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Economic Analysis of the Final Significant New Use Rule for Nine Benzidine 

Based Chemical Substances

(EPA Docket EPA-HQ-OPPT-2010-0573 

RIN 2070-AJ73) 

FINAL

July 22November 20, 2014 

San5456_Final redline_3-Chemical-SNUR_FRM_EA_9 Dyes_2014-11-

20.docxSan5456_FAR_3-Chemical-SNUR_FRM_EA_9 Dyes_2014-7-22_.docx

—Does not contain TSCA CBI—

Prepared by: 

Economic and Policy Analysis Branch 

Economics, Exposure and TechnologyChemistry, Economics, and Sustainable Strategies

Division 

Office of Pollution Prevention and Toxics 

U.S. Environmental Protection Agency 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 
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CONTRIBUTORS 

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

EP-W-08-010. 
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ABSTRACT 

This report presents the estimated costs of the U.S. Environmental Protection Agency (EPA)’s final 

Significant New Use Rule (SNUR) that adds the nine benzidine-based chemical substances specified in 

Table 1Table 1 to an existing SNUR for benzidine-based chemical substances at 40 CFR section 

721.1660. Additionally, the final rule also revokes the article exemption described in 40 CFR section 

721.45(f) for the chemical substances regulated under a 1996 SNUR; 40 CFR 721.1660(a)(1) (see 

Appendix A) as well as the nine chemicals in Table 1.1

 

Table 1: Benzidine-Based Chemical Substances Subject to Final SNUR

CAS/Accession 

No.1 Chemical Name2

117-33-9 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-

4-yl]azo]- 

65150-87-0 1,3,6-Naphthalenetrisulfonic acid, 8-hydroxy-7-[[4'-[(2-hydroxy-1-

naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-, trilithium salt 

68214-82-4 

2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-

naphthalenyl) azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt [CI Direct Navy 

BH] 

72379-45-4 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4'-[[2-hydroxy-4-[(2-

methylphenyl) amino]phenyl]azo] [1,1'-biphenyl]-4-yl]azo]-6-(phenylazo)- 

26701 Phenylazoaminohydroxynaphthalenylazobiphenylazo substituted benzenesodium 

sulfonate 

24921 4-(substituted naphthalenyl)azo-diphenylyl azo-substituted carbopolycycle azo 

benzenesulfonic acid, sodium salt 

26267 4-(Substituted phenyl)azo biphenylyl azo - substituted carbopolycycle azo 

benzenesulfonic acid, sodium salt 

26256 4-(Substituted phenyl)azo biphenylyl azo-substituted carbopolycycloazo benzenesulfonic 

acid, sodium salt 

21808 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy[[[(substituted phenyl)amino] 

substituted phenylazo]diphenyl]azo-, phenylazo-, disodium salt 

1. Note that the CAS numbers and chemical names for the last 5 dyes are CBI; so Accession numbers and generic names have 

been used instead 

2. Common names are not unique identifiers as they may correspond to more than one CAS No.; however, they are frequently 

used, even in peer-reviewed literature. 

Benzidine and its congeners constitute a family of synthetic aromatic amines which are predominately 

used in the synthesis of colorants (dyes and pigments). The colorants listed in Table 1 (called azo 

colorants) have historically been used in the production of dyes for textiles, paints, printing inks, paper, 

and pharmaceuticals. Because they have the potential to metabolize to carcinogenic amines both in and on 

the human body, EPA is concerned about the potential risk from exposure to products containing 

benzidine-based chemical substances. 

The most recent data from the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) 

database (2012 reporting) indicates no evidence of production of the nine new benzidine-based chemical 

substances subject to the final rule (EPA, 2013a). The Agency did not receive any comments after the 

publication of the Benzidine Dyes Action Plan to indicate any current production of the four non-CBI 

chemical substances listed in Table 1Table 1. In addition, no manufacturers of any of the benzidine-based 

 

1

 The final rule does not revoke the exemptions granted in 40 CFR section 721.1660(a)(2) for laboratory stains and 

other analytical reagents. 
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chemical substances subject to the final rule were listed in the Colour Index or identified through internet 

queries.2

 However, global and domestic manufacturers for several of the benzidine-based chemical 

substances specified at 40 CFR section 721.1660 were identified; EPA found no information to indicate 

the currently manufactured chemical substances are being imported and/or processed domestically as part 

of articles. As a result, there is expected to be little or no economic impact from the final rule. 

The final rule will require persons to notify EPA at least 90 days before commencing the manufacture, 

import, or processing of any of the chemicals specified in Table 1Table 1. It will also make inapplicable 

the article exemption at 40 CFR section 721.45(f), requiring notification of the import and/or processing 

as part of an article of any of the benzidine-based chemical substances subject to the final rule or specified 

at 40 CFR section 721.1660. A firm intending to engage in these activities will be required to submit a 

Significant New Use Notice (SNUN). While EPA was encouraged by the discontinuation of the use of the 

chemical substances regulated under a 1996 SNUR at 40 CFR 721.1660, it was concerned that the 

manufacture, import, and processing of these chemical substances and the articles containing them could 

be reinitiated in the future. EPA was also concerned that articles containing the chemical substances 

specified at 40 CFR section 721.1660 could be available for human exposure or eventual release to the 

environment. The SNUN provides EPA with the opportunity to evaluate the intended use and, if 

necessary, to prohibit or limit that activity before it occurs. 

When submitting a SNUN, a firm incurs a modest submission cost of $8,571 and potentially other minor 

costs. While no firms were identified that manufacture, import, process or import or process as part of an 

article the benzidine-based chemical substances subject to the final rule, global manufacturers of several 

of the benzidine-based chemical substances (dyes) specified at 40 CFR section 721.1660 were identified. 

However, there is no information to conclude that these currently manufactured chemical substances are 

being imported or processed domestically as part of articles. As a result, EPA does not expect that any 

firm will incur a cost of submitting a SNUN as the result of the final rule. EPA does not require the 

development of test data for submission of a SNUN, although a firm may submit test data already in its 

possession or describe any other available data. Because EPA does not require the development of test 

data, EPA assumes that no firms will incur testing costs as a result of the final SNUR. 

In addition to the firms that make a SNUN submission, the final SNUR may also impact firms that do not 

make a submission. By avoiding a significant new use, a firm can avoid submission and testing costs but 

may incur other costs. However, this may not be a concern given that there currently is no manufacture or 

import of the chemicals in Table 1 and that there is no evidence to suggest that the chemicals specified at 

40 CFR section 721.1660 that are currently manufactured are being imported and/or processed 

domestically as part of articles. 

Costs are estimated at the firm level or unit level and reflect the burden of a SNUR on firms that may 

make a SNUN submission.3 

 

2

 The Colour Index is an international directory of manufacturers of pigments and dyes published by the UK Society 

of Dyers and Colourists (SDC) and the American Association of Textile Chemists and Colorists (AATCC). 

3 While the majority of costs are incurred at the firm level, costs associated with some activities such as submitting 

export notifications or testing articles are incurred at the unit level. 
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TABLE OF CONTENTS

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

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

1. INTRODUCTION ................................................................................................................................ 1 

1.1 Background ................................................................................................................................. 2 

1.2 Statutory Authority ..................................................................................................................... 5 

1.3 Summary of Methodology .......................................................................................................... 5 

1.4 Organization of this Report ...................................................................................................... 65

2. INDUSTRY COMPLIANCE COSTS .................................................................................................. 7 

2.1 Wage Rates ................................................................................................................................. 8 

2.2 Unit Industry Compliance Costs ............................................................................................. 109

2.3 Industry Costs of SNUR, by Option ..................................................................................... 2422

2.4 Likelihood of a SNUN Submission ...................................................................................... 2422

2.5 Potential for Subsequent Regulatory Action ........................................................................ 2523

3. AGENCY COSTS ........................................................................................................................... 2724

3.1 Labor Rates for EPA Staff .................................................................................................... 2724

3.2 SNUN Processing Costs ....................................................................................................... 2724

3.3 Export Notification Cost ....................................................................................................... 3127

4. ADDITIONAL ANALYSES .......................................................................................................... 3228

4.1 Regulatory Flexibility Act .................................................................................................... 3228

4.2 Unfunded Mandates Reform Act .......................................................................................... 3228

4.3 Paperwork Reduction Act ..................................................................................................... 3329

4.4 Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations ........................................................................... 3329

4.5 Executive Order 13045: Protection of Children from Environmental Health Risks and Safety 

Risks ..................................................................................................................................... 3329

4.6 Executive Order 13132: Federalism ..................................................................................... 3329

4.7 Executive Order 13175: Consultation and Coordination with Indian Tribal Governments 3531

4.8 Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use

 .............................................................................................................................................. 3531

4.9 Executive Order 13563, Improving Regulation and Regulatory Review ........................... 3531

5. Benefits ........................................................................................................................................... 3632

6. REFERENCES ................................................................................................................................ 3733

A. INFLATORS AND WAGE RATES ................................................................................................ A-1 

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

A.2 Derivation of Inflation Factors ............................................................................................... A-4 

Appendix B – Benzidine-Based Dyes Specified at 40 CFR section 721.1660 ......................................... B-1 
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LIST OF TABLES 

Table 1: Benzidine-Based Chemicals Subject to Final SNUR ..................................................................... 1

Table 2: Loaded Industry Wage Rates, December 2011 ............................................................................... 8

Table 3: Rule Familiarization Burden and Cost for SNUR Submitters .................................................... 109

Table 4: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Burden and Cost for 

First-Time Submitters ............................................................................................................................. 1110

Table 5: Industry Cost Estimate to Complete the SNUN Form .............................................................. 1312

Table 6: Industry Cost Estimate to Complete and Submit the SNUN Form ........................................... 1312

Table 7: Examples of Industries that may Import Articles Containing Benzidine Chemical Substances

 ................................................................................................................................................................ 1312

Table 8: Range of costs associated with an importer’s identification of chemicals subject to SNURs in 

articles ..................................................................................................................................................... 2119

Table 9: Compliance Options and Associated Costs Incurred by a Firm Due to the Final SNUR ......... 2422

Table 10: Derivation of Loaded Agency Wage Rates ............................................................................ 2724

Table 11: Derivation of Inflation Factors for Agency Extramural Costs ................................................ 2825

Table 12: Agency Costs for SNUN and Other Submission Review and Processing .............................. 2926

Table A-2: Derivation of Inflation Factors ............................................................................................... A-5

Table B-1: Benzidine-Based Dyes Specified at 40 CFR Section 721.1660 .............................................. B-1
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1. INTRODUCTION 

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

Toxics’ (OPPT’s) analysis of the potential costs incurred as a result of a final Significant New Use Rule 

(SNUR) that adds the nine benzidine-based chemical substances listed in Table 1Table 1 to an existing 

SNUR at 40 CFR section 721.1660. EPA is also proposing to revoke the article exemption at 40 CFR 

section 721.45(f) for the chemical substances included regulated under a 1996 SNUR at 40 CFR 

721.1660(a)(1) (see Appendix A) as well as the nine chemicals included in the final rule. However, the 

final rule does not revoke the significant new use exemptions granted in 40 CFR section 721.1660(a)(2) 

for uses as laboratory stains and other analytical reagents. 

Table 1: Benzidine-Based Chemicals Subject to Final SNUR

CAS/Accession 

No.1 Chemical Name2

117-33-9 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-

4-yl]azo]- 

65150-87-0 1,3,6-Naphthalenetrisulfonic acid, 8-hydroxy-7-[[4'-[(2-hydroxy-1-

naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-, trilithium salt 

68214-82-4 

2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-

naphthalenyl) azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt [CI Direct Navy 

BH] 

72379-45-4 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4'-[[2-hydroxy-4-[(2-

methylphenyl) amino]phenyl]azo] [1,1'-biphenyl]-4-yl]azo]-6-(phenylazo)- 

26701 Phenylazoaminohydroxynaphthalenylazobiphenylazo substituted benzenesodium 

sulfonate 

24921 4-(substituted naphthalenyl)azo-diphenylyl azo-substituted carbopolycycle azo 

benzenesulfonic acid, sodium salt 

26267 4-(Substituted phenyl)azo biphenylyl azo - substituted carbopolycycle azo 

benzenesulfonic acid, sodium salt 

26256 4-(Substituted phenyl)azo biphenylyl azo-substituted carbopolycycloazo benzenesulfonic 

acid, sodium salt 

21808 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy[[[(substituted phenyl)amino] 

substituted phenylazo]diphenyl]azo-, phenylazo-, disodium salt 

1. Note that the CAS numbers and chemical names for the last 5 dyes are CBI; so Accession numbers and generic names have 

been used instead 

2. Common names are not unique identifiers as they may correspond to more than one CAS No.; however, they are frequently 

used, even in peer-reviewed literature. 

EPA is concerned that in the future benzidine-based chemical substances may be incorporated into 

articles and then imported into the United States, which will increase human and environmental exposure 

to the chemicals. There is potential for exposure to benzidine-based chemicals incorporated into imported 

finished articles; therefore, EPA is proposing to make the article exemption at §721.45(f) inapplicable to 

persons who import the benzidine-dye chemical substances included in the rule as part of articles. 

SNURs are proposed by EPA under the authority granted by Section 5(a)(2) of TSCA. The final SNUR 

will require persons to notify EPA at least 90 days before commencing any manufacture, import, or 
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 Economic and Policy Analysis Branch 

processing of the benzidine-based chemical substances subject to the final rule or any import or 

processing of articles containing them or the benzidine-based substances specified at 40 CFR section 

721.1660.4.5 EPA promulgates a SNUR for a substance when potential uses could result in increased 

exposure to, or releases of, the substance, which in turn, could present an unreasonable risk to health or 

the environment. 

1.1 Background 

In 1995, as part of a risk management strategy to reduce the risks associated with the manufacture and use 

of azo dyes in the United States, EPA proposed a SNUR for several benzidine-based substances (FR 

45119, 8/30/95). The final SNUR (§721.1660) included 24 benzidine-based substances; however, EPA 

recognized that additional substances would need to be added. The four non-CBI dyes specified in Table 

1Table 1 were included in draft additions to §721.1660, but were never finalized (61 FR 52287, 10/7/96). 

As part of a more recent effort to enhance the existing chemicals program under TSCA, EPA created a list 

of widely recognized chemicals for the development of an Action Plan. Azo dyes were selected because 

they have the potential to metabolize to carcinogenic amines both in and on the human body. The Action 

Plan summarized readily available use, exposure, and hazard information for forty-eight azo dyes;6

considered which authorities provided under TSCA and other statutes could be used to address potential 

concerns; and described various courses of actions available to EPA to address the concerns (EPA 2009c). 

It is important to note that, unless specified, the following sections, which use information from the 

Action Plan, describe azo dyes in general, not just benzidine-based dyes. 

Uses and Substitutes 

The benzidine-based chemical substances listed in Table 1 and regulated under a 1996 SNUR at 40 CFR 

721.1660(a)(1) have predominately been used as azo dyes in the production of textiles, paints, printing 

inks, paper, and pharmaceuticals.7

 They are also used as reagents and biological stains in laboratories, and 

in the food industries (Dapson, 2009). The European Union (E.U.) has banned certain azo dyes from use 

in textiles and leather that are in prolonged contact with human skin. Although there continue to be azo 

dyes found in articles meant for import into the E.U., many similar articles do not contain azo dyes 

(European Commission, 2010). As a result, it is believed that there are readily available substitutes for the 

benzidine-based dyes subject to the final SNUR. 

 

4 In accordance with TSCA section 12(a) and 40 CFR 721.45(g), persons who manufacture or process these 

benzidine-based dyes solely for export will be exempt from the notification requirements of 40 CFR 721.25, if when 

distributing the substance in commerce, it is labeled in accordance with TSCA section 12(a)(1)(B). Further, EPA 

notes that the exemption from the TSCA section 12(b) notification requirements for exported articles (see 40 CFR 

707.60(b)) will remain in force. Thus, persons who export benzidine-based dyes as part of an article will not be 

required to provide export notification. 

5 Section 5(h)(3) of TSCA, 15 USC 2604(h) exempts substances that are manufactured in small quantities solely for 

research and development (R&D) from the section 5(a) notice requirements. No application is required for the 

exemption for R&D under section 5(h)(3) (U.S. EPA 1986).

6

 The four non-CBI benzidine-based dyes listed in Table 1, and forty-four benzidine congener-based dyes not 

subject to the proposed SNUR. The five CBI dyes listed in Table 1 were identified by Agency chemists from an 

inventory of CBI chemicals, which also had the potential to metabolize into benzidine. 

7

 Because the chemicals substances subject to the final rule are mostly used in as azo dyes, the chemical substances 

listed in Table 1 may be referred to as dyes, or colorants. 
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Health Effects 

The 1980 EPA Preliminary Risk Assessment on derivatives of benzidine and its congeners established 

that the primary hazard concern was for the carcinogenic effects to humans from exposure to specific 

metabolites of azo dyes (EPA 1980). Azo dyes are biologically active through their metabolites. 

Azoreduction of these compounds occurs in humans by an enzyme-mediated reaction. Azoreductases are 

found in the liver, in gut bacteria, and in skin bacteria. The result of this azoreduction is the release of the 

carcinogenic aromatic amine from the dye. Studies have demonstrated that the azoreduction of benzidinebased dyes occurs in the human body as well as on the skin (Golka et al. 2004). Therefore, the primary 

human health concern for consumers is exposure to azo dyes through oral, dermal, or inhalation routes. 

Evidence from animal studies suggests that there is early life susceptibility to benzidine carcinogenesis. 

Cancer potency for benzidine was substantially increased when the dose was given in early life as 

compared to adults (EPA 2005a). 

Environmental Exposure 

The primary route of consumer exposure to azo dyes is dermal absorption from wearing azo-dyed 

clothing or footwear.8

 Other products are either not available to consumers (laboratory chemicals) or will 

not likely be readily accessible in significant quantities (printing ink or LCD displays) to present exposure 

concern. Oral ingestion is an additional route for babies and young children who suck on clothing, 

blankets, and other non-food products, which might contain azo dyes. Inhalation exposure is a more 

prevalent route in occupational settings; however, it can also occur from the use of azo-dyed inks during 

‘air brushing’ or off-gassing from azo-dyed carpets to indoor air. Contact with azo dyes entering the 

environment through the whole life cycle of azo dyes in textiles is an additional potential source of 

exposure (Zeilmaker et al. 1999; Zeilmaker et al. 2000). 

The problems of discharge of dye contents to wastewaters from textile and other industries have resulted 

in extensive research for biological methods to degrade dyes. Biodegradation studies indicate that azo 

dyes will be expected to biodegrade at negligible to slow rates in aerobic conditions, while in anaerobic 

soils the dyes are likely to undergo azo reduction to benzidine and/congeners depending on structure. 

However, it is unclear whether metabolites from these reductions will be available in large concentrations 

or locations to be of concern to the general population. 

Current Manufacturing 

Dye production in the United States has been steadily declining for the past decade, largely due to the 

increase in imported finished textiles from less developed countries like China and India, which may have 

less stringent regulations on dye intermediates (Dapson 2009). The most recent data from the public 

TSCA CDR database (2013 reporting) did not indicate any domestic manufacture or import of the 

benzidine-based chemicals subject to the final SNUR.9

 EPA did not receive comment after the publication 

 

8

 The main factors determining dye releases from textiles to the skin include the type of dyed textile, contact with 

other substrates, amount of dye applied to the textile, and number of previous washings (Zeilmaker et al. 1999; 

Zeilmaker et al. 2000). 

9

 The CDR compiles production data from manufacturers and importers of certain chemical substances listed on the 

TSCA Chemical Substance Inventory. Sites are only required to submit IUR data if they manufacture or import 

more that 25,000 pounds of a chemical during the reporting year. As a result, it is possible that some ongoing 
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of the Benzidine Dyes Action Plan to indicate any ongoing production of the four non-CBI dyes listed in 

Table 1Table 1. In addition, EPA received no comments indicating any ongoing domestic manufacture or 

uses after the promulgation of the proposed SNUR and none of the chemicals subject to the final SNUR 

were found in the Colour Index or during internet queries for manufacturers. However, domestic and/or 

international manufacturers were identified for 14 of the 24 benzidine-based chemical substances 

specified at 40 CFR section 721.1660.10 Searches for information by Colour Index Number suggest that 

nine of the chemicals may be manufactured domestically. In order to confirm their domestic or global 

manufacture of the chemical substances specified at 40 CFR section 721.1660, EPA searched company 

websites for lists of products available for sale. However, in some cases, company product lists contained 

common names for dyes. Common names are not unique identifiers for dyes as they may correspond to 

more than one CASRN; however, they are frequently used, even in peer-reviewed literature. Therefore, 

dyes listed as available solely by common name may not be the same chemical subject to the SNUR. 

Without further information, it is not possible to verify whether the currently manufactured dyes are being 

imported and/or processed domestically as part of articles. Because the remaining 10 dyes specified at 40 

CFR section 721.1660 are no longer manufactured anywhere in the world it is expected that they are not 

used in articles imported into the United States. 

Regulatory Environment 

Occupational exposure to some azo colorants has been regulated for many years; however, the potential 

for consumer exposure to products containing these colorants is still a potential concern. California’s 

Proposition 65 Chemical List includes benzidine-based dyes as a potential carcinogen and requires that 

firms provide a clear and reasonable warning before knowingly and intentionally exposing anyone to a 

listed chemical (CAEPA, 2013a and CAEPA, 2013b). This warning may include the labeling of consumer 

products (CAEPA, 2013b). 

The European Union (E.U.) has banned, in textile and leather articles which may come into direct and 

prolonged contact with humans, the use of azo dyes which can break down to release any of 22 listed 

carcinogenic aromatic amines (including benzidine and its congeners) in amounts above 30 ppm 

(European Commission 2009).11 The European Commission’s Directorate General for Health and 

Consumers maintains the RAPEX database that member countries can use to report dangerous products 

and the measures they have taken to prevent or restrict those products. Despite the E.U. ban, small 

numbers of products containing such azo dyes have recently been listed on RAPEX. The products are 

typically voluntarily withdrawn from the market and/or destroyed by the importer or have been placed 

under an order by the authorities to cease sales (European Commission, 2010). Therefore, azo dyes in 

imported articles still remain a potential issue in the E.U. 

Other countries have also banned the manufacture and use of the azo dyes in textiles. Currently the 

manufacture of azo dyes is banned in South Korea and Japan (IARC, 2012). Use of these chemicals is 

banned by Egypt, India, China, South Korea, Taiwan and Vietnam (Textination, 2012) and Indonesia has 

banned the use of the dyes in children’s and baby’s clothing (Intertek, 2013). In 2012, the Japanese 

textiles and leather industry announced voluntary restrictions of the chemicals (Textination, 2012 and 

 

manufacture and import of the dyes could occur at sites not meeting this threshold. While it is not known how many 

sites fall into this latter category, the Agency believes it likely to be very few if any. 

10 In addition to the 14 dyes with confirmed ongoing manufacture, there were an additional three dyes for which 

there was some information suggesting current production; however, it was not possible for EPA to verify this 

information. 

11 See Restriction 43 in REACH Annex XVII. 
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HKTDC, 2012). Canada has also expressed concern about the potential release of benzidine or its 

congeners from azo dyes and is evaluating potential approaches for addressing azo dyes (Environment 

Canada 2009). In addition, the American Apparel and Footwear Association (AAFA), the national trade 

association representing apparel, footwear and other sewn products companies and their suppliers, which 

compete in the global market, includes benzidine on its Restricted Substances List (AAFA, 2010). 

In 1995, as part of a risk management strategy to reduce the risks associated with the manufacture and use 

of azo dyes in the United States, EPA proposed a SNUR for several benzidine-based substances (FR 

45119, 8/30/95). The proposed SNUR (§721.1660) included 24 benzidine-based substances; however, 

EPA recognized that additional substances will need to be added. The four non-CBI dyes specified in 

Table 1Table 1 were included in draft additions to §721.1660, but were never finalized (61 FR 52287, 

10/7/96). 

As part of a more recent effort to enhance the existing chemicals program under TSCA, EPA created a list 

of widely recognized chemicals for the development of an Action Plan. Azo dyes were selected because 

they have the potential to metabolize to carcinogenic amines both in and on the human body. The Action 

Plan summarized readily available use, exposure, and hazard information for forty-eight azo dyes;12

considered which authorities provided under TSCA and other statutes could be used to address potential 

concerns; and described various courses of action available to EPA to address the concerns (EPA 2009c). 

It is important to note that, unless specified, the following sections, which use information from the 

Action Plan, describe azo dyes in general, not just benzidine-based dyes. 

1.2 Statutory Authority 

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical 

substance is a “significant new use.” EPA must make this determination by rule after considering all 

relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a 

chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a SNUN 

to EPA at least 90 days before manufacturing, importing, or processing the chemical substance for that 

use (15 U.S.C. 2604(a)(1)(B)). 

The general SNUR provisions are found at 40 CFR Part 721, Subpart A. 

1.3 Summary of Methodology 

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

costs to industry associated with performing the required reporting and recordkeeping activities, and the 

costs to EPA of administering the rule. Industry costs consist of rule familiarization; registration with the 

Central Data Exchange (CDX) electronic reporting tool; collection, compilation, and submission of 

required information for significant new uses of the subject chemicals; export notification; and 

recordkeeping. Agency costs include reviewing and processing the data received as a result of the rule. 

Data sources for this analysis include burden estimates derived from previous information collection 

requests and economic analyses for related rules, compensation data acquired from government 

publications, and supplementary market research. 

 

12 The four non-CBI benzidine-based dyes listed in Table 1, and forty-four benzidine congener-based dyes not 

subject to the final SNUR. The five CBI dyes listed in Table 1 were identified by Agency chemists from an 

inventory of CBI chemicals which also had the potential to metabolize into benzidine. 
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In addition to estimated costs, this report qualitatively discusses the benefits of the final rule based on the 

value of the information it will provide. 

1.4 Organization of this Report 

The remainder of this report presents EPA’s economic analysis in support of the final rule. Chapter 2 

contains estimates of the industry costs to comply with the final rule, and Chapter 3 shows estimates of 

the government costs associated with the administration of the final rule. Several additional impact 

analyses are presented in Chapter 4, including: small entity impact analysis, as mandated by the 

Regulatory Flexibility Act (RFA); a burden hour analysis that responds to the requirements of the 

Paperwork Reduction Act (PRA); an analysis of unfunded mandates that pertains to the Unfunded 

Mandates Reform Act (UMRA); an analysis of environmental justice implications that addresses the 

requirements of Executive Order 12898; and an analysis of children’s health pertinent to Executive Order 

13045. Chapter 5 addresses the benefits of the final rule. 

Note that all dollar amounts in this analysis are reported in December 2011 dollars, except for U.S. Postal 

Service mailing rates, which were acquired in January 2012. 
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2. INDUSTRY COMPLIANCE COSTS 

The final SNUR discussed in this report specifies that significant new uses of the benzidine-based 

chemical substances specified in Table 1Table 1 that require reporting under section 5(a)(2)(A) of TSCA 

include the manufacture, import, or processing of the chemicals, excluding use as laboratory stains and 

other analytical reagents. In addition, the final rule revokes the article exemption described in 40 CFR 

section 721.45(f) for the chemicals regulated under a 1996 SNUR at 40 CFR 721.1660(a)(1) (see 

Appendix A), as well the nine chemicals in the final rule. Therefore, a firm intending to manufacture, 

import, or process the chemicals subject to the final rule for any non-exempt use, or import or process 

articles containing chemicals subject to the final rule or specified at 40 CFR section 721.1660, must 

submit a SNUN. Alternatively, a firm can decide not to manufacture, import, and/or process the 

chemicals and articles containing them for a significant new use. The firm, therefore, has two options: 

 Option 1: Submit a SNUN. A SNUN indicates to EPA that the firm would like to manufacture, 

import, and/or process the chemical(s) for a significant new use, which, in this case, means the 

manufacture, import, and/or processing of the chemicals subject to the final rule for any use and/or 

any import and processing of chemicals subject to the rule (including those specified at 40 CFR 

section 721.1660) as part of an article.1314.15 The firm must submit the SNUN to EPA at least 90 days 

before it plans to commence these activities; 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 costs 

associated with this option are the costs of submitting the SNUN (including a user fee) plus, if there is 

any export of these products, the export notification costs that result from TSCA Section 12(b) 

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

Section 2.2.72.2.7 for details). 

 Option 2: Decide not to manufacture16 and/or process the chemical or import or process the 

chemical as part of an article. The firm may decide simply not to proceed to manufacture or process 

the chemicals subject to the final rule, or import or process the chemical substances subject to the rule 

or those specified at 40 CFR section 721.1660 as part of articles. While this option avoids the costs of 

submitting a SNUN, it entails the ‘hidden’ cost of the profit that will be foregone as a result of not 

engaging in the commercial activity originally planned. Similarly, if the firm would have used a given 

amount of the chemical in the production of another product, and must substitute to more costly 

substance, it will incur those additional “hidden” costs of production. However, these hidden costs are 

 

13 The specific excluded laboratory uses are use as a reagent to test for hydrogen peroxide in milk; a reagent to test 

for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain in microscopy; a reagent for detecting blood, and as an 

analytical standard. 

14 In accordance with TSCA section 12(a) and 40 CFR 721.45(g), persons who manufacture or process these 

benzidine-based chemicals solely for export will be exempt from the notification requirements of 40 CFR 721.25, if 

when distributing the substance in commerce, it is labeled in accordance with TSCA section 12(a)(1)(B). Further, 

EPA notes that the exemption from the TSCA section 12(b) notification requirements for exported articles (see 40 

CFR 707.60(b)) will remain in force. Thus, persons who export benzidine-based dyes as part of an article will not be 

required to provide export notification. 

15 Section 5(h)(3) of TSCA, 15 USC 2604(h) exempts substances that are manufactured in small quantities solely for 

research and development (R&D) from the section 5(a) notice requirements. No application is required for the 

exemption for R&D under section 5(h)(3) (U.S. EPA 1986).

16 Under TSCA section 3(7), the definition of “manufacture” means to “import..., produce or manufacture” and 

importers are responsible parties under the final SNUR. 
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expected to be minimal, if not zero, because EPA found no evidence to suggest that many of the dyes 

are available anywhere. It is believed that they have largely been substituted for, and EPA also has no 

information that the regulated chemicals are part of articles imported into or processed within the U.S. 

If the firm elects to produce the chemical for research and development (R&D) purposes only (an 

exemption for R&D purposes is provided in 40 CFR §721.47), it may have costs associated with 

R&D recordkeeping. 

Because there is no evidence to suggest that the currently manufactured chemicals are being imported 

and/or processed domestically as part of articles, EPA does not expect there to be compliance costs 

associated with either of the options. 

The remainder of this chapter estimates the quantified portion of costs associated with the final SNUR. 

Section 2.12.1 summarizes the wage rates used in this chapter. Section 2.2 provides the unit industry 

compliance costs, including the costs of rule familiarization, registration with the Central Data Exchange 

(CDX) electronic reporting tool, completing the SNUN form, submission fee, import certification, and 

export notification. Total costs under each option are presented in Section 2.3 

2.1 Wage Rates 

The final rule involves activities that may require efforts by employees in three labor classifications: 

managerial, technical, and clerical. Costs for each activity are calculated by estimating the labor hours 

required in each labor category and multiplying those burdens by the wage rate for each labor category. 

This section presents the estimated wage rate in each labor category. 

Loaded wage rates for managerial, technical, and clerical personnel are derived by combining data on 

wages and fringe benefits with estimates of overhead rates, following the methodology described in 

“Wage Rates for Economic Analysis of the Toxics Release Inventory Program” (EPA 2002b). Wage data 

for each labor category in December 2011 are provided by the Employer Costs for Employee 

Compensation (ECEC) Supplemental Tables available on the BLS website (BLS 2012a). The loaded 

wage rate for managerial labor is $70.72; for technical labor, $64.66; and for clerical labor, $29.63. Table 

2Table 2 presents the basic data used to calculate the loaded wage rates for all three labor categories. 

Table 2: Loaded Industry Wage Rates, December 2011 

Labor 

Category Data Sources 

Wage 

(2011$) 

Fringe 

Benefit 

(2011$) 

Fringes 

as % 

wage 

Overhead % 

wage2

Fringe + 

overhead 

factor 

Loaded 

Wages1 

(2011$) 

(a) (b) (c) 

=(b)/(a) 

(d) (e)=(c)+ 

(d)+1 

(f)=(a) x 

(e) 

Managerial 

BLS ECEC, Private 

Manufacturing industries, “Mgt, 

Business, and Financial”3

$43.01 $20.40 47.43% 17% 1.64 $70.72 

Professional/ 

Technical 

BLS ECEC, Private 

Manufacturing industries, 

“Professional and related“3

$38.48 $19.64 51.04% 17% 1.68 $64.66 
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Table 2: Loaded Industry Wage Rates, December 2011 

Clerical 

BLS ECEC, Private 

Manufacturing industries, 

“Office and Administrative 

Support” 3

$17.69 $8.93 50.48% 17% 1.67 $29.63 

1 Wage data are rounded to the nearest cent pennies in this table. 2 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory 

Program (EPA 2002b), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). 3 Employer Costs for Employee Compensation Supplementary Tables: December 2011. US Bureau of Labor Statistics, March 14, 

2012 (BLS 2012a).
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2.2 Unit Industry Compliance Costs 

2.2.1 Rule Familiarization 

EPA believes that as a consequence of the final rule, some chemical manufacturers and processors and 

importers and processors of articles and their staff will need to become familiar with the SNUR and its 

various requirements. Rule familiarization is estimated to require 0.55 hours of technical labor and 0.27 

hours of managerial labor, as described in the Economic Analysis of the Premanufacture Notification 

Electronic Reporting Final Rule (EPA, 2009a), which measures the costs of mandatory electronic 

reporting of SNUNs and other TSCA Section 5 notices. As shown in Table 3Table 3, the total labor cost 

associated with rule familiarization is estimated at $54.43. 

Table 3: Rule Familiarization Burden and Cost for SNUR Submitters

Reporting Activity 

Clerical Labor (at 

$29.63/hour) 

Technical Labor (at 

$64.66/hour) 

Managerial Labor 

(at $70.72/hour) 

Total Labor Cost 

Burden

(hours) 

Cost 

(2011$) 

Burden

(hours) 

Cost 

(2011$) 

Burden

(hours) 

Cost 

(2011$) 

Burden

(hours) 

Cost 

(2011$) 

Rule Familiarization 0.00 $0.00 0.55 $35.56 0.27 $18.86 0.82 $54.43 

Total 0.00 $0.00 0.55 $35.56 0.27 $18.86 0.82 $54.43 

Source: BLS 2012a (labor rates); EPA 2009a (burden hours) 

2.2.2 CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup 

The final SNUR requires submission of a SNUN for any firm that chooses to manufacture, import, and/or 

process a chemical for a significant new use or import or process a chemical subject to the rule as part of 

an article. First-time submitters of any TSCA section 5 notice (including Premanufacture Notices 

(PMNs), SNUNs, Test Market Exemption (TME) applications, Low Volume Exemption (LVE) notices, 

Low Exposure/Low Release (LoREX) exemption notices, Biotechnology Notices for genetically modified 

microorganisms, Notices of Commencement of Manufacture or Import (NOCs), and support documents 

to Section 5 notices) are required to register their company and key users with the CDX reporting tool, 

deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E-payment account.17 These 

activities are only required of sites that have not previously registered with CDX for other activities such 

as CDR reporting or the submission of other Section 5 notices (PMNs, MCANs, etc.). These activities are 

estimated to require the following burden hours, based on the estimates presented in the Economic 

Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a): 

 CDX registration: EPA estimates that companies will spend approximately 0.18 hours per 

employee to register with CDX, and that an average of four technical staff members and one 

manager will need to register for each company, totaling approximately 0.92 hours of burden per 

company. 

 CDX electronic signature: EPA estimates that companies will spend 0.25 hours preparing, 

submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA 

 

17 Although the final rule does not require submitters to establish and use a Pay.gov account, the burden estimates in 

this analysis are conservative insofar as to include the use of Pay.gov as a required activity. 
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per employee. This burden will apply to four technical staff members and one manager per 

company, totaling 1.25 hours of burden per company. In addition, EPA estimates that a manager 

will spend an additional 0.50 hours accessing, preparing, and submitting verification forms 

(Verification of Authorization) for all authorized submitters to EPA. The total burden incurred by 

companies submitting and then verifying electronic signature agreements is 1.75 hours. Note that 

this burden does not include any additional time required to contact EPA’s CDX help desk to 

notify a change of submitter status, should one occur. Filing the electronic signature agreement 

may be done either through mail or electronically. EPA believes the cost of electronic filing to be 

negligible, and the cost of a paper filing via the US Postal Service to be to be $2.55 per company 

(including five $0.45 stamps18 and five $0.06 business envelopes19). 

 Payment via Pay.gov account: EPA estimates that one manager per company will spend 

approximately 0.13 hours setting up a Pay.gov ID account, logging into the system, finding the 

appropriate form, and filling it out. This burden does not include the time required to click 

‘submit’ on the form and wait for payment processing. 

As shown in Table 4Table 4, the cost associated with CDX registration, CDX electronic signature, and 

Pay.gov account setup is $190, and this cost is only incurred by a first-time submitter. 

Table 4: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Burden 

and Cost for First-Time Submitters 

Reporting Activity 

Clerical Labor (at 

$29.63/hour) 

Technical Labor (at 

$64.66/hour) 

Managerial Labor 

(at $70.72/hour) Total Cost 

Burden

(hours) 

Cost 

(2011$) 

Burden

(hours) 

Cost 

(2011$) 

Burden

(hours) 

Cost 

(2011$) 

Burden

(hours) 

Cost 

(2011$) 

CDX Registration 0.00 $0.00 0.73 $47.42 0.18 $12.96 0.92 $60.38 

CDX Electronic 

Signature 0.00 $0.00 1 $64.66 0.75 $53.04 1.75 $118 

Mailing Cost $2.55 

E-Payment (Pay.gov 

ID) 0.00 $0.00 0.00 $0.00 0.13 $9.43 0.13 $9.43 

Total 0.00 $0.00 1.73 $112 1.07 $75.43 2.80 $190 

Source: BLS, 2012a (labor rates); EPA, 2009a (burden hours); USPS, 2012 (mailing cost) 

2.2.3 Form Completion and Submission Fee 

Respondents who choose to submit a SNUN are required to gather and submit information regarding the 

data elements identified in the applicable SNUN reporting form. The methodology and calculations used 

in this analysis assume that the employee responsible for collecting, filling out, and submitting the 

requested information has a reasonable level of familiarity with the company and knowledge of 

operations at the site. It is assumed that for most entities these tasks are similar to other employee duties 

that require familiarity with EPA, State, and other Federal agency requests for chemical information and 

 

18 Price for a stamp was taken from the U.S. Postal Service website on January 24, 2012. (See U.S. PS, 2012)

19 Price for an envelope was determined based on the per unit price of a regular business envelope. See “Staples® 

#10, Self-Sealing Envelopes, 500/Box." Available at: http://www.staples.com/ (Accessed 1/25/2012). 
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do not require additional familiarization or training beyond the basic rule familiarization described above. 

In addition, this analysis focuses on the marginal costs of submitting information for the final rule and not 

the total costs for the company to comply with a range of other Federal and State environmental, health, 

and safety regulations or accounting requirements that rely on this type of information. 

Estimates of the costs of completing a SNUN form are based on the costs of completing a PMN 

submission, since the data requirements are the same and the same form is used for both. 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, which 

became the American Chemistry Council. These burdens include “the time spent reading and becoming 

familiar with the form, gathering the required information and preparing the report, producing sanitized 

responses for items claimed as confidential business information, and maintaining a file of the 

submission” (EPA, 1994. p. III 11-13). The burden associated with SNUN 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. Electronic submission 

of SNUN forms is expected to remove all clerical burden and reduce the recordkeeping burden associated 

with preparing a SNUN (EPA, 2009a).20 In addition, electronic submission is expected to generate and an 

additional 0.18 hours of technical burden, for the completion of the User Fee Payment Identification 

Number and email address data elements on the electronic SNUN form. 

SNUN form completion and electronic submission is estimated to require approximately 74 hours of 

technical labor and 18 hours of managerial labor (EPA, 2009a). Table 5Table 5 combines the estimated 

reporting burden and loaded wage rates for all three labor categories to estimate the per-SNUN cost of 

form completion. The labor cost incurred by a SNUN submission for both large and small business 

submitters is estimated at $6,071. 

 

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

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

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

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

associated with PMN submissions. 

Therefore, for this analysis, the 0.5 hour for clerical labor and the 0.5 hour for technical labor were removed. It is 

important to note that for this analysis, clerical burden changes are not applicable because the entire clerical burden 

is assumed to be eliminated under the electronic reporting requirements. In summary, we do not include the one 

hour recordkeeping burden (0.5 hour for clerical, 0.5 for technical) reported in the ePMN EA. 
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Table 5: Industry Cost Estimate to Complete the SNUN Form 

Reporting Activity 

Clerical Labor (at 

$29.63/hour) 

Technical Labor (at 

$64.66/hour) 

Managerial Labor 

(at $70.72/hour) Total Labor Cost 

Burden

(hours) 

Cost 

(2011$) 

Burden

(hours) 

Cost 

(2011$) 

Burden

(hours) 

Cost 

(2011$) 

Burden

(hours) 

Cost 

(2011$) 

Form Completion 0.00 $0.00 74.2 $4,798 18 $1,273 92.2 $6,071 

Source: 1 Loaded wages include fringe benefits and overhead. 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 Technical and managerial labor burden is from the PMN Amendments RIA (EPA, 1994, Table III-2). An additional eleven 

minutes (0.18 hours) of technical burden is estimated to complete the User Fee Payment Identification Number and Email 

Address data elements on the Electronic SNUN form (EPA, 2009a page 15). 

In addition, each submitting large business must pay a $2,500 per-SNUN submission fee, and each 

submitting small business must pay a $100 per-SNUN submission fee. Table 6Table 6 adds the labor cost 

and submission fee to estimate the total cost of a SNUN submission. The total cost of a SNUN 

submission is $8,571 for large business submitters and $6,171 for small business submitters. 

Table 6: Industry Cost Estimate to Complete and Submit the SNUN Form

Reporting Population Labor Cost Submission Fee Total Cost 

(2011$) 

Large Business Submitters $6,071 $2,500 $8,571 

Small Business Submitters $6,071 $100 $6,171 

Source: EPA, 2009a. 

2.2.4 Recordkeeping 

Companies submitting a SNUN must, under 40 CFR §721.40, keep records of the information contained 

in the SNUN. Some EPA reports have assumed that SNUN recordkeeping hours will be five percent of 

SNUN submission hours, or about five to six hours. For this report, the SNUN recordkeeping hours were 

included in the SNUN submission hours (see Section 2.2.3) and the SNUN recordkeeping costs under 40 

CFR §721.40 were not separately estimated.21 

2.2.5 Customer Notification 

Manufacturers, processors, and importers of chemicals subject to SNURs and processors and importers of 

chemicals subject to the rule as part of articles must notify recipients of such chemicals of the SNUR or 

verify that knowledge of the SNUR has been otherwise acquired by recipients, or that the recipients are 

 

21 SNUN submission costs estimated in Section 2.2.3 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 EPA 1994) included recordkeeping hours. 
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unable to engage in significant new uses. Since it is not expected that all such entities will have complete 

knowledge of all uses of any products subject to a SNUR, it is generally assumed that manufacturers, 

processors, and importers will most often choose to notify their customers of SNUR regulatory activities. 

As this notification may be accomplished by simply annotating an MSDS, EPA estimates the associated 

burden to be about one hour of a technical employee's time or $64.66 per manufacturer, processor, or 

importer per chemical. However, for this SNUR, the regulated chemicals are not used in the U.S., and 

therefore, no manufacturers, processors, or importers will be affected. Thus, customer notifications will 

not be necessary. 

2.2.6 Import Certification 

In general, promulgation of a SNUR triggers a TSCA Section 13 import certification requirement and the 

corresponding regulations at 19 CFR §12.118 to 12.127 and 19 CFR §127.28 for all imports of the 

relevant chemical substances. Thus, any U.S. manufacturer, importer, or processor receiving an imported 

shipment of chemicals subject to the final SNUR will have to certify that all chemical substances in the 

shipment either comply with all applicable rules and orders under TSCA or that all chemical substances in 

the shipment are not subject to TSCA.22 The statement must be on or attached to a commercial invoice or 

entry document belonging to the imported shipment. 

Import certification is fulfilled by checking a box on an invoice or entry document and EPA assumes that 

it generally imposes no additional burden or cost on the importer. Any potential burden associated with 

submitter’s familiarization with this requirement is assumed to be included in the more general SNUR 

familiarization burden discussed above. 

2.2.7 Export Notification 

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 requirement23 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). However, the percent of notifications resulting from SNURs in general is 

unknown, and it is assumed that there will be no notifications from this rulemaking as there are no U.S. 

manufacturers. 

2.2.8 Article Importation and Processing 

Certain SNURs may require importers or processors who choose to import or process regulated chemical 

substances as part of articles to comply with notification requirements, such as notifying EPA at least 90 

 

22 The exact statements are as follows: For imports of chemical substances subject to TSCA, “I certify that all 

chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not 

offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.” For 

imports of chemical substances not subject to TSCA (e.g., pesticides), “I certify that all chemicals in this shipment 

are not subject to TSCA.” (40 CFR 707.20) 

23 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). 
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days before commencing the import of any articles containing chemicals subject to the rule. Additionally, 

if a SNUR does not contain an exemption for processors and importers of articles, those that import or 

process articles may choose to undertake activities to assure themselves that they are not importing or 

processing regulated chemicals as part of articles even though these activities are not required by the 

SNUR. A number of potential activities that importers may choose to undertake to determine whether the 

articles they import contain regulated chemical substances are outlined in this paper. This determination 

may involve gathering information from suppliers in their supply chain, and/or testing samples of the 

article itself. More information on the activities that an importer may choose to undertake and what 

factors may affect that choice are found in Understanding the Costs Associated with Eliminating 

Exemptions for Articles in SNURs (EPA, 2013b). 

Affected Entities 

Importers have varying levels of knowledge about the chemical content of the articles they import, yet 

under TSCA the definition of “manufacture” means to “import..., produce or manufacture”24 and 

importers are responsible parties under the final SNUR. In order to understand and monitor their liability, 

companies might undertake a range of activities to ensure that the articles they import do not violate 

existing regulations. 

SNUR reporting requirements for persons who may process chemicals as part of articles are similarly 

described in § 40 CFR 721.5; however, the reporting requirements for processors (including processors of 

subject chemicals as part of articles) do not apply in some circumstances. As described in § 40 CFR 

721.5(c), a processor is not required to submit a SNUN if he can document that (1) he does not know the 

specific chemical identity of the chemical substance being processed; and (2) that he is processing the 

chemical substance without knowledge that the substance is subject to a SNUR. This analysis focuses on 

the standard business practices that EPA believes a processor would already undertake that would serve to 

provide information regarding the chemical content of articles they process. 

Table 7 contains examples NAICS codes for firms that may import or process articles that use chemical 

substances subject to the SNUR. The benzidine-based chemical substances subject to the rule have 

predominately been used as azo dyes in the production of textiles, paints, printing inks, paper, and 

pharmaceuticals. This is not meant to be an exhaustive list, but rather an example of the types of 

industries that may be impacted by the articles exemption. As shown in Table 7, a wide variety of 

industries may import articles containing the dyes, including chemical, apparel, and textile manufacturers, 

wholesalers, and retail stores. 

 

24 TSCA section 3(7). 
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Table 7: Examples of Industries that may Import or Process Articles Containing Benzidine Chemical 

NAICS Code Section Description 314 Textile Product Mills Industries in the Textile Product Mills subsector group establishments that make textile produc

a few exceptions, processes used in these industries are generally cut and sew (i.e., purchasing 

sewing to make nonapparel textile products, such as sheets and towels). 

315 Apparel Manufacturing Industries in the Apparel Manufacturing subsector group establishments with two distinct man

cut and sew (i.e., purchasing fabric and cutting and sewing to make a garment), and (2) the maestablishments that first knit fabric and then cut and sew the fabric into a garment. The Appareincludes a diverse range of establishments manufacturing full lines of ready-to-wear apparel acontractors, performing cutting or sewing operations on materials owned by others; jobbers pefunctions involved in apparel manufacture; and tailors, manufacturing custom garments for indincluded. 

423 Merchant Wholesalers, 

Durable Goods 

Industries in the Merchant Wholesalers, Durable Goods subsector sell capital or durable goods Durable goods are new or used items generally with a normal life expectancy of three years or merchant wholesale trade establishments are engaged in wholesaling products, such as motor vconstruction materials, machinery and equipment (including household-type appliances), metapetroleum), sporting goods, toys and hobby goods, recyclable materials, and parts. 

424 Merchant Wholesalers, 

Nondurable Goods 

Industries in the Merchant Wholesalers, Nondurable Goods subsector sell nondurable goods to Nondurable goods are items generally with a normal life expectancy of less than three years. Nmerchant wholesale trade establishments are engaged in wholesaling products, such as paper achemicals and chemical products, drugs, textiles and textile products, apparel, footwear, grocepetroleum and petroleum products, alcoholic beverages, books, magazines, newspapers, flowe

tobacco products. 
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Table 7: Examples of Industries that may Import or Process Articles Containing Benzidine Chemical 

NAICS Code Section Description 442 Furniture and Home 

Furnishings Stores 

Industries in the Furniture and Home Furnishings Stores subsector retail new furniture and hompoint-of-sale locations. Establishments in this subsector usually operate from showrooms and the presentation of their products. 

448 Clothing and Clothing 

Accessories Stores 

Industries in the Clothing and Clothing Accessories Stores subsector retail new clothing and cmerchandise from fixed point-of-sale locations. Establishments in this subsector have similar d

staff that is knowledgeable regarding fashion trends and the proper match of styles, colors, and and accessories to the characteristics and tastes of the customer. 

449 Sporting Goods, Hobby, 

Musical Instrument, and Book Stores 

Industries in the Sporting Goods, Hobby, Musical Instrument, and Book Stores subsector are eproviding expertise on the use of sporting equipment or other specific leisure activities, such a

instruments. Book stores are also included in this subsector. 

450 General Merchandise 

Stores 

Industries in the General Merchandise Stores subsector retail new general merchandise from flocations. Establishments in this subsector are unique in that they have the equipment and staflarge variety of goods from a single location. This includes a variety of display equipment and information on many lines of products. 

451 Nonstore Retailers Industries in the Nonstore Retailers subsector retail merchandise using methods, such as the br

infomercials, the broadcasting and publishing of direct-response advertising, the publishing of catalogs, door-to-door solicitation, in-home demonstration, selling from portable stalls and dismachines. Establishments in this subsector include mail-order houses, vending machine opera

door-to-door sales, party plan sales, electronic shopping, and sales through portable stalls (e.gfood). Establishments engaged in the direct sale (i.e., nonstore) of products, such as home heatnewspaper delivery service providers are included in this subsector. 
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Potential Compliance Activities (Article Importers) 

The rule does not prescribe steps that an importer must take to identify a chemical subject to the SNUR in 

articles; therefore, there are a variety of potential actions that a company could take to identify specific 

substances in its articles, should they choose to do so. These activities range in cost; however, costs 

incurred are at the discretion of any individual importer. EPA expects that in all likelihood, importers 

would take actions that are commensurate with the level of risk each company’s perceived likelihood that 

the regulated chemical is part of the article they intend to import perceives, and the resources it has 

available. 

There is currently no single widely accepted standard procedure to identify regulated chemicals in the 

supply chain. However, there are a number of organizations that help provide information on the content 

of articles, organize declarations from suppliers, or certify suppliers based on materials or processes used. 

Importers (or processors) subject to SNURs may refer to these sources for assistance in their own strategy 

to identify a chemical subject to a SNUR in articles. 

The American Apparel & Footwear Association (AAFA) RSL (Restricted Substances List) Management 

(AFIRM) Working Group has developed a toolkit to help apparel and footwear companies “to reduce the 

use and impact of harmful substances in the apparel and footwear supply chain”. According to Massey et 

al., 2008, companies in this industry may require that suppliers sign agreements certifying that specified 

products do not contain substances that are of interest to the company. In addition, some agreements 

specify that if testing identifies a restricted material, the supplier must cover all associated costs. 

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), has 

developed a Standard Guide for Assessment of Materials and Products for Declarable Substances

(“ASTM F2577”), which provides guidance for the decision process to assess materials and products for 

declarable substances. The following list includes activities that an importer might perform to identify any 

restricted chemicals in imported articles. Any rule familiarization burden associated with the proposed 

SNUR for importers of articles is discussed in Section 2.2.1 of this report. This list is intended to capture 

the general types of activities that might be performed. 

1) Understand applicable requirements (per-firm cost). All importers would read and understand 

the SNUR, within the context of the company’s products. This burden is derived in Section 2.2.1 

of this report 

2) Identify the type of imported articles that potentially contain the chemicals subject to this 

SNUR (per-firm cost). This determination may be done based on an understanding of the uses of 

the subject chemical substances (e.g., those described in Section 1.1 of this analysis) and the 

application of any a priori knowledge of the material and its manufacture to assess the probability 

whether each regulated substance may be present. 

3) Identify all suppliers involved (per-firm cost). The importer may choose to identify all 

suppliers from whom the articles identified in the previous step are imported, and as appropriate, 

to make them aware of the importer’s potential notice obligations respecting the regulated 

chemical substances.

4) Collect data from suppliers (per-article cost). Importers may choose to obtain verification from 

suppliers identified in step 3 that the regulated chemical substance is or is not found in the article. 

This may be accomplished through, for example, agreements with suppliers, declarations through 

databases or surveys, or by using a third-party certification system. 
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5) Chemical testing (per-article cost). Importers may choose to assess imported articles for 

chemical content. This could involve requiring suppliers to provide certificates of 

analysis/laboratory reports for a lot or batch of the material produced. Importers may perform 

their own laboratory testing of certain articles (or components of articles) to determine if they 

contain the restricted substance. 

6) Recordkeeping (per-firm cost). The importer may choose to keep records confirming the 

activities completed.

Table 8Table 8 contains the cost ranges associated with the above activities. The activities and cost 

derivations are discussed in more detail in Understanding the Costs Associated with Eliminating 

Exemptions for Articles in SNURs (EPA, 2013b). 

 
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Table 8: Range of costs associated with an importer’s identification of chemicals subject to SNURs in 

Activity Cost (2011$) Notes 

Per Rule Costs

Rule familiarization $55 Discussed in Section 2.2.12.2.1 of this document Identify the type of imported articles that potentially contain the restricted substances 

$130 to $1,550 Actual costs may vary based on number of articl

the complexity of the article itself (number of co

Identify all suppliers involved $950

Actual costs may vary depending on the number imported, number of suppliers, and frequency of changes 

Recordkeeping $10 Actual costs may vary depending on recordkeepi

already in place 

Per Article-Related Costs 

Collect data from suppliers

$5 to $515 per article 

reviewed.

$0 if no data collected.

Actual costs only apply to those companies that collect data from suppliers. They will vary depenspecific data collection method chosen. Total coconsiderations including the number of articles imnumber of suppliers, and frequency of supplier c

Chemical testing $130 per article tested. $0 if no testing.

Actual costs only apply to those companies that collect data from suppliers. They will vary depenspecific chemical being tested for; the complexitand sample preparation required; and the exact flaboratory chosen for the analysis. Total costs pedepend on considerations including the number otested, which may be affected by the number of srisk associated with each, and frequency of supp

Source: EPA, 2013b 
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Variation in costs associated with these activities would depend on a company’s level of activity to 

comply with other regulations on chemicals in articles, the complexity of the supply chains, and the size 

of the company. Total costs per article importer will further depend on the number of affected articles and 

the frequency of supplier change. Total costs associated with these activities to any article importer are 

not quantified, but are believed to be minimal for this particular SNUR because firms may already be 

taking actions to avoid certain azo dyes as part of articles they import and because the dyes are not as 

readily available and therefore are not expected to be widely used in articles. 

Since the 1990s, the import, manufacture, export, and sale of many textile products made with certain azo 

dyes has been banned in a number of European companies. Also in the 1990s most European and North 

American members of the Ecological and Toxicological Association of Dyes and Organic Pigments 

Manufacturers voluntarily ceased manufacturing benzidine dyes and salts. Developing countries that 

manufacture dyes and produce leather and textiles with azo dyes were affected by the changes in the 

marketplace. Cost for textile exporters (in developing countries) to switch to nonregulated azo substitutes 

have been high; however, compliance with European regulations seems high with a rate of over 96% for 

some samples tested for export to Europe (OECD, 2002). 

EPA believes import of the subject chemicals as part of articles to be unlikely given foreign bans on the 

use of certain azo dyes in fabrics and leather products and a general decline in the availability of certain 

azo dyes in the marketplace as many leather and textile producers have moved to substitute dyes (OECD, 

2002). Because firms operating in countries and/or states where azo dyes are already regulated are 

expected to be complying with existing regulations, EPA also expects that they are more likely to use 

non-regulated substances, rather than have a separate product stream that may only be used in certain 

countries or states. Furthermore, firms that have previously selected suppliers that have agreed to uphold 

certain standards, or who have otherwise sufficiently demonstrated that they are not supplying benzidinebased chemicals, would not likely incur any additional costs associated with these activities. Essentially, 

the product’s certification would allow importers or processors of articles to learn whether an article does 

or does not contain certain azo dyes or whether suppliers have agreed to uphold certain production 

standards. There are labeling systems for products in which independent entities ensure that the 

production of products does not utilize specific chemicals. For example, the European Union has 

developed a voluntary labeling system, called the EU Ecolabel. Producers, importers and retailers can 

voluntarily apply for the EU Ecolabel (EC, 2013). Labeled products signal to consumers that the product 

in question has a reduced environmental impact throughout the product’s life cycle, such as at the 

manufacturing stage and/or during the final product disposal. The criteria are specifically designed to 

focus on the stage of the life cycle where a product has the most environmental impact (EC, 2013). For 

textiles, the criteria are based on the manufacturing process when fabrics are dyed, printed, and bleached 

since this is the stage with the largest impact (EC, 2013). Another international association, OEKOTEX®25 set up an independent testing and certification system specifically for textiles, called the OEKOTEX® Standard 100 (OEKO-TEX®, No Date b). The system looks at products at different stages of 

production, including, raw materials, intermediates, and end products. The label signals to customers that 

the textiles have been tested for (1) illegal substances, (2) legally regulated substances, (3) known harmful 

unregulated chemicals, and (4) parameters for healthcare. The company also looks at the uses of the 

textile to see the intensity of contact between the product and skin for their parameters. (OEKO-TEX®, 

No Date b). 

 

25 The International Association for Research and Testing in the Field of Textile a union of 15 institutes for textile 

research and testing in Europe and Japan (OEKO-TEX®, No Date a). 
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Similarly, firms that operate in places where azo dyes are already regulated would presumably have 

mechanisms in place to identify the content of any articles they import. Firms already subject to REACH 

requirements could potentially rely on any article testing that may have been completed to comply with 

REACH to assess the likelihood of a chemical regulated under the SNUR being a constituent of an 

imported article. EPA believes that the analytical testing standards listed under REACH that detect azo 

dyes that contain benzidine, are suitable for testing the benzidine-based chemicals listed in Table 1Table 

1. This is because all chemicals regulated under the final SNUR will release benzidine when tested using 

the REACH requirements. Therefore, any firm that is currently testing articles for benzidine prior to 

importation into the EU would not need to conduct additional testing to learn about the presence or 

absence of the chemicals covered by the SNUR, as the results from the REACH test could be used to 

show the presence or absence of benzidine in an article. 

Firms with less experience with other regulations that are planning to import articles that could potentially 

contain benzidine-based chemicals may incur a larger burden should they choose to conduct some or all 

of the activities listed above to learn about the chemical content of those articles. These firms may choose 

to reach out to a wide variety of upstream firms, including subcontractors, accessory suppliers, dye mills, 

print mills, tanneries, and chemical suppliers, to gather information on the chemical content of articles, 

for documentation. Firms may also choose to conduct additional research on their suppliers to ensure that 

they are purchasing from reputable manufacturers and chemical suppliers who will provide necessary 

technical support and will use high quality dyes that meet customer color and quality, as well as 

regulatory standards (AFIRM, 2011). Furthermore, a company could choose to have articles tested. If a 

company chooses to conduct testing, they may also need to conduct additional research to ensure the 

laboratory is accredited, reliable and follows Good Laboratory Practices (GLP) (AFIRM, 2011). 

There are no requirements in the SNUR for importers to develop any information regarding the content of 

the articles they import. Given existing regulatory limitations both internationally and within the U.S., 

industry-wide processes, resources that support companies in understanding and managing their supply 

chains, and the evidence showing minimal worldwide availability of the dyes regulated under the SNUR, 

EPA believes that article importers that choose to investigate their products would incur costs at the lower 

end of the ranges presented in Table 8Table 8, as a result of this rule. For those companies choosing to 

undertake actions to assess the composition of the articles they import, EPA expects that in all likelihood, 

these importers would take actions that are commensurate with the perceived likelihood that the regulated 

chemical is part of the article they intend to importlevel of risk (of a chemical to be a part of an article) 

each company perceives, and the resources it has available. 

Potential Compliance Activities (Processors of Articles) 

Under § 40 CFR 721.5(a)(2), manufacturers, importers, or processors of subject chemical substances who 

distribute the substance in commerce must notify the recipient, in writing, of the applicability of SNUR 

requirements, or document that the recipient has such knowledge or will not undertake any significant 

new use described in the rule. Therefore, the article processor, as the recipient of any subject chemical 

substance, should receive written notification from the supplier and would presumably keep this 

documentation as a standard business practice, along with other documentation such as Material Safety 

Data Sheets, shipping or labeling documents, etc. that may provide information on the chemicals in the 

articles they process. 

To the extent that processors desire extra certainty that the articles they process are not subject to a 

SNUR, they may undertake the steps to identify regulated chemicals outlined above for importers. 
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However, as stated above, given the international bans on the use of azo dyes in fabrics and leather 

products, it is unlikely that these chemicals will be imported into the United States as part of finished 

articles. 

2.3 Industry Costs of SNUR, by Option 

The number of firms affected by not making submissions to EPA is not known; therefore, costs are not 

aggregated across the affected entities. Table 9 summarizes the costs to comply with the final rule, as 

described in more detail in Section 2.2 above 

Table 9: Compliance Options and Associated Costs Incurred by a Firm Due to the Final SNUR

Option1 Costs Quantified Costs per Chemical (2011$)2

1. 

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 rule 

familiarization, CDX registration 

(for companies that are first-time 

submitters), form completion, user 

fee, export notification cost (if 

relevant). Rarely, a firm may 

choose to conduct toxicity or fate 

testing to support the SNUN, but 

such testing is not required by law. 

$54.43 rule familiarization cost; $8,571 

submission cost (including SNUN 

recordkeeping under 40 CFR §721.40 and fee 

$2,500 for large businesses). EPA usually 

receives well under ten SNUNs per year. First 

time submitters will incur $190 for CDX 

registration and associated activities. 

2. 

Decide not to 

manufacture, import, 

or process the 

chemical for any nonexempt uses. 

Cost of the profit foregone as a 

result of not engaging in the 

commercial activity originally 

planned (opportunity costs). Other 

costs include rule familiarization, 

and export notification costs. 

Opportunity costs are not quantified. Other 

costs such as rule familiarization ($54.43) may 

apply. Costs associated with article importation 

may include activities such article identification 

($130-$1,550), supplier identification ($950) 

recordkeeping ($10), collecting data from 

suppliers ($5 - $515 per article), and testing, if 

completed ($130 per article). 

Notes: 

1

 Firms may experience costs related to both options at once since submission of a SNUN results in profits foregone 

as a result of not manufacturing, importing, or processing the dyes subject to the final rule, or importing or 

processing articles containing these dyes or those specified at 40 CFR section 721.1660. Additionally, export 

notification costs are somewhat independent of the option because the production of benzidine-based dyes subject to 

the final rule for export purposes only does not require notification under 40 CFR 721.25. 

2 Quantified costs are attributable to the SNUR only if a firm will not otherwise follow the specified practices 3 EPA does not require the development of test data for submission of a SNUN, although a firm may submit test data 

already in its possession and/or describe any other available data. Because EPA does not require the development of 

test data, EPA assumes that no firms will incur testing costs as a result of the final SNUR. 

2.4 Likelihood of a SNUN Submission 

The domestic manufacture, import and processing of the dyes specified in Table 1Table 1 and the articles 

containing them have been phased out. Additionally, there appears to be no production of the majority of 
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the dyes specified at 40 CFR section 721.1660 either domestically or globally, although some may have 

appeared on websites of some companies26. Of those that appear to remain in production either 

domestically or globally, there is insufficient information to identify the use (including non-exempt uses 

or as part of an article imported into the US.)27. 

The E.U. has banned the use of azo dyes which can break down to release any of 22 listed carcinogenic 

aromatic amines (including benzidine and its congeners) in amounts above 30 ppm in textile and leather 

articles which may come into direct and prolonged contact with humans (European Commission 2009).28

Despite the E.U. ban, products are occasionally found in articles meant for import (European 

Commission, 2010) and certain azo dyes in articles may remain an ongoing issue. However, EPA has 

found no information to support the conclusion that articles containing the specific dyes specified at 40 

CFR section 721.1660 are currently imported into the US. 

Canada has also expressed concern about the potential release of benzidine or its congeners from azo dyes 

and is evaluating potential approaches for addressing azo dyes (Environment Canada 2009). In addition, 

the American Apparel and Footwear Association (AAFA), the national trade association representing 

apparel, footwear and other sewn products companies and their suppliers, which compete in the global 

market, includes benzidine on its Restricted Substances List (AAFA 2010. 

Clearly, benzidine-based dyes are a concern internationally to governments and industry. Many of the 

dyes, including those listed in Table 1, have been phased-out of production. Exporters of textile and 

leather products that are located in developing countries have incurred costs to adopt azo substitutes and 

some samples of tested products have shown over a 96% compliance rate with European requirements 

(OECD, 2002). Given the international concern for these chemicals, market reemergence of those not 

currently manufactured or imported is not expected. While research identified global and domestic 

manufacturers that have listed availability of several of the dyes specified at 40 CFR section 721.1660 

there is no evidence to suggest that these dyes are being used in non-exempt uses or are being imported 

and/or processed domestically as part of articles (see section 1.1). Additionally, the actual availability of 

those dyes was not confirmed. Therefore, EPA believes that submission of a SNUN for these chemicals is 

unlikely. 

2.5 Potential for Subsequent Regulatory Action 

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. 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). 

 

26 Dyes may appear on website listings, however, actual availability is not confirmed. 27 In some cases, company product lists contained common names for dyes. Common names are not unique 

identifiers for dyes as they may correspond to more than one CASRN; however, they are frequently used, even in 

peer-reviewed literature. Therefore, dyes listed as available solely by common name may not be the same chemical 

subject to the SNUR. 

28 See Restriction 43 in REACH Annex XVII. 
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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, as appropriate, 

will be an assessment of the costs and benefits of those actions. 

 
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3. AGENCY COSTS 

As described in the following sections, EPA’s costs to review and process SNUN submissions are 

assumed to be the same as EPA costs to review PMNs. 

3.1 Labor Rates for EPA Staff 

Agency labor costs are calculated based on annual Federal salaries for the Washington-Baltimore area 

published by the Office of Personnel Management effective January 2011 (OPM, 2011). EPA assumes 

that, on average, a federal GS-13, Step 5 full-time equivalent (FTE) will conduct its collection and 

administrative activities under the final rule.29 The average salary for a GS-13 Step 5 employee was 

$100,904 in 2011 without fringe benefits and overhead costs. In order to derive the fully loaded salary, 

EPA multiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and 

overhead (EPA, 2009c), which results in a fully loaded annual salary of $161,446 (see Table 10Table 10). 

Dividing the fully loaded annual salary by 2,080 hours (i.e., the number of hours in a work year) yields an 

estimated hourly FTE wage rate of $77.62. 

Fully loaded costs for Agency labor are shown in Table 10Table 10. 

Table 10: Derivation of Loaded Agency Wage Rates 

Labor 

Category 

Data Source for Wage 

Information Date

Wage 

Fringe 

Benefit

Fringes as 

% wage 

Overhead 

as % wage

Fringe + 

overhead 

factor 

Loaded 

Wages 

(a) (b) (c)=(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a)*(e) 

EPA staff 

FTE 

Annual federal staff cost: 

OPM WashingtonBaltimore-Northern 

Virginia, DC-MD-PAVA-WV, area, GS-13 

Step 1 pay rates a 

Jan 

2011

$100,904 

(annual) 

-- 

Included 

in 60% 

overhead 

60%2

 1.60 

$161,446 

(annual) 

$48.51 

(hourly) 

$77.62 

(hourly) 

Notes: a

 The Agency salary is the unloaded federal GS-13 Step 5 salary ($100,904 for 2011), from the OPM salary table for the 

Washington-Baltimore-Northern Virginia Locality Pay Area (OPM 2011). Hourly rates are based on annual salary divided by 

2,080 hours. 

b The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) 

(EPA 1992, page 30, footnote 9).

3.2 SNUN Processing Costs 

The list of review steps, 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 PMN has been adjusted to 

 

29 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, 2003), which used an average of GS-12 Step 1 and GS-12 Step 10 

salaries. 
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reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that 

requires the electronic submission of all TSCA section 5 notices. Electronic submission of SNUN forms 

is expected to reduce Agency burden by 16.5 percent (EPA, 2009a, p.28). 

For each review step, the “EPA staff” cost is calculated by multiplying the number of FTEs (in the first 

column) by the fully loaded hourly 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 is inflated from 1993 prices using the Bureau of Labor 

Statistics (BLS) Employment Cost Index (ECI) data (BLS 2012b). The not seasonally adjusted ECI for 

total compensation of private industry professional and related workers (Series ID CIU2010000120000I) 

is used because it is the only series with continuous data since 1985, and that includes professional and 

technical labor, which perform the majority of Agency extramural activities. Table 11Table 11, below 

contains the derivation of inflation factors for Agency extramural costs. 

Table 11: Derivation of Inflation Factors for Agency Extramural Costs 

Item Inflation index source Starting 

year

Index 

for 

starting 

year 

(a) 

Index 

for 

2011 

(b) 

Inflation 

factor 

(b)/(a) 2

Agency Extramural costs 

White collar labor; 

equipment; supplies

BLS ECI, Total comp, Private 

industry, Professional and related, 

4th Q [BLS 2012b] 4

1993 67.0 115.7 1.73 

Source: 

Bureau of Labor Statistics. Employment Cost Index – Total Compensation: Professional and Related Private Industry, Not 

Seasonally Adjusted. (Series ID: CIU2010000120000I), extracted March 22, 2012 (BLS 2012b).

The Percent of Cases column in Table 12Table 12 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 

will 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. 

Values in the ‘Weighted Cost’ column are calculated by multiplying the un-weighted 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. As shown in Table 12Table 12, this calculation yields total Agency costs of $5,066, per 

SNUN, for submission review and processing. 
***FAR Draft – Deliberative – Do not Cite, Quote, or Release*** 

EO 12866 Review Draft – As Revised 11/20/2014 

Economic Analysis of SNUR for 29 U.S. EPA Office of PolluNine Benzidine Based Dyes Economic a

Table 12: 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

ePM

Burd

Reduc

FTE 

fraction 

Cost per 

FTE 1

FTE Total 

($2011) 

1993 

dollars 

2011 

dollars 

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

Pre-notice consultation 0.0024 $161,446 $387.47 $4.00 $6.91 $394 41% $161.70 0.1Administrative prescreen/ notice receipt/user fee 0.0024 $161,446 $387.47 $92.00 $158.87 $546 100% $546.34 0.1CRSS (Chemical Review and Search Strategy) 0.0025 $161,446 $403.62 $268.00 $462.80 $866 100% $866.42 0.1SAT (Structure Activity Team) 0.0006 $161,446 $96.87 $14.00 $24.18 $121 100% $121.04 0.1Engineering/Exposure 0.0015 $161,446 $242.17 $56.00 $96.70 $339 100% $338.87 0.1Exposure/Fate 0.0008 $161,446 $129.16 $0.00 $0.00 $129 100% $129.16 0.1Focus 0.0009 $161,446 $145.30 $23.00 $39.72 $185 100% $185.02 0.1Standard Review Functions 0.0219 $161,446 $3,535.68 $511.00 $882.43 $4,418 29% $1,281.25 0.1Division Directors Meeting 0.0129 $161,446 $2,082.66 $113.00 $195.14 $2,278 15% $341.67 0.1Order Development/Negotiation Review 

0.0171 $161,446 $2,760.73 $22.00 $37.99 $2,799 3% $83.96 0.1

Post Order Data Review 0.0886 $161,446 $14,304.15 $0.00 $0.00 $14,304 3% $429.12 0.1Order Modification 0.2167 $161,446 $34,985.43 $0.00 $0.00 $34,985 3% $1,049.56 0.1New Chemical SNUR Development 0.0277 $161,446 $4,472.07 $85.00 $146.78 $4,619 7% $323.32 0.1Notices of Commencement 0.0012 $161,446 $193.74 $40.00 $69.07 $263 31% $81.47 0.1FOIA (Freedom of Information Act) Requests 0.0333 $161,446 $5,376.17 $287.00 $495.61 $5,872 1% $58.72 0.1CBI (Confidential Business Information) Substantiation 0.0004 $161,446 $64.58 $3.00 $5.18 $70 100% $69.76 0.1TOTAL $6,067 0.1Notes: 1 GS-13 Step 5 salaries loaded with benefits and overhead. See Table 10Table 10 for derivation.2 Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993 prices using the 11Table 11. 
***FAR Draft – Deliberative – Do not Cite, Quote, or Release*** 

EO 12866 Review Draft – As Revised 11/20/2014 

Economic Analysis of SNUR for 30 U.S. EPA Office of PolluNine Benzidine Based Dyes Economic a

3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values shown in this table4 Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009b, p. 28).

Sources: FTEs per review step, 1993 extramural costs, and percent of cases are from EPA, 1994 Table VII-1, GS-13 salaries are from OPM 2011.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Based Chemical Substances 31 Economic and Policy Analysis Branch 

3.3 Export Notification Cost 

Under TSCA Section 12(b), exporters must notify EPA if they intend to export chemicals subject to 

SNURs. 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 U.S. embassies (EPA, 2009b). However, as stated in Section 2.2.7, EPA 

believes there will be no notifications from this rulemaking as there are no U.S. manufacturers; therefore, 

the Agency will not incur any costs associated with export notification as a result of the SNUR. 

 
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Based Chemical Substances 32 Economic and Policy Analysis Branch 

4. ADDITIONAL ANALYSES 

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

various statutes and executive orders. 

4.1 Regulatory Flexibility Act 

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency 

hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a 

substantial number of small entities. The rationale supporting this conclusion is as follows. The 

requirement to submit a SNUN applies to any person (including small or large entities) who intends to 

engage in any activity described in the rule as a significant new use. Where a use is new, by definition no 

small or large entities presently engage in such activities. Although some small entities may decide to 

manufacture or process a substance for the new use after the SNUR is promulgated, EPA receives very 

few SNUNs, and few of those are submitted by small entities. In response to the promulgation of SNURs 

covering over 1,000 chemical substances, the Agency receives only a handful of SNUNs per year. For 

example, the number of SNUNs was four in Federal fiscal year 2005, eight in FY2006, six in FY2007, 

eight in FY2008, seven in FY2009, two in 2010, and ten in 2011 (EPA, 2012), for an average of 6 per 

year from all SNURs. EPA has no reason to believe that this SNUR will alter the pattern of SNUN 

submissions that EPA has historically seen. In addition, the estimated reporting cost for submission of a 

SNUN is minimal regardless of the size of the firm, averaging about $8,600 including SNUN 

recordkeeping and reporting costs. The Agency currently offers some relief to certain small businesses 

with sales (including those of subsidiary/parent companies) of less than $40 million per year by reducing 

the SNUN submission fee from $2,500 to $100. This lower fee reduces the cost of submitting a SNUN to 

about $6,200 for smaller firms. During the six year period from 2005-2010, only three submitters selfidentified as small in their SNUN submission30 (EPA, 2012). EPA believes the cost of submitting a 

SNUN is relatively small compared the cost of developing and marketing a chemical new to a firm and 

that the requirement to submit a SNUN generally does not have a significant economic impact. 

EPA believes that there will be minimal impact to processors and importers of the chemical substance 

subject to the final SNUR as part of an article. The SNUR does not require processors and importers of 

articles to conduct specific activities to ascertain if they are importing or processing chemicals regulated 

by the SNUR as part of an article. Therefore, processors and importers are, in all likelihood, expected to 

take actions that are commensurate with the level their perceived likelihood that the regulated chemical is 

part of the article they intend to process or importof risk (of a chemical being part of an article) each 

company perceives, and the resources it has available. EPA has no reason to believe that a firm would 

voluntarily incur substantial costs to evaluate its articles, but rather EPA believes each firm will choose 

the most efficient route to identify whether it is importing or processing the subject chemical substances 

as part of articles. 

4.2 Unfunded Mandates Reform Act 

The final rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have 

any effect on small governments because none of the current producers of the subject chemicals are 

governments. Additionally, it is not expected that any governments will initiate production of these 

chemicals. 

 

30 The three “small” submitters were identified by review of actual SNUN submissions from the years 2005-2010. 
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Based Chemical Substances 33 Economic and Policy Analysis Branch 

4.3 Paperwork Reduction Act 

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 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 OMB 

approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB 

Control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing 

in the Federal Register, are listed in 40 CFR, part 9, and included on the related collection instrument, or 

form, if applicable. The information collection requirements related to this action have already been 

approved by OMB pursuant to the PRA under OMB control numbers 2070-0038 (EPA ICR No. 1188) 

and 2070-0030 (EPA ICR No. 0795). 

If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average 98.2 hours 

per response: 0.82 hours for rule familiarization (Section 2.2.1); 2.80 hours for CDX registration, CDX 

electronic signature, and pay.gov account setup (Section 2.2.2); 92.2 hours for form completion, 

submission and recordkeeping under CFR §721.40 (Sections 2.2.3 and 2.2.4); 1 hour for consumer 

notifications (Section 2.2.5); and 1.36 hours for export notification (Section 2.2.6). The burdens for rule 

familiarization, CDX registration, CDX electronic signature, pay.gov account setup form completion, 

submission, and recordkeeping are approved under EPA ICR No. 1188 (OMB control number 2070-

0038). The burden for export notification is approved under EPA ICR No. 0795 (OMB control number 

2070-0030). 

4.4 Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations 

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

Low Income Populations” (59 FR 7629, February 16, 1994), establishes federal executive policy on 

environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and 

permitted by law, to make environmental justice part of their mission by identifying and addressing, as 

appropriate, disproportionately high and adverse human health or environmental effects of their programs, 

policies, and activities on minority populations and low-income populations in the United States. 

The information collected under this final rule will assist EPA and others in determining the potential 

hazards and risks associated with various benzidine-related chemicals. Although not directly impacting 

environmental justice-related concerns, this information will enable the Agency to better protect human 

health and the environment, including in low-income and minority communities. 

4.5 Executive Order 13045: Protection of Children from Environmental Health Risks and Safety 

Risks 

Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 

19885, April 23, 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 this SNUR will be less than $100 million. 

4.6 Executive Order 13132: Federalism 

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an 

accountable process to ensure “meaningful and timely input by State and local officials in the 

development of regulatory policies that have federalism implications.” Policies that have federalism 

implications are defined in the Executive Order to include regulations that have “substantial direct effects 
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Based Chemical Substances 34 Economic and Policy Analysis Branch 

on the 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” (64 FR 43255, August 10, 1999). 

The final rule establishes reporting and recordkeeping requirements that apply to manufacturers 

(including importers) and processors of certain chemicals. EPA has no information to indicate that any 

state or local government manufactures or processes the chemical substances covered by this action. 

 
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Based Chemical Substances 35 Economic and Policy Analysis Branch 

4.7 Executive Order 13175: Consultation and Coordination with Indian 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 EPA has no information to 

indicate that any tribal government manufactures or processes the chemical substances covered by this 

action. 

4.8 Executive Order 13211: Actions that Significantly Affect 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. 

4.9 Executive Order 13563, Improving Regulation and Regulatory Review 

Executive Order 13563, Improving Regulation and Regulatory Review (76 FR 3821, January 21, 2011), 

requires EPA to base regulations on the best available science; allow for public participation and the open 

exchange of ideas; promote predictability and reduce uncertainty; identify and use the best, most 

innovative, and least burdensome tools for achieving regulatory ends; consider both the costs and benefits 

qualitatively and quantitatively; and ensure regulations are accessible, consistent, written in plain 

language, and easy to understand. 

The proposed rule establishes reporting and recordkeeping requirements that apply to manufacturers 

(including importers) and processors of certain chemicals. Consistent with EO 13563, this document 

qualitatively and quantitatively describes both the costs and benefits of the proposed rule as well as the 

underlying data used in the analyses. EPA chose the best available data to analyze the costs and benefits 

described in this document and the best analytic approaches given the available data and other constraints. 
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Based Chemical Substances 36 Economic and Policy Analysis Branch 

5. BENEFITS 

A SNUN submission provides EPA with the opportunity to evaluate the intended use and, if necessary, to 

prohibit or limit that activity before it occurs. It allows the Agency to take immediate action to mitigate an 

activity that the Agency deems harmful to the environment or human health. The final SNUR allows EPA 

to evaluate the use of, or exposure to these chemicals and allow the Agency to take preventive action to 

limit or prohibit any Significant New Use. 

EPA requires additional information to fulfill its mandate under TSCA to fully assess the risks posed by 

the production, sale, use, and import in articles, such as imported finished textiles, of certain benzidinebased dyes in the United States. A SNUN submission provides EPA with the opportunity to evaluate the 

intended use and, if necessary, to prohibit or limit that activity before it occurs. It allows the Agency to 

take immediate action to mitigate an activity that the Agency deems harmful to the environment or human 

health. The final SNUR allows EPA to evaluate the use of, or exposure to, these chemicals and allows the 

Agency to take preventive action to limit or prohibit any Significant New Use. EPA also expects the final 

rule may restrict future uses and thereby exposures to the chemicals, as a company may choose to modify 

planned uses of the chemicals order to not be subject to the SNUR, as opposed to submitting a SNUN. 

Therefore, the final SNUR may limit future exposure (e.g., worker, consumer) to the chemicals. 

Quantification of the benefits of the final rule will require more specific information about each user’s use 

patterns and preferences, as well as the changes in these patterns and preferences that will result from the 

additional information made available under the final rule. These data are not readily available and 

collecting such data will be cost-prohibitive. 

 
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Based Chemical Substances 37 Economic and Policy Analysis Branch 

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Vipul Dye Chem LTD. 2010. “Products.” Accessed November 22, 2010. Available at: 

http://www.vipuldyes.com/

 

Winchem Industrial Co. LTD. 2010. “Products.” Accessed November 22, 2010. Available at: 

http://www.win-chemical.com/

Zeilmaker, M.J.; Rosese, E.D.; van Haperen, P.; van Veen, M.P.; Bremmer, H.J.; van Kranen, H.J.; 

Wouters, M.F.A.; Janus, J.A. 1999. Cancer risk assessment of azo dyes and aromatic amines 

from garment and footwear. RIVM Report 601503014. Netherlands. 

Zeilmaker, M.J.; van Kranen, H.J.; van Veen, M.P.; Janus, J.A. 2000. Cancer risk assessment of azo dyes 

and aromatic amines from tattoo bands, folders of paper, toys, bed clothes. 
APPENDIX A 

INFLATORS AND WAGE RATES
Economic Analysis of SNUR for A-1 U.S. EPA Office of Chemical Safety and Pollution Prevention 

Nine Benzidine Chemical Substances Economic and Policy Analysis Branch 

A. 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 presented in this report are in 2011 dollars. 

A.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 A-1. Costs 

are calculated for several labor categories: Managerial, Professional/Technical, Clerical, 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). 

A.1.1 Derivation of Labor Rates for Managerial, Professional/Technical, Clerical, and Production 

Labor 

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

Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data,31 for 

December 2011, for manufacturing industries.32

The cost of fringe benefits, such as paid leave and insurance, specific to each labor category, are taken 

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

category. For example, for December 2011, the average wage rate for professional/technical33 labor was 

$38.48; the average fringe benefit was $19.64. Fringe benefits as a percent of wages were $19.64/$38.48, 

or approximately 51.0 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 

 

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

Substances: EPA Docket OPPT-2003-0063 (EPAB, 2007b). 32 Employer Costs for Employee Compensation Supplementary Tables December 2011. (BLS, 2012a). This follows the 

approach introduced in EPAB, 2007a. Earlier PMN SNUR economic analyses, such as EPA, 2003, 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. 33 This follows terminology introduced in EPAB, 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).
Economic Analysis of SNUR for A-2 U.S. EPA Office of Chemical Safety and Pollution Prevention 

Nine Benzidine Chemical Substances Economic and Policy Analysis Branch 

rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b), 

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

This overhead loading factor is added to the benefits loading factor, and the total is then applied to the 

base wage to derive the fully loaded wage. For example, the December 2011 fully loaded wage for 

professional/technical labor is $38.48 × (1+0.5104 + 0.17) = $64.66. 

Fully loaded costs for managerial and clerical labor are calculated in a similar manner, as shown in Table 

A-1Table A-1. 

A.1.2 Derivation of Labor Rates for EPA Staff 

Agency labor costs are calculated based on annual Federal salaries for the Washington-Baltimore area 

published by the Office of Personnel Management effective January 2011 (OPM, 2011). The average 

salary for one FTE staff member is estimated as the salary for a GS-13 Step 5 employee.34 

Multiplying the annual pay by an assumed loading factor of 1.6 to reflect Federal fringe benefits and 

overhead, the loaded annual salary of EPA staff was calculated to be $161,446. 

The Agency loading factor is from an EPA guide, Instructions for Preparing Information Collection 

Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 percent assumption was labeled “the benefits 

multiplication factor” in the EPA Guide, but has been used in many EPA Office of Pollution Prevention 

and Toxics ICRs to reflect both fringe benefits and overhead for Federal staff. For example, it was used in 

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

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

factor). The multiplication factor used is recommended in EPA’s Office of Policy, Planning, and 

Evaluation’s Instructions for Preparing Information Collection Requests (ICRs) (June 1, 1992). An EPA 

internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 

1994, indicated that the 1.6 factor included not only benefits but also overhead. (ICR No.1139.06) 

 

34 The GS-13 Step 5 is consistent with ICR No. 0574.14 (12/18/2007), which covers PMN SNURs. Use of this grade level 

follows the approach introduced in EPAB, 2007a. That report represented a change from the earlier PMN SNUR economic 

analysis (EPA, 2003), which used an average of GS-12 Step 1 and GS-12 Step 10 salaries.
Economic Analysis of SNUR for A-3 U.S. EPA Office of Chemica

Nine Benzidine Chemical Substances Econo

Table A-1: Derivation of Loaded Wage Rates 

EPAB Labor 

Category Data Sources Date Wage Fringe Benefit Fringes as % Wage Over- head % Wage2 Fringe + Overhead Factor 

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

Managerial 

BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial”3

Dec-11 $43.01 $20.40 47.43% 17% 1.64 

Professional/ 

Technical 

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

Dec-11 $38.48 $19.64 51.04% 17% 1.68 

Clerical 

BLS ECEC, Private Manufacturing 

industries, “Office and Administrative Support” 3

Dec-11 $17.69 $8.93 50.48% 17% 1.67 

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. 3

Jan-11 $48.51 -- 

[Included in 

60% 

overhead] 

60% 1.6 

Notes: 1Wage data are rounded to the closest penny in this table; however, in calculations using these numbers for this report, unrounded values were used. 2An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b), 

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

3The salary is unloaded Federal GS-13 Step 5 salary for calendar year 2011, from the Office of Personnel Management salary table for Washington-Baltim

2011). The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992a, page 
Economic Analysis of SNUR for A-4 U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Chemical Substances Economic and Policy Analysis Branch 

A.2 Derivation of Inflation Factors 

Detailed information on the derivation of the inflation factors used is presented in Table A-2Table A-2. 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. 

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 

A-2Table A-2 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).35 

“Starting year” indices in Table A-2Table A-2 continue to be SIC-OCS 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. 

 

35 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 SNUR for A-5 U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Chemical Substances Economic and Policy Analysis Branch 

Table A-2: Derivation of Inflation Factors 

Item Inflation Index Source1 Starting

Year 

Index for 

Starting 

Year (a) 

Index for 

2011 

(b) 

Inflation 

Factor 

(b)/(a)2

Agency Extramural costs 

White collar labor; 

equipment; supplies

BLS ECI, Total comp, Private 

industry, Professional and 

related, 4th Q [BLS, 2012b]3

1993 67 115.7 1.727

Labels, placards etc. BLS CPI, All urban consumers, 

not SA. CUUR0000SA0, Annual 

[BLS, 2012c] 

1997 160.5 224.939 1.401

File cabinet 

 

Photocopies BLS CPI, All urban consumers, 

not SA. CUUR0000SA0, Annual 

[BLS, 2012c] 

Record keeping materials 1988 118.3 224.939 1.901

 

Key: BLS = Bureau of Labor Statistics. CPI = Consumer Price Index. ECI = Employment Cost Index. SA = Seasonally Adjusted. Total 

Comp = Total Compensation (wages/salaries and benefits). 4th Q = Fourth Quarter. “ECS10002I” etc. refer to BLS series Ids. 

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. 

2Inflation factors are rounded; however, unrounded values were used in calculations. 

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

OPPT-2009-0922 (EPA, 2011b) 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 “whitecollar” series.
Economic Analysis of SNUR for B-1 U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Chemical Substances Economic and Policy Analysis Branch 

APPENDIX B – BENZIDINE-BASED DYES SPECIFIED AT 40 CFR SECTION 721.1660 

Table B-1 provides a list of the benzidine-based dyes specified at 40 CFR section 721.1660. It also 

indicates whether or not EPA found evidence of current manufacture of the dye, and where that 

manufacture occurred. 

Table B-1: Benzidine-Based Dyes Specified at 40 CFR Section 721.1660 

CAS No. Chemical Name1 Current 

Manufacture? 

92-87-5 [1,1′-Biphenyl]-4,4′-diamine [CI Azoic Diazo Component 112] N 

531-85-1 [1,1′-Biphenyl]-4,4′-diamine, dihydrochloride N 

573-58-0 1- Naphthalenesulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[4-amino-, 

disodium salt [CI Direct Red 28] Domestic 

1937-37-7 

2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2, 4-diaminophenyl)azo][1,1′-

biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt [CI Direct Black 

38] 

Domestic 

2302-97-8 1-Naphthalenesulfonic acid, 8,8′-[[1,1′-biphenyl] -4,4′-diylbis(azo)]bis[7-

hydroxy-, disodium salt [CI Direct Red 44] N 

2429-73-4 

2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4′-[(7-amino-1-hydroxy-3-sulfo-2-

naphthalenyl)azo][1,1′-biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt [CI Direct 

Blue 2] 

Domestic 

2429-79-0 Benzoic acid, 5-[[4′-[(1-amino-4-sulfo-2-naphthalenyl)azo][1,1′-biphenyl]-4-

yl]azo]-2- hydroxy-, disodium salt [CI Direct Orange 8] Domestic 

2429-81-4 

Benzoic acid, 5-[[4′-[[2,6-diamino-3-[[8-hydroxy-3,6-disulfo-7-[(4-sulfo-1-

naphthalenyl)azo]-2-naphthalenyl]azo]-5-methylphenyl]azo][1,1′-biphenyl]-4-

yl]azo]-2-hydroxy-, tetrasodium salt [CI Direct Brown 31] 

Domestic 

2429-82-5 Benzoic acid, 5-[[4′-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1′-

biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt [CI Direct Brown 2] Global 

2429-83-6 

2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2,4-diamino-5-

methylphenyl)azo][1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium 

salt [CI Direct Black 4] 

N 

2429-84-7 Benzoic acid, 5-[[4′-[(2-amino-8-hydroxy-6-sulfo-1-naphthalenyl)azo][1,1′-

biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt [CI Direct Red 1] N 

2586-58-5 

Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4-

sulfophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt 

[CI Direct Brown 1:2] 

Global 

2602-46-2 2,7-Naphthalenedisulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5-

amino-4-hydroxy-, tetrasodium salt [CI Direct Blue 6] Domestic 

2893-80-3 Benzoic acid, 5-[[4′-[[2,4-dihydroxy-3- [(4-sulfophenyl)azo]phenyl]azo][1,1′-

biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt [CI Direct Brown 6] N 

3530-19-6 1,3-Naphthalenedisulfonic acid, 8-[[4′-[(4-ethoxyphenyl)azo][1,1′-biphenyl]-4-

yl]azo]-7-hydroxy-, disodium salt [CI Direct Red 37] Global 

3567-65-5 

1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4′-[[4-[[(4-

methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-, disodium salt 

[CI Acid Red 85] 

Global 

3626-28-6 

2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-3-[[4′-[(4-

hydroxyphenyl)azo][1,1′- biphenyl]-4-yl]azo]-6-(phenylazo)-, disodium salt [CI 

Direct Green 1] 

Global 

3811-71-0 Benzoic acid, 5-[[4′-[[2,4-diamino-5-[(4- sulfophenyl)azo]phenyl]azo][1,1′-

biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt [CI Direction Brown 1] N 
Economic Analysis of SNUR for B-2 U.S. EPA Office of Pollution Prevention and Toxics 

Nine Benzidine Chemical Substances Economic and Policy Analysis Branch 

Table B-1: Benzidine-Based Dyes Specified at 40 CFR Section 721.1660 

CAS No. Chemical Name1 Current 

Manufacture? 

4335-09-5 

2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-6-[[4′-[(4-

hydroxyphenyl)azo][1,1′-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium 

salt [CI Direct Green 6] 

Domestic 

6358-80-1 

2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-3-[[4′-[[4-hydroxy-2-[(2-

methylphenyl)amino]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-6-[(4-

sulfophenyl)azo]-, trisodium salt [CI Acid Black 94] 

N 

6360-29-8 

Benzoic acid, 5-[[4′-[[4-[(4-amino-7-sulfo-1- naphthalenyl)azo]-6-sulfo-1-

naphthalenyl]azo][1,1′-biphenyl]-4-yl]azo]-2-hydroxy-, trisodium salt [CI Direct 

Brown 27] 

N 

6360-54-9 

Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4-

sulfophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-2-hydroxy-3-methyl-, 

disodium salt [CI Direct Brown 154] 

Domestic 

8014-91-3 

Benzoic acid, 3,3′-[(3,7-disulfo-1,5- naphthalenediyl)bis[azo(6-hydroxy-3,1-

phenylene)azo[6(or7)-sulfo-4,1-naphthalenediyl]azo[1,1′-biphenyl]-4,4′- 

diylazo]]bis[6-hydroxy-, hexasodium salt [CI Direct Brown 74] 

N 

16071-86-6 

Cuprate(2-), [5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy- 5-

sulfophenyl)azo]phenyl]azo][1,1′-biphenyl] -4-yl]azo]-2-hydroxybenzoato(4-)]-, 

disodium [CI Direct Brown 95]

Domestic 

1. Common names are not unique identifiers as they may correspond to more than one CAS No.; however, they are frequently 

used, even in peer-reviewed literature.