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# Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances ( EPA Docket EPA
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Contract # EP
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September 9, 2015

-- Does not contain TSCA CBI

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

### This Page Was Intentionally Left BlankEcono mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Contributors
The EPA analyst responsible for this report was Stephanie Suazo 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

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### Table of Contents

1 Introduction

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

- 1

1.1 Statutory Authority and Significant New Uses under the Proposed SNURs

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

- 1

1.2 Summary of Methodology

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

- 2

1.3 Organization of this Report

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

- 2

2 Costs of a Significant New Use Rule (SNUR), by Option

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

- 1

2.1 Comply with SNUR Limits (Option 1)

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

- 3

2.1.1 Hazard Communication

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

- 4

2.1.2 Protection in the Workplace

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

- 5

2.1.3 Recordkeeping

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

- 9

2.1.4 Hidden Costs: production volume limits, limiting releases to water, PMN uses, import

- only, and disposal

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

- 10

2.2 Request Modifica tion or Revocation of a SNUR (Option 2)

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

- 11

2.2.1 Costs of Developing and Submitting Testing Data

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

- 11

2.2.2 Costs for Submitting a Request for Modification or Revocation of a SNUR

....... 2

- 12

2.2.3 Other Costs

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

- 13

2.2.4 Total Costs for Option 2

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

- 13

2.3 Submit SNUN (Option 3)

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

- 13

2.3.1 SNUR “New” Chemicals

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

- 14

2.3.2 Advance Compliance Exemption

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

- 15

2.3.3 Costs for Submitting a SNUN

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

- 15

2.3.4 Potential for Subsequent Regulatory Actions

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

- 15

2.4 Request Equivalency Determination (Option 4)

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

- 16

2.5 Decide Not to Produce Chemical (Option 5)

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

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2.6 Summary of Costs for Each Option

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

- 16

3 Export Notification Costs

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

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### 3.1 Estimated Number of Annual Export Notifications per Exporter

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

- 1

3.2 Exporter Costs

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

- 2

3.2.1 Estimated Submission (Mailing) Costs

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

- 2

3.2.2 Compile and Maintain the List of Products

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

- 2

3.2.3 Write or Revise Export Notification

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

- 3

3.2.4 Check Orders and Send Notifications

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

- 3

4 Agency Costs

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

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4.1 SNUN Processing Costs

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

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4. 2 Export Notification Processing Burden

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

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5 Additional Analyses

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

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5.1 Regulatory Flexibility Act (RFA)

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

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5.2 Unfunded Mandates Reform Act (UMRA)

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

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5.3 Paperwork Reduction Act (PRA)

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

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5.4 Executive Order 12866, Regulatory Planning and Review

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

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5.5 Executive Order 13132, Federalism

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

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5.6 Executive Order 12898, Environmental Justice

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

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5.7 Executive Order 13045, Protection of Children

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

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5.8 Executive Order 13175, Tribal Governments

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

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5.9 Executive Order 13211, Energy Supply, Distribution, or Use

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

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### List of Tables
Table ES

- 1. Compliance Options and Associated Costs Incurred by a Firm due to SNUR

....................... vii Table 1. Summary of Compliance Options and Associated Costs Potentially due to a SNUR

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

- 2 Table 2. Production and Use Restrictions/Requirements

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

- 4 Table 3. Annual Costs of Hazard Communication Requirements

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

- 5 Table 4. Annual Costs of Workplace Protection Requirement

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

- 6 Table 5. Sample Costs of Workplace Protection

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

- 8 Table 6. Annual Costs of Recordkeeping Requirement s (40 CFR §721.125)

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

- 10 Table 7. Sample Costs of Recommended Testing

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

- 11 Table 8. Costs of Requirement to Modify/Revoke SNUR or Submit SNUN

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

- 13 Table 9. Derivation of Total Mailing Cost for 13 Notices

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

- 2 Table 10. TSCA 12(b) Export Notification Cost per Notification

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

- 3 Table 11. Agency Costs for SNUN and Other Submission Review and Processing

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

- 3 Table 12. TSCA 12(b) Export Notification Cost: Agency Burden per Activity (2013$)

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

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Table A

- 1. PMNs and Chemical Names Referenced in this Economic Analysis

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

- 1

Table B

- 1. Derivation of Loaded Wage Rates

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

- 4

Table B

- 2. Derivation of Industrial Hygienist Wage Rate (NAICS 31, 32, 33)

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

- 5

Table B

- 3. Derivation of Inflation Factors

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

- 7

Table C

- 1. Annual Costs of Labeling for Distribution in Commerce [40 CFR §721.72(b)(2)]

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

- 3

Table C

- 2. Annual Costs of Labeling for Use in Workplace [40 CFR §721.72(b)(1)]

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

- 4

Table C

- 3. Annual Costs for Material Safety Data Sheets (MSDSs) [40 CFR §721.72(c)]

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

- 4

Table C

- 4. Annual Costs for Employee Training, Per Chemical [40 CFR §721.72(d)]

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

- 5

Table C

- 5. Annual Costs for Dermal Protection Selection [40 CFR §721.63(a)(1)]

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

- 6

Table C

- 6. Annual Costs of Impermeability Testing [40 CFR §721.63(a)(3)]

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

- 7

Table C

- 7. Annual Cost of Gloves [40 CFR §721.63(a)(2)(i)]

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

- 8

Table C

- 8. Annual Cost of Protective Eyewear [40 CFR §721.63(a)(2)(iii)]

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

- 9

Table C

- 9. Annual Cost of Protective Clothing [40 CFR §721.63(a)(2)]

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

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### Table C

- 10. Crosswalk Between SNUR Text and Respirator Types at 40 CFR §721.63(a)(5)

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

- 11

Table C

- 11. Annual Per

- Chemical Costs for Respiratory Protection [40 CFR §721.63(a)(4)]

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

- 13

Table C

- 13. Recordkeeping Estimates from Kearney 1988a and 1988b

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

- 24

Table C

- 14. Annual Per

- Chemical Costs of Recordkeeping Requirement [40 CFR 721.125]

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

- 25

Table D

- 1. Cost Estimates for Test Guidelines Cited in SNURs

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

- 3

Table D

- 2. Default Parameters for Species, Route, and Study Type

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

- 16

Table D

- 3. Persistent Bioaccumulative Toxic (PBT) Tiered Testing Requi rements

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

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### Executive Summary
This Economic Analysis estimates the potential costs of Significant New Use Rules (SNURs) covering thirty chemicals that have been the subject of TSCA premanufacture notices (PMNs). Appendix A lists each regulated chemical’s generic or specific chemical name and Chemical Abstract Service Registry Number (CASRN) (if non

- confidential). The SNURs are being published under the r ulemaking docket number EPA

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- 0388 as direct final rules. The SNURs define “Significant New Uses” that trigger EPA notification requirements. To submit a Significant New Use Notice or request a SNUR modification, a firm incurs a modest submission cost, plus costs of any addit ional data generated to support the submission. By avoiding a Significant New Use, a firm can avoid submission costs, but may incur other compliance costs. For example, it may incur costs associated with restricting chemical releases to water or preventing worker exposure. The options available to a firm considering the manufacture, import, and/or processing of a chemical covered under a SNUR, and the types of associated costs to the firm, are summarized in Table ES

- 1

. It should be noted that the costs listed in Table ES

- 1 may be incurred for reasons other than the SNUR. The costs of avoiding a Significant New Use are attributable to the SNUR only if, in the absence of the SNUR, the firm would have adopted a different approach. For example, a SNUR may define any use other than that described in the PM N as a Significant New Use. If the PMN submitter would have conformed to the uses described in the PMN even without the SNUR, then any associated costs of adhering to the PMN uses would not be due to the SNUR. Costs to a PMN submitter of practices required by a TSCA Section 5(e) Consent Order would be attributable to the Consent Order, not the SNUR. If a processor would have workers wear gloves even without SNUR requirements, then the gloves costs would not be attributable to the SNUR. The costs in Table ES

- 1 are attributable to the SNUR only if the firm adopts a different approach due to the Significant New Use Rule.Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table ES
- 1 . Compliance Options and Associated Costs Incurred by a Firm due to SNUR

Option 1 Costs Quantified Costs per Chemical ( 201 4 $) 2

1 Manufacture, import, or process in a way that avoids a Significant New Use, such as limiting water releases, engaging in PMN uses

only, importing only, limiting volumes, providing workplace protection, or providing hazard communications. All SNUR chemicals require ongoing recordkeeping. In addition, many SNUR chemicals may involve costs of complying with water release restri ctions and foregoing non

- PMN uses; these costs were not quantified for this report. Costs for worker protection and hazard communication apply to relatively few chemicals, but are quantified. Typically, annual costs for recordkeeping are under $440. For th e few SNUR chemicals where these apply, annual costs for worker protection may be $37,04 3 or

more and for haz

- comm are $1,141

2 Submit a request for modification or revocation of the SNUR (§721.185). Costs of submitting a request for modification or revocation, including costs of developing supporting data (e.g., testing, if needed). $6,803 submission cost plus any testing costs.3 EPA receives very few such

requests, typically 0

- 3 per year

3 Electronic submission of a Significant New Use Notice (SNUN ), indicating to EPA that the

firm would like to manufacture, import, or process the chemical for a Significant New Use as defined in the SNUR. Costs of electronically submitting a SNUN (including SNUN recordkeeping and user fee 4 ) plus ongoing recordkeeping. Rarely, a firm may choose to conduct toxicity or fate testing to support the SNUN, but such testing is not required by law. $9,303 submission cost (including SNUN recordkeeping and $2,500 fee)4,5 plus ongoing recordkeeping cos ts of under $440. EPA usually receives well under ten SNUNs in a year. Based on review of recent SNUNs, it appears that firms rarely conduct toxicity or fate testing to support a SNUN (such testing would be voluntary).

4 Petition EPA for an equivalency determination to consider alternative controls to prevent

release or exposure that are equivalent to those identified in the SNUR (§721.30). Costs of submitting an electronic request for equivalency determination. $6,803 one

- time submission cost.

5 Do not manufacture, import, or process the substance except for

R&D (the R&D exemption is covered in 40 CFR §721.47). Cost of profits foregone due to delaying or avoiding commercial activity that would otherwise be pursued. R&D recordkeeping costs if manufacture for R&D. Costs not quantified.

Notes: Section numbers refer to 40 CFR §721 (in the Code of Federal Regulations).
1 Firms may follow multiple Options simultaneously.
2 Quantified costs are attributable to the SNUR Significant New Use definition only if a firm would not otherwise follow the sp ecified practices. $ 37, 04 3 is the annual cost for dermal protection selection; impermeability testing, heavy

- duty gloves, and a lo wer

- cost respirator (see Table 5 ). Some firms may have export notification costs (see Chapter 3 of this report).
3 See Appendix D for costs of individual tests recommended in current and re cent SNURs.
4 EPA charges a nominal flat fee of $2,500 for a PMN or SNUN submission.
5 SNUR chemicals not on the TSCA Inventory are “new” chemicals requiring a PMN, so some firms may need to make a submission before commercial production or import, even in the absence of a SNUR (see Section 2.3 of this report). Sources: Costs come from Table 3 through Table 8Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## 1 Introduction
This report presents the U.S. Environmental Protection Agency (EPA), Office of Chemical Safety and Pollution Prevention ’s (O CSPP ) ’s analysis of the potential costs incurred as a result of direct final Significant New Use Rules (SNURs) being promulgated for thirty chemical substances which have gone t hrough premanufacture notice (PMN) review. 1 

### The SNURs are being published under the rulemaking docket number EPA

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. Appendix A lists the generic or specific chemical name and Chemical Abstract Service Registry Number ( CAS RN) (if non

- confidential) for each PMN.



### 1.1 Statutory Authority and Significant New Uses under the Proposed SNURs

EPA may promulgate a SNUR for a substance when ( 1) the substance is the subject of a section 5(e) Consent Order (40 CFR §721.160) , or ( 2) the Agency determines that activities other than those described in the PMN may result in significant changes in human exposure or environmental release levels and/or that concern exists about the substance’s health or environmental effects (40 CFR §721.170)

. In contrast to PMN requirements, which apply mainly to manufact urers and importers ( TSCA § 5(a)(1)(A), 40 CFR §720.22), the SNUR applies to processors as well as to manufacturers and importers ( TSCA § 5(a)(1)(B), 40 CFR §721.5).

Each substance analyzed here was the subject of at least one premanufacture notice submitt ed under the Toxic Substances Control Act (TSCA), and is now being regulated as a result of P MN review

. For the current rulemaking , six of the thirty chemicals have commenced commercial manufactur e or import and so are listed on the TSCA Inventory; they are no longer “ new ” chemicals. For chemicals in this type of rulemaking, SNUR requirements are sometimes based on past Consent Orders entered into with a PMN or SNUN submitter under TSCA Section 5(e )

. For the current rulemaking , nine of the thirty substances have SNUR requirements are based on prior Consent Orders

. EPA promulgates a SNUR to designate specific activities involving the chemical substance that EPA has determined constitute a “ significant new use. ” No person may manufacture or process a chemical substance for a significant new use, unless they submit a significant new use notice (SNUN) to EPA at least 90 days in advance

. Examples of typical “ significant new uses ” that can trigge r the requirement to submit a SNUN (if EPA has promulgated a SNUR applying these requirements to a specific chemical) include:

• Domestic manufacture in the United States

• Manufacture of a particular aggregate or annual volume

• Use other than that specified in the PMN

• Releases to water resulting in a surface water concentration exceeding a specified amount

1 This report covers chemicals that went through PMN review and are part of an expedited rulemaking. The relevant Office of Management and Budget Information Collection Request number is ICR No. 0574 (OMB Control Number 2070

- 0012). EPA also promulgates SNURs through conventional rulemaking t hat are covered by ICR No. 1188 (OMB Control Number 2070

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### • Handling the chemical without employing specified personal protective equipment (e.g., gloves, goggles, respirators) or hazard communication (haz

- comm) measu res (e.g., label, MSDS, worker training) If EPA does not promulgate a SNUR for a given chemical, then these requirements would not apply (unless they apply to a PMN submitter via a §5(e) Consent Order)

. If EPA has promulgated a SNUR containing these types of significant new use designations, as long as the person does not engage (nor intend to engage) in any activities defined by the SNUR as a significant new use, then that person may proceed to handle the chemical without submitting a SNUN.



### 1.2 Summary of Me thodology This analysis quantifies, to the extent possible, the costs to society of the proposed rule by identifying the costs to industry ass ociated with complying with the rule , and the costs to EPA of administering the rule. Types of i ndustry costs anal yzed include those for worker protection, hazard communication, testing, submission of required information , export notification, and recordkeeping. Agency costs include reviewing and processing the data received as a result of the rule. Data sources for t his analysis include burden estimates derived from previous information collection requests and economic analyses for related rules, compensation data acquired from government publications, and supplementary market research to produce an estimate of the un iverse of affected entities and measure the impact of the proposed rule on small entities. In previous economic analyses of SNURs, EPA identified those requirements under Subparts A, B, C, and D of 40 CFR §721 that may indirectly impose costs on manufactur ers, importers, and processors of PMN substances (e.g., EPA, 1989 )

. Some of these costs, such as providing personal protective equipment under §721.63, were estimated in earlier SNUR economic analyses and are presented as part of this analysis

. Resources w ere not available to quantify other costs, such as for limiting releases to water, avoiding uses not listed in the PMN, or keeping production below a specified level; they are described only qualitatively.

It was not feasible within available resources to aggregate costs , or to estimate how often costs are actually incurred as a result of SNURs , except for costs of SNUN submission s

. 

### 1.3 Organization of this Report The remainder of this report estimates the quantified portion of costs potentially associated with SNURs such as those included in this rulemaking

. Chapter 2 presents estimates of the costs that could be incurred by manufacturers, importers, and/or processors u nder the various SNUR options. Chapter 3 addresses export notification costs

. Chapter 4 addresses costs to EPA of administering the SNURs, while Chapter 5 presents an analysis of other impacts, as required by various statutes and exec utive orders

. Appendix A lists the chemicals that are subject to the proposed SNURs. Appendix B provides the wage rates and inflators used in this analysis

. Other appendices give cost estimation details and references.Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## 2 Costs of a Significant New Use Rule (SNUR), by Option

A SNUR specifies requirements that a firm must meet if it chooses to manufacture, import, or process a PMN chemical without engaging in a Significant New Use that would trigger notification to EPA

. A SNUR also requires recordkeeping for anyone manufacturin g, importing, or processing the SNUR chemical

. A SNUR recommends testing, but does not require testing . EPA rarely receives results of tests performed specifically to support a SNUN

. Table 1 sets forth possible responses to a SNUR

. A firm may select more than one course of action

. For example, it may produce a chemical in a way that avoids a Significant New Use, while simultaneously submitting a Signifi cant New Use Notice for a proposed new

use

. These options are described below along with their costs.Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table 1 . Summary of Compliance Options and Associated Costs Potentially due to a SNUR

Option 1 Costs Quantified Costs per Chemical (2014$) 2

1 Manufacture, import, or process in a way that avoids a Significant New Use , such as limiting water releases, engaging in PMN uses only, importing

only, limiting volumes, providing workplace protection, or providing hazard communication s. All SNUR chemicals require ongoing recordkeeping . In addition, many SNUR chemicals may involve costs of complying with water release restrictions , and foregoing

non

- PMN uses ; these costs were not quantified for this report. Costs for worker protection and hazard communication apply to relatively few chemicals, but are quantified

. Typically, annual costs for recordkeeping are under $440. For the few SNUR chemicals where these apply, annual costs for worker protection may be $37,04 3 or

more and for haz

- co mm are $1,141

2 Submit a request for modification or revocation of the SNUR (§721.185). Costs of submitting a request for modification or revocation, including costs of developing supporting data (e.g., testing, if needed). $6,803 submission cost plus any testing costs.3 EPA receives very few such

requests, typically 0

- 3 per year

3 Electronic submission of a Significant New Use Notice (SNUN), indicating to EPA that the firm would like to manufacture, import, or process the chemical for a Significant New U se as defined in the SNUR. Costs of electronically submitting a SNUN ( including SNUN recordkeeping and user fee 4 ) plus ongoing recordkeeping. Rarely, a firm may choose to conduct toxicity or fate testing to support the SNUN , but such testing is not required by law $9,303 submission cost (including SNUN recordkeeping and $2,500 fee)4,5 plus ongoing recordkeeping costs of under $440. EPA usually receives well under ten

SNUNs in a year. Based on review of recent SNUNs, it appears that firms rarely conduct toxicity or fate testing to support a SNUN (such testing would be voluntary).

4 Pet ition EPA for an equivalency determination to consider alternative controls to prevent release or exposure that are equivalent to those identified in the SNUR (§721.30). Costs of submitting an electronic request for equivalency determination. $6,803 one

- t ime submission cost.

5 Do not manufacture, import, or process the substance except for R&D (the R&D exemption is covered in 40 CFR §721.47). Cost of profits foregone due to delaying or avoiding commercial activity that would otherwise be pursued. R&D re cordkeeping costs if manufacture for R&D. Costs not quantified.

Notes: Section numbers refer to 40 CFR §721 (in the Code of Federal Regulations).
1 Firms may follow multiple Options simultaneously.
2 Quantified costs are attributable to the SNUR Significant New Use definition only if a firm would not otherwise follow the sp ecified practices. $ 37, 04 3 is the annual cost for dermal protection selection; impermeability testing, heavy

- duty gloves, and a lower

- cost respirator (see Table 5 ). Some firms ma y have export notification costs (see Chapter 3 of this report).
3 See Appendix D for costs of individual tests recommended in current and recent SNURs.
4 EPA charges a nominal flat fee of $2,500 for a PMN or SNUN submission.
5 SNUR chemicals not on the TSCA Inventory are “new” chemicals requi ring a PMN, so some firms may need to make a submission before commercial production or import, even in the absence of a SNUR (see Section 2.3 of this report). Sources: Costs come from Table 3 through Table 8Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### 2.1 Comply with SNUR Limits (Option 1) A firm can avoid engaging in a Significant New Use and submitting a SNUN by meeting all applicable SNUR requirements

. The firm may also pursue this option temporarily by complying with SNUR restrictions while also pursuing other options such as making a submission to EPA

. If it does avoid engaging in a Significant New Use (and if the chemical is on the TSCA Inventory or if the firm has already submitted a PMN), no notice to EPA is required. 2 

### Table 2 shows the types of requirements a firm must meet to avoid engaging in a Significant New Use

. The Significant New Use designation in a SNUR for a specific chemical reflect s either the use scenario described in the PMN for that chemical (what the submitter was already planning to do) or the requirements in the 5(e) Consent Order resulting from the PMN submission

. Thus , it is likely that the typica l PMN submitter will incur no added costs of complying with the SNUR requirements so as to avoid a Significant New Use

. However, if there is any export of these chemicals, the re will be export notification costs that result from the TSCA Section 12 (b) req uirements that are automatically triggered for chemicals regulated under TSCA Section 5 (see Chapter 3 for details).

2 Under the Toxic Substances Control Act § 3(9), if a chemical is not on the TSCA Inventory, it is a “new chemical.” Prior to manufacture or import of a new chemical for general commercial use, a notice must be filed with EPA under Section 5(a)(1)(A) of TSCA (40 CFR §720.3 and 40 CFR §720.22).Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table 2

. Production and Use Restrictions/Requirements

40 CFR Reference (Code of Federal

Regulations) Restriction/Requirement Number of Chemicals Affected 1 Sample Costs Per Chemical

( 2014$ ) §721.63 Workplace protection 5 $18,243 to $37,043 §721.72 Hazard communication 6 $1,141 Industrial Commercial, and Consumer Activities (§721.80) §721.80(a, b, c) Enclosed use only 0 Not quantified §721.80(d, e) Use at site only 0 Not quantified §721.80(f) Import only (do not manufacture) 1 Not quantified §721.80(g, h, i) Use only as intermediate 1 Not quantified §721.80(j, k) Engage only in uses listed in PMN or Consent Order 10 Not quantified §721.80(l, m, n, o) Limits non

- industrial uses 5 Not quantified §721.80(p, q, s, t) Limit production volume 9 Not quantified §721.80(r, u) Volume

- triggered testing 0 Not quantified §721.80(v, w, x, y) Restricts physical form of chemical 5 Not quantified Disposal, water release, recordkeeping §721.85 Disposal 0 Not quantified §721.90 Limit releases to water 0 Not quantified
§721.125 3 Recordkeeping for all manufacturers, importers, and processors 30 Up to $440

Notes:
1 Some chemicals have more than one type of restriction.
2 $ 18, 243 is the annual cost for dermal protection selection and heavy duty gloves. $ 37, 04 3 is the annual cost for dermal protection selection; heavy duty gloves, impermeability testing/evaluation of manufacturer specifications, and a lower

- cost respirator (see Table 5 ).
3 This excludes SNUN recordkeeping under §721.40. See the recordkeeping discussion in Appendix C

. Sources : Costs are summarized in Table 3 , Table 4 , and Table 6 , and derived in Appendix C

. 

### The costs of meeting the haz

- comm, protective equipment, and recordkeeping requirements are quantified for this report

. Appendix C presents a more detailed derivation of these costs

. The export notification costs are summarized in Chapter 3

. Complying with requirements to avoid a Significant New Use also may result in additional costs that affe ct a significant number of the chemicals, such as costs associated with limiting releases to water, that were not quantified for this report; these costs are also summarized below.

2.1.1 Hazard Communication
Requirements

. Each SNU R may require firms that manufac ture, import, or process one of the PMN substances to implement a haz

- comm program for the applicable chemical , or else submit a SNUN

. For purposes of the economic analysis, it is assumed that each facility has in place a haz

- comm program consistent with t hat required by OSHA’s Hazard Communication standard (29 CFR 1910; November 25, 1983)

. Much of the haz

- comm cost methodology used in this analysis came from a 1989 EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical FollowupEcono mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### ( EPA, 1989 )

. The cost estimates provided here are for one chemical produced at one site , assumed to have 25 exposed workers and roughly a 10,000 kilogram annual shipment volume

. Higher volumes would increase costs, although not necessarily proportionately

. The major elements of a haz

- comm program that could apply to a SNUR chemical, based on the requirements in §721.72, are:

• Revision of the existing written haz

- comm program to incorporate information about the chemical [§721.72(a )];

• Creation of labels and application of labels to containers used for distributing the chemical in commerce [§721.72(b)];

• Creation of labels or signage and posting of hazard data in areas of the facility where the chemical is used or stored [§721.72(b)];

• Creation and distribution of material safety data sheets (MSDSs) [§721.72(c)]; and

• Employee awareness training on where and how the chemical is used, the hazards associated and availability of hazard information about the chemical, and protective equipmen t and other measures in place to reduce and minimize exposure to the chemical [§721.72(d)].

Costs

. The annual costs of compliance with the haz

- comm requirements for PMN substances subject to haz

- comm requirements appear in Table 3

. Further, the costs are for substances with full haz

- comm requirements, and may overstate haz

- comm costs for substances with partial requirements

. Appendix C gives the detaile d cost derivation.

Table 3 . Annual Costs of Hazard Communication R equirements

Requirement Cost ( 2014 $ ) Hours Update written program $224 4 Labeling Distribution in commerce $ 1 42 0.5 Use in the workplace $ 3 92 1.5 MSDS preparation $156 2.25 Employee training $227 6.75 TOTAL $1,141 15 Notes:
1 Figures are rounded to whole dollars. Substances not subject to all of these requirements may have lower costs. Sources : See Table C

- 1 through Table C

- 4 , and Section C.1.1 for derivations. Hourly labor costs are derived in Table B

- 1

.



### 2.1.2 P rotection in the Wo rkplace
Requirements. Under 40 CFR §721.63, manufacturers, importers, or processors must comply with worker protection requirements as specified in the SNUR on the regulated chemical, or else submit a SNUN

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### core components of the worker protection requirements include provision of personal protective equipment (PPE) such as gloves, goggles, protective clothing, and respirators. In some cases, EPA specifies the type of PPE required

. In other cases, EPA requires adequate dermal protection but does not specify particular PPE

. Instead, it requires the employer to evaluate worker exposure conditions and hazards, and select appropriate PPE

. Generally the employer is also required to determine that dermal PPE is impervious to the PMN substance by one or bot h of the following methods : (1) perform impermeability testing on the PPE under the expected conditions of exposure, and/or (2) rely on equipment manufacturers' specifications

. Employers not already providing adequate dermal protection would need to do so.

Costs. Annual costs for worker protection items are shown in Table 4 below

. The derivation of the sample minimum and maximum annual costs for worker p rotection is found in Table 5

. The costs of worker protection were originally e stimated in a 1989 EPA report, Economic Analysis of Final Significant Ne w Use Rules: General Provisions for New Chemical Follow

- Up ( EPA, 1989 ), as a range of costs, depending on the assumed number of worker

- days of exposure

. This report uses the high end of the assumptions about worker

- day exposure, updated to adjust for infla tion

. The estimates are for one chemical at one site with 25 exposed workers; actual costs would vary with the number of workers. Appendix C gives the detailed cost derivation.
Table 4

. Annual Costs of Workplace Protection Requirement

Personal Protective Equipment and Requirement Citation at 40 CFR Unit Cost ( 201 4 $) 1 Quantity Required 1 Total Annual Cost 2 ( 201 4 $)

Dermal Protection Selection §721.63(a)(1) 10 hours industrial hygienist (IH) time $56.01 10 $560 Impermeability Testing §721.63(a)(3) Impermeability Test $1,418 1 $1,418 Evaluation of Manufacturer's Specifications $224 1 $224 Gloves §721.63(a)(2)(i) Standard (disposable) $0.44 6,250 $2,761 Heavy

- duty butyl $70.73 250 $17,683 Protective clothing §721.63(a)(2) [ii]

- Full

- body (coverall with hood) $11 8 75 $8,846 [iv]

- Coverall (no hood) $41.00 75 $3,075 Eyewear §721.63(a)(2)(iii) Standard goggles $8.73 75 $655 Heavy

- duty goggles $11.95 75 $896 Respirator Types 3 Supplied

- air respirator operated in pressure demand or continuous flow mode and equipped with a tight

- fitting full facepiece. [similar to §721.63(a)(5)(ii)] $1,857 25 $46,425
Supplied

- air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight

- fitting facepiece (either half

- or full

- face). [similar to §721.63(a)(5)(iii)] $2,34 3 25 $58,575Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 7 Personal Protective Equipment and Requirement Citation at 40 CFR Unit Cost ( 201 4 $) 1 Quantity Required 1 Total Annual Cost 2 ( 201 4 $)

Air

- purifying respirator equipped with a tight

- fitting full facepiece and High Efficiency Particulate Air (HEPA) filters.[similar to §721.63(a)(5)(iv)] $686 25 $17,158

Air

- purifying, tight

- fitting respirator (either half

- or full

- face) equipped with N100 (if aerosols absent), R100, or P100 filters. [similar to §721.63(a)(5)(iv)] $686 25 $17,158

Powered air

- purifying, tight

- fitting full

- face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. [similar to §721.63(a)(5)(v)] $2,486 25 $62,150

Powered air

- purifying respirator equipped with a tight

- fitting facepiece (either half

- or full

- face) and HEPA filters. [similar to §721.63(a)(5)(v)] $2,486 25 $62,150

Powered air

- purifying respirator equipped with a loose

- fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters. [similar to §721.63(a)(5)(vi)] $5,264 25 $131,607

Notes:
1 Quantities assume: 1) 25 workers exposed 250 days per year; 2) standard gloves replaced daily and heavy

- duty gloves replaced every 25 days; 3) respirator units replaced annually and cartridge sets replaced every five days (50 cartridges sets per year); 4) goggles and protective clothing replaced three times yearly.
2 Total annual costs were calculated using unrounded unit cost estimates, and may not equal the product of the rounded estimate s shown in this table.
3 This table lists respirator choices that typically would satisfy SNUR requirements for a particular chem ical, for current and recent SNURs. Future SNURs may list different choices. The citations in brackets refer to respirator types listed at 40 CFR. While t he SNURs no longer reference the §721.63(a)(5) categories, costs in this analysis are based on costs e stimated in 2014 for the §721.63(a)(5) categories. See Table C

- 10 for the crosswalk between respirator types in SNURs and in this table. The respirator “unit cost” is per worker. Total respirator costs include costs of the respirator plus the costs of any add

- on items such as hoods, helmets, cartridges, filters, and cap s, if these items are required for a particular respirator. Sources: Appendix C , Table C

- 5 through Table C

- 11

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### The costs of purchasing protective equipment are derived in Appendix C , and have been annualized based on the assumptions listed above regarding their use and lifetime in the workplace

. Costs for evaluating hazards when PPE is not specified in the SNUR are based on estimates of the reasonable time required for a safety professional to perform such evaluations

. Costs for conducting impermeability testing are based on consultation with PPE vendors, as described in Appendix C

. Table 4 summarizes the annual costs associated with protection in the workplace, including the PP E itself, as well as selecting required dermal protection, and performing impermeability testing and/or evaluating manufacturer's information.

Table 5 shows a sample of the minimum and maximum annual cost of workplace protection, assuming 25 workers who are exposed for 250 hours per year

. The minimum cost includes the cost of heavy

- duty butyl gloves, and 10 hours of an industrial hygienist’s time for de rmal protection selection

. The maximum cost includes the cost of gloves, dermal protection, impermeability testing, and the annual cost of the least expensive respirator and filters for 25 workers

. Table 5 . Sample Costs of Workplac e Protection

Cost Element Annual Cost ( 2014 $) Example #1: Gloves and Dermal Protection Selection Heavy

- duty butyl Gloves $17,683 Dermal Protection Selection $560 Total per site with 25 workers $18,243 Example #2: Gloves , Testing, and Respirator Heavy

- duty butyl Gloves $17,683 Dermal Protection Selection $560 Impermeability Test $1,418 Evaluation of Manufacturer's Specifications $224 Least Cost Respirator $17,158 Total per site with 25 workers $37,043 Source : Table 4

. 

### In cases where the SNUR specifies the type of protective gear, the estimates assume workers would not otherwise wear adequate protective equipment

. To the extent that workers would otherwise be adequately protected (as a result of the company ’ s own safety program related to other chemical hazards, or to comply with OSHA ’ s PPE standards), these costs may be an overes timate of the actual costs. In some cases, the SNUR requires dermal protection but does not specify any particular gear , allowing regulated companies to make that determination

. Table 4 shows costs of assessing needs and demonstrating impermeability

. These cost estimates would reflect a situation where the dermal protection is already in place but the manufacturer must demon strate that it is adequate

. If companies also have to purchase additional protective gear, incremental costs attributable to the SNUR would include the added items

. For example, if a firm already providing gloves and goggles determined that it would have t o add protective clothing to avoid engaging in a Significant New Use, this would increase costs even if particular protective clothing is not specified in the SNUR.Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### 2.1.3 Recordkeeping
Requirements

. Under 40 CFR §721.40, recordkeeping is required for SNUN submitters

. This recordkeeping cost was included in the SNUN submission cost and is not separately estimated here. 3


### In addition, the SNURs specify recordkeeping requirements for manufacturers, importers, and processors, by identifying paragraphs selected f rom 40 CFR §721.125(a) through (k)

. These recordkeeping requirements apply even if the firm does not engage in a reportable New Use or make a submission to EPA, so long as it manufactures, imports, or processes the chemical

. The recordkeeping requirements vary by chemical

. For example, only chemicals that must establish a Hazard Communications program to avoid a Significant New Use would be required to keep records documenting their haz

- comm program. (For firms producing under the R&D exemption, R&D recordk eeping would be needed. R&D recordkeeping costs were not estimated for this report.) SNUR recordkeeping requirements essentially involve electronically storing relevant records, including those related to manufacturing, importing, or processing volumes; sh ipment amounts and customer information; clothing impermeability determinations; the hazard communication program including labels and MSDS copies; compliance with disposal and water discharge limitations; and/or compliance with restrictions on volumes, na ture of manufacture or use, or on the chemical’s physical form (powder, liquid etc.).

Costs

. Annual costs for compliance with 40 CFR §721.125 recordkeeping requirements are low, but do potentially apply to all SNUR chemicals, and the recordkeeping could co ntinue for years

. Costs are presented in Table 6 and derived in Appendix C

. They are estimated for one chemical at one site, and include technical a nd clerical labor time, photocopying charges, and costs for records storage.

Table 6 summarizes recordkeeping costs by requirement at 40 CFR §721.125

. The totals in Table 6 provide the cost if all recordkeeping requirements in paragraphs §721.125 (a) through (k) were required; this would seldom, if ever, be the case for a single chemical.

3 For example, OPPT’s Information Collection Request (ICR) for TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (Renewal), October 11, 2005, estimated SNUN recordkeeping costs at 5.67 hours (EPA, 2005b, page 12).Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table 6 . Annual Costs of Recordkeeping Requirements (40 CFR §721.125)
40CFR §721.1252 Cost Element Cost ( 2014 $ ) 1 Hours (a)(b)(c) Volumes & sales/transfer data $124 3.56

(d)(e) Protective clothing [§721.63] and $5.13 0.15

(f) Haz com program [§721.72] $64 1.83 (g) Label copies [§721.72(b)] $1.28 0.04 (h) MSDS copies [§721.72(c)] $1.28 0.04 (i) Use limitations compliance [§721.80] $64 1.83 (j) Disposal compliance [§721.80] $154 4.40 (k) Water discharge compliance [§721.90] $25.65 0.73 TOTAL $440 12.58 Note s : 1 Recordkeeping applies to all SNUR chemicals. This table does not cover recordkeeping for SNUN submissions. Sources: See Appendix C Table C

- 14 for derivations.



### 2.1.4 Hi dden Costs: p roduction volume limits, limiting releases to water , PMN uses, import
- only, and disposal
Several types of costs that may be incurred by complying with the significant new use designations are not quantified in this report , including production volume limits , r elease s to w ater, disposal, and other use restrictions

. For example:

• Keeping production volume below specified limits to avoid a Significant New Use could result in a decrease in profits; a potential “hidden” cost. A firm producing for sal e may have to restrict its sales of the chemical. If the chemical is for internal use, it may have to substitute to a less cost

effective chemical.

• A producer could incur costs of determining whether discharges to water would constitute a Significant New Use and of limiting releases in order to avoid the Significant New Use.

• Similarly, avoiding uses not listed in the original PMN could result in “hidden” costs of foregone profits if the firm cannot market the chemical for certain applications

. If the firm wants to use the chemical for internal use, it may have to substitute to other chemicals or technologies that cost more or have lesser performance resulting in higher production costs.

• Importing could be costlier than manufacturing a PMN substance in the U nited States.Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### 2.2 Request Modification or Revocation of a SNUR (Option 2) Under 40 CFR §721.185, EPA may modify or revoke a SNUR upon review of a submittal from a manufacturer, importer, or processor

. Consequently, the second option for a firm is to request modification or revocation of the SNUR

. According to New Chemical Program records EPA receives few modify/revoke requests (typically up to three per year) due to SNURs. This option may have some or all of the following associated costs:

• One

- time costs of testing to develop health and environmental effects data for a chemical subject to the SNUR;

• One

- time costs of submitting a request for modification or revocation;

• Ongoing costs of complying with SNUR restrictions (Option 1 in this report) or of avoiding production while the modification request is being processed (Option 5)

. The firm may also incur costs of complying with any SNUR restrictions that are not ultimately revoked or may incur hidden costs of avoiding production altogether.

These costs are dis cussed below.

2.2.1 Costs of Developing and Submitting Testing Data
40 CFR §721.185(b)(1) requires that a modification request include “information sufficient to support the request.” For each PMN substance, the SNUR identifies health, ecological, and/or fate/tr ansport/transformation testing that would help characterize the risks associated with the substance

. However, there is no requirement for a requester to perform the recommended tests or even to perform testing at all

. It is possible that some of the recommended tests, or other tests, would be performed b y the submitter to support a request for modification and revocation of a SNUR

. For informational purposes, costs for various tests recommended in SNURs over the years are listed in Appendix D

. If no a dditional testing is performed to support a modification request, costs may be similar to costs of a SNUN

– discussed later in this section

– minus the user fee.

Table 7 below provides an example of potential costs if a firm were to perform a standard set of basic ecotoxicity tests to support a request to modify or revoke a SNUR

. Table 7 . Sample Costs of Recommended Testing

Test Guideline Test D escription Estimated Cost ( 2014 $ ) Ecotoxicity Base Set OPPTS 850.5400 Algal Toxicity, Tiers I and II $20,071 OPPTS 850.1010 Daphnid Acute Toxicity $16,609 OPPTS 850.1075 Fish Acute Toxicity $22,889 Sample TOTAL Testing Cost: $59,569 Source: Costs are from Table D

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### 2.2.2 Costs for Submitting a Request for Modification or Revocation of a SNUR
The costs associated with submitting a request for modification and revocation of a SNUR (or of submitting a SNUN) ar e estimated to be similar to the costs for preparing a PMN submission, except that there is no user fee for the modify/revoke request

. The PMN submission costs came from EPA ’ s 1994 Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications, which relied on industry estimates of the effort needed to collect and compile all data required for a PMN submission, prepare the form, submit the form and data to EPA, and maintain a file of the submission (EPA, 1994, Table III

- 2 and pages III

- 11,

- 12, and

- 13)

. The 1994 estimates were based on a survey conducted by the Chemical Manufacturers Association (CMA, 1991), which became the American Chemistry Council

. The burden associated with PMN submission and preparation has bee n adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices. 4 

### Electronic submission of SNUN forms is expected to remove all clerical burde n associated with preparing a SNUN (EPA, 2009a, p.7)

. In addition , electronic submission is expected reduce all recordkeeping burden associated with SNUN submissions by fifty percent

. Because, the recordkeeping burden for PMNs was not estimated separately, for the purposes of this report we assume this burden reduction is captured in the removal of all clerical burden. 5


### In the 1994 EPA report, the average effort required to prepare and submit a PMN was 95 to 114 hours

. This burden is reduced to 83 to 100 ho urs after accounting for the ePMN savings (EPA, 2009a)

. This included recordkeeping for the submission, but the recordkeeping cost was not broken out

. For this analysis, the costs of a preparing a SNUN were derived using the averages of the hours for each type of labor from the 1994 report, after adjusting for the ePMN savings

. The method of calculating hourly loaded labor costs is described in Appendix B

.

4 Economic Analysis of Expedited Significant New Use Rules for 2 5 Chemical Substances: EPA Docket OPPT

- 2009

- 092 2, was the first report to consider the burden reductions resulting from electronic submission of SNUN forms and requests for eq uivalency determination. Previously , all burdens were based upon 1994 paper submission estimates.

5 The Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a) reported a 0.5 hour clerical and a 0.5 hour technical burden associated with recordkeeping in addition to the burden estimates from the 1994 RIA (EPA, 1994, p. III

- 14). These burden estimates (the 0.5 for clerical burden and 0.5 for technical burden) are based on the recordkeeping burden for polymer exceptio ns and not the recordkeeping burden associated with PMN submissions. Therefore, for this analysis, the 0.5 hour for clerical labor and the 0.5 hour for technical labor were removed. It is important to note that for this analysis, clerical burden changes ar e not applicable because the entire clerical burden is assumed to be eliminated under the electronic reporting requirements . In summary, we do not include the one hour recordkeeping burden (0.5 hour for clerical, 0.5 for technical) reported in the ePMN EA

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### 2.2.3 Other Costs

EPA’s review of the submitter ’ s request may cause delays in the start of manufacturing or processing activities

. Such delays could cause the company to forego opportunities to earn profits for the duration of the review period

. Alternatively, the submitter may elect to produce under the constraints of the SNUR during the review period, so as to avoid a Significant New Use

. EPA may not revoke all SNUR provisions as a result of th e request

. If the company is allowed to continue production and chooses to do so, it would bear costs of complying with any SNUR restrictions that are not revoked

. Costs of complying with SNUR restrictions pending EPA modification or revocation were discus sed under Option 1.
Table 8 . Costs of Requirement to Modify/Revoke SNUR or Submit SNUN

Labor Category Average Hours Loaded Wage Rate 1 ( 2014 $ ) Total Labor Cost ( L oaded W age x Average H ours) Request to Modify SNUR (Option 2) SNUN (Option 3) Equivalency Determination

(Option 4)
Clerical 2 0 $31.26 $0 $0 $0 Technical 3 74.2 $72.22 $5,359 $5,359 $5,359 Managerial 3 18 $80.22 $1,444 $1,444 $1,444 Subtotal 92.2

-- $6,803 $6,803 $6,803 User Fees (SNUN only) $0 $2,500 $0 TOTAL $6,803 $9,303 $6,803 Test Costs Sometimes Rarely Notes:
1 Loaded wages include fringe benefits and overhead. See Appendix B of this report for derivation. Wage rates presented in this table are rounded values; however, unrounded values are used to calculate total labor costs. For this reason, total labo r costs may not equal the product of rounded values.
2 The estimate of no clerical burden is taken from the Economic Analysis of the Premanufacture Notice Electronic Reporting Final Rule (EPA, 2009a, page 7).
3 Hours range for each technical and managerial labor is from the PMN Amendments RIA (EPA, 1994, Table III

- 2).



### 2.2.4 Total Costs for Option 2
The total costs associated with requesting a modification or revocation of a SNUR include the costs of generating new supporting data plus the administrative cost of preparing the submission

. 

### 2.3 Submit SNUN (Option 3) Under 40 CFR §721.5, manufacturers, importers, or processors who would like to undertake a Significant New Use of a substance listed in a SNUR are required to submit a Significant New Use Notice (SNUN) at least 90 days be fore the firm plans to commence the manufacture, import, or processing of the substance

. For example, they could submit a SNUN if they wish to produce above the volume limit listed in the SNUR for a given chemical, since any production beyond that volume w ould be defined as a Significant New Use.Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### The SNUN provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs

. The notice form used to submit a SNUN is the same as that for a PMN, a nd the costs of submitting a SNUN are estimated based on the costs incurred to submit a PMN. This option could have the following costs:

• One

- time costs of the SNUN and $2,500 user fee. (However, in some cases, a notification may be needed for reasons other than the SNUR; see Section 2.3.1 below.)

• Ongoing costs of complying with SNUR restrictions to avoid engaging in a Significant New Use (Option 1 in this report) or of avoiding production while the SNUN is being processed (Option 5); costs of recordkeeping , and of complying with any restrictions resulting from the SNUN review.

• Rarely, the SNUN submitter may elect to perform some of the testing recomme nded in the SNUR as a way to characterize effects of a chemical

. These tests are not mandatory , and firms do not usually conduct testing to support a SNUN, so any such costs are likely to be zero or low. The assumption regarding testing is based on an ana lysis of the 18 SNUNs submitted over a three

- year period, from 2005 through 200 7

. A list of human health tests submitted to EPA with PMNs and SNUNs was also available from a confidential database maintained by EPA ’s O ffice of Pollution Prevention and Toxics Risk Assessment Division

. Only one SNUN described toxicity or environmental fate testing that seemed reasonably likely to have been performed to support a SNUN

. In that case, two relatively low

- cost tests (fish acut e toxicity and daphnid acute toxicity) may have been conducted to support a SNUN, although it is also possible that the testing was done for some other reason not apparent in the SNUN itself

. A substantial portion of the SNUNs did provide or reference test results

. However, in almost all
cases, the testing appeared to have been conducted for reasons other than a SNUR

. For example, the SNUN might include laboratory reports that had already been submitted for a PMN for the same chemical

. 2.3.1 SNUR “New” Chemicals
If a SNUR chemical is not on the TSCA Inventory and a potential manufacturer or importer has not yet filed a PMN, submission costs may be incurred but are not attributable to the SNUR.

All SNUR chemicals in this rulemaking were the subject of at least one PMN. For PMN chemicals to be added to the TSCA Inventory, manufacturing (or import) must have commenced, with notification to EPA through a Notice of Commencement, or NOC

. Thus, SNUR chemicals not yet in commercial manufacture (or import) are not on the TS CA Inventory

. They legally remain “new” chemicals subject to PMN requirements. For “new” chemicals, firms who have not yet submitted a PMN must notify EPA 90 days before manufacturing/importing the chemical for commercial purposes

. This submission is still designated a PMN but may contain information demonstrating the submitter intends to engage in a significant new use

. Either way, the firm uses the same submission form and provides the data listed at 40 CFR §720.45

. Consequently, for this special situatio n, the submission cost is incurred due to PMN requirements, not dueEcono mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### to the SNUR

. (See EPA ’ s 1997 Chemistry Assistance Manual for Premanufacture Notification Submitters for an overview of New Chemicals requirements [EPA, 1997]).
2.3.2 Advance Compliance Exemption
Another option available to firms before the SNUR is promulgated is to seek an advance compliance exemption under 40 CFR §721.45(h)

. The submission cost for this option is the same as that for a SNUN, but by negotiating an advance compliance agreement wit h EPA a firm might diminish any loss of profits due to delay

. This option is not available after the SNUR is promulgated.
2.3.3 Costs for Submitting a SNUN
As with Option 2 above (Request Modification or Revocation of a SNUR), the costs for submitting a SNUN are estimated to be equivalent to the costs of completing a PMN submission

. If the SNUN is submitted at the same time as a request to modify a SNUR (Option 2), the added cost would be less than shown here due to overlap in information in the two submissions

. Table 8 shows the costs of preparing a SNUN

. 2.3.4 Potential for Subsequent Regulatory Actions
The Agency recognizes that if submission of a SNUN does result from a SNUR , the Agency may take additional regulatory actions under TSCA

. These additional regulatory actions might be necessary to further evaluate an intended new use and associated activities, or to prohibit or limit that activity before it occurs to prevent unreasonable risk of injury to human health or the environment

. It is not known what specific subsequent regulatory actions, if any, the Agency may determine are necessary after reviewing a SNUN

. Any such actions are highly dependent on the circums tances surrounding the individual SNUN (e.g., available information and scientific understanding about the chemical and its risks at the time the SNUN is being reviewed)

. Should the Agency’s review of the SNUN result in further regulatory actions , the Age ncy will initiate and follow the appropriate procedures for taking those actions

. Included in those procedures would be an assessment of the costs and benefits of those actions.

S ubsequent regulatory action may be a Consent Order under TSCA Section 5(e). Assessments of costs and benefits for a Consent Order would be limited, similar to those supporting PMN reviews leading to Consent Orders , in contrast to the in

- depth benefit

- cost analyses prepared under some other TSCA Sections.

T he description above was a dapted from text in Economic Analysis of the Significant New Use Rule for Chloranil , January 8, 2008 , Section 2.4; and Economic Analysis of the Final Significant New Use Rule for 183 Perfluoroalkyl Sulfonates , August 20, 2007, Section 3.4

. Both reports a re from the U.S. EPA Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch

. The nature of the follow

- up regulatory action and benefit/cost analysis may differ between SNUNs for newer chemicals submitted as a result of a direct fina l rulemaking such as this one, and SNUNs for older chemicals such as chloranil and most p erfluoroalkyl sulfonates

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### 2.4 Request Equivalency Determination (Option 4) Under 40 CFR §721.30, EPA may review applications from facilities who propose alternative method s of controlling or preventing exposures or releases to those specified in the SNUR

. In these cases, EPA evaluates the alternatives using an abbreviated review process

. As shown in Table 8 , the costs of submitting an equivalency determination request are expected to be the same as those for submitting a SNUN except that no user fee is required. For this option the EPA review period is 45 days compared t o 90 days for a SNUN, therefore any potential loss of profits due to delays may be less than for a SNUN under Option 3. In addition to the costs of submitting the equivalency determination request, each submitter will also incur costs to develop data to su pport the request

. However, total costs of the equivalency option should be no more than the costs of complying with controls in the SNUR to avoid a significant new use

-- for example, controls related to workplace protection or environmental release

. Otherwise, presumably there would be no incentive for the submitter to choose this alternative

. Finally, to produce the chemical following EPA review, the submitter would incur costs from recordkeeping and from any restrictions not waived (see Option 1).


### 2.5 D ecide Not to Produce Chemical (Option 5) Some firms may find that the costs of meeting the SNUR requirements and/or restrictions (Option 1) or preparing a SNUN or other submission (Options 2, 3, or 4) are financially unattractive

. In these cases, the firm could choose not to manufacture, import, or process the PMN substance. While this option avoids the costs of meeting the specifications in the SNUR or submitting a request for some alternative, it entails the “hidden” cost of the profit that will be forego ne as a result of not engaging in the commercial activity originally planned. For example, if the firm does not produce the SNUR substance, then it will forego the profit it would have achieved by producing it

. That foregone profit is a potential “hidden” cost of Option 5

. Similarly, if the firm would have used the SNUR substance in the production of another product and must substitute to a more costly substance, it will incur those additional costs of production

. If the firm elects to produce for R&D purpo ses only, it may have costs associated with R&D recordkeeping attributable to the SNUR.

Firms that exercise O ption 5 may still incur export notification costs, if they export any existing stockpiles of the product

. This cost is quantified in Chapter 3 below.


### 2.6 Summary of Costs for Each Option

Table 1 , above, gave an overview of compliance options

. Table 3 through Table 6 summarized the quantified portion of potential costs of either following restrictions to avoid engaging in a Significant New Use, or of making a submission to EPA

. Table 7 presented sample testing costs

. Costs are for one chemical at one site, and

– where volume is relevant

– are based on standard assumptions that include 25 exposed workers per site and, for ha z

- comm costs, annual shipments of about 10,000 kilograms per site

. Costs are not otherwise adjusted for the nature of the chemical or process, volume, location, or other firm

specific or chemical

- specific factors.Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### As mentioned above, costs are estimated fo r one chemical at one site, not for aggregate production

. Resources were not available to estimate aggregate costs

. Among other things, it is not known how many firms are affected by the SNURs. EPA receives a handful of Significant New Use Notices per year due to SNURs. However, if a SNUR chemical is on the TSCA Inventory, a firm may use the chemical in a way that avoids a Significant New Use (Option 1), and never make a submission

. It is not known how many firms are affected but do not make a submission

. A lso, it is not known whether firms avoid the chemical altogether specifically due to the SNUR

. However, at least for the years immediately following SNUR promulgation, these numbers are likely to be small

. This is because the chemicals in this type of SNUR rulemaking are still relatively new

– as Appendix A indicates, most were submitted to EPA as PMNs in the past four Federal fiscal years

– and, in addition, often have confidential chemical identities.

• For firms manufacturing , importing, or processing wit hin SNUR restrictions to avoid a Significant New Use (Option 1), quantifiable costs can range from a bout $ 425 (if the only added cost is for recordkeeping) to over $ 37 ,000 per chemical if the firm must add worker protection measures such as gloves, protective clothing, and respirators that it would not otherwise use

. Most chemicals are also subject to costs that could be significant but are not quantified in this report, su ch as restrictions on releases to water or on other aspects of use.

• For submissions to EPA (Options 2, 3, and 4), the basic one

- time submission cost is estimated at $ 6,803 , including recordkeeping for the submission

. For the SNUN (Option 3), EPA also colle cts a $2,500 fee.

• One objective of the rule is that EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that r egulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7

. Consequently, after submitting a SNUN, the firm may need to comply with restrictions as a result of the SNUN review process, possibly leading to further costs similar to those in Option 1

.

• Rarely , f irms may choose to perform toxicity and/or environmental fate testing to support a SNUN (Option 3)

. S uch testing is not mandatory

. C osts for such testing are expected to be zero for most SNUNs and expected to be l ow for the few SNUNs for which a submitter might voluntarily perform such testing.

• Companies that might have manufactured, imported, or processed a chemical in the absence of the SNUR may incur “hidden” costs, such as loss of profits from delayed or foregone sales, if they avoid the chem ical altogether (Option 5)

. These costs were not quantified.

• Companies may incur costs from more than one Option, for example if they temporarily produce in conformance with SNUR restrictions while submitting a SNUN and waiting the required 90 days plus an y extensions

. For some firms, costs may be attributable to EPA’s New Chemicals review process, but not to the SNUR itself

. For example, a firm may already be bound by a TSCA Section 5(e) Consent Order following review of its PMN, so that the SNUR based on the 5(e) order imposes no added costs for that firm

. As another example, in rulemakings where a SNUR chemical is not on the TSCA Inventory, firms that haveEcono mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### not yet submitted a PMN must submit one to EPA before commercial production/import, with or without the SNUR (see Section 2.3 , SNUR “New” Chemicals)

. If the SNUR reflects the PMN use scenario, and the PMN submitter would stick to the PMN uses even in the absence of a SNUR, then there would be no added costs for the PMN submitter attributable to the SNUR

. Also, firms may also incur worker protection, haz

- comm a nd other costs for reasons other than the SNUR, so that SNUR requirements may impose no added costs. 6

6 Earlier SNUR economic analyses calculated possible haz

- comm, worker protection, testing, and other costs for each PMN chemical ( EPA, 2007b , Tables 9, 10, D

- 4)

. The chemical

- specific tables were dropped from a later SNUR economic analysis ( EPA, 2007c )

. They reflected SNUR requirements and “recommended” testing, but were not otherwise tailored to the particular situation, and so were unreliable predictors of actual SNUR costs.Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## 3 Export Notification Costs

Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical subject to various TSCA se ctions (40 CFR §707.60 through 75)

. For TSCA 5(a)(2) (the section under which EPA promulgates significant new use rules) and certain other TSCA sections, this is a one

- time notification requirement 7 

### per destination country for each exporter of a chemical s ubstance

. After receiving a notification from a firm, EPA notifies the importing country and the United States State Department (40 CFR §707.70 )

. To calculate the burden associated with making export notifications, EPA first estimated the average annual number of export notifications made by an exporter, in Section 3.1

. EPA then derived the annual and per notification burden associated with preparin g and submitting an export notification, in Section 3.2

. 8


### EPA estimated the average burden associated with making a single notification, but did n ot estimate either the total number of exporters of a SNUR chemical or the number of notifications per SNUR chemical

. This is because the SNURs apply to a variety of different chemicals with a variety of unrelated uses, manufactures, and processors, making it impractical within the resources available for this report to assess the potential number of exporters and importing countries per chemical

. Most underlying data in this section come from t he 2012 TSCA Section 12(b) ICR, ICR No.: 0795.1 4 [Information Collection Request for] Notification of Chemical Exports

- TSCA Section 12(b) Supporting Statement for Request for OMB Review under the Paperwork Reduction Act ( EPA, 2012 ), with updating for inflation

. 

### 3.1 E stimated Number of Annual Export Notifications per Exporter

EPA ’s 20 12 TSCA Section 12(b) ICR estimated that th e average exporter making notifications will make 1 3 notifications per year

. 9 

### This includes notifications resulting from SNURs and notifications resulting from other TSCA activities

. A notification is typically no more than one page per chemical/country combination, and one notification mailing often include s multiple chemicals and/or destination countries. 10

7 On November 14, 2006, EPA revised the export notification requirement for che micals subject to TSCA §5(a)(2), 5(b), 5(e)(1) and 5(e)(2) from an annual to a one

- time requirement per destination country for each exporter (November 14, 2006, 71 FR 66234).
8 Beginning with this report ( Economic Analysis of Expedited Significant New Us e Rules for 2 5 Chemical Substances: EPA Docket OPPT

- 2009

- 0922 ) , the cost per notification is presented as well as the cost for the average submitter making export notifications.
9 EPA calculated the average number of export notifications per exporter in th e 20 12 TSCA Section 12(b) ICR ( EPA, 2012 by dividing the estimated number of submitted notifications (3, 090 ) by the estimated number of exporters ( 240).
10 Based on review by an EPA economist of notifications received under TSCA Sections 4, 5 and 6 over app roximately three weeks in early 2010.Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### The percent of notifications due to PMN SNURs is unknown , and it is also unkn own how many

n otifications may result from this rulemaking , as n ot all manufacturers may choose to export a chemical, or they may make several notifications for a single chemical.



### 3.2 Exporter Costs

The 20 12 TSCA Section 12(b) ICR ( EPA, 2012 , page 11, Table 3 ), estimated the annual export notification cost for an exporter under the one

- time export notification requirement

. These costs include the cost to the exporter of compiling a list of their products that are subject to TSCA Section 12(b) requirements, wri ting or revising an export notification letter to EPA, checking the outgoing shipments, and sending the notification letters with the associated shipping costs

. The per

- notification cost was calculated based on the average burden per firm making notifications

. Exporters making more notifications per year may benefit from economies of scale and have lower costs per notification; those making fewer notifications may have higher costs per notification.
3.2.1 Estimated Submission (Mailing) Costs
Regulated c ompanies will incur mailing costs for export notifications delivered to EPA

. Notifications are assumed shipped via the U.S. Postal Service (USPS) as first

- class registered mail with a return receipt (USPS, 201 4 )

. The estimated per

- shipment and annual maili ng costs incurred by individual submitters are detailed in Table 9

. Table 9

. Derivation of Total Mailing Cost for 1 3 Notices

P ostal Service Cost Registered mail, regular, with $0 declared value $11.95 Return receipt, requested at time of mailing (receive by mail) $2.70 Postage, regular First Class, up to 1 ounce $0.49 Cost per export notice

- Subtotal $15.14 × 13 Total Mailing Cost for 1 3 Notices $196.82 Source s : Mailing rates are from the US Postal S ervice web site as of September 2014 (https://www.usps.com/ship/service

- chart.htm). The mailing method comes from the Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements, November 2005 (EPA, 2005a), as clarified in a later SNUR economic analysis (EPA, 2007c, Table 8).


### 3.2.2 Compile and Maintain the List of Products

Since TSCA §12(b) information collection activity has been in place for over twenty years, most respondents will have already developed a list of their products subject to TSCA §12(b) export notification

. Respondents need only check for new regulations promulgated and any n ew products exported by the company

. Updating the list is estimated to take an average of one hour of technical time, which may also include some proportion of legal time ( EPA, 2012 )

. The total burden can vary from two hours per year up to two hours per month, depending on the number of products exported by the company and the number of their products subject to TSCA §12(b) ( EPA, 2012 ).Econo mic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### The number of submitters per year who report under TSCA §12(b) has varied over time, rising from around 160 in 1991 to o ver 460 in 2000, and declining since

. In the most recent TSCA §12(b) ICR, EPA estimated there would be approximately 240 submitters per year in near

- future years ( EPA, 2012 )

. Of these 240 submitters, EPA estimated that 160 companies were near the lower bur den estimate of 2 hours per year, and 80 companies were near the upper estimate of 24 hours per year

. Compiling the list for all respondents was therefore estimated to take 2,240 hours (2 hours × 

### 160 firms plus 24 hours × 

### 80 firms), or an average of about 9.3 hours of technical time per firm per year for 1 3 notifications per year (EPA, 2012 ).

3.2.3 Write or Revise Export Notification
Companies that export chemicals subject to TSCA §12(b) reporting must prepare an export notification to send to EPA when export shi pments are made

. Time for initial preparation of the export notice may vary depending on whether the company has prior experience with this requirement

. This step is estimated to take an average of one hour of technical time (which may also include some pr oportion of legal time) per firm per year f or 1 3 notifications per year ( EPA, 2012 ).
3.2.4 Check Orders and Send Notifications
Companies that export chemicals subject to TSCA §12(b) reporting must check outgoing shipments against the list of their products descr ibed above

. A form letter notifying EPA and providing the required data must be printed and mailed within the required time period

. This process is estimated to take an average one half hour of clerical time per export notification or 6 .5 hours for 1 3 notifications ( EPA, 2012 )

. The burdens and associated costs for each notification activity are provided in Table 10 below

. Table 10

. TSCA 12(b) Export Notification Cost per Notification

Technical Clerical Total $/Hr Hours 2014 $ $/Hr Hours 2014 $ 2014 $ Hours Compile list $72.22 9.3 $672

-- -- -- $672 9.3 Write letter $72.22 1 $72.22

-- -- -- $72 1 Check order and send

-- -- -- $31.26 6.5 $203 $203 6.5 Mailing cost 1

-- -- -- -- -- -- $165

- Total per facility 2` 10.3 $744 6.5 $203 $1,112 16.8 Total per Notification 0.79 $57.22 0.50 $15.63 $85.54 1.29 Notes:
1 Mailing costs reflect September 2014 USPS rates and can be found in Table 9

. 2 An average facility submitting notifications is assumed to submit 13 export notifications per year. Sourc e s : Appendix B of this report derives technical and clerical hourly labor costs. Other costs are from ICR No.: 0795.14 [Information Collection Request for] Notification of Chemical Exports

- TSCA Section 12 (b) Supporting Statement for Request for OMB Review under the Paperwork Reduction Act (EPA, 2012, p.10), a nd are updated to 2014 dollars.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## 4 Agency Costs

This SNUR is expected to generate Agency costs for both SNUN review and processing , and export notification processing

. Because it is unknown how many SNUNs and export notifications will be submitted as a result of this rulemaking, all Agency costs are estimated at the per

- case level and are not aggregated to estimate the total Agency burden

. Section 4.1 describes the burden to the Agency of reviewing and processing a single SNUN submission

. Section 4.2 derives the Agency burden of processing and reviewing export notifications.



### 4.1 SNUN Processing Costs EPA’s costs to review and process industry submissions (SNUNs, requests to modify or revoke the SNUR, and requests for equivalency determinations) are assumed to be the same as EPA costs to review PMNs and are presented in Table 11

. Costs to review and process industry submissions

– SNUNs, requests to modify a SNUR, and requests for equivalency determination

– are assumed to be similar to EPA costs to review PMNs. 11


### The list of review steps, es ti mates of staff

- year full

- time equivalents (FTEs), estimates of extramural costs, and the percent of chemicals requiring a particular review step are derived from the costs for processing PMN submissions in Table VII

- 1 of a 1994 EPA report, Regulatory Impac t Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994)

. The Agency burden associated with processing a SNUN has been adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic Reporting ( ePMN) Rule that requires the electronic submission of all TSCA section 5 notices. 12 

### The ePMN rule affects SNUN submissions and requests for equivalency determination, but not requests to modify or revoke a SNUR

. However, for simplicity, this analysis contin ues to assume that Agency per

- submission costs are the same for all three types of submissions

. Electronic submission of SNUN forms is expected to reduce Agency burden by 16.5 percent (EPA, 2009a, p.28). The GS levels used for Agency staff reflect the judg ment of Agency staff familiar with the PMN/SNUN review process

. The salary of a Full Time Equivalent EPA staff was calculated using GS

- 13 Step 5 salary data (OPM, 201 3 )

. The original PMN cost estimates were for GS 12 and were presented as low and high esti mates, based on the most junior (Step 1) and the most senior (Step 10) GS

- 12 pay rates, respectively

. However, this analysis uses the higher GS

- 13 staff level and, for simplicity, a single intermediate pay rate (Step 5) within that GS level

. A loading fact or of 1.6 was applied to the salary to reflect fringe benefits and overhead (EPA, 1992)

. The loaded salary calculations are described in Appendix B.

11 For an overview of the PMN review process, see the Chemistry Assistance Manual for Premanufacture Notification Submitters, EPA, 1997.

12 Economic Analysis of Expedited Significant New Use Rules for 2 5 Chemical Substances: EPA Docket OPPT

2009

- 092 2, was the first report to consider the burden reductions resulting from electronic submission of SNUN forms and requests for equivalency determination

. Previously , all burdens were based upon 1994 paper submi ssion estimates

.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### For each review step, the “EPA staff” cost is calculated by multiplying the number of FTEs (in the first

c olumn) by the fully loaded average salary

. This shows EPA staff cost for chemicals requiring the selected review step. The Extramural Cost column shows costs for contractor support and other outside purchases for chemicals requiring the selected review st ep, inflated from 1993 prices, as explained in Appendix B

. The Percent of Cases is a weighting factor applied to reflect the fact that not all che micals require each review step

. For example, in the PMN process, all chemicals require Administrative Prescreening, but not all chemicals require the intensive scrutiny of “Standard Review.” The three types of submissions resulting from a SNUR may have we ighting factors that differ from each other and from the weighting factors for PMNs

. Changes in weighting factors could cause actual review costs to be higher or lower than calculated here

. For example, some SNUNs require little review because they are det ermined to be “invalid”

– i.e. not required in the first place

. However, often a SNUN may take more Agency time than a typical PMN because of factors such as the need to retrieve old PMN records from archives, and the likelihood that more data requiring EP A review is submitted with a SNUN than would be submitted on average with a PMN

. Resources were not available to update the review hours to reflect the current review process or to tailor the cost estimates to SNUNs

. Therefore, for this analysis, the revie w steps and weighting factors are assumed to be the same as those derived in 1994 for PMNs. The Weighted Cost column is calculated by multiplying the Unweighted Costs (EPA staff cost plus extramural costs) by the percentage of cases requiring this review s tep

. Weighted costs are then multiplied by the burden reduction of 16.5 percent to account for burden savings generated electronic submission

. This calculation yields total Agency costs for submission review and processing shown in Table 11

.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table 11 . Agency Costs for SNUN and Other Submission Review and Processing

Re view Steps EPA staff (FTE) Cost Extramural Cost 2 Unweighted Cost Pct. of Cases Weighted Cost 3 ePMN Burden Reduction 4 Weighted Cost with ePMN

Burden Reduction FTE fraction Cost per FTE 1 FTE Total ( 201 4 $ ) 1993 $ 201 4 $
(a) (b) (c)=(a)*(b) (d) (e) (f)=(c)+(e) (g) (h)=(f)*(g) (i) (j)=(h)*(1

- (i)) Pre

- notice C onsultation 0.0024 $164,691 $395 $4.00 $7.34 $403 41% $165 0.165 $138 Administrative Prescreen/N otice R eceipt/ U ser F ee 0.0024 $164,691 $395 $92.00 $168.76 $564 100% $564 0.165 $471
CRSS (Chemical Review and Search Strategy) 0.0025 $164,691 $412 $268.00 $491.60 $903 100% $903 0.165 $754
SAT (Structure Activity Team) 0.0006 $164,691 $98.81 $14.00 $25.68 $124 100% $124 0.165 $103.95 Engineering/Exposure 0.0015 $164,691 $247 $56.00 $102.72 $350 100% $350 0.165 $292 Exposure/Fate 0.0008 $164,691 $132 $0.00 $0.00 $132 100% $132 0.165 $110 Focus 0.0009 $164,691 $148 $23.00 $42.19 $190 100% $190 0.165 $159 Standard Review Functions 0.0219 $164,691 $3,607 $511.00 $937.34 $4,544 29% $1,318 0.165 $1,100 Division Directors Meeting 0.0129 $164,691 $2,125 $113.00 $207.28 $2,332 15% $350 0.165 $292 Order Development/Negotiation Review 0.0171 $164,691 $2,816 $22.00 $40.36 $2,857 3% $85.70 0.165 $71.56 Post Order Data Review 0.0886 $164,691 $14,592 $0.00 $0.00 $14,592 3% $438 0.165 $366 Order Modification 0.2167 $164,691 $35,689 $0.00 $0.00 $35,689 3% $1,071 0.165 $894 New Chemical SNUR Development 0.0277 $164,691 $4,562 $85.00 $155.92 $4,718 7% $330 0.165 $276 Notices of Commencement 0.0012 $164,691 $198 $40.00 $73.37 $271 31% $84.01 0.165 $70.15 FOIA (Freedom of Information Act) Requests 0.0333 $164,691 $5,484 $287.00 $526.45 $6,011 1% $60.11 0.165 $50.19
CBI (Confidential Business Information) Substantiation 0.0004 $164,691 $65.88 $3.00 $5.50 $71.38 100% $71.38 0.165 $59.60

TOTAL $2,785 $73,750 $6,236 0.165 $5,207 Notes:
1 GS

- 13 Step 5 salaries loaded with benefits and overhead. See Table B

- 1 derivation.
2 Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993 prices as described in Appendix B

. 3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values shown in this table.
4 Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009a, p. 28). Sources: FTEs per review step, 1993 extramural costs, and percent of cases are from EPA, 1994 Table VII

- 1, GS

- 13 salaries are from OPM, 2013.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### 4.2 Export Notification Processing Burden Under TSCA Section 12(b), exporters must notify EPA if they intend to export chemicals sub ject to SNURs, as described in Chapter 3 above

. The Agency burden and cost due to TSCA §12(b) export notification result from three tasks

. In the first task, EPA receives export notifications from companies that i ntend to export one of the chemicals subject to TSCA §12(b) (EPA, 2012 )

. In the second task, EPA staff prepares separate notification letters that are subsequently reviewed and delivered to importing countries, their embassies, or representatives , and to the importing country’s US embassies (EPA, 2012 )

. ( S ee Table 9 for the cost of mailing one notification)

. The third task is comprise d of EPA staff res ponse s to public inquiries and other TSCA 12(b) activities

. The work of responding to non

- routine requests for information and clarification from industry and importing countries , and of handling other tasks associated with the TSCA §12(b) program , was est imated to require roughly 400 hours per year (EPA, 2012 )

. Since the current rulemaking covers only a very small percent of the chemicals subject to TSCA 12(b) reporting, a very small percent of such activity will be attributable to the current rulemaking.
Because it is unknown how many , if any, notification s EPA will receive or send as a result of the current rulemaking, the costs to the Agency are presented per activity

. 13 

### The burden for the first two A gency activit ies is provided in Table 12 below

. To estimate the Agency cost, hourly burden s are multiplied by the loaded wage rate of a GS

- 13, Step 5, which is derived in Appendix B

. Table 12

. TSCA 12(b) Export Notification Cost: Agency Burden per Activity ( 2014 $ )

Agency Activity Hours per Act ivity FTE per Activity 1 Loaded GS

- 13, Step 5 FTE Wage Rate Mailing Cost Total Agency Cost per Activity
(a) (b) = (a)/2,080 (c) (d) (e) = ((b)*(c))+(d) Process notices from companies 0.1 0.000048 $164,691 $7.92

Process notices to importing countries 0.5 0.000240 $164,691 $14.21 $53.80

Notes:
1 The burden associated with an Agency activity is the burden for the Agency to process one incoming notification, or to prepar e and mail an outgoing notification Source s : Appendix B of this report derives Agency labor costs. Mailing costs are from Table 9 of this report. Other burdens are from ICR No.: 0795.14 [Information Collection Request for] Notification of Chemical Exports

- TSCA Section 12(b) Supporting Statement for Request for OMB Review under the Paperwor k Reduction Act (EPA 2012), updated for inflation.

13 Beginning with th e report Economic Analysis of Expedited Significant New Use Rules for 2 5 Chemical Substances: EPA Docket OPPT

- 2009

- 0922 , the Agency cost per activity is presented, and not the entire Agency costs resulting from export n otifications.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## 5 Additio nal Analyses

This chapter presents additional analysis of other potential impacts of this rulemaking, as required under various statutes and executive orders.


### 5.1 Regulatory Flexibility Act (RFA) The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et. seq.), as amended by the Small Business Regulatory Enforcement Fairness Act, requires regulators to consider the impact of regulations on small entities, in particular small businesses

. The requirement to submit a SNUN applies to any person (including small o r large entities) who intends to engage in any activity described in the rule as a significant new use. Where a use is new, by definition no small or large entities presently engage in such activiti es. Although some small entities may decide to manufacture or process a substance for the new use after the SNUR is promulgated, EPA recei ves very few SNUNs, and few of those are submitted by small entities. In response to the promulgation of SNURs coverin g over 1000 chemical substances, the Agency receives only a handful of SNUNs per year. For example, the number of SNUNs was four in Federal fiscal year 2005, eight in FY2006, six in FY2007, eight in FY2008, seven in FY2009, two in 2010, and ten in 2011 (E PA, 2012), for an averag e of 6 per year from all SNURs. EPA has no reason to believe that this SNUR would alter the pattern of SNUN submissions that EPA has historically seen. In addition, the estimated reporting cost for submission of a SNUN is minimal re gardless of the size of the firm, averaging about $ 8,6 00 including SNUN recordkeeping and reporting costs. The Agency currently offers some relief to certain small businesses with sales (including those of subsidiary /parent companies) of less than $40 mill ion per year by reducing the SNUN submission fee from $2,500 to $100. This lower fee reduces the cost of submitting a SNUN to about $ 6, 800 for smaller firms. During the six year period from 2005

- 2010, only three submitters sel f

- identified as small in their SNUN submission 14 

### (EPA, 2012). EPA believes the cost of subm itting a SNUN is relativ ely small compared the cost of developing and marketing a chemical new to firm and that the requirement to submit a SNUN generally does not have a significant economic impa ct. In response to a SNUR, firms could also decide to request an equivalency determination or a request for SNUR modification or revocation. The submission cost for these requests is about $ 6, 1 00 . EPA believes this cost to be low compared to the cost of d eveloping and marketing a chemical new to the firm. The expected number of requests is also expected to be small. In general, EPA receives from zero to three modification/revocation requests per year due to SNURs, therefore it is unlikely that a substantia l number of small entities would be affected.


### 5.2 Unfunded Mandates Reform Act (UMRA) EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (Public Law 104

- 4).

14 The three “small” submitters were identified by review of actual SNUN submissions from the years 2005

- 2010.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### 5.3 Paperwork Reduction Act (PRA) According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., an agency may not conduct or sponsor, a nd 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 currently valid OMB control number

. The information collect ion requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070

- 0012 (EPA, 2007a )

. This action does not impose any additional burden requiring OMB approval

. 

### 5.4 Executive Order 12866, Regulatory Plan ning and Review
Executive Order 12866, Regulatory Planning and Review, requires OMB review for rules with an impact on the economy of $100 million or more, or with any other potential significant impact

. OMB has previously determined that these types of SN URs are not a “significant regulatory action” that would require OMB review under this Executive Order.


### 5.5 Executive Order 13132, Federalism
Executive Order 13132, Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to en sure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” This action will not have a substantial direct effect on States, on the relationship between the national governmen t and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).


### 5.6 Executive Order 12898, Environmental Justice

This acti on does not involve special considerations of environmental justice related issues as required by Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations (59 FR 7629, February 16, 1994).


### 5.7 Ex ecutive Order 13045, Protection of Children
Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 27 , 1997), requires EPA to identify and assess environmental health and safety risks that may disproportionately affect children

. This type of analysis is required for rules that will have an impact of $100 million or more only

. The impact of these SNURs will be less than $100 million and therefore no analysis of s uch impacts on children is required.


### 5.8 Executive Order 13175, Tribal Governments

Executive Order 13175 is Consultation and Coordination with Indian Tribal Governments (59 FR 22951, November 6, 2000)

. This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### 5.9 Executive Order 13211, Energy Supply, Distribution, or Use This rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## APPENDIX A: List of PMNs and their Chemical Names
Table A
- 1

. PMNs Referenced in this Economic Analysis

No

. PMN 1 Chemical Name 2 CA S RN 2

1 P

- 12

- 0069 Fatty acids compound with cyclohexanamine (generic) N/A 2 P

- 12

- 0070 Fatty acids compound with cyclohexanamine (generic) N/A 3 P

- 12

- 0169 Fluoro

- modified acrylic copolymer (generic) N/A
4 P

- 12

- 0351 Siloxanes and Silicones, alkyl, alky propoxy ethyl, methyl octyl, alkyl polyfluorooctyl (generic) N/A

5 P

- 12

- 0450 Partially fluorinated alcohol, reaction products with phosphorus oxide (P2O5), amine salts (generic) N/A

6 P

- 12

- 0451 Partially fluorinated alcohol, reaction products with phosphorus oxide (P2O5), amine salts (generic) N/A
7 P

- 12

- 0520 Fatty acids amine salt (generic) N/A 8 P

- 13

- 0292 Organophosphorus polymer (generic) N/A 9 P

- 13

- 0305 Fluorinated acid alkylester (generic) N/A 10 P

- 14

- 0563 Quaternary alkyl methyl amine ethoxylate methyl chloride (generic) N/A 11 P

- 14

- 0756 Substituted carboxamide (generic) N/A 12 P

- 14

- 0804 Phosphoric acid, sodium titanium (4+) salt (3:1:2) 22239

- 24

- 3 13 P

- 15

- 0001 Oxirane, 2

- methyl

- , polymer with oxirane, monohexadecyl ether, phosphate 73361

- 29

- 2
14 P

- 15

- 0002 Oxirane, 2

- methyl

- , polymer with oxirane, monohexadecyl ether, phosphate, sodium salt 151688

- 56

- 1

15 P

- 15

- 0003 Oxirane, 2

- methyl

- , polymer with oxirane, monohexadecyl ether, phosphate, potassium salt 1456802

- 88

- 2

16 P

- 15

- 0004 Oxirane, 2

- methyl

- , polymer with oxirane, monohexadecyl ether, phosphate, ammonium salt 1456802

- 89

- 3

17 P

- 15

- 0005 Ethanol, 2

- amino

- , compd. with 2

- methyloxirane polymer with oxirane monohexadecyl ether phosphate 1456803

- 12

- 5

18 P

- 15

- 0006 Ethanol, 2,2'2'',

- nitrilotris

- , compd. with 2

- methyloxirane polymer with oxirane monohexadecyl ether phosphate 1456803

- 14

- 7
19 P

- 15

- 0025 Nitrile amine (generic) N/A 20 P

- 15

- 0026 1,3

- Propanediamine, N1, N1

- alkyl (generic) N/A 21 P

- 15

- 0036 2

- Pyridinecarboxylic acid, 4,5,6

- trichloro

- 496849

- 77

- 5
22 P

- 15

- 0061 Imidazoliurn, polymer with cyclic anhydride and alkenoic acid, alkali salt (generic) N/A
23 P

- 15

- 0098 Hydrochlorofluorocarbon (generic) N/A 2 4 P

- 15

- 0136 Alkylalkenoic acid copolymer (generic) N/A 25 P

- 15

- 0141 D

- Glucitol, alkylamino

- N

- acyl derivs. (generic) N/A 26 P

- 15

- 0150 Cyclohexanedicarboxylic acid, dialkyl ester (generic) N/A 27 P

- 15

- 0221 Isocyanate prepolymer (generic) N/A 28 P

- 15

- 0242 Heteropolycyclic, polymer with alkanedioic acid, di

- alkenoate (generic) N/A 29 P

- 15

- 0247 Methylene diisocyanate polymer with diols and triols (generic) N/A
3 0 P

- 15

- 0278 Polymer of isophorone diisocyanate and amine

- terminated propoxylatedpolyol (generic) N/AEconomic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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No

. PMN 1 Chemical Name 2 CA S RN 2 Notes:
1 The PMN number reflects the Federal Fiscal Year and sequence of submission. For example, those starting “P

- 011” were submitted in the twelve months in Fiscal Year 2011, October 1 st 2010

– September 30, 2011.
2 If a CAS RN is identified as “N/A” meaning “Not available” and/or the chemical name is indicated to be “generic” then the chemical identity is indicated to be confidential.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## APPENDIX B: I nflators and W age R ates This appendix describes the derivation of the fully loaded labor rates and inflation factors used in calculating costs of labor, materials, and other inputs

. Costs for this report are for year

- end 2013

. 

### B.1 Derivation of Loaded Wage Rates
Unit labor costs are calculated by adding fringe benefits and overhead to the wage or salary to derive a fully loaded labor cost

. The basic method is described in Wage Rates for E conomic Analysis of the Toxics Release Inventory Program ( EPA, 2002b )

. The resulting loaded labor rates are given in Table B

- 1

. Costs are calculated f or several labor categories: Managerial, Professional/ Technical, Clerical, Production Workers, Industrial Hygienists, and EPA staff. In March 2004, BLS began using the North American Industry Classification System (NAICS) codes instead of the Standard Ind ustrial Classification (SIC) System, and the Standard Occupational Classification (SOC) system instead of the Occupational Classification System (OCS)

. The following table shows the crosswalk between old and new occupational titles.
EPAB Reports Labor Cate gory BLS Old Title (OCS) BLS New Title (SOC) Managerial Executive, administrative, and managerial Management, business, and financial

Professional/Technical Professional specialty and technical Professional and related

Clerical Administrative support, including clerical Office and administrative support

Source: Employer Costs for Employee Compensation: Changes to NAICS and SOC, Table 2

. ECEC Occupational Comparability between SOC and OCS (BLS, 2006a); and Weinstein, 2004.


### B.2 Derivation of Labor Rates for Managerial, Professional/Technical, Clerical, and Production Labor
Wages and fringe benefits for managerial, professional/technical, clerical and production labor were taken from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data, 15 

### for December, for manufacturing industries. 16

15 This follows the approach introduced in Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances: EPA Docket OPPT

- 2003

- 0063 (EPA, 2007b). In earlier PMN SNUR economic analyses, such as EPA, 2003a, wage rates for production workers came from the BLS National Employment, Hours, and Earnings, Average Hourly Earnings of Production Workers, while fringe benefit s were taken from the ECEC data. Here, as in EPA, 2007b , both wages and fringes for production workers come from ECEC data, for better consistency with the method of estimating labor costs for other labor categories.

16 Employer Costs for Employee Compensat ion Supplementary Tables December 20 14 (BLS, 2015). This follows the approach introduced in EPA, 2007b. Earlier PMN SNUR economic analyses, such as EPA, 2003a, usedEconomic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### The cost of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same ECEC series

. Fringe benefits as a percent of wages are calculated separately for each labor category

. For example, for December 201 4 , the average wage rate for professional/technical 17 

### labor was $42.19 ; the average fringe benefit was $ 22.86

. Fringe benefits as a percent of wages were $ 22.86 / $42.19
, or approximately 54.18%

. An additional loading factor of 17 percent is applied to wages to account for overhead

. This approach is used for consistency with Office of Pollution Prevention and Toxics economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the T oxics Release Inventory Program ( EPA, 2002b ), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report ( EPA, 2002a )

. This overhead loading factor is added to the benefits loading factor, and the total is then applied to the bas e wage to derive the fully loaded wage

. For example, the December 201 4 fully loaded wage for professional/technical labor is $42.19 × (1 + 0. 5418 + 0.17) = $ $72.22

. Fully loaded costs for managerial, clerical, and production labor are calculated in a simila r manner, as shown in Table B

- 1

. 

### B.3 Derivation of Labor Rates for Industrial Hygienists
For industrial hygienists, wages were based on another BLS data se ries, Occupational Employment Statistics [OES], National Industry

- Specific Occupational Employment and Wage Estimates

. OES data were used because ECEC data were not available for very specific occupations

. However, the OES data covers only wages, not fring e benefits

. Therefore, the Industrial Hygienist fringe benefits continue to be based on ECEC data. 18


### The wage rate for Industrial Hygienists is a weighted average of the hourly mean wage for Occupational Health and Safety Specialists, Standard Occupational Classification (SOC) 29

- 9011, and Occupational Health and Safety Technicians, SOC 29

- 9012, in Manufacturing

. The wage rate for each occupation was weighted by employment for the occupation

. The North American Industry Classification System (NAICS) codes for Manufacturing are 31, 32, and 33 (BLS, 2005)

. The calculations are shown in Table B

- 2

.

ECEC data for “All Goods Producing” sectors (manufacturing, mining, and construction). Howe ver, the manufacturing sector data seem more relevant since the SNURs mainly affect the chemicals industry.

17 This follows terminology introduced in EPA, 2007b. Earlier SNUR economic analyses used the term “technical” labor. Here the category is called “pr ofessional/technical” labor, to make clear how it relates to BLS categories. In 2004, BLS changed from the Occupational Classification System, OCS, to the Standard Occupational Classification system, SOC. In the process, the “Professional specialty and tec hnical” category became the “Professional and related” category. However, the coverage of the old and new occupational groups is approximately the same. See the BLS article, C omparing Current and Former Industry and Occupation ECEC Series (Weinstein, 2004 ).

18 This follows the approach for calculating Industry Hygienist wages introduced in EPA, 2007b and is a change from the method used in earlier PMN SNUR economic reports such as EPA, 2003a, which used data from a 1997 professional journal salary survey.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### As with other labor categories, the fringe benefits factor c ame from the BLS Employer Costs for Employee Compensation Supplementary Tables December 201 4 (BLS, 201 5a )

. Benefits for “professional specialty and technical” occupations were used, and loaded wages were calculated as for other types of labor

. An additiona l loading factor of 17 percent of wages was applied for overhead

. Calculations are shown in Table B

- 1

. 

### B.4 Derivation of Labor Rates for EPA Staff
Agency l abor costs are calculated based on annual Federal salaries for the Washington

- Baltimore area published by the Office of Personnel Management effective January 201 4 (OPM, 201 4 )

. The average salary for one Full Time Equivalent (FTE) staff is estimated as the salary for a GS

- 13 Step 5 employee. 19


### Multiplying the annual pay by an assumed loading factor of 1.6 to reflect Federal fringe benefits and overhead, the loaded annual salary of EPA staff was calculated to be $ 164 , 691

. The Agency loading factor is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) ( EPA, 1992 , page 30, footnote 9)

. The 60 percent assumption was labeled “the benefits multiplication factor” in the EPA Guide, but has been used in many EPA Office of Pollution Pr evention and Toxics ICRs to reflect both fringe benefits and overhead for Federal staff

. For example, it was used in an August 2000 document supporting ICR No. 1139.06 (EPA, 2000) , with the following explanation:

“The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits multiplication factor)

. The multiplication factor used is recommended in EPA's Office of Policy, Planning, and Evaluation's Instructions for Preparing Information Collection Requests (ICRs) (June 1, 1992)

. An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Ko ch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits but also overhead.” ( EPA, 2000 )

19 The GS

- 13 Step 5 is consistent with ICR No. 0574.14 (12/18/2007) (EPA, 2007a), which covers PMN SNURs. Use of this grade level follows the approach introduced in EPA, 2007b. That report represented a change from an earlier PMN SNUR economic analysis (EPA, 2003a), which used an average of GS

- 12 Step 1 and GS

- 12 Step 10 salaries.`

September 9, 2015 B
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### Table B
- 1

. Derivation of Loaded Wage Rates

EPAB Labor Category Data Sources Date Wage Fringe Benefit Fringes as % wage Over

head %

wage 2 Fringe + O verhead

F actor Loaded Wages 1
(a) (b) (c) =(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a) x (e)
Managerial BLS ECEC , Private Manufacturing industries
, “Mgt, Business, and Financial” 3 Dec

- 14 $47.90 $24.18 50.48% 17% 1.67 $80.22

Professional/ Technical BLS ECEC , Private Manufacturing industries, “Professional and related“ 3 Dec

- 14 $42.19 $22.86 54.18% 17% 1.71 $72.22

Clerical BLS ECEC , Private Manufacturing industries, “Office and Administrative Support” 3 Dec

- 14 $18.68 $9.40 50.32% 17% 1.67 $31.26

Production Worker BLS ECEC , Private Manufacturing industries, “Production, transport, and material moving.” 3 Dec

- 14 $17.81 $9.69 54.41% 17% 1.71 $30.53

Industrial Hygienist Wage : BLS OES Occupat . Employ. and Wages, for Manufacturing (NAICS 31, 32, 33), average of wages for Occup. Health/ Safety Specialists (SOC 29

- 9011) and Occup. Health/Safety Technicians (SOC 29

- 9012), weighted by employment. 4 Fringes: BLS ECEC , Private Manufacturing industries, “Professional and related” 3 Wag e: May

- 14

Fringe: Dec

- 14 $32.72

-- 54.18% 17% 1.71 $56.01

EPA staff FTE Annual Federal staff cost: OPM Washington

Baltimore

- Northern Virginia, DC

- MD

- PA

- VA

WV, area, GS

- 13 Step 5 pay rates, with 60% overhead. 5 Jan

- 1 4 $ 102,932 (annual) -- [Included in 60% overhead] 60% 1.6 $ 164 , 691 (annual)

Notes:
1 Wage data are rounded to the closest pennies in this table; however, in calculations using these numbers for this report, unr ounded values were used.
2 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). 3 Employer Co sts for Employee Compensation Supplementary Tables Historical Data December 2006

– June 2014 , US Bureau of Labor Statistics, September 10 , 2014 (BLS, 201 5 a ).
4 Employment and unweighted wages are from BLS Occupational Employment Statistics (National Indust ry
- Specific Employment and Wage Estimates), May 201 4 (BLS, 2014).
5 The salary is unloaded Federal GS

- 13 Step 5 salary for calendar 201 4 , from the Office of Personnel Management salary table for Washington

- Baltimore

- Northern Virginia (OPM, 201 4 ). The 60% fringes

- and

- overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9).Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table B
- 2

. Derivation of Industrial Hygienist Wage Rate ( NAICS 31, 32, 33)

Occupation Title (SOC C ode) Employment Mean H ourly W age Weight Weighted Wage 1 (a) (b) (c) (d) = (c) × (b) Occupational Health & Safety Specialists (29

- 9011) 11,220 $34.52 0.826 $28.50

Occupational Health & Safety Technicians (29

- 9012) 2,370 $24.18 0.174 $4.22

Industrial Hygienist (weighted average) 13,590

-- 1 $32.72

Notes:
1 Wage data are rounded to the closest pennies in this table; however, in calculations using these numbers for this report, unr ounded values were used. Sources : Employment and unweighted wages are for manufacturing (NAICS 31, 32, 33) from BLS Occupational Employment Statistics (Occupational Employment and Wages) , for May 201 4 (BLS, 201 4 ).


### B.5 Derivation of Inflation Factors
Costs of equipment and supplies were inflated using the Consumer Price Index

– All Urban Consumers; wages were inflated using the appropriate Employment Cost Index (ECI)

. Where both labor and equipment/supplies were involved, we used the inflation factor corresponding to the dominant cost category

. 20 

### For example, test costs include a mix of labor, equipment, and supplies

. Assuming that the largest component of test costs comes from labor, we used the ECI for private industry, all workers

. Complete information on the derivation of the inflation factors used is given in Table B

- 3 below. In 2006, the Bureau of Labor Statistics (BLS) made several changes to the Employment Cost Index

. The changes are described on a BLS web page, “Change has come to the ECI,” (BLS, 2006c) and in several April 2006 Monthly Labor Review articles posted on the BLS web site: “Changes affecting the Employment Cost Index: an overview” (Caroll 2006); “Employment Cost Index P ublication P lans” (Sleemi, 2006); and “ Seasonal adjustment in the ECI and the conversion to NAICS and SOC” (Branch, 2006).

20 Prior SNUR economic analyses used the seasonally adjusted E CI for the total compensation , private industry white collar workers (Series ID CIS2010000W00000I) to inflate export not ification and Agency extramural cost

. However, in 2008 B LS retired both the “white

- collar” and “blue

- collar” series (BLS, 2008, p. BLS

- 45) . T herefore , beginning with th e report , Economic Analysis of Expedited Significant New Use Rules for 2 5 Chemical Subst ances: EPA Docket OPPT

- 2009

- 092 2 , the “white

- collar” series was replaced with the not seasonally adjusted E CI for total compensation of private industry professional and related workers (Series ID CIU2010000120000I ). The

“ professional and related workers ” series was chosen because it is the only series with continuous data since 1985 , and the majority of export notification and Agency extramural activities are performed by professional and technical labor.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Under a mandate from OMB, BLS changed its classification of industries and occupations from the Standard Industrial Classification (SIC) and Occupational Classification Sys tem (OCS) to the North American Industry Classification System (NAICS) and Standard Occupational Classification (SOC) system

. In 2006, BLS adjusted all ECI series to reflect this change

. In addition to changing the industry and occupational classification systems, in 2006, BLS rebased the ECI from June 1989 = 100 to December 2005 = 100 for all current and historical non

- seasonally adjusted series, including the NAICS and SIC based series

. (Seasonally adjusted indices, including those in Table B

- 3 of this r eport, may not exactly equal 100 for December 2005 as a result of the seasonal adjustment

. Seasonal adjustments are explained in Branch, 2006.) According to BLS, the official ECI for the years 1975

- 2005 is the SIC

- OCS based series, and for subsequent yea rs, the official ECI is the NAICS

- SOC based series (Sleemi, 2006, p.8). 21


### “Starting year” indices in Table B

- 3 continue to be SIC

- SOC based

. Current y ear indices are NAICS

- SOC based

. We use indices from both the NAICS

- SOC and the SIC

- OCS based ECI series because neither series spans the entire period over which testing and other costs need to be inflated

.

21 BLS has been publishing the NAICS

- SOC based ECI series since March 2001 and it became official in March 2006. The SIC

OCS based series and NAICS

- SOC series have different series ID numbers, even when they describe essentially the same population. For example the series ID for seasonally adjusted total compensation for all private industry workers is ECS10002I for the SIC

- OCS series and CIS2010000000000I for the NAICS

- SOC series



### .Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table B
- 3

. Derivation of Inflation Factors

Item Inflation I ndex S ource 1 Starting Y ear Index for S tarting

Y ear

(a) Index for 201 4

(b) Inflation F actor (b)/(a) 2

Chemical testing (toxicity, ecological effects etc.) BLS ECI, SA, Total comp, Private industry, All Workers, 4 th Q [BLS 2006d and 201 5 c] varies varies 122.3 varies

White collar/other labor mix; equipment; supplies. Example for item costed in 1993 1993 66.5 122.3 1.839
Tests were first costed out in various years, depending on the test; inflation factors vary depending original cost date. Example for test costed in 2000 2000 83.8 122.3 1.459

Impermeability testing of gloves and other gear 3 BLS ECI, SA, Total comp, Private industry, All Workers, 4 th Q [BLS 2006d and 201 5 c] 1997 74.9 122.3 1.633

Export notification BLS ECI, ,Total comp, Private industry, Professional and related, 4 th Q [BLS 201 5 d ] 4 1992 64.9 122.9 1.894

Agency Extramural costs White collar labor; equipment; supplies BLS ECI, Total comp, Private industry, Professional and related, 4 th Q [BLS 201 5 d ] 4 1993 67.0 122.9 1.834

Labels, placards, gloves, eyewear, clothing, respirators, file cabinet BLS CPI, All urban consumers, not SA. CUUR0000SA0, Annual [BLS 201 5 b ] 1997 160.5 236.736 1.475

Photocopies Record keeping materials BLS CPI, All urban consumers, not SA. CUUR0000SA0, Annual [BLS 201 5 b ] 1988 118.3 236.736 2.001

Notes:
1 In 2006, Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) series “were rebased to December 2005 = 100 from June 1 989 = 100.” The change is reflected in the indices in this table and explained on the BLS website, Employment Cost Index News Rele ase Text: Employment Cost Index, March 2006 (BLS, 2006b). The Consumer Price Index (CPI) was not rebased. “Starting year” ECI indices are SIC

- OCS based: Seasonally Adjusted (SA) ECS10002I for private industry All Workers, and not SA ECU11122I for private industry Professional and Related Workers. After 2006, ECI indices are NAICS

- SOC based: Seasonally Adjusted (SA) CIS2010000000000I for private industry All Workers, and not SA CIU2010000120000I (B) for private industry Professional, and Related workers.
2 Inflation factors are rounded to three decimal places in this table, but calculations in this report use the unrounded values . BLS CPI values were published with one decimal place through 2006 and with three decimal places after that.
3 We began using t he ECI for Private Industry All Workers in EPA, 2007b, to better reflect the labor mix for impermeability testing. Earlier PMN SNUR economic analyses used the ECI for Private Industry White Collar Workers.
4 Beginning with the report, Economic Analysis of Expedited Significant New Use Rules for 25 Chemical Substances: EPA Docket OPPT

2009

- 0922 , we began to use the not

- seasonally adjusted CIU2010000120000I for private industry Professional, and Related workers, instead of S A CIS2010000W00000I for private industry white collar workers because BLS retired the “white

- collar” series.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## APPENDIX C: C osts of H azard C ommunication , P rotection in the W orkplace , and Recordkeeping R equirements

Section 2.1 of the main text of this report discusses costs of worker protection, hazard communication (haz

comm), and recordkeeping for SNURs

. This appendix presents dollar costs and labor hours of thes e requirements, for one chemical at one site

. Some requirements listed here may not be cited in the current rulemaking, but have been cited in past SNUR rulemakings.

The haz

- comm costs reflect the annual costs of updating the written program, labeling for chemical distribution and storage, creating and distributing material safety data sheets (MSDS), and employee training

. The personal protective equipment (PPE) costs reflect the annualized costs of providing required equipment (i.e., gloves, goggles, clot hing, or respirators), assessing dermal protection needs associated with the chemical, and performing required impermeability testing, and/or evaluating manufacturer’s information

. Finally, the annual recordkeeping costs include labor, photocopying, and re cord storage costs.

To estimate the costs of haz

- comm, worker protection, and recordkeeping requirements, a number of assumptions were made, based on the original EPA analysis for generic SNUR provisions, Economic Analysis of Final Significant New Use Rule : General Provisions for New Chemical Followup ( EPA, 1989 )

. In that report, EPA estimated that the number of workers exposed to any one substance would range from 10 to 25, and that a worker potentially would be exposed to a substance for a minimum of 50 days per year to a maximum of 250 days per year

. The current analysis uses the high ends of those two ranges

. Thus, each site is assumed to have 25 chemically

- exposed workers requiring training and/or protective equipment, with each of them assumed to be e xposed for 250 days per year.

Labor costs are derived from the United States Bureau of Labor Statistics sources as described in Appendix B

. Material costs were primarily obtained from a national industrial equipment supply website ( Grainger, 2014

. Costs of haz

- comm, workplace protection, and recordkeeping are discussed in Sections C.1 , C.2 , and C.3 , respectively

. Table 4 and Table 6 in the main text summarize these costs by SNUR requirement.


### C.1 Modifying the Hazard Communication Program

As mentioned in Section 2.1 , it is assumed that each facility has in place a haz

- comm program consistent with that required by OSHA’s Hazard Communication standard (29 CFR 1910; November 25, 1983), so that costs attributable to the SNU R are costs of adding one chemical to the program

. Much of the haz

- comm methodology and assumptions came from the EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Followup ( EPA, 1989 ), which in turn reli ed partly on the 1983 OSHA study, Final Regulatory Impact and Regulatory Flexibility Analyses of the Hazard Communication Standard OSHA, 1983).

It was assumed that the haz

- comm costs would be incurred each year

. For example, there would be worker turnover and need for refresher training, the MSDS would need revision due to changing information, placards would wear out ( EPA, 1989 )

. To the extent that some steps would not need repeating each year,Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### costs could be lower than estimated here

. The hazard communica tion costs summarized in Table 3 above are detailed here.

C.1.1 Updating the Written Program

If the SNUR cites 40 CFR §721.72(a), then to avoid engaging in a Significant New Use, which would trigger other SNUR requirements, manufacturers must update their written haz

- comm program to incorporate information about the chemical

. The written part of the program includes data and information about hazardous chemic als present in the workplace, the hazards associated with such chemicals, procedures for employees who routinely work with or around such chemicals, procedures for non

- routine tasks that may involve exposure (e.g., tank cleaning), and personal protective e quipment requirements when working with or around such chemicals. While material safety data sheets may provide much of the information needed to update the written haz

comm program, many employers may perform a more detailed assessment of exposure risks a ssociated with the chemical and develop more site

- specific procedures for workers potentially exposed to such chemicals

. For purposes of the economic analysis, EPA assumes that each employer will engage the services of a professional industrial hygienist ( IH), either in

- house or on a consulting basis, for four hours to perform such an assessment

. Loaded hourly rates for IH services were calculated based on Bureau of Labor Statistics data, as described in Table B

- 1 and Table B

- 2

. Costs for the written haz

- comm program , in 201 4 dollars, are as follows 22


### 4 hours Industrial Hygienist time × $56.01 per hour = $ 224
The estimates of IH hours to update the program come from a 1998 EPA report ( EPA, 1998 ).

C.1.2 Labeling
If the SNUR cites 40 CFR §721.72(b), then to avoid engaging in a Significant New Use, manufacturers must ensure that containers used to distribute the PMN substance in commerce are labeled with the necessary hazardou s substance warnings and procedures

. In addition, containers used in the workplace must bear similar labels or, alternatively, the employer must provide equivalent signage, operating procedures, or other written material to communicate hazard information t o workers

. The cost of providing such labeling was estimated in a 1989 EPA report ( EPA, 1989 ) and has been updated here using more recent cost information. Standard formats are assumed to be used for creating labels or other signage, and the information re quired for the labels is assumed to be already available from the MSDS for the chemical (see below).

Chemicals Distributed in Commerce

. For chemicals distributed in commerce, the labeling process is assumed to require 0.5 hours of technical labor time per chemical to compile label information

. It is assumed to require 480 labels per chemical

. The assumption of 480 labels per chemical is from a 1989 EPA report ( EPA, 1989 ), and is based on the assumption that, on average, each chemical is shipped twice monthl y to 20

22 Figures presented here are rounded.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### customers

. This is consistent with roughly 10,000 kilograms of chemical per year shipped in 40 five

- gallon containers per month ( EPA, 1989 ). 23


### Technical labor is fully loaded with fringe benefits and overhead, as described in Appendix B

. Labeling materials costs were obtained from a national safety equipment supply website ( Grainger , 2014 )

. The resulting costs of labeling for chemicals distrib uted in commerce, per chemical substance at one site, are shown in Table C

- 1

. Table C
- 1 . Annual Costs of Labeling for Distr ibution in Commerce [40 CFR §721.72(b)(2)]

Cost Element Unit Cost ( 2014 $ ) Inflation Factor Unit Cost ( 2014 $ ) Hours Total Cost
0.5 hours technical time

-- -- $72.22 per hour 0.5 $36.11

480 labels $0.22 per label 1.000 $0.22 per label

-- $10 6

TOTAL 0.5 $142
Notes: Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B ), so results may differ from calculations using the rounded values shown in this table. Sources: Label cost, Grainger, 2014 ; cost elements, quantities, RIB 1989; inflators, labor, Table B

- 1 and Table B

- 3

.



### Chemicals Used in the Workplace

. Costs for w orkplace labeling requirements are estimated by assuming that the facility purchases six large signs, priced at $ 54.30 each in 2014 dollars ( Grainger , 2014 )

. These signs will be mounted in areas where the chemicals are used or formula ted

. For example, a placard might be posted at each of six vessels: a mixing tank, a reactor, two separators, and two storage vessels ( EPA, 1989 )

. The labeling process is also assumed to require 0.5 hours of technical time to compile label information and ten minutes of production worker time to post each placard

. Technical labor costs include wages, fringe benefits, and overhead, as described in Appendix B

. The resulting per chemical, per site costs of labeling for chemicals in the workplace are shown in Table C

- 2

.

23 Data on PMN notices suggest that some PMN submitters expected to produce less than 10,000 kilograms per year of the SNUR chemicals, but many expected to produce much more. It is not known whether volumes listed in the PMNs were realized in practice. Production volumes of secondary suppliers affected by the SNUR are also unknown. Annual v olumes significantly greater than 10,000 kg could lead to higher haz

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### Table C
- 2

. Annual Costs of Labeling for Use in Workplace [40 CFR §721.72(b)(1)]

Cost Element Unit Cost ( 2014 $) Inflation Factor Unit Cost ( 201 4 $ ) Hours Total Cost

0.5 hours technical time

-- -- $72.22 per hour 0.5 $36.11

6 labels or placards $54.30 per item 1 $54.30 per item

-- $326 10 minutes per label/placard

production worker time -- -- $30.53 per hour 1.0 $30.53

TOTAL 1.5 $392
Note s : Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B ), so results may differ from calculations using the rounded values shown in this table. Sources: P lacard cost, Grainger 2014 ; cost elements and quantities, EPA, 1989; inflators and labor unit costs, Table B

- 1 and Table B

- 3

. 

### C.1.3 Preparing Material Safety Data Sheet (MSDS) Information
If the SNUR cites 40 CFR §721.72(c), then to avoid engaging in a Significant New Use, each facility is required to create, post, and distribute material safety data sheets (MSDSs)

. Based on estimates in OSHA 1983, the 1989 EPA report ( EPA, 1989 ) has estimated that creation of an MSDS for a chemical substance requires 2.0 hours of technical labor time and 0.25 hours of clerical time

. Further, EPA assumes that the manufacturer provides 20 copies of the MSDS to customers and retains 20 copies for use onsite, for a total of 40 copies ( EPA, 1989 )

. The loaded hourly wage rates and the inflator used in estimating unit photocopy costs are derived in Appendix B

. The resulting cost of MSDS preparation is shown in Table C

- 3

. Table C
- 3 . Annual Costs for Material Safety Data Sheets (MSDSs) [40 CFR §721.72(c)]

Cost Element Unit Cost (1988 $ ) Inflation Factor Unit Cost ( 201 4 $ ) Hours Total Cost

2.0 hours technical time

-- -- $72.22 per hour 2 $144

0.25 hours clerical time

-- -- $31.26 per hour 0.25 $7.81 40 copies $0.05 2.001 $0.10 per copy

-- $4.00
TOTAL 2.25 $156
Note: Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B ), so results may differ from calculations using t he rounded values shown in this table. Sources: Cost elements, quantities, and 1988 copy cost, RIB 1989; inflators and labor unit costs, Table B

- 1 and Table B

- 3

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### C.1.4 Employee Training
The final required component of the haz

- comm program is employee training, based on 40 CFR §721.72(d)

. The 1989 EPA report, Economic Analysis of Final Significant New U se Rules: General Provisions for New Chemical Follow

- up ( EPA, 1989 ), assumes that a training program currently is in place, but the existing program must be modified to add new information pertaining to the PMN substance

. Subsequently, the training program must be expanded to include such material each time the training course is presented

. Costs of modifying the program and presenting the modified program are mainly labor costs for the trainer and the trainees. Inserting the new information about the PMN s ubstance into the training program and conducting the revised training is assumed to require 0.5 hours of the trainer’s time

. An additional 0.25 hours per trainee is estimated to be required, and an average of 25 affected workers is assumed per facility ( E PA, 1989 )

. If additional production workers needed to be trained, for example because they might come into contact with the chemical due to spills or leaks, training costs could be higher than estimated here ( EPA, 1989 ). Labor rates for training are based on the loaded rates derived in Appendix B for chemical technicians and chemical industry production workers

. The total cost of the employee training requirement is shown in Table C

- 4

. Table C
- 4

. Annual Costs for Employee Training, Per Chemical [40 CFR §721.72(d)]

Cost Element Unit Cost ( 201 4 $ ) Hours Total Cost
0.5 hours technical time (trainer) $72.22 per hour 0.5 $36.11 0.25 hours per production employee X average of 25 workers per plant = 6.25 hours $30.53 per hour 6.25 $191
TOTAL 6.75 $227
Note s : Total costs were calculated using unrounded values from (see Appendix B ), so results may differ from calculations using the rounded values shown in this table. Source s : Cost elements and quantities, EPA, 1989 ; labor unit costs, Table B

- 1


### C.2 Protection in the Workplace
The following section estimates costs of assessing needs for dermal protection and evaluating protective gear for impermeability, as well as the costs of gloves, goggles, protective clothing, and respirators.

C.2.1 Dermal Protection Selection
If the SNUR cites 40 CFR §721.63(a)(1), then to avoid engaging in a Significant New Use, the employer must ensure that each person who is likely to experience dermal exposure to a PMN chemical, must be provided with and is required to wear personal protective equipment (e.g., gloves) that will prevent dermal exposure to the substance

. The equipment must be selected and used in accordance with 29 CFR § § 1910.132 and 1910.133 (promulgated by the Occupational Safety and Health Administration, OSHA)

. TheEconomic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### selection and administration of this dermal protection is estimated to require 10 hours labor by an industr ial hygienist, annually ( EPA, 1999 )

. The wage rate of the hygienist was calculated as described in Appendix B

. The cost calculations for the dermal protection selection requirement are given in Table C

- 5

. This covers only costs of selecting the dermal protection needed, not costs of the items the mselves

. For costs of purchasing dermal protective items, see the sections below on costs of gloves, eyewear, and clothing.
Table C
- 5 . Annual Costs for Dermal Protection Selection [40 CFR §721.63(a)(1)]

Cost Element Unit Cost ( 20 1 4 $ ) Hours Total Cost 1

10 hours industrial hygienist (IH) time $ 56.01 

### per hour 10 $ 560
Notes: Total costs were calculated using unrounded values (see Appendix B ), so results may differ from calculations using the rounded values shown in this table. Source s : Labor rates, Table B

- 1 ; cost elements and quantities, EPA, 1999.


### C.2.2 Impermeability Testing
As part of the workplace protection requirements specified under 40 CFR §721.63(a)(3), to avoid engaging in a Significant New Use, the SNUR may require that employers demonstrate that each item of protective equipment provided (e.g., gloves) provides an impervious barrier, to protect employees from dermal exposure

. Requirements outlined in §721.63(a)(3) are provided in two parts, §721 .63(a)(3)(i) and (ii )

. The employer may use a combination of (i) testing and/or (ii) evaluating manufacturer specifications

. The following discussion is based on the Economic Analysis of Expedited Significant New Use Rules for 168 Chemical Substances and Background Support Do cument for Economic Analysis of Significant New Use Rules ( EPA, 1998 ) and assumes that the manufacturer uses both testing and evaluation of manufacturer specifications

. The analysis assumes that costs are incurred annually. The first step, described at 40 CFR §721.63(a)(3)(i), is to perform actual impermeability testing

. To determine the costs of impermeability testing compliance, Best Manufacturing Company, a leading manufacturer and tester of chemical resistant articles, was consulted (Best, 1997).

As des cribed in EPA, 1998 , Best used one of two methodologies for impermeability testing

. In the first method, chemical samples were submitted to Best with a specific article to be tested for impermeability

. This method was cheaper, costing $200 (1997 dollars) p er chemical, but the burden of finding an appropriate article of protection lay with the chemical manufacturer

. In the second method, the chemical manufacturer simply submitted chemical samples to Best, who in turn determined the most appropriate product, even if a competitor manufactured the product

. This method was more costly at $800 (1997 dollars) per chemical

. The second method of impermeability testing is favored in this analysis for several reasons

. First, the burden of finding and submitting an arti cle of protection is shifted from the chemical manufacturer to the testing company, who would have greater experience in Personal Protective Equipment (PPE) selection

. Second, should the article submitted fail the impermeability test, other articles may ha ve to be submitted until satisfactory test results are obtained

. Furthermore, substances subject to SNURs may include new and/or rare chemicals, which may have undiscovered or unknown properties

. This uncertainty may impede chemicalEconomic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### manufacturers’ ability to effectively submit appropriate PPE articles for testing

. Finally, the first method is essentially a pass

- fail test

. If an article passes the impermeability test, then it is acceptable

. In the second method, several articles may be tested and compared, a nd, while one or more acceptable articles may result, the most impermeable article is always determined for the chemical

. To obtain the best article rather than merely a satisfactory article of protection, the second method of testing is more appropriate

. For these reasons, unit costs of $800 per chemical (1997 dollars) are assumed for impermeability testing

. The cost of the impermeability testing is assumed to be driven by labor costs of the company performing the testing, thus test costs were inflated wit h an Employment Cost Index as described in Appendix B

. The administration of this test would also require two hours of industrial hygienist labor ( EPA, 1999 ). The second step to compliance with the workplace protection requirements at §721.63 (a)(3)(ii) is the evaluation of specifications from the manufacturer or supplier of the protective equipment

. This requirement helps ensure that the protective equipment will be impervious to the PMN chemical(s)

. The evaluation of manufacturer specifications requires an estimated four hours of industrial hygienist labor. Annual costs of the impermeability testing requirements are presented in Table C

- 6

. Table C
- 6

. Annual Costs of Impermeability Testing [40 CFR §721.63(a )(3)]

Cost Element Unit Cost (1997 $ ) Inflation Factor Unit Cost ( 201 4 $ ) Hours Total Cost 1
Impermeability Testing [§721.63(a)(3)(i)] Impermeability Test $800 per chemical 1. 63 3 $1, 307 per chemical $1, 30 6 Industrial Hygienist time $ 56.01 per hour 2 $1 12 Subtotal 2 $1, 41 8
Evaluation of Manufacturer ’ s Specifications [§721.63(a)(3)(ii)]

Industrial Hygienist time $5 6.01 per hour 4 $ 2 24 Subtotal 4 $ 2 24
TOTAL 6 $ 1,64 7 Note:
1 Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B ), so results may differ from calculations using the rounded values shown in this table. Sources: 1997 costs, Best, 1997; cost elements and quantities, EPA, 1998 and EPA, 1999; inflators and labor rates, Table B

- 1 through Table B

- 3

. 

### C.2.3 Gloves
If the SNUR cites 40 CFR §721.63(a)(2)(i), then gloves must be worn to avoid engaging in a Significant New Use

. Gloves may also be acquired as a result of the dermal protection selection at §721.63 (a)( 1)

. If standard, disposable medical

- grade gloves are used, they are assumed to be worn and discarded by the worker following each day of exposure

. Each site is assumed to have 25 workers, each of them exposed 25 0 days per year

. This reflects the high

- side assumptions in EPA, 1989 (page 25) for the number of workers and exposure days

. Each pair was estimated to cost $0. 4 4 in 2014 ( Grainger, 2014 )

. Total annual costs of providing disposable gloves are developed by applying the assumptions above regarding the number ofEconomic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### workers exposed (25 per site) and frequency of replacement (one pair per worker per day of exposure H 250 days of exposure per year)

. For some chemicals, heavy

- duty gloves may be used

. They are general ly not disposed of daily, but are more expensive

. The estimated costs of gloves purchased in compliance with SNUR Personal Protective Equipment requirements are presented below in Table C

- 7

. The cost estimates for each chemical assume that the more expensive heavy

- duty gloves are used in cases where the SNUR explicitly requires gloves.
Table C
- 7

. Annual Cost of Gloves [40 CFR § 721.63(a)(2)(i)]

Cost Element Unit Cost ( 2014 $ per pair) Inflation Factor Unit Cost ( 2014 $ per pair) Number of Pairs Required 1 Total Cost ( 201 4 $ ) 2
Disposable nitrile gloves (replaced daily) $0.44 1.000 $0.44 $6,250 $2,761
Heavy duty butyl gloves (replaced every 25 work days) $70.73 1.000 $70.73 $250 $17,683

Notes : 1 The analysis assumes that 25 workers who are exposed 250 days/year replace disposable gloves daily and replace heavy duty gloves every 25 work days.
2 Total costs were calculated using unrounded unit cost values and inflation factors ( Table B

- 3 ), so results may differ from calculations using the rou nded values shown in this table. Sources : I tem costs, Grainger, 2014 ; item type and quantity, EPA, 1998; inflator, Table B

- 3

. 

### C.2.4 Eyewear
If the SNUR cites 40 CFR §721.63(a)(2)(iii), then to avoid engaging in a Significant New Use, employer must provide eye protection

. Eye protection may also be acquired as a result o f the dermal protection selection at §721.63 (a)( 1)

. Protective goggles are expected to be used at a rate of one set per worker and replaced every four months

. Each site is assumed to have 25 workers, each of them exposed 250 days per year

. The SNUR may n ot specify the exact type of eyewear required

. OSHA guidelines in 29 CFR § 1910.133 (b)( 1), however, state that protective eye and face devices purchased after July 5, 1994 shall comply with ANSI Z87.1

- 1989

. To determine the cost of goggles that meet this standard, EPA consulted with eyewear specialists at equipment supplier LSS

. A standard pair of goggles that meets the ANSI Z87.1

- 1989 specification was priced at $ 8.73 per pair in 2014 ( Grainger, 2014 ; RIB, 1998)

. A price estimate for a heavy

duty pair of goggles compliant with the ANSI standard is also included in Table C

- 8

. The cost estimates for each chemical assume that the more expensive heavy

- duty goggles are used in cases where the SNUR explicitly requires goggles

. Costs of protective eyewear were inflated as described in Appendix B and are presented in Table C

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### Table C
- 8

. Annual Cost of Protective Eyewear [40 CF R §721.63(a)(2)(iii)]

Cost Element Unit Cost ( 2014 $ per pair) Inflation Factor Unit Cost ( 201 4 $ per pair) Number of Pairs Required 1 Total Cost ( 201 4 $ ) 2
Standard Goggles $8.73 1.000 $8.73 75 $655 Heavy duty chemical

- splash/impact goggles $11.95 1.000 $11.95 75 $896

Notes : 1 The analysis assumes 25 workers replacing goggles three times per year.
2 Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B ), so results may differ from calculations using the rounded values shown in this table. Sources: I tem costs, Grainger, 2014 ; item type and quantity, EPA, 1998; inflator, Table B

- 3

. 

### C.2.5 Clothing
Costs for a standard coverall clothing set, estimated at $36.25 in 1997 (LSS, 1997), were inflated as described in Appendix B and are shown in Table C

- 9 below

. Costs for full

- body protective clothing are based on the coverall clothing set w ith a hood (LSS, 1997) as shown in Table C

- 9

. If the SNUR cites 40 CFR §721.63(a)(2)(ii) or (iv), then to avoid engaging in a Significant New Use, emp loyers must provide protective clothing

. Protective clothing may also be acquired as a result of the dermal protection selection at §721.63(a)(1)

. Protective clothing, (a)(2)(iv), and full

- body chemical resistant clothing, (a)(2)(ii), are assumed to last f our months

. Each site is assumed to have 25 workers, each of them exposed 250 days per year.

Table C

- 9 shows estimated costs, after inflating as descr ibed in Appendix B, for a standard coverall clothing set that cost $ 41.00 in 2014 ( Grainger, 2014 ) and for full

- body protective clothing

– the coverall clothing set with a hood

– costing $ 117. 94 in 2014 ( Grainger, 2014 ).
Table C
- 9 . Annual Cost of Protective Clothing [40 CFR §721.63(a)(2)]

Cost Element Unit Cost ( 2014 $ per set) Inflation Factor Unit Cost ( 201 4 $ per set) Number Required 1 Total Cost ( 201 4 $ ) 2 Coverall with hood [full

- body

clothing] §721.63(a)(2)(ii) $117.94 1.000 $117.94 75 $8,846
Coverall §721.63(a)(2)(iv) $41.00 1.000 $41.00 75 $3,075
Notes : 1 The analysis assumes 25 workers replacing coverall three times per year.
2 Totals were calculated using unrounded unit cost values and inflation factors (see Table B

- 3 ), so results may differ from calculations using the rounded values shown in this table. Sources: I tem costs, Grainger, 201 4 ; item type and q uantity, EPA, 1998; inflation factor, Table B

- 3

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### C.2.6 Respirators
For some PMN chemicals, to avoid engaging in a Significant New Use, the SNUR requires either the use of respirators or compliance with a New Chemical Exposure Limit (NCEL)

. Both requirements differ by chemical. 18 24 

### For costing purposes, this analysis assumes that respirators are used

. Earlier, PMN SNURs referenced specific paragraphs at 40 CF R §721.63 (a)(5) that identified fifteen types of NIOSH

- approved respirator units

. However, with rulemaking docket OPPT

- 2003

- 0063 ( EPA, 2007b ), PMN SNURs began to describe respirator choices directly

. Costs of the SNUR respirator choices were estimated bas ed on the costs of the respirator in §721.63 (a)(5) that appeared to best match the SNUR descriptions.

24 EPA’s website at http://www.epa.gov/oppt/newchems/pubs/ncelmain.htm explains that in Consent Orders and subsequent SNURs, EPA can require respirators unless workplace air measurements show that air

- borne concentrations of the chemical are below a New Chemical Exposure Limit established by EPA to protect health. NCEL provi sions are modeled after Occupational Safety and Health Administration Permissible Exposure Limits (PELs), and also cover sampling and analytical methods, monitoring, respiratory protection, and recordkeeping.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table C
- 10

. Crosswalk Between SNUR Text and Respirator Types at 40 CFR §721.63(a)(5)

Respirator types at 40 CFR §721.63 (a)(5 ) 1 Requirement Stated in SNUR (exact SNUR wording may differ)
(ii) Category 19C Type C supplied

- air respirator operated in pressure demand or continuous f low mode and equipped with a tight

- fitting facepiece. Some SNURs may specify “full” facepiece Some SNURs may specify “or other positive pressure mode” Supplied

- air respirator operated in pressure demand or continuous flow mode and equipped with a tight

f itting full facepiece.
Supplied

- air respirator operated in pressure demand or other positive pressu re mode and equipped with a tight

- fitting full facepiece (iii) Category 19C Type C supplied

- air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight

- fitting facepiece. Some SNURs may specify “half” or “full” facepiece. Supplied

- air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight

- fitting facepi ece (either half

- or full

- face).

(iv) Category 21C air

- purifying respirator equipped with a full facepiece and high efficiency particulate filters. Some SNURs may specify a “half" or "full" facepiece.

Some SNURs may specify “if oil aerosols absent” or o ther restrictions related to oil aerosols. Air

- purifying respirator equipped with a tight

- fitting full facepiece and High Efficiency Particulate Air (HEPA) filters.

Air

- purifying, tight

- fitting respirator equipped with N100 (if oil aerosols absent), R10 0, or P100 filters (either half

- or full

- face).
Air

- purifyi ng, tight

- fitting respirator (either half

- or full

- face) equipped with N100 (if oil aerosols absent), R100 (restricted use when oil aerosols present), or P100 (appropriate when oil aerosols present) filters.

Air purifying, tight

- fitting full

- face respirat or equipped with the appropriate combination cartridges tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance

- specific cartridge), with a particulate filter (N100 if oil aerosols are absent, R100, or P100).
(v) Category 21C powered air

- purifying respirator equipped with a tight

- fitting facepiece and high efficiency particulate filters. Some SNURs may specify a “half" or "full" facepiece. Powered air

- purifying, tight

- fitting full

- face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. Powered air

- purifying respirator equipped with a tight

- fitting facepiece (either half

- or full

- face) and HEPA filters. (vi) Category 21C powered air

- purifying respirator equipped with a loose

- fitting hood or helmet and high efficiency particulate filters. Powered air

- purifying respirator equipped with a loose

- fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 12 Respirator types at 40 CFR §721.63 (a)(5 ) 1 Requirement Stated in SNUR (exact SNUR wording may differ) Note:
1 The table specifies respirator types at 40 CFR §721.63 (a)(5) that are most similar to the equipment described in the SNUR text for the current and recent SNUR rulemakings. Any significant differences between the specified respirator type at 40 CFR §721.63 (a)(5) and the SNUR text respirator type are noted in italics.



### Table C

- 11 gives average costs of various respirator types, both as originally estimated in 2014

. It also estimates costs per plant site for a chemica l requiring respirators. The respirators specified in the SNURs are typically comprised of a respirator unit and any number of the following: special cartridges (such as high efficiency particulate filters, organic vapor cartridges, and paint, lacquer, and enamel filters), hoods or helmets, and filter caps

. The costs for each site of providing respirators to chemically

- exposed workers, shown in Table 4 o f Chapter 2 of the report, are calculated based on the assumptions stated there, that (1) there are 25 chemically

- exposed workers requiring protective equipment, (2) respirators are replaced once a year, and (3) cartridges (and cartridge filters and caps) are replaced at a rate of one pair (two cartridges) every five of the 250 days that workers are exposed, or 50 times per year

. For example, for the respirator type described at 40 CFR §721.63(a)(5)(xv), the annual cost per worker in 2014 dollars would be a s follows:
$ 29.50 per respirator + ($ 6.38 per cartridge × 50 cartridges/year) = $ 348.50 per worker. Typically a SNUR describes more than one type of respirator, but only one type of respirator is needed to comply with the workplace protection requirements.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table C
- 11 . Annual Per
- Chemical Costs for Respiratory Protection [40 CF R §721.63(a)(4)]

721.63 (a)(5) par. NIOSH approval type at 40 CFR §721.63 (a)(5) (See Table C

- 10 for cross

- walk to respirators in SNUR) Annual Average Costs ( 2014 $ ) Annual Average Costs ( 201 4 $ ) 1
Respirator Unit Cartridge Set Per Worker 2 Inflation Factor Annual Per Worker Annual Per Site (25 workers) 3 (i) 19C Type C Supplied

- air with full facepiece $1,857 $0.00 $1,857 1.000 $1,857 $46,425 (ii) 19C Type C Supplied

- air with tight

- fitting facepiece $1,857 $0.00 $1,857 1.000 $1,857 $46,425 (iii) 19C Type C Supplied

- air with hood or helmet or tight

- fitting facepiece $2,343 $0.00 $2,343 1.000 $2,343 $58,575
(iv) 21C Air

- purifying with full facepiece and high efficiency particulate filters (HEPAs) $258 $8.57 $686 1.000 $686 $17,158
(v) 21C Powered air

- purifying (PAPR) with tight fitting facepiece and HEPAs $1,086 $28.00 $2,486 1.000 $2,486 $62,150 (vi) 21C PAPR with loose hood or helmet and HEPAs $2,497 $55.35 $5,264 1.000 $5,264 $131,607 (vii) 21C Air

- purifying with HEPA and disposable respirators $29.50 $6.38 $349 1.000 $349 $8,713
(viii) 23C air

- purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE) $252 $18.34 $1,169 1.000 $1,169 $29,225
(ix) 23C PAPR with tight

- fitting facepiece and combination cartridges approved PLE $1,086 $116 $6,886 1.000 $6,886 $172,150 (x) 23C PAPR with loose

- fitting hood or helmet and combination cartridges for PLE $2,362 $112 $7,981 1.000 $7,981 $199,524
(xi) 23C Air

- purifying with combination cartridges for PLE, including disposable respirators $29.50 $8.16 $438 1.000 $438 $10,938
(xii) 23C Air

- purifying with full

- facepiece and organic gas/vapor cartridges $258 $8.97 $707 1.000 $707 $17,663 (xiii) 23C PAPR with tight

- fitting facepiece and organic gas/vapor cartridges $1,086 $95.00 $5,836 1.000 $5,836 $145,900 (xiv) 23C PAPR with a loose

- fitting hood or helmet and organic gas/vapor cartridges $2,362 $87.23 $6,723 1.000 $6,723 $168,086 (xv) 23C Air

- purifying with organic gas/vapor cartridges, including disposable cartridges $29.50 $6.38 $349 1.000 $349 $8,713 Notes:
1 Annual average costs were inflated as described in Table B

- 3

. 2 “Respirator unit” costs include both the respirator and any required add

- ons such as hoods and helmets. A “cartridge set” includes two cartridges and any filters or caps required. Assumes cartridge sets are replaced every five days (50 times during 250 exp osure days) so that each worker requires one respirator unit and 50 cartridge sets per year.
3 Totals were estimated from unrounded unit costs and inflation factors, so results may differ from calculations using the roun ded values shown in this tableEconomic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table C

- 12 shows how the average costs per NIOSH

- type respirator were calculated, based on prices of respirators listed in on a n industrial supply website. To calculate the cost of respirators that meet the NIOSH criteria, the prices of units listed on the website that meet each NIOSH criteria were averaged

. Costs of additional items such as hoods, helmets, cartridges, and filter caps were also obtained

. These are added to the cost of the basic respirato r unit if they are required under the SNUR regulation and if the unit does not already include the item

. For example, §721.63(a)(5)(x) requires a hood or helmet

. One model in the catalog that satisfies the requirement already includes a hood, while another unit requires that a separate hood be purchased

. The cost of the hood was added to the unit cost and the combined cost was then averaged with the model with integrated hood. Many respirator specifications also require cartridges

. The costs of the cartridg es were averaged for the corresponding requirements

. In some instances, certain cartridges or filters require a secondary cartridge to function properly (e.g., some paint, lacquer and enamel filters required the organic vapors cartridges and filter retaine r caps)

. These additional items were priced and added to the cost for the basic cartridge before averages were taken. Some cartridge prices were unavailable , f or instance, §721.63(a)(5)(ix) and (x) require a powered air

purifying respirator (PAPR) with a p aint, lacquer and enamel cartridge

. The only cartridges available for these models of respirators are HEPA cartridges

. In these cases the costs of a paint, lacquer, and enamel cartridge are assumed to be the same as for a HEPA cartridge.

The 2014 purchase costs of the varying types of respiratory protective equipment are shown in Table C

12

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### Table C
- 12

. Respirator Prices and Average Costs in 2014 , by NIOSH Type

40CFR NIOSH Type 2014 Average Cost 2 §721.63

(a)(5) Item Number Respirator Description 1 2014 Cost Item Number Filter/Cartridge Description 1 2014 Cost Respirator Unit Cartridge Set

(i) 19C Type C Supplied

- air with full facepiece $ 1,857

-- 11W028 3M: Supplied Air Kit, Belt

- Mounted $1,323 22RP31 SPERIAN: Supplied Air Respirators $2,390
(ii) 19C Type C Supplied

- air with tight

- fitting facepiece $ 1,857

-- 11W028 3M: Supplied Air Kit, Belt

- Mounted $1,323 22RP31 SPERIAN: Supplied Air Respirators $2,390

(iii) 19C Type C Supplied

- air with hood or helmet or tight

- fitting facepiece $ 2,343

-- 2V152 SPEEDGLAS: Supplied Air System, PPA Hood $2,093 23UA35 ALLEGRO: Supplied Air System $2,593

(iv) 21C Air

- purifying with full facepiece and high efficiency particulate filters (HEPAs) $258 $8. 57
4JG19 3M: Low Maintenance Full Face Respirator, Silicone/Thermoplastic Elastomer Facepiece $232 3PB42 3M P100 Filters for Half and Full Face Respirator $6.90 5WZA2 3M Ultimate FX Respirator $340
3A183 North by Honeywell: Full Face Respirator, Silicone Facepiece $384 T451 North by Honeywell: Filter, Magenta $9.05 5VD41 North by Honeywell: Low Maintenance Full Face Respirator, Thermoplastic Elastomer Facepiece $194

5HB 59 Honeywell : Full Face Respirator, Silicone Facepiece. 5 point, Bayonet $165 3NVJ9 Honeywell: Bayonet Filter, P100 $9.95 3NV J2 Honeywell : Full Face Respirator, Silicone Facepiece, 5 point Bayonet with Mesh $276

3NVT7 Honeywell : Full Face Respirator, Silicone Facepiece, 5 point, Threaded $180 3NVL3 Honeywell: Threaded Filter, P100 $8.11 3NV T4 Honeywell : Full Face Respirator, Silicone Facepiece, 5 point Threaded with Mesh $269

3PP P3 MSA: Full Face Respirator, Silicone Facepiece 4 point, Bayonet $226 LN08 MSA : Bayonet Magenta Filter $5.95 3PB94 MSA: Full Face Respirator, Silicone Facepiece European Style 4 point, Bayonet $200

4LR28 MSA: Full Face Respirator, Silicone Facepiece European Style 5 point threaded $372 4LR74 MSA : Threaded Magenta Filter $11.44Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 16 40CFR NIOSH Type 2014 Average Cost 2 §721.63

(a)(5) Item Number Respirator Description 1 2014 Cost Item Number Filter/Cartridge Description 1 2014 Cost Respirator Unit Cartridge Set

(v) 21C Powered air

- purifying (PAPR) with tight fitting facepiece and HEPAs $1,086 $28 .00 8EM74 3M: PAPR System, L, Rechargeable NiMH $1,010 9W546 3M: PAPR HEPA Cartridge for 3M PAPR Systems $32.29 9CR J8 3M: PAPR System, M, Rechargeable NiMH $954 5JG F6 MSA: PAPR System, 4 Point Suspension $1,446 2YRD2 MSA:PAPR HEPA Cartridge for MSA TL PAPR $23.93 5KB69 MSA: PAPR System, 5 Point Suspension $933

(vi) 21C PAPR with loose hood or helmet and HEPAs $2,497 $55.35 11W052 3M: PAPR System, Belt

- Mounted, PETG, with hood $2,144 9W546 3M:PAPR HEPA Cartridge for 3M PAPR Systems $32.29 11W053 3M: PAPR System, Li

- Ion, Polycarbonate, with helmet $2,838

32HD65 ALLEGRO: Pureflo PAPR White Helmet/Hood HE Filter $3,036 32HD72 ALLEGRO: Pureflo HE (HEPA) Filter $104
16M2 51, 16M257, 16M249 North by Honeywell : PAPR System Backpack + Hood+ Breathing Tube $2,248
1AAN4 North by Honeywell: Magenta $ 29 .75 16M 250, 16M257, 16M249 North by Honeywell : PAPR System Belted + Hood+ Breathing Tube $2,218

(vii) 21C Air

- purifying with HEPA and disposable respirators $29.50 $6.38 8CCM3 3M 6000 Series Low

- Maintenance Respirator $29.50 5WYZ4 3M: Disk Filter P100 $6.38Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 17 40CFR NIOSH Type 2014 Average Cost 2 §721.63

(a)(5) Item Number Respirator Description 1 2014 Cost Item Number Filter/Cartridge Description 1 2014 Cost Respirator Unit Cartridge Set

(viii) 23C air

- purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE) $252 $18.34
4JG19 3M: Low Maintenance Full Face Respirator, Silicone/Thermoplastic Elastomer Facepiece $232 3PB42 3M: Black/Magenta Cartridge for Half and Full Face Respirator $19.88 5WZA2 3M Ultimate FX Respirator $340
3A183 North by Honeywell: Full Face Respirator, Silicone Facepiece $384 4JG10 North by Honeywell: Black/Magenta Cartridge $18.25
5VD41 North by Honeywell: Low Maintenance Full Face Respirator, Thermoplastic Elastomer Facepiece $194

4EU80 Honeywell: Combination Cartridge , Bayonet $19.20 5HB59 Honeywell: Full Face Respirator, Silicone Facepiece. 5 point, Bayonet $165

3NVJ2 Honeywell: Full Face Respirator, Silicone Facepiece. 5 point mesh $276

3NVT7 Honeywell: Full Face Respirator, Silicone Facepiece. 5 point threaded $180 3NVN9 Honeywell: Combination Cartridge , Threaded $18.29 3NVT4 Honeywell: Full Face Respirator, Silicone Facepiece. 5 point mesh, threaded $269

3PPP3 MSA: Full Face Respirator, Silicone Facepiece 4 point, Bayonet $226 4LN01 MSA: Combination Cartridge Bayonet $15.13 3PB94 MSA: Full Face Respirator, Silicone Facepiece European Style 4 point, Bayonet $200

4LR28 MSA: Full Face Respirator, Silicone Facepiece European Style 5 point threaded $372 4MG01 MSA: Combination Cartridge , Threaded $19.31

(ix) 23C PAPR with tight

- fitting facepiece and combination cartridges approved PLE $1,086 $116 8EM74 3M: PAPR System, L, Rechargeable NiMH $1,010 5F793 3M: PAPR OV, HEPA Filter $171 9CR J8 3M: PAPR System, M, Rechargeable NiMH $954 5JGF6 MSA: PAPR System, 4 Point Suspension $1,446 3NNF7 MSA: PAPR Black/Magenta Filter $60.17 5KB 69 MSA: PAPR System, 5 Point Suspension $933Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 18 40CFR NIOSH Type 2014 Average Cost 2 §721.63

(a)(5) Item Number Respirator Description 1 2014 Cost Item Number Filter/Cartridge Description 1 2014 Cost Respirator Unit Cartridge Set

(x) 23C PAPR with loose

- fitting hood or helmet and combination cartridges for PLE $2,362 $112 11W052 3M: PAPR System, Belt

- Mounted, PETG, with hood $2,144 5F793 3M: PAPR OV, HEPA Filter $171 11W053 3M: PAPR System, Li

- Ion, Polycarbonate, with helmet $2,838 16M251, 16M257, 16M249 North by Honeywell PAPR System Backpack + Hood+ Breathing Tube $2,248
1AAN4 North by Honeywell: Black and Magenta $53.75 16M250, 16M257, 16M249 North by Honeywell PAPR System Belted + Hood+ Breathing Tube $2,218

(xi) 23C Air

- purifying with combination cartridges for PLE, including disposable respirators $29.50 $8.16 8CCM3 3M 6000 Series Low

- Maintenance Respirator $29.50 5WYZ4 3M: Disk Filter P100 $ 8.16Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 19 40CFR NIOSH Type 2014 Average Cost 2 §721.63

(a)(5) Item Number Respirator Description 1 2014 Cost Item Number Filter/Cartridge Description 1 2014 Cost Respirator Unit Cartridge Set

(xii) 23C Air

- purifying with full

- facepiece and organic gas/vapor cartridges $258 $8.97
4JG19 3M: Low Maintenance Full Face Respirator, Silicone/Thermoplastic Elastomer Facepiece $232 6AM37 3M OV Filters for Half and Full Face Respirator $8.05 5WZA2 3M Ultimate FX Respirator $340
3A1 83 North by Honeywell: Full Face Respirator, Silicone Facepiece $384 16M237 North by Honeywell: Respirator Cartridge, Black $9.51 5VD41 North by Honeywell: Low Maintenance Full Face Respirator, Thermoplastic Elastomer Facepiece $194

5HB 59 Honeywell: Full Face Respirator, Silicone Facepiece. 5 point, Bayonet $165 4EU73 Honeywell: OV Chemical Cartridge, Bayonet $9.52 3NV J2 Honeywell: Full Face Respirator, Silicone Facepiece, 5 point Bayonet with Mesh $276

3NV T7 Honeywell: Full Face Respirator, Silicone Facepiece, 5 point, Threaded $180 4EU73 Honeywell: OV Chemical Cartridge, Threaded , Bayonet $9.25 3NVT4 Honeywell: Full Face Respirator, Silicone Facepiece, 5 point Threaded with Mesh $269

3PPP3 MSA: Full Face Respirator, Silicone Facepiece 4 point, Bayonet $226 4LM93 MSA: Black Chemical Cartridge $ 7.8 1 3PB94 MSA: Full Face Respirator, Silicone Facepiece European Style 4 point, Bayonet $200

4LR28 MSA: Full Face Respirator, Si licone Facepiece European Styl 5 point threaded $372 4LR57 MSA: Black Chemical Cartridge , Threaded $9.71

(xiii) 23C PAPR with tight

- fitting facepiece and organic gas/vapor cartridges $1,086 $95
8EM74 3M: PAPR System, L, Rechargeable NiMH $1,010 5F789 3M: PAPR Black Cartridge for 3M PAPR Systems $130 9CRJ8 3M: PAPR System, M, Rechargeable NiMH $954 5JGF6 MSA: PAPR System, 4 Point Suspension $1,446 3NNF7 MSA: PAPR Black/Magenta Filter $60.17 5KB69 MSA: PAPR System, 5 Point Suspension $933Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 20 40CFR NIOSH Type 2014 Average Cost 2 §721.63

(a)(5) Item Number Respirator Description 1 2014 Cost Item Number Filter/Cartridge Description 1 2014 Cost Respirator Unit Cartridge Set

(xiv) 23C PAPR with a loose

- fitting hood or helmet and organic gas/vapor cartridges $2,362 $87.23 11W052 3M: PAPR System, Belt

- Mounted, PETG, with hood $2,144 5F789 3M: PAPR Black Cartridge for 3M PAPR Systems $130 11W053 3M: PAPR System, Li

- Ion, Polycarbonate, with helmet $2,838 16M251, 16M257, 16M249 North by Honeywell PAPR System Backpack + Hood+ Breathing Tube $2,248
1AAN4 North by Honeywell: Black Cartidge $ 44.45 16M250, 16M257, 16M249 North by Honeywell PAPR System Belted + Hood+ Breathing Tube $2,218

(xv) 23C Air

- purifying with organic gas/vapor cartridges, including disposable cartridges $ 29.50 $ 6.38 8CCM3 3M 6000 Series Low

- Maintenance Respirator $29.50 5WYZ4 3M: OV Filter 4 $6.38 Notes: 1 See Table C

- 10 for the cross

- walk between respirator types in the SNUR and in this table. 2 Average costs presented in this table are rounde d to the nearest dollar figure, so results may differ from calculations using the rounded values shown in this table. 3 Paint, lacquer and enamel (PLE) cartridges for PAPRs were not listed in the catalog. The costs for PLE cartridges are assumed to be the same as combination HEPA and OV c artridges , as both particulate and vapor filters are recommended for paints (US Safety, 2011)

. 4 Organic Vapor cartridges were not listed in the catalog for disposable respirators . The costs for OV cartridges are assumed to be the same as HEPA cartridges. Sources: Grainger, 2014 ; EPAB 1999Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### C.3 Recordkeeping
There are two main types of recordkeeping requirements for the substances listed in the current SNURs: those for companies submitting a SNUN, and those for all companies that manufacture, import or process SNUR

- regulated substances, regardless of whether they have made a submission to EPA

. C.3.1 SNUN S ubmitters
Companies submitting a SNUN must keep records under 40 CFR §721.40

. Some EPA reports have

assu med that SNUN recordkeeping hours would be 5 percent of SNUN submission hours, or about five to six hours. 25 

### Other EPA reports have estimated that electronic submission of SNUNs is expected to reduce the recordkeeping burden to approximately one hour (EPA, 2009 a , p. 16 ) For this report, the SNUN recordkeeping hours were included in the SNUN submission hours (see Table 8 ) and the SNUN recordkeeping cost was not separately estimated. 26



### C.3.2 All Manufacturers, I mporters, and P rocessors
Whether or not they submit a SNUN, firms that manufacture, import, or process the SNUR substance must keep records based on 40 CFR §721.125(a) through (k), to document compliance with SNUR conditions for avoiding a Significant New Use

. (For firms producing under the R&D exemption, R& D recordkeeping would be needed

. R&D recordkeeping costs were not estimated for this report.) Recordkeeping requirements vary between PMN chemicals, reflecting differences in SNUR restrictions

. For all chemicals in the current SNURs, manufacturers, importers, and processors must keep records on quantities supplied or purchased under 40 CFR §721.125(a), (b), and (c)

. For chemicals with water discharge restrictions, companies must keep records concerning water discharge compliance, under §721.125(k)

. F or chemicals with other use restrictions, or for those few chemicals with workplace protection or hazard communication restrictions, companies must keep records under other 40CFR §721.125 paragraphs, to document compliance.

The 2009 final PMN Electronic Re porting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices. Therefore , EPA expects that records supporting TSCA section 5 submissions, including SNUNs, will be created and stored electronically, i ncluding records related to: manufacturing, importing, or processing volumes; shipment amounts and customer information; clothing impermeability

25 For example, OPPT’s Information Collection Re quest (ICR) for TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (Renewal), October 11, 2005, estimates SNUN recordkeeping costs at 5.67 hours (EPA 2005b, page 12).

26 SNUN submission costs estimated in Table 8 of this report were based on PMN submission costs from a 1994 report, Regulatory Impact Analysis of Amendments to Regulations for TSC Section 5 Premanufacture Notifications (EPA, 1994). Page III

- 14 of the 1994 re port refers to “the normal records kept with a PMN submission which are included in the estimates for submission costs.” Page III

- 12 identifies “maintaining a file of the submission” as part of the labor hours for the PMN reporting form. These statements imply that the 95 to 114 total hours for a PMN submission (page III

- 10 of RIB 1994) included recordkeeping hours.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### determinations; the hazard communication program including labels and MSDS copies; compliance with other use restrictions; and/or compliance with disposal and release to water limitations

. Records must be maintained for five years from the date of their creation.
Costs for compliance with the recordkeeping requirements for substances subject to a SNUR are based on the approach in Economic Ana lysis of Final Significant New Use Rules: General Provisions for New Chemical Followup ( EPA, 1989 ) which in turn was based on Recordkeeping Costs for a Generic SNUR , prepared for EPA in 1988 by Kearney/Centaur (Kearney, 1988a)

. These reports drew on record keeping costs estimated for the Comprehensive Assessment Information Rule, CAIR

. Industry recordkeeping costs for CAIR compliance were estimated in reports Kearney prepared for EPA, including Estimated Cost of the Final Comprehensive Assessment Information Rule , June 1, 1988 (Kearney, 1988b, pages 63 to 65)

. To accoun t for the burden reductions resulting from for electronic reportin g, these recordkeeping costs were updated using the approach outlined in The Economic Analysis of the Premanufacture Notificati on Electronic Reporting Rule (EPA, 2009a)

. This report uses the basic Kearney (1988a and 1988b) estimates and assumptions to estimate recordkeeping costs for SNUR requirements and adjusts for efficiencies and costs savings generated by electronic submissions . Unlike Kearney (1988a), this report presents costs for each §721.125 recordkeeping requirement separately

. This report also avoids minor rounding errors by calculating fro m unrounded data

. However, the underlying methodology is identical to the Kearney 1988a/RIB 1989 reports, resulting in identical costs per chemical except for differences due to inflation and rounding

. The paragraphs that follow describe estimates and assu mptions used from Kearney (1988a and 1988b). Cost per page

. Kearney (1988a) based recordkeeping costs on a cost per page basis and assumes that the ratios of labor hours to page count for each labor category, file drawer space to page count, and cost of mi scellaneous supplies such as folders and labels to page count, are the same as the per

- page ratios estimated for EPA’s Comprehensive Assessment and Reporting Rule

. The CAIR estimates are given in the 1988 report, Estimated Cost of the Final Comprehensive A ssessment Information Rule, June 1, 1988, page 65 (Kearney, 1988b)

. EPA ( 2009a) assumes that 

### the recordkeeping burden for SNURs will be reduced by half because of the efficiencies in creating and storing section 5 notices and supporting documents electroni cally . Therefore the per

- page labor burden estimates from the CAIR report (Kearney, 1988b ) have been reduced by half. In addition, all material costs associated with paper records, such as paper, and , filing cabinets have been removed, as files will now be stored electronically.

Table C

- 13 summarizes estimates from Kearney 1988a and the CAIR report (Kearney, 1988b) and adjusts for electronic reporting.

. It also shows the derivation of costs from these estimates , after inflation

. The method is as follows:

• Technical labor was estimated at 1 hour for 750 pages in the CAIR report (Kearney, 1988b, page 65), or .00133 hours per page

. Adjusting for electronic submissions this burden is now .00067 hours per page. The analysis estimates a cost per hour and per page using fully loaded labor rates from Table B

- 1

.

• Clerical labor was estimated at 10 hours for 750 pages in the CAIR report (Kearney, 1988b, page 65), or .01333 hours per page

. Adjusting for electronic submissions this burden is now .00667Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### hours per page. The analysis estimates a cost per hour and per page using fully loaded labor rates from Table B

- 1

.

• The photocopying cost of $0.05 per page ( Kearney 1988a ) , f ile storage cost s of $0.065 per page
, and mi scellaneous materials costs of $0.0133 ( Kearney, 1988b, page 65 ) were removed to account for the cost savings from keeping electronic files. 27 28 

### . It should be noted that none of the costs listed above account for inflation

27 The file storage needs from CAIR w ere estimated at 1⁄4 of a four

- drawer file cabinet for 750 pages (Kearney, 1988b, page 65) or 0.000333 of a cabinet per page. A standard, four

- drawer, full

- suspension file cabinet was priced from a national office products supplier at $195 in 1997 (BT Office Products, 1997; Item #LGM

- 202401; EPA, 1998). This results in $0.065 per page cost for file space, before inflation ($195 × 0.25 file cabinet/750 pages).

28 Miscellaneous materials costs were estimated at $10.00 for 750 pages in the CAIR report (Kearney, 1988b, page 65), or $0.0133/page before inflationEconomic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table C
- 13 . Recordkeeping Estimates from Kearney 1988a and 1988b

Kea rney Estimates for CAIR Rule (1988 a, b) Adjusted for I nflation Per P age C ost
- 201 4 $

Estimate ePMN Cost Savings CAIR Pages Cost Per Page Cost Per Hour Cost Per Page (a) (b) (c) (d) = [(a) * (1

- ( b) ) ]/(c) Labor Costs Technical 1 hour 50% 750 0.00067 $72.22 $0.0481

Clerical 10 hours 50% 750 0.00667 $31.26 $0.2084 Total Labor 0.00733 hours $0.2565 Material Costs
Photocopying $0.05 [1988 dollars] 1 00% 1 $0.00 $0.00

File Cabinet 1/4 of cabinet priced at $195 [1997 dollars] 100% 750 $0.00 $0.00

Misc. Materials $10 total [1988 dollars] 100% 750 $0.00 $0.00

Total Materials $0.00
Total Cost per Page (Labor & Materials) $0.2565

Note s : Per

- page labor hours and materials costs were originally estimated in Kearney 1988b for the CAIR rule. The CAIR per

- page costs were then used to estimate SNUR recordkeeping per

- page costs in Kearney 1988a , and adjusted for the burden reductions from electronic reporting using the approach outlined in EPA, 2009a . This clarifies the method by which the original C AIR per

- page costs and hours were calculated. It also adjusts costs for inflation using labor rates from Table B

- 1 and inflation factors from Table B

- 3



### .

Pages per chemical at one site. In order to estimate recordkeeping costs, the analysis multiplies the costs per page for each recordkeeping element estimated in Table C

- 13 by the numb er of pages required for each SNUR recordkeeping requirement at 40 CFR §721.125 as estimated by Kearney (1998a)

. The Kearney data was used by EPA in its original expedited

- SNUR economic analysis ( EPA, 1989 )

. For example, maintaining MSDS copies as required at §721.125(h) would require 5 pages

. The following estimates from Kearney (1988a) are also used:

• Manufacture and import volume, and sales and transfer data require 485 pages of records per year

. This reflects 40 invoices per month (see haz

- comm Section C.1 above), 480 for sales/transfer and 5 for manufacturer/import (Kearney, 1988a, p.11).

• Disposal compliance records, if required, cover items such as waste production, shipping manifests, permits, and transfer receipts

. The 600 disposal compliance pages a ssume 50 pages per month (Kearney, 1988a, p.11).Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### (This report uses slightly different terminology from EPA, 1989 : “Protective clothing” instead of “protective gloves,” “haz

- comm” instead of “employee information and training.” Recordkeeping for “impermeabi lity determination” was not separately costed out in EPA, 1989

. This report assumes it is included under “protective clothing” recordkeeping.) Cost per chemical

. Table C

- 14 shows annual recordkeeping activities at one site for one SNUR chemical, by CFR requirement

. If all recordkeeping requirements at 40 CFR §721.125 applied to a single chemical, there would be costs for 1.1 hours of technical time and 11.4 hours of clerical time

. However, in reality, few if any chemicals will have all of the recordkeeping requirements listed in Table C

- 14

. Recordkeeping costs would be lower for chemicals with relatively few SNUR restrictions because fewer pages would be needed to document SNUR compliance.

Table C

- 14 does not include costs of recordkeeping resulting from a SNUN submission; those costs were included in the SNUN submission cost.
Table C
- 14 . Annual Per
- Chemical Costs of Recordkeeping Requirement [40 CFR 721.125]

40CFR §721.125 2 Requirement Pages

(a) Labor and M aterials C ost 1 ( 201 4 $ ) Hours Per Page (b) Per Chemical (c)=(a)*(b) Per Page (d) Per Chemical (e)=(a)*(d) (a)(b)(c) Volumes & sales/transfer data 485 

### $0.2565 $124 0.00733 3.56

(d)(e) Protective clothing [§721.63] and impermeability [§721.63(a)(3)] 20 

### $0.2565 $5.13 0.00733 0.15 (f) Haz

- comm program [§721.72] 250 

### $0.2565 $64 0.00733 1.83 (g) Label copies [§721.72(b)] 5 

### $0.2565 $1.28 0.00733 0.04 (h) MSDS copies [§721.72(c)] 5 

### $0.2565 $1.28 0.00733 0.04 (i) Use limitations compliance [§721.80] 250 

### $0.2565 $64 0.00733 1.83 (j) Disposal compliance [§721.80] 600 

### $0.2565 $154 0.00733 4.40 (k) Release to water compliance [§721.90] 100 

### $0.2565 $25.65 0.00733 0.73
TOTAL 1,715 $0.2565 $440 0.00733 12.58 Notes:
1 This table multiplies cost per page estimates from Table C

- 13 by the number of pages estimated for each recordkeeping cost element. (This table does not include recordkeeping for SNUN submissions required by 40 CFR §721.40.) Total costs are calculated from unrounded values and may not equal the sum and/or product of rounded values.
2 40 CFR 721.125(a) through (k) list recordkeeping that may be specified in the SNUR. The recordkeeping specified depends on which 40 CFR §721 provisions [in brackets] were used by the SNUR to define reportable New Uses (§721.63, §721.72, §721.80, and/or §721.90). Few if any SNUR chemicals would require all of the recordkeeping costs listed above since few if any chemicals are subject to all of the requirements (a) through (k ).
3 Pages count estimates for each SNUR requirement are from Kearney, 1988a.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## APPENDIX D: C osts of T esting

EPA recognizes that TSCA Section 5 does not require developing any particular test data before submission of a Significant New Use Notice

. Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them

. (Upon review of a SNUN, the Agency has the authority to require appropriate testing, but that is a cos t of regulatory follow

- up , not of the SNUN submission itself.) For informational purposes, the SNURs describe t ests recommended by EPA to provide sufficient information to evaluate the chemical substance

. However, as was explained in the discussion of SNUN s earlier in this report , it appears that firms rarely elect to do these recommended tests to support a SNUN, and especially not the higher

- cost tests

. For informational purposes, t his appendix presents estimated costs for testing often recommended for che micals that have been the subject of PMNs and are subject to Significant New Use Rules (SNURs).



### D.1 Testing Guidelines
In the SNURs, EPA identifies a set of tests for each PMN chemical that can be used by firms making Significant New Use Notice or other subm issions to EPA to characterize risks of the chemical

. The tests are recommended in the SNUR, not mandatory

. They are identified by guideline numbers which can be used to look up published test protocols

. Table D

- 1 lists test guidelines cited in the current and recent SNUR rulemakings, and their associated costs, Table D

- 2 presents certain assumptions used in the analysis, and Table D

- 3 presents Persistent Bioaccumulative Toxic (PBT) tiered testing requirements

. The types of guidelines are described below.

D.1.1 OPPTS Harmonized Test Guidelines
Most SNUR tests are identified by their OPPTS number from the series of OPPTS Harmonized Test Guidelines and OPPTS harmonized public drafts not yet promulgated as OPPTS guidelines

. These guidelines blended testing guidance from OPPT (published in the Code of Federal Regulations), EPA's Office of Pesticide Programs, the Organization for Economic Cooperation and Development (OECD), and other sources

. The harmonized gu idelines fall into several categories, including the following:

• Series 835

-- Fate, Transport and Transformation Test Guidelines

• Series 850

-- Ecological Effects Test Guidelines

• Series 870

-- Health Effects Test Guidelines They are available electronically on EPA’s website ( EPA, 2006 )

. Cross

- references for health effects guidelines are listed at 63 FR 41847, August 5, 1998.

D.1.2 C ode of Federal Regulations
SNUR tests may also come from the Code of Federal Regulations (CFR) , identified for example as “40 CFR 799.9370 ” or just “799.9370.” In addition, in costing out test guidelines, this report sometimes usesEconomic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### costs for a CFR guideline when costs have not been developed for the equivalent OPPTS harmonized guideline

. 40 CFR parts 795 through 798 include pre

- harmonization test guidelines, typically updated before 1990

. 40 CFR part 799 includes more recent TSCA test guidelines, based on harmonized test guidelines. (63 FR 41845, August 5, 1998).

D.1.3 OECD
A few SNUR tests are identified by their OECD number

. The OECD guidelines may have OPPTS equivalents

. For example, OECD 407 28

- Day Oral Toxicity in Rats is essentially equivalent to OPPTS 870.3050.

D.1.4 OECD ’ s Guidance Manual for the Testing of Manufactured Nanomaterials
For some nanomaterials SNUR tests may refer to OECD’s Guidance Manual for the Testing of Manufactured Nanomaterials

. Because of the newness of nanomaterial testing test s may not have protocol numbers, but rather refer to the guidelines described in the manual

. D.1.5 PBT Category

For some chemicals, the SNUR cites tiered t esting according to a testing strategy published in the Federal Register (FR), Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999 (64 FR 60194), which in turn refers to a number of tests by OPPTS or OECD guideline number.

D.1.6 ASTM, NTIS, and O ther S ources
Test guidelines may also come from the American Society for Testing and Materials (for example, ASTM D2035

- 80 Modified Coagulation

- flocculation Jar Test of Water) (www.astm.org) or other sources

. The guideline for a n eurotoxicity functional observational battery, NTIS PB 91

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### T able D
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. Cost Estimates for Test Guidelines Cited in SNURs

Guideline Test Species Route/Method Cost 201 4 $
Product P roperties
830.6315 Flammability NA NA $2,446

830.7050 Absorption in Aqueous Solution: ultraviolet/visible spectra NA NA $2,472
830.7200 Melting Point / Melting Range NA 8

- test average $1,467
830.7550 Partition Coefficient (n

- Octanol/Water) NA Shake Flask Method $7,669
830.7560 Partition Coefficient (n

- Oct/Water) NA Generator Column $8,152
830.7570 Partition Coefficient (n

- Oct/Water) NA Liquid Chromatography $5,365
830.7840 Water Solubility NA Flask Method $11,083 830.7860 (796.1860) x Water Solubility: Column Generator Method NA Generator Column $23,394
D escribed EPA Consent Order A tmospheric Half Life T est NA NA *

Karel Vershueren Handbook, odor and taste test Odor and taste test (in Handbook of Environmental Data on Organic Chemicals, by Karel Vershueren, 4 th Ed, Vol. 1, Page 22) NA NA *

Fate, Transport, Transformation
835.1110 Activated Sludge Sorption Isotherm NA NA $21,431
835.1220 Sediment and Soil Adsorption/Desorption Isotherm NA NA $32,871

835.1230 Sediment and S oil A dsorption/ D esorption (batch equilibrium) NA NA $46,420
835.1240 Leaching and adsorption/desorption NA NA $61,043
835.2110 Hydrolysis as a Function of pH NA NA $64,583
835.2120 Hydrolysis test NA NA $45,548Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 4 Guideline Test Species Route/Method Cost 201 4 $ 835.2130 Hydrolysis as a Function of pH and Temperature NA NA * 835.2210 (796.3700) Photolysis in Aqueous Solution in Sunlight NA NA $129,191 835.3100 (796.3100) Aerobic Aquatic Biodegradation NA NA $17,736
835.3110 Ready Biodegradation NA Average of six methods $13,857
835.3120 Sealed

- Vessel CO2 Production Test NA NA $8,593
835.3140 CO2 in Sealed Vessels Test NA NA *
835.3170 Shake Flask Die

- Away Test NA NA $56,507
835.3180 Sediment/Water Microcosm Biodegradation NA Flow

- through $147,754

835.3190 Aerobic Mineralization in Surface Water

– Simulation Biodegradation Test NA NA *

835.3200 (OECD 302B) Inherent Biodegradation: Modified Zahn

- Wellens NA NA $11,229

835.3210 Modified SCAS Test NA NA $33,090
835.3220 Porous Pot Test NA NA $35,840
835.3400 Anaerobic Biodegradability of Organic Chemicals NA NA $13,641 835.5045 (OECD 302A) Inherent Biodegradability: Modified SCAS Test NA NA $15,762

835.5270 (795.7000) Sunlight Photolysis in Waters Containing Dissolved Humic Substances (Indirect Photolysis Screening Test) NA NA $27,249

D2035

- 80 (ASTM D 2035

- 80) Standard Practice for Coagulation

- Flocculation Jar Test of Water NA NA $4,706

OECD 303A Simulation Test

- Aerobic Sewage Treatment, with measurement of loss of the parent NA NA $47,396

OECD 307 Aerobic and Anaerobic Transformation in Soil NA Flow

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- 5 Guideline Test Species Route/Method Cost 201 4 $
OECD 307 Aerobic and Anaerobic Transformation in Soil NA Bio

- meter type flasks $293,812

OECD 308 Anaerobic transformation in aquatic sediment systems NA NA *

OECD 309 Aerobic mineralisation in surface water NA NA *

OECD 310 Ready biodegradability

- CO2 in Sealed Vessels (headspace test) NA NA *

OECD 311 (835.3400) Anaerobic biodegradability of organic compounds in digested sludge NA NA *

OECD TG 310 CO 2 in Sealed Vessels

– Headspace Test NA NA *
Draft OECD Jan 2002 Phototransformation of chemicals on soil surfaces

- 2 soils NA NA * Ecological Effects

850.1000 Special Considerations for Conducting Aquatic Laboratory Studies NA NA *
850.1010 (797.1300) Daphnid Acute Toxicity Daphnid Flow

- through $16,609 850.1010 (797.1300) Daphnid Acute Toxicity Daphnid Static $16,390
850.1075 (797.1400) Fish Acute Toxicity Fathead Minnow Flow

- through $22,889 850.1075 (797.1400) Fish Acute Toxicity NA Static $18,539

850.1085 Fish Acute Toxicity Test mitigated by humic acid Fathead Minnow Flow

- through *

850.1085 Fish Acute Toxicity Test mitigated by humic acid Fathead Minnow Static $19,324
850.1300 Daphnid Chronic Toxicity Test Daphnid Flow

- through $148,767
850.1350 Mysid Chronic Toxicity Test Mysid Flow

- through $48,831Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 6 Guideline Test Species Route/Method Cost 201 4 $

850.1400 Fish Early Life Stage Toxicity Rainbow Trout Flow

- through $75,866

850.1400 Fish Early Life Stage Toxicity Fathead Minnow Flow

- through $51,287

850.1730 Fish BCF Fathead Minnow Flow

- through $165,975

850.1925 Site

- Specific Aquatic Microcosm Test NA NA *
850.1950 Field testing for Aquatic Organisms 3 NA NA $738,069
850.5400 Algal Toxicity, Tiers I and II NA NA $20,071

850.5400 Shake

- Flask Test for Estimation of Biodegradability of Toxic Organic Substances in the Aquatic Environment. Ecotoxicology and Environmental Safety 14:239

- 251 on P

- 08

- 513 utilizing a 96

- Hour Bioassay in Algae NA NA *

OECD 218 Chironomid Sediment Toxicity NA NA $31,655
OECD 225 Effects on Sediment Species ( L umbriculus) NA Spiked Sediment $31,747 Cripe, C.R., Walker, W.W., Pritchard, P.H., Borquin, A.W. (1987) Modified Shake

- Flask Biodegradation Test NA NA *

Health Effects
870.1100 Acute Oral Toxicity Rats Gavage $9,198
870.1300 Acute Inhalation Toxicity Rats 4 Inhalation $19,076
870.2500 Acute Dermal Irritation Test Rabbits Dermal $6,848
870.2600 Dermal Sensitization Test Guinea Pigs NA $ 13,636
870.3050 Repeated Dose 28

- day Oral Toxicity Test Rodents NA *
870.3100 90

- Day Oral Toxicity Rats Gavage $173,276Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 7 Guideline Test Species Route/Method Cost 201 4 $ 870.3250 Subchronic Dermal Toxicity

- 90 days Rats Dermal $ 179,129
870.3465 1 Subchronic Inhalation Toxicity Rats Inhalation $567,948
870.3465 (mod) Subchronic Inhalation Toxicity (w/ 60 day recovery group) Rats Inhalation $270,920

870.3465 (OECD 413) 1 Subchronic Inhalation Toxicity (90

- day exposure/180

- day retention) Rats Inhalation $473,342

870.3550 Reproductive/Developmental Toxicity Screening Test NA Oral *

870.3650 Combined repeated dose toxicity test with the reproductive/developmental screening test Rats NA *

870.3700 Prenatal Developmental Toxicity {2 species} Rats Gavage $131,531

870.3800 Reproduction/Fertility Effects (2

- Generation Reproduction) Rats Gavage $437,851

870.4200 Carcinogenicity {2 species} (24 months) Rats Gavage $1,745,852
870.4200 Carcinogenicity {2 species} Rats Inhalation $1,385,495

870.4300 Combined Chronic Toxicity/Carcinogenicity Test Rats Gavage $1,333,462
870.5100 Bacterial reverse mutation test NA Direct plate $9,958

870.5265 Salmonella typhimurium Reverse Mutation Assay (Ames Test) NA Average of direct plate and Azo reduction $14, 372

870.5385 Mammalian Bone Marrow Chromosomal Aberration Test Rats Gavage $41,091

870.5395 In Vivo Mammalian Bone Marrow Cytogenetics Tests: Erythrocyte Micronucleus Assay (Average of 1 and 3 day dosings) Mice Gavage (Average of 1 and 3 day) $29,513

870.5395 In Vivo Mammalian Bone Marrow Cytogenetics Tests: Erythrocyte Micronucleus Assay (Average of 1 and 3 day dosings) Mice Intravenous (Two test average) $29,513Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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870.5550 Unscheduled DNA Synthesis in Mammalian Cells in Culture Rat Hepatocytes NA $25,169

870.6100 Delayed Neurotoxicity of Organophosphorus Substances (Acute) Hens Gavage (Acute) $43,031

870.6100 Delayed Neurotoxicity of Organophosphorus Substances (Subchronic 28

- day) Hens Gavage (Subchronic) $104,065

870.6200 Neurotoxicity Screening Battery (Acute) Rats Gavage $173,395
870.7485 Metabolism and Pharmacokinetics (Tier I) Rats Gavage $50,679
870.7800 Immunotoxicity Rats Gavage $73,671

ASTM F739

- 91 (ASTM F739) 2 Standard Test Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Continuous Contact NA Average (Gases and Liquids) $16,105

OECD 105 Water Solubility Test NA Flask Method $7,786
OECD 112 Dissociation Constant in Water Test NA Conductometric Method $6,823

OECD 206 Avian Reproduction Test Bobwhite Quail NA $112,778

OECD 206 Avian Reproduction Test Mallard Ducks NA $121,954

OECD 303A Simulation Test

- Aerobic Sewage Treatment: Activated Sludge Units NA NA $47,396

OECD 307 Aerobic and Anaerobic Transformation in Soil Test NA Flow Through $310,815
OECD 307 Aerobic and Anaerobic Transformation in Soil Test NA Bio

- meter Type Flasks $293,812

OECD 308 Aerobic and Anaerobic Transformation in Aquatic Sediment Systems Test NA NA *

OECD 311 Anaerobic Biodegradability of Organic Compounds in Digested Sludge Test NA NA *Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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OECD 314 Simulation Test to Assess the Biodegradability of Chemicals Discharged in Wastewater NA NA *
OECD 404 (870.2500) Acute Dermal Irritation Rabbits Dermal $6,848
OECD 405 (870.2400) Acute Eye Irritation Rabbits Eye $6,848 OECD 407 (870.3050) Repeated dose 28

- day oral toxicity study in rodents Rats Gavage (28 Days) $63,887
OECD 412 Repeated Dose Inhalation Toxicity (28

- Day Study) Rats Inhalation (28 Days) $143,039
OECD 416 Two

- Generation Reproduction Toxicity Test Rats Dietary $471,406 OECD 421 (870.3550) Reproduction/developmental toxicity screening tests Rats Gavage $74,934

OECD 422 (870.3650) Combined Repeated Dose Study with Reproductive/Developmental Toxicity Screen Rats Gavage $149,368

OECD 422 (mod) Combined Repeated Dose Study with Reproductive/Developmental Toxicity Screen (90 days w/ histopathology) Rats Gavage $280,824

OECD 425 Acute Oral toxicity: Up

- and

- down Procedure Rats Gavage $6,616
OECD 453 Combined Chronic Toxicity/Carcinogenicity Test Rats Inhalation $3,906,202

ASTM D6007

- 02 Small Scale Chamber Test to Determining Formaldehyde Concentration in Air from Wood Products NA NA *

EPA draft Inhalation Monitoring Data Collection Guidelines NA NA *
Described in EPA Consent Order I nformation to A ddress C ardiac S ensitization NA NA *
Endocrine Disruptor Screening Program Tests
890.1200 Aromatase (human recombinant) test NA NA *
OCSPP 890.1550 ( OECD 456 ) Steriodogenesis (human cell line

- H295R) test NA NA *Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 10 Guideline Test Species Route/Method Cost 201 4 $ Nanomaterial Specific Tests 5, 6

ASTM D2565

- 99(2008) Release of MWCNTs after exposure of liquid polymer forms to sunlight: NA Consult Standard Practice for Xenon

- Arc Exposure of Plastics Intended for Outdoor Applications *

ASTM E1354

- 09 Release of MWCNTs during the burning of liquid polymer forms: NA Consult Standard Test Method for Heat and Visible Smoke Release Rates for Materials and Products Using an Oxygen Consumption Calorimeter *

ASTM E2865

- 12 Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials NA Surface Charge by Electrophoresis *

EPA method 1320 Release of MWCNTs after landfill disposal: NA Multiple Extraction Procedure to determine the fraction of MWCNTs released during the leaching that the liquid polymer forms will undergo from repetitive precipitation of acid rain *

NCL Method PCC

- 2 Measuring the Zeta Potential of Nanoparticles NA NA *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials Dustiness Test NA EN 15051 Method $2
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OECD's Guidance Manual for the Testing of Manufactured Nanomaterials Dry particle size distribution by count for each PMN substance in a form which has the highest content of particles smaller than 10 microns as manufactured, processed or used in the workplace at sites controlled by the Company NA STEM (scanning transmission electron microscopy) method *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials Surface chemistry NA Average of Three Methods $65 7

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials Configuration of Carbon Nanotube ends NA NA $ 815

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials Release of MWCNTs during solid polymer form shipping and use NA A simple short

- term test consisting of placing the solid polymer forms in a standard rock tumbler and

determining the amount of free MWCNTs after a period of l, 5, 15, and 30 days to screen for significa nt release of MWCNTs from the solid polymer forms. *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM C100 (>90% MWCNTs. < 7% aluminia and <5% of iron oxide) NA NA *Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 12 Guideline Test Species Route/Method Cost 201 4 $ OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM U100 (>97% MWCNTs. <3% of iron oxide, 1% alumnia) NA NA *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM CSI

- 015, a viscous resin (honey

- like) comprised of 98.5% epoxy resin, 1,5% GRAPHISTRENGTH TM C100 NA NA *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM PEB

- 201, a very highly viscous resin (tar

- like paste) comprised of 64.3% polyester, 31.6% styrene, remainder GRAPHISTRENGTH T M C100 NA NA *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM CM1

- 20, a pellet comprised of 79% polyamide, 12.5% white mineral oil, remainder GRAPHISTRENGTH TM C100 NA NA *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM CM2

- 20 a pellet comprised of 78% polyamid resin, 22% GRAPHISTRENGTH TM C100 NA NA *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM CM3

- 20 a pellet comprised of 79% polyamid 11, 21% GRAPHISTRENGTH TM C100 NA NA *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM CM5

- 20 a pellet comprised of 60% polycarbonate, 20% flame retardant, 20% GRAPHISTRENGTH TM C100 NA NA *Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 13 Guideline Test Species Route/Method Cost 201 4 $ OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM CM12

- 30, a pellet comprised of cyclic butylenes trephthalate (CBT), 30% GRAPHISTRENGTH C100 NA NA *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM CM13

- 30, a pellet comprised of 65% polyacrylic

- polyolefin, 15% acrlonitrile

- butadiene copolymer, 20% GRAPHISTRENGTHTM C100 NA NA *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials GRAPHISTRENGTH TM C M6

- 20 a granule comprised of 80%polyamid6, 20% GRAPHISTRENGTH TM C100 NA NA *

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials Workplace exposure monitoring and characterization testing (including byproducts) NA NA *Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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- 14 Guideline Test Species Route/Method Cost 201 4 $ OECD's Guidance Manual for the Testing of Manufactured Nanomaterials Certain material characterization data NA NA *

Notes: * Indicates this cost has not been calculated for this report.

+ Indicates that EPA, EPAB staff estimated this test cost in fall of 2009 and it is more recent that the other EPA, OPPTS EPAB test cost estimates presented in the table, the majority of which were estimated prior to 1990. 1 For some PMNs, recommended testing under guideline 870.3465 would involve an additional 3 month recovery group, as well as other evaluation b eyond the standard requirements in the test guideline. These activities would raise testing cost substantially.
1 The recommended testing for some PMN chemicals may include a glove permeation test following ASTM F739 and F1194

- 99 guidelines. ASTM F1194

- 99 is a standard guide for documenting the results of chemical permeation tests (see www.astm.org ). The additional costs of following ASTM F1194

- 99 (average of gases and liquids) were not estimated for this report.
2 Costs for field testing will be site

- specific, with a wide range of actual costs. A report from EPA's Office of Pesticid e Programs estimated an average test cost of $600,000 ($2008) for guideline 850.1950, for simulated or actual field testing for aquatic organisms (EPA, 2008a, Appendix C).
3 Performing the test on species other than rats may change the test costs. For example, testing on rabbits is likely to increase costs.
4 Fate, transport and transformation, ecological effects, and health effects testing may be required for nanomaterials, however nano

- specific costs for these tests were not estimated for this report.
5 While the Agency expects that analytical methodology validation costs may be more expensive for nanomaterials than for tradit ional chemicals, EPA was unable to gather any information on nanomaterial

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### D.2 Test Costs by Guideline

Table D

- 1 gives dollar cost for each test, based on assumptions and adjustments discussed below

. This section describes the development of individual test costs. EPA’s Office of Pollution Prevention and Toxics, Economic and Analysis Branch, regularly develops cost estimates of test guidelines to su pport TSCA rule development

. Estimates are based on assumptions about species, route of administration, study duration, and other aspects of methodology

. Costs are calculated based on costs of labor, materials, and equipment needed to perform testing, with overhead and fee

. Many of the test costs were developed in the 1990s

. Test costs have been inflated using Employment Cost Index inflators from the Bureau of Labor Statistics (see Appendix B )

. However, generally they have not been updated to reflect subsequent changes in laboratory technologies. Testing laboratories perform analytical method validation to ensure that proper dose concentrations are

us ed in toxicity studies (EPA , 2005 a , p. 3

- 9)

. This analysis assumes that for health effects tests (e.g. 870 series guidelines), tests of up to 90 days in duration have method validation costs of $3,500, and longer

term tests have validation costs of $8,500 in 2004 dollars

. Using the inflation rates found in Appendix B , validation costs are $4, 403 and $ 10,693 in 201 4 dollars

. For simplicity, the method validation cost for ecological effects tests (e.g. 850 series guidelines) was assumed to be $ 4,403 for each test. In addition, this analysis assumes that analytical method validation costs are the same for both nanomaterials and traditional chemicals

. In cases where costs have not been estimated for the specified guideline, EPA uses the cost from an approximately equivalent guideline (listed in Table D

- 1 and Table D

- 3 in parentheses)

. Many of these equivalents are listed in the Federal Register at 63 FR 41847, August 5, 1998

. In some cases the test protocol itself states that it is essentially equivalent to another test upon which it was based

. Sometimes judgment was needed to select the closest equivalent(s)

. In some cases, EPA has not costed out the test for the species, r oute, duration, and/or other method listed in the SNUR, or the SNUR specifies a guideline but does not specify these details

. In such cases, EPA has made the adjustments described below

. The adjustments were selected based on discussions with EPA scientist s and on SNUR language, published test guidelines, assumptions underlying the cost estimates in EPAB's test cost database, EPA review and Consent Order history for specific PMNs, or other sources.

D.2.1 Default Parameters
Costs for many of the guidelines have b een estimated for different combinations of species, route, length of study and other aspects of methodology, but in some cases the SNUR may not specify all of these variables

. Where this occurs, EPA has used certain default parameters, listed in Table D

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### Table D
- 2

. Default Parameters for Species, Route, and Study Type

Variable Default

Species Mammals Fish Invertebrates Algae Rats Fathead minnow 1 Daphnids [Four species

-- see text]

Route/Method Mammalian Fish Invertebrates Gavage Flow

- through Flow

- through
Note s : 1 For guideline 850.1400 tests also in PBT tier tests, rainbow trout is the default species. (See PBT discussion below.)


### D.2.2 SNUR Testing Tiers
A SNUR may recommend tiered testing

. In such cases, costs are lower if only the first

- tier tests are performed, and higher if all tests listed for the chemical are performed

. Testing is “tiered” if later test s are contingent on the results of earlier tests, and/or if some tests are contingent on the firm reaching a certain chemical volume or time limit

. Some tiers are explicit in the SNUR text; others result because the SNUR references the tiered PBT Category testing described at 64 FR 60194

. D.2.3 Test Cost Assumptions and Comments
This section explains treatment of certain tests listed in this or past SNUR rulemakings.

• A SNUR may recommend algal acute toxicity testing according to OPPTS Guideline 850.5400

. This guideline has been previously costed by EPA for four separate algal species ( Navicula pelliculosa, Skeletonema costatum, Anabaena flos

- aquae, and Selenastrum capricornutum )

. If a SNUR does not specify the algal species to be used, the average costs of the four algal species tests are used.

• For OPPTS test guideline 835.3100 (A erobic Aquatic Biodegradation) , a SNUR may call for an additional analytical methodology to identify the isononyl phenol degradation product, which may be a substantial add

- on to the basic cost

. Table D

- 1 gives costs for 835.3100 but not for the extended test

.

• A SNUR may recommend a “modified” version of ASTM test guideline D2035

- 80 ( Coagulation

Flocculation Jar Test of Water)

. Table D

- 1 gives costs for D2035

- 8 0 but not for the additional analytical methodology

.

• For test guideline OECD 422 ( Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Screening), a SNUR may recommend extended histopathology

. Although the OECD 422 protocol does include histopathology, it is possible that extending the histopathology would increase the cost beyond that shown in Table D

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### • A SNUR may recommend t wo variations of test guideline OECD 218 (Chironomid Sediment Toxicity), one using the acute portion of the sediment and the other using the chronic portion

. Costs were not determined for these two variants

. The cost of the test performed on midge under fl ow through conditions was used for both.

• A SNUR may recommend “a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline)”

. “Freshwater and marine” refers to the name of the test, not the number of species required by EPA

. The cost e stimates assume only one species is used.

D.2.4 Persistent Bioaccumulative Toxic (PBT) tiered testing
A SNUR may cite tiered testing for Persistent Bioaccumulative Toxic chemical substances (PBTs) according to the testing strategy in EPA’s New Chemicals Program PBT Category document, published in the Federal Register notice, Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999, at 64 FR 60194

. In 64 FR 60194, there are three tiers of testing

. The results of Tier 1 determine whether Tier 2 testing is needed and the results of Tier 2 testing determine whether Tier 3 testing is needed

. Table D

- 3 l ists the tests in the PBT category document

. These tests are also listed in Table D

- 1

. To obtain a cost estimate for SNURs that cite PBT Category testi ng (64 FR 60194), costs of individual tests from 64 FR 60194 would have to be added up as appropriate, depending on the specific SNUR language

. The test list would also need to be adjusted to avoid double counting tests listed in the SNUR both explicitly b y guideline number, and implicitly due to their inclusion in PBT Category tiers. Other assumptions related to PBT testing are described below:

• The PBT category tests at 64 FR 60194 specify rainbow trout as the species for the chronic fish toxicity test, 850.1400

. For SNURs that recommend PBT Category testing, 850.1400 costs would be based on using rainbow trout

. If 850.1400 is recommended without PBT testing, costs would be based on using fathead minnows.

• For PBT Tier 1 ready biodegra dability tests, firms may either choose among six methods in test guideline 835.3110 or follow test guideline 835.3120

. The cost of 835.3110 is calculated as the average cost of its six possible methods

. The cost estimates assume an equal chance of using

e ither 835.3110 or 835.3120

.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### Table D
- 3 . Persistent Bioaccumulative Toxic (PBT) Tiered Testing Requirements

PBT Tier Guideline Test Cost 201 4 $

1 OPPTS 830.7560*

- or

OPPTS 830.7570* Partition Coefficient (n

- Oct/Water), Generator Column method

- or

Partition Coefficient (n

- Oct/Water), Liquid Chromatography method Average $8,152

$5,365 $6,758
1 OPPTS 835.2110 Hydrolysis as a Function of pH $64,583

1 OPPTS 835.3110

- or

OPPTS 835.3120 Ready Biodegradability (choose one of 6 methods; cost is average of the 6)

- or

- [Ready biodegradability] Sealed

- vessel CO 2 Production Test Average $13,857

$8,593 $11,225
2 OPPTS 835.3170 Shake

- flask Die

- away Test [measures biodegradability] $56,507
2 OPPTS 850.1730 Fish Bioconcentration $165,975
3 OPPTS 835.3180 Sediment/Water Microcosm Biodegradation $147,754

3 40CFR 797.1330 or 850.1300** Daphnid Chronic Toxicity Test $148,767

3 40CFR 797.1600 or 850.1400** Fish Early Life Stage Toxicity (in rainbow trout) $75,866

3 OECD 422 Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Screening (in rats) $ 280,282

Total cost, A ll tiers *** $ 958,260 Source s : 64 FR 60194, Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances , November 4, 1999, at http://www.epa.gov/EPA

- TOX/1999/November/Day

- 04/t28888.htm . Tests costs are from Table D

- 1

. * The PBT FR notice cites 830.7560 and 830.7570. This table used costs for similar tests 796.1720 and 796.1570, respectively. Tests 830.7550 (Partition Coefficient using Shake Flask method) and “the new ‘slow

- stir’ method currently under development by the OECD” are also mentioned as options for determining the Oct/Water partition coefficient, in the PBT FR notice Response to Comments but not in the main Testing Strategy discussion. ** PBT FR notice cites both test s as equivalents. This table uses costs for 850.1300 and 850.1400 since they were costed out more recently by EPA. *** Assuming all tests are conducted.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### D.3 T esting Costs by Chemical
Test costs attributable to a SNUN are likely to be much lower than the costs that would be implied by adding up costs of all of the testing recommended in the SNUR for that chemical, and usually are zero. 29 

### See the main text of this report for a discussion of testing.

29 A prior SNUR economic analysis calculated chemical

- spec ific test costs ( EPA, 2007b , Table D

- 4). The chemical

specific table was dropped from a later SNUR economic analysis ( EPA, 2007c ).Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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## APPENDIX E: R eferences

29 CFR 1910. Occupational Safety and Health Standards. Code of Federal Regulations, P art 1910, Title 29, November 25, 1983.

63 FR 41847. Test Guidelines; Notice of Availability, Federal Register, Volume 63, August 5, 1998.

64 FR 60914. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, Federal Register, Volume 64, November 8, 1999.

71 FR 6733. Export Notification; Proposed Change to Reporting Requirements, Federal Register, Volume 71, February 9, 2006. Available from the Federal Docket Management System as docket EPA

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- OPPT

- 2005

- 005 8 at http://www.regulations.gov

.
75 FR 773

. TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; R evisions to Notification Regulations
, Federal Register, Volume 75 , January 6 , 2010.
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. Best, 1997. Personal communication between Tom DeCoff of Eastern Research Group, Lexington, MA and Best Manufacturing Co. technical support services, Austin, TX, December 1997.

BLS, 2006a. U.S. Bureau of Labor Statistics, Employer Costs for Employee Compensation: Changes to NAICS and SOC, Table 2. ECEC Occupational Comparability between SOC and OCS. Downloaded February 2006 from http://www.bls.gov/ncs/ect/sp/ecsm0003 .htm.

BLS, 2006b. U.S. Bureau of Labor Statistics, Employment Cost Index News Release Text: Employment Cost Index, March 2006 (April 28, 2006), at http://www.bls.gov

. BLS, 2006c. U.S. Bureau of Labor Statistics. Change has Come to the ECI (June 14, 2006) at http://www.bls.gov/ncs/ect/sp/ecsm0001.htm
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. Employment Cost Index, Historical Listing Current

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. BLS, 200 8. U.S. Bureau of Labor Statistics, 2008 Congressional Budget Submission (2008) at http://www.dol.gov/dol/budget/2008/PDF/CBJ

- 2008

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– Manufacturing. (May 2014 ) at http://www.bls.gov/oes/current/naics2_31

- 33.htmEconomic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### BLS , 201 5a . U.S. Bureau of Labor Statistics. “ Employer Costs for Employee Co mpensation Supplementary Tables Historical Data December 2006

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. ” March 11, 2015
, 2014

. Available at: http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf (Note: The BLS report title and content are updated periodically to include more recent data, on the same website.)

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. BLS, 201 5 d . Bureau of Labor Statistics. Employment Cost Index

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. Branch, 2006. Raphael E. Branch and Lowell Mason. U.S. Bureau of Labor Statistics, “Seasonal adjustment in the ECI and the conversion to NAICS and SOC.” Monthly Labor Review . Vol. 129, No. 4, April 2006

. Available at www.bls.gov

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. Available a t www.bls.gov
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EPA, 1989

. U.S. EPA, Office of Toxic Substances, Regulatory Impacts Branch. Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Follow

- Up. Washington, DC, July 19, 1989. (OTS/RIB later became OPPT/EPAB.)

EPA, 1992 . U.S. EPA, Of fice of Policy, Planning, and Evaluation. Instructions for Preparing Information Collection Requests (ICRs). Washington, DC, June 1, 1992.

EPA, 1994 . U. S. EPA, Office of Toxic Substances, Regulatory Impacts Branch. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications. Washington, DC, September 9, 1994. (OTS/RIB later became OPPT/EPAB.)Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### EPA, 1997. Office of Pollution Prevention and Toxics. Chemistry Assistance Manual for Premanufacture Notification Submitte rs, EPA 744

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- 003, March 1997. http://www.epa.gov/oppt/newchems/pubs/chem

- pmn/
EPA, 1998 . U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 168 Chemical Substances and Background Support Document for Economic Analysis of Significant New Use Rules. Washington, DC, January 1998.

EPA, 1999 . U.S. EPA, Office of Pollution Prevention and Toxics, Ec onomic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 41 Chemical Substances and Background Support Document for Economic Analysis of Significant New Use Rules. Washington, DC, July 20, 1999

. (Docket OPPTS

- 50635.)

EPA, 2000

. U.S. EPA, Office of Pollution Prevention and Tox ics, ICR No. 1139.06. [Information Collection Request for] TSCA Existing Chemical Test Rules, Consent Orders, Test R ule Exemptions, and Voluntary Test Data Submissions: Supporting Statement for Request for OMB Review under the Paperwork Reduction Act . Attachment 5, Wage Rates Estimation, August 29, 2000.

EPA, 2002a . U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Washington, DC. August 2002.
EPA, 2002b

. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch, Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Washington, DC : June 10, 2002.
EPA, 2003a . U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances. Washington, DC, 2003. Available from the Federal Doc ket Management System as EPA

- HQ

OPPTS

- 2002

- 0078 at http://www.regulations.gov

. EPA, 2003b . U.S. EPA, Office of Pollution Prevention and Toxics. Significant New Uses of Certain Chemical Substances, 68 FR 15061, March 28, 2003. EPA Docket No. OPPT

2002

- 0060.

EPA, 2005 a

. Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements, Novembe r 2005, available from the Federal Docket Management System as EPA

- HQ

- OPPT

2005

- 005 8

- 0017 at http://www.regulations.gov

.Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### EPA, 2005 b

. U.S. EPA, Office of Pollution Prevention and Toxics ICR No. 118.08. [Informatio n Collection Request for] TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (Renewal). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act , October 11, 2005.

EPA, 2006 . U.S. EPA, Office of Pollution Preve ntion and Toxics, Harmonized Test Guidelines, available at http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Effects_Test _Guidelines/index.html

EPA, 2007a . U.S. EPA, Office of Pollution Prevention and Toxics
, ICR No. 0574.14. [Informatio n Collection Request for] Pre

- Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances: Supporting Statement for a Request for OMB Review under The Paperwork Reduction Act , December 6, 2007.

EPA, 2007b . U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances (EPA Docket OPPT

- 2003

- 0063 ), December 4, 2006 (Revised March 12, 2007).

EPA, 2007c . U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 38 Chemical Substances (EPA Docket OPPT

- 2006

- 0898 ), August 17, 2007
EPA, 2008a . U.S. EPA, Office of Pesticides Programs, Economic Analysis of the Proposed Change in Data Requirements for Antimicrobial Pesticides , June 2008, available from the Federal Docket Management System as EPA

- HQ

- OPP

- 2008

- 0 110

- 0046 at http://www.regulations.gov

. EPA, 2008b . U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Final Significant New Use Rule for 183 Perfluo roalkyl Sulfonates , August 20, 2007.

EPA, 2008c . U.S. EPA, Office of Pollution Prevention and Toxics, “New Chemicals Program: Is a Filing Necessary for my Chemical,” (Updated June 23, 2008) web page at www.epa.gov/opptintr/newchems/pubs/whofiles.htm
EPA, 2008d . U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Significant New Use Rule for Chloranil , January 8, 2008. EPA, 2009 a . U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch . Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule

. (EPA

- HQ

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- 0296 ) . July 13, 2009Economic Analysis of Expedited New Use Rule for Thirty Chemical Substances (EPA Docket EPA
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### EPA, 20 12

. U.S. EPA, Office of Pollution Prevention and Toxics. ICR No.: 0795. 1 4 [Information Collection Request for] Notification of Chemical Exports

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. December 18 , 20 12 at http://www.regulations.gov

. Grainger, 2014. Grainger Industrial Supply Online Catalog. Accessed June 2014 at http://www.grainger.com/ Kearney, 1988a. Memorandum to Bill Massouda, Reporting and recordkeeping costs for a generic SNUR, February 3, 1988. [Memo submitted to U.S. EPA/Office of Toxic Substances (now OPPT) under contract 68

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- 3980 with A.T.Kearney, Inc.].
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NTIS. National Technical Information Service. http://www.ntis.gov

. OECD. Organization for Economic Co operation and Development. http://www.oecd.org

. OECD, 2010. Organization for Economic Cooperation and Development. Guidance Manual for the Testing of Manufactured Nanomaterials. June 2010

. Accessed from http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2009)20/rev&d oclanguage=en
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- MD

- PA

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leave/salaries

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### Weinstein, 2004. Harriet G. Weinstein and Mark A. Loewenstein, U.S. Bureau of Labor Statistics. C omparing Current and F ormer Industry and Occupation ECEC Series. Originally posted August 25, 2004 at http://www.bls.gov/opub/cwc/cm20040823ar01p1.htm