Economic Analysis of Expedited 

Significant New Use Rules (SNURs) for 

36 Chemical Substances 

EPA Docket EPA-HQ-OPPT-2010-1075 
gysn;r 3 

Economic Analysis of Expedited Significant New Use Rules 

for 36 Chemical Substances 

(EPA DOCKET EPA-HQ- OPPT-2010-1075)

July 20, 2011

—Does not contain TSCA CBI—

Prepared by: 

Economic and Policy Analysis Branch 

Economics, Exposure and Technology Division 

Office of Pollution Prevention and Toxics 

Office of Chemical Safety and Pollution Prevention 

U.S. Environmental Protection Agency 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 i July 20, 2011 

CONTRIBUTORS 

The EPA analyst responsible for this report was Stephanie Suazo. Analytical and draft 

preparation support was provided by Abt Associates Inc. under EPA Contract No. EP-W08-010. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 ii July 20, 2011 

ABSTRACT 

This Economic Analysis estimates the potential costs of Significant New Use Rules 

(SNURs) covering 36 chemicals that have been the subject of TSCA premanufacture notices 

(PMNs). The SNURs are being published under the rulemaking docket number EPA-HQOPPT-2010-1075as direct final rules. The SNURs define “Significant New Uses” that trigger 

EPA notice 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 of restricting 

chemical releases to water or preventing worker exposure. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 iii July 20, 2011 

TABLE OF CONTENTS 

CONTRIBUTORS ........................................................................................................................... i

ABSTRACT .................................................................................................................................... ii

LIST OF TABLES ......................................................................................................................... iv

1.0 INTRODUCTION .............................................................................................................. 1

2.0 COSTS OF A SIGNIFICANT NEW USE RULE (SNUR), BY OPTION ........................ 5

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

2.2 Request Modification or Revocation of a SNUR (Option 2) ........................................ 12

2.3 Submit SNUN (Option 3) ............................................................................................. 15

2.4 Request Equivalency Determination (Option 4) ........................................................... 18

2.5 Decide Not to Produce Chemical (Option 5) ................................................................ 18

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

3.0 EXPORT NOTIFICATION COSTS ................................................................................ 21

3.1 Estimated Number of Annual Export Notifications per Exporter ................................ 21

3.2 Exporter Costs ............................................................................................................... 22

4.0 AGENCY COSTS ............................................................................................................ 25

4.1 SNUN Processing Costs ............................................................................................... 25

4.2 Export Notification Processing Burden ........................................................................ 28

5.0 ADDITIONAL ANALYSES ............................................................................................ 29

5.1 Regulatory Flexibility Act (RFA) ................................................................................. 29

5.2 Unfunded Mandates Reform Act (UMRA) .................................................................. 30

5.3 Paperwork Reduction Act (PRA) .................................................................................. 30

5.4 Executive Order 12866, Regulatory Planning and Review .......................................... 30

5.5 Executive Order 13132, Federalism ............................................................................. 30

5.6 Executive Order 12898, Environmental Justice ............................................................ 31

5.7 Executive Order 13045, Protection of Children ........................................................... 31

5.8 Executive Order 13175, Tribal Governments ............................................................... 31

5.9 Executive Order 13211, Energy Supply, Distribution, or Use ..................................... 31

APPENDIX A LIST OF PMNs AND THEIR CHEMICAL NAMES ................................... A-1

APPENDIX B INFLATORS AND WAGE RATES .............................................................. B-1

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

B.2 Derivation of Inflation Factors .................................................................................... B-5

APPENDIX C COSTS OF HAZARD COMMUNICATION, PROTECTION IN THE 

WORKPLACE, AND RECORDKEEPING REQUIREMENTS ............................................... C-1

C.1 Modifying the Hazard Communication Program ....................................................... C-1

C.2 Protection in the Workplace........................................................................................ C-6

C.3 Recordkeeping .......................................................................................................... C-19

APPENDIX D COSTS OF TESTING .................................................................................... D-1

D.1 Testing Guidelines ...................................................................................................... D-1

D.2 Test Costs by Guideline .............................................................................................. D-8

D.3 Testing Costs by Chemical ....................................................................................... D-12

APPENDIX E REFERENCES ................................................................................................ E-1
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 iv July 20, 2011 

LIST OF TABLES 

Table 1 Compliance Options and Associated Costs Incurred by a Firm due to SNUR .................. 3

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

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

Table 5 Sample Costs of Workplace Protection ........................................................................... 10

Table 6 Annual Costs of Recordkeeping Requirements (40 CFR §721.125) ............................... 12

Table 7 Sample Costs of Recommended Testing ......................................................................... 13

Table 8 Costs of Requirement to Modify/Revoke SNUR or Submit SNUN ................................ 15

Table 9: Derivation of Total Mailing Cost for 12 Notices ............................................................ 22

Table 10: TSCA 12(b) Export Notification Cost per Notification ............................................... 24

Table 11 Agency Costs for SNUN and Other Submission Review and Processing ..................... 27

Table 12: TSCA 12(b) Export Notification Cost: Agency Burden per Activity (2010$) ............. 28

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-5

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-8

Table C-7 Annual Cost of Gloves [40 CFR §721.63(a)(2)(i)].................................................... C-9

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-10

Table C-10 Crosswalk Between SNUR Text and Respirator Types at 40 CFR §721.63(a)(5) C-12

Table C-11 Annual Per-Chemical Costs for Respiratory Protection [40 CFR §721.63(a)(4)] . C-14

Table C-12 Respirator Prices and Average Costs in 1997, by NIOSH Type ........................... C-16

Table C-13 Recordkeeping Estimates from Kearney 1988a and 1988b ................................... C-21

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-9

Table D-3 Persistent Bioaccumulative Toxic (PBT) Tiered Testing Requirements ................. D-11
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 1 July 20, 2011 

1.0 INTRODUCTION 

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

Chemical Safety and Pollution Prevention (OCSPP’s) analysis of the potential costs incurred as 

a result of direct final Significant New Use Rules (SNURs) being promulgated for 36 chemical 

substances which have gone through premanufacture notice (PMN) review.1 The SNURs are 

being published under the rulemaking docket number OPPT-2010-1075. Appendix A lists the 

generic or specific chemical name and CAS number (if non-confidential) for each PMN. 

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, 9 of the 36 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 4 of the 36 substances are based on 

prior Consent Orders. 

EPA promulgates a significant new use rule (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 

 

1

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

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

2070-0012). EPA also promulgates SNURs through conventional rulemaking that are covered by ICR No. 1188 

(OMB Control Number 2070-0038). 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 2 July 20, 2011 

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

amount 

 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. 

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 1. Table 1 summarizes the costs associated with each option, other than 

the export notification costs that are discussed separately in Section 3. 

Table 1 and later tables list various costs. However, often such costs 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 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 SNURs, Docket OPPT-2010-1075 3 July 20, 2011 

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

Option1 Costs Quantified Costs per Chemical 

(2010$)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 $1,155. For 

the few SNUR chemicals where 

these apply, annual costs for worker 

protection may be $36,283 or more 

and for haz-comm is $1,056. 

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). 

$5,802 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. 

$8,302 submission cost (including 

SNUN recordkeeping and $2,500 

fee)4,5 plus ongoing recordkeeping 

costs of under $1,155. 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. 

$5,802 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. $36,283 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 

Section 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 SNURs, Docket OPPT-2010-1075 4 July 20, 2011 

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. 

The remainder of this report estimates the quantified portion of costs potentially 

associated with SNURs such as those included in this rulemaking. Section 2 presents estimates 

of the costs that could be incurred by manufacturers, importers, and/or processors under the 

SNUR options in Table 1. Section 3 addresses export notification costs. Section 4 addresses 

costs to EPA of administering the SNURs, while Section 5 presents an analysis of other impacts, 

as required by various statutes and executive orders. Appendix B provides the wage rates and 

inflators used in this analysis. Other appendices give cost estimation details and references. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 5 July 20, 2011 

2.0 COSTS OF A SIGNIFICANT NEW USE RULE (SNUR), BY OPTION 

A SNUR specifies requirements 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 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. 

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 below 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 TSCA Section 12 (b) 

requirements that are automatically triggered for chemicals regulated under TSCA Section 5 (see 

Section 3.0 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 SNURs, Docket OPPT-2010-1075 6 July 20, 2011 

Table 2 Production and Use Restrictions/Requirements 

40 CFR Reference 

(Code of Federal 

Regulations) 

Restriction/Requirement No. of Chemicals 

Affected1

Sample Costs Per 

Chemical 

(2010$) 

§721.63 Workplace protection 6 $12,061 to 

$36,2832 

§721.72 Hazard communication 2 $1,056 

Industrial Commercial, and Consumer Activities (§721.80) 

§721.80(a, b, c) Enclosed use only 0 Not quantified 

§721.80(d, e) Use at site only 0 Not quantified 

§721.80(f) Import only (do not manufacture) 2 Not quantified 

§721.80(g, h, i) Use only as intermediate 2 Not quantified 

§721.80(j, k) Engage only in uses listed in PMN or Consent 

Order 12 Not quantified 

§721.80(l, m, n, o) Limits non-industrial uses 1 Not quantified 

§721.80(p, q, s, t) Limit production volume 4 Not quantified 

§721.80(r, u) Volume-triggered testing 0 Not quantified 

§721.80(v, w, x, y) Restricts physical form of chemical 2 Not quantified 

Disposal, water release, recordkeeping 

§721.85 Disposal 0 Not quantified 

§721.90 Limit releases to water 26 Not quantified 

§721.1253 Recordkeeping for all manufacturers, 

importers, and processors 36 Up to $1,155 

Notes: 

1

Some chemicals have more than one type of restriction. 2 $12,061, is the annual cost for dermal protection selection and heavy duty gloves. $36,283 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 Section 3.0. 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. 

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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 7 July 20, 2011 

Rules: General Provisions for New Chemical Followup (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 

Hours 

(2010$)1,2

Update written program $205 4 

Labeling Distribution in commerce $135 0.5 

 Use in the workplace $372 1.5 

MSDS preparation $134 2.25 

Employee training $210 6.75 

TOTAL $1,056 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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 8 July 20, 2011 

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. 

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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 9 July 20, 2011 

Table 4 Annual Costs of Workplace Protection Requirement

Personal Protective Equipment and Requirement Citation at 40 CFR Unit Cost 

(2010$)1 

Quantity 

Required1

Total Annual 

Cost2 (2010$) 

Dermal Protection Selection §721.63(a)(1)

 10 hours industrial hygienist (IH) time $51.24 10 $512 

Impermeability Testing §721.63(a)(3) 

 Impermeability Test $1,306 1 $1,306 

 Evaluation of Manufacturer's Specifications $205 1 $205 

Gloves §721.63(a)(2)(i) 

 Standard (disposable) $0.58 6,250 $3,651 

 Heavy-duty butyl $46.19 250 $11,548 

Protective clothing §721.63(a)(2) 

 [ii] - Full-body (coverall with hood) $83.15 75 $6,236 

 [iv] - Coverall (no hood) $49.25 75 $3,694 

Eyewear §721.63(a)(2)(iii) 

 Standard goggles $5.50 75 $413 

 Heavy-duty goggles $8.22 75 $616 

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)] $1,092 25 $27,309 

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)] 

$1,266 25 $31,661 

Air-purifying respirator equipped with a tight-fitting full facepiece and High 

Efficiency Particulate Air (HEPA) filters.[similar to §721.63(a)(5)(iv)] $908 25 $22,711 

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)] 

$908 25 $22,711 

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)] $3,264 25 $81,599 

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)] $3,264 25 $81,599 

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)] 

$2,540 25 $63,512 

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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 10 July 20, 2011 

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 is 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

(2010$) 

Example #1: Gloves and Dermal Protection Selection 

 Heavy-duty butyl Gloves $11,548 

 Dermal Protection Selection $512 

Total per site with 25 workers $12,061 

Example #2: Gloves , Testing, and Respirator 

 Heavy-duty butyl Gloves $11,548 

 Dermal Protection Selection $512 

 Impermeability Test $1,306 

 Evaluation of Manufacturer's Specifications $205 

 Least Cost Respirator $22,711 

Total per site with 25 workers $36,283 

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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 11 July 20, 2011 

engaging in a Significant New Use, this would increase costs even if particular protective 

clothing is not specified in the SNUR. 

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, 2005, 

page 12). 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 12 July 20, 2011 

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

40CFR §721.1252 Cost Element Cost (2010$)1 Hours 

(a)(b)(c) Volumes & sales/transfer data $327 7.11 

(d)(e) Protective clothing [§721.63] and 

impermeability [§721.63(a)(3)] $13.47 0.29 

(f) Haz com program [§721.72] $168 3.67 

(g) Label copies [§721.72(b)] $3.37 0.07 

(h) MSDS copies [§721.72(c)] $3.37 0.07 

(i) Use limitations compliance [§721.80] $168 3.67 

(j) Disposal compliance [§721.80] $404 8.80 

(k) Water discharge compliance [§721.90] $67.37 1.47 

TOTAL $1,155 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. 

PMN uses, production volume limits, import-only, releases to water and disposal 

Several types of costs that may be incurred by complying with the significant new use 

designations are not quantified in this report. 

Release to water, disposal, and other use restrictions may result in costs not quantified 

for this report. For example: 

 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. 

 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 cost-effective chemical. 

 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.

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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 13 July 20, 2011 

firm is to request modification or revocation of the SNUR. According to New Chemical 

Program records EPA receives few modify/revoke requests (typically 0-3 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. 

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

(2010$) 

Ecotoxicity Base Set 

OPPTS 850.5400 Algal Toxicity, Tiers I and II $18,480 

OPPTS 850.1010 Daphnid Acute Toxicity $15,293 

OPPTS 850.1075 Fish Acute Toxicity $21,076 

Sample TOTAL Testing Cost: $54,848 

Notes: 

1

 Costs are from Table D-1 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 14 July 20, 2011 

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 

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 

 

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) 

estimates 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, which include the burden for recordkeeping (EPA, 1994, p. III-14). These burden 

estimates are based on the recordkeeping burden for polymer exceptions and not the recordkeeping burden 

associated with PMN submissions. Therefore, for this analysis we assume that any reduction in recordkeeping 

burden is captured in the reduction of the clerical burden, and we do not consider the one hour recordkeeping burden 

from the ePMN EA to avoid double counting. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 15 July 20, 2011 

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 Hours 

Range 

Average 

Hours 

Loaded 

Wage 

Rate1

(2010$) 

Total Labor Cost (loaded wage X hours) 

Request to 

Modify 

SNUR 

(Option 2) 

SNUN 

(Option 

3) 

Equivalency 

Determination (Option 4) 

Clerical2 0 0 $28.98 $0 $0 $0 

Technical3 67 - 80 73.68 $61.71 $4,547 $4,547 $4,547 

Managerial3 16 - 20 18 $69.74 $1,255 $1,255 $1,255 

Subtotal 83 - 100 91.68 $5,802 $5,802 $5,802 

User fees (SNUN only) $0 $2,500 $0 

TOTAL $5,802 $8,302 $5,802 

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)

 

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. 

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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 16 July 20, 2011 

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 the “SNUR ‘New’ 

Chemicals” discussion 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. 

This observation 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. 

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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 17 July 20, 2011 

listed at 40 CFR §720.45. Consequently, for this special situation, the submission cost is 

incurred due to PMN requirements, not due to the SNUR. (See EPA's 1997 Chemistry 

Assistance Manual for Premanufacture Notification Submitters for an overview of New 

Chemicals requirements [EPA, 1997]). 

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. 

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. 

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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 18 July 20, 2011 

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. 

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 Section 3.0 below. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 19 July 20, 2011 

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 firm-specific or chemical-specific 

factors. 

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 one thousand 

dollars (if the only added cost is for recordkeeping) to over $35,000 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 $5,802, 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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 20 July 20, 2011 

 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 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 SNURs, Docket OPPT-2010-1075 21 July 20, 2011 

3.0 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 the 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 SNURs, Docket OPPT-2010-1075 22 July 20, 2011 

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. 

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, 2009). 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 

Dates that the rates were verified on United States Postal Service web 

site: 

April 2010 

Postal services costs

Registered mail, regular, with $0 declared value $10.60 

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

Postage, regular First Class, up to 1 ounce $0.44

Cost per export notice - Subtotal $13.34 

× 12

Total Mailing Cost for 12 Notices $160.08 

Source: Mailing rates are from the US Postal Service web site as of April 2010 

(http://www.usps.com/prices/). 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). 

Compile and Maintain the List of Products 

Since TSCA §12(b) information collection activity has been in place for 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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 23 July 20, 2011 

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). 

 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 x 200 firms plus 24 hours x 100 firms), or an average of about 9.3 

hours of technical time per firm per year for 12 notifications per year (EPA, 2009b). 

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). 

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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 24 July 20, 2011 

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

 Technical Clerical Total 

 $/Hr Hours 2010$ $/Hr Hours 2010$ 2010$ Hours 

Compile list $61.71 9.3 $574 -- -- -- $574 9.3 

Write letter $61.71 1 $61.71 -- -- -- $62 1 

Check order and send 

notice 

-- -- -- $28.98 6 $174 $174 6 

Mailing cost1 -- -- -- -- -- -- $160 - 

Total per facility2` 10.3 $636 6 $174 $970 16.3 

Total per Notification 0.86 $52.97 0.50 $14.49 $80.80 1.36 

Notes: 

1

 Mailing costs reflect April 2010 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 

2010 dollars. 

 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 25 July 20, 2011 

4.0 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 persubmission 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, 2010). 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 SNURs, Docket OPPT-2010-1075 26 July 20, 2011 

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 SNURs, Docket OPPT-2010-1075 27 

Table 11 Agency Costs for SNUN and Other Submission Review and Processing 

Review 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 

(2010$) 

1993 

dollars 

2010 

dollars 

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

Pre-notice consultation 0.0024 $161,446 $387 $4.00 $6.78 $394 41% $162 Administrative prescreen/ notice receipt/user fee 0.0024 $161,446 $387 $92.00 $155.85 $543 100% $543 CRSS (Chemical Review and Search Strategy) 0.0025 $161,446 $404 $268.00 $454.00 $858 100% $858 SAT (Structure Activity Team) 0.0006 $161,446 $96.87 $14.00 $23.72 $121 100% $121 Engineering/Exposure 0.0015 $161,446 $242 $56.00 $94.87 $337 100% $337 Exposure/Fate 0.0008 $161,446 $129 $0.00 $0.00 $129 100% $129 Focus 0.0009 $161,446 $145 $23.00 $38.96 $184 100% $184 Standard Review Functions 0.0219 $161,446 $3,536 $511.00 $865.65 $4,401 29% $1,276 Division Directors Meeting 0.0129 $161,446 $2,083 $113.00 $191.43 $2,274 15% $341 Order Development/Negotiation Review 

0.0171 $161,446 $2,761 $22.00 $37.27 $2,798 3% $83.94 

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 $143.99 $4,616 7% $323 Notices of Commencement 0.0012 $161,446 $194 $40.00 $67.76 $261 31% $81 FOIA (Freedom of Information Act) Requests 0.0333 $161,446 $5,376 $287.00 $486.19 $5,862 1% $59 CBI (Confidential Business Information) Substantiation 0.0004 $161,446 $64.58 $3.00 $5.08 $69.66 100% $69.66 TOTAL $6,046 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 

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, 2010.
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 28 July, 2011 

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 Section 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 (2010$) 

Agency Activity 

Hours per 

Activity 

FTE per 

Activity1

Loaded Mailing 

Cost 

Total Agency Cost per 

Activity GS-13, Step 5 

FTE Wage Rate 

(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 $13.34 $52.15 

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 A 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 reportEconomic 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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 29 July, 2011 

5.0 ADDITIONAL ANALYSES 

This section 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. EPA's experience to date is that, in 

response to the promulgation of SNURS covering over 1,000 chemicals, the Agency receives 

only a handful of notices per year. For example, the number of SNUNs was 4 in Federal fiscal 

year in 2005, 8 in FY2006, 6 in FY2007, 8 in FY2008, and 7 in FY2009.14 During this five-year 

period, three small entities submitted a SNUN.15 The criteria for 'small business' was that the 

company checked the box on the PMN form, page 2, stating that it was a small business for the 

purpose of paying the $100 fee instead of the normal fee. 

This leaves open the question of how many small businesses are affected but do not 

submit SNUNs. For example, businesses may change their behavior in order to use a chemical 

in a manner that avoids triggering Significant New Use notification requirements, and make no 

submission to EPA. Data and resources were not available to estimate the number of such 

small businesses affected by the current rule. However, a 1989 analysis suggested that few 

small businesses would be affected by SNURs for chemicals that have undergone PMN review. 

The 1989 report estimated that 9 percent of firms subject to SNURs would be small businesses, 

based on the portion of PMN submitters who were small businesses (EPA, 1989). The 

threshold to be considered a “small business” was $40 million in sales, which is consistent with 

the definition used at 40 CFR §700.43 to set PMN fees. 

Past bona fide submissions also suggest that few firms other than possibly some PMN 

submitters will be affected.16 EPA has received few bona fides indicating interest in 

manufacturing or importing chemicals subject to past SNURs. EPA also has received few public 

comments during rulemaking on SNURs covering PMN chemicals. For example, a SNUR 

published in the spring of 2003 covering 62 chemicals resulted in industry comments on only 

three PMNs, none from small businesses (EPA, 2003b). 

It remains possible that some small businesses are affected by SNURs without EPA being 

aware, for example if the firms have made no submissions or comments to EPA. However, even 

if a small business were interested in supplying a SNUR chemical, the SNUR's impact on profits 

 

14 February 5, 2009 email from Carol Rawie, EPA Office of Pollution Prevention and Toxics, to Tulika Narayan and Kimberly 

Wilson, Abt Associates, and counts of SNUN submissions that had been assigned an identifying number by EPA. The counts 

include both “valid” and “invalid” SNUNs. SNUN numbering is according to Federal fiscal year, ending September 30. 15 February 5, 2009 email from Carol Rawie, EPA Office of Pollution Prevention and Toxics to Tulika Narayan and Kimberly 

Wilson, Abt Associates and reviews of SNUN submissions on April 8, 2010 by Abt staff. 16 Bona fides are submitted to EPA by manufacturers and importers to determine a chemical's TSCA Chemical Inventory and 

regulatory status
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 30 July, 2011 

is generally expected to be minor. For example, the firm may have a small expense of keeping 

records and/or of changing workplace practices to comply with restrictions. If modifying 

practices would be overly costly, the small business may instead forego production, thus 

sacrificing profits. The lost profits, if any, were not quantified for this report, but EPA expects 

them to be low. This is because SNUR chemicals are unlikely to be central to a firm’s business 

because they are relatively new and few compared to the many thousands of chemicals on the 

TSCA Inventory. 

Based on these considerations and on the limited data available, EPA expects that any 

compliance with a SNUR will not have a significant economic impact on a substantial number of 

small entities. 

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). 

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). 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 31 July, 2011 

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. 

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. 
APPENDIX A 

LIST OF PMNs AND THEIR CHEMICAL NAMES 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 A-1 July 20, 2011 

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 P06-0036 389623-01-2 Rutile, tin zinc, calcium-doped 

2 P06-0037 389623-07-8 Rutile, tin zinc, sodium-doped 

3 P08-0694 N/A N-arylamino-phenol-formaldehyde condensate (generic) 

4 P08-0704 N/A Linear alkyl epoxide (generic) 

5 P09-0061 N/A Hydroxy-chloro-cyclopropyl-heteromonocyclic carboxylic acid (generic) 

6 P09-0072 71119-07-8 Phenol, 2-ethoxy-4-(ethoxymethyl)- 

7 P09-0139 91933-40-3 1-Propanamine, 3-[2-(2-methoxyethoxy)ethoxy]- 

8 P09-0146 1065544-88-8 Formaldehyde, polymers with acetone-phenol reaction products and phenol, sodium salts 

9 P09-0147 1072227-60-1 Formaldehyde, polymers with acetone-phenol reaction products and phenol, potassium 

sodium salts 

10 P09-0152 N/A Trivalent chromium complex of a substituted beta-naphthol amine azo dye (generic) 

11 P09-0153 N/A Trivalent chromium complex of a substituted beta-naphthol amine azo dye (generic) 

12 P09-0154 N/A Olefinic carbocycle, reaction products with alkoxysilane (generic) 

13 P09-0155 N/A Olefinic carbocycle, reaction products with alkoxysilane, sulfurized (generic) 

14 P09-0156 N/A Olefinic carbocycle, reaction products with alkoxysilane, polysulfurized (generic) 

15 P09-0193 55088-28-3 Phosphonic acid, P-[2-[bis(2-hydroxyethyl)amino]ethyl]-, bis(2-chloroethyl) ester 

16 P09-0195 1094213-37-2 Phosphonic acid, P-[2-[bis(2-hydroxyethyl)amino]ethyl]-, 2-[bis(2-

chloroethoxy)phosphinyl]ethyl 2-chloroethyl ester 

17 P09-0207 N/A Branched and linear fatty alcohol ethoxylate (generic) 

18 P09-0234 N/A Alkylpolyhydroxy polymer (generic) 

19 P09-0258 N/A Bis-phenoxyethanol fluorene diacrylate (generic) 

20 P09-0259 N/A Aromatic bromide (generic) 

21 P09-0316 N/A Disubstituted phenol (generic) 

22 P09-0356 N/A Zirconium lysine complex (generic) 

23 P09-0366 N/A Fatty acids, reaction products with alkanolamine (generic) 

24 P09-0373 1033050-53-1 Thiosulfuric acid (H2S2O3), manganese(2+) salt (1:1) 

25 P09-0388 1134078-27-5 Butanedioic acid, 2-methylene-, polymer with 2,5 furanedione, copper(2+) manganese(2+) 

sodium zinc salt, hydrogen peroxide-initiated 

26 P09-0390 N/A Substituted acrylamide (generic) 

27 P09-0400 N/A Vinyl carboxylic acid ester (generic) 

28 P09-0479 925246-00-0 Benzoic acid, 4-(dimethylamino)-, 1,1'-[(methylimino)di-2,I-ethanediyl] ester 

29 P09-0532 N/A Butyl aromatic bisurea (generic) 

30 P09-0535 N/A Aromatic hydrocarbon (generic) 

31 P09-0540 N/A Halogenated aromatic hydrocarbon (generic) 

32 P09-0552 37133-18-9 Benzene, 1,3-bis(1-chloro-1-methylethyl)- 

33 P09-0589 N/A Oxime, di-Me silane (generic) 

34 P09-0590 N/A Oxime, Me vinyl silane (generic) 

35 P09-0634 3279-07-0 Phenol, 4-(1,1-dimethylethyl)-2-nitro36 P10-0343 N/A Polycarbocyclic methacrylate (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 “Not available” and/or the chemical name is indicated to be “generic” than the chemical identity is indicated to be 

confidential. 
APPENDIX B 

INFLATORS AND WAGE RATES 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 B-1 July 20. 2011 

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 2010. 

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.1.1 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,17 for December, for manufacturing industries.18

 

17 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. 

18 Employer Costs for Employee Compensation Supplementary Tables December 2010. (BLS, 2011a). 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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 B-2 July 20. 2011 

 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 2010, the average 

wage rate for professional/technical19 labor was $36.93; the average fringe benefit was $18.50. 

Fringe benefits as a percent of wages were $18.50/$36.93, or approximately 50.09%percent. 

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 2010 fully loaded wage for professional/technical labor is 

$36.93× (1+0.5009 + 0.17) = $61.71. 

Fully loaded costs for managerial, clerical, and production labor are calculated in a 

similar manner, as shown in Table B-1. 

B.1.2 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.20

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 2010 (BLS, 2011a). 

Benefits for “professional specialty and technical” occupations were used, and loaded wages 

 

19 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). 20 This follows the approach for calculating Industry Hygienist wages introduced in EPA, 2007b and is a change 

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

professional journal salary survey. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 B-3 July 20. 2011 

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.1.3 Derivation of Labor Rates for EPA Staff 

Agency labor costs are calculated based on annual Federal salaries for the WashingtonBaltimore area published by the Office of Personnel Management effective January 2010 (OPM, 

2010). The average salary for one Full Time Equivalent (FTE) staff is estimated as the salary for 

a GS-13 Step 5 employee.21

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$161,446.40. 

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)

 

21 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.
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 B-4 

Table B-1 Derivation of Loaded Wage Rates 

EPAB Labor 

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

ove

fa

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

Managerial 

BLS ECEC, Private Manufacturing 

industries, “Mgt, Business, and Financial”3

Dec-10 $42.82 $19.64 45.87% 17% 1

Professional/ 

Technical 

BLS ECEC, Private Manufacturing industries, “Professional and related“3

Dec-10 $36.93 $18.50 50.09% 17% 1

Clerical 

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

Dec-10 $17.36 $8.67 49.94% 17% 1

Production 

Worker 

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

Dec-10 $16.72 $9.05 54.13% 17% 1

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-10 

 Fringe: 

Dec-10 

$30.67 -- 50.09% 17% 1

EPA staff 

FTE 

Annual Federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-13 Step 5 pay rates, with 60% overhead. 5

Dec-10 $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 2010, US Bureau of Labor Statistics, March 9, 2011 (BLS, 2011a).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 2010, from the Office of Personnel Management salary table for Washington-Baltim

(OPM, 2010). The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 19
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 B-5 July 20, 2011 

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) X (b) 

Occupational Health & Safety Specialists 

(29-9011) 8,520 $31.91 0.861 $27.49 

Occupational Health & Safety 

Technicians (29-9012) 1,370 $22.94 0.139 $3.18 

Industrial Hygienist (weighted average) 9,890 -- 1 $30.67 

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 2010 (BLS, 2011e). 

B.2 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 category22. 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). 

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. 

 

22 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.
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 B-6 July 20, 2011 

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).23 

“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. 

 

 

23 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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 B-7 July 20, 2011 

Table B-3 Derivation of Inflation Factors 

Item Inflation index source1 Starting 

year

Index for 

starting 

year 

 (a)

Index 

for 

2010 

(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 2010c] 

varies varies 112.7 varies 

White collar/other labor mix; 

equipment; supplies. Example for test costed in 1993 1993 66.5 112.7 1.695 

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 83.8 112.7 1.345 

Impermeability testing of 

gloves and other gear3

BLS ECI, SA, Total comp, Private 

industry, All Workers, 4th Q [BLS 

2006d and 2010c] 

1997 74.9 112.7 1.505 

Export notification 

BLS ECI, ,Total comp, Private 

industry, Professional and related, 4th

Q [BLS 2010d] 4 

1992 64.9 113.5 1.749 

Agency Extramural costs 

White collar labor; 

equipment; supplies

BLS ECI, Total comp, Private industry, 

Professional and related, 4th Q [BLS 

2010d] 4

1993 67.0 113.5 1.694 

Labels, placards, gloves, 

eyewear, clothing, 

respirators, file cabinet 

BLS CPI, All urban consumers, not 

SA. CUUR0000SA0, Annual [BLS 

2010b] 

1997 160.5 218.056 1.359 

Photocopies 

Record keeping materials 

BLS CPI, All urban consumers, not 

SA. CUUR0000SA0, Annual [BLS 

2010b] 

1988 118.3 218.056 1.843 

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. 
APPENDIX C 

COSTS OF HAZARD COMMUNICATION, PROTECTION IN THE WORKPLACE, AND 

RECORDKEEPING REQUIREMENTS 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-1 July 20, 2011 

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 (haz-comm), 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). 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-2 July 20, 2011 

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, 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 hazcomm 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 haz-comm 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 tables B-1 and B-2. Costs for the written haz-comm program, in 2010 dollars, are as 

follows24

4 hours Industrial Hygienist time × $51.24 per hour = $205 

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). 

 

24 Figures presented here are rounded. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-3 July 20, 2011 

C.1.2.1 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 customers. This is consistent with roughly 10,000 kilograms of chemical per year 

shipped in 40 five-gallon containers per month (EPA, 1989).25

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 Dollars) Inflation Factor Unit Cost  (2010 Dollars) Hours Total Cost 

0.5 hours technical time -- -- $61.71 per hour 0.5 $31 

480 labels $0.16 per label 1.359 $0.22 per label -- $104 

TOTAL 0.5 $135 

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. 

C.1.2.2 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. 

 

25 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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-4 July 20, 2011 

The resulting per chemical, per site costs of labeling for chemicals in the workplace are 

shown in Table C-2. 

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

Cost Element Unit Cost 

(1997 Dollars) 

Inflation 

Factor 

Unit Cost 

(2010 Dollars) Hours Total 

Cost 

0.5 hours technical time -- -- $61.71 per hour 0.5 $30.85 

 

6 labels or placards (14" x 10") $38.30 per item 1.359 $52.03 per item -- $312 

 

10 minutes per label/placard 

production worker time -- -- $28.61 per hour 1.0 $28.61 

TOTAL 1.5 $372 

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. 

 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-5 July 20, 2011 

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

Cost Element Unit Cost 

(1988 Dollars) 

Inflation 

Factor 

Unit Cost 

 (2010 Dollars) Hours Total Cost 

2.0 hours technical 

time -- -- $61.71 per hour 2 $123 

0.25 hours clerical 

time -- -- $28.98 per hour 0.25 $7.25 

40 copies $0.05 1.843 $0.09 per copy -- $3.69 

TOTAL 2.25 $134 

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 B3

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 

(2010 Dollars) Hours Total Cost 

0.5 hours technical time (trainer) $61.71 per hour 0.5 $30.85 

0.25 hours per production employee X average of 

25 workers per plant = 6.25 hours $28.61 per hour 6.25 $179 

TOTAL 6.75 $210 

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.
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-6 July 20, 2011 

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 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 

(2010 Dollars) Hours Total Cost1

10 hours industrial hygienist (IH) time $51.24 per hour 10 $512 

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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-7 July 20, 2011 

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 

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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-8 July 20, 2011 

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

Cost Element 

Unit Cost 

 (1997 Dollars) 

Inflation 

Factor 

Unit Cost 

(2010 Dollars) 

Hours Total Cost1 

Impermeability Testing 

[§721.63(a)(3)(i)]

 

 

 

 Impermeability Test $800 per chemical 1.505 $1,204 per chemical $1,204 

 Industrial Hygienist time $51.24 per hour 2 $102.49 

 

 

 

 Subtotal 2 $1,306 

Evaluation of Manufacturer's 

Specifications 

[§721.63(a)(3)(ii)] 

 

 Industrial Hygienist time $51.24 per hour 4 $205 

 

 

 Subtotal 4 $205 

TOTAL 6 $1,511 

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 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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-9 July 20, 2011 

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 

 ($2010 per pair) 

Number 

of Pairs 

Required1

Total Cost 

($2010)2

Disposable nitrile gloves 

(replaced daily) $0.43 1.359 $0.58 6,250 $3,651 

Heavy duty butyl gloves 

(replaced every 25 work days) $34.00 1.359 $46.19 250 $11,548 

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. 

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 

 (2010$ per pair) 

Number of 

Pairs 

Required1

Total 

Cost 

($2010) 2

Standard Goggles $4.05 1.359 $5.50 75 $413 

Heavy duty chemical-splash/impact 

goggles $6.05 1.359 $8.22 75 $616 

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.
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-10 July 20, 2011 

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 

(2010$ per set) 

Number 

Required1

Total Cost 

($2010)2

Coverall with hood [full-body 

clothing] §721.63(a)(2)(ii) $61.20 1.359 $83.15 75 $6,236 

Coverall §721.63(a)(2)(iv) $36.25 1.359 $49.25 75 $3,694 

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. 

 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-11 July 20, 2011 

C.2.6 Respirators 

For some PMN chemicals, to avoid engaging in a Significant New Use, the SNUR 

requires either the use of respirators or compliance with a New Chemical Exposure Limit 

(NCEL). Both requirements differ by chemical.1826For 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. 

 

26 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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-12 July 20, 2011 

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 substancespecific cartridge), with a particulate filter (N100 if 

oil aerosols are absent, R100, or P100). 

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

with a tight-fitting facepiece and high efficiency particulate 

filters. 

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

Powered air-purifying, tight-fitting full-face 

respirator equipped with N100 (if oil aerosols 

absent), R100, or P100 filters. 

Powered air-purifying respirator equipped with a 

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

HEPA filters. 

(vi) Category 21C powered air-purifying respirator 

equipped with a loose-fitting hood or helmet and high 

efficiency particulate filters. 

Powered air-purifying respirator equipped with a 

loose-fitting hood or helmet and High Efficiency 

Particulate Air (HEPA) filters. 

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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-13 July 20, 2011 

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 Section 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 SNURs, Docket OPPT-2010-1075 C-14 

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 Dollars) 

Respirator 

Unit 

Cartridge 

Set 

Per 

Worker2

Inflation 

Factor 

(i) 19C Type C Supplied-air with full facepiece $804 $0.00 $804 1.359 

(ii) 19C Type C Supplied-air with tight-fitting facepiece $804 $0.00 $804 1.359 

(iii) 19C Type C Supplied-air with hood or helmet or tight-fitting facepiece $932 $0.00 $932 1.359 

(iv) 21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs) $181 $9.76 $669 1.359 

(v) 21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs $627 $35.50 $2,402 1.359 

(vi) 21C PAPR with loose hood or helmet and HEPAs $525 $26.89 $1,870 1.359 

(vii) 21C Air-purifying with HEPA and disposable respirators $12.53 $7.00 $363 1.359 

(viii) 23C air-purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE) $192 $15.71 $978 1.359 

(ix) 23C PAPR with tight-fitting facepiece and combination cartridges approved PLE $627 $35.50 $2,402 1.359 

(x) 23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE $525 $26.88 $1,869 1.359 

(xi) 23C Air-purifying with combination cartridges for PLE, including disposable respirators $14.30 $8.90 $459 1.359 

(xii) 23C Air-purifying with full-facepiece and organic gas/vapor cartridges $192 $10.47 $716 1.359 

(xiii) 23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges $826 $41.15 $2,884 1.359 

(xiv) 23C PAPR with a loose-fitting hood or helmet and organic gas/vapor cartridges $640 $41.15 $2,697 1.359 

(xv) 23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges $10.83 $8.94 $458 1.359 

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 cartri

required. Assumes cartridge sets are replaced every five days (50 times during 250 exposure days) so that each worker requires one respirator 

year. 

3 Totals were estimated from unrounded unit costs and inflation factors, so results may differ from calculations using the rounded values show
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-15 July 20, 2011 

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 C-12. 

 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-16 July 20, 2011 

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 

(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 

(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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-17 July 20, 2011 

40CFR NIOSH 

Type 

Catalog 

Item 

Number 

Description1 1997 

Cost 

1997 Average Cost2

§721.63 

(a)(5) 

Respirator 

Unit 

Cartridge 

Set 

 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 

(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 Willson Retainer Caps, p136 $2.03 

 7A-33826 Moldex 8000 Series Half-Mask Respirator, p139 $10.75 

 7A-22751 Moldex Organic Vapors Cartridge, p139 $8.03 

 7A-22753 Moldex Paint Spray/Pesticides Prefilter, p139 $2.56 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-18 July 20, 2011 

40CFR NIOSH 

Type 

Catalog 

Item 

Number 

Description1 1997 

Cost 

1997 Average Cost2

§721.63 

(a)(5) 

Respirator 

Unit 

Cartridge 

Set 

 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 

(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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-19 July 20, 2011 

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. 

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 5 to 6 hours.27 Other EPA reports have estimated that electronic submission of 

SNUNs is expected to reduce the recordkeeping burden to approximately 1 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.28 

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 

 

27 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 

2005, page 12). 

 

28 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 SNURs, Docket OPPT-2010-1075 C-20 July 20, 2011 

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). 

This report uses the basic Kearney (1988a and 1988b) estimates and assumptions to 

estimate recordkeeping costs for SNUR requirements.29 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. 

 

29 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 SNURs, Docket OPPT-2010-1075 C-21 July 20, 2011 

 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. 

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

Labor Costs 

Kearney Estimates for CAIR Rule (1988b) Adjusted for inflation 

Per page cost - 2010$ 

Hours CAIR 

Pages Hours Per Page Cost Per Hour 

Cost Per 

Page 

Technical 1 750 0.00133 $61.71 $0.0823 

Clerical 10 750 0.01333 $28.98 $0.3864 

Total Labor 0.01467 $0.4687 

 

Materials Costs 

Kearney Estimates for CAIR Rule (1988a) Adjusted for inflation 

Per page cost - 2010$ 

Estimate CAIR 

Pages Cost Per Page Inflation 

Factor 

Cost Per 

Page 

Photocopying $0.05 [1988 dollars] 1 $0.050 1.843 $0.0922 

File Cabinet 1/4 of cabinet priced 

at $195 [1997 dollars] 750 $0.065 1.359 $0.0883 

Misc. Materials $10 total [1988 

dollars] 750 $0.013 1.843 $0.0246 

Total Materials 0.1283 $0.2050 

 Total Cost per Page (Labor & Materials) $0.6737 

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: 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-22 July 20, 2011 

 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.) 

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. 

 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 C-23 July 20, 2011 

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

40CFR 

§721.1252 Requirement Pages3 

Labor and materials cost1

(2010$) 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 $0.6737 $327 0.01467 7.11 

(d)(e) Protective clothing [§721.63] and 

impermeability [§721.63(a)(3)] 20 $0.6737 $13.47 0.01467 0.29 

(f) Haz-comm program [§721.72] 250 $0.6737 $168 0.01467 3.67 

(g) Label copies [§721.72(b)] 5 $0.6737 $3.37 0.01467 0.07 

(h) MSDS copies [§721.72(c)] 5 $0.6737 $3.37 0.01467 0.07 

(i) Use limitations compliance 

[§721.80] 250 $0.6737 $168 0.01467 3.67 

(j) Disposal compliance [§721.80] 600 $0.6737 $404 0.01467 8.80 

(k) Release to water compliance 

[§721.90] 100 $0.6737 $67.37 0.01467 1.47 

TOTAL 1,715 $0.6737 $1,155 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.
APPENDIX D 

COSTS OF TESTING 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-1 July 20, 2011 

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. 

 OPPTS Harmonized. 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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-2 July 20, 2011 

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. 

 CFR. SNUR tests may also come from the Code of Federal Regulations, identified 

for example as “40 CFR 799.9370” or just “799.9370.” In addition, in costing out test 

guidelines, this report sometimes uses 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). 

 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. 

 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. 

 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 SNURs, Docket OPPT-2010-1075 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 835.2110 Hydrolysis as a Function of pH NA NA 835.2130 Hydrolysis as a Function of pH and Temperature NA NA 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 835.314 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 835.3200 (OECD 302B) Inherent Biodegradation: Modified Zahn-Wellens NA NA 835.3220 Porous Pot Test NA NA 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-4 

Guideline Test Species Route/Method 

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 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 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 850.1400 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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-5 

Guideline Test Species Route/Method 

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 870.3100 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 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 $870.43 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 870.5395 

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 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-6 

Guideline Test Species Route/Method 

870.6100 Delayed Neurotoxicity of Organophosphorus Substances (Acute) Hens Gavage (Acute) 870.6100 Delayed Neurotoxicity of Organophosphorus Substances (Subchronic 28-day) Hens Gavage (Subchronic) 870.6200 Neurotoxicity Screening Battery (Acute) 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 404 (870.2500) Acute Dermal Irritation Rabbits Dermal 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 ASTM D6007-02 

Small Scale Chamber Test to Determining Formaldehyde Concentration in Air from Wood Products 

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

as other evaluation beyond the standard requirements in the test guideline. These activities would raise testing cost substantially. 

2 The recommended testing for some PMN chemicals may include a glove permeation test following ASTM F739 and F1194-99 guidelines. ASTM Ffor documenting the results of chemical permeation tests (see www.astm.org). The additional costs of following ASTM F1194-99 (average of gases a

estimated for this report. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-7 

3 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). 4 Performing the test on species other than rats may change the test costs. For example, testing on rabbits is likely to increase costs. 

Source: EPA OPPTS Economic and Policy Analysis Branch cost estimates. Many costs were estimated in the 1990s or earlier. All have been inflated B-3 for inflation index). Dollar costs include $4,054or $9,854 for analytical method validation; where applicable (see text). Species and route or method m

or may be unspecified but assumed in this table for costing purposes. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-8 July 20, 2011 

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 longer-term tests have validation costs of $8,500 in 2004 dollars. 

Using the inflation rates found in Appendix B, validation costs are $4,054 and $9,854in 2010 

dollars. For simplicity, the method validation cost for ecological effects tests (e.g. 850 series 

guidelines) was assumed to be $4,054 for each test. 

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. 

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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-9 July 20, 2011 

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.)

SNUR Testing Tiers

 A SNUR may recommend tiered testing. In such cases, costs are lower if only the firsttier 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. 

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 

(Coagulation-Flocculation Jar Test of Water). Table D-1 gives costs for D2035-80 but 

not for the additional analytical methodology. 

 For test guideline OECD 422 (Combined Repeated Dose Oral Toxicity with 

Reproductive/ Developmental Toxicity Screening), a SNUR may recommend extended 

histopathology. Although the OECD 422 protocol does include histopathology, it is 

possible that extending the histopathology would increase the cost beyond that shown in 

Table D-1. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-10 July 20, 2011 

 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. 

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 SNURs, Docket OPPT-2010-1075 D-11 July 20, 2011 

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

PBT 

Tier 

Guideline Test Cost 

2010$ 

1 

OPPTS 830.7560* 

-orOPPTS 830.7570* 

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

-orPartition Coefficient (n-Oct/Water), Liquid Chromatography method 

Average 

$7,506 

 

$4,940

$6,223

1 OPPTS 835.2110 Hydrolysis as a Function of pH $59,465

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

$12,759 

 

$7,912

$10,336

2 OPPTS 835.3170 Shake-flask Die-away Test [measures biodegradability] $52,029 

2 OPPTS 850.1730 Fish Bioconcentration $152,822

3 OPPTS 835.3180 Sediment/Water Microcosm Biodegradation $136,045

3 40CFR 797.1330 

or 850.1300** Daphnid Chronic Toxicity Test $136,977

3 40CFR 797.1600 

or 850.1400** Fish Early Life Stage Toxicity (in rainbow trout) $69,853 

3 OECD 422 Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental 

Toxicity Screening (in rats) $137,531

Total cost, all tiers (assuming all tests are conducted) $761,280

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. 
Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 D-12 July 20, 2011 

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

 30 A prior SNUR economic analysis calculated chemical-specific test costs (EPA, 2007b, Table D-4). The 

chemical-specific table was dropped from a later SNUR economic analysis (EPA, 2007c). 
APPENDIX E 

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Economic Analysis of Expedited SNURs, Docket OPPT-2010-1075 E-1 July 20, 2011 

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