### EO12866_IUR ModificationNPRM_EA_2010-01-28_revised_07-14.doc



# DRAFT January 14 Ju ne ly 6 1 7 14 , 2010

—Does not contain TSCA CBI—

Prepared by:

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

U.S. Environmental Protection Agency 1200 Pennsylvania Avenue

Washington, D.C. 20460

_ 

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

### i 

## Contributors

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

EP-W-08-010.

### ***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***

ii 

## Table of Contents

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

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

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

Executive Summary.............................................................................................................. ....................... xv

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

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

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

2. Current IUR Requirements and A ffected Entities............................................................................. 2 -1

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

2.2 Overview of the Regulated Commun ity ......................................................................................... 2-2

3. Changes in Reporting Requirements under the Pr oposed IUR Modifications Rule ..................... 3-1

3.1 Technical Modifications to the Re gulatory Text............................................................................ 3-1

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

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

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

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

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

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

3.1.6 Correcting Text Associated With Reporting Number of Sites and Number of Workers.t 3-

2

3.2 Modifications to Selected Defin itions .......................................................................................... .. 3-2

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

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

3.2.3 Electronic-Reporting Related Definitions.......... ...............................................................3-4

3.2.4 Processing and Use-Related Definitions ............ ...............................................................3-4

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

3.3 Modifications to Reporting Thresholds .......................................................................................... 3-5

3.3.1 Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements................................................................................................................... ...3-5

3.3.2 Eliminate 300,000 lb. Threshold for Processin g and Use Information ............................3-6

3.3.3 Eliminate the 25,000 lb. Threshold for Certai n Regulated Chemicals.............................3-6

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

3.4.1 Make Chemicals 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 Partia lly 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 .............................................................................................................. 3-8

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

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

............................................................................................................................... .............3-8

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

3.5.6 Indicate Whether Imported Chemicals Are Phys ically at Reporting Site ........................3-9

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

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

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

or Reworked .................................................................................................................... ...3-9

3.6 Concentration Ranges ........................................................................................................... .......... 3-9

3.7 Industrial Processing and Use Information Reportin g .................................................................3-10

3.7.1 Revise Industrial Function Cate gories.............................................................................3-10

3.7.2 Revise Industrial Sectors ......... ........................................................................................3-10

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

3.8.1 Revise Consumer and Commercial Product Ca tegories .................................................3-11

3.8.2 Designation of Consumer or Commercial Use . ..............................................................3-11

3.8.3 Number of Commercial Workers Reasonably Likely To Be Exposed ..........................3-11

3.9 Changes to Standard for the Reporting of Proce ssing and Use Information...............................3-11

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

3.10.1 Chemical Identity CBI Claims.........................................................................................3-12

3.10.2 Upfront Substantiation for Processing and Use Information CBI Claims .....................3-12

3.10.3 Limitation on Confidentiality Claims for Data Elements Identified as “Not Known or Reasonably Ascertainable”......... .....................................................................................3-13

3.11 Method of Submission ........................................................................................................... .......3-13

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

3.11.2 Require Electronic Submissions over the Intern et..........................................................3-14

3.11.3 Electronic Signature Process ...... .....................................................................................3-14

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 Anal ysis ............................................................. 4-1

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

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

4.2.2 Estimates of Baseline Labor Hours (Burden) .... ...............................................................4-2

4.2.3 Estimates of Baseline Submission (Mailing) Cost s ..........................................................4-7

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

4.2.5 Estimates of the Number of Sites and Reports ................................................................4-12

4.2.6 Estimates of Future Reporting Cycles’ Labor Hours (Burden) ......................................4-12

4.3 Total Baseline IUR Industry Compliance Burden and Costs.......................................................4-18

4.4 Changes in Industry Burden and Costs Due to the Proposed IUR Modifications Rule..............4-19

4.4.1 Technical Modifications to the Regulatory Text ............................................................4-19

4.4.2 Modifications to Selected Defi nitions.............................................................................4-19

4.4.3 Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements................................................................................................................... .4-19

4.4.4 Eliminate the 300,000 lb. Threshold for Pro cessing and Use Reporting .......................4-21

4.4.5 Eliminate the 25,000 lb. Threshold for Certai n Regulated Chemicals...........................4-23

4.4.6 Make Chemicals Subject to Enforceable Consent Agreements (ECAs) Ineligible for Exemptions..................................................................................................................... ..4-25

4.4.7 Full Exemption for Manufactured Water ........... .............................................................4-27

4.4.8 Remove Fully-Exempt Polymers from the Par tially-Exempt List .................................4-28

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- 28

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

iv 4.4.13 Volume of Chemical Substance Used On-Site .. .............................................................4-30

4.4.14 Indicate Whether Chemical Is Physically at Reporting Site...........................................4-31

4.4.15 Report Production Volume Exported ..............................................................................4-32

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

or Reworked .................................................................................................................... .4-33

4.4.17 Concentration Ranges ......................................................................................................4-34

4.4.18 Revise Industrial Function Cate gories.............................................................................4-35

4.4.19 Revise Industrial Sectors ......... ........................................................................................4-36

4.4.20 Revise Consumer and Commercial Product Ca tegories .................................................4-36

4.4.21 Designation of Consumer or Commercial Use . ..............................................................4-38

4.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed ..........................4-38

4.4.23 Changes to the Standard for the Reporting of Processing and Use Information............4-39

4.4.24 Chemical Identity CBI Claims.........................................................................................4-40

4.4.25 Upfront Substantiation for Processing and Use Information CBI Claims .....................4-40

4.4.26 Limitation on the Confidentiality Claims for Data Elements Identified as “Not Known or Reasonably Ascertainable”......... .....................................................................................4-41

4.4.27 Require Electronic Submissions over the Intern et..........................................................4-41

4.4.28 Updated e-IUR Reporting Software ................................................................................4-44

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

4.4.30 Modifications Specifically Affecting Importers .............................................................4-45

4.4.31 Modify Reporting Frequency ..........................................................................................4-46

4.5 Total Industry Compliance Burden and Cost of a ll Amendments...............................................4-50

4.5.1 Modifications that Affect the Number of Rep orts Submitted.........................................4-50

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

4.5.3 Amendment that Affects the Reporting Frequency . .......................................................4-57

4.5.4 Average Cost and Burden per Site .................. ................................................................4-57

4.6 Annualized Industry Cost Estimate s for all Modifications ..........................................................4-60

5. Agency Burden and Cost Esti mates ............................................................................................ ......... 5-1

5.1 Methodology for Agency Burden an d Cost.................................................................................... 5-1

5.2 Data for Agency Cost Estimate s ................................................................................................. .... 5-1

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

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

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

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

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

5.4.2 Modifications to Selected Defi nitions...............................................................................5-4

5.4.3 Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements................................................................................................................... ...5-4

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

5.4.5 Eliminate the 25,000 lb. Threshold for Certai n Regulated Chemicals.............................5-7

5.4.6 Make Chemicals Subject to Enforceable Consent Agreements (ECAs) Ineligible for Exemptions..................................................................................................................... ....5-8

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

5.4.8 Remove Fully-Exempt Polymers from the Par tially-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 -10

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

10

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

v 5.4.13 Volume of Chemical Substance Used On-Site .. .............................................................5-11

5.4.14 Indicate Whether Chemical Is Physically at Reporting Site...........................................5-12

5.4.15 Report Production Volume Exported ..............................................................................5-13

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

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

5.4.17 Concentration Ranges ......................................................................................................5-14

5.4.18 Revise Industrial Function Cate gories.............................................................................5-14

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

5.4.20 Revise Consumer and Commercial Product Ca tegories .................................................5-15

5.4.21 Designation of Consumer or Commercial Use . ..............................................................5-16

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

5.4.23 Changes to the Standard for the Reporting of Processing and Use Information............5-18

5.4.24 Chemical Identity CBI Claims.........................................................................................5-18

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

5.4.26 Limitation on Confidentiality Claims for Data Elements Identified as “Not Known or Reasonably Ascertainable”......... .....................................................................................5-19

5.4.27 Require Electronic Submissions over the Intern et..........................................................5-19

5.4.28 Updated e-IUR Reporting Software ................................................................................5-20

5.4.29 Electronic Signature Process ...... .....................................................................................5-20

5.4.30 Modifications Specifically Affecting Importers .............................................................5-21

5.4.31 Modify Reporting Frequency ..........................................................................................5-21

5.5 Total Agency Cost of All Modifi cations ......................................................................................5-2 4

5.6 Annualized Agency Cost Estimates for All Modifi cations..........................................................5-29

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

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

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

.......................................................................... . 7-1

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

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

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

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

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

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

7.3.1 EPA Risk-Screening and Management Programs. ..........................................................7-13

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

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

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

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

8.1 Select a Relevant Small Entity De finition...................................................................................... 8-1

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

8.3 Estimate Number of Parent Comp anies.......................................................................................... 8- 3

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

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

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

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

9.1 Executive Order 12866.........................................

................................................................. .......... 9-1

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

9.3 Paperwork Reduction Act (PRA)...............................

................................................................... .. 9-1

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vi 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

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

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

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

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

Appendix B. Proposed Revised Form U..................

.......................................................................... ...... B-1

Appendix C. – Current and Proposed Industrial Func tion Categories .............................................. C-1

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

Appendix E. – Industrial Sectors..........................

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

Appendix F. – Sensitivity Analyses....................

......................................................................... ..............F-1

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

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

F.3 Modifying Industrial Function Categories.............. ........................................................................F -5

F.4 “Other” as a Consumer and/or Commercial Product Category .....................................................F-7

F.5 Upfront CBI Substantiation ..................................................................................................... .......F-9

Appendix G. – Alternative Regulato ry Options................................................................................... ..G-1

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

G.1.1 Annual Reporting Cost and Burden when the Opti on is Considered by Itself................G-1

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

Considered..................................................................................................................... ....G-5

G.1.3 Small Entity Analysis .......................................................................................................G-9

G.2 Modify Reporting Frequency to a Three-Year Cycle ................................................................. G-11

G.2.1 Three-Year Reporting Cycle Cost when the Optio n is Considered by Itself ................G-11

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

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

G.2.3 Small Entity Anaylsis .....................................................................................................G-23

G.3 Change the Threshold for Reporting to 10,000 lb..... .................................................................. G-24

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

............................................................................................................................... ..........G-24

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

Considered..................................................................................................................... ..G-27

G.3.3 Small Entity Analysis .....................................................................................................G-36

Appendix H. Additional Exposure-Related Data Elem ents .................................................................H-1

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

H.2 Industry Burden Estimate....................................................................................................... ........ H-7

H.3 Industry Cost Estimate ......................................................................................................... ........ H-12

H.4 Agency Burden Estimate......................................................................................................... ..... H-16

H.5 Agency Cost Estimate ........................................................................................................... ....... H-22

H.6 Small Entity Analysis.......................................................................................................... ......... H-28

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

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

Elements....................................................................................................................... .................................I-1

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

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

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

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

I.5 Agency Cost Estimate ........................................................................................................... ...........I-8

I.6 Small Entity Analysis.......................................................................................................... ...........I-10

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

viii 

## List of Tables

Table 4-1: Derivation of Loaded Wage Rates for the Private Manufacturing Sector (2008$) ..................4-2 Table 4-2: Baseline First-Cycle Labor Burden per Form U, in Hours........................................................4-4 Table 4-3: Burden Percentages Attributed to Site-Limited Activity and Production Volume Questions .4-7 Table 4-4: Mailing Submission Costs (December, 2009) ...

........................................................................ 4-7 Table 4-5: Baseline First-Cycle Tota l Cost per Form U (2008$)................. ...............................................4- 9
Table 4-6: Baseline Number of Re ports and Sites................................................................................ .....4-12 Table 4-7: Weighting Factors for Burden Estimates for Sites That Have Previously Submitted a Form U4-

13 Table 4-8: Baseline Future-Cycle Labor Burden per Re port, in Hours ....................................................4-14 Table 4-9: Baseline Future-Cycle To tal Cost per Report (2008$) ............................................................4-16

Table 4-10: Total Baseline Cost and Burden to Indus try (2011 Reporting Cycle) ..................................4-18

Table 4-11: Total Baseline Cost and Burden to Indus try (Future Reporting Cycles) ..............................4-18 Table 4-12: Change in Industry Burden as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requireme nts ................................................................4-20 Table 4-13: Change in Industry Cost as a Result of Modifying the Method for Determining Whether a Manufacturer is Subject to IUR Reporting Requireme nts ................................................................4-21 Table 4-14: Change in Industry Burden as a Result of Eliminating the 300,000 lb. Threshold for Downstream Processing and Use Information Reportin g .................................................................4-22 Table 4-15: Change in Industry Cost as a Result of Eliminating the 300,000 lb. Threshold for Downstream Processing and Use Information Reportin g .................................................................4-23 Table 4-16: Change in Industry Burden as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals............................................................................................................ ..............4-24 Table 4-17: Change in Industry Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals............................................................................................................ ..............4-24 Table 4-18: Change in Industry Burden as Result of Making Chemicals Subject to ECAs Ineligible for Exemptions ..................................................................................................................... ....................4-26 Table 4-19: Change in Industry Cost as a Result of Making Chemicals 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 Requiring the Reporting of Production Volume in all Non-Principal Reporting Years.........................

..................................................................... .......4-29 Table 4-23: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume in all Non-Principal Reporting Years...........................

....................................................................... ........4-29 Table 4-24: Change in Industry Burden as a Result of Requiring the Reporting of Production Volume

Used On-Site................................................................................................................... ....................4-30 Table 4-25: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume

Used On-Site................................................................................................................... ....................4-31 Table 4-26: Change in Industry Burden as a Result of Indicating Whether a Chemical is Physically at Reporting Site ................................................................................................................. ....................4-31 Table 4-27: Change in Industry Cost as a Result of Indicating Whether a Chemical is Physically at Reporting Site ................................................................................................................. ....................4-32 Table 4-28: Change in Industry Burden as a Result of Requiring Reporting of Volume Exported ........4-32 Table 4-29: Change in Industry Cost as a Result of Requiring Reporting of Volume Exported .............4-33 Table 4-30: Change in Industry Burden as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reus ed, or Reworked......................................................................4-34

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

ix Table 4-31: Change in Industry Cost as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reus ed, or Reworked......................................................................4-34 Table 4-32: Change in Industry Burden as a Result of Modifying the Industrial Function Categories...4-35 Table 4-33: Change in Industry Cost as a Result of Modifying the Industrial Function Categories .......4-36 Table 4-34: Change in Industry Burden as a Result of Modifying the Consumer and Commercial Product Categories ..................................................................................................................... ......................4-37 Table 4-35: Change in Industry Cost as a Result of Modifying the Consumer and Commercial Product Categories ..................................................................................................................... ......................4-38 Table 4-36: Change in Industry Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed........................

........................................................................ ....4-39 Table 4-37: Change in Industry Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed........................

........................................................................ ....4-39 Table 4-38: Change in Industry Burden as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI .......................................................................................... ..4-40 Table 4-39: Change in Industry Cost as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI .......................................................................................... ..4-41 Table 4-40: Change in Industry Burden as a Result of Requiring Electronic Submission.......................4-43 Table 4-41: Change in Industry Cost as a Result of Requiring Electronic Submission ...........................4-44 Table 4-42: Change in Industry Burden as a Result of Requiring CDX Registration for Secondary

Submitters ..................................................................................................................... ......................4-45 Table 4-43: Change in Industry Cost as a Result of Requiring CDX Registration for Secondary Submitters

............................................................................................................................... ..............................4-46 Table 4-44: Change in Industry Burden as a Result of Modifying the Reporting Frequency, over a 25-

Year Period .................................................................................................................... .....................4-47 Table 4-45: Change in Industry Cost as a Result of Modifying the Reporting Frequency, over a 20-Year

Period ......................................................................................................................... .........................4-49 Table 4-46: Change in the Number of Sites and Re ports Submitted for All Amendments Combined ...4-52 Table 4-47: Change in the 2011 Reporting Cycle Burden for All Amendments Combined, by Labor Category....................................................................................................................... .......................4-54 Table 4-48: Change in the Future Reporting Cycle Burden for All Amendments Combined, by Labor Category....................................................................................................................... .......................4-55 Table 4-49: Total Industry Burden for All Amendments Combined ........................................................4-56 Table 4-50: Total Industry Cost When All Amendments Are Combined ................................................4-57 Table 4-51: Average Number of Full and Partial Reports per Site...........................................................4-58 Table 4-52: Average Total Burden per Site...................................................................................... .........4-59 Table 4-53: Average Total Cost pe r Site ........................................................................................ ...........4-60 Table 4-54: Industry Burden over a Period of 25 Years if All Proposed Amendments Are Implemented .4-

61 Table 4-55: Industry Cost over a Period of 25 Years if All Proposed Amendments Are Implemented..4-63 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 Re quirements.........................................................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 Requirement s ..................................................................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 Requirement s ..................................................................5-6 Table 5-7: Change in Agency Burden as a Result of Eliminating the 300,000 lb. Threshold for Processing and Use Reporting .............................................................................................................. ..................5-7 Table 5-8: Change in Agency Cost as a Result of Eliminating the 300,000 lb. Threshold for Processing and Use Reporting .............................................................................................................. ..................5-7

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

x Table 5-9: Change in Agency Burden as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals............................................................................................................ ................5-8 Table 5-10: Change in Agency Cost as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals............................................................................................................ ................5-8 Table 5-11: Change in Agency Burden as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions ..................................................................................................................... ......................5-8 Table 5-12: Change in Agency Cost as a Result of Making Chemicals Subject to ECAs Ineligible for Exemptions ..................................................................................................................... ......................5-9 Table 5-13: Change in Agency Burden as a Result of a Full Exemption for Manufactured Water...........5-9 Table 5-14: Change in Agency Cost as a Result of a Full Exemption for Manufactured Water ...............5-9 Table 5-15: Change in Agency Burden as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year............

.......................................................................... ..5-11 Table 5-16: Change in Agency Cost as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year ......................

...................................................................... ......5-11 Table 5-17: Change in Agency Burden as a Result of Reporting of Production Volume Used On-Site.5-11 Table 5-18: Change in Agency Cost as a Result of Reporting of Production Volume Used On-Site .....5-12 Table 5-19: Change in Agency Burden as a Result of Indicating Whether an Imported Chemical is Physically On-Site ............................................................................................................. .................5-12 Table 5-20: Change in Agency Cost as a Result of Indicating Whether an Imported Chemical is Physically On-Site ............................................................................................................. .................5-12 Table 5-21: Change in Agency Burden as a Result of Requiring the Reporting of Export Volume .......5-13 Table 5-22: Change in Agency Cost as a Result of Requiring the Reporting of Export Volume............5-13 Table 5-23: Change in Agency Burden as a Result of Indicating Whether Chemical is Recycled, Remanufacture, Reprocessed, Reused, or Reworked.. ......................................................................5-14 Table 5-24: Change in Agency Cost as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reus ed, or Reworked......................................................................5-14 Table 5-25: Change in Agency Burden as a Result of Revising the Industrial Function Categories ......5-15 Table 5-26: Change in Agency Cost as a Result of Revising the Industrial Function Categories ...........5-15 Table 5-27: Change in Agency Burden as a Result of Revising the Consumer and Commercial Product Categories ..................................................................................................................... ......................5-16 Table 5-28: Change in Agency Cost as a Result of Revising the Consumer and Commercial Product Categories ..................................................................................................................... ......................5-16 Table 5-29: Change in Agency Burden as a Result of Designation of Consumer or Commercial Use...5-17 Table 5-30: Change in Agency Cost as a Result of Designation of Consumer or Commercial Use .......5-17 Table 5-31: Change in Agency Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed........................

........................................................................ ....5-17 Table 5-32: Change in Agency Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed........................

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

.........................................................................................................................5-18 Table 5-34: Change in Agency Cost as a Result of Requiring Upfront Substantiation for CBI Claims .5-19 Table 5-35: Change in Agency Burden as a Result of Requiring Electronic Submission .......................5-19 Table 5-36: Change in Agency Cost as a Result of Requiring Electronic Submission............................5-20 Table 5-37: Change in Agency Burden as a Result of Modifying the Reporting Frequency...................5-21 Table 5-38: Change in Agency Cost as a Result of Modifying the Reporting Frequency .......................5-23 Table 5-39: Change in Agency Burden as a Result of All the Proposed IUR Modifications ..................5-24 Table 5-40: Total Agency Burden for All Amendments Combined.........................................................5-25 Table 5-41: Total Agency Cost of All Amendments Co mbined...............................................................5-25 Table 5-42: Agency Burden per Report when All Amen dments are Combined ......................................5-27 Table 5-43: Agency Cost per Report When All Amendm ents are Combined..........................................5-27 Table 5-44: Agency Cost per Repor t when All Amendments Are Combined..........................................5-28

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

29
Table 5-46: Annual and Discounted Total Cost to the Agency of All Modifications..............................5-31 Table 6-1: Change in Total Burden to Society If Al l Modifications Are Implemented.............................6-1 Table 6-2: Change in Total Costs to Society if All Modifications Are Implemented................................6-3 Table 8-1: Results of Dun & Bradstreet Analysis ...

............................................................................. .......8-3 Table 8-2: Estimated Number of Small Companies under the Proposed IUR Rule Amendments ............8-4 Table 8-3: Derivation of Cost-to-Sales Ratios for Small Companies under the Proposed IUR Rule

Amendments..................................................................................................................... ....................8-5 Table C-1: List of Current and Proposed Industrial Fu nction Categories ................................................. C-1 Table D-1: List of Current and Proposed Consumer and Commercial Product Categories......................D-1 Table F-1: Sensitivity Analysis of Industry Burden Estimates for Modifying the Method for Determining

Whether the Threshold Is Met................................................................................................... ...........F-2 Table F-2: Sensitivity Analysis of Industry Cost Estimates for Modifying the Method for Determining

Whether the Threshold Is Met................................................................................................... ...........F-2 Table F-3: Sensitivity Analysis of Agency Burden Estimates for Modifying the Method for Determining

Whether the Threshold Is Met................................................................................................... ...........F-3 Table F-4: Sensitivity Analysis of Agency Cost Estimates for Modifying the Method for Determining

Whether the Threshold Is Met................................................................................................... ...........F-3Table F-5: Sensitivity Analysis of Industry Burden Estimates for Reporting Production Volume Used OnSite ........................................................................................................................... .............................F-4Table F-6: Sensitivity Analysis of Industry Cost Estimates for Reporting Production Volume Used OnSite ........................................................................................................................... .............................F-4Table F-7: Sensitivity Analysis of Agency Burden Estimates for Reporting Production Volume Used OnSite ........................................................................................................................... .............................F-5Table F-8: Sensitivity Analysis of Agency Cost Estimates for Reporting Production Volume Used OnSite ........................................................................................................................... .............................F-5 Table F-9: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category..........................

...................................................................... ...........F-6 Table F-10: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category......

............................................................................................. .............F-6 Table F-11: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category..........................

...................................................................... ...........F-7 Table F-12: Sensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category......

............................................................................................. .............F-7 Table F-13: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category..... ........................................................................F-8 Table F-14: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category........ ........................................................................F-8 Table F-15: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category..... ........................................................................F-9 Table F-16: Sensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category........ ........................................................................F-9 Table F-17: Sensitivity Analysis of Industry Burden Estimates for Requiring Upfront CBI Substantiation

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

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

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xii Table G-1: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data Annually....................................................................................................................... ........................G-1 Table G-2: Industry Cost under the Alternative Op tion to Require Submitters to Submit Full Data Annually....................................................................................................................... ........................G-2 Table G-3: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data Annually....................................................................................................................... ........................G-3 Table G-4: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually....................................................................................................................... ........................G-5 Table G-5: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Cons idered .........................................................G-6 Table G-6: Industry Cost under the Alternative Op tion to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Cons idered .........................................................G-7 Table G-7: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Cons idered .........................................................G-8 Table G-8: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Cons idered .........................................................G-9

Table G-9: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of Annual Reporting ...................................................................................................................... .....................G-11 Table G-10: Annual Industry Burden under the Alternative Option of a Three-Year Reporting Cycle.G-12 Table G-11: Industry Cost under the Alternative Opti on of a Three-Year Reporting Cycle ..................G-13 Table G-12: Burden to the Agency under the Alternative Option of a Three-Year Reporting Cycle ....G-15 Table G-13: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle ...................G-16 Table G-14: Annual Industry Burden under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments ar e Considered ..........................................................................G-17 Table G-15: Industry Cost under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered .............. ........................................................................G-1 8 Table G-16: Agency Burden under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered .............. ........................................................................G-2 0 Table G-17: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered .................... ........................................................................G -21 Table G-18: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a Three-Year Reporting Cycle .......................................................................................................................... ........................G-24 Table G-19: Number of Reports and Sites in 2002 ....

............................................................................ ..G-25 Table G-20: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. ........G-25 Table G-21: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb..............G-26 Table G-22: Change in Burden to the Agency as a Result of Changing the Threshold for Reporting to 10,000 lb. ..................................................................................................................... ......................G-26 Table G-23: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb.

...................................................................................................................G-27 Table G-24: Change in the Number of Sites and Re ports Submitted of All Amendments Combined with the 10,000 lb. Reporting Threshold ..........................

................................................................... .....G-29 Table G-25: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered .................... ........................................................................G -30 Table G-26: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered .................... ........................................................................G -31 Table G-27: Industry Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered ...........................................G-31 Table G-28: Change in Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. and All Other Amendments when All Proposed Ame ndments are Considered ..............................G-32 Table G-29: Agency Burden as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered ....... .....................................................................G-33

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xiii Table G-30: Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered ......................................................................................G-3 4 Table G-31: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered ...........................................G-34 Table G-32: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. and All Other Amendments when All Proposed Ame ndments are Considered ..............................G-35 Table G-33: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a 10,000 lb. Reporting

Threshold ...................................................................................................................... .....................G-37 Table H-1: Description of Additional Data Elemen ts ............................................................................. ...H-1 Table H-2: Change in Industry Burden to Manufacturers as a Result of Additional Exposure-Related Data

Elements....................................................................................................................... ........................H-8 Table H-3: Schedule of Annual Industry Burden to Manufacturers if All Proposed Amendments Are Implemented .................................................................................................................... ....................H-9 Table H-4: Change in Industry Burden to Processors as a Result of Additional Exposure-Related Data

Elements....................................................................................................................... ......................H-10 Table H-5: Schedule of Annual Industry Burden to Proc essors ..............................................................H-10 Table H-6: Change in Industry Burden to Manufacturers and Processors as a Result of Additional Exposure-Related Data Elements..

............................................................................................... .....H-11 Table H-7: Schedule of Annual Industry Burden to Manufacturers and Processors if All Proposed Amendments Are Implemented ..................................................................................................... ...H-11 Table H-8: Per-Report Cost for Additional Data Elem ents, based on PMN Burden ..............................H-12 Table H-9: Change in Industry Cost to Manufacturers as a Result of Additional Exposure-Related Data

Elements....................................................................................................................... ......................H-13 Table H-10: Annual Increase in Industry Cost to Manufacturers if All Proposed Amendments Are Implemented (2008$) ............................................................................................................ ............H-13 Table H-11: Change in Industry Cost to Processors as a Result of Additional Exposure-Related Data

Elements....................................................................................................................... ......................H-14 Table H-12: Annual Increase in Industry Cost to Processors if All Proposed Amendments Are Implemented (2008$) ............................................................................................................ ............H-14 Table H-13: Change in Industry Cost to Manufacturers and Processors as a Result of Additional Exposure-Related Data Elements..

............................................................................................... .....H-16 Table H-14: Annualized Increase in Industry Cost to Manufacturers and Processors if All Amendments Are Implemented (2008$) ......................................

.................................................................. .........H-16Table H-15: Change in Agency Burden to Process Manufacturer Data as a Result of Additional ExposureRelated Data Elements .......................................................................................................... ............H-17 Table H-16: Annual Increase in Agency Burden to Process Manufacturer Data if All Proposed Amendments Are Implemented ..................................................................................................... ...H-18Table H-17: Change in Agency Burden to Process Processor Data as a Result of Additional ExposureRelated Data Elements .......................................................................................................... ............H-19 Table H-18: Annual Increase in Agency Burden to Process Processor Data if All Proposed Amendments Are Implemented ................................................................................................................ ...............H-19 Table H-19: Change in Agency Burden to Process Manufacturer and Processor Data as a Result of Additional Exposure-Related Data El ements ...................................................................................H-2 0 Table H-20: Annual Increase in Agency Burden to Process Data if All Proposed Amendments Are Implemented .................................................................................................................... ..................H-21 Table H-21: Change in Agency Cost of Processing Manufacturer Data as a Result of Additional Exposure-Related Data Elements..

............................................................................................... .....H-23 Table H-22: Annual Increase in Agency Cost to Process Manufacturer Data if All Proposed Amendments Are Implemented (2008$) ......................................

.................................................................. .........H-23Table H-23: Change in Agency Cost to Process Processor Data as a Result of Additional ExposureRelated Data Elements .......................................................................................................... ............H-25

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xiv Table H-24: Annual Increase in Agency Cost to Process Processor Data if All Proposed Amendments Are Implemented (2008$) ............................................................................................................ ............H-25 Table H-25: Change in Agency Cost of Processing Manufacture and Processor Data as a Result of Additional Exposure-Related Data El ements ...................................................................................H-2 6 Table H-26: Annual Increase in Agency Cost to Process Manufacturer and Processor Data if All Proposed Amendments Are Implemented (2008$) ..........................................................................................H-2 7
Table H-27. Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of Additional Data

Elements....................................................................................................................... ......................H-30

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

Elements....................................................................................................................... ......................H-31 Table I-1: Annual Industry Burden as a Result of a TSCA Section 8(a) Data Collec tion ..........................I-3 Table I-2: Schedule of Annual Industry Burden.................................................................................. .........I-3 Table I-3: Per-Report Cost for Additional Data Elem ents, based on PMN Burden....................................I-4 Table I-4: Annual Industry Cost as a Result of a TSCA Section 8(a) Data Collection...............................I-5 Table I-5: Annual Increase in Industry Cost if All Amendments Are Implemented (2008$)) ...................I-6 Table I-6: Per-Report Burden for Data Elements Similar to Those Included in a TSCA Section 8(a) Data

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

............................................................................. ........I-7 Table I-9: Per-Report Cost for Data Elements Similar to Those Included in a TSCA Section 8(a) Data

Collection..................................................................................................................... ..........................I-8 Table I-10: Agency Cost to Process Data as a Result of the TSCA Section 8(a) Data Collection ............I-8 Table I-11: Annual Increase in Agency Cost (2008$)

............................................................................. .....I-9Table I-12: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of ExposureRelated Data Elements .......................................................................................................... ..............I-11 Table I-13: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of Exposure-Related

Data Elements.................................................................................................................. ....................I-12

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xv 

## Executive Summary

The U.S. Environmental Protection Agency (EPA) requires manufacturers and (including importers ) of certain chemical substances to periodically report information to the Agency under reporting requirements known as the Inventory Update Reporting (IUR) rule. This information is collected based on EPA’s authority under section 8(a) of the Toxic Substances Control Act (TSCA), which required requires EPA to compile and keep current a listing of chemicals in commerce in the United States. The data reported under the IUR rule are used to support many EPA and other federal agency health, safety, and environmental protection activities. Established in 1986, the IUR rule was amended extensively in 2003, and amended again in 2005.

Currently, the IUR rule requires companies to report information every five years on certain chemical substances listed on the TSCA Inventory, which is a listing of chemicals that are in commerce in the United States. For reportable substances that a company manufactures or imports in volumes of 25,000 lb. or more at a plant site during the principal reporting year, a submitter is required to provide plant site, production volume, and manufacturing information. Sites must also provide processing and use

information for chemicals that are manufactured (including or imported ) in volumes that meet or exceed a 300,000 lb. per year threshold. Submitters do not need to provide this processing and use information for chemicals below the 300,000 lb. threshold, or chemicals that are “partially exempt,” such as specifically listed petroleum process streams, and listed chemical substances for which the IUR information is of low current interest. These chemicals are all referred to as “partially exempt” from reporting because companies must provide manufacturing information for them but not processing and use information.

EPA now is proposing amendments to the IUR rule to modify the current IUR data reporting process in the following ways:

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

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

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

 Add definitions for “manufacturer,” “Central Data Exchange (CDX),” “ e lectronic IUR (e

IUR ),” web”

, and “industrial function”;

 For the reporting cycle s submission period subsequent to the 2011 submission period reporting cycle

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

per year;

 Eliminate the 300,000 lb. reporting threshold for processing and use information , thereby requiring all reporters of non-excluded substances to report information in all parts of the IUR reporting form;

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

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

 Exempt manufactured water from reporting requirements;

 Remove fully exempt polymers from the partially exempt list;

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

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

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

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

 Require submitters to report production volume exported;

 Require submitters to i dentify indicate whether the chemical is to be recycled, remanufactured, reprocessed, reused, or reworked;

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

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

 Require that submitters 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 electronically submit forms using the e- IUR IURweb software and EPA’s

Central Data Exchange ( CDX ) ; and

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

These amendments overall will increase IUR rule reporting costs. Over the first 2 0 5 years of the rule,

EPA estimates that the net present value of the rule modifications will be $ 5 80.36 70.41 501.69 million in social cost. Annualized costs are expected to be $2 6

. 25 2 1

. 0 5 8 million (at a three percent discount rate)
and $ 19.93 2 0.54 7. 84 million (at a seven percent discount rate). 1 

### EPA estimates that all of the amendments combined would increase the burden to industry by approximately 1. 39 5 6 million hours to

3. 24 40 million hours i n total for the 2011 reporting cycle , and increase the cost to industry by approximately $91.87 million to $198.84 million hours in total for the 2011 reporting cycle . EPA estimates in future reporting cycles, the industry burden will increase by 1.21 million hours to a total of

2.64 million hours , and industry cost will increase by $79.27 million to $162.08 million . EPA further

estimates that over a 2 0 5 -year period, industry burden will increase by 7. 81 8.859.01 million hours. EPA

estimates that the net burden to society will increase by 9.01 7. 81 8.85 million hours over a 2 0 5 -year period because EPA will experience a small reduction in burden as a result of the proposed rule. The information gathered will enable the Agency to continue to target educational, regulatory, or enforcement

activities to industries or chemicals that pos ing e the greatest potential risks and to target programs for population groups that are at the highest potential risk.

With this better targeted information designed to better meet Agency needs, EPA will improve its ability to screen chemicals to identify whether a dditional risk assessment and management steps are needed. More complete reporting of the processing and use data, more careful consideration of confidentiality claims, and adjustments to specific data elements will help provide the needed data. By enhancing the data supplied to Agency risk-screening programs, EPA expects to more effectively and expeditiously reduce the risks posed by chemicals. The more EPA can base its decisions on actual data

, rather than on assumptions, the better EPA is able to tailor its risk management decisions to the level of actual risk, whether higher or lower than it would be if based only on assumptions. Ultimately, enhancing

1 All values are in year 2008 dollars.

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xvii the risk screening process will have positive conseque nces for human and ecosyst em 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 comp atibility with other EPA da tabases. EPA would have an increased ability to anticipate industry trends, particularly for chemicals for which EPA has concerns.

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1-1 

## 1. Introduction

This report assesses the costs and benefits EPA expects to result from its 2009 2010 proposal to modify the Inventory Update Reporting (IUR) rule. The proposed amendments would provide information to better address Agency and public in formation 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 chem ical 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 whet her an entity qualifies as a small manufacturer for purposes of 40 CFR part 710 is found at 40 CFR 704.3. Processors currently are not subject to the regulations at 40 CFR part 710.



### 1.2 Regulatory History

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

Commencement. 2



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

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

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1-2 chemicals, polymers, microorganisms, and naturally occurring chemical substances were generally excluded from reporting.) From 1986 to 1998, an average of 9,200 individual chemicals was reported per reporting cycle. The IUR data provided a more up-to-date picture of a subset of the TSCA chemicals in commerce, generating data that were used to support TSCA risk management activities, as well as to provide support to other EPA and non-EPA program activities.

In January 2003, EPA promulgated amendments to the IUR rule, referred to in this report as the “2003 Amendments” (68 FR 848). The amended IUR rule, applicable to the 2006 reporting cycle and beyond, currently is codified at 40 CFR Part 710 Subpart C. The 2003 Amendments required reporting for inorganic chemical substances

, ; added new site and manufacturing data elements

, ; required companies to provide basic additional manufacturing, processing, and use information related to potential chemical

exposures , ; changed the period of coverage from corporate fiscal year to calendar year

, ; and extended the recordkeeping period from four years to five years. The 2003 Amendments partially mitigated the industry burden increase by raising the reporting threshold to 25,000 lb.; creating a partial exemption from reporting processing and use information for inorganic chemicals for the 2006 IUR collection only, and for specifically-listed petroleum process streams and other specifically listed chemical substances for 2006 and future reporting cycles; and by exempting from reporting certain natural gas substances. As part of the interagency review of the 2003 Amendments under Executive Order 12866, EPA agreed to propose a subsequent rulemaking to change the reporting frequency in an effort to further reduce industry reporting burden. In 2005, EPA promulgated further modifications to the IUR rule (70 FR 75059) (referred to in this report as the “2005 Amendments”) , which extended the reporting cycle to five years, and made further changes to the rule that reduced industry burden and clarified rule requirements.

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2-1 

## 2. Current IUR Requirement s and Affected Entities

2.1 Overview of Current IUR Requirements

The IUR rule requires U.S. manufacturers (including importers) of chemicals listed on the TSCA Inventory to report to EPA every five years the identity of chemical substances manufactured (including imported) during the principal reporting year in quantities of 25,000 lb. or greater at any single site they own or control (see 40 CFR part 710, subpart C). The principal reporting year is defined as the calendar year in which full manufacturing, processing, and use activities associated with the data reported to EPA during an IUR submission period occur. IUR data was collected last in 2006. EPA uses the TSCA Inventory and data reported under the IUR rule to support many TSCA-related activities and to provide overall support for a number of EPA and other federal health, safety, and environmental protection activities. To the extent possible due to restric tions 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 chemicals was required to be reported. The IUR rule generally exempts several groups of chemical substances from its reporting requirements, i.e., polymers, microorganisms, naturally occurring chemical substances, and certain natural gas substances (40 CFR §710.46).

Manufacturers (including importers) of chemicals in larger volumes (i.e., 300,000 lb. or greater manufactured or imported during the principal reporting year at any single site) additionally are required to report exposure-related processing and use information (40 CFR §710.52(c)(4)). The IUR rule generally partially exempts specifi cally-listed petroleum process str eams and other specifically-listed chemical substances, and manufacturers (including importers) of such substances were not required to report processing and use information for those substances. For the 2006 IUR only, inorganic chemicals were partially exempted.

Form U, the tool used to collect the IUR informatio n, is divided into three parts: Site Identification Information (Part I), Manufacturing Information (Part II), and Processing and Use Information (Part III). A copy of the 2006 IUR Form U is in Appendix A of this report. An overview of the information

collected under the IUR rule in 2006 is as follows:

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

 Certification statement . A form that must be signed by a company

- authorized official must sign the form, certifying , to certify that the information provided is complete and accurate.

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

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

that is reporting.

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

for a technical contact.

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

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

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

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

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

 Confidential Business Information (CBI)

. CBI status can be claimed for each data element reported. Submitters who claim the chemical identity or plant site identity as CBI must provide upfront substantiation of the need for such confidentiality.

Non-confidential data, including both searchable and separately downloadable databases and a 2006 IUR data summary report, are available for public use on the IUR website (http://www.epa.gov/iur).



### 2.2 Overview of the Regulated Community

The regulated community for the IUR rule (i.e., those who potentially will be affected by the proposed amendments to the IUR rule) consists of companies manufacturing or importing chemicals in amounts of 25,000 lb. or more annually that are listed on the TSCA Inventory and are regulated under TSCA §8. Manufacturers and (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 chemicals under the IUR rule. Some chemical substances might have both TSCA and non-TSCA uses. In that case, the production associated with the TSCA use must be reported. Companies engaged in chemical manufacturing (NAICS code 325) or petroleum refining (NAICS code 324110) are the most likely to report under the IUR rule. Chemical users and processors who may manufacture a byproduct chemical substance, e.g., utilities, paper manufactur ers, ing, primary metal manufactur ers, ing , and semiconductor and other electronic component manufactur ers ing (NAICS codes 22, 322, 331, and 3344) also are likely to be subject to the rule. However, companies in any industry are subject to reporting if they manufacture or import listed chemicals at or above the reporting threshold. Companies must review the rule to determine whether they are required to report.

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## 3. Changes in Reporting Requ irements under the Proposed
IUR Modifications Rule

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

amendments is described below.



### 3.1 Technical Modifications to the Regulatory Text

Currently, 40 CFR part 710 contains three subparts. Subpart A contains regulatory text associated with the original compilation of the TSCA Inventory; Subpart B contains regulatory text associated with

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

associated with the IUR rule for 2006 and beyond. The chemicals that are covered by the IUR rule are on the Master Inventory File, which includes chemicals from the original Inventory compilation and those added subsequently through the notice requirements of section 5 of TSCA

. . Because the IUR rule applies to a list of chemicals included in the original Inventory plus additional chemicals added subsequently, and because the Agency from time to time has modified the IUR rule, the 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, contains the IUR regulatory text. EPA is proposing to move all of the Subpart C text from 40 CFR part 710 to a new 40 CFR part 711 and would add a new Scope and Compliance section ( § 40 CFR 711.1). Specific sections would be moved as follows: § § 710.43 would become § 711.3; § 710.45 would become § 711.5; § 710.46 would become § 711.6; § 710.48 would become § 711.8; § 710.49 would become § 711.9; § 710.50 would become § 711.10; § 710.52 would become § 711.12; § 710.53 would become § 711.13; § 710.55 would become § 711.15; § 710.57 would become § 711.17; § 710.58 would become § 711.18; and § 710.59 would become § 711.19. Because all of the text of Subpart C would be moved to 40 CFR part 711, 40 CFR part 710 would no longer have a Subpart C. Neither part 710 nor part 711 would have any subparts.

3.1.2 Consolidation of Definitions



### As part of moving the regulatory text from P art 40 CFR part 710 S ubpart , subpart C to 40 CFR part 711, EPA is proposing to consolidate the definitions copied from 40 CFR 710.3 and those currently found

at § 710.3 and § 40 CFR 710.43 into the proposed § new 40 CFR 711.3, except where an appropriate definition is already in place in section 3 of TSCA or at § 40 CFR 704.3, and an additional definition of

the term in proposed § 40 CFR 711.3 would therefore be unnecessarily duplicative

. . The definitions at §704.3 would be incorporated by reference into proposed §711.3, except insofar as proposed §711.3 provides a modified definition of a term also defined at §704.3.

The term mixture is defined in both §710.3 and section 3 of TSCA. For purposes of the IUR rule, EPA is proposing to incorporate the definition of mixture from section 3 of TSCA. The TSCA mixture definition differs from the definition in §710.3 and §720.3, the regulations used to determine the chemicals listed on the Inventory, in that it does not specifically address hydrates. While hydrates are not addressed specifically in the definition, a hydrate is a mixture of water and an anhydrous chemical substance. As with mixtures in general, the individual components of the mixture may be separately reportable at the time of their manufacture or import. EPA believes, for purposes of the IUR rule, that it is not necessary to include hydrates separately in the definition of mixture. The Agency will would continue

to include such a discussion in the Instructions.

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



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

3.1.4 Delete Subpart B Text



### EPA is proposing to delete the regulatory text contained in § 40 CFR part 710, §§ 710.23 t hrough § 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 Delete Superfluous Text Associated With Reporting Production Volumes



### EPA is proposing to delete the phrase “provided that the reported figures are within ±10% of the actual volume” from the production volume reporting requirements currently found in 40 CFR 710.52(c)(3)(iv) (proposed 40 CFR711.12(b)(3)(iv)). The revised wording would be

, “This amount must be reported to two significant figures of accuracy.” The deleted phrase is superfluous because any number reported accurately to two significant figur es is within ten percent of the correct value.

3.1.6 Correcting Text Associated With Reporting Number of Sites and Number of Workers.t



### EPA is proposing to replace the phrase “less than” with the phrase “fewer than” in the ranges used to report the number of workers currently found in the table in 40 CFR 710.52(c)(3)(v) (proposed 40 CFR 711.12(c)(3)(vii)) and the number of sites currently found in the table in 40 CFR 710.52(c)(4)(i)(E) (proposed 40 CFR 711.12(). This proposed change would make the phrases describing the ranges grammatically correct.



### 3.2 Modifications to Selected Definitions

As part of developing the definition section for part 711, EPA is proposing to modify six definitions associated with the IUR rule and to add four new definitions. In §704.3 and §710.3, EPA is also proposing to modify the citation in the definition of importer by removing the citation to 19 CFR 11.1 to 19 CFR 101.1. The citation, which would correctly read 19 CFR 101.1

, is not needed for this definition

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

3.2.1 Manufacture and Manufacturer



### In order to improve the information submitted through the IUR rule, EPA is proposing to modify the

definition of manufacture by incorporating elements from the §720.3 definition for manufacturer . The proposed §711.3 definition of manufacture would allow persons contracting with a toll manufacturer to report the chemical physically manufactured at the toll manufacturer’s site. Under the proposed definition

of site , the site information would reflect the toll manufacturer’s site. Adopting this definition would allow the person contracting for the manufacture of a chemical substance to report the information on the industrial processing and use of a chemical substance and on the consumer and commercial uses of a product containing the chemical substance. Information on the uses of a chemical substance is often unavailable to a toll manufacturer who produces a chemical substance for another person. EPA is proposing to modify the §711 definition of manufacture instead of adopting the definition of manufacturer from §720.3 because the 40 CFR part 711 regulations do not IUR rule does not use the term

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3-3 manufacturer . In order to avoid any confusion with the definitions of these terms found at §704.3, the Agency is also proposing to add a simple definition for the term manufacturer to the proposed §711.3

. In addition to the proposed change to the definition of manufacture , EPA is proposing to add a paragraph (c) to the proposed regulation at §711.15 to clarify the reporting relationship between the contracting company and the toll manufacturer. The contracting company is primarily responsible for the IUR reporting, but in the event the contracting company does not report, the toll manufacturer must report. Both the company and manufacturer are liable if no report is made. Note the contracting company and the toll manufacturer should confer with each other to avoid duplicate reporting

Under this proposal, the term manufacture therefore would be defined under the IUR rule to mean “to manufacture, produce, or import for commercial purposes. Manufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or a complex combination of substances. When a substance, manufactured other than by import, is (1) produced exclusively for another person who contracts for such production, and (2) that other person specifies the identity of the substance and controls the total amount produced and the basic technology for the plant process, that substance is jointly manufactured by the producing manufacturer and the person contracting for such production.”

. Also with this proposal, the term manufacturer would be defined under the IUR rule to mean “a person who manufactures a chemical substance.”

3.2.2 Site



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

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

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

location.

Under the proposal, the term site would be defined to mean “a contiguous property unit. Property divided only by a public right-of-way would 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 a person an importer who imports a chemical substance described in §711.5 is the U nited States .S. site of the operating unit within the person's organization that is directly responsible for importing the substance and that controls

the . The import transaction

. I n site, in some cases, it may be the organization's headquarters office in the United States. If there is no such operating unit or headquarters in the U .S. nited 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.”

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3-4 3.2.3 Electronic-Reporting Related Definitions



### EPA is proposing to add two new terms, Central Data Exchange (CDX) and e lectronic IUR (e

IUR ) web

. The Agency is adding these terms to provide clarity to the proposed requirement for electronic reporting of IUR data. The term CDX means “EPA’s centralized electronic document receiving system, or its successors, including associated instructions for registering to submit electronic documents.” The new definition would make the term consistent with the new Premanufacture Notice (PMN) definition. The

term e- IUR IURweb means the “electronic

- , web-based IUR software provided by the EPA for the completion and submission of the IUR Form U report.”

3.2.4 Processing and Use-Related Definitions



### EPA is proposing to amend the definitions of two the terms : c ommercial use and consumer use in

order to make the ir basic applications them more consistent with the definitions developed collaboratively by the United States and Canada. The proposed definitions for these two terms differ in wording from the Canadian version to ensure the use of terminology defined in IUR and related regulations, and EPA believes the basic application of these two terms would not differ from the basic application of the

Canadian definitions. The term c ommercial use would mean “the use of a chemical substance or a mixture containing a chemical substance (including products and manufactured items co mposed of or containing a chemical substance as part of an article ) in a commercial enterprise providing saleable goods or services.” Examples included in the § 710.43 definition were would be eliminated. The slightly

modified definition of consumer use would mean be “the use of a chemical substance that is itself, or as part of a mixture containing a chemical substance (including as part or all of a product or manufactured item), of an article) when sold to or made available to consumers for their use.” The restrictions associated with where a consumer would use the product would be removed.

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

defined industrial use and did not define industrial function . The inclusion of both definitions provides clarity for the industrial processing and use reporting requirements

, and would make the Agency’s requirements consistent with those developed collaboratively developed with Canada. With this proposal, industrial function would mean “the intended physical or chemical characteristic for which a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product

, or article; repackaged; or used.”

3.2.5 Principal Reporting Year and Submission Period



### As described in Section 3.13, EPA is proposing to change the reporting cycle from every five years to every four years and to require the reporting of production volumes for each calendar year since the last principal reporting year. EPA is proposing to modify the terms reporting year and submission period to reflect these changes.

The term reporting year would be modified to add the term “ principal ” and to replace the word “information” with “manufacturing, processing and use data.” EPA is proposing t he s e These changes are to indicate that the principal reporting year is the year in which most of the reported data are based. Under the current proposal, the principal reporting year is the latest complete calendar year proceeding the submission period. Additionally, EPA is proposing to remove the reference to “the calendar year at 5-year intervals thereafter” and to remove the reference to “calendar year 2005.” With these changes, the term principal reporting year would be defined as “ the latest complete calendar year preceding proceeding the submission period and in which manufacturing, processing, and use activities associated with the data reported to EPA during an IUR submission period occur. Production volume for manufacturing activities in other years of the reporting cycle may also be reportable during the submission period, but full manufacturing, processing, and use data are reported only for activities during the principal reporting

year t he calendar year in which manufacturing, processing, and use activities associated with the data to be

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3-5 reported to EPA during an IUR submission period occur

. Production volume for manufacturing activities in other years of the reporting cycle may also be r eportable during the submission period, but full manufacturing, processing and use data are reported only for activities during the principal reporting

year .”

The term submission period would be modified by deleting the phrase “generated during the reporting year.” With this change, the definition of submission period would reflect that data for years in addition to the principal reporting year would be reported. The new definition of submission period would mean “the period in which manufacturing, processing and use data are submitted to EPA.”



### 3.3 Modifications to Reporting Thresholds

Reporting thresholds are used to determine when IUR reporting is required for a subject chemical at amanufacturing (including importing) site. Every person manufacturing (including importing) a nonexcluded substance at or above the 25,000 lb. threshold is required to report information in Parts I and II of the IUR Form U. Beginning with the 2006 IUR submission year 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 proposing three changes related to the reporting threshold s : (1) how to determine determination of whether you meet the 25,000 lb. threshold, (2) the elimination of the 300,000 lb. threshold for reporting information in Part III, and (3) the elimination of the 25,000 lb. threshold requirement for certain chemicals.

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



### Currently, a one-year “snapshot” of manufacturing (including importing) is used to determine the need to report for the IUR rule. The method used to make the reporting determination involve s d identify ing determining that an entity manufactured ( or including imported) a chemical substance listed on the TSCA Inventory during the principal reporting year (e.g., 2005 for the 2006 IUR reporting cycle); that the chemical substance was not otherwise exempt; and that the associated production volume (domestically manufactured plus imported volumes) met or exceeded the 25,000 lb. threshold for the principal reporting year (e.g., 2005 for the 2006 IUR reporting cycle). EPA is not proposing to change the method for determing whether a manufacturer (including importer) is subject to IUR reporting requirements for the 2011 submission period.

EPA is proposing to modify the method used to determine whether a manufacturer person is subject to IUR reporting for submission periods subsequent to the 2011 submission period. if The proposed method for submission periods subsequent to 2011 would be to determine whether , for any calendar year since the previous last principal reporting year, the subject a chemical was manufactured (including imported) at a
site in production volumes of 25,000 lb. or greater.

. For example, assume the next submission period occurs in 2015. The principal reporting year for the 2011 submission period is calendar year 2010. Therefore, for the 2015 submission period, it would be necessary to examine the annual production volumes for the years 2011 to 2014 for the site. If the production volume for a reportable chemical substance were 25,000 lb. or greater for any calendar year during that four-year period, then it would be necessary to report the chemical substance, unless it is otherwise exempt. For instance, a subject chemical with production volumes of 5,000 lb. in 2014 and 35,000 lb. in 2012 would be reported for the 2015 IUR. Regardless of the 2014 production volume, in this example scenario the 2015 IUR submission would contain detailed information based on manufacturing during the 2014 calendar year and production volume information only for the years 2011 through 2013

. For the 2011 reporting cycle

, a site would submission period, it would be necessary to examine its the annual production volumes for the years 2006

to 2010 for the site . If the production volume for a reportable chemical substance was 25,000 lb. or greater for any calendar year during that five

- year period, then the site it would need be necessary to report the chemical substance, unless it is otherwise exempt. For instance, a subject chemical with production

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3-6 volumes of 5,000 lb. in 2010 and 35,000 lb. in 2007 would be reported for the 20 11 IUR. Regardless of the 2010 production volume, in this example scenario the 2011 IUR submission would contain detailed information based on manufacturing during the 2010 calendar year and production volume information only for the years 2006 through 200 9, due to the 2007 production volume

.

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



### EPA is proposing to eliminate the 300,000 lb. threshold for processing and use information, thereby requiring all reporters of non-excluded substances to report information in all parts of the IUR Form U. EPA is proposing to eliminate this reporting threshold in order to collect information necessary to complete screening-level exposure characterizations and subsequent risk

- based prioritizations for m ed ium production volume ( MPV ) for all IUR reportable chemicals. In The exposure information is an essential part of developing risk evaluations and, based on its experience in using this information, the preamble 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 chemicals. In addition, this change will provide the public with information on a greater number of

chemicals. In the 2003 Amendments final rule (68 FR 848, January 7, 2003), EPA acknowledged the

value of information for chemical substances manufactured in lower volumes and stated that if the Agency were to find it necessary in the future, it would collect information on chemical substances at reporting thresholds below the thresholds that were introduced in the that action . The IUR processing and use information is presently needed to complete the characterizations and prioritizations for those

chemicals manufac tured (including imported) in volumes of (i.e., 25,000 lb. to and 300,000 lb .).

. The Agency explored setting the threshold for reporting processing and use information to at an alternate level between the basic reporting threshold of 25,000 lb. and 300,000 lb. for this proposal action (EPA, 2008c). However, the need to complete characterizations for chemicals manufactured (including imported) in volumes of 25,000 lb. to 300,000 lb. in any year led the Agency to believe that it would be best to eliminate the upper threshold and collect full information for all reported chemicals

.

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



### EPA is proposing to eliminate the 25,000 lb. reporting threshold for certain chemical substances that are the subject of particular TSCA rules and/or orders and to require manufacturers (including importers) of such chemicals to report under the IUR rule, regardless of the production volume. This provision will ensure the availability of current information if EPA has expressed a c oncern in the form of regulatory action on those chemical substances, regardless of the production volume. EPA is proposing to eliminate the 25,000 lb. threshold for those chemicals that are: (1) the subject of a rule proposed or promulgated under section 5(a)(2), 5(b)(4), or 6 of TSCA; (2) the subject of an order issued under section 5(e) or 5(f) of TSCA; or, (3) the subject of relief that has been granted under a civil action under section 5 or 7 of

TSCA.



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

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



### EPA may enter into an enforceable consent agreement (ECA ) ), pursuant to procedures at 40 CFR part 790, with a manufacturer of a chemical substance, to obtain testing where a consensus exists among EPA, affected manufacturers and/or processors, and interested members of the public concerning the need for and scope of testing. Chemicals covered by ECAs are of demonstrated high interest to EPA. The Agency has an interest in identifying the manufacturing, processing, and use of substances under such agreements, and therefore is proposing to require that such substances be reported for IUR purposes, regardless of whether the substance otherwise meets the requirements listed in 40 CFR §710.46 ( proposed

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3-7 40 CFR §711.6) as an exempt or partially exempt chemical substance. This provision will ensure the availability of current information if EPA has expr essed a concern in the form of an ECA on any substance otherwise excluded from the IUR rule. For example, EPA could use the IUR data associated with these regulated chemicals to monitor chemical production and compliance with the agreements. EPA is therefore proposing to make chemical substances that are the subject of an ECA ineligible for IUR exemptions.

With this proposal, chemicals that are the subjec t of an ECA would be included in the list of

chemicals that are ineligible for an IUR exemption, in the introductory paragraph of 40 CFR 710.46 (proposed 40 CFR 711.6) listing the other chemicals that are likewise not eligible for an IUR exemption. With this proposed addition, t he The paragraph would state that a chemical “is not exempted from any of the reporting requirements of this part if that substance is the subject of a rule proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent agreement developed under the procedures of 40 CFR Part 790, or is the subject of an order issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of the Act.”

3.4.2 Full Exemption for Manufactured Water



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

3.4.3 Remove Fully Exempt Polymers from the Partially Exempt List



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



### 3.5 Modifications to Reportable Data Elements

3.5.1 Parent Company and Site Identity



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

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3-8 3.5.2 Technical Contact



### Manufacture r s (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 in dividuals who are not directly connected to the reporting site, and therefore, are not knowledgeable about either the chemical or the submission. EPA has also seen situations where the technical contact is a contracted employee who is able to address subsequent concerns only if he or she remains under contract. EPA is therefore is requesting comment on whether it should allow reporting of multiple tec hnical contacts on a chemical-by-chemical basis.

3.5.3 Chemical Identity



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

Manufacturers (including importers) will be allowed to supply an alternate chemical name, and in the case of importers, a trade name, in those instances where a supplier will not disclose to the submitter the specific chemical name of the imported Inventory substance or a reactant used to manufacture the Inventory substance. 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 ).

Chemical Identifying Number

. As part of the chemical identity, submitters provide a chemical identifying number associated with the correct CA Index Name. For most chemicals, the chemical identifying number is the CASRN correctly corresponding to the reported CA Index Name. If the CASRN number is not available because the chemical substance is listed on the confidential portion of the Inventory and a CASRN does not already exist for that substance, the submitter currently could report

either the associated TSCA Accession or PMN number.

EPA is proposing to allow submitters to report onl y the CASRN as a chemical identifying number or, in the case of confidential chemical substances, the accession number. Note that in cases where a CASRN exists for a confidential chemical, it can be reported instead of the accession number and claimed as confidential for purposes of the IUR submission. EPA is proposing to remove the PMN number as an allowed chemical identifying number because each Inventory substance has either (or both) a CASRN or a TSCA Accession Number, which are likely to be already known to the submitter. Furthermore, the Agency spends considerably more time and effort to access and review reported information that has only

been identified only by a PMN case number.

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



### EPA is proposing to require reporting of production volume for each of t he five year s since the last principal reporting year. Thus, for the 2011 IUR reporting cycle submission period , manufacturers (including importers) of a subject chemical who determine they are subject to IUR reporting requirements

as described in Section 3.3.1 at or above the 25,000 lb. threshold would report the production volume of

that chemical for each of the following calendar years: 2006, 2007, 2008, 2009, and 2010. Collecting the production volume for multiple years would provide EPA with more accurate and up-to-date information than what is provided under the current

, once-every- five- year reporting cycle years snapshot

.

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



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

3.5.6 Indicate Whether Imported Chemicals Are Physically at Reporting Site



### EPA is proposing to add a requirement to indicate whether an imported chemical is physically at the reporting site. Often, the site reporting an imported ch emical never physically receives the chemical, but instead ships it directly to another location such as a warehouse, a processing or use site, or a customer’s site. Identifying whether the chemical is physically at the reporting site provides more accurate information for screening-level analyses and other uses of the IUR data.

3.5.7 Report Production Volume Exported



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

substances.

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


### EPA is proposing to add a requirement to indicate via a check

- box when whether a manufactured chemical, such as a byproduct, is being to be recycled, remanufactured, reprocessed, reused, or reworked.

Submitters will would identify tha t their manufactured chemical, which otherwise would be disposed of as a waste, is being removed from the waste stream and has a commercial purpose (i.e

. ., it is being recycled, remanufactured, reprocessed, reused, or reworked). Checking this box does not affect the reporting requirements associated with any substance manufactured from the byproduct

. EPA believes

that such information will help the Agency to identify where these activitie s are already occurring, and can be used to encourage such activities. Collecting information on whether a chemical is being recycled, remanufactured, reprocessed or reused and is not entering the waste stream provides valuable information to EPA and others regarding trends in chemical manufacturing. This information also can be used to help determine the effectiveness of various programs, such as EPA’s Resource Conservation 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 chemicals of national concern in products and waste. Indicating a manufactured chemical, such as a byproduct, is to be recycled, remanufactured, reprocessed, reused, or reworked does not affect the reporting requirements associated with any substance manufactured from the byproduct.



### 3.6 Concentration Ranges

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

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### 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 quan tities of 300,000 lb. or greater during the principal reporting year. The industrial processing and use information included industrial function categories and North American Industrial Classification System (NAICS) codes. EPA found that knowing these two data elements for a chemical substance was useful in selecting a scenario that characteriz ing es the frequency, route, and duration of exposure to a chemical substance during manufacture, processing, and use of the substance. These data are also useful when EPA characterizes the quantity of the chemical substance in wastes and emissions entering the environment and for anticipating the environmental media into which wastes will be released. The Agency now is proposing to revise the list of industrial function categories and to replace the NAICS codes with industrial sector categories

.

3.7.1 Revise Industrial Function Categories



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

United States and Canada.

EPA is proposing to add eight new industrial function categories and to delete six existing categories from the current list; the total number of industrial function categories would be increase to 35. Also,

EPA has renamed is proposing to rename 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 proposing to require that if a submitter selects the category “Other,” the submitter must provide its own description of the indus trial function of the chemical substance. Appendix C lists both the existing and proposed sets of industrial function categories.

3.7.2 Revise Industrial Sectors



### EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) codes with 48 Industrial Sectors (IS). The IS sectors were developed 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 that there is a sector corresponding to any NAICS code. The Agency believes this change will would provide a number of several benefits. Expected

benefits include reduc ing First, the sectors would reduce reporting burden because submitters do would not have to look up the NAICS code s , encourag ing . Second, it would encourage more complete reporting by using terms already familiar terms, reduc ing to industry. Third, the sectors would reduce the likelihood of

errors which that result from the selection of miscellaneous or inappropriate NAICS codes. Fourth, it

would reduce the number of codes , and reduc ing the number of possible responses for correlation of the

information that could apply to one substance . Appendix E of this report provides a list of the proposed

industrial sectors.

When the category chosen for the 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.

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3-11 

### 3.8 Consumer and Commercial Use Reporting

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

3.8.1 Revise Consumer and Commercial Product Categories



### EPA is proposing to revise the list of consumer and commercial product categories by combining categories that lead ing to common exposure scenarios and adding categories that were not adequately described in the initial set of categories. EPA worked with Environment Canada and Health Canada to develop the proposed categories. The proposed list includes 33 product categories, including “Other.” Examples of new categories that which have been added include explosive materials, building/ construction products not covered elsewhere, and air care products. An example of a deleted category

is The glass and ceramic products

, which category had relatively few IUR submissions in 2006 and which overlaps with proposed new categories , and so has been proposed for elimination . Also, several of the consumer and commercial product categories have been would be renamed to better describe the

uses products that should be reported in those categories. See Appendix D of this report for a list of the new categories.

3.8.2 Designation of Consumer or Commercial Use


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

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

3.8.3 Number of Commercial Workers Reasonably Likely To Be Exposed


### EPA is proposing to require that 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 would be reported using the same definitions and ranges used for manufacturing and industrial processing and use workers, required by 40 CFR 710.52. The proposed ranges are: 1) fewer than 10 workers, 2) at least 10 but fewer than 25 workers, 3) at least 25 but fewer than 50 workers, 4) at least 50 but fewer than 100 workers, 5) at least 100 but fewer than 500 workers, 6) at least 500 but fewer than 1,000 workers, 7) at least 1,000 but fewer than 10,000 workers, and 8) at least 10,000 workers.



### 3.9 Changes to Standard for the Repo rting of Processing and Use Information

In order to collect more complete information regarding both the industrial processing and

use s industrial, commercial , and consumer and commercial use s use of chemicals, EPA is proposing in § 711.12(c)(4) to replace the “readily obtainable” reporting standard that was used for the reporting under 40 CFR 710.52(c)(4) in 2006 IUR with a 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 that is “ known to or reasonably ascertainable by the submitter. For the purposes of reporting under the IUR rule , a submitter would report ” the submitter. This is the same standard that currently applies to the reporting of information described in the regulatory text regulations at § § 710.52(c)(1), (c)(2), and (c)(3 ) tha t is known to or reasonably ascertainable by the submitter. This

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3-12 means ), and this standard would continue to apply to the reporting of such information under proposed §§ 711.12(c)(1), (c)(2), and (c)(3). It covers all information in a person’s possession or control, plus all

information that a reasonable person similarly situated might be expected to possess, control, or know. The “known to or reasonably ascertainable by” reporting standard was the only standard used for IUR reporting purposes prior to the 2006 IUR submission period

. EPA is proposing this change to the reporting standard because reporting under the “readily obtainable” reporting standard did not generate sufficiently complete processing and use information

. EPA believes the “readily obtaina ble” reporting standard , which limited the usefulness of the 2006 IUR processing and use data for screening level reviews. EPA believes the “readily obtainable” reporting standard was a major reason for the small amount of reporting processing and use data.



### 3.10 Modifications to Confidential Business Information (CBI) Claims

Submitters may currently claim certain information reported under the IUR as confidential business information (CBI) in accordance with 40 CFR part 2 and IUR rules at §710.38 (proposed 40 CFR 711.18). Submitters must assert claims of confidentiality at the time information is submitted to EPA. EPA’s procedures for handling information claimed as confidential are set forth at 40 CFR part 2, subpart

B.

To claim information as confidential, a submitter must indicate its claim by checking the appropriate box and signing the certification statement on the reporting form. A submitter must indicate its claims at

the time the information is submitted. If a submitter fails to follow these procedures, EPA may release the information to the public without further notice to the submitter. By signing the certification statement, the submitter attests to the secrecy and value of th e information for which confidentiality claims have been asserted. EPA expects that the proposed changes to the method for claiming information as CBI would reduce the number of unjustifiable CBI claims. Reducing the number of CBI claims would increase the amount of information available to the public and improve the timeliness of its public availability. As a result, the Agency would be able to publicly discuss and explain its risk management actions and decisions more clearly.

3.10.1 Chemical Identity CBI Claims



### Under the IUR, a submitter may assert a claim of c onfidentiality for data associated with the identity of the reported chemical substance when the chemical is listed on the confidential portion of the Master Inventory File and when the submitter provides the required substantiation at the time the submitter makes the confidentiality assertion. See 40 CFR 710.58(b) (proposed 40 CFR 711.18(b)). At times a submitter will assert a claim of confidentiality for the chemical identity of a substance that is listed on the public portion of the Master Inventory File. 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. EPA is proposing that , when this occurs, the Agency may make the information available to the public without further notice to the submitter. See the proposed regulatory text at 40 CFR 711.18(e).

3.10.2 Upfront Substantiation for Processing and Use Information CBI Claims



### Under the IUR rule, a submitter may assert a claim of confidentiality for data associated with the processing and use of its chemical if the submitter has reason to believe that release of the information would reveal trade secrets or confidential commercial or financial information, as provided by section 14 of TSCA and 40 CFR part 2. During the 2006 IUR, submitters made confidentiality claims for 25 to 50 percent of the reported processing and use information. While the Agency does not question that

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3-13 confidentiality claims are sometimes necessary, it en courages submitters to consider carefully whether such claims are in fact necessary before asserting them. The Agency has identified instances in which submitters have claimed the proces sing and use data as confidential, yet similar if not identical information was found in publicly available sources, such as company websites, published Material Safety Data Sheets (MSDSs), or information subm itted to the Agency and posted on the Agency’s HPVIS

website. EPA can take steps to challenge or verify confidentiality claims, but the Agency believes companies should limit their CBI claims to those they are capable of adequately substantiating. For the 2006 IUR, submitters were not required to provide upfront substantiation of CBI claims for processing and use data. In these amendments to the IUR rule, EPA is proposing to require upfront substantiation for

CBI claims for this information.

Under the proposed rule, in order to submit a claim of confidentiality for processing and use information data elements, the submitter would be required to both check the appropriate box on the reporting form and substantiate the claim in writing by answering certain questions provided in § 711.18(d) of the proposed rule. Where a submitter fails to substantiate the processing and use CBI claim in accordance with the applicable r equire ments rules (i.e., the subm itter does not provide an answer to the required questions) , EPA would consider the information not subject to a confidentiality claim and may make the information available to the public without further notice to the submitter.

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



### Under the proposed amendment s IUR rule , submitters would be unable to enter a claim of confidentiality if “not known or reasonably ascertainable” is selected for provide information on the industrial processing and use

, or and consumer and commercial use s of the IUR reportable chemicals they manufacture (including import). For the 2011 and future IUR collections, EPA is proposing submitters be required to report this information

. In to the extent it is known to or reasonably ascertainable by them. For the 2006 IUR collection, submitters reported the processing and use information to the extent that it was readily obtainable, and were permitted to identify wh en such information was not readily obtainable by entering “NRO.” EPA has considered the NRO designation and its relationship to a potential CBI or trade

secret claim

. Given that an NRO assertion is an assertion that no information is available, the Ag ency does not believe observed that the designation conveys trade secret or , on occasion, processing and use

information has been claimed as confidential commercial or financial information

. For this reason, EPA is proposing to prohibit claims of confidenti ality pertaining to the designation that information is not

“ known to or reasonably ascertainable” by the when a submitter determined the information was not readily obtainable

.



### 3.11 Method of Submission

EPA accepted 2006 IUR submissions in several ways. Submissions could be completed and delivered electronically via the Internet and CDX, or submissions could be completed on paper or electronic media (i.e., as a file on a CD) and delivered by mail or a delivery service. Approximately one-third of the submissions were made electronically, and EPA was able to immediately process and quickly begin to use the information from those electronic submissions. Submissions sent as a file on a CD were printed and, along with paper submissions, scanned by EPA into an electronic system. Due mostly to the time andresources needed to review and correct submitter- and scanning-related errors associated with nonelectronic submissions, EPA required more than two years to validate and process the data from the 2006

IUR.

EPA is proposing to require the mandatory use of an Agency-provided reporting software (eIUR web ) to complete the IUR Form U and the Central Data Exchange ( CDX ) to submit the completed

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3-14 Form U to the Agency. CDX users are required to re gister with CDX and to submit an authorized signature agreement.

3.11.1 Updated e-IUR Reporting Software



### EPA developed e-IUR reporting software for use in preparing and submitting reports electronically during the 2006 IUR reporting cycle ( see http:// www.epa.gov/iur ) /tools/software.html). For the 2011 submission period, EPA will provide a free

, web-based application in place of the 2006 downloadable

software . The 2011 e- IUR IURweb software features several enhancements over the 2006 e-IUR software, such as a sophisticated validation system, which would alert users when a required field on the form is either missing information or contains certain kinds of potentially incorrect information. Other updates are expected to include automated chemical identity checks, automated company and site identity checks,

and the facilitation of joint submissions and amendments. For the 2011 e

- IUR, EPA also is considering a

free web

- based application in place of, or in addition to, free downloadable software.

3.11.2 Require Electronic Submissions over the Internet



### EPA is proposing to require that manufacturers (including importers) to submit their IUR reports to the Agency through CDX via the Internet. EPA would require that all submissions be generated using eIUR IURweb reporting software. Electronic submissions would 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 would not be subject to subsequent data entry errors. Furthermore, EPA believes the required use of e- IUR IURweb and CDX would reduce the reporting burden on industry by reducing both the cost and the time required to review, edit and transmit data to the Agency. After the final rule’s effective date, EPA would no longer accept paper submissions or electronic media (i.e., as a file on a CD) for any IUR submission.

3.11.3 Electronic Signature Process



### Each IUR submission must have an authorized official, who is the person signing the certification statement and submitting the IUR report via CDX, associated with th e submission

. During the 2006 IUR, submitters were required to complete an electr onic signature agreement (ESA) and to submit the agreement in hard copy with a wet ink signature to EPA in order to complete the CDX registration. For 2011 IUR reports, EPA is modifying the 2006 ESA to identify more clearly the individual(s) required to sign the agreement. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder”) would download two forms: the Electronic Signature Agreement and t he Verification of Authorization. For authentication of identity, the registrant would complete the ESA, sign and date it, have the form notarized, and mail it to EPA. The Verification of Authorization form requires the signature of an immediate supervisor or witnessing official verifying that the registrant is the person who should sign their name in the certification statement box on Form U. Once both forms are received, EPA would activate the registrant’s CDX account and send a notification via email.

E PA is requesting comment in this proposal on possible ways to streamline the ESA and CDX registration process, and on allowing multiple individuals complete an ESA. Reporting sites may need or desire to have more than one individual complete an electronic signature agreement, so that other individuals can add information to an original IUR submission

. Persons submitting supplemental information for an IUR submission on behalf of a company would need to register with CDX by signing

an ESA and Verification of Supp lemental Submitter form. The Verification of Supp lemental Submitter form requires the signature of an immediate supervisor or witnessing official from the company and anyone he/she authorizes to submit additional information

. The company official can have the agreement with an unlimited number of supp lemental submitters, but will have to complete a form for each

supp lemental submitter

. Supp lemental submitters can work with an unlimited number of company officials, but will need an agreement with each c ompany official (even if the company officials work at

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3-15 the same company). A supp lemental submitter may be a paid employee of the company, an outside consultant for the company, or an authorized representative agent for the company

. While this individual

wo uld not be able to sign the certification statement required for the initial IUR submission, he or she would be able to provide additional information, if needed, using CDX

. For 2006 and prior IUR submissions, submitters were not able to provide additional information electronically

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

EPA is making changes to the registration process in order to address problems identified during the 2006 IUR electronic reporting. For 2011 IUR reports, EPA is modifying the 2006 ESA to identify more clearly the individual(s) required to sign the agreement. The Agency is developing an ESA process similar to that planned for New Chemical s 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 au thorized official would need to complete both an ESA and the CDX registration process



### 3.12 Modifications Specifically Affecting Importers

Submitters report IUR data on chemicals that they manufacture domestically and that they import into the United States. Current IUR regulations require that the site responsible for reporting for imported

chemicals to be is the site of the operating unit that is directly responsible for importing the substance and

that controls the import transaction. In some cases, the import site may be the organization’s headquarters in the United States. The regulations defining the site for importer reporting are found in both the

definition for site in §710.3 and in paragraph §710.48(b).

EPA is proposing to eliminate unnecessary duplication in the IUR regulation by moving the additional information regarding the importer site from §710.48(b) into a revised definition for site , and eliminating paragraph §710.48(b).

In addition, EPA has observed that submitters occasionally use a foreign address as the site address for the importer. EPA now is proposing to require that submitters 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 that is directly responsible for importing the substance and that controls the import transaction has no U.S. address. The Agency expects

that all importers will have a U.S. site, as defined in the proposed § 711.3 definition for site because, under Customs regulations at §141.18, a non-resident corporation is not permitted to enter merchandise for consumption unless it has a resident agent in th e State where the port of entry is located, who is authorized to accept service of process against the corporation.

For purposes of IUR, currently submitters are allowe d to report the IUR information jointly with the foreign manufacturer of the chemical. Importers may not know the specific chemical identity of a substance because the foreign supplier chooses to keep it confidential. In such a situation, the importer is still responsible for ensuring that the IUR information is submitted to EPA and may do so by submitting a joint report. To do so, the U.S. impor ter, as the primary submitter, comp letes the majority of the required information, but supplies a trade name or other de signation to identify the chemical substance. In addition, the primary submitter provides technical contact information for the foreign supplier. The

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3-16 primary submitter then contacts the foreign supplier, as the secondary submitter, to notify it of the need to report the specific chemical identity information to EPA. In addition to the chemical identity, the secondary submitter supplies its technical contact and company information but provides the primary submitter’s site information. The secondary submitter should also provide the upfront substantiation required for any confidentiality claims for chemical identity.

Under the proposed rule, the process would be the same, except that submitters would be required to

use CDX and e- IUR 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. Therefor e, the authorized officials of the jointly submitting companies would need to register in order to submit their reports to EPA. The secondary submitter (e.g., a foreign supplier or manufacturer) would have to register as someone authorized by the primary submitter’s (e.g., the importer’s) authorized official to send joint submissions to EPA.

For joint submissions to be submitted electronically, the primary submitter would use e- IUR IURweb to identify the need to submit a joint report and would identify itself as a primary submitter. The primary submitter would then complete his or her portion of the report and provide the secondary submitter's company information, along with select information on the chemical substance(s) that are manufactured using a chemical substance made by the secondary submitter. The primary submitter reports only the volume that it used. A secondary submitter would also need to use e- IUR IURweb to identify the need to submit a joint report and would identify itself as a secondary submitter. It would provide the primary submitter’s company information and its own techni cal contact information, and would identify the chemical substance(s) that is in its product, including the percentages. This information would be saved by the reporting tool and both submissions would be matched based upon company and chemical

information. Once the forms are were matched, the joint submission would be ready to be processed by EPA. The Agency is currently developing the process to submit joint reports electronically and welcomes any comments concerning this process.

For the 2006 IUR reporting cycle, EPA set aside joint submissions until both were received and

matched. Oftentimes, 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 that the use of the reporting tool will would help to make joint IUR reporting easier for industry and streamline EPA processing of the IUR information submitted in the 2011 reporting cycle.



### 3.13 Modify Reporting Frequency

Prior to the 2003 Amendments, the IUR collection occurred every four years. EPA reduced the reporting frequency from every four years to every five years starting with the 2006 IUR to reduce the burden associated with the amended IUR. The Agency now has determined that reporting every five years is too infrequent, and is proposing to return to reporting every four years.

While the less frequent reporting does reduce burden, EPA now believes that reporting every five years does not provide data sufficiently current to meet Agency and public needs. The Agency has been criticized for using outdated information. EPA, ther efore, is considering increasing the frequency of reporting to every three years, or possibly to annual reporting. The Agency believes that efficiencies are gained with more frequent reporting, both for the submitter and for EPA. With more frequent reporting, companies would be able to establish standard systems and practices to collect the required information.

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## 4. Industry Burden and Cost Estimates

4.1 Methodology for Compliance Cost and Burden Analysis

This chapter analyzes the changes in industry compliance burden and cost associated with the proposed amendments to the IUR rule. EPA calculates the incremental burden and cost, or savings, of the amendments by comparing the burden and cost of complying with the proposed amendments to the

burden and cost that industry would incur to comply with current IUR requirements in the 2011 reporting cycle absent the amendments (the baseline). The methodology for estimating the change in industry

burden and cost can be summarized as follows:

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

 Step 2 : Determine the unit burden and cost for all activities identified in Step 1, based on labor requirements for managerial, technical, and clerical staff

, ; current wage rates

, ; and other current costs.

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

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

 Step 5 : Subtract the compliance burden and cost after the proposed IUR amendments from the burden and cost under the current IUR requirements to calculate the incremental additional burden and cost or savings attributable to the amendments.

A chemical company may own many sites ; , each of which may manufacture (including import) multiple chemicals. Each site must submit a Form U if it exceeds the 25,000 lb. threshold for at least one

chemical that is not exempt from reporting. A site will submit one Form U Part I, and either a full or partial report for each chemical that meets or exceed s the reporting threshold. Each report is submitted for a unique chemical/site combination. The ac tivities under these tasks are as follows:

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

whether the site must submit a Form U.

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

 Preparation and Submission of Reports : Once a site has determined that it must submit a Form U

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

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4-2  Recordkeeping : Submitters must keep records supporting their submissions for five years.

More information on estimating compliance costs under the current IUR rule can be found in the economic analyses for the 2003 Amendments, Economic Analysis for the Amended Inventory Update

Rule (EPA, 2002a) and for the 2005 Amendments

, (EPA, 2005).



### 4.2 Industry Unit Burden and Cost Estimates

The industry reporting burden and cost are calculated based on estimates of wage rates, labor hours, and the numbers of sites and reports. This section describes the specific data used to develop these

estimates.

4.2.1 Estimates of Wage Rates



### Standard wage rates for managerial, technical, and clerical levels were developed from information published by the Bureau of Labor Statistics (BLS) and a method outlined in the document Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b). Average wage data for the three major occupational groups are published quarterly by the BLS in the Employer Costs for Employer Compensation (ECEC) reports. Managerial, technical, and clerical wage rates are taken from the “Management, Business, and Financial”, “Professional and Related”, and “Office and Administrative Support” occupational groups

, respectively. Wage data for the three occupational categories was gathered for manufacturing industries from Employer Costs for Employee Compensation Supplementary Tables:

Historical Data December 2006 – December 2008 (BLS, 2009).

Fringe benefits costs, such as health insurance and vacation, for each labor category are taken from the same ECEC series. Following the methodology outlined in ( EPA, 2002b ) , fringe benefits are calculated as a percentage of total wages for each category. An additional 17 percent is added to the wages in each category to account for overhead, based on information provided by the chemical industry and chemical industry trade associations in the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). The wages for each of the three categories were 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.

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

Wage 1 Fringe

Benefits 1 Fringes as % of Wage Overhead % of Wage 2 Fringe +

Overhead Factor Loaded Wages

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

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

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

Notes:

1 Employer Costs for Employee Compen sation Supplementary Tables: Historic al 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 Anal ysis 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. (See Appendix A for a copy of the current Form U). Each site must determine whether it must comply with the IUR rule. Sites that are

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4-3 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 va ry with the number of chemicals reported by the site. Each reporting site is required to file only one Part I of Form U, regardless of the number of reportable chemicals it manufactures or imports. The information required in Part I, such as site and company identification, are common to all chemicals produced at a single site; therefore, this information need only be reported once. For each reportable chemical, a site must prepare and submit Part II and, if applicable, Part III of Form U. For the purpose of this analysis, a “report” can be either a partial report (Parts I and II of Form U) or a full report (Parts I, II, and III of Form U), submitted for one chemical. Submission costs, in the baseline, consist of mailing costs, and are calculated per-site. Recordkeeping costs are calculated as per-report costs (so that total reporting and recordkeeping costs vary with the number of chemicals reported).

In summary, compliance costs are determined as follows:

 Compliance Determination: per-site basis ;

 Rule Familiarization: per-site basis ;

 Preparation of Part I: per-site basis ;

 Preparation of Parts II and III: per

- report basis ;

 Submission: per-site basis ; 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 determ ination, rule familiarizat ion, and recordkeeping burdens are also taken from the 2002 economic analysis. The economic analysis for the 2005 Amendments assumed a 15 percent re duction in burden for the completion of Part III because submitters

were no longer were required to report use and downstream processing information for exports. 3



### Therefore, this 15 percent reduction was applied to all of the 2002 burden estimates in Part III of the form, to estimate the current baseline.

The 2002 economic analysis presents low and high estimates for each burden element; for simplicity, this report uses the midpoints of these ranges. Table 4-2 contains the burden estimates, per site, to complete and submit a Form U (one report for one chemical).

3 In the 2005 economic analysis, EPA estimated that 15 percent of the production volume at an average site is exported. Because processing and use information was no longer required for this percentage of production volume, the effort to collect and report this information would decrease accordingly.***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-4Table 4-2: Baseline First-Cycle Labor Burden per Form U, in HoursClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Compliance Determination(Total Burden for Form U Compliance Determination)0.00 2.50 0.00 2.50Rule Familiarization(Total Burden for Form U Submission)0.00 19.00 9.00 28.00Recordkeeping(Total Burden for Form U Recordkeeping)1.50 3.00 1.50 6.00Submission(Total Burden for Form U Submission)0.00 0.00 0.00 0.00Mailing Burden 0.00 0.000.000.00Part I.Site Identification Information(Total Burden for Part I)0.76 0.95 1.05 2.761 Certification 0.68 0.85 1.01 2.542 Company InformationCompany Name,TechnicalContact, Address,D&BNumber, Mailing Address0.040.040.020.10Company Name, Technical Contact, Address, D&BNumber, Mailing Address0.040.040.020.103 Plant Site IdentificationPlant Name, D&B Number Address,MailingAddress0.050.060.020.13Plant Name, D&B Number,Address, MailingAddress0.050.060.020.13Part II.Manufacturing Information(Total Burden for Part II)1.55 8.78 3.49 13.821 Chemical Identification2 (Other) Manufacturing Information***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-5ClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Site-Limited, Activity, Production Volume (lb.) 0.52 2.28 0.56 3.36Chemical Identification Up-front CBISubstantiation0.26 1.45 0.67 2.38Plant Site Upf-Front Substantiation0.12 0.83 0.51 1.46Total Number of Workers0.21 1.43 0.59 2.23Maximum Concentration, Physical Form, PercentVolume of Production0.44 2.79 1.07 4.30Part IIIProcessing and Use Information(Total Burden for Part III)7.94 45.31 16.66 69.921 Industrial Processing and Use Exposure-Related DataDetermination of Applicability 0.13 1.01 0.28 1.42Industrial Function Category 2.11 4.41 2.07 8.59Function Code 0.19 0.94 0.40 1.52Percent of Production Volume 1.23 10.00 5.27 16.51Total Number of Processing and Use Sites 1.57 9.14 3.52 14.24Total Number of Potentially Exposed Workers 2.10 15.43 3.83 21.362 Consumer and Commercial Use Exposure-Related DataDetermination of Applicability 0.14 0.94 0.25 1.33Identification of Production Category/Use byChildren0.14 0.84 0.25 1.23Percent of Production Volume 0.20 1.26 0.45 1.91Maximum Concentration by Category 0.11 1.36 0.34 1.81Total Burden for Report Preparation and SubmissionPartial Report (Parts I, II,Recordkeeping and SubmissionBurden)3.81 34.23 15.04 53.08Full Report (Parts I, II, III, Recordkeeping and SubmissionBurden)11.74 79.54 31.70 122.99***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-6ClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Note: Totals may not sum due to rounding.Source:Revised Economic Analysis for the Amended Inventory Update Rule: Final Report(EPA, 2002a).

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4-7 The survey conducted for the economic analysis for the Final TSCA Inventory Reporting 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 is manufactured or imported;

 Providing the manufactured production volume; and

 Providing the imported production volume.

Several of the proposed amendments are expected to create burdens similar to one of the above activities, but none are expected to generate a burden equivalent to all four questions combined. To

estimate more accurately estimate the burden of several proposed amendments, EPA used its best professional judgment and estimated the percent burden each activity contributed to the total burden of

3.36 hours. These burdens are found in Table 4-3.

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

Activity Percent of Total

Burden Burden (hours) Answering a yes/no question to indicate whether the volume is site-limited

volume 5% 0.17

Indicating whether the chemical is manufactured or imported 5% 0.17

Providing the manufactured production volume 45% 1.51

Providing the imported production volume 45% 1.51

Total 100% 3.36

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

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

USPS Service Cost (2008$) Registered mail, regular, with $0 declared value 1 $10.60

Return receipt, requested at time of mailing (receive by mail) 1 $2.30

Postage, First Class Mail for larger envelopes, up to 1 ounce 2 $0.88

Total $13.78

Source: USPS, 2009

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4-8 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 co mpleting a partial report (Parts I, II, recordkeeping and submission costs) for the first time is $3,188. EPA estimate s d the cost to a site of submitting and completing a full report (Parts I, II, III, recordkeeping and submission costs) for the first time is $7,247, for one chemical. Table 4-5 contains the submission costs by section for first-time submitters, including the costs for compliance determination, rule familiari zation, report preparation, report submission, and recordkeeping costs.***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-9Table 4-5: BaselineFirst-CycleTotal Cost per Form U (2008$)Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Compliance Determination(Total Burden for Form U Compliance Determination)$0.00 $147 $0.00 $147Rule Familiarization(Total Burden for Form U Submission)$0.00 $1,118 $630 $1,748Recordkeeping(Total Cost for Form U Recordkeeping)$42.72 $177 $104 $324Submission(Total Cost for Form U Submission)$13.78Mailing Cost$13.78Part I.Site Identification Information(Total Cost for Part I)$21.50 $54.08 $73.53 $149.101 Certification $19.22 $50.01 $70.73 $139.962 Company InformationCompany Name, Contact, Address,D&B Number,Mailing Address$1.00$2.35$1.40$4.75Company Name, Contact, Address , D&B Number,Mailing Address$1.00$2.35$1.40$4.753 Plant Site IdentificationPlant Name, D&B Number Address,MailingAddress$1.28$1.71$1.40$4.39Plant Name, D&B Number,Address, MailingAddress$1.28$1.71$1.40$4.39Part II.Manufacturing Information(Total Burden for Part II)$44.14 $516.61 $244.40 $805.141 Chemical Identification2 (Other) Manufacturing Information***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-10Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Site-Limited, Activity, Production Volume (lb.) $14.81 $134.15 $39.22 $188.18Chemical Identification Up-front CBISubstantiation$7.40 $85.32 $53.57 $146.29Plant Site Up-front Substantiation$3.42 $48.84 $35.57 $87.97Total Number of Workers$5.98 $84.14 $40.97 $131.09Maximum Concentration, Physical Form, PercentVolume of Production$12.53 $164.16 $74.93 $251.62Part IIIProcessing and Use Information(Total Cost for Part III)$226.08 $2,666 $1,167 $4,0591 Industrial Processing and Use Exposure-Related DataDetermination of Applicability $3.63 $59.27 $19.94 $82.84Industrial Function Category $60.15 $259.57 $144.64 $464.36Function Code $5.33 $55.01 $27.68 $88.02Percent of Production Volume $35.10 $588.41 $369.34 $992.85Total Number of Processing and Use Sites $44.78 $537.89 $246.72 $829.40Total Number of Potentially Exposed Workers $59.91 $907.74 $268.15 $1,2362 Consumer and Commercial Use Exposure-Related DataDetermination of Applicability $4.11 $55.01 $17.56 $76.69Identification of Production Category/Use byChildren$4.11 $49.26 $17.56 $70.64Percent of Production Volume $5.81 $74.02 $31.55 $111.38Maximum Concentration by Category $3.15 $80.02 $24.11 $107.28Total Cost for Report Preparation and SubmissionPartial Report (Parts I, II, Recordkeeping and SubmissionCosts)$108 $2,012 $1,053 $3,188Full Report (Parts I, II, III, Recordkeeping and SubmissionCosts)$334 $4,678 $2,220 $7,247Note: Totals may not sum due to rounding.***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-11Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Source:Revised Economic Analysis for the Amended Inventory Update Rule: Final Report(EPA, 2002a).

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4-12 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, T t he total number of reports is broken down into sites that filed full reports and sites that filed partial reports

, because of the difference in cost between the two types of reports

. The number of reports EPA is expecting was estimated using data compiled from EPA’s 2006 IUR Database (EPA, 2008c). The database contains information collected under the IUR rule for previous reporting cycles and was used to generate estimated numbers of expected reports. The Agency assumes that because of the low company turnover rate within the chemical manufacturing industry, the baseline number of sites submitting Form U in 2011 will be equivalent to the number of sites submitting Form U in 2006. In addition, for the purposes of this analysis

, EPA assumes that the baseline number of reports submitted will not change from the 2006 submissions. In 2006, a total of 4,085 sites completed 25,896 reports forms

as shown in Table 4-6

Table 4-6: Baseline Number of Reports and Sites

Number of Partial Reports Number of Full Reports Total

Number of Sites 568 3,517 4,085

Number of Reports 8,821 17,075 25,896

Source: U.S. EPA, Office of Pollution Prevention a nd Toxics, Information Management Division 2006 IUR Database Statistics for IUR Modifications Rule . Washington, DC. December 17, 2008 (EPA, 2008c).



### Limitations of Analysis . Due to inconsistencies and limitations in the data collected in 2002 and 2006, including the amendment requiring reports for inorganic chemicals for the first time in 2006 and the change in the reporting threshold from 10,000 to 25,000 lb., it was not possible for EPA to compare

records to determine whether there was a significant change in the number of sites and reports submitted

for a consistent set of chemicals had changed significantly between the two reporting cycles. Such an analysis potentially could provide support for EPA’s assumption that the number of sites and reports will remain relatively unchanged in the next reporting cycle. Therefore, to the extent that changes in the chemical industry unrelated to the proposed IUR rule amendments could affect the number of site and reports submitted, this analysis may under- or overestimate costs and burden.

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



### EPA assumes that sites that that previously have submitted a Form U will incur a reduced have less of

a burden for processing and submitting Form U in future reporting cycles. All sites will incur a higher reporting cost in the first reporting cycle after the rule amendments are finalized, due to the need to an increase in burden to become familiar with the revised require ments. However, the Agency assumes that unit costs for report preparation and submission in futu re 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 cycl es and familiarity with reporting requirements will expedite the process for submitters who have previ ously submitted a Form U. The burden estimates for these sites are weighted to reflect this decreased burden (EPA, 2002a). Table 4-7 contains the weighting factors for each section of the form. Table 4-8 contains the baseline, future reporting cycle, per

- report burden estimates, which are calculated using the weights in Table 4-7 and the first reporting cycle burden estimates in Table 4-2. Table 4-9 contains the baseline future reporting cycle costs per report, which are calculated using the wage rate s in Table 4-1 and the hourly burden estimates from Table 4-8.

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4-13 Table 4-7: Weighting Factors for Burden Estimates for Sites That Have Previously Submitted a
Form U

Section of Form U Incurred Percent of Initial

Burden Incurred Burden 1

Part I. Site Identification

Certification 100%

Section A Company Information 20%

Section B Plant Site Identification 20%

Section C Technical Contact 20%

Part II. Manufacturing Information

Section A Chemical Identification 20%

Section B (Other) Manufacturing Information 80%

Part III. Processing and Use Information

Section A Industrial Processing and Use Exposure

Related Data 80%

Section B Industrial Processing and Use Exposure

Related Data 80%

1 Weighting factors are from the Revised Economic Analysis for the Amende d Inventory Update Rule: Final Report (EPA, 2002a), pp. 3-17.***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-14Table 4-8: Baseline Future-Cycle Labor Burden per Report, in HoursClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Compliance Determination(Total Burden for Form U Compliance Determination)0.00 2.50 0.00 2.50Rule Familiarization(Total Burden for Form U Submission)0.00 2.00 2.00 4.00Recordkeeping(Total Burden for Form U Recordkeeping)1.50 3.00 1.50 6.00Submission(Total Burden for Form U Submission)0.000.000.000.00Mailing Burden 0.000.000.000.00Part I.Site Identification Information(Total Burden for Part I)0.69 0.87 1.02 2.581 Certification 0.68 0.85 1.01 2.542 Company InformationCompany Name, Technical Contact, Address,D&B Number, Mailing Address0.01 0.01 0.00 0.023 Plant Site IdentificationPlant Name, D&B Number,Address, MailingAddress0.01 0.01 0.00 0.03Part II.Manufacturing Information(Total Burden for Part II)1.24 7.02 2.79 11.061 Chemical Identification2 (Other) Manufacturing InformationSite Limited, Activity, Production Volume (lbs.)0.42 1.82 0.45 2.69Chemical Identification Up-front CBISubstantiation0.21 1.16 0.61 1.98Plant Site Up-front Substantiation0.10 0.66 0.41 1.17***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-15ClericalBurdenTechnicalBurdenManagerialBurdenTotal BurdenForm U Section and Activity(a)(b)(c)(d) = (a)+(b)+(c)Total Number of Workers0.17 1.14 0.47 1.78Maximum Concentration,Physical Form, PercentVolume of Production0.35 2.23 0.86 3.44Part IIIProcessing and Use Information(Total Burden for Part III)6.35 36.25 13.33 55.931 Industrial Processing and Use Exposure-Related DataDetermination of Applicability 0.10 0.81 0.23 1.14Industrial Function Category 1.69 3.53 1.65 6.87Function Code 0.15 0.75 0.32 1.21Percent of Production Volume 0.99 8.00 4.22 13.21Total Number of Processing and Use Sites 1.26 7.31 2.82 11.39Total Number of Potentially Exposed Workers 1.68 12.34 3.06 17.092Consumer and Commercial Use Exposure-RelatedDataDetermination of Applicability 0.12 0.75 0.20 1.06Identification of Production Category/Use byChildren0.12 0.67 0.20 0.98Percent of Production Volume 0.16 1.01 0.36 1.53Maximum Concentration by Category 0.09 1.09 0.28 1.45Total Burden for Report Preparation and SubmissionPartial Form (Parts I, II,Recordkeeping and SubmissionBurden)3.43 15.39 7.31 26.14Full Form (Parts I, II, III, Recordkeeping and SubmissionBurden)9.78 51.64 20.64 82.07Note: Totals may not sum due to rounding.***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-16Table 4-9: Baseline Future-Cycle Total Cost per Report (2008$)Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Compliance Determination(Total Burden for Form U Compliance Determination)$0.00 $147 $0.00 $147Rule Familiarization(Total Burden for Form U Submission)$0.00 $118 $140 $258Recordkeeping and Submission Costs(Total Cost for Form U Recordkeeping)$42.72 $176.52 $105.04 $324.28Submission(Total Burden for Form U Submission)$13.78Mailing Cost$13.78Part I.Site Identification Information(Total Burden for Part I)$19.68 $51.19 $71.29 $142.161 Certification $19.22 $50.01 $70.73 $139.962 Company InformationCompany Name, Technical Contact, Address,D&B Number, Mailing Address$0.20 $0.47 $0.28 $0.953 Plant Site IdentificationPlant Name, D&B Number,Address, MailingAddress$0.26 $0.71 $0.28 $1.24Part II.Manufacturing Information(Total Burden for Part II)$35.31 $413.29 $195.52 $644.121 Chemical Identification2 (Other) Manufacturing InformationSite Limited, Activity, Production Volume (lbs) $11.85 $107.32 $31.37 $150.54Chemical Identification Up-front CBISubstantiation$5.92 $68.25 $42.86 $117.03Plant Site Up-front Substantiation$2.73 $39.07 $28.57 $70.37Total Number of Workers$4.78 $67.31 $32.77 $104.87***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-17Clerical CostTechnical CostManagerial CostTotal CostForm U Section and Activity(a)(b)(c)(d)=(a)+(b)+(c)Maximum Concentration, Physical Form,Percent Volume of Production$10.02 $131.33 $59.94 $201.30Part IIIProcessing and Use Information(Total Burden for Part III)$180.87 $2,132.97 $933.56 $3,247.401 Industrial Processing and Use Exposure-Related DataDetermination of Applicability $2.90 $47.41 $15.95 $66.27Industrial Function Category $48.12 $207.66 $115.71 $371.49Function Code $4.26 $44.01 $22.14 $70.41Percent of Production Volume $28.08 $470.73 $295.47 $794.28Total Number of Processing andUse Sites$35.82 $430.32 $197.38 $663.52Total Number of PotentiallyExposed Workers$47.93 $726.19 $214.52 $988.642 Consumer and Commercial Use Exposure-Related DataDetermination of Applicability $3.29 $44.01 $14.05 $61.35Identification of ProductionCode/Use by Children$3.29 $39.41 $13.81 $56.51Percent of Production Volume $4.65 $59.22 $25.24 $89.10Maximum Concentration byCategory$2.52 $64.02 $19.29 $85.82Total Cost for Report Preparation and SubmissionPartial Form (Parts I, II, Recordkeeping and SubmissionCosts)$97.71 $906 $512 $1,529Full Form (Parts I, II, III,Recordkeeping and SubmissionCosts)$279 $3,039 $1,446 $4,777Note: Totals may not sum due to rounding.

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4-18 

### 4.3 Total Baseline IUR Industry Compliance Burden and Costs

The estimated wage rates, burden hours, and number of sites were combined to estimate the total baseline costs to comply with the current IUR rule in the 2011 reporting cycle. Costs were aggregated either per site or per report, depending on how the costs are incurred. Compliance determination and rule familiarization were estimated on a per-site basis; the costs for completing Part I of Form U wereestimated on a per-site basis. The cost of completing Parts II and III of Form U were calculated on a perreport basis, and submission and recordkeeping were estimated on a per-report basis.

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

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

Burden for all Part Is, Rule Familiarization,

Compliance

Determination

and Submission Burden for all

Part IIs and Recordkeeping Burden for all

Part IIIs Total Burden Under

the Current IUR

Requirements

Burden in Hours 135,847 513,259 1,193,829 1,842,934

Cost (2008$) $8,407,651 $29,247,454 $69,311,707 $106,966,812



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

million.

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

Burden for all Part Is, Rule Familiarization,

Compliance

Determination

and Submission Burden for all

Part IIs and Recordkeeping Burden for all

Part IIIs Total Burden Under

the Current IUR

Requirements

Burden in Hours 37,088 441,682 955,063 1,433,833

Cost (2008$) $2,290,736 $25,077,449 $55,449,366 $82,817,550



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

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4-19 amendments could affect the number of site and re ports submitted, the baseline burden and cost may be

under- or overestimated.



### 4.4 Changes in Industry Burden and Costs Due to the Proposed IUR
Modifications Rule

The expected cost and burden impacts of each of the proposed amendments to the IUR rule are outlined below. See Section 3. for more detailed information about each of these proposed amendments.

In each of the following sections below , the burden estimates for each amendment are calculated independently of the other amendments . See Section 4.5 for an estimate of the aggregated impact of all proposed amendments.

4.4.1 Technical Modifications to the Regulatory Text



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

4.4.2 Modifications to Selected Definitions


### EPA is proposing to modify the definitions of “importer,” “manufacture,” “site,” “commercial use,” “consumer use,” “reporting year,” and “submission period,” and to add definitions for “manufacturer,” “Central Data Exchange (CDX),” “e lectronic IUR (e -IUR ) web ,” 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 subm itter completes a report only if its chemical production has met or exceeded the 25,000 lb. production reporting threshold during the principal reporting year. EPA is proposing to modify the timeframe for reporting, so that chemical manufacturers (including importers) will be subject to the IUR rule if a chemical’s production volume has exceeded the threshold in any calendar year since the last principal reporting year. This modification would not take

effect until after the first post-amendment reporting cycle (2011); for the first reporting cycle, submitters

w ould still consider production volume for only the principal reporting year.

EPA believes that this proposed amendment will cause an increase in the numbers of submitters and
reports in future reporting cycles . Because data on the production volume of chemicals reportable under the IUR rule during non-principal reporting years is not currently is not available, the actual percentage increase in these numbers is unknown. The Agency, using its best professional judgment, estimates that for the purpose of this analysis

, the amendment will increase the number of submitters and reports 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 that 204 additional sites will submit reports in future reporting cycles . EPA further estimates that those sites will submit an additional 854 full reports and 441 partial reports, for a total of 1,295 additional reports for the 201 1 reporting cycle and each future reporting cycle.

As described in Section 4.1, sites need to complete Part I of Form U only once, and complete Part II and Part III (as applicable) for each chemical manufactured or imported. Taking this allocation of activities into consideration, and using the baseline unit burden estimates as shown above in Table 4-2 and Table 4-8, Table 4-12 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that the amendment will not cause a change generate an annual increase in industry

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4-20 burden of approximately 92,1 5 0 hours during the 2011 reporting cycle , but will generate an increase of

and 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 33.26 4,085 4,2

89 19.82 19.82 25,896 2 7,191 69.92 69

.92 17,075 1 7,929 1,842,934 1 ,935,081

Change from the Baseline, First Cycle 0.00 0.00 0 204 0.00 0.00 0 1,295 0.00 0.0

0 0 854 0 92,147

Future Cycle

Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833

Future Cycle,

PostAmendment 9.08 4,289 17.06 27,191 55.93 17,929 1,505,524

Change from the Baseline, Future Cycles 0.00 204 0.00 1,295 0.00 854 71,692

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the 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 proposed amendment. EPA estimates that

the amendment will not cause a change in industry cost will increase by $ 5.35 million in the first reporting cycle , but will increase costs by and $4.14 million in all future reporting cycles.

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4-21 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 $2,058 4,085 4,2

89 $1,129 $1,129 25,896 2 7,191 $4,059 $4,059 17,075 1 7,929 $106.97 $112.32

Change from the Baseline, First Cycle $0 $0 0 204 $0 $0 0 1,295 $0 $0 0 854 $0.00
$5.35

Future Cycle

Baseline $561 4,085 $968 25,896 $3,247 17,075 $82.82

Future Cycle,

PostAmendment $561 4,289 $968 27,191 $3,247 17,929 $86.96

Change from the Baseline, Future Cycles $0 204 $0 1,295 $0 854 $4.14

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



### Limitations of Analysis. To the extent that the change in method for determining whether a manufacturer is subject to the IUR reporting requirem ents 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 F.1.

In the proposal, EPA also requested comment on returning to the previous, lower reporting threshold of 10,000 lb. Appendix G. contains an analysis of the cost and burden of this lower threshold.

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



### EPA is proposing to eliminate the 300,000 lb. threshold for processing and use reporting, thereby requiring all reporters of non-excluded substances to report information in all parts of the IUR Form U. Eliminating this threshold will increase industry burden by requiring more sites to complete Part III of Form U (Part III contains the downstream processing and use information).

This proposed amendment affects only the burden and costs associated with completing Part III; it would not cause an increase in the number of sites submitting reports. The baseline number of partial reports submitted (that is, forms with only Part I and Part II completed) is 8,821 (see Table 4-6). However, several of these reports are submitted for partially exempt chemicals. Under the proposed amendment, submitters of partially exempt chemicals still will not be required to submit a Part III. In 2006, EPA received a total of 618 partial reports (EPA, 2009a) on the 712 partially exempt chemicals (EPA, 2006a) currently on the partially exempt list.

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4-22 Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-14 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that the amendment will cause an increase in industry burden of approximately 573,500 hours during the first reporting cycle, and 458,800 hours during all future reporting cycles.

Table 4-14: Change in Industry Burden as a Result of Eliminating the 300,000 lb. Threshold for Downstream Processing and Use Information Reporting

Burden per Report (Part III) (hours) Total Number of Reports

with Part III Total Industry

Burden (hours)
First Cycle, Baseline 69.92 17,075 1,193,829
First Cycle, PostAmendment 69.92 25,278 1,767,356

Change from the Baseline, First Cycle 0 8,203 573,527

Future Cycle Baseline 55.93 17,075 955,063
Future Cycle, PostAmendment 55.93 25,278 1,413,884

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

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



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-15 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that the industry cost will increase by $33.3 million in the 2011 reporting cycle and by $26.64 million in all future reporting cycles.

EPA also explored the possibility of lowering the threshold for processing and use reporting to various levels below 300,000 lb., but greater than 25,000 lb. (e.g., not eliminating the threshold entirely) (EPA, 2008c). The current 300,000 lb. threshold applies to each chemical produced at each individual reporting site, and was sele cted with the intention that exposure-related processing and use information

would be collected for High Production Volume ( HPV ) chemicals. However, the uncertainty that thresholds lower than 300,000 lbs. would capture substantially more of the HPV chemicals, coupled with the need to complete characterizations for chemicals manufactured (including imported) in volumes of 25,000 lb. to 300,000 lb., led the Agency to believe that it would be best to eliminate the 300,000 lb. threshold altogether and collect full in formation for the all reported chemicals

.

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4-23 Table 4-15: Change in Industry Cost as a Result of Eliminating the 300,000 lb. Threshold for Downstream Processing and Use Information Reporting

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

with Part III Total Industry Cost (millions 2008$)

First Cycle, Baseline $4,059.25 17,075 $69.31
First Cycle, PostAmendment $4,059.25 25,278 $102.61

Change from the Baseline,

First-Year $0.00 8,203 $33.30

Future Cycle Baseline $3,247.40 17,075 $55.45
Future Cycle, PostAmendment $3,247.40 25,278 $82.09

Change from the Baseline, Future Cycles $0.00 8,203 $26.64

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



### Limitations of Analysis. EPA is assuming that each partially exempt chemical is produced at four

different sites. To the extent that this is not the case, this analysis may over- or underestimate the number

of additional Part IIIs.

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



### EPA is proposing to eliminate the 25,000 lb. threshold for chemicals that are: (1) the subject of a regulation proposed or promulgated under section 5(a)(2), 5(b)(4), or 6 of the Act; (2) the subject of an order issued under section 5(e) or 5(f) of the Act, or (3) the subject of relief that has been granted under a

civil action under section 5 or 7 of the Act. The manufacturers and (including importers ) of these chemicals would be required to report under the IUR rule, regardless of the production volume.

To determine how many chemicals this proposed amendment would affect, EPA referred to Appendix

C of the Instructions for Reporting for the 2006 Partial Updating of the TSCA Chemical Inventory

Database (EPA, 2006a), which lists chemical substances that are the subject of certain TSCA orders, proposed or final TSCA rules, or relief granted under civil actions. A count of all the chemical substances, listed by CASRN, that are subject to a regulation proposed or promulgated under sections 5(a)(2), 5(b)(4), or 6 of the Act, subject of an order issued under section 5(e) or 5(f) of the Act, or the subject of relief that has been granted under a civil action under section 5 or 7 of the Act, identified 1,131 chemicals. Because the proposed amendment would affect only chemicals subject to a promulgated rule, this figure is an

overestimate. CASRN numbers were provided for 740 of these chemicals, and an additional 391 chemicals were listed by accession numbers (EPA, 2006a). Of the 740 chemicals with CAS numbers, no reports were filed for 652 chemicals, or 88 percent of chemicals (EPA, 2009e). EPA also assumes that no reports were filed for 88 percent of the 391 chemicals with accession numbers, or 345 chemicals. In addition, Form Us were submitted voluntarily for eight chemicals with production volume levels below the 25,000 lb. threshold during the 2006 reporting cycle (EPA, 2009a). EPA estimates that reports will now be filed for approximately 1,005 additional chemicals for which reports are not currently required (652+345+8 = 1,005).

Based on the data provided in the 2006 IUR reporting cycle (EPA, 2008c), on average, each chemical is produced at approximately four sites; therefore, EPA expects 4,018 additional reports (Part IIs) to be submitted for these chemicals. The Agency also assumes that the reports generated by this amendment would be for production volumes lower than 25,000 lb. (therefore, lower than 300,000 lb.), so, as a result of this amendment alone, submitters would not be requir ed to complete Part III (see Section 4.5 for an estimate of the aggregated impact of all proposed amendments). In addition, the Agency is assuming that

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4-24 manufacturers (including importers) of these chemicals already would be submitting reports for other non-exempt chemicals; so, therefore, the number of sites would not increase from the baseline as a result

of this amendment.

Using the baseline unit burden estimate for completion of Part II as shown above in Table 4-2 and Table 4-8, Table 4-16 presents the estimated increase in industry burden as a result of this proposed amendment. The Agency estimates that the amendment will cause an increase in industry burden of approximately 79,600 hours during the first reporting cycle and 68,500 hours during all future reporting cycles.

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

Burden for Recordkeeping and to Prepare Part II

(hours per report) Number of Reports Industry Burden (hours)

First Cycle, Baseline 19.82 25,896 513,259
First Cycle, Post-Amendment 19.82 29,914 592,896
Change from the Baseline, First Cycle 0.00 4,018 79,637

Future Cycle Baseline 17.06 25,896 441,682
Future Cycle, Post-Amendment 17.06 29,914 510,213 Change from the Baseline, Future Cycles 0.00 4,018 68,531

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



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

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

Cost for Recordkeeping and to Prepare Part II

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

First Cycle, Baseline $1,129 25,896 $29.25
First Cycle, Post-Amendment $1,129 29,914 $33.79
Change from the Baseline, First Cycle $0 4,018 $4.54

Future Cycle Baseline $968 25,896 $25.08
Future Cycle, Post-Amendment $968 29,914 $28.97
Change from the Baseline, Future Cycles $0 4,018 $3.89

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



### Limitations of Analysis. The number of additional reports EPA receives as a result of this amendment may be an overestimate to the extent that manufacturers (including impor ters) already are submitting reports for these chemicals. That is, to the extent that some portion of these chemicals already are subject to IUR reporting because they are produced in volumes of 25,000 lb. or greater, the Agency is overestimating the number of additional reports it would receive as a result of the amendment. Furthermore, to the extent that manufacturers (including importers) of these chemicals do not already

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4-25 submit reports for other chemicals, EPA is underestimating the number of sites that would increase from

the baseline as a result of this amendment.

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



### Chemicals subject to enforceable consent agreements (ECAs) are of demonstrated interest to the Agency. For instance, EPA will use the IUR data associated with these regulated chemicals to monitor chemical production and compliance with the agreements. Therefore, EPA proposes to make these chemicals ineligible for reporting exemptions. Manuf acturers (including importers) of these chemicals

w ill no longer would 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 enforceable consent agreements for 67 chemicals. Six of the 67 chemicals were composite substances developed for the sole purpose of conducting testing under ECAs, and were never listed on the TSCA Inventory. Eliminating those six substances leaves a total of 61 chemicals subject to

ECAs.

EPA also maintains a table that show ing s the sunset date and status for chemicals subject to section 4 actions, including ECAs ( http://www.epa.gov/oppt/chemtest/pubs/sunset.html ) (EPA, 2009g). Only two

of the 61 chemicals were identified as currently being subject currently to an ongoing ECA. Therefore, only two chemicals will would lose the partial exemption and under the proposed amendment, and so would need to complete Part III of Form U. In addition, EPA is assuming that an additional two chemicals could be under ECAs in future reporting cycles. Therefore, EPA is estimating that the proposed

amendment would cause submitters of a total of four chemicals to complete Part III of Form U. Based on data from the 2006 IUR reporting cycle, the Agency estimates that approximately four sites produce each chemical (EPA, 2008c); therefore, a total of 16 Part IIIs would be submitted for the first time for chemicals subject to an ECA.

Using the baseline unit burden estimate for completion of Part III as shown above in Table 4-2 and Table 4-8, Table 4-18 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that the amendment will cause an increase in industry burden of approximately 1,1 0 1 0 hours during the first reporting cycle, and 900 hours during all future reporting cycles.

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4-26 Table 4-18: Change in Industry Burden as Result of Making Chemicals Subject to ECAs Ineligible for Exemptions

Burden per Report (Part III) (hours) Total Number of Reports

with Part III Total Industry Burden (hours)

First Cycle,

Baseline 69.92 17,075 1,193,829

First Cycle, PostAmendment 69.92 17,091 1,194,947

Change from the Baseline, First Cycle 0 16 1,119

Future Cycle

Baseline 55.93 17,075 955,063

Future Cycle, PostAmendment 55.93 17,091 955,958

Change from the Baseline, Future Cycles 0 16 895

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



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

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

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

with Part III Total Industry Cost (2008$) First Cycle, Baseline $4,059 17,075 $69,311,707
First Cycle, PostAmendment $4,059 17,091 $69,376,655

Change from the Baseline, First Cycle $0 16 $64,948

Future Cycle Baseline $3,247 17,075 $55,449,366
Future Cycle, PostAmendment $3,247 17,091 $55,501,324

Change from the Baseline, Future Cycles $0 16 $51,958

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



### Limitations of Analysis . EPA is assuming that each of these chemicals is produced at four different

sites. To the extent that this is not the case, this analysis may over- or underestimate the number of additional Part IIIs. In addition, some of these chemicals may be produced in volumes of 300,000 lb. or greater, and therefore would already be required to submit a full report. To the extent that this is the case, this analysis overestimates the total number of additional Part IIIs. Finally, to the extent that additional chemicals become subject to ECAs in the future, this analysis may underestimate the total number of

additional Part IIIs.

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4-27 4.4.7 Full Exemption for Manufactured Water



### Under the current IUR regulations, manufactured water is partially exempt from reporting; therefore,

facilities that produc ing e manufactured water only need to complete Parts I and II of Form U. The Agency is proposing to grant a full exemption for manufactured water. In 2006, a total of 43 partial reports were submitted for manufactured water (EPA, 2008c). EPA assumes that manufactured water is a byproduct of chemical production. Therefore, sites submitting a report for manufactured water will continue to submit reports for other chemicals. Thus the burden reduction for this proposed amendment would be the result of 43 fewer Part IIs being submitted.

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-20 shows the reduction in industry burden estimate as a result of this proposed amendment. The Agency

estimates that the amendment will cause a decrease in industry burden of approximately 850 hours during the first reporting cycle, and by 700 hours during all future reporting cycles.

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

Burden for Recordkeeping and to Prepare Part II (hours per report) Number of Reports Total Industry Burden (hours)

First Cycle, Baseline 19.82 25,896 513,259
First Cycle, Post-Amendment 19.82 25,853 512,406
Change from the Baseline, First Cycle 0 -43 -852

Future Cycle Baseline 17.06 25,896 441,682
Future Cycle, Post-Amendment 17.06 25,853 440,949
Change from the Baseline, Future Cycles 0 -43 -733

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



### The cost savings due to the amendment were determined using the unit costs shown in Table 4-5 and Table 4-9. Table 4-21 shows the industry cost estimate as a result of this proposed amendment. EPA

estimates that the industry cost will decrease by approximately $48,600 in the first reporting cycle and $41,600 in all future reporting cycles.

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

Cost for Recordkeeping and to Prepare Part II

(2008$ per report) Number of Reports Total Industry Cost (2008$)

First Cycle, Baseline $1,129 25,896 $29,247,454
First Cycle, Post-Amendment $1,129 25,853 $29,198,889
Change from the Baseline, First Cycle $0 -43 -$48,565

Future Cycle Baseline $968 25,896 $25,077,449
Future Cycle, Post-Amendment $968 25,853 $25,035,808
Change from the Baseline, Future Cycles $0 -43 -$41,641

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



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

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4-28 4.4.8 Remove Fully-Exempt Polymers from the Partially-Exempt List



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

4.4.9 Parent Company and Site Identity



### EPA is proposing that submitters provide the name, address, and D&B number of their ultimate domestic parent company, as well as for the site. This information was required as part of Form U prior to the 2006 amendments, so the 2002 economic analysis, on which these burden estimates are based, already included the cost of providing the information for the ultimate domestic parent company. The proposed rule will now be consistent with the 2002 analysis, and EPA assumes that the burden estimate will not change from the baseline. Furthermore, for companies that already may not have a D&B number, there is

no cost to obtain one.

4.4.10 Technical Contact



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

4.4.11 Chemical Identity



### EPA is proposing to require that IUR submitters to report the Chemical Abstracts (CA) Index Name currently used to list the substance in the Inventory. Currently, submitters are required to report a specific chemical name, with no further elaboration in the regulatory text. EPA is also proposing to allow submitters to report only the CASRN as a chemical id entifying number or, in the case of confidential chemical substances, the accession number. Note that in cases where a CASRN exists for a confidential chemical, it can be reported instead of the accession number and claimed as confidential for purposes of the IUR submission. EPA is proposing to remove the PMN number as an allowed chemical identifying number because each Inventory substance has either or both a CASRN or a TSCA Accession Number, which are likely to be already known to the submitter.

The Agency assumes that all manufacturers (including importers) know or can easily obtain the CA Index Names and CASRN numbers for the chemicals they produce. Therefore, EPA assumes that no additional burden will be incurred by requiring subm itters to report the CA Index Name and CASRN as the chemical identity instead of whicheve r unique identifier they currently use.

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



### EPA is proposing to require that submitters to report production volume for each of the five years since the last IUR principal reporting year. Thus, for the 2011 IUR, manufacturers (including importers) of subject chemicals would report the production volume for the calendar years 2006, 2007, 2008, 2009, and 2010. While sites will still submit data to EPA only in the submission year, EPA assumes that there will be an increase in burden as the result of gathering data and reporting production volumes for an additional four years.

According to the baseline burden estimate, a site spends approximately 3.36 hours to gather production volume and site-limited activity (see Table 4-3). EPA estimates that approximately 45 percent

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4-29 of these 3.36 hours (i.e., 1.51 hours) is attributed to gathering production volume information. (See Table 4-3 for an explanation of this percentage breakdown.) Therefore, the Agency estimates that a site would spend an additional 6.05 hours (i.e., 1.51 x 4) to gather the production volume information for the four additional non-principal reporting years.

Table 4-22 shows the increase in industry burden as a result of this proposed amendment. The Agency estimates that the amendment will cause a total increase in industry burden of approximately 156,600 hours in the first reporting cycle and 125,300 hours in all future reporting cycles.

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

Burden to Report

Production Volume (hours per report) Number of Reports Industry Burden (hours)

First Cycle, Baseline 1.51 25,896 39,155
First Cycle, Post-Amendment 7.56 25,896 195,774 Change from the Baseline, First Cycle 6.05 0 156,619

Future Cycle Baseline 1.21 25,896 31,324
Future Cycle, Post-Amendment 6.05 25,896 156,619 Change from the Baseline, Future Cycles 4.84 0 125,295

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



### The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9.

Table 4-23 s hows the industry cost estimate as a result of this proposed amendment. EPA estimates that the industry cost will increase by $8.77 million in the 2011 reporting cycle submission year and $7.02 million in all future reporting cycles.

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

Cost to Report

Production

Volume (2008$ per

report) Number

of Reports Industry Cost (millions 2008$)

First Cycle, Baseline $84.68 25,896 $2.19
First Cycle, Post-Amendment $423.40 25,896 $10.96
Change from the Baseline, First Cycle $338.72 0 $8.77

Future Cycle Baseline $67.74 25,896 $1.75
Future Cycle, Post-Amendment $338.72 25,896 $8.77
Change from the Baseline, Future Cycles $270.98 0 $7.02

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



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

amendment.

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4-30 4.4.13 Volume of Chemical Substance Used On-Site



### Previous Form U ’ s have required submitters to indicate whet her a chemical was site-limited, referring

to a chemical substance that is manufactured and/or processed only within a site and not distributed forcommercial purposes as a substance or as part of a mixture or article outside the site. A chemical used offsite is one that does not meet this definition; for example, a chemical produced as an end product. EPA is proposing the removal of the site-limited data element and requiring submitters to report the production

volume used on-site.

The Agency expects the burden to the submitter of reporting the production volume used on-site to be similar to the burden to report the total production volume, given that the activities to identify the necessary information are similar. EPA estimates that it will take a submitter 1.51 hours to provide the production volume (see Table 4-3).

EPA expects an increase in the number of submitters who would report volume used on-site, due to the way that this information would be reported, under the amendment. In the data submitted to EPA for the 2006 reporting year, about 14.8 percent of reports include a site-limited volume (EPA 2008c); therefore, EPA assumes this is the minimum number of reports that would be affected.

Site-limited chemicals are those that are not distributed (either as the chemical substance itself or in a mixture) outside the plant site for commercial purposes. Therefore, EPA assumes that all chemicals used on-site must be chemical intermediates. According to data from the 2006 IUR database (EPA, 2008c), approximately 24 percent of all reports containing downstream processing and use information included chemicals used as intermediates. Therefore, EPA assumes that 24 percent of all reports is the maximumpercentage of reports that would be affected. Not all chemicals produced as intermediates are used onsite; they may be shipped for use at another site. EPA used 19.4 percent, which is the midpoint of 14.8
percent and 24 percent , to estimate the increase in the number of reports with chemicals used on-site, i.e., 5,024 reports.

Table 4-24 shows the industry burden estimate as a result of this proposed amendment. The Agency

estimates that the amendment will cause a total increase in industry burden of approximately 7, 600 596 hours during the first reporting cycle and 6, 100 077 hours during all future reporting cycles.

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

Burden to Report

Production Volume

Used On-Site (hours) Number of Reports

with Production

Volume Used OnSite Information Total Industry

Burden (hours)

First Cycle, Baseline 0.00 0 0
First Cycle, Post-Amendment 1.51 5,024 7,596
Change from the Baseline, First Cycle 1.51 5,024 7,596

Future Cycle Baseline 0.00 0 0
Future Cycle, Post-Amendment 1.21 5,024 6,077
Change from the Baseline, Future Cycles 1.21 5,024 6,077

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



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

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

4-31 Table 4-25: Change in Industry Cost as a Result of Requiring the Reporting of Production Volume
Used On-Site

Cost to Report

Production Volume

Used On-Site

(2008$) Number of Reports

with Production

Volume Used OnSite Information Total Industry

Cost (2008$)

First Cycle, Baseline $0.00 0 $0.00
First Cycle, Post-Amendment $84.68 5,024 $425,416
Change from the Baseline, First Cycle $84.68 5,024 $425,416

Future Cycle Baseline $0.00 0 $0.00
Future Cycle, Post-Amendment $67.74 5,024 $340,333
Change from the Baseline, Future Cycles $67.74 5,024 $340,333

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



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

that this is not the case, the analysis may over- or underestimate the number of reports affected.

4.4.14 Indicate Whether Chemical Is Physically at Reporting Site



### EPA is proposing to require submitters to indicate whether an imported chemical is physically at the reporting site. Under the current IUR requirements, a submitter must state whether if the site’s chemical is manufactured or imported. The Agency estimates that providing this information requires 0.17 hours per report (see Table 4-3). EPA assumes that the burden to indicate whether a chemical is physically on-site

will be similar to the burden incurred to indicate wh ether a chemical is manufactured or imported, given the similarity of these activities to identify the necessary information. Table 4-26 shows the industry burden estimates as a result of this proposed amendment. The Agency estimates that the amendment will cause a total increase in industry burden of approximately 4, 400 351 hours for the 2011 reporting cycle, and 3, 50 48 0 for all future reporting cycles.

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

Burden to Indicate

Whether Chemical is at the Reporting Site (hours) Number of Reports Industry Burden (hours)

First Cycle, Baseline 0.00 25,896 0
First Cycle, Post-Amendment 0.17 25,896 4,351
Change from the Baseline, First Cycle 0.17 0 4,351

Future Cycle Baseline 0.00 25,896 0
Future Cycle, Post-Amendment 0.13 25,896 3,480
Change from the Baseline, Future Cycles 0.13 0 3,480

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

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

4-32 The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-27 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that the total industry cost will increase by approximately $243,700 in the first reporting cycle and $194,900 in all future reporting cycles.

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

Cost to Indicate

Whether Chemical is Physically at Reporting Site (2008$) Number of Reports Industry Cost (2008$)

First Cycle, Baseline $0.00 25,896 $0
First Cycle, Post-Amendment $9.41 25,896 $243,652
Change from the Baseline, First Cycle $9.41 0 $243,652

Future Cycle Baseline $0.00 25,896 $0
Future Cycle, Post-Amendment $7.53 25,896 $194,921
Change from the Baseline, Future Cycles $7.53 0 $194,921

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



### Limitations of Analysis . To the extent that the burden of indicating whether a chemical is physically at the reporting site is different from the burden to report whether a chemical is manufactured or imported, this analysis may over- or underestimate the burden and cost of this amendment. Furthermore, this requirement may only apply only to importers; the number of reports affected

, is therefore

, is likely to

be an overestimation.

4.4.15 Report Production Volume Exported



### EPA is proposing to add a requirement for submitters to report the production volume directly exported and not domestically processed or used.

The Agency assumes that the burden to the submitter to report the volume exported would be similar to the burden to report the production volume, given the similarity of the activities. EPA estimates that it will take a submitter 1.51 hours to provide the volume exported (see Table 4-3).

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-28 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that the amendment will increase industry burden by approximately 39,200 hours for the 2011 reporting cycle, and 31,300 hours for all future reporting cycles.

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

Burden to Report

Export Volume (hours) Number of Reports Industry

Burden (hours) First Cycle, Baseline 0.00 25,896 0 First Cycle, Post-Amendment 1.51 25,896 39,155 Change from the Baseline, First Cycle 1.51 0 39,155
Future Cycle Baseline 0.00 25,896 0 Future Cycle, Post-Amendment 1.21 25,896 31,324 Change from the Baseline, Future Cycles 1.21 0 31,324

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

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

4-33 The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-29 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that the industry cost will increase by $2.19 million during the first reporting cycle and $1.75 million during all future reporting cycles.

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

Burden to Report

Export Volume (2008$) Number of Reports Industry

Cost (millions 2008$) First Cycle, Baseline $0.00 25,896 $0.00
First Cycle, Post-Amendment $84.68 25,896 $2.19
Change from the Baseline, First Cycle $84.68 0 $2.19

Future Cycle Baseline 0 25,896 $0.00
Future Cycle, Post-Amendment $67.74 25,896 $1.75
Change from the Baseline, Future Cycles $67.74 $0.00 $1.75

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



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

burden and cost of this amendment.

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



### EPA is proposing to add a requirement to indicate via a checkbox whe ther n a manufactured chemical, such as a byproduct, is being recycled, remanufactured, reprocessed, reused, or reworked. Given the similarity in activities to research records and identif y the appropriate informatio n, the Agency estimates this activity will generate the same burden as indicati ng whether a chemical is used on-site. As shown in Table 4-3, EPA estimated this burden to be approximately 0.17 hours.

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-30 shows the industry burden estimates as a result of this proposed amendment. The Agency estimates that the amendment will cause a total increase in industry burden of approximately 4,400 hours in the first reporting cycle and approximately 3,500 hours during all future reporting cycles.

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

4-34 Table 4-30: Change in Industry Burden as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reused, or Reworked

Burden for Completing a

Checkbox to Indicate

Whether a Product

Chemical is Recycled,

Remanufactured, Reprocessed, Reused, or Reworked (hours) Number

of Reports Industry

Burden (hours)

First Cycle, Baseline 0.00 25,896 0
First Cycle, Post-Amendment 0.17 25,896 4,351
Change from the Baseline, First Cycle 0.17 0 4,351

Future Cycle Baseline 0.00 25,896 0
Future Cycle, Post-Amendment 0.13 25,896 3,480
Change from the Baseline, Future Cycles 0.13 0 3,480

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



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

Table 4-31: Change in Industry Cost as a Result of Indicating Whether Chemical is Recycled, Remanufactured, Reprocessed, Reused, or Reworked

Cost for Completing a

Checkbox to Indicate

Whether a Product

Chemical is Recycled,

Remanufactured, Reprocessed, Reused, or Reworked (2008$) Number

of Reports Industry Cost (millions 2008$)

First Cycle, Baseline $0.00 25,896 $0
First Cycle, Post-Amendment $9.41 25,896 $243,652
Change from the Baseline, First Cycle $9.41 0 $243,652

Future Cycle Baseline $0.00 25,896 $0
Future Cycle, Post-Amendment $7.53 25,896 $194,921
Change from the Baseline, Future Cycles $7.53 0 $194,921

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



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

4.4.17 Concentration Ranges



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

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

4-35 This is a technical correction to eliminate gaps in the ranges as previously listed in the IUR rule. Therefore, EPA assumes that it will have no impact on industry burden or cost.

4.4.18 Revise Industrial Function Categories



### EPA is proposing to modify the current industrial function categories (found in Part III, Section A of Form U), deleting six current categories and adding ei ght new categories. In addition, EPA is proposing to require submitters to write in a free-text descriptor when they select “Other”.

EPA anticipates that t here would be a small additional burden for submitters to familiarize themselves with the eight new categories; based on best professional judgment, EPA estimates 15 minutes of

technical labor burden. EPA also estimates that it would take three minutes of clerical burden, and six

minutes of technical burden to write in the text desc ription if the submitter selects “Other”. According to 2006 IUR data (EPA, 2008a), the response “Other” was selected in 1,206 reports. Using its best professional judgment, EPA expects that the new categories proposed in the IUR modifications rule will reduce by half the number of submitters selecting “Other” as an industrial function category. Therefore,

EPA estimates that this amendment would affect 603 reports.

Using the baseline unit burden estimates as shown above in Table 4-2 and Table 4-8, Table 4-32 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that the amendment will cause a total increase in industry burden in the first reporting cycle of approximately 4,400 hours. In future reporting cycles, submitters will no longer need to familiarize themselves with the new industrial function categories, and EPA estimates the industry burden to be approximately 70 hours.

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

Burden for Rule

Familiarization

of Additional

Categories

(hours) Number of Reports with

Function Categories Burden to

Write in

Text for

"Other" (hours) Number of Reports with

"Other" as a

Function Category Total Industry

Burden (hours)

First Cycle, Baseline 1.52 17,075 0.00 0 25,907First Cycle, PostAmendment 1.77 17,075 0.15 603 30,266

Change from the Baseline, First Cycle 0.25 0 0.15 603 4,359

Future Cycle Baseline 1.21 17,075 0.00 0 20,726Future Cycle, PostAmendment 1.21 17,075 0.12 603 20,798

Change from the Baseline, Future Cycles 0.00 0 0.12 603 72

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



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

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

4-36 Table 4-33: Change in Industry Cost as a Result of Modifying the Industrial Function Categories

Cost for Rule

Familiarization

of Additional

Categories

(2008$) Number of Reports with

Industrial

Function Categories Cost to

Write in

Text for

"Other" (2008$) Number of Reports

with Text for

"Other" Total Industry

Cost (2008$)

First Cycle, Baseline $88.02 17,075 $0.00 0 $1,502,913
First Cycle, PostAmendment $102.73 17,075 $7.31 603 $1,758,490

Change from the Baseline, First Cycle $14.71 0 $7.31 603 $255,577

Future Cycle Baseline $70.41 17,075 $0.00 0 $1,202,331
Future Cycle, PostAmendment $70.41 17,075 $5.85 603 $1,205,856

Change from the Baseline, Future Cycles $0.00 0 $5.85 603 $3,525

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



### Limitations of Analysis . EPA estimates submitters will use 15 minutes of technical labor burden to become familiar with the new categories; this may be an over- or underestimate. EPA is assuming that the number of submitters selecting “Other” as an indust rial function category will be reduced by half; this may be an over- or underestimate. In addition, EPA assumes that there is no burden for rule familiarization with the new industrial function categories during future reporting cycles. This may not be the case if sites have different employees complete Form U from reporting year to reporting year, or for

chemical companies sites submitting a Form U for the first time.

4.4.19 Revise Industrial Sectors



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

assumes that the burden reduction would be negligible and does not estimate it here.

4.4.20 Revise Consumer and Commercial Product Categories



### EPA is proposing to revise the list of consumer and commercial use categories by combining categories that lead ing to common exposure scenarios and adding categories that were not adequately described in the current set of codes. The resultant proposed list includes 34 use categories, including “Other.” Several of the existing consumer and commercial use categories have been renamed to better describe the products that should be reported under that category. EPA anticipates that the burden for submitters to familiarize themselves with the new categories will increase the burden for completing the consumer and commercial product categories by 0.84 hours. This is the burden for the technical employee to identify the consumer and commercial uses of a product (see Table 4-2). This burden will only occur only during the first reporting cycle.

EPA is also proposing to require that if the product category “Other” is reported, a descriptor for the

consumer and commercial use of the chemical substance must also be reported. Using its best professional judgment, EPA estimates that it would take three minutes of clerical burden and six minutes of technical burden to write in the text description.

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

4-37 According to 2006 IUR data (EPA, 2008c), “Other” was listed as a consumer or commercial product category in 1,207 reports. Based on best professional judgment, EPA expects that the new categories proposed in this rule will reduce by half the number of submitters selecting “Other” as a consumer and commercial product category. Therefore, EPA assumes that this amendment would affect 604 reports.

Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-34 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that the amendment will cause a total increase in industry burden of approximately 14,400 hours during the first reporting cycle. In future reporting cycles, the submitters will no longer will need to familiarize themselves with the new industrial function categories, so the industry burden to the industry is estimated at approximately 7 0 2 hours to write in text for “Other” responses.

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

Burden for Rule

Familiarization

for Additional

Categories

(hours) Number of Reports with

Industrial

Function Categories Burden to

Write in

Text for

"Other" (hours) Number of Reports with

"Other" as a

Function Category Total Industry

Burden (hours)

First Cycle, Baseline 1.23 17,075 0.00 0 20,972First Cycle, PostAmendment 2.07 17,075 0.15 604 35,359

Change from the Baseline, First Cycle 0.84 0 0.15 604 14,387

Future Cycle Baseline 0.98 17,075 0.00 0 16,778Future Cycle, PostAmendment 0.98 17,075 0.12 604 16,850

Change from the Baseline, Future Cycles 0.00 0 0.12 604 72

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

.



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

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

4-38 Table 4-35: Change in Industry Cost as a Result of Modifying the Consumer and Commercial Product Categories

Cost for Rule

Familiarization

for Additional

Categories

(2008$) Number of Reports with

Function Categories Cost to

Write in

Text for

"Other" (2008$) Number of Reports with

"Other" as a

Function Category Total Industry

Cost (2008$)

First Cycle, Baseline $70.64 17,075 $0.00 0 $1,206,177
First Cycle, 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 that the number of submitters selecting “Other” as a consumer and commerci al use code will be reduced by half; this may be an over- or underestimate. In addition, EPA assumes that there is no burden for rule familiarization with the new use categories during the future reporting cycles. This may not be the case if sites have different employees complete Form U from reporting year to reporting year, or for chemical c ompanies sites submitting a Form U for the first time.

4.4.21 Designation of Consumer or Commercial Use



### EPA is proposing to require submitters to indicate whether the downstream use of their chemical is a consumer or a commercial use, or both. The Agency’s experience using the 2006 IUR data identified a

need to 

### distinguish between potentially exposed consumers versus commercial populations. The

indication of consumer or commercial use will allo w EPA to complete a better characterization of the potentially exposed populations.

EPA anticipates that the submitter would indicate whether a use is a consumer or commercial use as part of the activity involved in selecting the correct consumer and commercial use categories, as described above. The burden to fill in a checkbox for the correct use would be negligible. Therefore, EPA assumes

that this amendment does not cause any additional burden beyond that estimated in s S ection 4.4.20 above

.

4.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed



### EPA is proposing to require that 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. EPA would provide a set of ranges of numbers of workers for the submitter to choose from. The Agency expects this reporting burden to be similar to the burden for providing the number of workers that are potentially exposed when using the chemical with respect to its industrial use, which is already required, because of the similarity of the required data. This burden is approximately 21.36 hours (see Table 4-2) or $1,236 (See Table 4-5) per report. EPA assumes that the number of submitters will not change from the baseline under this

amendment.

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

4-39 Using the baseline unit burden estimate as shown above in Table 4-2 and Table 4-8, Table 4-36 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates that the amendment will cause a total increase in industry burden of approximately 364,700 hours in the first reporting cycle and 291,800 during all future reporting cycles.

Table 4-36: Change in Industry Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed

Burden to Provide the

Number of Commercial Workers (hours) Number of Reports Burden (hours)

First Cycle, Baseline 0 17,075 0
First Cycle, Post-Amendment 21.36 17,075 364,731
Change from the Baseline, First Cycle 21.36 0 364,731

Future Cycle Baseline 0 17,075 0
Future Cycle, Post-Amendment 17.09 17,075 291,784
Change from the Baseline, Future Cycles 17.09 0 291,784

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the 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 proposed amendment. EPA estimates

that the industry cost will increase by $21.10 million for the 2011 reporting cycle, and $16.88 million during all future reporting cycles.

Table 4-37: Change in Industry Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed

Cost to Provide the

Number of Commercial Workers (2008$) Number of Reports Cost (millions 2008$) First Cycle, Baseline $0 17,075 $0
First Cycle, Post-Amendment $1,236 17,075 $21.10
Change from the Baseline, First Cycle $1,236 0 $21.10

Future Cycle Baseline $0 17,075 $0
Future Cycle, Post-Amendment $989 17,075 $16.88
Change from the Baseline, Future Cycles $989 0 $16.88

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



### Limitations of Analysis . EPA is assuming that 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 discussion of “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 proposing to eliminate the “ N n ot R r eadably O o btainable ” (NRO) ” standard and replace it with the more stringent “ K k nown to or R r easonably A a scertainable by” standard. EPA assumes this amendment will increase the reporting burden. However, all burden estimates in this economic analysis

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

4-40 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 “ R r easonably A a scertainable” information. The proposed rule will now be consistent with the higher standard of information used by the survey, therefore, the burden estimates will not change.

4.4.24 Chemical Identity CBI Claims



### EPA is proposing that , when a submitter asserts a claim of confidentiality for the chemical identify of

a substance that is listed on the public portion of the Master Inventory File, the Agency may make the information available to the public without further notice to the submitter. This will not reveal any data to the public that is actually confidential and will not incur any cost or burden on the manufacturer.

4.4.25 Upfront Substantiation for Processing and Use Information CBI Claims



### EPA is proposing to require an upfront substantiation when a submitter claims processing and use information as Confidential Business Information (CBI). Upfront substantiation involves providing a written response to a set of questions provided in the proposed rule, for each individual item to be claimed

as CBI.

In 2002, when EPA first required upfront substantiation for claiming the plant site ID as CBI, the Agency saw a 64 percent reduction in the number of CBI claims. The Agency expects the number of processing and use CBI claims to decrease by the same amount as a result of this proposed amendment. According to 2006 IUR data (EPA, 2008c), a total of 8,133 reports had claimed that processing and use information was CBI, with an average of three processing and use information CBI claims per report.

EPA estimates that the number of reports with processing and us e CBI claims will be reduced to 2,928 as a result of the proposed amendment.

For the purposes of this analysis, EPA assumes that the per-item burden

, per i tem, to complete this

substantiation will be similar to the burden estimate d to complete the substantiation questions when a submitter makes a plant site identity CBI claim and must answer the two questions in 40 CFR §710.58(c)(1). As shown in Table 4-2 and Table 4-4, this is a burden of 1.46 hours and cost of $87.34 per CBI claim. Assuming an average of three processing and use CBI claims per report, EPA estimates that submitters will incur 4.38 additional hours of burden per report as a result of the amendment.

Table 4-38 shows the industry burden estimate as a result of this proposed amendment. The Agency

estimates that the amendment will cause a total increase in industry burden of approximately 12,800 hours in the first reporting cycle and 10,300 hours in all future reporting cycles.

Table 4-38: Change in Industry Burden as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI

Burden for Upfront CBI

Substantiation for CBI

Claims in Part III (hours) Number of Reports with Upfront

Substantiation for

CBI Claims

in Part III Industry

Burden (hours)

First Cycle, Baseline 0 0 0
First Cycle, Post-Amendment 4.38 2,928 12,824
Change from the Baseline, First Cycle 4.38 2,928 12,824

Future Cycle Baseline 0 0 0
Future Cycle, Post-Amendment 3.50 2,928 10,259
Change from the Baseline, Future Cycles 3.50 2,928 10,259

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

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

4-41 The cost of the amendment was calculated using the unit costs shown in Table 4-5 and Table 4-9. Table 4-39 shows the industry cost estimate as a result of this proposed amendment. EPA estimates that the industry cost will increase by approximately $772, 7 3 00 in the first reporting cycle and $618,100 in future reporting cycles.

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

Cost for Upfront CBI

Substantiation for CBI

Claims in Part III Number of Reports with Upfront

Substantiation for

CBI Claims in Part

III Industry

Cost (2008$)

First Cycle, Baseline $0 0 $0
First Cycle, Post-Amendment $263.90 2,928 $772,678
Change from the Baseline, First Cycle $263.90 2,928 $772,678

Future Cycle Baseline $0 0 $0
Future Cycle, Post-Amendment $211.12 2,928 $618,143
Change from the Baseline, Future Cycles $211.12 2,928 $618,143

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



### Limitations of Analysis . EPA assumes that the percent reduction in CBI claims for processing and use information will be the same as the percent re duction when upfront substantiation was required

f or rom plant site identification. However, to the extent that the actual burden differs, this analysis may

over- or underestimate the burden and cost of this amendment.

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



### Under the proposed rulemaking, IUR submitters would be unable to enter a claim of confidentiality if “not known or reasonably ascertainable” is selected for the industrial processing and use or consumer and

commercial use information. EPA assumes that this amendment will not impact industry burden because submitters are not being required to do anything additi onal (e.g., gather information or provide a written response); they are simply prohibited from claiming “not known or reasonably ascertainable” data items

as CBI.

4.4.27 Require Electronic Submissions over the Internet



### EPA is proposing to require electronic submissions of all Form Us over the Internet using eIUR 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 that TSCA section 5 pre-manufacturing notices be submitted electronically. The costs and savings of this IUR amendment will be realized on a per-site basis, as well as per report.

Following the methodology outlined in the economic analysis for the e-PMN rule (EPA, 2009b) the clerical burden used in the preparation of Parts I, II and III of Form U will be eliminated with this proposed amendment. Specifically, the Agency assumes that the burden savings associated with electronic reporting and submission via CDX are due to the reduction or elimination of

clerical/administrative time. The baseline time estimat e 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

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

4-42 estimated in the Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis of 10 percent (EPA, 2004).

The technical burden to gather and organize data, and managerial burden for review and approval, will not change from the baseline. Overall, this proposed amendment would decrease the burden to prepare Parts I, II, and III.

In addition, estimates developed in the CROMERR report were used to develop estimates of burdens to register with EPA’s Central Data Exchange ( CDX ) , and to set up a Pay.gov account and 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 signa ture agreements, to be a total of 1.33 0.93 hours of managerial

burden and 2.28 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 4-40 shows the industry burden estimate as a result of this proposed amendment. The Agency

estimates that the amendment will cause a total decrease in industry burden of approximately

24 1

, 7 00 245,600 hours in the first reporting cycle and 2 09

, 6 00 210,200 hours in all future reporting cycles.

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4-43 Table 4-40: Change in Industry Burden as a Result of Requiring Electronic Submission

Burden for

Report
, Compliance Determination,

Rule Familiarization,

Submission and Part I (per site ) (hours) Number

of Sites Burden for

Record k eeping

and Part II ( h ours per

report ) Number

of Reports Burden

per Part

III ( hours ) Number

of Reports

with

Part III

(a) (b) (c) (d) (e) (f) Industry Burden (hours) ( g) = (a*b) + (c*d) + (e*f)

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 3 6 .1 2 35.17 4,085 15.27 25,896 61.98 17,075 1, 601,239 1,597,358

Change from the Baseline, First Cycle 2.86 1.91 0 -4.55 0 -7.94 0 - 241,695

- 245,576

Future Cycle

Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833

Future Cycle,

PostAmendment 11. 19 05 4,085 12.82 25,896 49.58 17,075 1,224,202 1,223,658

Change from the Baseline,

Future Cycles 2.11 1.98 0 -4.24 0 -6.35 0 - 209,631

- 210,175

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



### EPA calculated the cost savings of the amendment using the unit costs shown in Table 4-5 and Table 4-9. Table 4-41 shows the industry cost estimate as a result of this proposed amendment. EPA estimates

that the industry cost will decrease by $ 8. 77 9.02 million during the 2011 reporting cycle and by $ 7. 97 8.01 million during all future reporting cycles.

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4-44 Table 4-41: Change in Industry Cost as a Result of Requiring Electronic Submission

Cost for Report
, Compliance Determination,

Rule Familiarization,

Submission and Part I (per site) (2008 $ ) Number

of Sites Cost for

Record k eeping

and Part II (2008 $ per

report ) Number

of Reports Cost per

Part III (2008 $ ) Number

of Rep orts

with

Part III

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

Cost (millions

2008 $ ) ( g) = (a 

b)+ (c  d)+(e *f)

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, 251 190 4,085 $923 25,896 $3,833 17,075 $98. 55 30

Change from the Baseline, First Cycle $ 192 132 0 -$220 0 -$226 0 - $ 8.77 9.0

2 Future Cycle

Baseline $561 4,085 $982 25,896 $3,247 17,075 $83.17

Future Cycle,

PostAmendment $ 704 695 4,085 $771 25,896 $3,067 17,075 $75. 20 16

Change from the Baseline, Future Cycles $ 143 134 0 -$211 0 -$181 0 - $ 7.97 8.0

1

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



### Limitations of Analysis . EPA assumes that the clerical burden will decrease by percentages similar to

the decrease estimated for th e e-PMN rule. To the extent that any differences exist (given the differences in the two rules), this analysis may over- or underestimate the burden and cost of this amendment.

4.4.28 Updated e-IUR Reporting Software



### EPA developed the e-IUR reporting software for use in preparing and submitting reports electronically during the 2006 IUR reporting cycle. For the 2011 submission period, EPA will provide a

free

, web-based application in place of the 2006 downloadable software. The updated e-IURweb reporting tool would feature several improved capabi lities 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.

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4-45 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.

4.4.30 Modifications Specifically Affecting Importers



### For purposes of IUR, importers currently are allowed to report the IUR information jointly with the foreign manufacturer of the chemical. Importers, or primary submitters, may not know the specific chemical identity of a substance because the foreign supplier, or secondary submitter, chooses to keep it confidential. In such a situation, the importer is still responsible for ensuring that the IUR information is submitted to EPA and may do so by submitting a joint report. Overall, the amount of information submitted via Form U for primary and secondary submitters would not change as a result of this proposed amendment, although EPA plans to revise the Form U for joint submitters. Under the proposed amendment, the foreign manufacturer must now register with CDX and submit its report electronically. Previously, joint submissions could not be made electronically.

As described above in Section 4.4.27, submission costs to register with EPA’s Central Data Exchange ( CDX ), , and complete the Electronic Signature Agreement forms , and set up a Pay.gov account are incurred on a per-site basis. EPA estimated these cost s in the economic analysis for the e-PMN rule to be

a total of 1.33 0.93 hours of managerial burden and 2.28 1.73 hours of technical time per site (EPA, 2009b). Based on previous IUR submissions, EPA estimates that between 10 and 20 sites were importers, and therefore, the same approximate number were secondary submitters (EPA, 2009h). For this analysis, EPA uses the conservative upper-bound of 20 secondary submitter sites.

Table 4-42 shows the industry burden estimate as a result of this proposed amendment. The Agency

estimates that the amendment will cause an increase in industry burden of approximately 72.2 53.3 hours in the first reporting cycle. Future reporting cycles ar e assumed to the similar to the first reporting cycle.

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

Burden for CDX Registration (per site) (hours) Number of Sites Industry Burden (hours)

First Cycle, Baseline 0.00 0 0.00First Cycle, PostAmendment 3.61 2.67 20 72.2 53.3

Change from the Baseline, First Cycle 3.61 2.67 20 72.2 53.3

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



### Table 4-43 3 shows the industry cost estimate as a result of this proposed amendment. EPA estimates

that the industry cost will increase by approximately $ 4,500 3,3 05 0 during the 2011 and future reporting cycle s

.

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4-46 Table 4-43: Change in Industry Cost as a Result of Requiring CDX Registration for Secondary
Submitters

Cost for CDX Registration (per site) (2008$) Number of Sites Industry Cost (2008$)

First Cycle, Baseline $0 0 $0
First Cycle, PostAmendment $ 3.61 167 20 $4,546 $3.347

Change from the Baseline, First Cycle $ 3.61 167 20 $4,546 $3.347

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

4.4.31 Modify Reporting Frequency



### The Agency is proposing to modify the IUR reporting cycle from a five-year reporting frequency to a four-year reporting frequency. While the industry burden for the principal reporting year industry burden will not change, the longer-term industry burden will increase because reporting will become more frequent; therefore, EPA estimated the annual reporting burden to industry over a 25-year period. A 25-year period allows EPA to analyze a set of complete reporting cycles under both the baseline and postamendment 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 that the 2011 reporting cycle covers a 5-year period, under either scenario). For more information on the distribution of burden over a reporting cycle , see the

discussion in Section 4.6 20

- year period

. The baseline industry burden in the year 2011 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 that sites that have submitted Form U previously incur a lower burden for processing and submitting the Form, as these firms have become more familiar with reporting and may be more efficient at the compliance process. Table 4-11 contains the total annual baseline costs to industry for future reporting cycles – that is, the burden and cost to industry for reporting cycles after the 2011 cycle, in the absence of the proposed amendments. EPA assumes costs for report preparation and submission in future reporting cycles will be lower than costs in the first reporting cycle because of efficiencies achieved through the estab lishment of compliance processes, the availability of data from previous reporting cycles, and familiarity with reporting requirements (EPA, 2002a). The weighting factors found in Table 4-7 were applied to the baseline burden estimates found in Table 4-2 and Table 4-5, to estimate that in all future reporting cycles, the baseline burden to industry is approximately

1.43 million hours.

As shown in Table 4-44, EPA estimates that the industry burden will increase by 1.43 million hours

over a 20 25 -year period as a result of this amendment.

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4-47 Table 4-44: Change in Industry Burden as a Result of Modifying the Reporting Frequency, over a

2 0 5 -Year Period

Baseline Burden Post-Amendment

Burden Change in Burden Reporting Cycle 1 Year(s)

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 1.84 1.84 0.00

2012 to 2016 1.43

-- 2 2012 to 2015

-- 1.43 0.00

2017 to 2021 1.43

-- 3 2016 to 2019

-- 1.43 0.00

2022 to 2026 1.43

-- 4 2020 to 2023

-- 1.43 0.00

2027 to 2031 1.43

-- 5 2024 to 2027

-- 1.43 0.00

6 2028 to 2031

-- 1.43 1.43

Total 7.58 9.01 1.43
Annual Average 0.30 0.36 0.06

1 The non-italicized reporting cycles are baseline, five-year cy cles, and the italicized reporting cycles are proposed, four-yea r cycles.

Year Baseline Burden (million s of h ours ) Post

- Amendment Burden (million s of h ours ) Change in

Burden (million s of

hours)

2011 1.84 1.84 0.00

2012 0.00 0.00 0.00

2013 0.00 0.00 0.00

2014 0.00 0.00 0.00

2015 0.00 1.43 1.43

2016 1.43 0.00

- 1.43

2017 0.00 0.00 0.00

2018 0.00 0.00 0.00

2019 0.00 1.43 1.43

2020 0.00 0.00 0.00

2021 1.43 0.00

- 1.43

2022 0 .00 0.00 0.00

2023 0.00 1.43 1.43

2024 0.00 0.00 0.00

2025 0.00 0.00 0.00

2026 1.43 0.00

- 1.43

2027 0.00 1.43 1.43

2028 0.00 0.00 0.00

2029 0.00 0.00 0.00

2030 0.00 0.00 0.00

Total 6.14 7.58 1.43 Annual Average 0.31 0.38 0.07



### As shown in Table 4-10, the total industry cost in the baseline first reporting cycle is approximately $106.97 million, and as shown in Table 4-11, the baseline cost is $82.82 million in all future reporting cycles. 4-45 shows the annual industry cost estimate as a result of this amendment. In total, EPA

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4-48 estimates that the proposed amendment will increase the cost to industry by $82.82 million over a 2 5 0

- year period.

In the proposal, EPA is request ing ed comment on increasing the frequency of reporting to annual reporting of all data; biennial report ing ; and reporting once every three years, with processing and use data (Part III) reported only in the principal reporting year. EPA conducted a preliminary analysis of the cost and burden of increasing the frequency of reporting to annually, and every three years. The results of the analysis are presented in Appendix G.

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4-49 Table 4-45: Change in Industry Cost as a Result of Modifying the Reporting Frequency, over a 2 5 0

- Year Period

Year Baseline Cost ( millions 2008 $ ) Post

- Amendment Cost (millions 2008 $ ) Change in Cost (mill ions 2008 $ )

2011 $106.97 $106.97 $0.00

2012 $0.00 $0.00 $0.00

2013 $0.00 $0.00 $0.00

2014 $0.00 $0.00 $0.00

2015 $0.00 $82.82 $82.82

2016 $82.82 $0.00

- $82.82

2017 $0.00 $0.00 $0.00

2018 $0.00 $0.00 $0.00

2019 $0.00 $82.82 $82.82

2020 $0.00 $0.00 $0.00

2021 $82.82 $0.00

- $82.82

2022 $0.00 $0.00 $0.00

2023 $0.00 $82.82 $82.82

2024 $0.00 $0.00 $0.00

2025 $0.00 $0.00 $0.00

2026 $82.82 $0.00

- $82.82

2027 $0.00 $82.82 $82.82

2028 $0.00 $0.00 $0.00

2029 $0.00 $0.00 $0.00

2030 $0.00 $0.00 $0.00

Total $355.42 $438.24 $82.82 Annual Average $17.77 $21.91 $4.14

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

1 2007 to 2011 $106.97 $106.97 $0.00

2012 to 2016 $82.82

-- 2 2012 to 2015

-- $82.82 $0.00

2017 to 2021 $82.82

-- 3 2016 to 2019

-- $82.82 $0.00

2022 to 2026 $82.82

-- 4 2020 to 2023

-- $82.82 $0.00

2027 to 2031 $82.82

-- 5 2024 to 2027

-- $82.82 $0.00

6 2028 to 2031

-- $82.82 $82.82

Total $438.24 $521.05 $82.82
Annual Average $17.53 $20.84 $3.31

1 The non-italicized reporting cycles are baseline, five-year cycl es, and the italicized reporting cycles are proposed, four-yea r cycles.



### Limitations of Analysis . EPA assumes that future reporting cycle costs will decrease due to efficiency gains and a reduction in the time required for submitters to become familiar with the rule and its

amendments. To the extent that these reductions in burden do not occur, this analysis may underestimate

the burden and cost of the rule amendment.

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4-50 

### 4.5 Total Industry Compliance Burden and Cost of all Amendments

The burdens and costs presented in Section 4.4 are the stand-alone industry compliance burden and cost for each amendment, and do not take into account the interaction of amendments (i.e., how the impact of one amendment would affect the burden of another amendment .) ). For this reason, when calculating the total industry cost of all amendments described in EPA’s proposed rule, the Agency can not simply add the individual changes in burden for each proposed amendment, but must consider the affect of one amendment on another. As described below, amendments fall into three categories: those

that affect ing the number of reports submitted during a reporting cycle ; , those that affect ing the reporting

burden ; , and those that affect ing the reporting frequency. The impact that each amendment has on the others depends on its category.

4.5.1 Modifications that Affect the Number of Reports Submitted



### Several of the proposed IUR rule amendments change the number of full and/or partial reports EPA expects to be submitted, based on the specific chemicals they affect. The amendment that chang ing es the method for determining whether a manufacturer is subject to the IUR reporting requirements is expected to increase the overall number of reports and submitte rs by five percent; therefore, the combined impact would also increase each of the impacts of the other amendments in this category by five percent. Furthermore, the amendment to eliminate the 300,000 lb. threshold for downstream processing and use reporting would make Part IIIs necessary for all the additional Part IIs required by other amendments. The following steps below describe how the combined effect of the amendments affecting the number of reports was calculated.

Step 1: Sum the affected amendments. Table 4-46 and Table 4-47 present s the number of full and partial reports EPA expects to be submitted as a result of the proposed IUR amendments , in the 2011 reporting cycle and future reporting cycles, respectively . The proposed amendments that chang ing e the number of full and/or partial reports expected to be submitted are as follows:

 Eliminat ion of the e 300,000 lb. threshold for downstream processing and use reporting: When taken alone, EPA expects this amendment to increase the number of Part IIIs submitted by 8,203

additional reports (see Section 4.4.4).

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

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

 Full exemption for manufactured water: EPA expects that this amendment, by itself, will decrease the number of Part IIIs submitted by 43 fewer reports (see Section 4.4.7).

Step 2: Consider the effects of the change in method for determining rule applicability . The Agency expects the change in the method for determining whether a manufacturer is subject to the IUR reporting requirements to increase the number of reports and submitters by five percent in future reporting cycles . Therefore , for future reporting cycles , EPA multiplied the Step 1 results by 1.05, to account for this amendment. Then the Agency added in the number of additional sites and reports estimated for this amendment individually. (In Table 4-46 , 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 would generate d 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).

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4-51 Step 3: Consider the effect of eliminating the 300,000 lb. threshold for processing and use reporting (and avoid double-counting). 

### Under this amendment, all submitters of non-exempt chemicals would be required to submit a Part III. Therefore, the number of Part IIIs must be increased by the increased number of Part IIs, to account for the effect of eliminating the 300,000 lb. threshold for processing and use reporting. 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 (5,469), minus the number of new Part III reports as a result of making ECAs ineligible for exemptions (16) and the number of new Part II reports as a result of changing the method of determining whether a manufacturer is subject to reporting requirements (1,295). As shown in Table 4-47

, T t he number of reports with Part III will increase by 13,641 in future reporting cycles. Similar calculations are shown in Table 4-46 for the 2011 reporting cycle

. Step 4: Calculate the number of reports when all amendments are considered together. The total number of additional reports from Step 2 is added to the number of reports in the baseline to calculate the total number of reports when all the proposed amendments are considered together. There will now be a total of 4,289 Part Is, 31,365 Part IIs and 30,716 Part IIIs. The difference between the total number of Part IIs and Part IIIs, 649 reports, is equal to the number of partially exempt reports with the five percent increase taken into account (618x1.05 = 649).

Table 4-46 : Change in the 2011 Reporting Cycle Number of Sites and Reports Submitted for All
Amendments Combined

Modification Number of Sites Number of Reports Number of Reports

with Part III

Baseline 4,085 25,896 17,075

Step 1: Sum affected amendments

Eliminate 300,000 lb. Threshold for Downstream Processing and Use Reporting (see Section 4.4.6 ) -- -- 8,203

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

--

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

Full Exemption for 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 ) -- -- --

STEP 2 TOTAL

-- 3,975 8,219

Step 3: Consider the effect of eliminating the 300,000 lb. th reshold for processing and us e reporting (and avoid doublecounting)

Step 2 total for Part II reports minus number of new Part III reports as a result of making ECAs ineligible for exemptions and the number of new Part II reports as a result of changing the method of determining whether subject to reporting requirements -- -- 3,959

STEP 3 TOTAL (Step 3 + Step 2 Total )

-- 3,975 12,178

Step 4: Calculate the total number of reports by adding the Step 3 Total to the Baseline

STEP 4 TOTAL (Baseline + Step 3 Total) 4,085 29,871 29,253

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4-52 Table 4-47: Change in the Future Cycle Number of Sites and Reports Submitted for All
Amendments Combined

Modification Number of Sites Number of Reports Number of Reports

with Part III

Baseline 4,085 25,896 17,075

Step 1: Sum affected amendments

Eliminate 300,000 lb. Threshold for Downstream Processing and Use Reporting (see Section 4.4.6) -- -- 8,203

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

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

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

STEP 1 TOTAL -- 3,975 8,219

Step 2: Account for change in the method for determining whether you are subject to the IUR reporting requirements

Step 1 Total Multiplied by 1.05 4,174 8,630

Method for Determining Whether you are Subject to the IUR Reporting Requirements (see Section 4.4.3) 204 1,295 854

STEP 2 TOTAL 204 5,469 9,484

Step 3: Consider the effect of eliminating the 300,000 lb. th reshold for processing and us e reporting (and avoid doublecounting)

. Step 2 total for Part II reports minus number of new Part III reports as a result of making ECAs ineligible for exemptions and the number of new Part II reports as a result of changing the method of determining whether subject to reporting requirements -- -- 4,158

STEP 3 TOTAL (Step 3 + Step 2 Total ) 204 5,469 13,641

Step 4: Calculate the total number of reports by adding the Step 3 Total to the Baseline

STEP 4 TOTAL (Baseline + Step 3 Total) 4,289 31,365 30,716

4.5.2 Modifications That Affect the Reporting Burden



### Several amendments affect the burden to complete a report. As discussed in Section 4.4.27, EPA

assumes that the amendment to require electronic submissi on over the Internet will eliminate clerical burden used in the preparation of Parts I, II and III of Form U, and that the burden for recordkeeping across all wage rate categories will be reduced by half. Table 4-48 contains the total burden by labor category for the 2011 reporting cycle when all the amendments are considered together. Table 4-49 contains the future reporting cycle burden, by labor category. The steps below describe how the combined

effect of the amendments that affect ing ed the reporting burden was calculated.

Step 1: Sum the affected amendments. The amendments that affect ing the reporting burden are as

follows:

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

 Report production volume used on-site: This amendment is estimated to require 1.51 additional hours of burden to complete Part II (see Section 4.4.13). Table 4-48 presents the per-report total

burden of 0.293 hours to reflect that only 24 percent of reports are expected to report volume used on

site.

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4-53  Indicate whether the chemical is physically at reporting site: This amendment is estimated to require 0.17 additional hours of burden to complete Part II (see Section 4.4.14).

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

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

reworked: This amendment is estimated to require 0.17 additional hours of burden to complete Part II (see Section 4.4.16).

 Revise industrial function categories: This amendment is estimated to require 0.25 additional hours to complete Part III (for submitters to familiarize themselves with the new categories), and an additional 0.15 hours (for submitters selecting “Other”) (see Section 4.4.18). Table 4-48 presents the per-report total burden of 0.26 hours to reflect that only 3.5 percent of reports are expected to select

“Other” and thus incur this additional cost.

 Revise consumer and commercial product categories: This amendment is estimated to require 0.84 additional hours of burden to complete Part III (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 4-48 presents the per-report total burden of 0.84 hours, which reflects that only 3.5 percent of reports are expected to select “Other” and thus incur this additional burden.

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

 Upfront substantiation for processing and use information CBI Confidential Business

Information claims: This amendment is estimated to require 4.38 additional hours of burden to complete Part III for all submitters that claim ing processing and use information as CBI (see Section 4.4.25). Table 4-48 presents the per-report total burden of 0.75 hours, which reflects that only 17 percent of reports are expected to incur additional costs because of the amendment.

Step 2: Consider the effect of the amendment to require electronic submission over the Internet.
This amendment would eliminate the need for clerical tasks such as typing information into Form U, photocopying, and mailing. In Step 2, EPA subtracts the clerical burden for all proposed amendments, eliminating a burden of 0.76 hours per Part I, 2.82 hours per Part II, and 10.11 hours per Part III. The burden reductions in recordkeeping will be reduced by 50 percent for all wage categories and will not change from what is presented in Section 4.4.27.

Step 3: Calculate the total burden when all amendments are combined. To calculate the total industry burden estimates, EPA added the total from Step 2 to th e baseline. In total, the clerical burden will be 0.75 hours per full report with one chemical, the technical burden will be 102.83 hours per full report with one chemical, and the managerial burden will be 37.74 hours per full report with one chemical.***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-54Table 4-48: Change in the 2011 Reporting Cycle Burden for All Amendments Combined, by Labor CategoryModificationComplianceDetermination, RuleFamiliarization, andSubmissionBurdenBurden to CompletePart IRecordkeepingBurdenBurden to CompletePart IIBurden to CompletePart IIICTMCTMCTMCTMCTMBaseline-- 21.50 9.00 0.76 0.95 1.05 1.50 3.00 1.50 1.55 8.78 3.49 7.94 45.31 16.66Step 1: Sum the Affected AmendmentsReport production volume for each of theyears since last report-- -- -- -- -- -- -- -- -- 0.936 4.104 1.008 -- -- --Report production volume Used On-Site-- -- -- -- -- -- -- -- -- 0.045 0.199 0.049 -- -- --Indicate whether chemical is physically atreporting site-- -- -- -- -- -- -- -- -- 0.026 0.114 0.028 -- -- --Report the volume exported-- -- -- -- -- -- -- -- --0.234 1.026 0.252-- -- --Identify whether a chemical is to be recycled,remanufactured, reprocessed, reused, orreworked-- -- -- -- -- -- -- -- -- 0.026 0.114 0.028 ------Revise industrial function categories-- -- -- -- -- -- -- -- -- -- -- -- 0.003 0.254 0.000Revise commercial and consumer productcategories-- -- -- -- -- -- -- -- -- -- -- -- 0.003 0.841 0.000Number of commercial workers reasonablylikely to be exposed-- -- -- -- -- -- -- -- -- -- -- -- 2.104 15.428 3.829Upfront substantiation for processing and useinformation CBI claims-- -- -- -- -- -- -- -- -- -- -- -- 0.062 0.427 0.262Step 1 Total-- -- -- -- -- -- -- -- -- 1.267 5.557 1.365 2.171 16.949 4.092Step 2:Add the Effect of the Electronic Reporting AmendmentsElectronic Submission--2.281.731.330.93-0.76 -- -- -0.75 -1.50 -0.75 -2.82 -- -- -10.11 -- --Step 2 Total (Electronic Submission + Step1 Total)--2.281.731.330.93-0.76 -- -- -0.75 -1.50 -0.75 -1.55 5.56 1.36 -7.94 16.95 4.09Step 3 Total BurdenStep 2 Total + Baseline-- 23.782310.339.93-- 0.95 1.05 0.75 1.50 0.75 -- 14.34 4.85 -- 62.26 20.76Note: C = Clerical; T = Technical; and M = Managerial wage categories***EO 12866 Review DRAFT—Do not Cite, Quote or Release During Review***4-55Table 4-49: Change in the Future Reporting Cycle Burden for All Amendments Combined, by Labor CategoryModificationComplianceDetermination, RuleFamiliarization, andSubmissionBurdenBurden to CompletePart IRecordkeepingBurdenBurden to CompletePart IIBurden to CompletePart IIICTMCTMCTMCTMCTMBaseline--4.500 2.0000.691 0.870 1.018 1.500 3.000 1.500 1.240 7.024 2.792 6.351 36.251 13.33Step 1: Sum the Affected AmendmentsReport production volume for each of theyears since last report-- -- -- -- -- -- -- -- -- 0.749 3.283 0.806 -- -- --Report production volume used on-site-- -- -- -- -- -- -- -- -- 0.036 0.159 0.039 -- -- --Indicate whether chemical is physically atreporting site-- -- -- -- -- -- -- -- -- 0.021 0.091 0.022 -- -- --Report the volume exported-- -- -- -- -- -- -- -- -- 0.187 0.821 0.202 -- -- --Identify whether a chemical is to be recycled,remanufactured, reprocessed, reused, orreworked-- -- -- -- -- -- -- -- -- 0.021 0.091 0.022 ------Revise industrial function categories-- -- -- -- -- -- -- -- -- -- -- -- 0.002 0.003 0.000Revise commercial and consumer productcategories-- -- -- -- -- -- -- -- -- -- -- -- 0.002 0.003 0.000Number of commercial workers reasonablylikely to be exposed-- -- -- -- -- -- -- -- -- -- -- -- 1.683 12.342 3.063Upfront substantiation for processing and useinformation CBI claims-- -- -- -- -- -- -- -- -- -- -- -- 0.049 0.427 0.210Step 1 Total-- -- -- -- -- -- -- -- -- 1.014 4.446 1.092 1.737 12.775 3.273Step 2:Add the Effect of the Electronic Reporting AmendmentsElectronic Submission--1.731.070.93-0.69-- -- -0.75 -1.50 -0.75-2.25-- ---8.09----Step 2 Total (Electronic Submission + Step1 Total)-- 1.731.070.93-0.69 -- -- -0.75 -1.50 -0.75 -1.24 4.45 1.09 -6.35 12.77 3.27Step 3 Total BurdenStep 2 Total + Baseline-- 6.233.072.93-- 0.87 1.02 0.75 1.50 0.75 -- 11.47 3.88 -- 49.03 16.60Note: C = Clerical; T = Technical; and M = Managerial wage categories

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

4-56 Table 4-50 contains the estimated change in the burden and the total burden per reporting cycle as a result of the all the proposed IUR amendments during the first reporting cycle. It also presents the burden in future reporting cycles. EPA estimates the total industry burden will increase by approximately

1. 56 55 39 million hours to 3. 2 4 0 million hours in total for the 2011 reporting cycle. In future reporting cycles, EPA estimates that industry burden will increase by 1.21 million hours to 2.64 million hours.

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

Burden for Compliance Determination,

Rule Familiarization,

Submission and to Prepare Part

I (hours per site) Number

of Sites Burden for

Record Keeping

and to Prepare

Part II (hours per

report) Number

of Reports

(with Part II) Burden to Prepare

Part III (hours

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

Burden (millions of

hours)

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

(e  f) First Cycle,

Baseline 33.26 4,085 19.82 25,896 69.92 17,075 1.84

First Cycle,

PostAmendment 36.12 35.17 4,085 4,2

89 22.19 22.19 29,871 3 1,365 83.02 83.0

2 29,253 30,7

16 3.24 3.40

Change from the Baseline, First Cycle 2.86 1.91 0 204 2.37 2.37 3,975 5,4

69 13.10 13.1

0 12,178 13,6

41 1.39 1. 56 55

FutureCycle,

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

Future Cycle,

PostAmendment 11. 19 05 4,289 18.35 31,365 65.63 30,716 2.64

Change from the Baseline,

Future Cycles 2.11 1.98 204 1.30 5,469 9.70 13,641 1.21

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



### Table 4-51 shows the total industry cost. To calculate the total industry cost, the burden estimates

located in Table 4-48 and Table 4- 49 were multiplied by the wage rates found in Table 4-1. The costs were then multiplied by the number of submissions located in Table 4-47. EPA estimates the total industry cost will increase by approximately $ 102.07 101.81 91.87 million to $ 209.04 208.78 198.84 million in total for the 2011 reporting cycle. In future reporting cycles, EPA estimates that the industry cost will increase by $79. 31 27 million to $162. 12 08 million.

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

4-57 Table 4-51: Total Industry Cost When All Amendments Are Combined

Cost for Compliance Determination,

Rule Familiarization,

Submission and to Prepare Part

I (2008$ per site) Number

of Sites Cost for

Record Keeping

and to Prepare

Part II (2008$ per

report) Number

of

Partial Reports

(with Part II) Cost to

prepare Part III (2008$

per report) Number of

Full Reports (with Part III) Industry

Cost (millions 2008$)

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

(e  f) First Cycle,

Baseline $2,058 4,085 $1,129 25,896 $4,059 17,075 $106.97

First Cycle,

PostAmendment $2, 252 192 4,085 4,2

89 $1,346 $1,34

6 29,871 3 1,365 $5,117 $5,

117 29,253 30,7

16 $198.84 $209.04 $208.78 Change from the Baseline, First Cycle $ 194 134 0 204 $216 $216 3,975 5,4

69 $1,058 $1,

058 12,178 13,6

41 $91.87
$102.07
$101.81
Future-Cycle,

Baseline $561 4,085 $968.39 25,896 $3,247 17,075 $82.82

Future Cycle,

PostAmendment $ 704 695 4,289 $1,109 31,365 $4,047 30,716 $162. 12 08

Change from the Baseline, Future Cycles $ 143 134 204 $141 5,469 $800 13,641 $79. 31 27

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

4.5.3 Amendment that Affects the Reporting Frequency



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

4.5.4 Average Cost and Burden per Site



### Under the baseline, 4,085 sites submit a total of 25,896 reports; 17,075 of these are full reports and the remainder is partial reports (See Table 4-6). T hus, an average site submits IUR data for 6.34 chemicals (25,896 reports divided by 4,085 sites), and submits full reports for 4.18 of those chemicals (17,075 reports divided by 4,085 sites) (See Table 4-52). Table 4-50 contains the total number of reports submitted and sites when all the amendments are considered together. Under the first and future reporting cycles, A a n estimated 4.085 and 4,289 sites , respectively, submit a total of 29,871 and 31,365 reports ; , 29,253 and 30,716 of which will be full reports. Therefore, in the post-amendment scenario, an average site will submit 7.31 reports comprised of 7.16 full reports and 0.15 partial reports (See Table 4-52). This is a decrease of 2.01 partial reports per site and an increase of 2.98 full reports per site compared to the

baseline.

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

4-58 Table 4-52: Average Number of Full and Partial Reports per Site

Total

Number

of Sites Total

Number

of Reports Average

Number

of Reports per Site Total

Number

of Full Reports Average

Number

Full Reports per Site Average

Number of

Partial Reports per

Site

(a) (b) (c) = (b)/(a) (d) (e) = (d)/(a) (f) = (c)-(e)

First Cycle, Baseline 4,085 25,896 6.34 17,075 4.18 2.16

Post-Amendment 4,085 29,871 7.31 29,253 7.16 0.15

Change from the Baseline 0 3,975 0.97 12,178 2.98 -2.01

Future Cycle, Baseline 4,085 25,896 6.34 17,075 4.18 2.16

Future Cycle, Post-Amendment 4,289 31,365 7.31 30,716 7.16 0.15

Change from the Baseline, Future Cycles 204 5,469 0.97 13,641 2.98 -2.01
Source: U.S. EPA, Office of Pollution Preventi on and Toxics, Informati on Management Division 2006 IUR Database Statistics for IUR Modifications Rule . Washington, DC. December 17, 2008 (EPA, 2008c).

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



### Table 4-53 contains the average total burden per site. Each site will submit only one Part I under both the baseline and post-amendment scenarios. The average numbers of Part IIs and Part IIIs submitted per site are taken from Table 4-52. EPA calculated the baseline from the per-report burden presented in Table 4-2. In 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 4-50. The average burden per site is expected to be 793 792 hours in the first reporting cycle and 615 hours in future reporting cycles. This is an increase of 342 341 hours per site during the first reporting cycle and 264 hours per site in future reporting cycles compared to the baseline.

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

4-59 Table 4-53: Average Total Burden per Site

Burden for Compliance Determination,

Rule Familiarization,

Submission and to Prepare Part

I (hours per site) Average

Number of Part Is per

Site Burden for

Record Keeping and to Prepare

Part II (hours per

report) Average

Number

of Part IIs per

Site Burden

for

Part

III (hours

per report) Average

Number

of Part IIIs per

Site Total Average Burden per Site (hours)

(a) (b) (c) (d) (e) (f) (g) = (a*b) +(c*d)+(e*f) First Cycle,

Baseline 33.26 1 19.82 6.34 69.92 4.18 451

PostAmendment 36.12 35.17 1 22.19 7.31 83.02 7.16 793 792

Change from

the Baseline 2.86 1.91 0 2.37 0.97 13.10 2.98 342 341

Future Cycle,

Baseline 9.08 1 17.06 6.34 55.93 4.18 351

Future Cycle,

PostAmendment 11. 19 05 1 18.35 7.31 65.63 7.16 615

Change from the Baseline, Future Cycles 2.11 1.98 0 1.30 0.97 9.70 2.98 264

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



### The average baseline and post-amendment scenario cost s per site are found in Table 4-54. Baseline

cost s per report costs is are taken from Table 4-5 and Table 4-8 and used in calculating the average baseline cost per site. In the first reporting cycle, th e 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 s per report is are derived in Table 4-50 and Table 4-51. The average post-amendment cost per site is calculated

to be approximatly $48, 739 700 in first reporting cycle, and $37,800 for all future reporting cycles. This is

an increase of approximatly $22, 6 00 500 per site during the first reporting cycle and $17,500 during future reporting cycles compared to the baseline.

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

4-60 Table 4-54: Average Total Cost per Site

Cost for

Submission Compliance Determination,

Rule Familiarization, and to Prepare Part I (2008$

per site) Average

Number of Part Is per

Site Cost for

Record Keeping and to Prepare

Part II (2008$ per

report) Average

Number

of Part IIs per

Site Cost to Prepare

Part III (2008$

per report) Average

Number

of Part IIIs per

Site Total Average Cost per

Site (2008$)

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

(e*f) First Cycle,

Baseline $2,058 1 $1,129 6.34 $4,059 4.18 $26,185

PostAmendment $2, 252 192 1 $1,346 7.31 $5,117 7.16 $48, 739

678 Change from

the Baseline $ 194 134 0 $216 0.97 $1,058 2.98 $22, 553

493 Future Cycle

Baseline $561 1 $968 6.34 $3,247 4.18 $20,274

Future Cycle,

PostAmendment $ 704 695 1 $1,109 7.31 $4,047 7.16 $37, 800

790

Change from the Baseline, Future Cycles $ 143 134 0 $141 0.97 $800 2.98 $17, 526

517

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



### 4.6 Annualized Industry Cost Estimates for all Modifications

EPA estimated the total burden to industry of all of the proposed amendments over a 2 5 0 -year period.

This follows EPA ’s prac tice of using used a 20-year annualization period in the previous economic analyses of the IUR rule (EPA, 2002a and EPA, 2005) , but for this report

. In addition,

, a 2 0 5 -year period allows EPA to analyze a set of complete reporting cycles under both the baseline and post-amendment

scenarios. Under the baseline, a five

- year reporting cycle is used, and the cost of four complete cycles is analyzed. Under the post

- amendment scenario, reporting occurs every four years, and the cost of five complete cycles is pre sented.

While the IUR data submission activity itself occurs in one reporting year (e.g., 2011), EPA believes

that rule compliance and data collection activites, and thus, costs and burdens

, are incurred over the course of the reporting cycle. Consequently, c osts 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 that efforts related to rule compliance and data collection are spread out over multiple years. For example, EPA began receiving calls about reporting requirements for 2011 reporting in early 2009, and the Agency has already held conference calls with companies and EPA IT staff to discuss electronic reporting issues. Companies have stated that they prefer to set up a system to collect the IUR information during the time the chemicals are being manufactured. Thus, for the 2011 reporting cycle, EPA has evidence that some companies set up their data systems in 2009 to early 2010, are collecting the information in 2010, and will compile and report that information in 2011. Furthermore, as described in section 4.2.2, IUR burden

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

4-61 estimates are taken from the 2002 EPA Economic Analysis for the Amended Inventory Update Final Rule and were based on an industry survey conducted by EPA and designed to measure industry effort associated with collecting chemical exposure data under TSCA Section 8. 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 4-50 included the burden during the first reporting cycle. EPA expects that during future reporting cycles, the industry burden will decrease as submitters

become more efficient with the data and more fam iliar with the reporting requirements. Section 4.2.6

discusses the burden reductions associ ated with this rule familiarization and efficiency gains. Table 4-50 also shows the total burden to industry in future reporting cycles. Table 4-55 shows the burdens associated with each reporting cycle over a period of 25 years, including the years covered by the next (2011) reporting cycle. Under the baseline, a five-year reporting cycle is used, and the cost of four complete cycles is analyzed. Under the post-amendment scenario, reporting occurs every four years, and the cost of five complete cycles is presented. (Note that the 2011 reporting year covers a 5-year period

, under either scenario).

contains a schedule of the annual burden estimates. Over a 2 0 5 -year period, EPA estimates that the proposed amendments will increase industry burden by approximately 8.859.01 7.81 million hours.

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

Year Baseline Burden (millions of hours) Post

- Amendment

Burden (millions of hours) Change from

Baseline (millions of hours)

2011 1.84 3.40 1. 56 55

2012 0.00 0.00 0.00

2013 0.00 0.00 0.00

2014 0.00 0.00 0.00

2015 0.00 2.64 2.64

2016 1.43 0.00

- 1.43

2017 0.00 0.00 0.00

2018 0.00 0.00 0.00

2019 0.00 2.64 2.64

2020 0.00 0.00 0.00

2021 1.43 0.00

- 1.43

2022 0.00 0.00 0.00

2023 0.00 2.64 2. 64

2024 0.00 0.00 0.00

2025 0.00 0.00 0.00

2026 1.43 0.00

- 1.43

2027 0.00 2.64 2.64

2028 0.00 0.00 0.00

2029 0.00 0.00 0.00

2030 0.00 0.00 0.00

Total 6.14 13. 96 95 7.81 Annual Average 0.31 0.70 0.39

Baseline Burden Post-Amendment

Burden Change in Burden Reporting Cycle 1 Year(s)
(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 1.84 3.243.40 1.391.55

2 2012 to 2016 1.43

-- 1.21

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

4-62 Year Baseline Burden (millions of hours) Post

- Amendment

Burden (millions of hours) Change from

Baseline (millions of hours)

2012 to 2015

-- 2.64

2017 to 2021 1.43

-- 3 2016 to 2019

-- 2.64 1.21

2022 to 2026 1.43

-- 4 2020 to 2023

-- 2.64 1.21

2027 to 2031 1.43

-- 5 2024 to 2027

-- 2.64 1.21

6 2028 to 2031

-- 2.64 2.64

Total 7.58 16.4316.59 8.859.01
Annual Average 0.30 0.660.66 0.350.36

1 The non-italicized reporting cycles are baseline, five-year cy cles, and the italicized reportin g cycles are proposed, four-yea r cycles.



### Table 4-56 presents the annual and annualized costs estimates of all the proposed amendments. Over

a 2 5 0 -year period, EPA estimates that the proposed amendments to the IUR rule will increase the

annualized industry cost by $2 6. 27 25 12

. 6 1 0 million, with a three percent discount rate, and $ 27. 86 83 20.56 19.95 million with a seven percent discount rate.

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

4-63 Table 4-56: Annual Increase in Industry Cost over a Period of 25 Years if All Proposed Amendments Are Implemented (2008 $ )

Year Baseline Cost ( millions 2008$) Post

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

2011 $106.97 $209.04 $208.78 $ 102.07 $101.81

2012 $0.00 $0.00 $0.00

2013 $0.00 $0.00 $0.00

2014 $0.00 $0.00 $0.00

2015 $0.00 $162. 12 08 $162. 12 08

2016 $82.82 $0.00

- $82.82

2017 $0.00 $0.00 $0.00

2018 $0.00 $0.00 $0.00

2019 $0.00 $162. 12 08 $162. 12 08

2020 $0.00 $0.00 $0.00

2021 $82.82 $0.00

- $82.82

2022 $0.00 $0.00 $0.00

2023 $0.00 $162. 12 08 $162. 12 08

2024 $0.00 $0.00 $0.00

2025 $0.00 $0.00 $0.00

2026 $82.82 $0.00

- $82.82

2027 $0.00 $162. 12 08 $162. 12 08

2028 $0.00 $0.00 $0.00

2029 $0.00 $0.00 $0.00

2030 $0.00 $0.00 $0.00

Total $355.42 $857. 53 11 $502.11 $501.69 Annual Average $17.77 $42. 88 86 $25. 11 08

Annualized at 3% $19.13 $45. 41 38 $26. 27 25

Annualized at 7% $21.01 $48. 87 84 $27. 86 83

Baseline Cost Post-Amendment

Cost Change in Cost Reporting Cycle 1 Year(s)
(millions of 2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2011 $106.97 $198.84$208.78 $91.87$101.81

2012 to 2016 $82.82

-- 2 2012 to 2015

-- $162.08 $79.27

2017 to 2021 $82.82

-- 3 2016 to 2019

-- $162.08 $79.27

2022 to 2026 $82.82

-- 4 2020 to 2023

-- $162.08 $79.27

2027 to 2031 $82.82

-- 5 2024 to 2027

-- $162.08 $79.27

6 2028 to 2031

-- $162.08 $162.08

Total $438.24 $1,009.25$1,019.20 $571.01$580.96
Annual Average $17.53 $40.37 $40 .77 $22.84 $23.24
Annualized @ 3% $16.80 $38.40 $38.90 $21.61 $22.10
Annualized @ 7% $15.88 $35.83 $36.44 $19.95 $20.56

1 The non-italicized reporting cycles are baseline, five-year cy cles, and the italicized reporting cycles are proposed, four-yea r cycles.

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

5-1 

## 5. Agency Burden and Cost Estimates

5.1 Methodology for Agency Burden and Cost

This chapter analyzes the changes in burden and cost to EPA as a result of the proposed amendments to the IUR rule. This chapter calculates the increm ental cost and burden changes of the amendments by comparing the Agency costs under the current baseline to Agency costs after the proposed rule amendments. The methodology for estimating the change in Agency cost is similar to estimating the change in burden to industry:

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

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

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

 Step 4 : Subtract the total Agency cost or burden after the proposed IUR amendments from the cost or burden under the current IUR rule to calculate the incremental Agency cost or savings

Based on the supporting statement for the 2008 Information Collection Request for the Partial Update of the TSCA Production and Site Reports (EPA 2008d), tasks associated with the costs and burden to the Agency under the IUR rule include:

 Document receipt and tracking;

 Data entry and quality control of data entry;

 Backup systems operation;

 Data processing;

 Systems development;

 Contract oversight and management;

 Publication and printing of forms and materials; and

 Operation of the TSCA Hotline to handle IUR-related calls.

Costs related to using the data are not included. The one-time costs associated with the requirements of previous IUR amendments are also not considered here.



### 5.2 Data for Agency Cost Estimates

5.2.1 Agency Wage Rates



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

assumes that the Agency burden will remain the same for all reporting cycles.

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

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

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

levels.

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

Pay Grade Annual Salary Overhead and Fringe Benefits % of Wages Overhead and Fringe

Benefit Cost Total

GS 12 Step 3 $77,416 58% $44,901 $122,317
GS 13 Step 3 $88,493 58% $51,326 $139,819
Source: The unloaded Federal salary for calendar 2008 is from the Office of Personnel Management salary table for 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 that it will spend approximately $204,000 on these tasks per reporting cycle.

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

Tasks Performed by Contractor Staff Annual Cost (2007$) * 1 Inflation

Factor Annual Cost (2008$) Document Receipt, Tracking and Data Entry $90,737 1.04 $94,632
Maintaining and Operati ng Back Up Systems $56,711 1.04 $59,145 Printing and Publishing Forms and Materials $5,298 1.04 $5,525 Managing the TSCA Hotline $42,855 1.04 $44,694

Total $195,601 n/a $203,997

* 1 Source: ICR No. 1884.04. [Information Collection Request for] Partial Update of the TSCA S ection 8(b) Inventory Data Base, Production and Site Report Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act , September
5, 2008

. (EPA, 2008d)

.



### 5.3 Current Total Agency Burden and Cost

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

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

Task Staff Cost per Reporting Cycle (2008$)
VARIABLE COSTS (DEPENDENT ON THE NUMBER OF REPORTS SUBMITTED)

Quality Control of Data Entry EPA Employee (GS 12 Step 3) $122,317

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

TOTAL VARIABLE COST $216,949

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

Maintaining and Operating Back Up Systems Contractor $59,145

Printing and Publishing Forms and

Materials Contractor $5,525

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

TOTAL AGENCY COST $466,133
Note: Totals may not sum due to rounding.



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

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

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 nu mber of data items in that section to calculate the burden per item, 0.0009 hour (approximately .054 minutes) (See Equation 2).

Equation 2: Burden per Data Element = 0.017 hours / 19 = 0.0009 hours

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

Table 5-4: Baseline Agency Burden per Report

Burden per Data Element Total Number of Data Elements Burden (hours) Cost (2008$) Burden (hours) Cost (2008$)

Part I 19 0.0009 $0.09 0.017 $1.78

Part II 47 0.0009 $0.09 0.042 $4.40

Part III 60 0.0009 $0.09 0.054 $5.61

Total (Full Report) 126 - - 0.113 $11.79



### 5.4 Changes to Agency Burden and Cost as a Result of the Proposed
Modifications

The estimated cost and burden impacts on the Agency for each of the proposed amendments to the IUR are outlined below. See Section 3. for more information about each of the proposed amendments.

In each of the following sections below , the burden estimates for each amendment are calculated independently of the other amendments . See Section 5.5 for an estimate of the aggregated impact of all proposed amendments.

5.4.1 Technical Modifications to the Regulatory Text



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

5.4.2 Modifications to Selected Definitions



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

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



### EPA is proposing to require reporting if, for any calendar year since the previous IUR principal reporting year, the subject chemical was manufactured or imported in volumes of 25,000 lb. or greater. The Agency estimates this will increase the total nu mber of sites and reports by five percent from the

baseline. This modification would not take effect until after the first post-amendment reporting cycle (2011); for the first reporting cycle, submitters will still consider production volume only for the principal reporting year. This creates a difference in the number of sites and reports expected in the first cycle

versus future cycles. (See Section 4.4.3 for more information.) Therefore, the tables below show estimated changes in cost and burden for both the first and fiture reporting cycles.

Table 5-5 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates no change in burden for the first reporting cycle and

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5-5 a burden increase of 104 hours in future reporting cycles as a result of modifying the method for determining whether the 25,000 lb. reporting threshold is met.

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

Burden to

Process

Part I

Submission

(hours ) Number

of Sites Burden to

Process

Part II (hours per

report) Number

of Reports

(with Part II) Burden

to

Process

Part

III (hours

per report) Number

of Reports

with

Part III Agency Burden ( hours)

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

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080

Post

Amendment 0.017 4,289 0.042 27,191 0.054 17,929 2,184

Change

from the

Baseline 0.000 204 0.000 1,295 0.000 854 104

Note: Values in Change from the Baseline rows a re calculated by subtracting the co rresponding baseline value from the post

amendment value.

Burden to

Process

Part I

Submission

(hours) Number

of Sites Burden

to

Process

Part II (hours

per report) Number

of Reports

(with Part II) Burden to

Process Part

III (hours per report) Number

of Reports

with Part

III Agency

Burden (hours)

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

First Cycle, Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080
First Cycle, PostAmendment 0.017 4,085 0.042 25,896 0.054 17,075 2,080

Change from the Baseline, First Cycle 0.000 0 0.000 0 0.000 0 0

Future Cycle

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080

Future Cycle, PostAmendment 0.017 4,289 0.042 27,191 0.054 17,929 2,184

Change from the Baseline, Future Cycles 0.000 204 0.000 1,295 0.000 854 104

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



### Table 5-6 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates no change in cost for the first reporting cycle and a cost increase of approximately $10,8 00 in future reporting cycles 47

.

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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

P rocess Part I

Submission

(2008 $ ) Number

of Sites Cost to

Process

Part II (2008 $ per

report) Number

of Reports

(with Part II) Cost to

Process

Part III ( 2008$

per report) Number

of Reports

with

Part III Agency Burden (2008 $ )

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

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

Post

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

Change

from the

Baseline $0.00 204 $0.00 1,295 $0.00 854 $10,847

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

amendment value.

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, PostAmendment $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

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


### EPA is proposing to eliminate the 300,000 lb. threshold for reporting processing and use information, thereby requiring all submitters of non-excluded substances to report information in all parts of the IUR Form U. Eliminating this threshold will increase industry burden by requiring more sites to complete Part III of Form U (Part III contains the downstream processing and use information). EPA estimates that the number of Part IIIs submitted will increase by 8,203 reports (see Section 4.4.4 for more information).

Table 5-7 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency expects a burden increase of 441 hours as a result of this

amendment.

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

Burden to Process

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

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

Baseline 0.05 17,075 919

Post-Amendment 0.05 25,278 1,360
Change from the Baseline 0 8,203 441

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



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

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

Cost to Process Part

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

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

Baseline $5.61 17,075 $95,835

Post-Amendment $5.61 25,278 $141,876
Change from the Baseline $0.00 8,203 $46,040

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

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



### EPA is proposing to eliminate the 25,000 lb. reporting threshold for chemicals that are: (1) the subject of a regulation proposed or promulgated under sections 5(a)(2), 5(b)(4), or 6 of the Act; (2) the subject of an order issued under section 5(e) or 5(f) of the Act, or (3) the subject of relief that has been granted under a civil action under section 5 or 7 of the Act. The manufacturers (including importers) of these chemicals would be required to report under the IUR rule, regardless of the production volume.

Approximately 1,131 chemicals fall into these categories (EPA, 2006a). Because the proposed amendment would affect only chemicals subject to a promulgated rule, this figure is an overestimate. EPA estimated these chemicals are produced at a total of 4,018 sites (see Section 4.4.5 for more details).

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

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5-8 Table 5-9: Change in Agency Burden as a Result of Eliminating the 25,000 lb. Threshold for Certain Regulated Chemicals

Burden to Process

Part II (hours per report) Number of Reports Agency Burden (hours)

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

Baseline 0.04 25,896 1,092

Post-Amendment 0.04 29,914 1,261
Change from the Baseline 0 4,018 169

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



### Table 5-10 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $17, 700 665

.

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

Cost to Process Part

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

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

Baseline $4.40 25,896 $113,853

Post-Amendment $4.40 29,914 $131,518
Change from the Baseline $0.00 4,018 $17,665

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

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



### The Agency is proposing th at all chemicals subject to enforceable consent agreements be ineligible for exemptions. A total of four chemicals and 16 sites are affected by this amendment (see Section 4.4.6 for more information). These sites would submit Part III of Form U for these chemicals for the first time in the next submission period.

Table 5-11 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency expects a burden increase of one hour as a result of this

amendment.

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

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

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

Baseline 0.05 17,075 919

Post-Amendment 0.05 17,091 920 Change from the Baseline 0 16 1

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

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5-9 Table 5-12 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $90.

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

Cost to Process Part III (2008$ per report) Number of Reports Agency Cost (2008$) (a) (b) (c) = (a)*(b)

Baseline $5.61 17,075 $95,835

Post-Amendment $5.61 17,091 $97,925
Change from the Baseline $0.00 16 $90

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

5.4.7 Full Exemption for Manufactured Water


### Under the current IUR regulations, manufactured water is partially exempt from reporting; therefore, facilities that produce manufactured water need to complete only Parts I and II of Form U. The Agency now is proposing to grant a full exemption for manufactured water. Thus, the burden reduction for this proposed amendment would be the result of 43 fewer Part IIs being submitted (see s S ection 4.4.7 for more information.)

Table 5-13 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden reduction of two hours as a result of

this amendment.

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

Burden to Process Part

II (hours per report) Number of Reports Agency Burden (hours)

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

Baseline 0.04 25,896 1,092

Post-Amendment 0.04 25,853 1,090
Change from the Baseline 0 -43 -2

Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-amendment value.



### Table 5-14 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost savings of approximately $1 90 89

.

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.

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



### EPA is amending the list of partially exempt chemicals to remove three chemical substances (Starch (CASRN 9005-25-8), Dextrin (CASRN 9004-53-9), and Maltodextrin (CASRN 9049-76-7)) which, as polymers, are fully exempt from reporting. This will not change the Agency burden

, because these substances currently are fully exempt from repor ting, and therefore no additional reports will be

submitted to EPA.

5.4.9 Parent Company and Site Identity



### Manufacturers (including importers) currently are required to report the name and other information to identify the company associated with their plant site on Part I of Form U. EPA is proposing to require

that the company name to be the ultimate domestic parent na me. EPA assumes no additional Agency burden for processing the ultimate domestic parent name, compared to the current IUR reporting requirement of the parent company name.

5.4.10 Technical Contact



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

5.4.11 Chemical Identity


### EPA is proposing to require the reporting of the Chemical Abstracts (CA) Index Name currently used to list the substance in the Inventory as the chemic al name reported for IUR. Currently, submitters are required to report a specific chemical name, with no further elaboration in the regulatory text. EPA is also proposing to allow submitters to report only the CASRN as a chemical identifying number or, in the case of confidential chemical substances, the accession number. Note that in cases where a CASRN exists for a confidential chemical, it can be reported instead of the accession number and claimed as confidential for purposes of the IUR submission. EPA is proposing to remove the PMN number as an allowed chemical identifying number because each Inventory substance has either a CASRN or a TSCA A a ccession

N n umber or both, which are likely to be already known already to the submitter.

EPA assumes no additional Agency burden to process a CA Index Name or CASRN, compared to another chemical identity name or number.

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



### EPA is proposing to require reporting of a chemical’s production volume manufactured in each of the five years since the last IUR principal reporting year. Thus, for the 2011 IUR, manufacturers (including importers) of subject chemicals would report the production volume for the calendar years 2006, 2007, 2008, 2009, and 2010. This amendment will result in four additional data items for EPA to process in Part II of Form U, adding approximately 1.2 minutes (0.02 hours) of processing burden per form (see Table 5-4).

Table 5-15 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden increase of 93 hours as a result of

this amendment.

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5-11 Table 5-15: Change in Agency Burden as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year

Burden for Processing

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

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

Baseline 0.001 25,896 23

Post-Amendment 0.004 25,896 116 Change from the Baseline 0.004 0 93

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



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

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

Cost for Processing

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

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

Baseline $0.09 25,896 $2,422

Post-Amendment $0.47 25,896 $12,112
Change from the Baseline $0.37 0 $9,690

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

5.4.13 Volume of Chemical Substance Used On-Site



### Under the current IUR requirements, submitters who manufacture a chemical exclusively for on-site use are required to indicate this on Form U. The Agency is proposing to require submitters to report both production volumes used on- and off-site. EPA expects that there will be a slight increase in the number of submitters who would report product volume used on-site information; about 19.4 percent of all submitters will report the volume used on-site (see Section 5.4.13 for more information).

Table 5-17 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden increase of five hours as a result of

this amendment.

Table 5-17: Change in Agency Burden as a Result of Reporting of Production Volume Used OnSite

Burden to

Process

Information (hours per

report) Number of Reports Number of Reports

with Production

Volume Used On-Site Agency Burden (hours)

Baseline 0.042 25,896 0 1,092

Post-Amendment 0.043 25,896 5,024 1,096 Change from the

Baseline 0.001 0 5,024 5

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

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

5-12 Table 5-18 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $470.

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

Cost to Process

Information (2008$ per

report) Number of Reports Number of Reports

with Production

Volume Used On-Site Agency Cost (2008$)

Baseline $4.40 25,896 0 $113,853

Post-Amendment $4.49 25,896 5,024 $114,323 Change from the

Baseline $0.09 0 5,024 $470

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

5.4.14 Indicate Whether Chemical Is Physically at Reporting Site


### EPA is proposing to require submitters to indicate whether an imported chemical is physically at the reporting site. This will add one additional data element for EPA to process.

Table 5-19 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden increase of 23 hours as a result of

this amendment.

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

Burden to Process

Information (hours per report) Number of Reports Agency Burden (hours)

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

Baseline 0.042 25,896 1,092

Post-Amendment 0.043 25,896 1,115 Change from the

Baseline 0.001 0 23

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



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

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

Cost to Process

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

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

Baseline $4.40 25,896 $113,853

Post-Amendment $4.49 25,896 $116,275
Change from the

Baseline $0.09 0 $2,422

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

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

5-13 5.4.15 Report Production Volume Exported



### EPA is proposing to require that all submitters to provide the exported chemical volume in Section II of the report. This will add one additional data element to Part II of Form U for EPA to process.

Table 5-21 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden increase of 23 hours as a result of

this amendment.

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

Burden to Process

Information (hours per report) Number of Reports Agency Burden (hours)

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

Baseline 0.042 25,896 1,092

Post-Amendment 0.043 25,896 1,115 Change from the

Baseline 0.001 0 23

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



### Table 5-22 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $2,4 00 22

.

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

Cost to Process

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

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

Baseline $4.40 25,896 $113,853

Post-Amendment $4.49 25,896 $116,275
Change from the

Baseline $0.09 0 $2,422

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

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



### EPA is proposing to add a checkbox to Form U for submitters to indicate whether a chemical is to be recycled, remanufactured, reprocessed, reused, or reworked. This will add one ad ditional data element to Part II of Form U for EPA to process.

Table 5-23 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden increase of 23 hours as a result of

this amendment.

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

5-14 Table 5-23: Change in Agency Burden as a Result of Indicating Whether Chemical is Recycled, Remanufacture, Reprocessed, Reused, or Reworked

Burden to Process a Checkbox to

Indicate Whether a Product is

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

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

Baseline 0.042 25,896 1,092

Post-Amendment 0.043 25,896 1,115 Change from the

Baseline 0.001 0 23

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



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

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

Cost to Process a Checkbox to

Indicate Whether a Product is

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

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

Baseline $4.40 25,896 $113,853

Post-Amendment $4.49 25,896 $116,275
Change from the

Baseline $0.09 0 $2,422

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

5.4.17 Concentration Ranges



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

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 additional categories, eliminating six existing categories and requiring submitter s to write in text when they claim “Other” as the category. This would add one data element to Part III of Form U for EPA to process. EPA expects the number of submitters who select “Other” to decrease, for a total of 603 submitters expected to write-in this text descriptor (see Section 4.4.18 for more information).

Table 5-25 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden increase of 0.54 hours as a result of

this amendment.

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

5-15 Table 5-25: Change in Agency Burden as a Result of Revising the Industrial Function Categories

Burden to

Process

Function Categories (hours per

report) Number of Reports with

Function Categories Burden to

Process Writein Text for

"Other" (hours) Number of Reports with

Text Descriptor for

"Other" Burden (hours)

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

Baseline 0.05 17,075 0.000 0 918.82

Post-Amendment 0.05 17,075 0.001 603 919.36 Change from the

Baseline 0.00 0 0.001 603 0.54

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



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

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

Cost to

Process

Industrial

Function Categories (2008$ per

report) Number of Reports with

Industrial

Function Categories Cost to Process

Write-in Text

for "Other"

(2008$) Number of Reports with

Text Descriptor for

"Other" Cost (2008$)

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

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

Post-Amendment $5.61 17,075 $0.09 603 $95,892
Change from the

Baseline $0.00 0 $0.09 603 $56

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

5.4.19 Revise Industrial Sectors


### EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) codes with 48 Industrial Sectors. This amendment will not change the Agency’s data processing burden. EPA expects that the Agency’s burden to process the industrial sectors will remain the same regardless of the code system used.

5.4.20 Revise Consumer and Commercial Product Categories



### The Agency is proposing to revise the consumer and commercial product categories, by adding 12 new categories and requiring submitters to write in text when they select “Other” as a consumer or commercial product category. EPA expects 604 submitters to write in this text descriptor for “Other” (see Section 4.4.20 for more information), adding one ad ditional data element to Part III of Form U for EPA to

process.

Table 5-27 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a 0.54 hour burden increase as a result of this

amendment.

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

5-16 Table 5-27: Change in Agency Burden as a Result of Revising the Consumer and Commercial Product Categories

Burden to

Process

Consumer or

Commercial

Product Categories (hours per

report) Number of Reports with

Consumer or

Commercial

Product Categories Burden 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 th e corresponding baseline value from the post-amendment value.



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

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

Cost to Process

Consumer or

Commercial

Product Categories (hours per

report) Number of Reports with

Consumer or

Commercial

Product Categories Cost to Writein Text for

"Other" (2008$) Number of Reports with

Write-in

Text for

"Other" Cost (2008$)

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

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

Post-Amendment $5.61 17,075 $0.09 604 $95,892
Change from the

Baseline $0.00 0 $0.09 604 $56

Note: Values in Change from the Baseline rows are calculated by subtracting th e corresponding baseline value from the post-amendment value.

5.4.21 Designation of Consumer or Commercial Use



### EPA is proposing to require the identification of whether the downstream use is a consumer or a commercial use, or both, adding one data element to Part III of Form U for EPA to process.

Table 5-29 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency expects a burden increase of 15 hours as a result of this

amendment.

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

5-17 Table 5-29: Change in Agency Burden as a Result of Designation of Consumer or Commercial Use

Burden per Report (hours) Number of Reports

with Part III Burden (hours)

Baseline 0.054 17,075 919

Post-Amendment 0.055 17,075 934 Change from the

Baseline 0.001 0 15

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



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

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

Cost per Report (2008$) Number of Reports

with Part III Cost (2008$)

Baseline $5.61 17,075 $95,835

Post-Amendment $5.71 17,075 $97,433
Change from the

Baseline $0.09 0 $1,597

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

5.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed



### EPA is proposing to require that submitters of reports with processing and use information to provide the number of commercial workers who are reasonably likely to be exposed to a chemical. This amendment adds one data element to Part III of Form U for EPA to process.

Table 5-31 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency expects a burden increase of 15 hours as a result of this

amendment.

Table 5-31: Change in Agency Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed

Burden per Report (hours) Number of Reports

with Part III Burden (hours)

Baseline 0.054 17,075 919

Post-Amendment 0.055 17,075 934 Change from the

Baseline 0.001 0 15

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



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

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

5-18 Table 5-32: Change in Agency Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed

Cost per Report (2008$) Number of Reports

with Part III Cost (2008$)

Baseline $5.61 17,075 $95,835

Post-Amendment $5.71 17,075 $97,433
Change from the

Baseline $0.09 0 $1,597

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

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



### EPA is proposing to eliminate the “ N n ot R r eadily O o btainable (NRO)” standard and replace it with the more stringent “ K k nown to or R r easonably A a scertainable by” standard for reporting of processing

and use information. This amendment does not affect the number of submitters or the number of data elements in Form U, and therefore, EPA assumes that it will not increase the Agency burden or cost.

5.4.24 Chemical Identity CBI Claims



### EPA is proposing that , when a submitter asserts a claim of confidentiality for the chemical identi t f y of

a substance that is listed on the public portion of the Master Inventory File, the Agency may make the information available to the public without further notice to the submitter. See the proposed regulatory text at 40 CFR 711.18(e). Any such action on EPA’s part would be as part of regular and routine use of

the data and will not crea te any additional burden.

5.4.25 Upfront Substantiation for Processing and Use Information CBI Claims



### EPA is proposing to require upfront substantiation for all CBI claims in the processing and use section of Form U. This amendment adds two data elements per item claimed as CBI, to Part III of Form U for EPA to process. EPA expects that 2,928 reports will claim processing and use information as CBI, and on average they will make three CBI claims per report (see section 4.4.25 for more information).

Table 5-33 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency expects a burden increase of eight hours as a result of

this amendment.

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

Burden per Report (hours) Number of Reports with

Part III Burden for Upfront CBI

Substantiation

for CBI Claims

in Part III Number of Reports with

Substantiated

CBI Claims in

Part III Burden (hours)

Baseline 0.05 17,075 0.000 0 919

Post-Amendment 0.05 17,075 0.003 2,928 927 Change from the

Baseline 0.00 0 0.003 2,928 8

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



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

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

5-19 Table 5-34: Change in Agency Cost as a Result of Requiring Upfront Substantiation for CBI Claims

Cost per Report (2008$) Number of Reports with

Part III Cost for Upfront CBI

Substantiation

for CBI Claims

in Part III Number of Reports with

Substantiated

CBI Claims in

Part III Cost (2008$)

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

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

Baseline $0.00 0 $0.28 2,928 $822

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

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



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

5.4.27 Require Electronic Submissions over the Internet



### EPA is proposing to require that all Form Us to be submitted to the Agency electronically, via eIUR IURweb and EPA’s Central Data Exchange (CDX) over the Internet. EPA expects that mandatory electronic submission will reduce significantly the Agency’s data processing time. Based on a study conducted by EPA, “A Business Case Analysis of EPA’s Central Data Exchange” (EPA, 2007) on of the costs and 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 that are included in the general CDX operating budget.

Table 5-35 shows the estimated Agency burden of the proposed amendment, using the baseline burden estimates found in Table 5-4. The Agency estimates a burden decrease of approximately 1,800
hours as a result of this amendment.

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

Burden per Report to

Process

Part I (hours per site) Number of

Sites Burden per Report to

Process

Part II (hours per

report) Number of Reports Burden per Report to

Process

Part III (hours per site) Number of

Sites with

Part III Burden (hours)

Baseline 0.017 4,085 0.0422 25,896 0.054 17,075 2,080

PostAmendment 0.002 4,085 0.005 25,896 0.006 17,075 238

Change

from the

Baseline -0.015 0 -0.0373 0 -0.048 0 -1,842

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

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

5-20 Table 5-36 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost savings of approximately $192,200.

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

Cost per Report to

Process

Part I (2008$) Number of

Sites Cost per Report to

Process

Part II (2008$ per

report) Number of Reports Cost per Report to

Process

Part III (2008$ per site) Number of

Sites with

Part III Cost (2008$)

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

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

Change

from the

Baseline -$1.57 0 -$3.89 0 -$4.97 0 -$192,155

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

5.4.28 Updated e-IUR Reporting Software



### EPA developed the e-IUR reporting software for use by manufacturers and (including importers ) in preparing and submitting reports electronically during the 2006 IUR reporting cycle. For the 2011 submission period, EPA will provide a free

, web-based application in place of the 2006 downloadable

software. The updated e- IUR IURweb reporting tool for the 2011 IUR collection would feature several improved capabilities over the current e-IUR reporting tool. Although not quantified here, EPA expects

that improvements to the updated e- IUR IURweb software will reduce Agency burden to process and

correct errors in the form.

5.4.29 Electronic Signature Process



### In order to submit IUR data electronically to EPA via the Central Data Exchange ( CDX ) , individuals acting on behalf of the submitter must first register wi th CDX. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder”) downloads two forms: the Electronic Signature Agreement and the Verification by Company Authorizing Official Form. Registration enables CDX to perform two important functions: authenticate identity , and verify authorizati on. For authentication of identity, the submitter completes the Electronic Signa ture Agreement form, signs and dates it, has the form notarized, and mails it back to EPA. The Verifi cation of Authorization form requires the signatures of the authorized company official and anyone he/she authorizes to submit support documents for the

company.

The storage and processing of these forms is 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 ne w submitters or submissions as a result of employee turnover is 0.17 hours per form (EPA, 2004). All 4,085 sites will be required to submit new electronic signature agreements in the 2011 submission year. In future reporting cycles, only sites which have not previously registered with CDX or sites with a new authorized company official must submit the electronic signature agreements. EPA expects this number to be negligible. Therefore EPA expects the Agency burden of this amendment to be approximately 645 hours (4,085 sites x 0.17 hours per site).

The processing, reviewing, approving, and filing of th e electronic signature agreements is expected to be completed by the GS-13 Step-3 employee that is currently responsible for data processing, systems

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

5-21 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, 700 681 during the 2011 reporting cycle.

5.4.30 Modifications Specifically Affecting Importers



### For purposes of IUR, importers currently are allowed to report the IUR information jointly with the foreign manufacturer of the chemical. Under the proposed amendment, the foreign manufacturer must now register with CDX and submit its report electronically. Previously, joint submissions could not be made electronically.

For the 2006 IUR reporting cycle, EPA set aside joint submissions until both were received and matched. Oftentimes, EPA had no way to determine whether a submission was a “joint” submission, which increased the time required for manu al processing of the data. EPA anticipates that the use of the reporting tool will help to make joint IUR reporting easier for industry. Although not quantified, EPA also anticipates that the electronic reporting tool will streamline EPA ’s processing of the IUR information submitted in the 2011 reporting cycle, thus reducing Agency burden.

5.4.31 Modify Reporting Frequency


### EPA is proposing to modify the IUR reporting cycle from five years to four years. This will increase the Agency burden because the Agency will receive and process IUR data more frequently. The annual baseline Agency burden is two FTEs, or 4,160 hours. Table 5-37 contains the change in burden over a

2 0 5 -year period. In total, EPA estimates that the Agency will spend 4,160 more hours over a 2 0 5 -year period as a result of modifying the IUR reporting frequency.

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

Year Baseline Burden ( hours ) Post

- Amendment Burden ( hours ) Change in Burden ( hours )

2011 4,160 4,160 0

2012 0 0 0

2013 0 0 0

2014 0 0 0

2015 0 4,160 4,160

2016 4,160 0

- 4,160

2017 0 0 0

2018 0 0 0

2019 0 4,160 4,160

2020 0 0 0

2021 4,160 0

- 4,160

2022 0 0 0

2023 0 4,160 4,160

2024 0 0 0

2025 0 0 0

2026 4,160 0

- 4,160

2027 0 4,160 4,160

2028 0 0 0

2029 0 0 0

2030 0 0 0

Total 16,640 20,800 4,16 0

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

5-22 Annual Average 832 1,040 208

Baseline Burden Post-Amendment

Burden Change in Burden Reporting Cycle 1 Year(s)

(Hours) (Hours) (Hours)

1 200 7 to 2011 4,160 4,160 0

2012 to 2016 4,160

-- 2 2012 to 2015

-- 4,160 0

2017 to 2021 4,160

-- 3 2016 to 2019

-- 4,160 0

2022 to 2026 4,160

-- 4 2020 to 2023

-- 4,160 0

2027 to 2031 4,160

-- 5 2024 to 2027

-- 4,160 0

6 2028 to 2031

-- 4,160 4160

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

1 The non-italicized reporting cycles are baseline, five-year cycl es, and the italicized reporting cycles are proposed, four-yea r cycles



### Table 5-38 contains the 2 5 0 -year cost estimate as a result of modifying the reporting frequency. The baseline cost estimate is for data entry only and is discussed in Section 5.2. This table includes extramural costs which are incurred by the Agency. In total, EPA estimates that it will cost the Agencyapproximately $466,100 to increase the frequency of reporting from a five-year reporting cycle to a fouryear reporting cycle over a 2 5 0 -year period. EPA estimates that the annualized changes in cost would be $ 17,408 and $15,511 22,900 and $22,400 with a three percent and seven percent discount rate, respectively.

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

5-23 Table 5-38: Change in Agency Cost as a Result of Modifying the Reporting Frequency

Year Baseline Cost (2008 $ ) Post

- Amendment Cost (2008 $ ) Change in Cost (2008 $ )

2011 $466,133 $466,133 $0

2012 $0 $0 $0

2013 $0 $0 $0

2014 $0 $0 $0

2015 $0 $466,133 $466,133

2016 $466,133 $0

- $466,133

2017 $0 $0 $0

2018 $0 $0 $0

2019 $0 $466,133 $466,133

2020 $0 $0 $0

2021 $466,133 $0

- $466,133

2022 $0 $0 $0

2023 $0 $466,133 $466,133

2024 $0 $0 $0

202 5 $0 $0 $0

2026 $466,133 $0

- $466,133

2027 $0 $466,133 $466,133

2028 $0 $0 $0

2029 $0 $0 $0

2030 $0 $0 $0

Total $1,864,532 $2,330,664 $466,133 Annual Average $93,227 $116,533 $23,307

Annualized at 3% $98,818 $121,750 $22,932

Annualized at 7% $106, 248 $128,613 $22,365

Baseline Cost Post-Amendment

Cost Change in Cost Reporting Cycle 1 Year(s)

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

1 200 6 7 to 2011 $466,132.9 $466,132.9 $0.0

2012 to 2016 $466,132.9

-- 2 2012 to 2015

-- $466,132.9 $0.0

2017 to 2021 $466,132.9

-- 3 2016 to 2019

-- $466,132.9 $0.0

2022 to 2026 $466,132.9

-- 4 2020 to 2023

-- $466,132.9 $0.0

2027 to 2031 $466,132.9

-- 5 2024 to 2027

-- $466,132.9 $0.0

6 2028 to 2031

-- $466,132.9 $466,132.9

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

1 The non-italicized reporting cycles are baseline, five-year cycl es, and the italicized reporting cycles are proposed, four-yea r cycles

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

5-24 

### 5.5 Total Agency Cost of All Modifications

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

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



### To calculate the combined effect on Agency costs if all the proposed amendments were to be enacted, EPA used the baseline number of reports and sites taken from the 2006 IUR database (EPA, 2008c) and the baseline per report cost and burden estimates as found in Table 5-4. The change in the number of reports due to the effect of the amendments combined is calculated in Table 4-46 and Table 4-47 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 5-40 presents the total Agency burden for all the amendments combined. In total, EPA

estimates that the Agency will save 1,7 21 04 hours during the first reporting cycle and 1,704 hours in each future reporting cycle . Table 5-41 presents the total Agency cost estimates; the Agency will save approximately $179,600 in the first reporting cycle and $177,700 in future reporting cycles as a result of the proposed IUR amendments. The baseline and post-amendment costs both contain the cost of all extramural activities, found in Table 5-2. Option Burden per

Part I of Report (hours) Burden per

Part II of

Report (hours) Burden per

Part III of

Report (hours)

Baseline 0.02 0.04 0.05

Production Volume Used On-Site - 0.0002 --
Industrial Function Categories - -- 0.00003
Recycled, Remanufactured, Reprocessed, Reused, or Reworked - 0.001 --
Whether Chemical is Physi cally at Site - 0.001 --
Exported Volume Reporting - 0.001 --

Consumer/Commercial Produc t Categories - -- 0.00003 Number of Workers Exposed - -- 0.001

CBI - -- 0.0005

Production Volume in Off-Years - 0.0036 --

e

- IUR Electronic Submission -0.015 -0.043 -0.049
Total Change from the Baseline with All Amendments -0.015 -0.037 -0.047
Total, All Amendments 0.002 0.006 0.006

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

5-25 Table 5-40: Total Agency Burden for All Amendments Combined

Burden

per Report (Part I) (hours) Number

of Sites Burden to

Process

Part II (hours) Number

of Reports (with Part II) Burden to

Process

Part III (hours) Number

of Reports (with Part III) Agency

Burden (hours)

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

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

Amendment 0.002 4,085 0.006 29,871 0.006 29,253 2,439

Change from the Baseline, First year -0.015 0 -0.037 3,975 -0.047 12,178 -1,721

Future-cycle

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 4,160

Future cycle, Post

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

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

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

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) N umber of Reports (with Part III) Agency

Burden (hours)

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

(e  f)

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 4,160

Post

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

Change

from the

Baseline - 0.015 2 04

- 0.037 5,469

- 0.047 13,641

- 1,704

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

amendment value.

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

Cost per Report (Part I) (2008$) Number

of Sites Cost to

Process

Part II (2008$) Number

of Reports (with Part II) Cost to

Process

Part III (2008$) Number

of Reports (with Part III) Agency

Cost (2008$)

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

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

Amendment $0.20 4,085 $0.58 29,871 $0.66 29,253 $286,580

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

5-26 Change from the Baseline, First year -$1.57 $0.00 -$3.82 $3,975 -$4.95 $12,178 -$179,553
Future-cycle

Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133 Future cycle, Post

Amendment $0.20 4,289 $0.58 31,365 $0.66 30,716 $288,450 Change from the Baseline, Future cycles -1.574 204 -$3.82 5,469 -$4.95 13,641 -$177,683

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

Cost per Report (Part I) (2008 $ ) Number of

Sites Cost to

Process

Part II (2008 $ ) Number

of Reports

(with Part II) Cost to

Proces s Part III (2008 $ ) Number of Reports (with Part III) Agency

Cost (2008 $ )

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

(e  f)

Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133

Post

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

Change

f rom the

Baseline - $1.57 204

- $3.82 5,469

- $4.95 13,641

- $177,683

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

amendment value.



### To calculate the Agency burden per data element, EPA followed the same methodology used to calculate the baseline burden per data element (See Section 5.3). EPA calculated the total number of data elements in the proposed Form U (146 elements) and the percentage of data elements in each section of the form, and derived a weighted percentage of elements in each section of the form. For example, the

revised Part I there are contains 23 data elements in the revised Part I , and 4,289 sites are expected to submit Part I when all the amendments are considered. These 77,615 data elements (19 x 4,085 = 77,615) account for approximately 2.41 percent of all data elements. Similarly, 41.35 percent of all data elements are in Part II of the form, and 56.24 percent are in Part III. The Agency then multiplied the total variable burden of IUR processing, 376.5 hours, by the percentage of data elements in a section and divided by the total number reports submitted for each section. To calculate the total variable burden to the Agency, EPA took the total burden estimate of 2,456 hours (Table 5-40 above ) and subtracted the fixed burden of 2,080 hours. An example of this calculation can be seen in Equation 3 below for Part I.

Equation 3: Burden to Process Part I per Report = (376.5 hours x 0.0241) / 4,289 = 0.002 hours

The burden per section was then divided by the total numb er of data items in that section to calculate the burden per item, 0.00009 hour (approximately .0054 minutes) (See Equation 2).

Equation 4: Burden per Data Element = 0.002 hours / 19 = 0.00009 hours

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

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5-27 Table 5-42: Agency Burden per Report when All Amendments are Combined

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

U

Section Baseline PostAmendment Change

from

Baseline Baseline PostAmendment Change

from

Baseline Baseline PostAmendment Change

from

Baseline

Part I 19 23 4 0.0009 0.00008

-0.0008 - 0. 0008 0

17 0. 017 002 - 0. 002 01

5

Part II 47 66 19 0.0009 0.00008

-0.0008 - 0. 0008 0

42 0. 042 006 - 0. 006 03

7

Part III 60 75 15 0.0009 0.00008

-0.0008 - 0. 0008 0

54 0. 054 006 - 0. 006 04

8

Total (Full Report) 126 161 35 - - 0.113 0. 113 014 - 0. 014 09

9



### The burden per section was then divided by the total nu mber of data items in that section to calculate the burden per item, 0.00009 hour (approximately .0054 minutes) (see Equation 5 )

.
Equation 5: Burden per Data Element = 0.002 hours / 19 = 0.00009 hours

To calculate the cost to EPA, the process described above was repeated; however, instead of using the hourly burden, EPA used the combined cost for the quality control of data entry, and document receipt, tracking, and data entry, which was $39,366. This cost was calculated by subtracting the fixed Agency costs, $249,184 (see Table 5-3) from the total post amendment cost of $288,450 (See Table 5-41). Thus,

EPA calculated that it costs the Agency approximately $0.09 to process a single data element of Form U. The total Agency cost per report is approximately $1.44 in the post- amendment scenario. Table 5-43 contains the Agency cost per report by section of Form U. This baseline burden will remain the same for all reporting cycles.

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

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

U

Section Baseline PostAmendment Change

from

Baseline Baseline PostAmendment Change

from

Baseline Baseline PostAmendment Change

from

Baseline

Part I 19 23 4 $0.09 $0.009 -$0.085 $1.78 $0.20 -$1.57

Part II 47 66 19 $0.09 $0.009 -$0.085 $4.40 $0.57 -$3.83

Part III 60 75 15 $0.09 $0.009 -$0.085 $5.61 $0.67 -$4.94

Total (Full Report) 126 161 35 - - $11.79 $1.44 -$10.34



### Table 5-44 contains Agency costs per-data element and per-report separated by EPA and contractor staff. Using the values in Table 5-3, EPA estimates that in the baseline, approximately 56.4 percent of the variable Agency costs are attributed to EPA staff ($122,317/$216,949). The remaining 43.6 percent of data processing costs are incurred by contractor staff ($94,632/$216,949). EPA does not expect the distribution of costs between Agency and contractor staff to change as a result of the proposed rule. Thus, to calculate the post-amendment cost s attributed to contractor staff, EPA multiplied the per-report cost

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

5-28 and the per-data element cost by 43.6 percent. The cost to contract staff is approximately $0.63. Similarly, to derive the EPA staff cost of $0.81 per report, the total per-report cost s of $1.44 was multiplied by 56.4
percent.

Table 5-44: Agency Cost per Report when All Amendments Are Combined

Cost per Data Element (2008$) Total Cost per Report (2008$) 1

Form U Section Agency

Staff

Cost Contractor

Cost Total PostAmendment

Cost Agency

Staff

Cost Contractor

Cost Total PostAmendment

Cost

Part I $0.005 $0.004 $0.009 $0.11 $0.09 $0.20

Part II $0.005 $0.004 $0.009 $0.32 $0.25 $0.57

Part III $0.005 $0.004 $0.009 $0.37 $0.29 $0.66
Total (Full Report) - - $0.81 $0.63 $1.44

1 Note: Totals may not sum due to rounding.

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5-29 

### 5.6 Annual ized Burden a nd Discounted Total Agency Cost Estimates of for All
Modifications

Table 5-45 presents the annual Agency burden estimates for data entry and extramural costs over a

2 5 0 -year period. The annual baseline Agency burden is equivalent to two FTEs, or 4,160 hours. The postamendment Agency burden is calculated in Table 5-40, and an additional FTE is added to account for all the GS-13 level tasks (see Table 5-3), which are not affected by any of the proposed amendments. In total, EPA estimates that the Agency burden for the IUR rule will be reduced by 4,400 6,079 hours over a

2 5 0 -year period under the proposed IUR amendments.

Table 5-45: Annual Agency Burden over a Period of 25 Years if All Proposed Amendments Are Implemented Data Entry Burden to the Agency of all Modifications

Year Baseline Burden (hours) Post

- Amendment Burden (hours) Change from Baseline

2011 4,160 2,456

- 1,704

2012 0 0 0

2013 0 0 0

2014 0 0 0

2015 0 2,456 2,456

2016 4,160 0

- 4,160

2017 0 0 0

2018 0 0 0

2019 0 2,456 2,456

2020 0 0 0

2021 4,160 0

- 4,160

2022 0 0 0

2023 0 2,456 2,456

2024 0 0 0

2025 0 0 0

2026 4,160 0

- 4,160

2027 0 2,456 2,456

2028 0 0 0

2029 0 0 0

2030 0 0 0

Total 16,640 12,282

- 4,358

Annual A verage 832 614

- 218

Baseline Burden Post-Amendment

Burden Change in Burden Reporting Cycle 1 Year(s)
(Hours) (Hours) (Hours)

1 200 6 7 to 2011 4,160 2,439 2

, 456 -1,721- 1

, 704

2012 to 2016 4,160

-- 2 2012 to 2015

-- 2,456 -1,704

2017 to 2021 4,160

-- 3 2016 to 2019

-- 2,456 -1,704

4 2022 to 2026 4,160

-- -1,704

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

5-30 Year Baseline Burden (hours) Post

- Amendment Burden (hours) Change from Baseline

2020 to 2023

-- 2,456

2027 to 2031 4,160

-- 5 2024 to 2027

-- 2,456 -1,704

6 2028 to 2031

-- 2,456 2,456

Total 20,800 14,72114,739 -6,079- 6,061
Annual Average 832 589614 -243- 218

1 The non-italicized reporting cycles are baseline, five-year cy cles, and the italicized reporting cycles are proposed, four-yea r cycles



### To estimate the per-reporting cycle annual cost of all the proposed amendments over a 25-year period

, EPA used the total baseline cost estimate s over a 20

- year period in Table 5-3. These costs include the cost
of data entry performed by both EPA and contractor staff, and the cost of all extramural activities conducted by contractor staff. Under the baseline, EPA estimates that the total Agency cost will be $466,100 during each reporting cycle. The annualized post-amendment cost s also include s all extramural costs from Table 5-2 in addition to the data entry and quality control costs.

Table 5-46 contains the annualized cost estimation. In total, annual post-amendment cost s will be $ 286, 60 0 288,50 0 during the first reporting cycle and thereafter. Over a 2 0 5 -year period, EPA estimates

that the Agency will save approximately $ 601,8 00 599,963 422,300 . Annualized savings are approximately $22, 800 and $21,4 00 $2 2,7 3 ,5 00 and $2 6,7 1,3 00 , discounted at three percent and seven percent, respectively.

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5-31 Table 5-46: Annual and Discounted Total Cost to the Agency of All Modifications

Year Baseline Cost (2008 $ ) Post

- Amendment

Cost (2008 $ ) Change from Basel ine

2011 $466,133 $288,450

- $177,683

2012 $0 $0 $0

2013 $0 $0 $0

2014 $0 $0 $0

2015 $0 $288,450 $288,450

2016 $466,133 $0

- $466,133

2017 $0 $0 $0

2018 $0 $0 $0

2019 $0 $288,450 $288,450

2020 $0 $0 $0

2021 $466,133 $0

- $466,133

2022 $0 $0 $0

20 23 $0 $288,450 $288,450

2024 $0 $0 $0

2025 $0 $0 $0

2026 $466,133 $0

- $466,133

2027 $0 $288,450 $288,450

2028 $0 $0 $0

2029 $0 $0 $0

2030 $0 $0 $0

Total $1,864,532 $1,442,251

- $422,281
Annual Average $93,227 $72,113

- $21,114

Annualized at 3% $98, 818 $75,341

- $23,477

Annualized at 7% $106,248 $79,587

- $26,661

Baseline Cost Post-Amendment

Cost Change in Cost Reporting Cycle 1 Year(s)

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

1 200 7 to 2011 $466,133 $286,580 $288,450 -$179,553- $177,683

2012 to 2016 $466,133

-- 2 2012 to 2015

-- $288,450 -$177,683

2017 to 2021 $466,133

-- 3 2016 to 2019

-- $288,450 -$177,683

2022 to 2026 $466,133

-- 4 2020 to 2023

-- $288,450 -$177,683

2027 to 2031 $466,133

-- 5 2024 to 2027

-- $288,450 -$177,683

6 2028 to 2031

-- $288,450 $288,450

Total $2,330,664 $1,728,831$ 1,730,70

1 -$601,834- $599,963

Annual Average $93,227 $69,153 $69,228 -$24,073

- $23,999
Annualized @ 3% $87,798 $65,011 $ 65,103 -$22,788

- $22,695
Annualized @ 7% $81,056 $59,643 $ 59,757 -$21,414

- $21,299

1 The non-italicized reporting cycles are baseline, five-year cy cles, and the italicized reporting cycles are proposed, four-yea r cycles

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6-1 

## 6. Social Cost Summary

To calculate the total burden to society of the proposed IUR amendments, , EPA added the total industry burden to the Agency burden savings. Table 6-1 below contains the annual burden estimates for the years 20 11 07 through 203 0 1

. The baseline burden for the first reporting cycle is calculated by adding the baseline burden to industry, 1.84 million hours (see Table 4-10), and the baseline burden to EPA, 4,160 hours (see Table 5-3), for a total of 1.85 million hours. EPA estimates that the proposed IUR rule amendments would increase the industry burden in the first reporting cycle by 1. 39 56 million hours (see Table 4-50) and decrease Agency burden by 1,7 21 04 hours (see Table 5-40). The net burden increase is 1. 5 6 5 39 million

hours.

The burden in future reporting cycles would be less than for the first reporting cycle. The shift from a five-year cycle to a four-year cycle increases both industry and Agency burden. All of these changes are

shown in Table 6-1 below . EPA estimates that all of the amendments combined would increase the burden to society by 8.859.01 7.81 million hours over a 2 0 5 -year period. This includes a burden increase

of 8.859.01 7.81 million hours to the affected industry over the 2 0 5 years (see Table 4-55), and a burden

decrease of 4, 358 6,0 61 79 hours to the Agency (see Table 5-45) over the same period.

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

amendments over a 2 5 0 -year period will be 7.81 9 8.85.01 million hours.

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

Year Baseline Burden (millions of hours) Post

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

2011 1.85 3.40 1.56

2012 0.00 0.00 0.00

2013 0.00 0.00 0.00

2014 0.00 0.00 0.00

2015 0.00 2.64 2.64

2016 1.44 0.00

- 1.44

2017 0.00 0.00 0.00

2018 0.00 0.00 0.00

2019 0.00 2.64 2.64

2020 0.00 0.00 0.00

2021 1.44 0.00

- 1.44

2022 0.00 0.00 0.00

2023 0.00 2.64 2.64

2024 0.00 0.00 0.00

2025 0.00 0.00 0.00

2 026 1.44 0.00

- 1.44

2027 0.00 2.64 2.64

2028 0.00 0.00 0.00

2029 0.00 0.00 0.00

2030 0.00 0.00 0.00

Total 6.16 13.97 7.81

Baseline Burden Post-Amendment

Burden Change in Burden Reporting Cycle 1 Year(s)
(Hours) (Hours) (Hours)

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6-2 1 200 7 to 2011 1.85 3.243.40 1.391.55

2012 to 2016 1.44

-- 2 2012 to 2015

-- 2.64 1.20

2017 to 2021 1.44

-- 3 2016 to 2019

-- 2.64 1.20

2022 to 2026 1.44

-- 4

2020 to 2023

-- 2.64 1.20

2027 to 2031 1.44

-- 5 2024 to 2027

-- 2.64 1.20

6 2028 to 2031

-- 2.64 2.64

Total 7.60 16.4416.61 8.859.01
Annual Average 0.29 0.660.66 0.350.37

1 The non-italicized reporting cycles are baseline, five-year cy cles, and the italicized reporting cycles are proposed, four-yea r cycles



### Table 6-2 contains the total cost and change in cost to society as a result of the proposed IUR rule amendments. The cost to society is expected to increase by $5 01.69 70.4180. 3 6 million over the 2 5 0 -year period as a result of the proposed IUR amendements

, for a total cost of $ 858.97 million . The cost to industry is expected to increase by $ 502.11 580.96 571.01 million over this period (see Table 4-56), and the Agency cost is expected to decrease by $ 600,000 422, 281 601,834 (see Table 5-46). The annualized

cost burden to society over a 2 0 5 -year period is $2 1.582.08 million and $ 2 19.930.54 $ 26.25 million and $ 27.84 million at three percent and seven percent discount rates, respectively.

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

6-3 Table 6-2: Change in Total Costs to Society if All Modifications Are Implemented

Year Baseline Cost ( millions 2008 $ ) Post

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

2011 $107.43 $209.33 $101.90

2012 $0.00 $0.00 $0.00

2013 $0.00 $0.00 $0.00

2014 $0.00 $0.00 $0.00

2015 $0.00 $162.41 $162.41

2016 $83.28 $0.00

- $83.28

2017 $0.00 $0.00 $0.00

2018 $0.00 $0.00 $0.00

2019 $0.00 $162.41 $162.41

2020 $0.00 $0.00 $0.00

2021 $83.28 $0.00

- $83.28

2022 $0.00 $ 0.00 $0.00

2023 $0.00 $162.41 $162.41

2024 $0.00 $0.00 $0.00

2025 $0.00 $0.00 $0.00

2026 $83.28 $0.00

- $83.28

2027 $0.00 $162.41 $162.41

2028 $0.00 $0.00 $0.00

2029 $0.00 $0.00 $0.00

2030 $0.00 $0.00 $0.00

Total $357.28 $858.97 $501.69

Annualized at 3% $19.23 $45.48 $26.25

Annualized at 7% $21.11 $48.95 $27.84

Baseline Cost Post-Amendment

Cost Change in Cost Reporting

Cycle 1 Year(s) (millions of 2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2011 $107.43 $199.12$209.07 $91.69$101. 64

2012 to 2016 $83.28

-- 2 2012 to 2015

-- $162.37 $79.09

2017 to 2021 $83.28

-- 3 2016 to 2019

-- $162.37 $79.09

2022 to 2026 $83.28

-- 4 2020 to 2023

-- $162.37 $79.09

2027 to 2031 $83.28

-- 5 2024 to 2027

-- $162.37 $79.09

6 2028 to 2031

-- $162.37 $162.37

Total $440.57$440.57 $1,010.98$1,020.93 $570.41$580.36 Annual Average $17.62 $40.44 $22.82 Annualized @ 3% $16.88 $16.88 $38.47 $38.96 $21.58 $22.08 Annualized @ 7% $15.96 $15.96 $35.89 $36.49 $19.93 $20.54

1 The non-italicized reporting cycles are baseline, five-year cycl es, and the italicized reporting cycles are proposed, four-yea r cycles

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7-1 

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

The IUR rule is one of EPA’s most valuable tools for meeting the Agency’s mandate under TSCA to manage the risks resulting from chemical production and use in the United States. It is EPA’s most comprehensive source of data on the chemical industry, and IUR data are it is used in almost all of OPPT’s risk screening and management programs. However, the IUR data in their current form have numerous limitations, which in turn limit EPA’s effectiveness in meeting its mandate under TSCA.

In an effort to improve the quality and usefulness of the data the Agency collects under the IUR rule, EPA is proposing a set of IUR amendments. The proposed amendments would improve the completeness and accuracy of the IUR data by requiring electronic reporting using the e- IUR IURweb reporting software, expand ing the range of chemicals for which full information would be reported, adjust ing the specific reported information, increas ing e the frequency of collecting the information, and modify ing CBI requirements. EPA expects that the proposed amendments will reduce many of the current data constraints and, as a result, improve the effectiveness of EPA’s chemical risk management programs. Most importantly, the IUR rule amendments will require submitters to provide processing and use exposure-related information for more chemicals. Th is additional information will allow EPA to more accurately assess human and environmental exposures to specific chemicals, including the concentrations, frequency, and durations of these exposures.

With this additional information, EPA will improve its ability be able to screen chemicals better to identify whether additional risk assessment and management steps are needed. More complete reporting of the processing and use data, more careful consideration of confidentiality claims, and adjustments to specific data elements will help provide the needed data. By enhancing the data supplied to Agency riskscreening programs, EPA expects to more effectively and expeditiously reduce the risks posed by chemicals. The more EPA can base its decisions on actual data, rather than on assumptions, the better EPA is able to tailor its risk management decisions to the level of actual risk, whether higher or lower than it would be if based only on assumptions. Ultimately, enhancing the risk screening process will have positive consequences for human and ecosystem health, and will use EPA’s and society’s resources more efficiently. Additional benefits will accrue from ch anges in reporting requirements that will improve consistency and compatibility with other EPA databases. EPA would be better able to anticipate industry trends, particularly for chemicals for which EPA has concerns, and to measure the effectiveness of Agency programs.

The benefits resulting from the proposed IUR rule amendments are discussed qualitatively in this section. Quantification of the benefits of the proposed rule would require more specific information about each user’s use patterns and preferences, and the changes in the use patterns and preferences which se that would result from the additional information made available under the proposed rule. These data are not readily available, and collecting such data would be cost-prohibitive. For example, one approach would be to conduct a national willingness-to-pay (WTP) survey of the general public to determine the value

that the public places on the availability of the information resulting from the proposed rule. However, such a survey, or a survey to collect simi lar information, has not been conducted.



### 7.1 Benefits of Information-Based Policies

Improvements in the IUR data would allow EPA and others to use the data more effectively as part of the Agency’s risk screening and prioritization programs. Screening chemicals for potential risks is an essential first step in developing and prioritizing ri sk management activities. Effective risk-screening by EPA depends on the ability to characterize chemical us es accurately and to predict potential exposures. Current screening activities are greatly hampered by the incomplete data supplied through the 2006 IUR.

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

7-2 In addition, EPA’s current screening activities for medium production volume chemicals are further hampered further by the fact that EPA has only estimates of production volume for many chemicals and must rely on relatively limited public sources of information. This proposed rule will benefit society by filling these information gaps and contributing to better assessments of potential risks and risk management decisions.

The proposed amendments to the IUR rule will increase the amount of publicly available data about a chemical’s potential risks, and consequently are likely to result in (a) a reduction in the costs of risk-based decisions about the chemical, and (b) an improvement in the expected outcome of the decisions.

 Reduced cost of risk-based decision making. By making new information about toxic substances available to the public (including EPA and other government agencies), this proposed rule can replace other information-gathering, ma nagement, and dissemination acti vities related to the regulated chemicals. Once the data are pub licly available, information users and decision makers will avoid the time and resource costs required to individually perform these activities. In effect, the proposed rule increases the efficiency ( and strength ) of the decision-making process.

 Improved outcome of decisions. Information-based policies contribute to better decisions by redirecting resources toward their most highly valu ed uses. With incomplete information regarding toxic chemicals, public and private decision makers are unable to make adequate assessments of the

benefits and costs of actions that involv ing e these substances. For example, EPA decisions regarding whether, when, and how to target chemicals for further risk assessment can be misdirected if basic risk-screening information is unavailable or inadequate. With more information, EPA can better direct its limited resources toward high-priority risks. Improved information can therefore help lead to more socially optimal reductions in risks to humans and the environment.

The proposed rule amendments will generate both types of benefits. First, it will reduce EPA’s and other decision makers’ reliance on other databases and information sources that are inadequate for accurately and efficiently characterizing the risks associated with the thousands of chemicals in

commerce that need to be evaluated. As discusse d in Chapter 5. EPA will bear additional costs for collecting and managing the new IUR data; however, by providing more reliable and complete data on chemical uses and exposures, the rule will also a llow EPA to save time and resources in screening chemicals and in developing risk management priorities. Furthermore, by requiring data to be submitted electronically, the rule will reduce EP A’s costs of processing the IUR data and result in a better quality

database.

Second, it will allow EPA to better prioritize its ri sk management activities—to move more quickly in addressing chemicals that pos ing e relatively high risks (and/or relatively low risk-management costs).

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



### 7.2 Benefits of Individual Proposed Amendments

The proposed IUR amendments expand the range of chemicals for which full information is to be reported, adjust the specific reported information, in crease the frequency of collecting the information, and modify CBI requirements. These proposed amendments also would provide information to better address Agency and public information needs, improve the usability and reliability of the reported data,

and ensure that data are available in a timely manner. EPA is proposing these amendments to the IUR rule to meet four primary goals: (1) to tailor the information collected to better meet the Agency’s overall

information needs ; , (2) to increase its ability to effectively provide public access to the information ; , (3) to obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory ; , and (4) to improve the usefulness of the information reported. The

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

users.

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



### EPA’s efforts to use the 2006 IUR data have provided indications of areas where further improvements are needed. Several of the amendments described in this proposed rule would change some of the reporting requirements in an effort by EPA to increase the usability of the collected information and to focus IUR reporting on the information that is most needed most by the Agency. These proposed changes will enable EPA and other Federal agencies to improve their risk screening programs, enabling them to better assess and manage risk

, and improving 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) number to identify the company associated with the plant site, and also to report the site name, address, and D&B number. EPA received a variety of questions concerning the correct company name to report during the 2006 IUR reporting cycle. EPA is now clarifying what is meant by company name, by proposing to require that the company name provided to be the ultimate domestic parent company name. EPA believes this change will reduce confusion by ma king this reporting requirement consistent with the Toxic Release Inventory (TRI) requirements for parent company name. Reduced confusion leads to more accurate information, which in turn leads to more accurate risk characterizations.

Furthermore, the 2006 IUR submissions from different reporting sites contained varying D&B numbers for parent companies that appear ing ed to be the same company. In order to better identify when reporting sites are under the same parent company, EPA is proposing to include the address as well as the D&B number of the parent company. Similar to the proposed change in parent company name, T t his change also too will lead to more accurate information, which will lead to more accurate risk characterizations and small business analyses.

Technical Contact



### Manufacturers (including importers) are required to provide a technical contact for their IUR submission. The technical contact must be a person who can answer questions EPA may have about the reported chemical substance and should be a person located at the manufacturing site. Based on EPA’s experience with contacting the reported technical contact with follow-up questions concerning 2006 IUR submissions, submitters often provide the names of individuals who are not directly connected directly to the reporting site, and therefore, are not knowledgeable about either the chemical or the submission. EPA

has also seen situations where the technical contact is a contracted employee who is able to address subsequent concerns only as long as if he or she remains under contract to the company. EPA may raise follow-up questions about an IUR submission

, possibly for years or more after the submission date. EPA is considering allowing multiple technical contacts on a chemical-by-chemical basis. The benefit of this proposed amendment would be increased clarity, which leads to improved accuracy in the information collected, which in turn leads to more accurate risk characterizations.

Chemical Identity



### EPA is proposing to require the reporting of the Chemical Abstracts (CA) Index Name currently used to list the substance in the Inventory as the chemic al name reported for IUR. Currently, submitters are required to report a specific chemical name, with no further elaboration in the regulatory text. EPA has found, however, that submitters sometimes supply a name that is somewhat generic or excludes parts of the specific chemical identity that distinguish ing es one substance from another. EPA’s experience in the

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7-4 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 from the IUR database until the Agency was able to obtain correct and specific chemical identity

information from the submitter. EPA believes the benefit of the requirement to use the substance name as currently listed on the Inventory is that it will greatly reduce the number of poorly identified substances. Improved chemical identification ultimately lead s to more accurate risk characterizations.

EPA is also proposing to allow submitters to report only the CASRN as a chemical identifying number or, in the case of confidential chemical substances, the accession number. EPA is proposing to

eliminate the PMN number as an acceptable allowed chemical identifying number because each Inventory

substance has either a CASRN or a TSCA A a ccession N n umber or both, which are likely to be already

known to the submitter. The benefit of t T his proposed amendment would be to save the Agency considerable time and effort to access and review reported information that has only been identified only by a PMN case number.

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



### EPA is proposing to require reporting of production volume for each of the years since the last IUR principal reporting year. Thus, for the 2011 IUR reporting cycle, manufacturers (including importers) of a chemical at or above the 25,000 lb. threshold in the 2010 principal reporting year would report the production volume of that chemical for each of the calendar years: 2006, 2007, 2008, 2009 and 2010. Collecting the production volume for multiple years w ould provide greater detail than the current “onceevery-five-years” snapshot. For future reporting cycles, all manufacturers (including importers) who are required to report based on meeting or exceeding the 25,000 lb. threshold in any year since the last principal reporting year will be required to report production volume for each of those years.

EPA has mounting evidence that many chemicals, including larger volume chemicals, are manufactured in volumes that may widely fluctuate from year to year. This can result in the production volume of a chemical exceeding the threshold for several years, then falling below the threshold during the IUR principal reporting year. Therefore, EPA believes that a single snapshot of annual production volume (i.e., taken just once each reporting cycle) does not provide an accurate picture of the chemicals in commerce, and may provide an erroneous view of the exposure scenarios associated with a particular

chemical substance.

EPA uses production volume data in several important ways. The data help the Agency to establish trends in chemical manufacturing; to determine the effectiveness of various Agency programs; to estimate the magnitude of consumer, worker, and environmental exposures; and in economic analyses to determine the costs (and financial impacts) of potential control strategies in economic analyses . Voluntary EPA programs such as Design for the Environment (DfE) and other pollution prevention programs would use the annual production volume data to identify trends and program performance. Relying on a single snapshot of annual production volume in each reporting cycle hampers EPA’s ability to identify the programs and techniques that are most effective, using measurable, readily identifiable production trend data. Therefore, the benefit of this proposed amendment would be to provide information EPA and others need for the assessment of programs and would provide greater accuracy of the volumes of chemicals in commerce than the current one-year snapshot.

Volume of Chemical Substance Used On-Site



### EPA is proposing to require that submitters 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 that the chemical is site-limited. Under this proposal, either domestically manufactured or imported chemicals could be reported as used at the reporting site, whereas

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7-5 under the current reporting requirements, only domestically manufactured chemicals, consumed entirely at the site of manufacture, should be reported as site-limited.

EPA is proposing this change to simplify reporting and to collect information that better addresses the Agency’s needs. In the past, submitters sometimes erroneously reported their production volume separately to identify the portion of their chemical that was consumed at the manufacturing site. For the 2006 IUR, many submitters continued this practice and erroneously filed separate reports to indicate that a portion of their production volume was site-limited. Filing separate reports resulted in the need to report separately processing and use information when the combined production volume was 300,000 lb. or greater. Including all production volumes on one report simplifies reporting for such submitters and results in a less complicated database, thereby making the data easier to use. The benefit of t T he proposed amendment to require reporting the volume used on-site would be to provide valuable information related to potential exposures associated with the on-site volumes, therefore providing the Agency with better information for exposure assessments and other data analyses.

Indicate Whether Imported Chemicals Are Physically at Reporting Site



### EPA is proposing to add a requirement to indicate whether an imported chemical is physically at the reporting site. Often, the site reporting an imported ch emical never physically receives the chemical, but instead ships it directly to another location such as a warehouse, a processing or use site, or a customer’s site. Identifying whether the chemical is physically at the reporting site provides the benefit of more accurate information for screening-level analyses and other uses of the IUR data.

Report Volume Exported



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

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



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

Designation of Consumer or Commercial Use



### EPA is proposing to require submitters to designate via a checkbox whether the use is a consumer or a commercial use, or both. The Agency’s experience using the 2006 IUR data identified a need to distinguish between potentially exposed consumer and commercial populations. The benefit of the

d D esignation of consumer or commercial use, or both, would be to allow EPA to complete a better characterization for the potentially exposed populations.

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7-6 Number of Commercial Workers Reasonably Likely To Be Exposed



### EPA is proposing to require that 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 would be reported using the same definitions and ranges used for manufacturing and industrial processing and use workers. Information on the number of commercial workers reasonably likely to be exposed to the reportable chemical substance would be used to characterize the commercial population reasonably likely to be exposed to the subject chemical substance. Therefore, the benefit of this

amendment would be to improve the population characterization, which is important to the development of the overall exposure characterization.

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



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

Require Electronic Submissions over the Internet



### EPA is proposing to require the mandatory use of EPA’s Central Data Exchange (CDX) through the Internet for manufacturers (including importers) to report IUR information. EPA would require that all

submissions to be generated using the e- IUR IURweb reporting software. EPA would no longer accept paper submissions or electronic media for any IUR submission after the effective date of the final rule.

The proposed amendment to eliminate paper-based submissions in favor of mandatory e- IUR IURwebreporting would provide several benefits to EPA and industry. EPA believes the required use of eIUR IURweb and CDX would reduce the reporting burden on industry by reducing both the cost and the time required to review, edit and transmit data to the Agency. Data systems into which data were once manually entered would now be filed populated electronically, thus reducing the potential for error that

exists when data are entered by hand or when data are entered is interpreted through a scanning process. All information sent by submitters via CDX would be transmitted securely to protect CBI. EPA would be able to communicate electronically with submitters, e.g ., to confirm receipt of a submission or to identify a problem with the submission ) . Electronic submissions enable data to be available for Agency and public use more quickly and it eliminates inefficiencies and errors that were introduced in the process to scan paper submissions.

EPA developed e-IUR reporting software for use in preparing and submitting reports electronically during the 2006 IUR submission period (see www.epa.gov/iur). For the 2011 submission period, EPA will provide a free web-based application in place of the 2006 downloadable software. The 2011 eIUR IURweb would feature several enhancements over the 2006 e-IUR. These improvements include a sophisticated validation system, which would alert users when a required field on the form is either missing information or contains certain kinds of potentially incorrect information. Other updates are expected to include automated chemical identity check s, automated company and site identity checks, and

the facilitation of joint submissions and amendments. Additionally the reporting software would include user-friendly features such as drop-down selections, searchable chemical lists, imbedded help files, and an error-checking process to help identify common reporting errors before the submission is submitted. All of these applications will increase the accuracy of data and eliminate Agency time in manually performing these checks.

Coupled with EPA’s e- IUR 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

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7-7 comments regarding the use of CDX, the encrypted in ternet submission process, and the ability to use a secure electronic signature method to submit IUR reports.

7.2.3 Obtain New and Updated Exposure Information



### The EPA Administrator has announced her intention to increase efforts to assess, prioritize, and take action on existing chemicals, with particular emphasis on protecting children. The Agency is developing a broader, more vigorous approach on existing chemi cals, which will utilize the full range of TSCA regulatory tools to reduce or eliminate risks from chemicals of concern. The IUR rule is one of the tools available for this effort. Through the IUR rule, the Agency collects the information it needs to conduct an initial characterization and screening of potential exposures associated with chemicals. EPA needs more in-depth exposure-related information to fine-tune the screening process, and to better assess, prioritize, and take action on existing chemicals. The various programs and tools that EPA uses to evaluate and manage chemical risks are described in Section 7.3. The proposed amendments that would increase the amount of exposure information collected are described in the following sections.

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



### EPA is proposing to modify the method used to determine whether a manufacturer is subject to IUR reporting by requir ing reporting if , for any calendar year since the previous IUR principal reporting year

, the subject chemical was manufactured (including impo rted) in volumes of 25,000 lb. or greater. For the 2011 reporting cycle , reporting for subject chemicals would be required if the production volume in the 2010 principal reporting year only meets or exceeds the 25,000 lb. reporting threshold, which is the current requirement. For the 2016 reporting cycle and future reporting cycles, a site would examine its annual production volumes for each of the four calendar years since the last principal reporting year 2006

to 201 0 . If the production volume for a reportable chemical substance w ere as 25,000 lb. or greater for any calendar year during that five four -year period, then the site would need to report the chemical substance, unless it is otherwise exempt.

EPA is proposing this change because of the mounting evidence that many chemicals, even larger volume chemicals, often experience wide fluctuations in manufacturing volume from year to year. This can result in the production volume of chemical exceeding the threshold for several years, then falling below the threshold during the IUR principal reporting year. Consequently, historical IUR reporting has resulted in a change of approximately 30 percent in the composition of the chemicals being reported from one reporting cycle to the next. Therefore, the one-year snapshot of production volume does not provide an accurate picture of the chemicals in commerce, and may provide an erroneous view of the exposure scenarios associated with a particular chemical substance.

Further evidence that capturing production volume for only the IUR principal reporting year is causing EPA to miss a significant amount of chemical production was revealed in the comments the Agency received from the proposed “reset” of the TSCA Inventory. The Federal Register notice of November 21, 2008 (73 FR 70460) requested that industry provide comment on whether a three-year reporting cycle was sufficient for deciding whether a chemical that they manufactured or imported should remain listed on the TSCA Inventory. Commenters overwhelmingly expressed concern that the proposed three-year reporting cycle would dras tically misrepresent the chemicals that were presently in commerce. (See Docket No: EPA-HQ-OPPT-2008-0785.)

In submitted comments, industr y companies agreed unanimously agreed that if they were to report for one year only, the reset would inappropriately remove chemical substances from the Inventory. While all

commenters felt that the three-year reporting cycle was inadequate, a majority of the industry comments suggested that reporting should cover a 10-year period. The comments strongly indicated that there were chemicals manufactured or imported only occasionally, and that these chemicals would not be captured if the reporting covered too short a period. Therefore, requiring chemical manufacturers and ( importers ) to evaluate production volume for any calendar year since the previous IUR principal reporting year would

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7-8 benefit users of IUR data by yielding a much more accurate picture of the chemicals currently in commerce and properly the subject of EPA’s risk sc reening, assessment, and management activities.

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



### EPA is proposing to eliminate the 300,000 lb. threshold for reporting processing and use information, thereby requiring all submitters of non-excluded substances to report information in all parts of the IUR Form U. EPA is proposing to eliminate this reporting threshold in order to collect information necessary to complete screening-level exposu re characterizations and subsequent risk-based prioritizations for medium production volume (MPV) chemicals. In the 2003 Amendments final rule (68 FR 848, January 7, 2003), EPA acknowledged the value of information for chemical substances manufactured in lower

volumes and stated that if the Agency were to find it necessary in the future, it would collect information on chemical substances at reporting thresholds below the thresholds that were introduced in that that action. The IUR processing and use information is needed now to complete the characterizations and prioritizations for those chemicals manufactured (including imported) in volumes of 25,000 to 300,000 lb.

The Agency currently is unable to develop screening level risk evaluations for medium and lower production volume chemicals because most of these chemicals are produced below the volume for which exposure and use information is required under the current IUR rule (i.e. 300,000 lb. per year). The exposure information is an essential part of developing screening-level risk evaluations and, based on its experience in using this information, the Agency has concluded that collecting this information is critical to its mission of characterizing exposure, identifying potential risks, and noting uncertainties for these lower production volume chemicals.

Both hazard and exposure information are is needed to develop screening level evaluations. Once the IUR processing and use information is available for these medium and lower volume chemicals, EPA would be able to develop the exposure characterizations needed to develop the evaluations. As with the high-production volume ( HPV ) chemicals, EPA would then be able to identify potential risks, note scientific issues and uncertainties, and indicate the initial priority assigned by the Agency for potential future appropriate action. Therefore, a benefit of the proposed rule would be to provide this necessary processing and use information for chemicals manufactured or imported in volumes of 25,000 to 300,000

lb.

Eliminate 25,000 lb. Threshold for Certain Regulated Chemicals



### EPA is proposing to eliminate the 25,000 lb. reporting threshold for certain regulated chemical substances that are the subject of particular TSCA rules and/or orders and to require manufacturers (including importers) of such chemicals to report under the IUR, regardless of the production volume. Thus, for the 2011 IUR reporting cycle, manufacturers (including importers) of a chemical at or above the 25,000 lb. threshold would report the production volume of that chemical for each of the calendar years: 2010, 2009, 2008, 2007, and 2006. This provision will ensu re the availability of current information when EPA has expressed a concern in the form of regulatory action on those chemical substances, regardless of the production volume. EPA is proposing to eliminate the 25,000 lb. threshold for those chemicals that are: (1) the subject of a rule proposed or promulgated under sections 5(a)(2), 5(b)(4), or 6 of TSCA; (2) the subject of an order issued under section 5(e) or 5(f) of TSCA; or, (3) the subject of relief that has been granted under a civil action under section 5 or 7 of TSCA.

Under this proposal, a manufacturer, including importer, of such chemical substances would be required to report information on the manufacturing, processing, and use of the chemical substances if it manufactured (including imported) any quantity of these chemical substances during any of the years since the last principal reporting year, including volumes under 25,000 lb. For the 2011 reporting cycle, the manufacturer would need to consider the manufacture or import during the years 2006 through 2010. Manufacturers (including importers) of these chemicals would report the production volumes for each year from 2006 to 2010, and the full manufacturing, processing, and use information for 2010.

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7-9 Chemicals regulated under TSCA are of demonstrated interest to the Agency. EPA has made a determination that such substances either “may pres ent,” “will present,” or “do present” an unreasonable

risk to human health and/or the environment or that the substances have “substantial production/ significant or substantial exposure.” Therefore, the benefit of this proposed amendment is that EPA would

be en able EPA to use the IUR data associated with these regulated chemicals to monitor chemical production and compliance with the rules.

Making Chemicals Subject to Enforceable Consent Agreements Ineligible for Exemptions



### EPA may enter into an enforceable consent agreement (ECA) with a manufacturer of a chemical substance to obtain testing where a consensus exists among EPA, affected manufacturers and/or processors, and interested members of the public concerning the need for and scope of testing. Chemicals covered by ECAs are of demonstrated interest to EP A. The Agency has an interest in identifying the manufacturing, processing, and use of substances under such agreements, and therefore is proposing to require that such substances to be reported for IUR purposes, regardless of whether the substance otherwise meets the requirements listed in 40 CFR §710.46 (proposed §711.6) as an exempt or partially exempt chemical substance. Th e benefit of t T his proposed amendment is to would ensure the availability of current information if EPA has expressed a concern in the form of an ECA on any substance otherwise excluded from the IUR rule. For example, EPA could use the IUR data associated with these regulated chemicals to monitor chemical production and compliance with the agreements.

Changes to Standard for the Reporting of Processing and Use Information



### In order to collect more complete information regarding the industrial processing and use and commercial and consumer use of chemicals, EPA is proposing to replace the “readily obtainable” reporting standard in the 2006 IUR with the “known to or reasonably ascertainable by” reporting standard for the reporting of processing and use information. TSCA section 8(a)(2) authorizes EPA to require persons to report information that is “known to or reasonably ascertainable by” the submitter. This is the

same standard that currently appl ying ies to the reporting of information described in the regulations at 710.52(c)(1), (c)(2), and (c)(3). It covers all information in a person’s possession or control, plus all

information that a reasonable person similarly situated might be expected to possess, control, or know. The “known to or reasonably ascertainable by” reporting standard was the only standard used for IUR reporting purposes prior to the 2006 IUR reporting cycle.

EPA is proposing this change because reporting under the “readily obtainable” reporting standard did not generate sufficiently precise processing and use information for screening-level reviews. The Agency believes reporting under the “known to or reasonably ascertainable by” standard will generate processing and use information sufficiently precise for screening-level reviews.

The 2006 IUR response rate for the processing and use data captured only a portion of the volume the Agency suspects was actually was used for industrial processing and use or commercial and consumer use. Considering only those chemicals meeting the criteria to require reporting of processing and use information, only 72 percent of the total volume was accounted for in the industrial processing and use data and 22 percent in the commercial and consumer use data. At a minimum, EPA is lacking industrial processing and use data on 28 percent of the expected volume reported, and is lacking consumer and commercial processing and use data on 78 percent of the expected volume reported. 4 

### Because of this low

4 The Agency believes the percentage of missing processing and use information actually is larger than indicated by this analysis. As described in the 2003 Amendments final rule (68 FR 861), EPA anticipated that, on an individual report basis, the total percentages of production volumes associated with the in dustrial processing or use information may add up to more than 100 percent of the reported pr oduction volume. This could happen because the submitter reported on the distribution of a chemical to sites in its control as well as down stream sites, some of which were not immediate purchasers from the original manufacturing site.

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7-10 level of reporting, EPA now believes the reporting standard of “not readily obtainable” was too lenient and resulted in an underreporting of the actual processing and use situation.

The Agency’s experience using the 2006 IUR data to develop exposure characterizations has alerted

EPA to the fact that the IUR processing and use data are incomplete and inconsistent. Effective risk screening by EPA depends on the ability to accurately characterize chemic al uses and to predict potential exposures. If the information provided does not include these data, EPA must make assumptions about the use of the unreported production volume. Incorrect assumptions may lead EPA to designate an inappropriately high priority level to the chemical, resulting in unnecessary effort and resource expenditures for both regulated parties and EPA in cases where adequate data would have led the Agency to act differently.

Therefore, using the reporting standard “known to or reasonably ascertainable by” would generate the

benefit of result in companies reporting a more consistent and complete processing and use information in their IUR reports, and more efficient use of EPA resources.

Change to Reporting Frequency



### Prior to the 2003 Amendments, the IUR collection occurred every four years. EPA reduced the reporting frequency from every four years to every five years starting with the 2006 IUR rule modifications, to reduce the burden associated with the amended IUR requirements . While the less frequent reporting does reduce burden, the Agency now has determined that reporting every five years does not provide data sufficiently current to meet Agency and public needs, and is proposing to return to reporting every four years.

As described above, the Agency has been criticized for using outdated information. Also, a review of the previous reporting under IUR has revealed a change of approximately 30 percent in the chemicals that

are reported from one reporting cycle to the next. R eceiving IUR information more frequently will provide EPA with a more accurate, up-to-date overview of the chemical manufacturing industry, addressing a criticism that the Agency has received for relying on outdated information. More timely information will help EPA to better prioritize chemical s for screening, and will lead to more efficient use

of EPA resources.

7.2.4 Improve Utility of Information Reported



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

Industrial Function Categories



### EPA is proposing to revise the list of indus trial function categories by combining categories that

lead ing to common exposure scenarios and adding categories where the Agency believes the existing categories do not adequately describe potential uses. EPA worked with Environment Canada and Health Canada to develop the proposed set of categories, which would be used by both the United States and Canada for Inventory reporting. Harmonization of the categories for reporting the industrial functions of

chemical substances would benefit both EPA and Cana dian agencies by facilitating the exchange of information, and would serve as a model to be used by Mexico in developing an Inventory of chemical substances. In addition, the harmonized categories would facilitate consistent reporting of chemical use information by industry in the United States and Canada.

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7-11 Another benefit of revising the list of industrial function categories would be to reduce the number of uses reported as “Other.” EPA is proposing to require that if a submitter chooses the category “Other,” the

submitter must include a text description for the industrial function category associated with the use of

chemical substance.

Industrial Sectors



### EPA is proposing to replace the five-digit North American Industrial Classification System (NAICS) codes with 48 Industrial Sectors (IS). The industrial sectors were adopted from the European Union’s guidance on information requirements and chemical safety assessment. The chosen Industrial Sectors divide the entire range of NAICS codes into sectors so that there is a sector corresponding to any NAICS
code has a corresponding Industrial Sector.

. The Agency believes this change would provide several benefits. First, it would encourage more complete reporting by using terms that are already familiar to industry. Second, the industrial sectors would reduce the likelihood of errors that result ing from the selection of miscellaneous or inappropriate NAICS codes. Third, it would reduce the number of codes that could apply to one substance.

One of the primary purposes of the IUR data collection is to group together similar data for priority setting exercises and activities. Respondents to the 2006 IUR submitted 342 unique five-digit NAICS codes, which made it difficult for EPA to group chemicals based on industrial processing and use scenarios. The 2006 IUR database has 2,330 unique combinations of processing or use categories, NAICS, and industrial function categories, in all. Th is large number of unique combinations increases the difficulty and time required by EPA to sort and classify chemicals because EPA either would need to develop exposure scenarios for each unique combination, or determine which three-code combinations have similar exposure scenarios and can be grouped. Therefore, another benefit of using the industrial sectors would be to reduce the number of unique combinations, thereby increasing the usability of the

data.

Consumer and Commercial Product Categories



### EPA is proposing to revise the list of consumer and commercial use categories by combining categories that lead ing to common exposure scenarios and adding categories that were not adequately described in the initial set of categories. EPA worked with Environment Canada and Health Canada to develop the proposed categories

, which will be adopted by the United States and Canada for reporting of Inventory information. Harmonized categories for reporting the consumer and commercial uses of chemical substances will benefit both EPA and Canadian agency by facilitating the exchange of information and will serve as a model to be used by Mexico in developing an Inventory of chemical substances. In addition, the harmonized categories wi ll facilitate consistent reporting of chemical use information by industry in the United States and Canada.

Another Additional benefit s of expanding the list of consumer and commercial use categories would be to provide persons submitting IUR information with a greater opportunity to characterize the products in which chemical substances they manufacture are used

, and would to reduce the number of uses reported as “Other.”

EPA is proposing to require that if a submitter chooses the category “Other,” the submitter must include a text description for the consumer and commercial product containing the chemical substance. The 2006 IUR reports showed that the category “Other” was reported with the greatest frequency. A total of 1,206 reports, or 26 percent, out of 4,666 reports containing commercial and consumer use information, included “Other.” Although one of EPA’s objectives of revising the consumer and commercial product categories is to reduce the reporting frequency of “Other,” EPA believes that in many cases where “Other” was reported, submitters may not have selected the correct categories for their situation. In addition to revising the overall product categories, narrower definitions and expanded lists of examples of products in which the chemical substance would be used were added to each category

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7-12 descriptor. By requiring the submitters to supply a written description for “Other,” this amendment will

benefit EPA because the enable the Agency will be able to evaluate and improve the inclusiveness of future consumer and commercial category lists or descriptions.

Upfront Substantiation for Processing and Use Information CBI Claims



### Under the proposed rule, in order to submit a claim of confidentiality for processing and use information data elements, the submitter would be required to both check the appropriate box on the reporting form and substantiate the claim in writing by answering certain questions provided in the proposed rule. Where a submitter fails to substantiate the processing and use CBI claim in accordance with the applicable rules, EPA may make the information available to the public without further notice to

the submitter.

EPA has observed that , on occasion, processing and use information has been claimed as confidential even though it was revealed in submissions sent to the Agency in response to the HPV Challenge program and published on the EPA website. In addition, EPA has observed that some of the processing and use information claimed as confidential appears to be available on submitter’s websites or in published Material Safety Data Sheets (MSDS). The high number of confidentiality claims asserted for the reported 2006 IUR reports on industrial processing and use information meant that EPA was unable to make available to the public important data or to comple tely describe the analysis or provide the support information used to reach Agency conclusions. This included the number of processing sites, the number of potentially exposed industrial workers, and the percent production volume for each industrial processing or use scenario. The benefit of t T his amendment would be a decrease in the number of inappropriate CBI claims under the new substantia tion requirement, which would improve EPA’s ability to make current plant site information available to other Federal agencies and the public because more information submitted under IUR could be released p ublicly. This would increase the transparency and public accessibility of the chemical risk information, may increase public confidence in EPA’s chemical management program, and is consistent with the President’s policy goals for government reliance on and public availability of scientific information. 5



### 7.3 Potential Users of Information Generated by the Proposed IUR
Modifications Rule

EPA will be the primary user of the information generated by the proposed rule amendments, although other public and private organizations, in particular those with interests in managing chemical risks, will also use the data. The information is expect ed to be applied and disseminated by these users in a number of ways; however, it will serve primarily to reduce the costs of screening and managing chemical risks and to improve risk management decisions. The American public will be the ultimate

beneficiar y ies 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 th e net benefits (i.e., risk reductions net of control costs) are expected to be the largest.

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

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7-13 IUR data users and the benefits they derive from IUR data are discussed in more detail in the following sections below

.

7.3.1 EPA Risk-Screening and Management Programs



### EPA’s Office of Pollution Prevention and Toxics (O PPT) has a multifaceted approach to identifying and managing chemical risks. OPPT can initiate the re view of a chemical in a number of ways, including

due to 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 risks include:

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

.

 High Production Volume Chemical Testing. EPA’s major efforts to prioritize existing chemicals began with data collected under the High-Production Volume (HPV) Challenge Program, which makes available to the public screening-level envi ronmental and health effects information on HPV chemicals produced or imported in the United States in quantities of one million lb. or more per year. At the conclusion of the voluntary HPV Challenge Program, EPA developed the first in a series of test rules to require the testing of high production volume chemicals for which no voluntary agreement was made. EPA finalized its first HPV test rule, covering 37 chemicals, in 2005. A second HPV rule was proposed in 2008, and a third rule is expected to be proposed in 2009. EPA also plans to develop an initial set of screening-level assessments of medium production volume (MPV)

chemicals

- – those produced or imported in quantities above 25,000 lb. and less than one million lb. per year. In developing the test rules, EPA relied heavily on exposure information obtained from the IUR; improving the data collected through the IUR rule will enhance the quality of information used in decision making for future test rules.

 Existing Chemicals Program . The Existing Chemicals Program conducts detailed analyses of potentially high-risk chemicals and develops strategies to reduce or eliminate the exposure risks.

Chemicals are first screened first to identify those that (1) requir ing e additional testing, (2) present ing potentially significant risk management concerns, or (3) do not currently do not requir ing e further review. While the proposed amendments to the IU R data would increase EPA’s ability to screen existing chemicals based on exposure and, ultimately, risk, more in-depth data similar to the New Chemicals Program data would lead to improved screening and a quicker identification of chemicals with a high priority for follow-up action. This would result in a more appropriate entry into EPA’s chemical management programs. The range of benefits EPA anticipates from being able to obtain more accurate and broader use information could be expanded with a greater amount of in-depth exposure and use information. The improved IUR data would be particularly helpful for screening

medium and lower volume chemicals that are not covered by the HPV program.

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7-14  Use Cluster Scoring System (UCSS). The UCSS tool identifies potential risks of chemical substances used in similar applications, or “use clus ters.” This system enables the Agency to view the potential risks of a given chemical substance in the context of the potential ri sks 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 would also enable EPA to more easily conduct broader chemical screening analyses across several industries.

 Master Testing List. IUR data also help s to EPA determine which chemical s substances are on the Master Testing List (MTL). The MTL is a list of chemicals identified by the Agency as having inadequate data for health and/or environmental risk assessments. OPPT uses the MTL to establish priorities for chemical testing, keep the public informed, solicit input from industry on specificchemical exposure and risk assessment needs, and to encourage industry to perform testing. More indepth exposure-related manufacturing, processing, and use data would enable EPA to better target testing needs to situations in which potential exposures are known to occur, thereby increasing the efficiency of efforts in these programs and facilitating earlier completion of critical testing needs.

 Screening Information Data Set (SIDS) program. The voluntary 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 chemicals. The United States is responsible for testing 25 percent of the chemicals identified for the program. The information needed is collected by industry sponsors; however, the data elements included may not be consistent across sponsors, and some companies may not participate in developing all of the data elements. Currently collected data and data collected through more in-depth exposure and use data requirements will enable the EPA to meet many key needs for exposure data and will provide a

consistent database of information from manufacturers and (including importers ) . This information will increase the program’s efficiency by helping to identify chemicals requiring additional testing or assessment while excluding those with low domestic exposure. A n improved better exposure database will also improve evaluation of potential risk in th e assessment reports prepared at the end of the SIDS process.

 Design for the Environment (DfE) program. EPA’s DfE program incorporates principles and strategies from both the Existing Chemicals Program and the UCSS, by focusing on specific chemical uses and establishing partnerships with industry to develop voluntary

, long-range plans for risk management. Currently collected IUR data, which would be enhanced by data collected through more in-depth exposure and use data requirements, helps to identify use cluster candidates for this program. The more in-depth exposure-related data would also better enable the initial assessment of exposures and help identify potential substitutes. The data c ould be used to assist in ranking activities, identifying high-risk areas, and developing realistic approaches for reducing risk.

7.3.2 Other Federal Risk Management Programs



### Under TSCA section 4, EPA has the authority to require firms to conduct tests of specific chemicals to determine the potential risk posed by these substances. However, other governmental agencies, such as the Occupational Safety and Health Administrati on (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC), share regulatory authority over chemical substances or products containing them. In the case of NIOSH, the agency compiles summaries of available information and recommends exposure limits. Therefore, EPA serves as a conduit for chemical hazard information between the chemical producers and these other agencies.

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7-15 OSHA currently manages occupational exposure to chemicals by setting a variety of chemical and personal protection standards, by requiring preparation of emergency response and process safety management plans and by requiring provision of health and safety data to workers for chemicals used in the workplace. OSHA will be able to use the IUR data to identify chemicals with large numbers of potentially exposed workers or with uses that suggest ing greater exposure potential. The information provided by the proposed rule could increase OSHA’s ability to manage chemical hazards, exposures, and risks in occupational settings.

NIOSH will also benefit from the additional exposure-related information collected under the proposed rule amendments. The exposure information that NIOSH uses to determine occupational safety and health in businesses nationwide may be based on outdated information collected under the National Occupational Exposure Survey (NOES). Completed in 1983, NOES collected information such as plant site location, plant site 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 chemicals with large numbers of potentially exposed workers or with uses that suggest ing greater exposure potential.

CPSC also could use the new data directly in conducting its exposure and risk assessment activities (e.g. screening consumer products for chemical hazards). CPSC obtains risk information to screen chemical hazards from a network of hospital emergency rooms. This information is limited to injuries and illnesses resulting from acute exposures only.

Additional data required by the proposed IUR amendments would provide a better source of reliable information on the chemicals used in consumer products. CPSC would improve its ability to identify the chemicals used in consumer products and, with consideration of hazard data, to identify chemical

–

consumer use situations scenarios presenting greater potential risk. The information could improve CPSC’s ability to meet its program objective of protecting the public from chemical hazards in consumer products.

7.3.3 State and Local Programs



### IUR data also help state and lo cal authorities with rulemaking, in formation collection, and voluntary program activities. Because state and local governments must address chemicals, use patterns, and exposure scenarios that may be unique or isolated, stat e and local agency access to the enhanced data will assist in identifying situations that pos ing e 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 issu es or which counties may have multiple chemical problems 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 chemicals are used in general.

This will allow them to mo re effectively manage risks more effectively and participate in setting chemical priorities at community, regi onal, and national levels.

The publicly available (non-CBI) information provided by the IUR supports activities typically undertaken by NGOs, such as tracking industry trends, organizing grassroots involvement in risk-based decision making, and conducting outreach and educational programs. These organizations could use the new data to identify and establish priorities for risks; to evaluate chemicals and chemical use patterns to

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7-16 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 multip le companies. The American Chemistry Council’s Responsible Care ® Program is one example of a corporate product stewardship one such program that

could use this information. Use i nformation supplied through IUR could be used to further strengthen this

program. The Responsible Care Program requires companies to take responsibility for their products from cradle to grave, which requires an understanding of how their product is being used not only by their customers, but further down the chain. Despite this private effort, some companies have told EPA that they do not know how their chemicals are used. Non-CBI 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.

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8-1 

## 8. Small Entity Analysis

This chapter estimates the impact that the proposed amendments to the IUR rule may have on small entities by examining the relationship between th e compliance costs and company sales for small companies.

The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, requires regulators to assess the effects of regulations on small entities, including businesses, nonprofit 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 ag encies to prepare an initial and final regulatory flexibility analysis for each rule unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA, however, does not specifically define “a significant economic impact on a substantial number” of small entities. Sections 603 and 604 of the RFA require that regulatory flexibility analyses to identify the types, and estimate the numbers, of small entities to which the rule will apply ; , and describe the rule requirem ents to which small entities will be subject and any regulatory alternatives, including exemptions and deferral, that would lessen the rule’s

burden on small entities.

The existing IUR rule, at §710.29, generally exempts from reporting small businesses, defined at §704.3 as entities with annual sales of less than $40 million and less than 100,000 lb. production of any given chemical at a site; or annual sales of less than $4 million. This exemption is maintained in the proposed amendments. In addition, a small business currently is required to report if it produces any chemical substance that is the subject of a regulation proposed or promulgated under TSCA sections 4, 5(b)(4), or 6; or that is the subject of an order under TSCA section 5(e); or that is the subject of relief that has been granted pursuant to a civil action under TSCA section 5 or 7. A small business may also report voluntarily.

The major steps followed in the analysis are described in the following sections. below

.



### 8.1 Select a Relevant Small Entity Definition

The RFA relies on the definition of “small business” found in the Small Business Act, which authorizes the Small Business Administration (SBA) to develop definitions for “small business” for industries in each North American Industry Classification System (NAICS) code. The SBA definitions typically are based upon either a sales or an employment level, depending on the nature of the industry. Companies engaged in chemical manufacturing (NAICS Code 325) or petroleum refining (NAICS Code 324110) are the most likely to report under the IUR rule. Specifically, entities potentially affected by the proposed rule include companies manufacturing or importing chemicals in amounts of 25,000 lb. or more annually and that are listed on the TSCA Inventory and regulated under TSCA §8. Under 13 CFR part 121, SBA defines small business for the six-digit NAICS industry based on employment thresholds (SBA, 2004). These employee size standards range from 500 employees to 1,500 employees for NAICS Codes 325 and 324110. For example, SBA defines a company in NAICS 325320 (Pesticide and Other Agricultural Chemical Manufacturing) as small if it has fewer than 500 employees. In comparison, a company in NAICS 324110 (Petroleum Refineries) is considered small if it has fewer than 1,500 employees. To obtain an average estimate of the number of small companies affected by the proposed rule, EPA chose an employment threshold of 1,000 employees to determine small business status. Throughout the remainder of this report, this definition is referred to as the “employment-based

definition.”

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8-2 For comparative purposes, EPA also considered an alternative definition based upon sales. Under this definition, a manufacturer or importer is defined as small under 40 CFR 704.3 if it meets either of the following criteria:

 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or

 Total annual sales of the company, combined with those of any parent company, are below $4 million.

Consistent with the methodology used in the 2002 Economic Analysis for the Amended Inventory Update Final Rule (EPA, 2002) , EPA assumed that any company with sales less than or equal to $40 million is small, regardless of production volume. 6 

### This assumption may tend to overestimate the number

of small businesses affected because it includes entiti es that may not meet all small business requirementsunder TSCA §8(a). Throughout the remainder of this report, this definition is referred to as the “salesbased definition.”



### 8.2 Identify Number of Small Companies Reporting in 2006

To identify the percentage of small companies reporting under the IUR rule, EPA obtained a list of all companies that submitted a Form U during the 2006 reporting cycle (EPA, 2009c). Using the Dun & Bradstreet Number reported by the company, EPA identified the ultimate parent company and obtained sales and employment data for companies for which data are available from Dun & Bradstreet Corporate Leads Portal (Dun & Bradstreet, 2009). 7



### During the 2006 reporting cycle, 4,188 8 

### sites submitted reports. Of these, p P arent company data was
available for 3,392 of these sites 9



### , , 10 

### with 872 associated parent companies. Information for the remaining companies was unavailable for several reasons. First, these companies may be too small to be listed in Dun & Bradstreet. Second, the IUR data used may be out of date because it is based on IUR reporting for 2006 (e.g., some companies may have gone out of business or changed hands since the information was reported). Finally, certain companies may have requested to be removed from, or may have declined to provide information to, Dun & Bradstreet.

Using the sales data collected for the companies for which data was available, EPA estimated the average sales for the parent companies that are considered small under both definitions.

6 It is important to note that the $40 million level is for parent company sales, not individual site sales.

7 Dun & Bradstreet is a New York-based company that pr ovides business information through a global commercial database. It assigns DUNS numbers to identify businesses around the world. These numb ers are required for many U.S. federal government transactions and therefore are widely used and assigned. DUNS numbers are also used frequently in corporate research. Database entries provid e legal and trade names, physi cal and mailing addresses, geographical descriptions, product an d industry descriptors, sales and num ber of employees for three years and associated growth rates, as well as up to 40 vital statistics about each orga nization. While the reporting year varied by company, company sales and employment data we re retrieved from the da tabase in April 2009.

8 Note that this value (4,188) does not equal the number of sites assumed for the baseline in Table 4-6 (4,085). The data used to prepare Table 4-6 counted only sites submitti ng reports for chemicals with production volumes equal to or greater than 25,000 lb. (that is, th ose sites subject to the rule). The 4, 188 sites in this dataset may include submitters who voluntarily submitted reports for chem icals with production volumes lower than 25,000 lb.

9 This does not include parent companies listed in D&B as having either 0 employees or $0 sales.

10 This does not include parent companies listed in D&B as having either 0 employees or $0 sales.

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8-3 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 that between 21 and 35 percent of the regulated community could be considered small businesses (EPA, 2002a).

Table 8-1: Results of Dun & Bradstreet Analysis

Existing Sites (2006 Reporting Cycle) Employment-based

Definition Sales-based

Definition Number of Global Parent Companies with Data 872 872 Number of Global Parent Compan ies Considered Small 360 218 Percentage of Global Parent Compan ies Considered Small 41.3% 25.0% Average Annual Sales of Global Parent Companies Considered Small (2008$) $412,713,310 $11,638,441

Source: Analysis of data from Dun & Bradstreet’s Corporate Leads Portal , April 2009.



### 8.3 Estimate Number of Parent Companies

Incomplete information on global parent companies from Dun & Bradstreet for all of the companies that submitted IUR reports in 2006 required that EPA estimate the total number of parent companies in the baseline. One global parent company may submit re ports for more than one site. Based on the sample of companies for which the parent company information is available, EPA estimates that there are 3.89 sites per global parent company. Given that 4,188 sites submitted reports, EPA estimates that the number of parent companies for the 2006 IUR reporting baseline is 1,076.

As described in Section 4.5, the proposed amendments are expected to increase the number of sites reporting by 204. Therefore, EPA estimates that the total number of global parent companies reporting under the revised IUR rule to increase by 52 from the baseline (that is, 52 “new” companies (204 ÷ ÷ 3.89 = 52)).



### 8.4 Estimate Number of Small Companies

EPA estimated the number of small companies potentially impacted by the proposed IUR amendments by applying the percentage of small comp anies derived in Table 8-1 to the total number of expected parent companies EPA expects to be subject to the rule under the proposed amendments.

Table 8-2 shows the number of expected small companies, under both definitions.

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

Employment-based

Definition Sales-based

Definition

Baseline Companies New Companies Baseline Companies New Companies Total Number of Parent Companies 1,076 52 1,076 52 Percent of Parent Companies Considered Small 41.3% 24.8% Number of Parent Companies Considered

Small 444 22 267 13

Total Number of Parent Companies Considered

Small 466 280



### Limitations of the Analysis: The proposed amendments cause an increase in the number of sites reporting because of changes to the reporting volume thresholds and the timeframe in which the thresholds are applied. These amendments may have a disproportionate effect on smaller companies because they may be the ones that manufactur ing e (including importing) chemicals at or around the 25,000 lb. threshold. Therefore, this method may underestimate the number of small businesses. Furthermore, to the extent that the set of companies for which EPA was not able to find data is not statistically similar to the set of companies for which data was available, this analysis may under- or overestimate the percentage of small companies

. that are small.



### 8.5 Estimate Cost-to-Sales Ratios for Small Companies

Table 4-51 shows the total increase in industry costs associated with the proposed amendments, if all proposed amendments are implemented. As described in Section 4, industry costs involve compliance determination, rule familiarization, preparation and submission of reports, and recordkeeping. Because these costs would be incurred once every four years under a four-year reporting cycle, these costs were annualized over four years at both a three percent and seven percent discount rate 11



### . . 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 leve l of economic impacts faced by the small entities can be presumed as not significant (U.S. EPA, 2006b). Therefore, to determine the magnitude of any potential adverse impact, EPA compared the average, annualized incremental costs on a per-company basis to the

11 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent wi th OMB Circular A

- 4 (OMB, 2003). A three percent discount rate was also used as a sensitiv ity analysis to examine the robustness of the results to a change in the annualization assumptions.

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.

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8-5 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 Proposed IUR Rule
Amendments

Employment-based Definition Sales-based Definition

3% Discount

Rate 7% Discount

Rate 3% Discount

Rate 7% Discount

Rate

Total Annualized

Costs $21,607,475 $26, 660,775

249,251 $19,948,001 $28,163,588 $27,833,146 $21,607,475 $26, 660,775

249,251 $19,948,001 $28,163,588 $ 27,833,146

Annualized Costs per Site $5,289 $6, 527 120 $4,883 $6, 894 489 $5,289 $6, 527 120 $4,883 $6, 894 489

Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $9,309 $11,512 $10,771 $8,594 $12,161 $11,421 $10,156 $12,509 $11,751 $9,376 $13,214 $12,460

Annual Sales per

Small Parent Company $412,713,310 $412,713,310 $11,821,104 $11,821,104

Cost-to-Sales

Ratio 0.0023% 0. 0028% 0

026% 0.0021% 0. 0029% 0

028% 0.0859% 0. 1058% 0

994% 0.0793% 0. 1118% 1

054%

Number of Companies Potentially

Affected 466 280



### As shown in Table 8-3, under the employment-based definition, a small parent company affected by

the rule has, on average has

, sales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $ 12,161 11,421 9,309 at a seven three percent discount rate, and even lower under a seven three percent discount rate. The cost-to-sales ratio for an average small company under the employment-based definition would be 0.00 2 3 percent or less. Under the more conservative sales-based definition, small parent company sales are on average more than $11.8 million, with annualized costs associated with the proposed amendments of $ 13,214 12,460 10.156 or lower. The cost-to-sales ratio for an average small company under the sales-based definition would be

0. 09 11 percent or less.

Using the highest annual cost shown in Table 8-3, $ 12, 509 460 10,156 , a small company would have to have annual sales of less than $1. 25 02 million in order to have a cost-to-sales ratio larger than one percent. As mentioned above in Section 8. , firms with sales of $4 million or less are generally exempt from IUR reporting because they fall within the app licable definition of “small manufacturer,” regardless of production volume (40 CFR §704.3). Therefore, companies that are small enough to have a cost-tosales ratio greater than one percent generally will be exempt from reporting under the proposed IUR rule, and thus will not be significantly affected by the amendments.



### 8.6 Summary

EPA analyzed potential small business impacts from this rule using the SBA employment-based

definition and the TSCA sales-based definition. EPA estimates that 466 small firms potentially would be

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8-6 affected by this proposed rule under the employment-based definition of the term, and that 280 small firms potentially would be affected under the sales-based definition of the term. Based on costs annualized over a four-year period and average sales data, EPA estimated that the cost-to-sales ratio of the proposed rule would be 0.00 2 3 percent or less under the employment-based definition for an average small company subject to the rule, and 0. 09 11 percent or less under the sales-based definition. As noted above, EPA often defines the lower threshold as compliance costs of one percent of sales and the higher threshold as compliance costs of three percent of sale s to establish whether the level of economic impacts faced by the small entities can be presumed as not signi ficant. For a company to have a cost-to-sales ratio larger than one percent, company sales would have to be less than $1. 02 25 million. Because the small businesses affected by the proposed rule actually have average sales of more than $11 million, and because any potentially affected companies with sales of $1. 02 25 million or less would generally be exempt from reporting obligations under the IUR, sma ll entities will not be significantly affected by the proposed amendments to the IUR rule.

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9-1 

## 9. Additional Analyses

9.1 Executive Order 12866

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” under section 3(f) of the Executive Order because it may raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executiv e Order. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Order 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.



### 9.2 Unfunded Mandates Reform Act (UMRA)

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4), EPA has

determined that this regulatory action does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or for the private sector, in any one year. The analysis of the costs associated w ith this action is described in Unit VII.A. Thus, this rule is not subject to the requirements of sections 202 or 205 of UMRA.

In addition, EPA has determined that this rule does not significantly or uniquely affect small governments. This is because only manufacturers (including importers) of chemical substances are affected by the rule. No action is required by small governments that are not chemical manufacturers (including importers). Accordingly, this rule is not subject to the requirements of sections 203 of UMRA.



### 9.3 Paperwork Reduction Act (PRA)

According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq. , an agency may not conduct or sponsor, and a person is not required to respond, to a collection of information that requires Office of Management and Budget (OMB) approval under the PRA, unless it has been approved by OMB and displays a valid OMB control number. The information collection requirements related to the submission of Form Us are already approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq . That Information Collection Request (ICR) document has been assigned EPA ICR number 1884.04 and OMB control number 2070-0162. Because this rule involves new

or revised information collection activities that requir ing e additional OMB approval, EPA has prepared an addendum to the currently approved ICR (EPA, 2010).

The Paperwork Reduction Act mandates that federal agencies estimate the recordkeeping and reporting burden of a proposed rule. In this context, the term “burden” is interpreted as the total time, effort, or financial resources expended by people to generate, maintain, retain, disclose, or provide information to or for a federal agency. This includes the time needed by regulated entities to review instructions and to develop, acquire, install, and use technology and systems to collect, validate, verify, and disclose information. Time taken to adjust exis ting ways to comply with any previously applicable instructions and requirements and to train personnel to respond to the information collection task is also included. In this section, burden hours for both industry respondents and the government are estimated.

In this report, total industry burden hours represent the sum of time spent on reporting and on other administrative activities. Industry respondents will spend time on the following activities associated with the IUR rule: compliance determinati on, rule familiarization, preparati on and submission of reports, and recordkeeping.

As derived in Section 4.5 of this report, EPA estimates that the proposed rule would impose a total estimated incremental industry burden of 1. 5 6 3955 million hours, in the first reporting cycle

, if all

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9-2 proposed amendments are implemented. The burden for the average site will increase by approximately

342 341 hours per site to 7 93 792 hours.



### 9.4 Executive Order 13132 - Federalism

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federa lism implications.” “Polic ies that have federalism implications” is are defined in the Executive Order to include regulations that hav ing e “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

EPA has determined that this proposed rule does not have federalism implications because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in the Order. This rule simply amends th e Inventory Update Reporting rule in several ways to provide information to better address Agency and public information needs, improve the usability and reliability of the reported data, and ensure that data are available in a timely manner. Because EPA has no

information to indicat ing e that any state or local government manufactures or processes the chemical substances covered by this action, the proposed rule does not apply directly to states and localities and will not affect state and local governments. Thus, Executive Order 13132 does not apply to the proposed

rule.



### 9.5 Executive Order 12898 – Environmental Justice

Executive Order (EO) 12898, entitled Federal Actions to Address Envi ronmental Justice in Minority Populations and Low-Income Populations (59 FR 7629 (Feb. 16, 1994)), establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmenta l justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United

States.

The proposed rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities that requir ing e special consideration by the Agency under EO

12898. The Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with the chemicals covered by the rule. Because the IUR rule is an info rmation collection requirement, the information that will become available through the rule will enable th e Agency to target educational, regulatory, or

enforcement activities towards industries or chemicals that pos ing e 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 benef it potentially at-risk communities, some of which may be disadvantaged.

The proposed rule is directed at manufacturers or importers of chemicals. All consumers of these chemical products and all workers who come into co ntact with these chemicals could benefit if data regarding the chemicals’ health and environmental effects were developed. Therefore, it does not appear that the costs and the benefits of the proposed rule will be disproportionately distributed across different geographic regions or among different categories of individuals.

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9-3 

### 9.6 Executive Order 13045 – Children’s Health

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), requires that federal agencies examine the impacts of each regulatory action on children for any economically significant regulation (as defined by Executive Order 12866) that the agency has reason to believe may disproportionately affect children. The proposed rule is not subject to EO 13045, because it does not establish an environmental standard intended to mitigate health or safety risks, nor does it otherwise have a disproportionate effect on children. Furthermore, the proposed rule is not economically significant. Nevertheless, the information obtained by the reporting required by this rule will be used to inform the Ag ency’s decision-making proces s regarding chemicals to which children may be disproportionately exposed. This information will also assist the Agency and others in determining whether the chemicals in this proposed rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.



### 9.7 Executive Order 13175 – Consultation and Coordination with Indian Tribal
Governments

As required by Executive Order 13175, entitled Consultation and Coordination with Indian

Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this proposed rule does not have tribal implications because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in the Order. Thus, Executive Order 13175 does not apply to this rule.



### 9.8 Executive Order 13211 – Energy Supply, Distribution, or Use

This action is not a “significant energy action” as defined in Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355 (May 22, 2001)) because it is not likely to have a significant adverse effect on the supply, distribution, or use of

energy.



### 9.9 National Technology Transfer Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be in consistent with applicab le law or impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This proposed action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

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10-1 

## 10. References

BLS, 2009. U.S. Bureau of Labor Statistics. Employer Costs for Employee Compensation Supplementary

Tables: Historical Data December 2006 – December 2008. March 12, 2009. http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf

. Dun & Bradstreet, 2009. Dun & Bradstreet Corporate Leads Portal. Database searches. April 2009.

EPA, 1997. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Final Rule to Add Certain Industry Groups to EPCRA Section 313

. Washington, DC. April 1997.

EPA, 2002a. U.S. EPA, Office of Pollution Preve ntion and Toxics, Economic and Policy Analysis

Branch. Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA-HQ-OPPT2002-0054-0260 ). Washington, DC. August 2002

. EPA, 2002b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis

Branch. Wage Rates for Economic Analysis of the Toxics Release Inventory Program. June 10, 2002.

EPA, 2003. U.S. EPA, Office of Pollution Prevention and Toxics. ICR No. 574.12. [Information Collection Request for] Premanufacture Review Reporting and Exemption Requirement for New Chemical Substances and Significant Use Reporting Requirements for Chemicals Substances

. Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act. Washington, DC. November 25, 2003.

EPA, 2004. U.S. EPA. Office of Environmental Information. Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis: Final (EPA-HQ- OEI-2003-0001-0248). November 2004. Washington, DC. http://www.regulations.gov/

. EPA, 2005. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of IUR Modifications Final Rule (EPA-HQ OPPT 2004-0106-0055). Washington, DC. July 2005.

EPA, 2006a. U.S. EPA, Office of Pollution Prevention and Toxics. Instructions for Reporting for the 2006 Partial Updating of the TSCA Chemical Inventory Database . Washington, DC. November 2006. http://www.epa.gov/iur/pubs/2006_inst_tsca_cheminv.pdf

. EPA, 2006b. U.S. EPA, Office of Policy, Economics, and Innovation. Final Guidance for EPA Rulewriters: Regulatory Flexibility Act . Washington, DC. November 2006.

EPA, 2007. U.S. EPA, Office of Environmental Information. A Business Case Analysis of EPA’s Central Data Exchange . Washington, DC. March 2007.

EPA, 2008a. U.S. EPA, Office of Pollution Prevention and Toxics. What is the TSCA Chemical Substance Inventory? http://www.epa.gov/oppt/newchems/pubs/invntory.html . Washington, DC. Updated December 10, 2008.

EPA, 2008b

. U.S. EPA Office of Pollution Prevention and Toxics. Economic and Policy Analysis

Branch . Economic Analysis of Expedited Significant New Use Rules for 56 Chemical Substances (EPA-HQ-OPPT-2008-0251). October 2008.

EPA, 2008c. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. 2006 IUR Database Statistics for IUR Modifications Rule . Washington, DC. December 17, 2008.

EPA, 2008d. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1884.04. [Information Collection Request for] Partial Update of the TSCA Section 8(b) Inventory Data Base, Production

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

10-2 and Site Report, Supporting Statement for a Request for OMB Review under the Paperwork

Reduction Act . Washington, DC. September 5, 2008.

EPA, 2009a. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. Chemicals Ineligible for Exemptions under Proposed IUR Modifications Rule. (2006 IUR Database Statistics). Washington, DC. May 12, 2009.

EPA, 2009b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis

Branch . Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule

. (EPA-HQ-OPPT-2008-0296). Washington, DC. July 13, 2009.

EPA, 2009c. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. IUR Company Names and Related Information. (Database query results). Washington, DC. April 14,

2009.

EPA, 2009d. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. 2002 IUR Database Statistics for IUR Modifications Rule . Washington, DC. April 30, 2009.

EPA, 2009e. U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division. Email communication from Darryl Ballard to Wendy Hoffman. Washington, DC. May 19, 2009.

EPA, 2009f. U.S. EPA, Office of Pollution Prevention and Toxics. TSCA Section 4 Federal Register Enforceable Consent Agreements. http://www.epa.gov/oppt/chemtest/pubs/4eca.html

. Washington, DC. Updated October 1, 2009.

EPA, 2009g. U.S. EPA, Office of Pollution Prevention and Toxics, Sunset Dates of Chemicals Subject to Final TSCA Section 4 and Related 12(b) Actions, Modified on September 1, 2009. http://www.epa.gov/oppt/chemtest/pubs/sunset.html

. Washington, DC. Updated September 1, 2009.

EPA, 2009h. U.S. EPA, Office of Pollution Prevention and Toxics, Chemical Control Division. Memo from Susan Sharkey to Wendy Hoffman. Washington, DC. September 8, 2009.

EPA, 2010. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1884.05. [Information Collection Request for] Addendum to Partial Update of the TSCA Section 8(b) Inventory Data Base, Production and Site Reports . Washington, DC. June, 2010.

OPM, 2008. Office of Personnel Management, Salary Table 2008-DCB, Washington Baltimore-Northern Virginia, DC-MD-PA-VA-WV. http://www.opm.gov/oca/08tables/pdf/DCB.pdf

. U.S. Postal Service (USPS), 2009. USPS – Prices. http://www.usps.com/prices/

. December 15, 2009.

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A-1 

## Appendix A. 2006 Form U

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A-2

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B-1 

## Appendix B. Propo sed Revised Form U

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B-2

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B-3

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B-4

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B-5

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B-6

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B-7

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B-8

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C-1 

## Appendix C. – Curren t and Proposed Industri al Function Categories

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



### Current IUR Industrial Function Categories Proposed IUR Industrial Function Categories

1. Adsorbents and absorbents

2. Adhesives, binders, and sealants

3. Aerosol Propellants *



### 4. Agricultural chemicals (non-pesticidal)

5. Anti-adhesive agents

6. Bleaching agents

7. Coloring agents, dyes 1



### 8. Coloring agents, pigments 1



### 9. Corrosion inhibitors and anti-scaling agents

10. Fillers

11. Fixing agents *



### 12. Flame retardants

13. Flotation agents *



### 14. Fuels

15. Functional fluids 3



### 16. Intermediates

17. Lubricants 1



### 18. Odor agents 2



### 19. Oxidizing agents

20. pH-regulating agents *



### 21. Photosensitive chemicals

22. Plating agents and surface treating agents

23. Processing aids, not otherwise listed

24. Process regulators, used in vulcanization or polymerization processes 2



### 25. Process regulators, other than polymerization or vulcanization processes 2



### 26. Reducing agents 2



### 27. Solvents (for cleaning and degreasing)

28. Solvents (which become part of product formulation or mixture)

29. Solvents (for chemical manufacture and processing and are not part of product at greater than 1% by weight) *



### 30. Stabilizers *



### 31. Surface active agents

32. Viscosity adjustors

33. Other 1 

### 1. Abrasives +



### 2. Adsorbents and absorbents

3. Adhesives and sealant chemicals

4. Agricultural chemicals (non-pesticidal)

5. Anti-adhesive agents

6. Bleaching agents

7. Corrosion inhibitors and anti-scaling agents

8. Dyes 1



### 9. Fillers

10. Finishing agents +



### 11. Flame retardants

12. Fuels and fuel additives

13. Functional fluids (closed systems) 3



### 14. Functional fluids (open systems) 3



### 15. Intermediates

16. Ion exchange agents +



### 17. Lubricants and lubricant additives 1



### 18. Odor agents

19. Oxidizing/reducing agents 2



### 20. Photosensitive chemicals

21. Pigments 1



### 22. Plasticizers +



### 23. Plating agents and surface treating agents

24. Process regulators 2



### 25. Processing aids, specific to petroleum production +



### 26. Processing aids, not otherwise listed

27. Propellants and blowing agents +



### 28. Solids separation agents +



### 29. Solvents (for cleaning and degreasing)

30. Solvents (which become part of product formulation or mixture)

31. Surface active agents

32. Viscosity adjustors

33. Laboratory chemicals

34. Paint additives and coating additives not described by other categories

35. Other (specify) 1

Notes:

1 A current industrial function ca tegory has been renamed under the proposed amendm ent, but the definition of the category has n ot changed.

2 Two current industrial function categories have been co mbined into one category under the proposed rule.

3 A single industrial functi on category has been divided into two categories under the proposed rule.

* Indicates that a current industri al function category is being elimin ated under the proposed rule.

+ Indicates that a current function category is added under the proposed rule.

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D-1 

## Appendix D. Current and Proposed Consumer and Commercial Product Categories

EPA is proposing to revise the list of consumer and commercial product categories by combining categories that lead to common exposure scenarios and adding categories that were not adequately described in the current set of categories.

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



### Current IUR Consumer and Commercial Product Categories Proposed IUR Consumer and Commercial Product Categories

1. Adhesives and sealants 2. Agricultural products (non-pesticidal) 3. Artists' supplies 4. Automotive care products 5. Electrical and electronic products 6. Fabrics, textiles and apparel 7. Glass and ceramic products 8. Lawn and garden products (non-pesticidal) 9. Leather products 10. Lubricants, greases and fuel additives 11. Metal products 12. Paints and coatings 13. Paper products 14. Photographic supplies 15. Polishes and sanitation goods 16. Rubber and plastic products 17. Soaps and detergents 18. Transportation products

19. Wood and wood furniture

20. Other 21. Not readily obtainable Chemical Substances in Furnishing, Cleaning,

Treatment/Care Products 1. Floor Coverings 2. Foam Seating and Bedding Products 3. Furniture and Furnishings not covered elsewhere 4. Fabric, Textile, and Leather Products not covered

elsewhere 5. Cleaning and Furnishing Care Products 6. Laundry and Dishwashing Products

7. Water Treatment Products

8. Personal Care Products

9. Air Care Products 10. Apparel and Footwear Care Products Chemical Substances in Construction, Paint, Electrical, and Metal Products
11. Adhesives and Sealants 12. Paints and Coatings 13. Building/Construction Materials - Wood and Engineered Wood Products 14. Building/Construction Materials not covered

elsewhere

15. Electrical and Electronic Products

16. Metal Products not covered elsewhere

17. Batteries Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products 18. Food Packaging 19. Paper Products

20. Plastic and Rubber Products not covered

elsewhere 21. Toys, Playground, and Sporting Equipment 22. Arts, Crafts, and Hobby Materials 23. Ink, Toner, and Colorant Products 24. Photographic Supplies, Film, and Photochemicals Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products
25. Automotive Care Products

26. Lubricants and Greases 27. Anti-Freeze and De-icing Products

28. Fuels and Related Products 29. Explosive Materials

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D-2 30. Agricultural Products (non-pesticidal)

31. Lawn and Garden Care Products Chemical Substances in Products not Described by Other Categories

32. Non-TSCA Use 33. Other (specify)

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E-1 

## Appendix E. – I ndustrial Sectors

EPA is proposing to replace the NAICS codes used in the industrial processing and use information section with a new set of Industrial Sectors, developed from the European Union’s REACH program.

Code Sector Description IS1 Agriculture, Forestry, Fishing and Hunting IS2 Oil and Gas Drilling, Extraction, and support activities IS3 Mining (except Oil and Gas) and support

activities

IS4 Utilities

IS5 Construction IS6 Food, beverage, and tobacco product manufacturing IS7 Textiles, apparel, and leather manufacturing IS8 Wood Product Manufacturing IS9 Paper Manufacturing IS10 Printing and Relate d 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 a nd Resin Manufacturing IS23 Synthetic Rubber Manufacturing IS24 Organic Fiber Manufacturing IS25 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing

IS26 Pharmaceutical and Medicine Manufacturing IS27 Paint and Coating Manufacturing IS28 Adhesive Manufacturing IS29 Soap, Cleaning Compound, and Toilet Preparation Manufacturing IS30 Printing Ink Manufacturing IS31 Explosives Manufacturing IS32 Custom Compounding of Purchased

Resins IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing Code Sector Description

IS34 All Other Chemical Product and Preparation Manufacturing IS35 Plastics Product Manufacturing IS36 Rubber Product Manufacturing

IS37 Nonmetallic Mineral Product Manufacturing (includes clay, glass, cement, concrete, lime , gypsum, and other nonmetallic mineral product manufacturing) IS38 Primary Metal Manufacturing IS39 Fabricated Metal Product Manufacturing IS40 Machinery Manufacturing IS41 Computer and Electronic Product Manufacturing IS42 Electrical Equipment, Appliance, and Component Manufacturing IS43 Transportation Equipment Manufacturing

IS44 Furniture and Related Product Manufacturing IS45 Miscellaneous Manufacturing

IS46 Wholesale and Retail Trade

IS47 Services IS48 Other (requires additional information)

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F-1 

## Appendix F. – Se nsitivity Analyses

Some of EPA’s proposed amendments to the IUR rule are expected to change the number of submitters, reports, or the number of responses to a specific question on Form U. For several options, data available from the 2006 IUR was used to directly estimate the number of chemicals or submitters affected by the amendment. For example, the number of su bmitters who produce manufactured water above the threshold is known. However, a lack of available data for other amendments meant that EPA only was able to estimate the impact broadly, such as a percen tage 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 sele cts “Other” as a product function category

, (4) requiring writein text if selecting “Other” as a consumer or commercial use ; , and, (5) upfront substantiation for all processing and use information CBI claims. In estimating the cost of these amendments, EPA used a midpoint estimate for the percentage increase or decr ease in the number of submitters, reports filed, or number of submitters answering a specific question. To show the possible range of costs as a result of the proposed amendments more accurately, EPA presents a range of costs in this section, using the lower and upper bounds for the item estimated.



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

Currently, the IUR rule requires that a report be filed for a chemical only if the chemical’s production volume exceeds the 25,000 lb. threshold in the principal IUR reporting year. EPA is proposing to modify the timeframe for reporting in fulture reporting cycles subsequent to 2011 so that chemical manufacturers (including importers) w ould be subject to the IUR rule if a chemical’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 92 72 ,000 hours in future reporting cycles (see Table 4-12). Table F-1: contains the results of the sensitivity analysis using a lower bound estimate of a zero percent increase in the 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 to aproximat e ly 1 8 4, 0 00 43,000 hours as a result of modifying the method for determining whether the 25,000 lb. threshold is met in future reporting cycles

.

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

F-2 Table F-1: Sensitivity Analysis of Industry Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

Number of Sites Number of Reports (with Part II) Number of Reports (with Part III) Industry Burden (hours) Burden to Prepare Part I,

Rule Familiarization,

Compliance Determination,

and Submission (hours per site) Lower

Bound (0% increase) Upper

Bound (10% increase) Burden

to Prepare

Part II

and

Record Keeping (hours

per report) Lower

Bound (0% increase) Upper

Bound (10% increase) Burden

to Prepare

Part III (hours

per report) Lower

Bound (0% increase) Upper

Bound (0% increase) Lower

Bound (10% increase) Upper

Bound (10% increase)

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

Baseline 9.08 33.26 4,085 4,085 17.06 1

9.82 25,896 25,896 55.93 6

9.92 17,075 17,075 1,433,833 1,744,894 1,433,833 1,842,934

PostAmendment 9.08 33.26 4,085 4,494 17.06 1

9.82 25,896 28,486 55.93 6

9.92 17,075 18,783 1,433,833 1,744,894 1,577,216 2,027, 227

Change

from the

Baseline 0.00 0.00 0 409 0.00 0.

00 0 2,590 0.00 0.

00 0 1,708 0 0 143,383 1 84,293

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



### Table F-2 shows the range of cost estimates using a zero percent lower bound and ten percent upper bound increase in the number of reports and submitters as a result of the proposed amendment. All baseline cost estimates are taken from Table 4-5. EPA estimates a cost to industry between $0 and $ 10.7 8.28 million. The midpoint cost estimate of $ 5.35 4.14 million is used in Table 4-13.

Table F-2: Sensitivity Analysis of Industry Cost Estimates for Modifying the Method for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

Number of Sites Number of Reports (with Part II) Number of Reports (with Part III) Industry Cost (millions 2008$) Cost to Prepare

Part I, Rule Familiarization,

Compliance

Determination

and Submission (2008$ per site) Lower

Bound (0% increase) Upper

Bound (10% increase) Cost to Prepare

Part II

and

Record Keeping (2008$

per report) Lower

Bound (0% increase) Upper

Bound (10% increase) Cost to Prepare

Part III (2008$ per

report) Lower

Bound (0% increase) Upper

Bound (10% increase) Lower

Bound (0% increase) Upper

Bound (10% increase)

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

Baseline $560.77 $2,058

.18 4,085 4,085 $968.39 $1,129.4

2 25,896 25,896 $3,247.40 $4,059.25 17,075 17,075 $82.82 $

106.97 $82.82 $

106.97

PostAmendment $560.77 $2,058

.18 4,085 4,494 $968.39 $1,129.4

2 25,896 28,486 $3,247.40 $4,059.25 17,075 18,783 $82.82 $

106.97 $91.10 $

117.66

Change

from the

Baseline $0.00 $0.00 0 409 $0.00 $0.

00 0 2,590 $0.00 $0.0

0 0 1,708 $0.00 $0

.00 $8.28 $1

0.70

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



### The cost and burden to the Agency of this amendment were calculated in Section 5.4. With a five percent increase in the number of reports, the Agency’s burden is expected to increase by 104 hours (see Table 5-5). The range in the burden increase to EPA, using a lower bound zero percent increase in the number reports and an upper bound increase of ten percent, is presented in Table F-3. Baseline Agency burden is taken from Table 5-4. The proposed amendment is expected to increase the Agency burden by

between zero and 208 hours.

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

F-3 Table F-3: Sensitivity Analysis of Agency Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

Number of Sites Number of Reports (with Part II) Number of Reports (with Part III) Industry Burden (hours) Burden

to

Process

Part I (hours) Lower

Bound (0% increase) Upper

Bound (10% increase) Burden

to

Process

Part II (hours) Lower

Bound (0% increase) Upper

Bound (10% increase) Burden

to

Process

Part

III (hours) Lower

Bound (0% increase) Upper

Bound (10% increase) Lower

Bound (0% increase) Upper

Bound (10% increase)

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

Baseline 0.017 4,085 4,085 0.042 25,896 25,896 0.054 17,075 17,075 2,080 2,080

PostAmendment 0.017 4,085 4,494 0.042 25,896 28,486 0.054 17,075 18,783 2,080 2,288

Change

from the

Baseline 0.000 0 409 0.000 0 2,590 0.000 0 1,708 0 208

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



### Table F-4 shows the range in Agency costs as a result of modifying the method for determining whether the threshold is met. Baseline Agency costs are taken from Table 5-4. The proposed amendment is expected to increase the Agency cost between approximately $0 and $21,700 during the first reporting cycle.

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

Number of Sites Number of Reports (with Part II) Number of Reports (with Part III) Industry Cost (2008$) Cost

to

Process

Part I (2008$) Lower

Bound (0% increase) Upper

Bound (10% increase) Cost to

Process

Part II (2008$) Lower

Bound (0% increase) Upper

Bound (10% increase) Cost to

Process

Part

III (2008$) Lower

Bound (0% increase) Upper

Bound (10% increase) Lower

Bound (0% increase) Upper

Bound (10% increase)

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

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

PostAmendment $1.78 4,085 4,494 $4.40 25,896 28,486 $5.61 17,075 18,783 $216,949 $238,644

Change

from the

Baseline $0.00 0 409 $0.00 0 2,590 $0.00 0 1,708 $0 $21,695

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



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

The cost to industry of requiring the reporting of production volume used on-site is estimated in

Section 4.4.13. EPA estimated that between 14.8 percent of all reports (the percentage of reports which included a site-limited volume in 2006 reporting (EPA 2008c)) and 24 percent of all reports (the percentage of 2006 reports which claim the chemical s is an intermediate in the downstream use and processing section (EPA, 2008c)) would report production volume used on-site. Therefore, the total number of reports with volume used on-site ranges from 3,833 to 6,215 reports. Using a midpoint of 19.4 percent, industry burden is expected to increase by 7,596 hours (see Table 4-24). Table F-5 shows the burden estimates using the lower and upper bounds for the number of reports that will contain information on production volume used on-site. The baseline cost per report is taken from Table 4-6. EPA expects the total industry burden to range from 5,800 to 9,400 hours.

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

F-4 Table F-5: Sensitivity Analysis of Industry Burden Estimates for Reporting Production Volume
Used On-Site

Number of Reports with

Production Volume Used

On-Site Total Industry Burden (hours) Burden per Report to Report

Production

Volume Used OnSite (hours) Lower Limit (14.8% of all

Reports) Upper Limit (24% of all

Reports) Lower Limit (14.8% of all Reports) Upper Limit (24% of all

Reports)

Baseline 0.00 0 0 0 0

Post-Amendment 1.51 3,833 6,215 5,795 9,397 Change from the

Baseline 1.51 3,833 6,215 5,795 9,397

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



### Table F-6 contains the range of cost estimates using a 14.8 percent lower bound and 24 percent upper bound increase in the number of reports under the proposed amendment. All baseline cost estimates are taken from Table 4-5. EPA estimates a cost to industry between $324,500 and $526,300, with a midpoint estimate of $0.43 million (see Table 4-25).

Table F-6: Sensitivity Analysis of Industry Cost Estimates for Reporting Production Volume Used
On-Site

Number of Reports with

Production Volume Used

On-Site Total Industry Cost (2008$) Cost per Report to Report

Production

Volume Used On-Site (2008$) Lower Limit (14.8% of all Reports) Upper Limit (24% of all

Reports) Lower

Limit (14.8% of all Reports) Upper Limit (24% of all

Reports)

Baseline $0.00 0 0 $0 $0

Post-Amendment $84.68 3,833 6,215 $324,544 $526,288
Change from the

Baseline $84.68 3,833 6,215 $324,544 $526,288

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



### The In Section 5.4.13 , EPA calculated the burden to the Agency , 4.51 hours, of requiring the reporting of production volume used on-site, whe re an estimated using 19.4 percent as the estimated

amount of reports list ing production volume is used on-site is calculated in Section 5.4.13 . The resulting

burden was 4.51 hours. In Table F-7 contains , 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 onsite. The resulting burden is 3.44 to 5.57 hours per reporting cycle. The baseline burden per report is taken

from Table 5-4.

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

F-5 Table F-7: Sensitivity Analysis of Agency Burden Estimates for Reporting Production Volume
Used On-Site

Number of Reports with

Production Volume Used

On-Site Burden per Report to Report

Production Volume Used On-Site (hours) Burden per Report to Report

Production

Volume Used OnSite (hours) Lower Limit (14.8% of all

Reports) Upper Limit (24% of all

Reports) Lower Limit (14.8% of all Reports) Upper Limit (24% of all

Reports)

Baseline 0.000 0 0 0.00 0.00

Post-Amendment 0.001 3,833 6,215 3.44 5.57
Change from the

Baseline 0.001 3,833 6,215 3.44 5.57

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



### Table F-8 contains the range in costs to EPA as a result of modifying the method for determining whether the threshold is met. Baseline costs to EPA are taken from Table 5-4. The proposed amendment is expected to increase the Agency cost between approximately $359 and $581 during the first reporting cycle.

Table F-8: Sensitivity Analysis of Agency Cost Estimates for Reporting Production Volume Used
On-Site

Number of Reports with

Production Volume Used

On-Site Cost per Report to Report

Production Volume Used On-Site (2008$) Cost per Report to Report Production

Volume Used On-Site (2008$) Lower Limit (14.8% of all

Reports) Upper Limit (24% of all

Reports) Lower Limit (14.8% of all Reports) Upper Limit (24% of all

Reports)

Baseline $0.00 0 0 $0.00 $0.00

Post-Amendment $0.09 3,833 6,215 $359 $581
Change from the

Baseline $0.09 3,833 6,215 $359 $581

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



### F.3 Modifying Industrial Function Categories

EPA is proposing to modify the current industrial function categories (found in Part III, Section A of Form U), by eliminating seven existing categories and adding seven new categories, and requiring submitters to write in a free-text descriptor when th ey select “Other”. EPA anticipates these actions will reduce the number of submitters selecting “Other” by approximately 50 percent, from 1,206 reports to 603 (EPA, 2008a). The burden increase of 4,400 hours and cost increase of $260,000 are calculated in

Section 4.4.18.

The Agency conducted a sensitivity analysis for these estimates, with the decrease in reports selecting “Other” ranging from a 25 percent reduction of the total (905 reports in total) to a 75 percent reduction in total (302 reports in total). The results of this analysis for industry burden are found in Table F-9. A 75 percent reduction in the number of submitters claiming “Other” means that 25 percent of submitters are now claiming “Other,” and a 25 percent reduction means that 75 percent of submitters are now claiming “Other.” The columns in this table and the remaining tables in this Appendix ar e 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.

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

F-6 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 F-9: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category

Number of Reports with

“Other”

Write-in Text Total Industry Burden (hours) Burden for

Rule

Familiarization

of Additional

Categories

(hours) Number of Reports

with

Industrial

Function Categories Burden

for

Write-in

Text for

"Other" (hours) Lower

Bound (25% of

Submitters

Claim "Other") Upper

Bound (75% of

Submitters

Claim "Other") Lower

Bound (25% of

Submitters

Claim "Other") Upper

Bound (75% of

Submitters

Claim "Other")

Baseline 8.59 17,075 0.00 0 0 146,661 146,661

PostAmendment 8.84 17,075 0.15 302 905 150,975 151,066

Change

from the

Baseline 0.25 0 0.15 302 905 4,314 4,404

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



### Table F-10 contains the range of cost estimates to industry with a lower bound estimate of a 75 percent decrease in the number of reports with “Other” as industrial function categories and an upper bound of a 25 percent decrease in the number of reports with “Other” as industrial function categories. All baseline cost estimates are taken from Table 4-5. EPA estimates a cost to industry between $253,400 and $257,800, with a midpoint estimate of $256,000 (see Table 4-33).

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

Number of Reports with

“Other” Write-in Text Total Industry Cost (2008$) Cost for Rule

Familiarization

of Additional

Categories

(2008$) Number of Reports

with

Industrial

Function Categories Cost for

Write-in

Text for

"Other" (2008$) Lower

Bound (25% of

Submitters

Claim "Other") Upper

Bound (75% of

Submitters

Claim "Other") Lower

Bound (25% of

Submitters

Claim "Other") Upper

Bound (75% of

Submitters

Claim "Other")

Baseline $88.02 17,075 $0.00 0 0 $1,502,913 $1,502,913

PostAmendment $102.73 17,075 $7.31 302 905 $1,756,287 $1,760,693

Change

from the

Baseline $14.71 0 $7.31 302 905 $253,374 $257,780

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



### Using a 50 percent decrease in the number of repor ts with “Other” selected, the burden to the Agency during a reporting cycle is 0.54 hours and is calculated in Section 5.4.18. Table F-11 contains the range of burden estimates to the Agency, 0.27 hour to 0.81 hours per reporting cycle. The baseline Agency burden estimates per report are taken from Table 5-4.

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

F-7 Table F-11: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as an Industrial Function Category

Number of Reports with "Other"

Write-in Text Total Agency Burden (hours) Burden to

Process

Write-in

Text for

"Other" (hours) Lower Bound (25% of

Submitters

Claim "Other") Upper Bound (75% of

Submitters

Claim "Other") Lower Bound (25% of

Submitters

Claim "Other") Upper Bound (75% of

Submitters

Claim "Other")

Baseline 0.000 0 0 0.00 0.00

Post-Amendment 0.001 302 905 0.27 0.81 Change from the

Baseline 0.001 302 905 0.27 0.81

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



### Table F-12 contains the range in costs to EPA as a result of modifying the industrial function categories. Baseline costs to EPA are taken from Table 5-4. The proposed amendment is expected to increase the Agency cost between approximately $28 and $85 during the first reporting cycle.

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

Number of Reports with "Other"

Write-in Text Total Agency Cost (2008$) Cost to

Process

Write-in

Text for

"Other" (2008$) Lower Bound (25% of

Submitters

Claim "Other") Upper Bound (75% of

Submitters

Claim "Other") Lower Bound (25% of

Submitters

Claim "Other") Upper Bound (75% of

Submitters

Claim "Other")

Baseline $0.00 0 0 $0 $0

Post-Amendment $0.09 302 905 $28 $85
Change from the

Baseline $0.09 302 905 $28 $85

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



### F.4 “Other” as a Consumer and/or Commercial Product Category

EPA is proposing to revise the list of consumer and commercial product categories by combining categories that lead ing to common exposure scenarios and adding categories that were not adequately described in the current set of categories. The resultant proposed list includes 33 product categories, including “Other.” Several consumer and commercial product categories have been renamed to better describe the products that should be reported in that category. EPA is also proposing to require that if the product category “Other” is selected; a descriptor for the consumer and/or commercial product containing

the chemical substance must also 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 that the new categories in the proposed amendment will reduce by half the number of submitters selecting “Other” as a consumer and/or commercial product category. Therefore, this amendment would affect 604 reports. The cost and burden to industry with a 50 percent reduction in

the number of submitters is found in Section 4.4.20.

The Agency conducted a sensitivity analysis for the decrease in reports selecting “Other” ranging from a 25 percent reduction of the total (905 reports in total) to a 75 percent reduction of the total (302 reports in total). The results of this analysis for industry are found in Table F-13. Baseline burden

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

F-8 estimates are taken from Table 4-2 and the baseline number of reports is found in Table 4-6. EPA estimates the burden to industry will increase between 16,000 and 16,100 hours.

Table F-13: Sensitivity Analysis of Industry Burden Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category

Number of Reports with

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

Rule

Familiarization

of Additional

Categories

(hours) Number of Reports

with

Consumer/

Commercial

Product Categories Burden

for

Write-in

Text for

"Other" (hours) Lower

Bound (25% of

Submitters

Claim "Other") Upper

Bound (75% of

Submitters

Claim "Other") Lower

Bound (25% of

Submitters

Claim "Other") Upper

Bound (75% of

Submitters

Claim "Other")

Baseline 8.59 17,075 0.00 0 0 146,661 146,661

PostAmendment 9.52 17,075 0.15 302 905 162,672 162,762

Change

from the

Baseline 0.94 0 0.15 302 905 16,010 16,101

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



### Table F-14 shows the range of cost estimates to industry with a lower bound estimate of a 75 percent decrease in the number of “Other” as a consumer and/or commercial product category and an upper bound of a 25 percent decrease in the number of “Other” as a consumer and/or commercial product categories. All baseline cost estimates are taken from Table 4-5. EPA estimates a cost to industry of between $843,000 and $848,000, with a midpoint estimate of $846,000 (see Table 4-35).

Table F-14: Sensitivity Analysis of Industry Cost Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category

Number of Reports with

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

Familiarization

of Additional

Categories

(2008$) Number of Reports

with

Consumer/

Commercial

Product Categories Cost for

Write-in

Text for

"Other" (2008$) Lower

Bound (25% of

Submitters

Claim "Other") Upper

Bound (75% of

Submitters

Claim "Other") Lower

Bound (25% of

Submitters

Claim "Other") Upper

Bound (75% of

Submitters

Claim "Other")

Baseline $70.64 17,075 $0.00 0 0 $1,206,177 $1,206,177

PostAmendment $119.90 17,075 $7.31 302 905 $2,049,551 $2,053,962

Change

from the

Baseline $49.26 0 $7.31 302 905 $843,374 $847,785

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



### Using a 50 percent decrease in the number of repor ts with “Other” selected, the burden to the Agency during each reporting cycle is 0.54 hours and is calculated in Section 5.4.20. Table F-15 shows the range of burden estimates to the Agency; 0.27 hour to 0.81 hours per reporting cycle. The baseline Agency burden estimates per report are taken from Table 5-4.

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

F-9 Table F-15: Sensitivity Analysis of Agency Burden Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category

Number of Reports with "Other"

Write-in Text Total Agency Burden (hours) Burden to

Process

Write-in

Text for

"Other" (hours) Lower Bound (25% of

Submitters

Claim "Other") Upper Bound (75% of

Submitters

Claim "Other") Lower Bound (25% of

Submitters

Claim "Other") Upper Bound (75% of

Submitters

Claim "Other")

Baseline 0.000 0 0 0.00 0.00

Post-Amendment 0.001 302 905 0.27 0.81 Change from the

Baseline 0.001 302 905 0.27 0.81

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



### Table F-16 shows the range in costs to EPA as a result of modifying the consumer and commercial product categories. Baseline costs to EPA are taken from Table 5-4. The proposed amendment is expected to increase the Agency cost between $28 and approximately $85 during the first reporting cycle.

Table F-16: Sensitivity Analysis of Agency Cost Estimates for Requiring Write-in Text for “Other” as a Consumer and/or Commercial Product Category

Number of Reports with "Other" Writein Text Total Agency Cost (2008$)

Lower Bound

(25% of

Submitters

Claim "Other") Upper Bound (75% of

Submitters

Claim "Other") Lower Bound (25% of Submitters

Claim "Other") Upper Bound (75% of Submitters

Claim "Other")

Baseline 0 0 $0 $0

Post-Amendment 302 905 $28 $85
Change from the

Baseline 302 905 $28 $85

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



### F.5 Upfront CBI Substantiation

EPA is requiring an upfront substantiation when a submitter claims processing and use information as confidential business information (CBI). In 2002, when EPA first required upfront substantiation for claiming plant site IDs as CBI, the Agency saw a 64 percent reduction in the number of CBI claims. The Agency expects the number of DPU CBI claims to decrease by the same amount as a result of this proposed amendment. According to 2006 IUR data (EPA, 2008c), a total of 8,133 reports had claimed

that processing and use information was CBI, with an average of three CBI claims for processing and use information per report. The estimates for industry cost of $773,000 and burden of 12,800 hours, associated with the 8,133 CBI claims are found in Section 4.4.25.

The Agency conducted a sensitivity analysis, assuming the reduction in CBI claims has a lower bound of 84 percent, meaning that 16 percent of submitters make a CBI claim in Part III, and an upper bound of 44 percent, meaning that 56 percent of submitters make a CBI claim in Part III. Table F-17 contains range in burden increase to industry as a result of the proposed amendment. The burden is expected to increase by between 5,700 and 19,900 hours.

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

F-10 Table F-17: Sensitivity Analysis of Industry Burden Estimates for Requiring Upfront CBI
Substantiation

Number of Reports with CBI Claims

in Part III Industry Burden (hours) Burden for Upfront CBI

Substantiation

for CBI

Claims in Part

III (hours) Lower Limit (16% of

Submitters Claim CBI) Upper Limit (56% of

Submitters Claim CBI) Lower Limit (16% of

Submitters Claim CBI) Upper Limit (56% of

Submitters Claim CBI)

Baseline 0.00 8,133 8,133 0 0

PostAmendment 4.38 1,301 4,554 5,700 19,949

Change from

the Baseline 4.38 -6,832 -3,579 5,700 19,949

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



### Table F-18 shows the range of cost estimates to industry, with a lower bound estimate of an 84 percent decrease in the number of DPU CBI claims and an upper bound of a 44 percent decrease in the number of DPU CBI claims. All baseline cost estimates are taken from Table 4-5. EPA estimates industry cost of between $343,400 and $1.2 million, with a midpoint estimate of $773,000 (see Table 4-33).

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

Number of Reports with CBI Claims

in Part III Industry Cost (2008$) Cost for Upfront CBI

Substantiation

for CBI

Claims in Part

III (2008$) Lower Limit (16% of

Submitters Claim CBI) Upper Limit (56% of

Submitters Claim CBI) Lower Limit (16% of

Submitters Claim CBI) Upper Limit (56% of

Submitters Claim CBI)

Baseline $0.00 8,133 8,133 $0 $0

PostAmendment $263.90 1,301 4,554 $343,413 $1,201,944

Change from

the Baseline $263.90 -6,832 -3,579 $343,413 $1,201,944

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



### Using a 64 percent decrease in the number CBI claims, the Agency burden increase during each reporting cycle is calculated as eight hours in Section 5.4.25. Table F-19 contains the range of burden estimates to the Agency, which is 3.50 hours to 12.25 hours per reporting cycle. The baseline Agency burden estimates per report are taken from Table 5-4.

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

F-11 Table F-19: Sensitivity Analysis of Agency Burden Estimates for Requiring Upfront CBI
Substantiation

Number of Reports with CBI Claims

in Part III Agency Burden (hours) Burden for Upfront CBI

Substantiation

for CBI

Claims in Part

III (hours) Lower Limit (16% of

Submitters Claim CBI) Upper Limit (56% of

Submitters Claim CBI) Lower Limit (16% of

Submitters Claim CBI) Upper Limit (56% of

Submitters Claim CBI)

Baseline 0.00 8,133 8,133 0 0

PostAmendment 0.28 1,301 4,554 3.50 12.25

Change

from the

Baseline 0.28 -6,832 -3,579 3.50 12.25

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

value.



### Table F-20 contains the range in costs to EPA as a result of modifying the industrial function categories. Baseline costs to EPA are taken from Table 5-4. The proposed amendment is expected to increase the Agency cost between $365 and $1,278 during the first reporting cycle.

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

Number of Reports with CBI Claims

in Part III Agency Cost (2008$) Cost for Upfront CBI

Substantiation

for CBI

Claims in Part

III Lower Limit (16% of

Submitters Claim CBI) Upper Limit (56% of

Submitters Claim CBI) Lower Limit (16% of

Submitters Claim CBI) Upper Limit (56% of

Submitters Claim CBI)

Baseline $0.00 8,133 8,133 $0 $0

PostAmendment $0.28 1,301 4,554 $365 $1,278

Change

from the

Baseline $0.28 -6,832 -3,579 $365 $1,278

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

value.

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

G-1 

## Appendix G. – Alternat ive Regulatory Options

In developing the proposed amendments to the IUR rule, EPA considered other regulatory options as alternatives to some of the proposed amendments. These options are considered both as alternatives to all the proposed amendments, and in addition to the proposed amendments outlined in Chapter 3. The burden and cost for these alternate regulatory options are described in the following sections below

.



### G.1 Require Submitters to Submit Full Data Annually

As an alternative to the amendment described in Section 3.5.4, which would require submitters to report production volume for each of the years since the last IUR report, EPA considered an option in which submitters would be required to submit all Form U data for each year they meet or exceed the reporting threshold. EPA calculated the cost and burden of this option under two different scenarios. The first calculates the cost and burden to the industry and the Agency without considering the other proposed amendments. The section scenario estimates the cost and burden to all affected entities if all the proposed

amendments outlined in Section 3. are enacted.

G.1.1 Annual Reporting Cost and Burden when the Option is Considered by Itself



### Under this alternative option, EPA estimated the cost to the industry and the Agency of annual reporting when the option is considered by itself, with none of the other proposed amendments considered. The annual reporting cost and burden would be the same as in the baseline burden shown in

Table 4-10. The number of submitters is not expected to change from year to year , after the first reporting

year 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 that on average, the total number of sites and reports would remain unchanged from year to year.

EPA analyzed the burden and costs over a 20 25 -year period. EPA assumes that submitters will become more efficient at reporting data over time, and therefore incur a smaller burden in future reporting cycles. Future-cycle reporting burden is taken from Table 4-11.

The annual industry burden under the baseline and the alternative option is shown in Table G-1. In total, EPA estimates that the industry burden would increase by approximately 22.94 million hours over

2 0 5 years (f ive our reporting cycles). Over one future five-year reporting cycle, the industry burden is expected to increase by 5.74 million hours (1.43 million hours x 4 years) compared to the baseline.

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

Baseline Burden Post-Alternative Option Burden Change from

Baseline Reporting Cycle 1 Years
(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 1.84 1.84 0.00

2 2012 to 2016 1.43 7.17 5.74

3 2017 to 2021 1.43 7.17 5.74

4 2022 to 2026 1.43 7.17 5.74

5 2027 to 2031 1.43 7.17 5.74

Total 7.58 30.52 22.94
Annual Average 0.30 1.22 0.92

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

G-2 Year Basel ine Burden (million s of hours) Post

- Alternative Option

Burden (million s of hours) Change from Baseline (million s of hours)

2011 1.84 1.84 0.00

2012 0.00 1.43 1.43

2013 0.00 1.43 1.43

2014 0.00 1.43 1.43

2015 0.00 1.43 1.43

2016 1.43 1.43 0.00

2017 0 .00 1.43 1.43

2018 0.00 1.43 1.43

2019 0.00 1.43 1.43

2020 0.00 1.43 1.43

2021 1.43 1.43 0.00

2022 0.00 1.43 1.43

2023 0.00 1.43 1.43

2024 0.00 1.43 1.43

2025 0.00 1.43 1.43

2026 1.43 1.43 0.00

2027 0.00 1.43 1.43

2028 0.00 1.43 1.43

2029 0.00 1.43 1.43

2030 0.00 1.43 1.43

Total 6.14 29.09 22.94 Annual Average 0.31 1.45 1.15



### The industry cost under the baseline and this alternative option is shown in Table G-2. EPA estimates

that the industry cost would increase by $1.33 billion over a 20 25 -year period. The annualized cost increase ranges from $ 63.95 44.34 million with a seven percent discount rate to and $ 65.26 49.54 million with a three percent discount rate. Over one five-year reporting cycle, this option would increase industry cost by approximately $331 million ($82.8 million x 4 years) compared to the baseline.

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

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting Cycle 1 Years
(2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $106.97 $106.97 $0.00

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

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

G-3 Year Baselin e Cost (2008$ millions) Post

- Alternative Option

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

2011 $106.97 $106.97 $0.00

2012 $0.00 $82.82 $82.82

2013 $0.00 $82.82 $82.82

2014 $0.00 $82.82 $82.82

2015 $0.00 $82.82 $82.82

2016 $82.82 $8 2.82 $0.00

2017 $0.00 $82.82 $82.82

2018 $0.00 $82.82 $82.82

2019 $0.00 $82.82 $82.82

2020 $0.00 $82.82 $82.82

2021 $82.82 $82.82 $0.00

2022 $0.00 $82.82 $82.82

2023 $0.00 $82.82 $82.82

2024 $0.00 $82.82 $82.82

2025 $0.00 $82.82 $82.82

2026 $82.8 2 $82.82 $0.00

2027 $0.00 $82.82 $82.82

2028 $0.00 $82.82 $82.82

2029 $0.00 $82.82 $82.82

2030 $0.00 $82.82 $82.82

Total $355.42 $1,680.50 $1,325.08
Annual Average $17.77 $84.03 $66.25

Annualized at 3% $19.13 $84.39 $65.26

Annualized at 7% $21.01 $ 84.95 $63.94



### The baseline burden to EPA during each reporting cycle is two FTEs, or 4,160 hours (see Section 5-2). While the burden for each reporting cycle will not change as a result of this amendment, more frequent reporting would increase costs to the Agency. Table G-3 contains the total Agency burden of the annual reporting option, over a 2 0 5 -year period. EPA estimates that Agency burden would increase by a total of 66,600 hours over a 2 5 0 -year period (f our ive reporting cycles). Over one five-year reporting cycle, the Agency burden would increase by 16,600 hours (4,160 hours x 4 years) compared to the baseline.

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

Baseline

Burden Post-Alternative Option Burden Change from Baseline Reporting

Cycle 1
Years hours hours hours

1 2007 to

2011 4,160 4,160 0

2 2012 to

2016 4,160 20,800 16,640

3 2017 to

2021 4,160 20,800 16,640

4 2022 to

2026 4,160 20,800 16,640 Baseline Burden (hours) Post

Alterna t

Optio n Burde (hour s Formatted Table

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

G-4 5 2027 to

2031 4,160 20,800 16,640

Total 20,800 87,360 66,560
Annual Average 832 3,494 2,662

Year

2011 4,160 4,16 0

2012 0.00 4,16 0

2013 0.00 4,16 0

2014 0.00 4,16 0

2015 0.00 4,16 0

2016 4,160 4,16 0

2017 0.00 4,16 0

2018 0.00 4,16 0

2019 0.00 4,16 0

2020 0.00 4,16 0

2021 4, 160 4,16 0

2022 0.00 4,16 0

2023 0.00 4,16 0

2024 0.00 4,16 0

2025 0.00 4,16 0

2026 4,160 4,16 0

2027 0.00 4,16 0

2028 0.00 4,16 0

2029 0.00 4,16 0

2030 0.00 4,16 0

Total 16,640 83,20 0

Annua l Average 832 4,16 0

Baseline Burden Post-Alternative Option Change from

Baseline Reporting Cycle Years

(hours) (hours) (hours)

1 2007 to 2011 4,160 4,160 0

2 2012 to 2016 4,160 20,800 16,640

3 2017 to 2021 4,160 20,800 16,640

4 2022 to 2026 4,160 20,800 16,640

5 2027 to 2031 4,160 20,800 16,640

Total 20,800 87,360 66,560
Annual Average 832 3,494 2,662



### The annual Agency cost under the baseline and the alternative option is shown in Table G-4, and is taken from Table 5-3. In total, EPA estimates that this option would increase the Agency cost by approximately $1.86 million over one five-year reporting cycle. Over a 2 0 5 -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.

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

G-5 Table G-4: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually

Year Baseline Cost (2008 $ ) Post

- Alternative Option

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

2011 $466,133 $466,133 $0 .00

2012 $0.00 $466,133 $466,133

2013 $0.00 $466,133 $466,133

2014 $0.00 $466,133 $466,133

2015 $0 .00 $466,133 $466,133

2016 $466,133 $466,133 $0 .00

2017 $0.00 $466,133 $466,133

2018 $0.00 $466,133 $466,133

2019 $0.00 $466,133 $466,133

2020 $0.00 $466,133 $466,133

2021 $466,133 $466,133 $0 .00

2022 $0.00 $466,133 $466,133

2023 $0.00 $466,133 $46 6,133

2024 $0.00 $466,133 $466,133

2025 $0.00 $466,133 $466,133

2026 $466,133 $466,133 $0 .00

2027 $0.00 $466,133 $466,133

2028 $0.00 $466,133 $466,133

2029 $0.00 $466,133 $466,133

2030 $0.00 $466,133 $466,133

Total $1,864,532 $9,322,660 $7,458,128
Annual Average $93,227 $466,133 $372,906

Annualized at 3% $98,818 $466,133 $367,315

Annualized at 7% $106,248 $466,133 $359,885

Baseline Cost Post-Alternative Option

Cost Change from

Baseline Reporting Cycle Years
(2008$) (2008$) (2008$)

1 2007 to 2011 $466,133 $466,132 .88 $0.00

2 2012 to 2016 $466,133 $2,330,664 $1,864,53 1.52 2

3 2017 to 2021 $466,133 $2,330,664 $1,864,53 21.52

4 2022 to 2026 $466,133 $2,330,664 $1,864,53 21.52

5 2027 to 2031 $466,133 $2,330,664 $1,864,53 21.52

Total $2,330,664 $9,788,790 .47 $7,458,126 .07 Annual Average $93,227 $391,552 $298,325

Annualized at 3% $87,798 $366,630 $291,617

Annualized at 7% $81,056 $466,133 $359,885

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

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

G-6 the burden when all the amendments are considered, as shown in Table 4-50. After the first reporting cycle, T t he number of submitters is not expected to change from year to year.

The industry burden of annual reporting is shown in Table G-5. The annual reporting option is expected to increase the industry burden by approximately 39. 59 58 million hours over a 20 25 -year period, for a total industry burden of 53. 55 54 56.01 million hours. EPA estimates that over one four-year reporting cycle (note that under the proposed amendments, a reporting cycle would be changed to four years)

. the industry burden would increase by approximately 7.92 million hours (2.64 million hours x 3 years) compared to the baseline.

Table G-5: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Baseline Burden Post-Alternative Option Burden Change from

Baseline Reporting Cycle 1 Years
(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 3.24 3.24 0.00

2 2012 to 2015 2.64 10.56 7.92

3 2016 to 2019 2.64 10.56 7.92

4 2020 to 2023 2.64 10.56 7.92

5 202 4 to 2027 2.64 10.56 7.92

6 202 8 to 2031 2.64 10.56 7.92

Total 16.43 56.01 39.58
Annual Average 0.66 2.24 1.58

Year Total Burden

When all Proposed

Amendments are

C onsidered (millions of hours) Post

- A lternative Option Burden (millions of hours) Total Change in Industry Burden (millions of ho urs)

2011 3.40 3.40 0.00

2012 0.00 2.64 2.64

2013 0.00 2.64 2.64

2014 0.00 2.64 2.64

2015 2.64 2.64 0.00

2016 0.00 2.64 2.64

2017 0.00 2.64 2.64

2018 0.00 2.64 2.64

2019 2.64 2.64 0.00

2020 0.00 2.64 2.64

2021 0.00 2.64 2.64

2022 0.00 2.64 2.64

2023 2.64 2.64 0.00

2024 0.00 2.64 2.64

2025 0.00 2.64 2.64

2026 0.00 2.64 2.64

2027 2.64 2.64 0.00

2028 0.00 2.64 2.64

2029 0.00 2.64 2.64

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G-7 Year Total Burden

When all Proposed

Amendments are

C onsidered (millions of hours) Post

- A lternative Option Burden (millions of hours) Total Change in Industry Burden (millions of ho urs)

2030 0.00 2.64 2.64

Total 13. 96 95 53. 55 54 39. 59 58 Annual Average 0.70 2.68 1.98



### The industry baseline cost is take n from Table 4-51. EPA estimates that annual reporting would increase industry cost by approximately $2.43 billion over a 20 25 -year period. The change in annualized cost ranges from $ 117 81.39 million with a seven percent discount rate to $ 120 90.90 million with a three percent discount rate as shown in Table G-6. Over one four-year reporting cycle, this option would increase industry cost by approximately $486 million ($162. 12 08 x 3 years) compared to the baseline.

Table G-6: Industry Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting Cycle 1 Years
(2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $198.84 $198.84 $0.00

2 2012 to 2015 $162.08 $648.33 $486.25

3 2016 to 2019 $162.08 $648.33 $486.25

4 2020 to 2023 $162.08 $648.33 $486.25

5 2024 to 2027 $162.08 $648.33 $486.25

6 2028 to 2031 $162.08 $648.33 $486.25

Total $1,009.25 $3,440.49 $2,431.24
Annual Average $40.37 $137.62 $97.25

Annualized at 3% $38.40 $129.30 $90.90

Annualized at 7% $35.83 $117.22 $81.39

Year Total Cost When all Proposed Amendments are C onsidered (2008$ millions) Post

- Alternative Option Cost (2008$ millions) Total Change in Industry

Cost (2008$ millions)

2011 $209.04 $208.78 $209.04 $208.78 $0.00

2012 $0.00 $162. 12 08 $162. 12 08

2013 $0.00 $162. 12 08 $162. 12 08

2014 $0.00 $162. 12 08 $162. 12 08

2015 $162. 12 08 $162. 12 08 $0.00

2016 $0.00 $162. 12 08 $162. 12 08

2017 $0.00 $162. 12 08 $162. 12 08

2018 $0.00 $162. 12 08 $162. 12 08

2019 $162. 12 08 $162. 12 0 8 $0.00

2020 $0.00 $162. 12 08 $162. 12 08

2021 $0.00 $162. 12 08 $162. 12 08

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G-8 Year Total Cost When all Proposed Amendments are C onsidered (2008$ millions) Post

- Alternative Option Cost (2008$ millions) Total Change in Industry

Cost (2008$ millions)

2022 $0.00 $162. 12 08 $162. 12 08

2023 $162. 12 08 $162. 12 08 $0.00

2024 $0.00 $162. 12 08 $162. 12 08

2025 $0.00 $162. 12 08 $162. 12 08

2026 $0.00 $162. 12 08 $162. 12 08

2027 $162. 12 08 $162. 12 08 $0.00

2028 $0.00 $162. 12 08 $162. 12 08

2029 $0.00 $162. 12 08 $162. 12 08

2030 $0.00 $162. 12 08 $162. 12 08

Total $857. 53 11 $3, 289.37 288.35 $2,431. 84 24
Annual Average $42. 88 86 $164. 47 42 $121. 59 56

Annualized at 3% $45. 41 38 $165. 18 13 $119. 78 75

Annualized at 7% $48. 87 84 $166. 26 20 $117. 39 36



### The Agency baseline burden when all the proposed amendments are considered is taken from Table 5-40. The annual reporting option is expected to increase Agency burden by approximately 36,8 00 40 hours when all amendments are considered (see Table G-7). Over a four-year reporting cycle, EPA

estimates that Agency burden would increase by approximately 7,400 hours (2,456 hours x 3 years) compared to the baseline.

Table G-7: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Year Total Burden

When all Proposed Amendments are C onsidered (hours) Post

- Alternative Option Burden (hours) Total Change in Agency Burden (hours)

2011 2,456 2,456 0

2012 0 2,456 2,456

2013 0 2,456 2,456

2014 0 2,456 2,456

2015 2,456 2,456 0

2016 0 2,456 2,456

2017 0 2,456 2,456

2018 0 2,456 2,456

2019 2,456 2,456 0

2020 0 2,456 2,456

2021 0 2,456 2,456

2022 0 2,456 2,456

2023 2,456 2,456 0

2024 0 2,456 2,456

2025 0 2,456 2,456

2026 0 2,456 2,456

2027 2,456 2,456 0

2028 0 2,456 2 ,456

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

G-9 Year Total Burden

When all Proposed Amendments are C onsidered (hours) Post

- Alternative Option Burden (hours) Total Change in Agency Burden (hours)

2029 0 2,456 2,456

2030 0 2,456 2,456

Total 12,280 49,120 36,840
Annual Average 614 2,456 1,842

Baseline Burden Post-Alternative Option Burden Change from

Baseline Reporting Cycle Years

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 2,439 2,439 0

2 2012 to 2015 2,456 9,826 7,369

3 2016 to 2019 2,456 9,826 7,369

4 2020 to 2023 2,456 9,826 7,369

5 2024 to 2027 2,456 9,826 7,369

6 2028 to 2031 2,456 9,826 7,369

Total 14,721 51,568 36,847
Annual Average 589 2,063 1,474



### The baseline Agency cost when all the proposed amendments are enacted is taken from Table 5-41. The total Agency cost under the annual reporting option when all proposed amendments are considered is

shown in Table G-8. Over a 2 0 5 -year period, Agency cost would increase by approximately $4.33

million

, with annualized costs increases ranging from approximately $20 9 5 ,000 with a seven percent discount rate to $2 27 13 ,000 with a three percent discount rate. Over one four-year reporting cycle, the Agency cost is expected to increase by $865,000 ($288,450 x 3 years) compared to the baseline.

Table G-8: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting Cycle Years (2008$) (2008$ millions) (2008$ millions)

1 2007 to 2011 $286,580 $286,580 $0

2 2012 to 2015 $288,450 $1,153,800 $865,350

3 2016 to 2019 $288,450 $1,153,800 $865,350

4 2020 to 2023 $288,450 $1,153,800 $865,350

5 2024 to 2027 $288,450 $1,153,800 $865,350

6 2028 to 2031 $288,450 $1,153,800 $865,350

Total $1,728,830 $6,055,580 $4,326,750
Annual Average $69,153 $242,223 $173,070

Annualized at 3% $65,011 $226,783 $161,773

Annualized at 7% $59,642 $204,495 $144,853

G.1.3 Small Entity Analysis



### The following section provides a preliminary assessment of the impact that annual Form U submissions may have on small entities by examini ng the relationship between the compliance costs and company sales for small companies. This analysis is based on the methodology described in Chapter 8 of this report. All costs and burdens are estimated under the assumption that all the proposed amendments

are enacted. Formatted Table

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G-10 EPA estimated in Chapter 8 of this report that there are 3.89 manufacturing sites per global parent company; 41.3 percent of global parent companies (466 companies) are considered small under the SBA employment-based definition 13



### , , 14 

### and 24.8 percent (280 companies) are considered small under the

TSCA sales-based definition 15



### . . 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 sales-based definition. EPA estimated average annual sales revenue of global parent companies considered small under either definition using data from Dun & Bradstreet, as also described in Chapter 8.

Table 4-51 shows the annual incremental cost of the rule to industry. Because this cost would be incurred once every year under an annual reporting cycle, it was not discounted. As shown in Table G-9 below, these costs were divided by the total number of sites expected to submit data, for the annualized costs per site. This was multiplied by the number of sites per small parent company to arrive at the annualized costs per small parent company. This value was divided by the annual sales per small parent company to derive the cost-to-sales ratio.

As shown in Table G-9, under the employment-base d definition, a small parent company affected by the rule on average has sales of more than $412.7 million. The annual costs of the proposed IUR rule amendments per small parent company, however, are $ 41, 886 780 37,699 39,582 . The cost-to-sales ratio for an average small company under the employment-based SBA definition would be 0.0 09 1 1 percent or
less. Under the more conservative sales-based TSCA definition, sma ll parent company sales are on average more than $11.8 million, with annualized costs associated with the proposed amendments of $ 45, 649 578 41 ,127 43,181 . The cost-to-sales ratio for an average small company under the sales-based

definition would be 0. 387 386 3 48 64 percent or less.

Using the highest annual cost shown in Table G-9 of $ 4 5,649 43,18141,127 , a small company would have to have annual sales of less than $4. 11 32 5 6 million in order to have a co st-to-sales ratio larger than
one percent.

13 Threshold of 1,000 employees

. 14 Threshold of 1,000 employees.

15 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 le ss 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.

16 Total annual sales of the company, combined with thos e of any parent company, are below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of any parent company, are below $4 million.

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G-11 Table G-9: Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of Annual Reporting

Employment-based

Definition Sales-based Definition

Total Incrementa l Annual Costs $91,871,064 .30 $102,073,745 $101,814,807

Total Number of Sites 4, 289 085
Annual costs per site $21,490 $23, 799 739
Number of sites per small parent company 1.76 1.76 1.92 1.92
Annualized costs per small parent company $39,582 $41, 886 780 $43,181 $45, 694 578 Annual sales per small parent company $412,713,310 $412,713,310 $11,821,104 $11,821,104

Cost-to-sales ratio 0.010% 0.01% 0.365% 0. 387% 386% Number of companies potentially affected 466 466 280 280



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

As an alternative to the proposed amendment described in Section 3.13, which would modify the reporting frequency to a four-year cycle, the Agency considered increasing the reporting frequency to once every three years, if the manufacturer exceeds the production volume threshold in any calendar year of the cycle. EPA estimates the burden of this op tion on all affected entities, both when the option is considered by itself and when all the proposed amendments are considered.

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



### EPA’s analysis of industry burden and cost for this amendment is similar to that described in Section 4.4.31; the burden in any one repor ting cycle will not change, but the lo nger-term burden to industry will increase because reporting will become more frequent. However, the Agency assumes that no additional reports will be submitted as a result of reducing the length of the reporting cycle. (While the mix of chemicals might change, EPA assumes that the total number of reports will remain relatively static.) To be comparable with the proposed four-year reporting cycle option, costs to industry are calculated over a 20-year period.

The annual industry burdens under the baseline and under this alternative option are shown in Table G-10. The industry burden is taken from Table 4-10 for the first reporting cycle and from Table 4-11 for all future reporting cycles. In total, EPA estimates that under this option, industry would incur an

additional burden of 4.30 2.87 million hours over a 20-year period.

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

G-12 Table G-10: Annual Industry Burden under the Alternative Option of a Three-Year Reporting Cycle

Baseline Burden Post-Amendment

Burden Change in Burden Reporting Cycle 1 Years
(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 1.84 1.84 0.00

2012 to 2016 1.43

-- 2 2012 to 2014

-- 1.43 0.00

2017 to 2021 1.43

-- 3 2015 to 2017

-- 1.43 0.00

2022 to 2026 1.43

-- 4 2018 to 2020

-- 1.43 0.00

5 2021 to 2023

-- 1.43 1.43

6 2024 to 2026

-- 1.43 1.43

Total 6.14 9.01 2.87
Annual Average 0.31 0.45 0.14

1 The non-italicized reporting cycles are baseline, five-year cycl es, and the italicized reporting cy cles are altern ative, three -year cycles

Year Baseline

Burden (million s of

hours) Post

- Amendment Burden (million s of hours) Change from Baseline (million s of hours)

2011 1.84 1.84 0.00

2012 0.00 0.00 0.00

2013 0.00 0.00 0.00

2014 0.00 1.43 1.43

2015 0.00 0.00 0.00

2016 1.43 0.00

- 1.43

2017 0.00 1.43 1.43

2018 0.00 0.00 0.00

2019 0.00 0.00 0.00

2020 0.00 1.43 1.43

2021 1.43 0.00

- 1.43

2022 0.00 0.00 0.00

2023 0.00 1.43 1.43

2024 0.00 0.00 0.00

2025 0.00 0.00 0.00

20 26 1.43 1.43 0.00

2027 0.00 0.00 0.00

2028 0.00 0.00 0.00

2029 0.00 1.43 1.43

2030 0.00 0.00 0.00

Total 6.14 10.45 4.30

Annual A verage 0.31 0.52 0.22



### The annual industry cost under the baseline and this alternative option are shown in Table G-11. In total, EPA estimates that this option would increase costs to industry by $ 248 16 6 5.64 million over a 20-

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

G-13 year period, with annualized costs increases ranging from $ 11.29 6.96 million with a seven percent discount rate to $ 11.90 7.75 million with a three percent discount rate.

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

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting Cycle 1 Year s (2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $106.97 106.97 0.00

2012 to 2016 $82.82

-- 2 2012 to 2014

-- $82.82 0.00

2017 to 2021 $82.82

-- 3 2015 to 2017

-- $82.82 0.00

2022 to 2026 $82.82

-- 4 2018 to 2020

-- $82.82 0.00

5 2021 to 2023

-- $82.82 $82.82

6 2024 to 2026

-- $82.82 $82.82

Total
$355.42 $521.05 $165.64 Annual Average
$17.77 $26.05 $8.28

Annualized at 3%
$17.00 $24.75 $7.75

Annualized at 7%
$16.03 $22.99 $6.96

1 The non-italicized reporting cycles are baseline, five-year cycl es, and the italicized reporting cy cles are altern ative, three -year cycles Formatted Table

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G-14 Year Baseline Cost (2008$ millions) Post

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

2 011 $106.97 $106.97 $0.00

2012 $0.00 $0.00 $0.00

2013 $0.00 $0.00 $0.00

2014 $0.00 $82.82 $82.82

2015 $0.00 $0.00 $0.00

2016 $82.82 $0.00

- $82.82

2017 $0.00 $82.82 $82.82

2018 $0.00 $0.00 $0.00

2019 $0.00 $0.00 $0.00

2020 $0.00 $82.82 $82.82

2021 $82.82 $0.00

- $82.82

2022 $0.00 $0.00 $0.00

2023 $0.00 $82.82 $82.82

2024 $0.00 $0.00 $0.00

2025 $0.00 $0.00 $0.00

2026 $82.82 $82.82 $0.00

2027 $0.00 $0.00 $0.00

2028 $0.00 $0.00 $0.00

2029 $0.00 $82.82 $82.82

2030 $0.00 $0.00 $0.00

Total $355. 42 $603.87 $248.45 Annual Average $17.77 $30.19 $12.42

Annualized at 3% $19.13 $31.03 $11.90

Annualized at 7% $21.01 $32.30 $11.29



### The baseline burden to EPA during reporting years is two FTEs or 4,160 hours (see Section 5-2). While the burden per reporting year would not change as a result of this alternative option, more frequent reporting would increase costs to the Agency. Table G-12 contains the total burden the Agency of the proposed option, over a 20-year period. During this period, EPA estimates that Agency burden would increase by a total of approximately 12,50 0 8,3 02 0 hours.

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G-15 Table G-12: Burden to the Agency under the Alternative Option of a Three-Year Reporting Cycle

Year Baseline Burden (hours) Post

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

2011 4,160 4,160 0 .00

2012 0.00 0.00 0 .00

2013 0.00 0.00 0 .00

2014 0.00 4,160 4,160

2015 0.00 0.00 0 .00

2016 4,160 0.00

- 4,160

2017 0.00 4,160 4,160

2018 0.00 0.00 0.00

2019 0.00 0.00 0.00

2020 0.00 4,160 4,160

2021 4,160 0.00

- 4,160

2022 0.00 0.00 0.00

2023 0.00 4,160 4,160

2024 0.00 0.00 0.00

2025 0.00 0.00 0.00

2026 4,160 4,160 0.00

2027 0.00 0.00 0.00

2028 0.00 0.00 0.00

2029 0.00 4,160 4,160

2030 0.00 0.00 0 .00

Total 16,640 29,120 12,480
Annual Average 832 1,456 624

Baseline Burden Post-Amendment

Burden Change in Burden Reporting Cycle 1 Years (millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 4,160 4,160 0

2012 to 2016 4,160

-- 2 2012 to 2014

-- 4,160 0

2017 to 2021 4,160

-- 3 2015 to 2017

-- 4,160 0

2022 to 2026 4,160

-- 4 2018 to 2020

-- 4,160 0

5 2021 to 2023

-- 4,160 4,160

6 2024 to 2026

-- 4,160 4,160

Total 16,640 24,960 8,320
Annual Average 832 1,248 416

1 The non-italicized reporting cycles are baseline, five-year cy cles, 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 G-13, and are taken from Table 5-3. In total, EPA estimates that this option would increase Agency costs by $ 1.4 932, 3002 66 million over a 20-year period with an annual average of $ 69,920 46,6 0013

.

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

G-16 Table G-13: Agency Cost under the Alternative Option of a Three-Year Reporting Cycle

Year Baseline Cost (2008$) Post

- Amendment

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

2011 $466,13 3 $466,133 $ 0.00

2012 $ 0.00 $ 0.00 $ 0.00

2013 $ 0.00 $ 0.00 $ 0.00

2014 $ 0.00 $466,133 $466,133

2015 $ 0.00 $ 0.00 $ 0.00

2016 $466,133 $ 0.00 $ 0.00

2017 $ 0.00 $466,133 $466,133

2018 $ 0.00 $ 0.00 $ 0.00

2019 $ 0.00 $ 0.00 $ 0.00

2020 $ 0.00 $466,133 $466,133

2 021 $466,133 $ 0.00

- $466,133

2022 $ 0.00 $ 0.00 $0 .00

2023 $ 0.00 $466,133 $466,133

2024 $ 0.00 $ 0.00 $0 .00

2025 $ 0.00 $ 0.00 $0 .00

2026 $466,133 $466,133 $0 .00

2027 $ 0.00 $0 .00 $0 .00

2028 $ 0.00 $0 .00 $0 .00

2029 $ 0.00 $466,133 $466,133

2030 $0.00 $0.00 $0.00

Total $1,864,532 $3,262,930 $1,398,399 Annual Average $93,22 7 $163,14 7 $69,9 20

Annualized at 3% $98,818 $165,773 $66,955

Annualized at 7% $106,248 $169,785 $63,537

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting Cycle 1 Year s (2008$) ( 2008$ ) (2008$)

1 2007 to 2011 $466,133 $466,133 $0

2012 to 2016 $466,133

-- 2 2012 to 2014

-- $466,133 $0

2017 to 2021 $466,133

-- 3 2015 to 2017

-- $466,133 $0

2022 to 2026 $466,133

-- 4 2018 to 2020

-- $466,133 $0

5 2021 to 2023

-- $466,133 $466,133

6 2024 to 2026

-- $466,133 $466,133

Total $1,864,532 $2,796,797 $932,266
Annual Average $93,227 $139,840 $46,613

Annualized at 3% $87,798 $131,412 $43,614

Annualized at 7% $81,056 $120,247 $39,190

1 The non-italicized reporting cycles are baseline, five-year cycl es, and the italicized reporting cy cles are altern ative, three -year cycles Formatted Table

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

G-17 G.2.2 Three-Year Cycle Cost and Burden when the All the Proposed Amendments are
Considered



### EPA estimated the cost and burden of a three-year reporting cycle in addition to the proposed amendments outlined in Chapter 3. Under this alte rnative option, the reporting burden for industry would be the same as the combined post amendment burden shown in Table 4-50; however the reporting cycle would be shortened from four years to three years. For both industry and the Agency, the post-amendment

burden will increase from the baseline becaus e of the increased reporting frequency.

The total increase in industry burden over 20 17 years as a result of increasing the reporting frequency

from to three years to from four years is 5.28 2.64 million hours (see Table G-14). This equates to an annual increase in the reporting burden of approximately 0. 26 13 million hours.

Table G-14: Annual Industry Burden under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered

Baseline Burden Post-Amendment

Burden Change in

Burden Reporting Cycle 1 Years
(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 3.24 3.24 0.00

2012 to 2015 2.64

-- 2 2012 to 2014

-- 2.64 0.00

2016 to 2019 2.64

-- 3 2015 to 2017

-- 2.64 0.00

2020 to 2023 2.64

-- 4 2018 to 2020

-- 2.64 0.00

5 2021 to 2023

-- 2.64 2.64

Total

11.15 13.79 2.64 Annual Average

0.56 0.69 0.13

1 The non-italicized reporting cycles are baseline, four-year cycl es, and the italicized reporting cy cles are altern ative, three -year cycles

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

G-18 Year Total Burden

When all Proposed

Amendments are

C onsidered (million s of hours) Post

- A lternative Option

Burden (million s of hours) Total Change in Industry

Burden (million s of hours)

2011 3.40 3.40 0.00

2012 0.00 0.00 0.00

2013 0.00 0.00 0.00

2014 0.00 2.64 2.64

2015 2.64 0.00

- 2.64

2016 0.00 0.00 0.00

2017 0.00 2.64 2.64

2018 0.00 0.00 0.00

2019 2.64 0.00

- 2.64

2020 0.00 2.64 2.64

2021 0.00 0.00 0.00

2022 0.00 0.00 0.00

2023 2.64 2.64 0.00

2024 0.00 0.00 0.00

20 25 0.00 0.00 0.00

2026 0.00 2.64 2.64

2027 2.64 0.00

- 2.64

2028 0.00 0.00 0.00

2029 0.00 2.64 2.64

2030 0.00 0.00 0.00

Total 13. 96 95 19. 24 23 5.28

Annual A verage 0.70 0.96 0.26



### The industry cost for a three-year reporting cycle is shown in Table G-15. Baseline costs are taken

from Table 4-50. Over a 20 17 -year period, total costs would increase by $ 324 162 .08 million, with an annualized increase of $ 15.31 8.93 million at a three percent discount rate and $ 14.32 8.07 million at a seven percent discount rate.

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

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting Cycle 1 Years
(2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $19.88 $19.88 $0.00

2012 to 2015 $162.08

-- 2 2012 to 2014

-- $162.08 $0.00

2016 to 2019 $162.08

-- 3 2015 to 2017

-- $162.08 $0.00

2020 to 2023 $162.08

-- 4 2018 to 2020

-- $162.08 $0.00

5 2021 to 2023

-- $162.08 $162.08

Total $506.13 $668.21 $162.08
Annual Average $29.77 $39.31 $9.53 Formatted Table

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G-19 Annualized at 3% $38.29 $47.23 $8.93

Annualized at 7% $35.70 $43.76 $8.07

1 The non-italicized reporting cycles are ba seline, four-year cycles, a nd the italicized reporting cycl es are altern ative, three -year cycles

Year Total Cost When all Proposed Amendments

are C onsidered ( 2008$ millions ) Post

- A lternative Option

Cost ( 2008$ mil lions ) Total Change in Industry

Cost ( 2008$ million s )

2011 $209.04 $208.78 $209.04 $208.78 $0.00

2012 $0.00 $0.00 $0.00

2013 $0.00 $0.00 $0.00

2014 $0.00 $162. 12 08 $162. 12 08

2015 $162. 12 08 $0.00

- $162. 12 08

2016 $0.00 $0.00 $0.00

2017 $0.00 $162. 12 08 $ 162. 12 08

2018 $0.00 $0.00 $0.00

2019 $162. 12 08 $0.00

- $162. 12 08

2020 $0.00 $162. 12 08 $162. 12 08

2021 $0.00 $0.00 $0.00

2022 $0.00 $0.00 $0.00

2023 $162. 12 08 $162. 12 08 $0.00

2024 $0.00 $0.00 $0.00

2025 $0.00 $0.00 $0.00

2026 $0.00 $162. 12 08 $162. 12 0 8

2027 $162. 12 08 $0.00

- $162. 12 08

2028 $0.00 $0.00 $0.00

2029 $0.00 $162. 12 08 $162. 12 08

2030 $0.00 $0.00 $0.00

Total $857. 53 11 $1,181. 78 28 $324. 25 17 Annual Average $42.88 $45.38 $59.09 $60.69 $16.21 $15.31

Annualized at 3% $45.41 $48.84 $60.72 $63.16 $15 .31 $14.32

Annualized at 7% $48.87 $42.86 $63.19 $59.06 $14.32 $16.21



### The Agency baseline burden s of 2,4 56 39 hours (first reporting cycle ) and 2, 456 (future reporting cycles ) when all the proposed amendments are considered together is taken from Table 5-40. The annual reporting option is expected to increase Agency burden by approximately 4,900 2, 500 hours over 17 years when all amendments are considered (see Table G-16).

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

G-20 Table G-16: Agency Burden under the Alternative Option of a Three-Year Reporting Cycle when the All the Proposed Amendments are Considered

Year Total Burden

When all Proposed

Amendments are

C onsidered (million s of hours) Post

- A lternative Opti on Burden (million s of hours) Total Change in Agency

Burden (million s of hours)

2011 2,456 2,456 0

2012 0 0 0

2013 0 0 0

2014 0 2,456 2,456

2015 2,456 0

- 2,456

2016 0 0 0

2017 0 2,456 2,456

2018 0 0 0

2019 2,456 0

- 2,456

2020 0 2,456 2,456

2021 0 0 0

2022 0 0 0

2023 2,456 2,456 0

2024 0 0 0

2025 0 0 0

2026 0 2,456 2,456

2027 2,456 0

- 2,456

2028 0 0 0

2029 0 2,456 2,456

2030 0 0 0

Total 12,280 17,192 4,912 Annual Average 614 860 246

Baseline Burden Post-Amendment

Burden Change in

Burden Reporting Cycle 1 Years ( hours) (hours) (hours)

1 2007 to 2011 2,439 2,439 0

2012 to 2015 2,456

-- 2 2012 to 2014

-- 2,456 0

2016 to 2019 2,456

-- 3 2015 to 2017

-- 2,456 0

2020 to 2023 2,456

-- 4 2018 to 2020

-- 2,456 0

5 2021 to 2023

-- 2,456 2,456

Total 9,807 12,264 2,456
Annual Average 577 721 145

1 The non-italicized reporting cycles are ba seline, four-year cycles, a nd the italicized reporting cycl es are alternative, three -year cycles



### Table G-17 contains the total Agency cost under a three-year reporting cycle. EPA estimates that the Agency cost would increase by approximately $ 576,900 288, 50 0 over a 20 17 -year period. The annualized

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

G-21 cost is expected to increase by $ 28,800 15, 600 with a three percent discount rate and $ 27,200 14, 400 with a seven percent discount rate.

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

Year Tot al Cost When all Proposed Amendments are

C onsidered

(2008$ ) Post

- Alternative Option

Cost (2008$) Total Change in Agency

Cost (2008$)

2011 $288,450 $288,450 $0.00

2012 $0.00 $0.00 $0.00

2013 $0.00 $0.00 $0.00

2014 $0.00 $288,450 $288,450

2015 $288,450 $0.00

- $288,450

2016 $0.00 $0.00 $0.00

2017 $0.00 $288,450 $288,450

2018 $0.00 $0.00 $0.00

2019 $288,450 $0.00

- $288,450

2020 $0.00 $288,450 $288,450

2021 $0.00 $0.00 $0.00

2022 $0.00 $0.00 $0.00

2023 $288,450 $288,450 $ 0.00

2024 $0.00 $0.00 $0.00

2025 $0.00 $0.00 $0.00

2026 $0.00 $288,450 $288,450

2027 $288,450 $0.00

- $288,450

2028 $0.00 $0.00 $0.0

2029 $0.00 $288,450 $288,450

2030 $0.00 $0.00 $0.0

Total $1,442,250 $2,019,150 $576,900

Annual Ave rag e $72,113 $100,958 $28,845

Annualized at

3% $75,341 $102,583 $27,242

Annualized at

7% $79,587 $105,065 $25,478

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting Cycle 1 Years
(2008$) (2008$) (2008$)

1 2007 to 2011 $286,580 $286,580 $0

2012 to 2015 $288,450

-- 2 2012 to 2014

-- $288,450 $0

2016 to 2019 $288,450

-- 3 2015 to 2017

-- $288,450 $0

2020 to 2023 $288,450

-- 4 2018 to 2020

-- $288,450 $0

5 2021 to 2023

-- $288,450 $288,450

Total $1,151,930 $1,440,380 $288,450

Annual Average $67,761 $84,728 $16,968

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

G-22 Year Tot al Cost When all Proposed Amendments are

C onsidered

(2008$ ) Post

- Alternative Option

Cost (2008$) Total Change in Agency

Cost (2008$)

Annualized at 3% $63,741 $79,637 $15,896

Annualized at 7% $58,612 $72,971 $14,359

1 The non-italicized reporting cycles are ba seline, four-year cycles, a nd the italicized reporting cycl es are alternative, three -year cycles

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

G-23 G.2.3 Small Entity Anaylsis



### The following section provides a preliminary assessment of the impact that a three-year reporting cycle may have on small entities by examining th e relationship between the compliance costs and company sales for small companies. This analysis is based on the methodology found in Chapter 8 of this report and all costs and burdens are estimated under the assumption that all the proposed amendments are enacted. EPA estimated 3.89 manufacturing sites per 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 17



### , , 18 

### and 24.8 percent (280 companies) are considered small under the

TSCA sales-based definition 19



### . . 20 

### EPA also estimated an average of approximately 1.76 sites per small company under the employment-based definition of small business, and approximately 1.92 sites per small company under the sales-based definition. Average annual sales revenue of global parent companies considered small under either definition were estimated using data from Dun & Bradstreet, as also

described in the EA.

Table 4-51 shows the incremental cost to the industry. Because these costs would be incurred once every three years under a three-year reporting cycle, these costs were summed and annualized over three years at both a three percent and seven percent discount rate 21



### . . 22 

### As shown in Table G-18 below , these costs were divided by the total number of sites expect ed 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-18, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $ 16, 273 231 14 ,,646 096 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. 003 6 003 3 4 5 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 $3 2 6

. 7 4 3 million or lower. The cost-to-sales ratio for an average small company under the sales-based definition would be

0.1 2 3 4 percent or less.

Using the highest annual cost shown in Table G-18 of $ 16, 273 231 1 4,646 5,378 , a small company would have to have annual sales of less than $1. 63 46 58 62 million in order to have a cost-to-sales ratio larger than one percent.

17 Threshold of 1,000 employees

. 18 Threshold of 1,000 employees.

19 Total annual sales of the co mpany, 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 Total annual sales of the company, combined with thos e 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.

21 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.

22 A seven percent discount rate, reflecting the opportunity cost of capital, is consiste nt with OMB Circular A-4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.

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

G-24 Table G-18: Derivation of Cost-to-Sales Ratios for Small Manufacturers for a Three-Year Reporting Cycle

Employment-based Definition Sales-based Definition

3%

Discount

Rate 7% Discount

Rate 3%

Discount

Rate 7% Discount Rate 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, 289 085

Annualized Costs per Site $7,719 $7,352 $8,009 $7,628 $7,719 $7,352 $8,009 $7,628
Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $13,586 $12,940 $14,096 $13,426 $14,821 $14,116 $15,378 $14,646

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

Cost-to-Sales Ratio 0.0033%0.00

31% 0.0034%0.0033% 0.1254%0.11

94% 0.1301%0.1239%

Number of Companies Potentially Affected 466 280



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

The Agency is also considering an option that would lower the reporting threshold from 25,000 lb. to 10,000 lb. Prior to the amendments to the 2006 IUR rule, EPA required that sites submit a Form U for chemicals produced at 10,000 lb. or greater. The 2006 amendments increased the threshold for reporting to 25,000 lb. This alternative regulatory option would return to the previous threshold for reporting.

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



### EPA used data from the 2002 reporting cycle (EPA, 2009d) to estimate the additional number of reports that would be submitted under the alternative threshold option. The total number of reports and sites reporting at three different production levels (10,000 lb. ≤ P V < 25,000 lb., 25,000 lb. ≤ P V < 300,000 lb., and PV ≥ 300,000 lb.) were analyzed to obtain the total range of reports submitted in 2002. Table G-19 contains the total number of reports and sites at all three production levels. In total, 882 sites, or 19 percent, of all the sites submitting reports data in 2002 produced chemicals in amounts between 10,000 lb. and 25,000 lb. Thirteen percent of all reports, or 3,595 reports, were submitted in 2002 for chemicals produced between 10,000 lb. and 25,000 lb.

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

G-25 Table G-19: Number of Reports and Sites in 2002

Production Volume Number of Sites Percent of Total Number of Reports Percent of

Total 10,000 lb. ≤ P V < 25,000

lb. 882 19% 3,595 13%

25,000 lb. ≤ P V < 300,000 lb. 1,392 30% 8,548 32%

PV ≤ 300,000 lb. 2,304 50% 14,818 55%

Total 4,578 100% 26,961 100%

Source: U.S. EPA, Office of Pollution Prevention a nd Toxics, Information Management Division 2002 IUR Database Statistics for IUR Modifications Rule . Washington, DC. April 30, 2009 (EPA, 2009d).



### To estimate the total number of additional sites submitting reports as a result of the proposed option, EPA applied the percentage of total sites with production volumes between 10,000 lb. and 25,000 lb. in 2002 (19 percent), to the total number of sites in 2006; 4,085 (baseline 2006 numbers are presented in Table 4-6). Therefore, the Agency estimates that 787 additional sites will submit reports as a result of the proposed amendment. The same methodology was applied to calculating the additional number of reports; EPA estimates a 13 percent increase in the number of 2006 reports, for a total of 3,453 new reports. Because all reports submitted as a result of the proposed amendments will be for production volumes less than 300,000 lb., EPA assumes that only additional partial reports (Part IIs) w oul d will be submitted.

As described in Section 4.2.2, sites need to complete Part I of Form U only once, and complete Part II and Part III (as applicable) for each chemical manufactured (or imported). Taking this allocation of activities into consideration, and using the baseline unit burden estimates as shown in Table 4-2, Table G-20 shows the industry burden estimate as a result of this proposed amendment. The Agency estimates

that the amendment will cause an increase in industry burden of approximately 94,600 hours.

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

Number

of Sites Burden per

Part I of Report, Compliance Determination,

Rule Familiarization,

and Submission Number

of

Partial Reports Burden per

Part II of Report and Recordkeeping Number

of Full Reports Burden per Part

III of Report Industry

Burden (hours)

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

(e*f)

Baseline 4,085 33.26 25,896 19.82 17,075 69.92 1,842,934

PostAmendment 4,872 33.26 29,349 19.82 17,075 69.92 1,937,544

Change

from the

Baseline 787 0 3,453 0 0 0 94,611

1 Baseline unit burden derivations shown in Table 4.4

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



### The cost of the amendment was calculated using the unit costs shown in Table 4-5. Table G-21 shows the industry cost estimate as a result of this proposed amendment. The cost to industry is expected to increase by $5.52 million.

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

G-26 Table G-21: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb.

Number

of Sites Cost per Part I of Report, Compliance Determination,

Rule Familiarization,

and Submission (2008$) Number

of Partial Reports Cost per Part II of Report

and Recordkeeping (2008$) Number

of Full Reports Cost per

Part III of Report

(2008$) Industry

Cost (millions 2008$)

Baseline 4,085 $2,058.18 25,896 $1,129.42 17,075 $4,059.25 $106.97

PostAmendment 4,872 $2,058.18 29,349 $1,129.42 17,075 $4,059.25 $112.49

Change

from the

Baseline 787 $0.00 3,453 $0.00 0 $0.00 $5.52

Note: Values in Change from the Baseline rows are calcula ted by subtracting the correspon ding baseline value from the postamendment value.



### The baseline burden to EPA of data processing and entry will not change from the baseline of 2,080 hours (see Section 5-2). However, the increased number of reports and submitters will increase the burden to the Agency. While the burden per reporting cycle will not change as a result of this amendment, more frequent reporting will increase costs to the Agency . Table G-22 contains the total Agency of the proposed option. EPA’s burden is expected to increase by a total of 159 hours.

Table G-22: Change in Burden to the Agency as a Result of Changing the Threshold for Reporting to 10,000 lb.

Burden to

Process Part

I Submission (hours) Number

of Sites Burden to

Process

Part II (hours per

report) Number

of Reports

(with Part II) Burden

to

Process

Part

III (hours

per report) Number

of Reports

(with

Part III) Agency Burden ( hours)

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

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080

PostAmendment 0.017 4,872 0.042 29,349 0.054 17,075 2,239

Change

from the

Baseline 0.000 787 0.000 3,453 0.000 0 159

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



### Table G-23 shows the estimated change in cost to EPA as a result of the proposed amendment. The Agency estimates a cost increase of approximately $16,600.

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

G-27 Table G-23: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000
lb.

Cost to

Process Part

I Submission (2008$) Number

of Sites Cost to

Process

Part II (2008$ per

report) Number

of Reports

(with Part II) Cost to

Process

Part

III (2008$

per report) Number

of Reports

(with

Part III) Agency Cost (2008$)

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

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

PostAmendment $1.78 4,872 $4.40 29,349 $5.61 17,075 $233,529

Change

from the

Baseline $0.00 787 $0.00 3,453 $0.00 0 $16,580

Note: Values in Change from the Baseline rows are calcula ted by subtracting the correspon ding baseline value from the postamendment value.

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



### EPA estimated the cost and burden of lowering the reporting threshold to 10,000 lb. when all of the proposed amendments outlined in Chapter 3. have been considered. A 10,000 lb. reporting threshold is expected to increase the number of partial reports submitted by approximately 13 percent and the number sites submitting data by 19 percent (See Table G-19). In addition, EPA assumes that this option would affect the proposed amendment to lower the threshold for reporting downstream processing and use information from 300,000 lb. to 25,000 lb. (See Section 3.3.2). Under this option, the threshold for reporting this information would be 10,000 lb. The total number of sites and reports, when all the proposed amendments and the 10,000 lb. threshold reporting option are considered, is found in Table G-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 Section 4.5.1, the other steps have been modified and an additional step has been added. The calculations for Steps 3, 4, and 5 are

outlined below.

Step 3: C onsider the effect of decreasing the reporting threshold to 10,000 lb. This amendment is expected to increase the number of sites submitting Form U by approximately 19 percent and the number of partial reports by approximately 13 percent (See Table G-19). To estimate this effect on the proposed amendments, EPA multiplied the total number of site s 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 G.3.1, which accounts for the increase from the baseline as a result of this option. The number of Part IIIs submitted is not affected by this step.

Step 4: Consider the effect of eliminating the 300,000 lb. threshold for processing and use reporting (and avoid double-counting). 

### Under this amendment, all submitters of non-exempt chemicals would be required to submit a Part III. Therefore, the number of Part IIIs must be increased by the increased number of Part IIs, to account for the effect of eliminating the 300,000 lb. threshold for processing and use reporting. EPA started with the Step 3 total for Part III reports ( 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

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

G-28 changing the method of determining whether a manufacturer is subject to reporting requirements ( 0 in the first reporting cycle and 1,295 in future reporting cycles ) and the number of new Part II reports that will be for EAC chemicals as a result of the 10,000 lb. threshold ( 80 in in the first reporting cycle and 86 in future reporting cycles ) 

### . The number of ECA chemicals as a result of the 10,000 lb. threshold in the first reporting cycle is calculated by multiplying the number of ECA chemicals by 1.13 in the firs t reporting cycle . In future reporting cycles

, the number of ECA chemicals as a result of the 10,000 lb. threshold is calculated by multiplying the number of ECA chemi cals after the five percent has been taken into account, 649, by 1.13. to calcu l ate the total number of EC A chemicals take into account the after the five
percent . This number has been taken into account

, , 649 , is then multiplied by by 1.13. The number of reports with Part III will increase by 16,801 in the first reporting cycle and 17,737 in future reporting cycles

. Step 5: Calculate the number of reports when all amendments are considered together. The total number of additional reports from Step 4 is added to the number of reports in the baseline to calculate the total number of reports when all the proposed amendments are considered together. There will now be a

total of 4,872 Part Is, 33,854 Part IIs and 33,156 Part IIIs in the first reporting cycle. In future reportin g cycles there will 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 E C A chemicals times

1.1 2 3 (618 x 1.13=698). In future cycles

, the diff e re n ce of 735 reports

, is equal to the number of partially exempt reports with the five and 13 percent increase taken into account ((618 x 1.05) x 1.13)) = 735).

Table G

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

Modification Number of Sites Number of Reports Number of Reports

with Part III

Baseline 4,085 25,896 17,075

Step 1: Sum affected amendments

Eliminate 300,000 lb. Threshold for Downstream Processing and Use Reporting (see Section 4.4.6 ) -- -- 8,203

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

--

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

Full Exemption for 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 reporti ng threshold (See Section

G.3.1 ) 787 3,453

--

STEP 3 TOTAL(Step 3 + Step 2 Total ) 787 7,985 8,219

Step 4: Consider the effect of eliminating the 300,000 lb. th reshold for processing and us e 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 -- -- 7,826

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

G-29 Modification Number of Sites Number of Reports Number of Reports

with Part III

for exemptions and the number of new Part II reports as a result of changing the method of determining whether subject to reporting requirements

STEP4 TOTAL (Step 4 + Step 3 Total ) 787 7,985 16,801

Step 5:Calculate the total number of reports by adding the Step 3 Total to the Baseline

STEP 5 TOTAL (Baseline + Step 3 Total) 4,872 33,854 33,156

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

Modification Number of Sites Number of Reports Number of Reports

with Part III

Baseline 4,085 25,896 17,075

Step 1: Sum affected amendments

Eliminate 300,000 lb. Threshold for Downstream Processing and Use Reporting (see Section 4.4.6) -- -- 8,203

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

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

Full Exemption for 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 reporti ng threshold (See Section G.3.1) 787 3,453

--

STEP 3 TOTAL(Step 3 + Step 2 Total ) 1,030 9,632 9,484

Step 4: Consider the effect of eliminating the 300,000 lb. th reshold for processing and us e reporting (and avoid doublecounting).

Step 3 total for Part II reports minus number of new Part III reports as a result of making ECAs ineligible for exemptions and the number of new Part II reports as a result of changing the method of determining whether subject to reporting requirements -- -- 8,253

STEP4 TOTAL (Step 4 + Step 3 Total ) 1,030 9,632 17,737

Step 5:Calculate the total number of reports by adding the Step 3 Total to the Baseline

STEP 5 TOTAL (Baseline + Step 3 Total) 5,115 35,528 34,812



### EPA estimated the cost to the industry of the 10,000 lb. threshold when all the amendments are considered in Table G-26. The baseline values are taken from Table 4-50. Lowering the reporting

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

G-30 threshold to 10,000 lb. will not increase the industry per-form burden; however it will increase the

number of Form Us submitted. EPA estimates that this option would increase the industry burden by 0. 46

44 million hours in the first reporting cycle and by 0.35 million hours in all future reporting cycles.

Table G-26: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered

Burden per Part I of Report

and

Submission (hours per site ) Number

of Sites Burden

for Part

II and

Record Keeping (hours per

report) Number

of Reports

(with Part II) Burden

for

Part

III and (hours

per report) Number

of Reports

(with Part III) Total Burden (millions of hours)

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

First-year

Baseline 35.17 36.12

35.17 4,085 4,28

9 22.19 22.19 29,871.00 31,365 83.02 8

3.02 29,253.00 30,716 3.24 3.40

First year,

Post

Amendment 35.17 36.12

35.17 4,872 5,11

5 22.19 22.19 33,854 35,

547 83.02 8

3.02 33,156 34,

812 3.68 3.86

Change from the Baseline, First year 0.00 0.00 787 826 0.00 0.00 3,983 4,18

2 0.00 0.0

0 3,903 4,09

6 0.44 0.46

Future-cycle

Baseline 11.05 11. 19

05 4,289 4,28

9 18.35 18.35 31,365.00 31,3 65 65.63 6

5.63 30,716.00 30,716 2.64 2.64

Future cycle,

Post

Amendment 11.05 11. 19

05 5,115 5,11

5 18.35 18.35 35,547 35,

547 65.63 6

5.63 34,812 34,

812 2.99 2.99

Change from the Baseline, Future cycles 0.00 0.00 826 826 0.00 0.00 4,182 4,18

2 0.00 0.0

0 4,096 4,09

6 0.35 0.3 5

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



### Baseline costs are taken from Table 4-51. The 10,000 lb. reporting threshold is expected to increase industry cost by $ 28. 45 40 27.06 million during the first reporting cycle and by $21. 80 79 million during all future reporting cycles (See Table G-27).

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G-31 Table G-27: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. when All Proposed Amendments are Considered

Cost per

Part I of Report and

Submission

(2008$) Number

of Sites Cost for

Part II and

Record Keeping (2008$) Number of Reports (with Part II) Cost

for

Part III

and (2008$) Number

of Reports

(with

Part III) Total Burden (millions of 2008$)

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

First-year

Baseline $2,192 $2, 252 192 4,085 4,289 $1,346 $1,346 29,871 31,365 $5,117 $5,117 29,253 30,716 $198.84 $209.04
$208.78
First year,

Post

Amendment $2,192 $2, 252 192 4,872 5,11

5 $1,346 $1,346 33,854 35,547 $5,117 $5,117 33,156 34,812 $225.89 $237. 49 18

Change

from the Baseline, First year $0 $0 787 826 $0 $0 3,983 4,182 $0 $0 3,903 4,0

96 $27.06 $28. 45 40

Futurecycle

Baseline $695 $ 704

695 4,289 4,28

9 $1,109 $1,109 31,365 31,3

65 $4,047 $4,047 30,716 3 0,716 $162.08 $162

Future cycle, Post

- Amendment $695 $ 704

695 5,115 5,11

5 $1,109 $1,109 35,547 35,5

47 $4,047 $4,047 34,812 3 4,812 $183.87 $183. 92 87

Change

from the Baseline,

Future cycles $0 $0 826 826 $0 $0 4,182 4,182 $0 $0 4,096 4,0

96 $21.79 $21. 80 79

Note: Values in Change from the Baseline rows are calcula ted by subtracting the correspon ding baseline value from the postamendment value.



### The annual industry burden over a 2 5 0 -year period is shown in Table G-28. Over a 20 25 -year period,

the total Agency industry burden will would increase by 1.88 2.12 million hours when all the proposed

amendments are considered.

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

,

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting

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

1 2007 to 2011 3.24 3.68 0.44

2 2012 to 2015 2.64 2.99 0.35

3 2016 to 2019 2.64 2.99 0.35

4 2020 to 2023 2.64 2.99 0.35

5 2023 to 2027 2.64 2.99 0.35

6 2026 to 2031 2.64 2.99 0.35

Total 16.43 18.64 2.21
Annual Average 0.66 0.75 0.09



### Table G-29 shows the annual industry cost over a 20 25 -year period as a result of lowering the reporting threshold. EPA estimates that a 10,000 lb. reporting threshold would increase costs by

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

G-32 approximately $1 15. 64 56 36.00 million. Annualized costs range from $ 6.13 5.78 5.18 million with a three percent discount rate to and $ 6. 60 12 4.84 million with a seven percent discount rate.

Table G-29: Change in Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. and All Other Amendments when All Proposed Amendments are Considered

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting

Cycle 1 Years
(2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $198.84 $225.89 $27.06

2 2012 to 2015 $162.08 $183.87 $21.79

3 2016 to 2019 $162.08 $183.87 $21.79

4 2020 to 2023 $162.08 $183.87 $21.79

5 2023 to 2027 $162.08 $183.87 $21.79

6 2026 to 2031 $162.08 $183.87 $21.79

Total $1,009.25 $1,145.25 $136.00
Annual Average $40.37 $45.81 $5.44

Annualized at 3% $38.40 $43.58 $5.18

Annualized at 7% $35.83 $40.66 $4.84



### As previously explained in Section G.3.1, the Agency burden per-report will not change as a result of lowering the reporting threshold. However, the number of reports and the number of sites submitting reports will increase. Table G-30 contains the Agency burden as a result of lowering the threshold for reporting when all the other amendments are consider ed. EPA estimates the Agency burden will increase by 48 hours in the first reporting cycle and 51 hours during each future reporting cycle. Formatted Table

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G-33 Table G-30: Agency Burden as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered

Burden to

Process

Part I

Submission

(hours) Number

of Sites Burden

to

Process

Part II (hours

per report) Number

of Reports

(with Part II) Burden to

Process

Part III (hours

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

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

Baseline

Baseline 0.002 0.002 4,085 4,2

89 0.0056 0

.006 29,871 3 1,365 0.0063 0.0

06 29,253 30,7

16 2,439 2,456

PostAmendment

Post

Amendment 0.002 0.002 4,872 5,1

15 0.0056 0

.006 33,854 3 5,528 0.0063 0.0

06 33,156 34,8

12 2,487 2,507 Change from

the Baseline Change from

the Baseline 0 0.0 00 787 826 0 0.000 3,983 41

63 0 0.000 3,903 4,096 48.29 51
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 correspondi ng baseline value from the postamendment value.



### Table G-31 contains the Agency cost as a resu lt of lowering the reporting threshold. Baseline values are taken from Table 5-41. Lowering the 10,000 lb. threshold is expected to increase the Agency cost by approximately $5,000 during the first reporting cyle and $5,300 in per future reporting cycle s

.

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G-34 Table G-31: Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered

Cost to

Process

Part I

Submission

(2008$) Number

of Sites Cost to

Process

Part II (2008$

per report) Number

of Reports

(with Part II) Cost to

Process

Part

III (2008$

per report) Number

of Reports

(with

Part III) Agency Burden (2008$)

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

Baseline $0.203 4,085 $0.58 29,871 $0.66 29,253 $37,396

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 Baseli

ne $0.203 $0.20 4,289 4,2

89 $0.58 $0.58 31,365 31,

365 $0.66 $0.66 30,716 3 0,716 $39,266 $39,266 Future cycle,

Post

Amendment Po

st

- Amendment $0.203 $0.20 5,115 5,1

15 $0.58 $0.58 35,547 35,

528 $0.66 $0.66 34,812 3 4,812 $44,554 $44,554 Change from the Baseline,

Future cycles Change

from the

Baseline $0.00 0.000 826 826 $0.00
$0.00 4,182 4,16

3 $0.00
$0.00 4,096 4,0

96 $5,287 $5,287

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



### The annual Agency burden over a 2 5 0 -year period is shown in Table G-32. Over a 2 5 0 -year period, the total Agency burden would increase by 302 253 hours over a 20

- year period when all the proposed

amendments are considered.

Table G-32: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered

Year Current Post

- Amendment Burden (hours) Future Post

- Amendment

Burden (hours) Total Change in Agency Burden (hours)

2011 2,456 2,507 51

2012 0 0 0

2013 0 0 0

2014 0 0 0

2015 2,456 2,507 51

2016 0 0 0

2017 0 0 0

2018 0 0 0

2019 2,456 2,507 51

2020 0 0 0

2021 0 0 0

2022 0 0 0

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G-35 Year Current Post

- Amendment Burden (hours) Future Post

- Amendment

Burden (hours) Total Change in Agency Burden (hours)

2023 2,456 2,507 51

2024 0 0 0

2025 0 0 0

2026 0 0 0

2027 2,456 2,507 51

2028 0 0 0

2029 0 0 0

2030 0 0 0

Total 12,282 12,536 253
Annual Average 614 627 13

Baseline Burden Post-Alternative Option Burden Change from

Baseline Reporting Cycle Years

hours hours Hours

1 2007 to 2011 2,439 2,487 48.29

2 2012 to 2015 2,456 2,507 50.69

3 2016 to 2019 2,456 2,507 50.69

4 2020 to 2023 2,456 2,507 50.69

5 2023 to 2027 2,456 2,507 50.69

6 2026 to 2031 2,456 2,507 50.69

Total 14,720.86 15,022.62 301.76
Annual Average 588.83 600.90 12.07



### Table G-33 contains the annual Agency cost over a 2 0 5 -year period

, as a result of lowering the reporting threshold. EPA estimates that a 10,000 lb. reporting threshold will increase the Agency cost by approximately $ 31,5 26,4 00 over 25 years . Annualized increases in costs range from $1, 100 460 with a seven percent discount rate to and $1, 200 380 with a three percent discount rate.

Table G-33: Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb. and All Other Amendments when All Proposed Amendments are Considered

Baseline Cost Post-Alternative Option Cost Change from

Baseline Reporting Cycle Years

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

1 2007 to 2011 $37,396 $42,433 $5,037

2 2012 to 2015 $39,266 $44,554 $5,287

3 2016 to 2019 $39,266 $44,554 $5,287

4 2020 to 2023 $39,266 $44,554 $5,287

5 2023 to 2027 $39,266 $44,554 $5,287

6 2026 to 2031 $39,266 $44,554 $5,287

Total $233,727 $265,201 $31,474
Annual Average $9,349 $10,608 $1,259

Annualized at 3% $8,770 $9,951 $1,181

Annualized at 7% $8,020 $9,100 $1,080

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

G-36 Year Current Post

- Amendment Cost (2008$ ) Future Post

Amendment

Cost (2008$) Total Change In Agency Cost (2008$)

2011 $39,266 $44,554 $5,287

2012 $0 $0 $0

2013 $0 $0 $0

2014 $0 $0 $0

2015 $39,266 $44,554 $5,287

2016 $0 $0 $0

2017 $0 $0 $0

2018 $0 $0 $0

2019 $39,266 $44,554 $5,287

2020 $0 $0 $0

2021 $0 $0 $0

2022 $0 $0 $0

2023 $39,266 $44,554 $5,287

2024 $0 $0 $0

2025 $0 $0 $0

2026 $0 $0 $0

2027 $39,266 $44,5 54 $5,287

2028 $0 $0 $0

2029 $0 $0 $0

2030 $0 $0 $0

Total $196,331 $222,769 $26,437
Annual Average $9,817 $11,138 $1,322

Annualized at 3% $10,256 $11,637 $1,381

Annualized at 7% $10,834 $12,293 $1,459

G.3.3 Small Entity Analysis



### The following section provides a preliminary assessment of the impact that a 10,000 lb. reporting threshold may have on small entities by examining the relationship between the compliance costs and company sales for small companies. This analysis is based on the methodology found in Chapter 8 of this report. All costs and burdens are estimated under the assumption that all the proposed amendments have been enacted. EPA estimated 3.89 manufacturing sites per global parent company in Chapter 8 of this report; 41.3 percent of global parent companies (466 companies) are considered small under the SBA employment-based definition 23 

### , and 24.8 percent (280 companies) are considered small under the TSCA

sales-based definition 24 

### . EPA also estimated an average of approximately 1.76 sites per small company under the employment-based definition of small 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.

23 Threshold of 1,000 employees.

24 Total annual sales of the company, combined with thos e of any parent company, are below $40 million and annual production volume or importation volume at the facility is le ss than or equal to 100,000 lb.; or total annual sales of the company, combined with those of any parent company, are below $4 million.

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G-37 Table G-29 above shows the cost to the industry as a result of annual reporting. Because these costs would be incurred once every four years under a proposed four-year reporting cycle, these costs were summed and annualized over four years at both a three percent and seven percent discount rate 25 

### . As
shown in Table G-34 below , these costs were divided by the total num ber of sites expected to submit data, for the annualized cost per site. This was multiplied by the 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 deri ve the cost-to-sales ratio.

As shown in Table G-34 under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $ 12, 392 363 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 $ 13, 518 486 12,931 or lower. The cost-tosales ratio for an average small company under the sales-based definition would be 0.11 percent or less.

Using the highest annual cost shown in Table G-34 of $ 13, 518 486 12,931 a small company would have to have annual sales of less than $1. 36 35 29 million in order to have a co st-to-sales ratio larger than
one percent.

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

Employment-based Definition Sales-based Definition

3% Discount Rate 7% Discount

Rate 3% Discount

Rate 7%

Discount

Rate

Incremental Costs of 10,000 lb. threshold $27,055,019 $28, 446,723 396,869

Incremental Costs of Proposed Other

Amendments $91,871,064 $102,073,745 $101,814,807

Total Annualized Costs $31,062,459 $ 34, 090,811 010,158 $32,813,387 $36,012,441 $35,927,241 $31,062,459 $3 4, 090,811 010,158 $32,813,387 $36,012,441 $35,927,24

1

Total Number of Sites 5,115 4,872

Annualized Costs per Site $6,376 $6, 665 649 $6,735 $7, 041 024 $6,376 $6, 665
649 $6,735 $7, 041 024 Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $11,221 $11, 731 703 $11,854 $12, 392
363 $12,241 $12, 797 767 $12,931 $13, 518 486

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

Cost-to-Sales Ratio 0.0027% 0.00

28% 0.0029% 0.0030% 0.1036% 0. 108

3% 1080% 0.1094% 0. 11

44% 1141%
Number of Companies Potentially Affected 466 280

25 A seven percent discount rate, reflecting the opportunity cost of capital, is consiste nt with OMB Circular A-4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.

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H-1 

## Appendix H. Additional Expo sure-Related Data Elements

EPA is considering the collection of additional exposure-related data, similar to the data collected under the TSCA section 5 New Chemicals Program, to further enhance the Agency’s capabilities in conducting screening-level risk assessments of chemical substances reported to the TSCA Inventory Update, and would substantially improve EP A’s ability to quantify chemical risks. The ability to quantify chemical risks would further improve the Agency’s ability to identify and manage those risks.

The additional exposure-related data elements and brief descriptions are as provided in Table H-1: EPA is soliciting comment in the preamble for the proposed IUR rule amendments on the suitability of these data elements for enabling the Agency to develop more comprehensive and complete screening assessments of the risks that may be encountered in manufacture, processing, and use of chemicals. Additionally, the Agency is interested in whether any additional data should be collected, and in any other considerations relating to the collection of addition al data. EPA is also soliciting comment on the best method to collect these data, and whether processors, in addition to manufacturers, should be required to report processing and use data. The Agency is considering three approaches to collecting the data. They are: 1) integrating these data elements into the IUR ; , 2) promulgating a new reporting mechanism under TSCA section 8(a ); ), and, 3) using TSCA section 11(c) subpoena authority to collect these data from known manufacturers (including importers). These additional data elements are not included as part of the current proposal; therefore, they are not addressed in the main part of this economic analysis.

This Appendix provides a preliminary estimate of the burden and cost of collecting data for these additional data elements under the first approach of integrating the data elements into the IUR rule requirements.

Table H-1: Description of Additional Data Elements

Data Element Description Manufacturing Process Information

1 Description of manufacturing process Provide a process flow diagram which de scribes the manufacturing operations involving the chemical subs tance. “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 formul ated into gels, mixtures, suspensions, solutions, etc. and in which the substance is transferred into interim storage or shipping containers. Indicate in the diagram the en try and exit points of the chemical substance. Number all points from which th e chemical substance will be released to the environment or to control equi pment, including small or intermittent releases (e.g. some cleaning releases, dr um residues, etc.) and trace amounts of

the substance.

2 Continuous or batch

process Indicate whether the chemical substance is manufactured in discrete batches or is produced by continuously adding 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 amoun t of substance in pounds manufactured each day.

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

5 Days of operation per year or number of batches

per year If the chemical substance is produced in discrete batches, indicate the number of batches necessary to produce the report ed 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.

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H-2 Data Element Description

6 Unit operations List the unit operations needed to produ ce 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-g allon 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, transf erring 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, indi cate the physical form of the substance at the time of exposure.

11 Maximum concentration For each worker activity, in dicate 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 sp ecific 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 occupa tional exposure monitoring data is included. Summary should include information on the number of workers involved, number of samples taken, types of samples (area or personal), average and standard deviations of exposure. Manufacturing Releases to the Environment

15 Release source (or release point) For each point of release containing the ch emical substance, identify and describe the point in the process description at wh ich the release occurs (e.g. releases due to spillage, residues, separation losses, an d 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, su rface water, on-site or off-site land or incineration, POTW, or other (specify)) which describes the release stream containing the chemical



### . indicate the media (air, liquid or aqueous solution, solid) and type of release [stack air, fugitive air, surface water, on

- site or off

- site land or incineration, publicly

- owned treatment works ( POTW ) or other (specify)] of a release stream containing the chemical substance.

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

18 Quantity of substance released a) directly to the environment or b) into control technology to the

environment b) into control technology to the environment in pounds per day for continuous operation or pounds per batc h for batch operations.

19 Control technology For each release, describe the type of tech nology used to contro l the release of the substance to the environment. Examples of control technologies include carbon filter, scrubber and biological treat ment (primary, secondary, etc.). Formatted: Font: 10 pt

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

H-3 Data Element Description

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 atmosphe re, or is otherwise disposed (specify).

22 Additional release related

information attached Indicate whether a description of the releas es, calculations or monitoring data on the quantities of releases, or additional in formation 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 subs tance. “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 formul ated 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 th e chemical substance will be released to the environment or to control equi pment, 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 wh ich 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 batche s, indicate the batch time (hours/batch); if the substance is proces sed 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 batche s, 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 proces s the chemical substa nce. 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.

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 tr ucks, and 20,000-gallon railcars.

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

H-4 Data Element Description Industrial Processing or Use Occ upational 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, transf erring substances from one container to another, changing filters, filling drums, loading and loading tank cars or trucks,

etc. Activities must be described even if workers wear protective equipment.

32 Duration and frequency of worker exposure For each worker activity, provide the numbe r of hours per day and the number of days per year during which the worker is engaged in processing or using the

chemical substance.

33 Physical form For each worker activity, indi cate the physical form of the substance at the time of exposure.

34 Maximum concentration For each worker activity, in dicate 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 sp ecific types of protective equipment and engineering controls that will be employ ed 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 occupati onal exposure monitoring data is included. Summary should include information on the # of workers involved, # of samples taken, types of samples (area or personal), average and standard deviations of exposure. Industrial Processing or Use Releas es to the Environment Information

38 Release source (or point) For each point of release containing the ch emical substance, identify and describe the point in the process description at wh ich the release occurs (e.g. releases due to spillage, residues, separation losses, an d other sources from each batch or each day).

39 Media and type of release For each release, indicate the media (air, liquid or aqueous solution, solid) and type of release [stack air, fugitive air, surface water, on

- site or off

- site l and or incineration, POTW or other (specify)] of a release stream containing the

chemical substance. type (gas or vapor, aqueous or liquid solution, or solid) and media (stack air, fugitive air, surface water, on-site or off-site land or incineration, POTW, or other (specify)) which describes the release stream containing the chemical.

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

41 Quantity of substance released a) directly to the environment or b) into control technology to the

environment b) into control technology to the environment in pounds per day for continuous operation or pounds per batc h for batch operations.

42 Control technology For each release, describe the type of tech nology used to contro l the release of the substance to the environment. Examples of control technologies include carbon filter, scrubber and biological treat ment (primary, secondary, etc.).

43 Efficiency of control technology Indicate the established efficiency of 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 releas es, calculations or monitoring data on the quantities of releases, or additional in formation on control technologies and/or

treatment is attached. Formatted: Font: 10 pt

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

H-5 Data Element Description Commercial Use Occupation al Exposure Information

46 Description of

commercial use Describe the commercial use(s) of produc ts 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 commerci al establishments who are reasonably likely to be exposed to the chemical substance.

49 Physical form of commercial product Indicate the physical form of the product containing the chemical substance.

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 th e 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 cons umer product containing the chemical substance, for example, chemicals in products that will be sprayed via pump sprayer or aerosols; products that are pou red, mixed, applied by hand/mechanical device; chemicals that can be released vi a diffusion, evaporation, abrasion, etc., from articles; or chemicals that are incor porated 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 frequenc y of consumer use, e.g. used more than once a day, used once a day, used several times a week, etc.

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

H-6 

### H.1 Estimated Number of Affected Entities

In order to estimate the burden and cost of collecting the additional data, EPA assumes that the impacts on manufacturers and processors would be different. Manufacturers would be required to complete an integrated Form U, which would be a Form U revised to incorporate the new data elements. For the purpose of this analysis, EPA assumes that all of the amendments currently being proposed also

would be included. EPA assumes that processors, on the other hand, would be required to complete a

tailored Form U that focus ing es only on the additional processing and use information.

Manufacturers

For manufacturers, EPA assumes that the numbers of sites and reports that would be affected by the requirement to provide additional exposure-related data would be the same as the numbers of manufacturing sites and reports as estimated in Section 4.5 of this report. As shown in Table 4-46, 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 4-47 , I i n future reporting cycles a total of 4,289 manufacturers are expected to submit a total of 31,365 reports

, including both full and partial reports , when all the propose d amendments are considered . To the extent

that any specific chemicals would be exempt from the requirement to provide these additional data elements, the number of manufacturers and reports may be an overestimate.

Processors

The number of processors that may be affected by a requirement to submit the additional data elements was estimated using data from EPA’s Toxic Release Inventory (TRI) reporting program. Under the TRI program, EPA collects information annually on toxic chemical releases and waste management activities from manufacturers, processors, and users of a set of 581 toxic chemicals and 30 toxic chemical categories. The chemicals regulated under the TRI program are a smaller set than those regulated under the IUR rule, but the TRI data collection activity currently is the most comprehensive information

collection that EPA administers for chemical processors. Therefore, EPA assumes that information on processors who report under TRI is a suitable proxy for processors who may report under an amended

IUR rule.

EPA used TRI Form R submission data from the 2007 TRI Public Data Release for 2002 through 2005 (to be consistent with the time period of the most recent IUR reporting cycle). EPA filtered the data to include only IUR chemicals (i.e., the chemicals listed in the public 2006 IUR database ) 26



### . ). 27 

### Processors submitted TRI data on an average of 220 of the IUR chemicals during each of the four years of interest. For this analysis, EPA counted as a “processor” each TRI submitter that indicat ing ed that it processes a toxic chemical as a reactant, as a formulation component, as an article component, for repackaging, or as an impurity; or, that it otherwise uses the chemical as a chemical processing aid. 28 

### Because EPA assumes

that any company that both manufactures and processes a chemical will be considered a manufacturer for the purposes of IUR reporting of the additional data elements, TRI submitters who indicated that they also

manufactured or otherwise used a chemical were filtered out of the dataset.

26 The TRI program may collect data on ce rtain 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.

27 The TRI program may collect data on certain chemical s for which IUR reporting is not required. A list of

CASRNs for the non-confidential IUR ch emicals was found at “Non-confident ial 2006 IUR Records by Chemical, including Manufacturing, Processing and Use Inform ation” http://cfpub.epa.gov/iursearch/index.cfm?s=chem Accessed August 30, 2009.

28 TRI submitters indicate their activities and uses of the toxic chemical at the facility in Part II Section 3 of Form

R.

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

H-7 The TRI data revealed that an average of 137 processors reported information per TRI chemical. However, the average value is greatly skewed by certain high-volume chemicals that are processed by a large number of processors. 29 

### Therefore, EPA chose to use the median number of 15 processors per chemical, assuming it to be more representative of the universe of chemical processors who would report

under the IUR rule.

Information was reported for a total of 6,140 chemicals under the IUR rule in 2006. By applying the average number of processors per chemical derived from TRI data, EPA estimates that a total of 92,100 reports would be submitted by processors as a result of this option (15 x 6,140 = 92,100).

This approach is limited to the extent that the universe of processors is different under the TRI regulation and IUR rule. Because the sets of chemicals covered under the TRI and IUR rules are different, the median number of processors per chemical may be an over- or underestimate. (EPA attempted to minimize this by filtering the TRI data to only include known IUR chemicals, but not all IUR chemicals would be subject to TRI reporting requirements.) Add itionally, the TRI rule applies to facilities included within a specific set of NAICS codes; the IUR rule presently does not limit its applicability to a defined set of NAICS codes. This may cause the number of processors estimated here to be an underestimate. Furthermore, “processor” may be defined differ ently by the two rules; any specific criteria that EPA may use to define a “processor” for the purpose of the IUR rule may cause the median number of processors per chemical estimated here to be an overestimate. Finally, the data used in this analysis was for submissions of TRI Form R only. This was done because Form A, the other, simpler, TRI reporting form, does not request information that would identify the s ubmitter as a processor or manufacturer. Form R is used for high-volume chemicals (i.e., those manufactured, processed, or otherwise used in amounts greater than one million pounds) or for chemicals meeting other specific criteria; as a result, processors of small volumes may not be included, causing the median number to be an under

- estimate.



### H.2 Industry Burden Estimate

Manufacturers

Given the similarity between the additional exposure-related data elements and the exposure data collected under EPA’s New Chemical Program, EPA assumes that the incremental cost for the additional

data elements will be similar to the estimate d burden to complete a premanufacture notice (PMN ) 30



### . ). 31


### Therefore, EPA calculated the burden to complete an “integrated Form U” (that is, a Form U modified to include the additional data elements) by adding the base burden for a full form (estimated in Section 4.5 of this report) to the burden to complete a PMN. EPA assumes that every site will be required to complete the additional exposure information.

The burden of completing a paper PMN form was estimated in the supporting statement for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requi rements 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

29 For example, an average of 3,240 proc essors per year reported for lead alone.

30 Anyone who plans to manufacture or im port a new chemical substance for a non

- exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice be fore initiating the activity. This premanufacture notice, or PMN, must be submitted at leas t 90 days prior to the manufacture or import of the chemical.

31 Anyone who plans to manufacture or import a new chem ical substance for a non-exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice be fore initiating the activity. This premanufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical.

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

H-8 Section 4.4.27 of this economic analysis), EPA reduced the estimated burden to 93 hours. Because paper filing would not be permitted under the amendment, all clerical burden is eliminated. Consistent with the method described in Section 4.2.6 of this report, the future cycle burden was calculated by applying a weighting factor of 80 percent to the first cycle burden, resulting in an estimated burden of 74.4 hours.

Using the numbers of manufacturing sites and reports as estimated in Section 4.5 of this report, EPA

estimates that the total burden to manufacturers to submit a dditional exposure-related da ta as part of their IUR reporting is 2. 92 78 million hours in the first reporting cycle and 2.33 million hours in all future reporting cycles (See Table H-2: below ).

This approach is limited to the extent that the data elements requested in any modification to the IUR match the PMN form and the burden it imposes. Furthermore, the PMN form includes some site and chemical identification data which may overlap with the data provided on IUR Part I; however, this overlap was considered to be minimal.

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

Burden for

Rule Familiarization,

Compliance Determination,

Submission and to Prepare Part

I (hours per site) Number

of Sites Burden

for

Record Keeping

and to Prepare

Part II (hours

per report) Number

of Reports

(with Part II) Burden

to Prepare

Part III (hours

per report) Number

of Reports

(with

Part III) Burden

to Complete

New

Data

elements (hours

per report) Number

of Reports

(with

New

Data elements) Industry

Burden (millions

of hours)

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a * b)+ (c * d)+ (e * f)+ (g*h) Manufacturer Burden (First Cycle) Considering all Proposed Amendments (As Estimated in Table 4-47) 35.17 36.12 35.1

7 4,085 4,

289 22.19 22

.19 29,871 3 1,365 83.02 83

.02 29,253 3 0,716 0.00 0 0 0 3.24 3.40

Total Manufacturer Burden (First Cycle) Including Additional Data

Elements 35.17 36.12 35.1

7 4,085 4,

289 22.19 22

.19 29,871 3 1,365 83.02 83

.02 29,253 3 0,716 93 93 29,871 31 ,365 6.01 6.32

Incremental Increase due to Additional Data Elements (First Cycle) 0.00 0.00 0 0 0.00 0.0

0 0 0 0.00 0.0

0 0 0 93.00 93 29,871 31 ,365 2.78 2.92

Manufacturer Burden (Future Cycles) Considering all Proposed Amendments (As Estimated in Table 4-47) 11.05 11. 19 05 4,289 4,

289 18.35 18

.35 31,365 3 1,365 65.63 65

.63 30,716 3 0,716 0 0 0 0 2.64 2.64

Total Manufacturer Burden (Future Cycles) Including Additional Data

Elements 11.05 11. 19 05 4,289 4,

289 18.35 32

.57 31,365 3 1,365 65.63 65

.63 30,716 3 0,716 74.4 74 31,365 31 ,365 4.97 4.97

Incremental Increase due to Additional Data Elements (Future Cycles) 0.00 0.00 0 0.00 0.00 14.

21 0 0 0.00 0.0

0 0 0 74.40 74 31,365 31 ,365 2.33 2.33

Note: Values in Incrememtal Increase rows are calculated by subtracting the correspondi ng baseline value from the post-amendment value.



### Table H-3 contains the annual burden to manufacturers of the additional enhanced data elements over

a 2 0 5 -year period. The baseline burden estimates for completing Form U after all the proposed

amendments are considered is taken from Table 4-55. EPA estimates that over a 20 25 -year period, the total burden to manufacturers for completing Form U, including the additional data elements, would be

26. 21 20 30.88 million hours. The additional data elements add 1 2.25 4.45 million additional hours to the industry burden over this period.

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

H-9 Table H-3: Schedule of Annual Industry Burden to Manufacturers if All Proposed Amendments Are Implemented

Reporting Cycle 1 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

that the burden on processors to complete an IUR form tailored to processing and use information would

be similar to that of a PMN form alone.

Using the number of processors and number of reports as estimated in Section H.1 above , the total burden to processors to submit exposure-related data elements is estimated to be 8.57 million hours in the first reporting cycle and 6.85 million hours in future reporting cycles, and is shown in Table H-4.

This approach is also limited to the extent that the data elements requested from processors in any modification to the IUR match the PMN form and the burden it imposes.

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

H-10 Table H-4: Change in Industry Burden to Processors as a Result of Additional Exposure-Related
Data Elements

Burden to Complete

Enhanced

Data

Elements (hours per

report) Number

of Reports

(with

Enhanced

Data Elements) Industry

Burden (millions of

hours)

Processor Burden (First Cycle) Considering all Proposed Amendments 0 0 0.00

Total Processor Burden (First Cycle) Including Additional Data Elements 93 92,100 8.57

Incremental Increase due to Additional Data Elements (First Cycle) 93 92,100 8.57

Processor Burden (Future Cycles) Considering all Proposed Amendments 0 0 0.00

Total Processor Burden (Future Cycles) Including Additional Data

Elements 74 92,100 6.85

Incremental Increase due to Additional Data Elements (Future Cycles) 74 92,100 6.85

Note: Values in Incremental Increase rows are calculated by subtracting th e corresponding baseline value from the postamendment value.



### Table H-5 contains the annual burden to processors of the additional enhanced data elements over a

2 5 0 -year period. EPA estimates that over a 20 25 -year period, the total burden to processors for completing Form U, including the additional data elements, would be 35.97 42.83 million hours. This burden consists of labor to complete only the additio nal data elements because processors currently are not required to submit Form U.

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

Reporting Cycle Years Baseline Form U

Burden (When all

Amendments are

Considered) (millions of hours) Burden for

Enhanced

Data

Elements (millions of

hours) Total Industry Burden (millions of hours)

1 2007 to 2011 0.00 8.57 8.57

2 2012 to 2015 0.00 6.85 6.85

3 2016 to 2019 0.00 6.85 6.85

4 2020 to 2023 0.00 6.85 6.85

5 2023 to 2027 0.00 6.85 6.85

6 2026 to 2031 0.00 6.85 6.85

Total 0.00 42.83 42.83
Annual Average 0.00 1.71 1.71



### The total industry burden to both manufacturers and processors if EPA were to require them to provide the additional exposure data is calculated by summing the total additional burdens for manufacturers and processors. The result is an estimated 11. 48 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

H-6 below

.

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

H-11 Table H-6: Change in Industry Burden to Manufacturers and Processors as a Result of Additional Exposure-Related Data Elements

Total Burden to

Manufacturers (millions of hours) Total Burden to

Processors (millions of

hours) Total Industry

Burden (millions of

hours)
Burden (First Cycle) Considering all Proposed Amendments 3.40 3.24 0.00 3.24 3.40

Total Burden (First Cycle) Including Additional

Data Elements 6.32 8.57 14.88

Incremental Increase due to Additional Data Elements (First Cycle) 2.78 2. 92 8.57 8.57 11.34 11.48

Burden (Future Cycles) Considering all Proposed Amendments 2.64 0.00 2.64

Total Burden (Future Cycles) Including

Additional Data Elements 4.97 6.85 11.83

Incremental Increase due to Additional Data Elements (Future Cycles) 2.33 6.85 9.19

Note: Values in Incremental Increase rows are calculated by subtracting th e corresponding baseline value from the postamendment value.



### Table H-7 contains the annual burden to industry of the additional enhanced data elements over a

2 5 0 -year period. The baseline burden estimates for completing Form U after all the proposed amendments

are considered is taken from Table 4-52. EPA estimates that over a 20 25 -year period, the total burden to industry for completing Form U, including the additional data elements, would be 62.18 73.70 million

hours. The additional data elements add 48.23 57.27 million additional hours to the industry burden over this period.

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

Reporting Cycle Years Baseline Form U

Burden (When all Amendments are Considered) (millions of hours) Form U

Burden with

Enhanced

Data

Elements (millions of

hours) Total Industry Burden (millions of hours)

1 2007 to 2011 3.24 11.34 14.58

2 2012 to 2015 2.64 9.19 11.82

3 2016 to 2019 2.64 9.19 11.82

4 2020 to 2023 2.64 9.19 11.82

5 2023 to 2027 2.64 9.19 11.82

6 2026 to 2031 2.64 9.19 11.82

Total 16.43 57.27 73.70
Annual Average 0.66 2.29 2.95

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

H-12 

### H.3 Industry Cost Estimate

EPA calculated the per-report cost to industry of the additional data elements by multiplying the managerial and technical burdens found in Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for

Chemical Substances , EPA ICR No: 574.12 (EPA, 2003) by the wage rates for technical and managerial

staff described in Section 4.2.1. No clerical cost was calculated because EPA assumes that the proposed electronic submission requirement will eliminate all clerical burden for processing and submitting Form U. As shown in Table H-8, EPA estimates the additional per report cost to be $5,673 in the first reporting cycle and $4,539 in all future reporting cycles, as a result of the requirement to report the additional data.

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

Technical Managerial Total

Burden (hours) Wage

Rate (2008$) Cost (2008$) Burden (hours) Wage

Rate (2008$) Cost (2008$) Burden (hours) Cost (2008$)

PMN Burden/Cost per Report (First Cycle) 75 $58.84 $4,413 18 $70.03 $1,260 93 $5,673

PMN Burden/Cost per Report (Future Cycles) 60 $58.84 $3,530 14.4 $70.03 $1,008 74.4 $4,539



### Manufacturers

The cost to manufacturers of the additional data elements was derived as shown in Table H-9. EPA estimates the option will cost manufacturers an additional $ 178 169 million during the first reporting cycle and an additional $142 million during all future reporting cycles.

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

H-13 Table H-9: Change in Industry Cost to Manufacturers as a Result of Additional Exposure-Related
Data Elements

Cost for Submission, Compliance Determination,

Rule Familiarization, and to Prepare

Part I (2008$) Number

of Sites Cost for

Record Keeping

and to Prepare

Part II (2008$) Number

of Reports

(with Part II) Cost to Prepare

Part III (2008$) Number

of Reports

(with Part III) Cost to Complete

New Data

Elements (2008$) Number

of Reports

(with

New Data Elements) Industry

Cost (millions of 2008$)

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a * b) +(c *d)+ (e * f)+(g*h)

Manufacturer Cost (First Cycle) Considering all Proposed Amendments (As Estimated in Table 4-48) $2,192 $2, 252 192 4,085 4,

289 $1,346 $1,346 29,871 31,365 $5,117 $5,117 29,253 3 0,716 0 0 0 0 $198.84 $

209.4 $20

8.78

Total Manufacturer Cost (First Cycle) Including Additional Data Elements $2,192 $2, 252 192 4,085 4,

289 $1,346 $1,346 29,871 31,365 $5,117 $5,117 29,253 3 0,716 $5,673 $5,673 29,871 31 ,365 $368.31 $

386. 99 73

Incremental Increase due to

Additional Data Elem ents (First Cycle) $0.00 $0.00 0 0 $0.00
$0 .00 0 0 $0.00
$0.00 $0.00 0 $5,673.44 $5,673 29,871 31 ,365 $169.47 $

177.95

Manufacturer Cost (Future Cycles) Considering all Proposed Amendments (As Estimated in Table 4-48) $695 $ 704 695 4,289 4,

289 $1,109 $1,109 31,365 31,365 $4,047 $4,047 $30,716 30,716 0 0 0 0 $162.08 $

162. 12 08

Total Manufacturer Cost (Future Cycles) Including Additional Data

Elements $695 $ 704 695 4,289 4,

289 $1,109 $1,109 31,365 31,365 $4,047 $4,047 30,716 3 0,716 $4,538.75 $4,539 31,365 31 ,365 $304.44 $

3 ,3 04. 48 4

4

Incremental Increase due to Additional Data Elements (Future Cycles) $0.00 $0.00 0 0 $0.00
$0.00 0 0 $0.00
$0.00 0 0 $4,539 $4,539 31,365 31 ,365 $142.36 $

142.36

Note: Values in Incremental Increase rows are calculated by subtracting the correspondi ng baseline value from the post-amendment value.



### Table H-10 presents the annual and annualized cost s estimates to manufacturers of competing Form U with the additional exposure-related data elements. The baseline cost estimates for completion of Form

U come from Table 4-56. Over a 20 25 -year period, EPA estimates that the annualized cost to manufacturers will be $ 85 72 million at a three percent discount rate, and $ 91 67 million at a seven percent discount rate.

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

Reporting

Cycle Years Baseline Form U Cost (When all

Amendments are

Considered) (millions 2008$) Form U Cost for

Enhanced Data

Elements (millions 2008$) Total Cost To Industry (millions 2008$)

1 2007 to 2011 $198.84 $169.47 $368.31

2 2012 to 2015 $162.08 $142.36 $304.44

3 2016 to 2019 $162.08 $142.36 $304.44

4 2020 to 2023 $162.08 $142.36 $304.44

5 2023 to 2027 $162.08 $142.36 $304.44

6 2026 to 2031 $162.08 $142.36 $304.44

Total $1,009.25 $881.26 $1,890.51

Annual Average $40.37 $35.25 $75.62

Annualized at 3% $38.40 $33.47 $71.88

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

H-14 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 H-11, EPA estimates the cost to processors to be $523 million in the first reporting cycle and $418 million in all future reporting cycles.

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

Cost to Prepare

New Data

Elements (2008$) Number of Reports (with New

Data Elements) Industry Cost (millions 2008$)

Processor Cost (First Cycle) Considering all Proposed Amendments 0 0 $0

Total Processor Cost (First Cycle) Including Additional Data

Elements $5,673 92,100 $523

Incremental Increase due to Additional Data Elements (First Cycle) $5,673 92,100 $523

Processor Cost (Future Cycles) Considering all Proposed Amendments 0 0 $0

Total Processor Cost (Future Cycles) Including Additional Data

Elements $4,539 92,100 $418

Incremental Increase due to Additional Data Elements (Future Cycles) $4,539 92,100 $418

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



### Table H-12 presents the annual and annualized costs estimates to processors of competing Form U with the additional exposure-related data elements. Over a 20 25 -year period, EPA estimates that the annualized cost to processors will be $ 116 116 million at a three percent discount rate, and $125 million at a seven percent discount rate.

Table H-12: Annual Increase in Industry Cost to Processors if All Proposed Amendments Are Implemented (2008$)

Reportng

Cycle Years Baseline Form U Cost (When all Amendments are Considered) (millions 2008$) Form U Cost

for Enhanced

Data Elements (millions 2008$) Total Cost To Industry (millions 2008$)

1 2007 to 2011 $0.00 $523.00 $523.00

2 2012 to 2015 $0.00 $418.00 $418.00

3 2016 to 2019 $0.00 $418.00 $418.00

4 2020 to 2023 $0.00 $418.00 $418.00

5 2023 to 2027 $0.00 $418.00 $418.00

6 2026 to 2031 $0.00 $418.00 $418.00

Total $0.00 $2,613.00 $2,613.00
Annual Average $0.00 $104.52 $104.52

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

H-15 Annualized at 3% $0.00 $116.03 $116.03

Annualized at 7% $0.00 $125.45 $125.45

Year Baseline Form U Cost (When all Amendments

are C onsidered) (millions 2008$ ) Form U Cost for

Enhanced Data

Elements (millions 2008$ ) Total Cost To Industry (millions 2008$ )

2011 $0 $523 $523

2012 $0 $0 $0

2013 $0 $0 $0

2014 $0 $0 $0

2015 $0 $418 $418

2016 $0 $0 $0

2017 $0 $0 $0

2018 $0 $0 $0

2019 $0 $418 $418

2020 $0 $0 $0

2021 $0 $0 $0

2022 $ 0 $0 $0

2023 $0 $418 $418

2024 $0 $0 $0

2025 $0 $0 $0

2026 $0 $0 $0

2027 $0 $418 $418

2028 $0 $0 $0

2029 $0 $0 $0

2030 $0 $0 $0

Total $0 $2,195 $2,195
Annual Average $0 $110 $110

Annualized at 3% $0 $116 $116

Annualized at 7% $0 $125 $12 5



### Total estimated industry cost is presented in Table H-13 and is calculated by summing the costs to both manufactures and processors. EPA estimates the cost to the industry of the additional exposure elements, if both manufacturers and processor are required to provide the data, will be $ 700 701 692 million in the first reporting cycle and $560 million in all future reporting cycles.

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

H-16 Table H-13: Change in Industry Cost to Manufacturers and Processors as a Result of Additional Exposure-Related Data Elements

Total Cost to

Manufacturers (millions 2008$) Total Cost to

Processors (millions 2008$) Total Industry

Cost (millions 2008$)
Cost (First Cycle) Considering all Proposed Amendments $199 $ 209 $0 $0 $199 $ 209

Total Cost (First Cycle) Including Additional

Data Elements $368 $ 387 $523 $523 $891 $ 910

Incremental Increase due to Additional Data Elements (First Cycle) $169 $178 $523 $523 $692 $ 700 701

Cost (Future Cycles) Considering all Proposed Amendments $162 $ 162 $0 $0 $162 $ 162

Total Cost (Future Cycles) Including Additional

Data Elements $304 $ 304 $418 $418 $722 $ 722

Incremental Increase due to Additional Data Elements (Future Cycles) $142 $142 $418 $418 $560 $560

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



### Table H-14 presents the annual and annualized costs 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 2 0 5 -year period, EPA estimates that the annualized cost to the industry will be $ 201 166 million at a three percent discount rate, and $ 216 150 million at a seven percent discount

rate.

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

Reporting

Cycle Years Baseline Form U Cost (When all Amendments are considered) (millions 2008$) Form U Burden with

Enhanced data

Elements (millions 2008$) Total Cost To Industry (millions 2008$)

1 2007 to 2011 $198.84 $692.47 $891.31

2 2012 to 2015 $162.08 $560.36 $722.44

3 2016 to 2019 $162.08 $560.36 $722.44

4 2020 to 2023 $162.08 $560.36 $722.44

5 2023 to 2027 $162.08 $560.36 $722.44

6 2026 to 2031 $162.08 $560.36 $722.44

Total $1,009.25 $3,494.26 $4,503.51

Annual Average $40.37 $139.77 $180.14

Annualized at 3% $37.28 $129.14 $166.43

Annualized at 7% $33.48 $116.05 $149.53



### H.4 Agency Burden Estimate

Agency burden for both contractor and EPA staff related to document receipt, tracking and data entry quality control of data entry would increase with the promulgation of additional exposure-related data elements. To calculate the additional Agency burden associated with the additional data elements, EPA used the per-data element burden to the EPA after all the proposed amendments are considered, 0.00008 hours, as derived in Section 5.5). This burden was multiplied by the number of new data elements, 57 (as

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

H-17 listed in Table H-1) to calculate the total per-report burden of processing the new data elements for manufacturers, 0.0048 hours. EPA assumes that there will be no change in the fixed Agency costs associated with this modification to the IUR rule, as described in Table 5-3.

Manufacturers

All manufactures are expected to submit the additional data, increasing the Agency burden by 150 hours for all report years, as estimated in Table H-15 below . EPA does not expect the future reporting cycle burden to differ from first reporting cycle burden.

Table H-15: Change in Agency Burden to Process Manufacturer Data as a Result of Additional Exposure-Related Data Elements

Burden to

Process

Part I (hours) Number

of Sites Burden to

Process Part

II (hours) Number of Reports (with Part II) Burden to

Process

Part III (hours) Number of Reports (with Part III) Burden to

Process

New Data

Elements (hours) Number of Reports (with new

data elements) Agency

Burden (hours)

First Year,

Baseline Burden (All

Proposed Amendments) 0.0019 4,085 0.0056 29,871 0.0063 29,253 0 0 2,439

First year, With

Enhanced Data

Elements 0.0019 4,085 0.0056 29,871 0.0063 29,253 0.0048 29,871 2,582

Change, first

year 0 0 0 0 0 0 0.0048 29,871 143

Future-cycle

Baseline 0.0019 4,289 0.0056 31,365 0.0063 30,716 0 0 2,456

Future cycle,

Post

Amendment 0.0019 4,289 0.0056 31,365 0.0063 30,716 0.0048 31,365 2,607

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



### Table H-16 presents the estimated annual burden to the Agency of processing Form U with the additional exposure-related data elements. Over a 20 25 -year period, EPA estimates that the total Agency burden to process manufacturer data will be 13,034 15,6 00 hours.

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

H-18 Table H-16: Annual Increase in Agency Burden to Process Manufacturer Data if All Proposed Amendments Are Implemented

Reporting Cycle Years Baseline Form

U Burden (When all

Amendments are Considered) (hours) Form U

Burden with

Enhanced

Data

Elements (hours) Total Industry

Burden (hours)

1 2007 to 2011 2,439 143 2,582

2 2012 to 2015 2,456 150 2,607

3 2016 to 2019 2,456 150 2,607

4 2020 to 2023 2,456 150 2,607

5 2023 to 2027 2,456 150 2,607

6 2026 to 2031 2,456 150 2,607

Total 14,721 896 15,617
Annual Average 589 36 625

Year Baselin e Burden (When all Amendments are

C onsidered)

(hours) Form U Burden with

Enhanced D ata Elements (hours) Total Agency Burden (hours)

2011 2,456 150 2,607

2012 0 0 0

2013 0 0 0

2014 0 0 0

2015 2,456 150 2,607

2016 0 0 0

2017 0 0 0

2018 0 0 0

2019 2, 456 150 2,607

2020 0 0 0

2021 0 0 0

2022 0 0 0

2023 2,456 150 2,607

2024 0 0 0

2025 0 0 0

2026 0 0 0

2027 2,456 150 2,607

2028 0 0 0

2029 0 0 0

2030 0 0 0

Total 12,282 752 13,034 Annual Average 614.1 37.62 651.72



### Manufacturers and Processors Combined

Table H-17 shows the estimated burden to the Agency of processing the additional data submitted by processors. As described above, EPA expects to receive a total of 92,100 processor reports. The Agency

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

H-19 burden, per-report, to process the additional data elements is 0.0048 hours, and is the same for both processors and manufactures. Therefore, as shown in Table H-10, the Agency burden to process the processor data is approximately 442 hours for all reporting cycles.

Table H-17: Change in Agency Burden to Process Processor Data as a Result of Additional Exposure-Related Data Elements

Per-Report

Burden to Process

New Data Elements (hours) Number of Reports (with

New Data Elements) Agency Burden (hours)

Agency Burden to Process Processor Data Considering all Proposed Amendments 0.0000 0 0

Total Agency Burden Including Processing Additional Data

Elements for Processors 0.0048 92,100 442

Incremental Increase due to Additional Data Elements 0.0048 92,100 442

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



### Table H-18 presents the estimated annual burden to the Agency of processing Form U with the additional exposure-related data elements. Over a 20 25 -year period, EPA estimates that the total Agency burden to process processor data will be 2, 209 651 hours.

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

Reporting Cycle 1 Years Baseline Form U

Burden (When all

Amendments are

Considered)

(hours) Form U Burden with

Enhanced Data

Elements (hours) Total Industry

Burden (hours))

millions of hours millions of hours millions of

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

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

H-20 Year Baseline Burden (When all Amendments are

C onsidered)

(hours) Form U Burden with

Enhanced Data Elements (hours) Total Agency Burden (hours)

2011 0 442 442

2012 0 0 0

2013 0 0 0

2014 0 0 0

2015 0 442 442

2016 0 0 0

2017 0 0 0

2018 0 0 0

2019 0 442 442

2020 0 0 0

2021 0 0 0

2022 0 0 0

2023 0 442 442

2024 0 0 0

2025 0 0 0

2026 0 0 0

2027 0 442 442

2028 0 0 0

2029 0 0 0

2030 0 0 0

Total 0 2,209 2,209 Annual Average 0 110.5 110.5



### Table H-19 presents the burden to EPA of processing the additional data elements from both the processors and the manufacturers. This option is expected to increase the Agency burden by 59 2 3 hours for all reporting cycles.

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

Total Agency

Burden Total Burden of Processing Manufacturer data (hours) Total Burden of Processing Processor data (hours) (hours)

Burden (First Cycle) Considering all Proposed

Amendments 2,439 0 2,439

Total Burden (First Cycle) Including Additional Data

Elements 2,582 442 3,024

Incremental Increase due to

Additional Data Elements (First Cycle) 143 442 585

Burden (Future Years) Considering all Proposed

Amendments 2,456 0 2,456

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

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

H-21 Elements

Incremental Increase due to

Additional Data Elements (Future Years) 150 442 592

Total Burden of Processing

Manufacturer data (hours) Total

Burden of Processing

Processor

data (hours) Total Agency

Burden (hours)

Burden ( First Cycle ) Considering all Proposed Amendments 2,456 0 2,456

Total Burden ( First Cycle ) Includin g Additional Data Elements 2,607 442 3,049

Incremental Increase due to Additional Data Elements ( First Cycle ) 15 1 442 59 3

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post

amendment va lue.



### Table H-20 presents the estimated annual burden to the Agency of processing Form U with the additional exposure-related data elements from both manufacturers and processors. Over a 20 25 -year period, EPA estimates that the total Agency burden to process manufacturer and processor data will be 2,962 18,269 hours.

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

Reporting

Cycle 1 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

Reporting Cycle Total Burden of Processing Manufacturer data (hours) Total Burden of Processing Processor data (hours) Tota l Agency

Burden (hours) Burden (First Cycle) Considering all Proposed

Amendments 2,439 0 2,439

Burden (Future Years) Considering all Proposed

Amendments 2,456 0 2,456

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

H-22 Year Baseline Burden (When all Amendments are

C onsidered)

(hours) Form U Burden with

Enhanced data Elements (hours) Total Agency Burden (hours)

2011 2,456 3,049 593

2012 0 0 0

2013 0 0 0

2014 0 0 0

2015 2,456 3,049 593

2016 0 0 0

2017 0 0 0

2018 0 0 0

2019 2,456 3,049 593

2020 0 0 0

2021 0 0 0

2022 0 0 0

2023 2,456 3,049 593

2024 0 0 0

2025 0 0 0

2026 0 0 0

2027 2,456 3,049 593

2028 0 0 0

2029 0 0 0

2030 0 0 0

Total 12,282 15,244 2,962 Annual Average 614 762 148



### H.5 Agency Cost Estimate

The additional exposure data elements are expected to increase the cost to both EPA and contractor staff. To calculate the additional Agency cost associ ated 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 num ber of new data elements, 57 (as listed in Table H-1) to calculate the total per-report cost of processing the new data elements for manufacturers, $0.51.

Manufacturers

The total cost to EPA of processing these new data elements for manufacturers is approximately $15,

8 0 8 10 0 in the first reporting cycle and $15,800 in future reporting cycles , as shown in Table H-21. This table reflects both the variable cost to the Agency, which is dependent on the number of reports, and a fixed cost to the Agency of $249,200 (see Section 5.3) which will not change as a result of including the additional data option in the IUR.

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

H-23 Table H-21: Change in Agency Cost of Processing Manufacturer Data as a Result of Additional Exposure-Related Data Elements

Cost to

Process

Part I (2008$) Number

of Sites Cost to

Process

Part II (2008$) Number

of Reports

(with Part II) Cost to

Process

Part III (2008$) Number

of Reports

(with Part III) Cost to

Process

New

Data

Elements (2008$) Number

of Reports

(with

new data elements) Agency

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 3 4,289 $0.58 31,365 $0.66 30,716 0.00 0 $243,263

Future cycle, Post

Amendment $0.20 3 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 H-22 presents the annual and annualized costs estimates to the Agency of processing manufacturer Form U with the additional exposure-related data elements. Over a 20 25 -year period, EPA

estimates that the annualized cost to the Agency will be $ 79,500 58,350 at a three percent discount rate, and $ 84,000 53,517 at a seven percent discount rate.

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

Reporting Cycle Years Baseline Cost (2008$

millions ) PostAlternative Option Cost (2008$

millions ) Change

from

Baseline (2008$

millions )

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

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

H-24 Year Baseline Cost (When all Amendments are Considered)

( $2008 ) Cost ( $2008 ) Total Agency Cost ( $2008 )

2011 $288,450 $15,843 $304,294

2012 $0 $0 $0

2013 $0 $0 $0

2014 $0 $0 $0

2015 $288,450 $15,843 $30 4,294

2016 $0 $0 $0

2017 $0 $0 $0

2018 $0 $0 $0

2019 $288,450 $15,843 $304,294

2020 $0 $0 $0

2021 $0 $0 $0

2022 $0 $0 $0

2023 $288,450 $15,843 $304,294

2024 $0 $0 $0

2025 $0 $0 $0

2026 $0 $0 $0

2027 $288,450 $15,843 $304 ,294

2028 $0 $0 $0

2029 $0 $0 $0

2030 $0 $0 $0

Total $1,442,251 $79,217 $1,521,468
Annual Average $72,112.55 $3,960.84 $76,073.39

Annualized at

3% $75,341 $4,138 $79,479

Annualized at

7% $112,467 $4,371 $83,959



### Manufacturers and Processors Combined

Table H-23 shows the Agency cost of processing the processor data. To estimate this cost, EPA multiplied the number of processors derived in Section H.1 (141,220) by the per report cost of processing the additional data, $0.51. EPA estimates that the total Agency cost to pr ocess the processor data is $46,500.

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

H-25 Table H-23: Change in Agency Cost to Process Processor Data as a Result of Additional Exposure-Related Data Elements

Per-Report Cost to

Process New Data

Elements (2008$) Number of Reports (with New

Data Elements) Agency Cost (2008$)

Agency Cost to Process Processor Data Considering all Proposed Amendments $0.00 0 $0

Total Agency Cost Including Processing Additional Data

Elements for Processors $0.51 92,100 $46,522

Incremental Increase due to Additional Data Elements $0.51 92,100 $46,522

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



### Table H-24 presents the annual and annualized costs estimates to the Agency of processing a processor Form U with the additional ex posure-related data elements. Over a 20 25 -year period, EPA

estimates that annualized cost to the Agency will be $ 12,200 10,500 at a three percent discount rate, and $ 12,800 1 9

, 0 6 00 at a seven percent discount rate.

Table H-24: Annual Increase in Agency Cost to Process Processor Data if All Proposed Amendments Are Implemented (2008$)

Reporting

Cycle 1 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

Ye ar Baseline Cost (When all Amendments are

C onsidered)

( $2008 ) Cost ( $2008 ) Total Agency Cost ( $2008 )

2011 $0 $46,522 $46,522

2012 $0 $0 $0

2013 $0 $0 $0

2014 $0 $0 $0

2015 $0 $46,522 $46,522

2016 $0 $0 $0

2017 $0 $0 $0

2018 $0 $0 $0

2019 $0 $46,522 $46,522

2020 $0 $0 $0

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

H-26 2021 $0 $0 $0

2022 $0 $0 $0

2023 $0 $46,522 $46,522

2024 $0 $0 $0

2025 $0 $0 $0

2026 $0 $0 $0

2027 $0 $46,522 $46,522

2028 $0 $0 $0

2029 $0 $0 $0

2030 $0 $0 $0

Total $0 $232,612 $232,612
Annual Average $0 $11,630.59 $11,630.59

Annualized at 3% $0 $12,151 $12,151

Annualized at 7% $0 $12,836 $12,836



### Table H-25 shows the cost to EPA of processing the additional data elements from both the processors and the manufactures. This option is expected to increase the Agency cost by $6 2,400 1,600 in the first rep o rting cycle and $6 1 2 ,400 in all future reporting cycles.

Table H-25: Change in Agency Cost of Processing Manufacture and Processor Data as a Result of Additional Exposure-Related Data Elements

Total Agency Burden Total Burden of Processing Manufacturer data (2008$) Total Burden of Processing Processor data (2008$) (2008$)

Cost (First Cycle) Considering all Proposed

Amendments $241,393 $0 $241,393

Total Cost (First Cycle) Including Additional Data

Elements $256,481 $46,522 $303,004

Incremental Increase due to

Additional Data Elements (First Cycle) $15,089 $46,522 $61,611

Cost (Future Years) Considering all Proposed

Amendments $243,263 $0 $241,393

Total Cost (Future Years) Including Additional Data

Elements $259,106 $46,522 $305,629

Incremental Increase due to

Additional Data Elements (Future Years) $15,843 $46,522 $62,366

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

H-27 Cost to P rocess New

Data Elements (2008 $ ) Number of Reports (with N ew D ata

E lements) Agency Cost (2008 $ )

Cost ( First Cycle ) Considering all Proposed Amendments $288,450 $0 $288,450

Total Cost ( First Cycle ) Including Additional

Data Elements $304,294 $46,522 $3 50,816

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

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### Table H-26 presents the annual and annualized costs estimates to the Agency of processing manufacturer and processor Form Us with the additional exposure-related data elements. Over a 20 25

- year period, EPA estimates that annualized cost to the Agency will be $ 91,60 0 68, 90 0 at a three percent discount rate, and $ 96,800 63, 200 at a seven percent discount rate.

Table H-26: Annual Increase in Agency Cost to Process Manufacturer and Processor Data if All Proposed Amendments Are Implemented (2008$)

Reporting Cycl e ing 1 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

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H-28 Year Baseline Cost (When all Amendments are

C onsidered)

( $2008 ) Form U Cost with Enhanced

data Elements ( $2008 ) Total Agency Cost ( $2008 )

2011 $ 288,450 $62,366 $350,816

2012 $0 $0 $0

2013 $0 $0 $0

2014 $0 $0 $0

2015 $288,450 $62,366 $350,816

2016 $0 $0 $0

2017 $0 $0 $0

2018 $0 $0 $0

2019 $288,450 $62,366 $350,816

2020 $0 $0 $0

2021 $0 $0 $0

2022 $0 $0 $0

2023 $2 88,450 $62,366 $350,816

2024 $0 $0 $0

2025 $0 $0 $0

2026 $0 $0 $0

2027 $288,450 $62,366 $350,816

2028 $0 $0 $0

2029 $0 $0 $0

2030 $0 $0 $0

Total $1,442,250 $311,829 $1,754,079 Annual Average $72,11 3 $15,591 $87,70 4

Annualized at

3 % $75,341 $16,289 $91,630

Annualized at

7% $112,467 $17,208 $96,795



### H.6 Small Entity Analysis

As described in Chapter 8 of this economic analysis, EPA assessed the impact that the proposed amendments to the IUR rule may have on small entities by examining the relationship between the compliance costs and company sales for small companies. EPA performed a similar analysis to determine the impact of the collection of additional exposure-related data elements on small entities.

Manufacturers

For manufacturers, EPA estimated (in Chapter 8) 3.89 manufacturing sites per global parent company; 41.3 percent of global parent companies (466 companies) are considered small under the SBA employment-based definition 32



### , , 33 

### and 24.8 percent (280 companies) are considered small under the

32 Threshold of 1,000 employees

. 33 Threshold of 1,000 employees.

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H-29 TSCA sales-based definition 34



### . . 35 

### EPA also estimated an average of approximately 1.76 sites per small company under the employment-based definition of small business and approximately 1.92 sites per small company under the sales-based definition. Average annual sales revenue of global parent companies considered small under either definition were estimated using data from Dun & Bradstreet, as also described in Chapter 8.

Table H-13 above shows the incremental cost to manufacturers as a result of adding the additional exposure related data elements to Form U. Table 4-48 (in the main text of the report) shows the incremental cost to manufacturers related to the other proposed amendments. Because these costs would be incurred once every four years under a proposed four-year reporting cycle, these costs were summed and annualized over four years at both a three percent and seven percent discount rate 36



### . . 37 

### As shown in

Table H-27 below , these costs were divided by the total number of sites expected to submit data, for the annualized costs per site. This was multiplied by the number of sites per small parent company to arrive at the annualized costs per small parent company. This value was divided by the annual sales per small parent company to derive the cost-to-sales ratio.

As shown in Table H-27, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $31, 705 675 067 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 $3 4, 587 555 3,892 or lower. The cost-to-sales ratio for an average small compa ny under the sales-based definition would be 0.29 percent or less.

Using the highest annual cost shown in Table H-27 of $ 33,892 34, 587 555 a small company would have to have annual sales of less than $3. 45 4 6 39 million in order to have a co st-to-sales ratio larger than
one percent.

34 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume or imp ortation 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.

35 Total annual sales of the company, combined with thos e 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.

36 A seven percent discount ra te, 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 sensitiv ity analysis to examine the robustness of the results to a change in the annualization assumptions.

37 A seven percent discount rate, reflecting the opportunity cost of capital, is consiste nt with OMB Circular A-4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.

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

H-30 Table H-27. Derivation of Cost-to-Sales Ratios for Small Manufacturers for Collection of Additional
Data Elements

Employment-based Definition Sales-based Definition

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate

Incremental Costs of

Enhanced Data Elements $169,471,347.15 $177,947,467 .56

Incremental Costs of Proposed Other

Amendments $91,871,064.30 $102,073,744 $101,814,806.58

Total Annualized Costs $68,260,366 $73, 139,

106 071,474 $72,108,063 $77, 261,

808 190,364 $68,260,366 $73, 139,

106 071,474 $72,108,063 $77, 261,

808 190,364

Total Number of Sites 4,085 4,289

Annualized Costs per Site $16,710 $17, 053 037 $17,652 $18,014 $17,

997 $16,710 $17, 053 037 $17,652 $18,014 $17,

997 Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $29,410 $30,013 $29,985 $31,067 $31, 705 675 $32,083 $32, 741 711 $33,892 $34, 587 555

Annual Sales per Small Parent Company $412,713

. , 310 $11,821,104

Cost-to-Sales Ratio 0.007% 0.008% 0. 277 271 % 0. 293% 2 92 87 %

Number of Companies Potentially Affected 466 280



### Processors

EPA is limited in its efforts to estimate the impact of the collection of additional exposure-related data elements on processors by the availability of data. As described above, EPA used TRI submission data to estimate the number of processors that may be affected by the requirement. However, data provided under the TRI program does not include information about a submitter’s parent company or annual revenues. For this screening-level analysis, EPA assumes that the chemical processor industry shares many characteristics with the chemical manufacturing industry. To the extent that this is not the case, this analysis may over- or underestimate the impact of additional data elements on processors.

Specifically, EPA assumes 3.89 manufacturing sites per global parent company. EPA also assumes

that 41.3 percent of global parent companies are considered small under an employment-based definition, and 24.8 percent are considered small under a sales-based definition. EPA further assumes 1.76 sites per small parent company under the employment-based definition, and 1.92 sites per small parent company under the sales-based definition, consistent with manufacturer information. Given the large number of companies identified as processors according to TRI submissions, EPA was unable to examine Dun & Bradstreet data to estimate annual parent company revenue for this analysis. EPA used manufacturer revenue as a proxy, so this analysis provides only a preliminary estimate of impacts.

EPA divided the number of expected processor reports (92,100) by the average number of chemicals for which a processor submitted TRI data (2.45) to obtain the estimated number of processors (37,592) who would report under an amended IUR rule. EPA divided this number by 3.89 (the number of sites per global parent company) for an estimated 9,664 global parent companies. This number was then multiplied by 41.3 percent and 24.8 percent to estimate the number of small global parent companies (the number of companies potentially affected), under the employment-based and sales-based definitions, respectively. To calculate cost-to-sales ratios, EPA followed the same methodology for processors as described above for manufacturers. Results are presented in Table H-28 below

.

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H-31 Table H-28: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of Additional
Data Elements

Employment-based Definition Sales-based Definition

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate

Incremental Costs of

Enhanced Data Elements $522,523,888

Incremental Costs of Proposed

Other Amendments $0.00

Total Annualized Costs $136,478,697 $144,171,723 $136,478,697 $144,171,723

Total Number of Sites 37,592

Annualized Costs per Site $3,631 $3,835 $3,631 $3,835

Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $6,390 $6,750 $6,971 $7,364

Annual Sales per Small Parent Company $412,7613,310 $11,821,104

Cost-to-Sales Ratio 0.002% 0.002% 0.059% 0.062%

Number of Companies Potentially Affected 3,990 2,397



### As shown in Table H-28, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $6,750 at a seven percent discount rate, and even lower under a three percent discount rate. The cost-to-sales ratio for an average small company under the employment-based definition would be 0.002 percent or less. Under the more conservative sales-based definition, small parent company sales on average are more than $11.8 million, with annualized costs associated with the proposed amendments of $7,364 or lower. The cost-to-sales ratio for an average small company under the sales-based definition would be 0.062 percent or less.

As described in Chapter 8, the Regulatory Flexibilit y Act does not define the terms “significant” or “substantial” analytically with rega rd to extent of economic impact and number of small entities affected. However, EPA typically defines a threshold as compliance costs of one percent of sales to establish whether the level of economic impacts faced by the small entities can be presumed as not significant (EPA, 2006b). Using the highest annual cost shown in Table H-28, $7,346, a small company would have to have annual sales of less than $734,600 in order to have a cost-to-sales ratio larger than one percent.

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

I-1 

## Appendix I. - Estima ted Burden and Cost of a Section 8(a) Rule for Exposure-Related Data Elements

EPA is considering the annual collection of exposure-related data elements for approximately 100 chemicals under a TSCA section 8(a) rulemaking. TSCA section 8(a) gives EPA the authority to require, by rulemaking, manufacturers (including importers) and processors of chemical substances to maintain records and/or report such data as EPA may reasonably require to carry out the TSCA mandates. Section 8(a) regulations can be tailored to meet unique information needs (e.g., via chemical-specific rules) or information can be obtained via use of “model” or standardized reporting rules. The Agency is requesting comment on a “model” reporting rule that would enable the Agency to undertake periodic data collection of information similar to that collected under the TSCA section 5 New Chemicals Program. The information would enhance the Agency’s capabilities to conduct screening-level risk assessments of

selected chemical substances. Each data collection woul d be specific to a unique set of IUR chemicals for which the information is needed; EPA would request the information through one or more notices or letter writing actions per year, for an approximate total of 100 chemical substances per year.

The additional data elements are the same as those proposed under the option outlined in Appendix H. A brief description of the exposure-related data elements that may be included in such a section 8(a) rule are provided in Table H-1.



### I.1 Estimated Number of Affected Entities

For the purpose of this analysis, EPA assumes that a section 8(a) rule would apply to both manufacturers and processors of the subject chemicals.

Manufacturers

Because the applicability of a section 8(a) rule would be similar to that of the IUR rule (i.e., it would apply to manufacturers or importers of a subject chemical when produced in volumes greater than 25,000 lb.), EPA estimated the number of manufacturers who would report and the number of reports it expects to be submitted using data from Section 4.2.5 of this report. On average, 0.66 sites submit data under the IUR rule per regulated chemical, and an average of 4.21 full reports are submitted for each chemical. Therefore, EPA estimates that a total of 66 sites will submit 421 reports for the estimated 100 chemicals.

To the extent that the specific chemicals subject to a section 8(a) rule do not have an average number of manufacturers, this may be an over- or underestimate.

Processors

The number of processors that may be affected by a section 8(a) rule was estimated using data from EPA’s Toxic Release Inventory (TRI) reporting program. Under the TRI program, EPA collects information annually on toxic chemical releases and waste management activities from manufacturers, processors, and users of a set of 581 toxic chemicals and 30 toxic chemical categories. The chemicals regulated under the TRI program are a smaller set than those regulated under the IUR rule, but the TRI data collection activity currently is the mo st comprehensive collection of information that EPA administers for chemical processors. Therefore, EPA assumes that information on processors who report under TRI is a suitable proxy for processors who may report under a section 8(a) rule.

EPA used TRI Form R submission data from the 2007 TRI Public Data Release in this analysis. To be consistent with the Economic Analysis for the Proposed IUR Modifications Rule (from which other data for this analysis is derived), EPA used TRI data for the years 2002 through 2005 (the time period of the most recent IUR reporting cycle), filtered to include only IUR chemicals (i.e., the chemicals listed in

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

I-2 the public 2006 IUR database ) 38



### . ). 39 

### Processors submitted TRI data on an average of 220 of the IUR chemicals during each of the four years of interest. For this analysis, EPA counted as a “processor” each

TRI submitter who indicated that it processes a toxic chemical as a reactant, as a formulation component, as an article component, for repackaging, or as an impurity; or, that it otherwise uses the toxic chemical as a chemical processing aid. 40 

### Because EPA assumes that any company that both manufactures and processes a chemical will be considered a manufacturer for the purposes of a section 8(a) rule, TRI

submitters who indicated that they also manufactured or otherwise used a chemical were filtered out of

the dataset.

The TRI data revealed that an average of 137 processors reported information per TRI chemical. However, the average value is greatly skewed by certain high-volume chemicals that are processed by a large number of processors. 41 

### Therefore, EPA chose to use the median number of 15 processors per chemical, assuming it to be more representative of the universe of TSCA chemical processors. Using the median of 15 processors per chemical, EPA expects that a total of 1,500 reports will be submitted for an estimated 100 chemicals. According to the TRI data, each processor processes approximately 2.45 chemicals; therefore, EPA expects a section 8(a) rule to affect 612 sites.

This approach is limited to the extent that the universe of TRI processors is different from that of a section 8(a) rule. Because the set of chemicals covered under the rules is different, the median number of processors per chemical may be an over- or underestimate. Additionally, the TRI rule is applicable to facilities included within a specific set of NAICS code s; a section 8(a) rule may not limit its applicability to a defined set of NAICS codes, which could cause the number of processors estimated here to be an underestimate. Furthermore, “processor” may be defined differently by the two rules; any specific criteria

that EPA may use to define a “processor” for the purpose of a section 8(a) rule may cause the median number of processors per chemical estimated here to be an overestimate. Finally, the data used in this analysis was for submissions of TRI Form R only. This was done because Form A, the other, simpler, TRI reporting form, does not request information that would identify the submitter as a processor or manufacturer. Form R is used for high-volume chemicals (i.e., those manufactured, processed, or otherwise used in amounts greater than one million pounds) or for chemicals meeting other specific criteria; as a result, processors of small volumes may not be included, causing the median number to be an

underestimate.



### I.2 Industry Burden Estimate

The section 8(a) rule would require submitters (bot h manufacturers and processors) to provide data similar to the exposure-related data elements that are collected under EPA’s New Chemicals Program through a premanufacture notice (PMN) and under the IUR rule. Therefore, the burden associated with a section 8(a) rule is calculated by estimating the burden to complete a PMN.

The burden to complete a paper PMN form was estimated in the supporting statement for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requi rements for Chemical Substances , EPA ICR No: 574.12 (EPA, 2003). According to this source, the total burden to complete a PMN form is 107 hours. EPA assumes that

38 The TRI program may collect data on certain chemicals for wh ich 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 Manufac turing, Processing and Use Information” http://cfpub.epa.gov/iursearch/index.cfm?s=chem Accessed August 30, 2009.

39 The TRI program may collect data on certain chemical s for which IUR reporting is not required. A list of

CASRNs for the non-confidential IUR ch emicals was found at “Non-confident ial 2006 IUR Records by Chemical, including Manufacturing, Processing and Use Inform ation” http://cfpub.epa.gov/iursearch/index.cfm?s=chem Accessed August 30, 2009.

40 TRI submitters indicate their activities and uses of the toxic chemical at th e facility in Part II Section 3 of Form R.

41 For example, an average of 3,240 processors reported under TRI per year for lead alone.

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I-3 a section 8(a) rule would require electronic submission, so EPA reduced the estimated burden to 93 hours.

This reduction is consistent with the assumption in section 4.4.27; that all clerical burden will be eliminated because paper filing will not be permitted with electronic submission.

Using the number of manufacturer reports as estimated in Section I-1 of this appendix, the total burden to manufacturers to submit additional exposure-related data elements as part of their IUR reporting is estimated to be 39,200 hours. Using the number of processor reports as estimated in Section I-1 above, the total burden to processors to submit exposure-related data elements is estimated to be 139,500 hours (See Table I-1 below ). Because each individual collection under the rule would be for a different set of chemicals, EPA assumes that different sites will be submitting reports every year, so the

burden would be the same in future individual collections.

This approach is limited to the extent that the data elements requested in a section 8(a) rule match the IUR Form U and the PMN form, and the burden they incur.

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

Entity Subject to the Data Collection Burden to Complete Exposure-Related

Data Elements (hours per report) Number of Reports Total Burden (hours)

Manufacturers 93 421 39,166
Processors 93 1,500 139,500
Total for Manufacturers and Processors 93 1,921 178,666



### Annual Industry Burden Estimates

EPA estimated the total annual burden and cost to industry of a section 8(a) rule over a 2 5 0 -year period. A 2 0 5 -year period was used so that the burden and cost to the industry are directly comparable to the annual burden presented in Table 4-52 and the annual cost estimates for the proposed amendments to the IUR rule, found in Table 4-53. Table I-2 contains the annual burden to industry over 20 years as a result of a section 8(a) rule and of completing Form U. Over a 20 25 -year period, EPA estimates that the total burden to industry of both the IUR data collection and a section 8(a) collection will be 17.4 20.04 1 million hours. The section 8(a) rule adds 3.57 million hours to the industry burden during this time period.

Table I-2: Schedule of Annual Industry Burden

Baseline Cost (When

all

Amendments

are Considered) Manufacturer Section 8(a)

Cost Processor Section 8(a)

Cost Manufacturer

and Processor

Section 8(a)

Cost Total Cost to Industry (Manufacturer

and Processor

+ Baseline) Reporting

Cycle Years

(millions of hours) (millions of hours) (millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 3.24 0.04 0.14 0.18 3.41

2 2012 to 2015 2.61 0.16 0.56 0.71 3.32

3 2016 to 2019 2.61 0.16 0.56 0.71 3.32

4 2020 to 2023 2.61 0.16 0.56 0.71 3.32

5 2023 to 2027 2.61 0.16 0.56 0.71 3.32

6 2026 to 2031 2.61 0.16 0.56 0.71 3.32

Total 16.29 0.82 2.93 3.75 20.04
Annual Average 0.65 0.03 0.12 0.15 0.80

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

I-4 Year Baseline Industry Burden (When all

Amendments are

C onsidered) (millions of

ho urs) Manufacturer Section 8(a) Burden (millions of hours) Processor Section 8(a) Burden (millions of hours) Manufacturer

and Processor

Section 8(a) Burden (millions of hours) Total Burden

To t o Industry (Manufacturer

and Processor + Baseline) (millions of

h ours)

2011 3.40 0.039 0.140 0.179 3.580

2012 0 0.039 0.140 0.179 0.179

2013 0 0.039 0.140 0.179 0.179

2014 0 0.039 0.140 0.179 0.179

2015 2.61 0.039 0.140 0.179 2.789

2016 0 0.039 0.140 0.179 0.179

2017 0 0.039 0.140 0.179 0.179

2018 0 0.039 0.140 0.179 0.179

2019 2.61 0.039 0.140 0.179 2.789

2020 0 0.039 0.140 0.179 0.179

2021 0 0.039 0.140 0.179 0.179

2022 0 0.039 0.140 0.179 0.179

2023 2.61 0.039 0.140 0.179 2.789

2024 0 0.039 0.140 0.179 0.179

2025 0 0.039 0.140 0.179 0.179

2026 0 0.039 0.140 0.179 0.179

2027 2.61 0.039 0.140 0.179 2.789

2028 0 0.039 0.140 0.179 0.179

2029 0 0.039 0.140 0.179 0.179

2030 0 0.039 0.140 0.179 0.179

Total 13.84 0.78 2.79 3.57 17.41

Annual Average 0.69 0.04 0.14 0.18 0.87



### I.3 Industry Cost Estimate

EPA calculated the per-report cost to industry of the additional data elements by multiplying the managerial and technical burdens found in Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for

Chemical Substances , EPA ICR No: 574.12 (EPA, 2003), by the wage rates for technical and managerial staff described in Section 4.2.1. No clerical cost was calculated because of the proposed electronic submission requirement (see Section 4.4.27) which EPA assumes that all clerical burden for preparing and submitting Form U is eliminated. As shown in Tabl e I-3, EPA estimates the additional per report cost to be $5,673.

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

Technical Managerial Total

Burden (hours) Wage

Rate (2008$) Cost (2008$) Burden (hours) Wage

Rate (2008$) Cost (2008$) Burden (hours) Cost (2008$)

PMN Burden/Cost per Report 75 $58.84 $4,413 18 $70.03 $1,260 93 $5,673

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

I-5 The cost to manufacturers and processors to submit the exposure-related data elements was derived as shown in Table I-4. EPA estimates the section 8(a) rule would cost manufacturers $2.39 million and processors $8.51 million each year.

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

Entity Subject to the Data Collection Cost to Prepare Exposure-related Data Elements (2008$) Number of Reports Industry Cost (millions of 2008$)

Manufacturers $5,673 421 $2.39
Processors $5,673 1,500 $8.51

Total for Manufacturers and Processors $5,673 1,921 $10.90



### Annual Industry Cost Estimates

Table I-5 presents the annual and annualized cost estimates to industry of completing Form U and a section 8(a) collection. The cost estimates for co mpletion of Form U come from Table 4-53. Over a 20 25

- year period, EPA estimates that total annualized cost to the industry will be $ 56

. 31 28 46.98 million, with a three percent discount rate, and $ 59. 77 74 43.56 million with a seven percent discount rate.

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

I-6 Table I-5: Annual Increase in Industry Cost if All Amendments Are Implemented (2008$) )

Baseline Cost

(When all

Amendments

are Considered) Manufacturer Section 8(a)

Cost Processor Section 8(a)

Cost Manufacturer

and Processor

Section 8(a)

Cost Total Cost to Industry (Manufacturer

and Processor

+ Baseline) Reporting

Cycle Years

(2008$ millions) (2008$ millions) (2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $198.84 $2.39 $8.51 $10.90 $209.74

2 2012 to 2015 $162.08 $9.56 $34.04 $43.60 $205.68

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

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

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

6 2026 to 2031 $162.08 $9.56 $34.04 $43.60 $205.68

Total $1,009.25 $50.19 $178.71 $228.90 $1,238.15

Annual Average $40.37 $2.01 $7.15 $9.16 $49.53

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

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



### I.4 Agency Burden Estimate

For the purposes of this analysis, EPA assumed that the Agency burden was similar to that associated with the IUR rule, and would include contractor and EPA staff burden related to document receipt,tracking and quality control of data entry. To calculate the Agency burden associated with the exposurerelated data elements, EPA used the per-data element burden to EPA after all the proposed amendments are considered, 0.00008 hours, as calculated in Section 5.5. The number of exposure-related data elements is 57, as shown in Table H-1. The section 8(a) burden per-report is estimated as shown in Table I-6.

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

Data Elements Number of Data

Elements Per-Data Element Burden (hours) Per-report Burden (hours)

Exposure-related Data Elements 57 0.00008 0.0048



### Table I-7 shows the estimated burden to the Agency of processing the data submitted by chemical manufacturers and processors. As described above, EPA expects a total of 421 manufacturer reports and 1,500 processor reports. The Agency burden to process the exposure-related data elements, per-form, 0.0048 hours, is the same for both processors and manufacturers. Therefore, the Agency burden to process the manufacturer data is 2.02 hours, and for processor data, is approximately 7.20 hours.

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

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

Per-Report Burden to

Process Exposure-Related Data Elements (hours) Number of Reports Agency Burden (hours)

Agency Burden to Process Manufacturer

Data 0.0048 421 2.02

Agency Burden to Pr ocess Processor Data 0.0048 1,500 7.20
Total Agency Burden 0.0048 1,921 9.22



### Annual Agency Burden Estimates

Table I-8 presents the annual Agency burden estimates for data entry and extramural costs during all principal reporting and non-principal reporting years over a 2 5 0 -year period. The Agency burden for processing Form U is taken from Table 5-42. In total, EPA estimates that the Agency burden for the IUR rule and a section 8(a) rule will be 12,464 1 5,000 hours over a 20 25 -year period. The total burden as a result of a section 8(a) rule will be 184 2 39. 64 40 hours over a 20 25 -year period.

Table I-8: Schedule of Annual Agency Burden

Baseline Cost (When

all

Amendments

are Considered) Manufacturer Section 8(a)

Cost Processor

Section 8(a) Cost Manufacturer

and Processor

Section 8(a)

Cost Total Cost to Industry (Manufacturer

and Processor + Baseline) Reporting

Cycle 1 Years

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

1 2007 to 2011 2,439 2.02 7.20 9.22 2,448

2 2012 to 2015 2,456 10.10 35.98 46.08 2,503

3 2016 to 2019 2,456 10.10 35.98 46.08 2,503

4 2020 to 2023 2,456 10.10 35.98 46.08 2,503

5 2023 to 2027 2,456 10.10 35.98 46.08 2,503

6 2026 to 2031 2,456 10.10 35.98 46.08 2,503

Total 14,721 52.52 187.12 239.64 14,960

Annual Average 589 2.10 7.48 9.59 598

Year Baseline Agency

Burden (When all

Amendments are considered) ( hours) Agency Burden

to Process

Manufacturer

Section 8(a)

(hours) Agency Burden

to Process

Processor Section 8(a)

(hours) Agency Burden

to Process

Manuf acturer

and Processor

Section 8(a)

(hours) Total Burden To Agency (Manufacturer

and Processor + Baseline) (hours)

2011 2,456 2.02 7.20 9.22 2,465

2012 0 2.02 7.20 9.22 9.22

2013 0 2.02 7.20 9.22 9.22

2014 0 2.02 7.20 9.22 9.22

2015 2,456 2.02 7.20 9.2 2 2,465

2016 0 2.02 7.20 9.22 9.22

2017 0 2.02 7.20 9.22 9.22

2018 0 2.02 7.20 9.22 9.22

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

I-8 Year Baseline Agency

Burden (When all

Amendments are considered) ( hours) Agency Burden

to Process

Manufacturer

Section 8(a)

(hours) Agency Burden

to Process

Processor Section 8(a)

(hours) Agency Burden

to Process

Manuf acturer

and Processor

Section 8(a)

(hours) Total Burden To Agency (Manufacturer

and Processor + Baseline) (hours)

2019 2,456 2.02 7.20 9.22 2,465

2020 0 2.02 7.20 9.22 9.22

2021 0 2.02 7.20 9.22 9.22

2022 0 2.02 7.20 9.22 9.22

2023 2,456 2.02 7.20 9.22 2,465

2024 0 2.02 7 .20 9.22 9.22

2025 0 2.02 7.20 9.22 9.22

2026 0 2.02 7.20 9.22 9.22

2027 2,456 2.02 7.20 9.22 2,465

2028 0 2.02 7.20 9.22 9.22

2029 0 2.02 7.20 9.22 9.22

2030 0 2.02 7.20 9.22 9.22

Total 12,282 40 144 184 12,464

Annual Average 614 2.02 7.20 9.22 62 3



### I.5 Agency Cost Estimate

To calculate the Agency cost associated with processing the data received from a section 8(a) rule, EPA used the cost per-data element to the EPA estimated in the IUR EA, $0.0089 (Section 5.5). This unit cost was multiplied by the number of data elements to calculate the total per-report cost of processing the data elements, as shown in Table I-9.

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

Data Elements Number of Data

Elements Per-Data Element Cost (2008$) Per-Report Cost (2008$) Exposure-related Data Elements 57 $0.0089 $0.51



### Table I-10 shows the Agency cost of processing the processor data. EPA estimates that the total Agency cost to process the manufacturer data is $213, and the total cost to the Agency of processing the processor data is $758. The total Agency data processing cost is $970.

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

Per-Report Cost

to Process Exposure-Related

Data Elements (2008$) Number of Reports Agency Cost (2008$)

Agency Cost to Proces s Manufacturer Data $0.51 421 $213
Agency Cost to Pro cess Processor Data $0.51 1,500 $758
Total Agen cy Cost $0.51 1,921 $970



### Annual Agency Cost Estimates

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

I-9 Table I-11 presents the estimated annual and annualized costs to the Agency of processing Form U and a section 8(a) data collection. The cost estimates for completion of Form U come from Table 4-53.

Over a 20 25 -year period, EPA estimates that total cost to the Agency will be $ 76,300 65, 800 , with a three percent discount rate, and $ 80,600 60,3 00 with a seven percent discount rate.

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

Baseline Cost (When

all

Amendments

are Considered) Manufacturer Section 8(a)

Cost Processor Section 8(a)

Cost Manufacturer

and Processor

Section 8(a)

Cost Total Cost to Industry (Manufacturer

and Processor

+ Baseline) Reporting

Cycle 1

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

1 2007 to 2011 $286,580 $213 $758 $970 $287,550

2 2012 to 2015 $288,450 $1,065 $3,790 $4,855 $293,305

3 2016 to 2019 $288,450 $1,065 $3,790 $4,855 $293,305

4 2020 to 2023 $288,450 $1,065 $3,790 $4,855 $293,305

5 2023 to 2027 $288,450 $1,065 $3,790 $4,855 $293,305

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
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

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

I-10 Year Baseline Agency Cost

(When all

Amendments

are C onsidered)

( 2008$ ) Agency Cost to

Process

Manufacturer

Section 8(a)

(2008$) Agency Cost to

Process

Processor Section 8(a)

(2008$) Agency Cost to

Process

Manufacturer

and Processor

Section 8(a)

(2008$) Total Cost

To t o Agency (Manufacturer

and Processor

+ Baseline)

(2008$)

2011 $288,450 $213 $758 $970 $289,420

2012 $0 $213 $758 $970 $970

2013 $0 $213 $758 $970 $970

2014 $0 $213 $758 $970 $970

2015 $288,450 $213 $758 $9 70 $289,420

2016 $0 $213 $758 $970 $970

2017 $0 $213 $758 $970 $970

2018 $0 $213 $758 $970 $970

2019 $288,450 $213 $758 $970 $289,420

2020 $0 $213 $758 $970 $970

2021 $0 $213 $758 $970 $970

2022 $0 $213 $758 $970 $970

2 023 $288,450 $213 $758 $970 $289,420

2024 $0 $213 $758 $970 $970

2025 $0 $213 $758 $970 $970

2026 $0 $213 $758 $970 $970

2027 $288,450 $213 $758 $970 $289,420

2028 $0 $213 $758 $970 $970

2029 $0 $213 $758 $970 $970

2030 $ 0 $213 $758 $970 $970

Total $1,442,250 $4,253 $15,154 $19,407 $1,461,657 Annual Average $72,113 $213 $758 $970 $73,083

Annualized at 3% $75,341 $213 $758 $970 $76,311

Annualized at 7% $79,587 $213 $758 $970 $80,558



### I.6 Small Entity Analysis

The following section provides a preliminary assessment of the impact that a section 8(a) rule may have on small entities by examining the relationship between the compliance costs and company sales for small companies. This analysis is based on the methodology found in Chapter 8 of this report.

Manufacturers

For manufacturers, EPA estimated 3.89 manufacturing sites per global parent company in Chapter 8; 41.3 percent of global parent companies (466 companies) are considered small under the SBA employment-based definition 42



### , , 43 

### and 24.8 percent (280 companies) are considered small under the

TSCA sales-based definition 44



### . , 45 

### EPA also estimated an average of approximately 1.76 sites per small

42 Threshold of 1,000 employees

. 43 Threshold of 1,000 employees.

44 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 t he 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.

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

I-11 company under the employment-based definition of small business, and approximately 1.92 sites per small company under the sales-based definition. Average annual sales revenue of global parent companies considered small under either definition were estimated using data from Dun & Bradstreet, as also described in Chapter 8.

Table I-4 above shows the cost to manufacturers as a result of a section 8(a) rule. These costs were summed and annualized over four years (the likely timeframe for the rule) at both a three percent and seven percent discount rate 46



### . . 47 

### As shown in Table I-12 below , these costs were divided by the total number of sites eected to submit data, for the annualized costs per site. This was multiplied by the number of sites per small parent company to arrive at the annualized costs per small parent company. This value was divided by the annual sales per small parent company to derive the cost-to-sales ratio.

As shown in Table I-12, 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 perc ent or less. Under the mo re conservative salesbased TSCA definition, small parent company sale s are on average more than $11.8 million, with annualized costs associated with the proposed amendments of $19,047 or lower. The cost-to-sales ratio for an average small company under the sales-based definition would be 0.16% or less.

Using the highest annual cost shown in Table I-12 of $19,443, a small company would have to have annual sales of less than $1.94 million in order to have a cost-to-sales ratio larg er than one percent.

This approach is limited to the extent that the universe of manufacturers identified under the economic analysis for the IUR rule would be similar to the manufacturers subject to a section 8(a) rule.

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

Employment-based Definition Sales-based Definition

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate

Cost of Section 8(a) Rule $2,388,518.53

Total Annualized Costs $623,860 $659,026 $623,860 $659,026

Total Number of Sites 66

Annualized Costs per site $9,391 $9,920 $9,391 $9,920

Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $16,528 $19,443 $18,030 $19,047

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

Cost-to-sales Ratio 0.004% 0.005% 0.153% 0.161%
Number of Companies Potentially Affected 7 4

45 Total annual sales of the company, combined with thos e 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.

46 A seven percent discount rate, reflecting the o pportunity cost of capital, is consistent with OMB Circular A

- 4 (OMB, 2003). A three percent discount rate was also used as a sensitiv ity analysis to examine the robustness of the results to a change in the annualization assumptions.

47 A seven percent discount rate, reflecting the opportunity cost of capital, is consiste nt with OMB Circular A-4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.

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

I-12 Processors

To estimate the impact of the collection of exposure-related data elements on processors, EPA is limited by the availability of data. As described above, EPA estimated the number of processors that may be impacted by the requirement using TRI submission data. However, data provided under the TRI program does not include information about a submitter’s parent company or annual revenues.

For this screening-level analysis, EPA assumes that the chemical processor industry shares many characteristics with the chemical manufacturing industry subject to the IUR rule. To the extent that this is not the case, this analysis may over- or underestimate the impact of additional data elements on processors. Specifically, EPA assumes 3.89 manufacturing sites per global parent company. EPA also

assumes that 41.3 percent of global parent companies are considered small under an employment-based definition, and 24.8 percent are considered small under a sales-based definition. EPA further assumes 1.76 sites per small parent company under the employment-based definition, and 1.92 sites per small parent company under the sales-based definition, consistent with manufacturer information. Given the large number of companies identified as processors according to TRI submissions, EPA was unable to examine Dun & Bradstreet data to estimate annual parent company revenue for this analysis, so manufacturer revenue was used as a proxy. Therefore, this analysis provides only a preliminary estimate of impacts.

EPA divided the number of expected processor reports (1,500) by the average number of chemicals for which a processor submitted TRI data (2.45) to obtain the estimated number of processors (612). EPA divided this number by 3.89 (the number of sites per global parent company) for an estimated 157 global parent companies. This number was then multiplied by 41.3 percent and 24.8 percent to estimate the number of small global parent companies (the number of companies potentially affected), under the employment-based definition and sales-based definition, respectively. To calculate cost-to-sales ratios, EPA followed the same methodology for processors as described above for manufacturers. Results are presented in Table I-13 below

.

Table I-13: Derivation of Cost-to-Sales Ratios for Small Processors for Collection of ExposureRelated Data Elements

Employment-based Definition Sales-based Definition

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate

Cost of Section 8(a) Rule $8,510,161

Total Annualized Costs $2,222,780 $2,348,074 $2,222,780 $2,348,074

Total Number of Sites 612

Annualized Costs per Site $3,631 $3,835 $3,631 $3,835

Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $6,390 $6,750 $6,971 $7,364

Annual Sales per Small Parent Company $412,713,310 $11,821,000

Cost-to-sales Ratio 0.0015% 0.0016% 0.059% 0.062%

Number of Companies Potentially Affected 65 39



### As shown in Table I-13, under the employment-based definition, a small parent company affected by the rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $6,750 at a seven percent discount rate, and even lower under a three percent discount rate. The cost-to-sales ratio for an average small company under the employment-based definition would be 0.0016 percent or less. Under the more conservative sales-based

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

I-13 definition, small parent company sales are on aver age 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 Flexibilit y Act does not define the terms “significant” or “substantial” analytically with rega rd to extent of economic impact and number of small entities affected. However, EPA typically defines a threshold as compliance costs of one percent of sales to establish whether the level of economic impacts faced by the small entities can be presumed as not significant (U.S. EPA, 2006b). Using the highest annual cost shown in Table I-13, $7,364, a small company would have to have annual sales of less than $736,400 in order to have a cost-to-sales ratio larger than one
percent.