`

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 Blank
Economic 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 Stephanie Suazo of the Economic and Policy Analysis 

Branch; Economics, Exposure and Technology Division; Office of Pollution Prevention and Toxics. 

Analytical and draft preparation support was provided by Abt Associates Inc. under EPA Contract No. 

EP-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 costs of Significant New Use Rules (SNURs) covering 78 

chemicals that have been the subject of TSCA premanufacture notices (PMNs). APPENDIX A: lists each 

regulated chemical’s generic or specific chemical name and Chemical Abstract Service Registry Number 

(CASRN) (if non-confidential). The SNURs are being published under the rulemaking docket number 

EPA-HQ- OPPT-2012-0277 as direct final rules. The SNURs define “Significant New Uses” that trigger 

EPA notification requirements. To submit a Significant New Use Notice or request a SNUR modification, 

a firm incurs a modest submission cost, plus costs of any 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 associated with restricting chemical releases to water or 

preventing worker exposure. The options available to a firm considering the manufacture, import, and/or 

processing of a chemical covered under a SNUR, and the types of associated costs to the firm, are 

summarized in Table ES-1. 

It should be noted that the costs listed in Table ES-1 may be incurred for reasons other than the SNUR. 

The costs of avoiding a Significant New Use are attributable to the SNUR only if, in the absence of the 

SNUR, the firm would have adopted a different approach. For example, a SNUR may define any use 

other than that described in the PMN as a Significant New Use. If the PMN submitter would have 

conformed to the uses described in the PMN even without the SNUR, then any associated costs of 

adhering to the PMN uses would not be due to the SNUR. Costs to a PMN submitter of practices required 

by a TSCA Section 5(e) Consent Order would be attributable to the Consent Order, not the SNUR. If a 

processor would have workers wear gloves even without SNUR requirements, then the gloves costs 

would not be attributable to the SNUR. The costs in Table ES-1 are attributable to the SNUR only if the 

firm adopts a different approach due to the Significant New Use Rule. 

 
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 

Option1 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 electronically submitting a SNUN 

(including SNUN recordkeeping and user 

fee4

) 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 activity that would 

otherwise be pursued. R&D recordkeeping 

costs if manufacture for R&D.

Costs not quantified.

Notes: 

Section numbers refer to 40 CFR §721 (in the Code of Federal Regulations). Costs come from 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 

specified practices. $37,412 is the annual cost for dermal protection selection; impermeability 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” chemicals requiring a PMN, so some firms may need to make a 

submission before commercial production or import, even in the absence of a SNUR (see Section 2.3 of this report).
Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 iv 

 Table of Contents 

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

1.1 Statutory Authority and Significant New Uses under the Proposed SNURs ........................ 1-1

1.2 Summary of Methodology .................................................................................................... 1-2

1.3 Organization of this Report ................................................................................................... 1-2

2 Costs of a Significant New Use Rule (SNUR), by Option ........................................................... 2-3

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 Determination (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 ......................................... 3-1
Economic 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 Processing 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 their Chemical Names .............................................................. A-1

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

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

Recordkeeping Requirements ................................................................................................................ C-1

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

APPENDIX E: References ................................................................................................................. E-1
Economic 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 Associated 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 Workplace 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 Notification Cost per Notification ............................................................. 3-3

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

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

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

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

Table B-2. Derivation of Industrial Hygienist Wage Rate (NAICS 31, 32, 33) ....................................... B-5

Table B-3. Derivation of Inflation Factors ................................................................................................ B-7

Table C-1. Annual Costs of Labeling for Distribution in Commerce [40 CFR §721.72(b)(2)] ............... C-3

Table C-2. Annual Costs of Labeling for Use in Workplace [40 CFR §721.72(b)(1)] ............................ C-4

Table C-3. Annual Costs for Material Safety Data Sheets (MSDSs) [40 CFR §721.72(c)] ..................... C-4

Table C-4. Annual Costs for Employee Training, Per Chemical [40 CFR §721.72(d)] ........................... C-5

Table C-5. Annual Costs for Dermal Protection Selection [40 CFR §721.63(a)(1)] ................................ C-6

Table C-6. Annual Costs of Impermeability Testing [40 CFR §721.63(a)(3)] ......................................... C-7

Table C-7. Annual Cost of Gloves [40 CFR §721.63(a)(2)(i)] ................................................................. C-8

Table C-8. Annual Cost of Protective Eyewear [40 CFR §721.63(a)(2)(iii)] ........................................... C-9

Table C-9. Annual Cost of Protective Clothing [40 CFR §721.63(a)(2)] ................................................. C-9
Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 vii 

Table C-10. Crosswalk Between SNUR Text and Respirator Types at 40 CFR §721.63(a)(5) ............. C-11

Table C-11. Annual Per-Chemical Costs for Respiratory Protection [40 CFR §721.63(a)(4)] .............. C-13

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

Table C-14. Annual Per-Chemical Costs of Recordkeeping 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 Toxic (PBT) Tiered Testing Requirements .............................. D-17
Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

August 29, 2012 1-1 

1 Introduction 

This report presents the U.S. Environmental Protection Agency (EPA), Office of Chemical Safety and 

Pollution Prevention’s (OCSPP)’s analysis of the potential costs incurred as a result of direct final 

Significant New Use Rules (SNURs) being promulgated 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 the generic or specific chemical name and 

Chemical Abstract Service Registry Number (CASRN) (if non-confidential) for each PMN. 

1.1 Statutory Authority and Significant New Uses under the Proposed SNURs 

EPA may promulgate a SNUR for a substance when (1) the substance is the subject of a section 5(e) 

Consent Order (40 CFR §721.160), or (2) the Agency determines that activities other than those described 

in the PMN may result in significant changes in human exposure or environmental release levels and/or 

that concern exists about the substance’s health or environmental effects (40 CFR §721.170). In contrast 

to PMN requirements, which apply mainly to manufacturers and importers (TSCA § 5(a)(1)(A), 40 CFR 

§720.22), the SNUR applies to processors as well as to manufacturers and importers (TSCA § 5(a)(1)(B), 

40 CFR §721.5). 

Each substance analyzed here was the subject of at least one premanufacture notice 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 current rulemaking, SNUR requirements for 7 of 

the 78 substances are based on prior Consent Orders. 

EPA promulgates a SNUR to designate specific activities involving the chemical substance that EPA has 

determined constitute a “significant new use.” No person may manufacture or process a chemical substance 

for a significant new use, unless they submit a significant new use notice (SNUN) to EPA at least 90 days in 

advance. Examples of typical “significant new uses” that can trigger the requirement to submit a SNUN (if 

EPA has promulgated a SNUR applying these requirements to a specific chemical) include: 

 Domestic manufacture in the United States 

 Manufacture of a particular aggregate or annual volume 

 Use other than that specified in the PMN 

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

 

1

 This report covers chemicals that went through PMN review and are part of an expedited rulemaking. The relevant 

Office of Management and Budget Information Collection Request number is ICR No. 0574 (OMB Control 

Number 2070-0012). EPA also promulgates SNURs through conventional rulemaking that are covered by ICR 

No. 1188 (OMB Control Number 2070-0038). 
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August 29, 2012 1-2 

 Handling the chemical without employing specified personal protective equipment (e.g., gloves, 

goggles, respirators) or hazard communication (haz-comm) measures (e.g., label, MSDS, worker 

training) 

If EPA does not promulgate a SNUR for a given chemical, then these requirements would not apply 

(unless they apply to a PMN submitter via a §5(e) Consent Order). If EPA has promulgated a SNUR 

containing these types of significant new use designations, as long as the person does not engage (nor 

intend to engage) in any activities defined by the SNUR as a significant new use, then that person may 

proceed to handle the chemical without submitting a SNUN. 

1.2 Summary of Methodology 

This analysis quantifies, to the extent possible, the costs to society of the proposed rule by identifying the 

costs to industry associated with complying with the rule, 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 notification, 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 collection requests and economic analyses for related 

rules, compensation data acquired from government publications, and supplementary market research to 

produce an estimate of the universe of affected entities and measure the impact of the proposed rule on 

small entities. 

In previous economic analyses of SNURs, EPA identified those requirements under Subparts A, B, C, and 

D of 40 CFR §721 that may indirectly impose costs on 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 analyses 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 below a specified level; they are described only 

qualitatively. 

It was not feasible within available resources to aggregate costs, or to estimate how often costs are 

actually incurred as a result of SNURs, except for costs of SNUN 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 presents 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 proposed SNURs. Appendix B provides the wage rates and 

inflators used in this analysis. Other appendices give cost estimation details and references. 
Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQOPPT-2012-0277)

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

A SNUR specifies requirements that a firm must meet if it chooses to manufacture, import, or process a 

PMN chemical without engaging in a Significant New Use that would trigger notification to EPA. A 

SNUR also requires recordkeeping for anyone manufacturing, importing, or processing the SNUR 

chemical. A SNUR recommends testing, but does not require testing. EPA rarely receives results of tests 

performed specifically to support a SNUN. Table 1 sets forth possible responses to a SNUR. A firm may 

select more than one course of action. For example, it may produce a chemical in a way that avoids a 

Significant New Use, while simultaneously submitting a 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 

Option1 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 electronically submitting a SNUN 

(including SNUN recordkeeping and user 

fee4

) 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.

$8,571submission 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 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 activity that would 

otherwise be pursued. R&D recordkeeping 

costs if manufacture for R&D.

Costs not quantified.

Notes: Section numbers refer to 40 CFR §721 (in the Code of Federal Regulations). Costs come from 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 specified 

practices. $37,412 is the annual cost for dermal protection selection; impermeability 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” chemicals requiring a PMN, so some firms may need to make a submission before 

commercial production or import, even in the absence of a SNUR (see Section 2.3 of this report).

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

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2.1 Comply with SNUR Limits (Option 1) 

A firm can avoid engaging in a Significant New Use and submitting a SNUN by meeting all applicable 

SNUR requirements. The firm may also pursue this option temporarily by complying with SNUR 

restrictions while also pursuing other options such as making a submission to EPA. If it does avoid 

engaging in a Significant New Use (and if the chemical is on the TSCA Inventory or if the firm has 

already submitted a PMN), no notice to EPA is required.2

 Table 2 shows the types of requirements a firm 

must meet to avoid engaging in a Significant New Use. 

The Significant New Use designation in a SNUR for a specific chemical reflects either the use scenario 

described in the PMN for that chemical (what the submitter was already planning to do) or the 

requirements in the 5(e) Consent Order resulting from the PMN submission. Thus, it is likely that the 

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 general commercial use, a notice must be filed with EPA 

under Section 5(a)(1)(A) of TSCA (40 CFR §720.3 and 40 CFR §720.22). 
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 

Affected1

Sample Costs Per 

Chemical 

(2011$) 

§721.63 Workplace protection 24 $12,439 to $37,412

§721.72 Hazard communication 9 $1,088 

Industrial Commercial, and Consumer 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 

Order

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 

§721.1253 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 protection selection and heavy duty gloves. $37,412 is the annual cost for dermal 

protection selection; heavy duty gloves, impermeability testing/evaluation of manufacturer specifications, and a lower-cost 

respirator (see Table 5). 

3

 This excludes SNUN recordkeeping under §721.40. See the recordkeeping discussion in APPENDIX C:. 

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 equipment, and recordkeeping requirements are quantified 

for this report. APPENDIX C: presents a more detailed derivation of these costs. The export notification 

costs are summarized in Chapter 3. Complying with requirements to avoid a Significant New Use also 

may result in additional costs that affect a significant number of the chemicals, such as costs associated 

with limiting releases to water, that were not quantified for this report; these costs are also summarized 

below. 

2.1.1 Hazard Communication 

Requirements. Each 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 Rules: General Provisions for New Chemical Followup 
Economic 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 safety data sheets (MSDSs) [§721.72(c)]; and 

 Employee awareness training on where and how the chemical is used, the hazards associated and 

availability of hazard information about the chemical, and protective 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-comm requirements for PMN substances subject to 

haz-comm requirements appear in Table 3. Further, the costs are for substances with full haz-comm 

requirements, and may overstate haz-comm costs for substances with partial requirements. Appendix C 

gives the 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 not subject to all of these 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. 
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In some cases, EPA specifies the type of PPE required. In other cases, EPA requires adequate dermal 

protection but does not specify particular PPE. Instead, it requires the employer to evaluate worker 

exposure conditions and hazards, and select appropriate PPE. Generally the employer is also required to 

determine that dermal PPE is impervious to the PMN substance by one or 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 protection 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 inflation. The estimates are for one chemical at one site 

with 25 exposed workers; actual costs would vary with the number of workers. APPENDIX C: gives the 

detailed cost derivation. 
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Table 4. Annual Costs of Workplace Protection Requirement 

Personal Protective Equipment and Requirement Citation at 40 CFR Unit Cost 

(2011$)1 

Quantity 

Required1

Total Annual 

Cost2 

(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 Manufacturer'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-body (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 Types3 

Supplied-air respirator operated in pressure demand or continuous flow 

mode and equipped with a tight-fitting full facepiece. [similar to 

§721.63(a)(5)(ii)] 

$1,127 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). [similar 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 Air (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), R100, 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 equipped 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 equipped with a loose-fitting hood or 

helmet and High Efficiency Particulate Air (HEPA) filters. [similar to 

§721.63(a)(5)(vi)] 

$2,621 25 $65,517 
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Notes: 

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

25 days; 3) respirator units replaced annually and cartridge sets replaced every five days (50 cartridges sets per year); 4) goggles and 

protective clothing replaced three times yearly. 

2 Total annual costs were calculated using unrounded unit cost estimates, and may not equal the product of the rounded estimates 

shown in this table. 

3 This table lists respirator choices that typically would satisfy SNUR requirements for a particular chemical, for current and recent 

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) categories, costs in this analysis are based on costs estimated in 1997 for the 

§721.63(a)(5) categories. See Table C-10 for the crosswalk between respirator types in SNURs and in this table. The respirator “unit 

cost” is per worker. Total respirator costs include costs of the respirator plus the costs of any add-on items such as hoods, helmets, 

cartridges, filters, and caps, if these items are required for a particular respirator. 

Source: APPENDIX C:, Tables Table C-5 through Table C-11. 
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The costs of purchasing protective equipment are derived in APPENDIX C:, and have been annualized 

based on the assumptions listed above regarding their use and lifetime in the workplace. Costs for 

evaluating hazards when PPE is not specified in the SNUR are based on estimates of the reasonable time 

required for a safety professional to perform such evaluations. Costs for conducting impermeability 

testing are based on consultation with PPE vendors, as described in APPENDIX C:. Table 4 summarizes 

the annual costs associated with protection in the workplace, including the 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 time for dermal protection selection. The maximum cost 

includes the cost of gloves, dermal protection, impermeability testing, and the annual cost of the least 

expensive respirator and filters for 25 workers. 

Table 5. Sample Costs of 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 protective gear, the estimates assume workers would not 

otherwise wear adequate protective equipment. To the extent that workers would otherwise be adequately 

protected (as a result of the company’s own safety program related to other chemical hazards, or to comply 

with OSHA’s PPE standards), these costs may be an 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 determination. Table 4 shows costs of assessing needs and 

demonstrating impermeability. These cost estimates would reflect a situation where the dermal protection 

is already in place but the manufacturer must demonstrate that it is adequate. If companies also have to 

purchase additional protective gear, incremental costs attributable to the SNUR would include the added 

items. For example, if a firm already providing gloves and goggles determined that it would have to add 

protective clothing to avoid engaging in a Significant New Use, this would increase costs even if 

particular protective clothing is not specified in the SNUR. 
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2.1.3 Recordkeeping 

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

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

In addition, the SNURs specify recordkeeping requirements for manufacturers, importers, and processors, 

by identifying paragraphs selected from 40 CFR §721.125(a) through (k). These recordkeeping 

requirements apply even if the firm does not engage in a reportable New Use or make a submission to 

EPA, so long as it manufactures, imports, or processes the chemical. The recordkeeping requirements 

vary by chemical. For example, only chemicals that must establish a Hazard Communications program to 

avoid a Significant New Use would be required to keep records documenting their haz-comm program. 

(For firms producing under the R&D exemption, R&D recordkeeping would be needed. R&D 

recordkeeping costs were not estimated for this report.) 

SNUR recordkeeping requirements essentially involve copying and filing relevant records, including 

those related to manufacturing, importing, or processing 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 recordkeeping 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, photocopying charges, and costs for records storage. 

Table 6 summarizes recordkeeping costs by requirement at 40 CFR §721.125. The totals in Table 6 provide 

the cost if all recordkeeping requirements in paragraphs §721.125 (a) through (k) were required; this would 

seldom, if ever, be the case for a single chemical. 

 

3

 For example, OPPT’s Information Collection Request (ICR) for TSCA Section 5(a)(2) Significant New Use Rules for 

Existing Chemicals (Renewal), October 11, 2005, estimated SNUN recordkeeping costs at 5.67 hours (EPA, 

2005b, page 12). 
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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/transfer 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 complying 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 internal 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 limiting releases in order to avoid the Significant New Use. 

 Similarly, avoiding uses not listed in the original PMN could result in “hidden” costs of foregone 

profits if the firm cannot market the chemical for certain applications. If the firm wants to use the 

chemical for internal use, it may have to substitute to other chemicals or technologies that cost 

more or have lesser performance resulting in higher production costs. 

 Importing could be costlier than manufacturing a PMN substance in the United States. 

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

Under 40 CFR §721.185, EPA may modify or revoke a SNUR upon review of a submittal from a 

manufacturer, importer, or processor. Consequently, the second option for a firm is to request modification 

or revocation of the SNUR. According to New Chemical Program records EPA receives few 

modify/revoke requests (typically up to three per year) due to SNURs. 

This option may have some or all of the following associated costs: 

 One-time costs of testing to develop health and environmental effects data for a chemical subject 

to the SNUR; 

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

 Ongoing costs of complying with SNUR restrictions (Option 1 in this report) or of avoiding 

production while the modification request is being processed (Option 5). The firm may also incur 

costs of complying with any SNUR restrictions that are not ultimately revoked or may incur 

hidden costs of avoiding production altogether. 

These costs are 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 SNUR identifies health, ecological, and/or 

fate/transport/transformation testing that would help characterize the risks associated with the substance. 

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

testing at all. It is possible that some of the recommended tests, or other tests, would be performed 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 modification request, costs may be similar to costs of a SNUN – discussed 

later in this section – minus the user fee. 

Table 7 below provides an example of potential costs if a firm were to perform a standard set of basic 

ecotoxicity tests to support a request to modify or revoke a SNUR. 

Table 7. Sample Costs of Recommended Testing 

Test Guideline Test 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.
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2.2.2 Costs for Submitting a Request for Modification or Revocation of a SNUR 

The costs associated with submitting a request for modification and revocation of a SNUR (or of 

submitting a SNUN) are estimated to be similar to the costs for preparing a PMN submission, except that 

there is no user fee for the modify/revoke request. The PMN submission costs came from EPA’s 1994 

Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture 

Notifications, which relied on industry estimates of the effort needed to collect and compile all data 

required for a PMN submission, prepare the form, submit the form and data to EPA, and maintain a file of 

the submission (EPA, 1994, Table III-2 and pages III-11, -12, and -13). The 1994 estimates were based on 

a survey conducted by the Chemical Manufacturers Association (CMA, 1991), which became the 

American Chemistry Council. The burden associated with PMN submission and preparation has 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 expected reduce all recordkeeping burden associated with 

SNUN submissions by fifty percent. Because, the recordkeeping burden for PMNs was not estimated 

separately, for the purposes of this report we assume this burden reduction is captured in the removal of 

all clerical burden.5

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

This burden is reduced to 83 to 100 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 derived using the averages of the hours for each type of 

labor from the 1994 report, after adjusting for the ePMN savings. The method of calculating hourly 

loaded labor costs is described in Appendix B. 

 

 

4 Economic Analysis of Expedited Significant New Use Rules for 25 Chemical Substances: EPA Docket OPPT-2009-

0922, 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. 

5 The Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a) reported 

a 0.5 hour clerical and a 0.5 hour technical burden associated with recordkeeping in addition to the burden 

estimates from the 1994 RIA (EPA, 1994, p. III-14). These burden estimates (the 0.5 for clerical burden and 0.5 

for technical burden) are based on the recordkeeping burden for polymer exceptions and not the recordkeeping 

burden associated with PMN submissions. Therefore, for this analysis, the 0.5 hour for clerical labor and the 0.5 

hour for technical labor were removed. It is important to note that for this analysis, clerical burden changes are 

not applicable because the entire clerical burden is assumed to be eliminated under the electronic reporting 

requirements. In summary, we do not include the one hour recordkeeping burden (0.5 hour for clerical, 0.5 for 

technical) reported in the ePMN EA. 
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2.2.3 Other Costs 

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

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

the review period. Alternatively, the submitter may elect to produce under the constraints of the SNUR 

during the review period, so as to avoid a Significant New Use. EPA may not revoke all SNUR 

provisions as a result of 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 modification 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 

Rate1

(2011$)

Total Labor Cost (Loaded Wage x Average Hours)

Request to Modify 

SNUR 

(Option 2)

SNUN 

(Option 3)

Equivalency 

Determination 

(Option 4)

Clerical2 0 $29.63 $0 $0 $0

Technical3 74.2 $64.66 $4,798 $4,798 $4,798

Managerial3 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, unrounded values are used to calculate 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 managerial labor is from the PMN Amendments RIA (EPA, 1994, Table III-2).

2.2.4 Total Costs for Option 2 

The total costs associated with requesting a modification or revocation of a SNUR include the costs of 

generating new supporting data plus the administrative cost of preparing the submission. 

2.3 Submit SNUN (Option 3) 

Under 40 CFR §721.5, manufacturers, importers, or processors who would like to undertake a Significant 

New Use of a substance listed in a SNUR are required to submit a Significant New Use Notice (SNUN) at 

least 90 days before the firm plans to commence the manufacture, import, or processing of the substance. 

For example, they could submit a SNUN if they wish to produce above the volume limit listed in the 

SNUR for a given chemical, since any production beyond that volume would be defined as a Significant 

New Use. 
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The SNUN provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit 

or limit that activity before it occurs. The notice form used to submit a SNUN is the same as that for a 

PMN, 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 production while the SNUN is being processed (Option 5); 

costs of recordkeeping, and of complying with any restrictions resulting from the SNUN review. 

 Rarely, the SNUN submitter may elect to perform some of the testing 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 any such costs are likely to be zero or low. 

The assumption regarding testing is based on an analysis of the 18 SNUNs submitted over a three-year 

period, from 2005 through 2007. A list of human health tests submitted to EPA with PMNs and SNUNs 

was also available from a confidential database maintained by EPA’s Office of Pollution Prevention and 

Toxics Risk Assessment Division. Only one SNUN described toxicity or environmental fate testing that 

seemed reasonably likely to have been performed to support a SNUN. In that case, two relatively low-cost 

tests (fish acute toxicity and daphnid acute toxicity) may have been conducted to support a SNUN, 

although it is also possible that the testing was done for some other reason not apparent in the SNUN 

itself. A substantial portion of the SNUNs did provide or reference test results. However, in almost all 

cases, the testing appeared to have been conducted for reasons other than a SNUR. For example, the 

SNUN might include laboratory reports that had already been submitted for a PMN for the same 

chemical. 

2.3.1 SNUR “New” Chemicals 

If a SNUR chemical is not on the TSCA Inventory and a potential manufacturer or importer has not yet 

filed a PMN, submission costs may be incurred but are not attributable to the SNUR. 

All SNUR chemicals in this rulemaking were the subject of at least one PMN. For PMN chemicals to be 

added to the TSCA Inventory, manufacturing (or import) must have commenced, with notification to 

EPA through a Notice of Commencement, or NOC. Thus, SNUR chemicals not yet in commercial 

manufacture (or import) are not on the 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 submitter intends to engage in a significant new use. 

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

Consequently, for this special situation, the submission cost is incurred due to PMN requirements, not due 
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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 with EPA a firm might diminish any loss of profits 

due to delay. This option is not available after the SNUR is promulgated. 

2.3.3 Costs for Submitting a SNUN 

As with Option 2 above (Request Modification or Revocation of a SNUR), the costs for submitting a 

SNUN are estimated to be equivalent to the costs of completing a PMN submission. If the SNUN is 

submitted at the same time as a request to modify a SNUR (Option 2), the added cost would be less than 

shown here due to overlap in information in the two submissions. Table 8 shows the costs of preparing a 

SNUN. 

2.3.4 Potential for Subsequent Regulatory Actions 

The Agency recognizes that if submission of a SNUN does result from a SNUR, the Agency may take 

additional regulatory actions under TSCA. These additional regulatory actions might be necessary to 

further evaluate an intended new use and associated activities, or to prohibit or limit that activity before it 

occurs to prevent unreasonable risk of injury to human health or the environment. It is not known what 

specific subsequent regulatory actions, if any, the Agency may determine are necessary after reviewing a 

SNUN. Any such actions are highly dependent on the circumstances surrounding the individual SNUN 

(e.g., available information and scientific understanding about the chemical and its risks at the time the 

SNUN is being reviewed). 

Should the Agency’s review of the SNUN result in further regulatory actions, the Agency will initiate and 

follow the appropriate procedures for taking those actions. Included in those procedures would be an 

assessment of the costs and benefits of those actions. 

Subsequent regulatory action may be a Consent Order under TSCA Section 5(e). Assessments of costs 

and benefits for a Consent Order would be limited, similar to those supporting PMN reviews leading to 

Consent Orders, in contrast to the in-depth benefit-cost analyses prepared under some other TSCA 

Sections. 

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 Policy Analysis Branch. The nature of the follow-up 

regulatory action and benefit/cost analysis may differ between SNUNs for newer chemicals submitted as 

a result of a direct final rulemaking such as this one, and SNUNs for older chemicals such as chloranil 

and most perfluoroalkyl sulfonates. 
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2.4 Request Equivalency Determination (Option 4) 

Under 40 CFR §721.30, EPA may review applications from facilities who propose alternative 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 equivalency 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 complying with controls in the SNUR to avoid a significant new use -- for 

example, controls related to workplace protection or environmental release. Otherwise, presumably there 

would be no incentive for the submitter to choose this alternative. Finally, to produce the chemical 

following EPA review, the submitter would incur costs from recordkeeping and from any restrictions not 

waived (see Option 1). 

2.5 Decide Not to Produce Chemical (Option 5) 

Some firms may find that the costs of meeting the SNUR requirements and/or restrictions (Option 1) or 

preparing a SNUN or other submission (Options 2, 3, or 4) are financially unattractive. In these cases, the 

firm could choose not to manufacture, import, or process the PMN substance. 

While this option avoids the costs of meeting the specifications in the SNUR or submitting a request for 

some alternative, it entails the “hidden” cost of the profit that will be foregone as a result of not engaging 

in the commercial activity originally planned. For example, if the firm does not produce the SNUR 

substance, then it will forego the profit it would have achieved by producing it. That foregone profit is a 

potential “hidden” cost of Option 5. Similarly, if the firm would have used the SNUR substance in the 

production of another product and must substitute to a more costly substance, it will incur those additional 

costs of production. If the firm elects to produce for R&D purposes only, it may have costs associated 

with R&D recordkeeping attributable to the SNUR. 

Firms that exercise Option 5 may still incur export notification costs, if they export any existing 

stockpiles of the product. This cost is quantified in Chapter 3 below. 

2.6 Summary of Costs for Each Option 

Table 1, above, gave an overview of compliance options. Table 3 through Table 6 summarized the 

quantified portion of potential costs of either following restrictions to avoid engaging in a Significant 

New Use, or of making a submission to EPA. Table 7 presented sample testing costs. Costs are for one 

chemical at one site, and – where volume is relevant – are based on standard assumptions that include 25 

exposed workers per site and, for haz-comm costs, annual shipments of about 10,000 kilograms per site. 

Costs are not otherwise adjusted for the nature of the chemical or process, volume, location, or other 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 chemical at one site, not for aggregate production. 

Resources were not available to estimate aggregate costs. Among other things, it is not known how many 

firms are affected by the SNURs. EPA receives a handful of Significant New Use Notices per year due to 

SNURs. However, if a SNUR chemical is on the TSCA Inventory, a firm may use the chemical in a way 

that avoids a Significant New Use (Option 1), and never make a submission. It is not known how many 

firms are affected but do not make a submission. Also, it is not known whether firms avoid the chemical 

altogether specifically due to the SNUR. However, at least for the years immediately following SNUR 

promulgation, these numbers are likely to be small. This is because the chemicals in this type of SNUR 

rulemaking are still relatively new – as Appendix A indicates, most were submitted to EPA as PMNs in the 

past four Federal fiscal years – and, in addition, often have confidential chemical identities. 

 For firms manufacturing, importing, or processing within SNUR restrictions to avoid a 

Significant New Use (Option 1), quantifiable costs 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), the basic one-time submission cost is estimated at 

$6,071, including recordkeeping for the submission. 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 substance 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 submitting a SNUN, the firm may need to comply with 

restrictions as a result of the SNUN review process, possibly leading to further costs similar to 

those in Option 1. 

 Rarely, firms may choose to perform toxicity and/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 for the few SNUNs for which a submitter might 

voluntarily perform such testing. 

 Companies that might have manufactured, imported, or processed a chemical in the absence of 

the SNUR may incur “hidden” costs, such as loss of profits from delayed or foregone sales, if they 

avoid the 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 bound by a TSCA Section 5(e) Consent Order following 

review of its PMN, so that the SNUR based on the 5(e) order imposes no added costs for that firm. As 

another example, in rulemakings where a SNUR chemical is not on the TSCA Inventory, firms that have 
Economic 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 before commercial production/import, with or without 

the SNUR (see Section 2.3, SNUR “New” Chemicals). 

If the SNUR reflects the PMN use scenario, and the PMN submitter would stick to the PMN uses even in 

the absence of a SNUR, then there would be no added costs for the PMN submitter attributable to the 

SNUR. Also, firms may also incur worker protection, haz-comm and other costs for reasons other than 

the SNUR, so that SNUR requirements may impose no added costs.6

 

6

 Earlier SNUR economic analyses calculated possible haz-comm, worker protection, testing, and other costs for 

each PMN chemical (EPA, 2007b, Tables 9, 10, D-4). The chemical-specific tables were dropped from a later 

SNUR economic analysis (EPA, 2007c). They reflected SNUR requirements and “recommended” testing, but 

were not otherwise tailored to the particular situation, and so were unreliable predictors of actual SNUR costs. 
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 sections (40 CFR §707.60 through 75). For TSCA 5(a)(2) (the section under 

which EPA promulgates significant new use rules) and certain other TSCA sections, this is a one-time 

notification requirement7

 per destination country for each exporter 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 burden associated with making export notifications, EPA 

first estimated the average annual number of export notifications made by an exporter, in Section 3.1. 

EPA then derived the annual and per notification burden associated with preparing and submitting an 

export notification, in Section 3.2.8

 

EPA estimated the average burden associated with making a single notification, but did not estimate 

either the total number of exporters of a SNUR chemical or the number of notifications per SNUR 

chemical. This is because the SNURs apply to a variety of different chemicals with a variety of unrelated 

uses, manufactures, and processors, making it impractical within the resources available for this report to 

assess the potential number of exporters and importing countries per chemical. 

Most underlying data in this section come from 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 exporter 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 typically 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 notification 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 weeks 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, page 11, Table 3), estimated the annual export 

notification cost for an exporter under the one-time export notification requirement. These costs include 

the cost to the exporter of compiling a list of their products that are subject to TSCA Section 12(b) 

requirements, writing or revising an export notification letter to EPA, checking the outgoing shipments, 

and sending the notification letters with the associated shipping costs. 

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

Exporters making more notifications per year may benefit from economies of scale and have lower costs 

per notification; those making fewer notifications may have higher costs per notification. 

3.2.1 Estimated Submission (Mailing) Costs 

Regulated 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 mailing 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/service-chart.htm). The mailing method comes from the Economic Analysis 

of the Proposed Change to TSCA Section 12(b) Export Notification Requirements, November 2005 (EPA, 

2005a), as clarified in a later SNUR economic analysis (EPA, 2007c, Table 8). 

3.2.2 Compile and Maintain the List of Products 

Since TSCA §12(b) information collection activity has been in place for over twenty years, most 

respondents will have already developed a list of their products subject to TSCA §12(b) export 

notification. Respondents need only check for new regulations promulgated and any 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 time (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 under 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 approximately 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 estimate 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 per 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 for initial preparation of the export notice may vary 

depending on whether the company has prior experience with this requirement. This step is estimated to 

take an average of one hour of technical time (which may also include some 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 notification or 6 hours for 12 notifications (EPA, 2009b). 

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

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

Technical Clerical Total

$/Hr Hours 2011$ $/Hr Hours 2011$ 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 cost1 -- -- -- -- -- -- $165 -

Total per facility2` 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 USPS rates and can be found in Table 9.

2

An average facility submitting notifications is assumed to submit 12 export notifications per year. 

Source: Appendix B of this report derives technical and clerical hourly labor costs. Other costs are from 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, 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 costs for both SNUN review and processing, and export 

notification processing. Because it is unknown how many SNUNs and export notifications will be 

submitted as a result of this rulemaking, all Agency costs are estimated at the per-case level and are not 

aggregated to estimate the total Agency burden. Section 4.1 describes the burden to the Agency of 

reviewing and processing a single SNUN submission. Section 4.2 derives the Agency burden of 

processing and reviewing export notifications. 

4.1 SNUN Processing Costs 

EPA’s costs to review and process industry submissions (SNUNs, requests to modify or revoke the 

SNUR, and requests for equivalency determinations) are assumed to be the same as EPA costs to review 

PMNs and are presented in Table 11. Costs to review and process industry submissions – SNUNs, 

requests to modify a SNUR, and requests for equivalency determination – are assumed to be similar to 

EPA costs to review PMNs.11

The list of review steps, estimates of staff-year full-time equivalents (FTEs), estimates of extramural 

costs, and the percent of chemicals requiring a particular review step are derived from the costs for 

processing PMN submissions in Table VII-1 of a 1994 EPA report, Regulatory Impact Analysis of 

Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994). The Agency 

burden associated with processing a SNUN has been adjusted to reflect burden reductions resulting from 

the 2009 final PMN Electronic Reporting (ePMN) Rule that requires the electronic submission of all 

TSCA section 5 notices.12 The ePMN rule affects SNUN submissions and requests for equivalency 

determination, but not requests to modify or revoke a SNUR. However, for simplicity, this analysis 

continues to assume that Agency per-submission costs are the same for all three types of submissions. 

Electronic submission of SNUN forms is expected to reduce Agency burden by 16.5 percent (EPA, 

2009a, p.28). 

The GS levels used for Agency staff reflect the judgment 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 level 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 calculations are described in Appendix B. 

 

11 For an overview of the PMN review process, see the Chemistry Assistance Manual for Premanufacture 

Notification Submitters, EPA, 1997.

12Economic Analysis of Expedited Significant New Use Rules for 25 Chemical Substances: EPA Docket OPPT2009-0922, 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 calculated by multiplying the number of FTEs (in the first 

column) by the fully loaded average salary. This shows EPA staff cost for chemicals requiring the 

selected review step. 

The Extramural Cost column shows costs for contractor support and other outside purchases for 

chemicals requiring the selected review step, inflated from 1993 prices, as explained in Appendix B. 

The Percent of Cases is a weighting factor applied to reflect the fact that not all 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 “Standard Review.” The three types of submissions 

resulting from a SNUR may have weighting factors that differ from each other and from the weighting 

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

calculated here. For example, some SNUNs require little review because they are determined to be 

“invalid” – i.e. not required in the first place. However, often a SNUN may take more Agency time than a 

typical PMN because of factors such as the need to retrieve old PMN records from archives, and the 

likelihood that more data requiring 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 multiplying 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 submission review and processing shown in Table 11. 
Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2

August 29, 2012 4-3 Table 11. Agency Costs for SNUN and Other Submission Review and Processing 

view Steps

EPA staff (FTE) Cost Extramural Cost 2 Unweighted 

Cost

Pct. of 

Cases

Weighted 

Cost3

e

B

Re

FTE 

fraction

Cost per 

FTE 1

FTE Total 

(2011$) 1993$ 2011$ 

(a) (b) (c)=(a)*(b) (d) (e) (f)=(c)+(e) (g) (h)=(f)*(g) 

Pre-notice Consultation 0.0024 $161,446 $387 $4.00 $6.91 $394 41% $162 Administrative Prescreen/Notice Receipt/User Fee

0.0024 $161,446 $387 $92.00 $158.87 $546 100% $546 

CRSS (Chemical Review and Search Strategy)

0.0025 $161,446 $404 $268 $462.80 $866 100% $866 

SAT (Structure Activity Team) 0.0006 $161,446 $96.87 $14.00 $24.18 $121 100% $121 Engineering/Exposure 0.0015 $161,446 $242 $56.00 $96.70 $339 100% $339 Exposure/Fate 0.0008 $161,446 $129 $0.00 $0.00 $129 100% $129 Focus 0.0009 $161,446 $145 $23.00 $39.72 $185 100% $185 Standard Review Functions 0.0219 $161,446 $3,536 $511 $882.43 $4,418 29% $1,281 Division Directors Meeting 0.0129 $161,446 $2,083 $113 $195.14 $2,278 15% $342 Order Development/Negotiation Review 0.0171 $161,446 $2,761 $22.00 $37.99 $2,799 3% $83.96 Post Order Data Review 0.0886 $161,446 $14,304 $0.00 $0.00 $14,304 3% $429 Order Modification 0.2167 $161,446 $34,985 $0.00 $0.00 $34,985 3% $1,050 New Chemical SNUR Development 0.0277 $161,446 $4,472 $85.00 $146.78 $4,619 7% $323 Notices of Commencement 0.0012 $161,446 $194 $40.00 $69.07 $263 31% $81.47 FOIA (Freedom of Information Act) Requests

0.0333 $161,446 $5,376 $287 $495.61 $5,872 1% $58.72 

CBI (Confidential Business Information) Substantiation

0.0004 $161,446 $64.58 $3.00 $5.18 $69.76 100% $69.76 

TOTAL $6,067 

Notes: 1 GS-13 Step 5 salaries loaded with benefits and overhead. See Table B-1 derivation.

2 Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993 prices as described in A

3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values shown in this table. 4 Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009a, p. 28). 

Sources: FTEs per review step, 1993 extramural costs, and percent of cases are from EPA, 1994 Table VII-1, GS-13 salaries are from OPM, 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 Agency burden and cost due to TSCA §12(b) export 

notification result from three tasks. In the first task, EPA receives export notifications from companies 

that 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 importing 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 chemicals subject to TSCA 

12(b) reporting, a very small percent of such activity will be attributable to the current rulemaking. 

Because it is unknown how many, if any, notifications EPA will receive or send as a result of the current 

rulemaking, the costs to the Agency are presented per activity.13 The burden for the first two 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 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), updated for inflation.

 

13 Beginning with the report Economic Analysis of Expedited Significant New Use Rules for 25 Chemical 

Substances: EPA Docket OPPT-2009-0922, the Agency cost per activity is presented, and not the entire Agency 

costs resulting from export notifications. 
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August 29, 2012 5-1 

5 Additional Analyses 

This chapter presents additional analysis of other potential impacts of this rulemaking, as required under 

various statutes and executive orders. 

5.1 Regulatory Flexibility Act (RFA) 

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et. seq.), as amended by the Small Business 

Regulatory Enforcement Fairness Act, requires regulators to consider the impact of regulations on small 

entities, in particular small businesses. The requirement to submit a SNUN applies to any person 

(including small 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 definition 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, eight 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 (including 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-identified as small in their SNUN submission14 (EPA, 2012). EPA 

believes the cost of submitting a SNUN is relatively small compared the cost of developing and marketing 

a chemical new to firm and that the requirement to submit a SNUN generally does not have a significant 

economic impact. 

In response to a SNUR, firms could also decide to request an equivalency determination or a request for 

SNUR modification or revocation. The submission cost for these requests is about $6,100. EPA believes 

this cost to be low compared to the cost of developing 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 Mandates Reform Act of 1995 (Public Law 104-4). 

 

14 The three “small” submitters were identified by review of actual SNUN submissions from the years 2005-2010. 
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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) approval under the PRA, unless it has been approved by OMB and 

displays a currently valid OMB control number. The information collection requirements related to this 

action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0012 

(EPA, 2007a). This action does not impose any additional burden requiring OMB approval. 

5.4 Executive Order 12866, Regulatory 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 timely input by State and local officials in the 

development of regulatory policies that have federalism implications.” This action will not have a 

substantial direct effect on States, on the relationship between the national 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 Federalism (64 FR 43255, August 10, 1999). 

5.6 Executive Order 12898, Environmental Justice 

This action does not involve special considerations of environmental justice related issues as required by 

Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and 

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

5.7 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 assess environmental health and safety risks that may 

disproportionately affect children. This type of analysis is required for rules that will have an impact of 

$100 million or more only. The impact of these SNURs will be less than $100 million and therefore no 

analysis of such impacts on children is required. 

5.8 Executive Order 13175, Tribal Governments 

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

November 6, 2000). This rule does not have Tribal implications because it is not expected to have 

substantial direct effects on Indian Tribes. 
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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. 
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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. PMN1 CAS RN2 Name2

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 modified 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-C12-

15-alkyl ethers 

22 P-06-0451 620610-66-4 Poly(oxy-1,2-ethanediyl),.alpha.-(2-methyl-2-propenyl)-.omega.-hydroxy-C10-

16-alkyl ethers 

23 P-06-0452 675869-05-3 Poly(oxy-1,2-ethanediyl),.alpha.-(2-methyl-2-propenyl)-.omega.-hydroxy-C12-

16-alkyl ethers 

24 P-06-0793 887947-29-7 Morpholine, 4-C6-12 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-(C12-15-alkyloxy) derivs. 

33 P-08-0300 N/A Amidoamine salt (generic) 
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No. PMN1 CAS RN2 Name2

34 P-08-0464 N/A Diethanolamine salt of polymeric acid (generic) 

35 P-08-0471 N/A Tricyclic quaternary amine salt (generic) 

36 P-08-0537 N/A Cyclic amine reaction product with acetophenone and formaldehyde 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 treated 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 oxide 
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No. PMN1 CAS RN2 Name2

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

67 P-11-0272 1262279-30-0 Calcium cobalt lead strontium 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 polymer 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 = Chemical Abstract Service Registry Number.

Notes: 

1

The PMN number reflects the Federal Fiscal Year and sequence 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: Inflators and Wage Rates 

This appendix describes the derivation of the fully loaded labor rates and inflation factors used in 

calculating costs of labor, materials, and other inputs. Costs for this report are for year-end 2011. 

B.1 Derivation of Loaded Wage Rates 

Unit labor costs are calculated by adding fringe benefits and overhead to the wage or salary to derive a 

fully loaded labor cost. The basic method is described in Wage Rates for 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 Classification 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 Rates for Managerial, Professional/Technical, Clerical, 

and Production Labor 

Wages and fringe benefits for managerial, professional/technical, clerical and production labor were taken 

from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data,15

for December, for manufacturing industries.16

 

15 This follows the approach introduced in Economic Analysis of Expedited Significant New Use Rules for 65 

Chemical Substances: EPA Docket OPPT-2003-0063 (EPA, 2007b). In earlier PMN SNUR economic analyses, 

such as EPA, 2003a, wage rates for production workers came from the BLS National Employment, Hours, and 

Earnings, Average Hourly Earnings of Production Workers, while fringe 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 SNUR 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 since the SNURs mainly affect the chemicals industry. 
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The cost of fringe benefits such as paid leave and insurance, specific to each labor category, are taken 

from the same ECEC series. Fringe benefits as a percent of wages are calculated separately for each labor 

category. For example, for December 2011, the average wage rate for professional/technical17 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 applied to wages to account for overhead. This approach is 

used for consistency with Office of Pollution Prevention and Toxics economic analyses for two major 

rulemakings: Wage Rates for Economic Analyses of the 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 production labor are calculated in a similar manner, as 

shown in Table B-1. 

B.3 Derivation of Labor Rates for Industrial Hygienists 

For industrial hygienists, wages were based on another BLS data series, Occupational Employment 

Statistics [OES], National Industry-Specific Occupational Employment and Wage Estimates. OES data 

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

covers only wages, not fringe benefits. Therefore, the Industrial Hygienist fringe benefits continue to be 

based on ECEC data.18

The wage rate for Industrial Hygienists is a weighted average of the hourly mean wage for Occupational 

Health and Safety Specialists, Standard Occupational Classification (SOC) 29-9011, and Occupational 

Health and Safety Technicians, SOC 29-9012, in Manufacturing. The wage rate for each occupation was 

weighted by employment for the occupation. The North American Industry Classification System 

(NAICS) codes for Manufacturing are 31, 32, and 33 (BLS, 2005). The calculations are shown in Table 

B-2. 

As with other labor categories, the fringe benefits factor came from the BLS Employer Costs for 

Employee Compensation Supplementary Tables December 2011 (BLS, 2012a). Benefits for “professional 

 

17 This follows terminology introduced in EPA, 2007b. Earlier 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, Comparing Current and Former Industry and Occupation ECEC 

Series (Weinstein, 2004).

18 This follows the approach for calculating Industry Hygienist wages introduced in EPA, 2007b and is a change 

from the method used in earlier PMN SNUR economic reports such as EPA, 2003a, which used data from a 1997 

professional journal salary survey. 
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August 29, 2012 B-3 

specialty and technical” occupations were used, and loaded 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 annual 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 percent 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 overhead for Federal staff. For example, it was used in 

an August 2000 document supporting ICR No. 1139.06 (EPA, 2000), with the following explanation: 

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

multiplication factor). The multiplication factor used is recommended in EPA's Office of Policy, 

Planning, and Evaluation's Instructions for Preparing Information Collection Requests (ICRs)

(June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl 

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 introduced in EPA, 2007b. That report represented a change from an earlier PMN SNUR 

economic analysis (EPA, 2003a), which used an average of GS-12 Step 1 and GS-12 Step 10 salaries.
`

August 29, 201 Table B-1. Derivation of Loaded Wage Rates 

EPAB Labor 

Category

Data Sources Date Wage Fringe Benefit Fringes as % wage Over- head % wage2 

O

(a) (b) (c) =(b)/(a) (d) (e

Managerial BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial”3 Dec-11 $43.01 $20.40 47.43% 17% Professional/ Technical

BLS ECEC, Private Manufacturing industries, 

“Professional and related“3 Dec-11 $38.48 $19.64 51.04% 17% 

Clerical BLS ECEC, Private Manufacturing industries, “Office and Administrative Support” 3 Dec-11 $17.69 $8.93 50.48% 17% Production Worker

BLS ECEC, Private Manufacturing industries, 

“Production, transport, and material moving.” 3 Dec-11 $16.86 $9.32 55.28% 17% 

Industrial Hygienist

Wage: BLS OES Occupat. Employ. and Wages, for 

Manufacturing (NAICS 31, 32, 33), average of wages for Occup. Health/ Safety Specialists (SOC 29-9011) and Occup. Health/Safety Technicians(SOC 29-9012), weighted by employment. 4

Fringes: BLS ECEC, Private Manufacturing industries, “Professional and related” 3

Wage: May-11Fringe: Dec-11

$31.32 -- 51.04% 17% 

EPA staff FTE

Annual Federal staff cost: OPM WashingtonBaltimore-Northern Virginia, DC-MD-PA-VAWV, area, GS-13 Step 5 pay rates, with 60% 

h d 5

Jan-11

$100,904 

(annual)

--

[Included in 

60% 

overhead]

60% 

Notes: 1 Wage data are rounded to the closest pennies in this table; however, in calculations using these numbers for this report, unrounded values were used. 2 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 200

Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). 

3 Employer Costs for Employee Compensation Supplementary Tables December 2011, US Bureau of Labor Statistics, March 14, 2012 (BLS, 2012a).4 Employment and unweighted wages are from BLS Occupational Employment Statistics (National Industry-Specific Employment and Wage Estimate5 The salary is unloaded Federal GS-13 Step 5 salary for calendar 2011, from the Office of Personnel Management salary table for Washington-Baltim

(OPM, 2011). The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 19
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Table B-2. Derivation of Industrial Hygienist Wage Rate (NAICS 31, 32, 33) 

Occupation Title (SOC Code)

Employment Mean Hourly 

Wage Weight Weighted Wage1

(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 Hygienist (weighted average) 10,910 -- 1 $31.32

 Notes: 

1

 Wage data are rounded to the closest pennies in this table; however, in calculations using these numbers for this report, 

unrounded values were used. 

Source: Employment and unweighted wages are for 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 using the Consumer Price Index – All Urban Consumers; 

wages were inflated using the appropriate Employment Cost Index (ECI). Where both labor and 

equipment/supplies were involved, we used the inflation factor corresponding to the dominant cost 

category20. For example, test costs include a mix of labor, equipment, and supplies. Assuming that the 

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

Complete information on the derivation of the inflation factors used is given in Table B-3 below. 

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

changes are described on a BLS web page, “Change has come to the ECI,” (BLS, 2006c) and in several 

April 2006 Monthly Labor Review articles posted on the BLS web site: “Changes affecting the 

Employment Cost Index: an overview” (Caroll 2006); “Employment Cost Index 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 adjusted 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, 2008, p. BLS-45). Therefore, 

beginning with the report, Economic Analysis of Expedited Significant New Use Rules for 25 Chemical Substances: 

EPA Docket OPPT-2009-0922, 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” series was chosen because it is the only series with continuous data since 1985, 

and the majority of export notification and Agency extramural activities are performed by professional and technical 

labor.
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Under a mandate from OMB, BLS changed its classification of industries and occupations from the 

Standard Industrial Classification (SIC) and Occupational Classification 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 industry and occupational classification systems, in 2006, BLS rebased the 

ECI from June 1989 = 100 to December 2005 = 100 for all current and historical non-seasonally adjusted 

series, including the NAICS and SIC based series. (Seasonally adjusted indices, including those in Table 

B-3 of this 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 years 1975-2005 is the SIC-OCS based series, and for 

subsequent years, the official ECI is the NAICS-SOC based series (Sleemi, 2006, p.8).21 

“Starting year” indices in Table B-3 continue to be SIC-SOC based. Current year indices are NAICS-SOC 

based. We use indices from both the NAICS-SOC and the SIC-OCS based ECI series because neither 

series spans the entire period over which testing and other costs need to be inflated. 

 

 

21 BLS has been publishing the NAICS-SOC based ECI series since March 2001 and it became official in March 2006. The SICOCS based series and NAICS-SOC series have different series ID numbers, even when they describe essentially the same 

population. For example the series ID for seasonally adjusted total compensation for all private industry workers is ECS10002I 

for the SIC-OCS series and CIS2010000000000I for the NAICS-SOC series. 
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August 29, 2012 B-7 

Table B-3. Derivation of Inflation Factors 

Item Inflation Index Source1 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, 4th 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 gear3

BLS ECI, SA, Total comp, Private 

industry, All Workers, 4th Q [BLS 2006d 

and 2012c]

1997 74.9 115.1 1.537 

Export notification

BLS ECI, ,Total comp, Private industry, 

Professional and related, 4th 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, 4th 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 Index (ECI) series “were rebased to December 2005 = 100 from June 

1989 = 100.” The change is reflected in the indices 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 Adjusted (SA) ECS10002I for private industry All Workers, and not SA

ECU11122I for private industry Professional and Related Workers. 

After 2006, ECI indices are NAICS-SOC based: Seasonally Adjusted (SA) CIS2010000000000I for private industry All Workers, and 

not SA CIU2010000120000I (B) for private industry Professional, and Related workers. 2 Inflation factors are rounded to three decimal places in this table, but calculations in this report use the unrounded values. BLS CPI 

values were published with one decimal place through 2006 and with three decimal places after that. 3 We began using the ECI for Private Industry All Workers in EPA, 2007b, to better reflect the labor mix for impermeability testing. 

Earlier PMN SNUR economic analyses used the ECI for Private Industry White Collar Workers. 4

 Beginning with the report, Economic Analysis of Expedited Significant New Use Rules for 25 Chemical Substances: EPA Docket 

OPPT-2009-0922, we began to use the not-seasonally adjusted CIU2010000120000I for private industry Professional, and Related 

workers, instead of SA CIS2010000W00000I for private industry white collar workers because BLS retired the “white-collar” series. 
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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 appendix presents dollar costs and labor hours of these 

requirements, for one chemical at one site. Some requirements listed here may not be cited in the current 

rulemaking, but have been cited in past SNUR rulemakings. 

The haz-comm costs reflect the annual costs of updating the written program, labeling for chemical distribution 

and storage, creating and distributing material safety data sheets (MSDS), and employee training. The 

personal protective equipment (PPE) costs reflect the annualized costs of providing required equipment (i.e., 

gloves, goggles, clothing, or respirators), assessing dermal protection needs associated with the chemical, 

and performing required impermeability testing, and/or evaluating manufacturer’s information. Finally, the 

annual recordkeeping costs include labor, photocopying, and 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: General Provisions for New Chemical Followup (EPA, 1989). 

In that report, EPA estimated that the number of workers exposed to any one substance would range from 10 

to 25, and that a worker potentially would be exposed to a substance for a minimum of 50 days per year to a 

maximum of 250 days per year. The current analysis uses the high ends of those two ranges. Thus, each site 

is assumed to have 25 chemically-exposed workers requiring training and/or protective equipment, with each 

of them assumed to be 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 recordkeeping are discussed in Sections C.1, C.2, and C.3, 

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

C.1 Modifying the Hazard Communication Program 

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

with that required by OSHA’s Hazard Communication standard (29 CFR 1910; November 25, 1983), so that 

costs attributable to the 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 Flexibility Analyses of the Hazard Communication 

Standard OSHA, 1983). 

It was assumed that the haz-comm costs would be incurred each year. For example, there would be worker 

turnover and need for refresher training, the MSDS would need revision due to changing information, 

placards would wear out (EPA, 1989). To the extent that some steps would not need repeating each year, 
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costs could be lower than estimated here. The hazard 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 hazards associated with such chemicals, procedures for 

employees who routinely work with or around such chemicals, procedures for non-routine tasks that may 

involve exposure (e.g., tank cleaning), and personal protective 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 detailed assessment of exposure risks associated with 

the chemical and develop more site-specific procedures for workers potentially exposed to such chemicals. 

For purposes of the economic analysis, EPA assumes that each employer will engage the services of a 

professional industrial hygienist (IH), either in-house or on a consulting basis, for four hours to perform such 

an assessment. Loaded hourly rates for IH services were calculated based on Bureau of Labor Statistics data, 

as described in Table B-1and Table B-2. Costs for the written haz-comm program, in 2011 dollars, are as 

follows22

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

The estimates of IH hours to update the program come from a 1998 EPA report (EPA, 1998). 

C.1.2 Labeling 

If the SNUR cites 40 CFR §721.72(b), then to avoid engaging in a Significant New Use, manufacturers must 

ensure that containers used to distribute the PMN substance in commerce are labeled with the necessary 

hazardous substance warnings and procedures. In addition, containers used in the workplace must bear 

similar labels or, alternatively, the employer must provide equivalent signage, operating procedures, or other 

written material to communicate hazard information 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 average, each chemical is shipped twice monthly to 20 

 

22 Figures presented here are rounded. 
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customers. This is consistent with roughly 10,000 kilograms of chemical per year shipped in 40 five-gallon 

containers per month (EPA, 1989).23

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

materials costs were obtained from a national safety equipment supply house catalog (LSS, 1997) and were 

inflated as described in Appendix B. The resulting costs 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 unit cost values and inflation factors (see Appendix B), so results may differ from

calculations using the rounded values shown in this table. 

Source: 1997 label cost, EPAB 1998, LSS 1997; cost elements, quantities, RIB 1989; inflators, labor, 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 Appendix 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 wages, fringe benefits, and overhead, as described in 

Appendix B. 

The resulting per chemical, per site costs of labeling for chemicals in the workplace are shown in Table C-2. 

 

 

23 Data on PMN notices suggest that some PMN submitters expected to produce less than 10,000 kilograms per year of the 

SNUR chemicals, but many expected to produce much more. It is not known whether volumes listed in the PMNs were realized 

in practice. Production volumes of secondary suppliers affected by the SNUR are also unknown. Annual volumes significantly 

greater than 10,000 kg could lead to higher haz-comm costs than those estimated here. 
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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 unit cost values and inflation factors (see Appendix B), so results may differ from

calculations using the rounded values shown in this table. 

Source: 1997 placard cost, EPA, 1998, LSS, 1997; cost elements and quantities, EPA, 1989; inflators and labor unit costs, Table B-1 

and Table B-3. 

C.1.3 Preparing Material Safety Data Sheet (MSDS) Information 

If the SNUR cites 40 CFR §721.72(c), then to avoid engaging in a Significant New Use, each facility is 

required to create, post, and distribute material safety data sheets (MSDSs). Based on estimates in OSHA 

1983, the 1989 EPA report (EPA, 1989) has estimated that creation of an MSDS for a chemical substance 

requires 2.0 hours of technical labor time and 0.25 hours of clerical time. Further, EPA assumes that the 

manufacturer provides 20 copies of the MSDS to customers and retains 20 copies for use onsite, for a total of 

40 copies (EPA, 1989). The loaded hourly wage rates and the inflator used in estimating unit photocopy costs 

are derived in Appendix B. The resulting cost of MSDS preparation is shown in Table C-3. 

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

Cost Element Unit Cost 

(1988$)

Inflation 

Factor

Unit Cost

(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 unit cost values and inflation factors (see Appendix B), so results may differ from

calculations using the rounded values shown in this table. 

Source: Cost elements, quantities, and 1988 copy cost, RIB 1989; inflators and labor unit costs, Table B-1 and Table B-3.
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C.1.4 Employee Training 

The final required component of the haz-comm program is employee training, based on 40 CFR §721.72(d). 

The 1989 EPA report, Economic Analysis of Final Significant New 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 program are mainly labor costs for the trainer and the 

trainees. 

Inserting the new information about the PMN substance into the training program and conducting the revised 

training is assumed to require 0.5 hours of the trainer’s time. An additional 0.25 hours per trainee is 

estimated to be required, and an average of 25 affected workers is assumed per facility (EPA, 1989). If 

additional production workers needed to be trained, for example because they might come into contact with 

the chemical due to spills or leaks, training costs could be higher than estimated here (EPA, 1989). 

Labor rates for training are based on the loaded rates derived in Appendix B for chemical technicians and 

chemical industry production workers. The total cost of the employee training requirement is shown in Table 

C-4. 

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

Cost Element

Unit Cost

(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 needs for dermal protection and evaluating protective 

gear for impermeability, as well as the costs of gloves, goggles, protective clothing, and respirators. 

C.2.1 Dermal Protection Selection 

If the SNUR cites 40 CFR §721.63(a)(1), then to avoid engaging in a Significant New Use, the employer 

must ensure that each person who is likely to experience dermal exposure to a PMN chemical, must be 

provided with and is required to wear personal protective equipment (e.g., gloves) that will prevent dermal 

exposure to the substance. The equipment must be selected and used in accordance with 29 CFR § § 

1910.132 and 1910.133 (promulgated by the Occupational Safety and Health Administration, OSHA). The 
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selection and administration of this dermal protection is estimated to require 10 hours 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 selection 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 Cost1

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

Notes: 

Total costs were calculated using unrounded values (see Appendix B), so results may differ from calculations using the rounded 

values shown in this table.

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

C.2.2 Impermeability Testing 

As part of the workplace protection requirements specified under 40 CFR §721.63(a)(3), to avoid engaging 

in a Significant New Use, the SNUR may require that employers demonstrate that each item of protective 

equipment provided (e.g., gloves) provides an impervious barrier, to protect employees from dermal 

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

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

following discussion is based on the Economic Analysis of Expedited Significant New Use Rules for 168 

Chemical Substances and Background Support 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 chemical, but the burden of finding an appropriate 

article of protection lay with the chemical manufacturer. In the second method, the chemical manufacturer 

simply submitted chemical samples to Best, who in turn determined the most appropriate product, even if a 

competitor manufactured the product. This method was more costly at $800 (1997 dollars) per chemical. 

The second method of impermeability testing is favored in this analysis for several reasons. First, the burden 

of finding and submitting an article of protection is shifted from the chemical manufacturer to the testing 

company, who would have greater experience in Personal Protective Equipment (PPE) selection. Second, 

should the article submitted fail the impermeability test, other articles may have to be submitted until 

satisfactory test results are obtained. Furthermore, substances subject to SNURs may include new and/or rare 

chemicals, which may have undiscovered or unknown properties. This uncertainty may impede chemical 
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manufacturers’ ability to effectively submit appropriate PPE articles for testing. Finally, the first method is 

essentially a pass-fail test. If an article passes the impermeability test, then it is acceptable. In the second 

method, several articles may be tested and compared, 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 second method of testing is more appropriate. For these 

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

the impermeability testing is assumed to be driven by labor costs of the company performing the testing, thus 

test costs were inflated with an Employment Cost Index as described in Appendix B. The administration of 

this test would also require two hours of industrial hygienist labor (EPA, 1999). 

The second step to compliance with the workplace protection requirements at §721.63 (a)(3)(ii) is the 

evaluation of specifications from the manufacturer or supplier of the protective equipment. This requirement 

helps ensure that the protective equipment will be impervious to the PMN chemical(s). The evaluation of 

manufacturer specifications requires an estimated four hours of industrial hygienist labor. 

Annual costs of the impermeability testing requirements are presented in Table C-6. 

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

Cost Element Unit Cost 

 (1997$)

Inflation 

Factor

Unit Cost

(2011$) Hours Total Cost1

 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 values shown in this table. 

Source: 1997 costs, Best, 1997; cost elements and quantities, EPA, 1998 and EPA, 1999; inflators and labor rates, Table B-1 

through Table B-3.

C.2.3 Gloves 

If the SNUR cites 40 CFR §721.63(a)(2)(i), then gloves must be worn to avoid engaging in a Significant 

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

standard, disposable medical-grade gloves are used, they are assumed to be worn and discarded by the 

worker following each day of exposure. Each site is assumed to have 25 workers, each of them exposed 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 providing disposable gloves are developed by applying the 
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assumptions above regarding the number of workers exposed (25 per site) and frequency of replacement (one 

pair per worker per day of exposure H 250 days of exposure per year). For some chemicals, heavy-duty 

gloves may be used. They are 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 

Required1

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/year replace disposable gloves daily and replace heavy duty gloves 

every 25 work days.

2

 Total costs were calculated using unrounded unit cost values and inflation factors (Table B-3), so results may differ from 

calculations using the rounded values 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 workers, 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 purchased after July 5, 1994 shall comply with ANSI 

Z87.1-1989. To determine the cost of goggles that meet this standard, EPA consulted with eyewear 

specialists at equipment supplier LSS. A standard pair of goggles that meets the ANSI Z87.1-1989 

specification was priced at $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. 
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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 

Required1

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 and inflation factors (see Appendix B), so results may differ from

calculations using the rounded values 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 Table 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. Each site is assumed to have 25 workers, each of them 

exposed 250 days per year. 

Table C-9 shows estimated costs, after inflating as described 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 

Required1

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 unit cost values and inflation factors (see Table B-3), so results may differ from 

calculations using the rounded values shown in this table. 

Source: 1997 item costs, LSS, 1997; item type and quantity, EPA, 1998; inflation factor, Table B-3.

C.2.6 Respirators 

For some PMN chemicals, to avoid engaging in a Significant New Use, the SNUR requires either the use of 

respirators or compliance with a New Chemical Exposure Limit (NCEL). Both requirements differ by 
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chemical.1824For 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 docket 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 appeared to best match the SNUR descriptions. 

 

 

24 EPA’s website at http://www.epa.gov/oppt/newchems/pubs/ncelmain.htm explains that in Consent Orders and 

subsequent SNURs, EPA can require respirators unless workplace air measurements show that air-borne 

concentrations of the chemical are below a New Chemical Exposure Limit established by EPA to protect health. 

NCEL provisions are modeled after Occupational Safety and Health Administration Permissible Exposure Limits 

(PELs), and also cover sampling and analytical methods, monitoring, respiratory protection, and recordkeeping. 
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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 operated in pressure demand

or continuous flow mode and equipped with a tightfitting full facepiece. 

Supplied-air respirator operated 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 operated 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 efficiency 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 Efficiency 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-fitting full-face respirator 

equipped with the appropriate combination cartridges 

tested and approved for the gas/vapor substance (i.e., 

organic vapor, acid gas, or substance-specific 

cartridge), with a particulate filter (N100 if oil 

aerosols are absent, R100, or P100).

(v) Category 21C powered air-purifying respirator equipped

with a tight-fitting facepiece and high efficiency particulate

filters.

Some SNURs may specify a “half" or "full" facepiece.

Powered air-purifying, tight-fitting full-face

respirator equipped with N100 (if oil aerosols

absent), R100, or P100 filters.

Powered air-purifying respirator equipped with a

tight-fitting facepiece (either half- or full-face) and

HEPA filters.
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 rulemakings. Any significant differences between the specified respirator type at 40 CFR §721.63 (a)(5)

and the SNUR text respirator type are noted in italics. 

Table C-11 gives average costs of various respirator types, both as originally estimated in 1997 and after 

applying inflation factors from Table B-3. It also estimates costs per plant site for a chemical requiring 

respirators. 

The respirators specified in the SNURs are typically comprised of a respirator unit and any number of the 

following: special cartridges (such as high efficiency particulate filters, organic vapor cartridges, and paint, 

lacquer, and enamel filters), hoods or helmets, and filter caps. The costs for each site of providing respirators 

to chemically-exposed workers, shown in Table 4 of Chapter 2 of the report, are calculated based on the 

assumptions stated there, that (1) there are 25 chemically-exposed workers requiring protective equipment, 

(2) respirators are replaced once a year, and (3) cartridges (and cartridge filters and caps) are replaced at a rate 

of one pair (two cartridges) every five of the 250 days that workers are exposed, or 50 times per year. For 

example, for the respirator type described at 40 CFR §721.63(a)(5)(xv), the annual cost per worker in 1997 

dollars would be as follows: 

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

The 1997 cost was adjusted for inflation as shown in Table C-11. Typically a SNUR describes more than one 

type of respirator, but only one type of respirator is needed to comply with the workplace protection 

requirements.
Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT-2012

September 20, 2012 C-13 Table 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$)

Respirator 

Unit

Cartridge 

Set

Per 

Worker2

Inflatio

Factor

(i) 19C Type C Supplied-air with full facepiece $804 $0.00 $804 1.401 (ii) 19C Type C Supplied-air with tight-fitting facepiece $804 $0.00 $804 1.401 (iii) 19C Type C Supplied-air with hood or helmet or tight-fitting facepiece $932 $0.00 $932 1.401 (iv) 21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs) $181 $9.76 $669 1.401 (v) 21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs $627 $35.50 $2,402 1.401 (vi) 21C PAPR with loose hood or helmet and HEPAs $525 $26.89 $1,870 1.401 (vii) 21C Air-purifying with HEPA and disposable respirators $12.53 $7.00 $363 1.401 (viii) 23C air-purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE) $192 $15.71 $978 1.401 (ix) 23C PAPR with tight-fitting facepiece and combination cartridges approved PLE $627 $35.50 $2,402 1.401 (x) 23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE $525 $26.88 $1,869 1.401 (xi) 23C Air-purifying with combination cartridges for PLE, including disposable respirators $14.30 $8.90 $459 1.401 (xii) 23C Air-purifying with full-facepiece and organic gas/vapor cartridges $192 $10.47 $716 1.401 (xiii) 23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges $826 $41.15 $2,884 1.401 (xiv) 23C PAPR with a loose-fitting hood or helmet and organic gas/vapor cartridges $640 $41.15 $2,697 1.401 (xv) 23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges $10.83 $8.94 $458 1.401 Notes: 1 Annual average costs were inflated as described in Table B-3. 2 “Respirator unit” costs include both the respirator and any required add-ons such as hoods and helmets. A “cartridge set” includes two cartridges and any filter

cartridge 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. 

3 Totals were estimated from unrounded unit costs and inflation factors, so results may differ from calculations using the rounded values shown in this 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 are required under the SNUR regulation and if the unit does 

not already include the item. For example, §721.63(a)(5)(x) requires a hood or helmet. One model in the 

catalog that satisfies the requirement already includes a hood, while another unit requires that a separate 

hood be purchased. The cost of the hood was added to the unit cost and the combined cost was then 

averaged with the model with integrated hood. 

Many respirator specifications also require cartridges. The costs of the cartridges listed in LSS (1997) 

were averaged for the corresponding requirements. In some instances, certain cartridges or filters require a 

secondary cartridge to function properly (e.g., some paint, lacquer and enamel filters required the organic 

vapors cartridges and filter retainer caps). These additional 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 paint, 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 respiratory 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 

Description1 1997 

Cost 

1997 Average Cost2

§721.63 

(a)(5) 

Respirator 

Unit 

Cartridge 

Set 

(i) 

19C Type C Supplied-air with 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 North Full-Face Respirator, p114 $210.10 

 7A-7122 North HEPA Cartridge, p115 $11.15 

 7A-12338 Willson Full-Face Silicone Respirator, p116 $215.10 

 7A-7526 Willson HEPA Cartridge, p117 $11.75 

 7A-10516 3M 7800 Full-Facepiece Respirator, p118 $202.10 

 7A-11839 3M HEPA Cartridge, p118 $7.00 

 7A-33446 Pro-Tech Full-Face Respirator, p122 $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 Respirator (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 $34.50 
Economic 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 

Description1 1997 

Cost 

1997 Average Cost2

§721.63 

(a)(5) 

Respirator 

Unit 

Cartridge 

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 Replacement 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 $7.00 
Economic 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 

Description1 1997 

Cost 

1997 Average Cost2

§721.63 

(a)(5) 

Respirator 

Unit 

Cartridge 

Set 

(viii) 

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

paints, lacquers and enamels (PLE) 

$192 $16 

 7A-9838 North Full-Face Respirator, p114 $210.10 

 7A-7117 North Organic Vapors Cartridge, p115 $10.50 

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

 7A-7125-2 North Filter Covers, p115 $4.35 

 7A-12338 Willson Full-Face Silicone Respirator, p116 $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 Full-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, p122 $106.45 

 7A-955-4 Pro-Tech Organic Vapors Cartridge, p123 $9.27 

 7A-9605 Pro-Tech Paint Spray 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/Paint Spray Prefilter, p125 $3.36 

 7A-3858 Willson Retainer Caps, p125 $4.27 

 7A-23959 AO7Star Full-Face Respirator (Silicone), p126 $203.25 

 7A-9935 AO7Star Organic Vapors Cartridge, p127 $8.76 

 7A-10043 AO7Star Dusts/Mists/Paint Spray Prefilter, p127 $3.07 

 7A-10044 AO7Star Retainer Clips, p 127 $3.20 

(ix) 

23C PAPR with tight-fitting facepiece and combination cartridges approved PLE $627 $36 

 7A-13599 3M Face-Mounted PAPR System, p142 $720.00 

 --- Paint, Lacquer, Enamel Cartridge3 $36.50 

 7A-32505 RACAL Powerflow PAPR, p142 $534.90 

 --- Paint, Lacquer, Enamel Cartridge3 $34.50 
Economic 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 

Description1 1997 

Cost 

1997 Average Cost2

§721.63 

(a)(5) 

Respirator 

Unit 

Cartridge 

Set 

(x) 

23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE $525 $27 

 7A-32506 RACAL Air-Mate PAPR 12, p143 $411.05 

 --- Paint, Lacquer, Enamel Cartridge3 $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 Cartridge3 $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/Pesticides Prefilter, p139 $2.56 

 7A-22754 Moldex Retainer Caps, p139 $2.65 

(xii) 

23C Air-purifying with full-facepiece and organic gas/vapor cartridges $192 $10 

 7A-9838 North Full-Face Respirator, p114 $210.10 

 7A-7117 North Organic Vapors Cartridge, p115 $10.50 

 7A-12338 Willson Full-Face Silicone Respirator, p116 $215.10 

 7A-7527 Willson Organic Vapors Cartridge, p117 $10.25 

 7A-10516 3M 7800 Full-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, p122 $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 Respirator (Silicone), p126 $203.25 

 7A-9935 AO7Star Organic Vapors Cartridge, p127 $8.76 
Economic 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 

Description1 1997 

Cost 

1997 Average Cost2

§721.63 

(a)(5) 

Respirator 

Unit 

Cartridge 

Set 

(xiii) 

23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges $826 $41 

 7A-32473 RACAL Breathe-Easy Organic Vapors and Turbo 

Unit, p141 

$548.50 

 7A-12844 RACAL Breathe-Easy 7 Full Face, p140 $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 respirator types in the SNUR and in this table. 

2 Average costs presented in this table are rounded to the nearest dollar figure, so results may differ from calculations using the 

rounded values shown in this table.

3 Paint, lacquer and enamel (PLE) cartridges for PAPRs were not listed in the catalog. The costs for PLE cartridges are 

assumed to be the same as HEPA cartridges.

Source: LSS 1997; EPAB 1999 

C.3 Recordkeeping 

There are two main types of recordkeeping requirements for the substances listed in the current SNURs: 

those for companies submitting a SNUN, and those for all companies that manufacture, import or process 

SNUR-regulated substances, regardless of whether they have made a submission to EPA. 

C.3.1 SNUN 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 percent of SNUN submission hours, or about five to 
Economic 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 electronic submission of SNUNs is expected to reduce 

the recordkeeping burden to approximately one hour (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. (For firms producing under the R&D exemption, R&D 

recordkeeping would be needed. R&D recordkeeping costs were not estimated for this report.) 

Recordkeeping requirements vary between PMN chemicals, reflecting differences in SNUR restrictions. 

For all chemicals in the current SNURs, manufacturers, importers, and processors must keep records on 

quantities supplied or purchased under 40 CFR §721.125(a), (b), and (c). For chemicals with water 

discharge restrictions, companies must keep records concerning water discharge compliance, under 

§721.125(k). For chemicals with other use restrictions, or for those few chemicals with workplace 

protection or hazard communication restrictions, companies must keep records under other 40CFR 

§721.125 paragraphs, to document compliance. 

All recordkeeping requirements essentially involve copying and filing relevant records, including those 

related to: manufacturing, importing, or processing volumes; shipment amounts and customer 

information; clothing impermeability determinations; the hazard communication program including labels 

and MSDS copies; compliance with other use restrictions; and/or compliance with disposal and release to 

water limitations. Records must be maintained for five years from the date of their creation. 

Costs for compliance with the recordkeeping requirements for substances subject to a SNUR are based on 

the approach in Economic 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 (Kearney, 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 Comprehensive 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 recordkeeping costs at 5.67 hours (EPA 

2005b, page 12). 

26 SNUN submission costs estimated in Table 8 of this report were based on PMN submission costs from a 1994 

report, Regulatory Impact Analysis of Amendments to Regulations for TSC Section 5 Premanufacture 

Notifications (EPA, 1994). Page III-14 of the 1994 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 and 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 underlying methodology is identical to the Kearney 

1988a/RIB 1989 reports, resulting in identical costs per chemical except for differences due to inflation 

and rounding. The paragraphs that follow describe estimates and assumptions used from Kearney (1988a 

and 1988b). 

Cost per page. Recordkeeping costs are based on cost per page. Kearney (1988a) assumes that the ratios 

of labor hours to page count for each labor category, 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 and Reporting Rule. The CAIR estimates are given in 

the 1988 report, Estimated Cost of the Final Comprehensive Assessment Information Rule, June 1, 1988, 

page 65 (Kearney, 1988b). Table C-13 summarizes estimates from Kearney 1988a and the CAIR report 

(Kearney, 1988b). It also shows the derivation of costs from these estimates, after inflation. The method is 

as follows: 

 Technical labor was estimated at 1 hour for 750 pages in the CAIR report (Kearney, 1988b, page 

65), or .00133 hours per page. The analysis estimates a cost per hour and per page using fully 

loaded labor rates from Table B-1. 

 Clerical labor was estimated at 10 hours for 750 pages in the CAIR report (Kearney, 1988b, page 

65), or .01333 hours per page. The analysis estimates 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 four-drawer file cabinet for 750 pages (Kearney, 

1988b, page 65) or 0.000333 of a cabinet per page. A standard, four-drawer, full-suspension file 

cabinet was priced from a national office products supplier at $195 in 1997 (BT Office Products, 

1997; Item #LGM-202401; EPA, 1998). This results in $0.065 per page cost for file space, before 

inflation ($195 × 0.25 file cabinet/750 pages). 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 $0.0133/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 materials costs were originally estimated in Kearney 1988b for the CAIR rule. The CAIR per-page 

costs were then used to estimate SNUR recordkeeping per-page costs in Kearney 1988a. This clarifies the method by which the 

original CAIR per-page costs and hours were calculated. It also adjusts costs for inflation using labor rates from Table B-1 and 

inflation factors from Table B-3. 

Pages per chemical at one site. In order to estimate recordkeeping costs, the analysis multiplies the costs 

per page for each recordkeeping element estimated in Table C-13 by the 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 transfer data require 485 pages of records per 

year. This reflects 40 invoices per month (see haz-comm Section C.1 above), 480 for 

sales/transfer and 5 for manufacturer/import (Kearney, 1988a, p.11). 

Disposal compliance records, if required, cover items such as waste production, shipping 

manifests, permits, and transfer receipts. The 600 disposal compliance pages 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 “employee 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 activities at one site for one SNUR chemical, 

by CFR requirement. If all recordkeeping requirements at 40 CFR §721.125 applied to a single chemical, 

there would be costs for 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 chemicals with relatively few SNUR restrictions because 

fewer pages would be needed to document SNUR compliance. 

Table C-14 does not include costs of recordkeeping resulting from a SNUN submission; those costs were 

included in the SNUN submission cost. 

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

40CFR 

§721.1252 Requirement Pages3 

Labor and Materials Cost1

(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 SNUN submissions required by 40 CFR §721.40.) Total costs are 

calculated from unrounded values and may not equal the sum and/or product of rounded values. 

2 40 CFR 721.125(a) through (k) list recordkeeping that may be specified in the SNUR. The recordkeeping specified depends 

on which 40 CFR §721 provisions [in brackets] were used by the SNUR to define reportable New Uses (§721.63, §721.72, 

§721.80, and/or §721.90). Few if any SNUR chemicals would require all of the recordkeeping costs listed above since few if 

any chemicals are subject to all of the requirements (a) through (k). 

3 Pages count estimates for each SNUR requirement are from Kearney, 1988a.
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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 the 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 earlier in this report, it appears that firms rarely 

elect to do these recommended tests to support a SNUN, and especially not the higher-cost tests. For 

informational purposes, this appendix presents estimated 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 are identified by guideline numbers which can be 

used to look up published test protocols. Table D-1 lists test guidelines cited in the current and recent 

SNUR rulemakings, and their associated costs, Table D-2 presents certain assumptions used in the 

analysis, and Table D-3 presents Persistent Bioaccumulative Toxic (PBT) tiered testing requirements. The 

types of guidelines are described below. 

D.1.1 OPPTS Harmonized Test Guidelines 

Most SNUR tests are identified by their OPPTS number from the series of OPPTS Harmonized Test 

Guidelines and OPPTS harmonized public drafts not yet promulgated as OPPTS guidelines. These 

guidelines blended testing guidance from OPPT (published in the Code of Federal Regulations), EPA's 

Office of Pesticide Programs, the Organization for Economic Cooperation and Development (OECD), 

and other sources. The harmonized 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 Federal Regulations (CFR), identified for example as “40 

CFR 799.9370” or just “799.9370.” In addition, in costing out test guidelines, this report sometimes uses 
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September 20, 2012 D-2 

costs for a CFR guideline when costs have not been developed for the equivalent OPPTS harmonized 

guideline. 40 CFR parts 795 through 798 include pre-harmonization test guidelines, typically updated 

before 1990. 40 CFR part 799 includes more recent TSCA test guidelines, based on harmonized test 

guidelines. (63 FR 41845, August 5, 1998). 

D.1.3 OECD 

A few SNUR tests are identified by their OECD number. The OECD guidelines may have OPPTS 

equivalents. For example, OECD 407 28-Day Oral Toxicity in Rats is essentially equivalent to OPPTS 

870.3050. 

D.1.4 OECD’s Guidance Manual for the Testing of Manufactured Nanomaterials 

For some nanomaterials SNUR tests may refer to OECD’s Guidance Manual for the Testing of 

Manufactured Nanomaterials. Because of the newness of nanomaterial testing 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 according to a testing strategy published in the Federal 

Register (FR), Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances,

November 4, 1999 (64 FR 60194), which in turn refers to a number of tests by OPPTS or OECD 

guideline number. 

D.1.6 ASTM, NTIS, and Other Sources 

Test guidelines may also come from the American Society for Testing and Materials (for example, ASTM 

D2035-80 Modified Coagulation-flocculation Jar Test of Water) (www.astm.org) or other sources. The 

guideline for a 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-2

September 20, 2012 D-3 Table D-1. Cost Estimates for Test Guidelines Cited in SNURs 

Guideline Test Species Route/Method 

Product Properties 830.6315 Flammability NA NA 830.7050 Absorption in Aqueous Solution: ultraviolet/visible 

spectra NA NA 

830.7200 Melting Point / Melting Range NA 8-test average 830.7550 Partition Coefficient (n-Octanol/Water) NA Shake Flask Method 830.7560 Partition Coefficient (n-Oct/Water) NA Generator Column 830.7570 Partition Coefficient (n-Oct/Water) NA Liquid Chromatography 830.7840 Water Solubility NA Flask Method 830.7860 (796.1860)x Water Solubility: Column Generator Method NA Generator Column Karel Vershueren Handbook, odor and taste test 

Odor and taste test (in Handbook of Environmental Data on Organic Chemicals, by Karel Vershueren, 4th Ed,Vol. 1, Page 22) 

NA NA 

Fate, Transport, Transformation 835.1110 Activated Sludge Sorption Isotherm NA NA 835.1220 Sediment and Soil Adsorption/Desorption Isotherm NA NA 835.1230 Sediment and Soil Adsorption/Desorption (batch equilibrium) NA NA 835.1240 Leaching and adsorption/desorption NA NA 835.2110 Hydrolysis as a Function of pH NA NA 835.2120 Hydrolysis test NA NA 835.2130 Hydrolysis as a Function of pH and Temperature NA NA 
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Guideline Test Species Route/Method 

835.2210 (796.3700) Photolysis in Aqueous Solution in Sunlight NA NA 835.3100 (796.3100) Aerobic Aquatic Biodegradation NA NA 835.3110 Ready Biodegradation NA Average of six methods 835.3120 Sealed-Vessel CO2 Production Test NA NA 835.3140 CO2 in Sealed Vessels Test NA NA 835.3170 Shake Flask Die-Away Test NA NA 835.3180 Sediment/Water Microcosm Biodegradation NA Flow-through 835.3190 Aerobic Mineralization in Surface Water – Simulation Biodegradation Test NA NA 835.3200 (OECD 302B) Inherent Biodegradation: Modified Zahn-Wellens NA NA 835.3210 Modified SCAS Test NA NA 835.3220 Porous Pot Test NA NA 835.3400 Anaerobic Biodegradability of Organic Chemicals NA NA 835.5045 (OECD 302A) Inherent Biodegradability: Modified SCAS Test NA NA 835.5270 (795.7000) 

Sunlight Photolysis in Waters Containing Dissolved Humic Substances (Indirect Photolysis 

Screening Test) 

NA NA 

D2035-80 (ASTM D 2035-80) 

Standard Practice for Coagulation-Flocculation Jar Test of Water NA NA 

OECD 303A Simulation Test - Aerobic Sewage Treatment, with measurement of loss of the parent NA NA OECD 307 Aerobic and Anaerobic Transformation in Soil NA Flow-through OECD 307 Aerobic and Anaerobic Transformation in Soil NA Bio-meter type flasks 
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Guideline Test Species Route/Method 

OECD 308 Anaerobic transformation in aquatic sediment 

systems 

NA NA 

OECD 309 Aerobic mineralisation in surface water NA NA OECD 310 Ready biodegradability-CO2 in Sealed Vessels (headspace test) NA NA OECD 311 (835.3400) Anaerobic biodegradability of organic compounds in digested sludge NA NA OECD TG 310 CO2 in Sealed Vessels – Headspace Test NA NA Draft OECD Jan 2002 Phototransformation of chemicals on soil surfaces- 2 soils NA NA Ecological Effects 850.1000 Special Considerations for Conducting Aquatic Laboratory Studies NA NA 850.1010 (797.1300) Daphnid Acute Toxicity Daphnid Flow-through 850.1010 (797.1300) Daphnid Acute Toxicity Daphnid Static 850.1075 (797.1400) Fish Acute Toxicity Fathead Minnow Flow-through 850.1075 (797.1400) Fish Acute Toxicity NA Static 850.1085 Fish Acute Toxicity Test mitigated by humic acid Fathead Minnow Flow-through 850.1085 Fish Acute Toxicity Test mitigated by humic acid Fathead Minnow Static 850.1300 Daphnid Chronic Toxicity Test Daphnid Flow-through 850.1350 Mysid Chronic Toxicity Test Mysid Flow-through 
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Guideline Test Species Route/Method 

850.1400 Fish Early Life Stage Toxicity Rainbow Trout Flow-through 850.1400 Fish Early Life Stage Toxicity Fathead Minnow Flow-through 850.1730 Fish BCF Fathead Minnow Flow-through 850.1925 Site-Specific Aquatic Microcosm Test NA NA 850.1950 Field testing for Aquatic Organisms3 NA NA OECD 218 Chironomid Sediment Toxicity NA NA 850.5400 Algal Toxicity, Tiers I and II NA NA Health Effects 870.1100 Acute Oral Toxicity Rats Gavage 870.1300 Acute Inhalation Toxicity Rats4 Inhalation 870.2500 Acute Dermal Irritation Test Rabbits Dermal 870.2600 Dermal Sensitization Test Guinea Pigs NA 870.3050 Repeated Dose 28-day Oral Toxicity Test Rodents NA 870.3100 90-Day Oral Toxicity Rats Gavage 870.3250 Subchronic Dermal Toxicity - 90 days Rats Dermal 870.34651 Subchronic Inhalation Toxicity Rats Inhalation 870.3465 (mod) Subchronic Inhalation Toxicity (w/ 60 day recovery group) Rats Inhalation 870.3465 (OECD 413)1 Subchronic Inhalation Toxicity (90-day exposure/180-day retention) Rats Inhalation 
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Guideline Test Species Route/Method 

870.3550 Reproductive/Developmental Toxicity Screening Test NA Oral 870.3650 Combined repeated dose toxicity test with the reproductive/developmental screening test Rats NA 870.3700 Prenatal Developmental Toxicity {2 species} Rats Gavage 870.3800 Reproduction/Fertility Effects (2-Generation Reproduction) Rats Gavage 870.4200 Carcinogenicity {2 species} (24 months) Rats Gavage 870.4200 Carcinogenicity {2 species} Rats Inhalation 870.4300 Combined Chronic Toxicity/Carcinogenicity Test Rats Gavage 870.5100 Bacterial reverse mutation test NA Direct plate 870.5265 Salmonella typhimurium Reverse Mutation Assay (Ames Test) NA Average of direct plate and Azo reduction 870.5385 Mammalian Bone Marrow Chromosomal Aberration Test Rats Gavage 870.5395 

In Vivo Mammalian Bone Marrow Cytogenetics Tests: Erythrocyte Micronucleus Assay (Average of 1 and 3 day dosings) 

Mice Gavage (Average of 1 and 3 day) 

870.5395 

In Vivo Mammalian Bone Marrow Cytogenetics Tests: Erythrocyte Micronucleus Assay (Average of 1 and 3 day dosings) 

Mice Intravenous (Two test average) 

870.5550 Unscheduled DNA Synthesis in Mammalian Cells in Culture Rat Hepatocytes NA 870.6100 Delayed Neurotoxicity of Organophosphorus Substances (Acute) Hens Gavage (Acute) 
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Guideline Test Species Route/Method 

870.6100 Delayed Neurotoxicity of Organophosphorus Substances (Subchronic 28-day) Hens Gavage (Subchronic) 870.6200 Neurotoxicity Screening Battery (Acute) Rats Gavage 870.7485 Metabolism and Pharmacokinetics (Tier I) Rats Gavage 870.7800 Immunotoxicity Rats Gavage ASTM F739 -91 (ASTM F739)2

Standard Test Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Continuous Contact 

NA Average (Gases and Liquids) 

OECD 105 Water Solubility Test NA Flask Method OECD 112 Dissociation Constant in Water Test NA Conductometric Method OECD 206 Avian Reproduction Test Bobwhite Quail NA OECD 206 Avian Reproduction Test Mallard Ducks NA OECD 303A Simulation Test - Aerobic Sewage Treatment: Activated Sludge Units NA NA OECD 307 Aerobic and Anaerobic Transformation in Soil Test NA Flow Through OECD 307 Aerobic and Anaerobic Transformation in Soil Test NA Bio-meter Type Flasks OECD 308 Aerobic and Anaerobic Transformation in Aquatic Sediment Systems Test NA NA OECD 311 Anaerobic Biodegradability of Organic Compounds in Digested Sludge Test NA NA OECD 314 Simulation Test to Assess the Biodegradability of Chemicals Discharged in Wastewater NA NA OECD 404 (870.2500) Acute Dermal Irritation Rabbits Dermal 
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Guideline Test Species Route/Method 

OECD 405 (870.2400) Acute Eye Irritation Rabbits Eye OECD 407 (870.3050) Repeated dose 28-day oral toxicity study in rodents Rats Gavage (28 Days) OECD 412 Repeated Dose Inhalation Toxicity (28-Day Study) Rats Inhalation (28 Days) OECD 416 Two-Generation Reproduction Toxicity Test Rats Dietary OECD 421 (870.3550) Reproduction/developmental toxicity screening tests Rats Gavage OECD 422 (870.3650) Combined Repeated Dose Study with Reproductive/Developmental Toxicity Screen Rats Gavage OECD 422 (mod) 

Combined Repeated Dose Study with 

Reproductive/Developmental Toxicity Screen (90 days w/ histopathology) 

Rats Gavage 

OECD 425 Acute Oral toxicity: Up-and-down Procedure Rats Gavage OECD 453 Combined Chronic Toxicity/Carcinogenicity Test Rats Inhalation ASTM D6007-02 

Small Scale Chamber Test to Determining Formaldehyde Concentration in Air from Wood Products 

NA NA 

EPA draft - Inhalation Monitoring Data Collection Guidelines 

NA NA NA 

Nanomaterial Specific Tests5, 6 OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

Dustiness Test NA EN 15051 Method 
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Guideline Test Species Route/Method 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

Dry particle size distribution by count for each PMN substance in a form which has the highest content of particles smaller than 10 microns as manufactured, processed or used in the workplace at sites controlled by the Company 

NA 

STEM (scanning transmission electron microscopy) method 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

Surface chemistry NA Average of Three Methods 

ASTM D2565-99(2008) Release of MWCNTs after exposure of liquid polymer forms to sunlight: NA 

 Consult Standard Practice for XenonArc Exposure of Plastics Intended for Outdoor Applications 

ASTM E1354-09 Release of MWCNTs during the burning of liquid polymer forms: NA 

Consult Standard Test Method for Heat and Visible Smoke Release Rates for Materials and Products Using an Oxygen Consumption Calorimeter 
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Guideline Test Species Route/Method 

EPA method 1320 Release of MWCNTs after landfill disposal: NA 

Multiple Extraction Procedure to determine the fraction of MWCNTs released during the leaching that the liquid polymer forms will undergo from repetitive precipitation of acid rain 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

Configuration of Carbon Nanotube ends NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

Release of MWCNTs during solid polymer form shipping and use NA 

A simple short-term test consisting of placing the solid polymer forms in a standard rock tumbler and determining the amount of free MWCNTs after a period of l, 5, 15, and 30 days to screen for significant release of MWCNTs from the solid polymer forms. 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM C100 (>90% MWCNTs. < 7% aluminia and <5% of iron oxide) NA NA 
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Guideline Test Species Route/Method 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM U100 (>97% MWCNTs. <3% of iron oxide, 1% alumnia) NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM CSI-015, a viscous resin (honey-like) comprised of 98.5% epoxy resin, 1,5% GRAPHISTRENGTH TM C100 

NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM PEB-201, a very highly viscous resin (tar-like paste) comprised of 64.3% polyester, 31.6% styrene, remainder GRAPHISTRENGTH TM C100 

NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM CM1-20, a pellet comprised of 79% polyamide, 12.5% white mineral oil, remainder GRAPHISTRENGTH TM C100 

NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM CM2-20 a pellet comprised of 78% polyamid resin, 22% GRAPHISTRENGTH TM C100 

NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM CM3-20 a pellet comprised of 79% polyamid 11, 21% GRAPHISTRENGTH TM C100 

NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM CM5-20 a pellet comprised of 60% polycarbonate, 20% flame retardant, 20% GRAPHISTRENGTH TM C100 

NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM CM12-30, a pellet comprised of cyclic butylenes trephthalate (CBT), 30% GRAPHISTRENGTH C100 

NA NA 
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Guideline Test Species Route/Method 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM CM13-30, a pellet comprised of 65% polyacrylic-polyolefin, 15% acrlonitrile-butadiene copolymer, 20% GRAPHISTRENGTHTM C100 

NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

GRAPHISTRENGTH TM C M6-20 a granule comprised of 80%polyamid6, 20% GRAPHISTRENGTH TM C100 

NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

Workplace exposure monitoring and 

characterization testing (including byproducts) NA NA 

OECD's Guidance Manual for the Testing of Manufactured Nanomaterials 

Certain material characterization data NA NA 

Notes: * Indicates this cost has not been calculated for this report. + Indicates that EPA, EPAB staff estimated this test cost in fall of 2009 and it is more recent that the other EPA, OPPTS EPAB test cost estimates pres

majority of which were estimated prior to 1990. 1 For some PMNs, recommended testing under guideline 870.3465 would involve an additional 3 mon

other evaluation beyond the standard requirements in the test guideline. These activities would raise testing cost substantially. 

1 The recommended testing for some PMN chemicals may include a glove permeation test following ASTM F739 and F1194-99 guidelines. ASTM F1for documenting the results of chemical permeation tests (see www.astm.org). The additional costs of following ASTM F1194-99 (average of gases an

for this report.

2 Costs for field testing will be site-specific, with a wide range of actual costs. A report from EPA's Office of Pesticide Programs estimated an average 

guideline 850.1950, for simulated or actual field testing for aquatic organisms (EPA, 2008a, Appendix C). 3 Performing the test on species other than rats may change the test costs. For example, testing on rabbits is likely to increase costs. 4 Fate, transport and transformation, ecological effects, and health effects testing may be required for nanomaterials, however nano-specific costs for th

for this report. 

5 While the Agency expects that analytical methodology validation costs may be more expensive for nanomaterials than for traditional chemicals, EPA 

information on nanomaterial-specific analytical methodology validation and therefore uses the traditional chemical costs as a proxy.

6 The 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 been inflated 

3 for inflation index). Dollar costs include $4,140 or $10,055 for analytical method validation; where applicable (see text). Species and route or method m

may be unspecified but assumed in this table for costing purposes.
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D.2 Test Costs by Guideline 

Table D-1 gives dollar cost for each test, based on assumptions and adjustments discussed below. This 

section describes the development of individual test costs. 

EPA’s Office of Pollution Prevention and Toxics, Economic and Analysis Branch, regularly develops 

cost estimates of test guidelines to 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 equipment needed to perform testing, with overhead and 

fee. Many of the test costs were developed in the 1990s. Test costs have been inflated using Employment 

Cost Index inflators from the Bureau of Labor Statistics (see Appendix B). However, generally they have 

not been updated to reflect subsequent changes in laboratory technologies. 

Testing laboratories perform analytical method validation to ensure that proper dose concentrations are 

used in toxicity studies (EPA, 2005a, p. 3-9). This analysis assumes that for health effects tests (e.g. 870 

series guidelines), tests of up to 90 days in duration have method validation costs of $3,500, and 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 validation costs are the same for both nanomaterials and 

traditional chemicals. 

In cases where costs have not been estimated for the specified guideline, EPA uses the cost from an 

approximately equivalent guideline (listed in Table D-1 and Table D-3 in parentheses). Many of these 

equivalents are listed in the Federal Register at 63 FR 41847, August 5, 1998. In some cases the test 

protocol itself states that it is essentially equivalent to another test upon which it was based. Sometimes 

judgment was needed to select the closest equivalent(s). 

In some cases, EPA has not costed out the test for the species, 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 adjustments were selected based on discussions with EPA 

scientists and on SNUR language, published test guidelines, assumptions underlying the cost estimates in 

EPAB's test cost database, EPA review and Consent Order history for specific PMNs, or other sources. 

D.2.1 Default Parameters 

Costs for many of the guidelines have been estimated for different combinations of species, route, length 

of study and other aspects of methodology, but in some cases the SNUR may not specify all of these 

variables. Where this occurs, EPA has used certain default parameters, listed in Table D-2. 
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Table D-2. Default Parameters for Species, Route, and Study Type

Variable Default

Species 

Mammals 

Fish 

Invertebrates 

Algae 

Rats 

Fathead minnow1

Daphnids 

[Four species -- see text] 

Route/Method 

Mammalian 

Fish 

Invertebrates 

Gavage 

Flow-through 

Flow-through 

Notes: 

1 For guideline 850.1400 tests also in PBT tier tests, rainbow trout is the default species. (See PBT discussion below.) 

D.2.2 SNUR Testing Tiers 

A SNUR may recommend tiered testing. In such cases, costs are lower if only the first-tier tests are 

performed, and higher if all tests listed for the chemical are performed. Testing is “tiered” if later 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 testing described at 64 FR 60194. 

D.2.3 Test Cost Assumptions and Comments 

This section explains treatment of certain tests listed in this or past SNUR rulemakings. 

 A SNUR may recommend algal acute toxicity testing according to OPPTS Guideline 850.5400. 

This guideline has been previously costed by EPA for four separate algal species (Navicula 

pelliculosa, Skeletonema costatum, Anabaena flos-aquae, and Selenastrum capricornutum). If a 

SNUR does not specify the algal species to be used, the average costs of the four algal species 

tests are used. 

 For OPPTS test guideline 835.3100 (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. Table D-1 gives costs for 835.3100 but not for the 

extended test. 

 A SNUR may recommend a “modified” version of ASTM test guideline D2035-80 (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. 
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 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 Bioaccumulative Toxic chemical substances (PBTs) 

according to the testing strategy in EPA’s New Chemicals Program PBT Category document, published 

in the Federal Register notice, Category for Persistent, Bioaccumulative, and Toxic New Chemical 

Substances, November 4, 1999, at 64 FR 60194. 

In 64 FR 60194, there are three tiers of testing. The results of Tier 1 determine whether Tier 2 testing is 

needed and the results of Tier 2 testing determine whether Tier 3 testing is needed. Table D-3 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 adjusted 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 rainbow trout as the species for the chronic fish 

toxicity test, 850.1400. For SNURs that recommend PBT Category testing, 850.1400 costs would 

be based on using rainbow trout. If 850.1400 is recommended without PBT testing, costs would 

be based on using fathead minnows. 

 For PBT Tier 1 ready biodegradability tests, firms may either choose among six methods in test 

guideline 835.3110 or follow test guideline 835.3120. The cost of 835.3110 is calculated as the 

average cost of its six possible methods. The cost estimates assume an equal chance of using 

either 835.3110 or 835.3120. 
Economic Analysis of Expedited New Use Rule for 78 Chemical Substances (EPA Docket EPA-HQ-OPPT2012-0277)

September 20, 2012 D-17 

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 CO2 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 are conducted) $777,491 

Source: 64 FR 60194, Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999, at 

http://www.epa.gov/EPA-TOX/1999/November/Day-04/t28888.htm. Tests costs are from Table D-1. 

* The PBT FR notice cites 830.7560 and 830.7570. This table used costs for similar tests 796.1720 and 796.1570, respectively. 

Tests 830.7550 (Partition Coefficient using Shake Flask method) and “the new ‘slow-stir’ method currently under development 

by the OECD” are also mentioned as options for determining the Oct/Water partition coefficient, in the PBT FR notice Response 

to Comments but not in the main Testing Strategy discussion. 

** PBT FR notice cites both tests as equivalents. 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 much lower than the costs that would be implied by 

adding up costs of all of the testing recommended in the SNUR for that chemical, and usually are zero.28

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

 

28 A prior SNUR economic analysis calculated chemical-specific test costs (EPA, 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 

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September 20, 2012 D-2 

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

September 20, 2012 D-4 

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