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August 29, 201 

# Economic Analysis of Expedited New Use Rule for 78 Chemical Substances(EPA Docket EPA-HQOPPT-2012-0277)

Contract # EP-W-08-010

Final Draft

September 20, 2012

-- Does not contain TSCA CBI –

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 BlankEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 i 

### Contributors

The EPA analyst responsible for this report was St ephanie 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-W08-010.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 ii 

### Executive Summary

This Economic Analysis estimates the potential cost s of Significant New Use Rules (SNURs) covering 78 chemicals that have been the subject of TSCA pr emanufacture notices (PMNs). APPENDIX A: lists each regulated chemical’s generic or specific chemical na me and Chemical Abstract Service Registry Number (CASRN) (if non-confidential). The SNURs are bei ng published under the rulemaking docket number EPA-HQ- OPPT-2012-0277 as direct final rules. The S NURs 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 cost s of any additional 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 associa ted 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 attr ibutable to the SNUR only if, in the absence of the SNUR, the firm would have adopted a different a pproach. For example, a SNUR may define any use other than that described in the PMN as a Signi ficant 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 SN UR. 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 w ithout 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.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 iii 

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

Option 1 Costs Quantified Costs per Chemical (2011$) 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 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 $1,188. For the few SNUR chemicals where these apply, annual costs for worker protection may be $37,412 or more and for haz-comm is $1,088.

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). $6,071 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 electronical ly 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. $8,571 submission cost (including SNUN recordkeeping and $2,500 fee) 4,5 plus ongoing recordkeeping costs of under $1,188. 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. $6,071 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 ac tivity 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 Federa l Regulations). Costs come from Table 3 through Table 8.

1 Firms may follow multiple Options simultaneously.

2 Quantified costs are attributable to the SNUR Significant Ne w Use definition only if a firm would not otherwise follow the specified practices. $37,412 is the annual cost for dermal pr otection selection; impe rmeability testing, heavy-duty gloves, and a lower-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 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” chemic als requiring a PMN, so some firms may need to make a
submission before commerc ial production or import, even in the absence of a SNUR (see Section 2.3 of this report).Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

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### Table of Contents

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

1.1 Statutory Authority and Significant Ne w 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 ........................................................... 2-3

2.1 Comply with SNUR Limits (Option 1) ................................................................................. 2-5

2.1.1 Hazard Communication .......................................................................................... 2-6

2.1.2 Protection in the Workplace .................................................................................... 2-7

2.1.3 Recordkeeping....................................................................................................... 2-12

2.1.4 Hidden Costs: production volume limits, limiting releases to water, PMN uses, import-only, and disposal .................................................................................................... 2-13

2.2 Request Modification or Revocation of a SNUR (Option 2) .............................................. 2-14

2.2.1 Costs of Developing and Submitting Testing Data ............................................... 2-14

2.2.2 Costs for Submitting a Request for Modification or Revocation of a SNUR ....... 2-15

2.2.3 Other Costs ............................................................................................................ 2-16

2.2.4 Total Costs for Option 2 ........................................................................................ 2-16

2.3 Submit SNUN (Option 3) ................................................................................................... 2-16

2.3.1 SNUR “New” Chemicals ...................................................................................... 2-17

2.3.2 Advance Compliance Exemption .......................................................................... 2-18

2.3.3 Costs for Submitting a SNUN ............................................................................... 2-18

2.3.4 Potential for Subsequent Regulatory Actions ....................................................... 2-18

2.4 Request Equivalency Determ ination (Option 4) ................................................................. 2-19

2.5 Decide Not to Produce Chemical (Option 5) ...................................................................... 2-19

2.6 Summary of Costs for Each Option .................................................................................... 2-19

3 Export Notification Costs ..................................................................................................... ......... 3-1

3.1 Estimated Number of Annual Export Notifications per Exporter ......................................... 3-1Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 v 

### 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 .................................................................................................................. ................ 4-1

4.1 SNUN Processi ng Costs ........................................................................................................ 4-1

4.2 Export Notification Processing Burden ................................................................................ 4-4

5 Additional Analyses ........................................................................................................... ............ 5-1

5.1 Regulatory Flexibility Act (RFA) ......................................................................................... 5-1

5.2 Unfunded Mandates Reform Act (UMRA) ........................................................................... 5-1

5.3 Paperwork Reduction Act (PRA) .......................................................................................... 5-2

5.4 Executive Order 12866, Regulatory Planning and Review ................................................... 5-2

5.5 Executive Order 13132, Federalism ...................................................................................... 5-2

5.6 Executive Order 12898, Environmental Justice .................................................................... 5-2

5.7 Executive Order 13045, Protection of Children .................................................................... 5-2

5.8 Executive Order 13175, Tribal Governments ....................................................................... 5-2

5.9 Executive Order 13211, Energy Supply, Distribution, or Use .............................................. 5-3

APPENDIX A: List of PMNs and thei r Chemical Names .............................................................. A-1

APPENDIX B: Inflators and Wage Rates ........................................................................................ B-1

APPENDIX C: Costs of Hazard Communication, Pr otection in the Workplace, and Recordkeeping Requirements .................................................................................................... ............ C-1

APPENDIX D: Costs of Testing ........................................................................................................ D-1

APPENDIX E: References ................................................................................................................. E- 1Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 vi 

### List of Tables

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

Table 1. Summary of Compliance Options and Asso ciated Costs Potentially due to a SNUR ................. 2-4

Table 2. Production and Use Restrictions/Requirements ......................................................................... .. 2-6

Table 3. Annual Costs of Hazard Communication Requirements ............................................................. 2-7

Table 4. Annual Costs of Wor kplace Protection Requirement .................................................................. 2- 9

Table 5. Sample Costs of Workplace Protection ................................................................................. .... 2-11

Table 6. Annual Costs of Recordkeeping Requirements (40 CFR §721.125) ......................................... 2-13

Table 7. Sample Costs of Recommended Testing .................................................................................. . 2-14

Table 8. Costs of Requirement to Modify/Revoke SNUR or Submit SNUN .......................................... 2-16

Table 9. Derivation of Total Mailing Cost for 12 Notices ...................................................................... ... 3-2

Table 10. TSCA 12(b) Export Notifi cation Cost per Notification ............................................................. 3- 3

Table 11. Agency Costs for SNUN and Othe r Submission Review and Processing ................................. 4-3

Table 12. TSCA 12(b) Export Notification Cos t: Agency Burden per Activity (2011$) .......................... 4-4

Table A-1. PMNs and Chemical Names Refe renced in this Economic Analysis ..................................... A-1

Table B-1. Derivation of Loaded Wage Rates .................................................................................... ...... B-4

Table B-2. Derivation of Industrial Hygien ist 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 Distri bution 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 Protec tion Selection [40 CFR §721.63(a)(1)] ................................ C-6

Table C-6. Annual Costs of Impermeabilit y 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-9Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

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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 Respir atory Protection [40 CFR §721.63(a)(4)] .............. C-13

Table C-13. Recordkeeping Estimates from Kearney 1988a and 1988b ................................................ C-22

Table C-14. Annual Per-Chemical Costs of Reco rdkeeping Requirement [40 CFR 721.125] ............... C-23

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-15

Table D-3. Persistent Bioaccumulative Toxi c (PBT) Tiered Testing Requirements .............................. D-17Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

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## 1 Introduction

This report presents the U.S. Environmental Protecti on Agency (EPA), Office of Chemical Safety and Pollution Prevention’s (OCSPP)’s analysis of the po tential costs incurred as a result of direct final Significant New Use Rules (SNURs) being promulga ted for 78 chemical substances which have gone through premanufacture notice (PMN) review. 1 

### The SNURs are being published under the rulemaking
docket number OPPT-2012-0277. APPENDIX A: lists th e generic or specific chemical name and Chemical Abstract Service Registry Number (CASRN) (if non-confidential) for each PMN.



### 1.1 Statutory Authority and Significan t 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 manuf acturers 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 wa s the subject of at least one premanufacture notice submitted under the Toxic Substances Control Act (TSCA), and is now being regulated as a result of PMN review. For the current rulemaking, 41 of the 78 chemicals have commenced commercial manufacture 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 cu rrent rulemaking, SNUR requirements for 7 of the 78 substances are based on prior Consent Orders.

EPA promulgates a SNUR to designate specific activ ities involving the chemical substance that EPA has determined constitute a “significant new use.” No pers on may manufacture or process a chemical substance for a significant new use, unless they submit a signific ant new use notice (SNUN) to EPA at least 90 days in advance. Examples of typical “significant new uses” th at can trigger the requirement to submit a SNUN (if EPA has promulgated a SNUR a pplying 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 wate r 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 that are covered by ICR No. 1188 (OMB Control Number 2070-0038).Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 1-2 

###  Handling the chemical without employing specifi ed personal protective equipment (e.g., gloves, goggles, respirators) or hazard communication (h az-comm) measures (e.g., label, MSDS, worker training)

If EPA does not promulgate a SNUR for a given ch emical, 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 designa tions, as long as the person does not engage (nor intend to engage) in any activities defined by the S NUR as a significant new use, then that person may proceed to handle the chemical without submitting a SNUN.



### 1.2 Summary of Methodology

This analysis quantifies, to the extent possible, the co sts to society of the propo sed rule by identifying the costs to industry associated with complying with the ru le, and the costs to EPA of administering the rule. Types of industry costs analyzed include those for worker protection, hazard communication, testing, submission of required information, export notifi cation, and recordkeeping. Agency costs include reviewing and processing the data received as a result of the rule. Data sources for this analysis include burden estimates derived from previous information co llection requests and economic analyses for related rules, compensation data acquired from government pub lications, and supplementary market research to produce an estimate of the universe of affected entitie s and measure the impact of the proposed rule on
small entities.

In previous economic analyses of SNURs, EPA identif ied those requirements under Subparts A, B, C, and D of 40 CFR §721 that may indirectly impose costs on manufacturers, 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 anal yses and are presented as part of this analysis. Resources were not available to quantify other costs, such as for limiting releases to water, avoiding uses not listed in the PMN, or keeping production be low a specified level; they are described only qualitatively.

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



### 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 pr esents estimates of the costs that could be incurred by manufacturers, importers, and/or processors under 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 executive orders. APPENDIX A: lists the chemicals that are subject to the propo sed SNURs. Appendix B provides the wage rates and inflators used in this analysis. Other appendi ces give cost estimation details and references.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-3 

## 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 manufacturing, importing, or processing the SNUR chemical. A SNUR recommends testing, but does not requi re 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 submitti ng a Significant New Use Notice for a proposed new use. These options are described below along with their costs.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-4 

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

Option 1 Costs Quantified Costs per Chemical (2011$) 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 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 $1,188. For the few SNUR chemicals where these apply, annual costs for worker protection may be $37,412 or more and for haz-comm is $1,088.

2 Submit a request fo r 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). $6,071 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 electronical ly 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 S NUN, but such testing
is not required by law. $8,571submission cost (including SNUN recordkeeping and $2,500 fee) 4,5 plus ongoing recordkeeping costs of under $1,188. 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 w ould 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 de termination. $6,071 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 ac tivity 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 Federa l Regulations). Costs come fr om Table 3 through Table 8.

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 spe cified practices. $37,412 is the annual cost for dermal protection sele ction; impermeab ility testing, heavy-dut y gloves, and a lower-c ost respirator (see Table 5). Some firms may have export notific ation 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 requ iring a PMN, so some firms may need to make a submission befo re commercial production or import, even in the abse nce of a SNUR (see Section 2.3 of this report).Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-5 

### 2.1 Comply with SNUR Limits (Option 1)

A firm can avoid engaging in a Significant New Us e 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 reflects either the use scenario described in the PMN for that chemical (what th e submitter was already planning to do) or the requirements in the 5(e) Consent Order resulting fro m the PMN submission. Thus, it is likely that the typical 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, there will be export
notification costs that result from the TSCA Section 12 (b) requirements 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 gene ral 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).Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-6 

### 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

(2011$)

§721.63 Workplace protection 24 $12,439 to $37,412
§721.72 Hazard communi cation 9 $1,088 Industrial Commercial, and Cons umer Activities (§721.80) §721.80(a, b, c) Enclosed use only 1 Not quantified §721.80(d, e) Use at site only 0 Not quantified §721.80(f) Import only (do not manufacture) 5 Not quantified §721.80(g, h, i) Use only as intermediate 3 Not quantified §721.80(j, k) Engage only in uses listed in PMN or Consent
Orde r 18 Not quantified

§721.80(l, m, n, o) Limits non-industrial uses 11 Not quantified §721.80(p, q, s, t) Limit production volume 15 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 1 Not quantified §721.90 Limit releases to water 50 Not quantified §721.125 3 Recordkeeping for all manufacturers, 78 Up to $1,188

Notes:

1 Some chemicals have more than one type of restriction.

2 $12,439 is the annual cost for dermal prot ection selection and heavy duty gloves. $37,412 is the annual cost for dermal protection selection; heav y duty gloves, impermeability tes ting/evaluation of manufacturer specifications, and a lower-cost respirator (see Table 5).

3 This excludes SNUN recordkeepi ng under §721.40. See the recordk eeping discussion in APPENDIX C:.

Source : Costs are summarized in Table 3, Table 4, and Table 6, and derived in APPENDIX C:.


### The costs of meeting the haz-comm, protective equipm ent, and recordkeeping requirements are quantified for this report. APPENDIX C: presents a more detaile d 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 affect a significant number of the chemicals, such as costs associated with limiting releases to water, that were not quant ified for this report; these costs are also summarized
below.

2.1.1 Hazard Communication

Requirements. Each SNUR may require firms that manufacture, 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 that 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 Rul es: General Provisions for New Chemical FollowupEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-7 

### (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 saf ety 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 equipment 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-co mm 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 detailed cost derivation.

Table 3. Annual Costs of Hazard Communication Requirements

Requirement Cost (2011$) 1,2 Hours

Update written program $211 4

Labeling Distribution in commerce $140 0.5 Use in the workplace $383 1.5 MSDS preparation $141 2.25 Employee training $214 6.75
TOTAL $1,088 15

Notes: 1 Figures are rounded to whole dollars. Substances no t subject to all of thes e requirements may have lower costs. See Table C-1 through Table C-4, and Section C.1.1 for derivations.

2 Hourly labor costs are derived in Table B-1.



### 2.1.2 Protection in the Workplace

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. The core components of the worker protection requirements include provision of personal protective equipment (PPE) such as gloves, goggles, protective clothing, and respirators.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-8 

### In some cases, EPA specifies the type of PPE require d. 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 PM N substance by one or both 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 protec tion is found in Table 5. The costs of worker protection were originally estimated in a 1989 EPA report, Economic Analysis of Final Significant New
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 w ith the number of workers. APPENDIX C: gives the
detailed cost derivation.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-9 

### Table 4. Annual Costs of Workplace Protection Requirement

Personal Protective Equipment an d Requirement Citation at 40 CFR Unit Cost (2011$) 1 Quantity Required 1 Total Annual
Cost 2 (2011$) Dermal Protection Selection §721.63(a)(1) 10 hours industrial hygienist (IH) time $52.63 10 $526 Impermeability Testing §721.63(a)(3) Impermeability Test $1,335 1 $1,335
Evaluation of Manufactur er's Specifications $211 1 $211 Gloves §721.63(a)(2)(i) Standard (disposable) $0.60 6,250 $3,767 Heavy-duty butyl $47.65 250 $11,913 Protective clothing §721.63(a)(2) [ii] - Full- b od y ( coverall with hood ) $85.77 75 $6,433 [iv] - Coverall (no hood) $50.80 75 $3,810 Eyewear §721.63(a)(2)(iii) Standard goggles $5.68 75 $426 Heavy-duty goggles $8.48 75 $636 Respirator Types 3 Supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-f itting full facepiece. [similar to §721.63(a)(5)(ii)] $1,127 25 $28,171

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). [s imilar to §721 .63(a)(5)(iii)] $1,306 25 $32,660

Air-purifying respirator equipped with a tight-fitting full facepiece and High Efficiency Particulate Ai r (HEPA) filters.[similar to §721.63(a)(5)(iv)] $937 25 $23,428

Air-purifying, tight-fitting respirator (either half- or full-face) equipped with N100 (if aerosols absent), R 100, or P100 filters. [similar to §721.63(a)(5)(iv)] $937 25 $23,428

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)] $3,367 25 $84,175

Powered air-purifying respirator eq uipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters. [similar to §721.63(a)(5)(v)] $3,367 25 $84,175

Powered air-purifying respirator equi pped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters. [similar to §721.63(a)(5)(vi)] $2,621 25 $65,517Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-10 Notes:

1 Quantities assume: 1) 25 workers exposed 250 days per year; 2) standard gloves replaced daily and heavy-duty gloves replaced ev ery 25 days; 3) respirator units replaced annually and cartridge sets replaced every five days (50 cartridges sets per year); 4) go ggles and protective clothing replaced three times yearly.

2 Total annual costs were calculated using unrounded unit cost estima tes, and may not equal the product of the rounded estimates
shown in this table.

3 This table lists respirator choices that typically would satisfy SNUR requirements fo r a particular chemical, for current and r ecent SNURs. Future SNURs may list different choices. The citations in brackets refer to respirator types listed at 40 CFR. While the SNURs no longer reference the §721.63(a)(5) ca tegories, costs in this analysis are based on costs estimated in 1997 for the §721.63(a)(5) categories. See Table C-10 for th e 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 an y add-on items such as hoods, h elmets, cartridges, filters, and caps, if these items are required for a particular respirator.

Source: APPENDIX C : , Tables Table C-5 through Table C-11.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-11 

### The costs of purchasing protective equipment are de rived in APPENDIX C:, and have been annualized based on the assumptions listed above regarding thei r use and lifetime in the workplace. Costs for evaluating hazards when PPE is not specified in th e 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 th e workplace, including the PPE 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 tim e for dermal protection selection. The maximum cost includes the cost of gloves, dermal protection, impe rmeability testing, and the annual cost of the least expensive respirator and filters for 25 workers.

Table 5. Sample Costs of Workplace Protection

Cost Element Annual Cost (2011$)
Example #1: Gloves and Dermal Protection Selection Heavy-duty butyl Gloves $11,913 Dermal Protection Selection $526 Total per site with 25 workers $12,439 Example #2: Gloves , Testing, and Respirator Heavy-duty butyl Gloves $11,913

Dermal Protection Selection $526 Impermeability Test $1,335 Evaluation of Manufacturer's Specifications $211 Least Cost Respirator $23,428 Total per site with 25 workers $37,412

Source : Table 4.



### In cases where the SNUR specifies the type of protec tive 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 progra m related to other chemical hazards, or to comply with OSHA’s PPE standards), these costs may be an overestimate 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 determina tion. Table 4 shows costs of assessing needs and demonstrating impermeability. These cost estimates woul d reflect a situation where the dermal protection is already in place but the manufacturer must demonstrate that it is adequate. If companies also have to purchase additional protective gear, incremental costs a ttributable to the SNUR would include the added items. For example, if a firm already providing gloves and goggles determined that it would have to add protective clothing to avoid engaging in a Signifi cant New Use, this would increase costs even if particular protective clothing is not specified in the SNUR.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-12 

### 2.1.3 Recordkeeping

Requirements. Under 40 CFR §721.40, recordkeeping is required for SNUN submitters. This recordkeeping cost was included in the SNUN submi ssion cost and is not separately estimated here. 3



### In addition, the SNURs specify recordkeeping requi rements for manufacturers, importers, and processors, by identifying paragraphs selected from 40 CF R §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 recordkeeping would be needed. R&D recordkeeping costs were not estimated for this report.)

SNUR recordkeeping requirements essentially involv e copying and filing relevant records, including those related to manufacturing, importing, or pr ocessing volumes; shipment 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, nature 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 r ecordkeeping could continue 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 and clerical labor time, photocop ying charges, and costs for records storage.

Table 6 summarizes recordkeeping co sts by requirement at 40 CFR §721.125. The totals in Table 6 provide the cost if all recordkeeping requi rements 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 Informat ion 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).Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-13 

### Table 6. Annual Costs of Recordkeeping Requirements (40 CFR §721.125)

40CFR §721.1252 Cost Element Cost (2011$) 1 Hours (a)(b)(c) Volumes & sales/tr ansfer data $336 7.11

(d)(e) Protective clothing [§721.63] and $13.86 0.29

(f) Haz com program [§721.72] $173 3.67 (g) Label copies [§721.72(b)] $3.46 0.07 (h) MSDS copies [§721.72(c)] $3.46 0.07 (i) Use limitations compliance [§721.80] $173 3.67 (j) Disposal compliance [§721.80] $416 8.80 (k) Water discharge compliance [§721.90] $69.28 1.47 TOTAL $1,188 25.15

Notes:

1 Recordkeeping applies to all SNUR chemicals. This table does not cover recordkeeping for SNUN submissions. See
APPENDIX C : Table C-14 for derivations.



### 2.1.4 Hidden Costs: production volume limits, limiting releases to water, PMN uses, import-only, and disposal

Several types of costs that may be incurred by co mplying with the significant new use designations are not quantified in this report, including production volume limits, releases to water, 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 sale may have to restrict its
sales of the chemical. If the chemical is for intern al use, it may have to substitute to a less costeffective chemical.

 A producer could incur costs of determining whether discharges to water would constitute a Significant New Use and of li miting 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 substitu te to other chemicals or technologies that cost more or have lesser performance resulting in higher production costs.

 Importing could be costlier than manufacturi ng a PMN substance in the United States.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-14 

### 2.2 Request Modification or R evocation of a S NUR (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 restricti ons (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 discussed 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 S NUR identifies health, ecological, and/or fate/transport/transformation testing that would help ch aracterize 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 recomme nded tests, or other tests, would be performed by 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 additional testing is performed to support a m odification request, costs may be simi lar 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 Description Estimated Cost (2011$)
Ecotoxicity Base Set OPPTS 850.5400 Algal Toxicity, Tiers I and II $18,873 OPPTS 850.1010 Daphnid Acute Toxicity $15,619 OPPTS 850.1075 Fish Acute Toxicity $21,524 Sample TOTAL Testing Cost: $56,016

Source: Costs are from Table D-1.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-15 

### 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) are estimated to be similar to th e 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 th e 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 Manufactur ers Association (CMA, 1991), which became the American Chemistry Council. The burden associated with PMN submission and preparation 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. 4 

### Electronic submission of SNUN forms is expected to remove all clerical burden associated with preparing a SNUN (EPA, 2009a, p.7). In addition, electronic submission is expect ed reduce all recordkeeping burden associated with SNUN submissions by fifty percent. Because, the re cordkeeping 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 hours 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 deri ved 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 d escribed in Appendix B.

4 Economic Analysis of Expedited Significant New Use Ru les for 25 Chemical Subst ances: EPA Docket OPPT-2009-
092 2, was the first report to consider the burden redu ctions resulting from elect ronic submission of SNUN forms and requests for equivalency 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 r ecordkeeping in addition to the burden estimates from the 1994 RIA (EPA, 1994, p. III-14). These burden estimates (the 0.5 fo r clerical burden and 0.5 for technical burden) are based on the recordkeeping burden for polymer exceptions and not the recordkeeping
burden associated with PMN submissions. Therefore, for this analysis, th e 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 are not applicable because the entire cler ical burden is assumed to be elim inated under the el ectronic reporting requirements. In summary, we do not include the one hou r recordkeeping burden (0.5 hour for clerical, 0.5 for technical) reported in the ePMN EA.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-16 

### 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 fo rego 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 Si gnificant New Use. EPA may not revoke all SNUR provisions as a result of the 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 modificati on or revocation were discussed under Option 1.

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

Labor Category Average
Hours Loaded Wage
Rate 1 (2011$) Total Labor Cost (Loaded Wage x Average Hours) Request to Modify
SNUR (Option 2) SNUN (Option 3) Equivalency
Determination

(Option 4)

Clerical 2 0 $29.63 $0 $0 $0

Technical 3 74.2 $64.66 $4,798 $4,798 $4,798 Managerial 3 18 $70.72 $1,273 $1,273 $1,273
Subtotal 92.2

-- $6,071 $6,071 $6,071 User Fees (SNUN only) $0 $2,500 $0

TOTAL $6,071 $8,571 $6,071

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, unr ounded values are used to calc ulate total labor costs. For this reason, total labor 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 ma nagerial labor is from the PMN Am endments RIA (EPA, 1994, Table III-2).



### 2.2.4 Total Costs for Option 2

The total costs associated with requesting a modifica tion 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 before the firm plans to commence the manufacture, import, or processing of the substance. For example, they could submit a SNUN if they wi sh to produce above the volume limit listed in the SNUR for a given chemical, since any production be yond that volume would be defined as a Significant
New Use.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-17 

### The SNUN provides EPA with the opportunity to evalua te 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, and 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 produc tion 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 recommended 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 a ny such costs are likely to be zero or low.

The assumption regarding testing is based on an anal ysis of the 18 SNUNs submitted over a three-year period, from 2005 through 2007. A lis t of human health tests submitted to EPA with PMNs and SNUNs
was also available from a confidential database main tained by EPA’s Office of Pollution Prevention and Toxics Risk Assessment Division. Only one SNUN describ ed 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 acute toxicity and daphnid acute toxi city) 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 subj ect 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 TSCA 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 subm itter intends to engage in a significant new use. Either way, the firm uses the same submission fo rm and provides the data listed at 40 CFR §720.45. Consequently, for this special situation, the submissi on cost is incurred due to PMN requirements, not dueEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-18 

### 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 w ith EPA a firm might diminish any loss of profits due to delay. This option is not ava ilable 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 cost s 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 a dditional regulatory actions might be necessary to
further evaluate an intended new use and associated activ ities, or to prohibit or li mit 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 circumstances surroundi ng the individual SNUN (e.g., available information and sci entific 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 furt her regulatory actions, the Agency will initiate and follow the appropriate procedures for taking those ac tions. Included in those procedures would be an
assessment of the costs and benefits of those actions.

Subsequent regulatory action may be a Consent Or der 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 be nefit-cost analyses prepared under some other TSCA
Sections.

The description above was adapted 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 are from the U.S. EPA Office of Pollution Prevention and Toxics, Economic and Poli cy Analysis Branch. The nature of the follow-up regulatory action and benefit/cost analysis may diffe r between SNUNs for newer chemicals submitted as a result of a direct final rulemaking such as this one, and SNUNs for older chemicals such as chloranil and most perfluoroalkyl sulfonates.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-19 

### 2.4 Request Equivalency Determination (Option 4)

Under 40 CFR §721.30, EPA may review applications from facilities who propose alternative methods 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 to 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 equivalenc y determination request, each submitter will also incur costs to develop data to support the request. However, total costs of the equivalency option should be no more than the costs of complyin g 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 Decide Not to Produ ce Chemical (Option 5)

Some firms may find that the costs of meeting the S NUR requirements and/or rest rictions (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 sp ecifications in the SNUR or submitting a request for some alternative, it entails the “hi dden” cost of the profit that will be foregone as a result of not engaging in the commercial activity originally planned. Fo r example, if the firm does not produce the SNUR substance, then it will forego the profit it would ha ve 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 subs tance, it will incur those additional costs of production. If the firm elects to produce for R&D purposes only, it may have costs associated with R&D recordkeeping attributable to the SNUR.

Firms that exercise Option 5 may still incur export no tification 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 complian ce 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, annua l shipments of a bout 10,000 kilograms per site. Costs are not otherwise adjusted for the nature of the chemical or process, volume, location, or other firmspecific or chemical-specific factors.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-20 

### As mentioned above, costs are estimated for one ch emical at one site, not for aggregate production. Resources were not available to estimate aggregate co sts. Among other things, it is not known how many firms are affected by the SNURs. EPA receives a ha ndful 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 ne ver make a submission. It is not known how many
firms are affected but do not make a submission. Al so, 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 additi on, often have confidentia l chemical identities.

 For firms manufacturing, importing, or processing within SNUR restrictions to avoid a Significant New Use (Option 1), quantifiable co sts can range from about $1,200 (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, such as restrictions on releases to water or on other aspects of use.

 For submissions to EPA (Options 2, 3, and 4), th e basic one-time submission cost is estimated at $6,071, including recordkeeping for the submissi on. For the SNUN (Option 3), EPA also collects 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 subs tance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7. Consequently, after submitti ng a SNUN, the firm may need to comply with restrictions as a result of the SNUN review pro cess, possibly leading to further costs similar to those in Option 1.

 Rarely, firms may choose to perform toxicity an d/or environmental fate testing to support a SNUN (Option 3). Such testing is not mandatory. Costs for such testing are expected to be zero for most SNUNs and expected to be low fo r the few SNUNs for which a submitter might voluntarily perform such testing.

 Companies that might have manufactured, importe d, or processed a chemical in the absence of the SNUR may incur “hidden” costs, such as loss of profits from delayed or fo regone sales, if they avoid the chemical 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 any 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 boun d 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 chemi cal is not on the TSCA Inventory, firms that haveEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 2-21 

### not yet submitted a PMN must submit one to EPA be fore commercial production/import, with or wit hout the SNUR (see Section 2.3, SNUR “New” Chemicals).

If the SNUR reflects the PMN use scenario, and the PM N 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 and other costs for reasons other than the SNUR, so that SNUR requirements may impose no added costs. 6

6 Earlier SNUR economic analyses calcu lated possible haz-comm, worker protection, testing, and other costs for each PMN chemical (EPA, 2007b, Tables 9, 10, D-4). The chemi cal-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.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 3-1 

## 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 secti ons (40 CFR §707.60 through 75). Fo r TSCA 5(a)(2) (the section under which EPA promulgates significant new use rules) a nd certain other TSCA sections, this is a one-time notification requirement 7 

### per destination country for each expor ter of a chemical substance. 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 bur den associated with making export notifications, EPA first estimated the average annual number of export no tifications made by an exporter, in Section 3.1.
EPA then derived the annual and per notification burden associated with preparing and submitting an export notification, in Section 3.2. 8



### EPA estimated the average burden associated with ma king a single notification, but did not estimate either the total number of exporters of a SNUR ch emical 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 the 2009 TSCA Section 12(b) ICR, ICR No.: 0795.13 [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, 2009b), with updating
for inflation.



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

EPA’s 2009 TSCA Section 12(b) ICR estimated that the average e xporter making notifications will make 12 notifications per year

. 9 

### This includes notifications resulting from SNURs and notifications resulting from other TSCA activities. A notification is typica lly no more than one page per chemical/country combination, and one notification mailing often includes multiple chemicals and/or destination
countries. 10

7 On November 14, 2006, EPA revised the export notifica tion requirement for chemicals 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 Use Rules for 25 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 the 2009 TSCA Section 12(b) ICR (EPA, 2009b) by dividing the estimated number of submitted notifications (3,500) by the estimated number of exporters (300).

10 Based on review by an EPA economist of notifications received under TSCA Sections 4, 5 and 6 over approximately three we eks in early 2010.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 3-2 

### The percent of notifications due to PMN SNURs is unknown, and it is also unknown how many notifications may result from this rulemaking, as not all manufacturers may choose to export a chemical, or they may make several notifications for a single chemical.



### 3.2 Exporter Costs

The 2009 TSCA Section 12(b) ICR (EPA, 2009b, pa ge 11, Table 3), estimated the annual export notification cost for an exporter under the one-tim e 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, writing or revising an export notifica tion letter to EPA, checking the outgoing shipments, and sending the notification letters w ith 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 be nefit from economies of scale and have lower costs per notification; those making fewer notificati ons may have higher costs per notification.

3.2.1 Estimated Submission (Mailing) Costs

Regulated companies 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, 2012). The estimated per-shipment and annual ma iling costs incurred by individual submitters are
detailed in Table 9.

Table 9. Derivation of Total Mailing Cost for 12 Notices

Postal Service Cost Registered mail, regular, with $0 declared value $10.95 Return receipt, requested at time of mailing (receive by mail) $2.35 Postage, regular First Class, up to 1 ounce $0.45 Cost per export notice - Subtotal $13.75
× 12 Total Mailing Cost for 12 Notices $165.00

Source: Mailing rates are from the US Postal Service web site as of March 2012 (https://www.usps.com/ship/se rvice-chart.htm). The mail ing 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 ec onomic analysis (EPA, 2007c, Table 8).



### 3.2.2 Compile and Maintain the List of Products

Since TSCA §12(b) information collection activity h as 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 new 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 tim e (EPA, 2009b). 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, 2009b).Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 3-3 

### The number of submitters per year who report unde r TSCA §12(b) has varied over time, rising from around 160 in 1991 to over 460 in 2000, and declining since. In the most recent TSCA §12(b) ICR, EPA estimated there would be approxima tely 300 submitters per year in near-future years (EPA, 2009b). Of these 300 submitters, EPA estimated that 200 companies were near the lower burden estimate of 2 hours per year, and 100 companies were near the upper estim ate of 24 hours per year. Compiling the list for all respondents was therefore estimated to take 2,800 hours (2 hours × 

### 200 firms plus 24 hours × 

### 100 firms), or an average of about 9.3 hours of technical time pe r firm per year for 12 notifications per year (EPA, 2009b).

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 shipments are made. Time fo r 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 proportion of legal time) per firm per year for 12 notifications per year (EPA, 2009b).

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 described 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 notif ication or 6 hours for 12 notifications (EPA, 2009b).

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

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

Technical Clerical Total
$/Hr Hours 2011$ $/Hr Hours 2011$ 2011$ Hours
Compile list $64.66 9.3 $601 --

-- -- $601 9.3

Write letter $64.66 1 $64.66 --

-- -- $65 1

Check order and send

-- -- -- $29.63 6 $178 $178 6
Mailing cost 1

-- -- -- -- -- -- $165 -
Total per facility 2` 10.3 $666 6 $178 $1,009 16.3
Total per Notification 0.86 $55.50 0.50 $14.81 $84.06 1.36

Notes:

1 Mailing costs reflect March 2012 U SPS rates and can be found in Table 9.

2 An average facility submitting notifications is assumed to submit 12 e xport notifications per year.

Source: Appendix B of this report derives technical a nd clerical hourly labor costs. Other costs are from ICR No.: 0795.13 [Information Collection Request for] Notifi cation of Chemical Exports - TSCA Section 12(b) Supporting Statement for Request for OMB Review under the Paperwork Reduction Act (EPA, 2009b, p.10), and are updated to 2011 dollars.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 4-1 

## 4 Agency Costs

This SNUR is expected to generate Agency co sts for both SNUN review and processing, and export notification processing. Because it is unknown how ma ny 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 equivale ncy determination – are assumed to be similar to
EPA costs to review PMNs. 11



### The list of review steps, estimates of staff-year full- time equivalents (FTEs), estimates of extramural costs, and the percent of chemicals requiring a par ticular review step are derived from the costs for processing PMN submissions in Tabl e VII-1 of a 1994 EPA report, Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994). The Agency burden associated with processing a SNUN has been adju sted 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 continues to assume that Agency per-submission cost s 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 j udgment 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, 2011). The original PMN cost estimates were for GS 12 and were presented as low and high estimates, 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 leve l and, for simplicity, a single intermediate pay rate (Step 5) within that GS level. A loading factor of 1.6 was applied to the salary to reflect fringe benefits and overhead (EPA, 1992). The loaded salary cal culations 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 Us e Rules for 25 Chemical Substances: EPA Docket OPPT2009-092 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
submission estimates.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 4-2 

### For each review step, the “EPA staff” cost is calcu lated by multiplying the number of FTEs (in the first column) by the fully loaded aver age 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 step, infl ated from 1993 prices, as explained in Appendix B

.
The Percent of Cases is a weighting factor applied to reflect the fact that not all chemicals require each review step. For example, in the PMN process, all chemicals require Administrative Prescreening, but not all chemicals require the intensive scrutiny of “S tandard Review.” The three types of submissions resulting from a SNUR may have weighting factors th at 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 determined to be “invalid” – i.e. not required in the first place. Howeve r, 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 requiri ng EPA 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 review steps and weighting factors are assumed to be the same as those derived in 1994 for PMNs.

The Weighted Cost column is calculated by multiply ing the Unweighted Costs (EPA staff cost plus extramural costs) by the percentage of cases requiring this review step. 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 s ubmission review and processing shown in Table 11.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)August 29, 2012 4-3Table 11. Agency Costs for SNUN and Other Submission Review and Processingview StepsEPA staff (FTE) CostExtramural Cost2UnweightedCostPct. ofCasesWeightedCost3ePMNBurdenReduction4Weighted Costwith ePMNBurden ReductionFTEfractionCost perFTE1FTE Total(2011$)1993$2011$(a)(b)(c)=(a)*(b)(d)(e)(f)=(c)+(e)(g)(h)=(f)*(g)(i)(j)=(h)*(1-(i))Pre-notice Consultation0.0024$161,446$387$4.00$6.91 $394 41%$162 0.165$135Administrative Prescreen/NoticeReceipt/User Fee0.0024$161,446$387$92.00$158.87 $546 100%$546 0.165$456CRSS (Chemical Review and SearchStrategy)0.0025 $161,446$404$268$462.80 $866 100%$866 0.165$723SAT (Structure Activity Team)0.0006 $161,446$96.87$14.00 $24.18 $121 100% $121 0.165$101.07Engineering/Exposure0.0015 $161,446$242$56.00$96.70 $339 100%$339 0.165$283Exposure/Fate0.0008$161,446$129$0.00$0.00 $129 100%$129 0.165$108Focus0.0009$161,446$145$23.00$39.72 $185 100%$185 0.165$154Standard Review Functions0.0219$161,446$3,536$511$882.43 $4,418 29%$1,281 0.165$1,070Division Directors Meeting0.0129$161,446$2,083$113$195.14 $2,278 15%$342 0.165$285Order Development/Negotiation Review0.0171$161,446$2,761$22.00$37.99 $2,799 3%$83.96 0.165$70.11Post Order Data Review0.0886$161,446$14,304$0.00$0.00 $14,304 3%$429 0.165$358Order Modification0.2167$161,446$34,985$0.00$0.00 $34,985 3%$1,050 0.165$876New Chemical SNUR Development0.0277$161,446$4,472$85.00$146.78 $4,619 7%$323 0.165$270Notices of Commencement0.0012$161,446$194$40.00$69.07 $263 31%$81.47 0.165$68.03FOIA (Freedom of Information Act)Requests0.0333$161,446$5,376$287$495.61 $5,872 1%$58.72 0.165$49.03CBI (Confidential Business Information)Substantiation0.0004$161,446$64.58$3.00$5.18 $69.76 100%$69.76 0.165$58.25TOTAL$6,0670.165$5,066Notes:1GS-13 Step 5 salaries loaded with benefits and overhead. See Table B-1 derivation.2Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993 prices as described in AppendixB.3Weighted costs were calculated using unrounded unit cost estimates, soresults may differ from calculations using the rounded values shown in this table.4Electronic submission is expected togenerate 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, 2011.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 4-4 

### 4.2 Export Notification Processing Burden

Under TSCA Section 12(b), exporters must notify EPA if they intend to export chemicals subject to SNURs, as described in Chapter 3 above. The Ag ency burden and cost due to TSCA §12(b) export
notification result from three tasks. In the first t ask, EPA receives export notifications from companies that intend to export one of the chemicals subject to TSCA §12(b) (EPA, 2009b). 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, 2009b). (See Table 9 for the cost of mailing one notification). The third task is comprised of EPA staff responses to public inquiries and other TSCA 12(b) activities. The work of responding to non-routine requests for information and clarification from industry and im porting countries, and of handling other tasks associated with the TSCA §12(b) program, was estimated to require roughly 400 hours per year (EPA, 2009b). Since the current rulemaking covers only a very small percent of the ch emicals subject to TSCA 12(b) reporting, a very small percent of such activit y will be attributable to the current rulemaking.

Because it is unknown how many, if an y, notifications EPA will receive or send as a result of the current rulemaking, the costs to the Ag ency are presented per activity. 13 

### The burden for the first two Agency activities is provided in Table 12 below. To estimate the Agency cost, hourly burdens 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 (2011$)

Agency Activity Hours per Activity FTE per Activity1 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 an incoming
notification from an exporting company 0.1 0.000048 $161,446 $7.76

Prepare and mail a
notification to an importing country 0.5 0.000240 $161,446 $13.75 $52.56

Notes:

1 The burden associated with an Agency activity is the burden for the Agency to process one incoming notification, or to prepare and mail an outgoing notification Source: APPENDIX B: of this report derives Agency labor costs. Mailing costs are from Table 9 of this report. Other burdens are from ICR No.: 0795.13 [Information Collectio n Request for] Notification of Chemical Exports - TSCA Section 12(b) Supporting Statement for Request for OMB Review under the Pape rwork Reduction Act (EPA 2009b), updated for inflation.

13 Beginning with the report Economic Analysis of Ex pedited Significant New Use Rules for 25 Chemical
Substances: EPA Docket OPPT-2009-0922 , the Agency cost per activity is pr esented, and not the entire Agency costs resulting from export notifications.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 5-1 

## 5 Additional Analyses

This chapter presents additional analysis of other po tential 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 regulator s to consider the impact of regulations on small entities, in particular small businesses. The requi rement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a significant new use. Where a use is new, by definiti on no small or large entities presently engage in such activities. Although some small entities may decide to manufacture or process a substance for the new use after the SNUR is promulgated, EPA receives very few SNUNs, and few of those are submitted by small entities. In response to the promulgation of SNURs covering 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, ei ght in FY2008, seven in FY2009, two in 2010, and ten in 2011 (EPA, 2012), for an average 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 regardless of the size of the firm, averaging about $8,600 including SNUN recordkeeping and reporting costs. The Agency currently offers some relief to certain small businesses with sales (includi ng those of subsidiary/parent companies) of less than $40 million 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 $6,200 for smaller firms. During the six year period from 2005-2010, only three submitters self-iden tified as small in their SNUN submission 14 

### (EPA, 2012). EPA believes the cost of submitting a SNUN is relatively sma ll 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 impact.

In response to a SNUR, firms could also decide to re quest an equivalency determination or a request for
SNUR modification or revocation. The submission co st for these requests is about $6,100. EPA believes this cost to be low compared to the cost of deve loping 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 substantial 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 Ma ndates Reform Act of 1995 (Public Law 104-4).

14 The three “small” submitters were id entified by review of actual SNUN submissions from the years 2005-2010.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 5-2 

### 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, and a person is not required to respond, to a collection of information that requires Office of Management and Budget (OMB) a pproval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The in formation collection requir ements 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, Regul atory Planning 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 SNURs 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 ensure “meaningful and timel y input by State and local officials in the development of regulatory policies that have fede ralism implications.” This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalis m (64 FR 43255, August 10, 1999).



### 5.6 Executive Order 12898, Environmental Justice

This action does not involve special considerations of environmental just ice related issues as required by Executive Order 12898, Federal Actions to Address Environmenta l Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).



### 5.7 Executive 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 asse ss environmental health and safety risks that may disproportionately affect children. This type of analys is 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 such impacts on children is required.



### 5.8 Executive Order 13175, Tribal Governments

Executive Order 13175 is Consultation and Coordination wi th 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 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 5-3 

### 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 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 A-1 

## APPENDIX A: List of PMNs and their Chemical Names

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

No. PMN 1 CAS RN 2 Name 2

1 P-00-0535 243640-46-2 1-Octadecanol, manuf. of, distn. lights, fractionation heavies, distn. lights. 2 P-01-0579 N/A Acrylate ester (generic)

3 P-02-0161 359406-89-6 Phosphonium, tetrakis(hydroxymethyl)-, chloride (1:1), reaction products with
1-tetradecanamine and urea 4 P-02-0653 N/A Bis[phenyl-2H-1,3-benzoxazine]derivative (generic) 5 P-02-0984 404362-22-7 1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.

6 P-03-0481 135285-90-4 5,2,6-(Iminomethenimino)-1H-imidazo[4,5-b]pyrazine, octahydro1,3,4,7,8,10-hexanitro7 P-03-0624 1731-79-9 Dodecanedioic acid, 1,12-dimethyl ester 8 P-04-0079 449177-94-0 Oxetane, 3-methyl-3-[(2,2,3,3,3-pentafluoropropoxy)methyl]- 9 P-04-0080 475678-78-5 Oxetane, 3-methyl-3-[[(3,3,4,4,5,5,6,6,6-nonafluorohexyl)oxy]methyl]-
10 P-04-0313 N/A Aminotriazine modifi ed cresol novolec resin (generic) 11 P-04-0340 N/A Pentenylated polyethylene glycol sulfate salt (generic) 12 P-04-0587 N/A Dialkyl dimethyl ammonium methylcarbonate (generic) 13 P-04-0624 N/A Mixed alkyl phosphate esters alkoxylated (generic) 14 P-04-0635 406-78-0 Ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoroethoxy)- 15 P-05-0324 N/A Rare earth salt of a carboxylic acid (generic) 16 P-05-0613 N/A Bisphenol S mono ether (generic) 17 P-05-0774 134818-68-1 Oxirane, 2-(1-chlorocyclopropyl)-2-[(2-chlorophenyl)methyl]-
18 P-06-0149 12673-69-7 Potassium titanium oxide 19 P-06-0153 N/A Iso-tridecanol (generic) 20 P-06-0370 670241-72-2 Benzoic acid nonyl ester, branched and linear

21 P-06-0450 675869-02-0 Poly(oxy-1,2-ethanediyl),.alpha.-(2-methyl-2-propenyl)-.omega.-hydroxy-C 12-

15 -alkyl ethers

22 P-06-0451 620610-66-4 Poly(oxy-1,2-ethanediyl),.alpha.-(2-methyl-2-propenyl)-.omega.-hydroxy-C 10-

16 -alkyl ethers

23 P-06-0452 675869-05-3 Poly(oxy-1,2-ethanediyl),.alpha.-(2-methyl-2-propenyl)-.omega.-hydroxy-C 12-

16 -alkyl ethers 24 P-06-0793 887947-29-7 Morpholine, 4-C 6-12 acyl derivs 25 P-07-0143 N/A Alkanoldioic dialkyl ester (generic) 26 P-07-0144 N/A Alkanoldioic dialkyl ester (generic) 27 P-07-0327 N/A Substituted phenols (generic) 28 P-07-0375 N/A Aluminum trihydrate and silane homopolymer (generic)

29 P-07-0496 71604-74-5 2-Oxiranemethanamine, N-[3-(2-oxiranylmethoxy)phenyl]-N-(2- oxiranylmethyl)-
30 P-08-0039 N/A Mixed amino diaryl sulfone isomers (generic)

31 P-08-0263 90367-25-2 Ethanol, 2,2’-[[3-[(2-hydroxyethyl)amino]propyl]imino]bis-, N-(hydrogenated tallow alkyl) derivs. 32 P-08-0292 944835-56-7 1-Propanamine, N- (1-methylethyl)-,3-(C 12-15 -alkyloxy) derivs. 33 P-08-0300 N/A Amidoamine salt (generic)Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 A-2 No. PMN 1 CAS RN 2 Name 2

34 P-08-0464 N/A Diethanolamine salt of polymeric acid (generic) 35 P-08-0471 N/A Tricyclic qua ternary amine salt (generic)

36 P-08-0537 N/A Cyclic amine reaction product with acet ophenone and form aldehyde acid salt (generic) 37 P-08-0611 1008753-84-1 1,3 Benzenediol, polymer with 1,1’ Methylenebis[isocyanatobenzene]38 P-08-0680 221667-31-8 Benzamide, N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy39 P-08-0737 N/A Magnesium hydroxide surface tr eated with substituted alkoxy silanes (generic)

40 P-09-0048 N/A Alkylcarboxy polyester acrylate reaction products with mixed metal oxides (generic)41 P-09-0480 71868-15-0 1-Propanone, 1,1'-(oxydi-4,1-phenylene)bis[2-hydroxy-2-methyl42 P-09-0486 N/A Polyalkenyl, N,N'-bistriazole (generic)

43 P-09-0636 852360-51-1 Benzenamine, 5-(1,1-dimethylethyl)-2-[(2-ethylhexyl)thio]-,4- methylbenzenesulfonate (1:1)
44 P-10-0231 N/A Unsaturated polyester imide (generic) 45 P-10-0367 N/A Carbon black derived from the pyrolysis of rubber tire shreds (generic)

46 P-10-0452 1220986-58-2 Poly[oxy(methyl-1,2-ethanediyl)], alpha, alpha'-[1,4- cyclohexanediylbis(methylene)]bis[omega-(2-aminomethylethoxy)-

47 P-10-0524 N/A Brominated polyurethane prepolymer of methylene diphenyl diisocyanate (MDI) (generic)

48 P-10-0525 N/A Brominated polyurethane prepolymer of methylene diphenyl diisocyanate (MDI) (generic)
49 P-10-0571 N/A Quaternary ammonium compound (generic)50 P-10-0588 2687-27-6 Benzenamine, 4,4'-[1,3-phenylenebis(1-methylethylidene)]bis51 P-11-0029 1892-03-1 Cyclopentene, 1,3,3,4,4,5,5-heptafluoro52 P-11-0043 121263-51-2 Disiloxane, 1-butyl-1,1,3,3-tetramethyl53 P-11-0044 4619-08-3 Disiloxane, 1,3-dibutyl-1,1,3,3-tetramethyl54 P-11-0081 2820-37-3 1H-Pyrazole, 3,4-dimethyl55 P-11-0098 1253404-90-8 Phenol, 2-[1-[[3-(1H-imidazol-1-yl)propyl]imino]ethyl]- 56 P-11-0106 N/A Unsaturated fatty acids, amides with polyethylenepolyamine (generic) 57 P-11-0107 N/A Fatty acids, amides with triethylentetramine (generic) 58 P-11-0110 N/A Tertiary ammonium compound (generic)59 P-11-0130 13325-10-5 1-Butanol, 4-amino60 P-11-0162 70293-55-9 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, 2-[(2-methyl-1-oxo2-propen-1-yl)oxy]ethyl ester

61 P-11-0173 1138156-39-4 Hexanedioic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,6- hexanediol, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,1'-[(1- methylethylidene)bis(4,1-phenyleneoxy)]bis[2-propanol], iso-Bu alc.-blocked, compds. with triethylamine 62 P-11-0230 1256282-88-8 Octadecen-1, aminium, N-ethyl, N-ethyl-N, N-dimethyl-, ethyl sulfate (1:1) 63 P-11-0234 N/A Oligomeric phenolic ether (generic) 64 P-11-0252 N/A Benzeneacetonitrile, alkoxy -[[(alkylsulfonyl)oxy ]imino]- (generic)
65 P-11-0270 61461-40-3 Lead strontium titanium zirconium oxideEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 A-3 No. PMN 1 CAS RN 2 Name 2

66 P-11-0271 1262279-31-1 Calcium cobalt lead titanium tungsten oxide

67 P-11-0272 1262 279-30-0 Calcium cobalt lead st rontium titanium tungsten oxide
68 P-11-0273 1227908-26-0 Lanthanum lead titanium zirconium oxide
69 P-11-0274 56572-83-9 Lead niobium titanium zirconium oxide 70 P-11-0280 N/A Epoxy modified alkyd resin, partially neutralized (generic) 71 P-11-0447 N/A Polyetherdiamine (generic)

72 P-11-0485 N/A Polyoxyalkylene ether, polymer with aliphatic diisocyanate, homopolymer, alkanol-blocked (generic)

73 P-11-0486 N/A Alkyl substituted alkanediol polymer with aliphatic and alicyclic diisocyanates (generic) 74 P-11-0488 N/A Aliphatic diisocyanate, homopolymer, alkanol-blocked (generic) 75 P-11-0489 N/A Aliphatic diisocyanate polyme r with alkanediol and alkylglycol (generic)

76 P-11-0548 1254743-03-7 Imidodicarbonic diamide, N,N' -dibutyl-N',2-bis[4-[(4- isocyanatophenyl)methyl]phenyl]-
77 P-11-0635 N/A Toluene diisocyanate, polymer with polyalkylene glycol (generic)

78 P-11-0636 N/A Toluene diisocyanate, polymer with polyalkylene glycol (generic)
Key: PMN = Premanufacture Notice. CAS RN = Ch emical Abstract Service Registry Number.

Notes:

1 The PMN number reflects the Federal Fiscal Year and sequenc e of submission. For example, those starting “P-07” were
submitted in the twelve months ending September 31, 2007.

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 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 B-1 

## APPENDIX B: Inflato rs and Wage Rates

This appendix describes the derivation of the fully lo aded labor rates and inflation factors used in calculating costs of labor, materials, and other in puts. Costs for this report are for year-end 2011.



### B.1 Derivation of Loaded Wage Rates

Unit labor costs are calculated by adding fringe benef its and overhead to the wage or salary to derive a fully loaded labor cost. The basic method is described in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (EPA, 2002b). The resulting loaded labor rates are given in Table B-1. Costs are calculated for 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 Industrial Classification (SIC) System, and the Standard Occupational Classification (SOC) system instead of the Occupational Classifica tion System (OCS). The following table shows the crosswalk between old and new occupational titles.

EPAB Reports Labor Category 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 Ra tes for Managerial, Prof essional/Technical, Clerical,
and Production Labor

Wages and fringe benefits for manage rial, professional/technical, cleric al 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 benefits 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 Compensation Supplementary Tables December 2011 (BLS, 2012a). This follows the approach introduced in EPA, 2007b. Earlier PMN SN UR economic analyses, such as EPA, 2003a, used ECEC data for “All Goods Producing” sectors (manufacturing, mining, and construction). However, the manufacturing sector data seem more relevant sinc e the SNURs mainly affect the chemicals industry.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 B-2 

### 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 perc ent of wages are calculated separately for each labor category. For example, for December 2011, th e average wage rate for professional/technical 17 

### labor was $38.48; the average fringe benefit was $19.64. Fringe benefits as a percent of wages were $19.64/$38.48, or approximately 51.04%.

An additional loading factor of 17 percent is applie d to wages to account for overhead. This approach is used for consistency with Office of Pollution Prev ention and Toxics economic analyses for two major rulemakings: 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). This overhead loading factor is added to the benefits loading factor, and the total is then applied to the base wage to derive the fully loaded wage. For example, the December 2011 fully loaded wage for professional/technical labor is $38.48 × (1 + 0.5104 + 0.17) = $64.66.

Fully loaded costs for managerial, clerical, and pr oduction labor are calculated in a similar manner, as
shown in Table B-1.



### B.3 Derivation of Labor Rat es for Industrial Hygienists

For industrial hygienists, wages were based on another BLS data series, Occupational Employment Statistics [OES], National I ndustry-Specific Occupational Em ployment and Wage Estimates. OES data
were used because ECEC data were not available fo r very specific occupations. However, the OES data covers only wages, not fringe benefits. Therefore, the Industrial Hygienist fringe be nefits 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 Classi fication (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.

As with other labor categories, the fringe benefits factor came from the BLS Employer Costs for Employee Compensation Suppl ementary Tables December 2011 (BLS, 2012a). Benefits for “professional

17 This follows terminology introduced in EPA, 2007b. Ea rlier SNUR economic analyses used the term “technical” labor. Here the category is called “professional/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 technical” 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 Hygi enist 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 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 B-3 

### specialty and technical” occupations were used, and lo aded wages were calculated as for other types of labor. An additional 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 labor costs are calculated based on annua l Federal salaries for the Washington-Baltimore area published by the Office of Personnel Management effective January 2011 (OPM, 2011). 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 $161,446.

The Agency loading factor is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 per cent assumption was labeled “the benefits multiplication factor” in the EPA Guide, but has been used in many EPA Office of Pollution Prevention and Toxics ICRs to reflect both fringe benefits and overh ead 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 Koch (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 introduc ed in EPA, 2007b. That report represente d a change from an earlier PMN SNUR economic analysis (EPA, 2003a), whic h used an average of GS-12 Step 1 and GS-12 Step 10 salaries.`August 29, 201Table B-1. Derivation of Loaded Wage RatesEPABLaborCategoryData SourcesDateWageFringeBenefitFringes as% wageOver-head %wage2Fringe +OverheadFactorLoadedWages1(a)(b)(c) =(b)/(a)(d)(e)=(c)+(d)+1(f)=(a) x (e)ManagerialBLSECEC, Private Manufacturing industries,“Mgt, Business, and Financial”3Dec-11$43.01 $20.40 47.43% 17%1.64 $70.72Professional/TechnicalBLSECEC, Private Manufacturing industries,“Professional and related“3Dec-11$38.48 $19.64 51.04% 17%1.68 $64.66ClericalBLSECEC, Private Manufacturing industries,“Office and Administrative Support”3Dec-11$17.69 $8.93 50.48% 17%1.67 $29.63ProductionWorkerBLSECEC, Private Manufacturing industries,“Production, transport, and material moving.”3Dec-11$16.86 $9.32 55.28% 17% 1.72 $29.05IndustrialHygienistWage: BLS OES Occupat. Employ. and Wages,forManufacturing (NAICS 31, 32, 33), average ofwages forOccup. Health/ Safety Specialists(SOC29-9011) andOccup. Health/Safety Technicians(SOC 29-9012), weighted by employment.4Fringes: BLSECEC, Private Manufacturingindustries, “Professional and related”3Wage:May-11Fringe:Dec-11$31.32--51.04%17%1.68 $52.63EPA staffFTEAnnual Federal staff cost: OPM WashingtonBaltimore-Northern Virginia, DC-MD-PA-VAWV, area, GS-13 Step 5 pay rates, with 60%h d5Jan-11$100,904(annual)--[Included in60%overhead]60%1.6$161,446(annual)Notes:1Wage data are rounded to the closest penniesin this table; however, in calculationsusing these numbers for this report, unrounded values were used.2An overhead rate of 17% was used based on assumptions inWage Rates for Economic Analyses ofthe Toxics Release Inventory Program(EPA, 2002b), and theRevisedEconomic Analysis for the AmendedInventory Update Rule: Final Report(EPA, 2002a).3Employer Costs for Employee Compensation Supplementary Tables December 2011, US Bureau of Labor Statistics, March 14, 2012 (BLS, 2012a).4Employment and unweighted wages are from BLSOccupational Employment Statistics (National Industry-Specific Employmentand Wage Estimates),May 2011 (BLS, 2012e).5The salary is unloaded Federal GS-13 Step5 salary for calendar 2011, from the Officeof Personnel Management salary table forWashington-Baltimore-Northern Virginia(OPM, 2011). 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 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 B-5



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

Occupation Title (SOC Code) Employment Mean Hourly Wage Weight Weighted Wage 1

(a) (b) (c) (d) = (c) × (b)

Occupational Health & Safety Specialists (29-9011) 9,340 $32.69 0.856 $27.99

Occupational Health & Safety Technicians (29-9012) 1,570 $23.17 0.144 $3.33

Industrial Hygienis t (weighted average) 10,910

-- 1 $31.32

Notes:

1 Wage data are rounded to the closest penni es in this table; however, in calculatio ns using these numbers for this report,
unrounded values were used.

Source: Employment and unweighted wages are fo r manufacturing (NAICS 31, 32, 33) from BLS Occupational Employment Statistics (Occupational Employment and Wages) , for May 2011 (BLS, 2012e).



### B.5 Derivation of Inflation Factors

Costs of equipment and supplies were inflated usi ng the Consumer Price Index – All Urban Consumers; wages were inflated using the appropriate Empl oyment Cost Index (ECI). Where both labor and equipment/supplies were involved, we used the in flation 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 infla tion 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 h as 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 Publication Plans” (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 ad justed ECI for the total compensation, private industry white collar workers (Series ID CIS2010000W00000I) to inflate export notification and Agency extramural cost. However, in 2008 BLS retired both the “white-collar” and “blue-collar” series (BLS, 200 8, p. BLS-45). Therefore, beginning with the report, Economic Analysis of Exped ited Significant New Use Rules for 25 Chemical Substances:
EPA Docket OPPT-2009-092 2, the “white-collar” series was replaced with the not seasonally adjusted ECI for total compensation of private industry professional and related workers (Series ID CIU2010000120000I). The “professional and related workers” seri es was chosen because it is the only se ries with continuou s data since 1985, and the majority of export notification and Agency extram ural activities are performed by professional and technical
labor.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 B-6 

### Under a mandate from OMB, BLS changed its classif ication of industries and occupations from the Standard Industrial Classification (SIC) and Occ upational Classification System (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 industr y and occupational classification syst ems, 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. (Seas onally adjusted indices, including those in Table B-3 of this report, 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 year s 1975-2005 is the SIC-OCS based series, and for subsequent years, the official ECI is th e NAICS-SOC based series (Sleemi, 2006, p.8). 21



### “Starting year” indices in Table B-3 continue to be SIC-SOC based. Current year indices are NAICS-SOC
based. We use indices from both the NAICS-SOC a nd the SIC-OCS based ECI series because neither series spans the entire period over which testi ng and other costs need to be inflated.

21 BLS has been publishing the NAICS-SOC based ECI series sinc e March 2001 and it became offici al in March 2006. The SICOCS based series and NAICS-SOC series ha ve different series ID numbers, even wh en they describe essentially the same population. For example the series ID for seasonally adjusted total compensation fo r 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 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 B-7



### Table B-3. Derivation of Inflation Factors

Item Inflation Index Source 1 Starting
Year Index for Starting

Year

(a) Index
for
2011

(b) Inflation
Factor (b)/(a) 2

Chemical testing (toxicity, ecological effects etc.) BLS ECI, SA, Total comp, Private industry, All Workers, 4 th Q [BLS 2006d and 2012c] varies varies 115.1 varies

White collar/other labor mix; equipment; supplies. Example for test costed in 1993 1993 66.5 115.1 1.731

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 83.8 115.1 1.374

Impermeability testing of gloves and other gear 3 BLS ECI, SA, Total comp, Private industry, All Workers, 4 th Q [BLS 2006d and 2012c] 1997 74.9 115.1 1.537

Export notification BLS ECI, ,Total comp, Private industry, Professional and related, 4 th Q [BLS 2012d] 4 1992 64.9 115.7 1.783

Agency Extramural costs White collar labor; equipment; supplies BLS ECI, Total comp, Private industry, Professional and related, 4 th Q [BLS 2012d] 4 1993 67.0 115.7 1.727

Labels, placards, gloves, eyewear, clothing, respirators, file cabinet BLS CPI, All urban consumers, not SA. CUUR0000SA0, Annual [BLS 2012b] 1997 160.5 224.939 1.401

Photocopies Record keeping materials BLS CPI, All urban consumers, not SA. CUUR0000SA0, Annual [BLS 2012b] 1988 118.3 224.939 1.901

Notes:

1 In 2006, Bureau of Labor Statistics (BLS) Employment Cost Inde x (ECI) series “were rebased to December 2005 = 100 from June 1989 = 100.” The change is reflected in the i ndices in this table and explained on the BLS website, Employment Cost Index News Release 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 Adju sted (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 Adju sted (SA) CIS2010000000000I for private industry All Workers, and not SA CIU2010000120000I (B) for private industry Professional, and Re lated workers.

2 Inflation factors are rounded to three decimal places in this ta ble, but calculations in this report use the unrounded values. BLS CPI values were published with one decimal place through 2006 and with th ree decimal places after that.

3 We began using the ECI for Private Industry All Workers in EPA, 2007b, to better reflect the labor mix for impermeability testing.
Earlier PMN SNUR economic anal yses used the ECI for Private Industry White Collar Workers.

4 Beginning with the report, Economic Analysis of Expedite d Significant New Use Rules for 25 Chemical Substances: EPA Docket
OPPT-2009-0922 , we began to use the not-seasona lly adjusted CIU2010000120000I for private industry Professional, and Related workers, instead of SA CIS2010000W00000I for pr ivate industry white collar workers becaus e BLS retired the “white-collar” serie s.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012- 0277)

September 20, 2012 C-1 

## APPENDIX C: Costs of Hazard Communication, Protection in the Workplace, and Recordkeeping Requirements

Section 2.1 of the main text of this report discusses costs of worker protection, hazard communication (hazcomm), and recordkeeping for SNURs. This appe ndix presents dollar costs and labor hours of these requirements, for one chemical at one site. Some requi rements 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 updati ng the written program, labeling for chemical distribution and storage, creating and distributing material saf ety data sheets (MSDS), and employee training. The personal protective equipment (PPE) costs reflect the a nnualized costs of providing required equipment (i.e., gloves, goggles, clothing, or respirators), assessing de rmal 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 record 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: Ge neral Provisions for New Chemical Followup (EPA, 1989). In that report, EPA estimated that the number of wo rkers 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 u ses the high ends of those two ranges. Thus, each site is assumed to have 25 chemically-exposed workers requi ring training and/or protec tive equipment, with each of them assumed to be exposed 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 safety equipment supply house catalog (LSS, 1997) and are inflated as described in Appendix B.

Costs of haz-comm, workplace protection, and recordkeep ing 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 st andard (29 CFR 1910; November 25, 1983), so that costs attributable to the SNUR 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 relied partly on the 1983 OSHA study, Final Regulatory Impact and Regulatory Flexib ility Analyses of the Hazard Communication
Standard OSHA, 1983).

It was assumed that the haz-comm costs would be in curred 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 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

August 29, 2012 C-2 

### costs could be lower than estimated here. The hazar d communication 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 chemicals present in the workplace, the haza rds 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 equipment requirements when working with or
around such chemicals.

While material safety data sheets may provide much of the information needed to update the written hazcomm program, many employers may perform a more de tailed assessment of exposure risks associated with the chemical and develop more site -specific procedures for workers poten tially 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 fo r IH services were calculated based on Bureau of Labor Statistics data,
as described in Table B-1and Table B-2. Costs for the written haz-comm program, in 2011 dollars, are as
follows 22



### 4 hours Industrial Hygienist time × $52.63 per hour = $211

The estimates of IH hours to update the pr ogram 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 hazardous substance warnings and pro cedures. In addition, containers used in the workplace must bear similar labels or, alternatively, the employer must pr ovide equivalent signage, ope rating procedures, or other
written material to communicate hazard information to 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 required 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 averag e, each chemical is shipped twice monthly to 20

22 Figures presented here are rounded.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

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### customers. This is consistent with roughly 10,000 kil ograms 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 ho use catalog (LSS, 1997) and were inflated as described in Appendix B. The resulting cost s of labeling for chemicals distributed in commerce, per chemical substance at one site, are shown in Table C-1.

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

Cost Element Unit Cost (1997$) Inflation Factor Unit Cost (2011$) Hours Total
Cost

0.5 hours technical time

-- -- $64.66 per hour 0.5 $32

480 labels $0.16 per label 1.401 $0.22 per label

-- $108
TOTAL 0.5 $140

Note:

Total costs were calculated using unrounded uni t cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded va lues shown in this table.

Source: 1997 label cost, EPAB 1998, LSS 1997; cost elements, quan tities, RIB 1989; inflators, la bor, Table B-1 and Table B-3.


### Chemicals Used in the Workplace. Workplace labeling requirements are costed by assuming the facility purchases six large (14" × 10") signs, priced at $38.30 each in 1997 dollars (LSS, 1997; EPA, 1998). Costs of these signs were inflated as described in Appendi x B. These signs will be mounted in areas where the chemicals are used or formulated. 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 10 minutes of production worker time to post each placard. Technical labor costs include wag es, 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 pr oduce much more. It is not known whether vol umes listed in the PM Ns were realized in practice. Production volumes of secondary suppliers affected by the SNUR are also unknown. Annual volumes significantly greater than 10,000 kg could lead to higher haz-comm costs than those estimated here.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

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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 (1997$) Inflation
Factor Unit Cost (2011$) Hours Total Cost

0.5 hours technical time

-- -- $64.66 per hour 0.5 $32.33
6 labels or placards (14" x 10") $38.30 per item 1.401 $53.68 per item

-- $322

10 minutes per label/placard

production worker time -- -- $29.05 per hour 1.0 $29.05

TOTAL 1.5 $383

Note:

Total costs were calculated using unrounded uni t cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded va lues shown in this table.

Source: 1997 placard cost, EPA, 1998, LSS, 1997; cost elements and quant ities, EPA, 1989; infl ators 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 e ngaging in a Significant New Use, each facility is required to create, post, and distribute material sa fety 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 ho urs of clerical time. Further, EPA assumes that the manufacturer provides 20 copies of the MSDS to customer s 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$) Inflation
Factor Unit Cost (2011$) Hours Total Cost

2.0 hours technical time

-- -- $64.66 per hour 2 $129

0.25 hours clerical time

-- -- $29.63 per hour 0.25 $7.41
40 copies $0.05 1.901 $0.10 per copy

-- $3.80

TOTAL 2.25 $141

Note:

Total costs were calculated using unrounded uni t cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded va lues shown in this table.

Source: Cost elemen ts, quantities, and 1988 copy cost, RIB 1989; inflators and labor unit costs, Table B-1 and Table B-3.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

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### C.1.4 Employee Training

The final required component of the haz-comm progr am is employee training, based on 40 CFR §721.72(d). The 1989 EPA report, Economic Analysis of Final Significant New Use 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 pr ogram are mainly labor costs for the trainer and the
trainees.

Inserting the new information about the PMN substance into the training program and c onducting the revised training is assumed to require 0.5 hours of the trai ner’s time. An additional 0.25 hours per trainee is estimated to be required, and an average of 25 a ffected workers is assumed per facility (EPA, 1989). If additional production workers needed to be trained, fo r example because they might come into contact with the chemical due to spills or leaks, training cost s 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 (2011$) Hours Total Cost

0.5 hours technical time (trainer) $64.66 per hour 0.5 $32.33
0.25 hours per production employee X average of 25 workers per plant = 6.25 hours $29.05 per hour 6.25 $182

TOTAL 6.75 $214

Note:

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: 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 need s 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 expe rience dermal exposure to a PMN chemical, must be provided with and is required to w ear 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 Occupationa l Safety and Health Administration, OSHA). TheEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

August 29, 2012 C-6 

### selection and administration of this dermal protection is estimated to require 10 ho urs labor by an industrial hygienist, annually (EPA, 1999). The wage rate of the hygienist was calculated as described in Appendix B. The cost calculations for the dermal protection selecti on requirement are given in Table C-5. This covers only costs of selecting the dermal protection needed, not costs of the items themselves. 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 (2011$) Hours Total Cost 1

10 hours industrial hygienist (IH) time $52.63 per hour 10 $526

Notes:

Total costs were calculated using unrounded va lues (see Appendix B), so results may differ from calculations using the rounded
values shown in this table.

Source: Labor rates, Table B-1; co st elements and quantities, EPA, 1999.



### C.2.2 Impermeability Testing

As part of the workplace protection requirements speci fied 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 pr ovided 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 Document 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 described 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) per ch emical, but the burden of finding an appropriate article of protection lay with the chemical manufact urer. 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 article of protection is sh ifted from the chemical manufacturer to the testing company, who would have greater experience in Pe rsonal Protective Equipment (PPE) selection. Second, should the article submitted fail the impermeability te st, other articles may have to be submitted until satisfactory test results are obtained. Furthermore, s ubstances subject to SNURs may include new and/or rare chemicals, which may have undiscove red or unknown properties. This uncertainty may impede chemicalEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

August 29, 2012 C-7 

### manufacturers’ ability to effectively submit appropriate PPE articles for testing. Finally, the first method is essentially a pass-fail test. If an artic le passes the impermeability test, then it is acceptable. In the second method, several articles may be tested and compared, and, 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 sec ond 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 la bor costs of the company performing the testing, thus test costs were inflated with an Employment Cost I ndex 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 pr otection requirements at §721.63 (a)(3)(ii) is the evaluation of specifications from the manufacturer or s upplier of the protective equipment. This requirement helps ensure that the protective equipment will be im pervious 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$) Inflation
Factor Unit Cost (2011$) Hours Total Cost 1

Impermeability Testing [§721.63(a)(3)(i)]
Impermeability Test $800 per chemical 1.537 $1,229 per chemical $1,229
Industrial Hygienist time $52.63 per hour 2 $105.26

Subtotal 2 $1,335
Evaluation of Manufacturer’s Specifications [§721.63(a)(3)(ii)]
Industrial Hygienist time $52.63 per hour 4 $211

Subtotal 4 $211

TOTAL 6 $1,545

Notes:

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 va lues shown in this table.

Source: 1997 costs, Best, 1997; cost elem ents 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 250 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 $0.43 in 1997 (LSS, 1997); the cost has been inflated as described in Appendix B. Total annual costs of providi ng disposable gloves are developed by applying theEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

August 29, 2012 C-8 

### assumptions above regarding the number of workers expo sed (25 per site) and frequency of replacement (one pair per worker per day of exposure H 250 days of ex posure per year). For some chemicals, heavy-duty gloves may be used. They are generally 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 (1997$ per pair) Inflation
Factor Unit Cost (2011$ per pair) Number
of Pairs Required 1 Total Cost (2011$) 2

Disposable nitrile gloves (replaced daily) $0.43 1.401 $0.60 6,250 $3,767

Heavy duty butyl gloves (replaced every 25 work days) $34.00 1.401 $47.65 250 $11,913

Notes:

1 The analysis assumes that 25 workers who are exposed 250 days/y ear replace disposable gloves da ily and replace heavy duty glov es 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 rounded va lues shown in this table.

Source: 1997 item costs, LSS, 1997; 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 of 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 worker s, each of them exposed 250 days per year. The SNUR may not specify the exact type of eyewear required. OSHA guidelines in 29 CFR § 1910.133 (b)( 1), however, state that protective eye and face devices pur chased 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 $4.05 per pair in 1997 (LSS, 1997; 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-8 below.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

August 29, 2012 C-9 

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

Cost Element Unit Cost (1997$ per pair) Inflation
Factor Unit Cost (2011$ per pair) Number of
Pairs
Re q uired 1 Total Cost (2011$) 2

Standard Goggles $4.05 1.401 $5.68 75 $426 Heavy duty chemical-splash/impact goggles $6.05 1.401 $8.48 75 $636

Notes:

1 The analysis assumes 25 workers replacing goggles three times per year.

2 Total costs were calculated using unrounded unit cost values a nd inflation factors (see Appendix B), so results may differ from calculations using the rounded va lues shown in this table.

Source: 1997 item costs, LSS, 1997; 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 Tabl e C-9 below. Costs for full-body protective clothing are based on the coverall clothing set with 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, employers 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 four months. E ach 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 $36.25 in 1997 (LSS, 1997) and for full-body protective clothing – the coverall clothing set with a hood – costing $61.20 in 1997 (LSS, 1997).

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

Cost Element Unit Cost (1997$ per set) Inflation
Factor Unit Cost (2011$ per set) Number Required 1 Total Cost (2011$) 2

Coverall with hood [full-body

clothing] §721.63(a)(2)(ii) $61.20 1.401 $85.77 75 $6,433

Coverall §721.63(a)(2)(iv) $36.25 1.401 $50.80 75 $3,810

Notes: 1 The analysis assumes 25 workers replacing coverall three times per year.

2 Totals were calculated using unrounded uni t cost values and inflation factors (see Table B-3), so results may differ from calculations using the rounded va lues shown in this table. Source: 1997 item costs, LSS, 19 97; item type and quant ity, EPA, 1998; infla tion factor, Table B-3.



### C.2.6 Respirators

For some PMN chemicals, to avoid engaging in a Signif icant New Use, the SNUR requires either the use of respirators or compliance with a New Chemical E xposure Limit (NCEL). Both requirements differ byEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

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### chemical. 18 24 

### For costing purposes, this analysis assumes that respirators are used. Earlier, PMN SNURs referenced specific paragraphs at 40 CFR §721.63 (a)(5) that identified fifteen types of NIOSH-approved respirator units. However, with rulemaking dock et OPPT-2003-0063 (EPA, 2007b), PMN SNURs began to describe respirator choices directly. Costs of the SNUR respirator choices were estimated based on the costs of the respirator in §721.63 (a)(5) that app eared 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 unle ss 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 provisions are modeled after Occupational Safety an d 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 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

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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 flow 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 oper ated in pressure demandor continuous flow mode and equipped with a tightfitting full facepiece.

Supplied-air respirator oper ated in pressure demand or other positive pressure 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 oper ated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-fitting facepiece (either half- or full-face).

(iv) Category 21C air-purifying respirator equipped with a full facepiece and high effici ency particulate filters. Some SNURs may specify a “half" or "full" facepiece.

Some SNURs may specify “if oil aerosols absent” or other
restrictions related to oil aerosols. Air-purifying respirator equipped with a tight-fitting full facepiece and High Effi ciency Particulate Air (HEPA) filters.

Air-purifying, tight-fitting respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters (either half- or full-face). Air-purifying, 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-fitti ng full-face respirator equipped with the appropriat e combination cartridges tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridge), with a partic ulate 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.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

August 29, 2012 C-12 Respirator types at 40 CFR §721.63 (a)(5) 1 Requirement Stated in SNUR (exact SNUR wording may differ)

(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.

Notes:

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 rulema kings. Any significant differences between the speci fied 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 1997 and after applying inflation factors from Table B-3. It also est imates costs per plant site for a chemical requiring respirators.

The respirators specified in the SNUR s are typically comprised of a respirator unit and any number of the following: special cartridges (such as high efficiency par ticulate 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 of Chapter 2 of the report, ar e calculated based on the assumptions stated there, that (1) there are 25 chem ically-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 da ys that workers are exposed, or 50 times per year. For example, for the respirator type described at 40 CF R §721.63(a)(5)(xv), the annual cost per worker in 1997
dollars would be as follows:

$10.83 per respirator + ($8.94 per cartridg e × 50 cartridges/year) = $457.83 per worker.

The 1997 cost was adjusted for inflation as shown in Ta ble C-11. Typically a SNUR describes more than one type of respirator, but only one ty pe of respirator is needed to comply with the workplace protection requirements.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 C-13Table C-11. Annual Per-Chemical Costs for Respiratory Protection [40 CFR §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(1997$)Annual Average Costs(2011$)1RespiratorUnitCartridgeSetPerWorker2InflationFactorAnnualPerWorkerAnnual PerSite (25workers)3(i)19C Type C Supplied-air with full facepiece$804$0.00$8041.401 $1,127 $28,171(ii)19C Type C Supplied-air with tight-fitting facepiece$804$0.00$8041.401 $1,127 $28,171(iii)19C Type C Supplied-air with hood orhelmet or tight-fitting facepiece$932$0.00$9321.401 $1,306 $32,660(iv)21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs)$181$9.76$6691.401 $937 $23,428(v)21C Powered air-purifying (PAPR) withtight fitting facepiece and HEPAs$627$35.50$2,4021.401 $3,367 $84,175(vi)21C PAPR with loose hood or helmet and HEPAs$525$26.89$1,8701.401 $2,621 $65,517(vii)21C Air-purifying with HEPA and disposable respirators$12.53$7.00$3631.401 $508 $12,702(viii)23C air-purifying with full facepiece andcombination cartridges approved for paints,lacquers and enamels (PLE)$192$15.71$9781.401 $1,370 $34,250(ix)23C PAPR with tight-fitting facepiece and combination cartridges approved PLE$627$35.50$2,4021.401 $3,367 $84,175(x)23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE$525$26.88$1,8691.401 $2,620 $65,500(xi)23C Air-purifying with combination cartridgesfor PLE, including disposable respirators$14.30$8.90$4591.401 $644 $16,093(xii)23C Air-purifying with full-facepiece and organic gas/vapor cartridges$192$10.47$7161.401 $1,003 $25,070(xiii)23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges$826$41.15$2,8841.401 $4,042 $101,044(xiv)23C PAPR with a loose-fitting hood orhelmet and organic gas/vapor cartridges$640$41.15$2,6971.401 $3,780 $94,506(xv)23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges$10.83$8.94$4581.401 $642 $16,041Notes:1Annual 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 hoodsand helmets. A “cartridge set” includes two cartridges and any filters or caps required. Assumescartridge sets are replaced every five days (50 times during 250 exposure days) so that each worker requires one respirator unit and 50 cartridge sets per year.3Totals were estimated from unrounded unit costs and inflation factors, so resultsmay differ from calculations using the rounded values shown inthis table.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

September 20, 2012 C-14 

### Table C-12 shows how the average costs per NIOSH-type respirator were calculated, based on prices of respirators listed in a 1997 catalog. To calculate the cost of respirators that meet the NIOSH criteria, the prices of all units in the supplier catalog (LSS, 1997) 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 respirator unit if they ar e 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 includ es 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 cartri dges. The costs of the cartridges listed in LSS (1997) were averaged for the corresponding requirements. In so me 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 retainer caps). These additiona l items were priced and added to the cost for the basic cartridge before averages were taken.

Some cartridge prices were unavailable from LSS (1997) . For instance, §721.63(a)(5)(ix) and (x) require a powered air-purifying respirator (PAPR) with a pain t, lacquer and enamel cartridge. The only cartridges available for these models of respirators in LSS (1997) 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 1997 purchase costs of the varying types of resp iratory protective equipment are shown in Table C12.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 C-15 

### Table C-12. Respirator Prices and Average Costs in 1997, by NIOSH Type

40CFR NIOSH Type Catalog
Item
Number Description 1 1997
Cost 1997 Average Cost 2

§721.63

(a)(5) Respirator
Unit Cartrid g e Set

(i) 19C Type C Supplied-air w ith full facepiece $804 --
7A-24506 Allegro Economical Full- Face Airline Kits, p144 $758.95
7A-32366 311Survivair Supplied Air Respirator Kits, p144 $849.10

(ii) 19C Type C Supplied-air with tight-fitting facepiece $80 --
7A-24506 Allegro Economical Full- Face Airline Kits, p144 $758.95
7A-32366 Survivair Supplied Air Respirator Kits, p144 $849.10

(iii) 19C Type C Supplied-air with hood or helmet or tight-fitting facepiece $932 --
7A-29363 Allegro Hood Systems, p144 $932.15

(iv) 21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs) $181 $10

7A-9838 N orth Full-Face Respirator, p114 $210.10

7A-7122 N orth HEPA Cartridge, p115 $11.15

7A-12338 Willson Full-Face Silicone Respirator, p11 6 $215.10
7A-7526 Willson HEPA Cartridge, p117 $11.75

7A-10516 3M 7800 Fu ll-Facepiece Respirator , p118 $202.10
7A-11839 3M HEPA Cartridge, p118 $7.00

7A-33446 Pro-Tech Full-Face Respirator, p1 22 $106.45
7A-3070-1 Pro-Tech HEPA Cartridge, p123 $9.87

7A-3195 Willson 1600/1700 Series Full-Face Respirators, p124 $215.10

7A-3202 Willson HEPA Cartridge, p125 $12.50
7A-23959 AO7Star Full-Face Respir ator (Silicone), p126 $203.25
7A-9940 AO7Star HEPA Cartridge, p127 $9.44
7A-24158 MSA Advantage 1000 Full- Face Respirator, p134 $112.60
7A-29946 MSA HEPA Cartridge, p134 $6.60

(v) 21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs $627 $36
7A-13599 3M Face-Mounted PAPR System, p142 $720.00
7A-13601 3M HEPA Replacement Cartridge, p142 $36.50
7A-32505 RACAL Powerflow PAPR, p142 $534.90
7A-11936 RACAL Replacement Cartridge, p142 $34.50Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 C-16

40CFR NIOSH Type Catalog
Item
Number Description 1 1997
Cost 1997 Average Cost 2

§721.63

(a)(5) Respirator
Unit Cartrid g e Set

(vi) 21C PAPR with loose hood or helmet and HEPAs $525 $27
7A-32506 RACAL Air-Mate PAPR 12, p143 $411.05
7A-24505 RACAL HEPA Replacemen t Cartridge, p143 $24.65

7A-32477 RACAL Breathe-Easy HEPA Cartridges and Turbo Unit, p141 $548.50

7A-12838 RACAL HEPA Replacement Cartridge $29.12
7A-12840 RACAL Breathe-Easy 10 Tyvek Hood, p140 $91.30

(vii) 21C Air-purifying with HEPA and disposable respirators $13 $7
7A-15255 3M 6000 Series Low-Maintenance Respirator, p135 $10.90
7A-12518P 3M Adaptor, p135 $1.63
7A-11839 3M HEPA Cartridge, p135 $7.00Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 C-17

40CFR NIOSH Type Catalog
Item
Number Description 1 1997
Cost 1997 Average Cost 2

§721.63

(a)(5) Respirator
Unit Cartrid g e Set

(viii) 23C air-purifying with full facepiece and combination cartridges approved for

p aints, lacquers and enamels (PLE) $192 $16

7A-9838 N orth Full-Face Respirator, p114 $210.10

7A-7117 N orth Organic Vapors Cartridge, p115 $10.50

7A-7125 N orth Paint Spray/Mists Prefilter, p115 $2.38

7A-7125-2 N orth Filter Covers, p115 $4.35

7A-12338 Willson Full-Face Silicone Respirator, p11 6 $215.10
7A-7527 Willson Organic Vapors Cartridge, p117 $10.25

7A-7531 Willson Dusts/Mists/Pesticides/Paint Spray Prefilter, p117 $2.52

7A-7532 Willson Retainer Caps, p117 $4.00

7A-10516 3M 7800 Fu ll-Facepiece Respirator , p118 $202.10
7A-9279 3M Organic Vapors Cartridge, p119 $8.91
7A-9284 3M Paint Spray Prefilter, p119 $2.37
7A-9292 3M Retainer Caps, p119 $3.90

7A-33446 Pro-Tech Full-Face Respirator, p1 22 $106.45
7A-955-4 Pro-Tech Organic Vapors Cartridge, p123 $9.27
7A-9605 Pro-Tech Paint Sp ray Prefilter, p123 $1.95

7A-3195 Willson 1600/1700 Series Full-Face Respirators, p124 $215.10

7A-3197 Willson Organic Vapors Cartridge, p125 $11.22

7A-3203 Willson Pesticides/Pai nt Spray Prefilter, p125 $3.36
7A-3858 Willson Retainer Caps, p125 $4.27
7A-23959 AO7Star Full-Face Respir ator (Silicone), p126 $203.25
7A-9935 AO7Star Organic Vapors Cartridge, p127 $8.76

7A-10043 AO7Star Dusts/Mists/Pain t Spray Prefilter, p127 $3.07
7A-10044 AO7Star Retainer Clips, p 127 $3.20

(ix) 23C PAPR with tight-fitting facepiece and comb ination cartridges ap proved PLE $627 $36
7A-13599 3M Face-Mounted PAPR System, p142 $720.00
--- Paint, Lacquer, Enamel Cartridge 3 $36.50
7A-32505 RACAL Powerflow PAPR, p142 $534.90
--- Paint, Lacquer, Enamel Cartridge 3 $34.50Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 C-18

40CFR NIOSH Type Catalog
Item
Number Description 1 1997
Cost 1997 Average Cost 2

§721.63

(a)(5) Respirator
Unit Cartrid g e Set

(x) 23C PAPR with loose-fitting hood or helmet and combination cartri dges for PLE $525 $27
7A-32506 RACAL Air-Mate PAPR 12, p143 $411.05
--- Paint, Lacquer, Enamel Cartridge 3 $24.65

7A-32477 RACAL Breathe-Easy HEPA Cartridges and Turbo Unit, p141 $548.50

7A-12840 RACAL Breathe-Easy 10 Tyvek Hood, p140 $91.30
--- Paint, Lacquer, Enamel Cartridge 3 $29.10

(xi) 23C Air-purifying with combination cartridges for PLE, including disposable respirators $14 $9

7A-12711 Willson Freedom 2000 Series Organic Vapors Respirator, p136 $17.85

7A-7531 Willson Dusts/Mists/Paint Spray/Pesticides Prefilter, p136 $2.52

7A-13509

7A-33826 Willson Retainer Caps, p136 Moldex 8000 Series Half-Mask Respirator, p139 $2.03
$10.75
7A-22751 Moldex Organic Vapors Cartridge, p139 $8.03
7A-22753 Moldex Paint Spray/Pes ticides Prefilter, p139 $2.56
7A-22754 Moldex Retainer Caps, p139 $2.65

(xii) 23C Air-purifying with fu ll-facepiece and orga nic gas/vapor cartridges $192 $10

7A-9838 N orth Full-Face Respirator, p114 $210.10

7A-7117 N orth Organic Vapors Cartridge, p115 $10.50

7A-12338 Willson Full-Face Silicone Respirator, p11 6 $215.10
7A-7527 Willson Organic Vapors Cartridge, p117 $10.25

7A-10516 3M 7800 Fu ll-Facepiece Respirator , p118 $202.10
7A-9279 3M Organic Vapors Cartridge, p119 $8.91
7A-9292 3M Retainer Caps, p119 $3.90

7A-33446 Pro-Tech Full-Face Respirator, p1 22 $106.45
7A-955-4 Pro-Tech Organic Vapors Cartridge, p123 $9.27

7A-3195 Willson 1600/1700 Series Full-Face Respirators, p124 $215.10

7A-3197 Willson Organic Vapors Cartridge, p125 $11.22
7A-23959 AO7Star Full-Face Respir ator (Silicone), p126 $203.25
7A-9935 AO7Star Organic Vapors Cartridge, p127 $8.76Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 C-19

40CFR NIOSH Type Catalog
Item
Number Description 1 1997
Cost 1997 Average Cost 2

§721.63

(a)(5) Respirator
Unit Cartrid g e Set

(xiii) 23C PAPR with tight-fitting facepiece and organic gas/vapor ca rtridges $826 $41

7A-32473 RACAL Breathe-Easy Organic Vapors and Turbo Unit, p141 $548.50

7A-12844 RACAL Breathe-Easy 7 Full Face, p 140 $277.90

7A-12830 RACAL Organic Vapors Replacement Cartridges, p141 $41.15

(xiv) 23C PAPR with a loose-fitting hood or helmet and organic gas/vapor cartridges $640 $41

7A-32473 RACAL Breathe-Easy Organic Vapors and Turbo Unit, p141 $548.50

7A-12840 RACAL Breathe-Easy 10 Tyvek Hood, p140 $91.30

7A-12830 RACAL Organic Vapors Replacement Cartridges, p141 $41.15

(xv) 23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges $11 $9

7A-15255 3M 6000 Series Low-Maintenance Respirator, p135 $10.90
7A-15256 3M Organic Vapors Cartridge, p135 $9.85
7A-33826 Moldex 8000 Series Half-Mask Respirator, p139 $10.75
7A-22751 Moldex Organic Vapors Cartridge, p139 $8.03

Notes:

1 See Table C-10 for the cross-walk between respir ator types in the SNUR and in this table.

2 Average costs presented in this table are rounded to the neares t dollar figure, so results may differ from calculations using t he
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 HEPA cartridges.

Source: LSS 1997; EPAB 1999



### C.3 Recordkeeping

There are two main types of recordkeeping requireme nts for the substances listed in the current SNURs: those for companies submitting a SNUN, and those fo r all companies that manufacture, import or process SNUR-regulated substances, regardless of whet her they have made a submission to EPA.

C.3.1 SNUN Submitters

Companies submitting a SNUN must keep records under 40 CFR §721.40. Some EPA reports have assumed that SNUN recordkeeping hours would be 5 per cent of SNUN submission hours, or about five toEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 C-20 

### six hours. 25 

### Other EPA reports have estimated that electr onic submission of SNUNs is expected to reduce the recordkeeping burden to approximately one ho ur (EPA, 2009a, 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, Importers, and Processors

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. (F or firms producing under the R&D exemption, R&D recordkeeping would be needed. R&D recordkeepin g costs were not estimated for this report.)

Recordkeeping requirements vary between PMN chemi cals, reflecting differences in SNUR restrictions. For all chemicals in the current SNURs, manufacturer s, 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 r ecords concerning water discharge compliance, under §721.125(k). For chemicals with other use restric tions, 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.

All recordkeeping requirements essentially involve copying and filing relevant records, including those related to: manufacturing, importing, or pro cessing volumes; shipment amounts and customer information; clothing impermeability determinations; the hazard communication program including labels and MSDS copies; compliance with other use restricti ons; 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 record keeping requirements for substances subject to a SNUR are based on the approach in Economic Analysis 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 (Kear ney, 1988a). These reports drew on recordkeeping 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 Comprehensi ve Assessment Information Rule , June 1, 1988 (Kearney, 1988b, pages 63 to 65).

25 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, estimates SNUN reco rdkeeping 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 report 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 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 C-21 

### This report uses the basic Kearney (1988a a nd 1988b) estimates and assumptions to estimate recordkeeping costs for SNUR requirements. 27 

### Unlike Kearney (1988a), this report presents costs for each §721.125 recordkeeping requirement separately. This report also avoids minor rounding errors by calculating from unrounded data. However, the underl ying methodology is identical to the Kearney 1988a/RIB 1989 reports, resulting in identical costs per chemical except for differ ences due to inflation and rounding. The paragraphs that follow describe estimates and assumptions used from Kearney (1988a and 1988b).

Cost per page. Recordkeeping costs are based on cost per pa ge. Kearney (1988a) assumes that the ratios of labor hours to page count for each labor categor y, file drawer space to page count, and cost of miscellaneous supplies such as folders and labels to page count, are the same as the per-page ratios estimated for EPA’s Comprehensive Assessment a nd Reporting Rule. The CAIR estimates are given in the 1988 report, Estimated Cost of the Final Comprehe nsive Assessment Information Rule, June 1, 1988, page 65 (Kearney, 1988b). Table C-13 summarizes es timates from Kearney 1988a and the CAIR report (Kearney, 1988b). It also shows the derivation of cost s 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. The analysis estim ates 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. The analysis estim ates a cost per hour and per page using fully
loaded labor rates from Table B-1.

 The photocopying cost from Kearney 1988a ($0.05 per page) was inflated using an inflation
factor from Table B-3.

 File space for CAIR was estimated at 1⁄4 of a f our-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). The cost per page was inflated using an inflation
factor from Table B-3.

 Miscellaneous materials costs were estimated at $10.00 for 750 pages in the CAIR report (Kearney, 1988b, page 65), or $0.0 133/page before inflation. This cost per page was inflated using an inflation factor from Table B-3.

27 This report follows the method in Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances (EPA Docket OPPT-2003-0063) , (EPA, 2007b), which used the Kearney data to calculate the cost breakdown by recordkeeping requirement.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 C-22 

### Table C-13. Recordkeeping Estimates from Kearney 1988a and 1988b

Kearney Estimates for CAIR Rule (1988a, b) Adjusted for Inflation Per Page Cost - 2011$

Estimate CAIR Pages Cost Per Page Cost Per Hour
or Inflation
Factor Cost Per Page

Labor Costs

Technical 1 hour 750 0.00133 hours $64.66 $0.0862

Clerical 10 hours 750 0.01333 hours $29.63 $0.3950

Total Labor 0.01467 hours $0.4812

Material Costs
Photocopying $0.05 [1988 dollars] 1 $0.050 1.901 $0.0951

File Cabinet 1/4 of cabinet priced at $195 [1997 dollars] 750 $0.065 1.401 $0.0911

Misc. Materials $10 total [1988 dollars] 750 $0.013 1.901 $0.0254

Total Materials $0.128 $0.2115
Total Cost per Page (Labor & Materials) $0.6928

Notes:

Per-page labor hours and material s costs were originally estimated in Kearne y 1988b for the CAIR rule. The CAIR per-page
costs were then used to estim ate SNUR recordkeeping per-page costs in Kearne y 1988a. This clarifies the method by which the original CAIR per-page costs and hours were calculated. It also adjust s costs for inflation using labor rates from Table B-1 an d
inflation factors from Table B-3.


### Pages per chemical at one site. In order to estimate recordkeeping co sts, the analysis multiplies the costs per page for each recordkeeping element estimated in Table C-13 by the number 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 tran sfer 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 assume 50 pages per month (Kearney, 1988a, p.11).

(This report uses slightly different terminology from EPA, 1989: “Protective clothing” instead of “protective gloves,” “haz-comm” instead of “employe e information and training.” Recordkeeping for “impermeability determination” was not separately costed out in EPA, 1989. This report assumes it is included under “protective clothing” recordkeeping.)Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 C-23 

### Cost per chemical. Table C-14 shows annual recordkeeping activiti es 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 2.3 hours of technical time, 23 hours of clerical time, 1,715 photocopies, approximately one-half of a four-drawer file cabinet, and other miscellaneous materials such as folders. 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 chemi cals 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 3 Labor and Materials Cost 1 (2011$) Hours

(a) Per Page (b) Per Chemical (c)=(a)*(b) Per Page (d) Per Chemical (e)=(a)*(d) (a)(b)(c) Volumes & sales/transfer data 485 $0.6928 $336 0.01467 7.11

(d)(e) Protective clothing [§721.63] and impermeability [§721.63(a)(3)] 20 $0.6928 $13.86 0.01467 0.29

(f) Haz-comm program [§721.72] 250 $0.6928 $173 0.01467 3.67 (g) Label copies [§721.72(b)] 5 $0.6928 $3.46 0.01467 0.07 (h) MSDS copies [§721.72(c)] 5 $0.6928 $3.46 0.01467 0.07

(i) Use limitations compliance [§721.80] 250 $0.6928 $173 0.01467 3.67

(j) Disposal compliance [§721.80] 600 $0.6928 $416 0.01467 8.80

(k) Release to water compliance [ §721.90] 100 $0.6928 $69.28 0.01467 1.47

TOTAL 1,715 $0.6928 $1,188 0.01467 25.15

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 S NUN 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 reportabl e New Uses (§721.63, §721.72, §721.80, and/or §721.90). Few if any SNUR ch emicals would require all of the recor dkeeping costs listed above since few if any chemicals are subject to all of the requirements (a) through (k).

3 Pages count estimates fo r each SNUR requirement are from Kearney, 1988a.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

September 20, 2012 D-1 

## APPENDIX D: Costs of Testing

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 th e authority to require appropriate testing, but that is a cost of regulatory follow-up, not of the SNUN submission itself.) For informational purposes, the SNURs describe tests recommended by EPA to provide sufficient information to evaluate the chemical substance. However, as was explained in the discussion of SNUNs ear lier 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, this appendix presents es timated costs for testing often recommended for chemicals 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 submissions to EPA to characterize risks of the chemical. The tests are recommended in the SNUR, not mandatory. They ar e 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, Tabl e D-2 presents certain assumptions used in the analysis, and Table D-3 presents Persistent Bioaccumu lative 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 (publishe d in the Code of Federal Regulations), EPA's Office of Pesticide Programs, the Organization fo r Economic Cooperation and Development (OECD), and other sources. The harmonized guidelines 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 Code of Federal Regulations

SNUR tests may also come from the Code of Federa l Regulations (CFR), identified for example as “40 CFR 799.9370” or just “799.9370.” In addition, in co sting out test guidelines, this report sometimes usesEconomic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 D-2 

### costs for a CFR guideline when costs have not b een developed for the e quivalent 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 T oxicity 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 tests 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 testing acco rding to a testing strategy published in the Federal Register (FR), Category for Persistent, Bioaccumulati ve, 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 Other Sources

Test guidelines may also come from the American Soci ety 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 neurotoxicity functional observational battery, NTIS PB 91-154617, is available from the National Technical Information Service (www.ntis.gov).Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-3Table D-1. Cost Estimates for Test Guidelines Cited in SNURsGuidelineTestSpeciesRoute/MethodCost2011$Product Properties830.6315 Flammability NA NA $2,300830.7050Absorption in Aqueous Solution: ultraviolet/visiblespectraNA NA $2,325830.7200 Melting Point / Melting Range NA 8-test average $1,380830.7550 Partition Coefficient (n-Octanol/Water) NA Shake Flask Method $7,212830.7560 Partition Coefficient (n-Oct/Water) NA Generator Column $7,665.48830.7570 Partition Coefficient (n-Oct/Water) NALiquidChromatography$5,045830.7840 Water Solubility NA Flask Method $10,422.28830.7860 (796.1860)xWater Solubility: Column Generator Method NA Generator Column $22,502.05Karel Vershueren Handbook,odor and taste testOdor and taste test (in Handbook of EnvironmentalData on Organic Chemicals, by Karel Vershueren,4thEd,Vol. 1, Page 22)NA NA *Fate, Transport, Transformation835.1110 Activated Sludge Sorption Isotherm NA NA $20,153835.1220 Sediment and Soil Adsorption/Desorption Isotherm NA NA $30,910835.1230Sediment and Soil Adsorption/Desorption (batchequilibrium)NA NA $43,651835.1240 Leaching and adsorption/desorption NA NA $57,403835.2110 Hydrolysis as a Function of pH NA NA $60,731835.2120 Hydrolysis test NA NA $41,938835.2130 Hydrolysis as a Function of pH and Temperature NA NA *Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-4GuidelineTestSpeciesRoute/MethodCost2011$835.2210 (796.3700) Photolysis in Aqueous Solution in Sunlight NA NA $121,486835.3100 (796.3100) Aerobic Aquatic Biodegradation NA NA $16,678835.3110 Ready Biodegradation NAAverage of sixmethods$13,031835.3120 Sealed-Vessel CO2 Production Test NA NA $8,081835.3140 CO2 in Sealed Vessels Test NA NA *835.3170 Shake Flask Die-Away Test NA NA $53,137835.3180 Sediment/Water Microcosm Biodegradation NA Flow-through $138,942835.3190Aerobic Mineralization in Surface Water –Simulation Biodegradation TestNA NA *835.3200 (OECD 302B) Inherent Biodegradation: Modified Zahn-Wellens NA NA $10,559835.3210 Modified SCAS Test NA NA $30,468835.3220 Porous Pot Test NA NA $33,703835.3400 Anaerobic Biodegradabilityof Organic Chemicals NA NA $12,828835.5045 (OECD 302A) Inherent Biodegradability: Modified SCAS Test NA NA $14,822835.5270 (795.7000)Sunlight Photolysis in Waters ContainingDissolved Humic Substances(Indirect PhotolysisScreening Test)NA NA $25,624D2035-80 (ASTM D 2035-80)Standard Practice for Coagulation-Flocculation JarTest of WaterNA NA $4,426OECD 303ASimulation Test - Aerobic Sewage Treatment, withmeasurement of loss of the parentNA NA $44,569OECD 307 Aerobic and Anaerobic Transformation in Soil NA Flow-through $292,278OECD 307 Aerobic and Anaerobic Transformation in Soil NA Bio-meter type flasks $276,289Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-5GuidelineTestSpeciesRoute/MethodCost2011$OECD 308Anaerobic transformation in aquatic sedimentsystemsNA NA *OECD 309 Aerobic mineralisation in surface water NA NA *OECD 310Ready biodegradability-CO2 in Sealed Vessels(headspace test)NANA*OECD 311 (835.3400)Anaerobic biodegradability of organic compoundsin digested sludgeNA NA *OECD TG 310 CO2in Sealed Vessels – Headspace Test NA NA *Draft OECD Jan 2002Phototransformation of chemicals on soil surfaces-2 soilsNA NA*Ecological Effects850.1000Special Considerations for Conducting AquaticLaboratory StudiesNA NA *850.1010 (797.1300) Daphnid Acute Toxicity Daphnid Flow-through $15,619850.1010 (797.1300) Daphnid Acute Toxicity Daphnid Static $15,412850.1075 (797.1400) Fish Acute ToxicityFatheadMinnowFlow-through$21,524850.1075 (797.1400) Fish Acute Toxicity NA Static $17,433850.1085 Fish Acute Toxicity Test mitigated by humic acidFatheadMinnowFlow-through *850.1085 Fish Acute Toxicity Test mitigated by humic acidFatheadMinnowStatic $18,172850.1300 Daphnid Chronic Toxicity Test Daphnid Flow-through $139,894850.1350 Mysid Chronic Toxicity Test Mysid Flow-through $44,961Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-6GuidelineTestSpeciesRoute/MethodCost2011$850.1400 Fish Early Life Stage ToxicityRainbowTroutFlow-through $71,341850.1400 Fish Early Life Stage ToxicityFatheadMinnowFlow-through $48,229850.1730 Fish BCFFatheadMinnowFlow-through $156,076850.1925 Site-Specific Aquatic Microcosm Test NA NA *850.1950 Field testing for Aquatic Organisms3NA NA $694,050OECD 218Chironomid Sediment Toxicity NA NA $29,767850.5400 Algal Toxicity, Tiers I and II NANA $18,873Health Effects870.1100 Acute Oral Toxicity Rats Gavage $8,134870.1300 Acute Inhalation Toxicity Rats4Inhalation $17,938870.2500 Acute Dermal Irritation Test Rabbits Dermal $6,306870.2600 Dermal Sensitization Test Guinea Pigs NA $12,092870.3050 Repeated Dose 28-day Oral Toxicity Test Rodents NA *870.3100 90-Day Oral Toxicity Rats Gavage $162,941870.3250 Subchronic Dermal Toxicity - 90 days Rats Dermal $172,991870.34651Subchronic Inhalation Toxicity Rats Inhalation $534,075870.3465 (mod)Subchronic Inhalation Toxicity (w/ 60 dayrecovery group)Rats Inhalation $254,763870.3465 (OECD 413)1Subchronic Inhalation Toxicity (90-dayexposure/180-day retention)Rats Inhalation $445,112Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-7GuidelineTestSpeciesRoute/MethodCost2011$870.3550Reproductive/Developmental Toxicity ScreeningTestNA Oral *870.3650Combined repeated dose toxicity test with thereproductive/developmental screening testRats NA *870.3700 Prenatal Developmental Toxicity {2 species} Rats Gavage $123,686870.3800Reproduction/Fertility Effects (2-GenerationReproduction)Rats Gavage $411,738870.4200 Carcinogenicity {2 species} (24 months) Rats Gavage $1,641,728870.4200 Carcinogenicity {2 species} Rats Inhalation $1,302,863870.4300 Combined Chronic Toxicity/Carcinogenicity Test Rats Gavage $1,253,934870.5100 Bacterial reverse mutation test NA Direct plate $9,364870.5265Salmonella typhimurium Reverse Mutation Assay(Ames Test)NAAverage of direct plateand Azo reduction$13,515870.5385Mammalian Bone Marrow ChromosomalAberration TestRats Gavage $37,836870.5395In Vivo Mammalian Bone Marrow CytogeneticsTests: Erythrocyte Micronucleus Assay (Averageof 1 and 3 day dosings)MiceGavage (Average of 1and 3 day)$22,919870.5395In Vivo Mammalian Bone Marrow CytogeneticsTests: Erythrocyte Micronucleus Assay (Averageof 1 and 3 day dosings)MiceIntravenous (Two testaverage)$22,919870.5550Unscheduled DNA Synthesis in Mammalian Cellsin CultureRatHepatocytesNA$23,668870.6100Delayed Neurotoxicity of OrganophosphorusSubstances (Acute)Hens Gavage (Acute)$40,464Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-8GuidelineTestSpeciesRoute/MethodCost2011$870.6100Delayed Neurotoxicity of OrganophosphorusSubstances (Subchronic 28-day)Hens Gavage (Subchronic)$97,858870.6200Neurotoxicity Screening Battery (Acute)RatsGavage$163,054870.7485Metabolism and Pharmacokinetics (Tier I)RatsGavage$47,656870.7800ImmunotoxicityRatsGavage$69,277ASTM F739 -91 (ASTMF739)2Standard Test Method for Resistance of ProtectiveClothing Materials to Permeation by Liquids orGases Under Conditions of Continuous ContactNAAverage (Gases andLiquids)$15,144OECD 105Water Solubility TestNAFlask Method$7,169OECD 112Dissociation Constant in Water TestNAConductometricMethod$6,416OECD 206Avian Reproduction TestBobwhiteQuailNA$106,052OECD 206Avian Reproduction TestMallardDucksNA$114,681OECD 303ASimulation Test - Aerobic Sewage Treatment:Activated Sludge UnitsNANA$44,569OECD 307Aerobic and Anaerobic Transformation in Soil TestNAFlow Through$292,278OECD 307Aerobic and Anaerobic Transformation in Soil TestNABio-meter Type Flasks$276,289OECD 308Aerobic and Anaerobic Transformation in AquaticSediment Systems TestNANA*OECD 311Anaerobic Biodegradability of OrganicCompounds in Digested Sludge TestNANA*OECD 314Simulation Test to Assess the Biodegradability ofChemicals Discharged in WastewaterNANA*OECD 404 (870.2500)Acute Dermal IrritationRabbitsDermal$6,440Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-9GuidelineTestSpeciesRoute/MethodCost2011$OECD 405 (870.2400)Acute Eye IrritationRabbitsEye$6,440OECD 407 (870.3050)Repeated dose 28-day oral toxicity study in rodentsRatsGavage (28 Days)$60,077OECD 412Repeated Dose Inhalation Toxicity (28-Day Study)RatsInhalation (28 Days)$134,508OECD 416Two-Generation Reproduction Toxicity TestRatsDietary$443,291OECD 421 (870.3550)Reproduction/developmental toxicity screeningtestsRatsGavage$70,465OECD 422 (870.3650)Combined RepeatedDose Study withReproductive/Developmental Toxicity ScreenRats Gavage $140,459OECD 422 (mod)Combined RepeatedDose Study withReproductive/Developmental Toxicity Screen (90days w/ histopathology)Rats Gavage $264,076OECD 425 Acute Oral toxicity: Up-and-down Procedure Rats Gavage $6,221OECD 453 Combined Chronic Toxicity/Carcinogenicity Test Rats Inhalation $3,606,487ASTM D6007-02Small Scale Chamber Test to DeterminingFormaldehyde Concentration in Air from WoodProductsNA NA *EPA draft - InhalationMonitoring Data CollectionGuidelinesNA NA NA *Nanomaterial Specific Tests5, 6OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsDustiness Test NA EN 15051 Method $2,625Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-10GuidelineTestSpeciesRoute/MethodCost2011$OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsDry particle size distribution by count for eachPMN substance in a form which has the highestcontent of particles smaller than 10 microns asmanufactured, processed or used in the workplaceat sites controlled by the CompanyNASTEM (scanningtransmission electronmicroscopy) method*OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsSurface chemistry NAAverage of ThreeMethods$5737ASTM D2565-99(2008)Release of MWCNTs after exposure of liquidpolymer forms to sunlight:NAConsult StandardPractice for XenonArc Exposure ofPlastics Intended forOutdoor Applications*ASTM E1354-09Release of MWCNTs during the burning of liquidpolymer forms:NAConsult Standard TestMethod for Heat andVisible SmokeRelease Rates forMaterials and ProductsUsing an OxygenConsumptionCalorimeter*Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-11GuidelineTestSpeciesRoute/MethodCost2011$EPA method 1320 Release of MWCNTs after landfill disposal: NAMultiple ExtractionProcedure todetermine the fractionof MWCNTs releasedduring the leachingthat the liquid polymerforms will undergofrom repetitiveprecipitation of acidrain*OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsConfiguration of Carbon Nanotube ends NA NA $766OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsRelease of MWCNTs during solid polymer formshipping and useNAA simple short-termtest consisting ofplacing the solidpolymer forms in astandard rock tumblerand determining theamount of freeMWCNTs after aperiod of l, 5, 15, and30 days to screen forsignificant release ofMWCNTs from thesolid polymer forms.*OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM C100 (>90%MWCNTs. < 7% aluminia and <5% of iron oxide)NA NA *Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-12GuidelineTestSpeciesRoute/MethodCost2011$OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM U100 (>97%MWCNTs. <3% of iron oxide, 1% alumnia)NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM CSI-015, a viscousresin (honey-like) comprised of 98.5% epoxy resin,1,5% GRAPHISTRENGTH TM C100NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM PEB-201, a very highlyviscous resin (tar-like paste) comprised of 64.3%polyester, 31.6% styrene, remainderGRAPHISTRENGTH TM C100NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM CM1-20, a pelletcomprised of 79% polyamide, 12.5% white mineraloil, remainder GRAPHISTRENGTH TM C100NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM CM2-20 a pelletcomprised of 78% polyamid resin, 22%GRAPHISTRENGTH TM C100NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM CM3-20 a pelletcomprised of 79% polyamid 11, 21%GRAPHISTRENGTH TM C100NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM CM5-20 a pelletcomprised of 60% polycarbonate, 20% flameretardant, 20% GRAPHISTRENGTH TM C100NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM CM12-30, a pelletcomprised of cyclic butylenes trephthalate (CBT),30% GRAPHISTRENGTH C100NA NA *Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012-0277)September 20, 2012 D-13GuidelineTestSpeciesRoute/MethodCost2011$OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM CM13-30, a pelletcomprised of 65% polyacrylic-polyolefin, 15%acrlonitrile-butadiene copolymer, 20%GRAPHISTRENGTHTM C100NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsGRAPHISTRENGTH TM C M6-20 a granulecomprised of 80%polyamid6, 20%GRAPHISTRENGTH TM C100NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsWorkplace exposuremonitoring andcharacterization testing (including byproducts)NA NA *OECD's Guidance Manualfor the Testing ofManufactured NanomaterialsCertain material characterization data NA NA *Notes:* Indicates this cost has not been calculated for this report.+Indicates that EPA, EPAB staffestimated this test costin fall of 2009 and it is more recent that the other EPA, OPPTS EPAB test cost estimates presented in the table, themajority of which wereestimated prior to 1990.1For some PMNs, recommended testing under guideline 870.3465 would involve an additional 3 monthrecovery group, as well asother evaluation beyond the standard requirements in the testguideline. These activities wouldraise testing cost substantially.1The recommended testing for some PMN chemicals may include a glove permeation testfollowing ASTM F739 and F1194-99 guidelines.ASTM F1194-99 is a standard guidefor documenting the results of chemical permeation tests (seewww.astm.org). The additional costs of following ASTM F1194-99 (average of gases and liquids) were not estimatedfor this report.2Costs for field testing will be site-specific, with a wide range of actual costs. Areport from EPA's Office of Pesticide Programs estimated an averagetest cost of $600,000 forguideline 850.1950, for simulated or actual field testing for aquatic organisms (EPA, 2008a, Appendix C).3Performing the test on species other than rats may change the test costs. For example, testing on rabbits is likely to increase costs.4Fate, transport and transformation, ecological effects, and health effects testing may be required for nanomaterials, howevernano-specific costs for these tests were not estimatedfor this report.5While the Agency expects that analytical methodology validationcosts may be more expensive for nanomaterials than for traditional chemicals, EPA was unable to gather anyinformation on nanomaterial-specific analytical methodology validation and therefore uses the traditional chemical costs as a proxy.6The test cost is an average of the test costs for three methods: EELS, XPS (ESCA), and Auger electron spectroscopy.Source:EPA OPPTS Economic and Policy Analysis Branch cost estimates. Many costs were estimated in the 1990s or earlier. All have beeninflated (see Table B-1 and Table B3 for inflation index). Dollar costs include $4,140 or $10,055 foranalytical method validation; where applicable (see text). Species and route or method may be specified in SNURs ormay be unspecified but assumed in this table for costing purposes.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

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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, Ec onomic and Analysis Branch, regularly develops cost estimates of test guidelines to support 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 equipm ent needed to perform testing, with overhead and fee. Many of the test costs were developed in the 19 90s. Test costs have been inflated using Employment
Cost Index inflators from the Bureau of Labor Statis tics (see Appendix B). Howeve r, generally they have not been updated to reflect subsequent changes in laborato ry technologies.

Testing laboratories perform analytical method valida tion to ensure that proper dose concentrations are used in toxicity studies (EPA, 2005a, p. 3-9). This anal ysis 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 longerterm tests have validation costs of $8,500 in 2004 dollars. Using the inflation rates found in Appendix B, validation costs are $4,140 and $10,055 in 2011 dollars. For simplicity, the method validation cost for ecological effects tests (e.g. 850 series guidelines) was assumed to be $4,140 for each test. In addition, this analysis assumes that analytical method validati on costs are the same for both nanomaterials and
traditional chemicals.

In cases where costs have not been estimated for th e specified guideline, EPA uses the cost from an approximately equivalent guideline (listed in Tabl e 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 th e species, route, 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 adjust ments were selected based on discussions with EPA scientists and on SNUR language, published test guide lines, 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 been estimated for different combinations of species, route, length of study and other aspects of methodology, but in so me cases the SNUR may not specify all of these variables. Where this occurs, EPA has used certa in default parameters, listed in Table D-2.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

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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

Notes:

1 For guideline 850.1400 test s 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 tests 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 tes ting described at 64 FR 60194.

D.2.3 Test Cost Assumptions and Comments

This section explains treatment of certain test s 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 cost atum, Anabaena flos-aquae, and Selenastrum capricornutum ). If a SNUR does not specify the algal species to be u sed, the average costs of the four algal species
tests are used.

 For OPPTS test guideline 835.3100 (Aerobic 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. Ta ble D-1 gives costs for 835.3100 but not for the
extended test.

 A SNUR may recommend a “modified” version ofASTM test guideline D2035-80 (CoagulationFlocculation Jar Test of Water). Table D-1 gives costs for D2035-80 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-1.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

September 20, 2012 D-16 

###  A SNUR may recommend two 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 flow 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 estimates assume only one species is used.

D.2.4 Persistent Bioaccumulative Toxic (PBT) tiered testing

A SNUR may cite tiered testing for Persistent Bi oaccumulative Toxic chemical substances (PBTs) according to the testing strategy in EPA’s New Ch emicals Program PBT Category document, published in the Federal Register notice, Category for Persistent, Bioaccumu lative, and Toxic New Chemical Substances, November 4, 1999, at 64 FR 60194.

In 64 FR 60194, there are three tiers of testing. The r esults of Tier 1 determine whether Tier 2 testing is needed and the results of Tier 2 testing determine wh ether Tier 3 testing is needed. Table D-3 lists 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 testing (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 adjust ed to avoid double counting tests listed in the SNUR both explicitly by 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 ra inbow 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 biodegradability tests, firm s 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 co st estimates assume an equal chance of using
either 835.3110 or 835.3120.Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

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### Table D-3. Persistent Bioaccumulative Toxic (PBT) Tiered Testing Requirements

PBT
Tier Guideline Test Cost 2011$

1 OPPTS 830.7560*

-orOPPTS 830.7570* Partition Coefficient (n-Oct/Water), Generator Column method

-orPartition Coefficient (n-Oct/Water), Liquid Chromatography method Average $7,665

$5,045 $6,355
1 OPPTS 835.2110 Hydrolysis as a Function of pH $60,731

1 OPPTS 835.3110

-orOPPTS 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 $13,031

$8,081 $10,556
2 OPPTS 835.3170 Shake-flask Die-away Test [measures biodegradability] $53,137
2 OPPTS 850.1730 Fish Bioconcentration $156,076
3 OPPTS 835.3180 Sediment/Water Microcosm Biodegradation $138,942

3 40CFR 797.1330
or 850.1300** Daphnid Chronic Toxicity Test $139,894

3 40CFR 797.1600
or 850.1400** Fish Early Life Stage Toxicity (in rainbow trout) $71,341

3 OECD 422 Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Screening (in rats) $140,459

Total cost, all tiers (assuming all tests a re conducted) $777,491

Source: 64 FR 60194, Category for Persistent, Bioaccumulati ve, 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 simila r 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 tests as equiva lents. This table uses costs for 850.1300 and 850.1400 since they were costed out more recently by EPA.



### D.3 Testing Costs by Chemical

Test costs attributable to a SNUN are likely to be mu ch 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. 28 

### See the main text of this report for a discussion of testing.

28 A prior SNUR economic analysis calcu lated chemical-specific test costs (E PA, 2007b, Table D-4). The chemicalspecific table was dropped from a later SNUR economic analysis (EPA, 2007c).Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

September 20, 2012 D-1 

## APPENDIX E: References

29 CFR 1910. Occupational Safe ty and Health Standards. Code of Federal Regulations, Part 1910, Title 29, November 25, 1983.

63 FR 41847. Test Guidelines; Notice of Availability, Federal Register, Volume 63, August 5, 1998.

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.

75 FR 773. TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations, Federal Register, Volume 75, January 6, 2010.

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