## June 30, 2011

— Does not contain TSCA CBI

—

Prepared by:

Economic and Policy Analysis Branch
Economic s, Exposure and Technology Division
Office of Pollution Prevention and Toxics U.S. Environmental Protection Agency 1200 Pennsylvania Avenue Washington, D.C. 20460

rr

_ 

# Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rulei 

## Contributors

The EPA analyst s responsible for this report are Wendy Hoffman and Lynne Blake

- Hedges of the
Economic and Policy Analysis Branch ; Economics, Exposure and Technology Division; Office of
Pollution Prevention and Toxics. Analytical and draft preparation support was provided by Abt

Associates Inc. under EPA Contract No. EP

- W

- 08

- 010.ii 

## Table o f Contents

Contributors

................................ ................................ ................................ ................................ ................. i
Table of Contents

................................ ................................ ................................ ................................ ........ ii
List of Tables

................................ ................................ ................................ ................................ ............. vii Executive Summary

................................ ................................ ................................ ................................ . xiv
1. Introduction

................................ ................................ ................................ ................................ .......... 1

- 1

1.1 Statutory Authority

................................ ................................ ................................ ....................... 1

- 1

1.2 Regulatory History

................................ ................................ ................................ ........................ 1

- 1 2. IUR Requirements and Affected Entities

................................ ................................ .......................... 2

- 1

2.1 Overview of IUR Requirements

................................ ................................ ................................ ... 2

- 1

2.2 Overview of the Regulated Community

................................ ................................ ....................... 2

- 2 3. Changes in Reporting Requirements under the Final IUR Modifications Rule

............................ 3

- 1

3.1 Technical Modificat ions to the Regulatory Text

................................ ................................ .......... 3

- 1

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

................................ ................................ ................................ .......................... 3

- 1

3.1.2 Consolidation of Definitions

................................ ................................ ............................ 3

- 1

3.1.3 Remove “Non

- isolated Intermediate” Definition from §710.3

................................ ........ 3

- 2

3.1.4 Remove Subpart B Text

................................ ................................ ................................ ... 3

- 2

3.1.5 Remove Superfluous Text Associated With Reporting Production Volumes

................. 3

- 2

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

...... 3

- 2

3.2 Modifications to Selected Definitions

................................ ................................ ........................... 3

- 2

3.2.1 Manufacture and Manufacturer

................................ ................................ ........................ 3

- 2

3.2.2 Site

................................ ................................ ................................ ................................ ... 3

- 3

3.2.3 Electronic Reporting

- Related Definitions

................................ ................................ ........ 3

- 3

3.2.4 Processing and Use

- Related Definitions

................................ ................................ .......... 3

- 3
3.2.5 Principal Reporting Year and Submission Period

................................ ............................ 3

- 4

3.3 Modifications to Reporting Thresholds

................................ ................................ ........................ 3

- 4

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

................................ ................................ ................................ ................... 3

- 4

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

...................... 3

- 5

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

........... 3

- 5

3.4 Changes to Chemical Substances Subject to the IUR Rule

................................ .......................... 3

- 6
3.4.1 Make Chemical Substances Subject to Enforceable Consent Agreements (ECAs) Ineligible for Exemptions

................................ ................................ ................................ 3

- 6
3.4.2 Full Exemption for Manufactured Water

................................ ................................ ......... 3

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

................................ .... 3

- 7

3.5 Modifications to Reportable Data Elements

................................ ................................ ................. 3

- 7
3.5.1 Parent Company and Site Identity

................................ ................................ ................... 3

- 7
3.5.2 Technical Contact

................................ ................................ ................................ ............ 3

- 7
3.5.3 Chemical Identity

................................ ................................ ................................ ............. 3

- 8
3.5.4 Report Production Volume for Each of the Years since the Last Principal Reporting Year

................................ ................................ ................................ ................................ ......... 3

- 9
3.5.5 Volume of Chemical Substance Used On

- Site

................................ ................................ 3

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

....... 3

- 9
3.5.7 Report Production Volume Exported

................................ ................................ ............... 3

- 9
3.5.8 Identify Whether a Chemical Substance is to be Recycled, Remanufactured, Reprocessed,

o r Reused

................................ ................................ ................................ ....................... 3

- 10iii

3.6 Concentration Ranges

................................ ................................ ................................ ................. 3

- 10

3.7 Industrial Processing and Use Information Reporting

................................ ................................ 3

- 10

3.7.1 Revise Industrial Function Categories

................................ ................................ ........... 3

- 10

3.7.2 Industrial Sectors

................................ ................................ ................................ ........... 3

- 11

3.8 Consumer and Commercia l Use Reporting

................................ ................................ ................ 3

- 11

3.8.1 Revise Consumer and Commercial Product Categories

................................ ................ 3

- 11

3.8.2 Designation of Consumer or Commercial Use

................................ .............................. 3

- 12

3.8.3 Number of Commercial Workers Reasonably Likely To Be Exposed

.......................... 3

- 12

3.9 Changes to Standard for the Reporting of Processing and U se Information

.............................. 3

- 12

3.10 Modifications to Confidential Business Information (CBI) Claims

................................ ........... 3

- 12

3.10.1 Chemical Identity CBI Claims

................................ ................................ ....................... 3

- 13

3.10.2 Upfront Substantiation for Processing and Use Information CBI Claims

..................... 3

- 13

3.10.3 Prohibition of Confidentiality Claims for Dat a Elements Identified as “Not Known or Reasonably Ascertainable”

................................ ................................ ............................ 3

- 14

3.11 Method of Submission

................................ ................................ ................................ ................ 3

- 14

3.11.1 Updated e

- IUR Reporting To ol

................................ ................................ ..................... 3

- 14

3.11.2 Require Electronic Submissions over the Internet

................................ ......................... 3

- 15

3.11.3 Electronic Signature Process

................................ ................................ .......................... 3

- 15

3.12 Modifications Specifically Affecting Importers

................................ ................................ ......... 3

- 15

3.13 Modify Reporting Frequency

................................ ................................ ................................ ...... 3

- 16
4. Industry Burden and Cost Estimates

................................ ................................ ................................ . 4

- 1

4.1 Methodology for Compliance Cost and Burden Analysis

................................ ............................ 4

- 1

4.2 Industry Unit Burden and Cost E stimates

................................ ................................ ..................... 4

- 2

4.2.1 Estimates of Wage Rates

................................ ................................ ................................ . 4

- 2

4.2.2 Estimates of Baseline Labor Hours (Burden)

................................ ................................ .. 4

- 3

4.2.3 Estimates of Baseline Submission (Mailing) Costs

................................ ......................... 4

- 7

4.2.4 Estimates of Baseline Cost per Report

................................ ................................ ............. 4

- 8
4.2.5 Estimates of the Number of Sites and Reports

................................ .............................. 4

- 11

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

................................ ..... 4

- 11

4.3 Tota l Baseline IUR Industry Compliance Burden and Costs

................................ ...................... 4

- 17

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

.................... 4

- 18

4.4.1 Technical Modifications to the Regulatory Text

................................ ........................... 4

- 18

4.4.2 Modifications to Selected Definitions

................................ ................................ ........... 4

- 18

4.4.3 Method for D etermining Whether a Manufacturer is Subject to IUR Reporting Requirements

................................ ................................ ................................ ................. 4

- 18

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

........................... 4

- 20
4.4.5 Reducing the 25,000 lb Threshold for Specific Regulated Chemical Substances

......... 4

- 22

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

Ineli gible for Exemptions

................................ ................................ .............................. 4

- 24

4.4.7 Full Exemption for Manufactured Water

................................ ................................ ....... 4

- 26

4.4.8 Remove Fully

- Exempt Polymers from the Partially

- Exemp t List

................................ . 4

- 27
4.4.9 Parent Company and Site Identity

................................ ................................ ................. 4

- 28

4.4.10 Technical Contact

................................ ................................ ................................ .......... 4

- 28

4.4.11 Chemical Identity

................................ ................................ ................................ ........... 4

- 28

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

... 4

- 29

4.4.13 Volume of Chemical Substance Used On

- Site

................................ .............................. 4

- 31

4.4.14 Indicate Whether Chemical Substance Is Physically at Reporting Site

......................... 4

- 32

4.4.15 Report Production Volume Exported

................................ ................................ ............. 4

- 34iv

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

................................ ................................ ................................ ....................... 4

- 35

4.4.17 Concentration Ranges

................................ ................................ ................................ .... 4

- 36

4.4.18 Revise Industrial Function Categories

................................ ................................ ........... 4

- 36
4.4.19 Replace NAICS Codes with Industrial Sectors

................................ .............................. 4

- 38

4.4.20 Revise Consumer and Commercial Product Categories

................................ ................ 4

- 38

4.4.21 Designation of Consumer or Commercia l Use

................................ .............................. 4

- 40

4.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed

.......................... 4

- 40

4.4.23 Changes to the Standard for the Reporting o f Processing and Use Information

............ 4

- 41

4.4.24 Chemical Identity CBI Claims

................................ ................................ ....................... 4

- 41
4.4.25 Upfront Substantiation for Processing and Use In formation CBI Claims

..................... 4

- 41

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

................................ ................................ ............................ 4

- 43

4.4.27 Require Electronic Submissions over the Internet

................................ ......................... 4

- 43

4.4.28 Updated e

- IUR Reporting Software

................................ ................................ ............... 4

- 45
4.4.29 Elec tronic Signature Process

................................ ................................ .......................... 4

- 45

4.4.30 Modifications Specifically Affecting Importers

................................ ............................ 4

- 46

4.4.31 Modify Reporting Frequency

................................ ................................ ......................... 4

- 47

4.5 Total Industry Compliance Burden and Cost of all Amendments

................................ .............. 4

- 49
4.5.1 Modifications that Affect the Number of Reports Submitted

................................ ........ 4

- 49

4.5.2 Modifications That Affect the Reporting Burden

................................ .......................... 4

- 52
4.5.3 Amendment that Affects the Reporting Frequency

................................ ....................... 4

- 58

4.5.4 Average Cost and Burden per Site

................................ ................................ ................. 4

- 58

4.6 Annualized Industry Cost Estimates for all Modifications

................................ ......................... 4

- 60 5. Agency Burden and Cost Estimates

................................ ................................ ................................ ... 5

- 1

5.1 Methodology for Agency Burden and Cost

................................ ................................ .................. 5

- 1

5.2 Data for Agency Cost Estim ates

................................ ................................ ................................ ... 5

- 1
5.2.1 Agency Wage Rates

................................ ................................ ................................ ......... 5

- 1
5.2.2 Extramural (Contractor) Costs

................................ ................................ ......................... 5

- 2

5.3 Current Total Agency Burden and Cost

................................ ................................ ........................ 5

- 2

5.4 Changes to Agency Burden and Cost as a Result of the Modifications

................................ ........ 5

- 4
5.4.1 Tech nical Modifications to the Regulatory Text

................................ ............................. 5

- 4
5.4.2 Modifications to Selected Definitions

................................ ................................ ............. 5

- 4
5.4.3 Method for Determining Whether a Manufacturer is subject to IUR Reporting Requirements

................................ ................................ ................................ ................... 5

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

............................. 5

- 6
5.4.5 Reduce the 25,000 lb Threshold for Specific Regulated Chemical Substances

.............. 5

- 7
5.4.6 Make Chemical Substances Subject to Enforceable Consent Agreements (ECAs) Ineligible for Exemptions

................................ ................................ ................................ 5

- 9
5.4.7 Full Exemption for Manufactured Water

................................ ................................ ......... 5

- 9
5.4.8 Remove Fully

- Exempt Polymers from the Partially

- Exempt List

................................ . 5

- 10
5.4.9 Parent Company and Site Identity

................................ ................................ ................. 5

- 10
5.4.10 Technical Contact

................................ ................................ ................................ .......... 5

- 10

5.4.11 Chemical Identity

................................ ................................ ................................ ........... 5

- 11
5.4.12 Report Production Volume for Each of the Years since Last Principal Reporting Year

... 5

- 12

5.4.13 Volume of Chemica l Substance Used On

- Site

................................ .............................. 5

- 13
5.4.14 Indicate Whether an Imported Chemical Substance Is Physically at the Reporting Site

... 5

- 1 4
5.4.15 R eport Production Volume Exported

................................ ................................ ............. 5

- 15v

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

................................ ................................ ................................ ....................... 5

- 15

5.4.17 Concentration Ranges

................................ ................................ ................................ .... 5

- 16
5.4.18 Revise Industrial Function Categories

................................ ................................ ........... 5

- 16
5.4.19 Replace NAICS Codes with Industria l Sectors

................................ .............................. 5

- 17
5.4.20 Revise Consumer and Commercial Product Categories

................................ ................ 5

- 17
5.4.21 Designation of Consumer or Commercial Use

................................ .............................. 5

- 19

5.4.22 Number of Commercial Workers Reasonably Likely To Be Exposed

.......................... 5

- 19
5.4.23 Changes to the Standard for the Reporting of Processing a nd Use Information

............ 5

- 20

5.4.24 Chemical Identity CBI Claims

................................ ................................ ....................... 5

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

..................... 5

- 20
5.4.26 Limitation on Confidentiality Claims for Data Elements Identified as “Not Known or Reasonably Ascertainable”

................................ ................................ ............................ 5

- 21
5 .4.27 Require Electronic Submissions over the Internet

................................ ......................... 5

- 21

5.4.28 Updated e

- IURweb Reporting Software

................................ ................................ ........ 5

- 22
5.4.29 Electronic Signatur e Process

................................ ................................ .......................... 5

- 22

5.4.30 Modifications Specifically Affecting Importers

................................ ............................ 5

- 23
5.4.31 Modify Reporting Frequency

................................ ................................ ......................... 5

- 23

5.5 Total Agency Cost of All Modifications

................................ ................................ ..................... 5

- 25

5.6 Annualized Agency Cost Estimates for All Modifications

................................ ........................... 5

- 1 6. Social Cost Summary

................................ ................................ ................................ ........................... 6

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

............................... 7

- 1

7.1 Bene fits of Information

- Based Policies

................................ ................................ ........................ 7

- 2

7.2 Benefits of Individual Amendments

................................ ................................ ............................. 7

- 3

7.2.1 Tailor Information Collected to More Closely Ma tch the Agency’s Information Needs 7

- 3

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

........... 7

- 7
7.2.3 Obtain New and Updated Exposure Information

................................ ............................. 7

- 8

7.2.4 Improve Utility of Information Reported

................................ ................................ ...... 7

- 12

7.3 Potential Users of Information Generated by the IUR Modifications Rule

................................ 7

- 14

7.3.1 EPA Risk

- Screening and Management Programs

................................ ......................... 7

- 15

7.3.2 Other Federal Risk Management Programs

................................ ................................ ... 7

- 18

7.3.3 State and Local Programs

................................ ................................ .............................. 7

- 18

7.3.4 Nongovernmental Organization (NGO) Initiatives and Private

- Sector Stewardship

.... 7

- 19 8. Small Entity Analysis

................................ ................................ ................................ ........................... 8

- 1

8.1 Select a Relevant Small Entity Definition

................................ ................................ .................... 8

- 1

8.2 Identify Number of Small Companies Reporting in 2006

................................ ............................ 8

- 2

8.3 Estimate Number of Parent Companies

................................ ................................ ........................ 8

- 3

8.4 Estimate Numb er of Small Companies

................................ ................................ ......................... 8

- 3

8.5 Estimate Cost

- to

- Sales Ratios for Small Companies

................................ ................................ .... 8

- 4

8.6 Summary

................................ ................................ ................................ ................................ ....... 8

- 6
9. Additional Analyses

................................ ................................ ................................ ............................. 9

- 1

9.1 Executive Order 12866

................................ ................................ ................................ ................. 9

- 1

9.2 Unfunded Mandates Reform Act (UMRA)

................................ ................................ .................. 9

- 1

9.3 Paperwork Reduction Act (PRA)

................................ ................................ ................................ .. 9

- 1

9.4 Executive Order 13132

- Federalism

................................ ................................ ............................ 9

- 2

9.5 Executive Order 12898

– Environmental Justice

................................ ................................ .......... 9

- 2

9.6 Executive Order 13045

– Children’s Health

................................ ................................ ................. 9

- 3

9.7 Executive Order 13175

– Consultation and Coordination with Indian Tribal Governments

........ 9

- 3vi

9.8 Executive Order 13211

– Energy Supply, Distribution, or Use

................................ .................... 9

- 3

9 .9 National Technology Transfer Advancement Act

................................ ................................ ........ 9

- 3
10. References

................................ ................................ ................................ ................................ ......... 10

- 1 Appendix A.

– Current and Revised Industrial Function Categori es

................................ ................ A

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

...................... B

- 1 Appendix C. Industrial Sectors

................................ ................................ ................................ .............. C

- 1 Appendix D. Sensitivity Analyses

................................ ................................ ................................ .......... D

- 1

D.1 Method for Determining Whether the Threshold Is Met

................................ ............................. D

- 1

D.2 Reporting Production Volume Used On

- Site

................................ ................................ ............... D

- 4

D.3 Revising Industrial Function Categories

................................ ................................ ...................... D

- 5

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

................................ ................... D

- 8

D.5 Upfront CBI Substantiation

................................ ................................ ................................ ....... D

- 10 Appendix E. Alternative Regulatory Options

................................ ................................ ...................... E

- 1

E.1 Require Submitters to Submit Full Data Annually

................................ ................................ ...... E

- 1

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

............... E

- 1

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

................................ ................................ ................................ ...................... E

- 3

E.1.3 Small Entity Analysis

................................ ................................ ................................ ..... E

- 5

E.2 Modify Reporting Frequency to a Three

- Year Cycle

................................ ................................ .. E

- 6
E.2.1 Three

- Year Reporting Cycle Cost and Burden when the Option is Considered by Itself E

6
E.2.2 Three

- Year Cycle Cost and Burden when the All the Proposed Amendments are
Considered

................................ ................................ ................................ ...................... E

- 9

E.2.3 Small Entity Analysis

................................ ................................ ................................ ... E

- 11

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

................................ ................................ ..... E

- 12

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

................................ ................................ ................................ ................................ ...... E

- 13

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

................................ ................................ ................................ .................... E

- 15

E.3.3 Small Enti ty Analysis

................................ ................................ ................................ ... E

- 24 Appendix F. Additional Exposure

- Related Data Elements

................................ ................................ . F

- 1

F.1 Estimated Number of Affected Entities

................................ ................................ ........................ F

- 6

F.2 Industry Burden Estimate

................................ ................................ ................................ ............. F

- 7

F.3 Industry Cost Estimate

................................ ................................ ................................ ................ F

- 11

F.4 Agency Burden Est imate

................................ ................................ ................................ ............ F

- 15

F.5 Agency Cost Estimate

................................ ................................ ................................ ................. F

- 19

F.6 Small Entity Analysis

................................ ................................ ................................ ................. F

- 23

A ppendix G. Estimated Burden and Cost of a Section 8(a) Rule for Exposure

- Related Data

Elements

................................ ................................ ................................ ................................ ................... G

- 1

G.1 Estimated Number of Affected Entities

................................ ................................ ....................... G

- 1

G.2 Industry Burden Estimate

................................ ................................ ................................ ............ G

- 2

G.3 Industry Cost Estimate

................................ ................................ ................................ ................. G

- 4

G.4 Agency Burden Estimate

................................ ................................ ................................ ............. G

- 5

G.5 Agency Cost Estimate

................................ ................................ ................................ .................. G

- 7

G.6 Small Entity Analysis

................................ ................................ ................................ .................. G

- 8vii 

### List of Tables

Table ES

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

................................ ..... xvii
Table 4

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

.................. 4

- 3

Table 4

- 2: Baseline First

- Cycle Labor Burden per Form U, in Hours

................................ ....................... 4

- 5
Table 4

- 3: Burden Percentages Attributed to Site

- Limited Activity and Production Volume Questions

. 4

- 7
Table 4

- 4: Mailing Submission Costs (December, 2009)

................................ ................................ .......... 4

- 8
Table 4

- 5: Baseline First

- Cycle Total Cost per Form U (2008$)

................................ .............................. 4

- 9
Table 4

- 6: Baseline Number of Reports and Sites

................................ ................................ ................... 4

- 11

Table 4

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

- 12

Table 4

- 8: Baseline Future

- Cycle Labor Burden per Report, in Hours

................................ ................... 4

- 13
Table 4

- 9: Baseline Future

- Cycle Total Cost per Report (2008$)

................................ ........................... 4

- 1 5
Table 4

- 10: Total Baseline Cost and Burden to Industry (2012 Reporting Cycle)

................................ .. 4

- 17

Table 4

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

.............................. 4

- 17
Table 4

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

................................ ............................... 4

- 19
Table 4

- 13: Change in Industry Cost as a Result of Modifying the M ethod for Determining Whether a Manufacturer is Subject to IUR Reporting Requirements

................................ ............................... 4

- 20
Table 4

- 14: Change in Industry Burden as a Result of Replacing the 300,000 lb Threshold for Downstream Processing and Use Information R eporting

................................ ................................ 4

- 21

Table 4

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

................................ ................................ ..................... 4

- 22

Table 4

- 16: Change in Industry Burde n as a Result of Reducing the 25,000 lb Threshold for Specific Regulated Chemical Substances

................................ ................................ ................................ ...... 4

- 23
Table 4

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

................................ ................................ ................................ ...... 4

- 24
Table 4

- 18: Change in Industry Burden as Result of Making Chemical Substances Subject to ECAs Ineligible for Exemptions

................................ ................................ ................................ ................. 4

- 25
Table 4

- 19: Change in Industry Cost as a Result of Making Chemical Substances Subject to ECAs Ineligible for Exemptions

................................ ................................ ................................ ................. 4

- 26

Table 4

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

.. 4

- 27

Table 4

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

.. 4

- 27
Table 4

- 22: Change in Industry Burden as a Result of Accession Number Requests

............................. 4

- 29
Table 4

- 23: Change in Industry Cost as a Result of Accession Number Requests

................................ .. 4

- 29

Table 4

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

- Principal Reporting Years

................................ ................................ ................................ ... 4

- 30

Table 4

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

Non

- Principal Reporting Years

................................ ................................ ................................ ........ 4

- 30
Table 4

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

Used On

- Site

................................ ................................ ................................ ................................ .... 4

- 32
Table 4

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

Used On

- Site

................................ ................................ ................................ ................................ .... 4

- 32
Table 4

- 28: Change in Industry Burden as a Result of Indicating Whether a Ch emical Substance is Physically at the Reporting Site

................................ ................................ ................................ ....... 4

- 33
Table 4

- 29: Change in Industry Cost as a Result of Indicating Whether a Chemical Substance is Physically at the Reporting Site

................................ ................................ ................................ ....... 4

- 33

Table 4

- 30: Change in Industry Burden as a Result of Requiring Reporting of Volume Exported

........ 4

- 34
Table 4

- 31: Change in Industry Cost as a Result of Requiring Reporting of Volume Exported

............. 4

- 34viii

Table 4

- 32 : Change in Industry Burden as a Result of Indicating Whether Chemical Substance is to be Recycled, Remanufactured, Reprocessed, or Reused

................................ ................................ ...... 4

- 35

Table 4

- 33: Change in Industry Cost as a Result of Indicating Whether Chemical Sub stance is to be Recycled, Remanufactured, Reprocessed, or Reused

................................ ................................ ...... 4

- 36

Table 4

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

...... 4

- 37
Table 4

- 35: Change in In dustry Cost as a Result of Revising the Industrial Function Categories

.......... 4

- 37
Table 4

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

................................ ................................ ................................ ................................ ........ 4

- 39
Table 4

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

................................ ................................ ................................ ................................ ........ 4

- 39
Table 4

- 38: Change in Industry Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed

................................ ................................ ................................ .. 4

- 40

Table 4

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

................................ ................................ ................................ .. 4

- 41

Table 4

- 40: Change in Industry Burden as a Result of Requiring Upfront Substantiation for Claiming Processing and Use Information as CBI

................................ ................................ .......................... 4

- 42

Table 4

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

................................ ................................ .......................... 4

- 43
Table 4

- 42: Change in Industry Burden as a Result of Requiring Electronic Submission

...................... 4

- 44

Table 4

- 43: Change in Industry Cost as a Result of Requiring Electronic Submission

........................... 4

- 45
Table 4

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

Submitters

................................ ................................ ................................ ................................ ........ 4

- 46
Table 4

- 45: Change in Industry Cost as a Result of Requiring CDX Registration for Secondary Submitte rs

................................ ................................ ................................ ................................ ......................... 4

- 46

Table 4

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

- Year Period

................................ ................................ ................................ ................................ ...... 4

- 48

Table 4

- 47: Change in Industry Cost as a Result of Modifying the Reportin g Frequency, over a 26

- Year
Period

................................ ................................ ................................ ................................ ............... 4

- 49
Table 4

- 48: Change in the Number of Sites and Reports Submitted for All Amendments Combined (First Reporting Cycle)

................................ ................................ ................................ .............................. 4

- 51
Table 4

- 49: Change in the Number of Sites and Reports Submitted for All Amendments Combined (Future Cycles)

................................ ................................ ................................ ................................ . 4

- 52
Table 4

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

................................ ................................ ................................ ................................ ........... 4

- 55

Table 4

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

................................ ................................ ................................ ................................ ........... 4

- 55

Table 4

- 52: Total Industry Burden for All Amendments Combined

................................ ....................... 4

- 57
Table 4

- 53: Total Industry Cost When All Amendments Are Combined

................................ ................ 4

- 58
Table 4

- 54: Average Number of Full and Partial Reports per Site

................................ .......................... 4

- 59

Table 4

- 55: Average Total Burden per Site

................................ ................................ ............................. 4

- 59
Table 4

- 56: Average Total Cost per Site

................................ ................................ ................................ . 4

- 60

Table 4

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

............. 4

- 61
Table 4

- 58: Industry Cost over a Period of 26 Years if All Amendm ents Are Implemented

.................. 4

- 62
Table 5

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

................................ ................................ 5

- 2
Table 5

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

................................ ..................... 5

- 2
Table 5

- 3: Total Agency Cost under the Current IUR Requirements

................................ ........................ 5

- 3
Table 5

- 4: Baseline Agency Burden per Report

................................ ................................ ........................ 5

- 4
Table 5

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

................................ ................................ . 5

- 5
Table 5

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

................................ ................................ . 5

- 6ix

Table 5

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

................................ ................................ ................................ .............................. 5

- 7
Table 5

- 8: Change in Agency Cost as a Result of Replacing the 300,000 lb Thre shold for Processing and Use Reporting

................................ ................................ ................................ ................................ .... 5

- 7
Table 5

- 9: Change in Agency Burden as a Result of Reducing the 25,000 lb Threshold for Specific Regulated Chemical Substances (Future Cycles Only)

................................ ................................ ..... 5

- 8

Ta ble 5

- 10: Change in Agency Cost as a Result of Reducing the 25,000 lb Threshold for Specific Regulated Chemical Substances (Future Cycles Only)

................................ ................................ ..... 5

- 8
Table 5

- 11: Change in Agency Burden as a Result of Making Chemical Substances Subject to ECAs Ineligible for Exemptions

................................ ................................ ................................ ................... 5

- 9
Table 5

- 12: Change in Agency Cost as a Result of Making Chemical Substances Subject to ECAs Ineligible for Exemptions

................................ ................................ ................................ ................... 5

- 9
Table 5

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

......... 5

- 10
Table 5

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

............. 5

- 10
Table 5

- 15: Change in Agency Burden as a Result of Accession Nnumber Requests

............................ 5

- 11
Table 5

- 16: Change in Agency Cost as a Result of Accession Number Requests

................................ ... 5

- 12
Table 5

- 17: Change in Agency Burden as a Result of Reporting of Prod uction Volume for Each of the Years since Last Principal Reporting Year

................................ ................................ ...................... 5

- 12
Table 5

- 18: Change in Agency Cost as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year

................................ ................................ ................................ 5

- 1 3
Table 5

- 19: Change in Agency Burden as a Result of Reporting of Production Volume Used On

- Site

. 5

- 13
Table 5

- 20: Change in Agency Cost as a Result of Reporting of Production Volume Used On

- Site

..... 5

- 14
Table 5

- 21: Change in Agency Burden as a Result of Indicating Whether an Imported Chemical Substance is Physically at the Reporting Site

................................ ................................ .................. 5

- 14
Table 5

- 22: Change in Agency Cost as a Result of Indicatin g Whether an Imported Chemical Substance is Physically at the Reporting Site

................................ ................................ ................................ ....... 5

- 14
Table 5

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

....... 5

- 15
Table 5

- 24: Chang e in Agency Cost as a Result of Requiring the Reporting of Export Volume

............ 5

- 15
Table 5

- 25: Change in Agency Burden as a Result of Indicating Whether Chemical Substance is to be Recycled, Remanufacture, Reprocessed, or Reused

................................ ................................ ........ 5

- 16
Table 5

- 26: Change in Agency Cost as a Result of Indicating Whether Chemical Substance is to be Recycled, Remanufactured, Reprocessed, or Reused

................................ ................................ ...... 5

- 16
Table 5

- 27: Change in Agency Burden as a Re sult of Revising the Industrial Function Categories

...... 5

- 17
Table 5

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

........... 5

- 17
Table 5

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

................................ ................................ ................................ ................................ ........ 5

- 18
Table 5

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

................................ ................................ ................................ ................................ ........ 5

- 18
Table 5

- 31: Cha nge in Agency Burden as a Result of Designation of Consumer or Commercial Use

... 5

- 19
Table 5

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

....... 5

- 19
Table 5

- 33: Chang e in Agency Burden as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed

................................ ................................ ................................ .. 5

- 19
Table 5

- 34: Change in Agency Cost as a Result of Requiring the Number of Commercial Workers Reasonably Likely To Be Exposed

................................ ................................ ................................ .. 5

- 20
Table 5

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

. 5

- 20
Table 5

- 36: Change in Agency Cost as a Result of Requiring Upfront Substant iation for CBI Claims

. 5

- 21
Table 5

- 37: Change in Agency Burden as a Result of Requiring Electronic Submission

....................... 5

- 22
Table 5

- 38: Change in Agency Cost as a Result of Requiring Electronic Submission

........................... 5

- 22
Table 5

- 39: Change in Agency Burden as a Result of Modifying the Reporting Frequency

.................. 5

- 24
Table 5

- 40: Change in Agency Cost as a Result of Modifying the Reporting Frequency

....................... 5

- 24x

Table 5

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

- 26
Table 5

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

................................ ................................ ................................ ................................ ............. 5

- 26
Table 5

- 43: Total Agency Burden for All Amendments Combined

................................ ........................ 5

- 27
Table 5

- 44: Total Agency Cost of All Amendments Combined

................................ .............................. 5

- 28
Table 5

- 45: Agency Burden per Repo rt when All Amendments are Combined (First Cycle)

................ 5

- 30
Table 5

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

............ 5

- 30
Table 5

- 47: Agency Cost per Report When All Amendm ents are Combined (First Reporting Cycle)

... 5

- 32
Table 5

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

.. 5

- 32
Table 5

- 49: Agency Cost per Report when All Amendm ents are Combined

................................ ............ 5

- 0
Table 5

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

................. 5

- 1
Table 5

- 51: Annual and Discounted Total Cost to the Agency of All Modifications

................................ 5

- 2
Table 6

- 1: Change in Total Burden to Society If All Modifications are Implemented

............................. 6

- 1
Table 6

- 2: Change in Total Costs to Society if All Modifications are Implemented

................................ . 6

- 2
Table 8

- 1: Results of Dun & Bradstreet Analysis

................................ ................................ ...................... 8

- 3
Table 8

- 2: Estimated Number of Small Companies under the IUR Rule Amendments

............................ 8

- 4
Table 8

- 3: Derivation of Cost

- to

- Sales Ratios for Small Co mpanies under the IUR Rule Amendments

. 8

- 5

Table A

- 1: List of Current and Revised Industrial Function Categories

................................ .................. A

- 1
Table B

- 1: List of Current and Revised Consumer and Commercial Product Categorie s

........................ B

- 1

Table D

- 1: Sensitivity Analysis of Industry Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

................................ ....................... D

- 2
Table D

- 2: Sensitivity A nalysis of Industry Cost Estimates for Modifying the Method for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

................................ ....................... D

- 2
Table D

- 3: Sensitivity Analysis of Agency Burden Estimates for Modifying the Method fo r Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

................................ ....................... D

- 3
Table D

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

................................ ....................... D

- 3

Table D

- 5: Sensitivity Analysis of Industry Burden Estimates for Reporting Production Volume Used On

Site

................................ ................................ ................................ ................................ .................... D

- 4

Table D

- 6: Sensitivity Analysis of Industry Cost Estimates for Reporting Production Volume Used On

Site

................................ ................................ ................................ ................................ .................... D

- 4
Table D

- 7: Sensitivity Analysis of Agency Burden Estimates for Reporting Production Volume Used On

Site

................................ ................................ ................................ ................................ .................... D

- 5
Table D

- 8: Sensitivity Analysis of Agency Cost Estim ates for Reporting Production Volume Used On

Site

................................ ................................ ................................ ................................ .................... D

- 5
Table D

- 9: Sensitivity Analysis of Industry Burden Estimates for Requiring Write

- in Text for “Other” as an Industrial Function Category

................................ ................................ ................................ ........ D

- 6

Ta ble D

- 10: Sensitivity Analysis of Industry Cost Estimates for Requiring Write

- in Text for “Other” as an Industrial Function Category

................................ ................................ ................................ ............ D

- 7
Table D

- 11: Sensitivity Analysis of Agency Burden Estimates for Requiring Write

- in Text f or “Other” as an Industrial Function Category

................................ ................................ ................................ ........ D

- 7
Table D

- 12: Sensitivity Analysis of Agency Cost Estimates for Requiring Write

- in Text for “Other” as an Industrial Function Category

................................ ................................ ................................ ............ D

- 8
Table D

- 1 3: Sensitivity Analysis of Industry Burden Estimates for Requiring Write

- in Text for “Other” as a Consumer and/or Commercial Product Category

................................ ................................ .......... D

- 9
Table D

- 14: Sensitivity Analysis of Industry Cost Estimates for Requiring Write

- in Text for “Other” as a Consumer and/or Commercial Product Category

................................ ................................ ............. D

- 9
Table D

- 15: Sensitivity Analysis of Agency Burden Estimates for Requiring Write

- in Text for “Other” as a Consumer and/or Commercial Product Category

................................ ................................ ........ D

- 10xi

Table D

- 16: Sensitivity Analysis of Agency Cost Estimates for Requiring Write

- in Text for “Other” as a Consumer and/or Commercial Product Category

................................ ................................ ........... D

- 10

Table D

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

................................ ................................ ................................ ................................ ........................ D

- 11

Table D

- 18: Sensitivity Analysis of Industry Cost Estimates for Requiring Upfront CBI Substantiation

. D

11
Table D

- 19: Sensitivity Ana lysis of Agency Burden Estimates for Requiring Upfront CBI Substantiation

................................ ................................ ................................ ................................ ........................ D

- 12
Table D

- 20: Sensitivity Analysis of Agency Cost Estimates for Requiring Upfront CBI Substantiation

.. 12

Table E

- 1: Indu stry Burden under the Alternative Option to Require Submitters to Submit Full Data Annually

................................ ................................ ................................ ................................ ............ E

- 1
Table E

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

................................ ................................ ................................ ................................ ............ E

- 2
Table E

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

................................ ................................ ................................ ................................ ............ E

- 2
Table E

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

................................ ................................ ................................ ................................ ............ E

- 3
Table E

- 5: Industry Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

................................ ........................ E

- 3

Table E

- 6: Industry Cost under the Alt ernative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

................................ ........................ E

- 4

Table E

- 7: Agency Burden under the Alternative Option to Require Submitters to Submit Full Data Annually wh en all the Proposed Amendments are Considered

................................ ........................ E

- 4
Table E

- 8: Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

................................ ........................ E

- 5
Table E

- 9: Derivation of Cost

- to

- Sales Ratios for Small Manufacturers for Collection of Annual Reporting

................................ ................................ ................................ ................................ ........... E

- 6
Table E

- 10: Annual Industry Burden under the Alternative Option of a Three

- Year Reporting Cycle

... E

- 7
Table E

- 11: Industry Cost under the Alternative Option of a Three

- Year Reporting Cycle

.................... E

- 7
Table E

- 12: Burden to the Agency under the Alternative Option of a Three

- Year Reporting Cycle

....... E

- 8
Table E

- 13: Agency Cost under the Alternative Option of a Three

- Year Reporting Cycle

..................... E

- 8

Table E

- 14: Annual Industry Burden under the Alternative Option of a Three

- Year Reporting Cycle when the All the Proposed Amendments are Considered

................................ ................................ ........... E

- 9
Table E

- 15: Industry Cost under the Alternative Option of a Three

- Year Reporting Cycle when the All the Proposed Amendments are Considered

................................ ................................ .......................... E

- 10
Table E

- 16: Agency Burd en under the Alternative Option of a Three

- Year Reporting Cycle when the All the Proposed Amendments are Considered

................................ ................................ ..................... E

- 10
Table E

- 17: Agency Cost under the Alternative Option of a Three

- Year Reporting Cycle when the All the

Pro posed Amendments are Considered

................................ ................................ .......................... E

- 11

Table E

- 18: Derivation of Cost

- to

- Sales Ratios for Small Manufacturers for a Three

- Year Reporting Cycle

................................ ................................ ................................ ................................ ............... E

- 12

Table E

- 19: Number of Reports and Sites in 2002

................................ ................................ ................. E

- 13
Table E

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

.......... E

- 14

Table E

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

.............. E

- 14
Table E

- 22: Change in Burden to the Agency as a Result of Changing the Threshold for Reporting to 10,000 lb

................................ ................................ ................................ ................................ ......... E

- 15

Table E

- 23: Change in Agency Cost as a Result of Changing the Threshold for Report ing to 10,000 lb

.. E

15

Table E

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

................................ ........................... E

- 17xii

Table E

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

................................ ....................... E

- 18

Table E

- 26: Industry Burden as a Result of Changing the Threshold for Reporting to 10,000 lb when All Proposed Amendments are Considered

................................ ................................ .......................... E

- 19

Table E

- 27: Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb when All Proposed Amendments are Considered

................................ ................................ .......................... E

- 20
Table E

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

Other Amendments when All Proposed Amendments are Considered

................................ .......... E

- 20
Table E

- 29: Change in Industry Cost as a Result of Chang ing the Threshold for Reporting to 10,000 lb and All Other Amendments when All Proposed Amendments are Considered

.............................. E

- 21
Table E

- 30: Agency Burden as a Result of Lowered Threshold Reporting and All Other Amendments when All Prop osed Amendments are Considered

................................ ................................ ........... E

- 22

Table E

- 31: Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered

................................ ................................ .................... E

- 23

Table E

- 32: Agency Burden under the Alternative Option of a Lowered Reporting Threshold and All Other Amendments when All Proposed Amendments are Considered

................................ .......... E

- 23

Table E

- 33: Change in Agency Cost as a Result of Changing the Threshold for Reporti ng to 10,000 lb and All Other Amendments when All Proposed Amendments are Considered

................................ .... E

- 24
Table E

- 34: Derivation of Cost

- to

- Sales Ratios for Small Manufacturers for a 10,000 lb Reporting

Threshold

................................ ................................ ................................ ................................ ........ E

- 25
Table F

- 1: Description of Additional Data Elements

................................ ................................ ............... F

- 1

Table F

- 2: Change in Industry Burden to Manufacturers as a Result of Additional Exposure

- Related Data
Elements

................................ ................................ ................................ ................................ ............ F

- 8
Table F

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

................................ ................................ ................................ ................................ ..... F

- 9
Table F

- 4: Change in Industry Burden to Processors as a Result of Additional Exposure

- Related Data

Elements

................................ ................................ ................................ ................................ ............ F

- 9
Table F

- 5: Schedule of Annual Industry Burden to Processors

................................ .............................. F

- 10
Table F

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

- Related Data Elements

................................ ................................ ................................ .... F

- 10
Table F

- 7: Schedule of Annual Industry Burden to Manufacturers and Processors if All Proposed Amendments Are Implemented

................................ ................................ ................................ ...... F

- 11
Table F

- 8: Per

- Report Cost for Additional Data Elements, based on PMN Burden

.............................. F

- 11
Table F

- 9: Change in Industry Cost to Manufacturers as a Result of Additional Exposure

- Related Data

Elements

................................ ................................ ................................ ................................ .......... F

- 12
Table F

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

I mplemented (2008$)

................................ ................................ ................................ ...................... F

- 13
Table F

- 11: Change in Industry Cost to Processors as a Result of Additional Exposure

- Related Data
Elements

................................ ................................ ................................ ................................ .......... F

- 13

Table F

- 12: Annual Increase in Industry Cost to Processors i f All Proposed Amendments Are Implemented (2008$)

................................ ................................ ................................ ...................... F

- 14

Table F

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

- Related Data Elements

................................ ................................ ................................ .... F

- 14

Table F

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

................................ ................................ ................................ ............... F

- 15
Table F

- 15: Change in Agency Burden to Process Manufacturer Data as a Result of Additional Exposure

Related D ata Elements

................................ ................................ ................................ .................... F

- 16
Table F

- 16: Annual Increase in Agency Burden to Process Manufacturer Data if All Proposed Amendments Are Implemented

................................ ................................ ................................ ...... F

- 17
Table F

- 17: Change in Agency Burden to Process Processor Data as a Result of Additional Exposure

Related Data Elements

................................ ................................ ................................ .................... F

- 1 7xiii

Table F

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

................................ ................................ ................................ ............................ F

- 18

Table F

- 1 9: Change in Agency Burden to Process Manufacturer and Processor Data as a Result of Additional Exposure

- Related Data Elements

................................ ................................ .................. F

- 18

Table F

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

Im plemented

................................ ................................ ................................ ................................ ... F

- 19
Table F

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

Related Data Elements

................................ ................................ ................................ .................... F

- 20
Table F

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

................................ ................................ ................................ ............... F

- 20
Table F

- 23: Change in Agency Cost to Process Processor Data as a Result of Additional Exposure

Related Data Elements

................................ ................................ ................................ .................... F

- 21

Table F

- 24: Annual Increase in Agency Cost to Process Processor Data if All Proposed Amendments Are Implemented (2008$)

................................ ................................ ................................ ...................... F

- 21

Table F

- 25: Change in Agency Cost of Processing Manufacture and Processor Data as a Result of
Additi onal Exposure

- Related Data Elements

................................ ................................ .................. F

- 22

Table F

- 26: Annual Increase in Agency Cost to Process Manufacturer and Processor Data if All Proposed Amendments Are Implemented (2008$)

................................ ................................ ......................... F

- 22
Table F

- 27. D erivation of Cost

- to

- Sales Ratios for Small Manufacturers for Collection of Additional Data

Elements

................................ ................................ ................................ ................................ .......... F

- 24
Table F

- 28: Derivation of Cost

- to

- Sales Ratios for Small Processors for Collection of Additional Data

Elements

................................ ................................ ................................ ................................ .......... F

- 25
Table G

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

...................... G

- 3
Table G

- 2: Schedule of Annual Industry Burden

................................ ................................ ..................... G

- 4
Table G

- 3: Per

- Report Cost for Additional Data Elements, based on PMN Burden

................................ G

- 4
Table G

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

........................... G

- 4
Table G

- 5: Annual Increase in Industry Cost if All Amendmen ts Are Implemented (2008$)

................. G

- 5
Table G

- 6: Per

- Report Burden for Data Elements Similar to Those Included in a TSCA Section 8(a) Data
Collection

................................ ................................ ................................ ................................ .......... G

- 5
Table G

- 7:Agency Burden to Process Data as a Resu lt of a TSCA Section 8(a) Data Collection

........... G

- 6
Table G

- 8: Schedule of Annual Agency Burden

................................ ................................ ...................... G

- 6
Table G

- 9: Per

- Report Cost for Data Elements Similar to Those Included in a TSCA Section 8(a) Data
Col lection

................................ ................................ ................................ ................................ .......... G

- 7
Table G

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

.......... G

- 7
Table G

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

................................ ................................ ............. G

- 7
Tab le G

- 12: Derivation of Cost

- to

- Sales Ratios for Small Manufacturers for Collection of Exposure

Related Data Elements

................................ ................................ ................................ ...................... G

- 9
Table G

- 13: Derivation of Cost

- to

- Sales Ratios for Small Processors for Collection of Exposure

- Related

Da ta Elements

................................ ................................ ................................ ................................ . G

- 10xiv 

### Executive Summary

As part of the Inventory Update Reporting ( IUR ) Modifications final rule, EPA is changing the identification of the regulation from IUR to Chemical Data Reporting ( CDR )

. However, EPA is retaining the use of the IUR acronym throughout this document. The reader should recognize that where IUR is used to refer to the 40 CFR 711 regulations or to future IUR submission periods, IUR and CDR are

synonymous.



### The U.S. Environmen tal Protection Agency (EPA) requires manufacturers (including importers ) of certain chemical substances to periodically report information to the Agency under reporting requirements known as the TSCA Inventory Update Reporting (IUR) rule . This

information is collected based on EPA’s authority under section 8(a) of the Toxic Substances Control Act (TSCA ), which requires EPA to compile and keep current a listing of chemical

substance s in commerce in the United States and is known as the TSCA Inventory. The da ta reported under the IUR rule are used to support many EPA and other federal agency health, safety, and environmental protection activities. Established in 1986, t he IUR rule was amended extensively in 2003 , and amended again in 2005

. EPA is now finalizin g further amendments to the IUR rule (“2011 amendments”)

.
Prior to the 2011 amendments , t he IUR rule require d companies to report information every five years on certain chemical substances listed on the TSCA Inventory

. For reportable

substances that a com pany manufactures (including imports ) in volumes of 25,000 lb or more at a plant site during the principal reporting year, a submitter is required to provide plant site, production volume, and manufacturing information. Sites must also provide processing a nd use

information for chemical substance s manufactured (including imported) in volumes that meet or

exceed a n annual 1 00,000 lb threshold. Submitters do not need to provide this processing and use

information for chemical substance s that are “partially ex empt,” such as specifically listed petroleum process streams, and listed chemical substances for which the IUR information is of
low current interest. These chemical substance s are all referred to as “partially exempt” from reporting because companies must provide manufacturing information for them but not processing and use information. Prior to the 2011 amendments, submitters did not need to provide the processing and use information for any chemicals manufactured (including imported)
below a 300,000 lb t hreshold

. Since the publishing of the proposed rule in August of 2010, EPA has issued a suspension of the 2011 data collection. Under the final rule, EPA has issued new IUR collection dates of February 1, 2012 to June 30, 2012, and a new principal reportin g year; 2011. In addition, EPA has made several other modifications to the final rule. Under the proposed rule, EPA required

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

last principal report ing year begin ning with the 2012 reporting cycle. Under the final rule the Agency is requiring the reporting of 2010 and 2011 production volumes with the 2012 reporting cycle, and the reporting of all past year production beginning with the 2016 reporting cycle. In

addi tion, EPA proposed the elimination of the 25,000 lb reporting threshold for specific regulated chemical substances and would have required manufacturers (including importers) of these chemical substances to report under the IUR rule, regardless of producti on volume. Under the final rule, EPA is reducing the reporting threshold for specific regulated chemical substances from 25,000 lb to 2,500 lb. Finally, EPA proposed the elimination of the 300,000 lb reportingxv



### threshold for processing and use information. Under the final rule, EPA has replaced this threshold. The complete list of IUR modifications under the final rule is found below:

Technical ly modify the regulatory text to move various provisions to other sections , to increase clarity;

C onsolidate the def

ini tions currently found at § 710.3 and §710.43 into the amended §711.3, except where an appropriate definition is a lready in place in section 3 of TSCA or at §704. 3

, and d elete the definition for “ non

- isolated intermediate ” from §710.3;

Modif y the definiti ons of “importer,” “manufacture

, ” “site

, ” “commercial use,” “consumer use,” “reporting year,” and “submission period” to increase clarity of these definitions and

make them consistent with the amendments to IUR requirements and with other regulations;

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

- IUR web” , and “industrial function”;

For the reporting cycles subsequent to the 201 2 reporting cycle , a dd a requirement to report

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

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

ye ar ; Replace the 300,000 lb reporting threshold for processing and use information by phasing in a lower reporting threshold. For the 2012 IUR manufacturers (including importers) of non

excluded substances with production volumes greater than 100,000 lb are required to report processing and use information. Subsequent to the 2012 reporting cycle, the reporting threshold for processing and us e information will be 25,000 lb; Reduce the 25,000 lb threshold for reporting to 2,500 lb for certain regulated chemical

substance s and require manufacturers (including importers) of such chemical substance s to report under the IUR rule

, if production vo lume is greater than 2,500 lb beginning with the 2016 reporting cycle;

Make chemical substance s subject to Enforceable Consent Agreements (ECAs) ineligible for exemptions ; Exempt manufactured water from reporting requirements ; Remove fully exempt polymers from the partially exempt list; Amend reportable data elements such as the company identification number, technical contact, and chemical identity ; Require, f

or the 2012 reporting cycle, submitters to report chemical substance production
volumes for both 2 010 and 2011. For the reporting cycles subsequent to the 201 2 reporting cycle

, submitters are required to report the chemical substance ’s production volume for each year since the last principal report ing year; Require submitters to report separately produ ction volume used on

- site; Require submitters of imported chemical substance s to indicate whether the chemical

substance is physically at the reporting site ; Require submitters to report production volume exported ; Require submitters to indicate whether th e chemical substance is to be recycled

,

r emanufacture d, reprocessed, or reused;

R evise the set of industrial function categories and provide industrial sector s instead of
NAICS codes

, f

or downstream processing and use information

, and revise the set of

c on sumer and commercial product categories ; Require submitters to identify whether a use is a consumer use, a commercial use , or both;xvi



### Require submitters to report the total number of commercial workers, including those at sites
not under the submitter’s cont rol, 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 ascertai nable by ” ; Require upfront substantiation for claims that processing and use data are confidential

business i nformation (CBI); Restrict submitters from being able to cl aim not “known to or reasonably ascertainable by ”

data as CBI ; Require submitters to sub mit forms electronically using the e

- IUR web tool and EPA’s CDX;
and Change the frequency of reporting from every five years to every four years.

These amendments overall will increase IUR rule reporting costs. Over the first 2 6 year s of the rule, EPA estim ates the net present value of the rule modifications will be $ 494. 7 million in social cost. Annualized costs are expected to be $ 17. 15 million (at a three percent discount rate) and $ 14. 70 million (at a seven percent discount rate). 1 

### EPA estimates all of t he amendments
combined will increase the burden to industry by approximately 0.5 0 million hours to 2. 34 million hours, and increase the cost to industry by approximately $ 36.8 million to $ 143.7 million in total for the 2012 report ing cycle. EPA estimates i n future reporting cycles, the industry burden will increase by 1.14 million hours to a total of 2. 57 million hours, and industry cost will increase by $ 75.1 2 million to $ 157.9 4 million. EPA further estimates over a 2 6

- year period, industry burden will inc rease by 7.6 2 million hours and Agency burden will decrease by 5

, 2 00 hours. EPA estimates the net burden to society will increase by 7. 6 1 million hours over a 2 6

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

, regulatory, or enforcement activities to industries or chemical substance s posing the greatest potential risks and to target programs for population groups at the highest potential risk.

With this more targeted information designed to better meet Agency needs, EPA will improve its ability to screen chemical substance s to identify whether additional risk assessment and management steps are needed. More complete reporting of the processing and use data, more careful consideration of confidentiality claims, and adjustments to specific data elements will help provide the needed data. By enhancing the data supplied to Agency risk

- screening programs, EPA expects to more effectively and expeditiously reduce the risks posed by chemical

substance s. The more EPA can base its decisions on actual data rather than on assumptions, the better EPA is able to tailor its risk management decisions to the level of actual risk, whether higher or lower than it would be if based only on assumptions. Ultimately, an enhanced risk

s creening process will have positive consequences for human and ecosystem health, and will use EPA’s and society’s resources more efficiently. Additional benefits will accrue from changes in reporting requirements that will improve consistency and compatibi lity with other EPA databases. EPA will have an increased ability to anticipate industry trends, particularly for

chemical substance s for which EPA has concerns.

The costs and benefits of the rule are summarized in Table ES

- 1 bel ow

.

1 All values are in year 2008 dollars.xvii

Table ES

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

Burden (Millions of Hours) Cost (Millions of 2010$)

Benefits (Not Quantified) First Reporting Cycle Future

Reporting Cycles Total

(over 26 years) First

Reporting Cycle Future

Reporting Cycle Total

(over 26 years)

Industry 2.34 2.5 7 15.20 $143.73 $157.94 $933.42 Electronic reporting and other changes, such as modifying and clarifying definitions, will increase the efficiency of industry reporting.

Agency 0.003 0.002 0.016 $0.399 $0.292 $ 1 .856 The IUR rule modifications will allow the Agency

to collect better information to meet the Agency’s

overall needs

, to increase its ability to effectively provide public access to the informatio n , to obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory, and to improve the usefulness of the information reported . It will also allow the Agency to save time and resources in screening chemical substances and in developing risk management priorities and reduce EPA’s costs of processing the IUR data and result in a better quality database.

TOTAL (Industry & Agency) 2.34 2.5 7 15.21 $144.13 $158.23 $ 935.28

--

Other
Government
Entities -- -- -- -- -- -- IUR data will help state and local authorities with rulemaking, information collection, and voluntary program activities. Because state and local governments must address chemical substances, use patterns, and exposure scenarios that may be unique or isolated, state and local agency access to the enhanced data will assist in identifying situations posing potentially high exposures for
individual states or locations within those states.xviii Burden (Millions of Hours) Cost (Millions of 2010$)

Benefits (Not Quantified) First Reporting Cycle Future

Reporting Cycles Total

(over 26 years) First

Reporting Cycle Future

Reporting Cycle Total

(over 26 years)

NGOs and
Other Private
Entities -- -- -- - - -- -- Private

- sector organizations with a strong interest in reducing risks and providing leadership in preventing pollution can better meet these objectives by developing a better understanding of

how chemical substances are used in general. This

will a llow them to manage exposures more effectively and participate in setting chemical substance priorities at community, regional, and
national levels.

General
Public -- -- -- -- -- -- The IUR rule modifications will reduce the cost of

risk

- based decision ma king in the public sector, and will free up resources for other public or private uses. The rule will also increase public access to the information and improve the usefulness of the information reported.1

- 1 

## 1. Introduction

As part of the Inventory Update Re porting ( IUR ) Modifications final rule, EPA is changing the identification of the regulation from IUR to Chemical Data Reporting ( CDR ) . However, EPA is retaining the use of the IUR acronym throughout this document. The reader should recognize that where IUR is used to refer to the 40 CFR 711 regulations or to future IUR submission periods, IUR and CDR are synonymous.

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

TSCA Inventory Update Reporting (IUR) r ule. The amendment s will provide information to better address Agency and public information needs, improve the usability and reliability of the reported data, and ensure that data are available in a timely manner. This chapter provides background information on EP A’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 manufactu rers and processors of chemical substances and mixtures must maintain such records and submit such information as the Administrator may reasonably require. TSCA section 8(a) generally excludes small manufacturers and processors of chemical substances from the reporting requirements established in TSCA section 8(a). However, EPA is authorized by TSCA section 8(a)(3) to require TSCA section 8(a) reporting from small manufacturers and processors with respect to any chemical substance that is the subject of a r egulation 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 d etermining whether an entity qualifies as a small manufacturer for purposes of 40 CFR part 710 is found at 40 CFR 704.3. Processors currently are not subject to the regulations at 40 CFR part 710.

1.2 

### Regulatory History

When Congress passed TSCA, it granted EP A broad authority to collect information on chemical substances to help EPA and others assess the magnitude and extent of human and environmental exposure to chemical substance s used in commerce. Specifically, under §8 of TSCA (15 U.S.C. 2607), EPA is auth orized to promulgate regulations requiring manufacturers and processors of chemical substance s to report manufacturing (including importing), processing and use information on various types and classes of chemical substance s. In 1977, EPA used its

authorit y under TSCA §8 to create the TSCA Chemical Substances Inventory, also known as the TSCA Inventory (42 FR 64572), which currently is codified at 40 CFR part 710 Subpart A. The TSCA Inventory lists all TSCA chemical substance s in commerce in the United Stat es, thereby providing a listing of chemical substance s manufactured or processed in the United States. All

chemical substance s are included, with the exception of pesticides, tobacco, nuclear material, firearms and ammunition, food and food additives, drug s, and cosmetics, which are not under the1

- 2



### jurisdiction of TSCA. Chemical Substance s are added to the TSCA Inventory after a company completes EPA’s New Chemical Substance s review process and files a Notice of

Commencement

. 2



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

chemical substance manufacturers, including importers, to report data periodically to EPA on certain chemical substances listed in the TSCA Inventory (51 FR 21447). The IUR regulations applicable to the 1986 through 2002 reporting cycles currently are codified at 40 CFR Part 710 Subpart B. These regulations are commonly called the TSCA Inventory Update Reporting rule, or IUR rule. Under this rule, EPA collected data every four years for organic chemical

s ubstance s produced in volumes of 10,000 lb or more per site. (Inorganic chemical substance s, polymers, microorganisms, and naturally occurring chemical substances were generally excluded from reporting.) From 1986 to 1998, an average of 9,200 individual ch emical substance s was reported per reporting cycle. The IUR data provided a more up

- to

- date picture of a subset of the

TSCA chemical substance s in commerce, generating data used to support TSCA risk management activities, as well as to provide support to o ther 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, wa s 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 po tential chemical substance exposures; changed the period of coverage from corporate fiscal year to calendar year; and extended the recordkeeping period from four years to five years. The 2003 Amendments partially mitigated the industry burden increase by r aising the reporting threshold to 25,000 lb ; creating a partial exemption from reporting processing and use information for inorganic chemical substance s for the 2006 IUR collection only, and for specifically

- listed petroleum process streams and other spec ifically 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 subseque nt 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.

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

- 1 

## 2. IUR Requirements and Affected Entities

2.1 

### Overview of IUR Requirement s

The IUR rule requires U.S. manufacturers (including impo rters) of chemical substance s 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. I UR 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 a ctivities. To the extent possible due to restrictions related to confidential business information (CBI), the Agency also makes the data available to the public.

Persons manufacturing (including importing) chemical substances are required to report

informa tion related to company, site, and chemical identity and, for each reportable chemical substance, manufacturing exposure

- related information (40 CFR §710.52). The 2006 submission year was the first time information on inorganic chemical substance s was requ ired 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).

Manufac turers (including importers) of chemical substance s in larger volumes (i.e., 300,000 lb or greater manufactured or imported during the principal reporting year at any single site) additionally are required to report exposure

- related processing and use info rmation (40 CFR §710.52(c)(4)). The IUR rule generally grants a partial exemption to specifically

- listed petroleum process streams and other specifically

- listed chemical substances, and manufacturers (including importers) of such substances were not requir ed to report processing and use information for those substances. For the 2006 IUR only, inorganic chemical substance s were partially exempted.

Form U, the tool used to collect the IUR information, is divided into three parts: Site

Identification Informat ion (Part I), Manufacturing Information (Part II), and Processing and Use Information (Part III). An overview of the information collected under the IUR rule in 2006 is as
follows:

Company Reporting Number

. An 8

- digit alphanumeric number assigned by the su bmitter to each specific IUR submission (for electronic submissions only).
Certification statement

. A form that must be signed by a company

- authorized official, to certify the information provided is complete and accurate. Company information

. Includes th e company name and Dun & Bradstreet number.
Plant site information

. Includes the name, address, and Dun & Bradstreet number for the plant site reporting.
Technical contact information

. Includes the name, address, telephone number, and email

address for a t echnical contact.2

- 2



### 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 whe ther the chemical substance is manufactured or imported; whether it is site

- limited (whether it is produced and used at the same site, and does not undergo packaging and shipping); and its manufactured (including imported) production volumes. Also contains the number of workers involved in manufacturing that are reasonably likely to be exposed to the chemical substance, the physical form(s) as the chemical substance leaves the site (including the percent of the production volume in each form), and the maxim um concentration of the chemical substance as it leaves the site. Codes representing ranges are used to report these data. These data are reported to the extent they are “known to or reasonably ascertainable” by the submitter. Industrial processing and use data

. Includes the types of process or use for the chemical substance, the related North American Industrial Classification System (NAICS) codes, and the industrial function categories. For each unique combination of process or use/NAICS/function, include s 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

subst ance . The industrial function categories used in the 2006 reporting are listed in Appendix A. of this report. These data are reported to the extent they are “readily obtainable by” the submitter.
Consumer and commercial end

- use data. Includes the relevant consumer and commercial product category, the percentage of the production volume in each product category, the

maximum concentration of the chemical substance in each final product, and an indication of
whether the chemical su bstance is used in a product intended for use by children. The consumer and commercial product categories used in the 2006 reporting are listed in Appendix B. of this report. These data are reported to the extent they are “read ily obtainable by” the submitter.
Confidential Business Information. CBI can be claimed for each data element reported. Submitters who claim the chemical identity or plant site identity as CBI must provide upfront

substantiation of the need for such confid entiality.

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 regulate d community for the IUR rule (i.e., those who potentially will be affected by the amendments to the IUR rule) consists of companies manufacturing or importing chemical

substance s in amounts of 25,000 lb or more annually listed on the TSCA Inventory and reg ulated under TSCA §8. Manufacturers (including importers) of non

- TSCA chemical substances (such as pesticides, tobacco, nuclear material, firearms and ammunition, food and food additives, drugs, and cosmetics) are not required to report information on thos e chemical substance s under the IUR rule. Some chemical substances might have both TSCA and non

- TSCA uses. In that case, the production associated with the TSCA use must be reported. Companies engaged in

chemical substance manufacturing (NAICS code 325) or petroleum refining (NAICS c ode2

- 3



### 324110) are the most likely to report under the IUR rule. Chemical substance users and processors who may manufacture a byproduct chemical substance

, e.g., utilities, paper

manufactur ers, primary metal manufactur ers, and sem iconductor and other electronic component

manufactur ers (NAICS codes 22, 322, 331, and 3344 ) also are likely to be subject to the rule. However, companies in any industry are subject to reporting if they manufacture or import listed

chemical substance s at or above the reporting threshold. Companies must review the rule to determine whether they are required to report

.3

- 1



## 3. Changes in Reporting Requirements under the Final IUR Modification s Rule

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

3.1 

### Technical Modifications to the Regulatory Text

Prior to the 2011 amendments

, 40 CFR part 710 contain ed three subparts

. Subpart A contain ed regulatory text associated with the original compilation of the TS CA Inventory; Subpart B contain ed regulatory text associated with the IUR rule covering the update reporting in 2002; and Subpart C

contain ed the regulatory text associated with the IUR rule for 2006 and beyond

. The chemical substance s covered by the IUR r ule are on the Master Inventory File, which includes chemical substance s from the original TSCA Inventory compilation and those added subsequently through the notice requirements of
section 5 of TSCA

. Because the IUR rule applies to a list of chemical subs tance s included in the original

TSCA Inventory plus additional chemical substance s 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 S ubpart C to 711 and Eliminate Subpart Divisions

Subpart C of 40 CF R part 710, §§ 710.43 to 710.59, contain ed the IUR regulatory text

. Under the 2011 amendments, EPA is mov ing all of the Subpart C text from 40 CFR part 710 to a new 40 CFR part
711 and is add ing a new Scope and Compliance section (40 CFR 711.1)

. Specific se ctions are being
moved as follows: § 710.43 become s § 711.3; § 710.45 become s § 711.5; § 710.46 become s § 711.6; § 710.48

become s § 711.8; § 710.49 become s § 711.9; § 710.50 become s § 711.10; § 710.52 become s §711.15 ; § 710.53 become s §711.20 ; § 710.55 become s §711.22 ; § 710.57 become s §711.25 ; § 710.58 become s § 711. 30 ; and § 710.59 become s §711.35. Because all of the text of Subpart C is being moved to 40 CFR
part 711, 40 CFR p art 710 no longer have a Subpart C

. Neither p art 710 n or p art 711 will have any subparts.

3.1.2 

### Consolid ation of Definition s
As part of moving the regulatory text from 40 CFR p art 710

, subpart C to 40 CFR p art 711,
EPA is consolidat ing definitions copied from § 710.3 and those currently found at § 710.43 into
the new § 711.3, except where an appropriate definit ion is already in place in section 3 of TSCA

or at § 704.3, and an additional definition of the term in § 711.3 would therefore be unnecessarily duplicative. The definitions at § 704.3 are inc lud ed in §711.3, except insofar as§ 711.3 provides a

modified defin i tion of a term also defined at § 704.3

.
The term mixture is defined in both § 710.3 and section 3 of TSCA

. For purposes of the IUR rule

, EPA is including the definition of mixture from section 3 of TSCA with the definitions at 40 CFR 711.3

. The TSCA mixture definition differs from the definition in § 710.3 and § 720.3, the regulations used to
determine the chemical substance s listed on the TSCA Inventory , in that it does not specifically address hydrates. A hydrate is a mixture of water and an anhydrous chemica l substance

. Because they are

mixtures , hydrates are not listed as such on the TSCA Inventory. For this reason, EPA believes it is superfluous to include hydrates separately in the definition of mixture

. The Agency will continue to

include such a discussi on in the Instructions for Reporting

.3

- 2

3.1.3 

### Remove “Non

- isolated I ntermediate ” D efinition from § 710.3

EPA added a definition to 40 CFR 710.43 for the term “non

- isolated intermediate” as part of the 2003 Amendments (68 FR 848, January 7, 2003). Subsequently, as part of the IUR Revisions Rule (70 FR 75059, December 19, 2005), EPA erroneously moved the definition to § 710.3 from § 710.43. EPA is

remov ing the definition from § 710.3 as this definition was not associated with the original TSCA Inventory, and therefore does not belong in § 710.3. A definition of this term, codified elsewhere at § 704.3, is inc luded with the IUR definitions at amended § 711.3

.

3.1.4 

### Remove Subpart B T ext

EPA is removing the regulatory text contained in 40 CFR part 710, §§ 710.23 to 710.39 (subpart B)

. This text refers to IUR submission periods of 2002 and earlier

, and is obsolete

. As noted in § 710.1, the Agency expressed its intent to remove subpart B once the 2002 update was complete.

3.1.5 

### Remove S uperfluous T ext A ssociated W ith R eporting P roduction V ol umes

EPA is removing the phrase “provided that the reported figures are within ±10% of the actual volume” from the production volume reporting requirements currently found in § 710.52( c)(3)(iv) which appears in the new § 711.15 (b)(3)(iv)

. The revised wordin g is, “This amount must be reported to two significant figures of accuracy.” The phrase that was removed is superfluous because any number reported accurately to two significant figures is within 10% of the correct value.

3.1.6 

### Correct Text Associated With Repor ting Number of Sites and Number of
Workers

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

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

the nu mber of sites found in the table in § 710.52(c)(4)(i)(E) which appears in the new § 711.15(b)(4)(i)(E). This change makes the phrases describing the ranges grammatically correct.

3.2 

### Modifications to Selected Definitions

As part of developing the definition sec tion for part 711, EPA is modifying six definitions associated with the IUR rule and adding four new definitions. In §704.3 and §710.3, EPA is also modifying the
citation in the definition of importer by removing the citation to 19 CFR 11.1 to 19 CFR 101.1

. .

3.2.1 

### Manufacture and Manufacturer

To improve the information submitted through the IUR rule, EPA is modifying the definition of manufacture by including elements from the §720.3 definition for manufacturer

. T he Agency is also
add ing a simple definition for the term manufacturer to §711 .3

. In addition to the change to the definition

of manufacture , EPA is adding a paragraph (c) to the regulation at §711.22 to clarify the reporting relationship between the contracting company and the toll manufacturer. Both th e 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

.

T his final rule defines the term m anufacture under the IUR to mean “to manufactur e, produce, or import, for commercial purposes. Manufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or a complex combination

of substances. When a chemical substance , manufactured other than by import, is:(1) Produced exclusively for another person who contracts for such production, and (2) that other person specifies the identity of the chemical substance and controls the total amount produced and the basic technolog y for the3

- 3

plant process, that chemical substance is comanufactured by the producing manufacturer and the person contracting for such production.” Also under this rule , the term manufacturer is defined under the IUR

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

3.2.2 

### Site

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

EPA identified the need to ac commodate 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 pro jects , and tanks used to mix anhydrous ammonia and water to manufacture ammonium hydroxide prior to application to agricultural
lands. EPA is interested in including chemical substance manufacturing that is, for instance, performed by road crews or is occurring at construction sites at which chemical substance s are mixed on site in such a manner to create a different chemical substance, e.g., asphalt emulsifiers. The site of physical manufacturing could change on a frequent basis. Manufacturers will report the aggregated produc tion volume for all of the portable manufacturing units sent out to different locations from a single distribution center. The address of the distribution center will be reported as the site location.

Under the final rule, the term site means “ a contiguou s property unit ”

. Property divided only by a public right

- of

- way shall be considered one site. M ore than one plant may be located on a single site. For substances manufactured under contract, i.e., by a toll manufacturer, the site is the location where the chemical substance is physically manufactured. The site for an importer who imports a chemical substance described in §71 1 .5 is the U.S. site of the operating unit within the person's organization directly responsible for importing the substance. The impo rt site, in some cases, may be the organization's headquarters in the United States. If there is no such operating unit or headquarters in the United States, the site address for the importer is the U.S. address of an agent acting on behalf of the importer who is authorized to accept service of process for the importer. For portable manufacturing units sent out to different locations from a single distribution center, the distribution center shall be considered the site.”

3.2.3 

### Electronic Reporting

- Related Defini tions

EPA is add ing two new terms, Central Data Exchange (CDX) and e

- IUR web to provide clarity to the requirement for electronic reporting of IUR data

. The term CDX means “EPA’s centralized electronic document receiving system, or its successors, including associated instructions for registering to submit
electronic documents.” The new definition make s the term consistent with the new Premanufacture Notice ( PMN ) definition

. The term e

- IUR web means the “electronic , web

- based IUR tool provided by the
EPA for the completion and submission of the IUR data .”

3.2.4 

### Processing and Use

- Related Definitions

EPA is amending the definitions of the terms c ommercial use and consumer use to make them more consistent with the definitions developed collaboratively by the United St ates and Canada. The new definitions for these two terms differ in wording from the Canadian version s to ensure the use of terminology defined in IUR and related regulations. EPA believes the basic application of these two terms
will not differ from the ba sic application of the Canadian definitions. The term c ommercial use mean s “the use of a chemical substance or a mixture containing a chemical substance (including as part of an

article ) in a commercial enterprise providing saleable goods or services.” Exa mples included in the § 710.43 definition have be en eliminated

. The slightly modified definition of consumer use is “the use of a

chemical substance or a mixture containing a chemical substance (including as part of a n article ) when3

- 4

sold to or made availabl e to consumers for their use.” The restrictions associated with where a consumer would use the product have be en removed.

EPA is adding a definition for the term industrial function

. For the 2006 IUR, EPA defined industrial

use and did not define industria l function

. The inclusion of both definitions provides clarity for the industrial processing and use reporting requirements and make s the Agency’s requirements consistent with those collaboratively developed with Canada

. With this final rule

, industrial fu nction mean s “the intended physical or chemical substance characteristic for which a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product, or article; repackaged;
or used.”

3.2.5 

### Principal Reporting Year and Submission Period

As described in S ection 3.13 , EPA is chang ing the reporting cycle from every five years to every four years and requiring the reporting of production volumes for each calendar year si nce the last principal reporting year

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

.
The term reporting year is modified to add the term “ principal ” a nd the word “information” is replace d with “manufacturing, pr ocessing and use data.” These changes are to indicate the principal reporting year is the year in which most of the reported data are base d

. Under the final rule , the principal reporting year is the latest complete calendar year proceeding the submission p eriod

. Additionally, EPA is removing the reference to “the calendar year at 5

- year intervals thereafter” and remov ing the reference to “calendar year 2005.” With these changes, the term principal repo rting year is defined as “the latest complete calendar y ear proceeding the submission period .” Production volume for manufacturing activities in other years of the reporting cycle may also be reportable during the submission period, but full manufacturing, processing, and use data are reported only for activiti es during the principal reporting

year.

The term submission period is modified by deleting the phrase “generated during the reporting year.” With this change, the definition of submission period reflect s that data for years in addition to the principal rep orting year would be reported . T he new definition of submission period mean s “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 report ing is required for a subject

chemical substance at a manufacturing (including importing) site. Every person manufacturing (including importing) a non

- excluded substance at or above the 25,000 lb threshold is required to report information in Parts I and I I of the IUR Form U. Beginning with the 2006 IUR submission period , every person manufacturing (including importing) a non

- excluded substance at or above

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

substanc e was partially exempt

. EPA is making three changes related to the reporting threshold s : (1) determination of whether you meet the 25,000 lb threshold, (2) replacing the 300,000 lb threshold for reporting information in Part III, and (3) reducing the 25,00 0 lb threshold requirement for specific regulated chemical substance s to 2,500 lb

.

3.3.1 

### Method for Determining Whether a Manufacturer is s ubject to IUR Reporting Requirements

Currently , a one

- year “ snapshot ” of manufacturing (including importing) i s used to det ermine the need to report for the IUR rule

. The method used to make the reporting determination
involve s determining that an entity manufactured ( including imported) a chemical substance3

- 5



### listed on the TSCA Inventory during the principal reporting year (e.g ., 2005 for the 2006 IUR reporting cycle ); the chemical substance was not otherwise exempt; and the associated production volume (domestically manufactured plus imported volumes) met or exceeded the 25,000 lb threshold for the principal reporting year (e.g ., 2005 for the 2006 IUR reporting cycle). EPA is not changing the method for determining whether a manufacturer (including importer) is subject to IUR reporting requirements for the 2012 submission period.

EPA is modify ing the method used to determine whe ther a person is subject to IUR reporting for submission periods subsequent to the 2012 submission period. The method for submission periods subsequent to 2012 is based on whether, for any calendar year since the last principal reporting year, a
chemical s ubstance was manufactured (including imported) at a site in production volumes of 25,000 lb or greater. For example, f or the 201 6 submission period, it will be necessary to examine the annual production volumes for the calendar years 201 2 to 201 5 for the s ite. If the production volume for a reportable chemical substance were 25,000 lb or greater for any calendar year during that four year period, then it will be necessary to report the chemical substance, unless it is otherwise exempt. For instance, a subje ct chemical substance with production volumes of 5,000 lb in 201 5 and 35,000 lb in 2012

will be reported for the 201 6 IUR. Regardless of the 201 5 production volume, in this example scenario
the 201 6 IUR submission will contain detailed information based on manufacturing during the 201 5 calendar year and only production volume information for the years 201 2 through 201 4

.

3.3.2 

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

EPA is replacing the 300,000 lb threshold for processing and use info rmation by phasing in a lower reporting threshold. For the 2012 IUR, all submitters of non

- excluded chemical substances are required to report processing and use information if they manufactured (including imported) 100,000 lb or more of a chemical substan ce in 2011. Subsequent to the 2012 reporting cycle, the reporting threshold will be 25,000 lb

. EPA is replacing in the 300,000 lb reporting threshold by phasing in the lower volume threshold in order to collect information necessary to complete screening

- l evel exposure characterizations for IUR

- reportable chemical substance s. The exposure information is an essential part of developing risk evaluations and, based on its experience in using this information, the Agency believes collecting this exposure inform ation is

critical to its mission of characterizing exposure, identifying potential risks, and noting uncertainties for these lower production volume chemical substance s. In addition, this change will provide the public with information on a greater number of chemical substance s. In the 2003 Amendments to the final rule (68 FR 848, January 7, 2003), EPA acknowledged the value of
information for chemical substances manufactured in lower volumes and stated that if the Agency were to find it necessary in the fu ture, it would collect information on chemical substances at reporting thresholds below the thresholds that were introduced in that action (i.e., 25,000 lb and 300,000 lb ).

3.3.3 

### Reduci ng the 25,000 lb Threshold for Specific R egulated Chemical
S ubstance s

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

chemical substances that are t he subject of a rule proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 6 ; t he subject of an order issued under TSCA section 5(e) or 5(f) ; or t he subject of relief that has been granted under a civil action under TSCA section 5 (See Appendix B of the Instructions for the 2012 TSCA Inventory Update Reporting (EPA, 2011) )

. F or the 201 6 submission period and submission

pe riods thereafter , a manufacturer (including importer) of such chemical substances is required to report manufacturing information on the chemical substances if they are manufactured (including imported) in3

- 6

volumes of 2,5 00 lb or more during any of the year s since the last principal reporting year (e.g., 201 1 ). Information on the processing and use of the chemical substances must be reported if they were manufactured (including imported) in volumes of 25 ,000 lb or more during any of the years since the last principal reporting year . In addition to the manufacturing, processi ng and use information for the principal reporting year (e.g., 2015), the production volume s for each year since the last principal reporting year must also be reported. F or the 2015 repor ting cycle

, for example, a manufacturer (including importer) must consider the manufacture d or import ed volume during the years 201 2 through 201 5 to determine the need to report ; must report the production volumes for each year from 201 2 to 201 5 ; and

must report the full manufacturing, processing, and use information for 201 5

.

Chemical substances that are the subject of these particular TSCA actions are of demonstrated high interest to the Agency. EPA is promulgating this change to help reduce the report ing burden for
submitters and to ensure the availability of current information when the Agency has expressed a concern in the form of regulatory action on those chemical substances manufactured below 25,000 lb. EPA will
use the IUR data associated with t hese specific regulated chemical substances to monitor chemical substance production and compliance with the rules . In the future, EPA may find it necessary to collect
information on chemical s ubstances at a reporting threshold below the 2,500 lb threshold introduced in this action. Although the 2,500 lb threshold is slightly higher than the proposed threshold of zero

, the

enhanced information that will be gathered during the 2016 reporting cycle will enable the Agency and
others to more efficiently identif y those chemical substances warranting further, more in depth review, as

well as chemical s ubstances of lesser concern

.

3.4 

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

3.4.1 

### Mak e Chemical Substances Subject to Enforceable Consent Agreements (ECAs) I nelig ible for E xemptions

EPA may enter into an e nforceable c onsent a greement (ECA) , pursuant to procedures at 40

CFR p art 790, with a manufacturer of a chemical substance, to obtain testing where a consensus exists among EPA, affected manufacturers and/or proce ssors, and interested members of the public concerning the need for and scope of testing. Chemical substances covered by an ECA are
of demonstrated high interest to EPA. The Agency has an interest in identifying the manufacturing, processing, and use of su bstances under such agreements, and therefore is requiring such substances be reported for IUR purposes, regardless of whether the substance otherwise meets the requirements listed in 40 CFR § 710.46 ( amended 40 CFR § 711.6) as an exempt or partially exempt chemical substance. This provision will ensure the availability of current information if EPA has expressed a concern in the form of an ECA on any substance
otherwise excluded from the IUR rule. For example, EPA could use the IUR data associated with

these regulated chemical substance s to monitor chemical substance production and compliance with the agreements. EPA is therefore making chemical substances that are the subject of an ECA ineligible for IUR exemptions

. Under this final rule, chemical substances that are the subject of an ECA will be included in the list of
chemical substance s ineligible for an IUR exemption, in the introductory paragraph of 40 CFR 710.46 ( amended 40 CFR 711 .6) listing the other chemical substance s likewise not eligible for an IU R exemption . T he paragraph will state a chemical substance “ i s 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 t he Act .”3

- 7

3.4.2 

### Full E xemption f or M anufactured W ater

Naturally occurring water is ex empted from reporting under the IUR rule , but manufactured water, which is not naturally occurring, is a reportable substance. EPA is granting a ful l
exempt ion to all (both natur ally occurring and manufactured) water (CASRN 7732

- 18

- 5) and is removing water from the petroleum streams partial exemption (40 CFR § 710.46(b)(1)).

3.4.3 

### Remove F ully E xe m pt P olymers from the P artially E xempt L ist

Polymers are a class of che mical substances for which IUR reporting is not required (40 CFR § 710.46(a)(1)). However, three polymers are listed in the partially exempt list of chemical

substance s at § 710.46(b)(2)(iv): S tarch (CASRN 9005

- 25

- 8), Dextrin (CASRN 9004

- 53

- 9), and Maltodextrin (CASRN 9050

- 36

- 6 ) . Improperly i ncluding substances meet ing the IUR definition of a polymer in the partially exempt list of chemical substance s may be confusing to submitters and may lead to unnecessary reporting for these substances. EPA is amending the partially exempt l ist of chemical substance s 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 C ompany and Site Identity

Manufacturers (including importers) ar e required to report the company name and Dun & Bradstreet (D&B) D

- U

- N

- S® number to identify the company associated with the plant site , and also to report the site name, address, and D

- U

- N

- S® num ber. If the company associated with the plant site does not have a D&B number, the manufacturer must obtain a D

- U

- N

- S® number for the company. Likewise, if the plant site does not have a D

- U

- N

- S® number, the manufacturer

must obtain a D

- U

- N

- S® number for t he site . EPA is now clarifying what is meant by company

name , by requiring the company name provided be the ultimate domestic parent company name.

“ U.S. parent company ” is defined to mean “ the highest level compan y, located in the United

States that directly owns at least 50 percent of the voting stock of the manuf acturer. ” 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 af fect the determination of small business status, which is not limited to domestic companies. Persons subject to the IUR rule should continue to base small business determinations on the ultimate parent company, regardless of whether that company is domestic or foreign.

The 2006 IUR submissions from different reporting sites contained varying D

- U

- N

- S® numbers for parent companies that appeared to be the same company. In order to better identify when reporting sites are under th e same parent company, EPA is requiring the address as well as

the D

- U

- N

- S® number of the parent company.

3.5.2 

### Technical C ontact

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 but does not have to be located at the manufacturing

site. Based on EPA’s experience with contacting the reported technical contact with follow

- up3

- 8



### questions concer ning 2006 IUR submissions, submitters often provide the names of individuals who are not directly connected to the reporting site, and therefore, are not knowledgeable about

either the chemical substance or the submission. EPA has also seen situations wher e the technical contact is a contracted employee who is able to address subsequent concerns only if he

or she remains under contract . EPA is also allowing multiple technical contacts on a chemical

substance

- by

- chemical substance basis, as provided by the n ew e

- IURweb tool

.

3.5.3 

### Chemical Identity

Chemical Name. EPA is requiri ng reporting of the Chemical Abstracts (CA) Index Name currently used to list the substance on the TSCA Inventory as the chemical name reported for IUR. Currently, submitters are required to report a specific chemical name, with no further elaboration in t he regulatory

text. For the 2012 submission period, the reporting software will be directly linked to the non

- confidential portion of the TSCA Inventory through the Agency’s Substance Regist ry System (SRS) database. Therefore, submitters will be required t o select the correct CA Index Name for their reportable chemical
substance (s) from SRS. EPA believes the requirement to use SRS to select the chemical name as currently

listed on the TSCA In ventory will greatly reduce the number of poorly identified chemical substances and allow the data to be released more quickly to the public.

Manufacturers (including importers) will be allowed to supply an alternate chemical name, and in the case of impor ters, a trade name, in those instances where a supplier will not disclose to the submitter the specific chemical name of the imported Inventory substance or a reactant used to manufacture TSCA Inventory substance. In these cases, the manufacturer (includin g importer) and the supplier report the information required in this part in a joint submission ( s ee Section 3.12 ).

In order to clarify this requirement, EPA is amending 40 CFR 711.15(b)(3)(i), to state that the importer must have the supplier of the confidential chemical subs tance directly provide EPA with the correct chemical identity, in a joint submission with the manufacturer. Furthermore, in the event the manufacturer submitting a report cannot provide the whole chemical identity because the reportable
chemical substance is manufactured using a reactant having a specific chemical identity claimed as confidential by its supplier, the manufacturer must submit a report directly to EPA containing all other
infor mation known to or reasonably ascertainable by the manufacturer ab out the chemical identity of the reported chemical substance and must properly ask that the supplier directly provides to EPA the correct chemical identity of the confidential reactant in a joint submission. Nothing in § 711.15(b)(3)(i) relieves a manufacturer (including an importer) of its obligation to report information that it actually knows or can reasonably ascertain

. Chemical Identifying Number

. As part of the chemical identity, submitt ers provide a chemical identifying number associated with the corr ect CA Index Name. EPA is requiring submitters to report only the CASRN as a chemical identifying number or, in the case of confidential chemical substances, the

TSCA accession number assign ed when the Notice of Commencement (NOC) was submitted to the Agen cy. Because the reporting tool will be directly linked to the non

- confidential portion of the TSCA Inventory through SRS, submitters no longer will be allowed to claim the CASRN as confident ial. For this reason, EPA is requiring submitters to report the TSCA accession number if they choose to assert a CBI claim on the chemical identity. Submitters will be able to look up the accession number in SRS using
the PMN number for their chemical subs tance. Only those submitters who know only the CAS number

and not the PMN number for the con fidential chemical substance should submit a written request to EPA
to obtain the TSCA accession number

. EPA also is removing the PMN number as an allowed chemical identifying number because each Inventory substance has either (or both) a CASRN (for the public Inventory) or a TSCA accession
number (for the confidential Inventory), which are likely to be known already to the submitter.3

- 9

3.5.4 

### Report P roduction V olume for Eac h of the Years since the Last Principal
R eport ing Year

For the 2012 submission period, manufactures (including importers) will be required to report the calendar year 2010 production volume of a chemical substance. For submission periods subsequent to the 2012 submission period, manufacturers (including importers) will be required to report the production volume for each year since the last IUR principal reporting year. For example, for the 2016 IUR, manufacturers (including importers) of a chemical

substan ce at or above the 25,000 lb threshold during the principal reporting year will report the production volume of that chemical substance for each of the following calendar years: 2015, 2014, 2013, and 2012. Collecting the production volume for multiple yea rs will provide EPA
with more accurate and up

- to

- date information than what is provided under the current, once

every

- five

- years snapshot

.

3.5.5 

### Volume of Chemical Substance Used O n - S ite

EPA is requiring submitters to report the volumes of a manufactured (inclu ding imported) chemical substance used at the reporting site. The requirement to report the volume used on

- site is replacing the requirement to indicate the chemical substance is site

- limited. Under this final

rule , either domestically manufactured or impo rted chemical substance s could be reported as used at the reporting site

, whereas

, under the current reporting requirements, only domestically

manufactured chemical substance s, consumed entirely at the manufacture site, were reported as

site

- limited

.

3.5.6 

### Indi cate Whether Imported Chemical Substances Are Physically at Reporting Site

EPA is adding a requirement to indicate whether an imported chemical substance is physically at the reporting site. Often, the site reporting an imported chemical substance never ph ysically receives the chemical substance , but instead ships it directly to another location such as a warehouse, a processing or use site, or a customer’s site. Identifying whether the chemical

substance is physically at the reporting site provides more ac curate information for screening

level analyses and other uses of the IUR data

.

3.5.7 

### Report Production V olume Exported

EPA is adding a requirement to report the production volume directly exported and not domestically processed or used. This will allow EPA to b etter identify the proportion of the production volume included in the use reporting, given that downstream reporting is not required for exported substances.3

- 10

3.5.8 

### Identify Whether a Chemical Substance i s t o b e Recycled, Remanufactured, Reprocessed, or Reused

E PA is adding a requirement to indicate w hether a manufactured chemical substance , such as a byproduct, is to be recycled, remanufactured, reprocessed, or reuse d. Submitters should
indicate whether their manufactured chemical substance , which otherwise woul d be disposed of as a waste, is being removed from the waste stream and has a commercial purpose (i.e., it is being recycled, re m anufactured, reprocessed, or reused ) . EPA believes such information will help the Agency identify where these activities are al ready occurring, and can be used to encourage such activities. Collecting information on whether a chemical substance is being recycled, remanufactured, reprocessed or reused and is not entering the waste stream provides
valuable information to EPA and oth ers regarding trends in chemical substance manufacturing.

This information also can be used to help determine the effectiveness of various programs, such as EPA’s Resource Conservation Challenge (RCC) Program. EPA launched the RCC in 2002, implementing Con gress’ instruction to prevent pollution and conserve natural resources and energy by managing materials more efficiently. The RCC Program’s goals include promoting reuse and recycling and reducing chemical substance s of national concern in products and was te

. Indicating a manufactured chemical substance , such as a byproduct, is to be recycled, remanufactured, reprocessed, or reused does not affect the reporting requirements associated with any substance manufactured from the byproduct.

3.6 

### Concentration Ranges

EPA is eliminating gaps in the ranges used to report concentration in § 710.52( c )(3) and (4)

. The new ranges are : ( 1) l ess than one percent by weight

, ( 2) a t least one percent but less than 30
percent by weight

, ( 3) a t least 30 percent but less than 60 per cent by weight

, ( 4) a t least 60
percent but less than 90 percent by weight , and ( 5) a t least 90 percent by weight

.

3.7 

### Industrial Processing and Use Information Reporting

In 2003, EPA added industrial processing and use data to the information collected throug h the IUR rule for chemical substances manufactured in quantities of 300,000 lb or greater during the principal reporting year. The industrial processing and use information included industrial function categories and
North American Industrial Classificati on System (NAICS) codes. EPA found that knowing these two data elements for a chemical substance was useful in selecting a scenario characterizing the frequency, route, and duration of exposure to a chemical substance during manufacture, processing, and us e of the substance. These data are also useful when EPA characterizes the quantity of the chemical substance in wastes and emissions entering the environment and for anticipating the environmental media into which wastes will be released. The Agency now is revising the list of industrial function categories and replacing the NAICS codes with industrial sectors.

3.7.1 

### Revise Industrial Function Categories

EPA is revising the list of industrial function cate gories by combining categories 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 revised set of categories, which will be used by both the Unite d States and Canada for Inventory reporting. Harmonization of the categories for reporting the

industrial functions of chemical substances will facilitate the exchange of information between3

- 11



### EPA and Canadian agencies and could serve as a model to be used b y Mexico in developing an inventory of chemical substances. In addition, the harmonized categories will facilitate consistent reporting of chemical substance use information by industry in the United States and Canada.

EPA is adding eight new industrial fu nction categories and removing six existing categories from the current list; the total number of industrial function categories will increase to 35. Also,

EPA is renaming several of the industrial function categories to provide a more informative descript ion of the function of the chemical substances that should be reported in that category. Lastly, EPA is requiring that if a submitter selects the category “Other,” the submitter must provide its own description of the industrial function of the chemical su bstance. Appendix A. lists both the existing and amended sets of industrial function categories.

3.7.2 

### Industrial Sectors

EPA is replacing the five

- digit North American Industrial Classification System (NAICS)

codes wi th 48 Industri al Sectors (IS). The sectors were adapted from the European Union’s (EU’s) “Guidance on I nformation R equirements and C hemical S afety A ssessment.” The Industrial Sectors chosen divide the entire range of NAICS codes into sectors so a sector correspond s to e very NAICS code. The Agency believes this change will provide several benefits. First, the sectors will reduce reporting burden because submitters will not have to look up the NAICS code. Second, it will encourage more complete reporting by using terms alr eady familiar to industry. Third, the sectors reduce the likelihood of errors that result from the selection of miscellaneous or inappropriate NAICS codes. Fourth, it will reduce the number of codes that could apply to one substance. Appendix A. of this report provides a list of the revised

industrial sectors

. When the category chosen for the Industrial Sector code is “Other,” a written description of the use of the chemical substance, which may include the NAICS code, also must be provided.

3.8 

### Consumer and C ommercial Use Reporting

In the 2003 Amendments, EPA added a reporting requirement for submitters to include information
about the consumer and commercial uses of chemical substances they reported under the IUR rule

. For
the 2006 IUR, manufacturers (including importers) of subject chemicals manufactured in quantities of 300,000 lb or more during calendar year 2005 were required to select up to ten consumer and commercial product categories from a list of 20 categorie s correspond in g to the actual use of the chemical substance they were reporting

.

3.8.1 

### Revise Consumer and Commercial Product Categories

EPA is revising the list of consumer and commercial product categories by combining categories leading to common exposure scenarios and ad ding categories not adequately described in the initial set of categories. EPA worked with Environment Canada and Health Canada to develop the revised categories.
The revised list includes 33 product categories, including “Other.” Examples of n ew categorie s that have been added include explosive materials, building/construction products not covered elsewhere, and air care products. The glass and ceramic products category had relatively few IUR submissions in 2006 and overlaps with new categories, and so has been eliminat ed. Also, several of the consumer and commercial product categories have been renamed to better describe the products that should be reported in those categories. See Appendix B. of this report for a list of the r evised categories.3

- 12

3.8.2 

### Designation of Consumer or Commercial Use

EPA is requiring submitters to designate whether the use is a consumer use or a commercial use, or both

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

3.8.3 

### Number of Commercial Workers Reasonably Likely To B e Exposed

EPA is requiring submitters to report the total number of commercial workers, including those at sites not under the submitter’s control, that are reasonably likely to be exposed while using the reportable chemical substance, with respect to each commercial use. The approximate
number of workers should be reported using the same definitions and ranges used for manufacturing and industrial processing and use workers , required by 40 CFR 710.52

. The

revised ranges are : ( 1) fewer than 10 workers

, ( 2) at least 10 but fewer than 25 workers

, ( 3) a t
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 10,0 00 workers, and ( 8) at least 10,000 workers.

3.9 

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

In order to collect more complete information regarding the industrial processing and industrial, commercial, and consumer use of chemical substance s, EPA is replacing the “readily obtainable” reporting standard used for reporting under 40 CFR 710.52(c)(4) in 2006 with the “known to or reasonably ascertainable by” reporting standard set forth under TSCA for this type of TSCA reporting

. TSCA s ection 8(a)(2) authorizes EPA to require persons to report information “known to or reasonably ascertainable by” the submitter. This is the same standard that currently applies to the reporting of information described in the regulations at §§ 710.52(c)(1), (c)(2), and (c)(3), and this standard will continue to apply to the reporting of

such information under amended §§ 711.1 5(c )(1), ( c)(2), and (c )(3). It covers all information in a person’s possession or control, plus all information a reasonable person sim ilarly situated might be expected to possess, control, or know. The “known to or reasonably ascertainable by” reporting standard was the only standard used for IUR reporting purposes prior to the 2006 IUR submission period.

EPA is clarifying that , in gene ral, submitters are not required to conduct customer surveys

. However, to the extent that customer surveys are already in the submitter’s possession or control,

and to the extent that reasonable efforts to analyze or synthesize already

- available customer

s urveys may develop new processing and use information, the information is generally
“reasonable ascertainable.” For certain data fields on Form U where the information is not known and cannot be reasonably ascertained, EPA is permitting submitters to enter “NKRA” (not known to or reasonably ascertainable by ).

3.10 

### Modifications to Confidential Business Information ( CBI ) C laims

Submitters currently may claim certain information reported under the IUR as confidential business information (CBI) in accordance with 4 0 CFR part 2 and IUR rules at § 710.383

- 13



### (amended § 711.30). Submitters must assert c laims of confidentiality at the time information is

submitted to EPA

. EPA’s procedures for handling information claimed as confidential are set forth at 40 CFR part 2, subpart B

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

assert its claims at the time the information is submitted. If a su bmitter fails to follow these procedures , EPA may release the information to the public without further notice to the

submitter. By signing the certification statement

, the submitter attests to the secrecy and value of
the information for which confidentia lity claims have been asserted. EPA expects the changes to the method for claiming information as CBI will reduce the number of un justifiable CBI claims. Reducing the number of CBI claims will increase the amount of information available to the public and improve the timeliness of its public availab i l ity. As a result, t he Agency will be able

to publicly discuss and explain its risk management actions and decisions more clearly

.

3.10.1 

### Chemical Identity CBI C laims

A submitter may assert a claim of confidentiality f or the identity of the reported chemical substance only when the chemical substance is listed on the confidential portion of the TSCA Inventory. Submitters who assert a confidentiality claim for chemical name must also provide

substantiation for the claim at time of filing. At times, submitters have asserted a claim of confidentiality for the chemical identity of a substance listed on the public portion of the Master Inventory File. Where the identity of a chemical substance is already provided on the publi c 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 inf ormation that might be derived from it about processes or portions, has already been disclosed

. Under the final rule, when this occurs, the Agency may make the information available to the public without further

notice to the submitter.

In this final rule , 40 CFR 711.15(a)(3)(i) has been revised to provide that submitters who wish to report chemical substances listed on the confidential portion of the TSCA Inventory will need to report the substance using a TSCA accession number . Requiring the use of acces sion numbers will allow EPA to adequately protect confidential CASRNs and CA Index Names (by omitting them from the pre

- populated selection list in the SRS) while still obtaining the improvements in reporting accuracy it sought in the proposed rule.

3.10.2 

### Upfron t Substantiation for P rocessing and Use In formation CBI C laims

U nder the IUR rule , a submitter may assert a claim of confidentiality for data associated with the processing and use of its chemical substance if the submitter has reason to believe release of

the information will reveal trade secrets or confidential commercial or financial information, as provided by section 14 of TSCA and 40 CFR part 2.

Under th e final rule, submitter s will be required to both check the appropriate box on the reporting form and substantiate the CBI claim in writing , within the reporting software, by answering certain questions provided in § 711.30 (d) of the final rule. Where a submitter fails to substantiate the processing and use CBI claim in accordance with the applicable rul es (i.e., the submitter does not provide an answer to the required questions), EPA will consider the3

- 14



### 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 

### Prohibitio n of Confidentiality Claims for Data Elements Identified as “Not Known or Reasonably Ascertainable”

Under the final rule, EPA is prohibiting claims of confidentiality pertaining to the designation that information is not “known to or reasonably ascertainab le by” (NKRA) the submitter. For the 2012 and future IUR collections, submitters will be required to report processing and use information to the extent that it is known to or reasonably ascertainable by them.

For the 2006 IUR collection, EPA observed tha t, on occasion, processing and use information was claimed as confidential when a submitter determined that the information was not readily obtainable.

Section 14 of TSCA limits the disclosure of information entitled to confidential treatment under Exempti on 4 of the Freedom of Information Act (FOIA). EPA has considered the NKRA designation and its relationship to a potential CBI or trade secret claim. Given that a NKRA assertion is an assertion that no information is available, the Agency does not believe that the designation conveys trade secret or
confidential commercial or financial information.

3.11 

### Method of Submission

EPA accepted 2006 IUR submissions in several ways. Submissions could be completed and delivered electronically via the Internet and CDX, or submissions could be completed on paper or electronic media (i.e., as a file on a CD

- ROM) and delivered by mail or a delivery service. Approximately one

- third of the submissions were made electronically, and EPA was able to immediately process and quickly begin to use

the information from those electronic submissions. Submissions sent as a file on a CD were printed and, along with paper submissions, scanned by EPA into an electronic system

. Due mostly to the time and
resources needed to review and correct submitter

- and s canning

- related errors associated with non

electronic submissions, EPA required more than two years to validate and process the data from t he 2006

IUR.

E PA now is requiring the mandatory use of Agency

- provided reporting tool (e

- IUR web ) to complete
the IUR Form U and CDX to submi t the completed Form U to the Agenc y. CDX users are required to register with CDX and to submit an authorized electronic signature agreement. Each IUR submission

must have an authorized official associated with the s ubmission, who is the person signing the certification statement and submitting the IUR report via CDX. The authorized official must complete both an ESA and the CDX registration process. The reporting software, instruction manual, and other guidance mater ials are available on EPA’s website at www.epa.gov/iur

.

3.11.1 

### Updated e - IUR Reporting Tool

EPA, based on its experience collecting and managing the 2006 IUR reports, has concluded that mandatory electronic reporting is a cri tical next step for collection of the 201 2 data. Optional electronic reporting for the 2006 IUR provided the Agency with experience relating to both industry and Agency needs, and the Agency has applied this experience in the course of developing of the 20 1 2 electronic reporting tool (e

- IURweb). For example, t he use of a web

- based tool for the 201 2 IUR will eliminate many of the software compatibility and firewall setting issues that were encountered during the 2006 submission period. In addition, e

- IURweb utilizes other Agency systems, such as SRS, enabling the submitter to readily select the chemical identity in the correct format, thereby eliminating problems relating to the previous need to type or write in the chemical name. With these enhancements, EPA
believes the use of e

- IURweb will substantially reduce error rates and burden

.3

- 15

3.11.2 

### Require Electronic Submissions over the I nternet

EPA is requiring manufacturers (including importers) to submit their IUR reports to the Agency through CDX via the Internet. EPA will require all submissions to be generated using e

- IURweb reporting software. Electronic submissions will ensure that IUR data will have completed a basic validation check, could be incorporated quickly into a database and be ready for immediate Agen cy use, and will not be subject to subsequent data entry errors

. Furthermore, EPA believes the required use of e

IURweb and CDX will reduce the reporting burden on industry by reducing both the cost and the time required to review, edit and transmit data t o the Agency. After the final rule’s effective date, EPA will no longer accept paper submissions or electronic media (i.e., as a file on a CD

- ROM) for any IUR
submission.

3.11.3 

### Electronic S ignature Process

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

EPA is making changes to the registration process in order to address problems identified during the 2006 IUR electronic reporting. For 201 2 IUR reports, EPA is modifying the 2006 ESA to ident ify 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 su bmission, who is the person signing the certification statement and submitting the IUR report via CDX. The authorized official will need to complete both an ESA and the CDX registration process

.

3.12 

### Modifications Specifically Affecting Importers

Submitters re port IUR data on chemical substance s they manufacture domestically and import into the United States . Current IUR regulations require the site responsible for reporting for imported chemical substance s to be the site of the operating unit directly responsi ble for impo rting the substance and controlling the import transaction. In some cases, the import site may be the organization’s headquarters in the United States . The regulations defining the site for importer reporting are found in both the definition fo r site in §710.3 and in paragraph § 710.48(b). EPA is eliminating unnecessary duplication in the IUR regulation by moving the additional information regarding the importer site from §710.48(b) into a revised definition for

site , and eliminating paragraph §7 10.48(b).

In addition, EPA has observed submitters occasionally use a foreign address as the site address for the importer . In the final rule, EPA is now is requiring submitter s to report a U.S. site a ddress , by modify ing

the definition for site to stat e s pecific ally that the site must be a U. S. site . The U.S. address of an agent acting on behalf of the importer, and authorized to accept service of process for the importer, may be reported as the importer’s site address if the operating unit directly respon sible for importing the substance and controlling the import transaction has no U.S. address. The Agency expects a ll importers will have a U.S. site, as defined in the amended §711.3 definition for site. Under U.S. Customs regulations at §141.18, a non

- res ident corporation is not permitted to enter merchandise for consumption3

- 16

unless it has a resident agent in the State where the port of entry is located, who is authorized to accept service of process against the corporation.

For purposes of IUR, submitters currently are allowed to report the IUR information jointly with the foreign manufacturer of the chemical substance. Importers may not know the specific chemical identity of a substance because the foreign supplier chooses to keep it confidential. In such a situation, the importer

must use e

- IURweb to ask the foreign supplier to submit its chemical identity information to EPA and may do so through by submitting a joint report. To submit a joint report, the importer completes the majority of the required inf ormation, and supplies a trade name or other designation to identify the chemical substance, and provides contact information for the foreign supplier. The importer then uses e

IURweb to contact the foreign supplier and to request that the foreign supplier notify it of the need to report the specific chemical identity information directly to EPA. The importer must submit a copy of such request to EPA, along with the rest of its IUR submission for the chemical substance. As a general matter, EPA expects that importers will supply the information described at § 711.15(b)(3)(i)(A), rather than a “NKRA” designation, when importers do not know the confidential chemical identity of a chemical substance they import. EPA believes that a NKRA designation would general ly be appropriate only in the unlikely event that an importer did not know, and could not reasonably ascertain, the information needed to link its submission with a secondary report from the supplier.

Under the final rule, the process will be the same, exc ept submitters will be required to use CDX and

e

- IURweb for preparation and submission of joint submissions. Previously, joint submissions could not be made electronically. In order to submit electronically to EPA via CDX, individuals must first register

w ith CDX. Therefore, the authorized officials of the jointly submitting companies will need to register in order to submit their reports to EPA. The secondary submitter (e.g., a foreign supplier or manufacturer) will have to register as someone authorized b y the primary submitter’s (e.g., the importer’s) authorized official to send joint submissions to EPA.

For joint submissions to be submitted electronically, the primary submitter will use e

- IURweb to identify the need to submit a joint report and will ide ntify itself as a primary submitter. The primary submitter will then complete his or her portion of the report and provide the secondary submitter ’ s company information, along with select information on the chemical substance(s) manufactured using a
chemic al substance made by the secondary submitter. The primary submitter reports only the volume that it used. A secondary submitter will also need to use e

- IURweb to identify the need to submit a joint report and will identify itself as a secondary submitter. In an acceptable joint submission, the secondary submitter supplies the chemical identity, as well as its technical contact and company information, and provides the primary submitter’s site information. EPA will not accept joint submissions that are not

s ubmitted electronically using e

- IURweb and CDX. All information will be saved by the reporting software and both submissions will be matched based upon company and chemical substance information. Once the forms are linked, EPA will process the joint submis sion as one report for the reported chemical

substance.

For the 2006 IUR reporting cycle, EPA set aside joint submissions until both were received and matched. EPA often had no way to determine whether a submission was a “joint” submission, which

increased the time required for manual processing of the data. EPA anticipates the use of the reporting tool will help to make joint IUR reporting easier for industry and streamline EPA processing of the IUR information submitted in the 2012 reporting cycle.

3.13 

### Modify Reporting Frequency

Prior to the 2003 Amendments , the IUR collection occurred every four years. EPA reduced the reporting frequency from every four years to every five years starting with the 2006 IUR to3

- 17



### lessen the burden associated with the amended IUR. The Agency now has determined that reporting every five year s is too infrequent, and is returning to reporting every four years

. While the less frequent reporting does reduce burden, EPA now believes reporting every five years does not provide data suffic iently current to meet Agency and public needs. The Agency has been criticized for using outdated information. EPA, therefore, considered increasing the frequency of reporting to every three years, or possibly to annual reporting. The Agency believes effic iencies are gained with more frequent reporting, both for the submitter and for EPA. With more frequent reporting, companies will be able to establish standard systems and practices to collect the required information.4

- 1 

## 4. Industry Burden and Cost Estimates

4.1 

### Me thodology for Compliance Cost and Burden Analysis

This chapter analyzes the changes in industry compliance burden and cost associated with the amendments to the IUR rule. EPA calculates the incremental burden and cost, or savings, of the amendments by comp aring the burden and cost of complying with the amendments to the burden and cost industry would incur to comply with current IUR requirements in the 2012 reporting cycle absent the amendments (the baseline). The methodology for estimating the change in

in dustry burden and cost can be summarized as follows:

Step 1 : Identify the tasks sites perform to comply with reporting requirements for both the current IUR requirements and the IUR amendments. Step 2 : Determine the unit burden and cost for all activities identified in Step 1, based on labor requirements for managerial, technical, and clerical staff; current wage rates; and other

current costs. Step 3 : Determine the expected number of sites and reports filed under both the current IUR requirements and the IUR amendments. Step 4 : Multiply the burden and cost per form by the number of forms to determine the estimated total burden and cost of compliance for the current IUR and the IUR amendments. Step 5 : Subtract the compliance burden and cost after the IUR am endments from the burden and cost under the current IUR requirements to calculate the incremental additional burden and cost or savings attributable to the amendments.

A chemical company may own many sites, each of which may manufacture (including import) multiple chemical substance s. Each site must submit a Form U if it exceeds the 25,000 lb

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

Compliance Determination : To determine whether it must submit a Form U, a si te must determine whether (1) it manufactures (including imports) any chemical substance s not falling into one of the categories exempt from reporting; (2) the annual production or import
volume of the chemical substance is at or above the reporting thresh old; and (3) the company meets the small business criteria set forth in the TSCA §8(a) Small Manufacturer Exemption Rule (40 CFR §704.3). For simplicity, the cost for compliance determination is considered to be incurred once per site, and not to vary with the number of chemical substance s at the site. A portion of the compliance determination cost depends on the number of chemical

substance s, but for most chemical substance s this component of the burden will be extremely small. The majority of the time req uired for this task involves identifying the requirements and reviewing information to determine whether the site must submit a Form U.

Rule Familiarization : Once a site has determined it must submit a Form U, staff must familiarize themselves with the req uirements of the rule. Sites reporting previously must become familiar with new requirements, and sites new to reporting must become familiar with all requirements. This entails reading the rule, understanding the various reporting and administrative requi rements, and determining the manner in which the reporting requirements will be met.4

- 2



### Preparation and Submission of Reports : Once a site has determined it must submit a Form

U for a chemical substance and has become familiar with the rule, the required info rmation must be collected and a Form U covering all of the reportable chemical substance s 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 co mpleting Form U (technical and clerical burden), managerial review, and any mailing or other submission

costs.

Recordkeeping : Submitters must keep records supporting their submissions for five years.

More information on estimating compliance costs under t he current IUR rule can be found in the economic analyses for the 2003 Amendment s, 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, techni cal, 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 th e 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

Da ta December 2006

– December 2008 (BLS, 200 9 ).

F ringe 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, 2002 b , fringe benefits are calculated as a p ercentage 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 Ana lysis for the Amended Inventory Update Rule: Final Report ( EPA, 2002a ). The wages for each of the three categories are then multiplied by benefits and overhead factors to estimat e loaded, annual

salaries in 200 8 dollars. Table 4

- 1 contains the loaded wage rates f or the managerial, technical and clerical occupation categories.4

- 3

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

Cl erical $17.22 $8.33 45.03% 17% 1.65 $28.48

Notes:

1 Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006

– December 2008, US Bureau of Labor Statistics, March 12, 2009 (BLS, 2009).

2 An overhead rate of 17% was estim ated based on industry data gathered for the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).

4.2.2 

### Estimates of Baseline Labor Hours (Burden)

As mentioned earlier, the reporting tool for the IUR rule is Form U. Each s ite must determine whether it must comply with the IUR rule. Sites that are required to report then must become familiar with the rule’s reporting requirements. The costs associated with these tasks are calculated per site, and do not vary with the number of chemical substance s reported by the site. Each reporting site is required to file only one Part I of Form U, regardless of the number of reportable chemical substance s it manufactures (including imports). The information required in Part I, such as site and company identification, are common to all chemical substance s produced at a single site; therefore, this information need only be reported once. For each reportable

chemical substance , a site must prepare and submit Part II and, if applicable, Part II I of Form U. For the purpose of this analysis, a “report” can be either a partial report (Parts I and II of Form U) or a full report (Parts I, II, and III of Form U), submitted for one chemical substance

. Submission costs, in the baseline, consist of maili ng costs , and are calculated per

- site. Recordkeeping costs are calculated as per

- report costs (so total reporting and recordkeeping costs vary with the number of chemical substance s reported).

In summary, compliance costs are determined as follows:

Complia nce 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 th e labor hours required for the var ious tasks are taken from the

E conomic A nalys e s f

rom the 200 2 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 complet e each section and subsection of Form U. Compliance determination, rule familiarization, and recordkeeping burdens are also taken from the 2002 Economic Analysis. The Economic Analysis for the 2005 Amendments assumed a 15 percent reduction in burden for th e4

- 4



### completion of Part III because submitters 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 substance ).

3 In the 2005 E conomic A nalysis, EPA estimated that 15 percent of the production volume at an average site is exported. Because processing and use information wa s no longer required for this percentage of production volume, the effort to collect and report this information would decrease accordingly.4

- 5

Table 4

- 2 : Baseline First

- Cycle Labor Burden per Form U, in Hours

Form U Section and Activity Clerical

Burden Technical

Burden M anagerial

Burden Total Burden

(a) (b) (c) (d) = (a)+(b)+(c) Compliance Determination (Total Burden for Form U Compliance Determination) 0.00 2.50 0.00 2.50

Rule Familiarization (Total Burden for Form U Submission) 0.00 19.00 9.00 28.00

Recordke eping (Total Burden for Form U Recordkeeping) 1.50 3.00 1.50 6.00

Submission (Total Burden for Form U Submission) 0.00 0.00 0.00 0.00

Mailing Burden 0.00 0.00 0.00 0.00

Part I. Site Identification Information

(Total Burden for Part I) 0.76 0.95 1.05 2.76

1 Certification 0.68 0.85 1.01 2.54

2 Company Information

Company Name, Technical Contact, Address, D&B Number, Mailing Address 0.04 0.04 0.02 0.10

3 Plant Site Identification

Plant Name, D&B Number, Address, Mailin g Address 0.05 0.06 0.02 0.13

Part II

. Manufacturing Information

(Total Burden for Part II) 1.55 8.78 3.49 13.82

1 Chemical Identification

2 (Other) Manufacturing Information

Site

- Limited, Activity, Production Volume (lb ) 0.52 2.28 0.56 3.36

Chemical Identification Upfront CBI Substantiation 0.26 1.45 0.67 2.38

Plant Site Upfront Substantiation 0.12 0.83 0.51 1.46

Total Number of Workers 0.21 1.43 0.59 2.234

- 6 Form U Section and Activity Clerical

Burden Technical

Burden M anagerial

Burden Total Burden

(a) (b) (c) (d) = (a)+(b)+(c) Maximum Concentration, Physical Form, Percent

Volume of Produ ction 0.44 2.79 1.07 4.30

Part III Processing and Use Information

(Total Burden for Part III) 7.94 45.31 16.66 69.92

1 Industrial Processing and Use Exposure

- Related Data

Determination of Applicability 0.13 1.01 0.28 1.42

Industrial Function Ca tegory 2.11 4.41 2.07 8.59

Function Code 0.19 0.94 0.40 1.52

Percent of Production Volume 1.23 10.00 5.27 16.51

Total Number of Processing and Use Sites 1.57 9.14 3.52 14.24
Total Number of Potentially Exposed Workers 2.10 15.43 3.83 21.36

2 C onsumer and Commercial Use Exposure

- Related Data

Determination of Applicability 0.14 0.94 0.25 1.33
Identification of Production Category/Use by Children 0.14 0.84 0.25 1.23

Percent of Production Volume 0.20 1.26 0.45 1.91

Maximum Concen tration by Category 0.11 1.36 0.34 1.81

Total Burden for Report Preparation and Submission

Partial Report (Parts I, II, Recordkeeping and Submission Burden) 3.81 34.23 15.04 53.08

Full Report (Parts I, II, III, Recordkeeping and Submission Burden) 11.74 79.54 31.70 122.99
Note: Totals may not sum due to rounding.

Source: Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a ).4

- 7



### The survey conducted for the economic analysis for the Final TSCA IUR rule 2003

Amendments (EPA, 2002a) estimated a single burden for reporting site

- limited activity and production volume. This burden is estimated to be 3.36 hours per site (see Table 4

- 3 ) and covers four separate activities:

A nswering a yes/no question to indicate whether the volume is site

- limited volume;

Indicating whether the chemical substance is manufactured or imported;

Providing the manufactured production volume; and

Providing the imported production volume.

Several of the amendm ents are expected to create burdens similar to one of the above activities, but none are expected to generate a burden equivalent to all four questions combined. To estimate more accurately the burden of several amendments, EPA used its best professional j udgment and estimated the percent burden each activity contributed to the total burden of 3.36

hours. These burden estimate s 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 subs tance is manufactured or imported 5% 0.17

Providing the manufactured production volume 45% 1.51

Providing the imported production volume 45% 1.51

Total 100% 3.36

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

4.2.3 

### Estimates of Baseline Submission (Mailing) Costs

As noted above, the baseline scenario in this analysis is the total cost a site would incur to comply with the current IUR rule, absent any of the amendments. Therefore, the Agency

estimated the cost of a mail

- in submission of Form U, using data from the United States Postal Service website. Following the mailing requirements outlined in the Economic Analysis of Expedited Significant New Use Rules for 56 Chemical Substances (EPA, 2008 b )

, a mail

- in submission is assumed to consist of mailing a document via first class registered mail with a

re turn receipt. The cost is estimated to be $13.78 per report and is itemized in Table 4

- 4

.4

- 8

Table 4

- 4 : Mailing Submission Costs ( December , 2009)

USPS Service Cost (200 9 $ ) 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 f or larger envelopes, up to 1 ounce 2 $0.88

Total $13.78

Source: USPS, 2009 Notes: While all other costs are presented in 2008$, the most recent mailing costs as of the preparation of this analysis were used

, f ol lowing the methodology outlined in other rep orts such as the Economic Analysis of Expedited Significant New Use Rules for 56

Chemical Substances (EPA, 2008b) . EPA does not expect mailing costs to significantly differ between 2008 and 2009.

4.2.4 

### Estimates of Baseline Cost per Report

EPA estimated the b aseline 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 S ection 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 sub mitting and completing a partial report ( Parts I, II, recordkeeping and submission costs) for the first time is $ 3,188

. EPA
estimate s the cost to a site of submitting and completing a full report (Parts I, II, III, recordkeeping and submission costs) for th e first time is $7,247, for one chemical substance

. Table 4

- 5 contains the submission costs by section for first

- time submitters, including the costs for compliance determination, rule familiarization, report prepa ration, report submission, and recordkeeping costs.4

- 9

Table 4

- 5 : Baseline First

- Cycle Total Cost per Form U (2008$)

Form U Section and Activity Clerical
Cost Technical Cost Managerial Cost Total Cost

(a) (b) (c) (d)=(a)+(b)+(c) Compliance Determination (Total Burden for Form U Compliance Determination) $0.00 $147 $0.00 $147

Rule Familiarization (Total Burden for Form U Submission) $0.00 $1,118 $630 $1,748

Recordkeeping (Total Cost for Form U Recordk eeping) $42.72 $177 $104 $324

Submission (Total Cost for Form U Submission) $13.78

Mailing Cost $13.78

Part I

. Site Identification Information

(Total Cost for Part I) $21.50 $54.08 $73.53 $149.10

1 Certification $19.22 $50.01 $70.73 $139. 96

2 Company Information

Company Name, Contact, Address , D&B Number, Mailing Address $1.00 $2.35 $1.40 $4.75

3 Plant Site Identification

Plant Name, D&B Number, Address, Mailing Address $1.28 $1.71 $1.40 $4.39

Part II

. Manufacturing Information

(Total Burden for Part II) $44.14 $516.61 $244.40 $805.14

1 Chemical Identification

2 (Other) Manufacturing Information

Site

- Limited, Activity, Production Volume (lb ) $14.81 $134.15 $39.22 $188.18

Chemical Ide ntification Upfront CBI Substantiation $7.40 $85.32 $53.57 $146.29

Plant Site Upfront Substantiation $3.42 $48.84 $35.57 $87.97

Total Number of Workers $5.98 $84.14 $40.97 $131.09

Maximum Concentration, Physical Form, Percent Volume of $12.53 $164.16 $74.93 $251.624

- 10 Form U Section and Activity Clerical
Cost Technical Cost Managerial Cost Total Cost

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

Producti on

Part III Processing and Use Information

(Total Cost for Part III) $226.08 $2,666 $1,167 $4,059

1 Industrial Processing and Use Exposure

- Related Data

Determination of Applicability $3.63 $59.27 $19.94 $82.84

Indu strial Function Category $60.15 $259.57 $144.64 $464.36

Function Code $5.33 $55.01 $27.68 $88.02

Percent of Production Volume $35.10 $588.41 $369.34 $992.85

Total Number of Processing and Use Sites $44.78 $537.89 $246.72 $829.40

Total Number of Potentially Exposed Workers $59.91 $907.74 $268.15 $1,236

2 Consumer and Commercial Use Exposure

- Related Data

Determination of Applicability $4.11 $55.01 $17.56 $76.69

Identification of Production Category/Use by Children $4.11 $49.26 $17.56 $7 0.64

Percent of Production Volume $5.81 $74.02 $31.55 $111.38

Maximum Concentration by Category $3.15 $80.02 $24.11 $107.28

Total Cost for Report Preparation and Submission

Partial Report (Parts I, II, Recordkeeping and Submission Costs) $108 $2 ,012 $1,053 $3,188

Full Report (Parts I, II, III, Recordkeeping and Submission Costs) $334 $4,678 $2,220 $7,247

Note: Totals may not sum due to rounding.

Source: Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).4

- 11

4.2.5 

### Estimates of the Number of Sites and Reports

The baseline number of reports EPA is expecting, and the number of sites submitting those reports, were calculated based on 2006 IUR submissions to EPA. Because there is a cost difference between the two types of reports, the total number of reports is broken down into sites that filed full reports and sites that filed partial reports. The number of reports EPA is expecting was estimated using data compiled from EPA’s 2006 IUR Database (EPA, 2008c)

. The databas e contains information collected under the IUR rule for previous reporting cycles and was used to generate estimated numbers of expected reports. The Agency assumes because of the low company turnover rate within the chemical manufacturing industry, the ba seline number of sites submitting Form U in 2012 will be equivalent to the number of sites submitting Form U in 2006. In addition, for the purposes of this analysis, EPA assumes the baseline number of reports submitted will not change from the 2006 submiss ions. In 2006, a total of 4,085 sites completed 25,896 reports as shown in Table 4

- 6

.

Table 4

- 6 : Baseline Number of Reports and Sites

Number of Partial Reports Number of Full Repor ts Total

Number of Sites 568 3,517 4,085

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

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



### Limitations of Analysis

. Due to inconsistencies and limitations in the data collected in 2002 and 2006, including the amendment requiring reports for inorganic chemical substance s for the
first time in 2006 and the change in the r eporting threshold from 10,000 lb to 25,000 lb

, it was not possible for EPA to compare records to determine whether the number of sites and reports

submitted for a consistent set of chemical substance s had change d significantly between the two reporting cy cle s. Such an analysis potentially could provide support for EPA’s assumption the

number of site s and reports will remain relatively unchanged in the next reporting cycle. Therefore, to the extent changes in the chemical industry unrelated to the IUR rule amendments

c ould affect the number of site and reports submitted, this analysis may under

- or overestimate

costs and burden.

4.2.6 

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

EPA assumes that sites that previously have submitted a Form U will incu r a reduced burden

for processing and submitting Form U in future reporting cycles

. All sites will incur a higher reporting cost in the first reporting cycle under the final rule due to the need to become familiar with the revised requirements. However, th e Agen cy assumes unit costs for report preparation and submission in future reporting cycles will be lower than the unit costs attributed to reporting in the first reporting cycle because of efficiencies achieved through the establishment of compliance pro cesses (EPA, 2002a). Furthermore, after a site’s first reporting cycle, the availability of data from previous reporting cycles and familiarity with reporting requirements will expedite the process for submitters who have previously submitted a Form U. T he burden

estimates for these sites are weighted to reflect this decreased burden (EPA, 2002a).4

- 12



### Table 4

- 7 contains the weighting factors for each section of the form. Table 4

- 8 contains the baseline, future reporting cycle, per

- report burden estimates, which are calculated using the weights in Table 4

- 7 and the first reporting cycle burden estimates in Table 4

- 2

. Table 4

- 9
contains the baseline future reporting cycle cost s per report , which are calculated using the wage

rate s in Table 4

- 1 and the hourly burden e stimates from Table 4

- 8

.

Table 4

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

Section of Form U Percent of Initial Burde n Incurred 1

Part I. Site Identification

Certification 100%

Section A Company Information 20%

Section B Plant Site Identification 20%

Section C Technical Contact 20%
Part II. Manufacturing Information

Section A Chemical Identification 20%

Sect ion 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 R evised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a), pp. 3

- 17.4

- 13

Table 4

- 8 : Baseline Future

- Cycle Labor Burden per Report, in Hours

Form U Section and Activity Clerical

B urden Technical

Burden Managerial

Burden Total Burden

(a) (b) (c) (d) = (a)+(b)+(c) Compliance Determination (Total Burden for Form U Compliance Determination) 0.00 2.50 0.00 2.50

Rule Familiarization (Total Burden for Form U Submission) 0.00 2.00 2.00 4.00

Recordkeeping (Total Burden for Form U Recordkeeping) 1.50 3.00 1.50 6.00

Submission (Total Burden for Form U Submission) 0.00 0.00 0.00 0.00

Mailing Burden 0.00 0.00 0.00 0.00

Part I. Site Identification Information

(Total Burden for Part I) 0.69 0.87 1.02 2.58

1 Certification 0.68 0.85 1.01 2.54

2 Company Information

Company Name, Technical Contact, Address, D&B Number, Mailing Address 0.01 0.01 0.00 0.02

3 Plant Site Identification

Plant Name, D&B Number, Address, Mailing Address 0.01 0.01 0.00 0.03

Part II. Manufacturing Information

(Total Burden for Part II) 1.24 7.02 2.79 11.06

1 Chemical Identification

2 (Other) Manufacturing Information

Site Limited, Activity, Production Volume ( lb ) 0.4 2 1.82 0.45 2.69

Chemical Identification Upfront CBI Substantiation 0.21 1.16 0.61 1.98

Plant Site Upfront Substantiation 0.10 0.66 0.41 1.17

Total Number of Workers 0.17 1.14 0.47 1.78

Maximum Concentration, Physical Form, Percent Volume o f Production 0.35 2.23 0.86 3.444

- 14 Form U Section and Activity Clerical

B urden Technical

Burden Managerial

Burden Total Burden

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

Part III Processing and Use Information

(Total Burden for Part III) 6.35 36.25 13.33 55.93

1 Industrial Processing and Use Exposure

- Related Data

Determination of Applicability 0.10 0.81 0.23 1.14

Industrial Func tion Category 1.69 3.53 1.65 6.87

Function Code 0.15 0.75 0.32 1.21

Percent of Production Volume 0.99 8.00 4.22 13.21
Total Number of Processing and Use Sites 1.26 7.31 2.82 11.39
Total Number of Potentially Exposed Workers 1.68 12.34 3.06 17.0 9

2 Consumer and Commercial Use Exposure

- Related Data

Determination of Applicability 0.12 0.75 0.20 1.06
Identification of Production Category/Use by Children 0.12 0.67 0.20 0.98

Percent of Production Volume 0.16 1.01 0.36 1.53

Maximum Concentration by Category 0.09 1.09 0.28 1.45

Total Burden for Report Preparation and Submission

Partial Form (Parts I, II, Recordkeeping and Submission Burden) 3.43 15.39 7.31 26.14

Full Form (Parts I, II, III, Recordkeeping and Submission Burden) 9.78 51.64 20.64 82.07
Note: Totals may not sum due to rounding.4

- 15

Table 4

- 9 : Baseline Future

- Cycle Total Cost per Report (2008$)

Form U Section and Activity Clerical
Cost Technical

Cost Managerial

Cost Total Co st

(a) (b) (c) (d)=(a)+(b)+(c) Compliance Determination (Total Cost for Form U Compliance Determination) $0.00 $147 $0.00 $147

Rule Familiarization (Total Cost for Form U Submission) $0.00 $118 $140 $258

Recordkeeping and Submission Costs (Tota l Cost for Form U Recordkeeping) $42.72 $176.52 $105.04 $324.28

Submission (Total Cost for Form U Submission) $13.78

Mailing Cost $13.78

Part I

. Site Identification Information

(Total Cost for Part I) $19.68 $51.19 $71.29 $142.16

1 Certifi cation $19.22 $50.01 $70.73 $139.96

2 Company Information

Company Name, Technical Contact, Address, D&B Number, Mailing Address $0.20 $0.47 $0.28 $0.95

3 Plant Site Identification

Plant Name, D&B Number, Address, Mailing Address $0 .26 $0.71 $0.28 $1.24

Part II

. Manufacturing Information

(Total Cost for Part II) $35.31 $413.29 $195.52 $644.12

1 Chemical Identification

2 (Other) Manufacturing Information

Site Limited, Activity, Production Volume ( lb ) $11.85 $107.32 $31.3 7 $150.54

Chemical Identification Upfront CBI Substantiation $5.92 $68.25 $42.86 $117.03

Plant Site Upfront Substantiation $2.73 $39.07 $28.57 $70.37

Total Number of Workers $4.78 $67.31 $32.77 $104.87

Maximum Concentration, Physical Form, Percent Volume of Production $10.02 $131.33 $59.94 $201.304

- 16 Form U Section and Activity Clerical
Cost Technical

Cost Managerial

Cost Total Co st

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

Part III Processing and Use Information

(Total Burden for Part III) $180.87 $2,132.97 $933.56 $3,247.40

1 Industrial Processing and Use Exposure

- Related Data

Determination of Applicability $2.90 $47.41 $15.95 $66.27

Industrial Function Category $48.12 $207.66 $115.71 $371.49

Function Code $4.26 $44.01 $22.14 $70.41

Percent of Production Volume $28.08 $470.73 $295.47 $794.28

Total Number of Processing and Use Sites $35.82 $430.32 $197.38 $663.52

Total Number of Potentially Exposed Workers $47.93 $726.19 $214.52 $988.64

2 Consumer and Commercial Use Exposure

- Related Data

Determination of Applicability $3.29 $44.01 $14.05 $61.35

Identification of Production Code/Use by Children $3.29 $39.41 $13.81 $56.51

Percent of Production Volume $4.65 $59.22 $25.24 $89.10

Maximum Concentration by Category $2.52 $64.02 $19.29 $85.82

Total Cost for Report Preparation and Submission

Partial Form (Parts I, II, Recordkeeping a nd Submission Costs) $97.71 $906 $512 $1,529

Full Form (Parts I, II, III, Recordkeeping and Submission Costs) $279 $3,039 $1,446 $4,777

Note: Totals may not sum due to rounding.4

- 17

4.3 

### Total Baseline IUR Industry Compliance Burden and Costs

The estimated wa ge rates, burden hours, and number of sites were combined to estimate the

total baseline costs to comply with the current IUR rule in the 2012 reporting cycle . Costs were aggregated either per site or per report, depending on how the costs are incurred . C o mpliance determination and rule familiarization were estimated on a per

- site basis ; the costs for completing Part I of Form U were estimated on a per

- site basis . The cost of comp l eting Parts II and III of Form U were calculated on a per

- report basis , and s ubmission 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 milli on hours and $ 106.97 million during the 2012 reporting cycle

.

Table 4

- 10 : Total Baseline Cost and Burden to Industry (201 2 Reporting Cycle)

Burden and Cost
for A ll Part Is
, Rule Familiarization, Compliance

D etermination
and Submission Burden and

Cost for A ll Part

IIs and Recordkeeping Burden and Cost

for Al l Part IIIs Total Burden and Cost

Under the Current IUR Requirements

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

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



### Table 4

- 11 contains the total annual baseline costs to industry for future reporting cycles; that is, the burden and cost to industry for reporting cycles after the 2012 cycle, in the absence of the amendments. The baseline for future reporting cycles is different than the baseline for the first reporting cycle due to efficiency gains. EPA assumes costs for report preparation and submission in future reporting cycles will be lower than costs in the first reporting cycle because of efficiencies achieved through the establishment of compliance processes, the availability of data from previous reporting cycles, and familiarity with reporting requirements (EPA, 2002a). The weighting factors found in Table 4

- 7 were applied to the baseline burden estimates found in

Table 4

- 2 and Table 4

- 5

. In all future reporting cycle s , EPA estimated the baseline burden to industry to be approximately 1.43 million hours and the cost, $82.82 million.

Table 4

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

Burden and Cost
for all Part Is
, Rule Familiarization, Compliance
Determination
and Submission Burden and Cost

for all Part IIs

and Recordkeeping Burden and Cost

for all Part IIIs Total Burden and

Cost Under the
Current IUR Requirements

Burden in Hours 37,088 441,6 82 955,063 1,433,833

Cost ( 2008 $) $2,290,736 $25,077,449 $55,449,366 $82,817,5504

- 18



### Limitations of Analysis

. As described in Section 4.2.5 , d ue to inconsistencies and limitations

in the IUR data collected in 2002 and 2006

, it w as not possible for EPA to compare records to determine whether there was a significant change in the number of sites and reports submitted

for a consistent set of chemical substance s between the two reporting cycle s. Such an analysis potentially could pro vide support for EPA’s assumption the number of site s and reports will remain relatively unchanged in the next reporting cycle. Therefore, to the extent changes in the chemical industry unrelated to the IUR rule amendment s c ould affect the number of site a nd reports submitted, the baseline burden and cost may be under

- or overestimate d

.

4.4 

### Changes in Industry Burden and Costs Due to the Final IUR Modification s Rule

The expected cost and burden impacts of each of the amendments to the IUR rule are

outlined belo w. See Section 3 for more detailed information about each of these amendments.

In each of the following sections, the burden estimates for each amendment are calculated independently of the other amendments

. See Section 4.5 for an estimate of the aggregated impact

of all amendment s.

4.4.1 

### Technical Modifications to the Regulatory Text

EPA is reorganizing certain existing rule text and deleting obsolete text. These amendments

do not substan tively affect the rule text, so EPA assumes these modifications will not affect industry burden or cost

.

4.4.2 

### Modifications to Selected Definitions

EPA is modifying the definitions of “importer,” “manufacture

, ” “site

, ” “commercial use,” “consumer use,” “reporti ng year,” and “submission period,” and adding definitions for “manufacturer,” “Central Data Exchange (CDX),” “e

- IURweb,” and “industrial function,” as described in Section 3. These changes are clarifications only; EPA is clarifying in rule text what

has be en 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 D etermining Whether a Manufacturer is S ubject to IUR Reporting Requirements

Under the current IUR rule requirements, a submitter completes a report only if its chemical

substance production has met or exceeded the 25,000 lb reporting threshold during the principal reporting year. EPA is modifying the timeframe for reporting, so chemical ma nufacturers (including importers) will be subject to the IUR rule if a chemical substance ’s production volume has exceeded the threshold in any calendar year since the last principal reporting year. This
modification will not take effect until after the fi rst post

- amendment reporting cycle (2012); for the first reporting cycle, submitters will still consider production volume for only the principal reporting year.

EPA believes this amendment will cause an increase in the number s of submitters and reports

in future reporting cycles

. Because data on the production volume of chemical substance s reportable under the IUR rule during non

- principal reporting years currently is not available, the

actual percentage increase in these numbers is unknown. The Agency, us ing its best professional4

- 19



### judgment, estimates for the purpose of this analysis

, the amendment will increase the number of submitters and reports in future reporting cycles by approximately five percent.

Using an estimated five percent increase over the bas eline number of sites and reports (baseline presented in Table 4

- 6), EPA estimates 204 additional sites will submit reports in future reporting cycles. EPA further estimates those sites will submit an additional 854 full reports and 441 partial reports, fo r a total of 1,295 additional reports for each future reporting cycle

.
As described in Section 4.1

, sites need to complete Part I of Form U only once, and complete Part II and Part III (as applicable) for each chemical substanc e manufactured or imported. Taking this allocation of activities into consideration, and using the baseline unit burden estimates as
shown in Table 4

- 2 and Table 4

- 8

, Table 4

- 12 shows the industry burden estimate as a result of this amendment. The Agency estimates the amendment will not cause a change in industry burden during the 201 2 reporting cycle, but will generate an increase of approximately 71,700 hours during all future r eporting cycles.

Table 4

- 12 : Change in Industry Burden as a Result of Modifying the Method for Determining Whether a Manufacturer is S ubject to IUR R eporting R equirements

Burde n for Compliance Determination,

Rule Familiarization,
Submission and

to P repare Part I (hours per site) Number

of Sites Burden for

Record k eeping

and to P repare Part II (hours per report) Number

of Reports Burden

to Prepare

Part III (hours

per report) Number

of Reports
with

Part III In dustry

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,

Post

Amendment 33.26 4,085 19.82 25,896 69.92 17,075 1,842,934

C hange from the Baseline, First Cycle 0.00 0 0.00 0 0.00 0 0

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

Future C ycle,

Post

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

Ch ange from the Baseline,
Future C ycles 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 v alue from the post

amendment v alue.



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and Table

4

- 9

. Table 4

- 13 shows the industry cost estimate as a result of this amendment. EPA estimates4

- 20



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

Table 4

- 13 : Change in Industry Cost as a Result of Modifying the Method for Determining
Whether a Manufa cturer is S ubject to IUR R eporting R equirements

Cost for Compliance Determination,

Rule Familiarization,
Submission and

to P repare Part I (2008 $ per s ite) Number

of Sites Cost for

Recordkeeping

and to P repare Part II (2008 $ per report) Number

of Reports Cost to

P repare 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 Cycl e, Post

Amendment $2,058 4,085 $1,129 25,896 $4,059 17,075 $106.97

C hange from the Baseline, First Cycle $0 0 $0 0 $0 0 $0.00

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

Future C ycle,

Post

Amendment $561 4,289 $968 2 7,191 $3,247 17,929 $86.96

Ch ange from the Baseline,
Future C ycles $0 204 $0 1,295 $0 854 $4.14

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Limitation s of Analysis

. To the extent the change in method for determining whether a manufacturer is subject to the IUR reporting requirements causes an increase in numbers of sites and reports submitted that is higher or lower than five percent, this analysis may under

- or overestimate the total burden and cost increase. A sensitivity analysis is performed in Appendix

D.1

. In the proposal, EPA also requested comment on returning to the previous, lower reporting threshold of 10,000 lb

. Appendix E. contains an analysis of the cost and burden of this lower

threshold , which EPA has decided not to adopt in the final rule

.

4.4.4 

### Replace the 300,000 lb T hreshold for P rocessing a nd U se R eporting

EPA is repl ac ing the 300,000 lb threshold for processing and use information and phasing in a lower reporting threshold. For the 2012 IUR, all submitters of non

- excluded chemical substances are required to report processing and use information if they manufactured (i ncluding imported) 100,000 lb or more of a chemical substance in 2011. Subsequent to the 2012 reporting cycle, the reporting threshold will be 25,000 lb

, therefore requiring all manufacture r s of non

- excluded substances to report information in all4

- 21

parts of the IUR Form U. Replacing this threshold will increase industry burden by requiring more sites to complete Part III of Form U (Part III contains the downstream processing and use information).

This amendment affects only the burden and costs associated wi th completing Part III; it will not cause an increase in the number of sites submitting reports. In the 2006 IUR reporting cycle

, a total of 3,627 reports were submitted with production volumes between 100,000 lb and 300,000 lb (EPA, 2008c). Therefore, EPA assumes that, due to the amended rule, there will be an increase of 3,627 reports with Part III in the first reporting cycle.



### In future reporting cycles ( after the 2012 cycle ) Part I I I will need to be completed for all non

excluded substances. In the 200 6 reporting cycle, the total number of partial reports submitted (that is, forms with only Part I and Part II completed) was 8,821 ( see Table 4

- 6 ) ; 618 of these
reports we re subm itted for partially exempt (i.e., ex cluded) chemical substance s (EPA, 2009a)

. ( Under the amendment, submitters of partially exempt chemical substance s still will not be required to submit a Part III. ) For the purposes of this analysis, EPA assumes that partially exempt chemical substances al l have production volumes less than 100,000 lb and therefore these reports are not considered in estimations for the first reporting cycle. Therefore, EPA assumes that, due to the amended rule, there will be an increase of 8,203 (i.e, 8,821 minus 618)

in f uture reporting cycles.

Us ing the baseline unit burden estimate as shown in Table 4

- 2 and Table 4

- 8

, Table 4

- 14
shows the industr y burden estimate as a result of this amendment. The Agency estimates the amendment will cause an increase in industry burden of approximately 253,600 hours during the first reporting cycle, and 4 58

, 8 00 hours during all future reporting cycles.

Table 4

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

Burden per Report (Part III) ( h ours) Total Number of Reports
with Part III Total Industry

Burden (hours)
First Cycle, Baseline 69.92 17,075 1,193,829
First Cycle, Post

Amendment 69.92 20,702 1,447,417

C hange from the Baseline, First Cycle 0 3,627 253,588

Future C ycle
, Baseline 55.93 17,075 955,063

Future C ycle, Post

Amendme nt 55.93 25,278 1,413,884

Ch ange from the Baseline,
Future C ycles 0 8,203 458,822

Note s : Values in Change from the Basel ine rows are calculated by subtracting the corresponding baseline value from the post

amendment value. Total s may not sum due to r ound ing

.



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and Table

4

- 9

. Table 4

- 15 shows the industry cost estimate as a result of this amendment. EPA estimates the industry cost will increase by $ 14.72 million in the 201 2 reporting cycle and by $26.64 million in all future reporting cycles.4

- 22

Table 4

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

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

First Cycle, Baseline $4,059.25 17,075 $69.31
First Cycle, Post

Amen dment $4,059.25 20,702 $84.03

Change from the Baseline,
First

- Year $0.00 3,627 $14.72

Future C ycle
, Baseline $3,247.40 17,075 $55.45

Future C ycle, Post

Amendment $3,247.40 25,278 $82.09

Ch ange from the Baseline,
Future C ycles $0.00 8,203 $26.64

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment value. Total s may not sum due to rounding

.



### Limitations of Analysis

. The estimate of 3,627 additional reports for the 2012 report ing cycle may be an overestimate as some of these reports may be for partially exempt chemicals that are not required to submit Part IIs. In subsequent reporting cycles EPA is assuming each partially
exempt chemical substance is produced at four different sites . To the extent this is not the case,

this analysis may over

- or underestimate the number of additional Part IIIs

.

4.4.5 

### Reducin g the 25,000 lb Threshold f or Specific R egulated Chemical
S ubstance s

B eginning with the 2016 submission period and for submissio n periods thereafter

, EPA is reducing the 25,000 lb threshold to 2,500 lb for chemical substances that are: (1) the subject of a regulation promulgated under section 5(a)(2), 5(b)(4), or 6 of the Act; (2) the subject of an order issued under section 5(e) o r 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. A s of the 2016 submission period, a manufacturer (including importer) of such chemical substances will be required to report

manufac turing information on the chemical substances if they are manufactured (including imported) in volumes of 2,500 lb or more during any of the years since the last principal reporting year (e.g., 2011). Information on the processing and use of the chemical s ubstances must be reported if they were manufactured (including imported) in volumes of 25,000 lb or more during any of the years since the last principal reporting year. To determine how many specific chemical substance s this amendment will affect, EPA re ferred to Appendix C of the Instructions for Reporting for the 2006 Partial Updating of the TSCA Chemical Inventory

Database (EPA, 2006 a ), which lists c hemical 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 section s 5(a)(2), 5 (b)(4), or 6 of the Act, subject of an order issued under section 5(e) or 5(f) 4 

### of the A ct, or the subject of relief that has been granted under a civil action under sectio n 5

4 T here are two chemicals subject of an order issued under section 5(f) of TSCA that would be subject to the reduced

threshold that have not been included in the development of estimates in this section of the Economic A nalysis,

howe ver, the overall estimates of costs and burdens for this requirement are not expected to be significantly affected.4

- 23



### or 7 of the Act, identified 1,1 29 chemical substance s

. CASRN s were provided for 7 39 of these

chemical substance s, and an additional 39 0 chemical substance s were listed by a ccession

n umbers (EPA, 2006a)

. Of the 7 39 chemical substance s with CAS RN s, no reports were filed for

65 1 chemical substance s, or 88 percent (EPA, 2009e). EPA also assumes no reports were filed for 88 percent of the 390 chemical substance s with access io n numbers

, or 34 4 chemical

substance s

. In addition, Form Us were submitted voluntarily for eight chemical substance s with production volume levels below the 25,000 lb threshold during the 2006 reporting cycle (EPA,
2009 a )

. EPA estimates that a total of app roximately 1,00 3 chemical substance s are subject to one of the TSCA sections above and are not currently reported under IUR ( 651 + 344 +8 = 1,003 )

. However, no production volume data are available for these chemical substance s. Therefore, EPA assumes that app roximately 90 percent of these chemical substance s (90 2 chemical

substance s) have production volumes between 2,500 and 25,000 lb

. Based on the data provided in the 2006 IUR reporting cycle (EPA, 2008 c ), on average, each

chemical substance is produced at ap proximately four sites; therefore, EPA expects 3,6 09 additional reports (Part IIs) to be submitted for these chemical substance s. The Agency also assumes the reports generated by this amendment will be for production volumes lower than 25,000 lb (therefore , lower than 300,000 lb ), so, as a result of this amendment alone, submitters
will not be required to complete Part III (see Section 4.5 for an estimate of the aggregated impact

of all amendment s)

. In addition, the Agency is assuming that manufacturers (including importers) of these chemical substance s already will be submitting reports for other non

- exempt
chemical substance s; so , therefore, the number of sites will not increase from the baseline as a

result of this amendment

. Using the baseline unit burden estimate for completion of Part II as shown in Table 4

- 2 and

Table 4

- 8

, Table 4

- 16 presents the estimated increase in industry burd en as a result of this amendment. The Agency estimates the amendment will cause an increase in industry burden of approximately 0 hours during the first reporting cycle and 61, 600 ho urs during all future reporting cycles.

Table 4

- 16 : Change in Industry Burden as a Result of Reducing the 25,000 lb Threshold
for Specific R egulated Chemical S ubstance s

Burden for Record k eeping

and to P repare Part II (hours per report) Number of Reports Industry Burden

(hours)

First Cycle, Baseline 0 0 0
First Cycle, Post

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

Future C ycle
, Baseline 17.06 25,896 441,682

Future C ycle, Post

- Amendment 17.06 29,505 503,241

Ch ange from the Baseline, Future
C ycles 0.00 3,6 09 61,559

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.4

- 24



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and Table

4

- 9

. Table 4

- 17 shows the industry cost estimate as a result of this amendment. The cost to industry is expected to increase by $3.50 million during all futur e reporting cycles , and will not increase during the 2011 reporting cycle.

Table 4

- 17 : Change in Industry Cost as a Result of Reducing the 25,000 lb Threshold for Specific R egulated Chemical S ubstance s

Cost for Record k eeping

and to P repare Part II (2008 $ per report) Number of Reports Industry Cost

( millions 2008$ )

First Cycle, Baseline $ 0 0 $ 0 First Cycle, Post

- Amendment $ 0 0 $ 0 Change from the Baseline, First Cycle $0 0 $ 0

Future C ycle
, Baseline $9 68 25,896 $25.08

Future C ycle, Post

- Amendment $968 29,505 $28.57

Ch ange from the Baseline, Future
C ycles $0 3,609 $3.50

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amen dment v alue.



### Limitation s of A nalysis. Th e number of additional reports EPA receives as a result of this

amendment may be an overestimate to the extent manufacturers (including importers) already are submitting reports for these chemical substance s . That is, to the extent some portion of these

chemical substance s already are subject to IUR reporting because they are produced in volumes of 25,000 lb or greater, the Agency is overestimating the number of additional reports it will
receive as a result of the amendment. Furthermore, to the extent manufacture r s (including importers) of these chemical substance s do not already submi t reports for other chemical

substance s, EPA is underestimating the number of sites will increase from the baseline as a result

of th is amendment. In addition, the number of chemical substance s with production volumes between 2,500 and 25,000 lb may be an over

- or underestimate.

4.4.6 

### Mak e Chemical S ubstance s Subject to Enforceable Consent Agreements (ECAs) I neligible for E xemptions

Chemical substance s subject to e nforceable consent a greements (ECAs) are of demonstrated interest to the Agency

. For instance, EPA will use the IUR data associated with these regulated chemical
substance s to monitor chemical substance production and compliance wit h the agreements

. Therefore,

EPA is mak ing these chemical substance s ineligible for reporting exemptions. Manufacturers (including importers) of these chemical substance s no longer will be partially exempt, and so must complete Part III
of Form U

. EPA pub lishes 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). S ince 1985 , the Agency has entered into ECAs for 67 chemical substance s. Six of the 67 chemical substance s 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 lea ve s a total of 61 chemical substance s subject to ECAs.

EPA also maintains a table show ing the sunset date and status for chemical substance s subject to section 4 actions, including ECAs ( http: //www.epa.gov/oppt/chemtest/pubs/sunset.html ) (EPA, 2009g). Only two of the 61 chemical substance s were identified as currently being subject to an ongoing4

- 25

ECA. Therefore, only two chemical substance s will lose the partial exemption under the amendment, an d
so will need to comple te Part III of Form U. In addition, EPA is assuming an additional two chemical

substance s could be under ECAs in future reporting cycles. Therefore, EPA is estimating the amendment
would cause submitters of a total of four chemical substance s to complete Part III of Form U. Based on

data from the 2006 IUR reporting cycle , the Agency estimates approximately four sites produc e each
chemical substance (EPA, 2008 c ); therefore, a total of 16 Part IIIs would be submitted for the first time
for chemical substance s subject to an ECA.



### Using the baseline unit burden estimate for completion of Part III as shown in Table 4

- 2 and

Table 4

- 8

, Table 4

- 18 shows the industry b urden estimate as a result of this amendment. The Agency estimates the amendment will cause an increase in industry burden of approximately 1,100 hours during the first reporting cycle, and 900 hours during all future reporting cycles.

Table 4

- 18 : Change in Industry Burden as Result of Making Chemical S ubstance s Subject to ECAs Ineligible for Exemptions

Burden per Report (Part III) ( h ours) Total Number of Reports
with Part III Total Industry Burden (hours)

First Cycle,
Baseline 69.92 17,075 1,193,829

First Cycle, Post

Amendment 69.92 17,091 1,194,947

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

Future C ycle
, Baseline 55.93 17,075 955,063

Future C ycle, Post

Amendment 55.93 17,091 955,958

Ch ange from the Baseline, Future
C ycles 0 16 895

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and Table

4

- 9

. Table 4

- 19 shows the industry cost estimate as a result of this amendment . EPA estimates the industry cost wil l increase by $64,900 during the 2011 reporting cycle and by approximately $52,000 during all future reporting cycles.4

- 26

Table 4

- 19 : Change in Industry Cost as a Result of Making Chemical S ubstance s 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, Post

Amendment $4,059 17,091 $69,376,655

Change from the Base line, First Cycle $0 16 $64,948

Future C ycle
, Baseline $3,247 17,075 $55,449,366

Future C ycle, Post

Amendment $3,247 17,091 $55,501,324

Ch ange from the Baseline,
Future C ycles $0 16 $51,958

Note: Values in Change from the Baseline rows are calcula ted by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Limitation s of A nalysis

. EPA is assuming each of these chemical substance s is produced at
four different sites . To the extent this is not the case, this analysis may over

- or underestimate the

number of additional Part IIIs . In addition, some of these chemical substance s may be produced in volumes of 300,000 lb or greater, and therefore already will be required to submit a full report. To the extent this is the case, this a nalysis overestimates the total number of additional Part IIIs. Finally, to the extent additional chemical substance s become subject to ECAs in the future, this analysis may underestimate the total number of additional Part IIIs.

4.4.7 

### Full E xemption f or M anufac tured W ater

Under the current IUR regulations, manufactured water is partially exempt from reporting; therefore, facilities producing manufactured water only need to complete Parts I and II of Form U. The Agency is granting a full exemption for manufacture d water. In 2006, a total of 43 partial reports were submitted for manufactured water (EPA, 2008c). EPA assumes manufactured water is a byproduct of chemical substance production. Therefore, sites submitting a report for
manufactured water will continue to submit reports for other chemical substance s. Thus

, the burden reduction for this amendment will be the result of 43 fewer Part IIs being submitted.

Using the baseline unit burden estimate as shown in Table 4

- 2 an d Table 4

- 8

, Table 4

- 20 shows the reduction in industry burden estimate as a result of th is amendment. The Agency estimates the amendment will cause a decrease in industry burden of approximately 850 hours during the first reporting cycle, and 700 hours during all future reporting cycles.4

- 27

Table 4

- 20 : Change in Industry Burden as a Result of Exempting Manufactured Water from Rep orting

Bu rden for Recordkeeping and to

P repare 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 C ycle
, Baseline 17.06 25,896 441,682

Future C ycle, Post

- Amendment 17.06 25,853 440,949

Ch ange from the Baseline, Future C ycles 0

- 43

- 733

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding b aseline v alue from the post

amendment v alue.



### 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 in dustry cost estimate as a result of this amendment. EPA estimates the industry cost will decrease by approximately $48,600 in the first reporting cycle and $41,600 in all future reporting cycles.

Table 4

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

Cost for Record k eeping

and to P repare Part II (2008 $ per report) Number of Reports Total Industry

Cost (2008 $ )

First Cycle, Baseline $1,129 25,896 $29,247,454
First Cycl e, Post

- Amendment $1,129 25,853 $29,198,889
Change from the Baseline, First Cycle $0

- 43

- $48,565

Future C ycle
, Baseline $968 25,896 $25,077,449

Future C ycle, Post

- Amendment $968 25,853 $25,035,808

Ch ange from the Baseline, Future C ycles $ 0

- 43

- $41,64 1

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Limitations of Analysis

. EPA is assuming the sites producing manufactured water are also producing other chemic al substance s above the reporting threshold, and will continue to submit a Form U, which may not be the case for all sites. In that case, the above estimate underestimates the savings to the industry.

4.4.8 

### Remove Fully

- Exempt P olymers from the P artially

- E xempt L ist

EPA is amending the partially

- exempt list of chemical substance s to remove three chemical

substances : S tarch (CASRN 9005

- 25

- 8), Dextrin (CASRN 9004

- 53

- 9), and Maltodextrin (CASRN 9049

- 76

- 7) .These chemical substance s , as polymers, are already fully exe mpt from reporting. EPA expects this amendment will not impact industry burden or costs, because these substances currently are fully exempt from reporting and therefore no submitters currently are required to submit reports for them. That is, this amendme nt is a clarification only and EPA assumes it will not change the behavior of the regulated community.4

- 28

4.4.9 

### Parent C ompany and Site Identity

Under the final rule, submitters will be required to p rovide the name, address , and D&B

number of their ultimate domesti c 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 E conomic A nalysis, on
which these burden estimates are based, already included the cost of providing the information

for th e ultimate domestic parent company

. T he rule is now consistent with the 2002 analysis , and

EPA assumes the burden estimate will not change from the baseline

. Furthermore, companies that do not yet have a D&B number incur no cost to obtain one.

4.4.10 

### Technical C o ntact

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

submission. EPA is amending the IUR rule to require the technical contact be a person who is knowledgeable about the chemical substance but does not need to be located at the plant site. Because submitters already are required to identify a technical contact, EPA assumes this
amendment will not cause an increase in burden.

4.4.11 

### Chemical I dentity

EPA is requiring submitters to report only the CASRN as a chemical id entifying number or, in the case of confidential chemical substances, the TSCA accession number assigned when the Notice of Commencement (NOC) was submitted to the Agency. EPA is removing the PMN number as an allowed chemical identifying number

. Because th e reporting tool will be directly linked to the non

- confidential portion of the TSCA Inventory through SRS, submitters no longer will be allowed to claim the CASRN as confidential. For this reason, EPA is requiring submitters to report the TSCA accession n umber if they choose to assert a CBI claim on the chemical identity. Submitters will be able to look up the accession

number in SRS using the PMN number for their chemical substance.

EPA expects that manufacturers (including importers) will have either the PMN number or a TSCA

accession number for their confidential Inventory substance, or will be able to obtain the accession
number . Those submitters who, in the past, have reported using the CASRN of a confidential substance or
do not have the PMN number or accession number , or who are not able to obtain the accession number using SRS, may contact EPA by letter if necessary to obtain the accession number

. Those submitters who
know only the CAS RN and not the PMN or Accession number for a confide ntial chemical substance are the only manufacturers that EPA expects to contact the Agency to obtain an accession number

. Those submitters who are not claiming the chemical identity as CBI will be able to continue using the CASRN.

EPA assumes that the time it will take submitters who do not already know their accession number to look it up using the PMN number in SRS will be minimal, and therefore, is not estimating that burden here. However, some submitters may not know either the PMN or accession number , and will there fore need to request it in writing from EPA. As an upper bound estimate, the number of 2006 IUR reports with

CA S RNs claimed as CBI was used as a proxy for the number letters submitted to EPA . ( All other 2006 IUR reports with CBI claims for chemical identit y were made using a ccession n umbers or PMN n umber,

and therefore , EPA assumes that th ose sites w ill not need to send a writte n request to EPA. ) A total of 343 reports claimed CAS RN s as CBI in 2006 (EPA, 2010b).

EPA assumes that the burden to submit a writ ten accession number request is half of the burden of providing the specific chemical identification in a bona fide submission. Bona fides are written requests a

company s en ds to EPA when the company intend s to manufacture (including import ) a chemical

sub stance

, but is unsure of the TSCA Inv entory status of the chemical substance . The s pecific chemical
identification information required by a b ona fide includes the CAS name and number as well as the

chemical substance ’s molecular formula, a chemical substa nce structure diagram, and the name of the4

- 29

chemical substance ’s precursors and reactants . EPA estimates that submitters of bona fides incur a burden
of a pproximately 2.0 hours of technical time per notice to prepare the notice (EPA, 1994). EPA estimates

th at the burden associated with written accession number requests is approximat e ly half of the burden (one hour) associated with providing specific chemical identification information for a bona fid e . The

accession number requests will not require informatio n on the chemical substance ’s molecular formula,

structure , or the name of the chemical substance ’s precursors and reactants . The total industry burden is approximately 343 hours (See Table 4

- 22 ). While some sites may need to submit an accession number request in future cycles, EPA expects that most sites that need a ccession n umbers will request them in the
first reporting cycle. Therefore, the burden to industry in future cycles is expected to be minimal and was

no t estimated for this analysis.

Table 4

- 22 : Change in Industry Burden as a Result of A ccession N umber Requests

Bu rden for A ccession

N umber Request (hours per reques t) Number of

R equest s Total Industry

Burden (hours)

First Cycle, Baseline 0 0 0
First Cycle, Post

- Amendment 1 .0 343 343
Change from the Baseline, First Cycle 1.0 343 343

Note: V alues in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

am endment v alue. Source: Burden hours are taken the Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notices (EPA, 1994, Table III

- 8) and adjusted based on EPA’s best professional judgment

Table 4

- 23 presents the change in industry cost as a result of accession number requests. EPA estimates a $20,200 increase in industry cost in the first reporting cycle.

Table 4

- 23 : Change in Industry Cost as a Result of A ccession N umber Requests

Cost for A ccession

N umber Requests (2008 $ per r equest ) Number of Requests Total Industry

Cost Million (2008 $ ) First Cycle, Baseline $0 0 $0
First Cycle, Post

- Amendment $58.84 343 $20,182
Change fro m the Baseline, First Cycle $58.84 343 $20,182

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.

4.4.12 

### Report P roduction V olume for Each of the Years since Last Principa l
R eport ing Year

EPA is requiring submitters to report production volume for both year 2010 and year 2011 in the 2012 reporting cycle . In subsequent reporting cycles, production volume must be reported for

each of the four years since the last IUR principa l reporting year

. Thus, for the 201 2 IUR
submission , manufacturers (including importers) of subject chemical substance s will report the production volume for the calendar years 2010 and 201 1, and will report production volumes for 2012, 2013, 2014, and 201 5 in the 201 6 reporting cycle. While sites will still submit data to EPA only in the submission year, EPA assumes there will be an increase in burden as the result of gathering data and reporting production volumes for an additional year in the first repor ting cycle and an additional four years in subsequent reporting cycles.

According to the baseline burden estimate, a site spends approximately 3.36 hours to gather production volume and site

- limited activity (see Table 4

- 3 ). EPA e stimates approximately 454

- 30



### percent of these 3.36 hours (i.e., 1.51 hours) is attributed to gathering production volume information. ( See Table 4

- 3 for an explanation of this percentage breakdown.) Therefore, the Age ncy estimates a site will spend an additional 1.51 hours to gather the production volume information for the extra year’s worth of data required in the first reporting cycle. In future reporting cycles, approximately an additional 3.63 hours (approximately ) (i.e., 1. 21 x 3 ) is expected to report production volumes for the three additional, non

- principal reporting years.

Table 4

- 24 shows the increase in industry burden as a result of this amendment. The Agency

estimates the amendmen t will cause a total increase in industry burden of approximately 39,200 hours in the first reporting cycle and approximately 94,000 hours in all future reporting cycles.

Table 4

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

- Principal Reporting Years

Burden to R eport
P roduction V olume (hours per report ) Number of Reports Industry Burden

(hours)

First Cycle, Baseline 1.51 25,896 39,155
First Cycle, Post

- Amendment 3.02 25,896 78,310 Change from the Baseline, First Cycle 1.51 0 39,155

Future C ycle
, Baseline 1.21 25,896 31,324

Future C ycle, Post

- Amendment 4.838 25,896 125,295

Ch ange from the Baseline, Future
C ycles 3.63 0 93,971

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and T able

4

- 9

. Table 4

- 25 shows the industry cost estimate as a result of this amendment. EPA estimates the industry cost will increase by $2.19 million in the 2012 reporting cycle and $ 5.26 million in all future reporting cycles.

Tab le 4

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

- Principal Reporting Years

Cost to R eport
P roduction

V olume (2008$ per report) Number of

Reports Industry Cost

( millions 2008$ )

First Cycle, Baseline $84.68 25,896 $2.19
First Cycle, Post

- Amendment $169.36 25,896 $4.39
Change from the Baseline, First Cycle $ 84.68 0 $ 2.19

Future C ycle
, Baseline $67.74 25,896 $1.75

Future C ycle, Post

- Amendment $270.98 25,8 96 $7.02

Ch ange from the Baseline, Future C ycles $203.23 0 $5.26

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### 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 the4

- 31



### extent the actual burden is higher or lower than estimated, this analysis under

- or overestimates

the burden and cost of this amendment.

4.4.13 

### Volume of Chemical Substance Used On

- Site

Previous Form Us have required submitters to indicate whether a chemical substance was site

- limited, referring to a chemical substance manufactured and /or processed only within a site

and not distribute d for commercial purposes as a substance or as part of a mixture or article

outside the site

. A chemical used off

- site is one that does not meet this definition; for example, a chemical produced as an end product . EPA is removing the site

- limited data elem ent 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 acti vities to identify the necessary information are similar. EPA estimates it will take a submitter 1.51 hours to provide the production volume (see Table 4

- 3 ).

EPA expects a n increase in the number of submitters who will report volume used on

- site

, due to the way this information will be reported under the amendment

. In the data submitted to EPA for the 2006 reporting year, about 14.8 percent of reports include a site

- limited volume ( EPA 2008c ); therefore, EPA assume s this is the minimum number of reports that will be

affected.

Site

- limited chemical substance s are those not distributed (either as the chemical substance

itself or in a mixture) outside the plant site for commercial purposes. Therefore, EPA assumes all

ch emical substance s used on

- site must be chemical substance intermediates. According to data
from the 2006 IUR database ( EPA, 2008c) , approximately 24 percent of all reports containing downstream processing and use information included chemical substance s us ed as intermediates

. T herefore, EPA assume s 24 percent of all reports is the maximum percentage of reports that will

be affected. Not all chemical substance s produced as intermediates are used on

- site; they may be shipped for use at another site. EPA used 19.4 percent, which is the midpoint of 14.8 and 24, to
estimate the increase in the number of reports with chemical substance s used on

- site, i.e., 5,024
reports.

Table 4

- 26 shows the industry burden estimate as a r esult of this amendment. The Agency estimates the amendment will cause a total increase in industry burden of approximately 7,600 hours during the first reporting cycle and 6,100 hours during all future reporting cycles.4

- 32

Table 4

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

- Site

Burden to Report
Production Volume
Used On

- Site (hours) Number of Reports

w ith Production

Volume Used On

Site I nformation Total Ind ustry
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 C ycle
, Baseline 0.00 0 0

Future C ycle, Post

- Amendment 1.21 5,024 6,077

Ch ange from the Bas eline, Future C ycles 1.21 5,024 6,077

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and Table

4

- 9

. Table 4

- 27 shows the industry cost estimate as a result of this amendment. EPA estimates the total industry c ost will increase by $425,400 during the first reporting cycle and $340,300 during all future reporting cycles.

Table 4

- 27 : Change in Industry Cost as a Result of Requiring the Reporting of Production
Volume U sed On

- Site

Cost to Report
Production Volume
Used On

- Site (2008$) Number of Reports

w ith Production

Volume Used On

Site I nformation 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 C ycle
, Baseline $0.00 0 $0.00

Future C ycle, Post

- Amendment $67.74 5,024 $340,333

Ch ange from the Baseline, Future C ycles $67.74 5,024 $340,333

Note: Values in Change from the Baseline rows ar e calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Limitations of Analysis

. To the extent the burden of reporting the production volume used

on

- site is different from the burden to report the total production volu me, this analysis may over

or underestimate the burden and cost of this amendment . Furthermore, to obtain the maximum number of reports that may be affected, EPA assumes the percentage of reports containing downstream processing and use information that i ncluded chemical substance s used as

intermediates will be the same as the percentage of all reports that include chemical substance s used as intermediates (that is, that the percentage of chemical substance s used as intermediates is
consistent whether a su bmitter completed Part III or not.) To the extent this is not the case , the analysis may over

- or underestimate the number of reports affected.

4.4.14 

### Indicate Whether Chemical S ubstance Is Physically at Reporting Site

EPA is requiring submitters to indicate whet her an imported chemical substance is physically

at the reporting site. Under the current IUR requirements, a submitter must state whether the
site’s chemical substance is manufactured or imported

. The Agency estimates providing this4

- 33



### information requires 0 .17 hours per report (see Table 4

- 3 ). EPA assumes the burden to i ndicate

whether a chemical substance is physically on

- site will be similar to the burden incurred to
indicate whether a chemical substance is manufac tured or imported, given the similarity of these activities to identify the necessary information. Table 4

- 28 shows the industry burden estimates as a result of this amendment. The Agency estimates the amendment wi ll cause a total increase in industry burden of approximately 4,400 hours for the 2011 reporting cycle, and 3,500 for all future reporting cycles.

Table 4

- 28 : Change in Industry Burden as a Result of Indicatin g Whether a Chemical
S ubstance is Physically at the Reporting Site

Burden to Indicate

Whether Chemical
S ubstance 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 C ycle
, Baseline 0.00 25,896 0

Future C ycle, Post

- Amendment 0.13 25,896 3,480

Ch ange from the Baseline, Future C ycles 0.13 0 3,480

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the
post

- amendment v alue.



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and Table

4

- 9

. Table 4

- 29 shows the industry cost estimate as a result of this amendment. EPA estimates the total industry cost will increase by approximately $243,700 in the first reporting cycle and $194,900 in all future reporting cycles.

Table 4

- 29 : Change in Industry Cost as a Result of Indicating Whether a Chemical
S ubstance is Physically at the Reporting Site

Cost to Indicate

Whether Chemical
S ubstance is Physically

at Reporting Site (2008 $ ) Number of

Re ports 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 C ycle
, Baseline $0.00 25,896 $0

Future C ycle, Post

- Amendment $7.53 25,896 $194,921

Ch ange from the Baseline, Future C ycles $7.53 0 $194,921

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Limitations of Analysis

. To the extent the bu rden of indicating whether a chemical substance is physically at the reporting site is dif ferent from the burden to report whether a chemical

substance is manufactured or imported, this analysis may over

- or underestimate the burden and

cost of this amendm ent. Furthermore, this requirement may apply only to importers; the number of reports affected, therefore, is likely to be an overestimation.4

- 34

4.4.15 

### Report Production V olume Exported

EPA is adding a requirement for submitters to report the production volume dire ctly exported and not domestically processed or used . The Agency assumes the burden to the submitter to report the volume exported will be similar to the burden to report the production volume, given the similarity of the activities. EPA estimates it will take a submitter 1.51 hours to provide the volume exported (see Table 4

- 3 ).

Using the baseline unit burden estimate as shown in Table 4

- 2 and Table 4

- 8

, Table 4

- 30 shows the industry burden estimate as a result of this amendment. The Agency estimates the amendment will increase industry burden by approximately 39,200 hours for the 2012 reporting cycle, and 31,300 hours for all future repor ting cycles.

Table 4

- 30 : Change in Industry Burden as a Result of Requiring Reporting of Volume Exported

Burden to R eport Export Volume (hours) Number of

Reports Industry

Burden (hours) First Cycle, Base line 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 C ycle
, Baseline 0.00 25,896 0

Future C ycle, Post

- Amendment 1.21 25,896 31,324

Ch ange from the Baseline, Future C ycles 1.21 0 3 1,324

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the
post

- amendment v alue.



### 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 am endment. EPA estimates the industry cost will increase by $2.19 million dur ing the first reporting cycle and $1.75 million during all future reporting cycles.

Table 4

- 31 : Change in Industry Cost as a Result of Requiring Reporting of Volume Exported

Cost to R eport 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 C ycle
, Baseline 0 25,896 $0.00

Future C ycle, Post

- Amendment $67.74 25,896 $1.75

Ch ange from the Baseline, Future C ycles $67.74 $0.00 $1.75

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Limitations of Analysis

. To the extent the burden of reporting the volume exported is different from the burden to report the total production volume, this analysis may over

- or underestimate the burden and cost of this amendment.4

- 35

4.4.16 

### Identify Whether a Chemical S ubstance i s t o b e R ecycled , Remanufacture d

, Reprocessed, or Reused

EPA is adding a requirement to indicate whe ther a manufactured chemical substance , such as a byproduct, is being recycled , r emanufacture d, reprocessed, or reused

. Given the similarity in
activities to researc h records and identify the appropriate information, the Agency estimates this activity will generate the same burden as indicating whether a chemical substance is used on

- site.
As shown in Table 4

- 3 , EPA estimated this burden to be approximately 0.17 hours.

Using the baseline uni t b urden estimate as shown in Table 4

- 2 and Table 4

- 8

, Table 4

- 3 2 shows the industry burden estimates as a result of this amendment. The Agency estimates the amendment will cause a total increase in industry burden of approximately 4,400 hours in the first reporting cycle and approximately 3,500 hours during all futur e reporting cycles.

Table 4

- 32 : Change in Industry Burden as a Result of Indicating Whether Chemical
S ubstance is to be Recycled, Remanufactured, Reprocessed, or Reused

Burden for Completing a
Check box to Ind icate

Whether a Chemical
S ubstance is Recycled
, Remanufacture d
, Reprocessed, or Reused, (hours) Number
of Reports Industry

Burden (hours)

First Cycle, Baseline 0.00 25,896 0
First Cycle, Post

- Amendment 0.17 25,896 4,351
Change from the Baseline, First C ycle 0.17 0 4,351

Future C ycle
, Baseline 0.00 25,896 0

Future C ycle, Post

- Amendment 0.13 25,896 3,480

Ch ange from the Baseline, Future C ycles 0.13 0 3,480

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding bas eline v alue from the post

amendment v alue.



### 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 es timate as a result of this amendment. EPA estimates the cost to industry will increase by $243,700 for the 201 2 reporting cycle and $194,900 for all future reporting cycles.4

- 36

Table 4

- 33 : Change in Industry Cos t as a Result of Indicating Whether Chemical
S ubstance is to be Recycled, Remanufactured, Reprocessed, or Reused

Cost for Completing a
Check box to Indicate

Whether a Chemical
S ubstance is Recycled
, Remanufacture d
, Reprocessed or Reused (2008 $ ) Number
of Reports Industry Cost

( millions 2008$ )

First Cycle, Baseline $0.00 25,896 $0
First Cycle, Post

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

Future C ycle
, Baseline $0.00 25,896 $0

Future C ycle, Post

- Amendm ent $7.53 25,896 $194,921

Ch ange from the Baseline, Future C ycles $7.53 0 $194,921

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Limitations of Analysis

. T o the extent the burden of indicating whether a chemical substance is recycled, r emanufacture d, reprocessed, or reused is different from the burden to report whether

a chemical substance is site

- limited , this analysis may over

- or underestimate the burden and cost

of this amendment.

4.4.17 

### Concentration R anges

EPA is amending the ranges used to report concentration in § 710.52(C)(3) and (4) by changing the ranges to: ( 1) less than one percent by weight

, ( 2) a t least one percent but less than

30 percent by weight

, ( 3) a t least 30 percent but less than 60 percent by weight

, ( 4) a t least 60
percent but less than 90 percent by weight, and ( 5) a t least 90 percent by weight.

This is a technical correction to eliminate gaps in the ranges as previously listed in the IUR
rul e. Therefore, EPA assumes i t will have no impact on industry burden or cost.

4.4.18 

### Revise Industrial F unction C ategories

EPA is revising the current industrial function categories (found in Part III, Section A of Form U), by deleting s ix current categories and a dding eight new categories

. In addition, EPA is requiring submitters to write in a free

- text descriptor when they select “ O ther”.

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

technical labor. EPA also estimates it will take three minutes of clerical labor and six minutes of

technical labor to write in the text description if the submitter select s “Other”

. Acc ording to 2006

IU R data (EPA, 2008a)

, the response “Other” was selected in 1,206 re ports. Using its best professional judgment, EPA expects the new categories in the IUR modifications rule will reduce by half the number of submitters selecting “Other” as a n industrial func tion category . Therefore, EPA estimates this amendment will affect 603 reports.

Using the baseline unit burden estimates as shown in Table 4

- 2 and Table 4

- 8

, Table 4

- 34 shows the industry burden estimate as a result of this amendment. The Agency estimates the amendment will cause a total increase in industry burden in the first reporting cycle of4

- 37



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

Table 4

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

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

Reports with
Function Categories Burden to

Write in
Text for
"Other" (hours) Number of

Reports with
"Oth er" as a
Function Category Total

Industry

Burden (hours)

First Cycle, Baseline 1.52 17,075 0.00 0 25,907 First Cycle, Post

Amendment 1.77 17,075 0.15 603 30,266

Change from the Baseline, First Cycle 0.25 0 0.15 603 4,359

Future C ycle
, Baseline 1.21 17, 075 0.00 0 20,726

Future C ycle, Post

Amendment 1.21 17,075 0.12 603 20,798

Ch ange from the Baseline,
Future C ycles 0.00 0 0.12 603 72

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the p ost

amendment v alue.



### 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 indust ry cost estimate as a result of this amendment. EPA estimates the industry cost will increase by approximately $255,600 in the first reporting cycle and $3,500 in the following reporting cycles.

Table 4

- 35 : Ch ange in Industry Cost as a Result of Revis ing 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

Repor ts
with Text for
"Other" Total

Industry
Cost (2008 $ )

First Cycle, Baseline $88.02 17,075 $0.00 0 $1,502,913
First Cycle, Post

Amendment $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 C ycle
, Baseline $70.41 17,075 $0.00 0 $1,202,331

Future C ycle, Post

Amendment $70.41 17,075 $5.85 603 $1,205,856

Ch ange from the Baseline,
Future C ycles $0.00 0 $5.85 603 $3,525

Note: Values in Change from the Baseline rows are calculated by subtracting the c orresponding baseline v alue from the post

amendment v alue.



### Limitation s of Analysis

. EPA estimates submitters will use 15 minutes of technical labor burden to become familiar with the new categories; this may be an over

- or underestimate. EPA is assuming the number of submitters selecting “Other” as an industrial function category will be4

- 38



### reduced by half; this may be an over

- or underestimate. In addition, EPA assumes there is no burden for rule familiarization with the new industrial function categories d uring future reporting cycles. This may not be the case if sites have different employees complete Form U from reporting year to reporting year, or for sites submitting a Form U for the first time.

4.4.19 

### Replace NAICS Codes with Industrial Sector s

EPA is replaci ng the five

- digit North American Industrial Classification System (NAICS)
codes with 4 8 Industrial Sector s (IS)

. The industrial sectors are based on those used in the European Union’s REACH program. The Agency believes this change may reduce the reporting

burden slightly because submitters will not need to look up NAICS code s, and the new industrial
sectors will be more intuitive . However, because the submitter still will be required to look up some type of code, EPA assumes the burden reduction will be neg ligible and does not estimate it

here.

4.4.20 

### Revise C onsumer and Commercial Product Categories

EPA is revising the list of consumer and commercial use categories by combining c ategories

lead ing to common exposure scenarios and adding categories not adequately de scribed in the

current set of c od es. The resultant revised list includes 3 3 product categories , including “ O the r. ”

S everal of the existing consumer and commercial use categories have been renamed to better describe the products that should be reported unde r that category . EPA anticipates the effort

submitters will make to famili arize themselves with the new categories will increase the burden for completing the consumer and commercial product categorie s by 0.84 hours. This is the

burden for the technical em ployee to identify the consumer and commercial uses of a product (see Table 4

- 2 ). This burden will occur only during the first reporting cycle

.
EPA is also requiring that if the product category “Other” is reported, a descriptor f or the

consumer and commercial use of the chemical substance also be reported. Using its best professional judgment, EPA estimates it will take three minutes of clerical burden and six

minutes of technical burden to write in the text description

. According to 2006 IUR data (EPA, 2008c), “Other” was listed as a consumer or commercial product category in 1,207 reports. Based on best professional judgment, EPA expects the new categories in this rule will reduce by half the number of submitters selecting “Other ” as a consumer and commercial product category. Therefore, EPA assumes this amendment will affect 604 reports.

Using the baseline unit burden estimate as shown in Table 4

- 2 and Table 4

- 8

, Tab le 4

- 36 shows the industry burden estimate as a result of this amendment. The Agency estimates the amendment will cause a total increase in industry burden of approximately 14,400 hours during

t he first reporting cycle. In future reporting cycles, submitters no longer will need to familiarize themselves with the new industrial function categories, so the industry burden is estimated at approximately 70 hours to write in text for “Other” responses

.4

- 39

Table 4

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

Burden for Rule
Familiarization
for Additional Categorie s (hours) Number of

Reports with

Industr ial
Function Categories Burden to

Write in
Text for
"Other" (hours) Number of

Reports with
"Other" as a
Function Category Total

Industry

Burden (hours)

First Cycle, Baseline 1.23 17,075 0.00 0 20,972 First Cycle, Post

Amendment 2.07 17,075 0.15 604 35,35 9

Change from the Baseline, First Cycle 0.84 0 0.15 604 14,387

Future C ycle
, Baseline 0.98 17,075 0.00 0 16,778

Future C ycle, Post

Amendment 0.98 17,075 0.12 604 16,850

Ch ange from the Baseline,
Future C ycles 0.00 0 0.12 604 72

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and Ta ble

4

- 9

. Table 4

- 37 shows the industry cost estimate as a result of this amendment. EPA estimates the industry cost will increase by approximately $845,600 in the first reporting cycle, and $3,500 during all future reporting cycl es.

Table 4

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

Cost for Rule
Familiarization
for Additional Categorie s (2008 $ ) Number of

Reports with
Function
C ategories Cost to

Write in
Text for
"Other" (2008 $ ) Number of

Reports with
"Other" as a
Function Category Total

Industry
Cost (2008 $ )

First Cycle, Baseline $70.64 17,075 $0.00 0 $1,206,177
First Cycle, Post

Amendment $119.90 17,075 $7.31 604 $2,051,756

Change from the Baseline, First Cycle $49.26 0 $7.31 604 $845,579

Future C ycle
, Baseline $56.51 17,075 $0.00 0 $964,942

Future C ycle, Post

Amendment $56.51 17,075 $5.85 604 $968,470

Ch ange from the Baseline,
Future C ycles $0.00 0 $5.85 604 $3,528

Not e: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Limitation s of Analysis

. EPA estimates submitters will need 0.84 hours of technical labor to
become familiar with the new codes; this may be an over

- or underestimate. EPA is assuming the number of submitters selecting “Other” as a consumer and commercial use code will be reduced by half; this may be an over

- or underestimate. In addition, EPA assumes there is no burden for rule familiarization with the new product categories during the future reporting cycles. This may not be the case if sites have different employees complete Form U from reporting year to reporting year, or for sites submitting a Form U for the first ti me.4

- 40

4.4.21 

### Designation of Consumer or Commercial Use

EPA is requiring submitters to indicate whether the downstream use of their chemical

substance is a consumer or a commercial use , or both

. The Agency’s experience using the 2006

IUR data identified a need to di stinguish between potentially exposed consumer s versus commercial populations

. The i ndication of consumer or commercial use will allow EPA to complete a better characterization of the potentially exposed populations.

EPA anticipates the submitter will indi cate 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. T he burden to fill in a checkbox for the correct use will be negligible. Therefore, EPA assumes this amendment does not cause any additional burden beyond that

estimated in S ection 4.4.20

.

4.4.22 

### Number of Commercial Workers Reasonably Likely To Be Exposed

EPA is requiring submitters to report the total number of commercial workers, including those at sites not under the submitter’s control, reasonably likely to be exposed while using the reportable chemical substance, with respect to each commercial use . EPA will provide a set of ranges of numbers of wor kers for the submitter to choose from. The Agency expects this reporting burden to be similar to the burden for providing the number of workers potentially exposed when using the chemical substance with respect to its industrial use, which is already requi red, because of the similarity of the required data. This burden is approximately 21.36 hours (see Table 4

- 2 ) or $1,236 ( s ee Table 4

- 5 ) per report. EPA assumes the number of submitters will not change fro m the baseline under this amendment.

Using the baseline unit burden estimate as shown in Table 4

- 2 and Table 4

- 8

, Table 4

- 38
shows the industry burden estimate as a result of this amendment. The Agency estimates the amendment will cause a total increase in industry burden of approximately 364,700 hours in the first reporting cycle and 291,800 during all future reporting cycles.

Tabl e 4

- 38 : Change in Industry Burden as a Result of Requiring the Number of
Commercial W orkers Reasonably Likely To Be E xposed

Burden to Provide the
Number of Commercial Workers (hours) Number of Reports Burde n

(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 C ycle
, Baseline 0 17,075 0
Future Cycle, Post

- Amendment 17.09 17,075 291,784
Change from the Bas eline, Future Cycles 17.09 0 291,784

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and Table

4

- 9

. Table 4

- 39 shows the industry cost estimate as a result of this amendment. EPA estimates the industry cost will increase by $21.10 million for the 201 2 reporting cycle and $16.88 million during all future reporting cycles.4

- 41

Table 4

- 39 : Change in Industry Cost as a Result of Requiring the Number of Commercial
W orkers Reasonably Likely To Be E xposed

Cost to P rovide the

N umber of Commercial

Workers (2008$) Number of Reports Cost

( millions 2008$ ) First Cycle, Baseline $0 17,075 $0
First Cycle, Post

- Amendment $1,23 6 17,075 $21.10
Change from the Baseline, First Cycle $1,23 6 0 $21.10

Future C ycle
, Bas eline $0 17,075 $0

Future C ycle, Post

- Amendment $98 9 17,075 $16.88

Ch ange from the Baseline, Future C ycles $98 9 0 $16.88

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Limitation s of Analysis

. EPA is assuming the burden to report the number of commercial workers reasonably likely to be exposed is equivalent to reporting the number of industrial workers likely to be exposed. However, this is likely an underestim ate of the burden for several reasons. There may be more commercial uses for a product, and more workers exposed than the submitter is aware of. The commercial uses may be difficult for manufacturers (including importers) to identify (see “NRO” discussion responses in Section 3.9 ); therefore, the number of workers exposed may be even more difficult to identify.

4.4.23 

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

EPA is eliminating the “ n ot r eadably o btain able” (NRO) standard and replac ing it with the more stringent “ k nown to or r easonably a scertainable by ” standard. EPA assumes this

amendment will increase the reporting burden. However, all burden estimates in this economic analysis are based on an industr y survey conducted for the 2002 IUR EA (EPA, 2002a)

. At the time of the survey, EPA required the higher reporting standard of “ r easonably a scertainable”

information. T he 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 C laims

EPA is proposing that when a submitter asserts a claim of confidentiality for the chemical identity of a substance listed on the public portion of the Master Inventory File, th e 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 f or Processing and Use Information CBI Claims

EPA is requiring an upfront substantiation when a submitter claims processing and use

information as C onfidential B usiness I nformation (CBI).Upfront substantiation involves providing a written response to a set of questions provided in the rule

, for each individual item to
be claimed as CBI

. In 2002, when EPA first required upfront substantiation for claiming the plant site ID as CBI, the Agency saw a 64 percent reduction in the number of CBI claims. The Agency e xpects the4

- 42



### number of processing and use CBI claims to decrease by the same amount as a result of this amendment. According to 2006 IUR data (EPA, 2008c), a total of 8,133 reports had claimed processing and use information was CBI, with an average of three processing and use information CBI claims per report. EPA estimates the number of reports with processing and use CBI claims will be reduced to 2,928 as a result of the amendment.

For the purposes of this analysis, EPA assumes the per

- item burden to compl ete this substantiation will be similar to the burden estimated to complete the substantiation questions when a submitter makes a plant site identity CBI claim and must answer the two questions in §710.58(c)(1). As shown in Table 4

- 2 and Table 4

- 4 , this is a burden of 1.46 hours and cost of $87.34 per CBI claim. Assuming an average of three processing and use CBI claims per report,
EPA estimates submitters will incur 4.38 ad ditional hours of burden per report as a result of the

amendment.

Table 4

- 40 shows the industry burden estimate as a result of this amendment. The Agency
estimates the amendment will cause a total increase in indus try burden of approximately 12,8 00
hours in the first reporting cycle and 10, 3 00 hours in all future reporting cycle s.

Table 4

- 40 : Change in Industry Burden as a Result of Requiring Upfront Substantiation
for Claiming Processing and Use Information as CBI

Burden for Upfront CBI
Substa ntia tion 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 C ycle
, Baseline 0 0 0

Future C ycle, Post

- Amendment 3.50 2,928 10,259

Ch ange from the Baseline, Future C ycles 3.50 2,928 10,259

Note: Values in Chang e from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### The cost of the amendment was calculated using the unit costs shown in Table 4

- 5 and Table

4

- 9

. Table 4

- 41 shows the industry cost estimate as a result of this amendment

. EPA estimates

t he industry cost will increase by approximately $772,700 in the first reporting cycle and $618,100 in future re porting cycles

.4

- 43

Table 4

- 41 : Change in Industry Cost as a Result of Requiring Upfront Substa ntia tion for Claiming Processing and Use Information as CBI

Cost for Upfront CBI
Substa ntia tion for CBI
Claims in Par t 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 C ycle
, Baseline $0 0 $0

Future C ycle, Post

- Amendment $211.12 2,928 $618,143

Ch ange from the Baseline, Future C ycles $211.12 2,928 $618,143

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from t he post

amendment v alue.



### Limitations of Analysis

. EPA assumes the percent reduction in CBI claims for processing and use information will be the same as the percent reduction when upfront substantiation was required for plant site identification. However , to the extent the actual burden differs, this analysis may over

- or underestimate the burden and cost of this amendment.

4.4.26 

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

Under the final rule

, IUR submitters will be unable to enter a claim of confidentiality if “not known or reasonably ascertainable” is selected for the industrial processing and use or consumer

and commercial use information. EPA assumes this amendment will not impact industry burden because submitters are not being required to do anything additional (e.g., gather information or provide a written response); they are simply prohibited from claim ing “not known or reasonably
ascertainable” data items as CBI.

4.4.27 

### Require Electronic Sub missions over the Internet

EPA is requiring electronic submissions of all Form Us over the Internet using e

- IURweb and EPA’s Central Data Exchange (CDX)

. The Agency’s cost estimates were calculated following the methodology outlined in the economic analysi s for the e

- PMN rule (EPA, 2009b)

, whe re EPA is requiring TSCA section 5 pre

- manufacturing notices be submitted electronically.

The costs and savings of this IUR amendment will be realized on a per

- site basis, as well as per
report.

F ollowing the methodolo gy 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 F orm U will be eliminated with this
amendment. Specifically, the Agency assumes the burden savings associated with el ectronic reporting and

submission via CDX are due to the reduction or elimination of clerical/administrative time. The baseline time estimate for clerical burden (approximately six percent of the burden) was assumed to approximate

the amount of clerical/ad ministrative time involved in filling out and submitting the paper IUR Form U. This estimate of potential form completion and submission savings is in line with the estimated savings in switching from paper to electronic submissions as estimated in the Cro ss

- Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis of 10 percent (EPA, 2004).4

- 44



### The technical burden to gather and organize data, and managerial burden for review and approval, will not change from the baseline. Overall, this amendment will d ecrease the burden to prepare Parts I, II, and III.

In addition, estimates developed in the CROMERR report were used to develop estimates of burdens to register with EPA’s CDX, and to complete electronic signature agreements. These burdens are incurred

on a per

- site basis. EPA estimated these costs in the economic analysis for the e

- PMN rule, which used CROMERR to develop estimates of burden from CDX registration and electronic signature agreements,

to be a total of 0.93 hours of managerial burden and 1.73 hours of technical time per site (EPA, 2009b; EPA, 2004).Based on the e

- PMN EA, recordkeeping costs will be halved because of the efficiencies in creating and storing documents electronically (EPA, 2009b), reducing overall burden per report by three

hours

. 

### Table 4

- 42 shows the industry burden estimate as a result of this amendment. The Agency estimates the amendment will cause a total decrease in industry burden of approximately 245,600 hours in the first reportin g cycle and 210,200 hours in all future reporting cycles.

Table 4

- 42 : Change in Industry Burden as a Result of Requiring Electronic Submission

Burden for Report, Compliance Determination,

Rule
Familiarizatio n, 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,

Post

Amendment 35.17 4,085 15.27 25,896 61.98 17,075 1,597,358

Change from the Baseline, First Cycle 1.91 0

- 4.55 0

- 7.94 0

- 245,576

Future Cycle
, Basel ine 9.08 4,085 17.06 25,896 55.93 17,075 1,433,833

Future Cycle,

Post

Amendment 11.05 4,085 12.82 25,896 49.58 17,075 1,223,658

Change from the Baseline, Future Cycles 1.98 0

- 4.24 0

- 6.35 0

- 210,175

Note: Values in Change from the Baseline rows are cal culated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### EPA calculated t he cost savings of the amendment using the unit costs shown in Table 4

- 5

and Table 4

- 9

. Table 4

- 43 shows the industry cost estimate as a result of this amendment

. EPA
estimates t he industry cost will decrease by $9.02 million during the first reporting cycle and by $8.01 million during all future reporting cycles.4

- 45

Table 4

- 43 : Change in Industry Cost as a Result of Requiring Electronic Submission

Cost for Report, Compliance Determination,

Rule Familiarization,
Submission and Part I (per site) (2008$) Number

of Sites Cost for

Recordkeeping

and Part II (2008$ per report) Number

of Reports Cost per

Part III (2008$) Number

of Reports
with Part

III Industry

Cost (millions 2008$)

(a) (b) (c) (d) (e) (f) (g) = (a b )+ (c d )+( e*f) First Cycle,
Baseline $2 ,058 4,085 $1,143 25,896 $4,059 17,075 $107.32

First Cycle, Post

Amendment $2,190 4,085 $923 25,896 $3,833 17,075 $98.30

Change from the Baseline, First Cycle $132 0

- $220 0

- $226 0

- $9.02

Future Cycle
, Baseline $561 4,085 $982 25,896 $3,247 17,075 $83.17

Future Cycle,

Post

- Amendment $695 4,085 $771 25,896 $3,067 17,075 $75.16

Change from the Baseline, Future Cycles $134 0

- $211 0

- $181 0

- $8.01

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baselin e v alue from the post

amendment v alue.



### Limitations of Analysis

. EPA assumes the clerical burden will decrease by percentages

similar to the decrease estimated for the e

- PMN rule. To the extent any differences exist (given
the differences in the two rules ), this analysis may over

- or underestimate the burden and cost of

this amendment.

4.4.28 

### Updated e - IUR Reporting Software

EPA developed the e

- IUR reporting software for use in preparing and submitting reports electronically during the 2006 IUR reporting cycle

. F or the 201 2 submission period, EPA will provide a free, web

- based application in place of the 2006 downloadable software. The updated

e

- IURweb reporting tool will feature several improved capabilities over the previous e

- IUR reporting tool

. This amendment is not expected to change industry burden, other than as
described in Section 4.4.27

.

4.4.29 

### Electronic S ignature 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 alon g with a signature and date, having the form notarized, and mail ing it back to EPA. The burden of the electronic signature agreement,

on e hour per submission, was included in the burden reduction estimate used in the economic analysis for the e

- PMN rule (EPA, 2009b). The burden and cost reduction estimates for electronic submission, as shown in Section 4.4.27

, include the cost of the electronic signature process because they are based on the estimates used in the economic analysis for the e

- PMN
rule.4

- 46

4.4.30 

### M odifications Specifically Affecting Importers

For purposes of IUR, importers currently are allowed to report th e IUR information jointly with the foreign manufacturer of the chemical substance

. Importers , or primary submitters, may not know the specific chemical identity of a substance because the foreign supplier, or secondary submitter, chooses to keep it confide ntial. In such a situation, the importer is still responsible for ensuring the IUR information is submitted to EPA and may do so by submitting a joint report. Overall, the amount of information submitted via Form U for primary and secondary submitters will not change as a result of this amendment, although EPA plans to revise the Form U for joint submitters. Under the amendment, the foreign manufacturer must now register with CDX and submit its report electronically. P reviously, joint
submissions could not be made electronically

.
As described in Section 4.4.27 , submission c osts to register with EPA’s CDX , and complete the

E lectronic S ignature Agreement forms are incurred on a per

- site basis . EPA estimated these costs in the

econo mic analysis for the e

- PMN rule to be a total of 0.93 hours of managerial burden and 1.73 hours of

technical time per site (EPA, 2009b). Based on previous IUR submissions, EPA estimates between 10 and 20 sites were importers, and therefore, the same approx imate number were secondary submitters (EPA, 2009h). For this analysis, EPA uses the conservative upper

- bound of 20 secondary submitter sites.



### Table 4

- 44 shows the industry burden estimate as a result of this amendment. The Agency estimates the amendment will cause an increase in industry burden of approximately 53.3 hours in the first reporting cycle. Future reporting cycles are assumed to the similar to the first reporting cycle.

Table 4

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

Burde n for CDX Registration (per site) (hours) Number of Sites Industry Burden (hours)

First Cycle, Baseline 0.00 0 0.00 First Cycle, Post

Amendment 2.67 20 53.3

Change from the Baseline, First Cycle 2.67 20 53.3

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.



### Table 4

- 45 shows the i ndustry cost estimate as a result of this amendment

. EPA estimates t he industry cost will increase by approximately $3,300 during the first and future reporting cycles.

Table 4

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

Cost for CDX Registration (per site) (2008$) Number of Sites Industry Cost (2008$)

First Cycle, Baseline $0 0 $0
First Cycle, Post

Amendment $ 167 20 $ 3.347

Change from the Baseline, First C ycle $ 167 20 $ 3.347

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.4

- 47

4.4.31 

### Modify Reporting Frequency

The Agency is modifying the IUR reporting cycle from a five

- year r eporting frequency to a

four

- year reporting frequency. While the industry burden for the principal reporting year will not change, the longer

- term industry burden will increase because reporting will become more frequent; therefore, EPA estimated the annua l reporting burden to industry over a 26

- year period.

A 26

- year period allows EPA to analyze a set of complete reporting cycles under both the baseline and post

- amendment scenarios. Under the baseline, a five

- year reporting cycle is used,

and the cost of f

ive complete cycles is presented. Under the post

- amendment scenario, reporting occurs every four years, and the cost of six complete cycles is presented. (Note the 201 2 reporting cycle covers a six

- year period, under either scenario). For more information on the distribution of burden over a reporting cycle, see the discussion in Section 4.6

.
The baseline industry burden in the 201 2 reporting cycle was calculated in Table 4

- 10 as 1.84

mi llion hours. As shown in Table 4

- 11 , t he industry rep orting burden in future reporting cycles is

reduced to 1.43 million hours because EPA assumes sites have submitted Form U previously

incur a lower burden for processing and subm itting the For m, 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 cyc les

– that is, the burden and cost to industry for reporting cycle s after the 201 2 cycle, in the absence of the amendment s

. EPA assumes costs for report preparation and submission in future reporting cycles will be lower than costs in the first reporting c ycle because of efficiencies achieved through the establishment of compliance processes, the availability of data from previous reporting cycles, and familiarity with reporting requirements (EPA, 2002a). The weighting factors found in Table 4

- 7 were applied to the baseline burden estimates found in Table 4

- 2 and Table 4

- 5 , to estimate i n all

future reporting cycle s, the baseline burden to industry is approximately 1.43 million hou rs

.
As shown in Table 4

- 46 , EPA estimates the industry burden will increase by 1.43 million

hours over a 26

- year period as a result of this amendment.4

- 48

Table 4

- 46 : Ch ange in Industry Burden as a Result of Modifying the Reporting Frequency,
over a 26

- Year Period

Reporting Cycle Year(s) Baseline Burden Post

- Amendment Burden Change in Burden
(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2012 1. 84 1.84 0.00

2 2013 to 2017 1.43

-- 0.00

2013 to 2016

-- 1.43

3 2018 to 2022 1.43

-- 0.00

2017 to 2020

-- 1.43

4 2023 to 2027 1.43

-- 0.00

2021 to 2024

-- 1.43

5 2028 to 2032 1.43

-- 0.00

2025 to 2028

-- 1.43

6 2029 to 2032

-- 1.43 1.43

T otal 7.58 9.01 1.43 Annual Average 0.29 0. 34 0.05

Note: The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are four

- year cycles

.



### As shown in Table 4

- 10 , the total industry c ost in the baseline first reporting cycle is approximately $106.97 million, and as shown in Table 4

- 11 , the baseline cost is $82.82 million in all future reporting cycles. Table 4

- 47 shows the annual indu stry cost estimate as a result of this amendment. In total, EPA estimates the amendment will increase the cost to industry by $82.82 million over a 2 6

- year period.

In the proposal, EPA request ed comment on increasing the frequency of reporting to annual

re porting 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 pres ented in Appendix E.4

- 49

Table 4

- 47 : Change in Industry Cost as a Result of Modifyin g the Reporting Frequency,
over a 2 6

- Year Period

Reporting Cycle Year(s) Baseline Cost Post

- Amendment
Cost Change in Cost

(millions of 2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2012 $106.97 $106.97 $0.00

2 2013 to 2017 $82.82

-- $0.00

2013 to 2016

-- $82.82

3 2018 to 2022 $82.82

-- $0.00

2017 to 2020

-- $82.82

4 2023 to 2027 $82.82

-- $0.00

2021 to 2024

-- $82.82

5 2028 to 2032 $82.82

-- $0.00

2025 to 2028

-- $82.82

6 2029 to 2032

-- $82.82 $82.82

Total $438.24 $521.05 $ 82.82 Annual Average $16.87 $20. 06 $3.19

Note: The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are four

- year cycles

.



### Limitations of Analysis

. EPA assumes future reporting cycle costs will decrease due to efficiency gains and a reduction in the time required for submitters to become familiar with the rule and its amendments. To the extent these reductions in burden do not occur, this analysis may

underestimate the burden and cost of the rule amendme nt.

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 d o n ot take into acc ount the interaction of amendments (i.e., how the impact of one amendment will affect the burden of another amendment). For this reason, when calculating the total industry cost of all amendments described in EPA’s rule, the Agency cannot simply add the in dividual changes in burden for each amendment, but must

consider the effect of one amendment on another. As described below, amendments fall into three categories: those affecting the number of reports submitted during a reporting cycle, those affecting th e reporting burden, and those affecting the reporting frequency. The impact each amendment has on the others depends on its category.

4.5.1 

### Modification s that Affect the Number of Reports Submitted

Several of the IUR rule amendments change the number of full and /or partial reports EPA expects to be submitted, based on the specific chemical substance s they affect. The amendment changing the method for determining whether a manufacturer is subject to the IUR reporting requirements is expected to increase the overal l number of reports and submitters by five percent; therefore, the combined impact will also increase each of the impacts of the other amendments in this category by five percent . Furthermore, the amendment to replace the 300,000

lb threshold for downstrea m processing and use reporting in future reporting cycles will make Part IIIs necessary for all the additional Part IIs required by other amendments. The following4

- 50



### steps describe how the combined effect of the amendments affecting the number of reports was

calculated.

Step 1: Sum the affected amendments

. Table 4

- 48 and Table 4

- 49 present the number of full and partial reports EPA expects to be submitted as a result of the IUR amendments, in the

201 2 report ing cycle and future reporting cycles, respectively. The amendments changing the number of full and/or partial reports expected to be submitted are as follows:

Reducing the 300,000 lb threshold for downstream processing and use reporting: When

taken alone

, EPA expects this amendment to increase the number of Part IIIs submitted by 3, 627 reports in the first reporting cycle and 8,203 reports in future reporting cycles (see
Section 4.4.4 ). Reducing the 25,000 lb th reshold for specific regulated chemical substance s: This amendment affects future reporting cycles only. Th e amendment , by itself, will increase in the number of Part IIs submitted by 3,6 09 in future reporting cycles (see Section 4.4.5 ).

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

Full exemption for manufactured water: EPA expects t his amendment , by itself, will

decrease the number of Part IIIs submitted by 43 reports (see Section 4.4.7 ).

Step 2 : Consider the effects of the change in method for determining r ule applicability (future cycles only)

. In future reporting cycles, t he 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 per cent. Therefore, for future reporting cycles, EPA multiplied the Step 1 results by 1.05, to account for this amendment. Then the Agency added in the number of additional sites and reports estimated for this amendment individually. (In Table

4

- 48

, for the first cycle calculations, this step is merely a placeholder and does not cause any change.)

Method for determining whether a manufacturer is subject to the IUR reporting requirements. When taken by itself, this amendment will g ener ate 204 additional submitters in future reporting cycles ( five percent of the baseline number of 4,08 5), 1,295 additional Part IIs (five percent of the baseline number of 25,896 ), and 854 additional Part IIIs (five
percent of the baseline number of 17,075 ) (see Section 4.4.3 )

. Step 3: Consider the effect of replacing the 300,000 lb. threshold for processing and use reporting (and avoid double

- counting) (future cycles only)

. In future cycles, under this amendment, all submitters of non

- exempt chemical substance s will be required to submit a Part III. Therefore, the number of Part IIIs must be increased by the increased number of Part II s , to
account for the effect of replacing the 300,000 lb threshold for processing and use report ing . For example, under the future reporting cycle calculations, EPA started with the Step 2 total for Part III reports (9,484), and added the Step 2 total for Part II reports ( 5, 039 ), minus the number of new Part III reports as a result of making ECAs ine ligible for exemptions (16) and the number of new Part II reports as a result of changing the method of determining whether a manufacturer is subject to reporting requirements (1,295). As shown in Table 4

- 49 , t he number of r eports with Part III will increase by 13, 212 in future reporting cycles

. This step is not needed for the 2012 reporting cycle, because during this first reporting cycle the threshold for processing and use information is not being eliminated

, but being lowered t o 100,000 lb ; additional Part IIs generated by the new modifications will be for chemical4

- 51



### substance s with production volumes less than 100,000 lb. In addition, no new Part IIs will be generated by the changing of the method of determining whether a manufac turer is subject to reporting requirements , because this modification will not go into effect until future reporting cycles.

Step 4: Calculate the number of reports when all amendments are considered together

. The total number of a dditional reports from S tep 3 is added to the number of reports in the

baseline to calculate the total number of r eports when all the final amend ments are considered together

. In future reporting cycles, t here will be a total of 4,289 Part Is, 3 0

, 935 Part IIs and 30, 287 Part IIIs

. The difference between the total number of Part IIs and Part IIIs, 64 8 reports, is equal to the number of partial ly exempt reports with the five percent increase taken into account (618 x 1.05 = 64 8 ).

Table 4

- 48 : Change in the Number of Sites and Reports Submitted for All Amendments
Combined (First Reporting Cycle)

Modification Number of Sites Number of Reports Number of Reports
with Part III

Baseline 4,085 25,896 17,075

Step 1: Sum affected amendments

Re place the 300,000 lb. Threshold for Downstream Processing and Use Reporting to 100,00lbs (see Section 4.4.6 ) -- -- 3,627

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

Full Exemption for Manufactured Water (see

Section 4.4.7 ). -- (43)

--

STEP 1 TOTAL

-- - 43 3,643

Step 2: Account for change in the method for determining w hether you are subject to the IUR reporting requirements

N/A

-- -- -- Step 3: Consider the effect of eliminating the 300,000 lb threshold for processing and use reporting (and avoid
double

- counting) (Future Cycles Only)

N/A

-- -- -- Step 4:Calculate th e total number of reports by adding the Step 1 Total to the Baseline

STEP 4 TOTAL (Baseline + Step 1 Total) 4, 085 25,853 20,7184

- 52

Table 4

- 49 : Change in the Number of Sites and Reports Submitted for All Amend ments Combined (Future Cycles)

Modification Number of Sites Number of Reports Number of Reports
with Part III

Baseline 4,085 25,896 17,075

Step 1:Sum affected amendments

Replace 300,000 lb Threshold for Downstream Processing and Use Reporting (see Secti on 4.4.6 ) -- -- 8,203

Reduce the 25,000 lb Threshold for Specific Regulated Chemical Substances to 2,500 lb (see

Section 4.4.5 ) -- 3,609

--

Make Chemical Substanc es 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

-- 3,56 6 8,219

Step 2:Account for change in the method for determining whether you are subject to the IUR reporting requirements

Step 1 Total Multiplied by 1.05 3,745 8,630
Method for Determining Whether you are Subject to the IUR Reporting Requirements (see Section

4.4.3 ) 204 1,295 854

STEP 2 TOTAL 204 5,039 9,484

Step 3: Consider the effect of replacing the 300,000 lb threshold for processing and use reporting (and avoid
double

- counting) (Future Cycles Only)

St ep 2 total for Part II reports minus number of new Part III reports as a result of making ECAs ineligible for exemptions and the number of new Part II reports as a result of changing the method of determining whether subject to reporting requirements -- -- 3,736

STEP 3 TOTAL (Step 3 + Step 2 Total ) 204 5,039 13,212

Step 4:Calculate the total number of reports by adding the Step 3 Total to the Baseline

STEP 4 TOTAL (Baseline + Step 3 Total) 4,289 30,935 30,287

4.5.2 

### Modification s That Affect the Reporting B urden

Several amendments affect the burden to complete a report. As discussed in Section 4.4.27 , EPA assumes the amendment to require electronic submission over the Internet will eliminate clerical burden used i n the preparation of Parts I, II and III of F orm U , and the burden for recordkeeping across all wage rate categories will be reduced by half. Table 4

- 50 contains the total burden by labor category for the 2011

repo rting cycle when all the amendments are considered together. Table 4

- 51 contains the future reporting cycle burden

, by labor category

. The steps below describe how the combined effect of the amendment s affecting th e reporting burden was calculated.



### Step 1: Sum the affected amendments. The amendment s affect ing the reporting burden are as
follows:4

- 53



### Report Chemical Identity : This amendment is estimated to require an additional hour of technical time in the first reporti ng cycle for approximately 343 reports (or 1 percent of all reports). Therefore

, this amendment will add approximately 0.013 hours per report in the first reporting cycle only (see Section 4.4.11 ). Report production volume for each of the years since last report: This amendment is estimated to require 1.51 hours of additional burden in the first reporting cycle (see Section

4.4.12 ). In future reporting cycles

, an additional 3.63 hours is needed to supply three years of additional production volumes per reporting cycle (1.51 x 3). Report p roduction v olume u sed on

- s ite: This amendment is estimated to require 1.51 additional hours of burden to complete Part II (see Section 4.4.13 ). Table 4

- 50 presents the

per

- report total burden of 0. 293 hours to reflect only 24 percent of r eports are expected to report volume used on site.
Indicate whether the chemical substance is physically at repo rting site: This amendment is estimated to require 0.17 additional hours of burden to complete Part II (see Section

4.4.14 ). Report v olume e xported: This amendment is estimated to require 1.51 additional hours of burden to comp lete Part II (see Section 4.4.15 ). Identify whether a chemical substance is to be recycled , remanufactured, reprocessed, reused, or reworked : This amendment is estimated to require 0.17 additional hours of burden to complete Pa rt 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 categorie s), and an add itional 0.15 hours (for submitters selecting “Other” ) (see Section

4.4.18 ). Table 4

- 50 presents the per

- report total burden of 0.2 6 hours to reflect that only 3.5
percent of r eports 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 t he new categorie s), and an additional 0.15 hours (for submitters selecting
“Other” ) (see Section 4.4.20 ). Table 4

- 50 presents the per

- report total burden of 0.84 hour s, which reflects only 3.5 percent of reports are expected to select “Other” and thus incur this

additional burden

. Number of commercial workers reasonably likely to be exposed: This amendment is estimated to require 21.36 additional hours to complete Part III (see Section 4.4.22 ). Upfront substantiation for processing and use information Confidential Business
Information claims: This amendment is estimated to require 4.38 additional hours of burden to complete Part III for all submitters claiming processing and use information as CBI (see
Section 4.4.25 ). Table 4

- 50 presents the per

- report total burden of 0. 75 hours

, which reflects that only 17 percent of reports are expected to incur addition al costs because of the

amendment

. Modifications s pecifically a ffecting i mporters: This amendment requires that those foreign
manufacturers who are filing joint submissions with an importer now register with CDX and submit its report electronically. EPA ex pects this will add an additional 2.63 hours to complete Part I of Form U for approximately 20 sites (0.5 percent of all sites). Therefore

, this amendment will add an additional burden of approximately 0.013 hours per site in the first reporting cycle only ( see Section 4.4.30 )

.4

- 54



### Step 2: Consider the effect of the amendment to require electronic submission over the

I nternet

. This amendment will eliminate the need for clerical tasks such as typing information

into Form U , photocopying, and mailing . In Step 2 , EPA subtracts the clerical burden for all amendments, eliminating a burden of 0.76 hours per Part I, 2.82 hours per Part II, and 10.11 hours per Part III

. The burden reductions in recordkeeping will be reduced by 50 percent for all wage categories and will not change from what is presented in Section 4.4.27

.

Step 3: Calculate the total burden when all amendments are combined. To calculate the total industry b urden estimates , EPA add ed the total from Step 2 to the baseline

. In total

, the clerical burden will be 0.75 hours per full report with one chemical substance , the technical burden will

be 102.83 hour s per full report with one chemical substance , and the managerial burden will be 37.74 hours per full report with on e chemical substance

.4

- 55

Table 4

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

Modification Compliance Determination, Rul e Familiarization, and
Submission Burden Burden to Complete

Part I Recordkeeping Burden Burden to Complete

Part II Burden to Complete

Part III

C T M C T M C T M C T M C T M

Baseline

-- 21.50 9.00 0.76 0.95 1.05 1.50 3.00 1.50 1.55 8.78 3.49 7.94 45.31 1 6.66

Step 1: Sum the Affected Amendments

Report c hemical i dentity as CAS number or

EPA Ascension Number -- -- -- -- -- -- -- -- -- -- 0.013

-- -- -- --

Report production volume for each of the years since last report -- -- -- -- -- -- -- -- -- 0 .234 1. 026 0. 252

-- -- --

Report production volume u sed o n

- s ite

-- -- -- -- -- -- -- -- -- 0.045 0.199 0.049

-- -- --

Indicate whether chemical substance is physically at reporting site -- -- -- -- -- -- -- -- -- 0.026 0.114 0.028

-- -- --

Report the volume ex ported

-- -- -- -- -- -- -- -- -- 0.234 1.026 0.252

-- -- -- Identify whether a chemical substance is to be recycled, remanufactured, reprocessed, reused, or reworked -- -- -- -- -- -- -- -- -- 0.026 0.114 0.028

-- -- --

Revise industrial function catego ries

-- -- -- -- -- -- -- -- -- -- -- -- 0.00 2 0.254 0.000

Revise commercial and consumer product categories -- -- -- -- -- -- -- -- -- -- -- -- 0.00 2 0.841 0.000

Number of commercial workers reasonably likely to be exposed -- -- -- -- -- -- -- -- -- -- -- -- 2.104 15.428 3.829

Upfront substantiation for processing and
use information CBI claims -- -- -- -- -- -- -- -- -- -- -- -- 0.062 0.427 0.262

CDX registration for j oint s ubmissions with

f oreign m anufactures -- -- -- -- 0.005 0.008

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

Step 1 Total

-- -- -- -- 0.005 0.008

-- -- -- 0.565 2.492 0.609 2.1 69 16.949 4.092

Step 2:Add the Effect of the Electronic Reporting Amendments

Electronic s ubmission

-- 1.73 0.93

- 0.76

-- -- - 0.75

- 1.50

- 0.75

- 2.12

-- -- - 10.11

-- -- Step 2 Total (Electronic Submission + Step 1 Total) -- 1.73 0.93

- 0.76 0.005 0.008

- 0.75

- 1.50

- 0.75

- 1.55 2.49 0.61

- 7.94 16.95 4.09

Step 3 Total Burden

Step 2 Total + Baseline

-- 23.23 9.93

-- 0.95 1.06 0.75 1.50 0.75

-- 11.27 4.10

-- 62.26 20.76

Note: C = C lerical; T = Technical; and M = Managerial wage categories

Table 4

- 51 : Change in the Future Reporting Cycle Burden for All Amendments Combined, by Labor Category4

- 56 Modification Compliance Determination, Rule Familiarization, and
Submission Burden Burden to Complete

Part I Recordkeeping

Burden Burden to Complete

Part II Burden to Complete Part

III

C T M C T M C T M C T M C T M

Baseline

-- 4.500 2.000 0.691 0.870 1.018 1.500 3.000 1.500 1.240 7.024 2.792 6.3 51 36.251 13.33

Step 1: Sum the Affected Amendments

Report production volume for each of the years since last report -- -- -- -- -- -- -- -- -- 0.562 2.462 0.605

-- -- --

Report production volume used on

- site

-- -- -- -- -- -- -- -- -- 0.036 0.159 0.039

-- -- --
Indicate whether chemical substance is physically at reporting site -- -- -- -- -- -- -- -- -- 0.021 0.091 0.022

-- -- --

Report the volume exported

-- -- -- -- -- -- -- -- -- 0.187 0.821 0.202

-- -- -- Identify whether a chemical substance is to be recycled, remanufactured, reprocessed, reused, or
reworked -- -- -- -- -- -- -- -- -- 0.021 0.091 0.022

-- -- --

Revise industrial function categories

-- -- -- -- -- -- -- -- -- -- -- -- 0.00 1 0.003 0.000

Revise commercial and consumer product

cat egories -- -- -- -- -- -- -- -- -- -- -- -- 0.00 1 0.003 0.000

Number of commercial workers reasonably likely to be exposed -- -- -- -- -- -- -- -- -- -- -- -- 1.683 12.342 3.063

Upfront substantiation for processing and use
information CBI claims -- -- - - -- -- -- -- -- -- -- -- -- 0.049 0.427 0.210

Step 1 Total

-- -- -- -- -- -- -- -- -- 0.827 3.625 0.890 1.73 5 12.775 3.273

Step 2:Add the Effect of the Electronic Reporting Amendments

Electronic Submission

-- 1.73 0.93

- 0.69

-- -- - 0.75

- 1.50

- 0.75

- 2. 07

-- -- - 8.09

-- -- Step 2 Total (Electronic Submission + Step 1 Total) -- 1.73 0.93

- 0.69

-- -- - 0.75

- 1.50

- 0.75

- 1.24 3.62 0.89

- 6.35 12.77 3.27

Step 3 Total Burden

Step 2 Total + Baseline

-- 6.23 2.93

-- 0.87 1.02 0.75 1.50 0.75

-- 10.65 3.68

-- 49 .03 16.60

Note: C = C lerical; T = Technical; and M = Managerial wage categories4

- 57

Table 4

- 52 contains the estimated change in the burden and the total burden per reporting cycle as a result of the all the IUR amendments during t he first reporting cycle. It also presents the burden in future reporting cycles. EPA estimates the total industry burden will increase by approximately 0.5 0 million
hours to 2.34 million hours in total for the 201 2 reporting cycle. In future reporting cyc les, EPA estimates industry burden will increase by 1.14 million hours to 2.57 million hours.

Table 4

- 52 : Total Industry Burden for All Amendments Combined

Burden for Compliance Determination,

Rule
Familiari zation,
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) I ndustry

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,

Post

Amendment 35.18 4,085 18.37 25,853 83.02 20,718 2.34

Change from the Baseline,
Firs t Cycle 1.92 0

- 1.45

- 43 13.10 3,643 0.50

Future

- Cycle,
Baseline 9.08 4,085 17.06 25,896 55.93 17,075 1.43

Future Cycle,

Post

Amendment 11.05 4,289 17.33 30,935 65.63 30,287 2.57

Change from the Baseline, Future Cycles 1.98 204 0.28 5,039 9.70 13,212 1. 14

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue

.

Table 4

- 53 shows the total industry cost. To calculate the total ind ustry cost, the burden estimates
located in Table 4

- 50 and Table 4

- 51 were m ultiplied by the wage rates found in Table 4

- 1 . The cos ts were then multiplied by the number of submissions located in Table 4

- 49 . EPA estimates the total industry cost will increase by approximately $ 36.76 million to $ 143.73 million in total for the 201 2 reporting cycle. In future rep orting cycles, EPA estimates the industry cost will increase by $ 75.1 2 million to $ 157.9 4 million.4

- 58

Table 4

- 53 : Total Industry Cost When All Amendments Are Combined

Cost for Compliance Determination,

Rule

Fam iliarization,
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 (w ith 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,

Post

Amendment $2,193 4,085 $1,112 25,853 $5,117 20,718 $143.73

Ch ange from the Baseline, First Cycle $135 0

- $16.99

- 43 $1,058 3,643 $36.76

Future

- Cycle,
Baseline $561 4,085 $968.39 25,896 $3,247 17,075 $82.82

Future Cycle,

Post

Amendment $695 4,289 $1,047 30,935 $4,047 30,287 $157.94

Change from

the Base line, Future Cycles $134 204 $78.18 5,039 $800 13,212 $75.12

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue

.

4.5.3 

### Amendment that Affect s the Reporting Frequency

Th is amendment to modify the reporting frequency from every five years to every four years
will not change the number of submission s o r the submission burden, but will increase t he cost to
submitters over multiple reporting cycles because submissions are mad e more frequently. The effect of this amendment, in combination with the other amendments, is shown in Section 4.5.4

.

4.5.4 

### Average Cost and Burden per Site

Under the baseline, 4,085 sites submit a total of 25,896 reports; 17,075 of these are full reports and the remainder is partial reports (See Table 4

- 6 ). Thus, an average site submits IUR data for 6.34 chemical
substance s (25,896 reports divided by 4,085 sites), and submits full reports for 4.18 of those c hemical
substance s (17,075 reports divided by 4,085 sites) (See Table 4

- 54 ). Table 4

- 52 contains the total number of reports submitted and sites when all the amendments are considered together. Under the first and future reporting cycles, an estimated 4

, 085 and 4,289 sites, respectively, submit a total of 25,853 and 30, 935 reports; 20, 718 and 30, 287 of which will be full reports. Therefore, in the post

- amendment scenario, an average site will submit 6.33 r eports comprised of 5.07 full reports and 1.26 partial reports in the first reporting cycle and 7.21 reports comprised of 7.06 full reports and 0.15 partial reports in future reporting cycles ( s ee Table 4

- 54 ). This is a decrease o f 0.90 partial reports per site in the first reporting cycle and 2.01 partial reports per site in future reporting cycles. The number of full reports per site will increase by

0. 89 reports in the first reporting cycle and 2.88 in future reporting cycles wh en compared to the baseline.4

- 59

Table 4

- 54 : Average N umber 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 Aver age

Number

Full Reports per
Site Average

Number of
Partial Reports per
Site
(a) (b) (c) = (b)/(a) (d) (e) = (d)/(a) (f) = (c)

- (e)

First Cycle, Baseline 4,085 25,896 6.34 17,075 4.18 2.16

Post

- Amendment 4,085 25,853 6.33 20,718 5.07 1.26

Change from t he Baseline 0

- 43

- 0. 01 3,643 0.89

- 0.90

Future Cycle, Baseline 4,085 25,896 6.34 17,075 4.18 2.16
Future Cycle, Post

Amendment 4,289 30,935 7.21 30,287 7.06 0.15

Change from the Baseline, Future Cycles 204 5,039 0.87 13,212 2.88

- 2.01

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

Note: Values in Change from the Baseline rows are calculated by subtracti ng the corresponding baseline v alue from the post

amendment v alue.

Table 4

- 55 contains the average total burden per site. Each site will submit only one Part I under both the baseline and post

- amendment scenarios. The average num bers of Part IIs and Part IIIs submitted per
site are taken from Table 4

- 54

. EPA calculated the baseline from the per

- report burden presented in Table

4

- 2

. In the first cycle baseline , the av erage site’ s burden is 451 ho urs during the first reporting cycle and 351 hours in future reporting cycles. The post

- amendment burden per report is found in Table 4

- 52 . The average burden per site is expected to be 572 hours in the first reporting cycle and 600 hours in future reporting cycles. This is an increase of 121 hours per site during the first reporting cycle and 249 hours per site in future reporting cycles compared to the baseline.

Table 4

- 55 : Average Total Burden per Site

Burden for Compliance Determination,

Rule Familiarization,
Submission and to Prepare Part I (hours per site) Average

Number of Part Is per
Site Burden for

Record Keeping and to Prepare Part II (hours

p er 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

Post

Amendment 35.18 1 18.37 6.33 83.02 5.07 572

Change from
the Baseline 1. 92 0

- 1.45

- 0. 01 13.10 0.89 121

Future Cycle,
Baseline 9.08 1 17.06 6.34 55.93 4.18 351

Future Cycle,

Post

Amendment 11.05 1 17.33 7.21 65.63 7.06 600

Cha nge from the Baseline, Future Cycles 1.98 0 0.28 0.87 9.70 2.88 249

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.4

- 60

The average baseline and post

- amendment scen ario cost s per site are found in Table 4

- 56

. Baseline

cost per report costs is taken from Table 4

- 5 and Table 4

- 8 and used in calculating the aver age baseline

cost per site . In the first reporting cycle, the average baseline cost per site is estimated to be $ 26,185. Future cycle average baseline cost is estimated to be $ 20,274 per site. Post

- amendment cost per report is

derived in Table 4

- 52 and Table 4

- 53

. The average post

- amendment cost per site is calculated to be approximately $ 35,200 in first reporting cycle, and $ 36,800 for all future reporting cycles. This is a n increase of approximately $ 9,000 per site during the first reporting cycle and $16,600 during future reporting cycles compared to the baseline.

Table 4

- 56 : Average Total Cost per Site

Cost for
Submission
Co mpliance 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$ p er 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

Post

Amendment $2,193 1 $1,112 6.33 $5,117 5.07 $3 5,185

Change from
the Baseline $135 0

- $16.99

- 0.01 $1,058 0.89 $9,000

Future Cycle
Baseline $561 1 $968 6.34 $3,247 4.18 $20,274

Future Cycle,

Post

Amendment $695 1 $1,047 7.21 $4,047 7.06 $36,824

Change from the Baseline, Future Cycles $13 4 0 $78.18 0.87 $800 2.88 $16,551

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline v alue from the post

amendment v alue.

4.6 

### Annualized Industry Cost Estimates for all Modifications

EPA estimated the t otal burden to industry of all of the amendments over a 26

- year period.
EPA used a 20

- year annualization period in the previous economic analyses of the IUR rule (EPA, 2002a and EPA, 2005), but for this report, a 26

- year period allows EPA to analyze a set of complete reporting cycles under both the baseline and post

- amendment scenarios.

While the IUR data submission activity itself occurs in one reporting year (e.g., 201 2 ), EPA believes rule compliance and data collection activities, and thus, costs and bur dens

, are in curred 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 s ite over a four

- or five

- year reporting cycle. Industry has indicated to EPA efforts related to rule compliance and data collection are spread out over multiple years. For example, EPA began receiving

calls about r eporting requirements for 201 2 reporting i n early 2009, and the Agency ha s already held
conference calls with companies and EPA IT staff to discuss electronic reporting issues. Companies have stated they prefer to set up a system to collect the IUR information during the time the chemical4

- 61

substanc e s are being manufactured. Thus, for the 201 2 reporting cycle, EPA has evidence some companies set up their data systems in 2009 to early 2010, are collecting the information in 2010 and

2011 , and will compile and report that information in 201 2

. Furthermo re, as described in section 4.2.2,
IUR burden estimates are taken from the 2002 EPA Economic Analysis for the Amended Inventory Update Final Rule and were based on an industry survey conducted by EPA and designed to measure industry effort associated with collecting chemical substance exposure data under TSCA Section 8. Nowhere in the survey or its cover letter are these burden estimates discussed as being annual burdens. They are interpreted in the 2002 EA, and in previous IUR ICRs, as being the total burd en incurred over
the entire reporting cycle.



### The total industry burden calculated in Table 4

- 52 included the burden during the first reporting cycle. EPA expects during future reporting cycles, the industry burden will decrease as submitters become more efficient with the data and more familiar with the reporting requirements. Section 4.2.6 discusses the burden reductions associated with this rule familiarization and efficiency gains. Table 4

- 52 also shows the total burden to industry in future reporting cycles. Table 4

- 57 shows the burdens associated with each reporting cycle over a period of 26 years, including the years covered by the next (2012) reporting cycle. Under the baseline, a five

- year reporting cycle is used, and the cost of four complete cycles is analyzed. Under the post

- amendment scenario, reporting occurs every four years, and the cost of five complete cycles is presented . (Note the 201 2 reporting year covers a six

- year period under either scenario).

Over a 26

- year period, EPA estimates the amendments will increase industry burden by approximately 7.62 million hours.

Table 4

- 57 : Industry Burden over a Period of 2 6 Years if All Amendments Are Implemented

Reporting Cycle 1 Year(s) Baseline Burden Post

- Amendment

Burden Change in Burden

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2012 1.84 2.34 0.50

2 2013 to 2017 1.43

-- 1.14

2013 to 2016

-- 2. 57

3 2087 to 2022 1.43

-- 1.14

2017 to 2020

-- 2. 57

4 2023 to 2027 1.43

-- 1.14

2021 to 2024

-- 2. 57

5 2028 to 2032 1.43

-- 1.14

2025 to 2028

-- 2. 57

6 2029 to 2032

-- 2. 57 2.57

Total 7.58 15.20 7.62 Annual Average 0.29 0.58 0.29

1 The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are four

- year cycles

.



### Table 4

- 58 presents the annual and annualized costs estimates o f all the amendments. Over a

26

- year period, EPA estimates the amendments to the IUR rule will increase the annualized industry cost by $ 17.1 6 million, with a three percent discount rate , and $ 14.71 million with a seven percent discount rate.4

- 62

Table 4

- 58 : Industry Cost over a Period of 2 6 Years if All Amendments Are Implemented

Reporting Cycle 1 Year(s) Baseline Cost Post

- Amendment
Cost Change in Cost

(millions of 2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2012 $106.97 $143.73 $36.76

2 2013 to 2017 $82.82

-- $75.12

2013 to 2016

-- $157.94

3 2087 to 2022 $82.82

-- $75.12

2017 to 2020

-- $157.94

4 2023 to 2027 $82.82

-- $75.12

2021 to 2024

-- $157.94

5 2028 to 2032 $82.82

-- $75.12

2 025 to 2028

-- $157.94

6 2029 to 2032

-- $157.94 $157.94

Total $438.24 $933.42 $495.19

Annualized @ 3% $15.88 $33.05 $17.16

Annualized @ 7% $14.62 $29.33 $14.71

1 The non

- italicized reporting cycles are baseline, five

- year cycles, and the italici zed reporting cycles are, four

- year cycles

.5

- 1 

## 5. Agency Burden and Cost Estimates

5.1 

### Methodology for Agency Burden and Cost

This chapter analyzes the changes in burden and cost to EPA as a result of the amendments to the IUR rule. This chapter calculates the inc remental cost and burden changes of the amendments by comparing the Agency costs under the current baseline to Agency costs after the

rule amendments. The methodology for estimating the change in Agency cost is similar to estimating the change in burden to industry:

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

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

Step 3 : Determ ine the estimated total c ost and burden by multiplying the unit cost and burden by the frequency of the activity

. Step 4 : Subtract the total Agency cost or burden after the IUR amendments from the cost or burden under the current IUR rule to calculate the incremental Agency cost or savings

Based on the supporting statement for the 2008 Information Collection Request for the Partial Update of the TSCA Production and Site Reports ( EPA 2008d) , tasks associated with the costs and burden to the Agency under the IUR rule include:

D ocum ent receipt and tracking ;

D ata entry and quality control of data entry ;

B ackup systems operation;

D ata processing ;

S ystems development ;

C ontract oversight and management;

P ublication and printing of forms and materials; and

O peration of the TSCA Hotline t o handle IUR

- related calls.

Costs related to using the data are not included. The one

- time costs associated with the requirements of previous IUR amendment s 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 contrac t oversight and management. Under the current IUR rule, t he Agency is expected to require one FTE at the GS

- 12 level , p er

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 ba seline burden to the Agency is5

- 2



### therefore 4,160 hours under the baseline. EPA assumes the Agency burden will remain the same for all reporting cycles.

EPA labor costs are based on annual Federal wage rates published by the Office of Personnel Management for the Washington

- Baltimore

- Northern Virginia, DC

- MD

- PA

- VA

- WV locality

pay area for 2008 (OPM, 2008). Wages are presented in terms of GS

- level and step. Based on previous IUR economics analyses

, a Step3 is assumed for all FTEs ( EPA, 2002a and EPA

, 2005). Fol lowing 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 ta ble for Washington

Baltimore

- Northern Virginia (OPM, 2008).

5.2.2 

### Extramural (Contractor) C osts

In addition to costs incurred by EPA staff

, burden is associated with extramural tasks performed by contractors. These tasks include data receipt

, tracking and dat a entry ; backup systems operations an d 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 inflate d 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 deriv ation of the
extramural task cost in 2008 dollars

. In total

, EPA estimates it will spend approximatel y $ 204,000 on these tasks per reporting cycle

.

Table 5

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

Tasks Performed by Contract or Staff Annual Cost ( 200 7$) 1 Inflation

Factor Annual Cost

( 2008 $) Document Receipt, Tracking and Data Entry $90,737 1.04 $94,6 32 Maintaining and Operating Back Up Systems $5 6

, 711 1.04 $59,1 45 Printing and Publishing Fo rms and Materials $5,298 1.04 $5,52 5 Managing the TSCA Hotline $42,855 1.04 $44, 694

Total $19 5,601 n/a $203,9 97

1 Source: ICR No. 1884.04. [Information Collection Request for] Partial Update of the TSCA Section 8(b) Inventory Data Base,
Production and Si te 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 t he total baseline Agency costs by combining the costs of EPA staff and the extramural tasks performed by contractors.5

- 3

Table 5

- 3 : Total Agency Cost under the Current IUR Requirements

Task Staff Cost per Reporting Cycle ( 2008 $ )

VARIABLE COSTS (DEPENDENT ON THE NUMBER OF REPORTS SUBMITTED)

Quality Control of Data Entry EPA Employee (GS 12 Step 3) $122,317

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

TOTAL VARIABLE COST $216,949

FIXED COSTS

Data Proces sing, 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 Co ntractor $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 est imates. 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 report s 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 repor ts
received. The combined cost of these activities is $216,949 ( s ee 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 th e Agency, not burden.) EPA assumes it incurs the same cost to perform the data entry and processing for each data element in Form U.

To calculate the Agency burden per data element, EPA followed a methodology outlined in

the Economic Analysis of the Final Rule to Add Certain Industry Groups to EPCRA Section 313 (EPA, 2007). EPA first calculated the total number of data elements in Form U (126 elements) and the percentage of data elements in each section of the form, and derived a weighted percentage of elem ents 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 perce nt 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 submit ted for each section

. An example of this

calculation can be seen in Equation 1 for Part I.5

- 4

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



### Th e burden per section was then divided by the total number of data items in that section to calculate the burden per item, 0.0009 hour s (approximately 0 .054 minutes) ( s ee Equation 2 ).

Equation 2 : Burden p er Data Element = 0.017 hours / 19 = 0.0009 hours



### To calculate the cost to EPA, the process described above was repeated; however, instead of using 2,080 hours, EPA used the combined cost for the quality control of data entry, and document receipt, tracki ng, and data entry, which was $216,949

. Thus, EPA calculated i t costs the Agency approximately $0.09 to process a single data element of Form U. The total Agency burden per report is approximately 0.113 hours and $11.79. Table 5

- 4 contains the Agency burden and cost per report by section of Form U. This baseline burden will remain the same for all reporting cycles.

Table 5

- 4 : Baseline Agency Burden per Report

Number of D ata
Elements Burden per Data Element Total

Burden ( hours ) Cost

(2 0 08 $ ) Burden

( hours ) Cost

(2 0 08 $ )

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 t he Modification s

The estimated cost and burden impacts on the Agency for each of the amendments to the IUR
are outlined below. See Section 3. for more information about each of the amendments.

In each of the following sections, the burden estimates for each amendment are calculated independently of the other amendments

. See Section 5.5 for an estimate of the aggregated impact

of all the amend ment s.

5.4.1 

### Technical Modifications to the Regulatory Text

EPA is reorganizing certain existing regulatory text and to delete obsolete regulatory text. These amendments do not substantively affect the regulatory text, so EPA assumes this amendment will not imp act Agency burden or cost.

5.4.2 

### Modifications to Selected Definitions

EPA is modifying the definitions of “importer,” “manufacture

, ” “site

, ” “commercial use,” “consumer use,” “reporting year,” and “submission period,” and to add definitions for “manufacturer,” “Central Data Exchange (CDX),” “e

- IURweb,” and “industrial function,” as described in Section 3. These changes are clarifications only; EPA is clarifying in regulatory text what has been previously explained through outreach with the regulated community. T herefore, EPA assumes these definition changes will not impact Agency burden or cost.5

- 5

5.4.3 

### Method fo r Determining Whether a Manufacturer is s ubject to IUR Reporting Requirements

EPA is requiring reporting if, for any calendar year since the previous IUR princip al reporting year, the subject chemical substance was manufactured or imported in volumes of 25,000 lb or greater. The Agency estimates this will increase the total number of sites and reports by five percent from the baseline. This modification would not take effect until after the first
post

- amendment reporting cycle (201 2 ); 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 exp ected in the first cycle versus future cycles. (See Section 4.4.3 for more information.) Therefore, the tables below show estimated changes in cost and burden for

both the first and future reporting cycles.

Table 5

- 5 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency estimates no change in burden for the first reporting cycle and a burden increase of 104 hours in future reporting cycles as a result of modifying the method for determining whether the 25,000 lb reporting threshold is met.

Table 5

- 5 : Change in Agency Burden as a Result o f 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

P rocess 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, Post

Amendment 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, Post

Amendment 0.017 4,289 0.042 27,191 0.054 17,929 2,184

Change from the
Baseli ne, 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 post

amendment value.



### Table 5

- 6 shows t he estimated change in cost to EPA as a result of the amendment. The Agency estimates no change in cost for the first reporting cycle and a cost increase of approximately $10,800 in future reporting cycles

.5

- 6

Table 5

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

Cost to

Process

Part I
Submission (2008$) Number

of Sites Cost to

Process

Part II (2008$

per report) Numb er

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

Firs t Cycle, Post

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

Change from the Baseline, First Cycle 0.000 0 0.000 0 0.000 0 0

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

Future Cycle,

Post

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

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

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

amendment value.

5.4.4 

### Re place the 300,000 lb T hreshold for P rocessing a nd U se R eporting

For the 2012 IUR submission

, all submitters of non

- excluded chemical substances are required to report processing and use information if they manufactured (including imported) 100,000 lb or mo re of a chemical substance in 2011. Subsequent to the 2012 reporting cycle, the reporting threshold will be 25,000 lb

. Replacing this threshold will increase industry burden by requiring more sites to complete Part III of Form U (Part III contains the down stre am processing and use information). EPA estimates the number of Part IIIs submitted will increase by 3 ,627
reports in the first reporting cycle and by 8,203 report s in future reporting cycles (see Section

4.4.4 for more inf

ormation).

Table 5

- 7 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency expects a burden increase of 195 hours in the f irst reporting cycle and 441 hours i n subsequent reporting cycles as a result of this amendment.5

- 7

Table 5

- 7 : Change in Agency Burden as a Result of Replacing the 300,000 lb Threshold for Processing and Use Repo rting

Burden to Process

Part I I I (hours per report) Number of Reports with

Part III Agency Burden (hours)

(a) (b) (c) = (a)*(b)
First Cycle, Baseline 0.05 17,075 919
First Cycle, Post

- Amendment 0.05 20,702 1,114 Change from the Baseline , First Cycl e 0 3,627 195

Future Cycle, Baseline 0.05 17,075 919
Future Cycle, Post

- Amendment 0.05 25, 278 1,3 60 Change from the Baseline , Future Cycles 0 8 ,203 4 41

Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseli ne value from the post

amendment value.



### Table 5

- 8 shows the estimated change in cost to EPA as a result of the amendment. The Agency estimates a cost increase of approximately $ 20,400 in the first reporting cycle and by $46,000 in future reporting cycles

.

Table 5

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

Cost to Process

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

(a) (b) (c) = (a)*(b)
First Cycle, Baseline $5.61 17,075 $95,835
First Cycle, Post

- Amendment $5.61 20,702 $116,192
Change from the Baseline , First Cycle 0.00 3,627 $20,357

Future Cycle, Baseline $ 5.61 17,075 $95,835

Future Cycle, Post

- Amendment $ 5.61 25, 278 $14 1,876 Change from the Baseline , Future Cycles $ 0.00 8 ,203 $4 6,040

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

amendment value.

5.4.5 

### Reduce t he 25,000 lb Threshold for Specific R egulated Chemical
S ubstance s
Beginning with the 2016 reporting cycle, EPA is reducing the 25,000 lb reporting threshold to 2,500 lb for chemical substance s that are: ( 1) the subject of a regulation promulgated under

sec tion s 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 importe rs) of these chemical substance s would be required to report under the IUR rule, regardless of the production volume.5

- 8



### Approximately 90 2 chemical substance s fall into these categories and are expected to have a production volume above 2,500 lb (EPA, 2006a) 5



### . Because the amendment would affect only

chemical substance s subject to a promulgated rule, this figure is an overestimate. EPA estimated

these chemical substance s will generate a total of 3, 609 additional reports (see Section 4.4.5 for more details).

Table 5

- 9 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency expects a burden increase of 152 hours as a result of

the lowering of the 25,000 lb threshold for certain regulated chemical substance s to 2,500 lb beginning with the 2016 reporting cycle.

Table 5

- 9 : Change in Agency Burden as a Result of Red ucing the 25,000 lb Threshold for Specific Regulated Chemical S ubstance s (Future Cycles Only)

Burden to Process

Part II (hours per r eport) Number of Reports Agency Burden (hours)

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

Baseline 0.04 25,896 1,092
Future Cycle, Post

- Am endment 0.04 29,505 1,244 Change from the Baseline , Future Cycles 0 3,609 152

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

amendment value.



### Table 5

- 1 0 shows the estimated change in cost to EPA as a result of the amendment. The Agency estimates a cost increase of approximately $ 1 5 ,900 beginning with the 2016 reporting cycle

.

Table 5

- 10 : Change in Agency Co st as a Result of Reducing the 25,000 lb Threshold for Specific R egulated Chemical S ubstance s (Future Cycles Only)

Cost to Process

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

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

Baseline $4.40 25,896 $113,853
Future Cycle, Post

- Amendment $4.40 29,505 $129,721
Change from the Baseline , Future Cycles $ 0.00 3,609 $15,868

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

amendment value.

5 There are two chemicals subject of an order issued under section 5(f) of TSCA that would be subject to the reduced

threshold that have n ot been included in the development of estimates in this section of the Economic A nalysis, however, the overall estimates of costs and burdens for this requirement are not expected to be significantly affected.5

- 9

5.4.6 

### M ake Chemical S ubstance s Subject to Enforceable Consent Agreements (ECAs) Ineligible for Exemptions

The Agency is making all chemical substance s subject to enforceable consent agreements ineligible for exemptions. A total of four chemical substance s and 16 sites are affected by this amendment (see Section 4.4.6 for more information). These sites would submit Part III of Form
U for these chemical substance s for the first time in the next submission period.

Table 5

- 11 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency expects a burden increase of one hour as a result of

this amendment.

Table 5

- 11 : Change in Agency Burden as a Re sult of Making Chemical S ubstance s Subject to ECAs Ineligible for Exemption s

Burden to Process

Part I II (hours per r eport) Number of Reports Agency Burden (hours)

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

Baseline 0.05 17,075 919

Post

- Amendment 0.05 17, 091 92 0 Change from the Baseline 0 16 1

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

amendment value.



### Table 5

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

Table 5

- 12 : Change in Agency Cost as a Re sult of Mak ing Chemical S ubstance s Subject to ECAs Ineligible for Exemption s

C ost to Process

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

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

Baseline $5.61 17,075 $95,835

Post

- Amendment $5.61 17, 091 $97, 925 Change from the Baseline $0.00 16 $ 90

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

amendment value.

5.4.7 

### Full E xemption for M anufactured W ater

Under the current IUR regulations, manufactured w ater is partially exempt from reporting; therefore, facilities that produce manufactured water need to complete only Parts I and II of

Form U. The Agency now is granting a full exemption for manufactured water. Thus, the burden

reduction for this amendment would be the result of 43 fewer Part IIs being submitted (see
Section 4.4.7 for more information.)

Table 5

- 13 shows the estimated Agency burden of the amendment, using the baseline burden

estimates fo und in Table 5

- 4

. The Agency estimates a burden reduction of two hours as a result

of this amendment.5

- 10

Table 5

- 13 : Change in Agency Burden as a Result of a Full Exempti on for Manufactured
Water

Burden to Process

Part I I (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 Cha nge from the Baseline rows are calculated by subtracting the corresponding baseline value from the
post

- amendment value.



### Table 5

- 14 shows the estimated change in cost to EPA as a result of the amendment. The Agency estimates a c ost savings of approximately $190.

Table 5

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

Cost to Process

Part I I (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 p ost

amendment value.

5.4.8 

### Remove Fully

- Exempt P olymers from the P artially

- E xempt L ist

EPA is amend ing the list of partially exempt chemical substance s to remove three chemical

substances ( S tarch (CASRN 9005

- 25

- 8), Dextrin (CASRN 9004

- 53

- 9), and Maltodextrin (C ASRN 9049

- 76

- 7) ) which, as polymers, are fully exempt from reporting. Th is will not change the Agency burden because these substances currently are fully exempt from reporting, and therefore no additional reports will be submitted to EPA.

5.4.9 

### Parent Company an d Site Identity

Manufacturers (including importers) currently are required to report the name and other

information to identify the company associated with their plant site on Part I of Form U. EPA is requiring the company name to be the ultimate domestic parent name. EPA assumes no additional Agency burden for processing the ultimate domestic parent name, compared to the current IUR reporting requirement of the parent company name.

5.4.10 

### Technical C ontact

Manufacturers ( including importers) are required to provi de a technical contact for their IUR

submission. EPA is amending the IUR rule to require the technical contact to be a person who
works at the site and is knowledgeable about the chemical substance

. EPA assumes no additional Agency burden to process the te chnical contact regardless of the location of the contact.5

- 11

5.4.11 

### Chemical I dentity

EPA is requiring reporting of the Chemical Abstracts (CA) Index Name currently used to list the
substance o n the TSCA Inventory as the chemical name reported for IUR. Currently

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

. For the 2011 submission period, the reporting software will be directly linked to the non

- confidential portion of the TSCA Inventory through the Agency’s Substance Registry System (SRS) database. Therefore, submitters will be required to select the correct CA Index Name for their reportable chemical substance (s)
from SRS.

Manufacturers (including importers) will be allowed to supply an alternate c hemical 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 nam e of the imported TSCA Inventory substance or a reactant used to manufacture the Inventory substance. In these cases, the manufacturer (including importer) and the supplier report the information required in this part in a joint submission

. For the chemical identifying number, EPA is requiring reporting of only the CASRN (for the public Inventory), o r in t he case of confidential chemical substances, the TSCA accession number . In addition,

EPA is removing the PMN number as an allowed chemical identifying number because each Inventory
substance has either a CASRN or a TSCA accession number or both, which are likely to be known already to the subm itter.



### EPA assumes no additional Agency burden to process either a CA Index Name compared to an alternative chemical name, or a request for an accession number compared to a CASRN for a chemical identifying number, and so is not adding any burden to the baseline Agency burden and cost estimates for chemical identity. However, there may be an increase in accession number requests because some submitters may not know their accession number or PMN number. The
number of 200 6 reports with CA S numbers claimed as CBI was used as a proxy for the number letters submitted to EPA; a total of 343 reports was estimated (EPA, 2010b). The Agency burden
to process an accession number request is 0.5 hours per request, based on EPA’s best professional judgment of the time needed to process a request and mail the accession number back to the company. Table 5

- 15 shows the change in Agency burden as a result of processing

accession number requests. EPA estimates a bu rden increase of 170 hours in the first reporting cycle. No change in burden is expected in future reporting cycles ( s ee Section 4.4.11 ).

Table 5

- 15 : Change in Agency Burden as a R esult of A ccession N umber Requests

Burden per Request (hours) Number of Requests Agency Burden (hours) (a) (b) (c) = (a)*(b)

Baseline 0 0 0.0

Post

- Amendment 0.5 343 171.5
Change from the Baseline 0.5 343 1 7 1.5

Note: Values in Change from the Baseli ne rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### Table 5

- 16 shows the change in Agency cost as a result of accession number requests. EPA estimates a cost increase of $11,528 in the first reporting cycle.5

- 12

Table 5

- 16 : Change in Agency Cost as a Result of A ccession N umber Requests

Cost per Request ( $ ) Number of

Requests Agency Cost ($ )

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

Baseline $0 0 $ 0. 0 0

Post

- Amendment $33.61 343 $11,528
Change from the Baseline $33.61 343 $11,528

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

amendment value.

5.4.12 

### R eport P roduction V olume for Each of the Years since Last Principal Reporting Year

EPA is requiring reporting of a chemical substance ’s production volume manufactured in 2010 and 2011 for the first reporting cycle and each of the f our years since the last IUR principal reporting year for s ubsequent reporting cycles

, beginning with the 2016 reporting cycle

. This
amendment will result in one additional data item for EPA to process in Part II of Form U in the first reporting cycle , adding approximately 0. 0 6 minutes (0.0 0 1 hours) of processing burden per

form . In future reporting cycles

, the Agency burden is expected to increase by 0.0 0 3 hours or

0. 16 minutes (see Table 5

- 4 )

.
Table 5

- 17 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency estimates a burden increase of 23 hours in the first reporting cycle and 70 hours in future reporting cycles as a result of this amendment

.

Table 5

- 17 : Change in Agency Burden as a Result of Reporting of Production Volu me for Each of the Years since Last Principal Reporting Year

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

(hours)

(a) (b) (c) = (a)*(b)
First Cycle, Baseline 0.001 25,896 23 First Cycle, Post

- Amendment 0.002 25,896 46 Change from the Baseline , First Cycle 0.001 0 23 Future Cycle, Baseline 0.001 25,896 23

Future Cycle, Post

- Amendment 0.004 25,896 93 Change from the Baseline , Future Cycles 0.00 3 0 70

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

amendment value.



### Table 5

- 18 shows the estimated change in cost to EPA as a result of the amendment. The Agency estimates a cost increase of approximately $2,400 in the first reporting cycle

, and $ 7

, 2 00 in future reporting cycles

.5

- 13

Table 5

- 18 : Chan ge in Agency Cost as a Result of Reporting of Production Volume for Each of the Years since Last Principal Reporting Year

Cost for Processing
Production Volume (2008 $ per report) Number of Reports Agency Cost

(2008 $ )

(a) (b) (c) = (a)*(b)
First Cycle, Baseline $0.09 25,896 $2,422
First Cycle, Post

- Amendment $0.19 25,896 $4,845
Change from the Baseline , First Cycle $0.09 0 $2,422

Future Cycle, Baseline $0.09 25,896 $2,422
Future Cycle, Post

- Amendment $0.37 25,89 6 $9,690
Change from the Baseline , Future Cycles $0.28 0 $7,267

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

amendment value.

5.4.13 

### Volume of Chemical Substance Used On

- Site

Under t he current IUR requirements, submitters who manufacture a chemical substance exclusively for on

- site use are required to indicate this on Form U. The Agency is requiring submitters to report both production volumes used on

- and off

- site. EPA expects there will be a slight increase in the number of submitters who w ill report product volume used on

- site; about

19.4 percent of all submitters will report the volume used on

- site (see Section 5.4.13 for more information).

Table 5

- 19 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency estimates a burden increase of five hours as a result of

this amendment.

Table 5

- 19 : Change in Agency Burden as a Result of Reporting of Production Volume
Used On

- S ite

Burden to

P rocess Information (hours per report) Number of

Reports Number of Reports

w ith Prod uction
Volume Used O n
- S ite 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 correspondi ng baseline value from the post

amendment value.



### Table 5

- 20 shows the estimated change in cost to EPA as a result of the amendment

. The Agency estimates a cost increase of approximately $ 470

.5

- 14

Table 5

- 20 : Change in Agency Cost as a Result of Reporting of Production Volume Used
On

- Site

Cost to Process

Information (2008 $ per report) Number of

Reports Number of Reports

w ith Production

Volume Use d On

- S ite Agency Cost (2 008 $ )

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 post

ame ndment value.

5.4.14 

### Indicate Whether an Imported Chemical S ubstance Is Physically at the Reporting Site

EPA is requiring submitters to indicate whether an imported chemical substance is physically

at the reporting site. This will add one data element for EPA to process.

Table 5

- 21 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency estimates a burden increase of 2 3 hours as a result of

this amendment.

Table 5

- 21 : Change in Agency Burden as a Result of Indicating Whether an Imported
Chemical S ubstance is Physically at the Reporting Site

Burden to P r ocess 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 subt racting the corresponding baseline value from the post

amendment value.



### Table 5

- 22 shows the estimated change in cost to EPA as a result of the amendment

. The Agency estimates a cost increase of approximately $ 2, 400

.

Table 5

- 22 : Change in Agency Cost as a Result of Indicating Whether an Imported
Chemical S ubstance is Physically at the Reporting Site

Cost to P rocess Information (2008 $ per report) Number of Reports A gency 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 ba seline value from the post

amendment value.5

- 15

5.4.15 

### Report Production Volume Exported

EPA is requiring all submitters to provide the exported chemical substance volume in Section

II of the report. This will add one data element to Part II of Form U for EPA to pro cess.

Table 5

- 23 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency estimates a burden increase of 23 ho urs as a result of

this amendment.

Table 5

- 23 : Change in Agency Burden as a Result of Re quiring 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 post

amendment value.



### Table 5

- 24 sho ws the estimated change in cost to EPA as a result of the amendment

. The Agency estimates a cost increase of approximately $ 2,400

.

Table 5

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

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

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

Baseline $4.40 25,896 $113,853

Post

- Amendment $4 .49 25,896 $116,275
Change from the
Baseline $0.09 0 $2,422

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

amendment value.

5.4.16 

### Identify Whether Chemical S ubstance i s t o b e Recycle d , Remanufacture d, Reprocessed, or Reused

EPA is revising Form U for submitters to indicate whether a chemical substance is to be recycled, r emanufacture d, reprocessed, or reused. This will add one data element to Part II of Form U for EPA to process.

Table 5

- 25 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency estimates a burden increase of 23 hours as a result of

this amendment.5

- 16

Table 5

- 25 : Change in Agency Burden a s a Result of Indicating Whether Chemical
S ubstance is to be Recycled , Remanufacture, Reprocessed, or Reused

Burden to Process a Check box to

Ind icate Whether a Product is Recycled , Remanufacture d
, Reprocessed, or Reused (hours per report) Number of Reports Agency Burden (hours)

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

Baseline 0.042 25,896 1,092

Post

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

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

amendment value.



### Table 5

- 26 shows the estimated change in cost to EPA as a result of the amendment

. The Agency estimates a cost increase of approximately $ 2,400

.

Table 5

- 26 : Change in Agency Cost as a Result of Indicati n g Whether Chemical
S ubstance is to be Recycled , Remanufacture d

, Reproce ssed, or Reused

Cost to Process a Check box to
Indicate Whether a Product is Recycled , Remanufacture d
, Reprocessed, or Reused (2008 $ per report) Number of Reports Agency Cost (2008 $ )

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

Baseline $4.40 25,896 $113,853

Post

- Amen dment $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 post

amendment value.

5.4.17 

### Concentration R anges

EPA is amending the ra nges used to report chemical substance concentration in § 710.52(C)(3) and (4) by changing the ranges to: ( 1) l ess than one percent by weight

, ( 2) a t least
one percent but less than 30 percent by weight

, ( 3) a t least 30 percent but less than 60 percent by

w eight

, ( 4) a t least 60 percent but less than 90 percent by weight, and ( 5) a t least 90 percent by weight.

This is a technical correction to eliminate gaps in the ranges as previously listed in the rule.

EPA assumes i t will have no impact on Agency burden o r cost.

5.4.18 

### Revise Industrial Function Categories

The Agency is revising the industrial function categories by adding eight new categories, eliminating six existing categories and requiring submitters to write in text when they claim “Other” as the category. T his would add one data element to Part III of Form U for EPA to

process. EPA expects the number of submitters who select “Other” to decrease, for a total of 603 submitters expected to write

- in this text descriptor (see Section 4.4.18 for more information).5

- 17



### Table 5

- 27 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Age ncy estimates a burden increase of 0.54 hours as a result of

this amendment.

Table 5

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

Burden to

P rocess Function Categori es (hours per report) Number of

Reports with
Function Categories Burden to

Process Write

in 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 91 8.82

Post

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

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

amendment value.



### Table 5

- 28 shows the estimated change in cost to EPA as a result of the amendment

. The Agency estimates a cost increase of approximately $ 56

.

Table 5

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

Cost to

P rocess Industrial
Function Categories (2008 $ per report) N umber of

Reports with
Industrial
Function Categories Cost to Process

Write

- in Text
for "Other" (2008 $ ) Number of

Reports with

Text

De scriptor 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 a re calculated by subtracting the corresponding baseline value from the post

amendment value.

5.4.19 

### Replace NAICS Codes with Industrial Sectors

EPA is replacing the five

- digit North American Industrial Classification System (NAICS)
codes with 48 Industrial Sect ors. This amendment will not change the Agency’s data processing

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

5.4.20 

### Revise C onsumer and C ommercial Product Categories
The Agency is revising the consumer and commercial product categorie s by adding 12 new categories and requiring submitters to write in text when they select “Other” as a consumer or5

- 18



### commercial product category. EPA expects 604 submitters to write in this text descri ptor for “Other” (see Section 4.4.20 for more information), adding one data element to Part III of Form U for EPA to process.

Table 5

- 29 shows the estimated Agency burde n of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency estimates a 0.54 hour burden increase as a result of

this amendment

.

Table 5

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

Burden to

Process
Consumer or
Commercial

Product Categories (hours per report) Number of

Reports with
Consumer or Commercial

Product Categories Burden to

Proc ess Write

in 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

Post

Amendment 0.05 17,075 0.001 604 919.36

Change from
the Baseline 0.00 0 0.001 604 0.54

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

- amendment value.



### Table 5

- 30 shows the estimated change in cost to EPA as a result of the amendment

. The Agency estimates a cost increase of approximately $ 56

.

Table 5

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

Cost to P roces s Consumer or
Commercial

Product Categories (hours per report) Number of

Reports with
Consumer or Commercial

Product Categories Cost to Write

in Text for
"Other" (2008 $ ) Number of

Reports with
Write

- in
Text for
"Other" Cost

(2008 $ )

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

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

Post

- Amendment $5.61 17,075 $0.09 604 $95,892
Change from the
Baseline $0.00 0 $0.09 604 $56

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

- amendment value.5

- 19

5.4.21 

### Designation of Consumer or Commercial Use

EPA is requiring the identification of whether the downstream use is a consumer or a

commercial use , or both, adding one data element to Part III of Form U for EPA to process.

Table 5

- 31 shows the estimate d Agency burden of the amendment , using the baseline burden

estimates found in Table 5

- 4

. The Agency expects a burden increase of 15 hours as a result of

this amendment

.

Table 5

- 31 : Change in Agency Burden as a Result of Designation of Consumer or C ommercial Use

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

B aseline 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 post

amendment value.



### Table 5

- 32 shows the estimated change in cost to EPA as a result of the amendment

. The Agency estimates a cost increase of approximately $1,600

.

Table 5

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

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

Baseline $5.61 17,075 $95,835

Post

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

Note: Values in C

hange from the Baseline rows are calculated by subtracting the corresponding baseline value from the post

amendment value.

5.4.22 

### Number of Commercial Workers Reasonably Likely To Be Exposed
EPA is requiring submitters of reports with processing and use informa tion to provide the number of commercial workers who are reasonably likely to be exposed to a chemical substance

, in ranges. This amendment adds one data element to Part III of Form U for EPA to process.

Table 5

- 33 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency expects a burden increase of 15 hours as a result of

this amendment

.

Table 5

- 33 : Change in Agency Burden as a Result of Requiring the Number of
Commercial W orkers Reasonably Likely To Be E xposed

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

Baseline 0.054 17,075 919

P ost

- Amendment 0.055 17,075 934 Change from the
Baseline 0.001 0 155

- 20

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

amendment value.



### Tab le 5

- 34 shows the estimated change in cost to EPA as a result of the amendment

. The Agency estimates a cost increase of approximately $ 1,600

.

Table 5

- 34 : Change in Agency Cost as a Result of Requiring the Num ber of Commercial Workers Reasonably Likely To Be Exposed

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

Baseline $5.61 17,075 $95,835

Post

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

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

amendment value.

5.4.23 

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

EPA is eliminating the “ n ot r ead i ly o btainable (NR O)” standard and replac ing it with the more stringent “ k nown to or r easonably 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 it will not increase the Agency burden or

cost.

5.4.24 

### Chemical Identity CBI C laims
EPA is proposing, when a submitter asserts a claim of confidentiality for the chemical identity of a substance listed on the public portion of the Master In ventory File, the Agency may make the information available to the public without further notice to the submitter. See the regulatory text at 40 CFR 711.30(e). Any such action on EPA’s part would be as part of regular

and routine use of the data and will n ot create any additional burden.

5.4.25 

### Upfront Substantiation for Processing and Use Information CBI Claims
EPA is requiring upfront substantiation for all CBI claims in the processing and use section

of Form U. This amendment adds two data element s per item cla imed as CBI, to Part III of Form U for EPA to process. EPA expects 2,928 reports will claim processing and use information as CBI, and on average they will make three CBI claims per report (see section 4.4.25 for more

informati on).

Table 5

- 35 shows the estimated Agency burden of the amendment, using the baseline burden

estimates found in Table 5

- 4

. The Agency expects a burden increase of eight ho urs as a result of

this amendment

.

Table 5

- 35 : Change in Agency Burden as a Result of Re quiring Upfront Substantiation for
CBI Claims

Burden per Report (hours) Number of

Reports with

Part III Burden for

Upfr ont CBI
Substantiation Number of

Reports with
Substantiated Burden

(hours)5

- 21 for CBI Claims
in Part III CBI Claims

in Part III

Baseline 0.05 17,075 0.000 0 919

Post

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

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

amendment value.



### Table 5

- 36 shows the estimated change in cost to EPA as a result of the amend ment

. The Agency estimates a cost increase of approximately $ 822

.

Table 5

- 36 : Change in Agency Cost as a Result of Re quiring 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 t he
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 post

amendment value.

5.4.26 

### Limitation on Confidentiality Claims for Data Elements Identified as “Not
Kn own or Reasonably Ascertainable”
EPA is no longer allow ing CBI claims for data elements identified as “not known or reasonably ascertainable.” EPA expects there will be no change in Agency burden as a result of

this amendment because the number of submitte rs and data elements will not change.

5.4.27 

### Require Electronic Submissions over the Internet

EPA is requiring all Form Us to be submitted to the Agency electronically, via e

- IURweb

and EPA’s Central Data Exchange (CDX) over the Internet . EPA expects m andatory e l ectronic

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 burde n is expected to decrease by 88 .6 percent , not including the operating and maintenance and troubleshooting costs included in the general CDX operating budget.

Table 5

- 37 shows the estimated Agency burden of the ame ndment, using the baseline burden

estimates found in Table 5

- 4

. The Agency estimates a burden decrease of approximately 1,800

hours as a result of this amendment.5

- 22

Table 5

- 37 : Change in Agency Burden as a Result of Requiring Electronic Submission

Burden per Report to
Process

Part I (hours per site ) Number of

Sites Burden per

Report to
Process

Part

II ( h ours per report ) Number of

Reports Burden per

Report to
Process

Part III ( h ours 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

Post

Amendment 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 post

amendment value.



### Table 5

- 38 shows the estimated change in cost to EPA as a result of the amendment

. T he Agency estimates a cost savings of approximately $ 192,200

.

Table 5

- 38 : Change in Agency Cost as a Result of Requiring Electronic Submission

Cost per Report to
Process

Part I ( 2008$ ) Number of

Sites Cost p er

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

Post

Amendment $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 post

amendment value.

5.4.28 

### Updated e - IURweb Reportin g Software
EPA developed the e

- IUR reporting software for use by manufacturers (including importers) in preparing and submitting reports electronically during the 2006 IUR reporting cycle

. For the

201 2 submission period, EPA will provide a free, web

- based application in place of the 2006
downloadable software. The updated e

- IURweb reporting tool for the 201 2 IUR collection w ill feature several improved capabilities over the current e

- IUR reporting tool

. Although not quantified here, EPA expects updated e

- IU Rweb tool will reduce Agency burden to process and

correct errors in the form.

5.4.29 

### Electronic Signature Process

In order to submit IUR data electronically to EPA via the Central Data Exchange ( CDX )

, individuals acting on behalf of the submitter must first reg ister with CDX

. To register in CDX, the CDX registrant (also referred to as “ Electronic Signature Holder ” ) downloads two forms: the Electronic Signature Agreement and the Verification by Company Authorizing Official Form. Registration enables CDX to perfor m two important functions: authenticat e identity, and verif y authorization. For authentication of identity, the submitter completes the Electronic Signature5

- 23



### Agreement form, signs and dates it, has the form notarized, and mails it back to EPA. The

Verificat ion 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

est imate 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 estimat es the burden to receive

, process, review, approve, and file wet

- ink signature agreements for new submitters or submissions as a result of employee turnover is 0.17 hours per form (EPA, 2004). All 4,085 sites will be required to submit new electronic signa ture agreements in the 201 2 submission year. In future reporting cycles, only sites which have not previously registered with CDX or sites with a new authorized company official must submit the electronic signature agreements. EPA expects this number to be negligible. Therefore EPA expects the Agency burden of this amendment to be approximately 645 hours (4,085 sites x 0.17 hours per site).

The processing, reviewing, approving, and filing of the electronic signature agreements is expected to be completed by the GS

- 13 Step

- 3 employee currently responsible for data processing, systems development, and contract oversight and management . EPA multiplied the burden estimate of 645 hours with an hourly wage rate of $67.22. This wage rate was calculated by dividing the annual total loaded wage of the GS

- 13 Step 3 employee ($ 139

, 819 ) found in Table 5

- 1 by one FTE of 2,080 hours. Therefore, the total cost to the Agency of processing, reviewing, approving, and filing of the electronic signature agreement form is approximately $46,700 during the 201 2 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 chemica l substance . Under the amendment, the foreign manufacturer must now register with CDX and submit its report electronically. P reviously, joint submissions could not be
made electronically.

For the 2006 IUR reporting cycle, EPA set aside joint submissions un til both were received and matched. Oftentimes, EPA had no way to determine whether a submission was a “joint” submission, which increased the time required for manual processing of the data. EPA anticipates the use of the reporting tool will help to make joint IUR reporting easier for industry. Although not quantified, EPA also anticipates the electronic reporting tool will streamline EPA’s processing of the IUR information

submitted in the 201 2 reporting cycle, thus reducing Agency burden.

5.4.31 

### Modify Reportin g Frequency
EPA is modifying the IUR reporting cycle from five years to four years. This will increase the Agency burden because the Agency will receive and process IUR data more frequently. The annual baseline Agency burden is two FTEs, or 4,160 hours. Table 5

- 39 contains the change in
burden over a 2 6

- year period. In total, EPA estimates the Agency will spend 4,160 more hours

over a 2 6

- year period as a result of modifying the IUR reporting frequency.5

- 24

Table 5

- 39 : Change in Agency Burden as a Result of Modifying the Reporting Frequency

Reporting Cycle 1 Year(s) Baseline Burden Post

- Amendment

Burden Change in

Burden

(Hours) (Hours) (Hours)

1 2006 to 2012 4,160 4,160 0

2 2013 to 2017 4,160

-- 0

2013 to 2016

-- 4,160

3 2018 to 2022 4,160

-- 0

2017 to 2020

-- 4,160

4 2023 to 2027 4,160

-- 0

2021 to 2024

-- 4,160

5 2028 to 2032 4,160

-- 0

2025 to 2028

-- 4,160

6 2029 to 2032

-- 4,160 4160

Total 20,80 0 24, 96 0 4,16 0
Annual Average 800 960 160

Note: 1 The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are four

- year cycles



### Table 5

- 40 contains the 2 6

- year cost est imate 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 est imates it will cost the Agency approximately $466,100 to increase the frequency of reporting from a five

- year reporting cycle to a four

- year reporting cycle over a 2 6

- year period. EPA estimates the annualized changes in cost would be $ 16,463 and $ 14,285 w ith a three percent and seven percent discount rate, respectively.

Table 5

- 40 : Change in Agency Cost as a Result of Modifying the Reporting Frequency

Reporting Cycle Year(s) Baseline Cost Post

- Amendment
Cost C hange in Cost

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

1 2006 to 2012 $466,132.9 $466,132.9 $0.0

2 2013 to 2017 $466,132.9

-- $0.0

2013 to 2016

-- $466,132.9

3 2018 to 2022 $466,132.9

-- $0.0

2017 to 2020

-- $466,132.9

4 2023 to 2027 $466,132.9

-- $0.0

2021 to 2024

-- $466,132.9

5 2028 to 2032 $466,132.9

-- $0.0

2025 to 2028

-- $466,132.9

6 2029 to 2032

-- $466,132.9 $466,132.9

Total $ 2,330,664 $ 2,796,797 $ 466,133

Annualized @ 3% $ 83,030 $ 99,493 $ 16,463

Annualized @ 7% $ 74,650 $ 88,935 $ 14,285

Note: The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are four

- year cycles5

- 25

5.5 

### Total Agency Cost of All Modifications

As EPA did with the industry cost calculations, EPA calculated the cost for each individual

amendment as a stand

- alone cost, and did not take into account the effect of individual

amendments on the others. For this reason, when calculating the total Agency cost, EPA could not simply add the changes in burden for each amendment, but had to consid er the interactions among the amendments. For a more detailed discussion of the interaction s among the amendments, see Section 4.5

. In the 2012 reporting cycle the Agency will also experience

additional burden o f accession number requests (see Section 5.4.11 ). The Agency will have to

p rocess electronic signature agreements (see Section 5.4.29 ) in both the 2012 and subsequent reporting cycles. However, in r eporting cycles following the 2012 reporting cycle, EPA will only need to process electronic signature agreements from new sites

, or approximately 5 percent of all

sites. As shown in Table 5

- 37 , EPA expects the electronic submissi on amendment wil l decrease Agency burden of processing a Form U by approximately 88.6 percent

.5

- 26

Table 5

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

Table 5

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



### To calcu late the combined effect on Agency costs when all amendments are enacted, EPA

used t he baseline number of reports and sites taken from the 2006 IUR database (EPA, 2008c) and the baseline per report cost and burden estimates as found in Table 5

- 4 . The change in the Option Bur den per
Part I of Report (hours) Burden per

Part II of Report (hours) Burden per

Part III of Report (hours)

Baseline 0.0170 0.0422 0.0538

Production V olume U sed O n

- S ite

-- 0.0002

-- Industrial F unction C ategories

-- -- 0.00003 Recycl ed, Remanufac tured, Reprocessed, or Reused,

-- 0.0009

-- Whether Chemical Substance is Physically at S ite

-- 0.0009

-- E xported V olume R eporting

-- 0.0009

-- Consumer/ Commercial Product Categories

-- -- 0.00003

Number of W orkers E xposed

-- -- 0.0009

CBI

-- -- 0.00 05

Production V olume in O ff

- Y ears

-- 0.0009

-- Electronic Submission

- 0.0151

- 0.0407

- 0.0489
Ascension Number Requests (First Reporting Cycle)

- 0.0058
Electronic Signature Agreements 0.1700

- Total Change from the Baseline with A ll Amendments 0. 1549

- 0.0311

- 0.0475 Total, A ll Amendments 0.1719 0.0111 0.0063

Option Burden per
Part I of Report (h ours) Burden per

Part II of Report (hours) Burden per Part

III of Report (hours)

Baseline 0.0170 0.0422 0.0538

Production V olume U sed O n

- S ite

-- 0.0002

-- Industrial F unction C ategories

-- -- 0.00003 Recycl ed, Remanufactured, Reprocessed, or Reused,

-- 0.0009

-- Whether Chemical substance is Physically at S ite

-- 0.0009

-- E xported V olume R eporting

-- 0.0009

-- Consumer/ Commercial Product Categories

-- -- 0.0000 3

Number of W orkers E xposed

-- -- 0.0009

CBI

-- -- 0.0005

Production V o lume in O ff

- Y ears

-- 0.0027

-- Electronic Submission

- 0.0151

- 0.0423

- 0.0489 Electronic Signature Agreements 0.0081

-- -- Total Change from the Baseline with A ll Amendment

- 0.0070

- 0.0367

- 0.0475
Total, A ll Amendments 0.0100 0.0054 0.00635

- 27



### number of reports due to the effect of the amendments combined is calculated in Table 4

- 48 and

Table 4

- 49 for the first and future report ing cycles, respectively. EPA added t he co st 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 cos ts not related to data entry (see Table 5

- 2 )

.
Table 5

- 43 presents the total Agency burden for all the amendment s combined. In total

, EPA estimates the Agency will save 9 40 hours during the first reporting cycle and 1,67 8 hours in each future reporting cycle. Table 5

- 44 presents the total Agency cost estimates; the Age ncy will save approximately $ 6 8,000 in the first reporting cycle a nd $ 175, 0 00 in future reporting cycles as a result of the IUR

amendments. The baseline and post

- amendment costs both contain the cost of all extramural activities,
found in Table 5

- 2

.

Table 5

- 43 : Total Agency Burden for All Amendments Combined

Burden

per Report (Part I) (hours) Number

of Sites Burden

to
Process

Part II (hours) Number of

Reports (with Part II) Burden

to
Process

Part III (hours) Number of

Reports (with Part III) Agency Burden

(hours)

(a) (b) (c) (d) (e) (f) (g) = (a b)+(c d)+(e f) 1,2

First

- year Baseline 0.017 4,085 0.042 25,896 0.05381 17,075 4,160

First year,

Post
Amendment 0.1719 4,085 0.012 25,853 0.00631 20,718 3,220

Change
from the Baseline,

F irst year 3 0.15 0

- 0.030

- 43

- 0.05 3,643

- 940

Future

cycle
Baseline 0.017 4,085 0.042 25,896 0.054 17,075 4,160

Future

cycle, Post
Amendment 0.01 4,289 0.005 30,935 0.01 30,287 2,482

Change
from the Baseline,

Future cycles 3 - 0.01 204

- 0.04 5,039

- 0.05 1 3,212

- 1,678

Note s :
1 Totals include an additional 2,080 hours to account for additional Agency activities conducted one GS

- 13 employee

. 2 Total may not sum due to rounding

. 3 Values in Change from the Baseline rows are calculated by subtracting the corr esponding baseline value from the post

amendment value.5

- 28

Table 5

- 44 : Total Agency Cost of All Amendments Combined

Cost per Report (Part I) (2008 $ ) Number

of Sites Cost to

Process

Part II (2008 $ ) Number of

Reports (with Part II) Cost to

Process

Part III (2008 $ ) Number of

Reports (with Part III) Agency Cost

(2008 $ )

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

First

- year Baseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133 First year,

Post
Amendment $11.63 4,085 $3.38 25,853 $0.70 20,718 $398,571 Change
from the Baseline, First year 3 $9.85 0

- $1.02

- 43

- $4.91 3,643

- $67,562

Future

cycle

B aseline $1.78 4,085 $4.40 25,896 $5.61 17,075 $466,133

Future

cycle, Post
Amendment $0.75 4,289 $0.58 30,935 $0.70 30,287 $291,515

Change
from the Baseline,

Future cycles 3 - $1.03 204

- $3.82 5,039

- $4.91 13,212

- $174,618

Note s :
1 Totals include an addit ional $149,387 to account for additional Agency activities conducted one GS

- 13 employee and contactor

staff.

2 Total may not sum due to rounding

. 3 Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### To calculate the Agency burden per report , EPA first followed the same methodology used to calculate the baseline burden per data element ( s ee Section 5.3 ). EPA calculated the total number

of data e lements in the revised Form U ( 16 6 elements in the first reporting cycle ) and the percentage of data elements in each section of the form, and derived a weighted percentage of elements in each section of the form. For example, the revised Part I contains 2 4 data elements, and 4, 085 sites are expected to submit Part I when all the amendments are considered. These 114,380 data elements ( 28 x 4,085 = 114,380 ) account for approximately 2. 9 percent of all data elements. Similarly

, 49.1 percent of all data element s are in Part II of the form, and 47.9 percent are in Part III. The Agency then multiplied the total variable burden of Form U processing, 274 hours, by the percentage of data elements in a section and divided by the total number reports

submitted for each section

. The total burden per data element does not account for the burden associated with processing electronic signature forms or accession number requests , because
these are not data elements on the Form U

. To calculate the total variable burden to the Agency,
EPA took the total burden estimate of 3,2 20 hours ( Table 5

- 43 ) and subtracted the fixed burden of 2,080 hours , the burden associated with processing electronic signature agreements, 695.55

- 29



### hours (Section 5.4.29 ) and the burden associated with accession number request 171.5 hours ( Table 5

- 15 )

. An example of this calculation can be seen in Equation 3 for Part I.

Equation 3 : Burden to Process Part I per Report = ( 274 hours x 0.0 323 9 ) / 4, 085 = 0.002 hours



### The burden per section was then divided by the total number of data items in that section to calculate the burden per item, 0.0000 8 hour s (approximately 0 .00 49 minutes) (See Equation 2 ).

Equation 4 : Burden per Data Element = 0.002 hours / 24 = 0.0000 8 hours



### EPA then added the burden for processing electronic signature forms and ascension number requests, which were no t included in the per data element burden. EPA added the burden per report for both activities from Table 5

- 43 to calculate the total burden per

- report. Therefore for section one, the per report burden of processing electronic sig natures (0.17 hours) was added to the total burden of processing all data elements in the section (0.002 hours) to calculate the total burden per report.

Equation 5 : Burden per Report Section = (0.00008 hours x 24 data elements) + 0.17 hours =
0.1720 hours

Table 5

- 45 contains the total post

- amendment burden to the Agency at the per

- report and per

data element level. Because of the electronic submission, the Agency burden increase by 0.77 hours per full re port in both the first reporting cycles and decreases by 0.091 hours in future reporting cycles despite 43 data elements being added to Form U in the second cycle.5

- 30

Table 5

- 45 : Agency Burden per Report when A ll Amendments are Combined (First Cycle)

Form U
Section Number of Data Elements Burden per Data Element Burden for Processing Other
Submissions Related to IUR Reporting Total Burden per Report

(hours) (hours) (hours)

Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendment Change

from
Baselin

e

Part I 19 24 5 0.0009 0.00008

- 0.0008 0. 0000 0. 1700 0.1700 0.017 0.1720 0.155

Part II 47 64 17 0.0009 0.00008

- 0.0008 0.0000 0.0066 0.0066 0.042 0.0118

- 0.030

Part III 60 78 18 0.0009 0.00008

- 0.0008 0.0000 0.0000 0.0000 0.054 0.0063

- 0.047

Total (Full Report) 126 166 40

- - - - - - 0.113 0.190 0.077

Note: Totals may not exactly match totals presen ted in Table 5

- 43 due to rounding

Table 5

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

Form

U
Section Number of Data Elements Burden p er Data Element Burden for Processing Other
Submissions Related to IUR Reporting Total Burden per Report

(hours) (hours) (hours)

Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendment Ch ange

from
Baseline Baseline Post

Amendment Change

from
Baseline

Part I 19 24 5 0.0009 0.00008

- 0.0008 0.0000 0.0081 0.00 81 0.017 0.0100

- 0.007

Part II 47 67 20 0.0009 0.00008

- 0.0008 0.0000 0.0000 0.0000 0.042 0.0054

- 0.037

Part III 60 78 18 0.0009 0.0 0008

- 0.0008 0.0000 0.0000 0.0000 0.054 0.0063

- 0.047

Total (Full Report) 126 169 43

- - - - - - 0.113 0.022

- 0.091

Note: Totals may not exactly match totals presented in Table 5

- 43 due to rounding5

- 31

To calcula te the cost to EPA, the process described above was repeated; however, instead of using the hourly burden, EPA used the combined cost for the quality control of data entry, document receipt, tracking, data entry processing electronic signature forms a n d as cension number requests which was $ 31,691

. This cost was calculated by subtracting the fixed Agency costs, $249,184 (see Table 5

- 3 )

, processing electronic signature forms $46,681 (Section 5.4.29 ) and the cost associated with ascension number requests $11,528 ( Table 5

- 16 ) from the total post

- amendment cost of $ 398,571 . Thus, EPA
calculated i t costs the Agency approximately $0.0 1 t o process a single data element of Form U. The total Agency cost per report is approximately $ 15.7 2 in the first reporting cycle and $2.03 in all future cycles

. Table 5

- 47 and Table 5

- 48 contain the Agen cy cost per report by section of Form U for the first and

future reporting cycles

.5

- 32

Table 5

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

Form

U
Section Number of Data Ele ments Cost per Data Element Cost for Processing Other
Submissions Related to IUR Reporting Total Cost per Report

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

Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendm ent Change

from
Baseline Baseline Post

Amendment Change

from
Baseline

Part I 19 24 5 $0.09 $0.01

- $0.08 $0.00 $11.43 $11.43 $1.71 $11.64 $9.93

Part II 47 64 17 $0.09 $0.01

- $0.08 $0.00 $2.82 $2.82 $4.23 $ 3. 39

- $0.84

Part

III 60 78 18 $0.09 $0.01

- $0.08 $0.00 $0.00 $0.00 $5.40 $0.69

- $4.71

Total (Full Report ) 126 166 40

- - $11.34 $15.72 $4.38

Note: Totals may not exactly match totals presented in Table 5

- 44 due to rounding

Table 5

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

Form
U
Section Number of Data Elements Cost per Data Element Cost for Processing Other
Submissions Related to IUR Reporting Total Cost p er Report

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

Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendment Change

from
Baseline Baseline Post

Amendment Change

from
Baseline

Part I 19 24 5 $0.09 $0.01

- $0 .08 $0.00 $0.54 $0.54 $1.71 $0.76

- $0.95

Part II 47 67 20 $0.09 $0.01

- $0.08 $0.00 $0.00 $0.00 $4.23 $0.59

- $3.64

Part III 60 78 18 $0.09 $0.01

- $0.08 $0.00 $0.00 $0.00 $5.40 $0.69

- $4.71

Total (Full Report) 126 169 43

- - $11.34 $2.03

- $9.3 1

Note: Totals may not exactly match totals presented in Table 5

- 44 due to rounding5

- 0

Table 5

- 49 contains Agency costs per

- data element and per

- report separated by EPA and contractor staff. Using the values in Table 5

- 3 , EPA estimates in the baseline, approximately 56.4 percent of the variable Agency costs are attributed to EPA staff ($122,317/$216,949). The remaining 43.6 perce nt of data processing costs are incurred by contractor staff ($94,632/$216,949). EPA does not expect the

distribution of per

- data element costs between Agency and contractor staff to change as a result of the rule. Thus, to calculate the post

- amendment cos t attributed to contractor staff, EPA multiplied the per

data element cost by 43.6 percent. All processing of electronic signature forms, and the processing of
accession number requests is expected to be conducted by Agency staff. Therefore

, the per

- report costs of processing submissions related to IUR reporting was added to the Agency staff total. The cost to contract staff is approximately $0.6 4 in the first reporting cycle and $0.65 in future reporting cycles per report

. The EPA staff cost is approximate ly $15.08 in the first reporting cycle and $1.38 in future reporting cycles.

Table 5

- 49 : Agency Cost per Report when All Amendments a re Combined

Form U Section Cost per Data Element ( 2008$ ) Total Cost per Re port ( 2008$ ) 1
Agency
Staff
Cost Contractor

Cost Total Post

Amendment
Cost Agency

Staff
Cost Contractor

Cost Total Post

Amendment
Cost

Part I $0.005 $0.004 $0.009 $11.55 $0.09 $11.64

Part II $0.005 $0.004 $0.009 $3.14 $0.25 $3.39

Pa rt III $0.005 $0.004 $0.009 $0.39 $0.30 $0.69
Total (Full Report)

- - - $ 15.08 $0. 64 $15.72

Part I (Future Cycles) $0.005 $0.004 $0.009 $0.66 $0.09 $0.76

Part II (Future Cycles) $0.005 $0.004 $0.009 $0.33 $0.26 $0.59

Part III (Fu ture Cycles) $0.005 $0.004 $0.009 $0.39 $0.30 $0.69

Total (Future Cycles) (Full Report) - - - $1.38 $0.65 $2.03

1 Note : T otals may not sum due to rounding

.5

- 1

5.6 

### Annualized Agency Cost Estimates for All Modifications

Ta ble 5

- 50 present s the annual Agency burden estimates for data e ntry and extramural costs

over a 2 6

- year period

. The annual baseline Agency burden is equivalent to two FTEs

, or 4,160
hours

. The post

- amendment Agency burden is calculated in Table 5

- 43 , and an FTE is added to
account for all the GS

- 13 level tasks (see Table 5

- 3 ), which are not affected by any of the

amendments

. In total

, EPA estimates the Agency burden for the IUR rule will b e reduced by 5, 202 hours over a 2 6

- year period under the IUR amendments

.

Table 5

- 50 : A gency Burden over a Period of 2 6 Years if All Amendments a re Implemented

Reporting Cycle 1 Year(s) Baseline Burden Post

- Amen dment

Burden Change in Burden

(Hours) (Hours) (Hours)

1 2006 to 2012 4,160 3,220

- 940

2 2013 to 2017 4,160

--

- 1,678

2013 to 2016

-- 2,482

3 2018 to 2022 4,160

--

- 1,678

2017 to 2020

-- 2,482

4 2023 to 2027 4,160

--

- 1,678

2021 to 2024

-- 2, 482

5 2028 to 2032 4,160

--

- 1,678

2025 to 2028

-- 2,482

6 2029 to 2032

-- 2,482 2,448

Total 20,800 15,632

- 5,202 Annual Average 800 601

- 199

1 The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are , four

- year cycles



### To estimate the per

- reporting cycle cost of all the amendments over a 2 6

- year period, EPA

used the total baseline cost estimate in Table 5

- 3

. These costs include the data entry perfo rmed

b y both EPA and contractor staff, and all extramural activities conducted by contract or staff.
Under the baseline , EPA estimates the total Agency cost will be $ 466,100 during each reporting cycle

. The annualized post

- amendment cost also include s all extramu ral costs from Table 5

- 2 in addition to the data entry and quality control costs.

Table 5

- 51 contains the annualized cost estimation

. In total

, annual post

- amendment cost w ill be $ 398,571 during the first reporting cycle and $291,5 15 thereafter. O ver a 2 6

- year period

, EPA
estimates the Agency will save approximately $ 474,500

. Annualized savings are approximately $ 15,300 and $ 12,100 , discounted at three percent and seven perc ent, respectively.5

- 2

Table 5

- 51 : Annual and Discounted Total Cost to the Agency of All Modifications

Reporting Cycle 1 Year(s) Baseline Cost Post

- Amendment
Cost Change in Cost

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

1 2006 t o 2012 $466,133 $ 398,571

- $67,562

2 2013 to 2017 $466,133

--

- $174,618

2013 to 2016

-- $291,515

3 2018 to 2022 $466,133

--

- $174,618

2017 to 2020

-- $291,515

4 2023 to 2027 $466,133

--

- $174,618

2021 to 2024

-- $291,515

5 2028 to 2032 $466,133

--

- $174,618

2025 to 2028

-- $291,515

6 2029 to 2032

-- $291,515 $291,515

Total $2,330,664 $1,856,146

- $474,519

Annualized @ 3% $80,612 $65,279

- $15,333

Annualized @ 7% $69,767 $57,618

- $12,149

1 The non

- italicized reporting cycles are baseline, f ive

- year cycles, and the italicized reporting cycles are , four

- year cycles6

- 1 

## 6. Social Cost Summary

To calculate the total burden to society of the IUR amendments

, EPA added the total industry

burden to the Agency burden savings. Table 6

- 1 contains the annual burden estimates for the years 20 0 6 through 203 2

.
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 t he IUR rule amendments would increase the industry burden in the first reporti ng cycle by 0.50 million hours (see Table 4

- 52 ) and decrease Agency burden by 940 hours (see Table 5

- 43 ). The net burden increase is 0.49
million hours.

The burden in future reporting cycles will be less than for the first reporting cycle. The shift

from a five

- year cycle to a four

- year cycle increases both industry and Agency burden. All of these changes are shown in Table 6

- 1

. EPA estimates all of the amendments combined would

i ncrease the burden to society by 7.61 million hours over a 2 6

- year period. This includes a

burden increas e of 7.62 million hours to the affected industry over the 2 6 years (see Table 4

- 57 ),
and a burden decrease of 5,200 hours to th e Agency (see Table 5

- 50 ) over the same period.

As shown in Table 6

- 1

, EPA estimates the total increase in burden as a result of the IUR rule

amendments over a 2 6

- year period will be 7.61 million hours

.

Table 6

- 1 : Change in Total Burden to Society If All Modifications a re Implemented

Reporting Cycle Year(s) Baseline Burden Post

- Amendment

Burden Change in Burde n

( millions of h ours ) ( millions of h ours ) ( millions of h ours )

1 2006 to 2012 1.85 2.34 0.49

2 2013 to 2017 1.44 0.00 1.14

2013 to 2016 0.00 2. 57

3 2018 to 2022 1.44 0.00 1.14

2017 to 2020 0.00 2. 57

4 2023 to 2027 1.44 0.00 1.14

2021 to 2024 0.00 2. 57

5 2028 to 2032 1.44 0.00 1.14

2025 to 2028 0.00 2. 57

6 2029 to 2032 0.00 2. 57 2.57

Total 7.60 15.21 7.61
Annual Average 0.29 0.59 0.29

Note: The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are four

- year cycle

. s



### Table 6

- 2 contains the total cost and change in cost to society as a result of the IUR rule

amendment s. The cost to society is expected to increase by $ 494. 71 m illion over the 2 6

- yea r period as a result of the IUR amendments

. The cost to industry is expected to increase by $ 495. 2 million over this period (see Table 4

- 58 ), and the Agency cost is expected to decrease by $6

- 2



### 474,500 (see T able 5

- 51 ). The annualized cost to society over a 2 6

- year period is $ 17.15 million and $ 14.70 million at three percent and seven percent discount rate s , respectively.

Table 6

- 2 : Change in Total Costs to Socie ty if All Modifications a re Implemented

Reporting Cycle 1 Year(s) Baseline Cost Post

- Amendment
Cost Change in Cost

(millions of 2008$) (millions of 2008$) (millions of 2008$)

1 2007 to 2011 $107.43 $ 144.13 $36.70

2 2012 to 2016 $83.28

-- $ 74.95

2012 to 2015

-- $ 158.2 3

3 2017 to 2021 $83.28

-- $ 74.95

2016 to 2019

-- $ 158.23

4 2022 to 2026 $83.28

-- $ 74.95

2020 to 2023

-- $ 158.23

5 2027 to 2031 $83.28

-- $ 74.95

2024 to 2027

-- $ 158.23

6 2028 to 2031

-- $ 158.23 $ 158.23

Total $440. 57 $935.28 $494.71

Annualized @ 3% $15.97 $33.11 $17.15

Annualized @ 7% $14.70 $29.39 $14.70

Note 1 The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are four

- year cycles7

- 1



## 7. Impact of the Final I UR Rule Modifications Rule on the Benefits of the IUR

T he IUR rule is one of EPA’s most valuable tools for meeting the Agency’s mandate under TSCA to manage the risks resulting from chemical substance production and use in the United
States. It is EPA’s mo st comprehensive source of data on the chemical industry, and IUR data

are used in almost all of OPPT’s risk screening and management programs. However, the IU R data in their current form have numerous limitations, which in turn limit EPA’s effectiveness i n meeting its mandate under TSCA

. In an effort to improve the quality and usefulness of the data the Agency collects under the IUR rule, EPA is promulgating a set of IUR amendments. The amendments would improve the completeness and accuracy of the IUR data by requiring electronic reporting using the e

- IURweb reporting software, expand ing the range of chemical substance s for which full information would be reported, adjust ing the specific reported information, increas ing the frequency of collecting

the infor mation, and modify ing CBI requirements . EPA expects the amendments will reduce many of the current data constraints and, as a result, improve the effectiveness of EPA’s

chemical substance risk management programs. Most importantly, the IUR rule amendment s will require submitters to provide processing and use exposure

- related information for more chemical

substance s. This additional information will allow EPA to more accurately assess human and

e nvironmental exposures to specific chemical substance s, includi ng the concentrations, frequency, and durations of these exposures.

With this additional information, EPA will improve its ability to screen chemical substance s to identify whether additional risk assessment and management steps are needed. More complete reporting of the processing and use data, more careful consideration of c onfidentiality 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 mo re effectively and expeditiously reduce the risks posed by chemical substance s. 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 actua l risk, whet her higher or lower than it would be if based only on assumptions. Ultimately, an enhanc ed risk screening process will have positive consequences for human and ecosystem health, and will use EPA’s and society’s resources more efficiently. Additional benefi ts will accrue from changes in reporting requirements that will improve consistency and compatibility with other EPA databases. EPA will be better able to anticipate industry trends, particularly for chemical substance s for which EPA has concerns , and

to m easure the effectiveness of Agency programs

. The benefits resulting from the IUR rule amendment s are discussed qualitatively in this section. Quantification of the benefits of the rule would require more specific information about each user’s use patterns and preferences, and the changes in the use patterns and preferences

which will result from the additional information made available under the rule. These data are not readily available , and collecting such data would be cost

- prohibitive. For example, one approach would be to conduct a national willingness

- to

- pay (WTP) survey of the general public to determine the value the public places on the availability of the information resulting from the rule. However, such a survey, or a survey to collect similar i nformation

, has not been conducted.7

- 2

7.1 

### Benefits of Information

- Based Policies

Improvements in the IUR data will allow EPA and others to use the data more effectively as part of the Agency’s risk screening and prioritization programs. Screening chemical substa nce s for potential risks is an essential first step in developing and prioritizing risk management
activities. Effective risk

- screening by EPA depends on the ability to characterize chemical

substance uses accurately and to predict potential exposures. Cur rent screening activities are greatly hampered by the incomplete data supplied through the 2006 IUR. In addition, EPA’s current screening activities for medium production volume chemical substance s are hampered further by the fact EPA has only estimates of production volume for many chemical substance s and must rely on relatively limited public sources of information. This final rule will benefit society by filling these information gaps and contributing to better assessments of potential risks

and risk man agement decisions.

The amendments to the IUR rule will increase the amount of publicly available data about a

chemical substance ’s potential risks , and consequently are likely to result in (a) a reduction in the

costs of risk

- based decisions about the chem ical substance , and (b) an improvement in the expected outcome of the decisions.

Reduced cost of risk

- based decision making. By making new information about toxic substances available to the public (including EPA and other government agencies), this rule

c an replace other information

- gathering, management, and dissemination activities related to the regulated chemical substance s. Once the data are publicly available, information users and decision makers will avoid the time and resource costs required to in dividually perform these activities. In effect, the 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 m ost highly valued uses. With incomplete information regarding toxic chemical substance s, public and private decision makers are un able to make adequate assess ments of the benefits and costs of actions involv ing these substances. For example, EPA decisions regarding whether, when, and how to target chemical substance s 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

- p riority risks. Improved information can therefore help lead to more socially optimal
reductions in risks to humans and the environment.

The rule amendments will generate both types of benefit s. First, it will reduce EPA’s and
other decision makers’ relian ce on other databases and information sources that are inadequate for accurately and efficiently characterizing the risks associated with the thousands of chemical

substance s in commerce that need to be evaluated. As discussed in Chapter 5. EPA will incur additional costs for collecting and managing the new IUR data; however, by providing more reliable and complete data on chemical substance uses and exposures, the rule will also allow
EPA to save time and resour ces in screening chemical substance s and in developing risk management priorities. Furthermore, by requiring data to be submitted electroni cally, the rule
will reduce EPA’s costs of processing the IUR data and result in a better quality database

. Second, i t will allow EPA to better prioritize its risk management activities and to move more quickly in addressing chemical substance s pos ing relatively high risks (and/or relatively
low risk

- management costs).7

- 3



### A more detailed discussion about the value of inform ation

- based policies can be found in the Economic Analysis for the 2003 Amendments (EPA, 2002a). Specific benefits accru ing from the use of the information generated by th is final rule are discussed in the following sections.

7.2 

### Benefits of Individual Amendme nts

The IUR amendments expand the range of chemical substance s for which full information is to be reported, adjust the specific reported information, increase the frequency of collecting the information, and modify CBI requirements. These amendment s also will provide information to better address Agency and public information needs, improve the usability and reliability of the reported data, and ensure data are available in a timely manner. EPA is finalizing these

amendment s to the IUR rule to meet four pr imary goals :(1) to tailor the information collected to

better meet the Agency’s overall information needs , (2) to increase its ability to effectively provide public access to the information, ( 3 ) to obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory, and ( 4 ) to improve the usefulness of the information reported

. The following sections describe how each of

the amendments meet s these goals and generate s benefits to data users.

7.2.1 

### Tai lor Information Collected to More Closely Match the Agency’s
Information Needs

EPA’s efforts to use the 2006 IUR data have identified areas where further improvements are

needed. Several of the amendment s described in this rule will change some of the repo rting requirements in an effort by EPA to increase the usability of the collected information and to focus IUR reporting on the information needed most by the Agency. These changes will enable EPA and other Federal agencies to improve their risk screening programs, enabling them to better assess and manage risk and improv e public awareness of basic information about a large

number of chemical substances. These amendment s and their specific benefits are described
below.



## Parent Company Name and Site Identity

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

- U

- N

- S® number to identify the company associated with the plant site, and also to report the site name, address, and D

- U

- N

- S® number EPA received a var iety of questions concerning the correct company name to report during the 2006 IUR reporting cycle. EPA is now clarifying what is meant by company name, by requiring the company name provided to be the ultimate domestic parent company
name. EPA believes t his change will reduce confusion by making this reporting requirement consistent with the Toxic Release Inventory (TRI) requirements for parent company name

. Reduced confusion leads to more accurate information, which in turn leads to more accurate risk ch aracterizations.

Furthermore, th e 2006 IUR submissions from different reporting sites contained varying D

- U

- N

- S® numbers for parent companies appearing to be the same company. In order to better identify when reporting sites are under the same parent compa ny, EPA is including the address as well as the D

- U

- N

- S® number of the parent company. Similar to the change in parent company name, this change also will lead to more accurate information, which will lead to more accurate risk characterizations and small business analyses.7

- 4



## Technical C ontact

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 substan ce 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 concernin g 2006 IUR submissions, submitter s often provide the names of individuals
who are not co nnected directly to the reporting site, and therefore, are not knowledgeable about

either the chemical substance or the submission. EPA has also seen situations where the technical contact is a contracted employee who is able to address subsequent concerns only as long as he or she remains under contract to the company

. EPA may raise follow

- up questions
about an IUR submission possibly for years after the submission date. EPA is now allowing multiple technical contacts on a chemical substance

- by

- chemical su bstance basis , and is no longer requiring that the technical contact be located at the manufacturing site

. The benefit of

this amendment will be increased clarity, which leads to improved accuracy in the information collected, which in turn leads to more a ccurate risk characterizations.



## Chemical Identity

EPA is requiring the reporting of the Chemical Abstracts (CA) Index Name currently used to list the

substance in the TSCA Inventory as the chemical name reported for IUR. Currently, submitters are required to report a specific chemical name, with no further elaboration in the regulatory text. EPA has found, however, that submitters sometimes supply a name that is somewhat generic or excludes parts of the specific chemical identity distinguishing one substanc e from another. EPA’s experience in the 2006 IUR was that up to five percent of the reports submitted contained chemical identity problems serious enough that the Agency was unable to precisely identify the substance. These problems resulted in the
tempora ry exclusion of the information associated with the poorly or erroneously identified chemical
substance from the IUR database until the Agency was able to obtain correct and specific chemical identity information from the submitter. EPA believes the requir ement to use the substance name as currently listed on the TSCA Inventory will greatly reduce the number of poorly identified substances. Improved chemical identification ultimately leads to more accurate risk characterizations.

EPA is removing the PMN nu mber as an allowed chemical identifying number because each Inventory substance has either ( or both ) a CASRN (for the public Inventory) or a TSCA accession

number (for the confidential Inventory) , which are likely to be known already to the submitter

.
This amendment will save the Agency considerable time and effort to access and review reported information that has been identified only by a PMN case number.



## Report Production Volume for E ach of the Y ears since the Last Principal Reporting Year

EPA is requiri ng reporting of production volume for each of the years since the last IUR principal reporting year in all future reporting cycles

, and the reporting of 2011 and 2010 production volumes for the 2012 reporting cycle. Thus, starting with the 2016 IUR reporti ng cycle , manufacturers (including importers) of a chemical substance at or above the 25,000 lb

threshold in any calendar year in the cycle will be required to report the production volumes for all years in the cycle (e.g., 2012

, 2013

, 2014 and 201 5 )

. Col lecting the production volume for multiple years will provide greater detail than the current “once

- every

- five

- years” snapshot.7

- 5



### EPA has mounting evidence that many chemical substance s, including larger volume

chemical substance s, are manufactured in volum es that may fluctuate widely from year to year.

This can result in the production volume of a chemical substance exceeding the threshold for several years, then falling below the threshold during the IUR principal reporting year. Therefore, EPA believes a single snapshot of annual production v olume (i.e., taken just once

each reporting cycle ) does not provide an accurate picture of the chemical substance s in commerce, and may provide an erroneous view of the exposure scenarios associated with a particular c hemical substance.

EPA uses production volume data in several important ways. The data help the Agency to establish trends in chemical manufacturing; to determine the effectiveness of various Agency

programs; to estimate the magnitude of consumer, worker, and environmental exposures; and to determine the costs (and financial impacts) of potential control strategies in economic analyses. Voluntary EPA programs such as Design for the Environment (DfE) and other pollution prevention programs will use the annua l 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, r eadily identifiable production trend data. Therefore, this amendment will provide information EPA and others need for the assessment of programs and will provide greater

accuracy of the volumes of chemical substance s in commerce than the current once

- every

- five

year snapshot.



## Volume of Chemical Substance Used On

- Site

EPA is requiring submitters to report the volumes of a manufactured or imported chemical substance used at the reporting site. The requirement to report the volume used on

- site is replacing the requirement to indicate whether the chemical substance is site

- limited. Under this

final rule , either domestically manufactured or imported chemical substance s could be reported

as used at the reporting site, whereas under the current reporting requiremen ts, only domestically

manufactured chemical substance s, consumed entirely at the site of manufacture, should be reported as site

- limited.

EPA is chang ing this requirement to simplify reporting and to collect information that better addresses the Agency’s n eeds. In the past, submitters sometimes erroneously reported their production volume separately to identify the portion of their chemical substance consumed at the manufacturing site

. For the 2006 IUR, many submitters c ontinued this practice and erroneous l y fi led separate reports to indicate a portion of their production volume was site

- limited. Filing separate reports resulted in the need to report separately processing and use information when the combined production volume was 300,000 lb or greater. Incl uding 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. T he amendment to require reporting the volume used on

- site will provide valuable informat ion related to potential exposures associated with the on

- site volumes, therefore providing the Agency with better information for exposure assessments and other data analyses.7

- 6



## Indicat e Whe ther Imported Chemical S ubstance s Are Physically at the Reporting Site

EPA is adding a requirement to indicate whether an imported chemical substance is physically at the reporting site. Often, the site reporting an imported chemical substance never physically receives the chemical substance , but instead ships it directl y to another location such as a warehouse, a processing or use site, or a customer’s site. Identifying whether the chemical

substance is physically at the reporting site provides more accurate information for screening

level analyses and other uses of the IUR data.



## Report Volume Exported

EPA is adding a requirement to report the production volume directly exported and not domestically processed or used. T his amendment will allow EPA to better identify the proportion of the production volume accounted for by the use reporting, given that downstream reporting is not required for exported substances.



## Identify Whether Chemical S ubstance Is To Be Recycled,
Remanufacture d

, Reprocessed, or Reused

EPA is adding a requirement t o indicate whether a manufactured chemic al substance , such as a byproduct, is being recycled , r emanufacture d, reprocessed, or reused

. Submitters will identify

that their manufactured chemical substance , which otherwise would be disposed of as a waste, is being removed from the waste stream and i s being used for a commercial purpose (i.e.

, recycled, remanufactured, reprocessed, or reused)

. Such information will benefit the Agency by identifying where these activities are already occurring, and can be used to encourage such
activities

. Collecting i nformation on whether a chemical substance is being recycled

,

r emanufacture d, reprocessed, or reused and is not entering the waste stream provides valuable information to EPA and others regarding trends in chemical manufacturing and can be used to help det ermine the effectiveness of various programs, such as EPA’s Resource Conservation Challenge (RCC) Program.



## Designation of Consumer or Commercial Use

EPA is requiring submitters to designate whether the use is a consumer or a commercial use,

or both

. The Ag ency’s experience using the 2006 IUR data identified a need to distinguish between potentially exposed consumer and commercial populations. D esignation of consumer or commercial use, or both, will allow EPA to complete a better characterization for the pot entially exposed populations.



## Number of Commercial Workers Reasonably Likely To Be Exposed

EPA is requiring submitters to report the total number of commercial workers, including those at sites not under the submitter’s control, that are reasonably likely to be exposed while using the reportable chemical substance, with respect to each commercial use. The approximate
number of workers will be reported using the same definitions and ranges used for manufacturing and industrial processing and use workers. In formation on the number of commercial workers reasonably likely to be exposed to the reportable chemical substance will be used to characterize the commercial population reasonably likely to be exposed to the subject7

- 7



### chemical substance. Therefore, this ame ndment will improve the population characterization, which is important to the development of the overall exposure characterization.

7.2.2 

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

EPA anticipates the amendments will result i n the Agency receiv ing 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 th e Agency to accomplish this.



## Require Electronic Submissions over the Internet

EPA is requiring the mandatory use of EPA’s Central Data Exchange ( CDX ) through the Internet for manufacturers (including importers) to report IUR information. EPA will require a ll

submissions to be generated using the e

- IURweb reporting software

. EPA will no longer accept paper submissions or electronic media for any IUR submission a fter the effective date of the

final rule.

The amendment to e liminat e paper

- based submissions in f avor of mandatory e

- IURweb reporting will provide several benefits to EPA and industry

. EPA expects the required use of e

IURweb and CDX will reduce the reporting burden on industry by reducing both the cost and the time required to review, edit and transm it data to the Agency. Data systems into which data were once manually entered will now be populated electronically, thus reducing the potential for error when data are entered by hand or when data are entered through a scanning process

. All

information se nt by submitters via CDX will be transmitted securely to protect CBI.EPA will be able to communicate electronically with submitters

, e.g., to confirm receipt of a submission or to identify a problem with the submission. Electronic submission s enable data t o be available for Age ncy and public use more quickly and it eliminates inefficiencies and errors introduced in the process to scan paper submissions.

EPA developed e

- IUR reporting software for use in preparing and submitting reports electronically during the 2006 IUR submission period (see www.epa.gov/iur). For the 201 2 submission period, EPA will provide a free web

- based application in place of the 2006 downloadable software. The 201 2 e

IURweb will feature several enhancements over the 2006 e

- IUR . These improvements include a sophisticated validation system, which will alert users when a required field on the form is either missing information or contains certain kinds of potentially incorrect information. Other updates are expected to
include automated c hemical identity checks, automated company and site identity checks, and the facilitation of joint submissions and amendments. The reporting software also will include user

- friendly features such as drop

- down selections, searchable chemical substance lists , imbedded help files, and an

error

- checking process to help identify common reporting errors before the report is submitted. All of these applications will increase the accuracy of the data and reduce Agency time spent in manually performing these checks.



### Coupled with EPA’s e

- IURweb reporting software, electronic reporting has become the most efficient method of reporting for industry as well as for EPA. During the comment period for the Information Collection Request (ICR) renewal (73 FR 51805 , September 5, 2008) , EPA received positive comments regarding the use of CDX, the encrypted I nternet submission process, and the ability to use a secure electronic signature method to submit IUR reports.7

- 8

7.2.3 

### Obtain New and Updated Exposure Information

The EPA Administrat or has announced her intention to increase efforts to assess, prioritize, and take action on existing chemical substance s, with particular emphasis on protecting children. The Agency is developing a broader, more vigorous approach on existing chemical subs tance s, which will utilize the full range of TSCA regulatory tools to reduce or eliminate risks from

chemical substance s of concern. The IUR rule is one of the tools available for this effort. Through the IUR rule, the Agency collects the information it ne eds to conduct an initial characterization and screening of potential exposures associated with chemical substance s. EPA
needs more in

- depth exposure

- related information to fine

- tune the screening process, and to better assess, prioritize, and take action on existing chemical substance s. The various programs and tools EPA uses to evaluate and manage chemical substance risks are described in Section

7.3

. The amendments will increase the amount of exposure information collected ar e described in the following sections.



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

For the 201 2 reporting cycle, reporting for subject chemical substance s will be required if the production volume in the 201 1 pri ncipal reporting year only meets or exceeds the 25,000 lb reporting threshold, which is the current requirement. For the 2016 reporting cycle and future reporting cycles, a site will examine its annual production volumes for each of the four calendar

years since the last principal reporting year

. If the production volume for a reportable chemical

substance is 25,000 lb or greater for any calendar year during that four

- year period, then the site
will need to report the chemical substance, unless it is otherw ise exempt.

EPA is chang ing the determination method because of the mounting evidence many chemical

substance s, even larger volume chemical substance s, often experience wide fluctuations in manufacturing volume from year to year. This can result in the pro duction volume of chemical

substance exceeding the threshold for several years, then falling below the threshold during the

IUR principal reporting year. Consequently, historical IUR reporting has resulted in a change of approximately 30 percent in the com position of the chemical substance s being reported from one reporting cycle to the next. Therefore, the one

- year snapshot of production volume does not provide an accurate picture of the chemical substance s in commerce, and may provide an
erroneous view of the exposure scenarios associated with a particular chemical substance.

Further evidence that capturing production volume for only the IUR principal reporting year is causing EPA to miss a significant amount of chemical substance production was revealed in

the comments the Agency recei ved from the proposed “reset” of the TSCA Inventory. The Federal Register notice of November 21, 2008 (73 FR 70460) requested industry provide
comment on whether a three

- year reporting cycle was sufficient for deciding wheth er a chemical

substance they manufactured or imported should remain listed on the TSCA Inventory. Commenters overwhelmingly expressed concern the proposed three

- year reporting cycle would drastically misrepresent the chemical substance s presently in commer ce.(See Docket No:EPA

HQ

- OPPT

- 2008

- 0785.)

In submitted comments, companies agreed unanimously that if they were to report for one year only, the reset would inappropriately remove chemical substances from the TSCA Inventory

. While all commenters felt the t hree

- year reporting cycle was inadequate, a majority of7

- 9



### the industry comments suggested reporting should cover a 10

- year period. The comments strongly indicated there were chemical substance s manufactured or imported only occasionally,

and these chemical s ubstance s would not be captured if the reporting covered too short a period. Therefore, requiring chemical substance manufacturers ( importers ) to evaluate production volume for any calendar year since the previous IUR principal reporting year would benefit users of IUR data by yielding a much more accurate picture of the chemical substance s currently in commerce and properly the subject of EPA’s risk screening, assessment, and management

activities.



## Replacing the 300,000 lb T hreshold for P rocessing and Use
Information Reporting

EPA is replacing the 300,000 lb threshold for reporting processing and use information to 100,000 lb for the 2012 reporting cycle

, and replacing the threshold for all subsequent reporting cycles. EPA is t her efore requiring all submitt ers of non

- excluded substances to report information in all parts of the IUR Form U in future reporting cycles

. EPA is lowering this reporting threshold in order to collect information necessary to complete screening

- level exposure characterizations and su bsequent risk

- based prioritizations for medium production volume (MPV) chemical substance s. In the 2003 Amen dments final rule (68 FR 848, January 7, 2003), EPA acknowledged the value of information for chemical substances manufactured in
lower volumes and stated if the Agency were to find it necessary in the future, it would collect information on chemical substances at reporting thresholds below the thresholds introduced in

that action. The IUR processing and use information is needed now to complete the

c haracterizations and prioritizations for those chemical substance s manufactured (including imported) in volumes of 100,000 to 300,000 lb in the first reporting cycle and 25,000 to 300,000

lb in all future reporting cycles.

The Agency currently is unable t o develop screening level risk evaluations for medium and lower production volume chemical substance s because most of these chemical substance s are produced below the volume for which exposure and use information is required under the current

IUR rule (i.e . 300,000 lb per year). The exposure information is an essential part of developing screening

- level risk evaluations and, based on its experience in using this information, the Agency has concluded collecting this information is critical to its mission of c haracterizing

exposure, identifying potential risks, and noting uncertainties for these lower production volume

chemical substance s

.
B oth ha zard and exposure information is needed to develop screening level evaluations

. Once the IUR processing and use info rmation is available for these medium and lower volume

chemical substance s, EPA will be able to develop the exposure characterizations needed to develop the evaluations

. As with the high

- production volume ( HPV ) chemical substance s, EPA
will then be able to identify potential risks, note scientific issues and uncertainties, and indicate the initial priority assigned by the Agency for potential future appropriate action. Therefore, the

rule will provide this necessary processing and use information for chemic al substance s manufactured or imported in volumes of 25,000 lb to 300,000 lb7

- 10



## Reduce the 25,000 lb Threshold for Specific Regulated Chemical
S ubstance s

In reporting cycles subsequent to the 2012 reporting cycle, EPA is reducing the 25,000 lb reporting thre shold to 2,500 lb for specific regulated chemical substances that are the subject of particular TSCA rules and/or orders and to require manufacturers (including importers) of such

chemical substance s to report under the IUR, regardless of the production vo lume

. This provision will ensure the availability of current information when EPA has expressed a concern in the form of regulatory action on those chemical substances, regardless of the production
volume. EPA is reducing the 25,000 lb threshold for those chemical substance s that are: ( 1) the subject of a rule promulgated under section s 5(a)(2), 5(b)(4), or 6 of TSCA ; ( 2) the subject of an

order issued und er section or 5(e) or 5(f) of TSCA; or , ( 3) the subject of relief that has been granted under a civil a ction under section 5 or 7 of TSCA.

Beginning with reporting cycles subsequent to 2012

, manufacturers (including importers) of

these specific regulated chemical substances will be required to report production volumes each year from 20 12 to 201 5

, and the f ull manufacturing, processing, and use information for 201 5, if they have production volumes above the 2,500 lb threshold.

Chemical substance s regulated under TSCA are of demonstrated interest to the Agency. EPA
has made a determination that such substance s either “may present,” “will present,” or “do present” an unreasonable risk to human health and/or the environment or that the substances have “substantial production/significant or substantial exposure.” Therefore, this amendment w ill

en able EPA to use t he IUR data associated with these regulated chemical substance s to monitor

chemical substance production and compliance with the rules.



## Making Chemical S ubstance s Subject to Enforceable C onsent
A greements Ineligible for Exemptions

EPA may enter into an enf orceable consent agreement (ECA) with a manufacturer of a chemical substance to obtain testing where a consensus exists among EPA, affected manufacturers and/or processors, and interested members of the public concerning the need for and scope of testing. Chemical substance s covered by ECAs are of demonstrated interest to EPA. The Agency has an interest in identifying the manufacturing, processing, and use of substances under such agreements, and therefore is requiring such substances to be reported for IUR purposes, regardless of whether the substance otherwise meets the requirements listed in 40 CFR §710.46 ( amended §711.6) as an exempt or partially exempt chemical substance. T his

amendment will ensure the availability of current information if EPA has exp ressed a concern in the form of an ECA on any substance otherwise excluded from the IUR rule. For example, EPA could use the IUR data associated with these regulated chemical substance s to monitor chemical

substance production and compliance with the agree ments.



## Changes to S tandard for the Reporting of Processing and Use
Information

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

commercial and consumer use of chemical substance s, EPA is replacing the “readily o btainable” 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) authorizes7

- 11



### EPA to require persons to report information “known to or reasonably ascertainable by” the

submitter. This is the same stan dard currently appl ying to the reporting of information described in the regulations at 710.52(c)(1), (c)(2), and (c)(3).It covers all information in a person’s possession or control, plus all information a reasonable person similarly situated might be expected to possess, control, or know. The “known to or reasonably ascertainable by” reporting standard was the only standard used for IUR reporting purposes prior to the 2006 IUR reporting

c ycle

. EPA is chang ing the reporting standard because reporting under the “readily obtainable” standard did not generate sufficiently precise processing and use information for screening

- level
reviews. The Agency believes reporting under the “known to or r easonably 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 actual ly was used for industrial processing and use or commercial

and consumer use. Considering only those chemical substance s meeting the criteria to require reporting of processing and use information, only 72 percent of the total volume was accounted

for in t he 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 a nd use data on 78 percent of the expected volume reported. 6 

### Because of this low level of reporting, EPA now believes the reporting standard of “not readily obtainable” was too lenient and resulted in an underreporting of the actual processing and use situa tion.

The Agency’s experience using the 2006 IUR data to develop exposure characterizations has alerted EPA to the fact the IUR processing and use data are incomplete and inconsistent. Effective risk screening by EPA depends on the ability to accurately ch aracterize chemical

substance uses and to predict potential exposures. If the information provided does not include these data, EPA must make assumptions about the use of the unreported production volume. Incorrect assumptions may lead EPA to designat e an inappropriately high priority level to the

chemical substance , resulting in unnecessary effort and resource expenditures for both regulated

pa rties and EPA in cases where adequate data would have led the Agency to act differently.

Therefore, using the repo rting standard “known to or reasonably ascertainable by” will result

in companies reporting more consistent and complete processing and use information in their IUR reports, and more efficient use of EPA resources.



## Change to Reporting Frequency

Prior to t he 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

6 The Agency believes the percentage of miss ing 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 w ith the industrial processing or use information may add up to more than 100 percent of the reported production volume. This could happen because the submitter reported on the distribution of a chemical to sites in its control as well as downstream sites, some of which were not immediate purchasers from the original manufacturing site.7

- 12



### modifications, to reduce the burden associated with the amended IUR requirements

. While the less frequent reporting does reduce burden, t he Agency now has determined reporting every five years does not provide data sufficiently current to meet Agency and public needs, and is

return ing to reporting every four years.

As described above, the Agency has been criticized for using outdated information. Also, a review of the previous reporting under IUR has revealed a change of approximately 30 percent in

the chemical substance s reported from one reporting cycle to the next. Receiving IUR

inf ormation more frequently will provide EPA with a more accurate, up

- to

- date overview of the chemical manufacturing industry , addressing a criticism the Agency has received fo r relying on

outdated inf

ormation . More timely information will help EPA to better prioritize chemical

substance s for screening, and will lead to more efficient use of EPA resources.

7.2.4 

### Improve Utility of Information Reported

Some of the amendment s in the final rule will change reporting requirements, in an effort by

EPA to increase the usa bility of the collected information. By increasing data transparency, increasing international compatibility, or changing the method by which the data are submitted,

these final changes will ultimately enable EPA and other Federal agencies to improve their risk screening programs, enabling them to better assess and manage risk, and improv e public awareness of basic information about a large number of chemical substances.



## Industrial Function Categories

EPA is revising the list of industrial function categori es by combining categories lead ing to common exposure scenarios and adding cate gories where the Agency believes the existing categories do not adequately describe potential uses. EPA worked with Environment Canada and Health Canada to develop the set of ca tegories , which will be used by both the United States and Canada for Inventory reporting. Harmonization of the categories for reporting the industrial

functions of chemical substances will benefit both EPA and Canadian agencies by facilitating the exchang e of information, and will serve as a model to be used by Mexico in developing an

I nventory of chemical substances .In addition, the harmonized categories will facilitate consistent reporting of chemical substance use information by industry in the United States and
Canada

.
Another benefit of revising the list of industrial function categories will be to reduce t he number of uses reported as “O ther.” EPA is requiring that if a submitter chooses the category “O ther,” the submitter include a text description for the industrial function category associated
with the use of chemical substance.



## Industrial Sectors

EPA is replacing the five

- digit North American Industrial Classification System (NAICS)
codes with 4 8 Industrial Sec tors (IS) .The industrial sectors were adopted from the European
Union’s guidance on information requirements and chemical substance safety assessment. The chosen Industrial Sectors divide the entire range of NAICS codes into sectors so any NAICS code has a corresponding Industrial Sector. The Agency believes this change will provide several

benefits .First, it will encourage more complete reporting by using terms already familiar to industry .Second, the industrial sectors will reduce the likelihood of errors result ing from the7

- 13



### selection of mi scellaneous or inappropriate NAICS codes. Third, it will reduce the number of codes that could apply to one substance.

One of the primary purposes of the IUR data collection is to group together similar data for priority setting exercises and activities. R espondents to the 2006 IUR submitted 342 unique five

digit NAICS codes, which made it difficult for EPA to group chemical substance s based on industrial processing and use scenarios. The 2006 IUR database has 2,330 unique combinations of processing or use categories , NAICS, and industrial function categories , in all. This large number of unique combinations increases the difficulty and time required by EPA to sort and classify chemical substance s because EPA either would need to develop exposure scenarios f or each unique combination, or determine which three

- code combinations have similar exposure scenarios and can be grouped. Therefore, another b enefit of using the industrial sectors will be to reduce the number of unique combinations, thereby increasing th e usability of the data.



## Consumer and Commercial Product Categories

EPA is revising the list of consumer and commercial use categories by combining categories

lead ing to common exposure scenarios and adding categories not adequately described in the

initia l set of categories. EPA worked with Environment Canada and Health Canada to develop

the categories, which will be adopted by the United States and Canada for reporting of Inventory

information. Harmonized categories for reporting the consumer and commerc ial uses of chemical substances will benefit both EPA and Canadian agency by facilitating the exchange of information and will serve as a model to be used by Mexico in de veloping an I nventory of

chemical substances. In addition, the harmonized categories w ill facilitate consistent reporting of

chemical substance use information by industry in the United States and Canada.

Additional benefit s of expanding the list of consumer and commercial use categories will be to provide persons submitting IUR information with a greater opportunity to characterize the product s in which chemical substances they manufacture are used

, and to reduce t he number of uses reported as “O ther.”

EPA is requiring that if a submitter chooses the category “O ther,” the submitter include a text description for the consumer and commercial product containing the chemical substance. The 2006 IUR reports showed the category “Other” was repor ted with the greatest frequency. A total

of 1

, 206 reports, or 26 percent, out of 4

, 666 reports containin g commercial and consumer use

information

, included “Other.” Although one of EPA’s objectives of revising the consumer and commercial product ca tegories is to redu ce the reporting frequency of “O ther,” EPA believes in many cases where “Other” was reported, submitters may not have selected the correct categories

for their situation

. In addition to revising the overall product categories, narrower definitions and expanded lists of examples of products in which the chemical substance will be used were added

to each category descriptor. By requiring the submitters to supply a written description for
“O ther,” this amendm ent will enable the Agency to evaluate and improve the inclusiveness of future consumer and commercial category lists or descriptions.



## Upfront S u bstantiation for P rocessing and Use Information CBI
C laims

Under the rule, in order to submit a claim of confidentiality for processing and use information data elements, the submitter will be required to both check the appropriate box on7

- 14



### the reporting for m and substantiate the claim in writing by answering certain questions provided

in the rule. Where a submitter fails to substantiate the processing and use CBI claim in accordance with the applicable rules, EPA may make the information available to the pub lic
without further notice to the submitter.

EPA has observed, on occasion, processing and use information has been claimed as confidential even though it was revealed in submissions sent to the Agency in response to the HPV Challenge program and published on the EPA website. In addition, EPA has observed some of the processing and use information claimed as confidential appears to be available on submitter’s websites or in published Material Safety Data Sheets (MSDS). The high number of confidentiality cla ims asserted for the reported 2006 IUR reports on industrial processing and use information meant EPA was unable to make available to the public important data or to completely describe the analysis or provide the support information used to reach Agency

c onclusions. 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. T his amendment decrease in the number of inappropriate CBI cla ims under the new substantiation requirement, which will improve EPA’s ability to make current plant site information available to other Federal agencies and the public because more information submitted under IUR could be released publicly. This will incr ease the transparency and public accessibility of the chemical substance risk information, may increase public confidence in EPA’s chemical management program, and is consistent with the President’s policy goals for government reliance on and public availa bility of scientific information. 7

7.3 

### Potential Users of Information Generated by the IUR Modifications Rule

EPA will be the primary user of the information generated by the rule amendments, although other public and private organizations, in particular those with interests in managing chemical

substance risks, will also use the data. The information is expected to be applied and disseminated by these users in a number of ways; however, it will serve primarily to reduce the costs of screening and managing chem ical substance risks and to improve risk management

decisions. The American public will be the ultimate beneficiar y 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 privat e uses. Similar gains will also result from cost savings in private

- sector decision making. By improving risk management decisions, the rule will also help to better target risk management activities to the areas where the net benefits (i.e., risk reductio ns net of control costs) are expected to be the largest.

IUR data users an d the benefits they derive from IUR data are discussed in more detail in the following sections.

7 On March 9, 2009, President Obama, writing about Scientific Integrity in a Presidential Memorandum for the Heads of Executive Departments and Agencies, wrote: “ The public m ust be able to trust the science and scientific process informing public policy decisions. Political officials should not suppress or alter scientific or technological findings and conclusions. If scientific and technological information is developed and u sed by the Federal Government, it should ordinarily be made available to the public. To the extent permitted by law, there should be transparency in the preparation, identification, and use of scientific and technological information in policymaking. ”7

- 15

7.3.1 

### EPA Risk

- Screening and Management Programs

EPA’s Office of Pollution Prevention and T oxics (OPPT) has a multifaceted approach to identifying and managing chemical substance risks. OPPT can initiate the review of a chemical

substance in a number of ways, including under an Agency program, through a request by the Interagency Testing Committ ee or because of a request by the public. The Agency has a number of more detailed screening tool s, 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

m anagement programs. These types of programs and the benefits derived from the processing and use information provided on the IUR Form U are examined in detail in the economic analysis for the 2003 Amendments (EPA, 2002). EPA’s current programs and tools to evaluate and manage chemical substance risks include:

Risk Screening . OPPT screens chemical substance s on the TSCA Inventory to identify potential risks and determine whether more detailed assessments should be undertaken. With the data currently availabl e, EPA does not have the information needed to effectively and systematically scre en some of the chemical substance s on the TSCA Inventory . The amended

IUR will supply exposure

- related information the Agency does not currently have, recognizing industry ha s a greater knowledge than EPA about its own operations and the uses

of chemical substance s it manufactures and sells. Without this information, EPA will likely: (1) not screen these chemical substance s, (2) screen them using outdated or anecdotal

exposure information, or (3) screen them but rely on exposure estimates (which are typically conservative) using modeling data. Therefore, data collected as a result of the rule will improve the Agency’s ability to screen chemical substance s in commerce, allowing the Agency to focus its chemical substance screening programs and to identify potentially risky situations earlier than otherwise possible.

T he 2006 IUR data did not provide sufficient information on m edium production volume (MPV) chemical substance s for r isk screening activities under the Agency’s Existing Chemicals Program, in particular . Screening chemical substance risks generally requires a combination of both hazard and exposure information. Because most MPV chemical

substance s were produced below the 300,000 lb reporting threshold for processing and use

information , EPA did not have exposure information available from the 2006 IUR for these

chemical substance s. EPA therefore developed hazard based prioritizations which were supported by a screening le vel hazard characterization and consideration of very limited exposure and use data. When the screening level hazard characterization for an MPV

chemical substance indicated that the hazard was low, the magnitude of exposure was generally less significant for the prioritization. However, when the screening level hazard characterization identified either a medium or high hazard, information on the magnitude and type of exposure w ould be essential for a realistic prioritization determination. Basic hazard

dat a are easier to find in existing databases; however, specific exposure data are needed to

make a priority determination risk

- based. EPA believes that the lower threshold will provide

more exposure

- related information on a greater number of MPV chemical sub stance s

. High Production Volume Chemical S ubstance Testing. EPA’s major efforts to prioritize existing chemical substance s began with data collected under the High

- Production Volume (HPV) Challenge Program , which makes available to the public screening

- level
environmental and health effects information on HPV chemical substance s produced or imported in the United States in quantities of one million lb or more per year. At the7

- 16



### conclusion of the voluntary HPV Challenge Program, EPA developed the first in a series of test rules to require the testing of high production volume chemical substance s for which no voluntary agreement was made. EPA finalized its first HPV test rule, covering 37 chemical

substance s, in 200 6

. A second HP V rule was promulgated in 20 11 for 19 chemical substances; a third rule wa s proposed in 2010 , and additional HPV test rules are being planned.

When attempting to use the 2006 IUR data for its screening level exposure assessments, EPA

foun d that numerous chemical substance s previously identified as HPVs were reported in amounts classifying them as MPV chemical substance s below the 300,000 lb cut

- off, and thus processing and use information was not provided for chemical substance s for which EPA had a relatively complete hazard data set from the HPV challenge. This led EPA to believe that the threshold was too high to provide sufficient exposure

- related information on

these chemical substance s. Additionally, some previously MPV chemical substa nce s were reported in amounts which classified them as HPV chemical substance s in 2006.

Existing and New Chemicals Program

. The Existing Chemicals Program conducts detailed analyses of potentially high

- risk chemical substance s and develops strategies to re duce or eliminate the exposure risks. Chemical substance s are screened first to identify those ( 1) requir ing additional testing, ( 2) present ing potentially significant risk management concerns,

or ( 3) currently not requir ing further review. While the amend ments to the IUR data will
increase EPA’s ability to screen existing chemical substance s based on exposure and, ultimately, risk, more in

- depth data similar to the New Chemicals Program data will lead to improved screening and a quicker identification of c hemical substance s with a high priority
for follow

- up action. This will result in a more appropriate entry into EPA’s chemical

substance management programs. The range of benefits EPA anticipates from being able to

obtain more accurate and broader use info rmation could be expanded with a greater amount

of in

- depth exposure and use information . The improved IUR data will be particularly helpful for screening medium and lower volume chemical substance s not covered by the HPV

program.
More recently, the Existi ng Chemicals Program used the IUR database when developing the
Chemical Action Plans. For some Action Plan chemical substance s, the 2006 IUR was not a

useful source of information. An example is the Action Plan for Dyes Derived from Benzidine and Its Conge ners, where the substances of concern are known or reasonably anticipated human carcinogens; however, those listed were produced in amounts below the 300,000 lb threshold and so little exposure data was reported. Based on IUR data from prior reporting peri ods, some of the other dyes had been reported in the 10,000 to 25,000 lb range, but no 2006 IUR data were available to determine whether these chemical substance s were still being used in amounts beyond the small amounts used as analytical reagents. The Ac tion
Plans are available on EPA’s web site at http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html

IUR data are also used under the New Chemicals Program as a source of information on

chemical substance s that are analogous to new chemical substance submissions to supplement data submitted with the new chemical substance . EPA is able to increase the rigor of its review of a new chemical substance submission by comparing its characteristics7

- 17



### with analogous chemical substance s that previously have undergone a review under the New Chemicals Program.

Use Cluster Scoring System (UCSS). The UCSS tool identifies potential risks of chemical substances used in similar ap plications, or “use clusters.” This system enables the Agency to view the potential risks of a given chemical substance in the context of the potential risks presented by related products on the market and allows the Agency to establish regulatory review p riorities for those use clusters. However, some of the UCSS data sources are

outdated and the estimating methodologies are approximate. More in

- depth exposure

- related data could be used to create a database providing additional information that will allow the Agency to provide more accurate screening

- level estimates for use clusters and to target Agency programs to areas currently needing attention. The additional exposure

- related data
will also enable EPA to more easily conduct broader chemical substance s creening analyses

across several industries.

Master Testing List. IUR d ata also help EPA determine which chemical substances are on the Master Testing List (MTL).The MTL is a list of chemical substance s identified by the Agency as having inadequate data fo r health and/or environmental risk assessments. OPPT uses the MTL to establish priorities for chemical substance testing, keep the public informed, solicit input from industry on specific chemical substance exposure and risk assessment

needs

, and to encour age industry to perform testing. More in

- depth exposure

- related manufacturing, processing, and use data will enable EPA to better target testing needs to situations in which potential exposures are known to occur, thereby increasing the efficiency

of effor ts in these programs and facilitating earlier completion of critical testing needs.

Screening Information Data Set (SIDS) program. The Organisation for Economic Co

operation and Development’s ( OECD ) voluntary SIDS program allows OECD member

countries to sh are the burden of testing internationally traded

, large production volume

chemical substance s. The United States is responsible for testing 25 percent of the chemical

substance s identified for the program. The information needed is collected by industry

sp onsors; however, the dat a elements included may not be consistent across sponsors, and some companies may not participate in developing all of the data elements. Curr ently collected data and data collected through more in

- depth exposure and use data requir ements will enable the EPA to meet many key needs for exposure data and will provide a consistent

database of information from manufacturers (including importers ) . This information will increase the program’s efficiency by helping to identify chemical subs tance s requiring additional testing or assessment while excluding those with low domestic exposure. A n improved exposure database will also improve evaluation of potential risk in the assessment reports prepared at the end of the SIDS process.

Design for t he Environment (DfE) program. EPA’s DfE program incorporates principles and strategies from bo th the Existing Chemicals P rogram and the UCSS, by focusing on specific chemical substance uses and establishing partnerships with industry to develop voluntary

, long

- range plans for risk management. Curr ently collected IUR data

, which will be enhanced by data collected through more in

- depth exposure and use data requirements

, helps to identify use cluster candidates for this program. The more in

- depth exposure

- rel ated

data will also better enable the initial assessment of exposures and help identify potential7

- 18



### substitutes . The data could be used to assist in ranking activities, identifying high

- risk areas, and developing realistic approaches for reducing risk.

7.3.2 

### Other Federal Risk Management Programs

Un der TSCA s ection 4, EPA has the authority to require firms to conduct tests of specific

chemical substance s to determine the potential risk posed by these substances. However, other governmental agencies, such as the Occ upational Safety and Health Administration (OSHA),the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC), share regulatory authority over chemical substances or products containing them . I n the case of NIOSH, the agency compile s summaries of available information

and recommend s exposure limits. Therefore, EPA serves as a conduit for chemical substance
hazard information between the chemical substance producers and these other agencies.

OSHA curr ently manages occupational exposure to chemical substance s by setting a variety

of chemical substance and personal protection standards, by requiring preparation of emergency response and process safety management plans and by requiring provision of health and safety
data to workers for chemical substance s used in the workplace. OSHA will be able to use the IUR data to identify chemical substance s with large numbers of potentially exposed workers or with uses suggest ing greater exposure potential. The infor mation provided by the rule could increase OSHA’s ability to manage chemical substance hazards, exposures, and risks in occupational settings.

NIOSH will also benefit from the additional exposure

- related information collected under the

rule amendments. The exposure information NIOSH uses to determine occupational safety and health in businesses nationwide may be based on outdated information collected under the National Occupational Exposure Survey (NOES). Completed in 1983, NOES collected

information such as plant site location, plant site Standard Industrial Classification ( SIC )

, information on the plant site’s occupational safety and health programs, occupational titles of workers potentially exposed, the number of employees per occupational title, inform ation on process steps, and trade names of products. NIOSH could use IUR data in place of the NOES data to identify chemical substance s with large numbers of potentially exposed workers or with
uses suggest ing greater exposure potential.

CPSC also could us e the new data directly in conducting its exposure and risk assessment activities ( e.g. screening consumer products for chemical substance hazards). CPSC obtains r isk

information to screen chemical substance hazards from a netw ork of hospital emergency roo ms. T his information is limited to injuries and illnesses resulting from acute exposures only.

Additional data required by the final IUR amendments will provide a better source of reliable

information on the chemical substance s used in consumer products

. CPSC will improve its ability to identify the chemical substance s used in consumer products and, with consideration of hazard data, to identify chemical substance consumer use scenarios presenting greater potential risk. The information could improve CPSC’ s ability to meet its program objective of protecting the public from chemical substance hazards in consumer products.

7.3.3 

### State and Local Programs
IUR data also help state and local authorities with rulemaking, information collection, and voluntary program ac tivities. Because state and local governments must address chemical

substance s, use patterns, and exposure scenarios that may be unique or isolated, state and local7

- 19



### agency access to the enhanced data will assist in identifying situations pos ing potentially high

risks for individual states or locations within those states. The information added to the IUR includes county data, which will enable states to identify which counties are likely to have specific issues or which counties may have multiple chemical s ubstance 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

Man y 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 un derstanding of how

chemical substance s are used in general. This will allow them to manage risks more effectively and participate in setting chemical substance priorities at community, regional, and national
levels.

The publicly available (non

- CBI) inform ation provided by the IUR support s 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 t he new data to identify and establish priorities for risks; to
evaluate chemical substance s and chemical substance use patterns to determine areas of concern; to identify and promote pollution prevention opportunities; and to focus pollution prevention,

pu blic outreach, and education initiatives and activities.

Industry can use the amended IUR information to improve corporate product stewardship programs through access to use information reported by multiple companies. The A merican Chemistry Council’s Respo nsible Care ® Program is one example of one such program that could use this information. The Responsible Care ® Program requires companies to take responsibility for their products from cradle to grave, which requires an understanding of how their product i s being used not only by their customers, but further down the chain. Despite this private effort, some companies have told EPA they do not know how their chemical substance s are used. Non

- CBI use information provided by multiple companies could give an in dividual company a better understanding of the downstream uses of its product s , therefore enabling more effective implementation of the Responsible Care ® concepts.8

- 1 

## 8. Small Entity Analysis

This chapter estimates the impact the amendments to the IUR rule may have on small entities by examin ing the relationship between the compliance costs and company sales for small compani es.
The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, re quires 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 effe cts on significantly impacted small entities. The RFA requires agencies to prepare an initial and final regulatory flexibility analysis for each rule unless the Agency certifies the rule will not have a significant economic impact on a substantial number

o f small entities. The RFA, however, does not specifically define “a significant economic impact on a substantial number” of small entities. Sections 603 and 604 of the RFA require regulatory flexibility analyses to identify the types, and estimate the numb ers, of small entities to which the rule will apply

, and describe the rule requirements to which small entities will be subject and any regulatory alternatives, including exemptions and deferral, that will lessen the rule’s burden on

small entities.

The ex isting IUR rule , at §710.29, generally exempts from r eporting small businesses, defined at §704.3 as entities with annual sales of less than $40 million and less than 100,000 lb production of any given chemical substance at a site; or annual sales of less than $4 million. T his exemption is maintained in the amendment s. In addition, a small business currently is required to
report if it produces any chemical substance that is the subject of a regulation proposed or promulgated under TSCA sections 4, 5(b)(4), or 6; that is the subject of an order under TSCA section 5(e); or that is the subject of relief that has been granted pursuant to a civil action under TSCA section 5 or 7. A small business may also report voluntarily

. The major steps followed in the analy sis are described in the following sections.

8.1 

### Select a Relevant Small Entity Definition

The RFA relies on the definition of “small business” found in the Small Business Act, which

authorizes the Small Business Administration ( SBA ) to develop definitions for “small b usiness”

for industries in each North American Industry Cl assification 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, e ntities potentially affected by the rule include companies manufacturing or importing chemicals in amounts of 25,000 l b or more annually and are listed on the TSCA Inventory and regulated under TSCA §8. Under 13 CFR part 121, SBA defines small business

for the six

- digit NAICS industry based on employment thresholds (SBA, 2004). These employee size standards range from 500 employees to 1,500 employees for NAICS Codes 325 and 324110. For example, SBA defines a company in NAICS 325320 (Pesticide and Other Agricultural Chemical Manufacturing) as small if it has fewer than 500 employees. In comparison , a company in NAICS 324110 (Petroleum Refineries) is considered small if it has fewer than 1,500 employees. To obtain a n average e stimate of the number of small companie s affected by the rule,8

- 2



### EPA chose an employment threshold of 1, 0 00 employees to determine small business status. Throughout the remainder of this report, this definition is referred to as the “employment

- based
definition.”

For comparative purposes, EPA also considered an alternative definition based upon sales. Under this definition, a manufacturer or importer is def ined 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 th an 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), E PA assumed any company with sales less than or equal to $40 million is small, regardless of production volume. 8 

### This assumption may tend to overestimate the number of small businesses affected because it includes entities that may not

meet all small busine ss requirements under TSCA §8(a). Throughout the remainder of this report, this definition is referred to as the “sales

- based definition. ”

8.2 

### Identify Number of Small Companies Reporting in 2006

To identify the percentage of small companies reporting under th e IUR rule, EPA obtained a list of all companies that submitted a Form U during the 2006 reporting cycle (EPA, 200 9c ). Using the Dun & Bradstreet D

- U

- N

- S® n umber reported by the company , EPA identified the ultimate parent company and obtained sales and emp loyment data for companies for which data

are available from Dun & Bradstreet Corporate Leads Portal ( Dun & Bradstreet, 2009). 9



### During the 2006 reporting cycle, 4,188 10 

### sites submitted reports. Parent company data was available for 3,392 of these sites, 11 

### wi th 872 associated parent companies. I nformation for the remaining companies was unavailable for several reasons . First, these compani es 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 I UR reporting for 2006 (e.g., some companies may have gone out of business or changed hands since the information was reported). Finally, certain companies may have

8 It is important to note that the $40 million level is for parent company sales, not individual site sales.

9 Dun & Bradstreet is a New York

- based company that provides business information through a global commercial database. It assigns D

- U

- N

- S ® numbers to i dentify businesses around the world. These numbers are required for many U.S. federal government transactions and therefore are widely used and assigned. D

- U

- N

- S ® numbers are also used frequently in corporate research. Database entries provide legal and tr ade names, physical and mailing addresses, geographical descriptions, product and industry descriptors, sales and number of employees for three years and associated growth rates, as well as up to 40 vital statistics about each organization. While the repor ting year varied by company, company sales and employment data were retrieved from the database in April 2009.

10 Note that this value (4,188) does not equal the number of sites assumed for the baseline in Table 4

- 6 (4,085).The data used to prepare Table 4

- 6 counted only sites submitting reports for chemicals with production volumes equal to or greater than 25,000 lb. (that is, those site s subject to t he rule )

. The 4,188 sites in this dataset may include submitters who voluntarily submitted reports for chemic als with production volumes lower than 25,000 lb.

11 This does not include parent companies listed in D&B as having either 0 employees or $0 sales.8

- 3



### requested to be removed from, or may have declined to provide information to, Dun &

Bradstre et.

Using the sales data collected for the companies for which data was available, EPA estimated the average sales for the parent companies considered small under both definitions.

Table 8

- 1 shows the percentage of p arent compan ie s from the 2006 IUR reporting which

q ualif ied for “small business” status, under both the employment

- based and the sales

- based definitions specified above. These results are fairly consistent with the 2002 EA’s estimates between 21 and 35 percent of the re gulated community could be considered small businesses (EPA, 2002a).

Table 8

- 1 : Results of Dun & Bradstreet Analysis

Existing Sites (2006 Reporting Cycle) Employment

- b ased
Definition Sales

- b ased
Definition

Number of G lobal P arent C ompanies with D ata 872 872

Number of G lobal P arent C ompanies C onsidered S mall 360 218 Percentage of G lobal P arent C ompanies C onsidered S mall 41.3% 25.0% Average Annual Sales of Global Parent Companies Considered Small (2008$) $4 12,713,310 $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 submitt ed IUR reports in 2006 required EPA estimate the total number of parent companies in the baseline. One global parent company may submit reports for more than one site. Based on the sample of companies for which the parent company information is available, EPA estimates 3.89 sites per global parent company. Given that 4,188 sites submitted reports, EPA estimates the number of parent companies for the 2006 IUR reporting baseline is 1,076.

As described in Section 4.5 , the amendment s are expected to increase the number of sites reporting by 204. Therefore, EPA estimates the total number of global parent companies reporting under the revised IUR rule to increase by 52 from the baseline (that is, 52 “new” companies (204÷3.89 = 52)).

8.4 

### Es timate Number of Small Companies

EPA estimated the number of small companies potentially impacted by the IUR amendments by applying the percentage of small companies derived in Table 8

- 1 to the total number of paren t companies EPA expects to be subject to the rule under the amendment s

.
Table 8

- 2 shows the number of expected small compani es, under both definitions

.8

- 4

Table 8

- 2 : Es timated Number of Small Companies under the IUR Rule Amendments

Employment

- based
Definition Sales

- based
Definition

Baseline Companies New

Companies Baseline

Companies New

Companies
Total N umber of P arent C ompanies 1, 076 5 2 1, 076 5 2

Percent of P arent C ompanies C onsidered S mall 41.3% 2 4 .8%

Number of P arent C ompanies C onsidered

S mall 444 22 267 13

Total Number of Parent Companies
Considered Small 466 280



### Limitations of the Analysis : T he amendments cause an increase in the number of sites reporting b ecause of changes to the reporting volume thresholds and the timeframe in which the

thresholds a re applied. T hese amendments may have a disproportiona te effect on smaller companies because they may be the ones manufactur ing (including importing) chemical

s ubstance s at or around the 25,000 lb threshold. Th erefore, th is method may underestimate the

number of small businesses. Furthermore, t o the extent the set of companies for which EPA was

not able to find data are not statistically similar to the set of com panies for which data was available, t his analysis may under

- or over

- estimate the percentage of small companies

.

8.5 

### Estimate Cost

- to

- Sales Ratios for Small Compani es

Table 4

- 53 shows the total increase in industry costs associated w ith the amendment s, if all

amendment s are implemented

. As described in Section 4, industry costs involve compliance determination, rule familiarization, preparation and submission of reports, and recordkeeping.

Because these costs will be incurred once eve ry four years under a four

- year reporting cycle,

these costs were annualized over four years at both a three percent and seven percent discount

rate

. 12 

### By dividing the annualized costs for the entire industry in the first reporting cycle by the

number of ex pected sites (4,085), EPA obtain ed 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 definitio n) 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 busine ss 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. Howeve r, EPA has often defined the lower threshold as complian ce costs of one percent of sales and the higher threshold as compliance costs of
three percent of sales to establish whether the level of economic impacts faced by the small entities can be presumed a s not significant. Therefore, to determine the magnitude of any potential adverse impact, EPA

12 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A

- 4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.8

- 5

compared the average

, annualized incremental costs on a per

- compan y basis to the average annual sales for small businesses to develop cost

- to

- sales ratios. The de rivation of these ratios is shown in Table 8

- 3

.

Table 8

- 3 : Derivation of Cost

- to

- Sales Ratios for Small Companies under the IUR Rule
Amendments

Employment

- based Defi nition Sales

- based Definition

3% Discount

Rate 7% Discount

Rate 3% Discount

Rate 7% Discount

Rate

Total Annualized
Costs $17,161,997.89 $14,709,281.77 $17,161,997.89 $14,709,281.77

Annualized Costs per Site $4,201 $3,601 $4,201 $3,601

Numbe r of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Company $7,394 $6,337 $8,066 $6,914

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

Cost

- to

- Sales
Ratio 0.0018% 0.0015% 0.068 2% 0.0585%

Number of Companies Potentially
Affected 466 280



### As shown in Table 8

- 3

, under the employment

- based definition, a small parent company affected by the rule on average has sales of more than $412.7 million. The annuali zed costs of the IUR rule amendments per small parent company, however, are $ 7, 394 at a three percent discount rate, and even lower under a seven percent discount rate. The cost

- to

- sales ratio for an average small company under the employment

- based definit ion will be 0.0 0 18 percent or less.
Under the more conservative sales

- based definition, small parent company sales are on average more than $11.8 million, with annualized costs associated with the amendments of $ 8, 066 or lower. The cost

- to

- sales ratio for an average small company under the sales

- based definition will

be 0. 068 percent or less.

Using the highest annual cost shown in Table 8

- 3 , $ 8, 066 , a small company will have to have

annual sales of less than $ 0. 81 million in order to have a cost

- to

- sales ratio larger than one
percent. As mentioned in Section 8.

, f irms with sales of $4 million or less are generally exempt from IUR reporting because they fall within the applicable definit ion of “small manufacturer,” regardless of prod uction volume (40 CFR §704.3).Th erefore, companies small enough to have a

cost

- to

- sal es ratio greater than one percent generally will be exempt from reporting under the

IUR rule, and thus will not be significa ntly affected by the amendment s.8

- 6

8.6 

### Summary

EPA analyzed potential small business impacts from this rule using the SBA employment

based definition and the TSCA sales

- based definition

. EPA estimates 466 small firms potentially
will be affected by this rule und er the employ ment

- based definition of the term , and 2 80 small

firms potentially will be affected under the sales

- based definition of the term . Based on costs
annualized over a four

- year period and average sales data, EPA estimated the cost

- to

- sales ratio

o f the rule will be 0. 0 18 percent or less under the employment

- based definition for an average small company subject to the rule , and 0.0 6 8 percent or less under the sales

- based definition. As noted above, EPA often define s the lower threshold as compliance costs of one percent of sales and the higher threshold as compliance costs of three percent of sales to establish whether the level of economic impacts faced by the small entities can be presumed as not significant

. For a company to have a cost

- to

- sales r atio larger than one percent, company sales will have to be less than $ 0.8 1 million. Because the small businesses affect ed by the rule actually have average sales of more than $11 million, and because any potentially affected companies with sales of $ 0.8 1 million or less will generally be exempt from reporting obligations under the IUR , small entities
will not be significantly affected by the amendments to the IUR r ule

.9

- 1 

## 9. Additional Analyses

9.1 

### Executive Order 12866

Under Executive Order 12866, entitled Regulato ry 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, o r the principles set forth in the Executive Order. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Order 12866 and any changes made in response to OMB recommendations have been

documented in th e docket for this action.

9.2 

### Unfunded Mandates Reform Act (UMRA)

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 104

- 4), EPA has determined this regulatory action does not contain a Federal mandate that may result i n expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or for the private s ector, in

any one year. The analysis of the cost s associated with this action is de scribed in Unit V II .A. Thus, this rule is not subject to the require ments of sections 202 or 205 of UMRA.

In addition, EPA has determined this rule does not significantly or uniquely affect small governments. This is because only manufacturers (including importers) of chemical substances are affected by the rule.
No acti on is required by small governments that are not chemical substance manufacturers (including importers)

. Accordingly , this rule is not subject to the requirements of sections 203 of UMRA.

9.3 

### Paperwork Reduction Act (PRA)

According to the Paperwork Reduction A ct (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 C ollection 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 requir ing additional OMB approval, EPA has prepared an

addendum to the cu rrently approved ICR (EPA, 2010a).

The Paperwork Reduction Act mandates federal agencies estimate the recordkeeping and reporting burden of a final rule. In this context, the term “burden” is interpreted as the total time, effort, or financial resources ex pended 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

coll ect, validate, verify, and disclose information. Time taken to adjust existing ways to comply with any previously applicable instructions and requirements and to train personnel to respond to

the information collection task is also included. In this sectio n, burden hours for both industry respondents and the government are estimated.9

- 2



### In this report, total industry burden hours represent the sum of time spent on reporting and on other administrative activities. Industry respondents will spend time on the fol lowing activities associated with the IUR rule: compliance determination, rule familiarization, preparation and submission of reports, and recordkeeping.

As derived in Section 4.5 of this report, EPA estimates t he rule will impose a total estimated incremental industry burden of 0.50 million hour s, in the first reporting cycle, if all amendments

a re implemented . The burden for the average site will increase by approximately 121 hours per

site to 572 hours.

9.4 

### Execut ive 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 poli cies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations
hav ing “substantial direct effects on the States, on the relationship between the national government and the St ates, or on the distribution of power and responsibilities among the various levels of government.”

EPA has determined this rule does not have federalism implications because it will not have substantial direct effects on the states, on the relationship be tween 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. T his rule simply amends the TSCA Inventory Update Reporting rule in several ways to provid e information to better address Agency and public information needs, improve the usability and reliability of the reported data, and ensure data are available in a timely manner. Because EPA has no information indicat ing any state or local government manuf

actures or processes the chemical substances covered by this action, the rule does not apply directly to states and localities and will not affect state and local governments. Thus, Executive Order 13132 does not apply to the rule.

9.5 

### Executive Order 12898

– Environmental Justice

Executive Order (EO) 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations (59 FR 7629 (Feb. 16, 1994)),establishes federal executive policy on environmental justice. Its m ain provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse
human health or environm ental effects of their programs, policies, and activities on minority populations and low

- income populations in the United States.

The rule does not have an adverse impact on the environmental and health conditions in low

income and minority communities re quir ing special consideration by the Agency under EO 12898.The Agency believes the information collected under this rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with the chemical substance s

covere d by the rule. Because the IUR rule is an information collection requirement, the information that will become available through the rule will enable the Agency to target educational, regulatory, or enforcement activities towards industries or chemical sub stance s9

- 3



### posing the greatest risks and/or to target programs for geographic areas that are at the highest risk. Thus, the information to be gathered under the rule will help EPA make decisions that will benefit potentially at

- risk communities, some of which may be disadvantaged.

The rule is directed at manufacturers or importers of chemical substance s. All consumers of

these chemical substance products and all workers who come into contact with these chemical

substance s could benefit if data regarding the ch emical substance s’ health and environmental effects were developed. Therefore, it does not appear that the costs and the benefits of the rule will be disproportionately distributed across different geographic regions or among different categories of indivi duals.

9.6 

### Executive Order 13045

– Children’s Health

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), requires that federal agencies examine the impacts of each regulatory action on children for any economically significant regulation (as defined by Executive Order 12866) that the agency has reason to believe may disproportionately affect children. The rule is not subject to EO 13045, because it does not establish an environmental

st andard intended to mitigate health or safety risks, nor does it otherwise have a disproportionate effect on children. Furthermore, the rule is not economically significant

. Nevertheless, the information obtained by the reporting required by this rule will be used to inform the Agency’s

decision

- making process regarding chemical substance s to which children may be disproportionately exposed. This information will also assist the Agency and others in determining whether the chemical substance s in this rule pr esent 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 Co nsultation and Coordination with Indian
Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this rule does not have tribal implications because it will not have any effect on tribal governments, on the relationship between the Feder al 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 

### E xecutive Order 13211

– Energy S upply, 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, 1 2(d) ( 15 U.S.C. 272 note) directs EPA to use voluntary9

- 4



### consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or impractical. Voluntary consensus standards are technical standards (e.g., materials specifi cations, 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

app licable voluntary consensus standards.

This action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.10

- 1 

## 10. References

BLS, 2009.U.S. Bureau of Labor Statistics. Employer Costs for Employee Compe nsation Supplementary
Tables: Historical Data December 2006

– December 2008. M arch 12, 2009. http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf

. Dun & Bradstreet, 2009.Dun & Bradstreet Corporate Leads Porta l. Database searches. [Proprietary]

. April 2009.

EPA, 1994.U.S. EPA Office of Pollution Prevention and Toxics. Regulatory Impact Analysis of
Amendments to Regulations for TSCA Section 5 Premanufacture Notificat i ons. Washington, DC. September 9, 1994.

EPA,1 997.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

- OPPT

- 2002

- 0054

- 0260 ).Washington, DC. August 2002

. EPA, 2002b.U.S. EPA, Office of Pollution Prevention and Toxics, Economic a nd 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 Re porting and Exemption Requirement for New Chemical Substances and Significant Use Reporting Requirements for Chemicals Substances

. Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act. Washington, DC. November 25, 2003.

EPA, 2004.U.S. EPA. Office of Environmental Information. Cross

- Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis: Final (EPA

- HQ

- OEI

- 2003

- 0001

- 0248).November 2004.Washington, DC. http://www.regulations.gov/

. EPA, 2005.U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of IUR Modifications Final Rule (EPA

- HQ

- OPPT

- 2004

- 0106

- 0055). Washington, DC. July 2005.

EPA, 2006.U.S.EPA, Office of Pollution Preventi on 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_c heminv.pdf

. EPA, 2007.U.S. EPA, Office of Environmental Information. A Business Case Analysis of EPA’s Central Data Exchange . Washington, DC. March 2007.

EPA, 2008a.U.S. EPA, Office of Pollution Prevention and Toxics. What is the TSCA Chemical Substance

I nventory? 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 A nalysis 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 St

atistics for IUR Modifications Rule

. Washington, DC. December 17, 2008.10

- 2

EPA, 2008d.U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1884.04. [Information Collection Request for] Partial Update of the TSCA Section 8(b) Inventory Data Base, Produ ction 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 Inelig ible 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 Premanufa cture 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. (Databa se 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 Regi ster 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, Sun set 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 Sept ember 1, 2009.

EPA, 2009h.U.S. EPA, Office of Pollution Prevention and Toxics, Chemical Control Division. Memo from Susan Sharkey to Wendy Hoffman. Washington, DC. September 8, 2009.

EPA, 2010a .U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1 884.05. [Information Collection Request for] Addendum to Partial Update of the TSCA Section 8(b) Inventory Data Base,

Pr oduction and Site Reports

. Washington, DC. July, 2010.

EPA, 2010 b .U.S. EPA, Office of Pollution Prevention and Toxics

. IUR Chemical Info rmation Statistics.
November 29 , 2010.

EPA, 2011. U.S. EPA , Office of Pollution Prevention and Toxics

. Instructions for the 2012 TSCA Inventory Update Reporting

. OPM, 2008.Office of Personnel Management, Salary Table 2008

- DCB, Washington Baltimore

- Norther n Virginia, DC

- MD

- PA

- VA

- WV. http://www.opm.gov/oca/08tables/pdf/DCB.pdf

. U.S. Postal Service (USPS), 2009. USPS

– P rices. http://www.usps.com/prices/ . December 15, 2009.A

- 1



## Appendix A.

– Current and Revised Industrial Function Categories

Table A

- 1 : List of Current and Revised Industrial Function Categories

Curre nt IUR Indus trial Function Categories Revised IUR Industrial Function Categories

1. Adsorbents and absorbents

2. Adhesives, binders, and sealants

3. Aerosol Propellants *

4. Agricultural chemicals (non

- pesticidal)

5. Anti

- adhesive agents

6. Bleaching agents

7. Coloring agents, dyes 1

8. Colo ring 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. P lating 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. Oth er 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 f

uel 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 agent s 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 beco me 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 (s pecify) 1

Notes:

1 A current industrial function category has been re named under the amendment, but the definition of the category has not changed.

2 Two current industrial function categories have been combined into one category under the final rule.

3 A single industrial function category has been divided into two categor ies under the final rule.

* Indicates that a current industrial function category is being eliminated under the final rule.

+ Indicates that a current function category is added under the final rule.B

- 1 

## Appendix B. Current and Revised Consumer and Commercial Product Ca tegories

EPA is revising the list of consumer and commercial product categories by combining categories that lead to common exposure scenarios and adding categories that were not ade quately described in the

current set of categories.

Table B

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

Current IUR Consumer and Commercial

Product Categories Revised IUR Consumer and Commercial Product Categories

1.Adhesives and sealants 2.Agricultur al 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, gre ases 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 furnitu re 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. M etal 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 Grea ses 27. Anti

- Freeze and De

- icing Products

28. Fuels and Related Products
29. Explosive Materials

30. Agricultural Products (non

- pesticidal)

31. Lawn an d Garden Care Products Chemical Substances in Products not Described byB

- 2

Current IUR Consumer and Commercial

Product Categories Revised IUR Consumer and Commercial Product Categories

Other Categories

32. Non

- TSCA Use

33. Other (specify)C

- 1 

## Appendix C. Industrial Sectors

EPA is replacing the NAICS codes used in the industrial processing and use information
section with a ne w 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 Te xtiles, apparel, and leather

manufacturing

IS8 Wood Product Manufacturing

IS9 Paper Manufacturing

IS10 Printing and Related Support Activities

IS11 Petroleum Refineries

IS12 Asphalt Paving, Roofing, and Coating

Materials Manufacturing

IS13 Petroleum Lubricating Oil and Grease

Manufacturing

IS14 All other Petroleum and Coal Products

Manufacturing

IS15 Petrochemical Manufacturing

IS16 Industrial Gas Manufacturing

IS17 Synthetic Dye and Pigment Manufacturing

IS18 Carbon Black Manufacturing

IS19 All Other Basic Inorganic Chemical

Manufacturing

IS20 Cyclic Crude and Intermediate

Manufacturing

IS21 All Other Basic Organic Chemical

Manufacturing

IS22 Plastics Material and Resin Manufacturing

IS23 Synthetic Rubber Manufacturing

IS24 Organic Fiber Ma nufacturing

IS25 Pesticide, Fertilizer, and Other Agricultural

Chemical Manufacturing

IS26 Pharmaceutical and Medicine

Manufacturing

IS27 Paint and Coating Manufacturing

IS28 Adhesive Manufacturing

IS29 Soap, Cleaning Compound, and Toilet

Preparation Manufacturing

IS30 Printing Ink Manufacturing

IS31 Explosives Manufacturing

IS32 Custom Compounding of Purchased

Resins

IS33 Photographic Film, Paper, Plate, and Code Sector Description Chemical Manufacturing

IS34 All Other Chemical Product and

Preparation Manufacturing

IS3 5 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 Manufacturin g IS39 Fabricated Metal Product Manufacturing

IS40 Machinery Manufacturing

IS41 Computer and Electronic Product

Manufacturing

IS42 Electrical Equipment, Appliance, and

Component Manufacturing

IS43 Transportation Equipment Manufacturing

IS44 Furniture and Related Product

Manufacturing

IS45 Miscellaneous Manufacturing

IS46 Wholesale and Retail Trade

IS47 Services

IS48 Other (requires additional information)D

- 1 

## Appendix D. Sensitivity Analyses

Some of EPA’s amendments to the IUR rule are expected to change the number of submitters, reports, or the number of responses to a specific question on Form U. For several options, data available from the 2006 IUR was used to directly estimate the number of chemical

substance s or submitters affected by the amendment. For e xample, the number of submitters who produce manufactured water above the threshold is known. However, a lack of available data for other amendments meant EPA only was able to estimate the impact broadly, such as a percentage

increase or decrease in the nu mber 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

su bmitter selects “Other” as a product function category, (4) requiring write

- in text if selecting
“Other” as a consumer or commercial use, and, (5) upfront substantiation for all CBI claims for processing and use information. In estimating the cost of these amendments, EPA used a midpoint estimate for the percentage increase or decrease in the number of submitters, reports filed, or number of submitters answering a specific question. To show the possible range of costs

as a result of the amendments more accu rately , EPA presents a range of costs in this section, using the lower and upper bounds for the item estimated.

D.1 

### Method for Determining Whether the Threshold Is Met

Currently, the IUR rule requires a report be filed for a chemical substance only if the

che mical substance ’s production volume exceeds the 25,000 lb threshold in the principal IUR reporting year. EPA is modifying the timeframe for reporting in future reporting cycles subsequent to 201 2 so chemical substance manufacturers (including importers) wi ll be subject to

the IUR rule if a chemical substance ’s production volume has met or exceeded the threshold in any calendar year since the last principal reporting year. The Agency expects this will increase

the number of sites and reports submitted by bet ween 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. Us ing a five percent increase in the number of sites and reports, EPA expects t he burden to industry will increase by approximately 72,000 hours in future reporting cycles (see Table 4

- 12 ). Table D

- 1 : contains the results of the sensitivity analysis using a lower bound estimate of a zero percent increase in the number of submitters and an upper bound estimate of a ten percent increase. All baseline burden estimates were taken from

Table 4

- 2

. The increase in burden to industry is expected to range from zero hours to approximately 143,000 hours as a result of modifying the method for determining whether the 25,000 lb threshold is met in future reporting cycles.D

- 2

Table D

- 1 : Sensitivity Analysis of Industry Burden Estimates for Modifying the Method for Determining Whether the Threshold Is Met (Future Reporting Cycles Only)

Burden to Prepare Part

I , Rule
Famili arizati

on, Compliance
Determinatio

n, and
Submission (hours per site) Number of Sites Burde

n to Prepa

re Part II

and

Recor
d Keepi

ng (hours

per report ) Number of Reports (with Part II) Burde

n to Prepa

re Part

III (hours

per report ) Number of Reports (with

Part III) Industry Burden ( hours )

Lower
Bound (0%
increas e) Upper
Bound (10%
increas e) Lower

Bound (0%
increas e) Upper
Bound (10%
increas e) Lower

Bound (0%
increas e) Upp er Bound (0%
increas e) Low er Bound (10% increase) Upper

Bound (10% increase)

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

Baseline 9.08 4,085 4,085 17.06 25,89

6 25,89

6 55.93 17,07

5 17,07

5 1,433,8

33 1,433,8

33

Post

Amendm

ent 9.08 4,085 4,494 17.06 25,89

6 28,48

6 55.93 17,07

5 18,78

3 1,433,8

33 1,577,2

16

Change
from the
Baseline 0.00 0 409 0.00 0 2,590 0.00 0 1 ,708 0 143,383

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

amendment value.



### Table D

- 2 shows the range of cost estimates using a zero percent lower b ound and ten percent upper bound increase in the number of reports and submitters as a result of the

amendment. All baseline cost estimates are taken from Table 4

- 5

. EPA estimates a cost to industry between $0 and $8.28 million. T he midpoint cost estimate of $ 4.14 million is used in

Table 4

- 13

.

Table D

- 2 : Sensitivity Analysis of Industry Cost Estimates for Modifyi ng the Method for Determining W hether the Threshold I s M et (Future Reporting Cycles Only)

Cost to Prepare Part

I , Rule
Familiarizatio n, Compliance
Determination

and
Submission (2008$ per site) Number of Sites Cost to Prepar
e Part

II and

Recor
d Keepin

g (2008$

per report) Number of

Repor ts (with Part II) Cost to

Prepare

Part III (2008$

per report) Number of

Reports (with Part III) Industry Cost

( millions 2008$ )

Lower

Bound (0%
increas e) Upper

Bound (10%
increas e) Lower

Bound (0%
increas e) Upper

Bound (10%
increas e) Lower

Bou nd (0%
increas e) Upper

Bound (10%
increas e) Lower

Bound (0%
increas e) Upper

Bound (10%
increas e)

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

Baseline $560.77 4,085 4,085 $968.3

9 25,896 25,896 $3,247.

40 17,075 17,075 $82.82 $82.82

Post

Amend

ment $560.77 4,085 4,494 $968.3

9 25,896 28,486 $3,247.

40 17,075 18,783 $82.82 $91.10

Change
from the
Baseline $0.00 0 409 $0.00 0 2,590 $ 0.00 0 1,708 $0.00 $8.28

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

amendment value.D

- 3



### The cost and burden to the Agency of this amendment were calculated in Section 5.4

. With a

five

- percent in crease 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 boun d zero percent increase in the number reports and an upper bound increase of ten percent, is presented

in Table D

- 3

. Baseline Agency burden is taken from Table 5

- 4

. The amendment is expect ed to increase the Agency burden by betw een zero and 208 hours.

Table D

- 3 : Sensitivity Analysis of Agency Burden Estimates for Modifying the Method for
Deter mining Whether the Threshold I s M et (Future Reportin g Cycles Only)

Burde

n to
Proces
s Part

I (hours ) Number of Sites Burde

n to
Proces
s Part

II (hours ) Number of Reports

(with Part II) Burde

n to
Proces

s Part

III (hours ) Number of Reports

(with Part III) Industry Burden (hours)

Lower

Bound (0%
inc rease ) Upper

Bound (10%
increase ) Lower

Bound (0%
increase ) Upper

Bound (10%
increase ) Lower

Bound (0%
increase ) Upper

Bound (10%
increase ) Lower

Bound (0%
increase ) Upper

Bound (10%
increase )

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

Baseline 0.017 4,085 4,085 0.042 25,896 25,896 0.054 17,075 17,075 2,080 2,080

Post

Amendmen

t 0.017 4,085 4,494 0.042 25,896 28,486 0.054 17,075 18,783 2,080 2,288

Change
from the
Baseline 0.000 0 409 0.000 0 2,590 0.000 0 1,708 0 208

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

- amendment value.



### Table D

- 4 shows the range in Agency cost s as a result of modifying the method for

determ ining whether the thr eshold is met. Baseline Agency costs are taken from Table 5

- 4

. The amendment is expected to increase the Agency cost between approximately $0 and $21,700 during the first reporting cycle.

Table D

- 4 : Sensitivity Analysis of Agency Cost Estimates for Modifying the Method fo r Determining Whether the Threshold Is M et (Future Reporting Cycles Only)

Cost

to
Proces
s Part

I (2008$ ) Number of Sites Cost

to
Proces
s Part

II (2008$ ) Number of Reports

(with Part II) Cost

to
Proces

s Part

III (2008$ ) Number of Reports

(with Part III) Industry Cost (2008$)

Lower

Bound (0%
increase ) Upper

Bound (10%
increase ) Lower

Bound (0%
increase ) Upper

Bound (10%
i ncrease ) Lower

Bound (0%
increase ) Upper

Bound (10 %
increase ) Lower
Bound ( 0% increase) Upper

Bound (10% increase)

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

Baseline $1.78 4,085 4,085 $4.40 25,896 25,896 $5.61 17,075 17,075 $216,94

9 $216,94

9

Post

Amendme

nt $1.78 4,085 4,494 $4.40 25,896 28,486 $5.61 17,075 18,783 $216,94

9 $238,64

4

Change
from the
Baseline $0.00 0 409 $0.00 0 2,590 $0.00 0 1,708 $0 $21,695

Note: Values in Change from the Baseline rows are calculated by subtracting t he corresponding baseline value from the post

- amendment
value.D

- 4

D.2 

### Reporting Production Volume Used On

- Site

The cost to industry of requiring the reporting of production volume used on

- site is estimated
in Section 4.4.13

. EPA esti mated 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 20 06 reports which claim the chemical substance s is an intermediate in
the downstream use and processing section (EPA, 2008c) ) will report production volume used

on

- site

. Therefore, the total number of reports with volume used on

- site ranges from 3,833 to 6,215 reports. Using a midpoint of 19.4 percent, industry burden is ex pected to increase by 7,596 hours (see Table 4

- 26 ). Table D

- 5 shows the burden estimates using the lower and uppe r bounds

for the number of reports that will contain information on producti on volume used on

- site

. The baseline cost per report is taken from Table 4

- 6

. EPA expects the total ind ustry burden to range from 5,800 to 9,400 hours.

Table D

- 5 : Sens itivity Analysis of Industry Burden Estimates for Reporting Production
Volume U sed O n
- S ite

Burden per Report to Report
Production

Volume Used
On

- Site (hours) Number of Reports with

Production Volume Used
On

- Site Total Industry Burden (hours)

Lower Limit (14.8% of all Reports) Upper Limit

(24% of all Reports) Lower Limit

(14.8% of all Reports) Upper Limit

(24% of all Reports)

Baseline 0.00 0 0 0 0

Post

- Amendment 1.51 3,833 6,215 5,795 9,397 Change from the
Baseline 1.51 3,833 6,215 5,795 9,397

No te: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the post

- amendment value.



### Table D

- 6 contains the r ange of cost estimates using a 14.8 percent lower bound and 24

per cent upper bound increase in the number of reports under the amendment .All baseline cost
estimates are taken from Table 4

- 5

. EPA estimates a cost to industry between $324,500 and $526,300, with a midpoint estimate of $0.43 million (see Table 4

- 27 )

.

Table D

- 6 : Sensitivity Analysis of Industry Cost Estimates for Reporting Production
Volume U sed On

- Site

Cost per Report to Report
Production

Volum e Used
On

- Site (2008$) Number of Reports with

Production Volume Used
On

- Site Total Industry Cost (2008 $ )

Lower Limit (14.8% of all Reports) Upper Limit

(24% of all Reports) Lower

Limit (14.8% of all Reports) Upper Limit

(24% of all Reports)

Baseline $0.00 0 0 $0 $0

Post

- Amendment $84.68 3,833 6,215 $324,544 $526,288
Change from the
Baseline $84.68 3,833 6,215 $324,544 $526,288

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

- amendment value.



### In Section 5.4.13 , EPA calculated the burden to the Agency of requiring the reporting of production volume used on

- site, using 19.4 percent as the estimated amount of reports list ingD

- 5



### productio n volume used on

- site is calculated in Section 5.4.13

. The resulting burden was 4.51

hours

. In Table D

- 7 , EPA calculates the range of burden estimates to the Agency, using a range

of 14 .8 to 24 percent as the amount of reports listing production volume used on

- site. The resulting burden is 3.44 to 5.57 hours per reporting cycle. The baseline burden per report is taken

fro m Table 5

- 4

.

Table D

- 7 : Sensitivity Analysis of Agency Burden Estimates for Reporting Production
Volume U sed On

- Site

Burden per Report to Report
Production

Volume Used
On

- Site (hours) Number of Reports with

Production Volume Used
On

- Site Burden per Report to Report
Production Volume Used
On

- Site (hours)

Lower Limit (14.8% of all Reports) Upper Limit

(24% of all Reports) Lower Limit

(14.8% of all Reports) Upper Limit

(24% of all Reports)

Baseline 0.000 0 0 0.00 0.00

Post

- Amend ment 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.



### T able D

- 8 contains the range in cost s to EPA as a result of modifying the method for determining whether the thr eshold is met. Baseline costs to EPA are taken from Table 5

- 4

. The amendment is expected to increase t he Agency cost between approximately $359 and $581 during the first reporting cycle.

Table D

- 8 : Sensitivity Analysis of Agency Cost Estimates for Reporting Production
Volume Used On

- Site

Cost per Report to

Re port Production

Volume Used
On

- Site (2008$) Number of Reports with

Production Volume Used
On

- Site Cost per Report to Report
Production Volume Used
On

- Site (2008$)

Lower Limit (14.8% of all Reports) Upper Limit

(24% of all Reports) Lower Limit

(14.8% o f 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 t he corresponding baseline value from the post

- amendment value.

D.3 

### Revising Industrial Function Categories

EPA is revising the current industrial function categories (found in Part III, Se ction A of Form U), by eliminating seven existing categories a nd adding seven new categories, and requiring submitters to write in a free

- tex t descriptor when they select “Other”. EPA anticipates these actions will reduce the number of submitters selecting “Other” by approximately 50 percent, from 1,206 reports to 603 (EPA, 2 008a). 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 f rom a 25 percent reduction of the total (905 reports in t otal) to a 75D

- 6



### percent reduction in total (302 reports in total)

. The results of thi s analysis for industry burden

are found in Table D

- 9 . A 75 percent reduction in the numbe r of submitters claiming “Other” means 25 percent of submitters are now claiming “Other,” and a 25 percent reduction means 75 percent of submitters are now claiming “Other.” The columns in this table and the remaining tables in this Appendix are labeled to reflect the resulting numbers; e.g., they show the lower resulting number in the “Lower Bound” column and the higher resulting number in the “Upper
Bound” column.

Baseline burden esti mate s are taken from Table 4

- 2 and the baseline number of reports is

found in Table 4

- 6

. EPA estimates the burden to industry will increase by between 4,300 and 4,400 hours.

Table D

- 9 : Sensitivity Analysis of Industry Burden Estimates for Requiring Write

- in Text for “Other” as an Industrial Function Category

Burden for

Rule
Fami liarization
of Additional Categories (hours) Number

of Reports
with
Industrial
Function Categories Burden

for
Write

- in

T ext for
"Other" (hours) Number of Reports with

“ Other ”
Write

- in Text Total Industry Burden (hours)

Lower

Bound (25% of
Submitters
Claim
"Other" ) Upper

Bound (75% of
Submitters
Claim "
Other" ) Lower

Bound (25% of
Submitters
Claim
"Other" ) Upper

Bound (75% of
Submitters
Claim
"Other" )

Baseline 8.59 17,075 0.00 0 0 146,661 146,661

Post

Amendment 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 calcula ted by subtracting the corresponding baseline value from the post

- amendment value.



### Table D

- 10 contains the range of cost estimates to industry with a lower bound estimate of a 75 percent decrease in the number of reports with “O ther” as industrial function categories and an upper bound of a 25 percent decrease in the number of reports with “Other” as industrial function categories. All baseline cost estimates are taken from Table 4

- 5

. EPA estimates a cost to industry between $253,400 and $257,800, with a midpoint estimate of $256,000 (see Table

4

- 35 )

.D

- 7

Table D

- 10 : Sensitivity Analysis of Industry Cost Estimates for Req uiring Write

- in Text for “Other” as an Industrial Function Category

Cost for Rule

Fa miliarization
of Additional Categories (2008 $ ) Number

of Reports
with
Industrial
Function Categories Cost for

Write

- in
Text for
"Other" (2008 $ ) Number of Reports with

“Ot her” Write

- in Text Total Industry Cost (2008 $ )

Lower

Bound (25% of
Submitters
Claim
"Other" ) Upper

Bound (75% of
Submitters
Claim
"Other" ) Lower

Bound (25% of
Submitters
Claim
"Other" ) Upper

Bound (75%of
Submitters
Claim
"Other" )

Baseline $88.02 17,075 $0.00 0 0 $1,502,913 $1,502,913

Post

Amendment $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 c orresponding baseline value from the post

- amendment value.



### Using a 50 percent decrease in the number of reports with “Other” selected

, the burden to the Agency during a reporting cycle is 0.54 hours and is calculated in Section 5.4.18

. Table D

- 11 contains the range of burden estimate s to the Agency , 0.27 hour to 0.81 hours per reporting cycle

. The baseline Agency burden estimates per report are taken from Table 5

- 4

.

Table D

- 11 : Sensitivity Analysis of Agency Burden Estimates for Requiring Write

- in Text for “Other” as an Industrial Function Category

Burden to
Process
Write

- in
Text for
"Other" (hours) Number of Repo rts with "Other"

Write

- in Text Total Agency Burden (hours)

Lower Bound (25% of
Submitters
Claim
"Other" ) Upper Bound

(75%of
Submitters
Claim
"Other" ) Lower Bound

(25% of
Submitters
Claim
"Other" ) Upper Bound

(75%of
Submitters
Claim
"Other" )

Baseli ne 0.00 0 0 0 0.00 0.00

Post

- Amendment 0.00 1 302 905 0.27 0.81 Change from the
Baseline 0.00 1 302 905 0.27 0.81

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

- amendment value.



### Table D

- 12 contains the range in costs to EPA as a result of modifying the industrial function categories

. Baseline costs to EPA are taken from Table 5

- 4

. The amendment is expected to

incr ease the Agency cost between approximately $28 and $85 during the first reporting cycle.D

- 8

Table D

- 12 : Sensitivity Analysis of Agency Cost Estimates for Requiring Write

- in Text for
“Other” as an Industrial Funct ion Category

Cost to
Process
Write

- in
Text for
"Other" ( 2008$ ) Numbe r of Reports with "Other"

Write

- in Text Total Agency Cost ( 2008$ )

Lower Bound (25%of
Submitters
Claim
"Other" ) Upper Bound

(75%of
Submitters
Claim
"Other" ) Lower Bound

(25%of
Submit ters
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 t he corresponding baseline value from the post

- amendment value

D.4 

### “Other” as a Consumer and/or Commercial Product Category

EPA is revising the list of consumer and commercial product categories by combining categories lead ing to common exposure scenarios and adding categories not ade quately

described in the current set of categories. The resultant list includes 33 product categories

, including “ O ther

. ” S everal consumer and commercial product categories have been renamed to better describe the products that sho uld be reported in that category. EPA is also requiring that if the product category “Other” is selected; a descriptor for the consumer and /or commercial product containing the chemical substance also to be reported. According to 2006 IUR data (EPA, 2008c)

, 1,207 reports listed “Other” as a consumer and/or commercial product category .Based on EPA’s best professional judgment, EPA expects the new categories in the amendment will reduce by half the n umber of submitters selecting “Other” as a consumer and/or commercial product category

. Therefore, this amendment will affect 604 reports. The cost and burden to industry with a 50 percent reduction in the number of submitters is found in Section 4.4.20

. The Agency conducted a sensitiv ity analysis for the decrease in reports selecting “Other” ranging from a 25 percent reduction of the total (905 reports in t otal) to a 75 percent reduction of

the total (3 02 reports in total). The results of this analysis for industry are found in Table D

- 13

. Baseline burden est imates are taken from Table 4

- 2 and the baseline number of reports is found

in Table 4

- 6

. EPA estimates the burden to indu stry will increase between 16,000 and 16,100
hours.D

- 9

Table D

- 13 : Sensitivity Analysis of Industry Burden Estimates for Requiring Write

- in Text for “Other” as a Consumer and/or Commercial Product Category

Bur den for

Rule
Familiarizatio
n of Additional Categorie s (hours) Number of

Reports
with
Consumer/
Commercia

l

Product Categories Burden

for
Write

in Text
for
"Other

" (hours) Numb er of Reports

with "Other" Write

- in

Text Total Industry Burden (hours)

Lower

Bound (25%of
Submitter

s Claim
"Other" ) Upper

Bound (75%of
Submitter

s Claim
"Other" ) Lower

Bound (25%of
Submitter

s Claim
"Other" ) Upper

Bound (75%of
Submitter

s Claim
"Other" )

Baseline 8.59 17,075 0.00 0 0 146,661 146,661

Post

Amendmen

t 9.52 17,075 0. 15 302 905 162,672 162,762

Change
from the
Baseline 0.94 0 0.15 302 905 16,010 16,101

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

- amendment value.



### Table D

- 14 s hows the range of cost estimates to industry with a lower bound estimate of a 75
percent decrease in the number of “ O ther” 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 fr om Table 4

- 5

. EPA
estimates a cost to industry of between $ 843,000 and $ 848,000 , with a midpoint estimate of $ 846,000 (see Table 4

- 37 )

.

Table D

- 14 : Sensitivity Analysis of Industry Cost Estimates for Requiring Write

- in Text for “Other” as a Consumer and/or Commercial Product Category

Cost for Rule
Familia rizatio
n of Additional Categorie s ( 2008$ ) Number of

Reports
with
Consumer/
Commercia

l

Product Categorie s Cost for

Write

in Text
for
"Other

" ( 2008$ ) Numbe r of Reports

with "Other" Write

- in

Text Total Industry Cost ( 2008$ )

Lower

Bound (25%of
Submitte r

s Claim
"Other" ) Upper

Bound (75%of
Submitter

s Claim
"Other" ) Lower

Bound (25%of
Submitter

s Claim
"Other" ) Upper

Bound (75%of
Submitter

s Claim
"Other" )

Baseline $70.64 17,075 $0.00 0 0 $1,206,177 $1,206,177

Post

Amendmen

t $119.90 17,075 $7.31 302 90 5 $2,049,55 1 $2,053,9 62

Change
from the
Baseline $49.26 0 $7.31 302 905 $843,37 4 $847,7 85

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 d ecrease in the number of reports with “Other” selected

, the burden to the Agency during each reporting cycle is 0.54 hours and is calculated in Section 5.4.20

. Table D

- 15D

- 10



### s hows the range of burden esti mate s to the Agency ; 0.27 hour to 0.81 hours per reporting cycle

. The baseline Agency burden estimates per report are taken from Table 5

- 4

.

Table D

- 15 : Sensitivity Ana lysis of Agency Burden Estimates for Requiring Write

- in Text for “Other” as a Consumer and/or Commercial Product Category

Burden to
Process
Write

- in
Text for
"Other" (hours) Number of Reports with "Other"

Write

- in Text Total Agency Burden (hours)

Lowe r 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 0.00 0.00

Post

- Amendment 0.00 1 302 905 0.27 0.81 Chang e from the
Baseline 0.00 1 302 905 0.27 0.81

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

- amendment value.



### Table D

- 16 s hows the range in costs to EPA as a result of modifying the consumer and commercial product categories

. Baseline costs to EPA are taken from Table 5

- 4 .The amendment is expected to increase the Agency cost between $28 and approximately $85 during the first reporting cycle

.

Table D

- 16 : Sensitivity Analysis of Agency Cost Estimates for Requiring Write

- in Text for
“Other” as a Consumer and/or Commercial Product Category

Number of Reports with "Other" Wr ite

in Text Total Agency Cost ( 2008$ )

Lower Bound (25%of Submitters
Claim
"Other" ) Upper Bound

(75%of Submitters
Claim
"Other" ) Lower Bound

(25%of Submitters
Claim
"Other" ) Upper Bound

(75%of Submitters
Claim
"Other" )

Baseline 0 0 $0 $0

Post

- Amendm ent 302 905 $28 $85
Change from the
Baseline 302 905 $28 $85

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

- amendment value.

D.5 

### Upfront CBI Substantiation

EPA is requiring an upfr ont 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 n umber of CBI claims. The Agency expects the number of DPU CBI claims to decrease by the same amount as a result of this amendment. According to 2006 IUR data (EPA, 2008c), a total of 8,133 reports had claimed processing and use information was CBI, with an average of three CBI claims for processing and use information per report. The estimates for industry cost of $773,000 and burden of 12,800 hours, associated with the 8,133 CBI claims are found in
Section 4.4.25

.D

- 11



### The Agency conducted a sensitivity analysis, assuming the reduction in CBI claims has a

lower bound of 84 percent, meaning 16 percent of submitters make a CBI claim in Part III, and an upper bound of 44 percent, meaning 56 percent of submitters make a CBI claim in Part III.

Table D

- 17 contains range in burden increase to industry as a result of the amendment. The burden is expected to increase by between 5,700 and 19,900 hours.

Table D

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

Burden for

Upfront CBI
Substantiation
for CBI
Claims in

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

Lower L imit (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

Post

Amendment 4.38 1,301 4,554 5,700 19,949

Change from

the Baseline 4.38

- 6,832

- 3,579 5,700 19,949

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

- amendment value.



### Table D

- 18 show s 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 fr om Table 4

- 5

. EPA estimates industry cost of between $343,400 and $1.2 million , with a midpoint estimate of $773,000 (see Table 4

- 35 )

.

Table D

- 18 : Sensitivity Analysis of Industry Cost Estimates for Requiring Upfront CBI
Substantiation

Cost for

Upfront CBI
Substantiation
for CBI
Claims in

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

Lower Limit (16%of
Submitters
Claim CBI ) Upper Limit

(56%of
Submitters
Claim CBI ) Lower Limit

(16%of
Submitters
Claim CBI ) Upper Limit

(56%of
Submitters
Claim CBI )

Baseline $0.00 8,133 8,133 $0 $0

Post

Amendment $263.90 1,301 4,554 $343,413 $1,201,944

Change from
the Baseline $263.90

- 6,832

- 3,579 $343,4 13 $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 A gency burden increase during each report ing cycle is calculated as eight hours in Section 5.4.25

. Table D

- 19 contains the range

of burden estimate s to the Agency , which is 3.5 0 hour s to 12.25 hours per reporting cycle

. The baseline Agency bu rden estimates per report are taken from Table 5

- 4

.D

- 12

Table D

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

Burden for Up front CBI
Substa ntia tion
for CBI
Claims in

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

Lower Limit (16%of
Submitters
Claim CBI ) Upper Limit

(56%of
Submitters
Claim CBI ) Lower Limit

(16%of
Submitters
Claim CBI ) Upper Limit

(56%of
Submitters
Claim CBI )

Baseline 0.00 8,133 8,133 0 0

Post

Amendment 0.28 1,301 4,554 3.50 12.25

Change
from the
Baseline 0.28

- 6,832

- 3,579 3.50 12.25

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

- amendment
value.



### Table D

- 20 contains the range in costs to EPA as a result of modifying the industrial function categories

. Baseline costs to EPA are taken from Table 5

- 4 .The amendment is expected to

incr ease the Agency cost between $365 and $ 1,278 during the first reporting cycle

.

Table D

- 20 : Sensitivity Analysis of Agency Cost Estimates for Requiri ng Upfront CBI
Substantiation

Cost for

Upfront CBI
Substa ntia tion
for CBI
Claims in

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

Lower Limit (16%of
Submitters
Claim CBI ) Upper Limit

(56%of
Submitters
Claim CBI ) Lower L imit

(16%of
Submitters
Claim CBI ) Upper Limit

(56%of
Submitters
Claim CBI )

Baseline $0.00 8,133 8,133 $0 $0

Post

Amendment $0.28 1,301 4,554 $365 $1,278

Change
from the
Baseline $0.28

- 6,832

- 3,579 $365 $1,278

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

- amendment
value.E

- 1 

## Appendix E. Alternative Regulatory Options

In developing the amendment s to the IUR rule, EPA considered other regulatory options as alternatives to some of the propo sed amendment s. These options were considered both as alternatives to all the proposed amendments, and in addition to the proposed amendments outlined in Chapter 3. The burden and cost for these alternate regulatory options are described in

the following sections. Because these options were considered only during the proposed rule, the total costs, submission dates, and annualization periods associated with them may not match what is presented in the main text for the final rule

.

E.1 

### Require Submitters to Submit Full Data Annually

As an alternative to the amendment described in Section 3.5.4

, which will require submitters to report production volume for each of the years since the last IU R 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 thresh old. EPA calculated the cost and burden of this option under two

different scenarios. The first calcula tes the cost and burden to the industry and the Agency without considering the other proposed amendments. The second scenario estimates the cost and burden to all affected entities if all the proposed amendments outlined in Section 3. are enacted.

E.1.1 

### Annual Reporting Cost and Burden when the Option is Considered by Itself

Under this alternative option, EPA estimated the cost to the industry and the Agency of annual reporting when the option is considered by itself, with none of th e 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 , af

ter the first reporting cycle . While the Agency is aware that a site’s production volume may vary yearly, causing the site to meet or exceed the threshold in some years but not in others, EPA believes on average, the total number of sites and reports would remain unchanged from year to year.

EPA analyzed the burden and costs over a 2 5

- year period. EPA assumes submitters will become more efficient at reporting data over time, and therefore incur a smaller burden in future reporting cycles. Future

- cycle repo rting burden is taken from Table 4

- 11

. The annual industry burden under the baseline and the alternative option is shown in Table

E

- 1

. In total, EPA estimates the industry burden would increase by appro ximately 22.94 million hours over 25 years (five reporting cycles). Over one future five

- year reporting cycle, the industry burden is expected to increase by 5.74 million hours (1.43 million hours x 4 years) compared to the baseline.

Table E

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

Reporting Cycle Years Baseline Burden Post

- Alternative Option Burden Change from
Baseline

( millions of hours ) ( millions o f hours ) ( millions of hours )

1 2007 to 2011 1.84 1.84 0.00

2 2012 to 2016 1.43 7.17 5.74E

- 2 3 2017 to 2021 1.43 7.17 5.74

4 2022 to 2026 1.43 7.17 5.74

5 2027 to 2031 1.43 7.17 5.74

Total 7.58 30.52 22.94
Annual Average 0.30 1.22 0.92



### The industry co st under the baseline an d this alternative option is shown in Table E

- 2

. EPA

est imates the industry cost would increase by $1.33 billion over a 25

- year period. The annualized cost increase ranges from $44.34 million with a seven percent discount rate to $49.54 million with a three percent discount rate. Over one five

- year reporting cycle, this option would increase industry cost by approximately $331 million ($82.8 million x 4 years) compared to the baseline.

Table E

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

Reporting Cycle Years Baseline Cost Post

- Alternative Option Cost Change from
Baseline (2008$ millions) (2008$ millions) (2 008$ 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

Annua l Average $17.53 $70.53 $53.00

Annualized at 3% $16.80 $66.34 $49.54

Annualized at 7% $15.88 $60.22 $44.34

The baseline burden to EPA during each reporting cycle is two FTEs, or 4,160 hours (see
Section 5

- 2 ). Whil e the burden for each reporting cycle w ould not change as a result of this amendment, more frequent reporting w ould increase costs to the Agency. Table E

- 3 contains the total Agency burden of the annual reporting option, over a 2 5

- year period. EPA estimates Agency burden w ould increase by
a total of 66,600 hours over a 25

- year period (five reporting cycles). Over one five

- year reporting cycle, the Agency burden would increase by 16,600 hours (4,160 hours x 4 years) compared to the baseline.

Table E

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

Reporting Cycle Years Baseline Burden Post

- Alternative Option Change

from
Baseline
( hours ) ( hours ) ( hours )

1 2007 to 2011 4,160 4,160 0

2 2012 to 2016 4,160 20,800 16,640

3 2017 to 2021 4,160 20,800 16,640

4 2022 to 2026 4,160 20,800 16,640

5 2027 to 2031 4,160 20,800 16,640

Total 20,800 87,360 66,560E

- 3

Annual Average 832 3,494 2,662



### Th e annual Agency cost under the baselin e and the alternative option is shown in Table E

- 4

, and is taken from Table 5

- 3 .In total , EPA estimates this option would increase the Agency cost by approximatel y $1.86 million over one five

- year reporting cycle. Over a 25

- year period

, the annualized Agency cost is expected to increase between $359,900 with a seven percent discou nt rate, and $367,300 with a three percent discount rate compared to the baseline.

Table E

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

Reporting Cycle Years Baseline Cost Post

- Alternative Option
Cost Change from

Baseline
(2008$ ) (2008$) (2008$)

1 2007 to 2011 $466,133 $466,132 $0.00

2 2012 to 2016 $466,133 $2,330,664 $1,864,53 2

3 2017 to 2021 $466,133 $2,330,664 $1,864,53 2

4 2022 to 2026 $466,133 $2,330,664 $1,864,53 2

5 2027 to 2031 $466,133 $2,330,664 $1,864,53 2

Total $2,330,664 $9,788,790 $7,458,126 Annual Average $93,227 $391,552 $298,325

Annualized at 3% $87,798 $366,630 $291,617

Annualized at 7% $81,056 $466,133 $359,885

E.1.2 

### Annual Reporting Cost and Burden when the All the Proposed
Amendments are Considered

EPA estimated the cost and burden of annual reporting in addition to the proposed amendments outlined in Chapter 3. Under this alternative, the annual reporting cost and burden
would be the same as the burden when al l the amendments are considered, as shown in Table

4

- 52 . After the first reporting cycle, the number of submitters is not expected to change from
year to year.

The industry burden of annual reporting is shown in Table E

- 5 . The annual reporting option is expected to increase the industry burden by approximately 39.58 million hours over a 25

- year period, for a total industry burden of 56.01 million hours. EPA estimates over one four

- year reporting cycle (n ote under the final amendments, a reporting cycle will be changed to four years) the industry burden would increase by approximately 7.92 million hours (2.64 million hours x 3 years) compared to the baseline.

Table E

- 5 : Industry Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Reporting Cycle Years Baseline Burden Post

- Alternative Option Burden Change from
Baseline
( millio ns 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 7.92E

- 4 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



### The industry baseline cost is taken from Table 4

- 53

. EPA est imates annual reporting would increase industry cost by approximately $2.43 billion over a 25

- year period. The change in

an nualized cost ranges from $81.39 million with a seven percent discount rate to $90.90 million with a three percent discount rate as shown in Table E

- 6 . Over one four

- year reporting cycle, this option would increase industry cost by approximately $486 million ($162.08 x 3 years) compared to the baseline.

Table E

- 6 : Industry Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendm ents are Considered

Reporting Cycle Years Baseline Cost Post

- Alternative Option Cost Change from

Baseline (2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $198.84 $198.84 $0.00

2 2012 to 2015 $162.08 $648.33 $486.25

3 2016 to 2019 $162.08 $648.33 $486.25

4 2020 to 2023 $162.08 $648.33 $486.25

5 202 4 to 2027 $162.08 $648.33 $486.25

6 202 8 to 2031 $162.08 $648.33 $486.25

Total $1,009.25 $3,440.49 $2,431.24
Annual Average $40.37 $137.62 $97.25

Annualized at 3% $38.40 $129 .30 $90.90

Annualized at 7% $35.83 $117.22 $81.39



### The Agency baseline burden when all the proposed amendments are considered is taken from

Table 5

- 43 . The annual reporting option is expected to increase Agency burden by a pproximately 36,800 hours when all amendments are considered (see Table E

- 7 ). Over a four

- year reporting cycle, EPA estimates Agency burden would increase by approximately 7,400 hours (2,456 hours x 3 years) compared to the basel ine.

Table E

- 7 : Agency Burden under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Reporting Cycle Years Baseline Burden Post

- Alternat ive Option Burden Change from
Baseline

( millions of hours ) ( millions of hours ) ( millions of hours )

1 2007 to 2011 2,439 2,439 0

2 2012 to 2015 2,456 9,826 7,369

3 2016 to 2019 2,456 9,826 7,369

4 2020 to 2023 2,456 9,826 7,369

5 2024 to 2027 2,456 9,826 7,369

6 2028 to 2031 2,456 9,826 7,369E

- 5

Total 14,721 51,568 36,847 Annual Average 589 2,063 1,474



### The baseline Agency cost when all the proposed amendments are enacted is taken from Table

5

- 44 . The total Agency cost unde r the annual reporting option when all proposed amendments
are considered is shown in Table E

- 8 . Over a 25

- year period, Agency cost would increase by approximately $4.33 million, with annualized costs increases ranging from appro ximately $205,000 with a seven percent discount rate to $227,000 with a three percent discount rate. Over

one four

- year reporting cycle, the Agency cost is expected to increase by $865,000 ($288,450 x 3 years) compared to the baseline.

Table E

- 8 : Agency Cost under the Alternative Option to Require Submitters to Submit Full Data Annually when all the Proposed Amendments are Considered

Reporting Cycle Years Baseline Cost Post

- Alternative Option Cost Change from

B aseline (2008$) (2008$ millions) (2008$ millions)

1 2007 to 2011 $286,580 $286,580 $0

2 2012 to 2015 $288,450 $1,153,800 $865,350

3 2016 to 2019 $288,450 $1,153,800 $865,350

4 2020 to 2023 $288,450 $1,153,800 $865,350

5 2024 to 2027 $288,450 $1,153 ,800 $865,350

6 2028 to 2031 $288,450 $1,153,800 $865,350

Total $1,728,830 $6,055,580 $4,326,750
Annual Average $69,153 $242,223 $173,070

Annualized at 3% $65,011 $226,783 $161,773

Annualized at 7% $59,642 $204,495 $144,853

E.1.3 

### Small Entity Analysis

The following section provides a preliminary a ssess ment of the impact annual Form U submissions may have on small entities by examining the relationship between the compliance costs and company sales for small companies . This analysis is based on the methodol ogy described in Chapter 8 of this report. All costs and burdens are estimated under the assumption all the proposed amendments are enacted.

EPA estimated in Chapter 8 of this report there are 3.89 manufacturing sites per global parent

company; 41.3 perce nt of global parent companies ( 466 companies) are considered small under
the SBA employment

- based definition

, 13 

### a nd 24.8 percent (280 companies) are considered small

under the TSCA sales

- based definition

. 14 

### EPA also estimated an average of approximately 1.76 sites per small company under the employ ment

- based definition of small business

, and approximately 1.92 sites per small company under the sales

- bas ed definition. EPA estimated

a verage annual sales revenue of global parent companies considered small under either definition using data from Dun & Bradstreet, as also described in Chapter 8.

13 Threshold of 1,000 employees

. 14 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of any parent company, are below $4 millio n.E

- 6



### Table 4

- 53 shows the annual incremental cost of the rule to industry. Be cause this cost would be incurred once every year under a n annual reportin g cycle, it was not discounted. As shown in

Table E

- 9 below, these costs were divided by the total number of sites expected to submit data,

for the annualize d costs per site

. This was multiplied by the number of sites per small p arent company to arrive at the annualized costs per small parent company

. This value was divided by the annual sales per small parent company to derive the cost

- to

- sales ratio.

As shown in Table E

- 9 , under the emp loyment

- based definition, a small parent company affected by the rule on average has sales of more than $4 12.7 million

. The annual costs of the proposed IUR rule amendments per small parent company, however, are $39,582. The cost

- to

sales ratio for an aver age small company under the employment

- based SBA definition would be

0.01 percent or less

. Under the more conservative sales

- based TSCA definition, small parent company sales are on average more than $11 .8 million, with annualized costs associated with the proposed amendments of $ 43,181 . The cost

- to

- sales ratio for an average small company under

the sales

- based definition would be 0.364 percent or less.

Using the highest annual cost shown in Table E

- 9 of $ 43 ,181 , a small company would have to
have annual sales of less than $4. 32 million in order to have a cost

- to

- sales ratio larger than one
percent

.

Table E

- 9 : Derivation of Cost

- to

- Sales Ratios for Small Manufacturers f or Collection of Annual Reporting

Employment

- based
Definition Sales

- based Definition

Total Incremental Annual Costs $91,871,064

Total Number of Sites 4,085
Annual costs per site $21,49 0
Number of sites per small parent company 1.76 1.92

Annualized c osts per small parent company $39,582 $43,181 Annual sales per small parent company $412,713,310 $11,821,104

Cost

- to

- sales ratio 0.010% 0.365% Number of companies potentially affected 466 280

E.2 

### Modify Reporting Frequency to a Three

- Year Cycle

As an a lternative to the amendment described in Section 3.13 , which will modify the reporting frequency to a four

- year cycle, t he Agency considered increas ing the reporting frequency to once every three years, if the m anufacturer exceed s the production volume threshold in any calendar year of the cycle . EPA estimates the burden of this option on all affected entities, both when the option is considered by itself and when all the proposed

amendments are considered.

E.2.1 

### Thre e - Year Reporting Cycle Cost and Burden when the Option is Considered by Itself

EPA’s analysis of industry burden and cost for this option is similar to that described in

Section 4.4.31 ; the burden in any one reporting cycle wou ld not change, but the longer

- term burden to industry would increase because reporting will become more frequent. However, the Agency assumes no additional reports would be submitted as a result of reducing the length ofE

- 7



### the reporting cycle.(While the mix of chemical substance s might change, EPA assumes the total number of reports would remain relatively static.) To be comparable with the four

- year reporting cycle amendment, costs to industry are calculated over a 20

- year period.

The annual industry burdens under the baseline and under this alternative option are shown in

Table E

- 10 . The industry burden is taken from Table 4

- 10 for the first reporting cycle and from

Table 4

- 11 for all future reporting cycles. In total, EPA estimates under this option, industry
would incur an additional burden of 2.87 million hours over a 20

- year period.

Table E

- 10 : Annual Industry Burden under the Alternative Option of a Three

- Year Reporting Cycle

Reporting Cycle 1 Years Baseline Burden Post

- Amendment

Burden Change in Burden

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 1.8 4 1.84 0.00

2 2012 to 2016 1.43

-- 0.00

2012 to 2014

-- 1.43

3 2017 to 2021 1.43

-- 0.00

2015 to 2017

-- 1.43

4 2022 to 2026 1.43

-- 0.00

2018 to 2020

-- 1.43

5 2021 to 2023

-- 1.43 1.43

6 2024 to 2026

-- 1.43 1.43

Total 6.14 9.01 2.87

Annu al Average 0.31 0.45 0.14

1 The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are alternative

, three

- year cycles

. 

### The annual industry cost under the baseline and this alternative option are shown in Table

E

- 11

. In total, EPA estimates this option would increase costs to industry by $165.64 million

over a 20

- year period, with annualized costs increases ranging from $6.96 million with a seven percent discount rate to $7.75 mill ion with a three percent discount rate.

Table E

- 11 : Industry Cost under the Alternative Option of a Three

- Year Reporting Cycle

Reporting Cycle 1 Year s Baseline Cost Post

- Alternative Option Cost Change from

Bas eline (2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $106.97 106.97 0.00

2 2012 to 2016 $82.82

-- 0.00

2012 to 2014

-- $82.82

3 2017 to 2021 $82.82

-- 0.00

2015 to 2017

-- $82.82

4 2022 to 2026 $82.82

-- 0.00

2018 to 2020

-- $82.82

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 $7.75E

- 8

Annualized at 7% $16.03 $22.99 $6.96

1 The non

- it alicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are alternative

, three

- year cycles

. 

### The baseline burden to EPA during reporting years would be two FTEs or 4,160 hours (see
Section 5

- 2 ). While the burden per reporting year would not change as a result of this alternative option, more frequent reporting would increase costs to the Ag ency. Table E

- 12 contains the total burden to the Agency of the option, ove r a 20

- year period. During this period, EPA estimates Agency burden would increase by a total of approximately 8,300 hours.

Table E

- 12 : Burden to the Agency under the Alternative Option of a Three

- Year Report ing Cycle

Reporting Cycle 1 Years Baseline Burden Post

- Amendment

Burden Change in Burden

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 4,160 4,160 0

2 2012 to 2016 4,160

-- 0

2012 to 2014

-- 4,160

3 2017 to 2021 4,160

- - 0

2015 to 2017

-- 4,160

4 2022 to 2026 4,160

-- 0

2018 to 2020

-- 4,160

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, fiv e

- year cycles, and the italicized reporting cycles are alternative

, three

- year cycles

.



### The annual Agency costs under the ba seline and the alternative option are shown in Table

E

- 13 , and are taken from Table 5

- 3

. In total , EPA estimates this option would increase Agency

cost s by $ 932,300 over a 20

- year period with an annual average of $46,600.

Table E

- 13 : Agency Cost under the Alternative Opt ion of a Three

- Year Reporting Cycle

Reporting Cycle 1 Year s Baseline Cost Post

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

1 2007 to 2011 $466,133 $466,133 $0

2 2012 to 2016 $466,133

-- $0

2012 to 2014

-- $466,133

3 2017 to 2021 $466,133

-- $0

2015 to 2017

-- $466,133

4 2022 to 2026 $466,133

-- $0

2018 to 2020

-- $466,133

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 $ 46,613E

- 9

Annualized at 3% $87,798 $131,412 $43,614

Annualized at 7% $81,056 $120,247 $39,190

1 The non

- italicized reporting cycles are baseline, five

- year cycles, and the italicized reporting cycles are alternative

, three

- year cycles

.

E.2.2 

### Three

- Year Cycle C ost and Burden when the All the Proposed Amendments
are Considered

EPA estimated the cost and burden of a three

- year reporting cycle in addition to the proposed amendments outlined in Chapter 3. Under this alternative option, th e reporting burden for industry would be the same as the combined post amendment burden shown in Table 4

- 52 ; however the reporting cycle would be shortened from four years to three years. For both industry and the Agency, the post

- amendment burden would increase from the baseline because of the increased reporting frequency.

The total increase in industry burden over 17 years as a result of increasing the reporting frequency to three years from four years is 2.64 million hours (se e Table E

- 14 ). This equates to

an annual increase in the reporting burden of approximately 0.13 million hours.

Table E

- 14 : Annual Industry Burden under the Alternative Option of a Th ree

- Year Reporting Cycle when the All the Proposed Amendments are Considered

Reporting Cycle 1 Years Baseline Burden Post

- Amendment

Burden Change in

Burden

(millions of hours) (millions of hours) (millions of hours)

1 2007 to 2011 3.24 3.24 0.00

2 2012 to 2015 2.64

-- 0.00

2012 to 2014

-- 2.64

3 201 6 to 2019 2.64

-- 0.00

2015 to 2017

-- 2.64

4 2020 to 2023 2.64

-- 0.00

2018 to 2020

-- 2.64

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

- italicize d rep orting cycles are baseline, four

- year cycles, and the italicized reporting cycles are alternative

, three

- year cycles

. 

### The industry cost for a three

- year reporting cycle is shown in Table E

- 15 . Baseline costs are

taken from Table 4

- 50. Over a 17

- year period, total costs would increase by $162.08 million, with an annualized increase of $8.93 million at a three percent discount rate and $8.07 million at a seven percent discount rate.E

- 10

Table E

- 15 : Industry Cost under the Alternative Option of a Three

- Year Reporting Cycle when the All the Proposed Amendments are Considered

Reporting Cycle 1 Year s Baseline Cost Post

- Alternative Option Cost Change from
Baseline (2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $19.88 $19.88 $0.00

2 2012 to 2015 $162.08

-- $0.00

2012 to 2014

-- $162.08

3 201 6 to 2019 $162.08

-- $0.00

2015 to 2017

-- $162.08

4 2020 to 2023 $162.08

-- $0.00

2018 to 2020

-- $162.08

5 2021 to 2 023

-- $162.08 $162.08

Total $506.13 $668.21 $162.08
Annual Average $29.77 $39.31 $9.53

Annualized at 3% $38.29 $47.23 $8.93

Annualized at 7% $35.70 $43.76 $8.07

1 The non

- italicized rep orting cycles are baseline, four

- year cycles, and the ita licized reporting cycles are alternative

, three

- year cycles

.



### The Agency baseline burdens of 2,439 hours (first reporting cycle) and 2,456 (future reporting cycles) when all the proposed amendments are considered together is taken from Table

5

- 43 . The annual reporting option is expected to increase Agency burden by approximately 2,500 hours over 17 years when all amendments are considered (see Table E

- 16 ).

Table E

- 16 : Agency Burden under the Alternative Option of a Three

- Year Reporting Cycle when the All the Proposed Amendments are Considered

Reporting Cycle 1 Year s Baseline Burden Post

- Amendment

Burden Change in

Burden

( hours) (hours) (hours)

1 2007 to 2011 2,439 2,439 0

2 2012 to 2015 2,456

-- 0

2012 to 2014

-- 2,456

3 201 6 to 2019 2,456

-- 0

2015 to 2017

-- 2,456

4 2020 to 2023 2,456

-- 0

2018 to 2020

-- 2,456

5 2021 to 2023

-- 2,456 2,456

Total 9,807 12,264 2,456
Annual Average 577 72 1 145

1 The non

- italicized rep orting cycles are baseline, four

- year cycles, and the italicized reporting cycles are alternative

, three

- year cycles

.



### Table E

- 17 contains the total Agency cost under a three

- year reporting cycle. EPA estimates the Agency cost would increase by approximately $288,500 over a 17

- year period. The annualized cost is expected to increase by $15,600 with a three percent discount rate and $14,400 with a seven percent discount rate.E

- 11

Table E

- 17 : Agency Cost under the Alternative Option of a Three

- Year Reporting Cycle when the All the Proposed Amendments are Considered

Reporting Cycle 1 Year s Baseline Cost Post

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

1 2007 to 2011 $286,580 $286,580 $0

2 2012 to 2015 $288,450

-- $0

2012 to 2014

-- $288,450

3 201 6 to 2019 $288,450

-- $0

2015 to 2017

-- $288,450

4 2020 to 2023 $288,450

-- $0

2018 to 2020

-- $288,450

5 2021 to 2023

-- $288, 450 $288,450

Total $1,151,930 $1,440,380 $288,450

Annual Average $67,761 $84,728 $16,968

Annualized at 3% $63,741 $79,637 $15,896

Annualized at 7% $58,612 $72,971 $14,359

1 The non

- italicized rep orting cycles are baseline, four

- year cycles, and the italicized reporting cycles are alternative

, three

- year cycles

.

E.2.3 

### Small Entity Analysis

The following section provides a preliminary assessment of the impact a three

- year reporting cycle may have on small entities by examining the relationship between the compliance costs and company sales for small companies. This analysis is based on the methodology found in Chapter 8 of this report and all costs and burdens are estimated under the assumption all the proposed amendments are enacted. EPA estimated 3.89 man ufacturing sites per global parent company in Chapter 8 of this report; 41.3 percent of global parent companies (466 companies) are considered small under the SBA employment

- based definition, 15 

### and 24.8 percent (280 companies) are considered small under the TSCA sales

- based definition. 16 

### EPA also estimated an average of approximately 1.76 sites per small company under the employment

- based definition of small business, and approximately 1.92 sites per small company under the sales

based definition. Average ann ual sales revenue of global parent companies considered small under either definition were estimated using data from Dun & Bradstreet, as also described in the

EA.

Table 4

- 53 shows the incremental cost to the indus try. Because these costs would be incurred once every three years under a three

- year reporting cycle, these costs were summed and annualized over three years at both a three percent and seven percent discount rate. 17 

### As shown

in Table E

- 18 , these costs were divided by the total number of sites expected to submit data, for

15 Threshold of 1,000 employees

. 16 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of any parent company, are below $4 million.

17 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A

- 4 (OMB, 2003). A three percent discount rate was also use d as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.E

- 12



### the annualized costs per site. This was multiplied by the number of sites per small parent company to arrive at the annualized costs per small pare nt company. This value was divided by the annual sales per small parent company to derive the cost

- to

- sales ratio.

As shown in Table E

- 18 , under the employment

- based definition, a small parent company affected by t he rule on average has sales of more than $412.7 million. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $14,096 at a seven percent discount rate, and even lower under a three percent discount rate. The cost

- to

- sales ratio for an average small company under the employment

- based SBA definition would be 0.0034 percent or less. Under the more conservative sales

- based TSCA definition, small parent company sales are on average more than $11.8 million, with annuali zed costs associated with the proposed amendments of $32.7 million or lower. The cost

- to

- sales ratio for an average small company

under the sales

- based definition would be 0.13 percent or less.

Using the highest annual cost shown in Table E

- 18 of $15,378, a small company would have to have annual sales of less than $1.58million in order to have a cost

- to

- sales ratio larger than
one percent.

Table E

- 18 : Derivation of Co st

- to

- Sales Ratios for Small Manufacturers for a Three

- Year Reporting Cycle

Employment

- based Definition Sales

- based Definition

3%
Discount

Rate 7% Discount

Rate 3%

Discount

Rate 7% Discount Rate Incremental Costs of Proposed
Other Amendments $91,871 ,064

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

Total Number of Sites 4, 085

Annualized Costs per Site $7,719 $8,009 $7,719 $8,009 Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per Small Parent Comp any $13,586 $14,096 $14,821 $15,378

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

Cost

- to

- Sales Ratio 0.0033% 0.0034% 0.1254% 0.1301%
Number of Companies Potentially Affected 466 280

E.3 

### Change the Threshold for Reporting to 10,000 lb

The Agency also considered an option that would lower the reporting threshold from 25,000

lb to 10,000 lb

. Prior to the amendments to the 2006 IUR rule, EPA required sites to submit a
Form U for chemical substance s produced at 10 ,000 lb or greater. The 2006 amendments increased the threshold for reporting to 25,000 lb

. This alternative regulatory option would return to the previous threshold for reporting.E

- 13

E.3.1 

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

EPA used data from the 2002 reporting cycle (EPA, 2009d) to estimate the additional number of reports that would be submitted under the alternative threshold option. The total number of reports and sites reporting at three different production l evels (10,000 lb ≤ P V < 25,000 lb , 25,000 lb ≤ P V < 300,000 lb , and PV ≥ 300,000 lb ) were analyzed to obtain the total range of reports submitted in 2002. Table E

- 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 chemical substance s in amounts between 10,000 lb and 25,000 lb

. Thirteen percent of all reports, or 3,595 reports, were submitted in 2002 for chemical substance s pr oduced between 10,000 lb and 25,000 lb

Table E

- 19 : Number of Reports and Sites in 2002

Production Volume Number of Sites Percent of Total Number of Reports Percent of

Total 10,000 lb ≤ P V < 25,000

lb 882 19% 3,595 13%

25,000 lb ≤ P V < 300,000 lb 1,392 30% 8,548 32%

PV ≤ 300,000 lb 2,304 50% 14,818 55%

Total 4,578 100% 26,961 100%

Source: U.S. EPA, Office of Pollution Prevention and Toxics, Information Management Division 2002 IU R Database Statistics for IUR Modifications Rule . Washington, DC. April 30, 2009 (EPA, 2009d).



### To estimate the total number of additional sites submitting reports as a result of the option, EPA applied the percentage of total sites with production volume s between 10,000 lb and 25,000

lb in 2002 (19 percent), to the total number of sites in 2006; 4,085 (baseline 2006 numbers are presented in Table 4

- 6 )

. Therefore, the Agency estimates 787 additional sites would sub mit
reports as a result of the option. The same methodology was applied to calculating the additional number of reports; EPA estimates a 13 percent increase in the number of 2006 reports, for a total of 3,453 new reports. Because all reports submitted as a result of the proposed amendments would be for production volumes less than 300,000 lb , EPA assumes only additional partial reports (Part IIs) would be submitted.

As described in Section 4.2.2

, sites need to complete Part I o f Form U only once, and complete Part II and Part III (as applicable) for each chemical substance manufactured (or imported). Taking this allocation of activities into consideration, and using the baseline unit
burden estimates as shown in Table 4

- 2

, Table E

- 20 shows the industry burden estimate as a

result of this option

. The Agency estimates the option would cause an increase in industry burden of approximately 94,600 hours.E

- 14

Table E

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

Number

of Sites Burden per

Part I of Report
, Compliance Determination,

Rule Familiarization,

and S ubmission Number

of
Partial Reports Burden p er

Part II of Report and

R ecordkeeping Number

of F ull

R eports 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

Post

Amendment 4,872 33 .26 29,349 19.82 17,075 69.92 1,937,544

Change
from the
Baseline 787 0 3,453 0 0 0 94,611

1 Baseline unit burden derivations shown in Table 4.4
Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline val ue from the post

amendment value.



### The cost of the option was calculated using the unit costs shown in Table 4

- 5

. Table E

- 21 shows the industry cost estimate as a result of this option

. The cost to industry is expected to increase by $5.52 million.

Table E

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

Number

of Sites Cost per Part I

of Report
, Compliance Determination,

Rule Familiarization,

and S ubmission (2008$) Number

of Partial Reports Cost per

Part II of Report and

R ecordkeeping (2008$) Number

of F ull

R eports 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

Post

Amendment 4,872 $2,058.18 29,349 $1,129.42 17,075 $4,059.25 $112.49

Change
from the
Baseline 787 $0.00 3,453 $0.00 0 $0.00 $5.52

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

amendment value.



### The baseline burden to EPA of data processing and entry would not change from the baseline of 2,080 hours (see Section 5

- 2 ). However, the increased number of reports and submitters would increase the burden to the Agency. While the burden p er reporting cycle would not change as a result of this option, more frequent reporting would increase costs to the Ag enc y. Table E

- 22

c ontains the total Agency of the option . EPA’s burden is expected to increase by a total of 159
hours.E

- 15

Table E

- 22 : Change in Burden to the Agency as a Result of Changing the Threshold for Reporting to 10,000 lb

Burden to
Process Part

I Submission (hours ) Number

of Sites Burden to

Process

Part II (hours per report) Number

of Reports (with Part II) Burden

to
Process

Part

III (hours

per report) Number

of Reports (with

Part III) Agency Burden

( hours)

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

Baseline 0.017 4,085 0.042 25,896 0.054 17,075 2,080

Post

Amendment 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 Baseli ne rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### Table E

- 23 shows the estimated change in cost to EPA as a result of the option

. The Agency estimates a cost increase of appro ximately $16,600.

Table E

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

Cost to

Process Part
I Submission (2008 $ ) Number

of Sites Cost to

Process

Part II (2008 $ per report) Number

of Reports (with Part II) Cost to

Process

Part

III ( 2008$

per report) Number

of Reports (with

Part III) Agency Cost

(2008 $ )

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

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

Post

A mendment $1.78 4,872 $4.40 29,349 $5.61 17,075 $233,529

Change
from the
Baseline $0.00 787 $0.00 3,453 $0.00 0 $16,580

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

amendment val ue.

E.3.2 

### Change the Threshold for Reporting to 10,000 lb when All Proposed
Amendments are Considered

EPA estimated the cost and burden of lowering the reporting threshold to 10,000 lb when all of the proposed amendments outlined in Chapter 3. have been considered. A 10,000 lb reporting threshold is expected to increase the number of partial reports submitted by approximately 13 percent and the number sites submitting data by 19 percent (See Table E

- 19 ). I n addition, EPA assumes this option would affect the proposed amendment to lower the threshold for reportingE

- 16



### downstream processing and use information from 300,000 lb to 25,000 lb (See Section 3.3.2 ). Under this option, the thr eshold for reporting this information would be 10,000 lb. The total number of sites and reports, when all the proposed amendments and the 10,000 lb. threshold reporting option are considered, is found in Table E

- 25 . To calculate t he 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 b een 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 option is expected to increase the number of sites submitting Form U by approximately 19 percent and the number of part ial reports by approximately 13 percent (See Table E

- 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 r eports and sites calculated in Section

E.3.1 , which accounts for the increase from the baseline as a result of this option. The number of Part IIIs submitted is not affected by this step.

Step 4: Consider the effect of elimina ting the 300,000 lb threshold for processing and use reporting (an d avoid double

- counting)

. Under this amendment, all submitters of non

exempt chemical substance s w ould be required to submit a Part III. Therefore, the number of

Part IIIs must be increased b y 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 I I reports as a result of 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 I I reports that will be for

ECA chemical substance s 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 chemical substance s as a result of the 10,000 lb threshold in the first reporting cycle is calculated by multiplying the number of ECA

chemical substance s by 1.13. In future reporting cycles, the number of ECA chemical substance s as a result of the 10,000 lb threshold is calculated by multiplying the number of ECA chemical

substance s after the five percent has been take n into account, 649, by 1.13 to calculate the total
number of ECA chemical substance s take into account the five percent. This number, 649, is then multiplied by 1.13. The number of reports with Part III would increase by 16,801 in the first reporting cycl e and 17,7 37 in future reporting cycles

. Step 5 : Calculate the number of reports when all amendments are considered together

. The total number of a dditional reports from Step 4 is added to the number of reports in the

baseline to calculate the total number of r eports when all the proposed amend ments are considered together

. There would now be a total of 4,872 Part Is, 3 3,854 Part IIs and 3 3,156 Part

IIIs in the first reporting cycle. In future reporting cycles there would be a total of 5,115 Part Is, 35,52 8 Part IIs and 34, 812 Part IIIs

. The difference between the total number of Part IIs and Part IIIs, 698 reports, is equal to the number of ECA chemical substance s times 1.13 (618 x 1.13=698).In future cycles, the difference of 735 reports is equal to the nu mber of partiallyE

- 17



### exempt reports with the five and 13 percent inc rease taken into account ((618x1. 05 )x1.13)) =

735 )

.

Table E

- 24 : Change in the Number of Sites and Reports Submitted of All Amendments Combined w ith 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 T hreshold for Do wnstream
P roce ssing and U se R eporting (see Section 4.4.6 ) -- -- 8,203

Eliminate the 25,000 lb T hreshold for Specific regulated Chemical substance s (see Section 4.4.5 ) -- 4,018

- -

Make Chemical substance s S ubject to ECAs I neligible

for E xemptions (see Section 4.4.6 ) -- -- 16

Full E xemption for M anufactured W ater (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 S ubject to
the IUR R e porting R equirements (see Section 4.4.3 ) 0 0 0

STEP 2 TOTAL 0 3,975 8,219

Step 3:Account for 10,000 lb reporting threshold

Step 2 Total Multiplied by 1.19 for sites and 1.13 for
reports 0 4,505

--

10,000 lb threshold reporting threshold (See Section

E.3.1 ) 787 3,453

--

STEP 3 TOTAL (Step 3 + Step 2 Total ) 787 7,985 8,219

Step 4 : Consider the effect of eliminating the 300,000 lb threshold for processing and use re porting (and avoid double

counting).

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 whethe r subject to reporting requirements -- -- 7,826

STEP 4 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 33,156E

- 18

Table E

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

Modification Number of Sites Number of Reports Number of Reports
with Part III

Baseline 4,085 25,896 17,075

Step 1: Sum affected amendments

Eliminate 300,000 T hreshold for Do wnstream
P rocessing and U se R eporting (see Section 4.4.6 ) -- -- 8,203

Eliminate the 25,000 lb T hreshold for Specific regulated Chemical substance s (see Section 4.4.5 ) -- 4,018

--

Make Chemical substance s S ubject to ECAs I neligible

for E xemptions (see Section 4.4.6 ) -- -- 16

Full E xemption for M anufactured W ater (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 t o the IUR reporting requirements

Step 1 Total Multiplied by 1.05

-- 4,174 8,630

Method for Determining Whether you are S ubject to
the IUR R eporting R equirements (see Section 4.4.3 ) 204 1,295 854

STEP 2 TOTAL 204 5,469 9,484

Step 3:Account for 10,000 lb reporting threshold

Step 2 Total Multiplied by 1.19 for sites and 1.13 for
reports 243 6,179

--

10,000 lb threshold reporting threshold (See Section

E.3.1 ) 787 3,4 53

--

STEP 3 TOTAL (Step 3 + Step 2 Total ) 1,030 9,632 9,484

Step 4 : Consider the effect of eliminating the 300,000 lb threshold for processing and use reporting (and avoid double

counting).

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

STEP 4 TOTAL (Step 4 + Step 3 Total ) 1,030 9,632 17 ,737

Step 5 :Calculate the total number of reports by adding the Step 3 Total to the Baseline

STEP 5 TOTAL (Baseline + Step 3 Total) 5,115 35,528 34, 812



### EPA estimated the cost to the industry of the 10,000 lb threshold when all the proposed

amendments are considered in Table E

- 26 . The baseline values are taken from Table 4

- 52

. Lowering the reporting threshold to 10,000 lb would not increase the industry per

- form burden;

however it would increase the nu mber of Form Us submitted. EPA estimates this option would increase the industry burden by 0.44 million hours in the first reporting cycle and by 0.35 million hours in all future reporting cycles.E

- 19

Table E

- 26 : Industry Burden as a Result of Chang ing the Threshold for Reporting to 10,000 lb when All Proposed Amendments are Considered

Burden per Part I of Report

and
S ubmission (hours per site ) Number

of Sites Burden for

Part II and

Record Keeping (hours

per re port) Number

of Reports (with Part II) Burden

for

Part

II I (hours

per report) Number

of Reports (with

Part III) Total Burden

(millions of hours)

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

First

- year Baseline 35.17 4,085 22.19 29,871 83.02 29,253 3 .24

First year,

Post
Amendment 35.17 4,872 22.19 33,854 83.02 33,156 3.68

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

Future

- Cycle
Baseline 11.05 4,289 18.35 31,365 65.63 30,716 2.64

Future Cycle,

Post
Amendment 11.05 5, 115 18.35 35,547 65.63 34,812 2.99

Change from the Baseline,

Future Cycles 0.00 826 0.00 4,182 0.00 4,096 0.35

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

amendment value.



### Baseline costs are taken from Table 4

- 53 . The 10,000 lb reporting threshold is expected to increase industry cost by $27.06 million during the first reporting cycle and by $21.79 million during all future reporting cycles (See Table E

- 27 ).E

- 20

Table E

- 27 : Industry Cost as a Result of Chang ing the Threshold for Reporting to 10,000
lb when All Proposed Amendments are Considered

Cost per Part I of Report and
S ubmi ssion (2008$) Number

of Sites Cost for Part II

and Record Keeping (2008$) Number

of Reports (with Part II) Cost

for

Part

II I and (2008$) Number

of Reports (with

Part III) Total Burden

(millions of 2008$ )

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

First

- year Baseline $2,192 4,085 $1,346 29,871 $5,117 29,253 $198.84

First year,

Post
Amendment $2,192 4,872 $1,346 33,854 $5,117 33,156 $225.89

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

Fut ure
C ycle
Baseline $695 4,289 $1,109 31,365 $4,047 30,716 $162.08

Future
C ycle, Post

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

Change
from the Baseline,

Future
C ycles $0 826 $0 4,182 $0 4,096 $21.79

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

amendment value.



### The annual industry burden over a 25

- year period is shown in Table E

- 28

. Over a 25

- year period, the total industry b urden would increase by 2.12 million hours when all the proposed

amendments are considered.

Table E

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

All Other Amendments wh en All Proposed Amendments are Considered

Reporting Cycle Years Baseline Cost Post

- Alternative Option Cost Change from
Baseline
( millions of hours ) (millions of hours) (millions of hours)

1 2007 to 2011 3.24 3.68 0.44

2 2012 to 2015 2.64 2.99 0.35

3 2016 to 2019 2.64 2.99 0.35

4 2020 to 2023 2.64 2.99 0.35

5 2023 to 2027 2.64 2.99 0.35

6 2026 to 2031 2.64 2.99 0.35

Total 16.43 18.64 2.21
Annual Average 0.66 0.75 0.09



### Table E

- 29 shows the annual industry cost over a 25

- year period as a result of lowering the reporting threshold. EPA estimates a 10,000 lb reporting threshold would increase costs byE

- 21



### approximately $136.00 million. Annualized costs range from $5.18 million with a three percent discount rate to $4.84 million with a seven percent discount rate.

Table E

- 29 : Change in Industry Cost as a Result of Changing the Threshold for Reporting to 10,000 lb and All Other Amendments when All Proposed Amendments are Considered

R eporting Cycle Years Baseline Cost Post

- Alternative Option Cost Change from
Baseline (2008$ millions) (2008$ millions) (2008$ millions)

1 2007 to 2011 $198.84 $225.89 $27.06

2 2012 to 2015 $162.08 $183.87 $21.79

3 2016 to 2019 $162.08 $183.87 $21.7 9

4 2020 to 2023 $162.08 $183.87 $21.79

5 2023 to 2027 $162.08 $183.87 $21.79

6 2026 to 2031 $162.08 $183.87 $21.79

Total $1,009.25 $1,145.25 $136.00
Annual Average $40.37 $45.81 $5.44

Annualized at 3% $38.40 $43.58 $5.18

Annualized at 7% $ 35.83 $40.66 $4.84



### As previously explained in Section E.3.1 , the Agency burden per

- report would not change as a result of lowering the reporting threshold. However, the number of reports and the number of sites submitting reports would increase. Table E

- 30 contains the Agency burden as a result of lowering the threshold for reporting when all the other amendments are considered. EPA estimates the Agency burden would increase by 48 hours in the firs t reporting cycle and 51hours during each future reporting cycle.E

- 22

Table E

- 30 : Agency Burden as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered

Bur den to
Process

Part I
Submission (hours ) Number

of Sites Burden

to
Process

Part II (hours

per report) Number

of Reports (with Part II) Burden to

Process

Part III (hours

per report) Number

of Reports (with Part III) Agency Burden

( hours)

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

Baseline 0.002 4,085 0.0056 29,871 0.0063 29,253 2,439

Post

Amendment 0.002 4,872 0.0056 33,854 0.0063 33,156 2,487

Change from
the Baseline 0 787 0 3,983 0 3,903 48.29

Future

- cycle
Baseline 0.002 4,289 0.006 31,365 0.006 30,716 2,456

Future cycle,

Post
Amendment 0.002 5,115 0.006 35,547 0.006 34,812 2,507

Change from the Baseline, Future cycles 0 826 0 4,182 0 4,096 50.69

Note: Values in Change from the Baseline rows are calculated by subtracting the correspondin g baseline value from the post

amendment value.

Table E

- 31 contains the Agency cost as a result of lowering the reporting threshold. Baseline values are
taken from Table 5

- 43 . Lowering the 10,000 lb threshold is expected to increase the Agency cost by approximately $5,000 during the first reporting cycle and $5,300 in future reporting cycles.E

- 23

Table E

- 31 : Agency Cost as a Result of Lowered Threshold Reporting and All Other Amendments when All Proposed Amendments are Considered

Cost to

Process

Part I
Submission (2008$ ) Number

of Sites Cost to

Process

Part II ( 2008$

per report) Number

of Reports (with Part II) Cost to

Process

Part

III ( 2008$

per report) Number

of Repo rts (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

Post

Amendment $0.203 4,872 $0.58 33,854 $0.66 33,156 $42,433 Change from
the Baseline 0 826 $0 .00 4,163 $0.00 4,096 $5,037

Future

- cycle
Baseline $0.203 4,289 $0.58 31,365 $0.66 30,716 $39,266 Future cycle,

Post
Amendment $0.203 5,115 $0.58 35,547 $0.66 34,812 $44,554 Change from the Baseline, Future cycles $0.00 826 $0.00 4,182 $0.00 4,096 $5,287
Note: Values in Change from the Baseline rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### The annual Agency burden over a 25

- year period is shown in Table E

- 32 . Over a 25

- year period, the total Agency burden would increase by 302 hours when all the proposed amendments

are considered.

Table E

- 32 : Agency Burden under the Alternative Option of a Lowered Re porting Threshold and
All Other Amendments when All Proposed Amendments are Considered

Reporting Cycle Years Baseline Burden Post

- Alternative Option Burden Change from
Baseline

hours hours Hours

1 2007 to 2011 2,439 2,487 48.29

2 2012 to 2015 2,456 2, 507 50.69

3 2016 to 2019 2,456 2,507 50.69

4 2020 to 2023 2,456 2,507 50.69

5 2023 to 2027 2,456 2,507 50.69

6 2026 to 2031 2,456 2,507 50.69

Total 14,720.86 15,022.62 301.76
Annual Average 588.83 600.90 12.07



### Table E

- 33 c ontains the annual Agency cost over a 25

- year period as a result of lowering the reporting threshold. EPA estimates a 10,000 lb reporting threshold would increase the Agency cost by approximately $31,500 over 25 years. Annualized increases in costs range f rom $1,100 with a seven percent discount rate to $1,200 with a three percent discount rate.E

- 24

Table E

- 33 : Change in Agency Cost as a Result of Changing the Threshold for Reporting to 10,000 lb and All Other Ame ndments when All Proposed Amendments are Considered

Reporting Cycle Years Baseline Cost Post

- Alternative Option Cost Change from

Baseline

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

1 2007 to 2011 $37,396 $42,433 $5,037

2 2012 to 2015 $39,266 $44,554 $5,287

3 2016 to 2019 $39,266 $44,554 $5,287

4 2020 to 2023 $39,266 $44,554 $5,287

5 2023 to 2027 $39,266 $44,554 $5,287

6 2026 to 2031 $39,266 $44,554 $5,287

Total $233,727 $265,201 $31,474
Annual Average $9,349 $10,608 $1,259

Annualized at 3% $8,770 $9,951 $1,181

Annualized at 7% $8,020 $9,100 $1,080

E.3.3 

### Small Entity Analysis

The following section provides a preliminary a ssess ment of the impact a 10,000 lb reporting threshold may have on small entities by examining the relationship between the compliance costs and company sales for small companies . This analysis is based on the methodology found in Chapter 8 of this report. All costs and burdens are estimated under the assumption all the proposed final amendments have been enacted. EPA estim ated 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 18 

### , a nd 24.8 percent (280 companies) are considered sm all under the TSCA sales

- based definition 19



### . EPA also estimated an average of approximately 1.76 sites per small company under the employ ment

based definition of small business

, and approximately 1.92 sites per small company under the

sales

- bas ed definition

. Average annual sales revenue of global parent companies considered small under either definition were estimated using data from Dun & Bradstreet, as also d escribed in Chapter 8

.
Table E

- 29 shows the cost to the industry as a res ult of annual reporting

. Because these costs would be incurred once every four years under a four

- year reporting cycle, these costs were summed and annualized over four years at both a three percent and seven percent discount rate 20



### . As shown in Table E

- 34 , these costs were divided by the total number of sites e xpected to submit data, for the annua lized cost per site

. This was multiplied by the number of sites per small parent company to arrive at the annualized cost s per small parent company

. This value was divided by the annual sales per small parent company to derive the cost

- to

- sales ratio.

18 Threshold of 1,000 employees

. 19 Total annual sales of the company, combined with those of any parent company, are below $40 million and annu al production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of any parent company, are below $4 million.

20 A seven percent discount rate, reflecting the opportun ity cost of capital, is consistent with OMB Circular A

- 4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.E

- 25



### As shown in Table E

- 34 under the em ployment

- based definition, a small parent company affected by th e rule on average has sales of more than $4 12.7 million

. The annualized costs of the proposed IUR rule amendments per small parent company, h owever, are $ 11,854 at a seven percent discount rate, and even lower under a three percent discount rate. The cost

- to

- sales ratio for an average small company under the employment

- based SBA definition would be 0.00 3 percent or less

. Under the more conservative sales

- based TSCA definition, small parent company sales are on average more than $11.8 million, with annualize d costs associated with the proposed amendments of $ 12,931 or lower. The cost

- to

- sales ratio for an average small company under the

sales

- based definition would be 0. 11 percent or le ss.
Using the highest annual cost shown in Table E

- 34 of $ 12,931 a small company would have to have annual sales of less than $ 1.29 million in order to have a cost

- to

- sales ratio larger t han
one percent

.

Table E

- 34 : Derivation of Cost

- to

- Sales Ratios for S mall Manufacturers for a 10,000 lb Reporting Threshold

Employment

- based Definition Sales

- based Definition

3% Discount

Rate 7% Discount

Rate 3% Discount

Rate 7% D iscount

Rate Incremental Costs of 10,000 lb threshold $27,055,019

Incremental Costs o f Proposed Other
Amendments $91,871,064

Total Annualized Costs $31,062,459 $32,813,387 $31,062,459 $32,813,387

Total Number of Sites 4,872
Annualized Costs per Site $6,376 $6,735 $6,376 $6,735 Number of Sites per Small Parent Company 1.76 1.92

An nualized Costs per Small Parent Company $11,221 $11,854 $12,241 $12,931

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

Cost

- to

- Sales Ratio 0.0027% 0.0029% 0.1036% 0.1094% Number of Companies Potentially Affected 466 280F

- 1



## Appendix F. Additional Exposure

- Related Data Elements

In developing the proposed rule EPA considered the collection of additional exposure

- related data, similar to the data collected under the TSCA section 5 New Chemicals Program, to further enhance the Agency’s capabilities in conducting screening

- level risk assessments of chemical substances reported to the TSCA Inventory Update, and would substantially improve EPA ’s ability to quantify chemical
substance risks. The ability to quantify chemical substance risks would further im prove the Agency’s ability to identify and manage those risks

. The burden and cost for these additional exposure

- related data
elements is described in the following Appendix

. Because this data collection was only considered during the proposed rule, the to tal costs, submission dates, and annualization periods associated with them may not match what is presented in the main text for the final rule. The additional exposure

- related data elements and brief descrip tions are as provided in Table F

- 1 : EPA solicit ed 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 b e encountered in manufacture, processing, and use of chemical substance s

. Additionally, the Agency was interested in
whether any additional data should be collected, and in any other considerations relating to the collection
of additional data

. EPA also so licit ed 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

. T he Agency considered three approaches to collecting the data. They are:1) integrating th e se data elements into the IUR, 2) promulgating a new reporting me chanism under TSCA section 8(a), and, 3) using TSCA section 11(c) subpoena authority to collect these data from known manufacturers (including importers)

. These additional data elements were n ot included as part of the proposed rule; therefore, they were not addressed in the main part of this economic analysis.

This Appendix provides a preliminary estimate of the burden and cost of collecting data for these

additional data elements under the fi rst approach of integrating the data elements into the IUR rule requirements.

Table F

- 1 : Description of Additional Data Elements

Data Element Description Manufacturing Process Information

1 Description of

m anufacturing process Provide a process flow diagram which describes the manufacturing operations involving the chemical substance

. “Unit operation” means a functional step in which substances undergo chemical changes and/or changes in location,
temperature , pressure, physical state, or similar characteristics

. Include steps in which the substance is formulated into gels, mixtures, suspensions, solutions, etc. and in which the substance is transferred into interim storage or shipping

containers

. Indicate in the diagram the entry and exit points of the chemical

substance

. Number all points from which the chemical substance will be released to the environment or to control equipment, including small or intermittent releases (e.g. some cleaning releases, drum re sidues, 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 sub stance produced per day or per

batch If the chemical substance is produced in discrete batches, indicate the amount of the substance in pounds produced in each batch; if the substance is produced in a continuous process, indicate the amount of substance in pounds manufactured each day.

4 Batch or daily run time If the chemical substance is produced in discrete batches, indicate the batch time (hours/batch); if the substance is produced in a continuous process, indicate the daily run time (hours/day).F

- 2

Data Element Description

5 Da ys of operation per year or number of batches

per year If the chemical substance is produced in discrete batches, indicate the number of batches necessary to produce the reported production volume; if the chemical substance is produced in a continuous proc ess, indicate the number of days of operation per year needed to produce the reported production volume.

6 Unit operations List the unit operations needed to produce the chemical substance

. Unit operation means a functional step in manufacturing, processi ng, 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 S torage and shipping

containers List the types of containers used to transport or store the chemical substance and their capacity

. Examples of containers include 1

- liter bottles, 5

- gallon pails, 55

- gallon drums, 200

- pound totes, 5000

- gallon tank trucks, and 20,000

- gallon

railcars. Manufacturing Worker Exposure Information

8 Worker activities Describe each specific activity in the operation during which workers may be exposed to the chemical substance

. Such activities may include charging reactor vessels, s ampling for quality control, transferring substances from one container to another, changing filters, filling drums, loading and loading tank cars or trucks,

etc

. Activities must be described even if workers wear protective equipment.

9 Duration and frequ ency 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 w orker activity, indicate the physical form of the substance at the time of exposure.

11 Maximum concentration For each worker activity, indicate the maximum concentration of the substance in the product at the time of exposure.

12 Personal protective

equ ipment and engineering controls used by workers For each worker activity, identify the specific types of protective equipment and engineering controls that will be employed to protect the worker from potential exposure to the chemical substance, i.e. glove s, 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 wh ether a summary of occupational exposure monitoring data are

included

. Summary should include information on the number of workers involved, number of samples taken, types of samples (area or personal), average and standard deviations of exposure.

Manufac turing Releases to the Environment

15 Release source (or release point) For each point of release containing the chemical substance, identify and describe the point in the process description at which the release occurs (e.g. releases due to spillage, res idues, separation losses, and other sources from each batch or each day).

16 Media and type of release For each release, indicate the type (gas or vapor, aqueous or liquid solution, or solid) and media (stack air, fugitive air, surface water, on

- site or off

- site land or incineration, POTW, or other (specify)) which describes the release stream containing the chemical

.F

- 3

Data Element Description

17 Quantity of substance released a) directly to the environment or b) into control technology to the

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

18 b) into control technology to the environment in pounds per day for continuous operation or pounds per batch for batch operations.

19 Control technology For each release, describe the type of technology used to control the release of the

substance to the environment

. Examples of control technologies include carbon filter, scrubber and biological treatment (primary, secondary, etc.)

.

20 Efficiency of control technology Indicate the established efficiency of the control technology in removing or destroying the chemical substance.

21 Destination of release For aqueous releases containing the chemical substance, indicate whether release enters a navigable water way, 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 wa ste landfill, a commercial incinerator, enters the atmosphere, or is otherwise disposed (specify).

22 Additional release related

information attached Indicate whether a description of the releases, calculations or monitoring data on the quantities of rele ases, or additional information on control technologies and/or

treatment is attached. Industrial Processing or Use Activities

23 Description of Processing

or Use Provide a process flow diagram which describes the processing or use operation involving the chemical substance

. “Unit operation” means a functional step in which substances undergo chemical changes and/or changes in location, temperature, pressure, physical state, or similar characteristics

. Include steps in

which the substance is formulated int o gels, mixtures, suspensions, solutions, etc. and in which the substance is transferred into interim storage or shipping

containers

. Indicate in your diagram the entry and exit points of the chemical

substance

. Number all points from which the chemical su bstance will be released to the environment or to control equipment, including small or intermittent releases (e.g. some cleaning releases, drum residues, etc.) and trace amounts of

the substance

.

24 Processing or use at sites controlled by

manufacturer Indicate whether the sites at which the chemical is processed or used are owned by the manufacturer or others.

25 Continuous or batch

process Indicate whether the industrial process in which the chemical is processed or used is a batch or continuous proce ss.

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 th e chemical substance is processed in discrete batches, indicate the batch time (hours/batch); if the substance is processed in a continuous process, indicate the daily run time (hours/day).

28 Days of operation per year or number of batches

per year If th e chemical substance is processed in discrete batches, indicate the number of batches necessary to process the reported production volume; if the chemical substance is produced in a continuous process, indicate the number of days of operation per year need ed to process the reported production volume.

29 Unit operations List the unit operations needed to process the chemical substance

. Unit operation means a functional step in manufacturing, processing, or use operation where substances undergo chemical cha nges, or changes in temperature, pressure, physical state, concentration, purity, or similar characteristics

. Examples of unit operations include blending, distillation, filtration, and drying.F

- 4

Data Element Description

30 Storage and shipping

containers used List the types of con tainers used to transport or store the chemical substance and their capacity

. Examples of containers include 1

- liter bottles, 5

- gallon pails, 55

- gallon drums, 5,000

- gallon tank trucks, and 20,000

- gallon railcars. Industrial Processing or Use Occupational Exposures Information

31 Worker activities Describe each specific activity in the operation during which workers may be exposed to the chemical substance

. Such activities may include charging reactor vessels, sampling for quality control, transferring sub stances 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 acti vity, provide the number of hours per day and the number of days per year during which the worker is engaged in processing or using the

chemical substance

.

33 Physical form For each worker activity, indicate the physical form of the substance at the time of exposure.

34 Maximum concentration For each worker activity, indicate the maximum concentration of the substance in the product at the time of exposure.

35 Personal protective equipment and engineering controls used by workers For each worker activit y, identify the specific types of protective equipment and engineering controls that will be employed to protect the worker from potential exposure to the chemical.

36 Worker monitoring data

available Indicate whether monitoring data on occupational expos ure of workers is

available.

37 Summary of occupational exposure monitoring

included Indicate whether a summary of occupational exposure monitoring data are

included

. Summary should include information on the # of workers involved, # of samples taken, typ es of samples (area or personal), average and standard deviations of exposure. Industrial Processing or Use Releases to the Environment Information

38 Release source (or point) For each point of release containing the chemical substance, identify and des cribe the point in the process description at which the release occurs (e.g. releases due to spillage, residues, separation losses, and other sources from each batch or each day).

39 Media and type of release For each release, indicate the type (gas or va por, aqueous or liquid solution, or solid) and media (stack air, fugitive air, surface water, on

- site or off

- site land or incineration, POTW, or other (specify)) which describes the release stream containing the chemical

.

40 Quantity of substance

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

41 b) into control technology to the environment in p ounds per day for continuous operation or pounds per batch for batch operations.

42 Control technology For each release, describe the type of technology used to control the release of the

substance to the environment

. Examples of control technologies incl ude carbon filter, scrubber and biological treatment (primary, secondary, etc.)

.

43 Efficiency of control technology Indicate the established efficiency of the control technology in removing or destroying the chemical substance.

44 Destination of releas e 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 whe ther the release goes to a municipal or hazardous waste landfill, a commercial incinerator, enters the atmosphere, or is otherwise disposed (specify).

45 Additional release related

information attached Indicate whether a description of the releases, calcu lations or monitoring data on the quantities of releases, or additional information on control technologies and/or

treatment is attached.F

- 5

Data Element Description Commercial Use Occupational Exposure Information

46 Description of

commercial use Describe the commercial use(s) of products containing the chemical substance.

47 Function of chemical in commercial product Describe the function of the chemical in the commercial product, e.g., dispersive dye, solvent, stabilizer, hardener, plasticizer, filler, etc.

48 Number of potenti ally exposed commercial

workers Indicate the number of workers in commercial establishments who are reasonably likely to be exposed to the chemical substance.

49 Physical form of commercial product Indicate the physical form of the product containing the chemical substance.

50 Method of commercial product application Describe the application method (e.g. sprayed applied via pump sprayer or aerosols, poured or applied manually) of the product containing the chemical
substance and whether the commercial use is destructive, contained, dispersive,

etc

.

51 Duration and frequency of commercial product

use Indicate the duration of use, e.g

. 5 minutes or less, 30 minutes or less, 1 hour or less, etc. and frequency of commercial use, e.g. used more than once a da y, 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 th e function of the chemical in the consumer product, e.g., dispersive dye, solvent, stabilizer, hardener, plasticizer, filler, etc.

54 Number of potentially exposed consumers Indicate the number of consumers reasonably likely to be exposed to the chemical

substance.

55 Physical form of consumer product(s) containing the chemical

substance Indicate the physical form, e.g., gel, foam, powder, etc. of the consumer product containing the chemical substance.

56 Method of consumer product application Describe t he application of the consumer product containing the chemical substance, for example, chemicals in products that will be sprayed via pump sprayer or aerosols; products that are poured, mixed, applied by hand/mechanical device; chemicals that can be releas ed via diffusion, evaporation, abrasion, etc., from articles; or chemicals that are incorporated into articles with no potential for release, etc

.

57 Duration and frequency of consumer product use Indicate the duration of consumer use, e.g., used for 5 m inutes or less, 30 minutes or less, less than 1 hour, etc. and frequency of consumer use, e.g. used more than once a day, used once a day, used several times a week, etc

.F

- 6

F.1 

### Estimated Number of Affected Entities

In order to estimate the burden and cost of collecting the additional data, EPA assumes the impacts on manufacturers and processors would be different. Manufacturers would be required to complete an integrated Form U, which would be a Form U revised to incorporate the new data elements. For the

pur pose of this analysis, EPA assumes all of the amendments currently being proposed also would be included. EPA assumes processors, on the other hand, would be required to complete a tailored Form U focusing only on the additional processing and use informat ion.

Manufacturers

For manufacturers, EPA assumes the numbers of sites and reports that would be affected by the requirement to provide additional exposure

- related data would be the same as the numbers of manufacturing sites and reports as estimated in Sec tion 4.5 of this report. As shown in Table 4

- 48 , a total of 4,085 manufacturers are expected to submit 29,871 reports in the first reporting cycle, including both full and partial reports, when all the proposed amendments are cons idered. As shown in Table 4

- 49 , in future reporting cycles a total of 4,289 manufacturers are expected to submit a total of 31,365 reports. To the extent any specific chemical substance s would be exempt from the requirement to pro vide 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. U nder the TRI program, EPA collects information annually on toxic chemical substance releases and waste management activities from manufacturers, processors, and users of a set of 581 toxic chemical
substance s and 30 toxic chemical substance categories . The chemical substance s regulated under the TRI program are a smaller set than those regulated under the IUR rule, but the TRI data collection activity currently is the most comprehensive information collection EPA administers for chemical substance

processors. Therefore, EPA assumes information on processors who report under TRI is a suitable proxy for processors who may report under an amended IUR rule.

EPA used T RI 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 c ycle). EPA filtered the data to include only IUR chemical substance s (i.e., the chemical substance s listed in the public 2006 IUR database). 21 Proces sors submitted TRI data on an average of 220 of the IUR chemical substance s during each of the four years of interest. For this analysis, EPA counted as a “processor” each TRI submitter indicating it processes a toxic chemical substance as a reactant, as a formulation component, as an article component, for repackaging, or as an impurity; or, that it otherwise uses the chemical substance as a chemical substance processing aid. 22 Because EPA assumes any company that both manufactures and

processes a chemical s ubstance would be considered a manufacturer for the purposes of IUR reporting of the additional data elements, TRI submitters who indicated they also manufactured or otherwise used a
chemical substance were filtered out of the dataset.

The TRI data reveale d an average of 1 37 p rocessors reported information per TRI chemical
substance

. However, the average value is greatly skewed by certain high

- volume chemical substance s

21 The TRI program may collect data on certain chemicals for which IUR reporting is not required. A list of

CASRNs for the non

- confidential IUR chemicals was found at “Non

- confidential 2006 IUR Records by Chemical, including Manufacturing, Processing and Use Information” http://cfpub.epa.gov/iursearch/index.cfm?s=chem Accessed August 30, 2009.

22 TRI submitters indicate their activities and uses of the toxic chemical at the facility in Part II Section 3 of Form R.F

- 7

processed by a large number of processors. 23 Therefore, EPA chose to use the median numbe r of 15

processors per chemical substance , assuming it to be more representative of the universe of chemical

substance processors who would report under the IUR rule.

Information was reported for a total of 6,140 chemical substance s under the IUR rule in 2 006

. By applying the average number of processors per chemical substance derived from TRI data, EPA estimate s 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 exte nt the universe of processors is different under the TRI regulation

and IUR rule. Because the sets of chemical substance s covered under the TRI and IUR rules are different, the median number of processors per chemical substance may be an over

- or underesti mate. (EPA attempted to minimize this by filtering the TRI data to only include known IUR chemical substance s, but
not all IUR chemical substance s would be subject to TRI reporting requirements.)Additionally, the TRI rule applies to facilities included wit hin a specific set of NAICS codes; the IUR rule presently does not limit its applicability to a defined set of NAICS codes. This may cause the number of processors estimated here to be an underestimate. Furthermore, “processor” may be defined differently b y the two rules; any specific criteria EPA may use to define a “processor” for the purpose of the IUR rule may cause the median number of processors per chemical substance estimated here to be an overestimate. Finally, the data used in this analysis was fo r submissions of TRI Form R only. This was done because Form A, the other, simpler, TRI reporting form, does not request information that would identify the submitter as a processor or manufacturer. Form R is used for high

- volume chemical substance s (i.e., those manufactured, processed, or otherwise used in amounts greater than one million pounds) or for chemical
substance s meeting other specific criteria; as a result, processors of small volumes may not be included, causing the median number to be an under estimate.

F.2 

### Industry Burden Estimate

Manufacturers

Given the similarity between the additional exposure

- related data elements and the exposure data collected under EPA’s New Chemical Program, EPA assumes the incremental cost for the additional data

elements would be similar to the estimated burden to complete a premanufacture notice (PMN). 24 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 every site would be required to complete the additional exposure information.

The burden of completing a paper PMN form was estimated in the supporting state ment for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances , EPA ICR No: 574.12 (EPA,. 2003). According to this source, the total burden to complete a PMN form in the first reporting cycle is

107 ho urs. To be consistent with the proposed amendment to require electronic submission (discussed in Section 4.4.27 of this economic analysis), EPA reduced the estimated burden to 93 hours. Because paper filing would not be permitted under the amendment, all clerical burden is eliminated. Consistent with the method described in Section 4.2.6 of this report, the future cycle burden was calculated by applying a weighting factor of 80 percent to the first cycle burd en, resulting in an estimated burden of 74.4 hours.

23 For example, an average of 3,240 processors per year reported for lead alone.

24 Anyone who plans to manufacture or import a new chemical substance for a non

- exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice before initi ating the activity. This premanufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical.F

- 8

Using the numbers of manufacturing sites and reports as estimated in Section 4.5 of this report, EPA estimates the total burden to manufacturers to submit additional exposure

- related data as part of their IUR reporting is 2.78 million hours in the first reporting cycle and 2.33 million hours in all future reporting cycles (See Table F

- 2 : ).

This approach is limited to the extent the data elements requested in any m odification 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.

T able F

- 2 : Change in Industry Burden to Manufacturers as a Result of Additional Exposure

- Related Data Elements

Burden for

Rule
Familiarizati

on, Compliance
Determinati

on, Submission

and to Prepare
Part I (hou rs per site) Numb

er of
Sites Burde

n for

Recor

d Keepi

ng and to Prepa

re Part

II (hours

per report ) Numb
er of Repor

ts (with

Part II) Burde

n to Prepa

re Part

III (hours

per report ) Numb
er of Repor

ts (with

Part III) Burden

to Comple

te New
Data

Elemen

ts (hours

p er report) Numbe

r of Report s (with

New

Data
elemen ts) Industry

Burden (millions of hours)

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a * b)+ (c * d)+(e * f)+(g *h) Manufacturer Burden (First Cycle) Considering all Proposed
Amendments (As Estimated in Table 4

- 47) 35.17 4,085 22.19 29,871 83.02 29,253 0.00 0 3.24

Total Manufacturer Burden (First Cycle) Including
Additional Data Elements 35.17 4,085 22.19 29,871 83.02 29,253 93 29,871 6.01

Incremental Increase due to
Additional Data Elements (First Cycle) 0.00 0 0.00 0 0.00 0 93.00 29,871 2.78

Manufacturer Burden (Future Cycles) Considering all Proposed
Amendments (As Estimated in Table 4

- 47) 11.05 4,289 18.35 31,365 65.63 30,716 0 0 2.64

Total Manufacturer Burden (Future Cycles) Including
Additional Data Ele ments 11.05 4,289 18.35 31,365 65.63 30,716 74.4 31,365 4.97

Incremental Increase due to
Additional Data Elements (Future Cycles) 0.00 0 0.00 0 0.00 0 74.40 31,365 2.33

Note: Values in Increme n tal Increase rows are calculated by subtracting the correspon ding baseline value from the post

amendment value.

Table F

- 3 contains the annual burden to manufacturers of the additional enhanced data elements over

a 25

- year period. The baseline burden estimates for completing Form U after a ll the proposed
amendments are considered is taken from Table 4

- 57

. EPA estimates over a 25

- year period, the total burden to manufacturers for completing Form U, including the additional data elements, would be 30.88
million hours . The data elements add 14.45 million hours to the industry burden over this period.F

- 9

Table F

- 3 : Schedule of Annual Industry Burden to Manufacturers if All Proposed Amendments Are Implemente d

Reporting Cycle Ye ars Baseline Form U

Burden (When all
Amendments are
C onsidered) (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 2 019 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 ma nufacturing information on Form U, Section II and other elements of Form U may not be applicable. For the purpose of this estimation, EPA assumes the burden on processors to complete an IUR form tailored to processing and use information would be

similar t o that of a PMN form alone.

Using the number of processors and number of reports as estimated in Section H.1, the total burden to processors to submit exposure

- related data elements is estimated to be 8.57 million hours in the first reporting cycle and 6.8 5 million hours in future reporting cycles, and is shown in Table F

- 4

. This approach is also limited to the extent the data elements requested from processors in any

modification to the IUR match the PMN form and the burden it im poses.

Table F

- 4 : Change in Industry Burden to Processors as a Result of Additional Exposure

Related Data Elements

Burden to Complete

Enhanced

D ata
E lements (hours per report) Number

of Reports (with

Enha nced

D ata
E lements) Industry

Burden (millions of

h ours)

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 Addit ional Data Elements ( First Cycle ) 93 92,100 8.57

Processor Burden ( Future Cycle s) Considering all Proposed Amendments 0 0 0.00

Total Processor Burden ( Future Cycle s) Including Additional Data

Elements 74 92,100 6.85

Incremental Increase due to Addition al Data Elements ( Future Cycle s) 74 92,100 6.85

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post

amendment value.F

- 10

Table F

- 5 contains the annual burden to pro cessors of the additional enhanced data elements over a

25

- year period. EPA estimates over a 25

- year period, the total burden to processors for completing Form U, including the additional data elements, would be 42.83 million hours. This burden consists of labor to complete only the additional data elements because processors currently are not required to submit Form

U.

Table F

- 5 : Schedule of Annual Industry Burden to Processors

Reporting Cycle Years Baseline F orm U

Burden (When all
Amendments are
C onsidered) (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 t he additional exposure data are calculated by summing the total additional burdens for manufacturers and processors. The result is an estimated 11.34 million hours in the first reporting cycle and 9.19 million hours all future reporting cycles. The derivat ion of these numbers is found in Table F

- 6

.

Table F

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

- Relate d Data Elements

Total Burd en to
Manufacturers (millions of hours) Total Burden to

Processors (millions of hours) Total Industry

Burden (millions of hours)
Burden ( First Cycle ) Considering all Proposed Amendments 3.24 0.00 3.24

Total Burden ( First Cycle ) Including Additional

Data Elements 6.32 8.57 14.88

Incremental Increase due to Additional Data Elements ( First Cycle ) 2.78 8.57 11.34

Burden ( Future Cycle s) Considering all Proposed Amendments 2.64 0.00 2.64

Total Burden ( Future Cycles ) Including
Additional Data Elements 4.97 6. 85 11.83

Incremental Increase due to Additional Data Elements ( Future Cycles ) 2.33 6.85 9.19

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### Table F

- 7 contains the annual burden to industry of the additional enhanced data elements

over a 25

- year period. The baseline burden estimates for completing Form U after all the proposed amendments are considered is taken from Table 4

- 52. EPA estimates over a 25

- year period, the total burden to industry for completing Form U, including the additional dataF

- 11



### elements, would be 73.70 million hours. The additional data elements add 57.27 million hours to the industry burden over this period.

Table F

- 7 : Schedule of Annual Industry Burden to Manufacturers and Processors if All Proposed Amendments Are Implemented

Reporting Cycle Years Baseline Form U Burden (When all Amendments are C onsidered)

(millions of hours) Fo rm U

Burden
with

Enhanced

Data

Elements (millions of hours) Total Industry

Burden (millions of hours)

1 2007 to 2011 3.24 11.34 14.58

2 2012 to 2015 2.64 9.19 11.82

3 2016 to 2019 2.64 9.19 11.82

4 2020 to 2023 2.64 9.19 11.82

5 2023 to 2027 2.64 9.19 11.82

6 2026 to 2031 2.64 9.19 11.82

Total 16.43 57.27 73.70
Annual Average 0.66 2.29 2.95

F.3 

### Industry Cost Estimate

EPA calculated the per

- report cost to industry of the additional data elements by multiplying the managerial and technical burdens found in Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for
Chemical Substances , EPA ICR No: 574.12 (EPA, 2003) by the wage rates for technical and managerial

staff described in Section 4.2.1

. No clerical cost was calculated because EPA assumes ele ctronic submission requirement will eliminate all clerical burden for processing and submitting Form U. As
shown in Table F

- 8

, E PA estimates the additional per report cost to be $5,673 in the first reporting cycle and $4,539 in all future reporting cycle s, as a result of the requirement to report the additional data

.

Table F

- 8 : Per

- R e port 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 Cycle s) 60 $58.84 $3,530 14.4 $70.03 $1,008 74.4 $4,539

Manufacturers

The cost to manufacture r s of the additional data elements was derived as shown in Table F

- 9

. EPA estimates the option would cost manufacture r s an additional $ 169 million during the first reporting cycle and an additional $142 million during all future reporting cycles

.F

- 12

Table F

- 9 : Change in Industry Cost to Manufacturers as a Result of Additional Exposure

Relate d Data Elements

Cost for Submission, Compliance
Determinati on, Rule
Familiarizat ion, and to Prepare

Part I (2008$) Numb

er of
Sites Cost

for

Recor

d Keepi

ng and to Prepa

re Part

II (2 008$ ) Numb
er of Repor

ts (with

Part II) Cost

to Prepa

re Part

III (2008 $) Numb
er of Repor

ts (with

Part III) Cost to Compl

ete
New

Data

Elemen

ts (2008$) Numbe

r of Reports (with

New

Data
Elemen ts) Industry Cost

(millions of 2008$)

(a) (b) (c) (d) (e) (f) (g) (h) (g) = (a * b) +(c *d)+ (e * f)+( g*h) Manufacturer Cost (First Cycle ) Considering all Proposed
Amendments (As Estimated in Table 4

- 48) $2,192 4,085 $1,346 29,871 $5,117 29,253 0 0 $198.84

Total Manufacturer Cost (First Cycle ) Including Additional

Dat a Elements $2,192 4,085 $1,346 29,871 $5,117 29,253 $5,673 29,871 $368.31

Incremental Increase due to
Additional Data Elements ( First Cycle) $0.00 0 $0.00 0 $0.00 $0.00 $5,673.

44 29,871 $169.47

Manufacturer Cost (Future Cycle s) Considering all P roposed
Amendments (As Estimated in Table 4

- 48) $695 4,289 $1,109 31,365 $4,047 $30,71

6 0 0 $162.08

Total Manufacturer Cost (Future Cycle s) Including
Additional Data Elements $695 4,289 $1,109 31,365 $4,047 30,716 $4,538.

75 31,365 $304.44

Increm ental Increase due to
Additional Data Elements ( Future Cycles) $0.00 0 $0.00 0 $0.00 0 $4,539 31,365 $142.36

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### Table F

- 10 presents the annual and annualized costs estimates to manufacturers of competing Form U with the additional exposure

- related data elements. The baseline cost estimates for completion of Form U come from Table 4

- 58 . Over a 25

- year period, EPA estimates the
annualized cost to manufacturers would be $ 72 million at a three percent discount rate, and $ 67 million at a seven percent discount rate.F

- 13

Table F

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

Reporting Cycle Years Baseline Form U Cost (When all
Amendments are
C onsidered) (millions 2008$ ) Form U Cost for

Enhanced Data

Elements (millions 2008$ ) To tal 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 $1 62.08 $142.36 $304.44

Total $1,009.25 $881.26 $1,890.51

Annual Average $40.37 $35.25 $75.62

Annualized at 3% $38.40 $33.47 $71.88

Annualized at 7% $35.83 $31.15 $66.98

Manufacturers and Processors Combined

To calculate the cost to processors

, EPA mu ltiplied the per report cost ($5,673 in the first reporting cycle and $4,539 during all future reporting cycle s) by the total number of reports EPA expects to be submitted by processors, 141,220 . As shown in Table F

- 11 , EPA estima tes t he cost to processors to be $ 523 million in the first reporting cycle and $ 418 million in all future reporting cycle s

.

Table F

- 11 : Change in Industry Cost to Processors as a Result of Additional Exposure

Relate d Data Element s

Cost to
P repare N ew D ata
E lements ( 2008$ ) Number of

Reports (with N ew D ata
E lements) Industry Cost

(millions 2008 $ )

Processor Cost ( First Cycle ) Considering all Proposed Amendments 0 0 $0

Total Processor Cost ( First Cycle ) Inclu ding 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 Cycle s) Considering all Proposed Amendments 0 0 $0

Total Processor Cost ( Future Cycle s) Includ ing Additional Data

Elements $4,539 92,100 $418

Incremental Increase due to Additional Data Elements ( Future Cycle s) $4,539 92,100 $418

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### Table F

- 12 presents the annual and annualized costs estimates to processors of competing Form U with the additional exposure

- related data elements. Over a 25

- year period, EPAF

- 14



### estimates the annualized cost to pr ocessors would be $ 116 million at a three percent discount rate, and $ 125 million at a seven percent discount rate.

Table F

- 12 : Annual Increase in Industry Cost to Processors if All Proposed Amendments
Are Im plemented (2008$ )

Reporting Cycle Years 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$ )

1 2007 to 2011 $0.00 $523.00 $523.00

2 2 012 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 $1 04.52

Annualized at 3% $0.00 $116.03 $116.03

Annualized at 7% $0.00 $125.45 $125.45

Total estimated industry cost is presented in Table F

- 13 and is calculated by summing the cost s to both manufactures and processors

. EP A estimates the cost to the industry of the additional exposure
elements

, if both manufacturers and processor are required to provide the data, w ould be $ 692 million in the first reporting cycle and $560 million in all future reporting cycle s

.

Table F

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

- Relate d Data Elements

Total Cost to
Manufacturers (millions 2008$) Total Cost to
Processors (millions 2008$) Total Industry
Cost (millions 2008$)

Cost ( First Cycle ) Considering all Proposed Amendments $199 $0 $199

Total Cost ( First Cycle ) Including Additional Data

Elements $368 $523 $891

Incremental Increase due to Additional Data Elements ( First Cycle ) $169 $523 $692

Cost ( Future Cycle s) Considering all Proposed Amendments $162 $0 $162

T otal Cost ( Future Cycles ) Including Additional

Data Elements $304 $418 $722

Incremental Increase due to Additional Data Elements ( Future Cycles ) $142 $418 $560

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post

amendment value.

Table F

- 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 25

- year period, EPA estimates the annualized cost to the industry would be $ 166 million at a three percent discount rate , and $ 150 million at a seven percent discount rate.F

- 15

Table F

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

Reporting Cycle Years Baseline F orm U Cost (When all Amendments A re C onsidered) (millions 2008$) Form U Burden with

Enhanced D ata
Elements (millions 2008$) Total Cost To Industry (millions 2008$)

1 2007 to 2011 $198.84 $692.47 $891.31

2 2012 to 2015 $162.08 $560.36 $722.44

3 2016 to 2019 $162.08 $560.36 $722.44

4 2020 to 2023 $162.08 $560.36 $722.44

5 2023 to 2027 $162.08 $560.36 $722.44

6 2026 to 2031 $162.08 $560.36 $722.44

Total $1,009.25 $3,494.26 $4,503.51

Annual Average $40.37 $139.77 $180.14

Annualized at 3% $37.28 $129. 14 $166.43

Annualized at 7% $33.48 $116.05 $149.53

F.4 

### Agency Burden Estimate

Agency burden for both contractor and EPA staff related to d ocument receipt, tracking and data entry quality control of data entry would increase with the promulgation of additiona l exposure

- related data elements. To calculate the additional Agency burden associated with the additional data elements, EPA used the per

- data element burden to the EPA after all the proposed amendments are considered, 0.00008 hours, as derived in Section 5.5 ). This burden was multiplied by the number of new data elements, 57 (as
listed in Table F

- 1 ) to calculate the total per

- report burden of processing the new data elements for manufacturers, 0.0048 hours. EPA assumes there would be no change in the fixed Agency costs associated with this modification to the IUR rule, as described in Table 5

- 3.

Manufacturers

All manufactures are expected to submit the additional data, increasing the Agency burden by 1 50 hours for all report years, as estimated in Table F

- 15 . EPA does not expect the future reporting cycle burden to differ from first reporting cycle burden.F

- 16

Table F

- 15 : Change in Ag ency Burden to Process Manufacturer Data as a Result of Additional Exposure

- Relate d Data Elements

Burden

to
Process

Part I (hours) Numb

er of
Sites Burden to

Process

Part II (hours) Number

of Reports (with Part II) Burden

to
Process

Part III (hours) Num ber

of Reports (with Part III) Burden

to
Process

New

Data

Elements (hours) Number

of Reports (With

New

Data

E lements ) Agenc

y Burde

n (hours)

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

First ye ar, 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 F

- 16 presents the estimated annual burden to the Agency of processing Form U with

the additional ex posure

- related data elements. Over a 25

- year period, EPA estimates the total Agency burden to process manufacturer data would be 15 ,600 hours.F

- 17

Table F

- 16 : Annual Increase in Agency Burden to Process Manufactu rer Data if All Proposed A mendments Are Implemented

Reporting Cycle Years Baseline Form

U Burden (When all
Amendments
are C onsidered) ( hours) Form U

Burden with

Enhanced

Data

Elements ( hours) Total

Industry

Burden ( hours)

1 2007 to 2011 2,439 143 2,582

2 2012 to 2015 2,456 150 2,607

3 2016 to 2019 2,456 150 2,607

4 2020 to 2023 2,456 150 2,607

5 2023 to 2027 2,456 150 2,607

6 2026 to 2031 2,456 150 2,607

Total 14,721 896 15,617 Annual Average 589 36 625

Manufacturers and Processors Combined

Table F

- 17 shows the estimated burden to the Agency of processing the additional data submitted by processors. As described above, EPA expects to receive a total of 92,100 processor report s. The Agency burden, per

- report, to process the additional data elements is 0.0048 hours, and is the same for both processors and manufactures. Therefore, as shown in Table H

- 10, the Agency burden to process the

processor data are approximately 442 hours for all reporting cycles.

Table F

- 17 : Change in Agency Burden to Process Processor Data as a Result of Additional Exposure

- Relate d Data Elements

Per

- Report

Burden to Process

New Data

Elements (hours) Number of

Reports (with

N ew D ata
E lements) 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 Element s 0.0048 92
, 100 442

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### Table F

- 18 presents the estimated annual burden to the Agency of proce ssing Form U with the additional exposure

- related data elements. Over a 25

- year period, EPA estimates the total Agency burden to process processor data would be 2,651 hours.F

- 18

Table F

- 18 : Annual Increase in Age ncy Burden to Process Processor Data if All Proposed
A mendments Are Implemented

Reporting Cycle Years Baseline Form U Burden (When all Amendments are C onsidered)

( hours) Form U Burden
with Enhanced

Data Elements ( hours) Total

Industry

Burden ( hours)

1 20 07 to 2011 0.00 442 442

2 2012 to 2015 0.00 442 442

3 2016 to 2019 0.00 442 442

4 2020 to 2023 0.00 442 442

5 2023 to 2027 0.00 442 442

6 2026 to 2031 0.00 442 442

Total 0.00 2
, 651 2
, 651
Annual Average 0.00 106 106

Table F

- 19 presents the burden to EPA of processing the additional data elements from both the processors and the manufacturers. This option is expected to increase the Agency burden by 592 hours for all reporting cycles.

Table F

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

- Relate d Data Elements

Total Bur den of Processing
Manufacturer D ata (hours) Total Burden of

Processing Processor

D ata (hours) Total Agency

Burden

(hours)
Burden (First Cycle) Considering all Proposed
Amendments 2,439 0 2,439

Total Burden (First Cycle) Including Additional Data

Elements 2,582 442 3,024

Incremental Increase due to
Additional Data Elements (First Cycle) 143 442 58 5

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

Total Burden (Future Years) Including Additional Data

Elements 2,607 442 3,049

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



### Table F

- 20 presents the estimated annual burden to the Agency of processing Form U with the additional exposure

- related data elements from both manufacturers and processors. Over a

25

- year period, EPA estimates the total Agency burden to process ma nufacturer and processor
data would be 18,269 hours.F

- 19

Table F

- 20 : Annual Increase in Agency Burden to Process Data if All Proposed
A mendments Are Implemented

Reporting Cycle Years Baseline Burden (When all Ame ndments are Considered) Form U Burden with

Enhanced D ata Elements (hours) Total Agency

Burden (hours)

1 2007 to 2011 2,439 585 3,024

2 2012 to 2015 2,456 592 3,049

3 2016 to 2019 2,456 592 3,049

4 2020 to 2023 2,456 592 3,049

5 2023 to 2027 2,456 592 3,049

6 2026 to 2031 2,456 592 3,049

Total 14,721 3,548 18,269

Annual Average 589 142 731

F.5 

### Agency Cost Estimate

The additional exposure data elements are expected to increase the cost to both EPA and contractor
staff . To calculate the additional Agenc y cost associated with the additional data elements, EPA used the

per

- data element cost to the EPA after all the proposed amendments are considered, $0.009, as derived in

Section 5.5 ) .This unit cost was multiplied by the number of new data elements, 57 (as listed in Table F

- 1 ) to calculate the total per

- report cost of processing the new data elements for manufacturers, $0.51.

Manufacturers

The total cost to EPA of processing these new data elements for manufacturers is approximately $1 5,100 in the first reporting cycle and $15,800 in future reporting cycles, as shown in Table F

- 21 . This table reflects both the variable cost to the Agency, which is dependent on the number of re ports, and a fixed cost to the Agency of $249,200 (see Section 5.3 ) which would not change as a result of including the additional data option in the IUR.F

- 20

Table F

- 21 : Change in Age ncy Cost of Processing Manufacturer Data as a Result of Additional Exposure

- Relate d 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

Re ports (with

Part III) Cost to

Process

New Data

Elements (2008$) Number

of Reports (with

new data elements) Agency

Burden (millions of 2008$)

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

First year, with

Enhanced

Data Elements $0.20 4,085 $0.58 29,871 $0.66 29,253 $0.51 29,871 $256,481

Change, first

year $0.00 0 $0.00 0 $0.00 0 $0.51 29,871 $15,089

Future

- Cycle
Baseline $0.20 4,289 $0.58 31,365 $0.66 30,716 0.00 0 $243,263

Future

- Cycle,

Post
Amendment $0.20 4,289 $0.58 31,365 $0.66 30,716 0.51 31,365 $259,106

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



### Table F

- 22 presents the annual and annualized costs estimates to the Agen cy of processing manufacturer Form U with the additional exposure

- related data elements. Over a 25

- year period, EPA estimates the annualized cost to the Agency would be $58,350 at a three percent discount

rate , and $53,517 at a seven percent discount rate.

Table F

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

Reporting Cycle Years Baseline Cost (2008$) Post

Alternative Option Cost (2008$) Cha nge

from
Baseline (2008$)

1 2007 to 2011 $241,393 $15,089 $256,481

2 2012 to 2015 $243,263 $15,843 $259,106

3 2016 to 2019 $243,263 $15,843 $259,106

4 2020 to 2023 $243,263 $15,843 $259,106

5 2023 to 2027 $243,263 $15,843 $259,106

6 2026 to 2031 $243 ,263 $15,843 $259,106

Total $1,457,707 $94,306 $1,552,013

Annual Average $58,308 $3,772 $62,081

Annualized at 3% $54,812 $3,538 $58,350

Annualized at 7% $50,281 $3,236 $53,517F

- 21

Manufacturers and Processors Combined

Table F

- 23 shows the Agency cost of processing the processor data

. To estimate this cost

, EPA multiplied the number of processors derived in Section H.1 (141,220) by the per report cost of processing
the additional data

, $0.5 1. EPA estimates t he total Agency cost t o process the processor data are $ 46,500.

Table F

- 23 : Change in Agency Cost to Process Processor Data as a Result of Additional Exposure

- Relate d Data Elements

Per

- Report Cost to
Process New Data

Elements ( 2008 $ ) Number of

Reports (with N ew D ata
E lements) 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 $0.5 1 92,100 $46,5 22

Incremental Increase due to Additional Data Elements $0.5 1 92,100 $46,522

Note: Values in Incremental Increase rows are calculated by subtracting the corresponding baseline value from the post

amendment value.



### Table F

- 24 p resents the annual and annualized costs estimates to the Agency of processing a processor Form U with the additional exposure

- related data elements. Over a 25

- year period, EPA estimates annualized cost to the Agency would be $ 10,500 at a three percent disc ount rate

, and $ 9,600 at a seven percent discount rate.

Table F

- 24 : Annual Increase in Agency Cost to Process Processor Data if All Proposed
A mendments Are Implemented (2008$)

Reporting Cycle Years Baseline C ost(2008$ ) Post

Alternative 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 20 26 to 2031 $0 $46,522 $46,522

Total $0 $279,132 $279,132
Annual Average $0 $11,165 $11,165

Annualized at 3% $0 $10,500 $10,500

Annualized at 7% $0 $9,638 $9,638



### Table F

- 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 $61,600 in the first reporting cycle and $62,400 in all future reporting cycles.F

- 22

Table F

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

- Related Data Elements

Total Burden of Processing Manufacturer data (2008$) Total Burden of

Processing Processor data (2008$) Total Agency Burden

(2008$)

Cost (First Cycle) Considering all Proposed
Amendments $241,393 $0 $241,393

Total Cost (First Cycle) Including Additional Data

Elements $256,481 $46,522 $303,004

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

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

Total Cost (Future Years) Including Additional Data

Elements $259,106 $46,522 $305,629

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



### Table F

- 26 presents the annual and annualized costs estimates to the Agency of processing manufacturer and processor Form Us with the additional exposure

- related data elements. Over a

25

- ye ar period, EPA estimates annualized cost to the Agency would be $ 68,900 at a three percent discount rate , and $ 63,200 at a seven percent discount rate.

Table F

- 26 : Annual Increase in Agency Cost to Process Ma nufacturer and Processor Data if All Proposed A mendments Are Implemented (2008$)

Reporting Cycl e Years Baseline Burden (When all
Amendments are Considered) (2008$) Form U Burden with Enhanced

data Elements (2008$) Total Agency Burden (2008$)

1 2007 to 201 1 $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 $63,155F

- 23

F.6 

### Small Entity Analysis

As described in Chapter 8 of this economic analysis, EPA assessed the impact the propose d 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

- rela ted 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

- bas ed definition

, 25 

### a nd 24.8 percent (280 companies) are considered small

under the TSCA sales

- based definition

. 26 

### EPA also estimated an average of approximately 1.76 sites per small company under the employ ment

- based definition of small business and approximate ly 1.92 sites per small company under the sales

- based definition

. Average annual sales revenue of global parent companies considered small under either definition were estimated using data from Dun & Bradstreet, as also described in Chapter 8.

Table F

- 13 shows the incremental cost to manufacturers as a result of adding the additional exposure related data elements to Form U . Table 4

- 48 (in the main text of the report) shows the

incremental cost to manufacturers related to the other proposed amendments

. Because these costs would be incurred once every four years under a proposed four

- year reporting cycle, these costs were summed and annualized over four years at both a three percent and seven percent discount

rate

. 27 

### As shown in Table F

- 27 , these costs were divided by the total number of sites expected to submit data, for the annualize d costs per site

. This was multiplied by the number of sites per small parent company to arrive at the annualized costs per sm all parent company

. This value was divided by the annual sales per small parent company to derive the cost

- to

- sales ratio.

As shown in Table F

- 27 , under the employment

- based definition, a small parent company affected by the rule on average has sales of more than $4 12.7 million

. The annualized costs of the proposed IUR rule amendments per small parent company, however, are $ 31,067 at a seven percent discount rate , and even lower under a three percent discount rate . The cost

- to

- sal es 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 pare nt company costs associated with the proposed amendments of $ 33,892 or lower. The cost

- to

- sales ratio for an average small company under the sales

- based definition would be 0.29 percent or less.

25 Threshold of 1,000 employees

. 26 Total annual sales of the company, combined with those of any parent company, a re below $40 million and annual production volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of any parent company, are below $4 million.

27 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A

- 4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.F

- 24



### Using the highest annual cost shown in Table F

- 27 of $ 33,892 a small company would have to have annual sales of less than $ 3.39 million in order to have a cost

- to

- sales ratio larger than
one percent

.

Table F

- 27

. Derivation of Cost

- to

- Sales Rat ios for Small Manufacturers for Collection of
Additional Data Elements

Employment

- based Definition Sales

- based Definition

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate

Incremental Costs of

Enhanced Data Elements $169,471,347.15

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

Total Annualized Costs $68,260,366 $72,108,063 $68,260,366 $72,108,063

Total Number of Sites 4,085

Annualized Costs per Site $16,710 $17,652 $16,710 $17,652
Number of Sites per Small

Paren t Company 1.76 1.92

Annualized Costs per Small Parent Company $29,410 $31,067 $32,083 $33,892

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

Cost

- to

- Sales Ratio 0.007% 0.008% 0.27 1 % 0.2 87 %

Number of Companies Potentially Affected 466 280

Processors

EPA is limited in its efforts to estimat e the impact of the collection of additional exposure

- rela ted data elements on processors by the availability of data

. As described above, EPA used TRI submission
data to estimate the number of p rocessors that may be affected by the requirement

. However, data provided under the TRI program does not include information about a submitter’s parent company or

annual revenues

. For this screening

- level analysis, EPA assumes the chemical substance proces sor industry shares many characteristics with the chemical substance manufacturing industry

. To the extent
this is not t he case , this analysis may over

- or underestimate the impact of additional data elements on

processors.


### Specifically, EPA assumes 3.89 manufacturing sites per global parent company . EPA also

assumes 41.3 percent of global parent companies are considered small under an employment

based definition , and 24.8 percent are considered small under a sales

- based definition

. EPA
further assumes 1.7 6 sites per small parent company under the employment

- based definition

, and 1.92 site s per small parent company under the sales

- based definition, consistent with

manufacturer information . G iven the large number of companies identified as processors

accord ing 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

t his analysi s provides only a preliminary estimate of impacts

.
EPA divided the number of expected processor reports ( 92,100 ) by the average number of chemical
substance s 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 n umber 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 definition s ,F

- 25

respectively. To calculate cost

- to

- sales ratios, EPA followed the same methodology for processors as
described above for manufacturers

. R esults are presented in Table F

- 28

.

Table F

- 28 : Derivation of Cost

- to

- Sales Ratios for Small Processor s 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 S ites 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 $11,821,1 04

Cost

- to

- Sales Ratio 0.00 2 % 0.0 02 % 0.059% 0.062%

Number of Companies Potentially Affected 3,990 2,397



### As shown in Table F

- 28

, under the employment

- based definition, a small parent company affected by the rule on average ha s sales of more than $4 12.7 million

. The annualized costs of the IUR rule amendments per small parent company, however, are $ 6,750 at a seven percent
discount rate , and even lower under a three percent discount rate . The cost

- to

- sales ratio for an

average small company under the employment

- based definition would be 0.00 2 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 ame ndments 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, t he Regulatory Flexibility Act does not define the terms “significant” or “substant ial” analytically with regard to extent of economic impact and number

of small entities affected. However, EPA typically define s a th reshold as compliance costs of one percent of sales to establish whether the level of economic impacts faced by the small e ntities

can b e presumed as not significant ( EPA, 2006)

. Using the highest annual cost shown in Table

F

- 28 , $ 7,346 , a small company would have to have annual sales of less than $7 34,600 in order to
have a cost

- to

- sales ratio large r than one percent

.G

- 1 

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

- Related
Data Elements

In developing the proposed rule, EPA considered the annual collection of exposure

- related data
elements for approximately 100 chemical substance s under a TSCA section 8 (a) rulemaking. TSCA

s ection 8(a) gives EPA the authority to require, by rulemaking, manufacturers (includ ing importers) and processors of chemical substances to maintain records and/or report such data as EPA may reasonably require to car

ry out the TSCA mandates. Section 8(a) regulations can be tailored to meet unique information needs (e.g., via chemical

- specific rules) or informat ion can be obtained via use of “model” or standardized reporting rules . The Agency requested comment on a “mo del” 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

- lev el risk assessments of selected chemical substances. Each data collection would be specific to a unique set of IUR chemical substance s for which the information is needed; EPA would request the information through one or more notices or letter writing acti ons per year, for an approximate total of 100 chemical substances per year. Because this data collection was only considered during the proposed rule, the total costs, submission dates, and annualization periods associated with them may not match what is p resented in the main text for the final rule

. The additional data elements are the same as those proposed under the option outlined in Appendix H. A brief description of t he exposure

- related data elements that may be included in such a section 8(a) rule

ar e provided in Table F

- 1

.

G.1 

### Estimated Number of Affected Entities

For the purpose of this analysis, EPA assumes a section 8(a) rule would apply to both manufacturers and processors of the subject chemical substance s.
Manufacturers

Because the applicability of a section 8(a) rule would be similar to that of the IUR rule (i.e., it would apply to manufacturers or importers of a subject chemical substance when produced in volumes greater than 25,000 lb ), EPA estimated the number of manu facturers 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 substance , and an average of 4.21 full reports are submitted for

each chemical substance . Therefore, EPA estimates a total of 66 sites would submit 421 reports for the
estimated 100 chemical substance s. To the extent the specific chemicals subject to a section 8(a) rule do
not hav e 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. U nder the TRI program, EPA collects
information annually on toxic chemical substance releases and waste management activities from manufacturers, processors, and users of a set of 581 toxic chemical substance s and 30 toxic chemical

substance categories . The chemical sub stance s regulated under the TRI program are a smaller set than those regulated under the IUR rule, but the TRI data collection activity currently is the most comprehensive collection of information EPA administers for chemical substance processors. Therefo re, EPA assumes information on processors who report under TRI is a suitable proxy for processors who may report under a section 8(a) rule

.
EPA used T RI Form R submission data from the 2007 TRI Public Data Release in this analysis. To
be consistent with t he Economic Analysis for the Proposed IUR Modifications Rule (from which otherG

- 2

data for this analysis is derived), EPA used TRI data for the years 2002 through 2005 (the t ime period of the most recent IUR reporting cycle )

, filtered to include only IUR chem ical substance s (i.e., the chemical

substance s listed in the public 2006 IUR database). 28 Processors submitted TRI data on an average of 220
of the IUR chemical substance s during each of the four years of interest. For this analysis, EPA counted as a “proce ssor” each TRI submitter who indicated it processes a toxic chemical substance as a reactant, as a formulation component, as an article component, for repackaging, or as an impurity; or, that it
otherwise uses the toxic chemical substance as a chemical sub stance processing aid. 29 Because EPA assumes any company that both manufactures and processes a chemical substance would be considered a manufacturer for the purposes of a section 8(a) rule, TRI submitters who indicated they also manufactured

or otherwise us ed a chemical substance were filtered out of the dataset.

The TRI data revealed an average of 1 37 p rocessors reported information per TRI chemical
substance . However, the average value is greatly skewed by certain high

- volume chemical substance s processed by a large number of processors. 30 Therefore, EPA chose to use the median number of 15

processors per chemical substance , assuming it to be more representative of the universe of TSCA

chemical substance processors. Using the median of 15 processors per chem ical substance , EPA expects a total of 1,500 reports would be submitted for an estimated 100 chemical substance s. According to the TRI data, each processor processes approximately 2.45 chemical substance s; therefore, EPA expects a section 8(a) rule to affe ct 612 sites.

This approach is limited to the extent the universe of TRI processors is different from that of a section 8(a) rule. Because the set of chemical substance s covered under the rules is different, the median number of processors per chemical sub stance may be an over

- or underestimate. Additionally, the TRI rule is applicable to facilities included within a specific set of NAICS codes; a section 8(a) rule may not limit its applicability to a defined set of NAICS codes, which could cause the number of processors estimated here to be an underestimate. Furthermore, “processor” may be defined differently by the two rules; any specific criteria EPA may use to define a “processor” for the purpose of a section 8(a) rule may cause the median number of proc essors per chemical substance estimated here to be an overestimate. Finally, the data used in this analysis was for submissions of TRI Form R only. This was done because Form A, the other, simpler, TRI reporting form, does not request information that woul d identify the submitter as a processor or manufacturer. Form R is used for high

- volume chemical substance s (i.e., those manufactured, processed, or otherwise used in amounts greater than one million pounds) or for chemical
substance s meeting other specifi c criteria; as a result, processors of small volumes may not be included, causing the median number to be an underestimate.

G.2 

### Industry Burden Estimate

The section 8(a) rule would require submitters (both manufacturers and processors) to provide data
similar to the exposure

- related data elements that are collected under EPA’s New Chemicals Program through a premanufacture notice (PMN) and under the IUR rule. Therefore, the burden associated with a section 8(a) rule is calculated by estimating the burden to com plete a PMN.

The burden to complete a paper PMN form was estimated in the supporting statement for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and

28 The TRI program may collect data on certain chemicals for which IUR reporting is not required. A list of
CASRNs for the non

- confidential IUR chemicals was found at “Non

- confidential 2006 IUR Records by Chemical, including Manufacturing, Processing and Us e Information” http://cfpub.epa.gov/iursearch/index.cfm?s=chem Accessed August 30, 2009.

29 TRI submitters indicate their activities and uses of the toxic chemical at the facility in Part II Sect ion 3 of Form R.

30 For example, an average of 3,240 processors reported under TRI per year for lead alone.G

- 3

Significant New Use Reporting Requirements for Chemical Substances , EPA ICR No: 574.12 (EPA, 2003). According to this source, the total burden to complete a PMN form is 107 hours

. EPA assumes a section 8 (a) rule would require electronic submission, so EPA reduced the estimated burden to 93 hours

. This reduction is c onsis tent with the assumption in section 4.4.27 ; a ll clerical burden will be eliminated because paper filing will not be permitted with electronic submission.

Using the number of manufactur er 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 t o processors to submit exposure

- related data elements is estimated to be 139,500 hours (See Table G

- 1 ) . Because each individual collection under the rule would be for a different
set of chemical substance s, EPA ass umes different sites would be submitting reports every year, so the
burden would be the same in future individual collections.

This approach is limited to the extent the data elements requested in a section 8(a) rule match the IUR Form U and the PMN form, and the burden they incur.

Table G

- 1 : Annual Industry Burden a s a Result of a TSCA Section 8(a) Data Collection

Entity Subject to the Data Collection Burden to Complete

E xposure
- R elated

D ata E lements (hours p er 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 indu stry of a section 8(a) rule over a 25

- year period. A 25

- year period was used so the burden and cost to the industry are directly comparable to the annual burden presented in Table 4

- 52 and the annual cost estimates for the proposed amendments to the IUR ru le, found in Table 4

- 53. Table G

- 2 contains the annual burden to industry over 20 years as a result of a section 8(a) rule and of completing Form U.
Over a 2 5

- year period, EPA estimates the total burden to industry of both the IUR data collection and a section 8(a) collection will be 20.04 million hours. The section 8(a) rule adds 3.57 million hours to the industry burden during this time period.G

- 4

Table G

- 2 : Schedule of Annual Industry Burden

Reporting Cycle Years Baseline Cost (When

all
Amendments

are Considered) Manufacturer

Section 8(a)
Cost Processor

Section 8(a)
Cost Manufacturer

and Processor Section 8(a)
Cost Total Cost to

Industry (Manufacturer

and Processor + Baseline)

(mill ions of hours) (millions of

hours) (millions of

hours) (millions of

hours) (millions of

hours)

1 2007 to 2011 3.24 0.04 0.14 0.18 3.41

2 2012 to 2015 2.61 0.16 0.56 0.71 3.32

3 2016 to 2019 2.61 0.16 0.56 0.71 3.32

4 2020 to 2023 2.61 0.16 0.56 0.71 3. 32

5 2023 to 2027 2.61 0.16 0.56 0.71 3.32

6 2026 to 2031 2.61 0.16 0.56 0.71 3.32

Total 16.29 0.82 2.93 3.75 20.04
Annual Average 0.65 0.03 0.12 0.15 0.80

G.3 

### Industry Cost Estimate

EPA calcu lated the per

- report cost to industry of the additional data el ements 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

submi ssion requirement (see Section 4.4.27 ) which EPA assumes al l clerical b urden for preparing and submitting Form U s eliminated. As shown in Table G

- 3

, EPA estimates the additional per report cost to be $5,673

.

Table G

- 3 : Per

- R eport Cost for Additional Data Elements, based on PMN Burden

Technical Managerial Total

Burden (hours) Wage

Rate (2008$) Cost

(2008$) Burden

(hours) Wage

Rate (2008$) Cost

(2008$) Burden

(hours) Cost

(2008$)

PMN Burden/Cost per Report 75 $58.84 $4,413 18 $70.03 $1,260 93 $5,673

The cost to manufacture r s and processors to submit the exposure

- related data elements was derived as
shown in Table G

- 4

. EPA estimates the section 8(a) rule would cost manufacture r s $ 2.39 million and processors $8.51 million each year.

Table G

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

Entity Subject to the Data Collection Cost to Prepare Exposure

- related Data Elements (2008$) Number of Reports Indust ry Cost (millions of 2008$)

Manufacturers $5,673 421 $2.39

Processors $5,673 1,500 $8.51

Total for Manufacturers and Processors $5,673 1,921 $10.90G

- 5

Annual Industry Cost Estimates



### Table G

- 5 presents the annual and annualized cost estimates to i ndustry of comp l eting Form
U and a section 8 (a) collection

. The cost estimates for completion of Form U come from Table 4

- 53

. Over a 2 5

- year period, EPA estimates total annualized cost to the industry would be $ 46.98 million, with a thre e percent discount rate , and $ 43.56 million with a seven percent discount rate

.

Table G

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

Reporting Cycle Years Baseline Cost (When all
Amendments

are Considered) Manufacturer

Section 8(a)
Cost Processor

Section 8(a)
Cost Manufacturer

and Processor Section 8(a)
Cost Total Cost to

Industry (Manufacturer

and Processor + Baseline) (2008$ millions) (2008$

millions) (2008$

millions) (200 8$

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 $16 2.08 $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% $35.8 3 $1.70 $6.04 $7.73 $43.56

G.4 

### Agency Burden Estimate

For the purposes of this analysis, EPA assumed the Agency burden was similar to that associated with the IUR rule, and would include contractor and EPA staff burden related to d ocument receipt, tracking

an d quality control of data entry. To calculate the Agency burden associated with the exposure

- related data elements, EPA used the per

- data element burden to EPA after all the proposed amendments are considered, 0.00008 hours, as calculated in Section 5.5 . The number of exposure

- related data elements is 57, as shown in Table F

- 1 . The section 8(a) burden per

- report is estimated as shown in Table G

- 6

.

Table G

- 6 : Per

- Report Burden for Data Elements Similar to Those Included in a TSCA Section 8(a) Data Collection

Data Elements Number of Data

Elements Per

- Data Element Burden (hours) Per

- report Burden (hours)

Exposure

- related Data Elemen ts 57 0.00008 0.00 48

Table G

- 7 shows the estimated burden to the Agency of processing the data submitted by chemical
substance manufacturers and processors. As described above, EPA expects a total of 421 manufacturer reports and 1,500 processor report s

. The Agency burden to process the exposure

- related data elements,

per

- form, 0.0048 hours, is the same for both processors and manufacturers. Therefore, the Agency burden to process the manufacturer data are 2.02 hours, and for proce ssor data, is approximately 7.20 hours.G

- 6

Table G

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

Per

- R eport Burden to

Process Exposure

- Related Data Elements (hours) Number of Reports Agency Burden (hours)

Agency Burden to Process Manufacturer

Data 0.0048 421 2.02

Agency Burden to Process Processor Data 0.0048 1,500 7.20
Total Agency Burden 0.0048 1,921 9.22

Annual Agency Burden Estimates



### Table G

- 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

- year period . The Agency burden for processing Form U is taken from Table 5

- 42. In total, EPA est imates the Agency burden for the IUR rule and a section 8(a) rule would be 15,000 hours over a 2 5

- year period . The total burden as a result of a section 8(a) rule would be 240 hours over a 25

- year period.

Table G

- 8 : Schedule of Annual Agency Burden

Reporting Cycle Years Baseline Cost (When

all
Amendments

are Considered) Manufacturer

Section 8(a)
Cost Processor

Section 8(a) Cost Manufacturer

and Processor Section 8(a)
Cost Total Cost to

Industry (Manufacturer

a nd Processor + Baseline)

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

1 2007 to 2011 2,439 2.02 7.20 9.22 2,448

2 2012 to 2015 2,456 10.10 35.98 46.08 2,503

3 2016 to 2019 2,456 10.10 35.98 46.08 2,503

4 2020 to 2023 2,456 10.10 35.98 46.08 2,503

5 2023 to 2027 2,456 10.10 35.98 46.08 2,503

6 2026 to 2031 2,456 10.10 35.98 46.08 2,503

Total 14,721 52.52 187.12 239.64 14,960

Annual Average 589 2.10 7.48 9.59 598G

- 7

G.5 

### Agency Cost Estimate

To calculate the Agency cost associated with processing the data rece ived from a section 8(a) rule, EPA used the cost per

- data element to the EPA estimated in the IUR EA, $0.0089 (Section 5.5 ).This unit cost was multiplied by the number of data elements to calculate the total per

- report cost of processing the data elements, as shown in Table G

- 9

.

Table G

- 9 : Per

- Report Cost for Data Elements Similar to Those Included in a TSCA Section 8(a) Data Collection

Data Elements Number of Data

Elements Per

- Data Element

Cost (2008$) Per

- Report Cost (2008$) Exposure

- related Data Elements 57 $0.0089 $0.51

Table G

- 10 shows the Agency cost of processing the processor data . EPA estimates t he total Agency

cost to proc ess the manufacturer data are $213, and t he total cost to the Agency of processing the

processor data are $ 758. The total Agency data processing cost would be $970.

Table G

- 10 :Agency Cost to Process Data a s a Result of the TSCA Section 8(a) Data
Collection

Per

- Report Cost

to Process Exposure

- Related

Data Elements (2008 $ ) Number of

Reports Agency Cost

(2008 $ )

Agency Cost to Process Manufacturer Data $0.51 421 $213
Agency Cost to Process Processor Dat a $0.51 1,500 $758
Total Agency Cost $0.51 1,921 $970

Annual Agency Cost Estimates



### Table G

- 11 pres ents the estimated annual and annualized costs to the Agency of processing Form U and a section 8(a) data collection

. The cost es timates for completion of Form U come

from Table 4

- 53

. Over a 2 5

- year period, EPA estimates total cost to the Agency w ould be $65,800 , with a three percent discount rate , and $60,300 with a seven percent discount rate

.

Table G

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

Reporting Cycle Years Baseline Cost (When

all
Amendments

are Considered) Manufacturer

Section 8(a)
Cost Processor

Section 8(a)
Cost Manufacturer

and Processor Section 8(a)
Cost Total Cost to

Ind ustry (Manufacturer

and Processor + Baseline)

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

1 2007 to 2011 $286,580 $213 $758 $970 $287,550

2 2012 to 2015 $288,450 $1,065 $3,790 $4,855 $293,305

3 2016 to 2019 $288,450 $1,065 $3,790 $4,855 $29 3,305

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 $1,754,076G

- 8

Annual Aver age $69,153 $222 $788 $1,010 $70,163

Annualized at 3% $65,011 $168 $596 $763 $65,774

Annualized at 7% $59,643 $151 $538 $688 $60,331

G.6 

### Small Entity Analysis

The following section provides a preliminary a ssess ment of the impact a section 8(a ) rule may have on small entities by examining the relationship between the compliance costs and company sales for small companies . This analysis is based on the methodology found in Chapter 8 of this report.

Manufacturers

Fo r manufacturers, EPA estimated 3.89 manufacturing sites per global parent company in Chapter 8; 41.3 percent of global parent companies ( 466 companies) are considered small under
the SBA employment

- based definition

, 31 

### a nd 24.8 percent (280 companies) are considered small

under the TSCA s ales

- based definition

, 32 

### EPA also estimated an average of approximately 1.76 sites per small company under the employ ment

- based definition of small business

, and approximately 1.92 sites per small company under the sales

- based definition

. Average annual

sal es revenue of global parent companies considered small under either definition were estimated using data from Dun & Bradstreet, as also described in Chapter 8

.
Table G

- 4 shows the cost to manufacturers as a result of a section 8(a ) rule. T hese costs were summed and annualized over four years (the likely timeframe for the rule) at both a three percent
and seven percent discount rate

. 33 

### As shown in Table I

- 12 , these costs were divided by the total

number of sites e lected to submit dat a, for the annualize d costs per site

. This was multiplied by the number of sites per small parent company to arrive at the annualized costs per small parent

company

. This value was divided by the annual sales per small parent company to derive the

cost

- to

- sales ratio.

As shown in Table G

- 12 , under the emplo yment

- based definition, a small parent company affected by the rule on average has sales of more than $4 12.7 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 0.00 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 $ 19,047 or lower. The cost

- to

- sales ratio for an average small com pany under the

sales

- based definition would be 0.16% or less.

31 Threshold of 1,000 employees

. 32 Total annual sales of the company, combined with those of any parent company, are below $40 million and annual produ ction volume or importation volume at the facility is less than or equal to 100,000 lb.; or total annual sales of the company, combined with those of any parent company, are below $4 million.

33 A seven percent discount rate, reflecting the opportunity cost of capital, is consistent with OMB Circular A

- 4 (OMB, 2003). A three percent discount rate was also used as a sensitivity analysis to examine the robustness of the results to a change in the annualization assumptions.G

- 9



### Using the highe st annual cost shown in Table G

- 12 of $ 19,443, a small company would have to have annual sales of less than $ 1.94 million in order to have a cost

- to

- sale s ratio larger than
one percent

. This approach is limited to the extent the universe of manufacturers identified under the economic analysis for the IUR rule would be similar to the manufacturers subject to a section 8(a) rule.

Table G

- 12 : Derivation of Cost

- to

- Sales Ratios for Small Manufacturers for Collection of Exposure

- Related Data Elements

Employment

- based Definition Sales

- based Definition

3% Discount R ate 7% Discount Rate 3% Discount Rate 7% Discou nt 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 C osts 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% 0.00 5 % 0.153% 0.161%
Number of Companies Potentially Affected 7 4

Processors

To estimate the im

pact of the collection of exposure

- related data elements on processors, EPA is limited by the availability of data

. As described above, EPA estimated the number of processors that may be impacted by the requirement using TRI submission data

. However, data provided under the TRI program does not include information about a submitter’s parent company or annual revenues

. For this screening

- level analysis, EPA assumes the chemical substance processor industry shares many characteristics with the chemical subst ance manufacturing industry subject to the IUR rule. To the

extent this is not the case , this analysis may over

- or underestimate the impact of additional data elements

on processors

. Specifically, EPA assumes 3.89 manufacturing sites per global parent com pany . EPA also

assumes 41.3 percent of global parent companies are considered small under an employment

- based definition, and 24.8 percent are considered small under a sales

- based definition. EPA further assumes 1.76 site s per small parent company under th e employment

- based definition, and 1.92 site s per small parent company under the sales

- based definition

, consistent with manufacturer information . G iven the large number of companies identified as processors according to TRI submissions, E PA was unable to

examine Dun & Br adstreet data to estimate annual parent company revenue for this analysis, so manufacturer revenue was used as a proxy. Therefore, t his analysi s provides only a preliminary estimate of impacts

. 

### EPA divided the number of expected processor r eports ( 1,500 ) by the average number of

chemical substance s for which a processor submitted TRI data (2.45) to obtain the estimated number of processors (612). EPA divided this number by 3.89 (the number of sites per global parent company) for an estimated 157 global parent companies

. This number was then multiplied by 41.3 percent and 24.8 percent to estimate the number of small global parent companies (the number of companies potentially affected), under the employment

- based definition and sales

-G

- 10



### based def inition, respectively. To calculate cost

- to

- sales ratios, EPA followed the same methodology for processors as described above for manufacturers

. R esults are presented in Table

G

- 13

Table G

- 13 : Derivation of Cost

- to

- Sales Ratios for Small Processor s for Collection of Exposure

- Related Data Elements

Employment

- based Definition Sales

- based Definition

3% Discount Rate 7% Discount Rate 3% Discount Rate 7% Discount Rate

Cost of Section 8(a) Rule $8,510,161

Total Annualized Costs $2,222,780 $2,348,074 $2,222,780 $2,348,074

Total Number of Sites 612

Annualized Costs per Site $3,631 $3,835 $3,631 $3,835
Number of Sites per Small Parent Company 1.76 1.92

Annualized Costs per
Small Pare nt 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 0.001 5 % 0.001 6 % 0.059% 0.062%

Number of Companies Potentially Affected 65 39



### Table G

- 13 , under the employment

- based definition, a small parent company affected by the

rule on average has sales of more than $4 12.7 million

. The annualized costs of the proposed I UR 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 0.001 6 percent or less

. Under
the more conservative sales

- based definition, small parent company sales are on average more than $11 .8 million, with annualized costs associated with the proposed amendments of $7,364 or

lower. The cost

- to

- sales ratio for an average small company under the sales

- based definition would be 0.062 percent or less.

A s described in Chapter 8, t he Regulatory Flexibility Act does not define the terms “significant” or “substantial” analytically with regard to extent of economic impact and number

of small entities affected. However, EPA typically define s a th reshold as com pliance costs of one percent of sales to establish whether the level of economic impacts faced by the small entities can be presumed as not significant (U.S. EPA, 2006)

. Using the highest annual cost shown in

Table G

- 13 , $ 7,364 , a small company would have to have annual sales of less than $7 36,400 in
order to have a cost

- to

- sales ratio larger than one percent.