Economic Analysis of the Proposed Significant New Use Rule for Nine 

Benzidine Based Dyes

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

RIN 2070-AJ73)

FINAL

—Does not contain TSCA CBI—

Prepared by:

Economic and Policy Analysis Branch

Economics, Exposure and Technology Division

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, N.W.

Washington, DC 20460
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Nine Benzidine Based Dyes i Economic and Policy Analysis Branch

CONTRIBUTORS

The EPA analyst responsible for this report was Lynne Blake-Hedges. Analytical and draft preparation 

support was provided by Abt Associates Inc. under EPA Contract No. EP-W-08-010.
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Nine Benzidine Based Dyes ii Economic and Policy Analysis Branch

ABSTRACT

This report estimates the costs of the U.S. Environmental Protection Agency (EPA)’s proposed 

Significant New Use Rule (SNUR) that adds the nine benzidine-based dyes specified in Table 1 to an 

existing SNUR for benzidine-based chemical substances at 40 CFR section 721.1660 The proposed rule

also revokes the article exemption described in 40 CFR section 721.45(f) for the chemical substances 

included in 40 CFR 721.1660(a)(1) (see Appendix A) as well as the nine chemicals in the proposed rule.

1

Table 1: Benzidine-Based Dyes Subject to Proposed 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 precursors in the 

synthesis of dyes. These dyes (called azo dyes) have historically been used in the production of 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 dyes.

The most recent data from the Toxic Substances Control Act (TSCA) Inventory Update Reporting (IUR) 

database (2006 reporting) indicates no evidence of production of the nine new benzidine-based dyes 

subject to the proposed rule (EPA 2006a). 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 dyes listed in

Table 1. In addition, no manufacturers of any of the dyes subject to the proposed rule were listed in the 

Colour Index or identified through internet queries.2

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

and other analytical reagents.

However, global and domestic manufacturers for 

several of the dyes specified at 40 CFR section 721.1660 were identified; although, information is 

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).
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insufficient to determine if the currently manufactured dyes 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 

proposed rule.

The proposed rule would require persons to notify EPA at least 90 days before commencing the

manufacture, import, or processing of any of the dyes specified in Table 1. It would 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 any of the dyes subject to the proposed rule or specified at 40 CFR section 

721.1660. A firm intending to engage in these activities would be required to submit a Significant New 

Use Notice (SNUN). While EPA is encouraged by the discontinuation of the use of the dyes subject to the 

proposed rule, it is concerned that the manufacture, import, and processing of these dyes and the articles 

containing them could be reinitiated in the future. EPA is also concerned that articles containing the dyes

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 $8,112 and potentially other minor 

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

article the dyes subject to the proposed rule, global and domestic manufacturers of several of the dyes 

specified at 40 CFR section 721.1660 were identified. However, there is there is insufficient information 

to conclude that these currently manufactured dyes 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 proposed 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 proposed SNUR.

In addition to the firms that make a SNUN submission, the proposed 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 not 

manufacture or import of chemicals in Table 1 and that there is no evidence to suggest that the dyes 

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

processed domestically as part of articles. 

However, costs are estimated at the firm level and reflect the burden of a SNUR on firms that may make a 

SNUN submission. 
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Nine Benzidine Based Dyes iv Economic and Policy Analysis Branch

TABLE OF CONTENTS

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

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

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

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

Uses and Substitutes...................................................................................................................2

Health Effects.............................................................................................................................3

Environmental Exposure ............................................................................................................3

Current Manufacturing ...............................................................................................................3

1.2 Statutory Authority.....................................................................................................................4

1.3 Summary of Methodology..........................................................................................................4

1.4 Organization of this Report ........................................................................................................4

2. INDUSTRY COMPLIANCE COSTS ..................................................................................................5

2.1 Wage Rates.................................................................................................................................6

2.2 Unit Industry Compliance Costs.................................................................................................6

2.2.1 Rule Familiarization ......................................................................................................7

2.2.2 CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup................7

2.2.3 Form Completion and Submission Fee..........................................................................8

2.2.4 Recordkeeping.............................................................................................................10

2.2.5 Import Certification .....................................................................................................10

2.2.6 Export Notification......................................................................................................10

2.3 Industry Costs of SNUR, by Option.........................................................................................12

2.4 Likelihood of a SNUN Submission ..........................................................................................13

2.5 Potential for Subsequent Regulatory Action ............................................................................14

3. AGENCY COSTS...............................................................................................................................15

3.1 Labor Rates for EPA Staff........................................................................................................15

3.2 SNUN Processing Costs...........................................................................................................16

3.3 Export Notification Cost...........................................................................................................19

4. ADDITIONAL ANALYSES..............................................................................................................20

4.1 Regulatory Flexibility Act ........................................................................................................20

4.2 Unfunded Mandates Reform Act..............................................................................................20

4.3 Paperwork Reduction Act.........................................................................................................20

4.4 National Technology Transfer and Advancement Act .............................................................21

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

Populations and Low-Income Populations...............................................................................21

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

Risks .........................................................................................................................................21

4.7 Executive Order 13132: Federalism.........................................................................................21

4.8 Executive Order 13175: Consultation and Coordination with Indian Tribal Governments....21

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

..................................................................................................................................................21

5. Benefits...............................................................................................................................................22

6. REFERENCES....................................................................................................................................23

7. Appendix A – Benzidine-Based Dyes Specified at 40 CFR section 721.1660...................................27
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LIST OF TABLES

Table 1: Benzidine-Based Dyes Subject to Proposed SNUR .......................................................................1

Table 2: Loaded Industry Wage Rates, December 2009...............................................................................6

Table 3: Rule Familiarization Burden and Cost for SNUR Submitters........................................................7

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

First-Time Submitters...................................................................................................................................8

Table 5: Industry Cost Estimate to Complete the SNUN Form....................................................................9

Table 6: Industry Cost Estimate to Complete and Submit the SNUN Form.................................................9

Table 7: Derivation of Total Mailing Cost for 12 Notices..........................................................................11

Table 8: TSCA 12(b) Export Notification Cost per Notification................................................................12

Table 9: Compliance Options and Associated Costs Incurred by a Firm Due to the Proposed SNUR ......13

Table 10: Derivation of Loaded Agency Wage Rates ................................................................................16

Table 11: Derivation of Inflation Factors for Agency Extramural Costs....................................................17

Table 12: Agency Costs for SNUN and Other Submission Review and Processing..................................18

Table 13: TSCA 12(b) Export Notification Cost: Agency Burden per Activity (2009$)...........................19

Table 14: Benzidine-Based Dyes Specified at 40 CFR Section 721.1660..................................................27
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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 proposed Significant New Use 

Rule (SNUR) that adds the nine benzidine-based dyes listed in Table 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 in 40 CFR 721.1660(a)(1) (see Appendix A) as well as the nine 

chemicals included in the proposed rule. However, the proposed rule does not revoke the exemptions 

granted in 40 CFR section 271.1660(a)(2) for uses as laboratory stains and other analytical reagents.

Table 1: Benzidine-Based Dyes Subject to Proposed 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.

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

SNUR would require persons to notify EPA at least 90 days before commencing any manufacture, 

import, or processing of the benzidine-based dyes subject to the proposed rule or any import or processing

of articles containing them or the dyes specified at 40 CFR section 721.1660.

3.4

 3 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 would 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)) would remain in force. Thus, persons who export benzidine-based dyes as part of an article would 

not be required to provide export notification.

EPA promulgates a 

4 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).
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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

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

consumer exposure to products containing these dyes is still a potential concern. 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).5

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).

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, 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 to cease sales by the authorities (European 

Commission, 2010). Therefore, azo dyes in imported articles still remain a potential issue in the E.U.

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 

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

Uses and Substitutes

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.

Azo dyes are used in the production of textiles, paints, printing inks, paper, and pharmaceuticals. They are 

also used as reagents and biological stains in laboratories, and in the food industries (Dapson, 2009). As 

mentioned above, the 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

proposed SNUR.

 5 See Restriction 43 in REACH Annex XVII.

6 The four non-CBI benzidine-based dyes listed inTable 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.
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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 the 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.

7

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 would 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 would be available in large 

concentrations or locations to be of concern to the general population.

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

would 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). 

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 TSCA IUR 

database (2006 reporting) did not indicate any domestic manufacture or import of the dyes subject to the

proposed SNUR.

8

Table 1

EPA did not receive comment after the publication of the Benzidine Dyes Action Plan

to indicate any ongoing production of the four non-CBI dyes listed in . In addition, none of the

dyes subject to the proposed SNUR were found in the Colour Index or during internet queries for 

manufacturers. However, global manufacturers were identified for 14 of the 24 dyes specified at 40 CFR 

 7 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).

8 The IUR 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 

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.
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section 721.1660.

9

,

10

1.2 Statutory Authority 

Nine of which were also manufactured domestically. However, 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.

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 

Significant New Use Notice (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 to society of the proposed rule by identifying the 

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

EPA of administering the rule. Industry costs may 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.

1.4 Organization of this Report

The remainder of this report provides EPA’s economic analysis in support of the proposed rule. Section 2

presents estimates of the costs incurred by manufacturers, importers, and/or processors under the SNUR 

options. Section 3 shows estimates of the government costs associated with the administration of the 

proposed rule. Chapter 4 presents an analysis of other impacts, as required by various statutes and 

executive orders.

Note that all dollar amounts in this analysis are reported in December 2009 dollars, the latest year with

complete data.

 9 There were three dyes for which there was some information suggesting current production; however, it was not 

possible to verify this information.

10 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 soley by common name may not be the same chemical 

subject to the SNUR. 
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2. INDUSTRY COMPLIANCE COSTS

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

dyes specified in Table 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 proposed rule revokes the article exemption described in 40 CFR 

section 721.45(f) for the chemicals specified in 40 CFR 721.1660(a)(1) (see Appendix A) as well the nine 

chemicals in the proposed rule. Therefore, a firm intending to manufacture, import, or process the dyes

subject to the proposed rule for any non-exempt use, or import or process articles containing dyes subject 

to the proposed 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 dyes 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 dyes subject to the proposed rule for any use excluding 

as laboratory stains and other analytical reagents, and/or any import and processing of articles 

containing dyes subject to the proposed rule or specified at 40 CFR section 721.1660.

11.12

2.2.6

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. If EPA allows for a significant new use, then 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 for details). Because there is no evidence to suggest that the currently manufactured 

dyes are being imported and/or processed domestically, EPA expects no firms will choose this option. 

• Option 2: Decide not to manufacture, import, and/or process the chemical. The firm may decide 

simply not to proceed to manufacture, import, or process the dyes subject to the proposed rule, or 

import or process articles containing these dyes or those specified at 40 CFR section 721.1660. 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 dye 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 expected to be minimal, if not zero, because there is no evidence to 

suggest that the current domestic manufacturers of the dyes specified at 40 CFR section 721.1660 use 

the dyes in articles. If the firm elects to produce the dye 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. 

 11 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 would 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)) would remain in force. Thus, persons who export benzidine-based dyes as part of an article would 

not be required to provide export notification.

12 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).
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 6 Economic and Policy Analysis Branch

Because there is no evidence to suggest that the currently manufactured dyes 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 proposed SNUR. Section 2.1 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 proposed 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 2009 are provided by the Employer Costs for Employee 

Compensation (ECEC) Supplemental Tables available on the BLS website (BLS 2010a). The loaded 

wage rate for managerial labor is $68.24; for technical labor, $59.49; and for clerical labor, $28.31. Table 

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

Table 2: Loaded Industry Wage Rates, December 2009

Labor 

Category Data Sources

Wage

(2009$)

Fringe 

Benefit

(2009$)

Fringes 

as % 

wage

Overhead % 

wage2

Fringe + 

overhead 

factor

Loaded 

Wages1

(2009$)

(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

$42.36 $18.68 44.10% 17% 1.61 $68.24

Professional/

Technical

BLS ECEC, Private 

Manufacturing industries, 

“Professional and related“3

$35.96 $17.42 48.44% 17% 1.65 $59.49

Clerical

BLS ECEC, Private 

Manufacturing industries,

“Office and Administrative 

Support” 3

$17.21 $8.17 47.47% 17% 1.64 $28.31

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 2009. US Bureau of Labor Statistics, March 10, 

201- (BLS 2010a).

2.2 Unit Industry Compliance Costs
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 7 Economic and Policy Analysis Branch

2.2.1 Rule Familiarization

The proposed rule requires submitters and their staff to become familiar with the SNUR and its various 

requirements. The per company burden associated with rule familiarization is approximately 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). As shown in Table 3 the total 

labor cost associated with rule familiarization by a first-time reporter is $50.92.

Table 3: Rule Familiarization Burden and Cost for SNUR Submitters

Reporting Activity

Clerical Labor (at 

$28.31/hour)

Technical Labor (at 

$59.49/hour)

Managerial Labor 

(at $68.24/hour)

Total Labor Cost

Burden

(hours)

Cost

(2009$)

Burden

(hours)

Cost

(2009$)

Burden

(hours)

Cost

(2009$)

Burden

(hours)

Cost

(2009$)

Rule Familiarization 0.00 $0.00 0.55 $32.72 0.27 $18.20 0.82 $50.92

Total 0.00 $0.00 0.55 $32.72 0.27 $18.20 0.82 $50.92

Source: BLS 2010a (labor rates); EPA 2009a (burden hours)

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

The proposed SNUR requires first-time submitters (that is, those companies who have not submitted 

information to EPA through CDX before) 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.

13

• 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.

These activities are only required of first-time submitters (companies already registered with CDX would 

not need to re-register for the purposes of complying with the proposed SNUR). The burdens associated 

with these activities were estimated in the Economic Analysis of the Premanufacture Notification 

Electronic Reporting Final Rule (EPA, 2009a) and are described in more detail below:

• 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 

per employee. This burden will apply to four technical staff members and one manager per 

company, totaling to 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 requires an additional mailing cost of $2.30 per 

company (including five $0.44 stamps and five $0.02 business envelopes) (USPS 2010).

 13 Although the proposed rule does not specifically require submitters to establish and use a Pay.gov account, the 

burden estimates in this analysis are higher-end insofar as to include the use of Pay.gov as a required activity.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 8 Economic and Policy Analysis Branch

• 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 4, the cost associated with CDX registration, CDX electronic signature, and Pay.gov 

account setup is $178.21, 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 

$28.31/hour)

Technical Labor (at 

$59.49/hour)

Managerial Labor 

(at $68.24/hour) Total Cost

Burden

(hours)

Cost

(2009$)

Burden

(hours)

Cost

(2009$)

Burden

(hours)

Cost

(2009$)

Burden

(hours)

Cost

(2009$)

CDX Registration 0.00 $0.00 0.73 $43.63 0.18 $12.51 0.92 $56.13

CDX Electronic 

Signature 0.00 $0.00 1.00 $59.49 0.75 $51.18 1.75 $110.67

Mailing Cost $2.30

E-Payment (Pay.gov

ID) 0.00 $0.00 0.00 $0.00 0.13 $9.10 0.13 $9.10

Total 0.00 $0.00 1.73 $103 1.07 $72.79 2.80 $178

Source: BLS, 2010a (labor rates); EPA, 2009a (burden hours); USPS, 2010 (mailing cost)

2.2.3 Form Completion and Submission Fee

Respondents 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 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 proposed 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 Significant New Use Notice (SNUN) form are based on the costs 

of completing a Premanufacture Notification (PMN) submission, since the data requirements are the same 

and the same form is used for both. The PMN submission costs are based on EPA's 1994 Regulatory 

Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications and the 

updates to this estimates in 2009 (EPA 2009a). The original 1994 estimates 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).

14

 14 Table III-2 and pages III-11, -12, and -13.

The 1994 estimates were 

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

American Chemistry Council. 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, 
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 9 Economic and Policy Analysis Branch

1994).

15 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 associated with preparing a SNUN (EPA 2009a)

16. In addition, electronic 

submission is expected to generate 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 73.68 hours of technical labor 

and 18.00 hours of managerial labor. Table 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 $5,612.

Table 5: Industry Cost Estimate to Complete the SNUN Form

Reporting Activity

Clerical Labor (at 

$28.31/hour)

Technical Labor (at 

$59.49/hour)

Managerial Labor 

(at $68.24/hour) Total Labor Cost

Burden

(hours)

Cost

(2009$)

Burden

(hours)

Cost

(2009$)

Burden

(hours)

Cost

(2009$)

Burden

(hours)

Cost

(2009$)

Form Completion 0.00 $0.00 73.68 $4,414 18.00 $1,228 91.68 $5,612

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 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 

$8,112 for large business submitters and $5,712 for small business submitters.

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

Reporting Population Labor Cost Submission Fee Total Cost 

(2009$)

Large Business Submitters $5,612 $2,500 $8,112

Small Business Submitters $5,612 $100 $5,712

Source: EPA, 2009a.

 15 p. III 11-13

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

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

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

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

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

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

from the ePMN EA in order to avoid double counting.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 10 Economic and Policy Analysis Branch

2.2.4 Recordkeeping

Companies submitting a SNUN must keep records under 40 CFR §721.40. Some EPA reports have 

assumed that SNUN recordkeeping hours would 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 were not separately estimated.

17

2.2.5 Import Certification

In general, promulgation of a final 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 proposed SNUR would 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.18

In practice, import certification is fulfilled by checking a box on an invoice or entry document and 

generally imposes no additional burden or cost on the importer (EPA 2009b). Any potential burden 

associated with a submitter’s familiarization with this requirement is assumed to be included in the more 

general SNUR familiarization burden discussed above.

The statement must be on or attached to a 

commercial invoice or entry document belonging to the imported shipment.

2.2.6 Export Notification

Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical or 

an article subject to various TSCA sections (40 CFR §707.60 through 75).

19 For TSCA 5(a)(2) (the 

section under which EPA promulgates significant new use rules) and certain other TSCA sections, this is 

a one-time notification requirement per destination country for each exporter of a chemical substance.

20

 17 SNUN submission costs estimated in Section 

After receiving a notification from a firm, EPA notifies the importing country and the U.S. State 

Department (40 CFR §707.70). To calculate the burden associated with making export notifications, EPA 

first estimated the average annual number of export notifications made by an exporter. EPA then derived 

the annual and per notification burden associated with preparing and submitting an export notification. 

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. 18 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)

19 While companies which manufacture or process the benzidine-based dyes subject to the proposed SNUR solely 

for export are exempt from the notification requirements of 40 CFR 721.25 if the chemical is labeled in accordance 

with TSCA section 12(a)(1)(B), they are required to submit export notifications under section 12(b). 20 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). 
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 11 Economic and Policy Analysis Branch

Exporter Costs21

The 2009 TSCA Section 12(b) ICR estimated the annual export notification cost for an exporter under the 

one-time export notification requirement (EPA 2009b).22

The per-notification cost was calculated based on the assumption that the average exporter makes 12 

notifications per year.

These costs include the cost to the exporter of 

compiling a list of their products that are subject to TSCA Section 12(b) requirements, writing or revising 

an export notification letter to EPA, checking the outgoing shipments, and sending the notification letters 

with the associated shipping costs. 

23

Estimated Submission (Mailing) Costs. Regulated companies will incur mailing costs for export 

notifications delivered to EPA. Notifications are assumed shipped via the U.S. Postal Service (USPS) as 

first-class registered mail with a return receipt (USPS 2010). The estimated per-shipment and annual 

mailing costs incurred by individual submitters are detailed in 

Exporters making more notifications per year may benefit from economies of 

scale and have lower costs per notification; those making fewer notifications may have higher costs per 

notification.

Table 7.

Table 7: Derivation of Total Mailing Cost for 12 Notices

Dates that the rates were verified on United States Postal Service web site: April 2010

Postal services costs

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

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

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

Cost per export notice – Subtotal $13.34

Source: Mailing rates are from the US Postal Service web site as of April 2010 (http://www.usps.com/prices/). The mailing 

method comes from the Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification 

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

Compile and Maintain the List of Products. Since TSCA §12(b) information collection activity has been 

in place for twenty years, most respondents will have already developed a list of their products subject to 

TSCA §12(b) export notification. Respondents need only check for new regulations promulgated and any 

new products exported by the company. Updating the list is estimated to take an average of one hour of 

technical time, which may also include some proportion of legal time (EPA 2009b). The total burden can 

vary from two hours per year up to two hours per month, depending on the number of products exported 

by the company and the number of their products subject to TSCA §12(b) (EPA 2009b).

Write or Revise Export Notification. Companies that export chemicals subject to TSCA §12(b) reporting 

must prepare an export notification to send to EPA when export shipments are made. Time for initial 

preparation of the export notice may vary depending on whether the company has prior experience with 

this requirement. This step is estimated to take an average of one hour of technical time (which may also 

include some proportion of legal time) per firm per year for 12 notifications per year, or 0.08 hours per 

 21 Most underlying data in this section come from the 2009 TSCA Section 12(b) ICR, ICR No.: 0795.13 

[Information Collection Request for] Notification of Chemical Exports - TSCA Section 12(b) Supporting Statement 

for Request for OMB Review under the Paperwork Reduction Act (EPA 2009b), with updating for inflation.

22 page 11, Table 3 23 EPA calculated the average number of export notifications per exporter in the 2009 TSCA Section 12(b) ICR

(EPA 2009b) by dividing the estimated number of submitted notifications (3,500) by the estimated number of 

exporters (300).
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 12 Economic and Policy Analysis Branch

notification (EPA 2009b). EPA has no evidence to suggest that the current domestic manufacturers of the 

dyes specified at 40 CFR section 721.1660 strictly export them or articles containing them and does not 

expect that this will start.

Check Orders and Send Notifications. Companies that export chemicals subject to TSCA §12(b) reporting 

must check outgoing shipments against the list of their products described above. A form letter notifying 

EPA and providing the required data must be printed and mailed within the required time period. This 

process is estimated to take an average one half hour of clerical time per export notification (EPA 2009b). 

The burdens and associated costs for each notification activity are provided in Table 8 below. 

Table 8: TSCA 12(b) Export Notification Cost per Notification

Technical Clerical Total

$/Hr Hours 2009$ $/Hr Hours 2009$ 2009$ Hours

Compile list $59.49 0.78 $46.08 -- -- -- $46.08 0.78

Write letter $59.49 0.08 $4.96 -- -- -- $4.96 0.08

Check order and send 

notice -- -- -- $28.31 0.50 $14.17 $14.17 0.50

Mailing cost1 -- -- -- $13.34 -

Total per notification 0.86 $51.04 0.50 $14.15 $78.54 1.36

Notes:

1 Mailing costs reflect April 2010 USPS rates and can be found in Table 7. 2

Per notification costs are based on an average facility submitting 12 export notifications per year.

Source: ICR No.: 0795.13 [Information Collection Request for] Notification of Chemical Exports - TSCA Section 

12(b) Supporting Statement for Request for OMB Review under the Paperwork Reduction Act (EPA 2009b, p.10), 

and are updated to 2009 dollars. 

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 proposed rule, as 

described in more detail in section 2.2 above.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 13 Economic and Policy Analysis Branch

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

Option1 Costs Quantified Costs per Chemical (2009$)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

$50.92 rule familiarization cost; $8,112 

submission cost (including SNUN 

recordkeeping and $2,500 fee). EPA usually 

receives well under ten SNUNs per year. 

Based on review of recent SNUNs, it appears 

that firms rarely conduct toxicity or fate testing 

to support a SNUN (such testing would be 

voluntary).3 Export notifications costs are 

estimated at $78.54 per notification; total cost 

per company will vary based on the number of 

countries of export. Those submitting 

information electronically through CDX for the 

first time would incur $178 for CDX 

registration and associated activities.

required by law.

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 including rule familiarization ($50.92), 

and export notification costs ($78.54 per 

notification if the chemical is exported only) 

would apply. 

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 proposed 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 proposed 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 would not otherwise follow the specified practices. 

Costs are detailed in Section 2.2. 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 proposed SNUR.

2.4 Likelihood of a SNUN Submission

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

containing them have been phased out. Additionally, there appears to be no production of the majority of 

the dyes specified at 40 CFR section 721.1660 either domestically or globally. 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.)24

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).

.

25

 24 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 soley by common name may not be the same chemical 

subject to the SNUR. 

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

25 See Restriction 43 in REACH Annex XVII.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 14 Economic and Policy Analysis Branch

Commission, 2010) and certain azo dyes in articles may remain an ongoing issue. However, there is not 

sufficient information to conclude 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. 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 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). Therefore,

EPA believes that submission of a SNUN for these chemicals is unlikely. 

2.5 Potential for Subsequent Regulatory Action

EPA recognizes that if submission of a SNUN does result from the proposed SNUR, the Agency may 

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

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

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

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

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

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

SNUN is being reviewed). 

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

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

assessment of the costs and benefits of those actions.
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Nine Benzidine Based Dyes 15 Economic and Policy Analysis Branch

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 2009 (OPM 2009). EPA assumes 

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

administrative activities under the proposed rule.26

Table 10

The average salary for a GS-13 Step 5 employee was 

$98,518 in 2009 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, which results in a fully loaded annual salary of $157,629 (see ). Dividing the fully 

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

compensation wage rate of $75.78.

The Agency loading factor of 1.6 is from an EPA guide entitled Instructions for Preparing Information 

Collection Requests (ICRs) (EPA 1992).27

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.

The 60 percent assumption was labeled “the benefits 

multiplication factor” in the EPA guide, but has been used in many EPA OPPT ICRs to reflect both fringe 

benefits and overhead for federal staff. For example, it was used in a document supporting EPA ICR No. 

1139.06 (EPA 2000), with the following explanation:

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

 26 The GS-13 Step 5 is consistent with ICR No. 0574.14 (12/18/2007) (EPA, 2007b), 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.

27 page 30, footnote 9.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 16 Economic and Policy Analysis Branch

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

Dec09

$98,518 

(annual)

--

[Included 

in 60% 

overhead]

60% b 1.60

$157,629 

(annual)

$47.36 

(hourly)

$75.78 

(hourly)

Notes: a The Agency salary is the unloaded federal GS-13 Step 5 salary ($98,518 for 2009), from the OPM salary table for the 

Washington-Baltimore-Northern Virginia Locality Pay Area (OPM 2009). 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 a1994 EPA report entitled,

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

Notifications (EPA 1994).28 The Agency burden associated with processing a PMN 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 reduce Agency burden by 16.5 percent (EPA, 2009a).

29

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 2010b). 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 11, below contains the 

derivation of inflation factors for Agency extramural costs.

 28 Table VII-1.

29 p. 28.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 17 Economic and Policy Analysis Branch

Table 11: Derivation of Inflation Factors for Agency Extramural Costs

Item Inflation index source Starting 

year

Index for 

starting 

year

(a)

Index 

for 

2009

(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 2010d] 4

1993 67.0 111.4 1.663

Source:

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

Seasonally Adjusted. (Series ID: CIU2010000120000I), extracted April 12, 2010 (BLS 2010b).

The Percent of Cases column in Table 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 

would be submitted, on average, with a PMN. Resources were not available to update the review hours to 

reflect the current review process or to tailor the cost estimates to SNUNs. Therefore, for this analysis, the 

review steps and weighting factors are assumed to be the same as those derived in 1994 for PMNs.

The Weighted Cost column is calculated by multiplying the 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 12, this calculation yields total Agency costs of $4,934, per SNUN, for submission 

review and processing.
Economic Analysis of SNUR for 18 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes Economic and Policy Analysis Branch

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

ePMN 

Burden 

Reduction4

Weighted Cost 

with ePMN 

Burden Reduction

FTE 

fraction

Cost per 

FTE 1

FTE Total 

($2009)

1993 

dollars

2009 

dollars

(a) (b) (c)=(a)*(b) (d) (e) (f)=(c)+(e) (g) (h)=(f)*(g) (i) (j)=(h)*(1-(i))

Pre-notice consultation 0.0024 $157,629 $378 $4.00 $6.65 $385 41% $158 0.165 $132

Administrative prescreen/ 

notice receipt/user fee 0.0024 $157,629 $378 $92.00 $152.97 $531 100% $531 0.165 $444

CRSS (Chemical Review and 

Search Strategy) 0.0025 $157,629 $394 $268.00 $445.60 $840 100% $840 0.165 $701

SAT (Structure Activity 

Team) 0.0006 $157,629 $94.58 $14.00 $23.28 $118 100% $118 0.165 $98.41

Engineering/Exposure 0.0015 $157,629 $236 $56.00 $93.11 $330 100% $330 0.165 $275

Exposure/Fate 0.0008 $157,629 $126 $0.00 $0.00 $126 100% $126 0.165 $105

Focus 0.0009 $157,629 $142 $23.00 $38.24 $180 100% $180 0.165 $150

Standard Review Functions 0.0219 $157,629 $3,452 $511.00 $849.63 $4,302 29% $1,247 0.165 $1,042

Division Directors Meeting 0.0129 $157,629 $2,033 $113.00 $187.88 $2,221 15% $333 0.165 $278

Order 

Development/Negotiation 

Review

0.0171 $157,629 $2,695 $22.00 $36.58 $2,732 3% $81.96 0.165 $68.44

Post Order Data Review 0.0886 $157,629 $13,966 $0.00 $0.00 $13,966 3% $419 0.165 $350

Order Modification 0.2167 $157,629 $34,158 $0.00 $0.00 $34,158 3% $1,025 0.165 $856

New Chemical SNUR 

Development 0.0277 $157,629 $4,366 $85.00 $141.33 $4,508 7% $316 0.165 $263

Notices of Commencement 0.0012 $157,629 $189 $40.00 $66.51 $256 31% $79 0.165 $66.18

FOIA (Freedom of 

Information Act) Requests 0.0333 $157,629 $5,249 $287.00 $477.19 $5,726 1% $57 0.165 $47.81

CBI (Confidential Business 

Information) Substantiation 0.0004 $157,629 $63.05 $3.00 $4.99 $68.04 100% $68.04 0.165 $56.81

TOTAL $5,909 0.165 $4,934 

Notes:

1 GS-13 Step 5 salaries loaded with benefits and overhead. See Table 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 factors presented in Table 11. 3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values shown in this table. 4 Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009b, p. 28).

Sources: FTEs per review step, 1993 extramural costs, and percents of cases are from EPA, 1994 Table VII-1, GS-13 salaries are from OPM 2009.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 19 Economic and Policy Analysis Branch

3.3 Export Notification Cost

The Agency burden and cost due to TSCA §12(b) export notification results from three tasks. In the first 

task, EPA receives export notifications from companies that intend to export one of the chemicals subject 

to TSCA §12(b) (EPA 2009b). In the second task, EPA staff prepares separate notification letters that are 

subsequently reviewed and delivered to importing countries, their embassies, or representatives, and to 

the importing country’s US embassies (EPA 2009b).30

Because domestic manufacture, import and processing of the dyes specified in 

The third task is comprised of EPA staff responses 

to public inquiries and other TSCA 12(b) activities. The work of responding to non-routine requests for 

information and clarification from industry and importing countries, and of handling other tasks 

associated with the TSCA §12(b) program, was estimated to require roughly 400 hours per year (EPA

2009b). 

Table 1 and the articles 

containing them have been phased out, and there is no evidence to suggest that the currently 

manufactured dyes specified at 40 CFR section 721.1660 are being imported and/or processed as part of 

articles, EPA does not expect to receive or send any export notifications. Nevertheless, should there be 

any notifications as a result of the current rulemaking, the costs to the Agency are presented per activity. 

The burden for the first two Agency activities is provided in Table 13 below. To estimate the Agency 

cost, hourly burdens are multiplied by the loaded wage rate of a GS-13, Step 5 (see Table 10). 

Table 13: TSCA 12(b) Export Notification Cost: Agency Burden per Activity (2009$)

Agency Activity

Hours per 

Activity

FTE per 

Activity1

Loaded Mailing 

Cost

Total Agency Cost per 

Activity GS-13, Step 5 FTE 

Wage Rate

(a) (b) = (a)/2,080 (c) (d) (e) = ((b)*(c))+(d)

Process an incoming 

notification from an 

exporting company

0.10 0.000048 $157,629 $0.00 $7.58

Prepare and mail a 

notification to an 

importing country

0.50 0.000240 $157,629 $13.34 $51.23

Notes: 1 The burden associated with an Agency activity is the burden for the Agency to process one incoming notification, or to prepare 

and mail an outgoing notification 

Source: Table 10 of this report derives Agency labor costs. Mailing costs are from Table 7 of this report. Other burdens are from 

EPA 2009b, updated for inflation.

 30 See Table 7 for the cost of mailing one notification.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 20 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

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

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

entities, in particular small businesses. EPA’s experience to date is that, in response to the promulgation 

of SNURs covering over 1,000 chemicals, the Agency receives only a handful of notices per year. For 

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

eight in FY2008, and seven in FY2009.31 During this five-year period, three small entities submitted a 

SNUN - the criteria for ‘small business’ was that the company checked the box on the PMN form, page 2, 

stating that it was a small business for the purpose of paying the $100 fee instead of the normal fee.

32,33

4.2 Unfunded Mandates Reform Act

 

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments 

have not been impacted by these rulemakings, and EPA does not expect that any State, local, or Tribal 

government would be impacted by this rulemaking. 

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 number 2070-0038 (EPA ICR No. 1188). 

If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average 97 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), 91.68 hours for form completion and 

submission (Section 2.2.3), and 1.36 hours for export notification (Section 2.2.5), 

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

Kimberly Wilson, Abt Associates. The counts include both “valid” and “invalid” SNUNs. SNUN numbering is 

according to Federal fiscal year, ending September 30. 

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

Kimberly Wilson, Abt Associates.

33 In order to submit SNUN as a “small business” a company needs to be classified as small using the TSCA based 

definition of annual revenue of less than $4,000,000 per year. This definition is not consistent with the definition of 

a small business using Small Business Administration (SBA) NAICs based definitions.
Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes 21 Economic and Policy Analysis Branch

4.4 National Technology Transfer and Advancement Act

The proposed SNUR does not involve any technical standards; therefore, section 12(d) of the National 

Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 

U.S.C. 272 note), does not apply.

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

Populations and Low-Income Populations

The proposed SNUR does not involve special considerations of environmental justice-related issues as 

required by Executive Order 12898, Federal Actions to Address Environmental Justice in Minority 

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

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

Risks

The proposed SNUR does not address environmental health or safety risks disproportionately affecting 

children.

4.7 Executive Order 13132: Federalism 

The proposed SNUR is not expected to have a substantial direct effect on States, on the relationship 

between the national government and the States, or on the distribution of power and responsibilities 

among the various levels of government as specified in Executive Order 13132, entitled Federalism (64 

FR 43255, August 10, 1999).

4.8 Executive Order 13175: Consultation and Coordination with Indian Tribal Governments 

This proposed SNUR would not have Tribal implications because it is not expected to have substantial 

direct effects on Indian Tribes. This proposed rule would not significantly or uniquely affect the 

communities of Indian Tribal governments, nor would it involve or impose any requirements that affect 

Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and 

Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), do not apply.

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

This proposed SNUR is not expected to affect energy supply, distribution, or use.
Economic Analysis of SNUR for 22 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes Economic and Policy Analysis Branch

5. BENEFITS

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 proposed 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 also expects the 

proposed rule may restrict future uses or exposure to the chemicals, as a company may choose modify 

planned uses, and worker exposures the chemical is such a way that does not trigger a SNUR, as opposed 

to submitting a SNUN. Therefore, the proposed SNUR may limit future exposure to the chemicals. 

Quantification of the benefits of the proposed rule would require more specific information about each 

user’s use patterns and preferences as well as the changes in these patterns and preferences that would 

result from the additional information made available under the proposed rule. These data are not readily 

available and collecting such data would be cost-prohibitive.
Economic Analysis of SNUR for 23 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes Economic and Policy Analysis Branch

6. REFERENCES 

15 U.S.C. 272, National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–

113, Section 12(d).

19 CFR 12, Customs Duties: Special Classes of Merchandise, Code of Federal Regulations, Part 12, Title 

19, August 1, 1983.

40 CFR 707, Chemical Imports and Exports, Code of Federal Regulations, Part 707, Title 40, July 1, 

2003.

40 CFR 720, Premanufacture Notification, Code of Federal Regulations, Part 720, Title 40, July 1, 2003.

40 CFR 721, Significant New Use of Chemical Substances, Code of Federal Regulations, Part 721, Title 

40, July 1, 2003.

59 FR 7629, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income 

Populations, Federal Register, Volume 59, February 16, 1994.

59 FR 22951, Consultation and Coordination with Indian Tribal Governments, Federal Register, Volume 

59, November 6, 2000.

62 FR 19885, Protection of Children from Environmental Health Risks and Safety Risks, Federal 

Register, Volume 62, April 23, 1997.

64 FR 43255, Federalism, Federal Register, Volume 65, August 10, 1999.

66 FR 28355, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or 

Use, Federal Register, Volume 66, May 22, 2001.

71 FR 66234, Export Notification; Change to Reporting Requirements, Final Rule, Federal Register, 

Volume 71, November 14, 2006. Available in docket EPA-HQ-OPPT-2005-0058 at 

http://www.regulations.gov.

Abbey Colour, 2010. “Table of Dyes.” Accessed November 23, 2010. Available at: 

http://www.abbeycolor.com/

American Apparel and Footwear Association (AAFA). 2010. Restricted Substance List.

American Association of Textile Chemists and Colorists, 2010. Colour Index International online. Fourth 

Edition. http://www.colour-index.org/ (Accessed various dates, November 2010).

BLS, 2010a. U.S. Bureau of Labor Statistics. “Employer Costs for Employee Compensation

Supplementary Tables December 2009.” (March 10, 2010) at 

http://www.bls.gov/ncs/ect/sp/ecsuptc13.pdf. (Note: The BLS report title and content is updated

periodically to include more recent data, on the same website.) 

BLS, 2010b. Bureau of Labor Statistics. Employment Cost Index – Total Compensation: Professional and 

Related Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I), extracted 

April 12, 2010.
Economic Analysis of SNUR for 24 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes Economic and Policy Analysis Branch

CMA, 1991. Chemical Manufacturers Association. Responses to Questions on Burden Associated with 

PMN Submissions. Distributed by the Chemical Manufacturers Association, Washington, DC.

Dapson, R.W. 2009. Benzidine-based dyes: effects on industrial practices, regulations, and world trade 

on the biological stains market. Biotechnic & Histochemistry 84(3): 95-100.

Environment Canada. 2009. Strategic options for the management of toxic substances benzidine and 3,3-

dichlorobenzidine. Available at: http://www.ec.gc.ca/toxics/docs/sor/bdine/EN/sum.cfm 

Accessed 10 September, 2009. 

EPA, 1980. U.S. EPA. Preliminary Risk Assessment: Phase I. Benzidine, its congeners, and their 

derivative dyes and pigments. EPA-560/11-80-019, June 1980.

EPA, 1986. U.S. EPA, Office of Toxic Substances. New Chemical Information Bulletin: Exemptions for 

Research and Development and Test Marketing. Washington, D.C. November, 1986. Available 

at: http://www.epa.gov/oppt/newchems/pubs/tmeranddbulletin.pdf

EPA, 1992. U.S. EPA, Office of Policy, Planning, and Evaluation. Instructions for Preparing Information 

Collection Requests (ICRs). Washington, DC, June 1, 1992.

EPA, 1994. U.S. EPA, Office of Toxic Substances, Regulatory Impacts Branch. Regulatory Impact 

Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications.

Washington, DC: U.S. EPA/OPPT/EETD/RIB, September 9, 1994.

EPA, 2000. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1139.06. [Information 

Collection Request for] TSCA Existing Chemical Test Rules, Consent Orders, Test Rule 

Exemptions, and Voluntary Test Data Submissions: Supporting Statement for Request for OMB 

Review under the Paperwork Reduction Act. Attachment 5, Wage Rates Estimation, August 29, 

2000.

EPA, 2002a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis 

Branch. Revised Economic Analysis for the Amended Inventory Update Rule: Final Report.

Washington, DC. August 2002.

EPA, 2002b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis 

Branch. Wage Rates for Economic Analysis of the Toxics Release Inventory Program.

Washington, DC, June 10, 2002.

EPA, 2003. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. 

Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances.

Washington, DC, 2003. Available in docket EPA-HQ-OPPTS-2002-0078 at 

EPA, 2005a. U.S. EPA. Supplemental Guidance for Assessing the Susceptibility from Early Life Exposure 

to Carcinogens. EPA 630/R-03/003F, March 2005.

http://www.regulations.gov.

EPA, 2005b. U.S. EPA. Office of Pollution Prevention and Toxics, Economic and Policy Analysis

Branch. Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification 
Economic Analysis of SNUR for 25 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes Economic and Policy Analysis Branch

Requirements, November 2005, available from the Federal Docket Management System as EPAHQ-OPPT-2005-005 8-0017 at http://www.regulations.gov.

EPA, 2006a. Inventory Update Reporting (IUR): Non-Confidential 2006 TSCA Inventory Update Rule 

(IUR) Records. Available at: http://cfpub.epa.gov/iursearch/index.cfm?s=chem. As cited in the 

Benzidine Dyes Action Plan (EPA, 2009c).

EPA, 2007a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis

Branch. Economic Analysis of Expedited Significant New Use Rules for 38 Chemical 

Substances (EPA Docket OPPT-2006-0898), August 17, 2007.

EPA, 2007b. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 0574.14. [Information 

Collection Request for] Pre-Manufacture Review Reporting and Exemption Requirements for 

New Chemical Substances and Significant New Use Reporting Requirements for Chemical 

Substances: Supporting Statement for a Request for OMB Review under The Paperwork 

Reduction Act, December 6, 2007.

EPA, 2009a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis 

Branch. Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule. 

(EPA-HQ-OPPT-2008-0296). July 13, 2009.

EPA, 2009b. U.S. EPA, Office of Pollution Prevention and Toxics. ICR No.: 0795.13 [Information 

Collection Request for] Notification of Chemical Exports - TSCA Section 12(b) Supporting 

Statement for Request for OMB Review under the Paperwork Reduction Act. March 6, 2009 at

http://www.regulations.gov.

EPA, 2009c. U.S. EPA, Office of Pollution Prevention and Toxics. Benzidine Dyes Action Plan. 

Available at: http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/benzidine.html

European Commission. 2009. Commission Regulation EC No. 552/2009 

Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 

1907/2006 of the European Parliament and of the Council on REACH as regards Annex XVII.

European Commission. 2010. RAPEX – Latest Notifications. Directorate General for Health and 

Consumers. http://ec.europa.eu/consumers/dynex/rapex/rapex_achives_en.cfm

Accessed on December 7, 2010.

Golka, K.; Kopps, S.; Myslak, Z.W. 2004. Carcinogenicity of azo colorants: influence of solubility and 

bioavailability. Tox Lett 151:203-210.

OPM, 2009. Office of Personnel Management, Salary Table 2009-DCB, Washington-Baltimore/Northern 

Virginia, DC-MD-PA-VA-WV. Accessed from http://www.opm.gov/oca/09tables/pdf/DCB.pdf

Rawie, Carol. 2009. EPA Office of Pollution Prevention and Toxics. Personal communication with Tulika 

Narayan and Kimberly Wilson of Abt Associates via e-mail. February 5, 2009.

Simpsons UK LTD. 2010. "Product Catalogue." Accessed November 18, 2010.

 Available at: http://www.dyemakers.com/
Economic Analysis of SNUR for 26 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes Economic and Policy Analysis Branch

Standard Dyes, Inc. 2010. "Product Catalogue." Accessed November 18, 2010.

 Available at: http://www.standarddyes.com/

Taiheung D&C. 2010. “Products.” Accessed November 22/23, 2010. Available at: 

http://www.taiheung.co.kr/eng/index.html

U.S. SBA. 2010. United States Small Business Administration. Table of Small Business Size Standards 

Matched to North American Industry Classification System Codes. Available at: 

http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf

USPS, 2010. U.S. Postal Service Mailing and postage rates. <http://www.usps.com/prices>. Accessed 16

August 2010.

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.
Economic Analysis of SNUR for 27 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes Economic and Policy Analysis Branch

7. APPENDIX A – BENZIDINE-BASED DYES SPECIFIED AT 40 CFR SECTION 721.1660

Table 14 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 14: 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-amino4-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

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
Economic Analysis of SNUR for 28 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes Economic and Policy Analysis Branch

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.