elements.................................................................................................... F-14

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

Are Implemented (2008$)............................................................................................................... F-15

Table F-15: Change in Agency Burden to Process Manufacturer Data as a Result of Additional ExposureRelated Data Elements.................................................................................................................... F-16

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

Amendments Are Implemented ...................................................................................................... F-17

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

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

Are Implemented ............................................................................................................................ F-18

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

Additional Exposure-Related Data Elements.................................................................................. F-18

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

Implemented ................................................................................................................................... F-19

Table F-21: Change in Agency Cost of Processing Manufacturer Data as a Result of Additional ExposureRelated Data Elements.................................................................................................................... F-20

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

Are Implemented (2008$)............................................................................................................... F-20

Table F-23: Change in Agency Cost to Process Processor Data as a Result of Additional ExposureRelated Data Elements.................................................................................................................... F-21

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

Implemented (2008$)...................................................................................................................... F-21

Table F-25: Change in Agency Cost of Processing Manufacture and Processor Data as a Result of 

Additional Exposure-Related Data Elements.................................................................................. F-22

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

Amendments Are Implemented (2008$)......................................................................................... F-22

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

Elements.......................................................................................................................................... F-24

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

Elements.......................................................................................................................................... F-25

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

Table G-2: Schedule of Annual Industry Burden .....................................................................................G-4

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

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

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

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

Collection..........................................................................................................................................G-5

Table G-7:Agency Burden to Process Data as a Result of a TSCA Section 8(a) Data Collection ...........G-6

Table G-8: Schedule of Annual Agency Burden ......................................................................................G-6

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

Collection..........................................................................................................................................G-7

Table G-10:Agency Cost to Process Data as a Result of the TSCA Section 8(a) Data Collection ..........G-7

Table G-11: Annual Increase in Agency Cost (2008$).............................................................................G-7

Table G-12: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of ExposureRelated Data Elements......................................................................................................................G-9

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

Data Elements.................................................................................................................................G-10
xiv

Executive Summary

As part of the Inventory Update Reporting (IUR) Modifications final rule, EPA is changing the 

identification of the regulation from IUR to Chemical Data Reporting (CDR). However, EPA is retaining 

the use of the IUR acronym throughout this document. The reader should recognize that where IUR is 

used to refer to the 40 CFR 711 regulations or to future IUR submission periods, IUR and CDR are 

synonymous.

The U.S. Environmental Protection Agency (EPA) requires manufacturers (including 

importers) of certain chemical substances to periodically report information to the Agency under 

reporting requirements known as the TSCA Inventory Update Reporting (IUR) rule. This 

information is collected based on EPA’s authority under section 8(a) of the Toxic Substances 

Control Act (TSCA), which requires EPA to compile and keep current a listing of chemical

substances in commerce in the United States and is known as the TSCA Inventory. 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. EPA is now finalizing further amendments to 

the IUR rule (“2011 amendments”).

Prior to the 2011 amendments, the IUR rule required companies to report information every 

five years on certain chemical substances listed on the TSCA Inventory. For reportable 

substances that a company manufactures (including 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 chemical substances manufactured (including imported) in volumes that meet or 

exceed an annual 100,000 lb threshold. Submitters do not need to provide this processing and use 

information for chemical substances 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 chemical substances are all referred to as “partially exempt” from 

reporting because companies must provide manufacturing information for them but not 

processing and use information. Prior to the 2011 amendments, submitters did not need to 

provide the processing and use information for any chemicals manufactured (including imported)

below a 300,000 lb threshold.

Since the publishing of the proposed rule in August of 2010, EPA has issued a suspension of 

the 2011 data collection. Under the final rule, EPA has issued new IUR collection dates of 

February 1, 2012 to June 30, 2012, and a new principal reporting year; 2011. In addition, EPA 

has made several other modifications to the final rule. Under the proposed rule, EPA required 

submitters to report chemical substance production volumes for each of the five years since the

last principal reporting year beginning with the 2012 reporting cycle. Under the final rule the 

Agency is requiring the reporting of 2010 and 2011 production volumes with the 2012 reporting 

cycle, and the reporting of all past year production beginning with the 2016 reporting cycle. In 

addition, EPA proposed the elimination of the 25,000 lb reporting threshold for specific 

regulated chemical substances and would have required manufacturers (including importers) of 

these chemical substances to report under the IUR rule, regardless of production volume. Under 

the final rule, EPA is reducing the reporting threshold for specific regulated chemical substances 

from 25,000 lb to 2,500 lb. Finally, EPA proposed the elimination of the 300,000 lb reporting
xv

threshold for processing and use information. Under the final rule, EPA has replaced this 

threshold. The complete list of IUR modifications under the final rule is found below:

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 amended §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 amendments to IUR requirements and with other regulations;

Add definitions for “manufacturer,” “Central Data Exchange (CDX),” “e-IURweb”, and 

“industrial function”;

For the reporting cycles subsequent to the 2012 reporting cycle, add a requirement to report 

whether, for any calendar year since the previous IUR principal reporting year, the subject 

chemical substance was manufactured in production volumes of 25,000 lb or greater per 

year;

Replace the 300,000 lb reporting threshold for processing and use information by phasing in 

a lower reporting threshold. For the 2012 IUR manufacturers (including importers) of nonexcluded substances with production volumes greater than 100,000 lb are required to report 

processing and use information. Subsequent to the 2012 reporting cycle, the reporting 

threshold for processing and use information will be 25,000 lb; 

Reduce the 25,000 lb threshold for reporting to 2,500 lb for certain regulated chemical 

substances and require manufacturers (including importers) of such chemical substances to 

report under the IUR rule, if production volume is greater than 2,500 lb beginning with the 

2016 reporting cycle;

Make chemical substances 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, for the 2012 reporting cycle, submitters to report chemical substance production 

volumes for both 2010 and 2011. For the reporting cycles subsequent to the 2012 reporting 

cycle, submitters are required to report the chemical substance’s production volume for each 

year since the last principal reporting year;

Require submitters to report separately production volume used on-site;

Require submitters of imported chemical substances to indicate whether the chemical 

substance is physically at the reporting site;

Require submitters to report production volume exported;

Require submitters to indicate whether the chemical substance is to be recycled, 

remanufactured, reprocessed, or reused;

Revise the set of industrial function categories and provide industrial sectors instead of 

NAICS codes, for downstream processing and use information, and revise the set of 

consumer and commercial product categories;

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

Require submitters to 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;

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

to “known to or reasonably ascertainable by”;

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

business information (CBI);

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

data as CBI;

Require submitters to submit forms electronically using the e-IURweb tool and EPA’s CDX; 

and

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

These amendments overall will increase IUR rule reporting costs. Over the first 26 years of 

the rule, EPA estimates the net present value of the rule modifications will be $494.7 million in 

social cost. Annualized costs are expected to be $17.15 million (at a three percent discount rate) 

and $14.70 million (at a seven percent discount rate).1EPA estimates all of the amendments 

combined will increase the burden to industry by approximately 0.50 million hours to 2.34

million hours, and increase the cost to industry by approximately $36.8 million to $143.7 million 

in total for the 2012 reporting cycle. EPA estimates in future reporting cycles, the industry 

burden will increase by 1.14 million hours to a total of 2.57 million hours, and industry cost will 

increase by $75.12 million to $157.94 million. EPA further estimates over a 26-year period, 

industry burden will increase by 7.62 million hours and Agency burden will decrease by 5,200 

hours. EPA estimates the net burden to society will increase by 7.61 million hours over a 26-year 

period. The information gathered will enable the Agency to continue to target educational, 

regulatory, or enforcement activities to industries or chemical substances posing the greatest 

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

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

improve its ability to screen chemical substances 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 chemical 

substances. 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, an enhanced 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 will have an increased ability to anticipate industry trends, particularly for 

chemical substances for which EPA has concerns.

The costs and benefits of the rule are summarized in Table ES- 1 below.

 

1 All values are in year 2008 dollars.
xvii

Table ES- 1 Summary of the Costs and Benefits Associated with the IUR Rule 

Burden

(Millions of Hours)

Cost

(Millions of 2010$)

Benefits 

(Not Quantified) First 

Reporting 

Cycle 

Future 

Reporting 

Cycles

Total

(over 26

years)

First 

Reporting 

Cycle 

Future 

Reporting 

Cycle

Total

(over 26 

years)

Industry 2.34 2.57 15.20 $143.73 $157.94 $933.42

Electronic reporting and other changes, such as 

modifying and clarifying definitions, will increase 

the efficiency of industry reporting. 

Agency 0.003 0.002 0.016 $0.399 $0.292 $1.856

The IUR rule modifications will allow the Agency 

to collect better information to meet the Agency’s 

overall needs, to increase its ability to effectively 

provide public access to the information, to obtain 

new and updated information relating to potential 

exposures to a subset of chemical substances listed 

on the TSCA Inventory, and to improve the 

usefulness of the information reported. It will also 

allow the Agency to save time and resources in

screening chemical substances and in developing 

risk management priorities and reduce EPA’s costs 

of processing the IUR data and result in a better 

quality database. 

TOTAL 

(Industry & 

Agency)

2.34 2.57 15.21 $144.13 $158.23 $935.28 --

Other 

Government 

Entities

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

IUR data will help state and local authorities with 

rulemaking, information collection, and voluntary 

program activities. Because state and local 

governments must address chemical substances, 

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 posing potentially high exposures for 

individual states or locations within those states. 
xviii

Burden

(Millions of Hours)

Cost

(Millions of 2010$)

Benefits 

(Not Quantified) First 

Reporting 

Cycle 

Future 

Reporting 

Cycles

Total

(over 26

years)

First 

Reporting 

Cycle 

Future 

Reporting 

Cycle

Total

(over 26 

years)

NGOs and 

Other Private 

Entities 

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

Private-sector organizations with a strong interest 

in reducing risks and providing leadership in 

preventing pollution can better meet these 

objectives by developing a better understanding of 

how chemical substances are used in general. This 

will allow them to manage exposures more 

effectively and participate in setting chemical 

substance priorities at community, regional, and 

national levels.

General 

Public -- -- -- -- -- --

The IUR rule modifications will reduce the cost of 

risk-based decision making in the public sector, 

and will free up resources for other public or 

private uses. The rule will also increase public 

access to the information and improve the 

usefulness of the information reported.
1-1

1. Introduction

As part of the Inventory Update Reporting (IUR) Modifications final rule, EPA is changing 

the identification of the regulation from IUR to Chemical Data Reporting (CDR). However, 

EPA is retaining the use of the IUR acronym throughout this document. The reader should 

recognize that where IUR is used to refer to the 40 CFR 711 regulations or to future IUR 

submission periods, IUR and CDR are synonymous.

This report assesses the costs and benefits EPA expects to result from the revisions to the 

TSCA Inventory Update Reporting (IUR) rule. The amendments will 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 chemical substances used in commerce. Specifically, under §8 of 

TSCA (15 U.S.C. 2607), EPA is authorized to promulgate regulations requiring manufacturers 

and processors of chemical substances to report manufacturing (including importing), processing 

and use information on various types and classes of chemical substances. 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 chemical substances in commerce in the United States, thereby 

providing a listing of chemical substances manufactured or processed in the United States. All 

chemical substances 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 
1-2

jurisdiction of TSCA. Chemical Substances are added to the TSCA Inventory after a company 

completes EPA’s New Chemical Substances review process and files a Notice of 

Commencement.

2

In 1986, EPA used its authority under TSCA §8(a) to promulgate regulations requiring 

chemical substance 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 chemical 

substances produced in volumes of 10,000 lb or more per site. (Inorganic chemical substances, 

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

from reporting.) From 1986 to 1998, an average of 9,200 individual chemical substances was 

reported per reporting cycle. The IUR data provided a more up-to-date picture of a subset of the 

TSCA chemical substances in commerce, generating data used to support TSCA risk 

management activities, as well as to provide support to other EPA and non-EPA program 

activities.

In January 2003, EPA promulgated amendments to the IUR rule, referred to in this report as 

the “2003 Amendments” (68 FR 848). The amended IUR rule, applicable to the 2006 reporting 

cycle and beyond, was 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 substance 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 chemical substances 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. 

 

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

2.1 Overview of IUR Requirements

The IUR rule requires U.S. manufacturers (including importers) of chemical substances 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 (CBI), 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 chemical substances 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 chemical substances 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 grants a partial exemption to 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 chemical substances 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). An overview of the information collected under the IUR rule in 2006 is as 

follows:

Company Reporting Number. An 8-digit alphanumeric number assigned by the submitter 

to each specific IUR submission (for electronic submissions only). 

Certification statement. A form that must be signed by a company-authorized official, to 

certify the information provided is complete and accurate.

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

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

plant site reporting.

Technical contact information. Includes the name, address, telephone number, and email 

address for a technical contact.
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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 (including 

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 substance leaves the site (including the percent of the 

production volume in each form), and the maximum concentration of the chemical substance

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 

substance. The industrial function categories used in the 2006 reporting are listed in 

Appendix A. 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 substance in each final product, and an indication of 

whether the chemical substance is used in a product intended for use by children. The 

consumer and commercial product categories used in the 2006 reporting are listed in 

Appendix B. of this report. These data are reported to the extent they are “readily obtainable 

by” the submitter.

Confidential Business Information. CBI can be claimed for each data element reported. 

Submitters who claim the chemical identity or plant site 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 

amendments to the IUR rule) consists of companies manufacturing or importing chemical 

substances in amounts of 25,000 lb or more annually listed on the TSCA Inventory and regulated 

under TSCA §8. Manufacturers (including importers) of non-TSCA 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 chemical substances 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 substance manufacturing (NAICS code 325) or petroleum refining (NAICS code 
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324110) are the most likely to report under the IUR rule. Chemical substance users and 

processors who may manufacture a byproduct chemical substance, e.g., utilities, paper 

manufacturers, primary metal manufacturers, and semiconductor and other electronic component 

manufacturers (NAICS codes 22, 322, 331, and 3344) also are likely to be subject to the rule.

However, companies in any industry are subject to reporting if they manufacture or import listed

chemical substances 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 Final IUR Modifications Rule

The 2011 final amendments encompass several specific changes to the IUR. Each of these 

amendments is described below.

3.1 Technical Modifications to the Regulatory Text

Prior to the 2011 amendments, 40 CFR part 710 contained three subparts. Subpart A contained

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

regulatory text associated with the IUR rule covering the update reporting in 2002; and Subpart C 

contained the regulatory text associated with the IUR rule for 2006 and beyond. The chemical substances 

covered by the IUR rule are on the Master Inventory File, which includes chemical substances from the 

original TSCA Inventory compilation and those added subsequently through the notice requirements of 

section 5 of TSCA. Because the IUR rule applies to a list of chemical substances included in the original 

TSCA Inventory plus additional chemical substances added subsequently, and because the Agency from 

time to time has modified the IUR rule, the Agency believes the regulatory text associated with the IUR 

rule should be in its own section in the Code of Federal Regulations (CFR), distinct from both the original 

TSCA Inventory rules and from the TSCA section 5 requirements. 

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

Subpart Divisions

Subpart C of 40 CFR part 710, §§710.43 to 710.59, contained the IUR regulatory text. Under the 

2011 amendments, EPA is moving all of the Subpart C text from 40 CFR part 710 to a new 40 CFR part 

711 and is adding a new Scope and Compliance section (40 CFR 711.1). Specific sections are being

moved as follows: §710.43 becomes §711.3; §710.45 becomes §711.5; §710.46 becomes §711.6; §710.48 

becomes §711.8; §710.49 becomes §711.9; §710.50 becomes §711.10; §710.52 becomes §711.15; 

§710.53 becomes §711.20; §710.55 becomes §711.22; §710.57 becomes §711.25; §710.58 becomes

§711.30; and §710.59 becomes §711.35. Because all of the text of Subpart C is being moved to 40 CFR 

part 711, 40 CFR part 710 no longer have a Subpart C. Neither part 710 nor part 711 will have any 

subparts.

3.1.2 Consolidation of Definitions

As part of moving the regulatory text from 40 CFR part 710, subpart C to 40 CFR part 711, 

EPA is consolidating definitions copied from §710.3 and those currently found at §710.43 into 

the new §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 §711.3 would therefore be unnecessarily 

duplicative. The definitions at §704.3 are included in §711.3, except insofar as§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 including the definition of mixture from section 3 of TSCA with the definitions at 40 CFR 711.3. 

The TSCA mixture definition differs from the definition in §710.3 and §720.3, the regulations used to 

determine the chemical substances listed on the TSCA Inventory, in that it does not specifically address 

hydrates. A hydrate is a mixture of water and an anhydrous chemical substance. Because they are 

mixtures, hydrates are not listed as such on the TSCA Inventory. For this reason, EPA believes it is 

superfluous to include hydrates separately in the definition of mixture. The Agency will continue to 

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

EPA added a definition to 40 CFR 710.43 for the term “non-isolated intermediate” as part of the 2003 

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

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

removing the definition from §710.3 as this definition was not associated with the original TSCA 

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

§704.3, is included with the IUR definitions at amended §711.3.

3.1.4 Remove Subpart B Text

EPA is removing the regulatory text contained in 40 CFR part 710, §§710.23 to 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.

3.1.5 Remove Superfluous Text Associated With Reporting Production Volumes

EPA is removing the phrase “provided that the reported figures are within ±10% of the actual 

volume” from the production volume reporting requirements currently found in §710.52(c)(3)(iv) which 

appears in the new §711.15(b)(3)(iv). The revised wording is, “This amount must be reported to two 

significant figures of accuracy.” The phrase that was removed is superfluous because any number 

reported accurately to two significant figures is within 10% of the correct value.

3.1.6 Correct Text Associated With Reporting Number of Sites and Number of 

Workers

EPA is replacing the phrase “less than” with the phrase “fewer than” in the ranges used to report the 

number of workers found in the table in §710.52(c)(3)(v) which appears in the new §711.15(b)(3)(vii) and 

the number of sites found in the table in §710.52(c)(4)(i)(E) which appears in the new

§711.15(b)(4)(i)(E). This change makes the phrases describing the ranges grammatically correct. 

3.2 Modifications to Selected Definitions

As part of developing the definition section for part 711, EPA is modifying six definitions associated 

with the IUR rule and adding four new definitions. In §704.3 and §710.3, EPA is also modifying the 

citation in the definition of importer by removing the citation to 19 CFR 11.1 to 19 CFR 101.1.. 

3.2.1 Manufacture and Manufacturer

To improve the information submitted through the IUR rule, EPA is modifying the definition of 

manufacture by including elements from the §720.3 definition for manufacturer. The Agency is also 

adding a simple definition for the term manufacturer to §711.3. In addition to the change to the definition 

of manufacture, EPA is adding a paragraph (c) to the regulation at §711.22 to clarify the reporting 

relationship between the contracting company and the toll manufacturer. Both the company and 

manufacturer are liable if no report is made. Note the contracting company and the toll manufacturer 

should confer with each other to avoid duplicate reporting.

This final rule defines the term manufacture under the IUR to mean “to manufacture, produce, or 

import, for commercial purposes. Manufacture includes the extraction, for commercial purposes, of a 

component chemical substance from a previously existing chemical substance or a complex combination 

of substances. When a chemical substance, manufactured other than by import, is:(1) Produced 

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

identity of the chemical substance and controls the total amount produced and the basic technology for the 
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plant process, that chemical substance is comanufactured by the producing manufacturer and the person 

contracting for such production.” Also under this rule, the term manufacturer is defined under the IUR 

rule to mean “a person who manufactures a chemical substance.”

3.2.2 Site

EPA is amending 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.

EPA identified the need to accommodate portable manufacturing units during the 2006 IUR 

submission period. Two examples of portable manufacturing units are tanks used to manufacture calcium 

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

anhydrous ammonia and water to manufacture ammonium hydroxide prior to application to agricultural 

lands. EPA is interested in including chemical substance manufacturing that is, for instance, performed by 

road crews or is occurring at construction sites at which chemical substances are mixed on site in such a 

manner to create a different chemical substance, e.g., asphalt emulsifiers. The site of physical 

manufacturing could change on a frequent basis. Manufacturers will 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 will be reported as the site location.

Under the final rule, the term site means “a contiguous property unit”. Property divided only by a 

public right-of-way shall be considered one site. More than one plant may be located on a single site. For 

substances manufactured under contract, i.e., by a toll manufacturer, the site is the location where the

chemical substance is physically manufactured. The site for an importer who imports a chemical 

substance described in §711.5 is the U.S. site of the operating unit within the person's organization 

directly responsible for importing the substance. The import site, in some cases, may be the organization's 

headquarters in the United States. If there is no such operating unit or headquarters in the United States, 

the site address for the importer is the U.S. address of an agent acting on behalf of the importer who is 

authorized to accept service of process for the importer. 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 adding two new terms, Central Data Exchange (CDX) and e-IURweb to provide clarity to the 

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 makes the term consistent with the new Premanufacture 

Notice (PMN) definition. The term e-IURweb means the “electronic, web-based IUR tool provided by the 

EPA for the completion and submission of the IUR data.”

3.2.4 Processing and Use-Related Definitions

EPA is amending the definitions of the terms commercial use and consumer use to make them more 

consistent with the definitions developed collaboratively by the United States and Canada. The new 

definitions for these two terms differ in wording from the Canadian versions to ensure the use of 

terminology defined in IUR and related regulations. EPA believes the basic application of these two terms 

will not differ from the basic application of the Canadian definitions. The term commercial use means

“the use of a chemical substance or a mixture containing a chemical substance (including as part of an 

article) in a commercial enterprise providing saleable goods or services.” Examples included in the 

§710.43 definition have been eliminated. The slightly modified definition of consumer use is “the use of a 

chemical substance or a mixture containing a chemical substance (including as part of an article) when
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sold to or made available to consumers for their use.” The restrictions associated with where a consumer 

would use the product have been removed.

EPA is adding 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 makes the Agency’s requirements consistent 

with those collaboratively developed with Canada. With this final rule, industrial function means “the 

intended physical or chemical substance 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 changing the reporting cycle from every five years to every four 

years and requiring the reporting of production volumes for each calendar year since the last principal

reporting year. EPA is modifying the terms reporting year and submission period to reflect these changes. 

The term reporting year is modified to add the term “principal” and the word “information” is 

replaced with “manufacturing, processing and use data.” These changes are to indicate the principal 

reporting year is the year in which most of the reported data are based. Under the final rule, the principal 

reporting year is the latest complete calendar year proceeding the submission period. Additionally, EPA is 

removing the reference to “the calendar year at 5-year intervals thereafter” and removing the reference to 

“calendar year 2005.” With these changes, the term principal reporting year is defined as “the latest 

complete calendar year proceeding the submission period.” 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 is modified by deleting the phrase “generated during the reporting year.” 

With this change, the definition of submission period reflects that data for years in addition to the 

principal reporting year would be reported. The new definition of submission period means “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 substance at a manufacturing (including importing) site. Every person manufacturing 

(including importing) a non-excluded 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 

period, every person manufacturing (including importing) a non-excluded substance at or above 

the 300,000 lb threshold was required to report information in Part III of Form U, unless the 

substance was partially exempt. EPA is making three changes related to the reporting thresholds:

(1) determination of whether you meet the 25,000 lb threshold, (2) replacing the 300,000 lb

threshold for reporting information in Part III, and (3) reducing the 25,000 lb threshold 

requirement for specific regulated chemical substances to 2,500 lb.

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 

involves determining that an entity manufactured (including imported) a chemical substance 
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listed on the TSCA Inventory during the principal reporting year (e.g., 2005 for the 2006 IUR 

reporting cycle); the chemical substance was not otherwise exempt; and the 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 not changing the method for determining whether a manufacturer (including importer) is 

subject to IUR reporting requirements for the 2012 submission period.

EPA is modifying the method used to determine whether a person is subject to IUR reporting for 

submission periods subsequent to the 2012 submission period. The method for submission periods 

subsequent to 2012 is based on whether, for any calendar year since the last principal reporting year, a 

chemical substance was manufactured (including imported) at a site in production volumes of 25,000 lb

or greater. For example, for the 2016 submission period, it will be necessary to examine the annual 

production volumes for the calendar years 2012 to 2015 for the site. If the production volume for a 

reportable chemical substance were 25,000 lb or greater for any calendar year during that four year 

period, then it will be necessary to report the chemical substance, unless it is otherwise exempt. For 

instance, a subject chemical substance with production volumes of 5,000 lb in 2015 and 35,000 lb in 2012 

will be reported for the 2016 IUR. Regardless of the 2015 production volume, in this example scenario 

the 2016 IUR submission will contain detailed information based on manufacturing during the 2015

calendar year and only production volume information for the years 2012 through 2014.

3.3.2 Replacing the 300,000 lb Threshold for Processing and Use Information

EPA is replacing the 300,000 lb threshold for processing and use information by phasing in a 

lower reporting threshold. For the 2012 IUR, all submitters of non-excluded chemical substances 

are required to report processing and use information if they manufactured (including imported) 

100,000 lb or more of a chemical substance in 2011. Subsequent to the 2012 reporting cycle, the 

reporting threshold will be 25,000 lb. EPA is replacing in the 300,000 lb reporting threshold by

phasing in the lower volume threshold in order to collect information necessary to complete 

screening-level exposure characterizations for IUR-reportable chemical substances. The 

exposure information is an essential part of developing risk evaluations and, based on its 

experience in using this information, the Agency believes collecting this exposure information is 

critical to its mission of characterizing exposure, identifying potential risks, and noting 

uncertainties for these lower production volume chemical substances. In addition, this change 

will provide the public with information on a greater number of chemical substances. In the 2003 

Amendments to the 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 (i.e., 

25,000 lb and 300,000 lb). 

3.3.3 Reducing the 25,000 lb Threshold for Specific Regulated Chemical 

Substances

Beginning with the 2016 reporting cycle, the reporting threshold will be reduced to 2,500 lb for those 

chemical substances that are the subject of a rule proposed or promulgated under TSCA section 5(a)(2), 

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

has been granted under a civil action under TSCA section 5 (See Appendix B of the Instructions for the 

2012 TSCA Inventory Update Reporting (EPA, 2011)). For the 2016 submission period and submission 

periods thereafter, a manufacturer (including importer) of such chemical substances is required to report 

manufacturing information on the chemical substances if they are manufactured (including imported) in 
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volumes of 2,500 lb or more during any of the years since the last principal reporting year (e.g., 2011). 

Information on the processing and use of the chemical substances must be reported if they were 

manufactured (including imported) in volumes of 25,000 lb or more during any of the years since the last 

principal reporting year. In addition to the manufacturing, processing and use information for the 

principal reporting year (e.g., 2015), the production volumes for each year since the last principal 

reporting year must also be reported. For the 2015 reporting cycle, for example, a manufacturer (including 

importer) must consider the manufactured or imported volume during the years 2012 through 2015 to 

determine the need to report; must report the production volumes for each year from 2012 to 2015; and 

must report the full manufacturing, processing, and use information for 2015. 

Chemical substances that are the subject of these particular TSCA actions are of demonstrated high 

interest to the Agency. EPA is promulgating this change to help reduce the reporting burden for 

submitters and to ensure the availability of current information when the Agency has expressed a concern 

in the form of regulatory action on those chemical substances manufactured below 25,000 lb. EPA will 

use the IUR data associated with these specific regulated chemical substances to monitor chemical 

substance production and compliance with the rules. In the future, EPA may find it necessary to collect

information on chemical substances at a reporting threshold below the 2,500 lb threshold introduced in 

this action. Although the 2,500 lb threshold is slightly higher than the proposed threshold of zero, the 

enhanced information that will be gathered during the 2016 reporting cycle will enable the Agency and 

others to more efficiently identify those chemical substances warranting further, more in depth review, as 

well as chemical substances of lesser concern. 

3.4 Changes to Chemical Substances Subject to the IUR Rule

3.4.1 Make Chemical Substances Subject to Enforceable Consent Agreements 

(ECAs) Ineligible for Exemptions

EPA may enter into an enforceable consent agreement (ECA), pursuant to procedures at 40 

CFR part 790, with a manufacturer of a chemical substance, to obtain testing where a consensus 

exists among EPA, affected manufacturers and/or processors, and interested members of the 

public concerning the need for and scope of testing. Chemical substances covered by an ECA 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 

requiring such substances be reported for IUR purposes, regardless of whether the substance 

otherwise meets the requirements listed in 40 CFR §710.46 (amended 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 chemical substances to monitor chemical substance production and compliance 

with the agreements. EPA is therefore making chemical substances that are the subject of an 

ECA ineligible for IUR exemptions.

Under this final rule, chemical substances that are the subject of an ECA will be included in the list of 

chemical substances ineligible for an IUR exemption, in the introductory paragraph of 40 CFR 710.46 

(amended 40 CFR 711.6) listing the other chemical substances likewise not eligible for an IUR 

exemption. The paragraph will state a chemical substance “is not exempted from any of the reporting 

requirements of this part if that substance is the subject of a rule proposed or promulgated under section 4, 

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

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

subject of relief that has been granted under a civil action under section 5 or 7 of the Act.”
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3.4.2 Full Exemption for Manufactured Water

Naturally occurring water is exempted from reporting under the IUR rule, but manufactured 

water, which is not naturally occurring, is a reportable substance. EPA is granting a full

exemption to all (both naturally occurring and manufactured) water (CASRN 7732-18-5) and is 

removing 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 chemical 

substances at §710.46(b)(2)(iv): Starch (CASRN 9005-25-8), Dextrin (CASRN 9004-53-9), and 

Maltodextrin (CASRN 9050-36-6). Improperly including substances meeting the IUR definition 

of a polymer in the partially exempt list of chemical substances may be confusing to submitters 

and may lead to unnecessary reporting for these substances. EPA is amending the partially 

exempt list of chemical substances at §710.46(b)(2)(iv) to remove these three chemical 

substances which, as polymers, are fully exempt from reporting.

3.5 Modifications to Reportable Data Elements

3.5.1 Parent Company and Site Identity

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

Bradstreet (D&B) D-U-N-S® number to identify the company associated with the plant site, and 

also to report the site name, address, and D-U-N-S® number. If the company associated with the 

plant site does not have a D&B number, the manufacturer must obtain a D-U-N-S® number for 

the company. Likewise, if the plant site does not have a D-U-N-S® number, the manufacturer 

must obtain a D-U-N-S® number for the site. EPA is now clarifying what is meant by company 

name, by requiring the company name provided be the ultimate domestic parent company name. 

“U.S. parent company” is defined to mean “the highest level company, located in the United 

States that directly owns at least 50 percent of the voting stock of the manufacturer.” 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.

The 2006 IUR submissions from different reporting sites contained varying D-U-N-S® 

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 requiring the address as well as 

the D-U-N-S® number of the parent company.

3.5.2 Technical Contact

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

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

about the reported chemical substance and but does not have to be located at the manufacturing 

site. Based on EPA’s experience with contacting the reported technical contact with follow-up 
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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 substance 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 also allowing multiple technical contacts on a chemical 

substance-by-chemical substance basis, as provided by the new e-IURweb tool.

3.5.3 Chemical Identity

Chemical Name. EPA is requiring reporting of the Chemical Abstracts (CA) Index Name currently 

used to list the substance on the TSCA Inventory as the chemical name reported for IUR. Currently, 

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

text. For the 2012 submission period, the reporting software will be directly linked to the non-confidential 

portion of the TSCA Inventory through the Agency’s Substance Registry System (SRS) database. 

Therefore, submitters will be required to select the correct CA Index Name for their reportable chemical 

substance(s) from SRS. EPA believes the requirement to use SRS to select the chemical name as currently 

listed on the TSCA Inventory will greatly reduce the number of poorly identified chemical substances and 

allow the data to be released more quickly to the public.

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 TSCA 

Inventory substance. In these cases, the manufacturer (including importer) and the supplier report the 

information required in this part in a joint submission (see Section 3.12).

In order to clarify this requirement, EPA is amending 40 CFR 711.15(b)(3)(i), to state that the

importer must have the supplier of the confidential chemical substance directly provide EPA with the 

correct chemical identity, in a joint submission with the manufacturer. Furthermore, in the event the 

manufacturer submitting a report cannot provide the whole chemical identity because the reportable 

chemical substance is manufactured using a reactant having a specific chemical identity claimed as 

confidential by its supplier, the manufacturer must submit a report directly to EPA containing all other 

information known to or reasonably ascertainable by the manufacturer about the chemical identity of the 

reported chemical substance and must properly ask that the supplier directly provides to EPA the correct 

chemical identity of the confidential reactant in a joint submission. Nothing in §711.15(b)(3)(i) relieves a 

manufacturer (including an importer) of its obligation to report information that it actually knows or can 

reasonably ascertain.

Chemical Identifying Number. As part of the chemical identity, submitters provide a chemical 

identifying number associated with the correct CA Index Name. EPA is requiring submitters to report 

only the CASRN as a chemical identifying number or, in the case of confidential chemical substances, the 

TSCA accession number assigned when the Notice of Commencement (NOC) was submitted to the 

Agency. Because the reporting tool will be directly linked to the non-confidential portion of the TSCA 

Inventory through SRS, submitters no longer will be allowed to claim the CASRN as confidential. For 

this reason, EPA is requiring submitters to report the TSCA accession number if they choose to assert a 

CBI claim on the chemical identity. Submitters will be able to look up the accession number in SRS using 

the PMN number for their chemical substance. Only those submitters who know only the CAS number 

and not the PMN number for the confidential chemical substance should submit a written request to EPA 

to obtain the TSCA accession number.

EPA also is removing the PMN number as an allowed chemical identifying number because each 

Inventory substance has either (or both) a CASRN (for the public Inventory) or a TSCA accession 

number (for the confidential Inventory), which are likely to be known already to the submitter.
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3.5.4 Report Production Volume for Each of the Years since the Last Principal 

Reporting Year

For the 2012 submission period, manufactures (including importers) will be required to 

report the calendar year 2010 production volume of a chemical substance. For submission 

periods subsequent to the 2012 submission period, manufacturers (including importers) will be 

required to report the production volume for each year since the last IUR principal reporting 

year. For example, for the 2016 IUR, manufacturers (including importers) of a chemical 

substance at or above the 25,000 lb threshold during the principal reporting year will report the 

production volume of that chemical substance for each of the following calendar years: 2015, 

2014, 2013, and 2012. Collecting the production volume for multiple years will provide EPA 

with more accurate and up-to-date information than what is provided under the current, onceevery-five-years snapshot. 

3.5.5 Volume of Chemical Substance Used On-Site

EPA is requiring submitters to report the volumes of a manufactured (including imported) 

chemical substance used at the reporting site. The requirement to report the volume used on-site 

is replacing the requirement to indicate the chemical substance is site-limited. Under this final 

rule, either domestically manufactured or imported chemical substances could be reported as 

used at the reporting site, whereas, under the current reporting requirements, only domestically 

manufactured chemical substances, consumed entirely at the manufacture site, were reported as 

site-limited. 

3.5.6 Indicate Whether Imported Chemical Substances Are Physically at 

Reporting Site

EPA is adding a requirement to indicate whether an imported chemical substance is 

physically at the reporting site. Often, the site reporting an imported chemical substance never 

physically receives the chemical substance, but instead ships it directly to another location such 

as a warehouse, a processing or use site, or a customer’s site. Identifying whether the chemical 

substance is physically at the reporting site provides more accurate information for screeninglevel analyses and other uses of the IUR data.

3.5.7 Report Production Volume Exported

EPA is adding a requirement to report the production volume directly exported and not 

domestically processed or used. This will 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.
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3.5.8 Identify Whether a Chemical Substance is to be Recycled, Remanufactured, 

Reprocessed, or Reused

EPA is adding a requirement to indicate whether a manufactured chemical substance, such as 

a byproduct, is to be recycled, remanufactured, reprocessed, or reused. Submitters should 

indicate whether their manufactured chemical substance, which otherwise would be disposed of 

as a waste, is being removed from the waste stream and has a commercial purpose (i.e., it is 

being recycled, remanufactured, reprocessed, or reused). EPA believes such information will 

help the Agency identify where these activities are already occurring, and can be used to 

encourage such activities. Collecting information on whether a chemical substance is being 

recycled, remanufactured, reprocessed or reused and is not entering the waste stream provides 

valuable information to EPA and others regarding trends in chemical substance manufacturing. 

This information also can be used to help determine the effectiveness of various programs, such 

as EPA’s Resource Conservation Challenge (RCC) Program. EPA launched the RCC in 2002, 

implementing Congress’ instruction to prevent pollution and conserve natural resources and 

energy by managing materials more efficiently. The RCC Program’s goals include promoting 

reuse and recycling and reducing chemical substances of national concern in products and waste.

Indicating a manufactured chemical substance, such as a byproduct, is to be recycled, 

remanufactured, reprocessed, or reused does not affect the reporting requirements associated 

with any substance manufactured from the byproduct. 

3.6 Concentration Ranges

EPA is eliminating gaps in the ranges used to report concentration in §710.52(c)(3) and (4). 

The new ranges are: (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 characterizing the frequency, route, 

and duration of exposure to a chemical substance during manufacture, processing, and use of the 

substance. These data are also useful when EPA characterizes the quantity of the chemical substance in 

wastes and emissions entering the environment and for anticipating the environmental media into which 

wastes will be released. The Agency now is revising the list of industrial function categories and 

replacing the NAICS codes with industrial sectors.

3.7.1 Revise Industrial Function Categories

EPA is revising the list of industrial function categories by combining categories leading 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 revised set of categories, which will be used by both the United 

States and Canada for Inventory reporting. Harmonization of the categories for reporting the 

industrial functions of chemical substances will facilitate the exchange of information between 
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EPA and Canadian agencies and could serve as a model to be used by Mexico in developing an 

inventory of chemical substances. In addition, the harmonized categories will facilitate consistent 

reporting of chemical substance use information by industry in the United States and Canada.

EPA is adding eight new industrial function categories and removing six existing categories 

from the current list; the total number of industrial function categories will increase to 35. Also, 

EPA is renaming several of the industrial function categories to provide a more informative 

description of the function of the chemical substances that should be reported in that category. 

Lastly, EPA is requiring that if a submitter selects the category “Other,” the submitter must 

provide its own description of the industrial function of the chemical substance. Appendix A. 

lists both the existing and amended sets of industrial function categories. 

3.7.2 Industrial Sectors

EPA is replacing the five-digit North American Industrial Classification System (NAICS) 

codes with 48 Industrial Sectors (IS). The sectors were adapted from the European Union’s 

(EU’s) “Guidance on Information Requirements and Chemical Safety Assessment.” The 

Industrial Sectors chosen divide the entire range of NAICS codes into sectors so a sector 

corresponds to every NAICS code. The Agency believes this change will provide several 

benefits. First, the sectors will reduce reporting burden because submitters will not have to look 

up the NAICS code. Second, it will encourage more complete reporting by using terms already 

familiar to industry. Third, the sectors reduce the likelihood of errors that result from the 

selection of miscellaneous or inappropriate NAICS codes. Fourth, it will reduce the number of 

codes that could apply to one substance. Appendix A. of this report provides a list of the revised 

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 chemical substances 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 corresponding to the actual use of the chemical substance 

they were reporting. 

3.8.1 Revise Consumer and Commercial Product Categories

EPA is revising the list of consumer and commercial product categories by combining categories 

leading to common exposure scenarios and adding categories not adequately described in the initial set of 

categories. EPA worked with Environment Canada and Health Canada to develop the revised categories. 

The revised list includes 33 product categories, including “Other.” Examples of new categories that have 

been added include explosive materials, building/construction products not covered elsewhere, and air 

care products. The glass and ceramic products category had relatively few IUR submissions in 2006 and 

overlaps with new categories, and so has been eliminated. Also, several of the consumer and commercial 

product categories have been renamed to better describe the products that should be reported in those 

categories. See Appendix B. of this report for a list of the revised categories.
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3.8.2 Designation of Consumer or Commercial Use

EPA is requiring submitters to designate whether the use is a consumer use or a commercial 

use, or both. The Agency’s experience using the 2006 IUR data identified a need to distinguish 

between potentially exposed consumer and commercial populations. The designation of 

consumer or commercial use, or both, will 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 requiring submitters to 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 should be reported using the same definitions and ranges used for 

manufacturing and industrial processing and use workers, required by 40 CFR 710.52. The

revised 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 the industrial processing and 

industrial, commercial, and consumer use of chemical substances, EPA is replacing the “readily 

obtainable” reporting standard used for reporting under 40 CFR 710.52(c)(4) in 2006 with the 

“known to or reasonably ascertainable by” reporting standard set forth under TSCA for this type 

of TSCA reporting. TSCA section 8(a)(2) authorizes EPA to require persons to report 

information “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), and this standard will continue to apply to the reporting of 

such information under amended §§711.15(c)(1), (c)(2), and (c)(3). It covers all information in a 

person’s possession or control, plus all information a reasonable person similarly situated might 

be expected to possess, control, or know. The “known to or reasonably ascertainable by” 

reporting standard was the only standard used for IUR reporting purposes prior to the 2006 IUR 

submission period. 

EPA is clarifying that, in general, submitters are not required to conduct customer surveys. 

However, to the extent that customer surveys are already in the submitter’s possession or control, 

and to the extent that reasonable efforts to analyze or synthesize already-available customer 

surveys may develop new processing and use information, the information is generally 

“reasonable ascertainable.” For certain data fields on Form U where the information is not 

known and cannot be reasonably ascertained, EPA is permitting submitters to enter “NKRA” 

(not known to or reasonably ascertainable by).

3.10 Modifications to Confidential Business Information (CBI) Claims

Submitters currently may 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 
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(amended §711.30). Submitters must assert claims of confidentiality at the time information is 

submitted to EPA. EPA’s procedures for handling information claimed as confidential are set 

forth at 40 CFR part 2, subpart B. 

To claim information as confidential, a submitter must assert its claim by checking the 

appropriate box and signing the certification statement on the reporting form. A submitter must 

assert 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 the changes to 

the method for claiming information as CBI will reduce the number of unjustifiable CBI claims.

Reducing the number of CBI claims will increase the amount of information available to the 

public and improve the timeliness of its public availability. As a result, the Agency will be able 

to publicly discuss and explain its risk management actions and decisions more clearly.

3.10.1 Chemical Identity CBI Claims

A submitter may assert a claim of confidentiality for the identity of the reported chemical 

substance only when the chemical substance is listed on the confidential portion of the TSCA 

Inventory. Submitters who assert a confidentiality claim for chemical name must also provide 

substantiation for the claim at time of filing. At times, submitters have asserted a claim of 

confidentiality for the chemical identity of a substance listed on the public portion of the Master 

Inventory File. Where the identity of a chemical substance is already provided on the public 

portion of the TSCA Chemical Substances Inventory, which is publicly available from the 

National Technical Information Service, EPA’s website and other sources, EPA believes the 

identity itself, even assuming it might otherwise be CBI, as well as any information that might be 

derived from it about processes or portions, has already been disclosed. Under the final rule, 

when this occurs, the Agency may make the information available to the public without further 

notice to the submitter. 

In this final rule, 40 CFR 711.15(a)(3)(i) has been revised to provide that submitters who 

wish to report chemical substances listed on the confidential portion of the TSCA Inventory will 

need to report the substance using a TSCA accession number. Requiring the use of accession 

numbers will allow EPA to adequately protect confidential CASRNs and CA Index Names (by 

omitting them from the pre-populated selection list in the SRS) while still obtaining the 

improvements in reporting accuracy it sought in the proposed rule.

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 substance if the submitter has reason to believe release of

the information will reveal trade secrets or confidential commercial or financial information, as 

provided by section 14 of TSCA and 40 CFR part 2.

Under the final rule, submitters will be required to both check the appropriate box on the 

reporting form and substantiate the CBI claim in writing, within the reporting software, by 

answering certain questions provided in§711.30(d) of the final rule. Where a submitter fails to 

substantiate the processing and use CBI claim in accordance with the applicable rules (i.e., the 

submitter does not provide an answer to the required questions), EPA will consider the 
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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 Prohibition of Confidentiality Claims for Data Elements Identified as “Not 

Known or Reasonably Ascertainable”

Under the final rule, EPA is prohibiting claims of confidentiality pertaining to the designation that 

information is not “known to or reasonably ascertainable by” (NKRA) the submitter. For the 2012 and 

future IUR collections, submitters will be required to report processing and use information to the extent 

that it is known to or reasonably ascertainable by them.

For the 2006 IUR collection, EPA observed that, on occasion, processing and use information was 

claimed as confidential when a submitter determined that the information was not readily obtainable. 

Section 14 of TSCA limits the disclosure of information entitled to confidential treatment under 

Exemption 4 of the Freedom of Information Act (FOIA). EPA has considered the NKRA designation and 

its relationship to a potential CBI or trade secret claim. Given that a NKRA 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. 

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-ROM) and delivered by mail or a delivery service. Approximately one-third of the 

submissions were made electronically, and EPA was able to immediately process and quickly begin to use 

the information from those electronic submissions. Submissions sent as a file on a CD 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 now is requiring the mandatory use of Agency-provided reporting tool (e-IURweb) to complete 

the IUR Form U and CDX to submit the completed Form U to the Agency. CDX users are required to 

register with CDX and to submit an authorized electronic signature agreement. Each IUR submission 

must have an authorized official associated with the submission, who is the person signing the 

certification statement and submitting the IUR report via CDX. The authorized official must complete 

both an ESA and the CDX registration process. The reporting software, instruction manual, and other 

guidance materials are available on EPA’s website at www.epa.gov/iur. 

3.11.1 Updated e-IUR Reporting Tool

EPA, based on its experience collecting and managing the 2006 IUR reports, has concluded that 

mandatory electronic reporting is a critical next step for collection of the 2012 data. Optional electronic 

reporting for the 2006 IUR provided the Agency with experience relating to both industry and Agency 

needs, and the Agency has applied this experience in the course of developing of the 2012 electronic 

reporting tool (e-IURweb). For example, the use of a web-based tool for the 2012 IUR will eliminate 

many of the software compatibility and firewall setting issues that were encountered during the 2006 

submission period. In addition, e-IURweb utilizes other Agency systems, such as SRS, enabling the 

submitter to readily select the chemical identity in the correct format, thereby eliminating problems 

relating to the previous need to type or write in the chemical name. With these enhancements, EPA

believes the use of e-IURweb will substantially reduce error rates and burden. 
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3.11.2 Require Electronic Submissions over the Internet

EPA is requiring manufacturers (including importers) to submit their IUR reports to the Agency 

through CDX via the Internet. EPA will require all submissions to be generated using e-IURweb 

reporting software. Electronic submissions will ensure that IUR data will have completed a basic 

validation check, could be incorporated quickly into a database and be ready for immediate Agency use, 

and will not be subject to subsequent data entry errors. Furthermore, EPA believes the required use of eIURweb and CDX will 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 will no 

longer accept paper submissions or electronic media (i.e., as a file on a CD-ROM) for any IUR 

submission. 

3.11.3 Electronic Signature Process

In order to submit electronically to EPA via CDX, individuals acting on behalf of the submitter must 

first register with CDX. CDX registration is a requirement for all electronic submissions using CDX and 

is not being introduced with this final rule. 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. There was confusion among some submitters 

regarding the correct identity of the individual eligible to register for CDX and the individual required to 

sign the ESA.

EPA is making changes to the registration process in order to address problems identified during the 

2006 IUR electronic reporting. For 2012 IUR reports, EPA is modifying the 2006 ESA to identify more 

clearly the individual(s) required to sign the agreement. The Agency is developing an ESA process 

similar to that planned for New Chemicals Program electronic submissions. Each IUR submission must 

have an authorized official associated with the submission, who is the person signing the certification 

statement and submitting the IUR report via CDX. The authorized official will need to complete both an 

ESA and the CDX registration process. 

3.12 Modifications Specifically Affecting Importers

Submitters report IUR data on chemical substances they manufacture domestically and 

import into the United States. Current IUR regulations require the site responsible for reporting 

for imported chemical substances to be the site of the operating unit directly responsible for 

importing the substance and controlling the import transaction. In some cases, the import site 

may be the organization’s headquarters in the United States. The regulations defining the site for 

importer reporting are found in both the definition for site in §710.3 and in paragraph 

§710.48(b). EPA is eliminating 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 submitters occasionally use a foreign address as the site address for the 

importer. In the final rule, EPA is now is requiring submitters to 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 directly responsible for importing the 

substance and controlling the import transaction has no U.S. address. The Agency expects all importers 

will have a U.S. site, as defined in the amended §711.3 definition for site. Under U.S. Customs 

regulations at §141.18, a non-resident corporation is not permitted to enter merchandise for consumption 
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unless it has a resident agent in the State where the port of entry is located, who is authorized to accept 

service of process against the corporation.

For purposes of IUR, submitters currently are allowed to report the IUR information jointly with the 

foreign manufacturer of the chemical substance. Importers may not know the specific chemical identity of 

a substance because the foreign supplier chooses to keep it confidential. In such a situation, the importer 

must use e-IURweb to ask the foreign supplier to submit its chemical identity information to EPA and 

may do so through by submitting a joint report. To submit a joint report, the importer completes the 

majority of the required information, and supplies a trade name or other designation to identify the 

chemical substance, and provides contact information for the foreign supplier. The importer then uses eIURweb to contact the foreign supplier and to request that the foreign supplier notify it of the need to 

report the specific chemical identity information directly to EPA. The importer must submit a copy of 

such request to EPA, along with the rest of its IUR submission for the chemical substance. As a general 

matter, EPA expects that importers will supply the information described at §711.15(b)(3)(i)(A), rather 

than a “NKRA” designation, when importers do not know the confidential chemical identity of a chemical 

substance they import. EPA believes that a NKRA designation would generally be appropriate only in the 

unlikely event that an importer did not know, and could not reasonably ascertain, the information needed 

to link its submission with a secondary report from the supplier.

Under the final rule, the process will be the same, except submitters will be required to use CDX and 

e-IURweb for preparation and submission of joint submissions. Previously, joint submissions could not 

be made electronically. In order to submit electronically to EPA via CDX, individuals must first register 

with CDX. Therefore, the authorized officials of the jointly submitting companies will need to register in 

order to submit their reports to EPA. The secondary submitter (e.g., a foreign supplier or manufacturer) 

will 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 will use e-IURweb to 

identify the need to submit a joint report and will identify itself as a primary submitter. The primary 

submitter will then complete his or her portion of the report and provide the secondary submitter’s 

company information, along with select information on the chemical substance(s) manufactured using a 

chemical substance made by the secondary submitter. The primary submitter reports only the volume that 

it used. A secondary submitter will also need to use e-IURweb to identify the need to submit a joint report 

and will identify itself as a secondary submitter. In an acceptable joint submission, the secondary 

submitter supplies the chemical identity, as well as its technical contact and company information, and 

provides the primary submitter’s site information. EPA will not accept joint submissions that are not 

submitted electronically using e-IURweb and CDX. All information will be saved by the reporting 

software and both submissions will be matched based upon company and chemical substance information. 

Once the forms are linked, EPA will process the joint submission as one report for the reported chemical 

substance.

For the 2006 IUR reporting cycle, EPA set aside joint submissions until both were received and 

matched. EPA often 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 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 2012 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 
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lessen the burden associated with the amended IUR. The Agency now has determined that 

reporting every five years is too infrequent, and is returning to reporting every four years. 

While the less frequent reporting does reduce burden, EPA now believes reporting every five years 

does not provide data sufficiently current to meet Agency and public needs. The Agency has been 

criticized for using outdated information. EPA, therefore, considered increasing the frequency of 

reporting to every three years, or possibly to annual reporting. The Agency believes efficiencies are 

gained with more frequent reporting, both for the submitter and for EPA. With more frequent reporting, 

companies will 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 

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 amendments to the burden 

and cost industry would incur to comply with current IUR requirements in the 2012 reporting 

cycle absent the amendments (the baseline). The methodology for estimating the change in 

industry burden and cost can be summarized as follows:

Step 1: Identify the tasks sites perform to comply with reporting requirements for both the 

current IUR requirements and the 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 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 IUR amendments.

Step 5: Subtract the compliance burden and cost after the 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 chemical substances. Each site must submit a Form U if it exceeds the 25,000 lb

threshold for at least one chemical substance not exempt from reporting. A site will submit one 

Form U Part I, and either a full or partial report for each chemical substance that meets or 

exceeds the reporting threshold. Each report is submitted for a unique chemical substance/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 (including imports) any chemical substances not 

falling into one of the categories exempt from reporting; (2) the annual production or import 

volume of the chemical substance 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 chemical substances at the site. 

A portion of the compliance determination cost depends on the number of chemical 

substances, but for most chemical substances 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 it must submit a Form U, staff must 

familiarize themselves with the requirements of the rule. Sites reporting previously must 

become familiar with new requirements, and sites new to reporting must become familiar 

with all requirements. This entails reading the rule, understanding the various reporting and 

administrative requirements, and determining the manner in which the reporting 

requirements will be met.
4-2

Preparation and Submission of Reports: Once a site has determined it must submit a Form 

U for a chemical substance and has become familiar with the rule, the required information 

must be collected and a Form U covering all of the reportable chemical substances 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. 

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 are then multiplied by benefits and overhead factors to estimate loaded, annual 

salaries in 2008 dollars. Table 4-1 contains the loaded wage rates for the managerial, technical 

and clerical occupation categories.
4-3

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:

1Employer 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).

4.2.2 Estimates of Baseline Labor Hours (Burden)

As mentioned earlier, the reporting tool for the IUR rule is 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 chemical substances reported by the site. 

Each reporting site is required to file only one Part I of Form U, regardless of the number of 

reportable chemical substances it manufactures (including imports). The information required in 

Part I, such as site and company identification, are common to all chemical substances produced 

at a single site; therefore, this information need only be reported once. For each reportable 

chemical substance, 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 substance. 

Submission costs, in the baseline, consist of mailing costs, and are calculated per-site. 

Recordkeeping costs are calculated as per-report costs (so total reporting and recordkeeping costs 

vary with the number of chemical substances reported).

In summary, compliance costs are determined as follows:

Compliance Determination: per-site basis;

Rule Familiarization: per-site basis;

Preparation of Part I: per-site basis;

Preparation of Parts II and III: per-report basis;

Submission: per-site basis; and

Recordkeeping: per-report basis.

The baseline estimates of the labor hours required for the various tasks are taken from the 

Economic Analyses from the 2002 and 2005 IUR rule 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 
4-4

completion of Part III because submitters no longer were required to report use and downstream 

processing information for exports.3Therefore, 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 substance).

 

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.
4-5

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

Form U Section and Activity

Clerical 

Burden

Technical 

Burden

Managerial 

Burden Total Burden

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

Compliance Determination 

(Total Burden for Form U Compliance Determination) 0.00 2.50 0.00 2.50

Rule Familiarization 

(Total Burden for Form U Submission) 0.00 19.00 9.00 28.00

Recordkeeping 

(Total Burden for Form U Recordkeeping) 1.50 3.00 1.50 6.00

Submission

(Total Burden for Form U Submission) 0.00 0.00 0.00 0.00

Mailing Burden 0.00 0.00 0.00 0.00

Part I. Site Identification Information

(Total Burden for Part I) 0.76 0.95 1.05 2.76

1 Certification 0.68 0.85 1.01 2.54

2 Company Information

Company Name, Technical Contact, Address, D&B 

Number, Mailing Address 0.04 0.04 0.02 0.10

3 Plant Site Identification 

Plant Name, D&B Number, Address, Mailing Address 0.05 0.06 0.02 0.13

Part II.

Manufacturing Information

(Total Burden for Part II) 1.55 8.78 3.49 13.82

1 Chemical Identification

2 (Other) Manufacturing Information

Site-Limited, Activity, Production Volume (lb) 0.52 2.28 0.56 3.36

Chemical Identification Upfront CBI Substantiation 0.26 1.45 0.67 2.38

Plant Site Upfront Substantiation 0.12 0.83 0.51 1.46

Total Number of Workers 0.21 1.43 0.59 2.23
4-6

Form U Section and Activity

Clerical 

Burden

Technical 

Burden

Managerial 

Burden Total Burden

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

Maximum Concentration, Physical Form, Percent 

Volume of Production 0.44 2.79 1.07 4.30

Part III Processing and Use Information

(Total Burden for Part III) 7.94 45.31 16.66 69.92

1 Industrial Processing and Use Exposure-Related Data

Determination of Applicability 0.13 1.01 0.28 1.42

Industrial Function Category 2.11 4.41 2.07 8.59

Function Code 0.19 0.94 0.40 1.52

Percent of Production Volume 1.23 10.00 5.27 16.51

Total Number of Processing and Use Sites 1.57 9.14 3.52 14.24

Total Number of Potentially Exposed Workers 2.10 15.43 3.83 21.36

2 Consumer and Commercial Use Exposure-Related Data

Determination of Applicability 0.14 0.94 0.25 1.33

Identification of Production Category/Use by Children 0.14 0.84 0.25 1.23

Percent of Production Volume 0.20 1.26 0.45 1.91

Maximum Concentration by Category 0.11 1.36 0.34 1.81

Total Burden for Report Preparation and Submission

Partial Report (Parts I, II, Recordkeeping and Submission Burden) 3.81 34.23 15.04 53.08

Full Report (Parts I, II, III, Recordkeeping and Submission Burden) 11.74 79.54 31.70 122.99

Note: Totals may not sum due to rounding.

Source: Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).
4-7

The survey conducted for the economic analysis for the Final TSCA IUR rule 2003 

Amendments (EPA, 2002a) estimated a single burden for reporting site-limited activity and 

production volume. This burden is estimated to be 3.36 hours per site (see Table 4-3) and covers 

four separate activities:

Answering a yes/no question to indicate whether the volume is site-limited volume;

Indicating whether the chemical substance is manufactured or imported;

Providing the manufactured production volume; and

Providing the imported production volume.

Several of the 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 estimate more accurately the burden of several amendments, EPA used its best professional 

judgment and estimated the percent burden each activity contributed to the total burden of 3.36 

hours. These burden estimates are found in Table 4-3.

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

Questions

Activity Percent of Total 

Burden

Burden 

(hours)

Answering a yes/no question to indicate whether the volume is site-limited 

volume 5% 0.17

Indicating whether the chemical substance is manufactured or imported 5% 0.17

Providing the manufactured production volume 45% 1.51

Providing the imported production volume 45% 1.51

Total 100% 3.36

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

4.2.3 Estimates of Baseline Submission (Mailing) Costs

As noted above, the baseline scenario in this analysis is the total cost a site would incur to 

comply with the current IUR rule, absent any of the 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.
4-8

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

USPS Service Cost (2009$)

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

Notes: While all other costs are presented in 2008$, the most recent mailing costs as of the preparation of this analysis were used,

following the methodology outlined in other reports such as the Economic Analysis of Expedited Significant New Use Rules for 56 

Chemical Substances (EPA, 2008b). EPA does not expect mailing costs to significantly differ between 2008 and 2009. 

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 

estimates the cost to a site of submitting and completing a full report (Parts I, II, III, 

recordkeeping and submission costs) for the first time is $7,247, for one chemical substance.

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.
4-9

Table 4-5: Baseline First-Cycle Total Cost per Form U (2008$)

Form U Section and Activity

Clerical 

Cost Technical Cost Managerial Cost Total Cost

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

Compliance Determination 

(Total Burden for Form U Compliance Determination) $0.00 $147 $0.00 $147

Rule Familiarization 

(Total Burden for Form U Submission) $0.00 $1,118 $630 $1,748

Recordkeeping 

(Total Cost for Form U Recordkeeping) $42.72 $177 $104 $324

Submission 

(Total Cost for Form U Submission) $13.78

Mailing Cost $13.78

Part I.

Site Identification Information

(Total Cost for Part I) $21.50 $54.08 $73.53 $149.10

1 Certification $19.22 $50.01 $70.73 $139.96

2 Company Information

Company Name, Contact, Address , D&B Number, Mailing Address $1.00 $2.35 $1.40 $4.75

3 Plant Site Identification 

Plant Name, D&B Number, Address, Mailing Address $1.28 $1.71 $1.40 $4.39

Part II.

Manufacturing Information

(Total Burden for Part II) $44.14 $516.61 $244.40 $805.14

1 Chemical Identification

2 (Other) Manufacturing Information

Site-Limited, Activity, Production Volume (lb) $14.81 $134.15 $39.22 $188.18

Chemical Identification Upfront CBI Substantiation $7.40 $85.32 $53.57 $146.29

Plant Site Upfront Substantiation $3.42 $48.84 $35.57 $87.97

Total Number of Workers $5.98 $84.14 $40.97 $131.09

Maximum Concentration, Physical Form, Percent Volume of $12.53 $164.16 $74.93 $251.62
4-10

Form U Section and Activity

Clerical 

Cost Technical Cost Managerial Cost Total Cost

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

Production

Part III Processing and Use Information

(Total Cost for Part III) $226.08 $2,666 $1,167 $4,059

1 Industrial Processing and Use Exposure-Related Data

Determination of Applicability $3.63 $59.27 $19.94 $82.84

Industrial Function Category $60.15 $259.57 $144.64 $464.36

Function Code $5.33 $55.01 $27.68 $88.02

Percent of Production Volume $35.10 $588.41 $369.34 $992.85

Total Number of Processing and Use Sites $44.78 $537.89 $246.72 $829.40

Total Number of Potentially Exposed Workers $59.91 $907.74 $268.15 $1,236

2 Consumer and Commercial Use Exposure-Related Data

Determination of Applicability $4.11 $55.01 $17.56 $76.69

Identification of Production Category/Use by Children $4.11 $49.26 $17.56 $70.64

Percent of Production Volume $5.81 $74.02 $31.55 $111.38

Maximum Concentration by Category $3.15 $80.02 $24.11 $107.28

Total Cost for Report Preparation and Submission

Partial Report (Parts I, II, Recordkeeping and Submission Costs) $108 $2,012 $1,053 $3,188

Full Report (Parts I, II, III, Recordkeeping and Submission Costs) $334 $4,678 $2,220 $7,247

Note: Totals may not sum due to rounding.

Source: Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).
4-11

4.2.5 Estimates of the Number of Sites and Reports

The baseline number of reports EPA is expecting, and the number of sites submitting those 

reports, were calculated based on 2006 IUR submissions to EPA. Because there is a cost 

difference between the two types of reports, the total number of reports is broken down into sites 

that filed full reports and sites that filed partial reports. The number of reports EPA is expecting 

was estimated using data compiled from EPA’s 2006 IUR Database (EPA, 2008c). The database 

contains information collected under the IUR rule for previous reporting cycles and was used to 

generate estimated numbers of expected reports. The Agency assumes because of the low 

company turnover rate within the chemical manufacturing industry, the baseline number of sites 

submitting Form U in 2012 will be equivalent to the number of sites submitting Form U in 2006.

In addition, for the purposes of this analysis, EPA assumes the baseline number of reports 

submitted will not change from the 2006 submissions. In 2006, a total of 4,085 sites completed 

25,896 reports as shown in Table 4-6.

Table 4-6: Baseline Number of Reports and Sites

Number of

Partial Reports

Number of

Full Reports Total

Number of Sites 568 3,517 4,085

Number of Reports 8,821 17,075 25,896

Source: U.S. EPA, Office of Pollution Prevention 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 chemical substances for the 

first time in 2006 and the change in the reporting threshold from 10,000 lb to 25,000 lb, it was 

not possible for EPA to compare records to determine whether the number of sites and reports 

submitted for a consistent set of chemical substances had changed significantly between the two 

reporting cycles. Such an analysis potentially could provide support for EPA’s assumption the 

number of sites and reports will remain relatively unchanged in the next reporting cycle.

Therefore, to the extent changes in the chemical industry unrelated to the 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 incur a reduced burden 

for processing and submitting Form U in future reporting cycles. All sites will incur a higher 

reporting cost in the first reporting cycle under the final rule due to the need to become familiar 

with the revised requirements. However, the Agency assumes 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). 
4-12

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 

rates in Table 4-1 and the hourly burden estimates from Table 4-8.

Table 4-7: Weighting Factors for Burden Estimates for Sites That Have Previously 

Submitted a Form U

Section of Form U Percent of Initial Burden 

Incurred 1

Part I. Site Identification 

Certification 100%

Section A Company Information 20%

Section B Plant Site Identification 20%

Section C Technical Contact 20%

Part II. Manufacturing Information

Section A Chemical Identification 20%

Section B (Other) Manufacturing Information 80%

Part III. Processing and Use Information

Section A Industrial Processing and Use Exposure 

Related Data 80%

Section B Industrial Processing and Use Exposure 

Related Data 80%

1 Weighting factors are from the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 

2002a), pp. 3-17.
4-13

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

Form U Section and Activity

Clerical 

Burden

Technical 

Burden

Managerial 

Burden Total Burden

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

Compliance Determination 

(Total Burden for Form U Compliance Determination) 0.00 2.50 0.00 2.50

Rule Familiarization 

(Total Burden for Form U Submission) 0.00 2.00 2.00 4.00

Recordkeeping 

(Total Burden for Form U Recordkeeping) 1.50 3.00 1.50 6.00

Submission

(Total Burden for Form U Submission) 0.00 0.00 0.00 0.00

Mailing Burden 0.00 0.00 0.00 0.00

Part I. Site Identification Information

(Total Burden for Part I) 0.69 0.87 1.02 2.58

1 Certification 0.68 0.85 1.01 2.54

2 Company Information

Company Name, Technical Contact, Address, D&B Number, Mailing Address 0.01 0.01 0.00 0.02

3 Plant Site Identification

Plant Name, D&B Number, Address, Mailing Address 0.01 0.01 0.00 0.03

Part II. Manufacturing Information

(Total Burden for Part II) 1.24 7.02 2.79 11.06

1 Chemical Identification

2 (Other) Manufacturing Information

Site Limited, Activity, Production Volume (lb) 0.42 1.82 0.45 2.69

Chemical Identification Upfront CBI Substantiation 0.21 1.16 0.61 1.98

Plant Site Upfront Substantiation 0.10 0.66 0.41 1.17

Total Number of Workers 0.17 1.14 0.47 1.78

Maximum Concentration, Physical Form, Percent Volume of Production 0.35 2.23 0.86 3.44
4-14

Form U Section and Activity

Clerical 

Burden

Technical 

Burden

Managerial 

Burden Total Burden

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

Part III Processing and Use Information

(Total Burden for Part III) 6.35 36.25 13.33 55.93

1 Industrial Processing and Use Exposure-Related Data

Determination of Applicability 0.10 0.81 0.23 1.14

Industrial Function Category 1.69 3.53 1.65 6.87

Function Code 0.15 0.75 0.32 1.21

Percent of Production Volume 0.99 8.00 4.22 13.21

Total Number of Processing and Use Sites 1.26 7.31 2.82 11.39

Total Number of Potentially Exposed Workers 1.68 12.34 3.06 17.09

2 Consumer and Commercial Use Exposure-Related Data

Determination of Applicability 0.12 0.75 0.20 1.06

Identification of Production Category/Use by Children 0.12 0.67 0.20 0.98

Percent of Production Volume 0.16 1.01 0.36 1.53

Maximum Concentration by Category 0.09 1.09 0.28 1.45

Total Burden for Report Preparation and Submission

Partial Form (Parts I, II, Recordkeeping and Submission Burden) 3.43 15.39 7.31 26.14

Full Form (Parts I, II, III, Recordkeeping and Submission Burden) 9.78 51.64 20.64 82.07

Note: Totals may not sum due to rounding.
4-15

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

Form U Section and Activity

Clerical 

Cost

Technical 

Cost

Managerial 

Cost Total Cost

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

Compliance Determination 

(Total Cost for Form U Compliance Determination) $0.00 $147 $0.00 $147

Rule Familiarization 

(Total Cost for Form U Submission) $0.00 $118 $140 $258

Recordkeeping and Submission Costs

(Total Cost for Form U Recordkeeping) $42.72 $176.52 $105.04 $324.28

Submission

(Total Cost for Form U Submission) $13.78

Mailing Cost $13.78

Part I.

Site Identification Information

(Total Cost for Part I) $19.68 $51.19 $71.29 $142.16

1 Certification $19.22 $50.01 $70.73 $139.96

2 Company Information

Company Name, Technical Contact, Address, D&B Number, Mailing Address $0.20 $0.47 $0.28 $0.95

3 Plant Site Identification 

Plant Name, D&B Number, Address, Mailing Address $0.26 $0.71 $0.28 $1.24

Part II.

Manufacturing Information

(Total Cost for Part II) $35.31 $413.29 $195.52 $644.12

1 Chemical Identification

2 (Other) Manufacturing Information

Site Limited, Activity, Production Volume (lb) $11.85 $107.32 $31.37 $150.54

Chemical Identification Upfront CBI Substantiation $5.92 $68.25 $42.86 $117.03

Plant Site Upfront Substantiation $2.73 $39.07 $28.57 $70.37

Total Number of Workers $4.78 $67.31 $32.77 $104.87

Maximum Concentration, Physical Form, Percent Volume of Production $10.02 $131.33 $59.94 $201.30
4-16

Form U Section and Activity

Clerical 

Cost

Technical 

Cost

Managerial 

Cost Total Cost

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

Part III Processing and Use Information

(Total Burden for Part III) $180.87 $2,132.97 $933.56 $3,247.40

1 Industrial Processing and Use Exposure-Related Data

Determination of Applicability $2.90 $47.41 $15.95 $66.27

Industrial Function Category $48.12 $207.66 $115.71 $371.49

Function Code $4.26 $44.01 $22.14 $70.41

Percent of Production Volume $28.08 $470.73 $295.47 $794.28

Total Number of Processing and Use Sites $35.82 $430.32 $197.38 $663.52

Total Number of Potentially Exposed Workers $47.93 $726.19 $214.52 $988.64

2 Consumer and Commercial Use Exposure-Related Data

Determination of Applicability $3.29 $44.01 $14.05 $61.35

Identification of Production Code/Use by Children $3.29 $39.41 $13.81 $56.51

Percent of Production Volume $4.65 $59.22 $25.24 $89.10

Maximum Concentration by Category $2.52 $64.02 $19.29 $85.82

Total Cost for Report Preparation and Submission

Partial Form (Parts I, II, Recordkeeping and Submission Costs) $97.71 $906 $512 $1,529

Full Form (Parts I, II, III, Recordkeeping and Submission Costs) $279 $3,039 $1,446 $4,777

Note: Totals may not sum due to rounding. 
4-17

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 2012 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 per-report basis, and submission and recordkeeping were 

estimated on a per-report basis.

Table 4-10 shows the total burden and cost to industry under the current baseline. The current

IUR rule would cost industry approximately 1.84 million hours and $106.97 million during the 

2012 reporting cycle. 

Table 4-10: Total Baseline Cost and Burden to Industry (2012 Reporting Cycle)

Burden and Cost 

for All Part Is, 

Rule 

Familiarization, 

Compliance 

Determination

and Submission

Burden and 

Cost for All Part 

IIs and 

Recordkeeping

Burden and Cost 

for All Part IIIs

Total Burden and Cost

Under the Current 

IUR Requirements

Burden in Hours 135,847 513,259 1,193,829 1,842,934

Cost (2008$) $8,407,651 $29,247,454 $69,311,707 $106,966,812

Table 4-11 contains the total annual baseline costs to industry for future reporting cycles; that 

is, the burden and cost to industry for reporting cycles after the 2012 cycle, in the absence of the 

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 to be approximately 1.43 million hours and the cost, $82.82 million.

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

Burden and Cost

for all Part Is, 

Rule 

Familiarization, 

Compliance 

Determination

and Submission

Burden and Cost

for all Part IIs 

and 

Recordkeeping

Burden and Cost

for all Part IIIs

Total Burden and 

Cost Under the 

Current IUR 

Requirements

Burden in Hours 37,088 441,682 955,063 1,433,833

Cost (2008$) $2,290,736 $25,077,449 $55,449,366 $82,817,550
4-18

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 chemical substances between the two reporting cycles. Such an analysis 

potentially could provide support for EPA’s assumption the number of sites and reports will 

remain relatively unchanged in the next reporting cycle. Therefore, to the extent changes in the 

chemical industry unrelated to the IUR rule amendments could affect the number of site and 

reports submitted, the baseline burden and cost may be under- or overestimated.

4.4 Changes in Industry Burden and Costs Due to the Final IUR Modifications 

Rule

The expected cost and burden impacts of each of the amendments to the IUR rule are 

outlined below. See Section 3 for more detailed information about each of these amendments.

In each of the following sections, 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 amendments. 

4.4.1 Technical Modifications to the Regulatory Text

EPA is reorganizing certain existing rule text and deleting obsolete text. These amendments 

do not substantively affect the rule text, so EPA assumes these modifications will not affect 

industry burden or cost.

4.4.2 Modifications to Selected Definitions

EPA is modifying the definitions of “importer,” “manufacture,” “site,” “commercial use,” 

“consumer use,” “reporting year,” and “submission period,” and adding definitions for 

“manufacturer,” “Central Data Exchange (CDX),” “e-IURweb,” and “industrial function,” as 

described in Section 3. These changes are clarifications only; EPA is clarifying in rule text what 

has been previously explained through outreach with the regulated community. Therefore, EPA 

does not expect changes to definitions to impact industry burden or cost.

4.4.3 Method for Determining Whether a Manufacturer is Subject to IUR 

Reporting Requirements

Under the current IUR rule requirements, a submitter completes a report only if its chemical 

substance production has met or exceeded the 25,000 lb reporting threshold during the principal 

reporting year. EPA is modifying the timeframe for reporting, so chemical manufacturers 

(including importers) will be subject to the IUR rule if a chemical substance’s production volume 

has exceeded the threshold in any calendar year since the last principal reporting year. This 

modification will not take effect until after the first post-amendment reporting cycle (2012); for 

the first reporting cycle, submitters will still consider production volume for only the principal 

reporting year.

EPA believes this amendment will cause an increase in the numbers of submitters and reports 

in future reporting cycles. Because data on the production volume of chemical substances 

reportable under the IUR rule during non-principal reporting years currently is not available, the 

actual percentage increase in these numbers is unknown. The Agency, using its best professional 
4-19

judgment, estimates for the purpose of this analysis, the amendment will increase the number of 

submitters and reports in future reporting cycles by approximately five percent.

Using an estimated five percent increase over the baseline number of sites and reports 

(baseline presented in Table 4-6), EPA estimates 204 additional sites will submit reports in 

future reporting cycles. EPA further estimates those sites will submit an additional 854 full 

reports and 441 partial reports, for a total of 1,295 additional reports for each future reporting 

cycle.

As described in Section 4.1, sites need to complete Part I of Form U only once, and complete 

Part II and Part III (as applicable) for each chemical substance manufactured or imported. Taking 

this allocation of activities into consideration, and using the baseline unit burden estimates as 

shown in Table 4-2 and Table 4-8, Table 4-12 shows the industry burden estimate as a result of 

this amendment. The Agency estimates the amendment will not cause a change in industry 

burden during the 2012 reporting cycle, but will generate an increase of approximately 71,700 

hours during all future reporting cycles.

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

Determining Whether a Manufacturer is Subject to IUR Reporting Requirements

Burden for

Compliance 

Determination, 

Rule 

Familiarization, 

Submission and 

to Prepare

Part I

(hours per site)

Number 

of Sites

Burden for 

Recordkeeping 

and to Prepare 

Part II

(hours per 

report)

Number 

of 

Reports

Burden 

to 

Prepare 

Part III 

(hours

per 

report)

Number 

of 

Reports 

with 

Part III

Industry 

Burden 

(hours)

(a) (b) (c) (d) (e) (f)

(g) = 

(a*b)+

(c*d)+(e*f)

First Cycle, 

Baseline 33.26 4,085 19.82 25,896 69.92 17,075 1,842,934

First Cycle, 

PostAmendment

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

Change from 

the Baseline,

First Cycle

0.00 0 0.00 0 0.00 0 0

Future Cycle,

Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833

Future Cycle, 

PostAmendment

9.08 4,289 17.06 27,191 55.93 17,929 1,505,524

Change from 

the Baseline, 

Future Cycles

0.00 204 0.00 1,295 0.00 854 71,692

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

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 

4-9. Table 4-13 shows the industry cost estimate as a result of this amendment. EPA estimates 
4-20

the amendment will not cause a change in industry cost in the first reporting cycle, but will 

increase costs by $4.14 million in all future reporting cycles.

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

Whether a Manufacturer is Subject to IUR Reporting Requirements

Cost for

Compliance 

Determination, 

Rule 

Familiarization, 

Submission and 

to Prepare

Part I

(2008$ per site)

Number 

of Sites

Cost for 

Recordkeeping 

and to Prepare 

Part II 

(2008$ per 

report)

Number 

of

Reports

Cost to 

Prepare 

Part III 

(2008$

per 

report)

Number 

of 

Reports 

with

Part III

Industry 

Cost 

(millions 

2008$)

(a) (b) (c) (d) (e) (f)

(g) = 

(a*b)+

(c*d)+(e*f)

First Cycle, 

Baseline $2,058 4,085 $1,129 25,896 $4,059 17,075 $106.97 

First Cycle, 

PostAmendment

$2,058 4,085 $1,129 25,896 $4,059 17,075 $106.97 

Change from 

the Baseline, 

First Cycle

$0 0 $0 0 $0 0 $0.00 

Future Cycle,

Baseline $561 4,085 $968 25,896 $3,247 17,075 $82.82 

Future Cycle, 

PostAmendment

$561 4,289 $968 27,191 $3,247 17,929 $86.96 

Change from 

the Baseline, 

Future Cycles

$0 204 $0 1,295 $0 854 $4.14 

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

Limitations of Analysis. To the extent the change in method for determining whether a 

manufacturer is subject to the IUR reporting requirements causes an increase in numbers of sites 

and reports submitted that is higher or lower than five percent, this analysis may under- or 

overestimate the total burden and cost increase. A sensitivity analysis is performed in Appendix 

D.1.

In the proposal, EPA also requested comment on returning to the previous, lower reporting 

threshold of 10,000 lb. Appendix E. contains an analysis of the cost and burden of this lower 

threshold, which EPA has decided not to adopt in the final rule.

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

EPA is replacing the 300,000 lb threshold for processing and use information and phasing in a lower 

reporting threshold. For the 2012 IUR, all submitters of non-excluded chemical substances are required to 

report processing and use information if they manufactured (including imported) 100,000 lb or more of a 

chemical substance in 2011. Subsequent to the 2012 reporting cycle, the reporting threshold will be 

25,000 lb, therefore requiring all manufacturers of non-excluded substances to report information in all 
4-21

parts of the IUR Form U. Replacing 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 amendment affects only the burden and costs associated with completing Part III; it will not 

cause an increase in the number of sites submitting reports. In the 2006 IUR reporting cycle, a total of 

3,627 reports were submitted with production volumes between 100,000 lb and 300,000 lb (EPA, 2008c). 

Therefore, EPA assumes that, due to the amended rule, there will be an increase of 3,627 reports with Part 

III in the first reporting cycle. 

In future reporting cycles (after the 2012 cycle) Part III will need to be completed for all nonexcluded substances. In the 2006 reporting cycle, the total number of partial reports submitted 

(that is, forms with only Part I and Part II completed) was 8,821 (see Table 4-6); 618 of these 

reports were submitted for partially exempt (i.e., excluded) chemical substances (EPA, 2009a).

(Under the amendment, submitters of partially exempt chemical substances still will not be 

required to submit a Part III.) For the purposes of this analysis, EPA assumes that partially 

exempt chemical substances all have production volumes less than 100,000 lb and therefore 

these reports are not considered in estimations for the first reporting cycle. Therefore, EPA 

assumes that, due to the amended rule, there will be an increase of 8,203 (i.e, 8,821 minus 618)

in future reporting cycles.

Using the baseline unit burden estimate as shown in Table 4-2 and Table 4-8, Table 4-14

shows the industry burden estimate as a result of this amendment. The Agency estimates the 

amendment will cause an increase in industry burden of approximately 253,600 hours during the 

first reporting cycle, and 458,800 hours during all future reporting cycles.

Table 4-14: Change in Industry Burden as a Result of Replacing 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 20,702 1,447,417

Change from the Baseline, 

First Cycle 0 3,627 253,588

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

Notes: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value. Totals may not sum due to rounding.

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 amendment. EPA estimates 

the industry cost will increase by $14.72 million in the 2012 reporting cycle and by $26.64 

million in all future reporting cycles.
4-22

Table 4-15: Change in Industry Cost as a Result of Reducing 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 20,702 $84.03

Change from the Baseline, 

First-Year $0.00 3,627 $14.72

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 postamendment value.Totals may not sum due to rounding.

Limitations of Analysis. The estimate of 3,627 additional reports for the 2012 reporting cycle 

may be an overestimate as some of these reports may be for partially exempt chemicals that are 

not required to submit Part IIs. In subsequent reporting cycles EPA is assuming each partially 

exempt chemical substance is produced at four different sites. To the extent this is not the case, 

this analysis may over- or underestimate the number of additional Part IIIs.

4.4.5 Reducing the 25,000 lb Threshold for Specific Regulated Chemical 

Substances

Beginning with the 2016 submission period and for submission periods thereafter, EPA is 

reducing the 25,000 lb threshold to 2,500 lb for chemical substances that are: (1) the subject of a 

regulation promulgated under section 5(a)(2), 5(b)(4), or 6 of the Act; (2) the subject of an order 

issued under section 5(e) or 5(f) of the Act, or (3) the subject of relief that has been granted 

under a civil action under section 5 or 7 of the Act. As of the 2016 submission period, a

manufacturer (including importer) of such chemical substances will be required to report 

manufacturing information on the chemical substances if they are manufactured (including 

imported) in volumes of 2,500 lb or more during any of the years since the last principal 

reporting year (e.g., 2011). Information on the processing and use of the chemical substances 

must be reported if they were manufactured (including imported) in volumes of 25,000 lb or 

more during any of the years since the last principal reporting year. To determine how many 

specific chemical substances this amendment will 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)4of the Act, or the subject of relief that has been granted under a civil action under section 5 

 

4 There are two chemicals subject of an order issued under section 5(f) of TSCA that would be subject to the reduced 

threshold that have not been included in the development of estimates in this section of the Economic Analysis, 

however, the overall estimates of costs and burdens for this requirement are not expected to be significantly affected.
4-23

or 7 of the Act, identified 1,129 chemical substances. CASRNs were provided for 739 of these 

chemical substances, and an additional 390 chemical substances were listed by accession 

numbers (EPA, 2006a). Of the 739 chemical substances with CASRNs, no reports were filed for 

651 chemical substances, or 88 percent (EPA, 2009e). EPA also assumes no reports were filed 

for 88 percent of the 390 chemical substances with accession numbers, or 344 chemical 

substances. In addition, Form Us were submitted voluntarily for eight chemical substances with 

production volume levels below the 25,000 lb threshold during the 2006 reporting cycle (EPA, 

2009a). EPA estimates that a total of approximately 1,003 chemical substances are subject to one 

of the TSCA sections above and are not currently reported under IUR (651+344+8 = 1,003).

However, no production volume data are available for these chemical substances. Therefore, 

EPA assumes that approximately 90 percent of these chemical substances (902 chemical 

substances) have production volumes between 2,500 and 25,000 lb.

Based on the data provided in the 2006 IUR reporting cycle (EPA, 2008c), on average, each 

chemical substance is produced at approximately four sites; therefore, EPA expects 3,609

additional reports (Part IIs) to be submitted for these chemical substances. The Agency also 

assumes the reports generated by this amendment will be for production volumes lower than 

25,000 lb (therefore, lower than 300,000 lb), so, as a result of this amendment alone, submitters 

will not be required to complete Part III (see Section 4.5 for an estimate of the aggregated impact 

of all amendments). In addition, the Agency is assuming that manufacturers (including 

importers) of these chemical substances already will be submitting reports for other non-exempt 

chemical substances; so, therefore, the number of sites will not increase from the baseline as a 

result of this amendment.

Using the baseline unit burden estimate for completion of Part II as shown in Table 4-2 and 

Table 4-8, Table 4-16 presents the estimated increase in industry burden as a result of this 

amendment. The Agency estimates the amendment will cause an increase in industry burden of 

approximately 0 hours during the first reporting cycle and 61,600 hours during all future 

reporting cycles. 

Table 4-16: Change in Industry Burden as a Result of Reducing the 25,000 lb Threshold 

for Specific Regulated Chemical Substances

Burden for Recordkeeping 

and to Prepare Part II 

(hours per report)

Number of 

Reports

Industry Burden

(hours)

First Cycle, Baseline 0 0 0

First Cycle, Post-Amendment 0 0 0

Change from the Baseline, First Cycle 0.00 0 0

Future Cycle, Baseline 17.06 25,896 441,682

Future Cycle, Post-Amendment 17.06 29,505 503,241

Change from the Baseline, Future 

Cycles 0.00 3,609 61,559

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

 
4-24

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 amendment. The cost to 

industry is expected to increase by $3.50 million during all future reporting cycles, and will not 

increase during the 2011 reporting cycle.

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

Specific Regulated Chemical Substances

Cost for Recordkeeping 

and to Prepare Part II 

(2008$ per report)

Number of 

Reports

Industry Cost 

(millions 2008$)

First Cycle, Baseline $0 0 $0

First Cycle, Post-Amendment $0 0 $0

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

Future Cycle, Baseline $968 25,896 $25.08 

Future Cycle, Post-Amendment $968 29,505 $28.57 

Change from the Baseline, Future 

Cycles $0 3,609 $3.50 

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

Limitations of Analysis. The number of additional reports EPA receives as a result of this 

amendment may be an overestimate to the extent manufacturers (including importers) already are

submitting reports for these chemical substances. That is, to the extent some portion of these 

chemical substances 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 will 

receive as a result of the amendment. Furthermore, to the extent manufacturers (including 

importers) of these chemical substances do not already submit reports for other chemical 

substances, EPA is underestimating the number of sites will increase from the baseline as a result 

of this amendment. In addition, the number of chemical substances with production volumes 

between 2,500 and 25,000 lb may be an over- or underestimate. 

4.4.6 Make Chemical Substances Subject to Enforceable Consent Agreements 

(ECAs) Ineligible for Exemptions

Chemical substances 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 chemical 

substances to monitor chemical substance production and compliance with the agreements. Therefore, 

EPA is making these chemical substances ineligible for reporting exemptions. Manufacturers (including 

importers) of these chemical substances no longer will be partially exempt, and so must complete Part III 

of Form U. 

EPA publishes and updates on its website a list of TSCA Section 4 Federal Register Enforceable 

Consent Agreements (http://www.epa.gov/oppt/chemtest/pubs/4eca.html) (EPA, 2009f). Since 1985, the 

Agency has entered into ECAs for 67 chemical substances. Six of the 67 chemical substances 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 chemical substances

subject to ECAs. 

EPA also maintains a table showing the sunset date and status for chemical substances subject to 

section 4 actions, including ECAs (http://www.epa.gov/oppt/chemtest/pubs/sunset.html) (EPA, 

2009g).Only two of the 61 chemical substances were identified as currently being subject to an ongoing 
4-25

ECA. Therefore, only two chemical substances will lose the partial exemption under the amendment, and 

so will need to complete Part III of Form U. In addition, EPA is assuming an additional two chemical 

substances could be under ECAs in future reporting cycles. Therefore, EPA is estimating the amendment 

would cause submitters of a total of four chemical substances to complete Part III of Form U. Based on 

data from the 2006 IUR reporting cycle, the Agency estimates approximately four sites produce each 

chemical substance (EPA, 2008c); therefore, a total of 16 Part IIIs would be submitted for the first time

for chemical substances subject to an ECA.

Using the baseline unit burden estimate for completion of Part III as shown in Table 4-2and 

Table 4-8, Table 4-18 shows the industry burden estimate as a result of this amendment. The 

Agency estimates the amendment will cause an increase in industry burden of approximately 

1,100 hours during the first reporting cycle, and 900 hours during all future reporting cycles.

Table 4-18: Change in Industry Burden as Result of Making Chemical Substances 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 amendment. EPA estimates 

the industry cost will increase by $64,900 during the 2011 reporting cycle and by approximately 

$52,000 during all future reporting cycles. 
4-26

Table 4-19: Change in Industry Cost as a Result of Making Chemical Substances 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 each of these chemical substances is produced at 

four different sites. To the extent this is not the case, this analysis may over- or underestimate the 

number of additional Part IIIs. In addition, some of these chemical substances may be produced 

in volumes of 300,000 lb or greater, and therefore already will be required to submit a full report. 

To the extent this is the case, this analysis overestimates the total number of additional Part IIIs. 

Finally, to the extent additional chemical substances 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 producing manufactured water only need to complete Parts I and II of Form 

U. The Agency is granting a full exemption for manufactured water. In 2006, a total of 43 partial 

reports were submitted for manufactured water (EPA, 2008c). EPA assumes manufactured water 

is a byproduct of chemical substance production. Therefore, sites submitting a report for 

manufactured water will continue to submit reports for other chemical substances. Thus, the 

burden reduction for this amendment will be the result of 43 fewer Part IIs being submitted.

Using the baseline unit burden estimate as shown in Table 4-2 and Table 4-8, Table 4-20

shows the reduction in industry burden estimate as a result of this amendment. The Agency 

estimates the amendment will cause a decrease in industry burden of approximately 850 hours 

during the first reporting cycle, and 700 hours during all future reporting cycles. 
4-27

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

from Reporting

Burden for 

Recordkeeping and to 

Prepare Part II

(hours per report)

Number of 

Reports

Total Industry 

Burden (hours)

First Cycle, Baseline 19.82 25,896 513,259

First Cycle, Post-Amendment 19.82 25,853 512,406

Change from the Baseline, First Cycle 0 -43 -852

Future Cycle, Baseline 17.06 25,896 441,682

Future Cycle, Post-Amendment 17.06 25,853 440,949

Change from the Baseline, Future Cycles 0 -43 -733

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

The cost savings due to the amendment were determined using the unit costs shown in Table 

4-5and Table 4-9. Table 4-21 shows the industry cost estimate as a result of this amendment. 

EPA estimates the industry cost will decrease by approximately $48,600 in the first reporting 

cycle and $41,600 in all future reporting cycles. 

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

Reporting

Cost for Recordkeeping 

and to Prepare Part II 

(2008$ per report)

Number of 

Reports

Total Industry 

Cost (2008$)

First Cycle, Baseline $1,129 25,896 $29,247,454

First Cycle, Post-Amendment $1,129 25,853 $29,198,889

Change from the Baseline, First Cycle $0 -43 -$48,565

Future Cycle, Baseline $968 25,896 $25,077,449

Future Cycle, Post-Amendment $968 25,853 $25,035,808

Change from the Baseline, Future Cycles $0 -43 -$41,641

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

Limitations of Analysis. EPA is assuming the sites producing manufactured water are also 

producing other chemical substances 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 underestimates 

the savings to the industry.

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

EPA is amending the partially-exempt list of chemical substances to remove three chemical 

substances: Starch (CASRN 9005-25-8), Dextrin (CASRN 9004-53-9), and Maltodextrin 

(CASRN 9049-76-7).These chemical substances, as polymers, are already fully exempt from 

reporting. EPA expects this 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.
4-28

4.4.9 Parent Company and Site Identity

Under the final rule, submitters will be required to 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 rule is now consistent with the 2002 analysis, and 

EPA assumes the burden estimate will not change from the baseline. Furthermore, companies 

that do not yet have a D&B number incur 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 amending the IUR rule to require the technical contact be a person who is 

knowledgeable about the chemical substance but does not need to be located at the plant site. 

Because submitters already are required to identify a technical contact, EPA assumes this 

amendment will not cause an increase in burden.

4.4.11 Chemical Identity

EPA is requiring submitters to report only the CASRN as a chemical identifying number or, in the 

case of confidential chemical substances, the TSCA accession number assigned when the Notice of 

Commencement (NOC) was submitted to the Agency. EPA is removing the PMN number as an allowed 

chemical identifying number. Because the reporting tool will be directly linked to the non-confidential 

portion of the TSCA Inventory through SRS, submitters no longer will be allowed to claim the CASRN 

as confidential. For this reason, EPA is requiring submitters to report the TSCA accession number if they 

choose to assert a CBI claim on the chemical identity. Submitters will be able to look up the accession 

number in SRS using the PMN number for their chemical substance.

EPA expects that manufacturers (including importers) will have either the PMN number or a TSCA 

accession number for their confidential Inventory substance, or will be able to obtain the accession 

number. Those submitters who, in the past, have reported using the CASRN of a confidential substance or 

do not have the PMN number or accession number, or who are not able to obtain the accession number

using SRS, may contact EPA by letter if necessary to obtain the accession number. Those submitters who

know only the CASRN and not the PMN or Accession number for a confidential chemical substance are 

the only manufacturers that EPA expects to contact the Agency to obtain an accession number. Those 

submitters who are not claiming the chemical identity as CBI will be able to continue using the CASRN.

EPA assumes that the time it will take submitters who do not already know their accession number to 

look it up using the PMN number in SRS will be minimal, and therefore, is not estimating that burden 

here. However, some submitters may not know either the PMN or accession number, and will therefore 

need to request it in writing from EPA. As an upper bound estimate, the number of 2006 IUR reports with 

CASRNs claimed as CBI was used as a proxy for the number letters submitted to EPA. (All other 2006 

IUR reports with CBI claims for chemical identity were made using accession numbers or PMN number, 

and therefore, EPA assumes that those sites will not need to send a written request to EPA.) A total of 343 

reports claimed CASRNs as CBI in 2006 (EPA, 2010b). 

EPA assumes that the burden to submit a written accession number request is half of the burden of 

providing the specific chemical identification in a bona fide submission. Bona fides are written requests a 

company sends to EPA when the company intends to manufacture (including import) a chemical 

substance, but is unsure of the TSCA Inventory status of the chemical substance. The specific chemical 

identification information required by a bona fide includes the CAS name and number as well as the 

chemical substance’s molecular formula, a chemical substance structure diagram, and the name of the 
4-29

chemical substance’s precursors and reactants. EPA estimates that submitters of bona fides incur a burden 

of approximately 2.0 hours of technical time per notice to prepare the notice (EPA, 1994). EPA estimates 

that the burden associated with written accession number requests is approximately half of the burden 

(one hour) associated with providing specific chemical identification information for a bona fide. The 

accession number requests will not require information on the chemical substance’s molecular formula, 

structure, or the name of the chemical substance’s precursors and reactants. The total industry burden is 

approximately 343 hours (See Table 4-22). While some sites may need to submit an accession number

request in future cycles, EPA expects that most sites that need accession numbers will request them in the 

first reporting cycle. Therefore, the burden to industry in future cycles is expected to be minimal and was 

not estimated for this analysis. 

Table 4-22: Change in Industry Burden as a Result of Accession Number Requests

Burden for Accession 

Number Request

(hours per request)

Number of 

Requests

Total Industry 

Burden (hours)

First Cycle, Baseline 0 0 0

First Cycle, Post-Amendment 1.0 343 343

Change from the Baseline, First Cycle 1.0 343 343

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

Source: Burden hours are taken the Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 

Premanufacture Notices (EPA, 1994, Table III-8) and adjusted based on EPA’s best professional judgment

Table 4-23 presents the change in industry cost as a result of accession number requests. EPA 

estimates a $20,200 increase in industry cost in the first reporting cycle. 

Table 4-23: Change in Industry Cost as a Result of Accession Number Requests

Cost for Accession 

Number Requests

(2008$ per request)

Number of 

Requests

Total Industry 

Cost Million 

(2008$)

First Cycle, Baseline $0 0 $0

First Cycle, Post-Amendment $58.84 343 $20,182

Change from the Baseline, First Cycle $58.84 343 $20,182

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

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

Reporting Year

EPA is requiring submitters to report production volume for both year 2010 and year 2011 in 

the 2012 reporting cycle. In subsequent reporting cycles, production volume must be reported for

each of the four years since the last IUR principal reporting year. Thus, for the 2012 IUR

submission, manufacturers (including importers) of subject chemical substances will report the 

production volume for the calendar years 2010 and 2011, and will report production volumes for 

2012, 2013, 2014, and 2015 in the 2016 reporting cycle. While sites will still submit data to EPA 

only in the submission year, EPA assumes there will be an increase in burden as the result of 

gathering data and reporting production volumes for an additional year in the first reporting cycle 

and an additional four years in subsequent reporting cycles.

According to the baseline burden estimate, a site spends approximately 3.36 hours to gather 

production volume and site-limited activity (see Table 4-3). EPA estimates approximately 45 
4-30

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 a site will spend an additional 1.51 hours to gather the production volume 

information for the extra year’s worth of data required in the first reporting cycle. In future 

reporting cycles, approximately an additional 3.63 hours (approximately) (i.e., 1.21 x 3) is 

expected to report production volumes for the three additional, non-principal reporting years.

Table 4-24 shows the increase in industry burden as a result of this amendment. The Agency 

estimates the amendment will cause a total increase in industry burden of approximately 39,200 

hours in the first reporting cycle and approximately 94,000 hours in all future reporting cycles. 

Table 4-24: 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 3.02 25,896 78,310

Change from the Baseline, First 

Cycle 1.51 0 39,155

Future Cycle, Baseline 1.21 25,896 31,324

Future Cycle, Post-Amendment 4.838 25,896 125,295

Change from the Baseline, Future 

Cycles 3.63 0 93,971

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 amendment. EPA estimates 

the industry cost will increase by $2.19 million in the 2012 reporting cycle and $5.26 million in 

all future reporting cycles.

Table 4-25: 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 $169.36 25,896 $4.39

Change from the Baseline, First Cycle $84.68 0 $2.19

Future Cycle, Baseline $67.74 25,896 $1.75

Future Cycle, Post-Amendment $270.98 25,896 $7.02

Change from the Baseline, Future Cycles $203.23 0 $5.26

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

Limitations of Analysis. This analysis is based on an assumption about the percentage 

breakdown of burden estimated to gather production volume and site-limited activity. To the 
4-31

extent 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 Us have required submitters to indicate whether a chemical substance was 

site-limited, referring to a chemical substance 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 off-site is one that does not meet this definition; for example, a 

chemical produced as an end product. EPA is removing 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 onsite to be similar to the burden to report the total production volume, given that the activities to 

identify the necessary information are similar. EPA estimates it will take a submitter 1.51 hours 

to provide the production volume (see Table 4-3).

EPA expects an increase in the number of submitters who will report volume used on-site, 

due to the way this information will 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 will be 

affected.

Site-limited chemical substances are those not distributed (either as the chemical substance 

itself or in a mixture) outside the plant site for commercial purposes. Therefore, EPA assumes all 

chemical substances used on-site must be chemical substance intermediates. According to data 

from the 2006 IUR database (EPA, 2008c), approximately 24 percent of all reports containing 

downstream processing and use information included chemical substances used as intermediates. 

Therefore, EPA assumes 24 percent of all reports is the maximum percentage of reports that will

be affected. Not all chemical substances produced as intermediates are used on-site; they may be 

shipped for use at another site. EPA used 19.4 percent, which is the midpoint of 14.8 and 24, to 

estimate the increase in the number of reports with chemical substances used on-site, i.e., 5,024

reports.

Table 4-26 shows the industry burden estimate as a result of this amendment. The Agency 

estimates the amendment will cause a total increase in industry burden of approximately 7,600 

hours during the first reporting cycle and 6,100 hours during all future reporting cycles.
4-32

Table 4-26: 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 4-27 shows the industry cost estimate as a result of this amendment. EPA estimates 

the total industry cost will increase by $425,400 during the first reporting cycle and $340,300 

during all future reporting cycles.

Table 4-27: 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 the burden of reporting the production volume used 

on-site is different from the burden to report the total production volume, this analysis may overor underestimate the burden and cost of this amendment. Furthermore, to obtain the maximum 

number of reports that may be affected, EPA assumes the percentage of reports containing 

downstream processing and use information that included chemical substances used as 

intermediates will be the same as the percentage of all reports that include chemical substances 

used as intermediates (that is, that the percentage of chemical substances used as intermediates is 

consistent whether a submitter completed Part III or not.) To the extent this is not the case, the 

analysis may over- or underestimate the number of reports affected.

4.4.14 Indicate Whether Chemical Substance Is Physically at Reporting Site

EPA is requiring submitters to indicate whether an imported chemical substance is physically 

at the reporting site. Under the current IUR requirements, a submitter must state whether the 

site’s chemical substance is manufactured or imported. The Agency estimates providing this 
4-33

information requires 0.17 hours per report (see Table 4-3). EPA assumes the burden to indicate

whether a chemical substance is physically on-site will be similar to the burden incurred to 

indicate whether a chemical substance is manufactured or imported, given the similarity of these 

activities to identify the necessary information. Table 4-28 shows the industry burden estimates 

as a result of this amendment. The Agency estimates the amendment will cause a total increase 

in industry burden of approximately 4,400 hours for the 2011 reporting cycle, and 3,500 for all 

future reporting cycles.

Table 4-28: Change in Industry Burden as a Result of Indicating Whether a Chemical 

Substance is Physically at the Reporting Site

Burden to Indicate 

Whether Chemical 

Substance 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 4-29 shows the industry cost estimate as a result of this amendment. EPA estimates 

the total industry cost will increase by approximately $243,700 in the first reporting cycle and 

$194,900 in all future reporting cycles.

Table 4-29: Change in Industry Cost as a Result of Indicating Whether a Chemical 

Substance is Physically at the Reporting Site

Cost to Indicate 

Whether Chemical 

Substance is Physically 

at Reporting Site

(2008$)

Number of 

Reports

Industry Cost 

(2008$)

First Cycle, Baseline $0.00 25,896 $0

First Cycle, Post-Amendment $9.41 25,896 $243,652

Change from the Baseline, First Cycle $9.41 0 $243,652

Future Cycle, Baseline $0.00 25,896 $0

Future Cycle, Post-Amendment $7.53 25,896 $194,921

Change from the Baseline, Future Cycles $7.53 0 $194,921

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

Limitations of Analysis. To the extent the burden of indicating whether a chemical substance

is physically at the reporting site is different from the burden to report whether a chemical 

substance is manufactured or imported, this analysis may over- or underestimate the burden and 

cost of this amendment. Furthermore, this requirement may apply only to importers; the number 

of reports affected, therefore, is likely to be an overestimation. 
4-34

4.4.15 Report Production Volume Exported

EPA is adding a requirement for submitters to report the production volume directly exported 

and not domestically processed or used. The Agency assumes the burden to the submitter to 

report the volume exported will be similar to the burden to report the production volume, given 

the similarity of the activities. EPA estimates 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 in Table 4-2 and Table 4-8, Table 4-30

shows the industry burden estimate as a result of this amendment. The Agency estimates the 

amendment will increase industry burden by approximately 39,200 hours for the 2012 reporting 

cycle, and 31,300 hours for all future reporting cycles.

Table 4-30: 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 4-31 shows the industry cost estimate as a result of this amendment. EPA estimates 

the industry cost will increase by $2.19 million during the first reporting cycle and $1.75 million 

during all future reporting cycles.

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

Exported

Cost to Report 

Export Volume

(2008$)

Number of 

Reports

Industry 

Cost 

(millions 

2008$)

First Cycle, Baseline $0.00 25,896 $0.00

First Cycle, Post-Amendment $84.68 25,896 $2.19

Change from the Baseline, First Cycle $84.68 0 $2.19

Future Cycle, Baseline 0 25,896 $0.00

Future Cycle, Post-Amendment $67.74 25,896 $1.75

Change from the Baseline, Future Cycles $67.74 $0.00 $1.75

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

Limitations of Analysis. To the extent the burden of reporting the volume exported is 

different from the burden to report the total production volume, this analysis may over- or 

underestimate the burden and cost of this amendment.
4-35

4.4.16 Identify Whether a Chemical Substance is to be Recycled, Remanufactured, 

Reprocessed, or Reused

EPA is adding a requirement to indicate whether a manufactured chemical substance, such as 

a byproduct, is being recycled, remanufactured, reprocessed, or reused. 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 substance 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 in Table 4-2 and Table 4-8, Table 4-32

shows the industry burden estimates as a result of this amendment. The Agency estimates 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 4-32: Change in Industry Burden as a Result of Indicating Whether Chemical 

Substance is to be Recycled, Remanufactured, Reprocessed, or Reused

Burden for Completing a 

Checkbox to Indicate 

Whether a Chemical 

Substance is Recycled, 

Remanufactured, 

Reprocessed, or Reused,

(hours)

Number 

of 

Reports

Industry 

Burden 

(hours)

First Cycle, Baseline 0.00 25,896 0

First Cycle, Post-Amendment 0.17 25,896 4,351

Change from the Baseline, First Cycle 0.17 0 4,351

Future Cycle, Baseline 0.00 25,896 0

Future Cycle, Post-Amendment 0.13 25,896 3,480

Change from the Baseline, Future Cycles 0.13 0 3,480

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

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 

4-9. Table 4-33 shows the industry cost estimate as a result of this amendment. EPA estimates 

the cost to industry will increase by $243,700 for the 2012 reporting cycle and $194,900 for all 

future reporting cycles. 
4-36

Table 4-33: Change in Industry Cost as a Result of Indicating Whether Chemical 

Substance is to be Recycled, Remanufactured, Reprocessed, or Reused

Cost for Completing a 

Checkbox to Indicate 

Whether a Chemical 

Substance is Recycled, 

Remanufactured, 

Reprocessed or Reused

(2008$)

Number 

of 

Reports

Industry Cost 

(millions 

2008$)

First Cycle, Baseline $0.00 25,896 $0 

First Cycle, Post-Amendment $9.41 25,896 $243,652 

Change from the Baseline, First Cycle $9.41 0 $243,652 

Future Cycle, Baseline $0.00 25,896 $0 

Future Cycle, Post-Amendment $7.53 25,896 $194,921 

Change from the Baseline, Future Cycles $7.53 0 $194,921 

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

Limitations of Analysis. To the extent the burden of indicating whether a chemical substance

is recycled, remanufactured, reprocessed, or reused is different from the burden to report whether 

a chemical substance is site-limited, this analysis may over- or underestimate the burden and cost 

of this amendment.

4.4.17 Concentration Ranges

EPA is amending 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 it will have no impact on industry burden or cost.

4.4.18 Revise Industrial Function Categories

EPA is revising the current industrial function categories (found in Part III, Section A of 

Form U), by deleting six current categories and adding eight new categories. In addition, EPA is 

requiring submitters to write in a free-text descriptor when they select “Other”.

EPA anticipates 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. EPA also estimates it will take three minutes of clerical labor and six minutes of 

technical labor 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 the new categories in the IUR modifications rule will reduce

by half the number of submitters selecting “Other” as an industrial function category. Therefore, 

EPA estimates this amendment will affect 603 reports.

Using the baseline unit burden estimates as shown in Table 4-2 and Table 4-8, Table 4-34

shows the industry burden estimate as a result of this amendment. The Agency estimates the 

amendment will cause a total increase in industry burden in the first reporting cycle of 
4-37

approximately 4,400 hours. In future reporting cycles, submitters will no longer need to 

familiarize themselves with the new industrial function categories, and EPA estimates the 

industry burden to be approximately 70 hours.

Table 4-34: Change in Industry Burden as a Result of Revising 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 4-35 shows the industry cost estimate as a result of this amendment. EPA estimates 

the industry cost will increase by approximately $255,600 in the first reporting cycle and $3,500 

in the following reporting cycles.

Table 4-35: Change in Industry Cost as a Result of Revising 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 the number of submitters selecting “Other” as an industrial function category will be 
4-38

reduced by half; this may be an over- or underestimate. In addition, EPA assumes there is no 

burden for rule familiarization with the new industrial function categories during future reporting 

cycles. This may not be the case if sites have different employees complete Form U from 

reporting year to reporting year, or for sites submitting a Form U for the first time.

4.4.19 Replace NAICS Codes with Industrial Sectors

EPA is replacing 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 will not need to look up NAICS codes, and the new industrial 

sectors will be more intuitive. However, because the submitter still will be required to look up 

some type of code, EPA assumes the burden reduction will be negligible and does not estimate it 

here.

4.4.20 Revise Consumer and Commercial Product Categories

EPA is revising the list of consumer and commercial use categories by combining categories

leading to common exposure scenarios and adding categories not adequately described in the 

current set of codes. The resultant revised list includes 33 product categories, including “Other.” 

Several of the existing consumer and commercial use categories have been renamed to better 

describe the products that should be reported under that category. EPA anticipates the effort

submitters will make 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 occur only during the first reporting cycle.

EPA is also requiring that if the product category “Other” is reported, a descriptor for the 

consumer and commercial use of the chemical substance also be reported. Using its best 

professional judgment, EPA estimates it will 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 the new 

categories in this rule will reduce by half the number of submitters selecting “Other” as a 

consumer and commercial product category. Therefore, EPA assumes this amendment will affect 

604 reports.

Using the baseline unit burden estimate as shown in Table 4-2 and Table 4-8, Table 4-36

shows the industry burden estimate as a result of this amendment. The Agency estimates the 

amendment will cause a total increase in industry burden of approximately 14,400 hours during 

the first reporting cycle. In future reporting cycles, submitters no longer will need to familiarize 

themselves with the new industrial function categories, so the industry burden is estimated at 

approximately 70 hours to write in text for “Other” responses.
4-39

Table 4-36: Change in Industry Burden as a Result of Revising 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, PostAmendment 2.07 17,075 0.15 604 35,359

Change from the Baseline, 

First Cycle 0.84 0 0.15 604 14,387

Future Cycle, Baseline 0.98 17,075 0.00 0 16,778

Future Cycle, PostAmendment 0.98 17,075 0.12 604 16,850

Change from the Baseline, 

Future Cycles 0.00 0 0.12 604 72

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

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 

4-9. Table 4-37 shows the industry cost estimate as a result of this amendment. EPA estimates 

the industry cost will increase by approximately $845,600 in the first reporting cycle, and $3,500 

during all future reporting cycles. 

Table 4-37: Change in Industry Cost as a Result of Revising 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, PostAmendment $119.90 17,075 $7.31 604 $2,051,756

Change from the Baseline, 

First Cycle $49.26 0 $7.31 604 $845,579

Future Cycle, Baseline $56.51 17,075 $0.00 0 $964,942 

Future Cycle, PostAmendment $56.51 17,075 $5.85 604 $968,470

Change from the Baseline, 

Future Cycles $0.00 0 $5.85 604 $3,528

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

Limitations of Analysis. EPA estimates submitters will need 0.84 hours of technical labor to 

become familiar with the new codes; this may be an over- or underestimate. EPA is assuming 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 there is no burden for 

rule familiarization with the new product categories during the future reporting cycles. This may 

not be the case if sites have different employees complete Form U from reporting year to 

reporting year, or for sites submitting a Form U for the first time.
4-40

4.4.21 Designation of Consumer or Commercial Use

EPA is requiring submitters to indicate whether the downstream use of their chemical 

substance is a consumer or a commercial use, or both. The Agency’s experience using the 2006 

IUR data identified a need to distinguish between potentially exposed consumers versus

commercial populations. The indication of consumer or commercial use will allow EPA to 

complete a better characterization of the potentially exposed populations.

EPA anticipates the submitter will 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 will be negligible.

Therefore, EPA assumes this amendment does not cause any additional burden beyond that 

estimated in Section 4.4.20.

4.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed

EPA is requiring submitters to report the total number of commercial workers, including 

those at sites not under the submitter’s control, reasonably likely to be exposed while using the 

reportable chemical substance, with respect to each commercial use. EPA will provide a set of 

ranges of numbers of workers for the submitter to choose from. The Agency expects this 

reporting burden to be similar to the burden for providing the number of workers potentially 

exposed when using the chemical substance with respect to its industrial use, which is already 

required, because of the similarity of the required data. This burden is approximately 21.36 hours 

(see Table 4-2) or $1,236 (see Table 4-5) per report. EPA assumes the number of submitters will 

not change from the baseline under this amendment.

Using the baseline unit burden estimate as shown in Table 4-2 and Table 4-8, Table 4-38

shows the industry burden estimate as a result of this amendment. The Agency estimates 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 4-38: Change in Industry Burden as a Result of Requiring the Number of 

Commercial Workers Reasonably Likely To Be Exposed

Burden to Provide the 

Number of Commercial 

Workers (hours)

Number of 

Reports 

Burden 

(hours)

First Cycle, Baseline 0 17,075 0

First Cycle, Post-Amendment 21.36 17,075 364,731

Change from the Baseline, First Cycle 21.36 0 364,731

Future Cycle, Baseline 0 17,075 0

Future Cycle, Post-Amendment 17.09 17,075 291,784

Change from the Baseline, Future Cycles 17.09 0 291,784

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

The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 

4-9. Table 4-39 shows the industry cost estimate as a result of this amendment. EPA estimates 

the industry cost will increase by $21.10 million for the 2012 reporting cycle and $16.88 million 

during all future reporting cycles. 
4-41

Table 4-39: Change in Industry Cost as a Result of Requiring the Number of Commercial 

Workers Reasonably Likely To Be Exposed

Cost to Provide the 

Number of Commercial 

Workers (2008$)

Number of 

Reports

Cost 

(millions 

2008$)

First Cycle, Baseline $0 17,075 $0

First Cycle, Post-Amendment $1,236 17,075 $21.10

Change from the Baseline, First Cycle $1,236 0 $21.10

Future Cycle, Baseline $0 17,075 $0

Future Cycle, Post-Amendment $989 17,075 $16.88

Change from the Baseline, Future Cycles $989 0 $16.88

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

Limitations of Analysis. EPA is assuming the burden to report the number of commercial 

workers reasonably likely to be exposed is equivalent to reporting the number of industrial 

workers likely to be exposed. However, this is likely an underestimate of the burden for several 

reasons. There may be more commercial uses for a product, and more workers exposed than the 

submitter is aware of. The commercial uses may be difficult for manufacturers (including 

importers) to identify (see “NRO” discussion responses in Section 3.9); therefore, the number of 

workers exposed may be even more difficult to identify.

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

Information

EPA is eliminating the “not readably obtainable” (NRO) standard and replacing 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 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 

identity of a substance 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 requiring 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 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 
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number of processing and use CBI claims to decrease by the same amount as a result of this 

amendment. According to 2006 IUR data (EPA, 2008c), a total of 8,133 reports had claimed 

processing and use information was CBI, with an average of three processing and use 

information CBI claims per report. EPA estimates the number of reports with processing and use 

CBI claims will be reduced to 2,928 as a result of the amendment. 

For the purposes of this analysis, EPA assumes the per-item burden to complete this 

substantiation will be similar to the burden estimated to complete the substantiation questions 

when a submitter makes a plant site identity CBI claim and must answer the two questions in 

§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 submitters will incur 4.38 additional hours of burden per report as a result of the 

amendment.

Table 4-40 shows the industry burden estimate as a result of this amendment. The Agency 

estimates 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 4-40: 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 4-41 shows the industry cost estimate as a result of this amendment. EPA estimates 

the industry cost will increase by approximately $772,700 in the first reporting cycle and 

$618,100 in future reporting cycles.
4-43

Table 4-41: Change in Industry Cost as a Result of Requiring Upfront Substantiation for 

Claiming Processing and Use Information as CBI

Cost for Upfront CBI 

Substantiation for CBI 

Claims in Part III

Number of Reports 

with Upfront 

Substantiation for 

CBI Claims in Part 

III

Industry 

Cost 

(2008$)

First Cycle, Baseline $0 0 $0

First Cycle, Post-Amendment $263.90 2,928 $772,678

Change from the Baseline, First Cycle $263.90 2,928 $772,678

Future Cycle, Baseline $0 0 $0

Future Cycle, Post-Amendment $211.12 2,928 $618,143

Change from the Baseline, Future Cycles $211.12 2,928 $618,143

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

Limitations of Analysis. EPA assumes the percent reduction in CBI claims for processing 

and use information will be the same as the percent reduction when upfront substantiation was 

required for plant site identification. However, to the extent the actual burden differs, this 

analysis may over- or underestimate the burden and cost of this amendment.

4.4.26 Limitation on the Confidentiality Claims for Data Elements Identified as 

“Not Known or Reasonably Ascertainable”

Under the final rule, IUR submitters will 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 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 requiring electronic submissions of all Form Us over the Internet using e-IURweb 

and EPA’s Central Data Exchange (CDX). The Agency’s cost estimates were calculated 

following the methodology outlined in the economic analysis for the e-PMN rule (EPA, 2009b), 

where EPA is requiring TSCA section 5 pre-manufacturing notices be submitted electronically.

The costs and savings of this IUR amendment will be realized on a per-site basis, as well as per 

report.

Following the methodology outlined in the economic analysis for the e-PMN rule (EPA, 2009b) the 

clerical burden used in the preparation of Parts I, II and III of Form U will be eliminated with this 

amendment. Specifically, the Agency assumes 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).
4-44

The technical burden to gather and organize data, and managerial burden for review and 

approval, will not change from the baseline. Overall, this amendment will 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 CDX, and to complete 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 0.93 hours of managerial burden and 1.73 hours of technical time per site (EPA, 2009b; 

EPA, 2004).Based on the e-PMN EA, recordkeeping costs will be halved because of the efficiencies in 

creating and storing documents electronically (EPA, 2009b), reducing overall burden per report by three 

hours. 

Table 4-42 shows the industry burden estimate as a result of this amendment. The Agency 

estimates the amendment will cause a total decrease in industry burden of approximately 245,600 

hours in the first reporting cycle and 210,200 hours in all future reporting cycles. 

Table 4-42: Change in Industry Burden as a Result of Requiring Electronic Submission

Burden for 

Report, 

Compliance 

Determination, 

Rule 

Familiarization, 

Submission and 

Part I (per site) 

(hours)

Number 

of Sites

Burden for 

Recordkeeping 

and Part II 

(hours per 

report)

Number 

of 

Reports 

Burden per 

Part 

III(hours)

Number 

of 

Reports 

with 

Part III

Industry 

Burden 

(hours)

(a) (b) (c) (d) (e) (f)

(g) = 

(a*b) + 

(c*d) + 

(e*f)

First Cycle, 

Baseline 33.26 4,085 19.82 25,896 69.92 17,075 1,842,934

First Cycle, 

PostAmendment

35.17 4,085 15.27 25,896 61.98 17,075 1,597,358

Change from 

the Baseline, 

First Cycle

1.91 0 -4.55 0 -7.94 0 -245,576

Future Cycle,

Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833

Future Cycle, 

PostAmendment11.05 4,085 12.82 25,896 49.58 17,075 1,223,658

Change from 

the Baseline, 

Future Cycles

1.98 0 -4.24 0 -6.35 0 -210,175

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

EPA calculated the cost savings of the amendment using the unit costs shown in Table 4-5

and Table 4-9. Table 4-43 shows the industry cost estimate as a result of this amendment. EPA 

estimates the industry cost will decrease by $9.02 million during the first reporting cycle and by 

$8.01 million during all future reporting cycles. 
4-45

Table 4-43: Change in Industry Cost as a Result of Requiring Electronic Submission

Cost for Report, 

Compliance 

Determination, 

Rule 

Familiarization, 

Submission and 

Part I (per site) 

(2008$)

Number 

of Sites

Cost for 

Recordkeeping 

and Part II 

(2008$ per 

report)

Number 

of 

Reports

Cost per 

Part III 

(2008$)

Number 

of 

Reports 

with Part 

III

Industry 

Cost 

(millions 

2008$)

(a) (b) (c) (d) (e) (f)

(g) = 

(a b)+

(c d)+(e*f)

First Cycle, 

Baseline $2,058 4,085 $1,143 25,896 $4,059 17,075 $107.32

First Cycle, PostAmendment $2,190 4,085 $923 25,896 $3,833 17,075 $98.30

Change from the 

Baseline, First 

Cycle

$132 0 -$220 0 -$226 0 -$9.02

Future Cycle,

Baseline $561 4,085 $982 25,896 $3,247 17,075 $83.17

Future Cycle, 

Post-Amendment $695 4,085 $771 25,896 $3,067 17,075 $75.16

Change from the 

Baseline, Future 

Cycles

$134 0 -$211 0 -$181 0 -$8.01

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

Limitations of Analysis. EPA assumes the clerical burden will decrease by percentages 

similar to the decrease estimated for the e-PMN rule. To the extent any differences exist (given 

the differences in the two rules), this analysis may over- or underestimate the burden and cost of 

this amendment.

4.4.28 Updated e-IUR Reporting Software

EPA developed the e-IUR reporting software for use in preparing and submitting reports 

electronically during the 2006 IUR reporting cycle. For the 2012 submission period, EPA will 

provide a free, web-based application in place of the 2006 downloadable software. The updated 

e-IURweb reporting tool will 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 (CDX), 

individuals acting on behalf of the submitter must first register with CDX. This process involves 

completing an Electronic Signature Agreement form along with a signature and date, having the 

form notarized, and mailing it back to EPA. The burden of the electronic signature agreement, 

one hour per submission, was included in the burden reduction estimate used in the economic 

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. 
4-46

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 substance. 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 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 will not change as a result of this 

amendment, although EPA plans to revise the Form U for joint submitters. Under the amendment, the 

foreign manufacturer must now register with CDX and submit its report electronically. Previously, joint 

submissions could not be made electronically.

As described in Section 4.4.27, submission costs to register with EPA’s CDX, and complete the 

Electronic Signature Agreement forms are incurred on a per-site basis. EPA estimated these costs in the 

economic analysis for the e-PMN rule to be a total of 0.93 hours of managerial burden and 1.73 hours of 

technical time per site (EPA, 2009b). Based on previous IUR submissions, EPA estimates 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 4-44 shows the industry burden estimate as a result of this amendment. The Agency

estimates the amendment will cause an increase in industry burden of approximately 53.3 hours 

in the first reporting cycle. Future reporting cycles are assumed to the similar to the first 

reporting cycle.

Table 4-44: 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 2.67 20 53.3

Change from the 

Baseline, First Cycle 2.67 20 53.3

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

Table 4-45 shows the industry cost estimate as a result of this amendment. EPA estimates the 

industry cost will increase by approximately $3,300 during the first and future reporting cycles.

Table 4-45: 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 $167 20 $3.347

Change from the 

Baseline, First Cycle $167 20 $3.347

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
4-47

4.4.31 Modify Reporting Frequency

The Agency is modifying the IUR reporting cycle from a five-year reporting frequency to a 

four-year reporting frequency. While the industry burden for the principal reporting year will not 

change, the longer-term industry burden will increase because reporting will become more 

frequent; therefore, EPA estimated the annual reporting burden to industry over a 26-year period. 

A 26-year period allows EPA to analyze a set of complete reporting cycles under both the 

baseline and post-amendment scenarios. Under the baseline, a five-year reporting cycle is used, 

and the cost of five complete cycles is presented. Under the post-amendment scenario, reporting 

occurs every four years, and the cost of six complete cycles is presented. (Note the 2012

reporting cycle covers a six-year period, under either scenario). For more information on the 

distribution of burden over a reporting cycle, see the discussion in Section 4.6.

The baseline industry burden in the 2012 reporting cycle 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 sites have submitted Form U previously 

incur a lower burden for processing and submitting the Form, as these firms have become more 

familiar with reporting and may be more efficient at the compliance process. Table 4-11 contains 

the total annual baseline costs to industry for future reporting cycles – that is, the burden and cost 

to industry for reporting cycles after the 2012 cycle, in the absence of the 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 in all 

future reporting cycles, the baseline burden to industry is approximately 1.43 million hours. 

As shown in Table 4-46, EPA estimates the industry burden will increase by 1.43 million 

hours over a 26-year period as a result of this amendment.
4-48

Table 4-46: Change in Industry Burden as a Result of Modifying the Reporting Frequency, 

over a 26-Year Period

Reporting 

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

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2012 1.84 1.84 0.00

2 2013 to 2017 1.43 --

0.00

2013 to 2016 -- 1.43

3 2018 to 2022 1.43 --

0.00

2017 to 2020 -- 1.43

4 2023 to 2027 1.43 --

0.00

2021 to 2024 -- 1.43

5 2028 to 2032 1.43 --

0.00

2025 to 2028 -- 1.43

6 2029 to 2032 -- 1.43 1.43

Total 7.58 9.01 1.43

Annual Average 0.29 0.34 0.05

Note: The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are four-year 

cycles.

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. Table 4-47 shows the annual industry cost estimate as a result of 

this amendment. In total, EPA estimates the amendment will increase the cost to industry by 

$82.82 million over a 26-year period.

In the proposal, EPA requested comment on increasing the frequency of reporting to annual 

reporting of all data; biennial reporting; 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 E. 
4-49

Table 4-47: Change in Industry Cost as a Result of Modifying the Reporting Frequency, 

over a 26-Year Period

Reporting Cycle Year(s)

Baseline Cost Post-Amendment 

Cost Change in Cost

(millions of 

2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2012 $106.97 $106.97 $0.00

2 2013 to 2017 $82.82 -- $0.00

2013 to 2016 -- $82.82

3 2018 to 2022 $82.82 -- $0.00

2017 to 2020 -- $82.82

4 2023 to 2027 $82.82 -- $0.00

2021 to 2024 -- $82.82

5 2028 to 2032 $82.82 -- $0.00

2025 to 2028 -- $82.82

6 2029 to 2032 -- $82.82 $82.82

Total $438.24 $521.05 $82.82

Annual Average $16.87 $20.06 $3.19

Note: The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are four-year cycles.

Limitations of Analysis. EPA assumes 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 these reductions in burden do not occur, this analysis may 

underestimate the burden and cost of the rule amendment.

4.5 Total Industry Compliance Burden and Cost of all Amendments

The burdens and costs presented in Section 4.4 are the stand-alone industry compliance 

burden and cost for each amendment, and do not take into account the interaction of amendments 

(i.e., how the impact of one amendment will affect the burden of another amendment). For this 

reason, when calculating the total industry cost of all amendments described in EPA’s rule, the 

Agency cannot simply add the individual changes in burden for each amendment, but must 

consider the effect of one amendment on another. As described below, amendments fall into 

three categories: those affecting the number of reports submitted during a reporting cycle, those 

affecting the reporting burden, and those affecting the reporting frequency. The impact each 

amendment has on the others depends on its category.

4.5.1 Modifications that Affect the Number of Reports Submitted

Several of the IUR rule amendments change the number of full and/or partial reports EPA 

expects to be submitted, based on the specific chemical substances they affect. The amendment 

changing 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 will also increase each of the impacts of the other 

amendments in this category by five percent. Furthermore, the amendment to replace the 300,000 

lb threshold for downstream processing and use reporting in future reporting cycles will make 

Part IIIs necessary for all the additional Part IIs required by other amendments. The following 
4-50

steps describe how the combined effect of the amendments affecting the number of reports was

calculated.

Step 1: Sum the affected amendments. Table 4-48 and Table 4-49 present the number of 

full and partial reports EPA expects to be submitted as a result of the IUR amendments, in the 

2012 reporting cycle and future reporting cycles, respectively. The amendments changing the 

number of full and/or partial reports expected to be submitted are as follows:

Reducing the 300,000 lb threshold for downstream processing and use reporting: When 

taken alone, EPA expects this amendment to increase the number of Part IIIs submitted by 

3,627 reports in the first reporting cycle and 8,203 reports in future reporting cycles (see 

Section 4.4.4).

Reducing the 25,000 lb threshold for specific regulated chemical substances: This 

amendment affects future reporting cycles only. The amendment, by itself, will increase in 

the number of Part IIs submitted by 3,609 in future reporting cycles (see Section 4.4.5).

Make chemical substances subject to ECAs ineligible for exemptions: EPA estimated this 

amendment will increase the number of Part IIIs submitted by 16 reports (see Section 4.4.6).

Full exemption for manufactured water: EPA expects this amendment, by itself, will

decrease the number of Part IIIs submitted by 43 reports (see Section 4.4.7).

Step 2: Consider the effects of the change in method for determining rule applicability

(future cycles only). In future reporting cycles, 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, for future reporting cycles, 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. (In Table 

4-48, for the first cycle calculations, this step is merely a placeholder and does not cause any 

change.)

Method for determining whether a manufacturer is subject to the IUR reporting 

requirements. When taken by itself, this amendment will generate 204 additional submitters

in future reporting cycles (five percent of the baseline number of 4,085), 1,295 additional 

Part IIs (five percent of the baseline number of 25,896), and 854 additional Part IIIs (five 

percent of the baseline number of 17,075) (see Section 4.4.3).

Step 3: Consider the effect of replacing the 300,000 lb. threshold for processing and use 

reporting (and avoid double-counting) (future cycles only). In future cycles, under this 

amendment, all submitters of non-exempt chemical substances will 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 replacing the 300,000 lb threshold for processing and use reporting. For 

example, under the future reporting cycle calculations, EPA started with the Step 2 total for Part 

III reports (9,484), and added the Step 2 total for Part II reports (5,039), 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). As shown in Table 4-49, the number of reports with 

Part III will increase by 13,212 in future reporting cycles.

This step is not needed for the 2012 reporting cycle, because during this first reporting cycle 

the threshold for processing and use information is not being eliminated, but being lowered to 

100,000 lb; additional Part IIs generated by the new modifications will be for chemical 
4-51

substances with production volumes less than 100,000 lb. In addition, no new Part IIs will be 

generated by the changing of the method of determining whether a manufacturer is subject to 

reporting requirements, because this modification will not go into effect until future reporting 

cycles.

Step 4: Calculate the number of reports when all amendments are considered together. 

The total number of additional reports from Step 3 is added to the number of reports in the 

baseline to calculate the total number of reports when all the final amendments are considered 

together. In future reporting cycles, there will be a total of 4,289 Part Is, 30,935 Part IIs and 

30,287 Part IIIs. The difference between the total number of Part IIs and Part IIIs, 648 reports, is 

equal to the number of partially exempt reports with the five percent increase taken into account 

(618 x 1.05 = 648). 

Table 4-48: Change in the Number of Sites and Reports Submitted for All Amendments 

Combined (First Reporting Cycle)

Modification Number of Sites Number of Reports Number of Reports 

with Part III

Baseline 4,085 25,896 17,075

Step 1: Sum affected amendments

Replace the 300,000 lb. Threshold for 

Downstream Processing and Use Reporting to 

100,00lbs (see Section 4.4.6) 

-- -- 3,627

Make Chemical Substances 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 -- -43 3,643

Step 2: Account for change in the method for determining whether you are subject to the IUR reporting 

requirements

N/A -- -- --

Step 3: Consider the effect of eliminating the 300,000 lb threshold for processing and use reporting (and avoid 

double-counting) (Future Cycles Only)

N/A -- -- --

Step 4:Calculate the total number of reports by adding the Step 1 Total to the Baseline 

STEP 4 TOTAL (Baseline + Step 1 Total) 4,085 25,853 20,718
4-52

Table 4-49: Change in the Number of Sites and Reports Submitted for All Amendments 

Combined (Future Cycles)

Modification Number of Sites Number of Reports Number of Reports 

with Part III

Baseline 4,085 25,896 17,075

Step 1:Sum affected amendments

Replace 300,000 lb Threshold for Downstream 

Processing and Use Reporting (see Section 4.4.6)

-- -- 8,203

Reduce the 25,000 lb Threshold for Specific 

Regulated Chemical Substances to 2,500 lb (see 

Section 4.4.5)

-- 3,609 --

Make Chemical Substances 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 -- 3,566 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 3,745 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 5,039 9,484

Step 3: Consider the effect of replacing the 300,000 lb threshold for processing and use reporting (and avoid 

double-counting) (Future Cycles Only)

Step 2 total for Part II reports minus number of 

new Part III reports as a result of making ECAs 

ineligible for exemptions and the number of new 

Part II reports as a result of changing the method 

of determining whether subject to reporting 

requirements

-- -- 3,736

STEP 3 TOTAL (Step 3 + Step 2 Total ) 204 5,039 13,212

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 30,935 30,287

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 

the amendment to require electronic submission over the Internet will eliminate clerical burden used in 

the preparation of Parts I, II and III of Form U, and the burden for recordkeeping across all wage rate 

categories will be reduced by half. Table 4-50 contains the total burden by labor category for the 2011 

reporting cycle when all the amendments are considered together. Table 4-51 contains the future reporting 

cycle burden, by labor category. The steps below describe how the combined effect of the amendments

affecting the reporting burden was calculated.

Step 1: Sum the affected amendments. The amendments affecting the reporting burden are as 

follows:
4-53

Report Chemical Identity: This amendment is estimated to require an additional hour of 

technical time in the first reporting cycle for approximately 343 reports (or 1 percent of all 

reports). Therefore, this amendment will add approximately 0.013 hours per report in the first 

reporting cycle only (see Section 4.4.11).

Report production volume for each of the years since last report: This amendment is 

estimated to require 1.51 hours of additional burden in the first reporting cycle (see Section 

4.4.12). In future reporting cycles, an additional 3.63 hours is needed to supply three years of 

additional production volumes per reporting cycle (1.51 x 3).

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 4-50 presents the 

per-report total burden of 0.293 hours to reflect only 24 percent of reports are expected to 

report volume used on site.

Indicate whether the chemical substance 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 substance 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 4-50 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 4-50 presents the per-report total burden of 0.84 hours, 

which reflects only 3.5 percent of reports are expected to select “Other” and thus incur this 

additional burden.

Number of commercial workers reasonably likely to be exposed: This amendment is 

estimated to require 21.36 additional hours to complete Part III (see Section 4.4.22).

Upfront substantiation for processing and use information Confidential Business 

Information claims: This amendment is estimated to require 4.38 additional hours of burden 

to complete Part III for all submitters claiming processing and use information as CBI (see 

Section 4.4.25). Table 4-50 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.

Modifications specifically affecting importers: This amendment requires that those foreign 

manufacturers who are filing joint submissions with an importer now register with CDX and 

submit its report electronically. EPA expects this will add an additional 2.63 hours to 

complete Part I of Form U for approximately 20 sites (0.5 percent of all sites). Therefore, this 

amendment will add an additional burden of approximately 0.013 hours per site in the first 

reporting cycle only (see Section 4.4.30).
4-54

Step 2: Consider the effect of the amendment to require electronic submission over the 

Internet. This amendment will 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 

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 substance, the technical burden will 

be 102.83 hours per full report with one chemical substance, and the managerial burden will be

37.74 hours per full report with one chemical substance.
4-55

Table 4-50: Change in the First Year 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 to Complete

Part III

C T M 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 7.94 45.31 16.66

Step 1: Sum the Affected Amendments

Report chemical identity as CAS number or 

EPA Ascension Number 

-- -- -- -- -- -- -- -- -- -- 0.013 -- -- -- --

Report production volume for each of the 

years since last report

-- -- -- -- -- -- -- -- -- 0.234 1.026 0.252 -- -- --

Report production volume used on-site -- -- -- -- -- -- -- -- -- 0.045 0.199 0.049 -- -- --

Indicate whether chemical substance 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 substance is to 

be recycled, remanufactured, reprocessed, 

reused, or reworked

-- -- -- -- -- -- -- -- -- 0.026 0.114 0.028 -- -- --

Revise industrial function categories -- -- -- -- -- -- -- -- -- -- -- -- 0.002 0.254 0.000

Revise commercial and consumer product 

categories

-- -- -- -- -- -- -- -- -- -- -- -- 0.002 0.841 0.000

Number of commercial workers reasonably 

likely to be exposed

-- -- -- -- -- -- -- -- -- -- -- -- 2.104 15.428 3.829

Upfront substantiation for processing and 

use information CBI claims

-- -- -- -- -- -- -- -- -- -- -- -- 0.062 0.427 0.262

CDX registration for joint submissions with 

foreign manufactures 

-- -- -- -- 0.005 0.008 -- -- -- -- -- -- -- -- --

Step 1 Total -- -- -- -- 0.005 0.008 -- -- -- 0.565 2.492 0.609 2.169 16.949 4.092

Step 2:Add the Effect of the Electronic Reporting Amendments

Electronic submission -- 1.73 0.93 -0.76 -- -- -0.75 -1.50 -0.75 -2.12 -- -- -10.11 -- --

Step 2 Total (Electronic Submission + 

Step 1 Total)

-- 1.73 0.93 -0.76 0.005 0.008 -0.75 -1.50 -0.75 -1.55 2.49 0.61 -7.94 16.95 4.09

Step 3 Total Burden

Step 2 Total + Baseline -- 23.23 9.93 -- 0.95 1.06 0.75 1.50 0.75 -- 11.27 4.10 -- 62.26 20.76

Note: C = Clerical; T = Technical; and M = Managerial wage categories

Table 4-51: Change in the Future Reporting Cycle Burden for All Amendments Combined, by Labor Category
4-56

Modification

Compliance 

Determination, Rule

Familiarization, and 

Submission Burden

Burden to Complete 

Part I

Recordkeeping 

Burden

Burden to Complete 

Part II

Burden to Complete Part 

III

C T M C T M C T M C T M C T M

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 36.251 13.33

Step 1: Sum the Affected Amendments

Report production volume for each of the years 

since last report

-- -- -- -- -- -- -- -- -- 0.562 2.462 0.605 -- -- --

Report production volume used on-site -- -- -- -- -- -- -- -- -- 0.036 0.159 0.039 -- -- --

Indicate whether chemical substance 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 substance is to be 

recycled, remanufactured, reprocessed, reused, or 

reworked

-- -- -- -- -- -- -- -- -- 0.021 0.091 0.022 -- -- --

Revise industrial function categories -- -- -- -- -- -- -- -- -- -- -- -- 0.001 0.003 0.000

Revise commercial and consumer product 

categories

-- -- -- -- -- -- -- -- -- -- -- -- 0.001 0.003 0.000

Number of commercial workers reasonably likely 

to be exposed

-- -- -- -- -- -- -- -- -- -- -- -- 1.683 12.342 3.063

Upfront substantiation for processing and use 

information CBI claims

-- -- -- -- -- -- -- -- -- -- -- -- 0.049 0.427 0.210

Step 1 Total -- -- -- -- -- -- -- -- -- 0.827 3.625 0.890 1.735 12.775 3.273

Step 2:Add the Effect of the Electronic Reporting Amendments

Electronic Submission -- 1.73 0.93 -0.69 -- -- -0.75 -1.50 -0.75 -2.07 -- -- -8.09 -- --

Step 2 Total (Electronic Submission + Step 1 

Total)

-- 1.73 0.93 -0.69 -- -- -0.75 -1.50 -0.75 -1.24 3.62 0.89 -6.35 12.77 3.27

Step 3 Total Burden

Step 2 Total + Baseline -- 6.23 2.93 -- 0.87 1.02 0.75 1.50 0.75 -- 10.65 3.68 -- 49.03 16.60

Note: C = Clerical; T = Technical; and M = Managerial wage categories
4-57

Table 4-52 contains the estimated change in the burden and the total burden per reporting cycle as a 

result of the all the 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 0.50 million 

hours to 2.34 million hours in total for the 2012 reporting cycle. In future reporting cycles, EPA estimates

industry burden will increase by 1.14 million hours to 2.57 million hours.

Table 4-52: 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, 

PostAmendment35.18 4,085 18.37 25,853 83.02 20,718 2.34

Change from 

the Baseline, 

First Cycle

1.92 0 -1.45 -43 13.10 3,643 0.50

Future-Cycle, 

Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1.43

Future Cycle, 

PostAmendment11.05 4,289 17.33 30,935 65.63 30,287 2.57

Change from 

the Baseline, 

Future Cycles

1.98 204 0.28 5,039 9.70 13,212 1.14

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

Table 4-53 shows the total industry cost. To calculate the total industry cost, the burden estimates 

located in Table 4-50 and Table 4-51were multiplied by the wage rates found in Table 4-1. The costs 

were then multiplied by the number of submissions located in Table 4-49. EPA estimates the total 

industry cost will increase by approximately $36.76 million to $143.73million in total for the 2012

reporting cycle. In future reporting cycles, EPA estimates the industry cost will increase by $75.12

million to $157.94 million.
4-58

Table 4-53: 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

$2,193 4,085 $1,112 25,853 $5,117 20,718 $143.73 

Change from 

the Baseline, 

First Cycle

$135 0 -$16.99 -43 $1,058 3,643 $36.76 

Future-Cycle, 

Baseline $561 4,085 $968.39 25,896 $3,247 17,075 $82.82 

Future Cycle, 

PostAmendment$695 4,289 $1,047 30,935 $4,047 30,287 $157.94 

Change from 

the Baseline, 

Future Cycles

$134 204 $78.18 5,039 $800 13,212 $75.12 

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 amendment to modify the reporting frequency from every five years to every four years 

will not change the number of submissions or the submission burden, but will 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 chemical 

substances (25,896 reports divided by 4,085 sites), and submits full reports for 4.18 of those chemical 

substances (17,075 reports divided by 4,085 sites) (See Table 4-54). Table 4-52 contains the total number 

of reports submitted and sites when all the amendments are considered together. Under the first and future 

reporting cycles, an estimated 4,085 and 4,289 sites, respectively, submit a total of 25,853 and 30,935 

reports; 20,718 and 30,287 of which will be full reports. Therefore, in the post-amendment scenario, an 

average site will submit 6.33 reports comprised of 5.07 full reports and 1.26 partial reports in the first 

reporting cycle and 7.21 reports comprised of 7.06 full reports and 0.15 partial reports in future reporting 

cycles (see Table 4-54). This is a decrease of 0.90 partial reports per site in the first reporting cycle and 

2.01 partial reports per site in future reporting cycles. The number of full reports per site will increase by 

0.89 reports in the first reporting cycle and 2.88 in future reporting cycles when compared to the baseline.
4-59

Table 4-54: Average Number of Full and Partial Reports per Site

Total 

Number of 

Sites

Total 

Number of 

Reports

Average 

Number of 

Reports per 

Site

Total 

Number of 

Full Reports 

Average 

Number 

Full 

Reports per 

Site

Average 

Number of 

Partial 

Reports per 

Site 

(a) (b) (c) = (b)/(a) (d) (e) = (d)/(a) (f) = (c)-(e)

First Cycle, Baseline 4,085 25,896 6.34 17,075 4.18 2.16

Post-Amendment 4,085 25,853 6.33 20,718 5.07 1.26

Change from the Baseline 0 -43 -0.01 3,643 0.89 -0.90

Future Cycle, Baseline 4,085 25,896 6.34 17,075 4.18 2.16

Future Cycle, PostAmendment 4,289 30,935 7.21 30,287 7.06 0.15

Change from the Baseline, 

Future Cycles 204 5,039 0.87 13,212 2.88 -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 4-55 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 4-54. 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 4-52. The 

average burden per site is expected to be 572 hours in the first reporting cycle and 600 hours in future 

reporting cycles. This is an increase of 121 hours per site during the first reporting cycle and 249 hours 

per site in future reporting cycles compared to the baseline.

Table 4-55: Average Total Burden per Site

Burden for 

Compliance 

Determination, 

Rule 

Familiarization, 

Submission and 

to Prepare Part I 

(hours per site)

Average 

Number of 

Part Is per 

Site

Burden for 

Record 

Keeping and 

to Prepare 

Part II (hours 

per report)

Average 

Number 

of Part 

IIs per 

Site

Burden 

for Part 

III (hours 

per 

report)

Average 

Number 

of Part 

IIIs per 

Site

Total 

Average 

Burden per 

Site (hours)

(a) (b) (c) (d) (e) (f) (g) = (a*b) 

+(c*d)+(e*f)

First Cycle, 

Baseline 33.26 1 19.82 6.34 69.92 4.18 451 

PostAmendment 35.18 1 18.37 6.33 83.02 5.07 572 

Change from 

the Baseline 1.92 0 -1.45 -0.01 13.10 0.89 121 

Future Cycle, 

Baseline 9.08 1 17.06 6.34 55.93 4.18 351 

Future Cycle, 

PostAmendment11.05 1 17.33 7.21 65.63 7.06 600 

Change from 

the Baseline, 

Future Cycles

1.98 0 0.28 0.87 9.70 2.88 249 

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
4-60

The average baseline and post-amendment scenario costs per site are found in Table 4-56. Baseline 

cost per report costs is 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 cost per report is

derived in Table 4-52 and Table 4-53. The average post-amendment cost per site is calculated to be 

approximately $35,200 in first reporting cycle, and $36,800 for all future reporting cycles. This is an 

increase of approximately $9,000 per site during the first reporting cycle and $16,600 during future 

reporting cycles compared to the baseline.

Table 4-56: 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 $2,193 1 $1,112 6.33 $5,117 5.07 $35,185 

Change from 

the Baseline $135 0 -$16.99 -0.01 $1,058 0.89 $9,000 

Future Cycle 

Baseline $561 1 $968 6.34 $3,247 4.18 $20,274 

Future Cycle, 

PostAmendment$695 1 $1,047 7.21 $4,047 7.06 $36,824 

Change from 

the Baseline, 

Future Cycles

$134 0 $78.18 0.87 $800 2.88 $16,551 

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

4.6 Annualized Industry Cost Estimates for all Modifications

EPA estimated the total burden to industry of all of the amendments over a 26-year period. 

EPA used a 20-year annualization period in the previous economic analyses of the IUR rule 

(EPA, 2002a and EPA, 2005), but for this report, a 26-year period allows EPA to analyze a set of 

complete reporting cycles under both the baseline and post-amendment scenarios.

While the IUR data submission activity itself occurs in one reporting year (e.g., 2012), EPA believes 

rule compliance and data collection activities, and thus, costs and burdens, are incurred over the course of 

the reporting cycle. Consequently, costs and burdens are presented for a reporting cycle, rather than per 

year, because EPA cannot precisely predict the annual breakdown of how the costs are actually incurred 

by each site over a four- or five-year reporting cycle. Industry has indicated to EPA efforts related to rule 

compliance and data collection are spread out over multiple years. For example, EPA began receiving 

calls about reporting requirements for 2012 reporting in early 2009, and the Agency has already held 

conference calls with companies and EPA IT staff to discuss electronic reporting issues. Companies have

stated they prefer to set up a system to collect the IUR information during the time the chemical 
4-61

substances are being manufactured. Thus, for the 2012 reporting cycle, EPA has evidence some 

companies set up their data systems in 2009 to early 2010, are collecting the information in 2010 and 

2011, and will compile and report that information in 2012. Furthermore, as described in section 4.2.2, 

IUR burden estimates are taken from the 2002 EPA Economic Analysis for the Amended Inventory 

Update Final Rule and were based on an industry survey conducted by EPA and designed to measure 

industry effort associated with collecting chemical substance exposure data under TSCA Section 8.

Nowhere in the survey or its cover letter are these burden estimates discussed as being annual burdens. 

They are interpreted in the 2002 EA, and in previous IUR ICRs, as being the total burden incurred over 

the entire reporting cycle.

The total industry burden calculated in Table 4-52 included the burden during the first 

reporting cycle. EPA expects 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 4-52 also shows the total burden to industry in future 

reporting cycles. Table 4-57 shows the burdens associated with each reporting cycle over a 

period of 26 years, including the years covered by the next (2012) reporting cycle. Under the 

baseline, a five-year reporting cycle is used, and the cost of four complete cycles is analyzed. 

Under the post-amendment scenario, reporting occurs every four years, and the cost of five 

complete cycles is presented. (Note the 2012 reporting year covers a six-year period under either 

scenario).

Over a 26-year period, EPA estimates the amendments will increase industry burden by 

approximately 7.62 million hours.

Table 4-57: Industry Burden over a Period of 26 Years if All Amendments Are 

Implemented

Reporting Cycle1 Year(s)

Baseline Burden Post-Amendment 

Burden Change in Burden

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2012 1.84 2.34 0.50

2 2013 to 2017 1.43 -- 1.14

2013 to 2016 -- 2.57

3 2087 to 2022 1.43 -- 1.14

2017 to 2020 -- 2.57

4 2023 to 2027 1.43 -- 1.14

2021 to 2024 -- 2.57

5 2028 to 2032 1.43 -- 1.14

2025 to 2028 -- 2.57

6 2029 to 2032 -- 2.57 2.57

Total 7.58 15.20 7.62

Annual Average 0.29 0.58 0.29

1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are four-year cycles.

Table 4-58 presents the annual and annualized costs estimates of all the amendments. Over a 

26-year period, EPA estimates the amendments to the IUR rule will increase the annualized 

industry cost by $17.16 million, with a three percent discount rate, and $14.71 million with a 

seven percent discount rate.
4-62

Table 4-58: Industry Cost over a Period of 26 Years if All Amendments Are Implemented

Reporting 

Cycle1 Year(s)

Baseline Cost Post-Amendment 

Cost Change in Cost

(millions of 2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2012 $106.97 $143.73 $36.76

2 2013 to 2017 $82.82 -- $75.12

2013 to 2016 -- $157.94

3 2087 to 2022 $82.82 -- $75.12

2017 to 2020 -- $157.94

4 2023 to 2027 $82.82 -- $75.12

2021 to 2024 -- $157.94

5 2028 to 2032 $82.82 -- $75.12

2025 to 2028 -- $157.94

6 2029 to 2032 -- $157.94 $157.94

Total $438.24 $933.42 $495.19

Annualized @ 3% $15.88 $33.05 $17.16

Annualized @ 7% $14.62 $29.33 $14.71

1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are, four-year cycles.
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 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 

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 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 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, perreporting 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 
5-2

therefore 4,160 hours under the baseline. EPA assumes the Agency burden will remain the same 

for all reporting cycles.

EPA labor costs are based on annual Federal wage rates published by the Office of Personnel 

Management for the Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV locality 

pay area for 2008 (OPM, 2008). Wages are presented in terms of GS-level and step. Based on 

previous IUR economics analyses, a Step3 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 WashingtonBaltimore-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 Information Collection Request (ICR) supporting statement (EPA, 

2008d) estimates these costs. EPA inflated these costs to 2008 dollars from 2007 dollars using an 

inflation factor developed from data from the BLS Employee Cost Index (ECI) “Professional, 

scientific, and technical services” group (BLS, 2009). Table 5-2 shows the derivation of the 

extramural task cost in 2008 dollars. In total, EPA estimates it will spend approximately 

$204,000 on these tasks per reporting cycle.

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

Tasks Performed by Contractor Staff Annual Cost 

(2007$)1

Inflation 

Factor

Annual Cost 

(2008$)

Document Receipt, Tracking and Data Entry $90,737 1.04 $94,632

Maintaining and 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

1

Source: ICR No. 1884.04. [Information Collection Request for] Partial Update of the TSCA Section 8(b) Inventory Data Base, 

Production and Site Report Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act, September 

5, 2008 (EPA, 2008d).

5.3 Current Total Agency Burden and Cost

As shown in Table 5-3, EPA calculated the total baseline Agency costs by combining the 

costs of EPA staff and the extramural tasks performed by contractors.
5-3

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

Task Staff Cost per Reporting 

Cycle(2008$)

VARIABLE COSTS (DEPENDENT ON 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 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 for Part I.
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 hours (approximately 0.054 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 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 5-4contains 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 of Data 

Elements

Burden per Data Element Total

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 Modifications

The estimated cost and burden impacts on the Agency for each of the amendments to the IUR 

are outlined below. See Section 3. for more information about each of the amendments.

In each of the following sections, 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 the amendments. 

5.4.1 Technical Modifications to the Regulatory Text

EPA is reorganizing certain existing regulatory text and to delete obsolete regulatory text. 

These amendments do not substantively affect the regulatory text, so EPA assumes this 

amendment will not impact Agency burden or cost.

5.4.2 Modifications to Selected Definitions

EPA is modifying 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),” “e-IURweb,” and “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 these definition changes will not impact Agency burden or cost.
5-5

5.4.3 Method for Determining Whether a Manufacturer is subject to IUR 

Reporting Requirements

EPA is requiring reporting if, for any calendar year since the previous IUR principal 

reporting year, the subject chemical substance 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. This modification would not take effect until after the first 

post-amendment reporting cycle (2012); for the first reporting cycle, submitters will still 

consider production volume only for the principal reporting year. This creates a difference in the 

number of sites and reports expected in the first cycle versus future cycles. (See Section 4.4.3 for 

more information.) Therefore, the tables below show estimated changes in cost and burden for 

both the first and future reporting cycles.

Table 5-5 shows the estimated Agency burden of the amendment, using the baseline burden 

estimates found in Table 5-4. The Agency estimates no change in burden for the first reporting 

cycle and a burden increase of 104 hours in future reporting cycles as a result of modifying the 

method for determining whether the 25,000 lb reporting threshold is met.

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

Determining Whether a Manufacturer is Subject to IUR Reporting Requirements

Burden to 

Process 

Part I 

Submission 

(hours)

Number 

of Sites

Burden

to 

Process 

Part II 

(hours 

per 

report)

Number 

of 

Reports

(with 

Part II)

Burden to 

Process

Part III 

(hours per 

report)

Number 

of 

Reports 

with Part 

III

Agency 

Burden

(hours)

(a) (b) (c) (d) (e) (f)

(g) = 

(a*b)+(c*d)

+(e*f)

First Cycle, 

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080

First Cycle, PostAmendment 0.017 4,085 0.042 25,896 0.054 17,075 2,080

Change from the 

Baseline, First 

Cycle

0.000 0 0.000 0 0.000 0 0

Future Cycle 

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080

Future Cycle, PostAmendment 0.017 4,289 0.042 27,191 0.054 17,929 2,184

Change from the 

Baseline, Future 

Cycles

0.000 204 0.000 1,295 0.000 854 104

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

Table 5-6 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates no change in cost for the first reporting cycle and a cost increase of 

approximately $10,800 in future reporting cycles.
5-6

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

Whether a Manufacturer is Subject to IUR Reporting Requirements

Cost to 

Process 

Part I 

Submission 

(2008$)

Number 

of Sites

Cost to 

Process 

Part II 

(2008$ 

per 

report)

Number 

of 

Reports

(with 

Part II)

Cost to 

Process 

Part III 

(2008$ per 

report)

Number 

of 

Reports 

with

Part III

Agency 

Burden

(2008$)

(a) (b) (c) (d) (e) (f)

(g) 

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

+(e*f)

First Cycle, 

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

First Cycle, PostAmendment $1.78 4,085 $4.40 25,896 $5.61 17,075 $216,949

Change from the 

Baseline, First 

Cycle

0.000 0 0.000 0 0.000 0 0

Future Cycle 

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

Future Cycle, 

Post-Amendment $1.78 4,289 $4.40 27,191 $5.61 17,929 $227,796

Change from the 

Baseline, Future 

Cycles

$0.00 204 $0.00 1,295 $0.00 854 $10,847

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

5.4.4 Replace the 300,000 lb Threshold for Processing and Use Reporting

For the 2012 IUR submission, all submitters of non-excluded chemical substances are 

required to report processing and use information if they manufactured (including imported) 

100,000 lb or more of a chemical substance in 2011. Subsequent to the 2012 reporting cycle, the 

reporting threshold will be 25,000 lb. Replacing 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 the number of Part IIIs submitted will increase by 3,627

reports in the first reporting cycle and by 8,203 reports in future reporting cycles (see Section 

4.4.4 for more information). 

Table 5-7 shows the estimated Agency burden of the amendment, using the baseline burden 

estimates found in Table 5-4. The Agency expects a burden increase of 195 hours in the first 

reporting cycle and 441 hours in subsequent reporting cycles as a result of this amendment.
5-7

Table 5-7: Change in Agency Burden as a Result of Replacing the 300,000 lb Threshold 

for Processing and Use Reporting

Burden to Process 

Part III 

(hours per report)

Number of 

Reports with 

Part III

Agency Burden

(hours)

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

First Cycle, Baseline 0.05 17,075 919

First Cycle, Post-Amendment 0.05 20,702 1,114

Change from the Baseline, First 

Cycle

0 3,627 195

Future Cycle, Baseline 0.05 17,075 919

Future Cycle, Post-Amendment 0.05 25,278 1,360

Change from the Baseline, Future 

Cycles 0 8,203 441

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

Table 5-8 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $20,400 in the first reporting cycle and by 

$46,000 in future reporting cycles.

Table 5-8: Change in Agency Cost as a Result of Replacing 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)

First Cycle, Baseline $5.61 17,075 $95,835 

First Cycle, Post-Amendment $5.61 20,702 $116,192 

Change from the Baseline, First 

Cycle 0.00 3,627 $20,357 

Future Cycle, Baseline $5.61 17,075 $95,835

Future Cycle, Post-Amendment $5.61 25,278 $141,876

Change from the Baseline, Future 

Cycles $0.00 8,203 $46,040

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

5.4.5 Reduce the 25,000 lb Threshold for Specific Regulated Chemical 

Substances

Beginning with the 2016 reporting cycle, EPA is reducing the 25,000 lb reporting threshold

to 2,500 lb for chemical substances that are: (1) the subject of a regulation 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 chemical substances would 

be required to report under the IUR rule, regardless of the production volume.
5-8

Approximately 902 chemical substances fall into these categories and are expected to have a 

production volume above 2,500 lb (EPA, 2006a)5. Because the amendment would affect only 

chemical substances subject to a promulgated rule, this figure is an overestimate. EPA estimated 

these chemical substances will generate a total of 3,609 additional reports (see Section 4.4.5 for 

more details).

Table 5-9 shows the estimated Agency burden of the amendment, using the baseline burden 

estimates found in Table 5-4. The Agency expects a burden increase of 152 hours as a result of 

the lowering of the 25,000 lb threshold for certain regulated chemical substances to 2,500 lb

beginning with the 2016 reporting cycle.

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

Specific Regulated Chemical Substances (Future Cycles Only)

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

Future Cycle, Post-Amendment 0.04 29,505 1,244

Change from the Baseline, Future 

Cycles 0 3,609 152

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

Table 5-10 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $15,900 beginning with the 2016 reporting 

cycle.

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

Specific Regulated Chemical Substances (Future Cycles Only)

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

Future Cycle, Post-Amendment $4.40 29,505 $129,721

Change from the Baseline, Future 

Cycles $0.00 3,609 $15,868

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

 

5 There are two chemicals subject of an order issued under section 5(f) of TSCA that would be subject to the reduced 

threshold that have not been included in the development of estimates in this section of the Economic Analysis, 

however, the overall estimates of costs and burdens for this requirement are not expected to be significantly affected.
5-9

5.4.6 Make Chemical Substances Subject to Enforceable Consent Agreements 

(ECAs) Ineligible for Exemptions

The Agency is making all chemical substances subject to enforceable consent agreements 

ineligible for exemptions. A total of four chemical substances 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 chemical substances for the first time in the next submission period.

Table 5-11 shows the estimated Agency burden of the 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.

Table 5-11: Change in Agency Burden as a Result of Making Chemical Substances 

Subject to ECAs Ineligible for Exemptions

Burden to Process 

Part III

(hours per report)

Number of 

Reports

Agency Burden 

(hours)

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

Baseline 0.05 17,075 919

Post-Amendment 0.05 17,091 920

Change from the Baseline 0 16 1

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

Table 5-12 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $90.

Table 5-12: Change in Agency Cost as a Result of Making Chemical Substances Subject 

to ECAs Ineligible for Exemptions

Cost to Process 

Part III 

(2008$ per report)

Number of 

Reports

Agency Cost

(2008$)

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

Baseline $5.61 17,075 $95,835

Post-Amendment $5.61 17,091 $97,925

Change from the Baseline $0.00 16 $90

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

5.4.7 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 granting a full exemption for manufactured water. Thus, the burden 

reduction for this 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 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.
5-10

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 amendment. The 

Agency estimates a cost savings of approximately $190.

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

Water

Cost to Process

Part II 

(2008$ per report)

Number of 

Reports 

Agency Cost 

(2008$)

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

Baseline $4.40 25,896 $113,853

Post-Amendment $4.40 25,853 $113,664

Change from the Baseline $0.00 -43 -$189

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

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

EPA is amending the list of partially exempt chemical substances 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 

requiring the company name to be the ultimate domestic parent name. EPA assumes no 

additional Agency burden for processing the ultimate domestic parent name, compared to the 

current IUR reporting requirement of the parent company name.

5.4.10 Technical Contact

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

submission. EPA is amending the IUR rule to require the technical contact to be a person who 

works at the site and is knowledgeable about the chemical substance. EPA assumes no additional 

Agency burden to process the technical contact regardless of the location of the contact.
5-11

5.4.11 Chemical Identity

EPA is requiring reporting of the Chemical Abstracts (CA) Index Name currently used to list the 

substance on the TSCA Inventory as the chemical name reported for IUR. Currently, submitters are 

required to report a specific chemical name, with no further elaboration in the regulatory text. For the 

2011 submission period, the reporting software will be directly linked to the non-confidential portion of 

the TSCA Inventory through the Agency’s Substance Registry System (SRS) database. Therefore, 

submitters will be required to select the correct CA Index Name for their reportable chemical substance(s) 

from SRS. 

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

case of importers, a trade name, in those instances where a supplier will not disclose to the submitter the 

specific chemical name of the imported TSCA Inventory substance or a reactant used to manufacture the 

Inventory substance. In these cases, the manufacturer (including importer) and the supplier report the 

information required in this part in a joint submission.

For the chemical identifying number, EPA is requiring reporting of only the CASRN (for the public 

Inventory), or in the case of confidential chemical substances, the TSCA accession number. In addition, 

EPA is removing 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 known 

already to the submitter.

EPA assumes no additional Agency burden to process either a CA Index Name compared to 

an alternative chemical name, or a request for an accession number compared to a CASRN for a 

chemical identifying number, and so is not adding any burden to the baseline Agency burden and 

cost estimates for chemical identity. However, there may be an increase in accession number

requests because some submitters may not know their accession number or PMN number. The 

number of 2006 reports with CAS numbers claimed as CBI was used as a proxy for the number 

letters submitted to EPA; a total of 343 reports was estimated (EPA, 2010b). The Agency burden 

to process an accession number request is 0.5 hours per request, based on EPA’s best

professional judgment of the time needed to process a request and mail the accession number

back to the company. Table 5-15 shows the change in Agency burden as a result of processing 

accession number requests. EPA estimates a burden increase of 170 hours in the first reporting 

cycle. No change in burden is expected in future reporting cycles (see Section 4.4.11).

Table 5-15: Change in Agency Burden as a Result of Accession Number Requests

Burden per Request

(hours)

Number of 

Requests 

Agency Burden

(hours)

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

Baseline 0 0 0.0

Post-Amendment 0.5 343 171.5

Change from the Baseline 0.5 343 171.5

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

Table 5-16 shows the change in Agency cost as a result of accession number requests. EPA 

estimates a cost increase of $11,528 in the first reporting cycle.
5-12

Table 5-16: Change in Agency Cost as a Result of Accession Number Requests

Cost per Request

($)

Number of 

Requests 

Agency Cost

($)

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

Baseline $0 0 $0.00

Post-Amendment $33.61 343 $11,528

Change from the Baseline $33.61 343 $11,528

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

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

Reporting Year

EPA is requiring reporting of a chemical substance’s production volume manufactured in

2010 and 2011 for the first reporting cycle and each of the four years since the last IUR principal 

reporting year for subsequent reporting cycles, beginning with the 2016 reporting cycle. This 

amendment will result in one additional data item for EPA to process in Part II of Form U in the 

first reporting cycle, adding approximately 0.06 minutes (0.001 hours) of processing burden per 

form. In future reporting cycles, the Agency burden is expected to increase by 0.003 hours or 

0.16 minutes (see Table 5-4).

Table 5-17 shows the estimated Agency burden of the amendment, using the baseline burden 

estimates found in Table 5-4. The Agency estimates a burden increase of 23 hours in the first 

reporting cycle and 70 hours in future reporting cycles as a result of this amendment.

Table 5-17: 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)

First Cycle, Baseline 0.001 25,896 23

First Cycle, Post-Amendment 0.002 25,896 46

Change from the Baseline, First Cycle 0.001 0 23

Future Cycle, Baseline 0.001 25,896 23

Future Cycle, Post-Amendment 0.004 25,896 93

Change from the Baseline, Future Cycles 0.003 0 70

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 amendment. The 

Agency estimates a cost increase of approximately $2,400 in the first reporting cycle, and $7,200

in future reporting cycles.
5-13

Table 5-18: 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)

First Cycle, Baseline $0.09 25,896 $2,422

First Cycle, Post-Amendment $0.19 25,896 $4,845

Change from the Baseline, First Cycle $0.09 0 $2,422

Future Cycle, Baseline $0.09 25,896 $2,422

Future Cycle, Post-Amendment $0.37 25,896 $9,690

Change from the Baseline, Future Cycles $0.28 0 $7,267

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

5.4.13 Volume of Chemical Substance Used On-Site

Under the current IUR requirements, submitters who manufacture a chemical substance

exclusively for on-site use are required to indicate this on Form U. The Agency is requiring 

submitters to report both production volumes used on- and off-site. EPA expects there will be a 

slight increase in the number of submitters who will report product volume used on-site; about 

19.4 percent of all submitters will report the volume used on-site (see Section 5.4.13 for more 

information).

Table 5-19 shows the estimated Agency burden of the 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.

Table 5-19: Change in Agency Burden as a Result of Reporting of Production Volume 

Used On-Site

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 5-20 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $470.
5-14

Table 5-20: 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 an Imported Chemical Substance Is Physically at the 

Reporting Site

EPA is requiring submitters to indicate whether an imported chemical substance is physically 

at the reporting site. This will add one data element for EPA to process.

Table 5-21 shows the estimated Agency burden of the 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 Indicating Whether an Imported 

Chemical Substance is Physically at the Reporting Site

Burden to Process 

Information 

(hours per report)

Number of Reports Agency Burden 

(hours)

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

Baseline 0.042 25,896 1,092

Post-Amendment 0.043 25,896 1,115

Change from the 

Baseline 0.001 0 23

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

Table 5-22 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $2,400.

Table 5-22: Change in Agency Cost as a Result of Indicating Whether an Imported 

Chemical Substance is Physically at the Reporting 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.
5-15

5.4.15 Report Production Volume Exported

EPA is requiring all submitters to provide the exported chemical substance volume in Section 

II of the report. This will add one data element to Part II of Form U for EPA to process.

Table 5-23 shows the estimated Agency burden of the 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 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 5-24 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $2,400.

Table 5-24: Change in Agency Cost as a Result of Requiring the Reporting of Export 

Volume

Cost to Process 

Information

(2008$ per report)

Number of Reports Agency Cost 

(2008$)

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

Baseline $4.40 25,896 $113,853

Post-Amendment $4.49 25,896 $116,275

Change from the 

Baseline $0.09 0 $2,422

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

5.4.16 Identify Whether Chemical Substance is to be Recycled, Remanufactured,

Reprocessed, or Reused 

EPA is revising Form U for submitters to indicate whether a chemical substance is to be 

recycled, remanufactured, reprocessed, or reused. This will add one data element to Part II of 

Form U for EPA to process.

Table 5-25 shows the estimated Agency burden of the 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.
5-16

Table 5-25: Change in Agency Burden as a Result of Indicating Whether Chemical 

Substance is to be Recycled, Remanufacture, Reprocessed, or Reused

Burden to Process a Checkbox to 

Indicate Whether a Product is 

Recycled, Remanufactured, 

Reprocessed, or Reused

(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 5-26 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $2,400.

Table 5-26: Change in Agency Cost as a Result of Indicating Whether Chemical 

Substance is to be Recycled, Remanufactured, Reprocessed, or Reused

Cost to Process a Checkbox to

Indicate Whether a Product is 

Recycled, Remanufactured, 

Reprocessed, or Reused

(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 amending the ranges used to report chemical substance 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 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 new 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).
5-17

Table 5-27 shows the estimated Agency burden of the 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 5-27: 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 5-28 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $56.

Table 5-28: Change in Agency Cost as a Result of Revising the Industrial Function 

Categories

Cost to 

Process 

Industrial 

Function 

Categories

(2008$ per 

report)

Number of 

Reports with 

Industrial 

Function 

Categories

Cost to Process 

Write-in Text 

for "Other" 

(2008$)

Number of 

Reports with 

Text 

Descriptor for 

"Other"

Cost 

(2008$)

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

(c*d)

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

Post-Amendment $5.61 17,075 $0.09 603 $95,892

Change from the 

Baseline $0.00 0 $0.09 603 $56

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

5.4.19 Replace NAICS Codes with Industrial Sectors

EPA is replacing the five-digit North American Industrial Classification System (NAICS) 

codes with 48 Industrial Sectors. This amendment will not change the Agency’s data processing 

burden. EPA expects the Agency’s burden to process the industrial sectors will remain the same 

regardless of the code system used.

5.4.20 Revise Consumer and Commercial Product Categories

The Agency is revising 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 
5-18

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 data element to Part III of Form U 

for EPA to process.

Table 5-29 shows the estimated Agency burden of the 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 5-29: 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 

post-amendment value.

Table 5-30 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $56.

Table 5-30: Change in Agency Cost as a Result of Revising the Consumer and 

Commercial Product Categories

Cost to Process 

Consumer or 

Commercial

Product 

Categories

(hours per 

report)

Number of 

Reports with 

Consumer or 

Commercial 

Product 

Categories

Cost to Writein Text for 

"Other" 

(2008$)

Number of 

Reports with 

Write-in 

Text for 

"Other" 

Cost 

(2008$)

(a) (b) (c) (d)

(e) = (a)*(b)+ 

(c)*(d)

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

Post-Amendment $5.61 17,075 $0.09 604 $95,892

Change from the 

Baseline $0.00 0 $0.09 604 $56

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

post-amendment value.
5-19

5.4.21 Designation of Consumer or Commercial Use

EPA is requiring 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 5-31 shows the estimated Agency burden of the 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 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 5-32 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $1,600.

Table 5-32: Change in Agency Cost as a Result of Designation of Consumer or 

Commercial Use

Cost per Report 

(2008$)

Number of Reports

with Part III

Cost 

(2008$)

Baseline $5.61 17,075 $95,835

Post-Amendment $5.71 17,075 $97,433

Change from the 

Baseline $0.09 0 $1,597

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

5.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed

EPA is requiring submitters of reports with processing and use information to provide the 

number of commercial workers who are reasonably likely to be exposed to a chemical substance, 

in ranges. This amendment adds one data element to Part III of Form U for EPA to process.

Table 5-33 shows the estimated Agency burden of the 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 5-33: 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
5-20

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 amendment. The 

Agency estimates a cost increase of approximately $1,600.

Table 5-34: 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 eliminating the “not readily obtainable (NRO)” standard and replacing it with the 

more stringent “known to or reasonably ascertainable by” standard for reporting of processing 

and use information. This amendment does not affect the number of submitters or the number of 

data elements in Form U, and therefore, EPA assumes it will not increase the Agency burden or 

cost.

5.4.24 Chemical Identity CBI Claims

EPA is proposing, when a submitter asserts a claim of confidentiality for the chemical 

identity of a substance listed on the public portion of the Master Inventory File, the Agency may 

make the information available to the public without further notice to the submitter. See the 

regulatory text at 40 CFR 711.30(e). Any such action on EPA’s part would be as part of regular 

and routine use of the data and will not create any additional burden.

5.4.25 Upfront Substantiation for Processing and Use Information CBI Claims

EPA is requiring 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 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 5-35 shows the estimated Agency burden of the 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 5-35: 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 

Number of 

Reports with 

Substantiated 

Burden 

(hours)
5-21

for CBI Claims 

in Part III

CBI Claims

in Part III

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 5-36shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost increase of approximately $822.

Table 5-36: 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 no longer allowing CBI claims for data elements identified as “not known or 

reasonably ascertainable.” EPA expects there will be no change in Agency burden as a result of 

this amendment because the number of submitters and data elements will not change.

5.4.27 Require Electronic Submissions over the Internet

EPA is requiring all Form Us to be submitted to the Agency electronically, via e-IURweb 

and EPA’s Central Data Exchange (CDX) over the Internet. EPA expects 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 benefits of the CDX system, EPA’s processing burden is expected to decrease 

by 88.6 percent, not including the operating and maintenance and troubleshooting costs included 

in the general CDX operating budget.

Table 5-37 shows the estimated Agency burden of the amendment, using the baseline burden 

estimates found in Table 5-4. The Agency estimates a burden decrease of approximately 1,800 

hours as a result of this amendment.
5-22

Table 5-37: 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 5-38 shows the estimated change in cost to EPA as a result of the amendment. The 

Agency estimates a cost savings of approximately $192,200.

Table 5-38: 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-IURweb Reporting Software

EPA developed the e-IUR reporting software for use by manufacturers (including importers)

in preparing and submitting reports electronically during the 2006 IUR reporting cycle. For the 

2012 submission period, EPA will provide a free, web-based application in place of the 2006 

downloadable software. The updated e-IURweb reporting tool for the 2012 IUR collection will

feature several improved capabilities over the current e-IUR reporting tool. Although not 

quantified here, EPA expects updated e-IURweb tool will reduce Agency burden to process and 

correct errors in the form. 

5.4.29 Electronic Signature Process

In order to submit IUR data electronically to EPA via the Central Data Exchange (CDX), 

individuals acting on behalf of the submitter must first register with CDX. To register in CDX, 

the CDX registrant (also referred to as “Electronic Signature Holder”) downloads two forms: the 

Electronic Signature Agreement and the Verification by Company 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 
5-23

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 2012 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 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 $46,700 during the 2012 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 substance. Under the 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 the use of the 

reporting tool will help to make joint IUR reporting easier for industry. Although not quantified, EPA 

also anticipates the electronic reporting tool will streamline EPA’s processing of the IUR information 

submitted in the 2012 reporting cycle, thus reducing Agency burden.

5.4.31 Modify Reporting Frequency

EPA is modifying 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 5-39 contains the change in 

burden over a 26-year period. In total, EPA estimates the Agency will spend 4,160 more hours 

over a 26-year period as a result of modifying the IUR reporting frequency.
5-24

Table 5-39: Change in Agency Burden as a Result of Modifying the Reporting Frequency

Reporting Cycle1 Year(s) Baseline Burden Post-Amendment 

Burden

Change in 

Burden

(Hours) (Hours) (Hours)

1 2006 to 2012 4,160 4,160 0

2

2013 to 2017 4,160 --

0

2013 to 2016 -- 4,160

3

2018 to 2022 4,160 --

0

2017 to 2020 -- 4,160

4

2023 to 2027 4,160 --

0

2021 to 2024 -- 4,160

5 2028 to 2032 4,160 --

0

2025 to 2028 -- 4,160

6 2029 to 2032 -- 4,160 4160

Total 20,800 24,960 4,160

Annual Average 800 960 160

Note: 1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are four-year cycles

Table 5-40 contains the 26-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 it will 

cost the Agency approximately $466,100 to increase the frequency of reporting from a five-year

reporting cycle to a four- year reporting cycle over a 26-year period. EPA estimates the 

annualized changes in cost would be $16,463 and $14,285 with a three percent and seven percent 

discount rate, respectively.

Table 5-40: Change in Agency Cost as a Result of Modifying the Reporting Frequency

Reporting Cycle Year(s) Baseline Cost Post-Amendment 

Cost Change in Cost

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

1 2006 to 2012 $466,132.9 $466,132.9 $0.0

2

2013 to 2017 $466,132.9 -- $0.0

2013 to 2016 -- $466,132.9

3

2018 to 2022 $466,132.9 --

$0.0

2017 to 2020 -- $466,132.9

4

2023 to 2027 $466,132.9 -- $0.0

2021 to 2024 -- $466,132.9

5

2028 to 2032 $466,132.9 -- $0.0

2025 to 2028 -- $466,132.9

6 2029 to 2032 -- $466,132.9 $466,132.9

Total $2,330,664 $2,796,797 $466,133

Annualized @ 3% $83,030 $99,493 $16,463

Annualized @ 7% $74,650 $88,935 $14,285

Note: The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are four-year cycles
5-25

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 amendment, but had to consider the interactions 

among the amendments. For a more detailed discussion of the interactions among the 

amendments, see Section 4.5. In the 2012 reporting cycle the Agency will also experience 

additional burden of accession number requests (see Section 5.4.11). The Agency will have to 

process electronic signature agreements (see Section 5.4.29) in both the 2012 and subsequent 

reporting cycles. However, in reporting cycles following the 2012 reporting cycle, EPA will only 

need to process electronic signature agreements from new sites, or approximately 5 percent of all 

sites. As shown in Table 5-37, EPA expects the electronic submission amendment will decrease 

Agency burden of processing a Form U by approximately 88.6 percent.
5-26

Table 5-41: Change in Agency Burden as a Result of All the IUR Modifications (First 

Reporting Cycle) 

Table 5-42: Change in Agency Burden as a Result of All the IUR Modifications (Future 

Reporting Cycles) 

To calculate the combined effect on Agency costs when all amendments are 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 

Option

Burden per 

Part I of 

Report

(hours)

Burden per 

Part II of 

Report

(hours)

Burden per 

Part III of 

Report

(hours)

Baseline 0.0170 0.0422 0.0538

Production Volume Used On-Site -- 0.0002 --

Industrial Function Categories -- -- 0.00003

Recycled, Remanufactured, Reprocessed, or Reused, -- 0.0009 --

Whether Chemical Substance is Physically at Site -- 0.0009 --

Exported Volume Reporting -- 0.0009 --

Consumer/Commercial Product Categories -- -- 0.00003

Number of Workers Exposed -- -- 0.0009

CBI -- -- 0.0005

Production Volume in Off-Years -- 0.0009 --

Electronic Submission -0.0151 -0.0407 -0.0489

Ascension Number Requests (First Reporting Cycle) - 0.0058

Electronic Signature Agreements 0.1700 -

Total Change from the Baseline with All Amendments 0.1549 -0.0311 -0.0475

Total, All Amendments 0.1719 0.0111 0.0063

Option

Burden per 

Part I of 

Report

(hours)

Burden per 

Part II of 

Report

(hours)

Burden per Part 

III of Report

(hours)

Baseline 0.0170 0.0422 0.0538 

Production Volume Used On-Site -- 0.0002 --

Industrial Function Categories -- -- 0.00003 

Recycled, Remanufactured, Reprocessed, or Reused, -- 0.0009 --

Whether Chemical substance is Physically at Site -- 0.0009 --

Exported Volume Reporting -- 0.0009 --

Consumer/Commercial Product Categories -- -- 0.00003

Number of Workers Exposed -- -- 0.0009 

CBI -- -- 0.0005 

Production Volume in Off-Years -- 0.0027 --

Electronic Submission -0.0151 -0.0423 -0.0489

Electronic Signature Agreements 0.0081 -- --

Total Change from the Baseline with All Amendment -0.0070 -0.0367 -0.0475

Total, All Amendments 0.0100 0.0054 0.0063
5-27

number of reports due to the effect of the amendments combined is calculated in Table 4-48 and 

Table 4-49 for the first and future reporting cycles, respectively. EPA added the cost of one 

additional FTE (2,080 hours) to the baseline hours to account for the additional activities 

conducted by the GS-13 employee (see Table 5-3) and all extramural costs not related to data 

entry (see Table 5-2). 

Table 5-43 presents the total Agency burden for all the amendments combined. In total, EPA

estimates the Agency will save 940 hours during the first reporting cycle and 1,678 hours in each future 

reporting cycle. Table 5-44 presents the total Agency cost estimates; the Agency will save approximately 

$68,000 in the first reporting cycle and $175,000 in future reporting cycles as a result of the IUR 

amendments. The baseline and post-amendment costs both contain the cost of all extramural activities, 

found in Table 5-2. 

Table 5-43: 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)1,2

First-year 

Baseline 0.017 4,085 0.042 25,896 0.05381 17,075 4,160

First year, 

Post 

Amendment

0.1719 4,085 0.012 25,853 0.00631 20,718 3,220

Change 

from the 

Baseline, 

First year3

0.15 0 -0.030 -43 -0.05 3,643 -940

Futurecycle 

Baseline

0.017 4,085 0.042 25,896 0.054 17,075 4,160

Futurecycle, Post 

Amendment

0.01 4,289 0.005 30,935 0.01 30,287 2,482

Change 

from the 

Baseline, 

Future 

cycles3

-0.01 204 -0.04 5,039 -0.05 13,212 -1,678

Notes: 

1 Totals include an additional 2,080 hours to account for additional Agency activities conducted one GS-13 employee.

2 Total may not sum due to rounding.

3 Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
5-28

Table 5-44: Total Agency Cost of All Amendments Combined

Cost per 

Report 

(Part I) 

(2008$)

Number 

of Sites

Cost to 

Process 

Part II 

(2008$)

Number of 

Reports 

(with

Part II)

Cost to 

Process

Part III 

(2008$)

Number of 

Reports 

(with 

Part III)

Agency Cost 

(2008$)

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

(c d)+(e f)

First-year 

Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133

First year, 

Post 

Amendment $11.63 4,085 $3.38 25,853 $0.70 20,718 $398,571

Change 

from the 

Baseline, 

First year3$9.85 0 -$1.02 -43 -$4.91 3,643 -$67,562

Futurecycle 

Baseline

$1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133

Futurecycle, Post 

Amendment

$0.75 4,289 $0.58 30,935 $0.70 30,287 $291,515

Change 

from the 

Baseline, 

Future 

cycles3

-$1.03 204 -$3.82 5,039 -$4.91 13,212 -$174,618

Notes: 

1 Totals include an additional $149,387 to account for additional Agency activities conducted one GS-13 employee and contactor 

staff.

2 Total may not sum due to rounding.

3 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 report, EPA first 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 revised Form U (166 elements in the first reporting cycle) 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, the revised Part I contains 24 data elements, 

and 4,085 sites are expected to submit Part I when all the amendments are considered. These 

114,380 data elements (28 x 4,085 = 114,380) account for approximately 2.9 percent of all data 

elements. Similarly, 49.1percent of all data elements are in Part II of the form, and 47.9 percent 

are in Part III. The Agency then multiplied the total variable burden of Form U processing, 274

hours, by the percentage of data elements in a section and divided by the total number reports 

submitted for each section. The total burden per data element does not account for the burden 

associated with processing electronic signature forms or accession number requests, because 

these are not data elements on the Form U. To calculate the total variable burden to the Agency, 

EPA took the total burden estimate of 3,220 hours (Table 5-43) and subtracted the fixed burden 

of 2,080 hours, the burden associated with processing electronic signature agreements, 695.5 
5-29

hours (Section 5.4.29) and the burden associated with accession number request 171.5 hours 

(Table 5-15). An example of this calculation can be seen in Equation 3 for Part I.

Equation 3: Burden to Process Part I per Report = (274 hours x 0.03239) / 4,085 = 0.002 hours

The burden per section was then divided by the total number of data items in that section to 

calculate the burden per item, 0.00008 hours (approximately 0.0049 minutes) (See Equation 2). 

Equation 4: Burden per Data Element = 0.002 hours / 24 = 0.00008 hours

EPA then added the burden for processing electronic signature forms and ascension number 

requests, which were not included in the per data element burden. EPA added the burden per 

report for both activities from Table 5-43 to calculate the total burden per-report. Therefore for 

section one, the per report burden of processing electronic signatures (0.17 hours) was added to 

the total burden of processing all data elements in the section (0.002 hours) to calculate the total 

burden per report.

Equation 5: Burden per Report Section = (0.00008 hours x 24 data elements) + 0.17 hours = 

0.1720 hours

Table 5-45 contains the total post-amendment burden to the Agency at the per-report and perdata element level. Because of the electronic submission, the Agency burden increase by 0.77 

hours per full report in both the first reporting cycles and decreases by 0.091 hours in future 

reporting cycles despite 43 data elements being added to Form U in the second cycle.
5-30

Table 5-45: Agency Burden per Report when All Amendments are Combined (First Cycle)

Form U 

Section

Number of Data Elements

Burden per Data Element

Burden for Processing Other 

Submissions Related to IUR 

Reporting

Total Burden per Report

(hours) (hours) (hours)

Baseline PostAmendment

Change

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baselin

e

Part I 19 24 5 0.0009 0.00008 -0.0008 0.0000 0.1700 0.1700 0.017 0.1720 0.155

Part II 47 64 17 0.0009 0.00008 -0.0008 0.0000 0.0066 0.0066 0.042 0.0118 -0.030

Part III 60 78 18 0.0009 0.00008 -0.0008 0.0000 0.0000 0.0000 0.054 0.0063 -0.047

Total 

(Full 

Report)

126 166 40 - - - - - - 0.113 0.190 0.077

Note: Totals may not exactly match totals presented in Table 5-43 due to rounding

Table 5-46: Agency Burden per Report when All Amendments are Combined (Future Cycles)

Form 

U 

Section

Number of Data Elements

Burden per Data Element

Burden for Processing Other 

Submissions Related to IUR 

Reporting

Total Burden per Report

(hours) (hours) (hours)

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Part I 19 24 5 0.0009 0.00008 -0.0008 0.0000 0.0081 0.0081 0.017 0.0100 -0.007

Part II 47 67 20 0.0009 0.00008 -0.0008 0.0000 0.0000 0.0000 0.042 0.0054 -0.037

Part III 60 78 18 0.0009 0.00008 -0.0008 0.0000 0.0000 0.0000 0.054 0.0063 -0.047

Total 

(Full 

Report)

126 169 43 - - - - - - 0.113 0.022 -0.091

Note: Totals may not exactly match totals presented in Table 5-43 due to rounding
5-31

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, document receipt, 

tracking, data entry processing electronic signature forms and ascension number requests which was 

$31,691. This cost was calculated by subtracting the fixed Agency costs, $249,184 (see Table 5-3), 

processing electronic signature forms $46,681 (Section 5.4.29) and the cost associated with ascension 

number requests $11,528 (Table 5-16) from the total post-amendment cost of $ 398,571. Thus, EPA 

calculated it costs the Agency approximately $0.01 to process a single data element of Form U. The total

Agency cost per report is approximately $15.72 in the first reporting cycle and $2.03 in all future cycles. 

Table 5-47 and Table 5-48 contain the Agency cost per report by section of Form U for the first and 

future reporting cycles. 
5-32

Table 5-47: Agency Cost per Report When All Amendments are Combined (First Reporting Cycle)

Form 

U 

Section

Number of Data Elements

Cost per Data Element Cost for Processing Other 

Submissions Related to IUR 

Reporting

Total Cost per Report

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

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Part I 19 24 5 $0.09 $0.01 -$0.08 $0.00 $11.43 $11.43 $1.71 $11.64 $9.93

Part II 47 64 17 $0.09 $0.01 -$0.08 $0.00 $2.82 $2.82 $4.23 $3.39 -$0.84

Part 

III 60 78 18 $0.09 $0.01 -$0.08 $0.00 $0.00 $0.00 $5.40 $0.69 -$4.71

Total 

(Full 

Report

)

126 166 40 - - $11.34 $15.72 $4.38

Note: Totals may not exactly match totals presented in Table 5-44 due to rounding

Table 5-48: Agency Cost per Report When All Amendments are Combined (Future Reporting Cycles)

Form 

U 

Section

Number of Data Elements

Cost per Data Element Cost for Processing Other 

Submissions Related to IUR 

Reporting

Total Cost per Report

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

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Baseline PostAmendment

Change 

from 

Baseline

Part I 19 24 5 $0.09 $0.01 -$0.08 $0.00 $0.54 $0.54 $1.71 $0.76 -$0.95

Part II 47 67 20 $0.09 $0.01 -$0.08 $0.00 $0.00 $0.00 $4.23 $0.59 -$3.64

Part III 60 78 18 $0.09 $0.01 -$0.08 $0.00 $0.00 $0.00 $5.40 $0.69 -$4.71

Total 

(Full 

Report)

126 169 43 - - $11.34 $2.03 -$9.31

Note: Totals may not exactly match totals presented in Table 5-44 due to rounding
5-0

Table 5-49 contains Agency costs per-data element and per-report separated by EPA and contractor 

staff. Using the values in Table 5-3, EPA estimates in the baseline, approximately 56.4 percent of the 

variable Agency costs are attributed to EPA 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 per-data element costs between Agency and contractor staff to change as a result of the 

rule. Thus, to calculate the post-amendment cost attributed to contractor staff, EPA multiplied the perdata element cost by 43.6 percent. All processing of electronic signature forms, and the processing of 

accession number requests is expected to be conducted by Agency staff. Therefore, the per-report costs of 

processing submissions related to IUR reporting was added to the Agency staff total. The cost to contract 

staff is approximately $0.64 in the first reporting cycle and $0.65 in future reporting cycles per report. 

The EPA staff cost is approximately $15.08 in the first reporting cycle and $1.38 in future reporting 

cycles. 

Table 5-49: Agency Cost per Report when All Amendments are Combined

Form U Section

Cost per Data Element

(2008$)

Total Cost per Report 

(2008$)

1

Agency 

Staff

Cost

Contractor 

Cost 

Total PostAmendment 

Cost 

Agency 

Staff

Cost

Contractor 

Cost 

Total PostAmendment 

Cost 

Part I $0.005 $0.004 $0.009 $11.55 $0.09 $11.64 

Part II $0.005 $0.004 $0.009 $3.14 $0.25 $3.39 

Part III $0.005 $0.004 $0.009 $0.39 $0.30 $0.69 

Total (Full Report) - - - $15.08 $0.64 $15.72 

Part I

(Future Cycles) $0.005 $0.004 $0.009 $0.66 $0.09 $0.76 

Part II

(Future Cycles) $0.005 $0.004 $0.009 $0.33 $0.26 $0.59 

Part III

(Future Cycles) $0.005 $0.004 $0.009 $0.39 $0.30 $0.69 

Total 

(Future Cycles)

(Full Report)

- - - $1.38 $0.65 $2.03 

1 Note: Totals may not sum due to rounding.
5-1

5.6 Annualized Agency Cost Estimates for All Modifications

Table 5-50 presents the annual Agency burden estimates for data entry and extramural costs

over a 26-year period. The annual baseline Agency burden is equivalent to two FTEs, or 4,160 

hours. The post-amendment Agency burden is calculated in Table 5-43, and an FTE is added to 

account for all the GS-13 level tasks (see Table 5-3), which are not affected by any of the 

amendments. In total, EPA estimates the Agency burden for the IUR rule will be reduced by

5,202 hours over a 26-year period under the IUR amendments.

Table 5-50: Agency Burden over a Period of 26 Years if All Amendments are Implemented

Reporting Cycle1 Year(s)

Baseline Burden Post-Amendment 

Burden Change in Burden

(Hours) (Hours) (Hours)

1 2006 to 2012 4,160 3,220 -940

2

2013 to 2017 4,160 --

-1,678

2013 to 2016 -- 2,482

3

2018 to 2022 4,160 --

-1,678

2017 to 2020 -- 2,482

4

2023 to 2027 4,160 --

-1,678

2021 to 2024 -- 2,482

5

2028 to 2032 4,160 --

-1,678

2025 to 2028 -- 2,482

6 2029 to 2032 -- 2,482 2,448

Total 20,800 15,632 -5,202

Annual Average 800 601 -199

1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are , four-year cycles

To estimate the per-reporting cycle cost of all the amendments over a 26-year period, EPA 

used the total baseline cost estimate in Table 5-3. These costs include the data entry performed 

by both EPA and contractor staff, and all extramural activities conducted by contractor staff.

Under the baseline, EPA estimates the total Agency cost will be $466,100 during each reporting 

cycle. The annualized post-amendment cost also includes all extramural costs from Table 5-2 in 

addition to the data entry and quality control costs.

Table 5-51 contains the annualized cost estimation. In total, annual post-amendment cost will 

be $398,571 during the first reporting cycle and $291,515 thereafter. Over a 26-year period, EPA 

estimates the Agency will save approximately $474,500. Annualized savings are approximately

$15,300 and $12,100, discounted at three percent and seven percent, respectively.
5-2

Table 5-51: Annual and Discounted Total Cost to the Agency of All Modifications

Reporting 

Cycle1 Year(s)

Baseline Cost Post-Amendment 

Cost Change in Cost

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

1 2006 to 2012 $466,133 $398,571 -$67,562

2

2013 to 2017 $466,133 --

-$174,618

2013 to 2016 -- $291,515

3

2018 to 2022 $466,133 --

-$174,618

2017 to 2020 -- $291,515

4

2023 to 2027 $466,133 --

-$174,618

2021 to 2024 -- $291,515

5

2028 to 2032 $466,133 --

-$174,618

2025 to 2028 -- $291,515

6 2029 to 2032 -- $291,515 $291,515

Total $2,330,664 $1,856,146 -$474,519

Annualized @ 3% $80,612 $65,279 -$15,333

Annualized @ 7% $69,767 $57,618 -$12,149

1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are , four-year cycles
6-1

6. Social Cost Summary

To calculate the total burden to society of the IUR amendments, EPA added the total industry 

burden to the Agency burden savings. Table 6-1 contains the annual burden estimates for the 

years 2006 through 2032.

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 the IUR rule amendments would

increase the industry burden in the first reporting cycle by 0.50 million hours (see Table 4-52) 

and decrease Agency burden by 940 hours (see Table 5-43). The net burden increase is 0.49 

million hours.

The burden in future reporting cycles will 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. EPA estimates all of the amendments combined would

increase the burden to society by 7.61 million hours over a 26-year period. This includes a

burden increase of 7.62 million hours to the affected industry over the 26 years (see Table 4-57), 

and a burden decrease of 5,200 hours to the Agency (see Table 5-50) over the same period. 

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

amendments over a 26-year period will be 7.61 million hours.

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

Reporting Cycle Year(s)

Baseline Burden Post-Amendment 

Burden Change in Burden

(millions of hours) (millions of hours) (millions of hours)

1 2006 to 2012 1.85 2.34 0.49

2

2013 to 2017 1.44 0.00 1.14

2013 to 2016 0.00 2.57

3

2018 to 2022 1.44 0.00 1.14

2017 to 2020 0.00 2.57

4

2023 to 2027 1.44 0.00 1.14

2021 to 2024 0.00 2.57

5

2028 to 2032 1.44 0.00 1.14

2025 to 2028 0.00 2.57

6 2029 to 2032 0.00 2.57 2.57

Total 7.60 15.21 7.61

Annual Average 0.29 0.59 0.29

Note: The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are four-year cycle.s

Table 6-2 contains the total cost and change in cost to society as a result of the IUR rule 

amendments. The cost to society is expected to increase by $494.71 million over the 26-year 

period as a result of the IUR amendments. The cost to industry is expected to increase by $495.2

million over this period (see Table 4-58), and the Agency cost is expected to decrease by $
6-2

474,500 (see Table 5-51). The annualized cost to society over a 26-year period is $17.15 million 

and $14.70 million at three percent and seven percent discount rates, respectively.

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

Reporting 

Cycle1 Year(s)

Baseline Cost Post-Amendment 

Cost Change in Cost

(millions of 2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2011 $107.43 $144.13 $36.70

2

2012 to 2016 $83.28 -- $74.95

2012 to 2015 -- $158.23

3

2017 to 2021 $83.28 -- $74.95

2016 to 2019 -- $158.23

4

2022 to 2026 $83.28 -- $74.95

2020 to 2023 -- $158.23

5

2027 to 2031 $83.28 -- $74.95

2024 to 2027 -- $158.23

6 2028 to 2031 -- $158.23 $158.23

Total $440.57 $935.28 $494.71

Annualized @ 3% $15.97 $33.11 $17.15 

Annualized @ 7% $14.70 $29.39 $14.70 

Note1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are four-year cycles
7-1

7. Impact of the Final 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 substance production and use in the United 

States. It is EPA’s most comprehensive source of data on the chemical industry, and IUR data 

are used in almost all of OPPT’s risk screening and management programs. However, the IUR 

data in their current form have numerous limitations, which in turn limit EPA’s 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 promulgating a set of IUR amendments. The amendments would improve the 

completeness and accuracy of the IUR data by requiring electronic reporting using the e-IURweb 

reporting software, expanding the range of chemical substances for which full information would 

be reported, adjusting the specific reported information, increasing the frequency of collecting 

the information, and modifying CBI requirements. EPA expects the amendments will reduce 

many of the current data constraints and, as a result, improve the effectiveness of EPA’s 

chemical substance risk management programs. Most importantly, the IUR rule amendments will 

require submitters to provide processing and use exposure-related information for more chemical 

substances. This additional information will allow EPA to more accurately assess human and 

environmental exposures to specific chemical substances, including the concentrations, 

frequency, and durations of these exposures. 

With this additional information, EPA will improve its ability to screen chemical substances 

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 chemical substances. 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, an enhanced 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 will be better able to 

anticipate industry trends, particularly for chemical substances for which EPA has concerns, and 

to measure the effectiveness of Agency programs.

The benefits resulting from the IUR rule amendments are discussed qualitatively in this 

section. Quantification of the benefits of the rule would require more specific information about 

each user’s use patterns and preferences, and the changes in the use patterns and preferences 

which will result from the additional information made available under the 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 the public places on the availability of the information resulting from the

rule. However, such a survey, or a survey to collect similar information, has not been conducted.
7-2

7.1 Benefits of Information-Based Policies

Improvements in the IUR data will allow EPA and others to use the data more effectively as 

part of the Agency’s risk screening and prioritization programs. Screening chemical substances 

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 

substance uses accurately and to predict potential exposures. Current screening activities are 

greatly hampered by the incomplete data supplied through the 2006 IUR. In addition, EPA’s 

current screening activities for medium production volume chemical substances are hampered 

further by the fact EPA has only estimates of production volume for many chemical substances 

and must rely on relatively limited public sources of information. This final rule will benefit 

society by filling these information gaps and contributing to better assessments of potential risks 

and risk management decisions.

The amendments to the IUR rule will increase the amount of publicly available data about a 

chemical substance’s potential risks, and consequently are likely to result in (a) a reduction in the 

costs of risk-based decisions about the chemical substance, 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 rule 

can replace other information-gathering, management, and dissemination activities related to 

the regulated chemical substances. 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 rule increases the efficiency and strength of the decisionmaking 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 chemical substances, public and private decision makers are unable to make 

adequate assessments of the benefits and costs of actions involving these substances. For 

example, EPA decisions regarding whether, when, and how to target chemical substances 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 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 chemical 

substances in commerce that need to be evaluated. As discussed in Chapter 5. EPA will incur

additional costs for collecting and managing the new IUR data; however, by providing more 

reliable and complete data on chemical substance uses and exposures, the rule will also allow 

EPA to save time and resources in screening chemical substances 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 and to move 

more quickly in addressing chemical substances posing relatively high risks (and/or relatively 

low risk-management costs).
7-3

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 accruing from the 

use of the information generated by this final rule are discussed in the following sections.

7.2 Benefits of Individual Amendments

The IUR amendments expand the range of chemical substances 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 amendments also will provide information to 

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

reported data, and ensure data are available in a timely manner. EPA is finalizing 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 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 identified areas where further improvements are 

needed. Several of the amendments described in this rule will change some of the reporting 

requirements in an effort by EPA to increase the usability of the collected information and to 

focus IUR reporting on the information needed most by the Agency. These changes will 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. 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) D-U-N-S® number to identify the company associated with the plant site, and also to report the 

site name, address, and D-U-N-S® 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 requiring the company name provided to 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-U-N-S® 

numbers for parent companies appearing to be the same company. In order to better identify when 

reporting sites are under the same parent company, EPA is including the address as well as the D-U-N-S® 

number of the parent company. Similar to the change in parent company name, this change also will lead 

to more accurate information, which will lead to more accurate risk characterizations and small business 

analyses. 
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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 connected directly to the reporting site, and therefore, are not knowledgeable about 

either the chemical substance or the submission. EPA has also seen situations where the 

technical contact is a contracted employee who is able to address subsequent concerns only as 

long as he or she remains under contract to the company. EPA may raise follow-up questions 

about an IUR submission possibly for years after the submission date. EPA is now allowing 

multiple technical contacts on a chemical substance-by-chemical substance basis, and is no 

longer requiring that the technical contact be located at the manufacturing site. The benefit of 

this amendment will 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 requiring the reporting of the Chemical Abstracts (CA) Index Name currently used to list the 

substance in the TSCA Inventory as the chemical name reported for IUR. Currently, submitters are 

required to report a specific chemical name, with no further elaboration in the regulatory text. EPA has 

found, however, that submitters sometimes supply a name that is somewhat generic or excludes parts of 

the specific chemical identity distinguishing one substance from another. EPA’s experience in the 2006 

IUR was 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 the 

temporary exclusion of the information associated with the poorly or erroneously identified chemical 

substance from the IUR database until the Agency was able to obtain correct and specific chemical 

identity information from the submitter. EPA believes the requirement to use the substance name as 

currently listed on the TSCA Inventory will greatly reduce the number of poorly identified substances. 

Improved chemical identification ultimately leads to more accurate risk characterizations. 

EPA is removing the PMN number as an allowed chemical identifying number because each 

Inventory substance has either (or both) a CASRN (for the public Inventory) or a TSCA accession 

number (for the confidential Inventory), which are likely to be known already to the submitter.

This amendment will save the Agency considerable time and effort to access and review reported 

information that has been identified only by a PMN case number.

Report Production Volume for Each of the Years since the Last 

Principal Reporting Year

EPA is requiring reporting of production volume for each of the years since the last IUR 

principal reporting year in all future reporting cycles, and the reporting of 2011 and 2010 

production volumes for the 2012 reporting cycle. Thus, starting with the 2016 IUR reporting 

cycle, manufacturers (including importers) of a chemical substance at or above the 25,000 lb

threshold in any calendar year in the cycle will be required to report the production volumes for 

all years in the cycle (e.g., 2012, 2013, 2014 and 2015). Collecting the production volume for 

multiple years will provide greater detail than the current “once-every-five-years” snapshot. 
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EPA has mounting evidence that many chemical substances, including larger volume 

chemical substances, are manufactured in volumes that may fluctuate widely from year to year. 

This can result in the production volume of a chemical substance exceeding the threshold for 

several years, then falling below the threshold during the IUR principal reporting year. 

Therefore, EPA believes a single snapshot of annual production volume (i.e., taken just once 

each reporting cycle) does not provide an accurate picture of the chemical substances 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 to 

determine the costs (and financial impacts) of potential control strategies in economic analyses.

Voluntary EPA programs such as Design for the Environment (DfE) and other pollution 

prevention programs will 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, this amendment will provide 

information EPA and others need for the assessment of programs and will provide greater 

accuracy of the volumes of chemical substances in commerce than the current once-every-five 

year snapshot.

Volume of Chemical Substance Used On-Site

EPA is requiring submitters to 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 whether the chemical substance is site-limited. Under this 

final rule, either domestically manufactured or imported chemical substances could be reported 

as used at the reporting site, whereas under the current reporting requirements, only domestically 

manufactured chemical substances, consumed entirely at the site of manufacture, should be 

reported as site-limited.

EPA is changing this requirement 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 substance consumed at the 

manufacturing site. For the 2006 IUR, many submitters continued this practice and erroneously 

filed separate reports to indicate 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 amendment to require reporting the volume used on-site will

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. 
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Indicate Whether Imported Chemical Substances Are Physically at the 

Reporting Site

EPA is adding a requirement to indicate whether an imported chemical substance is 

physically at the reporting site. Often, the site reporting an imported chemical substance never 

physically receives the chemical substance, but instead ships it directly to another location such 

as a warehouse, a processing or use site, or a customer’s site. Identifying whether the chemical 

substance is physically at the reporting site provides more accurate information for screeninglevel analyses and other uses of the IUR data.

Report Volume Exported

EPA is adding a requirement to report the production volume directly exported and not 

domestically processed or used. This amendment will 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 Substance Is To Be Recycled, 

Remanufactured, Reprocessed, or Reused

EPA is adding a requirement to indicate whether a manufactured chemical substance, such as 

a byproduct, is being recycled, remanufactured, reprocessed, or reused. Submitters will identify 

that their manufactured chemical substance, which otherwise would be disposed of as a waste, is 

being removed from the waste stream and is being used for a commercial purpose (i.e., recycled, 

remanufactured, reprocessed, or reused). 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 substance is being recycled, 

remanufactured, reprocessed, or reused and is not entering the waste stream provides valuable 

information to EPA and others regarding trends in chemical manufacturing 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 requiring submitters to designate 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. Designation of consumer or 

commercial use, or both, will allow EPA to complete a better characterization for the potentially 

exposed populations. 

Number of Commercial Workers Reasonably Likely To Be Exposed

EPA is requiring submitters to 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 will 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 will be 

used to characterize the commercial population reasonably likely to be exposed to the subject 
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chemical substance. Therefore, this amendment will improve the population characterization, 

which is important to the development of the overall exposure characterization.

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

Information

EPA anticipates the amendments will result in the Agency receiving more publicly available, nonCBI 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 requiring the mandatory use of EPA’s Central Data Exchange (CDX) through the 

Internet for manufacturers (including importers) to report IUR information. EPA will require all 

submissions to be generated using the e-IURweb reporting software. EPA will no longer accept 

paper submissions or electronic media for any IUR submission after the effective date of the 

final rule.

The amendment to eliminate paper-based submissions in favor of mandatory e-IURweb

reporting will provide several benefits to EPA and industry. EPA expects the required use of eIURweb and CDX will 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 will now be populated electronically, thus reducing the potential for error 

when data are entered by hand or when data are entered through a scanning process. All 

information sent by submitters via CDX will be transmitted securely to protect CBI.EPA will 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 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). For the 2012 submission period, EPA 

will provide a free web-based application in place of the 2006 downloadable software. The 2012 eIURweb will feature several enhancements over the 2006 e-IUR. These improvements include a 

sophisticated validation system, which will 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. The reporting software also will include user-friendly 

features such as drop-down selections, searchable chemical substance lists, imbedded help files, and an 

error-checking process to help identify common reporting errors before the report is submitted. All of 

these applications will increase the accuracy of the data and reduce Agency time spent in manually 

performing these checks.

Coupled with EPA’s e-IURweb 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 IUR reports.
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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 chemical substances, with particular emphasis on protecting children.

The Agency is developing a broader, more vigorous approach on existing chemical substances, 

which will utilize the full range of TSCA regulatory tools to reduce or eliminate risks from 

chemical substances 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 chemical substances. EPA 

needs more in-depth exposure-related information to fine-tune the screening process, and to 

better assess, prioritize, and take action on existing chemical substances. The various programs 

and tools EPA uses to evaluate and manage chemical substance risks are described in Section 

7.3. The amendments will 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 

For the 2012 reporting cycle, reporting for subject chemical substances will be required if the 

production volume in the 2011 principal reporting year only meets or exceeds the 25,000 lb

reporting threshold, which is the current requirement. For the 2016 reporting cycle and future 

reporting cycles, a site will examine its annual production volumes for each of the four calendar 

years since the last principal reporting year. If the production volume for a reportable chemical 

substance is 25,000 lb or greater for any calendar year during that four-year period, then the site 

will need to report the chemical substance, unless it is otherwise exempt.

EPA is changing the determination method because of the mounting evidence many chemical 

substances, even larger volume chemical substances, often experience wide fluctuations in 

manufacturing volume from year to year. This can result in the production volume of chemical 

substance 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 chemical substances 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 chemical substances 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 substance production was revealed in 

the comments the Agency received from the proposed “reset” of the TSCA Inventory. The 

Federal Register notice of November 21, 2008 (73 FR 70460) requested industry provide 

comment on whether a three-year reporting cycle was sufficient for deciding whether a chemical 

substance they manufactured or imported should remain listed on the TSCA Inventory. 

Commenters overwhelmingly expressed concern the proposed three-year reporting cycle would 

drastically misrepresent the chemical substances presently in commerce.(See Docket No:EPAHQ-OPPT-2008-0785.)

In submitted comments, companies agreed unanimously that if they were to report for one 

year only, the reset would inappropriately remove chemical substances from the TSCA 

Inventory. While all commenters felt the three-year reporting cycle was inadequate, a majority of 
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the industry comments suggested reporting should cover a 10-year period. The comments 

strongly indicated there were chemical substances manufactured or imported only occasionally, 

and these chemical substances would not be captured if the reporting covered too short a period.

Therefore, requiring chemical substance manufacturers (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 chemical substances currently in 

commerce and properly the subject of EPA’s risk screening, assessment, and management 

activities.

Replacing the 300,000 lb Threshold for Processing and Use 

Information Reporting

EPA is replacing the 300,000 lb threshold for reporting processing and use information to 

100,000 lb for the 2012 reporting cycle, and replacing the threshold for all subsequent reporting 

cycles. EPA is therefore requiring all submitters of non-excluded substances to report 

information in all parts of the IUR Form U in future reporting cycles. EPA is lowering 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) chemical substances. 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 if the Agency were to find it necessary in the future, it would collect 

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

that action. The IUR processing and use information is needed now to complete the 

characterizations and prioritizations for those chemical substances manufactured (including 

imported) in volumes of 100,000 to 300,000 lb in the first reporting cycle and 25,000 to 300,000 

lb in all future reporting cycles. 

The Agency currently is unable to develop screening level risk evaluations for medium and 

lower production volume chemical substances because most of these chemical substances 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 collecting this information is critical to its mission of characterizing 

exposure, identifying potential risks, and noting uncertainties for these lower production volume 

chemical substances.

Both hazard and exposure information is needed to develop screening level evaluations.

Once the IUR processing and use information is available for these medium and lower volume

chemical substances, EPA will be able to develop the exposure characterizations needed to 

develop the evaluations. As with the high-production volume (HPV) chemical substances, EPA 

will 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, the 

rule will provide this necessary processing and use information for chemical substances 

manufactured or imported in volumes of 25,000 lb to 300,000 lb
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Reduce the 25,000 lb Threshold for Specific Regulated Chemical 

Substances 

In reporting cycles subsequent to the 2012 reporting cycle, EPA is reducing the 25,000 lb

reporting threshold to 2,500 lb for specific regulated chemical substances that are the subject of 

particular TSCA rules and/or orders and to require manufacturers (including importers) of such 

chemical substances to report under the IUR, regardless of the production volume. This 

provision will ensure the availability of current information when EPA has expressed a concern 

in the form of regulatory action on those chemical substances, regardless of the production 

volume. EPA is reducing the 25,000 lb threshold for those chemical substances that are: (1) the 

subject of a rule promulgated under sections 5(a)(2), 5(b)(4), or 6 of TSCA; (2) the subject of an 

order issued under section or 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.

Beginning with reporting cycles subsequent to 2012, manufacturers (including importers) of 

these specific regulated chemical substances will be required to report production volumes each 

year from 2012 to 2015, and the full manufacturing, processing, and use information for 2015, if 

they have production volumes above the 2,500 lb threshold.

Chemical substances 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, this amendment will

enable EPA to use the IUR data associated with these regulated chemical substances to monitor 

chemical substance production and compliance with the rules.

Making Chemical Substances 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. Chemical substances covered by ECAs are of demonstrated interest to EPA.

The Agency has an interest in identifying the manufacturing, processing, and use of substances 

under such agreements, and therefore is requiring such substances to be reported for IUR

purposes, regardless of whether the substance otherwise meets the requirements listed in 40 CFR 

§710.46 (amended §711.6) as an exempt or partially exempt chemical substance. This 

amendment 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 chemical substances to monitor chemical 

substance 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 chemical substances, EPA is replacing 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 
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EPA to require persons to report information “known to or reasonably ascertainable by” the 

submitter. This is the same standard currently applying to the reporting of 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 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 changing the reporting standard because reporting under the “readily obtainable” 

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 actually was used for industrial processing and use or commercial 

and consumer use. Considering only those chemical substances 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.6 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 the IUR processing and use data are incomplete and inconsistent.

Effective risk screening by EPA depends on the ability to accurately characterize chemical 

substance 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 substance, 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.

Therefore, using the reporting standard “known to or reasonably ascertainable by” will result 

in companies reporting more consistent and complete processing and use information in their 

IUR reports, and more efficient use of EPA resources.

Change to Reporting Frequency 

Prior to the 2003 Amendments, the IUR collection occurred every four years. EPA reduced 

the reporting frequency from every four years to every five years starting with the 2006 IUR rule 

 

6The 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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modifications, to reduce the burden associated with the amended IUR requirements. While the 

less frequent reporting does reduce burden, the Agency now has determined reporting every five 

years does not provide data sufficiently current to meet Agency and public needs, and is 

returning 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 chemical substances 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 the Agency has received for relying on

outdated information. More timely information will help EPA to better prioritize chemical 

substances 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 final rule will 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 are submitted, 

these final 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 revising the list of industrial function categories by combining categories leading 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 set of categories, which will be used by both the United States and 

Canada for Inventory reporting. Harmonization of the categories for reporting the industrial 

functions of chemical substances will benefit both EPA and Canadian agencies 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 substance use information by industry in the United States and 

Canada.

Another benefit of revising the list of industrial function categories will be to reduce the 

number of uses reported as “Other.” EPA is requiring that if a submitter chooses the category 

“Other,” the submitter include a text description for the industrial function category associated 

with the use of chemical substance.

Industrial Sectors

EPA is replacing 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 substance safety assessment. The 

chosen Industrial Sectors divide the entire range of NAICS codes into sectors so any NAICS 

code has a corresponding Industrial Sector. The Agency believes this change will provide several 

benefits .First, it will encourage more complete reporting by using terms already familiar to 

industry .Second, the industrial sectors will reduce the likelihood of errors resulting from the 
7-13

selection of miscellaneous or inappropriate NAICS codes. Third, it will 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 fivedigit NAICS codes, which made it difficult for EPA to group chemical substances based on 

industrial processing and use scenarios. The 2006 IUR database has 2,330 unique combinations 

of processing or use 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 chemical substances because EPA either would need to develop exposure scenarios for 

each unique combination, or determine which three-code combinations have similar exposure 

scenarios and can be grouped. Therefore, another benefit of using the industrial sectors will be to 

reduce the number of unique combinations, thereby increasing the usability of the data.

Consumer and Commercial Product Categories

EPA is revising the list of consumer and commercial use categories by combining categories 

leading to common exposure scenarios and adding categories not adequately described in the 

initial set of categories. EPA worked with Environment Canada and Health Canada to develop 

the 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 substance use information by industry in the United States and Canada.

Additional benefits of expanding the list of consumer and commercial use categories will be 

to provide persons submitting IUR information with a greater opportunity to characterize the 

products in which chemical substances they manufacture are used, and to reduce the number of 

uses reported as “Other.”

EPA is requiring that if a submitter chooses the category “Other,” the submitter include a text 

description for the consumer and commercial product containing the chemical substance. The 

2006 IUR reports showed 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 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 will be used were added 

to each category descriptor. By requiring the submitters to supply a written description for 

“Other,” this amendment will enable the Agency to evaluate and improve the inclusiveness of 

future consumer and commercial category lists or descriptions.

Upfront Substantiation for Processing and Use Information CBI 

Claims

Under the rule, in order to submit a claim of confidentiality for processing and use 

information data elements, the submitter will be required to both check the appropriate box on 
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the reporting form and substantiate the claim in writing by answering certain questions provided 

in the 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, on occasion, processing and use information has been claimed as 

confidential even though it was revealed in submissions sent to the Agency in response to the 

HPV Challenge program and published on the EPA website. In addition, EPA has observed some 

of the processing and use information claimed as confidential appears to be available on 

submitter’s websites or in published Material Safety Data Sheets (MSDS). The high number of 

confidentiality claims asserted for the reported 2006 IUR reports on industrial processing and use 

information meant 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. This amendment decrease in the number of inappropriate CBI claims under the new 

substantiation requirement, which will 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 will increase the transparency and public 

accessibility of the chemical substance 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.7

7.3 Potential Users of Information Generated by the IUR Modifications Rule

EPA will be the primary user of the information generated by the rule amendments, although 

other public and private organizations, in particular those with interests in managing chemical 

substance 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 substance risks and to improve risk management 

decisions. The American public will be the ultimate beneficiary 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 

following sections.

 

7 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.”
7-15

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 substance risks. OPPT can initiate the review of a chemical 

substance in a number of ways, including under 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 substance risks include:

Risk Screening. OPPT screens chemical substances 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 chemical substances on the TSCA Inventory. The amended 

IUR will supply exposure-related information the Agency does not currently have, 

recognizing industry has a greater knowledge than EPA about its own operations and the uses 

of chemical substances it manufactures and sells. Without this information, EPA will likely: 

(1) not screen these chemical substances, (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 rule will 

improve the Agency’s ability to screen chemical substances in commerce, allowing the 

Agency to focus its chemical substance screening programs and to identify potentially risky 

situations earlier than otherwise possible.

The 2006 IUR data did not provide sufficient information on medium production volume 

(MPV) chemical substances for risk screening activities under the Agency’s Existing 

Chemicals Program, in particular. Screening chemical substance risks generally requires a 

combination of both hazard and exposure information. Because most MPV chemical 

substances were produced below the 300,000 lb reporting threshold for processing and use 

information, EPA did not have exposure information available from the 2006 IUR for these 

chemical substances. EPA therefore developed hazard based prioritizations which were 

supported by a screening level hazard characterization and consideration of very limited 

exposure and use data. When the screening level hazard characterization for an MPV 

chemical substance indicated that the hazard was low, the magnitude of exposure was 

generally less significant for the prioritization. However, when the screening level hazard 

characterization identified either a medium or high hazard, information on the magnitude and 

type of exposure would be essential for a realistic prioritization determination. Basic hazard 

data are easier to find in existing databases; however, specific exposure data are needed to 

make a priority determination risk-based. EPA believes that the lower threshold will provide

more exposure-related information on a greater number of MPV chemical substances.

High Production Volume Chemical Substance Testing. EPA’s major efforts to prioritize 

existing chemical substances 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 chemical substances produced or 

imported in the United States in quantities of one million lb or more per year. At the 
7-16

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 chemical substances for which no 

voluntary agreement was made. EPA finalized its first HPV test rule, covering 37 chemical 

substances, in 2006. A second HPV rule was promulgated in 2011 for 19 chemical 

substances; a third rule was proposed in 2010, and additional HPV test rules are being 

planned.

When attempting to use the 2006 IUR data for its screening level exposure assessments, EPA 

found that numerous chemical substances previously identified as HPVs were reported in 

amounts classifying them as MPV chemical substances below the 300,000 lb cut-off, and 

thus processing and use information was not provided for chemical substances for which 

EPA had a relatively complete hazard data set from the HPV challenge. This led EPA to 

believe that the threshold was too high to provide sufficient exposure-related information on 

these chemical substances. Additionally, some previously MPV chemical substances were 

reported in amounts which classified them as HPV chemical substances in 2006.

Existing and New Chemicals Program. The Existing Chemicals Program conducts detailed 

analyses of potentially high-risk chemical substances and develops strategies to reduce or 

eliminate the exposure risks. Chemical substances are screened first to identify those (1) 

requiring additional testing, (2) presenting potentially significant risk management concerns, 

or (3) currently not requiring further review. While the amendments to the IUR data will 

increase EPA’s ability to screen existing chemical substances based on exposure and, 

ultimately, risk, more in-depth data similar to the New Chemicals Program data will lead to 

improved screening and a quicker identification of chemical substances with a high priority 

for follow-up action. This will result in a more appropriate entry into EPA’s chemical 

substance 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 will be particularly helpful 

for screening medium and lower volume chemical substances not covered by the HPV 

program.

More recently, the Existing Chemicals Program used the IUR database when developing the 

Chemical Action Plans. For some Action Plan chemical substances, the 2006 IUR was not a 

useful source of information. An example is the Action Plan for Dyes Derived from 

Benzidine and Its Congeners, where the substances of concern are known or reasonably 

anticipated human carcinogens; however, those listed were produced in amounts below the 

300,000 lb threshold and so little exposure data was reported. Based on IUR data from prior 

reporting periods, some of the other dyes had been reported in the 10,000 to 25,000 lb range, 

but no 2006 IUR data were available to determine whether these chemical substances were 

still being used in amounts beyond the small amounts used as analytical reagents. The Action 

Plans are available on EPA’s web site at 

http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html

IUR data are also used under the New Chemicals Program as a source of information on 

chemical substances that are analogous to new chemical substance submissions to 

supplement data submitted with the new chemical substance. EPA is able to increase the 

rigor of its review of a new chemical substance submission by comparing its characteristics 
7-17

with analogous chemical substances that previously have undergone a review under the New 

Chemicals 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 the 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 

will also enable EPA to more easily conduct broader chemical substance screening analyses 

across several industries.

Master Testing List. IUR data also help EPA determine which chemical substances are on 

the Master Testing List (MTL).The MTL is a list of chemical substances identified by the 

Agency as having inadequate data for health and/or environmental risk assessments. OPPT 

uses the MTL to establish priorities for chemical substance testing, keep the public informed, 

solicit input from industry on specific chemical substance exposure and risk assessment 

needs, and to encourage industry to perform testing. More in-depth exposure-related 

manufacturing, processing, and use data will 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 Organisation for Economic Cooperation and Development’s (OECD) voluntary SIDS program allows OECD member 

countries to share the burden of testing internationally traded, large production volume 

chemical substances. The United States is responsible for testing 25 percent of the chemical 

substances 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 (including importers). This information will 

increase the program’s efficiency by helping to identify chemical substances requiring 

additional testing or assessment while excluding those with low domestic exposure. An 

improved 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 substance uses and establishing partnerships with industry to develop 

voluntary, long-range plans for risk management. Currently collected IUR data, which will

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 will also better enable the initial assessment of exposures and help identify potential 
7-18

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 

chemical substances 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 substance

hazard information between the chemical substance producers and these other agencies. 

OSHA currently manages occupational exposure to chemical substances by setting a variety 

of chemical substance 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 chemical substances used in the workplace. OSHA will be able to use the 

IUR data to identify chemical substances with large numbers of potentially exposed workers or 

with uses suggesting greater exposure potential. The information provided by the rule could 

increase OSHA’s ability to manage chemical substance hazards, exposures, and risks in 

occupational settings.

NIOSH will also benefit from the additional exposure-related information collected under the 

rule amendments. The exposure information 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 Standard Industrial Classification (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 NOES 

data to identify chemical substances with large numbers of potentially exposed workers or with 

uses suggesting greater exposure potential.

CPSC also could use the new data directly in conducting its exposure and risk assessment 

activities (e.g. screening consumer products for chemical substance hazards). CPSC obtains risk 

information to screen chemical substance 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 final IUR amendments will provide a better source of reliable 

information on the chemical substances used in consumer products. CPSC will improve its 

ability to identify the chemical substances used in consumer products and, with consideration of 

hazard data, to identify chemical substance consumer use scenarios presenting greater potential 

risk. The information could improve CPSC’s ability to meet its program objective of protecting 

the public from chemical substance 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 chemical 

substances, use patterns, and exposure scenarios that may be unique or isolated, state and local 
7-19

agency access to the enhanced data will assist in identifying situations posing 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 substance risk situations. 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 

chemical substances are used in general. This will allow them to manage risks more effectively 

and participate in setting chemical substance 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 chemical substances and chemical substance 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 one such program that 

could use this information. 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 they do not know how their chemical substances 

are used. Non-CBI use 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.
8-1

8. Small Entity Analysis

This chapter estimates the impact the 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 the rule will not have a significant economic impact on a substantial number 

of small entities. The RFA, however, does not specifically define “a significant economic impact 

on a substantial number” of small entities. Sections 603 and 604 of the RFA require regulatory 

flexibility analyses to identify the types, and 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 will 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 substance at a site; or annual sales of less than $4 million. This 

exemption is maintained in the 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; that is the subject of an order under TSCA 

section 5(e); or that is the subject of relief that has been granted pursuant to a civil action under 

TSCA section 5 or 7. A small business may also report voluntarily.

The major steps followed in the analysis are described in the following sections.

8.1 Select a Relevant Small Entity Definition

The RFA relies on the definition of “small business” found in the Small Business Act, which 

authorizes the Small Business Administration (SBA) to develop definitions for “small business” 

for industries in each North American Industry 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 rule include companies manufacturing or 

importing chemicals in amounts of 25,000 lb or more annually and are listed on the TSCA 

Inventory and regulated under TSCA §8. Under 13 CFR part 121, SBA defines small business 

for the six-digit NAICS industry based on employment thresholds (SBA, 2004). These employee 

size standards range from 500 employees to 1,500 employees for NAICS Codes 325 and 324110. 

For example, SBA defines a company in NAICS 325320 (Pesticide and Other Agricultural 

Chemical Manufacturing) as small if it has fewer than 500 employees. In comparison, a company 

in NAICS 324110 (Petroleum Refineries) is considered small if it has fewer than 1,500 

employees. To obtain an average estimate of the number of small companies affected by the rule, 
8-2

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.”

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 any company with sales less than or 

equal to $40 million is small, regardless of production volume.8This 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 “sales-based 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 D-U-N-S® 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).9

During the 2006 reporting cycle, 4,18810 sites submitted reports. Parent company data was 

available for 3,392 of these sites,11 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 

 

8

It is important to note that the $40 million level is for parent company sales, not individual site sales.

9Dun & Bradstreet is a New York-based company that provides business information through a global commercial 

database. It assigns D-U-N-S® 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. D-U-N-S® 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.

10Note 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.

11 This does not include parent companies listed in D&B as having either 0 employees or $0 sales.
8-3

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 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 above. These results are fairly consistent with the 2002 EA’s estimates

between 21 and 35 percent of the regulated community could be considered small businesses 

(EPA, 2002a).

Table 8-1: Results of Dun & Bradstreet Analysis

Existing Sites

(2006 Reporting Cycle)

Employment-based 

Definition

Sales-based

Definition

Number of Global Parent Companies with Data 872 872

Number of Global Parent Companies Considered Small 360 218

Percentage of Global Parent Companies Considered Small 41.3% 25.0%

Average Annual Sales of Global Parent Companies 

Considered Small (2008$) $412,713,310 $11,638,441

Source: Analysis of data from Dun & Bradstreet’s Corporate Leads Portal, April 2009.

8.3 Estimate Number of Parent Companies

Incomplete information on global parent companies from Dun & Bradstreet for all of the 

companies that submitted IUR reports in 2006 required EPA 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 3.89 sites per global parent company. Given that 4,188 sites submitted reports, 

EPA estimates the number of parent companies for the 2006 IUR reporting baseline is 1,076.

As described in Section 4.5, the amendments are expected to increase the number of sites 

reporting by 204. Therefore, EPA estimates the total number of global parent companies 

reporting under the revised IUR rule to increase by 52 from the baseline (that is, 52 “new” 

companies (204÷3.89 = 52)).

8.4 Estimate Number of Small Companies

EPA estimated the number of small companies potentially impacted by the IUR amendments 

by applying the percentage of small companies derived in Table 8-1to the total number of parent 

companies EPA expects to be subject to the rule under the amendments. 

Table 8-2 shows the number of expected small companies, under both definitions.
8-4

Table 8-2: Estimated Number of Small Companies under the 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 amendments cause an increase in the number of sites 

reporting because of changes to the reporting volume thresholds and the timeframe in which the 

thresholds are applied. These amendments may have a disproportionate effect on smaller 

companies because they may be the ones manufacturing (including importing) chemical 

substances at or around the 25,000 lb threshold. Therefore, this method may underestimate the 

number of small businesses. Furthermore, to the extent the set of companies for which EPA was

not able to find data are not statistically similar to the set of companies for which data was 

available, this analysis may under- or over-estimate the percentage of small companies.

8.5 Estimate Cost-to-Sales Ratios for Small Companies

Table 4-53 shows the total increase in industry costs associated with the amendments, if all 

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 will be incurred once every four years under a four-year reporting cycle, 

these costs were annualized over four years at both a three percent and seven percent discount 

rate.

12 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. Therefore, to determine the magnitude of any potential adverse impact, EPA 

 

12 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 

(OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the 

results to a change in the annualization assumptions.
8-5

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.

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

Amendments

Employment-based Definition Sales-based Definition 

3% Discount 

Rate

7% Discount 

Rate

3% Discount 

Rate

7% Discount

Rate

Total Annualized 

Costs $17,161,997.89 $14,709,281.77 $17,161,997.89 $14,709,281.77 

Annualized Costs 

per Site $4,201 $3,601 $4,201 $3,601 

Number of Sites 

per Small Parent 

Company

1.76 1.92

Annualized Costs 

per Small Parent 

Company

$7,394 $6,337 $8,066 $6,914 

Annual Sales per 

Small Parent 

Company

$412,713,310 $412,713,310 $11,821,104 $11,821,104 

Cost-to-Sales 

Ratio 0.0018% 0.0015% 0.0682% 0.0585%

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 on average has sales of more than $412.7 million. The annualized costs of 

the IUR rule amendments per small parent company, however, are $7,394 at a three percent 

discount rate, and even lower under a seven percent discount rate. The cost-to-sales ratio for an 

average small company under the employment-based definition will be 0.0018 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 amendments of $8,066 or 

lower. The cost-to-sales ratio for an average small company under the sales-based definition will 

be 0.068 percent or less. 

Using the highest annual cost shown in Table 8-3, $8,066, a small company will have to have 

annual sales of less than $0.81 million in order to have a cost-to-sales ratio larger than one 

percent. As mentioned in Section 8. , firms with sales of $4 million or less are generally exempt 

from IUR reporting because they fall within the applicable definition of “small manufacturer,” 

regardless of production volume (40 CFR §704.3).Therefore, companies small enough to have a 

cost-to-sales ratio greater than one percent generally will be exempt from reporting under the

IUR rule, and thus will not be significantly affected by the amendments.
8-6

8.6 Summary

EPA analyzed potential small business impacts from this rule using the SBA employmentbased definition and the TSCA sales-based definition. EPA estimates 466 small firms potentially 

will be affected by this rule under the employment-based definition of the term, and 280 small 

firms potentially will 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 the cost-to-sales ratio

of the rule will be 0.018 percent or less under the employment-based definition for an average 

small company subject to the rule, and 0.068 percent or less under the sales-based definition. As 

noted above, EPA often defines the lower threshold as compliance costs of one percent of sales 

and the higher threshold 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 will have to be less 

than $0.81 million. Because the small businesses affected by the rule actually have average sales

of more than $11 million, and because any potentially affected companies with sales of $0.81

million or less will generally be exempt from reporting obligations under the IUR, small entities 

will not be significantly affected by the amendments to the IUR rule.
9-1

9. Additional Analyses

9.1 Executive Order 12866

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

October 4, 1993), this action is a “significant regulatory action” under section 3(f) of the 

Executive Order because it may raise novel legal or policy issues arising out of legal mandates, 

the President’s priorities, or the principles set forth in the Executive Order. 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 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 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 substance 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.Because this rule involves new or revised 

information collection activities requiring additional OMB approval, EPA has prepared an 

addendum to the currently approved ICR (EPA, 2010a).

The Paperwork Reduction Act mandates federal agencies estimate the recordkeeping and 

reporting burden of a final 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.
9-2

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 the rule will impose a total estimated 

incremental industry burden of 0.50 million hours, in the first reporting cycle, if all amendments 

are implemented. The burden for the average site will increase by approximately 121 hours per 

site to 572 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” are defined in the Executive Order to include regulations 

having “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 this 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 TSCA 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 data are 

available in a timely manner. Because EPA has no information indicating any state or local 

government manufactures or processes the chemical substances covered by this action, the 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 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 rule does not have an adverse impact on the environmental and health conditions in lowincome and minority communities requiring special consideration by the Agency under EO 

12898.The Agency believes the information collected under this rule, if finalized, will assist EPA 

and others in determining the potential hazards and risks associated with the chemical substances 

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 chemical substances 
9-3

posing 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 rule is directed at manufacturers or importers of chemical substances. All consumers of 

these chemical substance products and all workers who come into contact with these chemical 

substances could benefit if data regarding the chemical substances’ health and environmental 

effects were developed. Therefore, it does not appear that the costs and the benefits of the rule 

will be disproportionately distributed across different geographic regions or among different 

categories of individuals.

9.6 Executive Order 13045 – Children’s Health

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety 

Risks” (62 FR 19885, April 23, 1997), requires that federal agencies 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 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 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 chemical substances to which children may be 

disproportionately exposed. This information will also assist the Agency and others in 

determining whether the chemical substances in this 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 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 
9-4

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 action does not involve technical standards. Therefore, EPA did not consider the use 

of any voluntary consensus standards.
10-1

10. References

BLS, 2009.U.S. Bureau of Labor Statistics. Employer Costs for Employee Compensation Supplementary 

Tables: Historical Data December 2006 – December 2008. March 12, 2009.

http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf. 

Dun & Bradstreet, 2009.Dun & Bradstreet Corporate Leads Portal. Database searches. [Proprietary]. 

April 2009.

EPA, 1994.U.S. EPA Office of Pollution Prevention and Toxics. Regulatory Impact Analysis of

Amendments to Regulations for TSCA Section 5 Premanufacture Notifications. Washington, DC.

September 9, 1994.

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-OPPT-2002-

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, 2006.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, 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.
10-2

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 

and Site Report, Supporting Statement for a Request for OMB Review under the Paperwork 

Reduction Act. Washington, DC. September 5, 2008.

EPA, 2009a.U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division.

Chemicals Ineligible for Exemptions under Proposed IUR Modifications Rule. (2006 IUR Database 

Statistics). Washington, DC. May 12, 2009.

EPA, 2009b.U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis 

Branch. Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule.

(EPA-HQ-OPPT-2008-0296). Washington, DC. July 13, 2009. 

EPA, 2009c.U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division.

IUR Company Names and Related Information. (Database query results).Washington, DC. April 14, 

2009.

EPA, 2009d.U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division.

2002 IUR Database Statistics for IUR Modifications Rule. Washington, DC. April 30, 2009.

EPA, 2009e.U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division.

Email communication from Darryl Ballard to Wendy Hoffman. Washington, DC. May 19, 2009.

EPA, 2009f.U.S. EPA, Office of Pollution Prevention and Toxics. TSCA Section 4 Federal Register 

Enforceable Consent Agreements. http://www.epa.gov/oppt/chemtest/pubs/4eca.html. Washington, 

DC. Updated October 1, 2009.

EPA, 2009g.U.S. EPA, Office of Pollution Prevention and Toxics, Sunset Dates of Chemicals Subject to 

Final TSCA Section 4 and Related 12(b) Actions, Modified on September 1, 2009. 

http://www.epa.gov/oppt/chemtest/pubs/sunset.html. Washington, DC. Updated September 1, 2009.

EPA, 2009h.U.S. EPA, Office of Pollution Prevention and Toxics, Chemical Control Division. Memo 

from Susan Sharkey to Wendy Hoffman. Washington, DC. September 8, 2009.

EPA, 2010a.U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1884.05. [Information 

Collection Request for] Addendum to Partial Update of the TSCA Section 8(b) Inventory Data Base, 

Production and Site Reports. Washington, DC. July, 2010.

EPA, 2010b.U.S. EPA, Office of Pollution Prevention and Toxics. IUR Chemical Information Statistics. 

November 29, 2010.

EPA, 2011. U.S. EPA, Office of Pollution Prevention and Toxics. Instructions for the 2012 TSCA 

Inventory Update Reporting.

OPM, 2008.Office of Personnel Management, Salary Table 2008-DCB, Washington Baltimore-Northern 

Virginia, DC-MD-PA-VA-WV. http://www.opm.gov/oca/08tables/pdf/DCB.pdf.

U.S. Postal Service (USPS), 2009. USPS – Prices. http://www.usps.com/prices/. December 15, 2009.
A-1

Appendix A. – Current and Revised Industrial Function Categories

Table A-1: List of Current and Revised Industrial Function Categories

Current IUR Industrial Function Categories Revised 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: 

1A current industrial function category has been renamed under the amendment, but the definition of the category has not changed.

2 Two current industrial function categories have been combined into one category under the final rule.

3 A single industrial function category has been divided into two categories under the final rule.

*

Indicates that a current industrial function category is being eliminated under the final rule.

+ Indicates that a current function category is added under the final rule.
B-1

Appendix B. Current and Revised Consumer and Commercial Product Categories

EPA is revising 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 B-1: List of Current and Revised Consumer and Commercial Product Categories

Current IUR Consumer and Commercial 

Product Categories

Revised 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 

30.Agricultural Products (non-pesticidal) 

31.Lawn and Garden Care Products 

Chemical Substances in Products not Described by 
B-2

Current IUR Consumer and Commercial 

Product Categories

Revised IUR Consumer and Commercial

Product Categories

Other Categories

32.Non-TSCA Use

33.Other (specify)
C-1

Appendix C. Industrial Sectors

EPA is replacing 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 

Code Sector Description

Chemical Manufacturing

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)
D-1

Appendix D. Sensitivity Analyses

Some of EPA’s 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 chemical 

substances 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 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 write-in text if selecting 

“Other” as a consumer or commercial use, and, (5) upfront substantiation for all CBI claims for 

processing and use information. 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 amendments more accurately, EPA presents a range of costs in this section, 

using the lower and upper bounds for the item estimated. 

D.1 Method for Determining Whether the Threshold Is Met

Currently, the IUR rule requires a report be filed for a chemical substance only if the 

chemical substance’s production volume exceeds the 25,000 lb threshold in the principal IUR 

reporting year. EPA is modifying the timeframe for reporting in future reporting cycles 

subsequent to 2012 so chemical substance manufacturers (including importers) will be subject to 

the IUR rule if a chemical substance’s production volume has met or exceeded the threshold in 

any calendar year since the last principal reporting year. The Agency expects this will increase 

the number of sites and reports submitted by between zero and ten percent of the baseline (see 

Table 4-6). In Section 5.4, the Agency estimated the 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 72,000 hours in 

future reporting cycles (see Table 4-12). Table D-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 

approximately 143,000 hours as a result of modifying the method for determining whether the 

25,000 lb threshold is met in future reporting cycles. 
D-2

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

for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

Burden to 

Prepare Part 

I, Rule 

Familiarizati

on, 

Compliance 

Determinatio

n, and 

Submission 

(hours per 

site)

Number of Sites

Burde

n to 

Prepa

re 

Part II 

and 

Recor

d 

Keepi

ng 

(hours 

per 

report

)

Number of 

Reports (with 

Part II) Burde

n to 

Prepa

re 

Part 

III 

(hours 

per 

report

)

Number of 

Reports (with 

Part III)

Industry Burden

(hours)

Lower 

Bound 

(0% 

increas

e)

Upper 

Bound 

(10% 

increas

e)

Lower 

Bound 

(0% 

increas

e)

Upper 

Bound 

(10% 

increas

e)

Lower 

Bound 

(0% 

increas

e)

Upper 

Bound 

(0% 

increas

e)

Lower 

Bound 

(10% 

increase)

Upper 

Bound 

(10% 

increase)

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

(c d)+(e f)

Baseline 9.08 4,085 4,085 17.06 25,89

6

25,89

6

55.93 17,07

5

17,07

5

1,433,8

33

1,433,8

33

PostAmendm

ent

9.08 4,085 4,494 17.06 25,89

6

28,48

6

55.93 17,07

5

18,78

3

1,433,8

33

1,577,2

16

Change 

from the 

Baseline

0.00 0 409 0.00 0 2,590 0.00 0 1,708 0 143,383

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

Table D-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 

amendment. All baseline cost estimates are taken from Table 4-5. EPA estimates a cost to 

industry between $0 and $8.28 million. The midpoint cost estimate of $4.14 million is used in 

Table 4-13.

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

Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

Cost to 

Prepare Part 

I, Rule 

Familiarizatio

n, Compliance 

Determination

and 

Submission 

(2008$ per 

site)

Number of Sites

Cost to 

Prepar

e Part 

II and 

Recor

d 

Keepin

g 

(2008$ 

per 

report)

Number of 

Reports (with 

Part II) Cost to 

Prepare 

Part III 

(2008$ 

per 

report)

Number of 

Reports (with 

Part III)

Industry Cost 

(millions 2008$)

Lower 

Bound 

(0% 

increas

e)

Upper 

Bound 

(10% 

increas

e)

Lower 

Bound 

(0% 

increas

e)

Upper 

Bound 

(10% 

increas

e)

Lower 

Bound 

(0% 

increas

e)

Upper 

Bound 

(10% 

increas

e)

Lower 

Bound 

(0% 

increas

e)

Upper 

Bound 

(10% 

increas

e)

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

(c d)+(e f)

Baseline $560.77 4,085 4,085 $968.3

9

25,896 25,896 $3,247.

40 17,075 17,075 $82.82 $82.82

PostAmend

ment

$560.77 4,085 4,494 $968.3

9

25,896 28,486 $3,247.

40 17,075 18,783 $82.82 $91.10

Change 

from the 

Baseline

$0.00 0 409 $0.00 0 2,590 $0.00 0 1,708 $0.00 $8.28

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the postamendment value.
D-3

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 D-3. Baseline Agency burden is taken from Table 5-4. The amendment is expected to 

increase the Agency burden by between zero and 208 hours.

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

Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

Burde

n to 

Proces

s Part 

I 

(hours

)

Number of Sites Burde

n to 

Proces

s Part 

II 

(hours

)

Number of Reports 

(with Part II)

Burde

n to 

Proces

s Part 

III 

(hours

)

Number of Reports 

(with Part III)

Industry Burden

(hours)

Lower 

Bound 

(0% 

increase

)

Upper 

Bound 

(10% 

increase

)

Lower 

Bound 

(0% 

increase

)

Upper 

Bound 

(10% 

increase

)

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

PostAmendmen

t

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 D-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 

amendment is expected to increase the Agency cost between approximately $0 and $21,700 

during the first reporting cycle.

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

Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

Cost

to 

Proces

s Part 

I 

(2008$

)

Number of Sites Cost 

to 

Proces

s Part 

II 

(2008$

)

Number of Reports 

(with Part II)

Cost 

to 

Proces

s Part 

III 

(2008$

)

Number of Reports 

(with Part III)

Industry Cost

(2008$)

Lower 

Bound 

(0% 

increase

)

Upper 

Bound 

(10% 

increase

)

Lower 

Bound 

(0% 

increase

)

Upper 

Bound 

(10% 

increase

)

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 $216,94

9

$216,94

9

PostAmendme

nt

$1.78 4,085 4,494 $4.40 25,896 28,486 $5.61 17,075 18,783 $216,94

9

$238,64

4

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.
D-4

D.2 Reporting Production Volume Used On-Site

The cost to industry of requiring the reporting of production volume used on-site is estimated 

in Section 4.4.13. EPA estimated between 14.8 percent of 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 chemical substances is an intermediate in

the downstream use and processing section (EPA, 2008c)) will 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 4-26). Table D-5shows 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 D-5: Sensitivity Analysis of Industry Burden Estimates for Reporting Production 

Volume Used On-Site

Burden per 

Report to Report 

Production 

Volume Used 

On-Site

(hours)

Number of Reports with

Production Volume Used

On-Site

Total Industry Burden

(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 D-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 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 4-27).

Table D-6: Sensitivity Analysis of Industry Cost Estimates for Reporting Production 

Volume Used On-Site

Cost per Report 

to Report 

Production 

Volume Used 

On-Site

(2008$)

Number of Reports with

Production Volume Used 

On-Site

Total Industry Cost

(2008$)

Lower Limit 

(14.8% of 

all Reports)

Upper Limit 

(24% of all 

Reports)

Lower 

Limit 

(14.8% of 

all Reports)

Upper Limit 

(24% of all 

Reports)

Baseline $0.00 0 0 $0 $0

Post-Amendment $84.68 3,833 6,215 $324,544 $526,288

Change from the 

Baseline $84.68 3,833 6,215 $324,544 $526,288

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

In Section 5.4.13, EPA calculated the burden to the Agency of requiring the reporting of 

production volume used on-site, using 19.4 percent as the estimated amount of reports listing
D-5

production volume used on-site is calculated in Section 5.4.13. The resulting burden was 4.51 

hours. In Table D-7, EPA calculates the range of burden estimates to the Agency, using a range 

of 14.8 to 24 percent as the amount of reports listing production volume used on-site. The 

resulting burden is 3.44 to 5.57 hours per reporting cycle. The baseline burden per report is taken 

from Table 5-4.

Table D-7: Sensitivity Analysis of Agency Burden Estimates for Reporting Production 

Volume Used On-Site

Burden per 

Report to Report 

Production 

Volume Used 

On-Site

(hours)

Number of Reports with

Production Volume Used 

On-Site

Burden per Report to Report 

Production Volume Used 

On-Site (hours)

Lower Limit 

(14.8% of all 

Reports)

Upper Limit 

(24% of all 

Reports)

Lower Limit 

(14.8% of 

all Reports)

Upper Limit 

(24% of all 

Reports)

Baseline 0.000 0 0 0.00 0.00

Post-Amendment 0.001 3,833 6,215 3.44 5.57

Change from the 

Baseline 0.001 3,833 6,215 3.44 5.57

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

Table D-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 

amendment is expected to increase the Agency cost between approximately $359 and $581 

during the first reporting cycle.

Table D-8: Sensitivity Analysis of Agency Cost Estimates for Reporting Production 

Volume Used On-Site

Cost per Report to 

Report Production 

Volume Used 

On-Site

(2008$)

Number of Reports with

Production Volume Used

On-Site

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.

D.3 Revising Industrial Function Categories

EPA is revising 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
D-6

percent reduction in total (302 reports in total). The results of this analysis for industry burden

are found in Table D-9. A 75 percent reduction in the number of submitters claiming “Other” 

means 25 percent of submitters are now claiming “Other,” and a 25 percent reduction means 75 

percent of submitters are now claiming “Other.” The columns in this table and the remaining 

tables in this Appendix are labeled to reflect the resulting numbers; e.g., they show the lower 

resulting number in the “Lower Bound” column and the higher resulting number in the “Upper 

Bound” column.

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. 

Table D-9: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text 

for “Other” as an Industrial Function Category

Burden for 

Rule 

Familiarization 

of Additional 

Categories

(hours)

Number 

of Reports 

with 

Industrial 

Function 

Categories

Burden 

for 

Write-in

Text for 

"Other" 

(hours)

Number of Reports with 

“Other”

Write-in Text

Total Industry Burden 

(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 D-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 

4-35).
D-7

Table D-10: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for 

“Other” as an Industrial Function Category

Cost for Rule 

Familiarization 

of Additional 

Categories

(2008$)

Number 

of Reports 

with 

Industrial 

Function 

Categories

Cost for 

Write-in 

Text for 

"Other" 

(2008$)

Number of Reports with 

“Other” Write-in Text

Total Industry 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 $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 D-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.

Table D-11: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text 

for “Other” as an Industrial Function Category

Burden to 

Process

Write-in 

Text for 

"Other" 

(hours)

Number of Reports with "Other" 

Write-in Text

Total Agency Burden 

(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 D-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 amendment is expected to 

increase the Agency cost between approximately $28 and $85 during the first reporting cycle.
D-8

Table D-12: Sensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for 

“Other” as an Industrial Function Category

Cost to 

Process

Write-in 

Text for 

"Other" 

(2008$)

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 $0.00 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

D.4 “Other” as a Consumer and/or Commercial Product Category

EPA is revising the list of consumer and commercial product categories by combining 

categories leading to common exposure scenarios and adding categories not adequately 

described in the current set of categories. The resultant 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 requiring that if 

the product category “Other” is selected; a descriptor for the consumer and/or commercial 

product containing the chemical substance also to be reported. According to 2006 IUR data 

(EPA, 2008c), 1,207 reports listed “Other” as a consumer and/or commercial product category

.Based on EPA’s best professional judgment, EPA expects the new categories in the amendment

will reduce by half the number of submitters selecting “Other” as a consumer and/or commercial 

product category. Therefore, this amendment will 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.

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 D-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. 
D-9

Table D-13: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text 

for “Other” as a Consumer and/or Commercial Product Category

Burden for 

Rule 

Familiarizatio

n of Additional 

Categories 

(hours)

Number of 

Reports 

with 

Consumer/

Commercia

l

Product

Categories

Burden 

for 

Writein Text 

for 

"Other

" 

(hours)

Number of Reports 

with "Other" Write-in 

Text

Total Industry Burden 

(hours)

Lower 

Bound 

(25%of 

Submitter

s

Claim

"Other")

Upper 

Bound 

(75%of 

Submitter

s

Claim

"Other")

Lower 

Bound 

(25%of 

Submitter

s

Claim

"Other")

Upper 

Bound 

(75%of 

Submitter

s

Claim

"Other")

Baseline 8.59 17,075 0.00 0 0 146,661 146,661

PostAmendmen

t

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 D-14shows 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 4-37).

Table D-14: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for 

“Other” as a Consumer and/or Commercial Product Category

Cost for Rule 

Familiarizatio

n of Additional 

Categories 

(2008$)

Number of 

Reports 

with 

Consumer/

Commercia

l

Product

Categories 

Cost for 

Writein Text 

for 

"Other

" 

(2008$)

Number of Reports 

with "Other" Write-in 

Text

Total Industry Cost

(2008$)

Lower 

Bound 

(25%of 

Submitter

s

Claim

"Other")

Upper 

Bound 

(75%of 

Submitter

s

Claim

"Other")

Lower 

Bound 

(25%of 

Submitter

s

Claim

"Other")

Upper 

Bound 

(75%of 

Submitter

s

Claim

"Other")

Baseline $70.64 17,075 $0.00 0 0 $1,206,177 $1,206,177

PostAmendmen

t

$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 D-15
D-10

shows the range of burden estimates to the Agency; 0.27 hour to 0.81 hours per reporting cycle.

The baseline Agency burden estimates per report are taken from Table 5-4.

Table D-15: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text 

for “Other” as a Consumer and/or Commercial Product Category

Burden to 

Process

Write-in 

Text for 

"Other" 

(hours)

Number of Reports with "Other" 

Write-in Text

Total Agency Burden 

(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 D-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 amendment

is expected to increase the Agency cost between $28 and approximately $85 during the first 

reporting cycle.

Table D-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" Writein TextTotal Agency Cost

(2008$)

Lower Bound 

(25%of Submitters

Claim

"Other")

Upper Bound 

(75%of Submitters

Claim

"Other")

Lower Bound 

(25%of Submitters

Claim

"Other")

Upper Bound 

(75%of Submitters

Claim

"Other")

Baseline 0 0 $0 $0

Post-Amendment 302 905 $28 $85

Change from the 

Baseline 302 905 $28 $85

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

D.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 amendment. According to 2006 IUR data (EPA, 2008c), a 

total of 8,133 reports had claimed 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. 
D-11

The Agency conducted a sensitivity analysis, assuming the reduction in CBI claims has a 

lower bound of 84 percent, meaning 16 percent of submitters make a CBI claim in Part III, and 

an upper bound of 44 percent, meaning 56 percent of submitters make a CBI claim in Part III.

Table D-17 contains range in burden increase to industry as a result of the amendment. The 

burden is expected to increase by between 5,700 and 19,900 hours.

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

Substantiation

Burden for 

Upfront CBI 

Substantiation

for CBI 

Claims in

Part III

(hours)

Number of Reports with CBI Claims 

in Part III

Industry Burden

(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 D-18shows 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 4-35).

Table D-18: Sensitivity Analysis of Industry Cost Estimates for Requiring Upfront CBI 

Substantiation

Cost for 

Upfront CBI 

Substantiation

for CBI 

Claims in

Part III

(2008$)

Number of Reports with CBI Claims 

in Part III

Industry Cost

(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 D-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.
D-12

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

Substantiation

Burden for 

Upfront CBI 

Substantiation 

for CBI 

Claims in 

Part III

(hours)

Number of Reports with CBI Claims 

in Part III

Agency Burden

(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 D-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 amendment is expected to 

increase the Agency cost between $365 and $1,278 during the first reporting cycle.

Table D-20: Sensitivity Analysis of Agency Cost Estimates for Requiring Upfront CBI 

Substantiation

Cost for 

Upfront CBI 

Substantiation 

for CBI 

Claims in

Part III

Number of Reports with CBI Claims 

in Part III

Agency Cost 

(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 $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.
E-1

Appendix E. Alternative Regulatory Options

In developing the amendments to the IUR rule, EPA considered other regulatory options as 

alternatives to some of the proposed amendments. These options were 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 following sections. Because these options were considered only during the proposed rule, the 

total costs, submission dates, and annualization periods associated with them may not match 

what is presented in the main text for the final rule. 

E.1 Require Submitters to Submit Full Data Annually

As an alternative to the amendment described in Section 3.5.4, which will 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 second scenario estimates the cost and 

burden to all affected entities if all the proposed amendments outlined in Section 3. are enacted. 

E.1.1 Annual Reporting Cost and Burden when the Option is Considered by Itself

Under this alternative option, EPA estimated the cost to the industry and the Agency of 

annual reporting when the option is considered by itself, with none of the other proposed 

amendments considered. The annual reporting cost and burden would be the same as in the 

baseline burden shown in Table 4-10. The number of submitters is not expected to change from 

year to year, after the first reporting cycle. While the Agency is aware that a site’s production 

volume may vary yearly, causing the site to meet or exceed the threshold in some years but not 

in others, EPA believes on average, the total number of sites and reports would remain 

unchanged from year to year. 

EPA analyzed the burden and costs over a 25-year period. EPA assumes submitters will 

become more efficient at reporting data over time, and 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 

E-1. In total, EPA estimates the industry burden would increase by approximately 22.94 million 

hours over 25 years (five reporting cycles). Over one future five-year reporting cycle, the 

industry burden is expected to increase by 5.74 million hours (1.43 million hours x 4 years) 

compared to the baseline.

Table E-1: Industry Burden under the Alternative Option to Require Submitters to Submit 

Full Data Annually

Reporting Cycle Years

Baseline Burden Post-Alternative 

Option Burden

Change from 

Baseline

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 1.84 1.84 0.00

2 2012 to 2016 1.43 7.17 5.74
E-2

3 2017 to 2021 1.43 7.17 5.74

4 2022 to 2026 1.43 7.17 5.74

5 2027 to 2031 1.43 7.17 5.74

Total 7.58 30.52 22.94

Annual Average 0.30 1.22 0.92

The industry cost under the baseline and this alternative option is shown in Table E-2. EPA 

estimates the industry cost would increase by $1.33 billion over a 25-year period. The annualized 

cost increase ranges from $44.34 million with a seven percent discount rate to $49.54 million 

with a three percent discount rate. Over one five-year reporting cycle, this option would increase 

industry cost by approximately $331 million ($82.8 million x 4 years) compared to the baseline.

Table E-2: Industry Cost under the Alternative Option to Require Submitters to Submit 

Full Data Annually

Reporting Cycle Years Baseline Cost Post-Alternative 

Option Cost

Change from 

Baseline

(2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $106.97 $106.97 $0.00 

2 2012 to 2016 $82.82 $414.09 $331.27

3 2017 to 2021 $82.82 $414.09 $331.27

4 2022 to 2026 $82.82 $414.09 $331.27

5 2027 to 2031 $82.82 $414.09 $331.27

Total $438.24 $1,763.32 $1,325.08 

Annual Average $17.53 $70.53 $53.00 

Annualized at 3% $16.80 $66.34 $49.54 

Annualized at 7% $15.88 $60.22 $44.34 

The baseline burden to EPA during each reporting cycle is two FTEs, or 4,160 hours (see 

Section 5-2). While the burden for each reporting cycle would not change as a result of this amendment, 

more frequent reporting would increase costs to the Agency. Table E-3 contains the total Agency burden 

of the annual reporting option, over a 25-year period. EPA estimates Agency burden would increase by 

a total of 66,600 hours over a 25-year period (five reporting cycles). Over one five-year reporting cycle, 

the Agency burden would increase by 16,600 hours (4,160 hours x 4 years) compared to the baseline.

Table E-3: Agency Burden under the Alternative Option to Require Submitters to Submit 

Full Data Annually

Reporting Cycle Years Baseline Burden

Post-Alternative 

Option 

Change 

from 

Baseline

(hours) (hours) (hours)

1 2007 to 2011 4,160 4,160 0

2 2012 to 2016 4,160 20,800 16,640

3 2017 to 2021 4,160 20,800 16,640

4 2022 to 2026 4,160 20,800 16,640

5 2027 to 2031 4,160 20,800 16,640

Total 20,800 87,360 66,560
E-3

Annual Average 832 3,494 2,662

The annual Agency cost under the baseline and the alternative option is shown in Table E-4, 

and is taken from Table 5-3.In total, EPA estimates this option would increase the Agency cost 

by approximately $1.86 million over one five-year reporting cycle. Over a 25-year period, the 

annualized Agency cost is expected to increase between $359,900 with a seven percent discount 

rate, and $367,300 with a three percent discount rate compared to the baseline. 

Table E-4: Agency Cost under the Alternative Option to Require Submitters to Submit 

Full Data Annually

Reporting Cycle Years

Baseline Cost Post-Alternative Option 

Cost

Change from 

Baseline

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

1 2007 to 2011 $466,133 $466,132 $0.00

2 2012 to 2016 $466,133 $2,330,664 $1,864,532

3 2017 to 2021 $466,133 $2,330,664 $1,864,532

4 2022 to 2026 $466,133 $2,330,664 $1,864,532

5 2027 to 2031 $466,133 $2,330,664 $1,864,532

Total $2,330,664 $9,788,790 $7,458,126 

Annual Average $93,227 $391,552 $298,325 

Annualized at 3% $87,798 $366,630 $291,617 

Annualized at 7% $81,056 $466,133 $359,885 

E.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 

4-52. After the first reporting cycle, the number of submitters is not expected to change from 

year to year. 

The industry burden of annual reporting is shown in Table E-5. The annual reporting option 

is expected to increase the industry burden by approximately 39.58 million hours over a 25-year 

period, for a total industry burden of 56.01 million hours. EPA estimates over one four-year 

reporting cycle (note under the final amendments, a reporting cycle will be changed to four 

years) the industry burden would increase by approximately 7.92 million hours (2.64 million 

hours x 3 years) compared to the baseline. 

Table E-5: Industry Burden under the Alternative Option to Require Submitters to Submit 

Full Data Annually when all the Proposed Amendments are Considered

Reporting Cycle Years Baseline Burden Post-Alternative 

Option Burden

Change from 

Baseline

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 3.24 3.24 0.00

2 2012 to 2015 2.64 10.56 7.92

3 2016 to 2019 2.64 10.56 7.92

4 2020 to 2023 2.64 10.56 7.92
E-4

5 2024 to 2027 2.64 10.56 7.92

6 2028 to 2031 2.64 10.56 7.92

Total 16.43 56.01 39.58

Annual Average 0.66 2.24 1.58

The industry baseline cost is taken from Table 4-53. EPA estimates annual reporting would 

increase industry cost by approximately $2.43 billion over a 25-year period. The change in 

annualized cost ranges from $81.39 million with a seven percent discount rate to $90.90 million 

with a three percent discount rate as shown in Table E-6. Over one four-year reporting cycle, this 

option would increase industry cost by approximately $486 million ($162.08 x 3 years) 

compared to the baseline.

Table E-6: Industry Cost under the Alternative Option to Require Submitters to Submit 

Full Data Annually when all the Proposed Amendments are Considered

Reporting Cycle Years Baseline Cost Post-Alternative 

Option Cost

Change from 

Baseline

(2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $198.84 $198.84 $0.00 

2 2012 to 2015 $162.08 $648.33 $486.25

3 2016 to 2019 $162.08 $648.33 $486.25

4 2020 to 2023 $162.08 $648.33 $486.25

5 2024 to 2027 $162.08 $648.33 $486.25

6 2028 to 2031 $162.08 $648.33 $486.25

Total $1,009.25 $3,440.49 $2,431.24 

Annual Average $40.37 $137.62 $97.25 

Annualized at 3% $38.40 $129.30 $90.90 

Annualized at 7% $35.83 $117.22 $81.39 

The Agency baseline burden when all the proposed amendments are considered is taken from 

Table 5-43. The annual reporting option is expected to increase Agency burden by approximately 

36,800 hours when all amendments are considered (see Table E-7). Over a four-year reporting 

cycle, EPA estimates Agency burden would increase by approximately 7,400 hours (2,456 hours 

x 3 years) compared to the baseline.

Table E-7: Agency Burden under the Alternative Option to Require Submitters to Submit 

Full Data Annually when all the Proposed Amendments are Considered

Reporting Cycle Years Baseline Burden Post-Alternative 

Option Burden

Change from 

Baseline

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 2,439 2,439 0

2 2012 to 2015 2,456 9,826 7,369

3 2016 to 2019 2,456 9,826 7,369

4 2020 to 2023 2,456 9,826 7,369

5 2024 to 2027 2,456 9,826 7,369

6 2028 to 2031 2,456 9,826 7,369
E-5

Total 14,721 51,568 36,847

Annual Average 589 2,063 1,474

The baseline Agency cost when all the proposed amendments are enacted is taken from Table 

5-44. The total Agency cost under the annual reporting option when all proposed amendments 

are considered is shown in Table E-8. Over a 25-year period, Agency cost would increase by 

approximately $4.33 million, with annualized costs increases ranging from approximately 

$205,000 with a seven percent discount rate to $227,000 with a three percent discount rate. Over 

one four-year reporting cycle, the Agency cost is expected to increase by $865,000 ($288,450 x 3 

years) compared to the baseline.

Table E-8: Agency Cost under the Alternative Option to Require Submitters to Submit 

Full Data Annually when all the Proposed Amendments are Considered

Reporting Cycle Years Baseline Cost

Post-Alternative 

Option Cost

Change from 

Baseline

(2008$) (2008$ millions) (2008$ millions)

1 2007 to 2011 $286,580 $286,580 $0

2 2012 to 2015 $288,450 $1,153,800 $865,350

3 2016 to 2019 $288,450 $1,153,800 $865,350

4 2020 to 2023 $288,450 $1,153,800 $865,350

5 2024 to 2027 $288,450 $1,153,800 $865,350

6 2028 to 2031 $288,450 $1,153,800 $865,350

Total $1,728,830 $6,055,580 $4,326,750

Annual Average $69,153 $242,223 $173,070

Annualized at 3% $65,011 $226,783 $161,773

Annualized at 7% $59,642 $204,495 $144,853

E.1.3 Small Entity Analysis

The following section provides a preliminary assessment of the impact 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 

all the proposed amendments are enacted. 

EPA estimated in Chapter 8 of this report there are 3.89 manufacturing sites per global parent 

company; 41.3 percent of global parent companies (466 companies) are considered small under 

the SBA employment-based definition,

13 and 24.8 percent (280 companies) are considered small 

under the TSCA sales-based definition.

14 EPA also estimated an average of approximately 1.76

sites per small company under the employment-based definition of small business, and 

approximately 1.92 sites per small company under the sales-based definition. 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.

 

13Threshold 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.
E-6

Table 4-53 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 E-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 E-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 $39,582. The cost-tosales 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 $43,181. The cost-to-sales ratio for an average small company under 

the sales-based definition would be 0.364 percent or less.

Using the highest annual cost shown in Table E-9of $43,181, a small company would have to 

have annual sales of less than $4.32 million in order to have a cost-to-sales ratio larger than one 

percent. 

Table E-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 $91,871,064

Total Number of Sites 4,085

Annual costs per site $21,490

Number of sites per small parent company 1.76 1.92

Annualized costs per small parent company $39,582 $43,181 

Annual sales per small parent company $412,713,310 $11,821,104 

Cost-to-sales ratio 0.010% 0.365%

Number of companies potentially affected 466 280

E.2 Modify Reporting Frequency to a Three-Year Cycle

As an alternative to the amendment described in Section 3.13, which will 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. 

E.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 option is similar to that described in 

Section 4.4.31; the burden in any one reporting cycle would not change, but the longer-term 

burden to industry would increase because reporting will become more frequent. However, the 

Agency assumes no additional reports would be submitted as a result of reducing the length of 
E-7

the reporting cycle.(While the mix of chemical substances might change, EPA assumes the total 

number of reports would remain relatively static.) To be comparable with the four-year reporting 

cycle amendment, 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 E-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 under this option, industry 

would incur an additional burden of 2.87 million hours over a 20-year period. 

Table E-10: Annual Industry Burden under the Alternative Option of a Three-Year 

Reporting Cycle

Reporting Cycle1 Years

Baseline Burden Post-Amendment 

Burden Change in Burden

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 1.84 1.84 0.00

2

2012 to 2016 1.43 --

2012 to 2014 -- 1.43 0.00

3

2017 to 2021 1.43 --

2015 to 2017 -- 1.43 0.00

4

2022 to 2026 1.43 --

2018 to 2020 -- 1.43 0.00

5 2021 to 2023 -- 1.43 1.43

6 2024 to 2026 -- 1.43 1.43

Total 6.14 9.01 2.87

Annual Average 0.31 0.45 0.14

1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are alternative, three-year 

cycles.

The annual industry cost under the baseline and this alternative option are shown in Table 

E-11. In total, EPA estimates this option would increase costs to industry by $165.64 million 

over a 20-year period, with annualized costs increases ranging from $6.96 million with a seven 

percent discount rate to $7.75 million with a three percent discount rate. 

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

Reporting Cycle1 Years

Baseline Cost Post-Alternative 

Option Cost

Change from 

Baseline

(2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $106.97 106.97 0.00

2

2012 to 2016 $82.82 --

2012 to 2014 -- $82.82 0.00

3

2017 to 2021 $82.82 --

2015 to 2017 -- $82.82 0.00

4

2022 to 2026 $82.82 --

2018 to 2020 -- $82.82 0.00

5 2021 to 2023 -- $82.82 $82.82 

6 2024 to 2026 -- $82.82 $82.82 

Total $355.42 $521.05 $165.64 

Annual Average $17.77 $26.05 $8.28 

Annualized at 3% $17.00 $24.75 $7.75 
E-8

Annualized at 7% $16.03 $22.99 $6.96 

1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are alternative, three-year 

cycles.

The baseline burden to EPA during reporting years would be 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 E-12 contains the 

total burden to the Agency of the option, over a 20-year period. During this period, EPA 

estimates Agency burden would increase by a total of approximately 8,300 hours. 

Table E-12: Burden to the Agency under the Alternative Option of a Three-Year Reporting 

Cycle

Reporting Cycle1 Years

Baseline Burden Post-Amendment 

Burden Change in Burden

(millions of 

hours) (millions of hours) (millions of hours)

1 2007 to 2011 4,160 4,160 0

2

2012 to 2016 4,160 --

2012 to 2014 -- 4,160 0

3

2017 to 2021 4,160 --

2015 to 2017 -- 4,160 0

4

2022 to 2026 4,160 --

2018 to 2020 -- 4,160 0

5 2021 to 2023 -- 4,160 4,160

6 2024 to 2026 -- 4,160 4,160

Total 16,640 24,960 8,320

Annual Average 832 1,248 416

1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are alternative, three-year 

cycles.

The annual Agency costs under the baseline and the alternative option are shown in Table 

E-13, and are taken from Table 5-3. In total, EPA estimates this option would increase Agency 

costs by$932,300 over a 20-year period with an annual average of $46,600. 

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

Reporting Cycle1 Years Baseline Cost

Post-Alternative 

Option Cost

Change from 

Baseline

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

1 2007 to 2011 $466,133 $466,133 $0

2

2012 to 2016 $466,133 --

2012 to 2014 -- $466,133 $0

3

2017 to 2021 $466,133 --

2015 to 2017 -- $466,133 $0

4

2022 to 2026 $466,133 --

2018 to 2020 -- $466,133 $0

5 2021 to 2023 -- $466,133 $466,133

6 2024 to 2026 -- $466,133 $466,133

Total $1,864,532 $2,796,797 $932,266

Annual Average $93,227 $139,840 $46,613
E-9

Annualized at 3% $87,798 $131,412 $43,614

Annualized at 7% $81,056 $120,247 $39,190

1 The non-italicized reporting cycles are baseline, five-year cycles, and the italicized reporting cycles are alternative, three-year 

cycles.

E.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 Chapter3. Under this alternative option, the reporting burden for 

industry would be the same as the combined post amendment burden shown in Table 4-52; 

however the reporting cycle would be shortened from four years to three years. For both industry 

and the Agency, the post-amendment burden would increase from the baseline because of the 

increased reporting frequency. 

The total increase in industry burden over 17 years as a result of increasing the reporting 

frequency to three years from four years is 2.64 million hours (see Table E-14). This equates to 

an annual increase in the reporting burden of approximately 0.13 million hours.

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

All the Proposed Amendments are Considered

Reporting Cycle1 Years

Baseline Burden Post-Amendment 

Burden

Change in 

Burden

(millions of hours) (millions of hours) (millions of 

hours)

1 2007 to 2011 3.24 3.24 0.00

2

2012 to 2015 2.64 --

2012 to 2014 -- 2.64 0.00

3

2016 to 2019 2.64 --

2015 to 2017 -- 2.64 0.00

4

2020 to 2023 2.64 --

2018 to 2020 -- 2.64 0.00

5 2021 to 2023 -- 2.64 2.64

Total 11.15 13.79 2.64

Annual Average 0.56 0.69 0.13

1 The non-italicized reporting cycles are baseline, four-year cycles, and the italicized reporting cycles are alternative, three-year 

cycles.

The industry cost for a three-year reporting cycle is shown in Table E-15. Baseline costs are 

taken from Table 4-50. Over a 17-year period, total costs would increase by $162.08 million, 

with an annualized increase of $8.93 million at a three percent discount rate and $8.07 million at 

a seven percent discount rate. 
E-10

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

Proposed Amendments are Considered

Reporting Cycle1 Years Baseline Cost

Post-Alternative 

Option Cost

Change from 

Baseline

(2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $19.88 $19.88 $0.00

2

2012 to 2015 $162.08 --

2012 to 2014 -- $162.08 $0.00

3

2016 to 2019 $162.08 --

2015 to 2017 -- $162.08 $0.00

4

2020 to 2023 $162.08 --

2018 to 2020 -- $162.08 $0.00

5 2021 to 2023 -- $162.08 $162.08

Total $506.13 $668.21 $162.08

Annual Average $29.77 $39.31 $9.53

Annualized at 3% $38.29 $47.23 $8.93

Annualized at 7% $35.70 $43.76 $8.07

1 The non-italicized reporting cycles are baseline, four-year cycles, and the italicized reporting cycles are alternative, three-year 

cycles.

The Agency baseline burdens of 2,439 hours (first reporting cycle) and 2,456 (future 

reporting cycles) when all the proposed amendments are considered together is taken from Table 

5-43. The annual reporting option is expected to increase Agency burden by approximately 2,500 

hours over 17 years when all amendments are considered (see Table E-16). 

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

Proposed Amendments are Considered

Reporting Cycle1 Years

Baseline Burden Post-Amendment 

Burden

Change in 

Burden

(hours) (hours) (hours)

1 2007 to 2011 2,439 2,439 0

2

2012 to 2015 2,456 -- 0

2012 to 2014 -- 2,456

3

2016 to 2019 2,456 -- 0

2015 to 2017 -- 2,456

4

2020 to 2023 2,456 -- 0

2018 to 2020 -- 2,456

5 2021 to 2023 -- 2,456 2,456

Total 9,807 12,264 2,456

Annual Average 577 721 145

1 The non-italicized reporting cycles are baseline, four-year cycles, and the italicized reporting cycles are alternative, three-year 

cycles.

Table E-17 contains the total Agency cost under a three-year reporting cycle. EPA estimates 

the Agency cost would increase by approximately $288,500 over a 17-year period. The 

annualized cost is expected to increase by $15,600 with a three percent discount rate and $14,400

with a seven percent discount rate.
E-11

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

Proposed Amendments are Considered

Reporting Cycle1 Years

Baseline Cost Post-Alternative 

Option Cost

Change from 

Baseline

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

1 2007 to 2011 $286,580 $286,580 $0

2

2012 to 2015 $288,450 -- $0

2012 to 2014 -- $288,450

3

2016 to 2019 $288,450 -- $0

2015 to 2017 -- $288,450

4

2020 to 2023 $288,450 -- $0

2018 to 2020 -- $288,450

5 2021 to 2023 -- $288,450 $288,450

Total $1,151,930 $1,440,380 $288,450

Annual Average $67,761 $84,728 $16,968

Annualized at 3% $63,741 $79,637 $15,896

Annualized at 7% $58,612 $72,971 $14,359

1 The non-italicized reporting cycles are baseline, four-year cycles, and the italicized reporting cycles are alternative, three-year 

cycles.

E.2.3 Small Entity Analysis

The following section provides a preliminary assessment of the impact 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 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 definition,15 and 24.8 percent (280 

companies) are considered small under the TSCA sales-based definition.16 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 salesbased 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 4-53 shows the incremental cost to the industry. Because these costs would be incurred 

once every three years under a three-year reporting cycle, these costs were summed and 

annualized over three years at both a three percent and seven percent discount rate.17 As shown 

in Table E-18, these costs were divided by the total number of sites expected to submit data, for 

 

15Threshold of 1,000 employees.

16 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.

17 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.
E-12

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 E-18, under the employment-based definition, a small parent company 

affected by the rule on average has sales of more than $412.7 million. The annualized costs of 

the proposed IUR rule amendments per small parent company, however, are $14,096 at a seven 

percent discount rate, and even lower under a three percent discount rate. The cost-to-sales ratio 

for an average small company under the employment-based SBA definition would be 0.0034

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 $32.7 million or lower. The cost-to-sales ratio for an average small company 

under the sales-based definition would be 0.13 percent or less.

Using the highest annual cost shown in Table E-18 of $15,378, a small company would have 

to have annual sales of less than $1.58million in order to have a cost-to-sales ratio larger than 

one percent. 

Table E-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

Incremental Costs of Proposed 

Other Amendments $91,871,064

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

Total Number of Sites 4,085

Annualized Costs per Site $7,719 $8,009 $7,719 $8,009 

Number of Sites per Small

Parent Company 1.76 1.92

Annualized Costs per Small 

Parent Company

$13,586 $14,096 $14,821 $15,378 

Annual Sales per Small Parent 

Company $412,713,310 $412,713,310 $11,821,104 $11,821,104

Cost-to-Sales Ratio 0.0033% 0.0034% 0.1254% 0.1301%

Number of Companies 

Potentially Affected 466 280

E.3 Change the Threshold for Reporting to 10,000 lb

The Agency also considered an option that would lower the reporting threshold from 25,000 

lb to 10,000 lb. Prior to the amendments to the 2006 IUR rule, EPA required sites to submit a 

Form U for chemical substances 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.
E-13

E.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 E-19contains 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 chemical substances in amounts between 10,000 lb and 25,000 lb. Thirteen 

percent of all reports, or 3,595 reports, were submitted in 2002 for chemical substances produced 

between 10,000 lb and 25,000 lb

Table E-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 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 787 additional sites would submit 

reports as a result of the option. 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 

would be for production volumes less than 300,000 lb, EPA assumes only additional partial 

reports (Part IIs) would be submitted. 

As described in Section 4.2.2, sites need to complete Part I of Form U only once, and 

complete Part II and Part III (as applicable) for each chemical substance manufactured (or 

imported). Taking this allocation of activities into consideration, and using the baseline unit 

burden estimates as shown in Table 4-2, Table E-20 shows the industry burden estimate as a 

result of this option. The Agency estimates the option would cause an increase in industry burden 

of approximately 94,600 hours. 
E-14

Table E-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 postamendment value.

The cost of the option was calculated using the unit costs shown in Table 4-5. Table E-21

shows the industry cost estimate as a result of this option. The cost to industry is expected to 

increase by $5.52 million.

Table E-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 postamendment value.

The baseline burden to EPA of data processing and entry would not change from the baseline 

of 2,080 hours (see Section 5-2). However, the increased number of reports and submitters 

would increase the burden to the Agency. While the burden per reporting cycle would not change 

as a result of this option, more frequent reporting would increase costs to the Agency. Table E-22

contains the total Agency of the option. EPA’s burden is expected to increase by a total of 159

hours.
E-15

Table E-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 postamendment value.

Table E-23 shows the estimated change in cost to EPA as a result of the option. The Agency 

estimates a cost increase of approximately $16,600. 

Table E-23: Change in Agency Cost as a Result of Changing the Threshold for Reporting 

to 10,000 lb

Cost to 

Process Part 

I Submission 

(2008$)

Number 

of Sites

Cost to 

Process 

Part II 

(2008$ per 

report)

Number 

of 

Reports

(with 

Part II)

Cost to 

Process 

Part 

III 

(2008$

per 

report)

Number 

of 

Reports 

(with 

Part

III)

Agency Cost

(2008$)

(a) (b) (c) (d) (e) (f) (g) 

=(a*b)+(c*d)+(e*f)

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

PostAmendment $1.78 4,872 $4.40 29,349 $5.61 17,075 $233,529

Change 

from the 

Baseline

$0.00 787 $0.00 3,453 $0.00 0 $16,580

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

E.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 E-19). In addition, EPA 

assumes this option would affect the proposed amendment to lower the threshold for reporting 
E-16

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 proposed amendments and the 10,000 lb. threshold 

reporting option are considered, is found in Table E-25. 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 option

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 E-19). To estimate this 

effect on the proposed amendments, EPA multiplied the total number of sites calculated in Step 2

(0 in the first reporting cycle and 204 in future reporting cycles) by 1.19 and the number of 

partial reports calculated in step 2 (3,975 in the first reporting cycle and 5,469 in future reporting 

cycles) by 1.13. EPA then added the additional number of reports and sites calculated in Section 

E.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 nonexempt chemical substances 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 (8,219 in the first reporting cycle and 9,484 in future reporting cycles), 

and added the Step 3 total for Part II reports (7,985 in the first reporting cycle and 9,632 in future 

reporting cycles), minus the number of new Part III reports as a result of making ECAs ineligible 

for exemptions (16), the number of new Part II reports as a result of changing the method of 

determining whether a manufacturer is subject to reporting requirements (0 in the first reporting 

cycle and1,295 in future reporting cycles) and the number of new Part II reports that will be for 

ECA chemical substances as a result of the 10,000 lb threshold (80 in in the first reporting cycle

and 86in future reporting cycles). The number of ECA chemical substances as a result of the 

10,000 lb threshold in the first reporting cycle is calculated by multiplying the number of ECA 

chemical substances by 1.13. In future reporting cycles, the number of ECA chemical substances 

as a result of the 10,000 lb threshold is calculated by multiplying the number of ECA chemical 

substances after the five percent has been taken into account, 649, by 1.13 to calculate the total 

number of ECA chemical substances take into account the five percent. This number, 649, is 

then multiplied by 1.13. The number of reports with Part III would increase by 16,801 in the first 

reporting cycle and 17,737 in future reporting cycles.

Step 5: Calculate the number of reports when all amendments are considered together.

The total number of additional reports from Step 4 is added to the number of reports in the 

baseline to calculate the total number of reports when all the proposed amendments are 

considered together. There would now be a total of 4,872 Part Is, 33,854 Part IIs and 33,156 Part 

IIIs in the first reporting cycle. In future reporting cycles there would 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, 698 reports, is equal to the number of ECA chemical substances times 1.13 (618 x 

1.13=698).In future cycles, the difference of 735 reports is equal to the number of partially 
E-17

exempt reports with the five and 13 percent increase taken into account ((618x1.05)x1.13)) = 

735).

Table E-24: Change in the Number of Sites and Reports Submitted of All Amendments 

Combined with the 10,000 lb Reporting Threshold (First Reporting Cycle)

Modification Number of Sites Number of Reports Number of Reports 

with Part III

Baseline 4,085 25,896 17,075

Step 1: Sum affected amendments

Eliminate 300,000 lb Threshold for Downstream 

Processing and Use Reporting (see Section 4.4.6) 

-- -- 8,203

Eliminate the 25,000 lb Threshold for Specific 

regulated Chemical substances (see Section 4.4.5) 

-- 4,018 --

Make Chemical substances 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 -- 3,975 8,219

Method for Determining Whether you are Subject to 

the IUR Reporting Requirements (see Section 4.4.3)

0 0 0

STEP 2 TOTAL 0 3,975 8,219

Step 3:Account for 10,000 lb reporting threshold

Step 2 Total Multiplied by 1.19 for sites and 1.13 for 

reports

0 4,505 --

10,000 lb threshold reporting threshold (See Section 

E.3.1)

787 3,453 --

STEP 3 TOTAL(Step 3 + Step 2 Total ) 787 7,985 8,219

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

-- -- 7,826

STEP4 TOTAL (Step 4 + Step 3 Total ) 787 7,985 16,801

Step 5:Calculate the total number of reports by adding the Step 3 Total to the Baseline 

STEP 5 TOTAL (Baseline + Step 3 Total) 4,872 33,854 33,156
E-18

Table E-25: Change in the Number of Sites and Reports Submitted of All Amendments 

Combined with the 10,000 lb Reporting Threshold (Future Reporting Cycles)

Modification Number of Sites Number of Reports Number of Reports 

with Part III

Baseline 4,085 25,896 17,075

Step 1: Sum affected amendments

Eliminate 300,000 Threshold for Downstream 

Processing and Use Reporting (see Section 4.4.6) 

-- -- 8,203

Eliminate the 25,000 lb Threshold for Specific 

regulated Chemical substances (see Section 4.4.5) 

-- 4,018 --

Make Chemical substances 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: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 

E.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 proposed 

amendments are considered in Table E-26. The baseline values are taken from Table 4-52. 

Lowering the reporting threshold to 10,000 lb would not increase the industry per-form burden; 

however it would increase the number of Form Us submitted. EPA estimates this option would 

increase the industry burden by 0.44 million hours in the first reporting cycle and by 0.35 million 

hours in all future reporting cycles. 
E-19

Table E-26: Industry Burden as a Result of Changing the Threshold for Reporting to 

10,000 lb when All Proposed Amendments are Considered

Burden 

per Part I 

of Report 

and 

Submission

(hours per 

site )

Number 

of Sites

Burden for

Part II and 

Record 

Keeping(hours 

per report)

Number 

of 

Reports

(with 

Part II)

Burden

for 

Part 

III 

(hours 

per 

report)

Number 

of 

Reports 

(with 

Part 

III)

Total Burden

(millions of hours)

(a) (b) (c) (d) (e) (f) (g) 

=(a*b)+(c*d)+(e*(f)

First-year 

Baseline 35.17 4,085 22.19 29,871 83.02 29,253 3.24 

First year, 

Post 

Amendment

35.17 4,872 22.19 33,854 83.02 33,156 3.68 

Change from 

the Baseline, 

First year

0.00 787 0.00 3,983 0.00 3,903 0.44

Future-Cycle 

Baseline 11.05 4,289 18.35 31,365 65.63 30,716 2.64 

Future Cycle, 

Post 

Amendment

11.05 5,115 18.35 35,547 65.63 34,812 2.99 

Change from 

the Baseline, 

Future 

Cycles

0.00 826 0.00 4,182 0.00 4,096 0.35

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

Baseline costs are taken from Table 4-53. The 10,000 lb reporting threshold is expected to 

increase industry cost by $27.06 million during the first reporting cycle and by $21.79 million 

during all future reporting cycles (See Table E-27). 
E-20

Table E-27: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 

lb when All Proposed Amendments are Considered

Cost per 

Part I of 

Report and 

Submission

(2008$)

Number 

of Sites

Cost for Part II

and Record 

Keeping(2008$)

Number 

of 

Reports

(with 

Part II)

Cost

for 

Part 

III and 

(2008$)

Number 

of 

Reports 

(with 

Part 

III)

Total Burden

(millions of 2008$)

(a) (b) (c) (d) (e) (f) (g) 

=(a*b)+(c*d)+(e*(f)

First-year 

Baseline $2,192 4,085 $1,346 29,871 $5,117 29,253 $198.84 

First year, 

Post 

Amendment

$2,192 4,872 $1,346 33,854 $5,117 33,156 $225.89 

Change 

from the 

Baseline, 

First year

$0 787 $0 3,983 $0 3,903 $27.06 

FutureCycle 

Baseline

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

Future 

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

Change 

from the 

Baseline, 

Future 

Cycles

$0 826 $0 4,182 $0 4,096 $21.79 

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

The annual industry burden over a 25-year period is shown in Table E-28. Over a 25-year 

period, the total industry burden would increase by 2.12 million hours when all the proposed 

amendments are considered.

Table E-28: Industry Burden under the Alternative Option of a Lowered Reporting Threshold and 

All Other Amendments when All Proposed Amendments are Considered

Reporting 

Cycle Years Baseline Cost Post-Alternative 

Option Cost

Change from 

Baseline

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 3.24 3.68 0.44

2 2012 to 2015 2.64 2.99 0.35

3 2016 to 2019 2.64 2.99 0.35

4 2020 to 2023 2.64 2.99 0.35

5 2023 to 2027 2.64 2.99 0.35

6 2026 to 2031 2.64 2.99 0.35

Total 16.43 18.64 2.21

Annual Average 0.66 0.75 0.09

Table E-29 shows the annual industry cost over a 25-year period as a result of lowering the 

reporting threshold. EPA estimates a 10,000 lb reporting threshold would increase costs by 
E-21

approximately $136.00 million. Annualized costs range from $5.18 million with a three percent 

discount rate to $4.84 million with a seven percent discount rate. 

Table E-29: Change in Industry Cost as a Result of Changing the Threshold for Reporting 

to 10,000 lb and All Other Amendments when All Proposed Amendments are Considered

Reporting 

Cycle Years Baseline Cost Post-Alternative 

Option Cost

Change from 

Baseline

(2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $198.84 $225.89 $27.06

2 2012 to 2015 $162.08 $183.87 $21.79

3 2016 to 2019 $162.08 $183.87 $21.79

4 2020 to 2023 $162.08 $183.87 $21.79

5 2023 to 2027 $162.08 $183.87 $21.79

6 2026 to 2031 $162.08 $183.87 $21.79

Total $1,009.25 $1,145.25 $136.00 

Annual Average $40.37 $45.81 $5.44 

Annualized at 3% $38.40 $43.58 $5.18 

Annualized at 7% $35.83 $40.66 $4.84 

As previously explained in Section E.3.1, the Agency burden per-report would not change as 

a result of lowering the reporting threshold. However, the number of reports and the number of 

sites submitting reports would increase. Table E-30 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 would increase by 48 hours in the first reporting cycle and 51hours 

during each future reporting cycle.
E-22

Table E-30: Agency Burden as a Result of Lowered Threshold Reporting and All Other 

Amendments when All Proposed Amendments are Considered

Burden to 

Process 

Part I 

Submission 

(hours)

Number 

of Sites

Burden

to 

Process 

Part II 

(hours 

per 

report)

Number 

of 

Reports

(with 

Part II)

Burden to 

Process 

Part III 

(hours 

per 

report)

Number 

of Reports 

(with

Part III)

Agency Burden

(hours)

(a) (b) (c) (d) (e) (f) (g) 

=(a*b)+(c*d)+(e*(f)

Baseline 0.002 4,085 0.0056 29,871 0.0063 29,253 2,439

PostAmendment 0.002 4,872 0.0056 33,854 0.0063 33,156 2,487

Change from 

the Baseline 0 787 0 3,983 0 3,903 48.29

Future-cycle 

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

Future cycle, 

Post 

Amendment

0.002 5,115 0.006 35,547 0.006 34,812 2,507

Change from 

the Baseline, 

Future cycles

0 826 0 4,182 0 4,096 50.69

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

Table E-31 contains the Agency cost as a result of lowering the reporting threshold. Baseline values are 

taken from Table 5-43. Lowering the 10,000 lb threshold is expected to increase the Agency cost by 

approximately $5,000 during the first reporting cycle and $5,300 in future reporting cycles. 
E-23

Table E-31: Agency Cost as a Result of Lowered Threshold Reporting and All Other 

Amendments when All Proposed Amendments are Considered

Cost to 

Process 

Part I 

Submission 

(2008$)

Number 

of Sites

Cost to 

Process 

Part II 

(2008$

per 

report)

Number 

of 

Reports

(with 

Part II)

Cost to 

Process 

Part 

III 

(2008$

per 

report)

Number 

of 

Reports 

(with 

Part 

III)

Agency Burden

(2008$)

(a) (b) (c) (d) (e) (f) (g) 

=(a*b)+(c*d)+(e*(f)

Baseline $0.203 4,085 $0.58 29,871 $0.66 29,253 $37,396

PostAmendment $0.203 4,872 $0.58 33,854 $0.66 33,156 $42,433

Change from 

the Baseline 0 826 $0.00 4,163 $0.00 4,096 $5,037

Future-cycle 

Baseline $0.203 4,289 $0.58 31,365 $0.66 30,716 $39,266

Future cycle, 

Post 

Amendment $0.203 5,115 $0.58 35,547 $0.66 34,812 $44,554

Change from 

the Baseline, 

Future cycles $0.00 826 $0.00 4,182 $0.00 4,096 $5,287

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

The annual Agency burden over a 25-year period is shown in Table E-32. Over a 25-year 

period, the total Agency burden would increase by 302 hours when all the proposed amendments 

are considered.

Table E-32: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and 

All Other Amendments when All Proposed Amendments are Considered

Reporting Cycle Years Baseline Burden Post-Alternative 

Option Burden

Change from 

Baseline

hours hours Hours

1 2007 to 2011 2,439 2,487 48.29

2 2012 to 2015 2,456 2,507 50.69

3 2016 to 2019 2,456 2,507 50.69

4 2020 to 2023 2,456 2,507 50.69

5 2023 to 2027 2,456 2,507 50.69

6 2026 to 2031 2,456 2,507 50.69

Total 14,720.86 15,022.62 301.76

Annual Average 588.83 600.90 12.07

Table E-33 contains the annual Agency cost over a 25-year period as a result of lowering the 

reporting threshold. EPA estimates a 10,000 lb reporting threshold would increase the Agency 

cost by approximately $31,500 over 25 years. Annualized increases in costs range from $1,100 

with a seven percent discount rate to $1,200 with a three percent discount rate. 
E-24

Table E-33: Change in Agency Cost as a Result of Changing the Threshold for Reporting 

to 10,000 lb and All Other Amendments when All Proposed Amendments are Considered

Reporting Cycle Years Baseline Cost Post-Alternative 

Option Cost

Change from 

Baseline

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

1 2007 to 2011 $37,396 $42,433 $5,037 

2 2012 to 2015 $39,266 $44,554 $5,287 

3 2016 to 2019 $39,266 $44,554 $5,287 

4 2020 to 2023 $39,266 $44,554 $5,287 

5 2023 to 2027 $39,266 $44,554 $5,287 

6 2026 to 2031 $39,266 $44,554 $5,287 

Total $233,727 $265,201 $31,474 

Annual Average $9,349 $10,608 $1,259 

Annualized at 3% $8,770 $9,951 $1,181 

Annualized at 7% $8,020 $9,100 $1,080 

E.3.3 Small Entity Analysis

The following section provides a preliminary assessment of the impact a 10,000 lb reporting 

threshold may have on small entities by examining 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 all the 

proposed final 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 definition18, and 24.8 

percent (280 companies) are considered small under the TSCA sales-based definition19. EPA 

also estimated an average of approximately 1.76 sites per small company under the employmentbased 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 E-29 shows the cost to the industry as a result of annual reporting. Because these costs 

would be incurred once every four years under a four-year reporting cycle, these costs were 

summed and annualized over four years at both a three percent and seven percent discount rate20. 

As shown in Table E-34, 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 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.

 

18Threshold of 1,000 employees.

19 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.

20 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.
E-25

As shown in Table E-34 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 $11,854 at a seven 

percent discount rate, and even lower under a three percent discount rate. The cost-to-sales ratio 

for an average small company under the employment-based SBA definition would be 0.003

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 $12,931 or lower. The cost-to-sales ratio for an average small company under the 

sales-based definition would be 0.11 percent or less.

Using the highest annual cost shown in Table E-34 of $12,931 a small company would have 

to have annual sales of less than $1.29 million in order to have a cost-to-sales ratio larger than 

one percent. 

Table E-34: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a 10,000 lb

Reporting Threshold

Employment-based Definition Sales-based Definition 

3% Discount 

Rate

7% Discount 

Rate

3% Discount 

Rate

7% Discount 

Rate

Incremental Costs of 10,000 lb threshold $27,055,019 

Incremental Costs of Proposed Other 

Amendments $91,871,064 

Total Annualized Costs $31,062,459 $32,813,387 $31,062,459 $32,813,387

Total Number of Sites 4,872

Annualized Costs per Site $6,376 $6,735 $6,376 $6,735 

Number of Sites per Small Parent 

Company 1.76 1.92

Annualized Costs per Small Parent 

Company $11,221 $11,854 $12,241 $12,931 

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

Cost-to-Sales Ratio 0.0027% 0.0029% 0.1036% 0.1094%

Number of Companies Potentially Affected 466 280
F-1

Appendix F. Additional Exposure-Related Data Elements

In developing the proposed rule EPA considered 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 

substance risks. The ability to quantify chemical substance risks would further improve the Agency’s 

ability to identify and manage those risks. The burden and cost for these additional exposure-related data

elements is described in the following Appendix. Because this data collection was only considered during 

the proposed rule, the total costs, submission dates, and annualization periods associated with them may 

not match what is presented in the main text for the final rule. The additional exposure-related data 

elements and brief descriptions are as provided in Table F-1: EPA solicited 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 chemical substances. Additionally, the Agency was interested in 

whether any additional data should be collected, and in any other considerations relating to the collection 

of additional data. EPA also solicited 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 considered 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 were not included as part of the proposed rule; therefore, they were 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 F-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).
F-2

Data Element Description

5

Days of operation per 

year or number of batches 

per year

If the chemical substance is produced in discrete batches, indicate the number of 

batches necessary to produce the reported production volume; if the chemical 

substance is produced in a continuous process, indicate the number of days of 

operation per year needed to produce the reported production volume.

6 Unit operations

List the unit operations needed to produce the chemical substance. Unit operation 

means a functional step in manufacturing, processing, or use operation where 

substances undergo chemical changes, or changes in temperature, pressure, 

physical state, concentration, purity, or similar characteristics. Examples of unit 

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 are

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 type (gas or vapor, aqueous or liquid solution, or 

solid) and media (stack air, fugitive air, surface water, on-site or off-site land or 

incineration, POTW, or other (specify)) which describes the release stream 

containing the chemical.
F-3

Data Element Description

17

Quantity of substance 

released a) directly to the 

environment or b) into 

control technology to the 

environment

For each release, provide the quantity (in pounds) of chemical substance released:

a) directly to the environment; or

18 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 National Pollutant Discharge 

Elimination System (NPDES) number 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.
F-4

Data Element Description

30 Storage and shipping 

containers used

List the types of containers used to transport or store the chemical substance and 

their capacity. Examples of containers include 1-liter bottles, 5-gallon pails, 55-

gallon drums, 5,000-gallon tank trucks, and 20,000-gallon railcars.

Industrial Processing or Use Occupational Exposures Information

31 Worker activities

Describe each specific activity in 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 are

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 type (gas or vapor, aqueous or liquid solution, or 

solid) and media (stack air, fugitive air, surface water, on-site or off-site land or 

incineration, POTW, or other (specify)) which describes the release stream 

containing the chemical.

40 Quantity of substance 

released a) directly to the 

environment or b) into 

control technology to the 

environment

For each release, provide the quantity (in pounds) of chemical substance released: 

a) directly to the environment; or 

41 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).

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.
F-5

Data Element Description

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. 
F-6

F.1 Estimated Number of Affected Entities

In order to estimate the burden and cost of collecting the additional data, EPA assumes the impacts 

on manufacturers and processors would be different. Manufacturers would be required to complete an 

integrated Form U, which would be a Form U revised to incorporate the new data elements. For the 

purpose of this analysis, EPA assumes all of the amendments currently being proposed also would be 

included. EPA assumes processors, on the other hand, would be required to complete a tailored Form U 

focusing only on the additional processing and use information.

Manufacturers

For manufacturers, EPA assumes the numbers of 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 4-48, a total 

of 4,085 manufacturers are expected to submit 29,871 reports in the first reporting cycle, including both 

full and partial reports, when all the proposed amendments are considered. As shown in Table 4-49, in 

future reporting cycles a total of 4,289 manufacturers are expected to submit a total of 31,365 reports. To 

the extent any specific chemical substances 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 substance releases and waste 

management activities from manufacturers, processors, and users of a set of 581 toxic chemical 

substances and 30 toxic chemical substance categories. The chemical substances regulated under the TRI 

program are a smaller set than those regulated under the IUR rule, but the TRI data collection activity 

currently is the most comprehensive information collection EPA administers for chemical substance

processors. Therefore, EPA assumes 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 chemical substances (i.e., the chemical substances listed in the public 2006 IUR 

database).21 Processors submitted TRI data on an average of 220 of the IUR chemical substances during 

each of the four years of interest. For this analysis, EPA counted as a “processor” each TRI submitter 

indicating it processes a toxic chemical substance as a reactant, as a formulation component, as an article 

component, for repackaging, or as an impurity; or, that it otherwise uses the chemical substance as a 

chemical substance processing aid.22Because EPA assumes any company that both manufactures and 

processes a chemical substance would be considered a manufacturer for the purposes of IUR reporting of 

the additional data elements, TRI submitters who indicated they also manufactured or otherwise used a 

chemical substance were filtered out of the dataset.

The TRI data revealed an average of 137 processors reported information per TRI chemical 

substance. However, the average value is greatly skewed by certain high-volume chemical substances 

 

21 The TRI program may collect data on certain chemicals for which IUR reporting is not required. A list of 

CASRNs for the non-confidential 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.

22TRI submitters indicate their activities and uses of the toxic chemical at the facility in Part II Section 3 of Form R.
F-7

processed by a large number of processors.23 Therefore, EPA chose to use the median number of 15 

processors per chemical substance, assuming it to be more representative of the universe of chemical 

substance processors who would report under the IUR rule.

Information was reported for a total of 6,140 chemical substances under the IUR rule in 2006. By 

applying the average number of processors per chemical substance derived from TRI data, EPA estimates

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 the universe of processors is different under the TRI regulation 

and IUR rule. Because the sets of chemical substances covered under the TRI and IUR rules are different, 

the median number of processors per chemical substance may be an over- or underestimate. (EPA 

attempted to minimize this by filtering the TRI data to only include known IUR chemical substances, but 

not all IUR chemical substances 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 EPA may use to define a “processor” for the purpose of the IUR rule may 

cause the median number of processors per chemical substance 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 chemical substances (i.e., those 

manufactured, processed, or otherwise used in amounts greater than one million pounds) or for chemical 

substances meeting other specific criteria; as a result, processors of small volumes may not be included, 

causing the median number to be an underestimate.

F.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 the incremental cost for the additional data 

elements would be similar to the estimated burden to complete a premanufacture notice 

(PMN).24Therefore, 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 every site would 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.

 

23 For example, an average of 3,240 processors per year reported for lead alone.

24Anyone 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.
F-8

Using the numbers of manufacturing sites and reports as estimated in Section 4.5 of this report, EPA 

estimates the total burden to manufacturers to submit additional exposure-related data as part of their IUR 

reporting is 2.78 million hours in the first reporting cycle and 2.33 million hours in all future reporting 

cycles (See Table F-2: ).

This approach is limited to the extent the data elements requested in any modification to the IUR 

match the PMN form and the burden it imposes. Furthermore, the PMN form includes some site and 

chemical identification data which may overlap with the data provided on IUR Part I; however, this 

overlap was considered to be minimal.

Table F-2: Change in Industry Burden to Manufacturers as a Result of Additional 

Exposure-Related Data Elements

Burden for 

Rule 

Familiarizati

on, 

Compliance 

Determinati

on,

Submission 

and to 

Prepare

Part I 

(hours per 

site)

Numb

er of 

Sites

Burde

n for 

Recor

d 

Keepi

ng 

and to 

Prepa

re 

Part 

II 

(hours 

per 

report

)

Numb

er of 

Repor

ts 

(with 

Part 

II)

Burde

n to 

Prepa

re 

Part 

III 

(hours 

per 

report

)

Numb

er of 

Repor

ts 

(with 

Part 

III)

Burden 

to 

Comple

te New 

Data 

Elemen

ts 

(hours 

per 

report)

Numbe

r of 

Report

s (with 

New 

Data 

elemen

ts)

Industry 

Burden 

(millions of 

hours)

(a) (b) (c) (d) (e) (f) (g) (h)

(g) = 

(a* b)+

(c*d)+(e*f)+(g

*h)

Manufacturer Burden (First 

Cycle)

Considering all Proposed 

Amendments 

(As Estimated in Table 4-47)

35.17 4,085 22.19 29,871 83.02 29,253 0.00 0 3.24

Total Manufacturer Burden 

(First Cycle) Including 

Additional Data Elements

35.17 4,085 22.19 29,871 83.02 29,253 93 29,871 6.01

Incremental Increase due to 

Additional Data Elements 

(First Cycle)

0.00 0 0.00 0 0.00 0 93.00 29,871 2.78

Manufacturer Burden (Future 

Cycles)

Considering all Proposed 

Amendments 

(As Estimated in Table 4-47)

11.05 4,289 18.35 31,365 65.63 30,716 0 0 2.64

Total Manufacturer Burden 

(Future Cycles) Including 

Additional Data Elements

11.05 4,289 18.35 31,365 65.63 30,716 74.4 31,365 4.97

Incremental Increase due to 

Additional Data Elements 

(Future Cycles)

0.00 0 0.00 0 0.00 0 74.40 31,365 2.33

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

Table F-3 contains the annual burden to manufacturers of the additional enhanced data elements over 

a 25-year period. The baseline burden estimates for completing Form U after all the proposed 

amendments are considered is taken from Table 4-57. EPA estimates over a 25-year period, the total 

burden to manufacturers for completing Form U, including the additional data elements, would be 30.88

million hours. The data elements add 14.45 million hours to the industry burden over this period.
F-9

Table F-3: Schedule of Annual Industry Burden to Manufacturers if All Proposed 

Amendments Are Implemented

Reporting Cycle Years

Baseline Form U 

Burden 

(When all 

Amendments are 

Considered)

(millions of hours)

Burden for 

Enhanced Data 

Elements 

(millions of hours)

Total Industry 

Burden

(millions of 

hours)

1 2007 to 2011 3.24 2.78 6.01

2 2012 to 2015 2.64 2.33 4.97

3 2016 to 2019 2.64 2.33 4.97

4 2020 to 2023 2.64 2.33 4.97

5 2023 to 2027 2.64 2.33 4.97

6 2026 to 2031 2.64 2.33 4.97

Total 16.43 14.45 30.88

Annual Average 0.66 0.58 1.24

Manufacturers and Processors Combined

Because processors would not need to complete manufacturing information on Form U, Section II 

and other elements of Form U may not be applicable. For the purpose of this estimation, EPA assumes the 

burden on processors to complete an IUR form 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, 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 F-4. 

This approach is also limited to the extent the data elements requested from processors in any 

modification to the IUR match the PMN form and the burden it imposes. 

Table F-4: Change in Industry Burden to Processors as a Result of Additional ExposureRelated 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.
F-10

Table F-5 contains the annual burden to processors of the additional enhanced data elements over a 

25-year period. EPA estimates over a 25-year period, the total burden to processors for completing Form 

U, including the additional data elements, would be 42.83 million hours. This burden consists of labor to 

complete only the additional data elements because processors currently are not required to submit Form

U.

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

Reporting Cycle Years

Baseline Form U 

Burden

(When all 

Amendments are 

Considered)

(millions of hours)

Burden for 

Enhanced 

Data 

Elements 

(millions of 

hours)

Total Industry Burden

(millions of hours)

1 2007 to 2011 0.00 8.57 8.57

2 2012 to 2015 0.00 6.85 6.85

3 2016 to 2019 0.00 6.85 6.85

4 2020 to 2023 0.00 6.85 6.85

5 2023 to 2027 0.00 6.85 6.85

6 2026 to 2031 0.00 6.85 6.85

Total 0.00 42.83 42.83

Annual Average 0.00 1.71 1.71

The total industry burden to both manufacturers and processors if EPA were to require them to 

provide the additional exposure data are calculated by summing the total additional burdens for 

manufacturers and processors. The result is an estimated 11.34 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 F-6. 

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

Additional Exposure-Related Data Elements

Total Burden to 

Manufacturers 

(millions of hours)

Total Burden to

Processors

(millions of 

hours)

Total Industry 

Burden

(millions of 

hours)

Burden (First Cycle)

Considering all Proposed Amendments 3.24 0.00 3.24

Total Burden (First Cycle) Including Additional 

Data Elements 6.32 8.57 14.88

Incremental Increase due to Additional Data 

Elements (First Cycle)

2.78 8.57 11.34

Burden (Future Cycles)

Considering all Proposed Amendments 2.64 0.00 2.64

Total Burden (Future Cycles) Including 

Additional Data Elements 4.97 6.85 11.83

Incremental Increase due to Additional Data 

Elements (Future Cycles)

2.33 6.85 9.19

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

Table F-7contains the annual burden to industry of the additional enhanced data elements 

over a 25-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 over a 25-year 

period, the total burden to industry for completing Form U, including the additional data 
F-11

elements, would be 73.70 million hours. The additional data elements add 57.27 million hours to 

the industry burden over this period. 

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

Proposed Amendments Are Implemented

Reporting Cycle Years

Baseline Form U Burden

(When all Amendments are Considered)

(millions of hours)

Form U 

Burden 

with 

Enhanced 

Data 

Elements

(millions 

of hours)

Total Industry 

Burden

(millions of 

hours)

1 2007 to 2011 3.24 11.34 14.58

2 2012 to 2015 2.64 9.19 11.82

3 2016 to 2019 2.64 9.19 11.82

4 2020 to 2023 2.64 9.19 11.82

5 2023 to 2027 2.64 9.19 11.82

6 2026 to 2031 2.64 9.19 11.82

Total 16.43 57.27 73.70

Annual Average 0.66 2.29 2.95

F.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 Section4.2.1. No clerical cost was calculated because EPA assumes electronic 

submission requirement will eliminate all clerical burden for processing and submitting Form U. As 

shown in Table F-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.

Table F-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 F-9. EPA 

estimates the option would cost manufacturers an additional $169 million during the first reporting cycle 

and an additional $142 million during all future reporting cycles. 
F-12

Table F-9: Change in Industry Cost to Manufacturers as a Result of Additional ExposureRelated Data Elements

Cost for 

Submission, 

Compliance 

Determinati

on, Rule 

Familiarizat

ion, and to 

Prepare 

Part I

(2008$)

Numb

er of 

Sites

Cost 

for 

Recor

d 

Keepi

ng 

and to 

Prepa

re 

Part 

II

(2008$

)

Numb

er of 

Repor

ts 

(with 

Part 

II)

Cost 

to 

Prepa

re 

Part 

III 

(2008

$)

Numb

er of 

Repor

ts 

(with 

Part 

III)

Cost to 

Compl

ete

New 

Data 

Elemen

ts 

(2008$)

Numbe

r of 

Reports 

(with 

New 

Data 

Elemen

ts)

Industry Cost 

(millions of 

2008$)

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a* b) 

+(c*d)+(e*f)+(

g*h)

Manufacturer Cost (First 

Cycle)

Considering all Proposed 

Amendments 

(As Estimated in Table 4-48)

$2,192 4,085 $1,346 29,871 $5,117 29,253 0 0 $198.84

Total Manufacturer Cost (First 

Cycle) Including Additional 

Data Elements

$2,192 4,085 $1,346 29,871 $5,117 29,253 $5,673 29,871 $368.31

Incremental Increase due to 

Additional Data Elements 

(First Cycle)

$0.00 0 $0.00 0 $0.00 $0.00 $5,673.

44 29,871 $169.47

Manufacturer Cost (Future 

Cycles)

Considering all Proposed 

Amendments 

(As Estimated in Table 4-48)

$695 4,289 $1,109 31,365 $4,047 $30,71

6 0 0 $162.08

Total Manufacturer Cost 

(Future Cycles) Including 

Additional Data Elements

$695 4,289 $1,109 31,365 $4,047 30,716 $4,538.

75 31,365 $304.44

Incremental Increase due to 

Additional Data Elements 

(Future Cycles)

$0.00 0 $0.00 0 $0.00 0 $4,539 31,365 $142.36

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

Table F-10presents 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 4-58. Over a 25-year period, EPA estimates the 

annualized cost to manufacturers would be $72 million at a three percent discount rate, and $67 

million at a seven percent discount rate. 
F-13

Table F-10: Annual Increase in Industry Cost to Manufacturers if All Proposed 

Amendments Are Implemented (2008$)

Reporting 

Cycle Years

Baseline Form U Cost

(When all 

Amendments are 

Considered)

(millions 2008$)

Form U Cost for 

Enhanced Data 

Elements

(millions 2008$)

Total Cost To 

Industry

(millions 2008$)

1 2007 to 2011 $198.84 $169.47 $368.31

2 2012 to 2015 $162.08 $142.36 $304.44

3 2016 to 2019 $162.08 $142.36 $304.44

4 2020 to 2023 $162.08 $142.36 $304.44

5 2023 to 2027 $162.08 $142.36 $304.44

6 2026 to 2031 $162.08 $142.36 $304.44

Total $1,009.25 $881.26 $1,890.51

Annual Average $40.37 $35.25 $75.62

Annualized at 3% $38.40 $33.47 $71.88

Annualized at 7% $35.83 $31.15 $66.98

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 F-11, EPA estimates the cost to processors to be 

$523 million in the first reporting cycle and $418 million in all future reporting cycles. 

Table F-11: Change in Industry Cost to Processors as a Result of Additional ExposureRelated 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 postamendment value.

Table F-12 presents the annual and annualized costs estimates to processors of competing 

Form U with the additional exposure-related data elements. Over a 25-year period, EPA 
F-14

estimates the annualized cost to processors would be $116 million at a three percent discount 

rate, and $125 million at a seven percent discount rate. 

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

Are Implemented (2008$)

Reporting

Cycle Years

Baseline Form U Cost

(When all Amendments are 

Considered)

(millions 2008$)

Form U Cost 

for Enhanced 

Data Elements

(millions 2008$)

Total Cost To 

Industry

(millions 2008$)

1 2007 to 2011 $0.00 $523.00 $523.00 

2 2012 to 2015 $0.00 $418.00 $418.00

3 2016 to 2019 $0.00 $418.00 $418.00

4 2020 to 2023 $0.00 $418.00 $418.00

5 2023 to 2027 $0.00 $418.00 $418.00

6 2026 to 2031 $0.00 $418.00 $418.00

Total $0.00 $2,613.00 $2,613.00 

Annual Average $0.00 $104.52 $104.52 

Annualized at 3% $0.00 $116.03 $116.03 

Annualized at 7% $0.00 $125.45 $125.45 

Total estimated industry cost is presented in Table F-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, would be $692 million in 

the first reporting cycle and $560 million in all future reporting cycles. 

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

Additional Exposure-Related Data Elements

Total Cost to 

Manufacturers 

(millions 2008$)

Total Cost to

Processors

(millions 2008$)

Total Industry 

Cost

(millions 2008$)

Cost (First Cycle)

Considering all Proposed Amendments $199 $0 $199 

Total Cost (First Cycle) Including Additional Data 

Elements $368 $523 $891 

Incremental Increase due to Additional Data 

Elements (First Cycle)

$169 $523 $692 

Cost (Future Cycles)

Considering all Proposed Amendments $162 $0 $162 

Total Cost (Future Cycles) Including Additional 

Data Elements $304 $418 $722 

Incremental Increase due to Additional Data 

Elements (Future Cycles)

$142 $418 $560 

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

Table F-14presents 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 25-year period, EPA estimates the annualized cost to the industry would be 

$166 million at a three percent discount rate, and $150 million at a seven percent discount rate. 
F-15

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

Amendments Are Implemented (2008$)

Reporting 

Cycle Years

Baseline Form U Cost 

(When all Amendments Are 

Considered)

(millions 2008$)

Form U Burden with 

Enhanced Data 

Elements 

(millions 2008$)

Total Cost To 

Industry

(millions 2008$)

1 2007 to 2011 $198.84 $692.47 $891.31

2 2012 to 2015 $162.08 $560.36 $722.44

3 2016 to 2019 $162.08 $560.36 $722.44

4 2020 to 2023 $162.08 $560.36 $722.44

5 2023 to 2027 $162.08 $560.36 $722.44

6 2026 to 2031 $162.08 $560.36 $722.44

Total $1,009.25 $3,494.26 $4,503.51

Annual Average $40.37 $139.77 $180.14

Annualized at 3% $37.28 $129.14 $166.43

Annualized at 7% $33.48 $116.05 $149.53

F.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 F-1) to calculate the total per-report burden of processing the new data elements for 

manufacturers, 0.0048 hours. EPA assumes there would 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 F-15. EPA does not expect the future reporting cycle 

burden to differ from first reporting cycle burden.
F-16

Table F-15: Change in Agency Burden to Process Manufacturer Data as a Result of 

Additional Exposure-Related Data Elements

Burden 

to 

Process

Part I 

(hours)

Numb

er of 

Sites

Burden to 

Process 

Part II

(hours)

Number 

of 

Reports 

(with 

Part II)

Burden 

to 

Process

Part III 

(hours)

Number 

of 

Reports 

(with

Part III)

Burden 

to 

Process 

New 

Data 

Elements 

(hours)

Number 

of 

Reports 

(With 

New 

Data 

Elements

)

Agenc

y 

Burde

n 

(hours)

First Year, 

Baseline 

Burden (All 

Proposed 

Amendment

s)

0.0019 4,085 0.0056 29,871 0.0063 29,253 0 0 2,439

First year, 

With 

Enhanced 

Data 

Elements

0.0019 4,085 0.0056 29,871 0.0063 29,253 0.0048 29,871 2,582

Change, 

first year 0 0 0 0 0 0 0.0048 29,871 143

Futurecycle 

Baseline

0.0019 4,289 0.0056 31,365 0.0063 30,716 0 0 2,456

Future 

cycle, Post 

Amendment

0.0019 4,289 0.0056 31,365 0.0063 30,716 0.0048 31,365 2,607

Change 

from the 

Baseline, 

Future 

cycles

0 0 0 0 0 0 0.0048 31,365 150

Table F-16 presents the estimated annual burden to the Agency of processing Form U with 

the additional exposure-related data elements. Over a 25-year period, EPA estimates the total 

Agency burden to process manufacturer data would be 15,600 hours. 
F-17

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

Proposed Amendments Are Implemented

Reporting Cycle Years

Baseline Form 

U Burden

(When all 

Amendments 

are Considered)

(hours)

Form U 

Burden with 

Enhanced 

Data 

Elements

(hours)

Total 

Industry 

Burden

(hours)

1 2007 to 2011 2,439 143 2,582

2 2012 to 2015 2,456 150 2,607

3 2016 to 2019 2,456 150 2,607

4 2020 to 2023 2,456 150 2,607

5 2023 to 2027 2,456 150 2,607

6 2026 to 2031 2,456 150 2,607

Total 14,721 896 15,617

Annual Average 589 36 625

Manufacturers and Processors Combined

Table F-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 are approximately 442 hours for all reporting cycles. 

Table F-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 F-18 presents the estimated annual burden to the Agency of processing Form U with 

the additional exposure-related data elements. Over a 25-year period, EPA estimates the total 

Agency burden to process processor data would be 2,651 hours. 
F-18

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

Amendments Are Implemented

Reporting Cycle Years

Baseline Form U Burden

(When all Amendments are Considered)

(hours)

Form U Burden 

with Enhanced 

Data Elements

(hours)

Total 

Industry 

Burden

(hours)

1 2007 to 2011 0.00 442 442

2 2012 to 2015 0.00 442 442

3 2016 to 2019 0.00 442 442

4 2020 to 2023 0.00 442 442

5 2023 to 2027 0.00 442 442

6 2026 to 2031 0.00 442 442

Total 0.00 2,651 2,651

Annual Average 0.00 106 106

Table F-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 592 hours for 

all reporting cycles. 

Table F-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

2,439 0 2,439

Total Burden (First Cycle) 

Including Additional Data 

Elements

2,582 442 3,024

Incremental Increase due to 

Additional Data Elements 

(First Cycle)

143 442 585

Burden (Future Years)

Considering all Proposed 

Amendments

2,456 0 2,456

Total Burden (Future Years) 

Including Additional Data 

Elements

2,607 442 3,049

Incremental Increase due to 

Additional Data Elements 

(Future Years)

150 442 592

Table F-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 

25-year period, EPA estimates the total Agency burden to process manufacturer and processor 

data would be 18,269 hours. 
F-19

Table F-20: Annual Increase in Agency Burden to Process Data if All Proposed 

Amendments Are Implemented

Reporting 

Cycle Years

Baseline Burden

(When all Amendments are 

Considered)

Form U Burden with 

Enhanced Data 

Elements (hours)

Total Agency 

Burden

(hours)

1 2007 to 2011 2,439 585 3,024

2 2012 to 2015 2,456 592 3,049

3 2016 to 2019 2,456 592 3,049

4 2020 to 2023 2,456 592 3,049

5 2023 to 2027 2,456 592 3,049

6 2026 to 2031 2,456 592 3,049

Total 14,721 3,548 18,269

Annual Average 589 142 731

F.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 F-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 

$15,100 in the first reporting cycle and $15,800 in future reporting cycles, as shown in Table F-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 would not change as a result of including 

the additional data option in the IUR.
F-20

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

Additional Exposure-Related Data Elements

Cost to 

Process 

Part I 

(2008$)

Number 

of Sites

Cost to 

Process 

Part II 

(2008$)

Number 

of 

Reports 

(with 

Part II)

Cost to 

Process 

Part 

III 

(2008$)

Number 

of 

Reports 

(with 

Part 

III)

Cost to 

Process 

New Data 

Elements 

(2008$)

Number 

of 

Reports 

(with 

new data 

elements)

Agency 

Burden 

(millions 

of 2008$)

First Year, 

Baseline Cost 

(All Proposed 

Amendments)

$0.20 4,085 $0.58 29,871 $0.66 29,253 $0.00 0 $241,393

First year, 

with

Enhanced 

Data Elements

$0.20 4,085 $0.58 29,871 $0.66 29,253 $0.51 29,871 $256,481

Change, first 

year

$0.00 0 $0.00 0 $0.00 0 $0.51 29,871 $15,089

Future-Cycle 

Baseline $0.20 4,289 $0.58 31,365 $0.66 30,716 0.00 0 $243,263

Future-Cycle, 

Post

Amendment

$0.20 4,289 $0.58 31,365 $0.66 30,716 0.51 31,365 $259,106

Change from 

the Baseline, 

Future Cycles

$0.00 0 $0.00 0 $0.00 0 0.51 31,365 $15,843

Table F-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 25-year period, 

EPA estimates the annualized cost to the Agency would be $58,350 at a three percent discount 

rate, and $53,517 at a seven percent discount rate.

Table F-22: Annual Increase in Agency Cost to Process Manufacturer Data if All 

Proposed Amendments Are Implemented (2008$)

Reporting Cycle Years Baseline Cost

(2008$)

PostAlternative 

Option Cost

(2008$)

Change 

from 

Baseline

(2008$)

1 2007 to 2011 $241,393 $15,089 $256,481

2 2012 to 2015 $243,263 $15,843 $259,106

3 2016 to 2019 $243,263 $15,843 $259,106

4 2020 to 2023 $243,263 $15,843 $259,106

5 2023 to 2027 $243,263 $15,843 $259,106

6 2026 to 2031 $243,263 $15,843 $259,106

Total $1,457,707 $94,306 $1,552,013

Annual Average $58,308 $3,772 $62,081

Annualized at 3% $54,812 $3,538 $58,350

Annualized at 7% $50,281 $3,236 $53,517
F-21

Manufacturers and Processors Combined

Table F-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 the total Agency cost to process the processor data are $46,500. 

Table F-23: Change in Agency Cost to Process Processor Data as a Result of Additional 

Exposure-Related Data Elements

Per-Report Cost to 

Process New Data 

Elements 

(2008$)

Number of 

Reports 

(with New 

Data 

Elements)

Agency Cost

(2008$)

Agency Cost to Process Processor Data

Considering all Proposed Amendments $0.00 0 $0

Total Agency Cost Including Processing Additional Data 

Elements for Processors $0.51 92,100 $46,522

Incremental Increase due to Additional Data Elements $0.51 92,100 $46,522

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

Table F-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 25-year period, 

EPA estimates annualized cost to the Agency would be $10,500 at a three percent discount rate, 

and $9,600 at a seven percent discount rate. 

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

Amendments Are Implemented (2008$)

Reporting 

Cycle Years Baseline Cost(2008$ )

PostAlternative 

Option 

Cost(2008$)

Change from 

Baseline(2008$)

1 2007 to 2011 $0 $46,522 $46,522

2 2012 to 2015 $0 $46,522 $46,522

3 2016 to 2019 $0 $46,522 $46,522

4 2020 to 2023 $0 $46,522 $46,522

5 2023 to 2027 $0 $46,522 $46,522

6 2026 to 2031 $0 $46,522 $46,522

Total $0 $279,132 $279,132

Annual Average $0 $11,165 $11,165

Annualized at 3% $0 $10,500 $10,500

Annualized at 7% $0 $9,638 $9,638

Table F-25shows 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 $61,600 

in the first reporting cycle and $62,400 in all future reporting cycles. 
F-22

Table F-25: Change in Agency Cost of Processing Manufacture and Processor Data as a 

Result of Additional Exposure-Related Data Elements

Total Burden of 

Processing Manufacturer 

data (2008$)

Total Burden of 

Processing Processor data 

(2008$)

Total Agency Burden

(2008$)

Cost (First Cycle)

Considering all Proposed 

Amendments

$241,393 $0 $241,393

Total Cost (First Cycle) 

Including Additional Data 

Elements

$256,481 $46,522 $303,004

Incremental Increase due to 

Additional Data Elements 

(First Cycle)

$15,089 $46,522 $61,611

Cost (Future Years)

Considering all Proposed 

Amendments

$243,263 $0 $241,393

Total Cost (Future Years) 

Including Additional Data 

Elements

$259,106 $46,522 $305,629

Incremental Increase due to 

Additional Data Elements 

(Future Years)

$15,843 $46,522 $62,366

Table F-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 

25-year period, EPA estimates annualized cost to the Agency would be $68,900 at a three 

percent discount rate, and $63,200 at a seven percent discount rate. 

Table F-26: Annual Increase in Agency Cost to Process Manufacturer and Processor Data 

if All Proposed Amendments Are Implemented (2008$)

Reporting Cycle Years

Baseline Burden

(When all 

Amendments are 

Considered)

(2008$)

Form U Burden with Enhanced 

data Elements

(2008$)

Total Agency Burden 

(2008$)

1 2007 to 2011 $241,393 $61,611 $303,004

2 2012 to 2015 $243,263 $62,366 $305,629

3 2016 to 2019 $243,263 $62,366 $305,629

4 2020 to 2023 $243,263 $62,366 $305,629

5 2023 to 2027 $243,263 $62,366 $305,629

6 2026 to 2031 $243,263 $62,366 $305,629

Total $1,457,707 $373,440 $1,831,147

Annual Average $58,308 $14,938 $73,246

Annualized at 3% $54,812 $14,039 $68,850

Annualized at 7% $50,281 $12,874 $63,155
F-23

F.6 Small Entity Analysis

As described in Chapter 8 of this economic analysis, EPA assessed the impact the proposed 

amendments to the IUR rule may have on small entities by examining the relationship between 

the compliance costs and company sales for small companies. EPA performed a similar analysis 

to determine the impact of the collection of additional 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 definition,

25 and 24.8 percent (280 companies) are considered small 

under the TSCA sales-based definition.

26EPA 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 F-13 shows the incremental cost to manufacturers as a result of adding the additional 

exposure related data elements to Form U. Table 4-48 (in the main text of the report) shows the 

incremental cost to manufacturers related to the other proposed amendments. Because these costs 

would be incurred once every four years under a proposed four-year reporting cycle, these costs 

were summed and annualized over four years at both a three percent and seven percent discount 

rate.

27 As shown in Table F-27, 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 F-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 $31,067 at a seven 

percent discount rate, and even lower under a three percent discount rate. The cost-to-sales ratio 

for an average small company under the employment-based SBA definition would be 0.008

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 $33,892 or lower. The cost-to-sales ratio for an average small 

company under the sales-based definition would be 0.29 percent or less.

 

25Threshold of 1,000 employees.

26 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.

27 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.
F-24

Using the highest annual cost shown in Table F-27of $33,892 a small company would have 

to have annual sales of less than $3.39 million in order to have a cost-to-sales ratio larger than 

one percent. 

Table F-27. Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of 

Additional Data Elements

Employment-based Definition Sales-based Definition 

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate

Incremental Costs of 

Enhanced Data Elements $169,471,347.15

Incremental Costs of 

Proposed Other 

Amendments

$91,871,064.30 

Total Annualized Costs $68,260,366 $72,108,063 $68,260,366 $72,108,063

Total Number of Sites 4,085

Annualized Costs per Site $16,710 $17,652 $16,710 $17,652

Number of Sites per Small

Parent Company 1.76 1.92

Annualized Costs per Small 

Parent Company $29,410 $31,067 $32,083 $33,892 

Annual Sales per Small 

Parent Company $412,713,310 $11,821,104 

Cost-to-Sales Ratio 0.007% 0.008% 0.271% 0.287%

Number of Companies 

Potentially Affected 466 280

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 the chemical substance processor 

industry shares many characteristics with the chemical substance manufacturing industry. To the extent 

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 41.3 percent of global parent companies are considered small under an employmentbased 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 chemical 

substances 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, 
F-25

respectively. To calculate cost-to-sales ratios, EPA followed the same methodology for processors as 

described above for manufacturers. Results are presented in Table F-28. 

Table F-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 F-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 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 $11.8million, 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, 2006). Using the highest annual cost shown in Table 

F-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.
G-1

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

Data Elements

In developing the proposed rule, EPA considered the annual collection of exposure-related data 

elements for approximately 100 chemical substances 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 requested 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 chemical substances 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. Because this data collection was only considered during the 

proposed rule, the total costs, submission dates, and annualization periods associated with them may not 

match what is presented in the main text for the final rule.

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 F-1.

G.1 Estimated Number of Affected Entities

For the purpose of this analysis, EPA assumes a section 8(a) rule would apply to both manufacturers 

and processors of the subject chemical substances. 

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 substance 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 Section4.2.5 of this report. On average, 0.66 sites submit data 

under the IUR rule per regulated chemical substance, and an average of 4.21 full reports are submitted for 

each chemical substance. Therefore, EPA estimates a total of 66 sites would submit 421 reports for the 

estimated 100 chemical substances. To the extent 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 substance releases and waste management activities from 

manufacturers, processors, and users of a set of 581 toxic chemical substances and 30 toxic chemical 

substance categories. The chemical substances 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 EPA administers for chemical substance processors. Therefore, 

EPA assumes information on processors who report under TRI is a suitable proxy for processors who 

may report under a section 8(a) rule. 

EPA used TRI Form R submission data from the 2007 TRI Public Data Release in this analysis. To

be consistent with the Economic Analysis for the Proposed IUR Modifications Rule (from which other 
G-2

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 chemical substances (i.e., the chemical 

substances listed in the public 2006 IUR database).28 Processors submitted TRI data on an average of 220 

of the IUR chemical substances during each of the four years of interest. For this analysis, EPA counted 

as a “processor” each TRI submitter who indicated it processes a toxic chemical substance 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 substance as a chemical substance processing aid.29Because EPA 

assumes any company that both manufactures and processes a chemical substance would be considered a 

manufacturer for the purposes of a section 8(a) rule, TRI submitters who indicated they also manufactured 

or otherwise used a chemical substance were filtered out of the dataset.

The TRI data revealed an average of 137 processors reported information per TRI chemical 

substance. However, the average value is greatly skewed by certain high-volume chemical substances 

processed by a large number of processors.30 Therefore, EPA chose to use the median number of 15 

processors per chemical substance, assuming it to be more representative of the universe of TSCA 

chemical substance processors. Using the median of 15 processors per chemical substance, EPA expects a 

total of 1,500 reports would be submitted for an estimated 100 chemical substances. According to the TRI 

data, each processor processes approximately 2.45 chemical substances; therefore, EPA expects a section 

8(a) rule to affect 612 sites.

This approach is limited to the extent the universe of TRI processors is different from that of a section 

8(a) rule. Because the set of chemical substances covered under the rules is different, the median number 

of processors per chemical substance 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 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 substance 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 chemical substances (i.e., those 

manufactured, processed, or otherwise used in amounts greater than one million pounds) or for chemical 

substances meeting other specific criteria; as a result, processors of small volumes may not be included, 

causing the median number to be an underestimate.

G.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 

 

28 The TRI program may collect data on certain chemicals for which IUR reporting is not required. A list of 

CASRNs for the non-confidential 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.

29 TRI submitters indicate their activities and uses of the toxic chemical at the facility in Part II Section 3 of Form R.

30 For example, an average of 3,240 processors reported under TRI per year for lead alone.
G-3

Significant New Use Reporting Requirements for Chemical Substances, EPA ICR No: 574.12 (EPA, 

2003). According to this source, the total burden to complete a PMN form is 107 hours. EPA assumes a 

section 8(a) rule would require electronic submission, so EPA reduced the estimated burden to 93 hours. 

This reduction is consistent with the assumption in section 4.4.27; all clerical burden will be eliminated

because paper filing will not be permitted with electronic submission. 

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 G-1). Because each individual collection under the rule would be for a different 

set of chemical substances, EPA assumes different sites would be submitting reports every year, so the 

burden would be the same in future individual collections.

This approach is limited to the extent the data elements requested in a section 8(a) rule match the IUR 

Form U and the PMN form, and the burden they incur. 

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

Entity Subject to the Data Collection

Burden to Complete 

Exposure-Related 

Data Elements 

(hours per report)

Number of Reports Total Burden

(hours)

Manufacturers 93 421 39,166

Processors 93 1,500 139,500

Total for Manufacturers and Processors 93 1,921 178,666

Annual Industry Burden Estimates

EPA estimated the total annual burden and cost to industry of a section 8(a) rule over a 25-

year period. A 25-year period was used so the burden and 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 G-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 25-year period, EPA estimates the total burden to industry of both the IUR data collection 

and a section 8(a) collection will be 20.04 million hours. The section 8(a) rule adds 3.57 million 

hours to the industry burden during this time period. 
G-4

Table G-2: Schedule of Annual Industry Burden

Reporting 

Cycle Years

Baseline 

Cost (When 

all 

Amendments 

are 

Considered)

Manufacturer 

Section 8(a) 

Cost

Processor 

Section 8(a) 

Cost

Manufacturer 

and Processor 

Section 8(a) 

Cost

Total Cost to 

Industry 

(Manufacturer 

and Processor 

+ Baseline)

(millions of 

hours)

(millions of 

hours)

(millions of 

hours)

(millions of 

hours)

(millions of 

hours)

1 2007 to 2011 3.24 0.04 0.14 0.18 3.41

2 2012 to 2015 2.61 0.16 0.56 0.71 3.32

3 2016 to 2019 2.61 0.16 0.56 0.71 3.32

4 2020 to 2023 2.61 0.16 0.56 0.71 3.32

5 2023 to 2027 2.61 0.16 0.56 0.71 3.32

6 2026 to 2031 2.61 0.16 0.56 0.71 3.32

Total 16.29 0.82 2.93 3.75 20.04

Annual Average 0.65 0.03 0.12 0.15 0.80

G.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 all clerical burden for preparing and 

submitting Form Us eliminated. As shown in Table G-3, EPA estimates the additional per report cost to 

be $5,673.

Table G-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 G-4. EPA estimates the section 8(a) rule would cost manufacturers $2.39 million and 

processors $8.51 million each year. 

Table G-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
G-5

Annual Industry Cost Estimates

Table G-5presents 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 25-year period, EPA estimates total annualized cost to the industry would be $46.98

million, with a three percent discount rate, and $43.56 million with a seven percent discount rate. 

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

Reporting 

Cycle Years

Baseline Cost 

(When all 

Amendments 

are 

Considered)

Manufacturer 

Section 8(a) 

Cost

Processor 

Section 8(a) 

Cost

Manufacturer 

and Processor 

Section 8(a) 

Cost

Total Cost to 

Industry 

(Manufacturer 

and Processor 

+ Baseline)

(2008$ 

millions)

(2008$ 

millions)

(2008$ 

millions)

(2008$ 

millions)

(2008$ 

millions)

1 2007 to 2011 $198.84 $2.39 $8.51 $10.90 $209.74

2 2012 to 2015 $162.08 $9.56 $34.04 $43.60 $205.68

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

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

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

6 2026 to 2031 $162.08 $9.56 $34.04 $43.60 $205.68

Total $1,009.25 $50.19 $178.71 $228.90 $1,238.15

Annual Average $40.37 $2.01 $7.15 $9.16 $49.53

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

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

G.4 Agency Burden Estimate

For the purposes of this analysis, EPA assumed 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 exposure-related 

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 F-1. The section 8(a) burden per-report is estimated as shown in Table G-6. 

Table G-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 G-7shows the estimated burden to the Agency of processing the data submitted by chemical 

substance 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 are 2.02 hours, and for processor data, is approximately 7.20 hours. 
G-6

Table G-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 G-8presents the annual Agency burden estimates for data entry and extramural costs 

during all principal reporting and non-principal reporting years over a 25-year period. The 

Agency burden for processing Form U is taken from Table 5-42. In total, EPA estimates the 

Agency burden for the IUR rule and a section 8(a) rule would be 15,000 hours over a 25-year 

period. The total burden as a result of a section 8(a) rule would be 240 hours over a 25-year 

period. 

Table G-8: Schedule of Annual Agency Burden

Reporting 

Cycle Years

Baseline 

Cost (When 

all 

Amendments 

are 

Considered)

Manufacturer 

Section 8(a) 

Cost

Processor 

Section 

8(a) Cost

Manufacturer 

and Processor 

Section 8(a) 

Cost

Total Cost to 

Industry 

(Manufacturer 

and Processor + 

Baseline)

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

1 2007 to 2011 2,439 2.02 7.20 9.22 2,448

2 2012 to 2015 2,456 10.10 35.98 46.08 2,503

3 2016 to 2019 2,456 10.10 35.98 46.08 2,503

4 2020 to 2023 2,456 10.10 35.98 46.08 2,503

5 2023 to 2027 2,456 10.10 35.98 46.08 2,503

6 2026 to 2031 2,456 10.10 35.98 46.08 2,503

Total 14,721 52.52 187.12 239.64 14,960

Annual Average 589 2.10 7.48 9.59 598
G-7

G.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 G-9.

Table G-9: Per-Report Cost for Data Elements Similar to Those Included in a TSCA 

Section 8(a) Data Collection

Data Elements Number of Data 

Elements

Per-Data Element 

Cost (2008$)

Per-Report Cost

(2008$)

Exposure-related Data Elements 57 $0.0089 $0.51

Table G-10 shows the Agency cost of processing the processor data. EPA estimates the total Agency 

cost to process the manufacturer data are $213, and the total cost to the Agency of processing the 

processor data are $758. The total Agency data processing cost would be $970.

Table G-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 G-11presents 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 25-year period, EPA estimates total cost to the Agency would be 

$65,800, with a three percent discount rate, and $60,300 with a seven percent discount rate. 

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

Reporting 

Cycle Years

Baseline 

Cost (When 

all 

Amendments 

are 

Considered)

Manufacturer 

Section 8(a) 

Cost

Processor 

Section 8(a) 

Cost

Manufacturer 

and Processor 

Section 8(a) 

Cost

Total Cost to 

Industry 

(Manufacturer 

and Processor 

+ Baseline)

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

1 2007 to 2011 $286,580 $213 $758 $970 $287,550 

2 2012 to 2015 $288,450 $1,065 $3,790 $4,855 $293,305 

3 2016 to 2019 $288,450 $1,065 $3,790 $4,855 $293,305 

4 2020 to 2023 $288,450 $1,065 $3,790 $4,855 $293,305 

5 2023 to 2027 $288,450 $1,065 $3,790 $4,855 $293,305 

6 2026 to 2031 $288,450 $1,065 $3,790 $4,855 $293,305 

Total $1,728,831 $5,538 $19,708 $25,245 $1,754,076 
G-8

Annual Average $69,153 $222 $788 $1,010 $70,163 

Annualized at 3% $65,011 $168 $596 $763 $65,774 

Annualized at 7% $59,643 $151 $538 $688 $60,331 

G.6 Small Entity Analysis

The following section provides a preliminary assessment of the impact a section 8(a) rule 

may have on small entities by examining the relationship between the compliance costs and 

company sales for small companies. This analysis is based on the methodology found in Chapter 

8 of this report.

Manufacturers

For manufacturers, EPA estimated 3.89 manufacturing 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 definition,

31 and 24.8 percent (280 companies) are considered small 

under the TSCA sales-based definition,

32 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-4 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 rate.

33 As shown in Table I-12, these costs were divided by the total 

number of sites elected 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-12, 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-to-sales 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 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.

 

31Threshold of 1,000 employees.

32 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.

33 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A-4 

(OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the 

results to a change in the annualization assumptions.
G-9

Using the highest annual cost shown in Table G-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 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 G-12: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of 

Exposure-Related 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

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 the chemical substance processor industry shares 

many characteristics with the chemical substance manufacturing industry subject to the IUR rule. To the 

extent 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 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 

chemical substances 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-
G-10

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 

G-13

Table G-13: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of 

Exposure-Related 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

Table G-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, 2006). Using the highest annual cost shown in 

Table G-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.