***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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## Economic Analysis of the Final Signif icant New Use Rule for Nine Benzidine
Based Chemical Substances
(EPA Docket EPA-HQ-OPPT-2010-0573 RIN 2070-AJ73)

FINAL



### July 22 December 03 , 2014

San5456_Final redline_3-Chemical-SNUR_FRM_EA_9 Dyes_2014-11- 20.docxSan5456_FAR_3-Chemical-SNUR_FRM_EA_9 Dyes_2014-7-22_.docx



## —Does not contain TSCA CBI—

Prepared by:

Economic and Policy Analysis Branch Economics, Exposure and TechnologyChemistry , Economics, and Sustainable Strategies

Division
Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, DC 20460***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of Final SNUR for U.S. EPA Office of Pollution Prevention and Toxics Benzidine-Based Chemical Substances i Economic and Policy Analysis Branch 

### CONTRIBUTORS

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

EP-W-08-010.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of Final SNUR for U.S. EPA Office of Pollution Prevention and Toxics Benzidine-Based Chemical Substances ii Economic and Policy Analysis Branch 

### ABSTRACT

This report presents the estimated costs of the U. S. Environmental Protection Agency (EPA)’s final Significant New Use Rule (SNUR) that adds the nine benzidine-based chemical substances specified in

Table 1Table 1 to an existing SNUR for benzidine-b ased chemical substances at 40 CFR section 721.1660. Additionally, the final rule also revokes the article exemption described in 40 CFR section 721.45(f) for the chemical substances regulated under a 1996 SNUR; 40 CFR 721.1660(a)(1) (see Appendix A) as well as the nine chemicals in Table 1. 1

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

CAS/Accession

No. 1 Chemical Name 2

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-subs tituted 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 correspo nd to more than one CAS No.; however, they are frequently used, even in peer-re viewed literature.

Benzidine and its congeners constitu te a family of synthetic aromatic amines which are predominately used in the synthesis of colorants (dyes and pigm ents). The colorants listed in Table 1 (called azo colorants) have historically been used in the produc tion of dyes for textiles, paints, printing inks, paper, and pharmaceuticals. Because they have the potential to metabolize to carcinogenic amines both in and on the human body, EPA is concerned about the poten tial risk from exposure to products containing

benzidine-based chemical substances.

The most recent data from the Toxic Substances C ontrol Act (TSCA) Chemical Data Reporting (CDR) database (2012 reporting) indicates no evidence of produc tion of the nine new benzidine-based chemical substances subject to the final rule (EPA, 2013a). The Agency did not receive any comments after the publication of the Benzidine Dyes Action Plan to indicate any current production of the four non-CBI

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

1 The final rule does not revoke the exemptions granted in 40 CFR section 721.1660(a)(2) for laboratory stains and other analytical reagents.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of Final SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Benzidine-Based Chemical Substances iii Economic and Policy Analysis Branch chemical substances subject to the final rule were lis ted in the Colour Index or identified through internet queries. 2 However, global and domestic manufacturers fo r several of the benzidine-based chemical substances specified at 40 CFR section 721.1660 were identified; EPA found no information to indicate the currently manufactured chemical substances are being imported and/or processed domestically as part of articles. As a result, there is expected to be little or no economic impact from the final rule.

The final rule will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of any of the chemicals specified in Table 1Table 1 . It will also make inapplicable the article exemption at 40 CFR section 721.45(f), re quiring notification of the import and/or processing as part of an article of any of the benzidine-based chem ical substances subject to the final rule or specified at 40 CFR section 721.1660. A firm intending to e ngage in these activities will be required to submit a Significant New Use Notice (SNUN). While EPA was encour aged by the discontinuation of the use of the chemical substances regulated under a 1996 SNUR at 40 CFR 721.1660, it was concerned that the manufacture, import, and processing of these chemical substances and the articles containing them could
be reinitiated in the future. EPA was also concerne d that articles containing the chemical substances specified at 40 CFR section 721.1660 could be availa ble for human exposure or eventual release to the environment. The SNUN provides EPA with the oppor tunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

When submitting a SNUN, a firm incurs a modest submission cost of $8,571 and potentially other minor costs. While no firms were identified that manufacture, import, process or import or process as part of an article the benzidine-based chemical substances subject to the final rule, global manufacturers of several of the benzidine-based chemical substances (dyes) specified at 40 CFR section 721.1660 were identified. However, there is no information to conclude that these currently manufactured chemical substances are being imported or processed domestically as part of ar ticles. As a result, EPA does not expect that any firm will incur a cost of submitting a SNUN as the result of the final rule. EPA does not require the development of test data for submission of a SNUN, a lthough a firm may submit test data already in its possession or describe any other available data. Becau se EPA does not require the development of test data, EPA assumes that no firms will incur t esting costs as a result of the final SNUR.

In addition to the firms that make a SNUN submission, the final SNUR may also impact firms that do not make a submission. By avoiding a significant new use, a firm can avoid submission and testing costs but may incur other costs. However, this may not be a c oncern given that there currently is no manufacture or import of the chemicals in Table 1 and that there is no evidence to suggest that the chemicals specified at 40 CFR section 721.1660 that are currently ma nufactured are being imported and/or processed domestically as part of articles.

Costs are estimated at the firm level or unit level and reflect the burden of a SNUR on firms that may
make a SNUN submission .3

2 The Colour Index is an international directory of manufacturers of pigments and dyes published by the UK Society of Dyers and Colourists (SDC) and the American Asso ciation of Textile Chemists and Colorists (AATCC). 3 While the majority of costs are incurred at the firm leve l, costs associated with some activities such as submitting export notifications or testing articles are incurred at the unit level.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of Final SNUR for U.S. EPA Office of Pollution Prevention and Toxics Benzidine-Based Chemical Substances iv Economic and Policy Analysis Branch TABLE OF CONTENTS

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

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

1. INTRODUCTION ............................................................................................................... ................. 1 1.1 Background ................................................................................................................ ................. 2 1.2 Statutory Authority ....................................................................................................... .............. 5 1.3 Summary of Methodology .................................................................................................... ...... 5 1.4 Organization of this Report ...............................................................................................

....... 65

2. INDUSTRY COMPLIANCE COSTS .................................................................................................. 7 2.1 Wage Rates ................................................................................................................ ................. 8 2.2 Unit Industry Compliance Costs ............................................................................................

. 109 2.3 Industry Costs of SNUR, by Option ..................................................................................... 2422
2.4 Likelihood of a SNUN Submission ...................................................................................... 2422 2.5 Potential for Subsequent Regulatory Action ........................................................................ 2523

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

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

... 2724

3.2 SNUN Proce ssing Costs .....................................................................................................

.. 2724 3.3 Export Notification Cost ..................................................................................................

..... 3127

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

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

.... 3228
4.2 Unfunded Mandates Reform Act .......................................................................................... 3228 4.3 Paperwork Reduction Act ...................................................................................................

.. 3329 4.4 Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-In come Populations ........................................................................... 3329
4.5 Executive Order 13045: Protection of Childre n from Environmental Health Risks and Safety

Risks .........................................................................................................................

............ 3329
4.6 Executive Order 13132: Federalism ..................................................................................... 3329
4.7 Executive Order 13175: Consultation and Coordination with Indian Tribal Governments 3531 4.8 Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use

.............................................................................................................................. ................ 3531 4.9 Executive Order 13563, Improving Regul ation and Regulatory Review ........................... 3531

5. Benefits ...................................................................................................................

........................ 3632

6. REFERENCES .................................................................................................................

............... 3733

A. INFLATORS AND WAGE RATES ................................................................................................ A- 1 A.1 Derivation of Loaded Wage Rates .......................................................................................... A-1
A.2 Derivation of Inflation Factors ........................................................................................... .... A-4
Appendix B – Benzidine-Based Dyes Speci fied at 40 CFR section 721.1660 ......................................... B-1***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of Final SNUR for U.S. EPA Office of Pollution Prevention and Toxics Benzidine-Based Chemical Substances v Economic and Policy Analysis Branch LIST OF TABLES Table 1: Benzidine-Based Chemicals Subject to Final SNUR ..................................................................... 1 Table 2: Loaded Industry Wa ge Rates, December 2011 ............................................................................ ... 8
Table 3: Rule Familiarization Burden and Cost for SNUR Submitters .................................................... 109 Table 4: CDX Registration, CDX Electronic Signature , and Pay.gov Account Setup Burden and Cost for

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

.................... 1110 Table 5: Industry Cost Estimate to Complete the SNUN Form .............................................................. 1312 Table 6: Industry Cost Estimate to Complete and Submit the SNUN Form ........................................... 1312 Table 7: Examples of Industries that may Import Articles Containing Benzidine Chemical Substances

.............................................................................................................................. .................................. 1312 Table 8: Range of costs associated with an importe r’s identification of chemicals subject to SNURs in

articles ......................................................................................................................

............................... 2119 Table 9: Compliance Options and Associated Cost s Incurred by a Firm Due to the Final SNUR ......... 2422 Table 10: Derivation of Loaded Agency Wage Rates ............................................................................ 2724 Table 11: Derivation of Inflation Factors for Agency Extramural Costs ................................................ 2825 Table 12: Agency Costs for SNUN and Ot her Submission Review and Processing .............................. 2926
Table A-2: Derivation of Inflation Factors .................................................................................... ........... A-5 Table B-1: Benzidine-Based Dyes Specifi ed at 40 CFR Section 721.1660 .............................................. B-1***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 1 Economic and Policy Analysis Branch 

### 1. INTRODUCTION

This report presents the U.S. Environmental Protecti on Agency (EPA), Office of Pollution Prevention and Toxics’ (OPPT’s) analysis of the potential costs incu rred as a result of a final Significant New Use Rule (SNUR) that adds the nine benzidine- based chemical substances listed in Table 1Table 1 to an existing SNUR at 40 CFR section 721.1660. EPA is also propos ing to revoke the article exemption at 40 CFR section 721.45(f) for the chemical substances in cluded regulated under a 1996 SNUR at 40 CFR 721.1660(a)(1) (see Appendix A) as well as the nine chem icals included in the final rule. However, the final rule does not revoke the significant new use ex emptions granted in 40 CFR section 721.1660(a)(2) for uses as laboratory stains and other analytical reagents.

Table 1: Benzidine-Based Chemicals Subject to Final SNUR

CAS/Accession

No. 1 Chemical Name 2

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-subs tituted 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 correspo nd to more than one CAS No.; however, they are frequently used, even in peer-re viewed literature.

EPA is concerned that in the future benzidine-b ased chemical substances may be incorporated into articles and then imported into the United States, which will increase human and environmental exposure to the chemicals. There is potential for exposure to benzidine-based chemicals in corporated into imported finished articles; therefore, EPA is proposing to make the article exemption at §721.45(f) inapplicable to persons who import the benzidine-dye chemical substa nces included in the rule as part of articles.

SNURs are proposed by EPA under the authority granted by Section 5(a)(2) of TSCA. The final SNUR will require persons to notify EPA at least 90 days before commencing any manufacture, import, or***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 2 Economic and Policy Analysis Branch processing of the benzidine-based chemical substanc es subject to the final rule or any import or processing of articles containing them or the benzidine-based substances specified at 40 CFR section

721.1660. 4.5 EPA promulgates a SNUR for a substance wh en potential uses could result in increased exposure to, or releases of, the substance, which in turn, could present an unreasonable risk to health or

the environment.

1.1 Background

In 1995, as part of a risk management strategy to reduce the risks associated with the manufacture and use of azo dyes in the United States, EPA proposed a S NUR for several benzidine-based substances (FR 45119, 8/30/95). The final SNUR (§721.1660) include d 24 benzidine-based substances; however, EPA recognized that additional substances would need to be added. The four non-CBI dyes specified in Table

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

As part of a more recent effort to enhance the existing chemicals program under TSCA, EPA created a list of widely recognized chemicals for the development of an Action Plan. Azo dyes were selected because they have the potential to metabolize to carcinogeni c amines both in and on the human body. The Action Plan summarized readily available use, exposure, and hazard information for forty-eight azo dyes; 6 considered which authorities provide d under TSCA and other statutes c ould be used to address potential concerns; and described various courses of actions av ailable to EPA to address the concerns (EPA 2009c). It is important to note that, unless specified, th e following sections, which use information from the Action Plan, describe azo dyes in genera l, not just benzidine-based dyes.

Uses and Substitutes

The benzidine-based chemical subs tances listed in Table 1 and re gulated under a 1996 SNUR at 40 CFR 721.1660(a)(1) have predominately been used as azo dyes in the production of textiles, paints, printing inks, paper, and pharmaceuticals. 7 They are also used as reagents and biological stains in laboratories, and in the food industries (Dapson, 2009). The European Union (E.U.) has banned certain azo dyes from use in textiles and leather that are in prolonged contact with human skin. Although there continue to be azo dyes found in articles meant for import into the E.U., many similar articles do not contain azo dyes (European Commission, 2010). As a result, it is believe d that there are readily available substitutes for the benzidine-based dyes subject to the final SNUR.

4 In accordance with TSCA section 12(a) and 40 CFR 721.45(g), persons who manufacture or process these benzidine-based dyes solely for export will be exempt from the notification requirements of 40 CFR 721.25, if when distributing the substance in commerce, it is labeled in accordance with TSCA section 12(a)(1)(B). Further, EPA notes that the exemption from the TSCA section 12(b ) notification requirements for exported articles ( see 40 CFR 707.60(b)) will remain in force. Thus, persons who export benzidine-based dyes as part of an article will not be required to provide export notification.

5 Section 5(h)(3) of TSCA, 15 USC 2604(h) exempts substan ces that are manufactured in small quantities solely for research and development (R&D) from the section 5(a) notice requirements. No application is required for the exemption for R&D under section 5(h)(3) (U.S. EPA 1986).

6 The four non-CBI benzidine-based dyes listed in Table 1, and forty-four benzidine congener-based dyes not subject to the proposed SNUR. The five CBI dyes listed in Table 1 were identified by Agency chemists from an inventory of CBI chemicals, which also had the potential to metabolize into benzidine.

7 Because the chemicals substances subject to the final rule are mostly used in as azo dyes, the chemical substances listed in Table 1 may be referred to as dyes, or colorants.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 3 Economic and Policy Analysis Branch Health Effects

The 1980 EPA Preliminary Risk Assessment on deriva tives of benzidine and its congeners established that the primary hazard concern was for the carci nogenic effects to humans from exposure to specific metabolites of azo dyes (EPA 1980). Azo dyes are biologically active through their metabolites. Azoreduction of these compounds occurs in humans by an enzyme-mediated reac tion. Azoreductases are found in the liver, in gut bacteria, and in skin bacter ia. 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 suggest s that there is early life susceptib ility to benzidine carcinogenesis. Cancer potency for benzidine was substantially increased when the dose was given in early life as compared to adults (EPA 2005a).

Environmental Exposure

The primary route of consumer exposure to azo dyes is dermal absorption from wearing azo-dyed clothing or footwear. 8 Other products are either not available to consumers (laboratory chemicals) or will not likely be readily accessible in significant quantities (printing ink or LCD displays) to present exposure concern. Oral ingestion is an additional route fo r babies and young children who suck on clothing, blankets, and other non-food prod ucts, which might contain azo dyes . Inhalation exposure is a more prevalent route in occupational settings; however, it can also occur from the use of azo-dyed inks during ‘air brushing’ or off-gassing from azo-dyed carpets to indoor air. Contact with azo dyes entering the environment through the whole life cycle of azo dyes in textiles is an additional potential source of exposure (Zeilmaker et al. 1999; Zeilmaker et al. 2000).

The problems of discharge of dye contents to wastew aters from textile and other industries have resulted in extensive research for biological methods to degr ade dyes. Biodegradation studies indicate that azo dyes will be expected to biodegrade at negligible to slow rates in aerobic conditions, while in anaerobic soils the dyes are likely to undergo azo reduction to benzidine and/congeners depending on structure. However, it is unclear whether metabolites from these re ductions will be available in large concentrations

or locations to be of conc ern to the general population.

Current Manufacturing

Dye production in the United States has been steadily declining for the past decade, largely due to the increase in imported finished textiles from less develope d countries like China and India, which may have less stringent regulations on dye intermediates (D apson 2009). The most recent data from the public TSCA CDR database (2013 reporting) did not indicate any domestic manufacture or import of the benzidine-based chemicals subject to the final SNUR. 9 EPA did not receive comment after the publication

8 The main factors determining dye releases from textiles to the skin include the type of dyed textile, contact with other substrates, amount of dye applied to the textile, an d number of previous washings (Zeilmaker et al. 1999; Zeilmaker et al. 2000).

9 The CDR compiles production data from manufacturers and importers of certain chemical substances listed on the TSCA Chemical Substance Inventory. Sites are only required to submit IUR data if they manufacture or import more that 25,000 pounds of a chemical during the repor ting year. As a result, it is possible that some ongoing***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 4 Economic and Policy Analysis Branch of the Benzidine Dyes Action Plan to indicate any ongoing production of the four non-CBI dyes listed in

Table 1Table 1 . In addition, EPA received no comments i ndicating any ongoing domestic manufacture or uses after the promulgation of the proposed SNUR and none of the chemicals subject to the final SNUR were found in the Colour Index or during internet queries for manufacturers. However, domestic and/or

international manufacturers were identified for 14 of the 24 benzidine-based chemical substances specified at 40 CFR section 721.1660. 10 Searches for information by Colour Index Number suggest that nine of the chemicals may be manufactured domestica lly. In order to confirm their domestic or global manufacture of the chemical substances specified at 40 CFR section 721.1660, EPA searched company websites for lists of products available for sale. Howe ver, in some cases, company product lists contained common names for dyes. Common names are not uniqu e identifiers for dyes as they may correspond to more than one CASRN; however, they are frequently used, even in peer-review ed literature. Therefore, dyes listed as available solely by common name may not be the same chemical subject to the SNUR. Without further information, it is not possible to ve rify whether the currently manufactured dyes are being imported and/or processed domestically as part of articles. Because the remaining 10 dyes specified at 40 CFR section 721.1660 are no longer manufactured anywhere in the world it is expected that they are not used in articles imported into the United States.

Regulatory Environment

Occupational exposure to some azo colorants has been regulated for many years; however, the potential for consumer exposure to products containing these co lorants is still a potential concern. California’s Proposition 65 Chemical List includes benzidine-b ased dyes as a potential carcinogen and requires that firms provide a clear and reasonable warning before knowingly and intentionally exposing anyone to a listed chemical (CAEPA, 2013a and CAEPA, 2013b). This warning may include the labeling of consumer products (CAEPA, 2013b).

The European Union (E.U.) has banned, in textile an d leather articles which may come into direct and prolonged contact with humans, the use of azo dy es which can break down to release any of 22 listed carcinogenic aromatic amines (including benzid ine and its congeners) in amounts above 30 ppm (European Commission 2009). 11 The European Commission’s Directorate General for Health and

Consumers maintains the RAPEX database that member countries can use to report dangerous products and the measures they have taken to prevent or rest rict those products. Despite the E.U. ban, small numbers of products containing such azo dyes have recently been listed on RAPEX. The products are typically voluntarily withdrawn from the market and/ or destroyed by the importer or have been placed under an order by the authorities to cease sales (Eur opean Commission, 2010). Therefore, azo dyes in imported articles still remain a potential issue in the E.U.

Other countries have also banned the manufacture and use of the azo dyes in textiles. Currently the manufacture of azo dyes is banned in South Korea and Japan (IARC, 2012). Use of these chemicals is banned by Egypt, India, China, South Korea, Taiwan and Vietnam (Textination, 2012) and Indonesia has banned the use of the dyes in children’s and baby ’s clothing (Intertek, 2013). In 2012, the Japanese textiles and leather industry announced voluntary rest rictions of the chemicals (Textination, 2012 and

manufacture and import of the dyes could occur at sites not meeting this threshold. While it is not known how many sites fall into this latter category, the Agency believes it likely to be very few if any.

10 In addition to the 14 dyes with confirmed ongoing ma nufacture, there were an additional three dyes for which there was some information suggesting current production; however, it was not possible for EPA to verify this
information.

11 See Restriction 43 in REACH Annex XVII.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 5 Economic and Policy Analysis Branch HKTDC, 2012). Canada has also expressed concern a bout the potential release of benzidine or its congeners from azo dyes and is evaluating poten tial approaches for addressing azo dyes (Environment Canada 2009). In addition, the American Apparel a nd Footwear Association (AAFA), the national trade association representing apparel, footwear and other sewn products companies and their suppliers, which compete in the global market, includes benzidine on its Restricted Substances List (AAFA, 2010).

In 1995, as part of a risk management strategy to reduce the risks associated with the manufacture and use of azo dyes in the United States, EPA proposed a S NUR for several benzidine-based substances (FR 45119, 8/30/95). The proposed SNUR (§721.1660) in cluded 24 benzidine-based substances; however, EPA recognized that additional substances will need to be added. The four non-CBI dyes specified in

Table 1Table 1 were included in draft additions to §721.1 660, 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 carcinogeni c amines both in and on the human body. The Action Plan summarized readily available use, exposure, and hazard information for forty-eight azo dyes; 12 considered which authorities provide d under TSCA and other statutes c ould be used to address potential concerns; and described various courses of action ava ilable to EPA to address the concerns (EPA 2009c). It is important to note that, unless specified, th e following sections, which use information from the Action Plan, describe azo dyes in genera l, not just benzidine-based dyes.

1.2 Statutory Authority

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) author izes 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 se ction 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA se ction 5(a)(1)(B) requires persons to submit a SNUN to EPA at least 90 days before manufacturing, importing, or processing the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)).

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

1.3 Summary of Methodology

This analysis quantifies, to the extent possible, the costs of the final rule to society by identifying the costs to industry associated with performing the required reporting and recordkeeping activities, and the costs to EPA of administering the rule. Industry costs consist of rule familiarization; registration with the Central Data Exchange (CDX) electronic reporting tool; collection, compilation, and submission of required information for significant new uses of the subject chemicals; export notification; and recordkeeping. Agency costs include reviewing and processing the data received as a result of the rule. Data sources for this analysis include burden est imates derived from previ ous information collection requests and economic analyses for related rul es, compensation data acquired from government publications, and supplementary market research.

12 The four non-CBI benzidine-based dyes listed in Table 1, and forty-four benzidine congener-based dyes not subject to the final SNUR. The five CBI dyes listed in Table 1 were identified by Agency chemists from an inventory of CBI chemicals which also had the potential to metabolize into benzidine.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
EO 12866 Review Draft – As Revised 12/03/2014

Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 6 Economic and Policy Analysis Branch In addition to estimated costs, this report qualitativel y discusses the benefits of the final rule based on the value of the information it will provide.

1.4 Organization of this Report

The remainder of this report presents EPA’s economic analysis in support of the final rule. Chapter 2 contains estimates of the industry costs to comply wi th the final rule, and Chapter 3 shows estimates of the government costs associated with the administra tion of the final rule. Several additional impact analyses are presented in Chapter 4, including: sm all entity impact analysis, as mandated by the Regulatory Flexibility Act (RFA); a burden hour anal ysis that responds to the requirements of the Paperwork Reduction Act (PRA); an analysis of un funded mandates that pertains to the Unfunded Mandates Reform Act (UMRA); an analysis of envi ronmental justice implications that addresses the requirements of Executive Order 12898; and an analysis of children’s health per tinent to Executive Order 13045. Chapter 5 addresses the benefits of the final rule.

Note that all dollar amounts in this analysis are re ported in December 2011 dollars, except for U.S. Postal Service mailing rates, which were acquired in January 2012.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
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Nine Benzidine Chemical Substances 7 Economic and Policy Analysis Branch 

### 2. INDUSTRY COMPLIANCE COSTS

The final SNUR discussed in this report specifies that significant new uses of the benzidine-based chemical substances specified in Table 1Table 1 that require reporting under section 5(a)(2)(A) of TSCA include the manufacture, import, or processing of the chemicals, excluding use as laboratory stains and other analytical reagents. In addition, the final ru le revokes the article exemption described in 40 CFR section 721.45(f) for the chemicals regulated unde r a 1996 SNUR at 40 CFR 721.1660(a)(1) (see Appendix A), as well the nine chemicals in the final rule. Therefore, a firm intending to manufacture, import, or process the chemicals subject to the final rule for any non-exempt use, or import or process articles containing chemicals subject to the final ru le or specified at 40 CFR section 721.1660, must submit a SNUN. Alternatively, a firm can decide not to manufacture, import, and/or process the chemicals and articles containing them for a significan t 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 signi ficant new use, which, in this case, means the manufacture, import, and/or processing of the chemical s subject to the final rule for any use and/or any import and processing of chemicals subject to the rule (including those specified at 40 CFR section 721.1660) as part of an article. 1314.15 The firm must submit the SNUN to EPA at least 90 days before it plans to commence these activities; th e SNUN provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohi bit or limit that activity before it occurs. The costs associated with this option are the costs of submitting the SNUN (including a user fee) plus, if there is any export of these products, the export notification costs that result from TSCA Section 12(b) requirements that are automatically triggered fo r chemicals regulated under TSCA Section 5 (see

Section 2.2.72.2.7 for details).

 Option 2: Decide not to manufacture 16 and/or process the chemical or import or process the chemical as part of an article . The firm may decide simply not to proceed to manufacture or process the chemicals subject to the final rule, or import or process the chemical substances subject to the rule or those specified at 40 CFR section 721.1660 as part of articles. While this option avoids the costs of submitting a SNUN, it entails the ‘hidden’ cost of th e profit that will be foregone as a result of not engaging in the commercial activity originally planned. Similarly, if the firm would have used a given amount of the chemical in the production of anot her product, and must substitute to more costly substance, it will incur those additional “hidden” co sts of production. However, these hidden costs are

13 The specific excluded laboratory uses are use as a reagent to test for hydrogen peroxide in milk; a reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain in microscopy; a reagent for detecting blood, and as an analytical standard.

14 In accordance with TSCA section 12(a) and 40 CFR 721.45(g), persons who manufacture or process these benzidine-based chemicals solely for export will be exempt from the notification requirements of 40 CFR 721.25, if when distributing the substance in commerce, it is labele d in accordance with TSCA section 12(a)(1)(B). Further, EPA notes that the exemption from the TSCA section 12(b) notification requirements for exported articles ( see 40 CFR 707.60(b)) will remain in force. Thus , persons who export benzidine-based dyes as part of an article will not be required to provide export notification.

15 Section 5(h)(3) of TSCA, 15 USC 2604(h) exempts substan ces that are manufactured in small quantities solely for research and development (R&D) from the section 5(a) notice requirements. No application is required for the exemption for R&D under section 5(h)(3) (U.S. EPA 1986).

16 Under TSCA section 3(7), the definition of “manufactur e” means to “import..., produce or manufacture” and importers are responsible parties under the final SNUR.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 8 Economic and Policy Analysis Branch expected to be minimal, if not zero, because EPA found no evidence to suggest that many of the dyes are available anywhere. It is believed that they ha ve largely been substituted for, and EPA also has no information that the regulated chemicals are part of articles imported into or processed within the U.S. If the firm elects to produce the chemical fo r research and development (R&D) purposes only (an exemption for R&D purposes is provided in 40 CF R §721.47), it may have costs associated with R&D recordkeeping.

Because there is no evidence to suggest that the currently manufactured chemicals are being imported and/or processed domestically as part of articles, EPA does not expect there to be compliance costs associated with either of the options.

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

Section 2.12.1 summarizes the wage rates used in this ch apter. Section 2.2 provides the unit industry compliance costs, including the costs of rule familiarization, registrati on with the Central Data Exchange (CDX) electronic reporting tool, completing the SNUN form, submission fee, import certification, and export notification. Total costs under each option are presented in Section 2.3

2.1 Wage Rates

The final rule involves activities that may require efforts by employees in three labor classifications: managerial, technical, and clerical. Costs for each act ivity 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 wa ge 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 overh ead rates, following the methodology described in “Wage Rates for Economic Analysis of the Toxics Release Inventory Program” (EPA 2002b). Wage data for each labor category in December 2011 are provided by the Employer Costs for Employee Compensation (ECEC) Supplemental Tables availabl e on the BLS website (BLS 2012a). The loaded wage rate for managerial labor is $70.72; for tec hnical labor, $64.66; and for clerical labor, $29.63. Table

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

Table 2: Loaded Industry Wage Rates, December 2011

Labor Category Data Sources Wage (2011$) Fringe

Benefit (2011$) Fringes

as %

wage Overhead %

wage 2 Fringe +

overhead

factor Loaded Wages 1 (2011$)

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

Managerial BLS ECEC , Private Manufacturing industries

, “Mgt, Business, and Financial” 3 $43.01 $20.40 47.43% 17% 1.64 $70.72

Professional/

Technical BLS ECEC , Private Manufacturing industries,
“Professional and related“ 3 $38.48 $19.64 51.04% 17% 1.68 $64.66***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
EO 12866 Review Draft – As Revised 12/03/2014

Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 9 Economic and Policy Analysis Branch Table 2: Loaded Industry Wage Rates, December 2011

Clerical BLS ECEC , Private Manufacturing industries,
“Office and Administrative Support” 3 $17.69 $8.93 50.48% 17% 1.67 $29.63

1 Wage data are rounded to the near est 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 Amen ded Inventory Update Rule: Final Report (EPA, 2002a).

3 Employer Costs for Employee Compensa tion Supplementary Tables: December 2011. US Bureau of Labor Statistics, March 14, 2012 (BLS 2012a).***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 10 Economic and Policy Analysis Branch 2.2 Unit Industry Compliance Costs



### 2.2.1 Rule Familiarization

EPA believes that as a consequence of the final ru le, some chemical manufacturers and processors and importers and processors of articles and their staff w ill need to become familiar with the SNUR and its various requirements. Rule familiarization is estimated to require 0.55 hours of technical labor and 0.27 hours of managerial labor, as described in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a), which measures the costs of mandatory electronic reporting of SNUNs and other TSCA Section 5 notices. As shown in Table 3Table 3 , the total labor cost associated with rule familiarization is estimated at $54.43.

Table 3: Rule Familiarization Burden and Cost for SNUR Submitters

Reporting Activity Clerical Labor (at $29.63/hour) Technical Labor (at $64.66/hour) Managerial Labor (at $70.72/hour) Total Labor Cost

Burden (hours) Cost (2011$) Burden (hours) Cost (2011$) Burden (hours) Cost (2011$) Burden (hours) Cost (2011$) Rule Familiarization 0.00 $0.00 0.55 $35.56 0.27 $18.86 0.82 $54.43 Total 0.00 $0.00 0.55 $35.56 0.27 $18.86 0.82 $54.43

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



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

The final SNUR requires submission of a SNUN for any firm that chooses to manufacture, import, and/or process a chemical for a significant new use or import or process a chemical subject to the rule as part of

an article. First-time submitters of any TSCA section 5 notice (including Premanufacture Notices (PMNs), SNUNs, Test Market Exemption (TME) app lications, Low Volume Exemption (LVE) notices, Low Exposure/Low Release (LoREX) exemption notices, Biotechnology Notices for genetically modified microorganisms, Notices of Commencement of Manuf acture or Import (NOCs), and support documents to Section 5 notices) are required to register thei r company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E-payment account. 17 These activities are only required of sites that have not previ ously registered with CDX for other activities such as CDR reporting or the submission of other Section 5 notices (PMNs, MCANs, etc.). These activities are estimated to require the following burden ho urs, based on the estimates presented in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a):

 CDX registration: EPA estimates that companies will spend approximately 0.18 hours per employee to register with CDX, and that an average of four technical staff members and one manager will need to register for each company, totaling approximately 0. 92 hours of burden per

company.

 CDX electronic signature: EPA estimates that companies will spend 0.25 hours preparing, submitting, and filing an electronic signature agreem ent (Authentication of Identity) form to EPA

17 Although the final rule does not require submitters to establish and use a Pay.gov acc ount, the burden estimates in this analysis are conservative insofar as to incl ude the use of Pay.gov as a required activity.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
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Nine Benzidine Chemical Substances 11 Economic and Policy Analysis Branch per employee. This burden will apply to four technical staff members and one manager per company, totaling 1.25 hours of burden per company. In addition, EPA estimates that a manager will spend an additional 0.50 hours accessing, preparing, and submitting verification forms (Verification of Authorization) for all authorized submitters to EPA. The total burden incurred by companies submitting and then verifying electronic si gnature 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 o ccur. Filing the electronic signature agreement may be done either through mail or electronically. EPA believes the cost of electronic filing to be negligible, and the cost of a paper filing via the US Postal Service to be to be $2.55 per company (including five $0.45 stamps 18 and five $0.06 business envelopes 19 ).

 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 burde n does not include the time required to click ‘submit’ on the form and wait for payment processing.

As shown in Table 4Table 4 , the cost associated with CDX registration, CDX electronic signature, and Pay.gov account setup is $190, and this cost is only incurred by a first-time submitter.

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

Reporting Activity Clerical Labor (at $29.63/hour) Technical Labor (at $64.66/hour) Managerial Labor (at $70.72/hour) Total Cost

Burden (hours) Cost (2011$) Burden (hours) Cost (2011$) Burden (hours) Cost (2011$) Burden (hours) Cost (2011$) CDX Registration 0.00 $0.00 0.73 $47.42 0.18 $12.96 0.92 $60.38

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

Mailing Cost $2.55 E-Payment (Pay.gov ID) 0.00 $0.00 0.00 $0.00 0.13 $9.43 0.13 $9.43

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

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



### 2.2.3 Form Completion and Submission Fee

Respondents who choose to submit a SNUN are required to gather and submit information regarding the data elements identified in the applicable SNUN reporting form. The methodology and calculations used in this analysis assume that the employee respons ible for collecting, filling out, and submitting the requested information has a reasonable level of familiarity with the company and knowledge of operations at the site. It is assumed that for most entities these tasks are similar to other employee duties that require familiarity with EPA, State, and other Federal agency requests for chemical information and

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

19 Price for an envelope was determined based on the per unit price of a regular business envelope. See “Staples® #10, Self-Sealing Envelopes, 50 0/Box." Available at: http://www.s taples.com/ (Accessed 1/25/2012).***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
EO 12866 Review Draft – As Revised 12/03/2014

Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 12 Economic and Policy Analysis Branch do not require additional familiarization or training be yond the basic rule familiarization described above. In addition, this analysis focuses on the marginal costs of submitting information for the final rule and not the total costs for the company to co mply with a range of other Federa l and State environmental, health, and safety regulations or accounting requirements that rely on this type of information.

Estimates of the costs of completing a SNUN fo rm are based on the costs of completing a PMN submission, since the data requirements are the same and the same form is used for both. The PMN

submission costs came from EPA's 1994 Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications, which relied on industry estimates of the effort needed to collect and compile all data required for a PMN submi ssion, prepare the form, submit the form and data to EPA, and maintain a file of the submission (EPA, 1 994, Table III-2 and pages III-11, -12, and -13). The 1994 estimates were based on a survey conducted by the Chemical Manufacturers Association, which became the American Chemistry Council. These burde ns include “the time spent reading and becoming familiar with the form, gathering the required info rmation and preparing the report, producing sanitized responses for items claimed as confidential business information, and maintaining a file of the submission” (EPA, 1994. p. III 11-13). The burden associated with SNUN submission and preparation has been adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices. Electronic submission of SNUN forms is expected to remove all clerical burden and reduce the recordkeeping burden associated with preparing a SNUN (EPA, 2009a). 20 In addition, electronic submission is expected to generate and an additional 0.18 hours of technical burden, for the completion of the User Fee Payment Identification
Number and email address data elements on the electronic SNUN form.

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

technical labor and 18 hours of ma nagerial labor (EPA, 2009a). Table 5Table 5 combines the estimated reporting burden and loaded wage rates for all three labor categories to estimate the per-SNUN cost of form completion. The labor cost incurred by a SNUN submission for both large and small business submitters is estimated at $6,071.

20 The Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a) reported a 0.5 hour clerical and a 0.5 hour technical burd en associated with recordkeeping in addition to the burden estimates from the 1994 RIA (EPA, 1994, p. III-14). These bu rden estimates (the 0.5 for clerical burden and 0.5 for technical burden) are based on the reco rdkeeping burden for polymer exceptions and not the recordkeeping burden
associated with PMN submissions. Therefore, for this analysis, the 0.5 ho ur for clerical labor and the 0.5 hour fo r technical labor were removed. It is important to note that for this analysis , clerical burden changes are not appli cable because the entir e clerical burden
is assumed to be eliminated under th e electronic reporting requirements. In summary, we do not include the one hour recordkeeping burden (0.5 hour for clerical, 0.5 for technical) reported in the ePMN EA.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Economic Analysis of SNUR for
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Nine Benzidine Chemical Substances 13 Economic and Policy Analysis Branch Table 5: Industry Cost Estimate to Complete the SNUN Form

Reporting Activity Clerical Labor (at $29.63/hour) Technical Labor (at $64.66/hour) Managerial Labor (at $70.72/hour) Total Labor Cost

Burden (hours) Cost (2011$) Burden (hours) Cost (2011$) Burden (hours) Cost (2011$) Burden (hours) Cost (2011$) Form Completion 0.00 $0.00 74.2 $4,798 18 $1,273 92.2 $6,071

Source :

1 Loaded wages include fringe benefits and overhead. Wage ra tes 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 Electr onic SNUN form (EPA, 2009a page 15).

In addition, each submitting large business must pay a $2,500 per-SNUN submission fee, and each submitting small business must pay a $100 per-SNUN submission fee. Table 6Table 6 adds the labor cost

and submission fee to estimate the total cost of a SNUN submission. The total cost of a SNUN submission is $8,571 for large business submitte rs and $6,171 for small business submitters.

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

Reporting Population Labor Cost Submission Fee Total Cost (2011$) Large Business Submitters $6,071 $2,500 $8,571 Small Business Submitters $6,071 $100 $6,171

Source : EPA, 2009a.



### 2.2.4 Recordkeeping

Companies submitting a SNUN must, under 40 CFR §721.40, keep records of the information contained in the SNUN. Some EPA reports have assumed that SNUN recordkeeping hours will be five percent of SNUN submission hours, or about five to six hours. For this report, the SNUN recordkeeping hours were included in the SNUN submission hours (see Section 2.2.3) and the SNUN recordkeeping costs under 40 CFR §721.40 were not separately estimated. 21



### 2.2.5 Customer Notification

Manufacturers, processors, and importers of chemicals subject to SNURs and processors and importers of chemicals subject to the rule as part of articles must notify recipients of such chemicals of the SNUR or verify that knowledge of the SNUR has been otherwi se acquired by recipients, or that the recipients are

21 SNUN submission costs estimated in Section 2.2.3 of this report were based on PMN submission costs from a 1994 report, Regulatory Impact Analysis of Amendments to Regulations for TSC Section 5 Premanufacture Notifications (EPA, 1994). Page III-14 of the 1994 report refers to “the normal records kept with a PMN submission
which are included in the estimates fo r submission costs.” Page III-12 iden tifies “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.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
EO 12866 Review Draft – As Revised 12/03/2014

Economic Analysis of SNUR for
U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances 14 Economic and Policy Analysis Branch unable to engage in significant new uses. Since it is no t expected that all such entities will have complete knowledge of all uses of any produc ts subject to a SNUR, it is generally assumed that manufacturers, processors, and importers will most often choose to no tify their customers of SNUR regulatory activities. As this notification may be accomplished by simply annotating an MSDS, EPA estimates the associated burden to be about one hour of a technical employ ee's time or $64.66 per manufacturer, processor, or importer per chemical. However, for this SNUR, the regulated chemicals are not used in the U.S., and therefore, no manufacturers, processors, or importers will be affected. Thus, customer notifications will not be necessary.



### 2.2.6 Import Certification

In general, promulgation of a SNUR triggers a TSC A 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. manuf acturer, importer, or processor receiving an imported shipment of chemicals subject to the final SNUR will have to certify that all chemical substances in the shipment either comply with all applicable rules a nd orders under TSCA or that all chemical substances in the shipment are not subject to TSCA. 22 The statement must be on or attached to a commercial invoice or entry document belonging to the imported shipment.

Import certification is fulfilled by checking a box on an invoice or entry document and EPA assumes that it generally imposes no additional burden or cost on the importer. Any potential burden associated with

submitter’s familiarization with this requirement is assumed to be in cluded in the more general SNUR
familiarization burden discussed above.



### 2.2.7 Export Notification

Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical subject to various TSCA secti ons (40 CFR §707.60 through 75). Fo r TSCA 5(a)(2) (the section under which EPA promulgates significant new use rules) a nd certain other TSCA sections, this is a one-time notification requirement 23 per destination country for each expor ter of a chemical substance. After receiving a notification from a firm, EPA notifies the importing country and the United States State Department (40 CFR §707.70). However, the percent of notifications resulting from SNURs in general is unknown, and it is assumed that there will be no notif ications from this rulemaking as there are no U.S.

manufacturers.



### 2.2.8 Article Importation and Processing

Certain SNURs may require importers or processors who choose to import or process regulated chemical substances as part of articles to comply with notifi cation requirements, such as notifying EPA at least 90

22 The exact statements are as follows: For imports of chemical substances su bject to TSCA, “I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.” For imports of chemical substances not subject to TSCA (e.g., pesticides), “I certify that all chemicals in this shipment are not subject to TSCA.” (40 CFR 707.20)

23 On November 14, 2006, EPA revised the export notifica tion requirement for chemicals subject to TSCA §5(a)(2), 5(b), 5(e)(1) and 5(e)(2) from an annual to a one-time requirement per destination country for each exporter (November 14, 2006, 71 FR 66234).***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 15 Economic and Policy Analysis Branch days before commencing the import of any articles cont aining chemicals subject to the rule. Additionally, if a SNUR does not contain an exemption for processors and importers of articles, those that import or process articles may choose to undertake activities to assure themselves that they are not importing or processing regulated chemicals as part of articles even though these activities are not required by the SNUR. A number of potential activities that importers may choose to undertake to determine whether the articles they import contain regulated chemical substa nces are outlined in this paper. This determination may involve gathering information from suppliers in their supply chain, and/or testing samples of the
article itself. More information on the activities that an importer may choose to undertake and what factors may affect that choice are found in Understanding the Costs Associated with Eliminating Exemptions for Articles in SNURs (EPA, 2013b).

Affected Entities

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

under TSCA the definition of “manufacture” me ans to “import..., produce or manufacture” 24 and importers are responsible parties under the final SNUR . In order to understand and monitor their liability, companies might undertake a range of activities to en sure that the articles they import do not violate existing regulations.

SNUR reporting requirements for persons who may pr ocess chemicals as part of articles are similarly described in § 40 CFR 721.5; however, the reporting requirements for processors (including processors of subject chemicals as part of articles) do not appl y in some circumstances. As described in § 40 CFR 721.5(c), a processor is not required to submit a SNUN if he can document that (1) he does not know the specific chemical identity of the chemical substan ce being processed; and (2) that he is processing the chemical substance without knowledge that the substa nce is subject to a SNUR. This analysis focuses on the standard business practices that EPA believes a pro cessor would already undertake that would serve to provide information regarding the chemi cal content of articles they process.

Table 7 contains examples NAICS codes for firms that may import or process articles that use chemical substances subject to the SNUR. The benzidine-based chemical substances subject to the rule have predominately been used as azo dyes in the productio n of textiles, paints, printing inks, paper, and pharmaceuticals. This is not meant to be an exhaus tive list, but rather an example of the types of industries that may be impacted by the articles exem ption. As shown in Table 7, a wide variety of industries may import articles containing the dyes, incl uding chemical, apparel, and textile manufacturers,
wholesalers, and retail stores.

24 TSCA section 3(7).***FAR Draft – Deliberative – Do notCite, Quote, or Release***EO 12866 Review Draft – As Revised 12/03/2014Economic Analysis of SNUR forU.S. EPA Office of Pollution Prevention and ToxicsNine Benzidine Chemical Substances 16Economic and Policy Analysis BranchTable 7:Examples of Industries that may Import or ProcessArticles Containing Benzidine Chemical SubstancesNAICSCodeSectionDescription314 Textile Product Mills Industries in the Textile Product Millssubsector group establishments that make textile products (except apparel). Witha few exceptions, processes used in these industries are generally cut and sew (i.e., purchasing fabric and cutting andsewing to make nonapparel textile products, such as sheets and towels).315 Apparel Manufacturing Industries in the Apparel Manufacturing subsector group establishments with two distinct manufacturing processes: (1)cut and sew (i.e., purchasing fabric and cutting and sewing to make a garment), and (2) the manufacture of garments inestablishments that first knit fabric and then cut and sew the fabric into a garment. The Apparel Manufacturing subsectorincludes a diverse range of establishments manufacturing full lines of ready-to-wear apparel and custom apparel: apparelcontractors, performing cutting or sewing operations on materials owned by others; jobbers performing entrepreneurialfunctions involved in apparel manufacture; and tailors, manufacturing custom garments for individual clients are allincluded.423 Merchant Wholesalers,Durable GoodsIndustries in the Merchant Wholesalers, Durable Goods subsector sell capital or durable goods to other businesses.Durable goods are new or used items generally with a normal life expectancy of threeyears or more. Durable goodsmerchant wholesale trade establishments are engaged inwholesaling products, such asmotor vehicles, furniture,construction materials, machinery and equipment (including household-type appliances), metals and minerals (exceptpetroleum), sporting goods, toys and hobby goods, recyclable materials, and parts.424 Merchant Wholesalers,Nondurable GoodsIndustries in the Merchant Wholesalers, Nondurable Goods subsector sell nondurable goods to other businesses.Nondurable goods are items generally with a normal life expectancy of lessthan three years. Nondurable goodsmerchant wholesale trade establishments are engaged in wholesaling products, such as paper and paper products,chemicals and chemical products, drugs, textiles and textileproducts, apparel, footwear, groceries, farm products,petroleum and petroleum products, alcoholic beverages, books, magazines, newspapers, flowers and nursery stock, andtobacco products.***FAR Draft – Deliberative – Do notCite, Quote, or Release***EO 12866 Review Draft – As Revised 12/03/2014Economic Analysis of SNUR forU.S. EPA Office of Pollution Prevention and ToxicsNine Benzidine Chemical Substances 17Economic and Policy Analysis BranchTable 7:Examples of Industries that may Import or ProcessArticles Containing Benzidine Chemical SubstancesNAICSCodeSectionDescription442 Furniture and HomeFurnishings StoresIndustries in the Furniture and Home Furnishings Stores subsector retail new furniture and home furnishings from fixedpoint-of-sale locations. Establishments in this subsector usually operate from showrooms and have substantial areas forthe presentation of their products.448 Clothing and ClothingAccessories StoresIndustries in the Clothing and Clothing Accessories Stores subsector retail new clothing and clothing accessoriesmerchandise from fixed point-of-sale locations. Establishments in this subsector have similar display equipment andstaff that is knowledgeable regarding fashion trends and the proper match of styles, colors, and combinations of clothingand accessories to the characteristics and tastes of the customer.449 Sporting Goods, Hobby,Musical Instrument, andBook StoresIndustries in the Sporting Goods, Hobby, Musical Instrument, and Book Stores subsector are engaged in retailing andproviding expertise on the use of sporting equipment or other specific leisure activities, such as needlework and musicalinstruments. Book stores are also included in this subsector.450 General MerchandiseStoresIndustries in the General Merchandise Stores subsectorretail new general merchandise from fixed point-of-salelocations. Establishments in this subsector are unique in that they have the equipment and staff capable of retailing alarge variety of goods from a single location. This includes a variety of display equipment and staff trained to provideinformation on many lines of products.451 Nonstore Retailers Industries in the Nonstore Retailers subsector retail merchandise using methods, such as the broadcasting ofinfomercials, the broadcasting and publishing of direct-response advertising, the publishing of paper and electroniccatalogs, door-to-door solicitation, in-home demonstration, selling from portable stalls and distribution through vendingmachines. Establishments in this subsector include mail-order houses, vending machine operators, home delivery sales,door-to-door sales, party plan sales, electronic shopping, and sales through portable stalls (e.g., street vendors, exceptfood). Establishments engaged in the direct sale (i.e., nonstore) of products, such as home heating oil dealers andnewspaper delivery service providers are included in this subsector.***FAR Draft – Deliberative – Do notCite, Quote, or Release***EO 12866 Review Draft – As Revised 12/03/2014Economic Analysis of SNUR forU.S. EPA Office of Pollution Prevention and ToxicsNine Benzidine Chemical Substances 18Economic and Policy Analysis Branch***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 19 Economic and Policy Analysis Branch Potential Compliance Activities (Article Importers)

The rule does not prescribe steps that an importer must ta ke to identify a chemical subject to the SNUR in articles; therefore, there are a variety of potential actions that a company coul d take to identify specific substances in its articles, should they choose to do so. These activities range in cost; however, costs incurred are at the discretion of any individual impor ter. EPA expects that in all likelihood, importers

would take actions that are commensurate with the level of risk each company ’s perceived likelihood that the regulated chemical is part of the article they intend to import perceives , and the resources it has
available.

There is currently no single widely accepted standard procedure to identify regulated chemicals in the supply chain. However, there are a number of organi zations that help provide information on the content of articles, organize declarations from suppliers, or certify suppliers based on materials or processes used. Importers (or processors) subject to SNURs may refer to these sources for assistance in their own strategy to identify a chemical subject to a SNUR in articles.

The American Apparel & Footwear Association (AAF A) RSL (Restricted Substances List) Management (AFIRM) Working Group has developed a toolkit to he lp apparel and footwear companies “to reduce the use and impact of harmful substances in the apparel and footwear supply chain”. According to Massey et al., 2008, companies in this industry may require that suppliers sign agreements certifying that specified products do not contain substances that are of inter est to the company. In addition, some agreements specify that if testing identifies a restricted mate rial, the supplier must cover all associated costs.

ASTM International, formerly known as the Americ an Society for Testing and Materials (ASTM), has developed a Standard Guide for Assessment of Material s and Products for Declarable Substances (“ASTM F2577”), which provides guidance for the d ecision process to assess materials and products for declarable substances. The following list includes activ ities that an importer might perform to identify any restricted chemicals in imported articles. Any rule familiarization burden associated with the proposed SNUR for importers of articles is discussed in Section 2. 2.1 of this report. This list is intended to capture the general types of activities that might be performed.

1) Understand applicable requirements (per-firm cost). All importers would read and understand the SNUR, within the context of the company’s pr oducts. This burden is derived in Section 2.2.1 of this report

2) Identify the type of imported articles that po tentially contain the chemicals subject to this SNUR (per-firm cost). This determination may be done b ased on an understanding of the uses of the subject chemical substances (e.g., those describ ed in Section 1.1 of this analysis) and the application of any a priori knowledge of the material and its manufacture to assess the probability whether each regulated substance may be present.

3) Identify all suppliers involved (per-firm cost). The importer may choose to identify all suppliers from whom the articles identified in th e previous step are imported, and as appropriate, to make them aware of the importer’s poten tial notice obligations respecting the regulated

chemical substances.

4) Collect data from suppliers (per-article cost). Importers may choose to obtain verification from suppliers identified in step 3 that the regulated chem ical substance is or is not found in the article. This may be accomplished through, for example, agreements with supplie rs, declarations through databases or surveys, or by using a third-party certification system.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 20 Economic and Policy Analysis Branch 5) Chemical testing (per-article cost). Importers may choose to assess imported articles for chemical content. This could involve requ iring suppliers to provide certificates of analysis/laboratory reports for a lot or batch of the material produced. Importers may perform their own laboratory testing of certain articles (o r components of articles) to determine if they
contain the restricted substance.

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

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

derivations are discussed in more detail in Understanding the Costs Associated with Eliminating Exemptions for Articles in SNURs (EPA, 2013b).***FAR Draft – Deliberative – Do notCite, Quote, or Release***EO 12866 Review Draft – As Revised 12/03/2014Economic Analysis of SNUR forU.S. EPA Office of Pollution Prevention and ToxicsNine Benzidine Chemical Substances 21Economic and Policy Analysis BranchTable 8: Range of costs associated with an importer’s identification of chemicals subject to SNURs in articlesActivityCost (2011$)NotesPer Rule CostsRule familiarization $55Discussed in Section2.2.12.2.1of this documentIdentify the type of imported articles thatpotentially contain the restrictedsubstances$130 to $1,550Actual costs may vary based on number of articles imported andthe complexity of the article itself (number of components)Identify all suppliers involved $950Actual costs may vary depending on the number of articlesimported, number of suppliers, and frequency of supplierchangesRecordkeeping $10Actual costs may vary depending on recordkeeping systemalready in placePer Article-Related CostsCollect data from suppliers$5 to $515 per articlereviewed.$0 if no data collected.Actual costs only apply to those companies that choose tocollect data from suppliers. They will vary depending on thespecific data collection method chosen. Total costs depend onconsiderations including thenumber of articles imported,number of suppliers, and frequency of supplier changes.Chemical testing$130 per article tested. $0if no testing.Actual costs only apply to those companies that choose tocollect data from suppliers. They will vary depending on thespecific chemical being tested for; the complexity of the articleand sample preparation required; and the exact fees of thelaboratory chosen for the analysis. Total costs per company willdepend on considerations including the number of articlestested, which may be affected bythe number of suppliers andrisk associated with each, and frequency of supplier changes.Source: EPA, 2013b***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 22 Economic and Policy Analysis Branch Variation in costs associated with these activities would depend on a company’s level of activity to comply with other regulations on chemicals in article s, the complexity of the supply chains, and the size of the company. Total costs per article importer will further depend on the number of affected articles and the frequency of supplier change. Total costs associat ed with these activities to any article importer are not quantified, but are believed to be minimal for th is particular SNUR because firms may already be taking actions to avoid certain azo dyes as part of articles they import and because the dyes are not as readily available and therefore are not exp ected to be widely used in articles.

Since the 1990s, the import, manufacture, export, and sal e of many textile products made with certain azo dyes has been banned in a number of European compan ies. Also in the 1990s most European and North American members of the Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers voluntarily ceased manufacturing benzid ine dyes and salts. Developing countries that manufacture dyes and produce leather and textiles with azo dyes were affected by the changes in the marketplace. Cost for textile exporters (in developi ng countries) to switch to nonregulated azo substitutes have been high; however, compliance with European re gulations seems high with a rate of over 96% for some samples tested for export to Europe (OECD, 2002).

EPA believes import of the subject chemicals as part of articles to be unlikely given foreign bans on the use of certain azo dyes in fabrics and leather products and a general decline in the availability of certain azo dyes in the marketplace as many leather and tex tile producers have moved to substitute dyes (OECD, 2002). Because firms operating in countries and/or states where azo dyes are already regulated are expected to be complying with existing regulations, EPA also expects that they are more likely to use non-regulated substances, rather than have a separate product stream that may only be used in certain countries or states. Furthermore, firms that have prev iously selected suppliers that have agreed to uphold certain standards, or who have otherwise sufficiently demonstrated that they are not supplying benzidinebased chemicals, would not likely incur any additio nal costs associated with these activities. Essentially, the product’s certification would allow importers or pr ocessors of articles to learn whether an article does or does not contain certain azo dyes or whether s uppliers have agreed to uphold certain production standards. There are labeling systems for products in which independent entities ensure that the production of products does not utilize specific chem icals. For example, th e European Union has developed a voluntary labeling system, called the EU Ecolabel. Producers, importers and retailers can voluntarily apply for the EU Ecolabel (EC, 2013). Labeled products signal to consumers that the product in question has a reduced environmental impact th roughout the product’s life cycle, such as at the manufacturing stage and/or during the final product di sposal. The criteria are specifically designed to focus on the stage of the life cycle where a product has the most environmental impact (EC, 2013). For textiles, the criteria are based on the manufacturing pr ocess when fabrics are dyed, printed, and bleached since this is the stage with th e largest impact (EC, 2013). Another international association, OEKOTEX® 25 set up an independent testing and certification system specifically for textiles, called the OEKOTEX® Standard 100 (OEKO-TEX®, No Date b). The sy stem looks at products at different stages of production, including, raw materials, intermediates, a nd end products. The label signals to customers that the textiles have been tested for (1) illegal substan ces, (2) legally regulated substances, (3) known harmful unregulated chemicals, and (4) parameters for hea lthcare. The company also looks at the uses of the textile to see the intensity of contact between the product and skin for their parameters. (OEKO-TEX®, No Date b).

25 The International Association for Research and Testing in the Field of Textile a union of 15 institutes for textile research and testing in Europe and Japan (OEKO-TEX®, No Date a).***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 23 Economic and Policy Analysis Branch Similarly, firms that operate in places where azo dyes are already regulated would presumably have mechanisms in place to identify the content of any ar ticles they import. Firms already subject to REACH requirements could potentially rely on any article test ing that may have been completed to comply with REACH to assess the likelihood of a chemical regul ated under the SNUR being a constituent of an imported article. EPA believes that the analytical t esting standards listed under REACH that detect azo dyes that contain benzidine, are suitable for t esting the benzidine-based chemicals listed in Table 1Table

1 . This is because all chemicals regulated under the fi nal SNUR will release benzidine when tested using the REACH requirements. Therefore, any firm that is currently testing articles for benzidine prior to importation into the EU would not need to conduc t additional testing to learn about the presence or absence of the chemicals covered by the SNUR, as th e results from the REACH test could be used to show the presence or absence of benzidine in an article.

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

contain benzidine-based chemicals ma y incur a larger burden should they choose to conduct some or all
of the activities listed above to learn about the chemic al content of those articles. These firms may choose to reach out to a wide variety of upstream firms, in cluding subcontractors, accessory suppliers, dye mills, print mills, tanneries, and chemical suppliers, to gath er information on the chemical content of articles, for documentation. Firms may also choose to conduct a dditional research on their suppliers to ensure that they are purchasing from reputable manufacturers an d chemical suppliers who will provide necessary technical support and will use high quality dyes that meet customer color and quality, as well as regulatory standards (AFIRM, 2011). Furthermore, a company could choose to have articles tested. If a company chooses to conduct testing, they may also need to conduct additional research to ensure the laboratory is accredited, reliable and follows Good Laboratory Practices (GLP) (AFIRM, 2011).

There are no requirements in the SNUR for importers to develop any information regarding the content of the articles they import. Given existing regulatory lim itations both internationally and within the U.S., industry-wide processes, resources that support comp anies in understanding and managing their supply chains, and the evidence showing minimal worldwide availability of the dyes regulated under the SNUR, EPA believes that article importers th at choose to investigate their produc ts would incur costs at the lower end of the ranges presented in Table 8Table 8 , as a result of this rule. For those companies choosing to undertake actions to assess the composition of the articl es they import, EPA expects that in all likelihood, these importers would take actions that are commensurate with the perceived likelihood that the regulated chemical is part of the article they intend to importleve l of risk (of a chemical to be a part of an article) each company perceives , and the resources it has available.

Potential Compliance Activities (Processors of Articles)

Under § 40 CFR 721.5(a)(2), manufacturers, importers, or processors of subject chemical substances who distribute the substance in commerce must notify the r ecipient, in writing, of the applicability of SNUR requirements, or document that the recipient has su ch knowledge or will not undertake any significant new use described in the rule. Therefore, the article processor, as the recipient of any subject chemical substance, should receive written notification from the supplier and would presumably keep this documentation as a standard business practice, along with other documentation such as Material Safety Data Sheets, shipping or labeling documents, etc. that may provide information on the chemicals in the articles they process.

To the extent that processors desi re extra certainty that the articl es they process are not subject to a SNUR, they may undertake the steps to identify regulated chemicals outlined above for importers.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 24 Economic and Policy Analysis Branch However, as stated above, given the international ba ns on the use of azo dyes in fabrics and leather products, it is unlikely that these chemicals will be imported into the United States as part of finished
articles.

2.3 Industry Costs of SNUR, by Option

The number of firms affected by not making submissions to EPA is not known; therefore, costs are not aggregated across the affected en tities. Table 9 summarizes the costs to comply with the final rule, as

described in more detail in Section 2.2 above

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

Option 1 Costs Quantified Costs per Chemical (2011$) 2

1. Electronic submission of a Significant New Use Notice (SNUN), indicating to EPA that
the firm would like to manufacture, import, or process the
chemical for a Significant New Use
as defined in the

SNUR. Costs of electroni cally submitting a SNUN, including rule familiarization, CDX registration (for companies that are first-time submitters), form completion, user fee, export notification cost (if relevant). Rarely, a firm may choose to conduct toxicity or fate testing to support the SNUN, but such testing is not required by law. $54.43 rule familiarization cost; $8,571 submission cost (including SNUN recordkeeping under 40 CFR §721.40 and fee $2,500 for large businesses). EPA usually receives well under ten SNUNs per year. First time submitters will incur $190 for CDX registration and associated activities.

2. Decide not to manufacture, import, or process thechemical for any nonexempt uses. Cost of the profit foregone as a result of not engaging in the commercial activity originally planned (opportunity costs). Other costs include rule familiarization, and export notification costs. Opportunity costs are not quantified. Other costs such as rule familiarization ($54.43) may apply. Costs associated with article importation may include activities such article identification ($130-$1,550), supplier identification ($950) recordkeeping ($10), collecting data from suppliers ($5 - $515 per article), and testing, if completed ($130 per article).

Notes:

1 Firms may experience costs related to both options at once since submission of a SNUN results in profits foregone as a result of not manufacturing, importing, or processing the dyes subject to the final rule, or importing or processing articles containing these dy es or those specified at 40 CFR section 721.1660. Additionally, export notification costs are somewhat independ ent of the option because the productio n of benzidine-based dyes subject to the final rule for export purposes only does not require notification under 40 CFR 721.25.

2 Quantified costs are attributable to the SNUR only if a firm will not otherwise follow the specified practices

3 EPA does not require the development of test data for submission of a SNUN, although a firm may submit test data already in its possession and/or descri be any other available data. Because EPA does not require the development of test data, EPA assumes that no firms will incur testing costs as a result of the final SNUR.

2.4 Likelihood of a SNUN Submission

The domestic manufacture, import and processing of the dyes specified in Table 1Table 1 and the articles containing them have been phased out. Additionally, ther e appears to be no production of the majority of***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 25 Economic and Policy Analysis Branch the dyes specified at 40 CFR section 721.1660 either do mestically or globally, although some may have appeared on websites of some companies 26 . Of those that appear to remain in production either domestically or globally, there is insufficient inform ation to identify the use (i ncluding non-exempt uses or as part of an article imported into the US.) 27

.
The E.U. has banned the use of azo dyes which can break down to release any of 22 listed carcinogenic aromatic amines (including benzidine and its congene rs) in amounts above 30 ppm in textile and leather articles which may come into direct and prolonge d contact with humans (European Commission 2009). 28 Despite the E.U. ban, products are occasionally found in articles meant for import (European Commission, 2010) and certain azo dyes in articles may remain an ongoing i ssue. However, EPA has found no information to support the conclusion that articles containing the specific dyes specified at 40 CFR section 721.1660 are currently imported into the US.

Canada has also expressed concern about the potential release of benzidine or its congeners from azo dyes and is evaluating potential approaches for addressi ng 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 internati onally to governments and industry. Many of the dyes, including those listed in Table 1, have been phased-out of production. Ex porters of textile and leather products that are located in developing count ries have incurred costs to adopt azo substitutes and some samples of tested products have shown over a 96% compliance rate with European requirements (OECD, 2002). Given the international concern for these chemicals, market reemergence of those not currently manufactured or imported is not expected. While research identified global and domestic manufacturers that have listed availability of sever al of the dyes specified at 40 CFR section 721.1660 there is no evidence to suggest that these dyes are being used in non-exempt uses or are being imported and/or processed domestically as part of articles (see section 1.1). Additionally, the actual availability of those dyes was not confirmed. Therefore, EPA believ es that submission of a SNUN for these chemicals is unlikely.

2.5 Potential for Subsequent Regulatory Action

The Agency recognizes that if submission of a SNUN does result from a SNUR, the Agency may take additional regulatory actions under TSCA. These a dditional regulatory actions might be necessary to

further evaluate an intended new use and associated activities. Any such actions are highly dependent on the circumstances surrounding the individual SNUN (e.g., available information and scientific understanding about the chemical and its risks at the time the SNUN is being reviewed).

26 Dyes may appear on website listings, however, actual availability is not confirmed.

27 In some cases, company product lists contained common names for dyes. Common names are not unique identifiers for dyes as they may corr espond to more than one CASRN; howev er, they are frequently used, even in peer-reviewed literature. Therefore, dyes listed as available solely by common name may not be the same chemical subject to the SNUR.

28 See Restriction 43 in REACH Annex XVII.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 26 Economic and Policy Analysis Branch Should the Agency’s review of the SNUN result in furt her regulatory actions, the Agency will initiate and follow the appropriate procedures for taking those actions. Included in those procedures, as appropriate,
will be an assessment of the costs and benefits of those actions.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 27 Economic and Policy Analysis Branch 

### 3. AGENCY COSTS

As described in the following sections, EPA’s co sts 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 annua l Federal salaries for the Washington-Baltimore area published by the Office of Personnel Management effective January 2011 (OPM, 2011). EPA assumes that, on average, a federal GS-13, Step 5 full-tim e equivalent (FTE) will conduct its collection and

administrative activities under the final rule. 29 The average salary for a GS-13 Step 5 employee was $100,904 in 2011 without fringe benefits and overhead co sts. In order to derive the fully loaded salary, EPA multiplied the annual salary by an assumed loading f actor of 1.6 to reflect federal fringe benefits and overhead (EPA, 2009c), which results in a fu lly loaded annual salary of $161,446 (see Table 10Table 10 ). Dividing the fully loaded annual salary by 2,080 hours (i.e., the number of hours in a work year) yields an estimated hourly FTE wage rate of $77.62.

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

.

Table 10: Derivation of Loaded Agency Wage Rates

Labor Category Data Source for Wage

Information Date Wage Fringe

Benefit Fringes as % wage Overhead as % wage Fringe +

overhead

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

EPA staff

FTE Annual federal staff cost:OPM WashingtonBaltimore-NorthernVirginia, DC-MD-PAVA-WV, area, GS-13 Step 1 pay rates a Jan

2011 $100,904 (annual)

-- Included
in 60%
overhead 60% 2 1.60 $161,446 (annual)

$48.51 (hourly) $77.62 (hourly)

Notes :

a The Agency salary is the unloaded federal GS-13 Step 5 salary ($100,904 for 2011), from the OPM salary table for the Washington-Baltimore-Northern Virginia Lo cality Pay Area (OPM 2011). Hourly rate s are based on annual salary divided by 2,080 hours.

b The 60% fringes-and-overhead rate is fro m an EPA guide, Instructions for Prepari ng Information Collect ion Requests (ICRs) (EPA 1992, page 30, footnote 9).

3.2 SNUN Processing Costs

The list of review steps, estimates of extramural costs, and the percent of chemicals requiring a particular review step are derived from the costs for processing PMN submissions in Table VII-1 of a 1994 EPA report, Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994). The Agency burden associat ed with processing a PMN has been adjusted to

29 The GS-13 Step 5 is consistent with ICR No. 0574.14 (12/18/2007) (EPA, 2007a), which covers PMN SNURs. Use of this grade level follows the approach introduced in EPA, 2007b. That report represented a change from an earlier PMN SNUR economic analysis (EPA , 2003), which used an average of GS-12 Step 1 and GS-12 Step 10
salaries.***FAR Draft – Deliberative – Do not Cite, Quote, or Release***
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Nine Benzidine Chemical Substances 28 Economic and Policy Analysis Branch reflect burden reductions resulting from the 2009 fi nal PMN Electronic Reporting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices. Electronic submission of SNUN forms is expected to reduce Agency burden by 16.5 percent (EPA, 2009a, p.28).

For each review step, the “EPA staff” cost is calcu lated by multiplying the number of FTEs (in the first column) by the fully loaded hourly salary. This s hows 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) da ta (BLS 2012b). The not seasonally adjusted ECI for total compensation of private industry professional and related workers (Series ID CIU2010000120000I) is used because it is the only series with continuous data since 1985, and that includes professional and technical labor, which perform the major ity of Agency extramural activities. Table 11Table 11 , below contains the derivation of inflation factors for Agency extramural costs.

Table 11: Derivation of Inflation Fa ctors for Agency Extramural Costs

Item Inflation index source Starting

year Index
for starting

year

(a) Index
for

2011

(b) Inflation

factor (b)/(a) 2

Agency Extramural costs White collar labor; equipment; supplies BLS ECI, Total comp, Private industry, Professional and related

, 4 th Q [BLS 2012b] 4 1993 67.0 115.7 1.73

Source:
Bureau of Labor Statistics. Employment Cost Index – Total Compensation: Professional and Related Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I) , extracted March 22, 2012 (BLS 2012b).

The Percent of Cases column in Table 12Table 12 is a weighting factor applied to reflect the fact that not all chemicals require each review step. For exam ple, in the PMN process, all chemicals require Administrative Prescreening, but not all chemicals requ ire 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. Cha nges 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 require d in the first place. However, often a SNUN may take more Agency time than a typical PMN because of fact ors such as the need to retrieve old PMN records from archives, and the likelihood that more data re quiring EPA review is submitted with a SNUN than will be submitted, on average, with a PMN. Resourc es were not available to update the review hours to reflect the current review process or to tailor the cost estimates to SNUNs. Therefore, for this analysis, the review steps and weighting factors are assumed to be the same as those derived in 1994 for PMNs.

Values in the ‘Weighted Cost’ column are calculate d by multiplying the un-weighted costs (EPA staff cost plus extramural costs) by the percentage of case s requiring this review step. Weighted costs are then multiplied by the burden reduction of 16.5 percent to account for burden savings generated electronic

submission. As shown in Table 12Table 12 , this calculation yields total Agency costs of $5,066, per SNUN, for submission review and processing.***FAR Draft – Deliberative – Do notCite, Quote, or Release***EO 12866 Review Draft – As Revised 12/03/2014Economic Analysis of SNUR for 29U.S. EPA Office of Pollution Prevention and ToxicsNine Benzidine Based Dyes Economic and Policy Analysis BranchTable 12: Agency Costs for SNUN and Other Submission Review and ProcessingReview StepsEPA staff (FTE) CostExtramural Cost2UnweightedCostPct. ofCasesWeightedCost3ePMNBurdenReduction4Weighted Costwith ePMNBurdenReductionFTEfractionCost perFTE1FTE Total($2011)1993dollars2011dollars(a)(b)(c)=(a)*(b)(d)(e)(f)=(c)+(e)(g)(h)=(f)*(g)(i)(j)=(h)*(1-(i))Pre-notice consultation 0.0024 $161,446 $387.47 $4.00 $6.91 $394 41% $161.70 0.165 $135Administrative prescreen/notice receipt/user fee0.0024 $161,446 $387.47 $92.00 $158.87 $546 100% $546.34 0.165 $456CRSS (Chemical Review andSearch Strategy)0.0025 $161,446 $403.62 $268.00 $462.80 $866 100% $866.42 0.165 $723SAT (Structure ActivityTeam)0.0006 $161,446 $96.87 $14.00 $24.18 $121 100% $121.04 0.165 $101Engineering/Exposure 0.0015 $161,446 $242.17 $56.00 $96.70 $339 100% $338.87 0.165 $283Exposure/Fate 0.0008 $161,446 $129.16 $0.00 $0.00 $129 100% $129.16 0.165 $108Focus 0.0009 $161,446 $145.30 $23.00 $39.72 $185 100% $185.02 0.165 $154Standard Review Functions 0.0219 $161,446 $3,535.68$511.00 $882.43 $4,418 29% $1,281.25 0.165 $1,070Division Directors Meeting 0.0129 $161,446 $2,082.66 $113.00 $195.14 $2,278 15% $341.67 0.165 $285OrderDevelopment/NegotiationReview0.0171 $161,446 $2,760.73 $22.00 $37.99 $2,799 3% $83.96 0.165 $70Post Order Data Review 0.0886 $161,446 $14,304.15 $0.00 $0.00 $14,304 3% $429.12 0.165 $358Order Modification 0.2167 $161,446 $34,985.43 $0.00 $0.00 $34,985 3% $1,049.56 0.165 $876New Chemical SNURDevelopment0.0277 $161,446 $4,472.07 $85.00 $146.78 $4,619 7% $323.32 0.165 $270Notices of Commencement 0.0012 $161,446 $193.74 $40.00 $69.07 $263 31% $81.47 0.165 $68FOIA (Freedom ofInformation Act) Requests0.0333 $161,446 $5,376.17 $287.00 $495.61 $5,872 1% $58.72 0.165 $49CBI (Confidential BusinessInformation) Substantiation0.0004 $161,446 $64.58 $3.00 $5.18 $70 100% $69.76 0.165 $58TOTAL$6,0670.165$5,066Notes:1GS-13 Step 5 salaries loaded with benefits and overhead. SeeTable 10Table 10for derivation.2Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993 prices using the factors presented inTable11Table 11.***FAR Draft – Deliberative – Do notCite, Quote, or Release***EO 12866 Review Draft – As Revised 12/03/2014Economic Analysis of SNUR for 30U.S. EPA Office of Pollution Prevention and ToxicsNine Benzidine Based Dyes Economic and Policy Analysis Branch3Weighted costs were calculated using unrounded unit cost estimates, soresults may differ from calculations using the rounded values shown in this table.4Electronic submission is expected togenerate a cost savings of 16.5% to the Agency (EPA 2009b, p. 28).Sources:FTEs per review step, 1993 extramural costs, and percent of cases are from EPA, 1994 Table VII-1, GS-13salaries are from OPM2011.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Based Chemical Substances 31 Economic and Policy Analysis Branch 3.3 Export Notification Cost

Under TSCA Section 12(b), exporters must notify EPA if they intend to export chemicals subject to SNURs. The Agency burden and cost due to TSCA §12( b) export notification result from three tasks. In the first task, EPA receives export notifications from co mpanies that intend to export one of the chemicals subject to TSCA §12(b) (EPA, 2009b). In the second t ask, EPA staff prepares separate notification letters that are subsequently reviewed and delivered to impor ting countries, their embassies, or representatives, and to the importing country’s U.S. embassies (EPA, 2009b). However, as stated in Section 2.2.7, EPA

believes there will be no notifications from this rule making as there are no U.S. manufacturers; therefore, the Agency will not incur any costs associated with export notification as a result of the SNUR.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Based Chemical Substances 32 Economic and Policy Analysis Branch 

### 4. ADDITIONAL ANALYSES

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

various statutes and executive orders.

4.1 Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a

substantial number of small entities. The rationa le supporting this conclusion is as follows. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a signi ficant new use. Where a use is new, by definition no small or large entities presently engage in such ac tivities. Although some small entities may decide to manufacture or process a substance for the new use after the SNUR is promulgated, EPA receives very few SNUNs, and few of those are submitted by sma ll entities. In response to the promulgation of SNURs covering over 1,000 chemical substances, the Agency receives only a handful of SNUNs per year. For example, the number of SNUNs was four in Federa l fiscal year 2005, eight in FY2006, six in FY2007, eight in FY2008, seven in FY2009, two in 2010, and ten in 2011 (EPA, 2012), for an average of 6 per year from all SNURs. EPA has no reason to believe that this SNUR will alter the pattern of SNUN submissions that EPA has historically seen. In add ition, the estimated reporting cost for submission of a SNUN is minimal regardless of the size of th e firm, averaging about $8,600 including SNUN recordkeeping and reporting costs. The Agency current ly offers some relief to certain small businesses with sales (including those of subsidiary/parent compan ies) of less than $40 million per year by reducing the SNUN submission fee from $2,500 to $100. This lower fee reduces the cost of submitting a SNUN toabout $6,200 for smaller firms. During the six year period from 2005-2010, only three submitters selfidentified as small in their SNUN submission 30 (EPA, 2012). EPA believes the cost of submitting a SNUN is relatively small compared the cost of devel oping and marketing a chemical new to a firm and that the requirement to submit a SNUN generally does not have a significant economic impact.

EPA believes that there will be minimal impact to processors and importers of the chemical substance subject to the final SNUR as part of an article. The SNUR does not require processors and importers of articles to conduct specific activities to ascertain if th ey are importing or processing chemicals regulated by the SNUR as part of an article. Therefore, processor s and importers are, in all likelihood, expected to

take actions that are commensurate with the level their perceived likelihood that the regulated chemical is part of the article they intend to process or importof risk (of a chemical being part of an article) each company perceives , and the resources it has available. EPA h as no reason to believe that a firm would voluntarily incur substantial costs to evaluate its ar ticles, but rather EPA believes each firm will choose the most efficient route to identify whether it is importing or processing the subject chemical substances as part of articles.

4.2 Unfunded Mandates Reform Act

The final rule does not impose any enforceable duty, contain any unfunded manda te, or otherwise have any effect on small governments because none of th e current producers of the subject chemicals are governments. Additionally, it is not expected th at any governments will initiate production of these

chemicals.

30 The three “small” submitters were id entified by review of actual SNUN submissions from the years 2005-2010.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Based Chemical Substances 33 Economic and Policy Analysis Branch 4.3 Paperwork Reduction Act

According to the Paperwork Reduction Act (PRA), 44 U. S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not requi red to respond to a collection of information that requires OMB approval under the PRA, unless it has been approve d by OMB and displays a currently valid OMB

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

in the Federal Register , are listed in 40 CFR, part 9, and incl uded on the related collection instrument, or form, if applicable. The information collection requi rements related to this action have already been approved by OMB pursuant to the PRA under OMB control numbers 2070-0038 (EPA ICR No. 1188) and 2070-0030 (EPA ICR No. 0795).

If an entity were to submit a SNUN to the Agency, th e annual burden is estimated to average 98.2 hours per response: 0.82 hours for rule familiarization (Sec tion 2.2.1); 2.80 hours for CDX registration, CDX electronic signature, and pay.gov account setup (Sec tion 2.2.2); 92.2 hours for form completion, submission and recordkeeping under CFR §721.40 (Secti ons 2.2.3 and 2.2.4); 1 hour for consumer notifications (Section 2.2.5); and 1.36 hours for expor t notification (Section 2.2.6). The burdens for rule familiarization, CDX registration, CDX electronic signature, pay.gov account setup form completion, submission, and recordkeeping are approved un der EPA ICR No. 1188 (OMB control number 2070- 0038). The burden for export notification is a pproved under EPA ICR No. 0795 (OMB control number 2070-0030).

4.4 Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations

Executive Order 12898, “Federal Actions to Address E nvironmental Justice in Minority Populations and Low Income Populations” (59 FR 7629, February 16, 1994), establishes federal executive policy on environmental justice. Its main provision directs fede ral agencies, to the greatest extent practicable and permitted by law, to make environmental justice pa rt of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations a nd low-income populations in the United States.

The information collected under this final rule will as sist EPA and others in determining the potential

hazards and risks associated with various benzidine -related chemicals. Although not directly impacting environmental justice-related concerns, this informat ion will enable the Agency to better protect human health and the environment, including in low-income and minority communities.

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

Risks

Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), requires EPA to identify and asse ss environmental health and safety risks that may disproportionately affect children. This type of analys is is required for rules that will have an impact of $100 million or more only. The impact of this SNUR will be less than $100 million.

4.6 Executive Order 13132: Federalism

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) , requires EPA to develop an accountable process to ensure “meaningful and timel y input by State and local officials in the development of regulatory policies that have federa lism implications.” Policies that have federalism implications are defined in the Executive Order to incl ude regulations that have “substantial direct effectsEconomic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Based Chemical Substances 34 Economic and Policy Analysis Branch on the States, on the relationship between the national gove rnment and the States, or on the distribution of power and responsibilities among the va rious levels of government” (64 FR 43255, August 10, 1999).

The final rule establishes reporting and recordkeep ing requirements that apply to manufacturers (including importers) and processors of certain chem icals. EPA has no information to indicate that any state or local government manufactures or processes th e chemical substances covered by this action.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Based Chemical Substances 35 Economic and Policy Analysis Branch 4.7 Executive Order 13175: Consultation and Coordi nation with Indian Tribal Governments

Executive Order 13175 is Consultation and Coordination wi th Indian Tribal Governments (59 FR 22951, November 6, 2000). This rule does not have Tribal implications because EPA has no information to indicate that any tribal government manufactures or processes the chemical substances covered by this

action.

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

This rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.

4.9 Executive Order 13563, Improving Regulation and Regulatory Review

Executive Order 13563, Improving Regulation and Regulatory Review (76 FR 3821, January 21, 2011), requires EPA to base regulations on the best availabl e science; allow for public participation and the open exchange of ideas; promote predictability and re duce uncertainty; identify and use the best, most innovative, and least burdensome tools for achieving regul atory ends; consider both the costs and benefits qualitatively and quantitatively; and ensure regulations are accessible, consistent, written in plain language, and easy to understand.

The proposed rule establishes reporting and recordk eeping requirements that apply to manufacturers (including importers) and processors of certain chemicals. Consiste nt with EO 13563, this document qualitatively and quantita tively describes both the costs and benef its of the proposed rule as well as the underlying data used in the analyses. EPA chose the b est available data to analyze the costs and benefits described in this document and the best analytic appr oaches given the available data and other constraints.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Based Chemical Substances 36 Economic and Policy Analysis Branch 

### 5. BENEFITS

A SNUN submission provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. It allo ws the Agency to take imme diate action to mitigate an activity that the Agency deems harm ful to the environment or human health. The final SNUR allows EPA to evaluate the use of, or exposure to these chemical s and allow the Agency to take preventive action to limit or prohibit any Significant New Use.

EPA requires additional information to fulfill its mandate under TSCA to fully assess the risks posed by the production, sale, use, and import in articles, such as imported finished textiles, of certain benzidinebased dyes in the United States. A SNUN submission pr ovides 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 th e Agency deems harmful to the environment or human
health. The final SNUR allows EPA to evaluate the u se of, or exposure to, these chemicals and allows the Agency to take preventive action to limit or prohibit any Significant New Use. EPA also expects the final rule may restrict future uses and thereby exposures to the chemicals, as a company may choose to modify planned uses of the chemicals order to not be s ubject to the SNUR, as opposed to submitting a SNUN. Therefore, the final SNUR may limit future exposur e (e.g., worker, consumer) to the chemicals.

Quantification of the benefits of the final rule will re quire more specific information about each user’s use patterns and preferences, as well as the changes in these patterns and preferences that will result from the

additional information made available under the fina l rule. These data are not readily available and collecting such data will be cost-prohibitive.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Based Chemical Substances 37 Economic and Policy Analysis Branch 

### 6. REFERENCES

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EPA 2013a. U.S. EPA, Office of Pollution Prevention and Toxics. Public 2012 Chemcial Data Reporting Rule (CDR) Database http://java.epa.gov/oppt_chemical_search/

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Nine Benzidine Based Chemical Substances 40 Economic and Policy Analysis Branch European Commission. 2009. Commission Regulation EC No. 552/2009 

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Nine Benzidine Based Chemical Substances 41 Economic and Policy Analysis Branch Simpsons UK LTD. 2010. "Product Cata logue." Accessed November 18, 2010.

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.APPENDIX A
INFLATORS AND WAGE RATESEconomic Analysis of SNUR for A- 1 U.S. EPA Office of Chemical Safety and Pollution Prevention
Nine Benzidine Chemical Substances Economic and Policy Analysis Branch 

### A. INFLATORS AND WAGE RATES

This appendix describes the derivation of the fully lo aded labor rates and inflation factors used in calculating costs of labor, materials, and other inputs. Costs presented in this report are in 2011 dollars.

A.1 Derivation of Loaded Wage Rates

Unit labor costs are calculated by adding fringe benef its and overhead to the wage or salary to derive a fully loaded labor cost. The basic method is described in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (EPA, 2002b). The resulting loaded labor rates are given in Table A-1. Costs are calculated for several labor categories: Managerial, Professional/Technical, Clerical, and EPA staff.

In March 2004, BLS began using the North American Industry Classification System (NAICS) codes
instead of the Standard Industrial Classificati on (SIC) System, and the Standard Occupational Classification (SOC) system instead of the Occupa tional Classification System (OCS). The following table shows the crosswalk between old and new occupational titles.

EPAB Reports Labor Category BLS Ol d Title (OCS) BLS New Title (SOC)

Managerial Executive, administrative, and managerial Management, business, and
financial Professional/Technical Professional specialty and technical Professional and related

Clerical Administrative support, including
clerical Office and administrative support

Source: Employer Costs for Employee Compensation: Changes to NAICS and SOC, Table 2 . ECEC Occupational Comparability between SOC and OCS (BLS, 2006a and Weinstein, 2004).

A.1.1 Derivation of Labor Rates for Managerial, Professional/Technical, Clerical, and Production

Labor

Wages and fringe benefits for managerial, professiona l/technical, and clerical labor were taken from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data, 31 for December 2011, for manufacturing industries. 32

The cost of fringe benefits, such as paid leave and insurance, specific to each labor category, are taken from the same ECEC series. Fringe benefits as a perc ent of wages are calculated separately for each labor category. For example, for December 2011, th e average wage rate for professional/technical 33 labor was $38.48; the average fringe benefit was $19.64. Fringe benefits as a percent of wages were $19.64/$38.48, or approximately 51.0 percent.

An additional loading factor of 17 percent is applie d to wages to account for overhead. This approach is used for consistency with Office of Pollution Prev ention and Toxics economic analyses for two major

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

Substances: EPA Do cket OPPT-2003-0063 (EPAB, 2007b).

32 Employer Costs for Employee Compensation Supplementary Tables December 2011. (BLS, 2012a). This follows the approach introduced in EPAB, 2007a. Earlier PMN SNUR economic analyses, such as EPA, 2003 , used ECEC data for “All Goods Producing” sectors (manufacturing, mining, and construction). However, the manufacturing sector data seem more relevant since the SNURs mainly affect the chemicals industry.

33 This follows terminology introduced in EPAB, 2007b. Earlier SNUR economic analyses used th e term “technical” labor. Here the category is called “professi onal/technical” labor, to make clear how it relates to BLS categories. In 2004, BLS changed from the Occupational Classificati on System, OCS, to the Standard Occupational Classification system, SOC. In the process, the “Professional specialty and te chnical” category became the “Professional and related” catego ry. However, the coverage of the old and new occupational groups is appr oximately the same. See the BLS article, C omparing Current and Former Industry

and Occ upation ECEC Series (Weinstein, 2004).Economic Analysis of SNUR for A- 2 U.S. EPA Office of Chemical Safety and Pollution Prevention
Nine Benzidine Chemical Substances Economic and Policy Analysis Branch rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b),

and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). This overhead loading factor is added to the benefits loading factor, and the total is then applied to the base wage to derive the fully loaded wage. For example, the December 2011 fully loaded wage for professional/technical labor is $38.48 × (1+0.5104 + 0.17) = $64.66.

Fully loaded costs for managerial and clerical la bor are calculated in a similar manner, as shown in Table

A-1Table A-1

.

A.1.2 Derivation of Labor Rates for EPA Staff

Agency labor costs are calculated based on annua l Federal salaries for the Washington-Baltimore area published by the Office of Personnel Management effective January 2011 (OPM, 2011). The average salary for one FTE staff member is estimated as the salary for a GS-13 Step 5 employee. 34

Multiplying the annual pay by an assumed loading factor of 1.6 to reflect Federal fringe benefits and overhead, the loaded annual salary of EPA staff was calculated to be $161,446.

The Agency loading factor is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 pe rcent assumption was labeled “the benefits multiplication factor” in the EPA Guide, but has been used in many EPA Office of Pollution Prevention and Toxics ICRs to reflect both fringe benefits and overh ead for Federal staff. For example, it was used in an August 2000 document supporting ICR No. 1139.06 (EPA, 2000), with the following explanation:

The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits multiplication factor). The multiplication factor used is reco mmended in EPA’s Office of Policy, Planning, and Evaluation’s Instructions for Preparing Information Collection Requests (ICRs) (June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits but also overhead. (ICR No.1139.06)

34 The GS-13 Step 5 is consistent with ICR No. 0574.14 (12/18/2007), which covers PMN SNURs. Use of this grade level follows the approach introduced in EPAB, 2007a. That repor t represented a change from th e earlier PMN SNUR economic analysis (EPA, 2003), which used an average of GS-12 Step 1 and GS-12 Step 10 salaries.Economic Analysis of SNUR forA-3U.S. EPA Office of Chemical Safety and Pollution PreventionNine Benzidine Chemical SubstancesEconomic and Policy Analysis BranchTable A-1: Derivation of Loaded Wage RatesEPAB LaborCategoryData SourcesDateWageFringeBenefitFringes as% WageOver-head %Wage2Fringe +OverheadFactorLoaded Wages1(a) (b) (c) =(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a) x (e)ManagerialBLSECEC, PrivateManufacturingindustries,“Mgt, Business, andFinancial”3Dec-11 $43.01 $20.40 47.43% 17% 1.64 $70.72Professional/TechnicalBLSECEC, PrivateManufacturingindustries, “Professional andrelated“3Dec-11 $38.48 $19.64 51.04% 17% 1.68 $64.66ClericalBLSECEC, PrivateManufacturingindustries,“Office andAdministrative Support”3Dec-11 $17.69 $8.93 50.48% 17% 1.67 $29.63EPA staffFTEAnnual Federal staff cost: OPMWashington-Baltimore-NorthernVirginia, DC-MD-PA-VA-WV, area,GS-13 Step 5 pay rates, with 60%overhead.3Jan-11 $48.51 --[Included in60%overhead]60% 1.6 $77.62Notes:1Wage data are rounded to the closest pennyin this table; however, in calculationsusing these numbers for this report, unrounded values were used.2An overhead rate of 17% was used based on assumptions inWage Rates for Economic Analyses of the Toxics Release Inventory Program(EPA, 2002b), and theRevised EconomicAnalysis for the Amended Inventory Update Rule: Final Report(EPA, 2002a).3The salary is unloaded Federal GS-13 Step5 salary for calendar year 2011, from the Office of Personnel Management salary tablefor Washington-Baltimore-Northern Virginia (OPM,2011). The 60% fringes-and-overhead rate is from an EPA guide,Instructions for Preparing Information Collection Requests (ICRs)(EPA, 1992a, page 30, footnote 9).Economic Analysis of SNUR for A- 4 U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances Economic and Policy Analysis Branch A.2 Derivation of Inflation Factors

Detailed information on the de rivation of the inflation factors used is presented in Table A-2Table A-2 . In 2006, the Bureau of Labor Statistics (BLS) made sev eral changes to the Employment Cost Index. The changes are described on a BLS web page, “Change h as come to the ECI,” (BLS, 2006c) and in several April 2006 Monthly Labor Review articles posted on the BLS web site: “Changes affecting the Employment Cost Index: an overview” (Caroll, 2006); “Employment Cost Index Publication Plans” (Sleemi, 2006); and “Seasonal adjustment in the ECI and the conversion to NAICS and SOC” (Branch, 2006).

Under a mandate from OMB, BLS changed its classif ication of industries and occupations from the Standard Industrial Classification (SIC) and Occ upational Classification System (OCS) to the North American Industry Classification System (NAICS) and Standard Occupational Classification (SOC) system. In 2006, BLS adjusted all ECI series to reflect this change.

In addition to changing the industr y and occupational classification syst ems, in 2006, BLS rebased the
ECI from June 1989 = 100 to December 2005 = 100 for all current and historical non-seasonally adjusted series, including the NAICS and SIC based series. (Seasonally adjusted indices, including those in Table

A-2Table A-2 of this report, may not exactly equal 1 00 for December 2005 as a result of the seasonal adjustment. Seasonal adjustments are explained in Branch, 2006.)

According to BLS, the official ECI for the year s 1975-2005 is the SIC-OCS based series, and for subsequent years, the official ECI is th e NAICS-SOC based series (Sleemi, 2006, p.8). 35

“Starting year” indices in Table A-2Table A-2 continue to be SIC-OCS based. Current year indices are

NAICS-SOC based. We use indices from both the NAICS-SOC and the SIC-OCS based ECI series because neither series spans the entire period over whic h testing and other costs need to be inflated.

35 BLS has been publishing the NAICS-SOC based ECI series si nce March 2001 and it became official in March 2006. The SICOCS based series and NAICS-SOC series ha ve different series ID numbers, even wh en they describe essentially the same population. For example the series ID for seasonally adjust ed total compensation for all private industry workers is

ECS10002I for the SIC-OCS series and CIS2010000000000I for the NAICS-SOC series

.Economic Analysis of SNUR for A- 5 U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances Economic and Policy Analysis Branch Table A-2: Derivation of Inflation Factors

Item Inflation Index Source 1 Startin g Year Index for Starting Year (a) Index for

2011

(b) Inflation

Factor (b)/(a) 2

Agency Extramural costs White collar labor; equipment; supplies BLS ECI, Total comp, Private industry, Professional and

related , 4 th Q [BLS, 2012b] 3 1993 67 115.7 1.727

Labels, placards etc. BLS CPI, All urban consumers, not SA. CUUR0000SA0, Annual [BLS, 2012c] 1997 160.5 224.939 1.401

File cabinet

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

Key: BLS = Bureau of Labor Statistics. CPI = Consumer Price Index. ECI = Employment Co st Index. SA = Seasonally Adjusted. Total Comp = Total Compensation (wages/salaries an d benefits). 4th Q = Fourth Quarter. “E CS10002I” etc. refer to BLS series Ids.

Notes:

1 In 2006, Bureau of Labor Statistics (BLS) Employment Cost Inde x (ECI) series “were rebased to December 2005 = 100 from June 1989 = 100.” The change is reflected in the indice s in this table and expl ained on the BLS website, Employment Cost Index News Release Text: Employment Cost Index, March 2006 (BLS, 2006b). The Consumer Price Index (CPI) was not rebased.

“Starting year” ECI indices are SIC-OCS based: Seasonally Adjust ed (SA) ECS10002I for private industry All Workers, and not SA ECU11122I for private industry Professional and Related Workers.

After 2006, ECI indices are NAICS-SOC based: Seasonally Adju sted (SA) CIS2010000000000I for private industry All Workers, and not SA CIU2010000120000I (B) for private industry Professional, and Re lated workers.

2 Inflation factors are rounded; however, unr ounded values were used in calculations.

3 Beginning with the report Economic Analysis of Expedited Sign ificant New Use Rules for 25 Chemical Substances: EPA Docket OPPT-2009-0922 (EPA, 2011b) we began to use the not-seasonall y adjusted CIU2010000120000I for private industry Professional,and Related workers, instead of SA CIS2010000W00000I for private industry white collar workers because BLS retired the “whitecollar” series.Economic Analysis of SNUR for B- 1 U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances Economic and Policy Analysis Branch 

### APPENDIX B – BENZIDINE-BASED DYES SPECIFIED AT 40 CFR SECTION 721.1660

Table B-1 provides a list of the benzidine-based dy es specified at 40 CFR section 721.1660. It also indicates whether or not EPA found evidence of current manufacture of the dye, and where that
manufacture occurred.

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

CAS No. Chemical Name 1 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-naphthalen yl]azo]-5-methylphenyl]azo][1,1 ′ -biphenyl]-4- yl]azo]-2-hydroxy-, tetrasodium salt [ CI Direct Brown 31 ] Domestic

2429-82-5 Benzoic acid, 5-[[4 ′ -[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1 ′

- biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt [ CI Direct Brown 2 ] Global

2429-83-6 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4 ′ -[(2,4-diamino-5- methylphenyl)azo][1,1 ′ -biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt [ CI Direct Black 4 ] N

2429-84-7 Benzoic acid, 5-[[4 ′ -[(2-amino-8-hydroxy-6-sulfo-1-naphthalenyl)azo][1,1 ′

- biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt [ CI Direct Red 1 ] N

2586-58-5 Benzoic acid, 5-[[4 ′ -[[2,6-diamino-3-methyl-5-[(4- sulfophenyl)azo]phenyl]azo][1,1 ′ -biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt [ CI Direct Brown 1:2 ] Global

2602-46-2 2,7-Naphthalenedisulfonic acid, 3,3 ′ -[[1,1 ′ -biphenyl]-4,4 ′ -diylbis(azo)]bis[5- amino-4-hydroxy-, tetrasodium salt [ CI Direct Blue 6 ] Domestic

2893-80-3 Benzoic acid, 5-[[4 ′ -[[2,4-dihydroxy-3- [(4-sulfophenyl)azo]phenyl]azo][1,1 ′

- biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt [ CI Direct Brown 6 ] N

3530-19-6 1,3-Naphthalenedisulfonic acid, 8-[[4 ′ -[(4-ethoxyphenyl)azo][1,1 ′ -biphenyl]-4- yl]azo]-7-hydroxy-, disodium salt [ CI Direct Red 37 ] Global

3567-65-5 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4 ′ -[[4-[[(4- methylphenyl)sulfonyl]oxy]phenyl]azo][1,1 ′ -biphenyl]-4-yl]azo]-, disodium salt [ CI Acid Red 85 ] Global

3626-28-6 2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-3-[[4 ′ -[(4- hydroxyphenyl)azo][1,1 ′ - biphenyl]-4-yl]azo]-6-(phenylazo)-, disodium salt [ CI
Direct Green 1 ] Global

3811-71-0 Benzoic acid, 5-[[4 ′ -[[2,4-diamino-5-[(4- sulfophenyl)azo]phenyl]azo][1,1 ′

- biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt [ CI Direction Brown 1 ] NEconomic Analysis of SNUR for B- 2 U.S. EPA Office of Pollution Prevention and Toxics
Nine Benzidine Chemical Substances Economic and Policy Analysis Branch

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

CAS No. Chemical Name 1 Current

Manufacture?

4335-09-5 2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-6-[[4 ′ -[(4- hydroxyphenyl)azo][1,1 ′ -biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt [ CI Direct Green 6 ] Domestic

6358-80-1 2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-3-[[4 ′ -[[4-hydroxy-2-[(2- methylphenyl)amino]phenyl]azo][1,1 ′ -biphenyl]-4-yl]azo]-6-[(4- sulfophenyl)azo]-, trisodium salt [ CI Acid Black 94 ] N

6360-29-8 Benzoic acid, 5-[[4 ′ -[[4-[(4-amino-7-sulfo-1- naphthalenyl)azo]-6-sulfo-1- naphthalenyl]azo][1,1 ′ -biphenyl]-4-yl]azo]-2-hydroxy-, trisodium salt [ CI Direct

Brown 27 ] N

6360-54-9 Benzoic acid, 5-[[4 ′ -[[2,6-diamino-3-methyl-5-[(4- sulfophenyl)azo]phenyl]azo][1,1 ′ -biphenyl]-4-yl]azo]-2-hydroxy-3-methyl-, disodium salt [ CI Direct Brown 154 ] Domestic

8014-91-3 Benzoic acid, 3,3 ′ -[(3,7-disulfo-1,5- naphthalenediyl)bis[azo(6-hydroxy-3,1- phenylene)azo[6(or7)-sulfo- 4,1-naphthalen ediyl]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 correspo nd to more than one CAS No.; however, they are frequently used, even in peer-re viewed literature.