## Economic Analysis of the Final Significant New Use Rule for Nine Benzidine Based Chemical Substances (EPA Docket EPA

- HQ

- OPPT

- 2010

- 0573

RIN 2070

- AJ73) FINAL



### November 20, 2014

San5456_Final_3

- Chemical

- SNUR_FRM_EA_9 Dyes_2014

- 11

- 20.docx



## — Does not contain TSCA CBI

—

Prepared by:

Economic and Policy Analysis Branch Chemistry, Economics, and Sustainable Strategies Division Office of Pollution Prevention and Toxics U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, DC 20460Economic 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 w as provided by Abt Associ ates Inc. under EPA Contract No. EP

- W

- 08

- 010.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 c osts of the U.S. Environmental Protection Agency (EPA)’s final Significant New Use Rule (SNUR) t hat adds the nine benzidine

- based chemical substances specified in Table 1 to an existing SNUR for benzidine

- based chemical substances at 40 CFR section 721.1660

. Additionally, the final rule also revoke s the article e xemption described in 40 CFR section 721.45(f) f or 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 S ubject 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

- substituted carbopolycycloazo benzenesulfonic

acid, sodium salt

21808 2,7

- Naphthalenedisulfonic acid, 4

- amino

- 5

- hydroxy[[[(substituted phenyl)amino]

substituted phenylazo]diphenyl]azo

- , phenylazo

- , disodium salt 1. Note that the CAS numbers and chemical names for the last 5 dyes are CBI; so Accession numbers and generic names have been used instead 2 . Common names are not unique identifie r s as they may correspond to more than one CAS No.; however, they are frequently used, even in peer

- reviewed literature.

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

- based chemical substances

.
The most recent data from the Toxic Substances Control Act (TSCA ) Chemical Data Reporting ( CDR ) database ( 2012 reporting) indicates no evidence of production of the nine new benzidine

- based chemical substances subject to the final ru le (EPA

, 2013 a )

. T he Agency did not receive any comments after the publication of the B enzidine D yes Action Plan to indicate any current production of the four non

- CBI chemical substances listed in Table 1

. In addition, no manufacturers of any of the benzidine

- based chemical substances subject to the final rule were listed in the Colour Index or identified through internet

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.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 queries. 2 However, global and domestic manufacturers for several of the benzidine

- based chemical substances specified at 40 CFR section 721.1660 were id entified; EPA found no information to indicate the currently manufactured chemical substances are being importe d and/or pro cessed domestically as part of arti cles

. 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 process ing o f any of the chemicals specified in Table 1

. It will also make inapplicable the article exemption at 40 CFR section 721.45(f), requiring notification of the import and / or processing as part of an article of any of t he benzidine

- based chemical substances s ubject to the final rule or specified at 40 CFR section 721.1660. A firm intending to engage in these activities will be required to submit a Significant New Use Notice (SNUN). While EPA was encouraged by the di scontinuation of the use of the chemical substances regulated under a 1996 SNUR at 40 CFR 721.1660 , it was concerned that the manufacture, import , and processing of these chemical substances and the articles containing them could be reinitiated in the future. EPA was also concerned that articles containing the chemical substances specified at 40 CFR section 721.1660 could be available for human exposure or eventual release to the environment. The SNUN provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs

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

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

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

- based chemical substances (dyes) specified at 40 CFR section 721.1660 were identified. However, there is no information to conclude that these currently manufactured chemical substances are being imported or processed domestically as part of articles. As a result, EPA does not expect that any firm will incur a cost of submitting a SNUN as the result of the final rule

. EPA does not require the development of test data for submission of a SNUN, although a firm may submit test d ata already in its possession or describe any other available dat a. Because EPA does not requir e the development of test data , EPA assumes that no firms will incur testing costs as a result of the final SNUR

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

.

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

. 3

2 The Colour Index is an international directory of manufacturers of pigments and dyes published by the UK Society of Dyers and Colourists (SDC) and the American Association of Textile Chemists and Colorists (AATCC). 3 While the majority of costs are incurr ed at the firm level, costs associated with some activities such as submitting export notifications or testing articles are incurred at the unit level.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 Su mmary of Methodology

................................ ................................ ................................ .......... 5 1.4 Organization of this Report

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

................................ ................................ ................................ .. 7 2.1 Wage Rates

................................ ................................ ................................ ................................ . 8 2.2 Unit Indus try Compliance Costs

................................ ................................ ............................... 10 2.3 Industry Costs of SNUR, by Option

................................ ................................ ......................... 23 2.4 Likelihood of a SNUN Submission

................................ ................................ .......................... 23 2.5 Potential for Subsequent Regulatory Action

................................ ................................ ............ 24
3. AGENCY COSTS

................................ ................................ ................................ ............................... 25 3.1 Labor Rates for EPA Staff

................................ ................................ ................................ ........ 25 3.2 SNUN Processing Costs

................................ ................................ ................................ ........... 25 3.3 Export Notification Cost

................................ ................................ ................................ ........... 29
4. ADDITIONAL ANALYSES

................................ ................................ ................................ .............. 30 4.1 Regulatory Flexibility Act

................................ ................................ ................................ ........ 30 4.2 Unfunded Mandates Reform Act

................................ ................................ .............................. 30 4.3 Paperwork Reduction Act

................................ ................................ ................................ ......... 30 4.4 Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations

................................ ................................ ............... 31 4.5 Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

................................ ................................ ................................ ................................ ......... 31 4.6 Executive Order 13132: Federalism

................................ ................................ ......................... 31 4.7 Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

.... 33 4.8 Executive Order 13211: Actions that Significant ly Affect Energy Supply, Distribution, or Use

................................ ................................ ................................ ................................ .................. 33 4.9 Executive Order 13563, Improving Regulation and Regulatory Review

............................... 33
5. Benefits

................................ ................................ ................................ ................................ ............... 34
6. REFERENCES

................................ ................................ ................................ ................................ .... 35
A. INFLATORS A ND WAGE RATES

................................ ................................ ................................ A

- 1 A.1 Derivation of Loaded Wage Rates

................................ ................................ .......................... A

- 1 A.2 Derivation of Inflation Factors

................................ ................................ ............................... A

- 4 Appendix B

– Benzidine

- Based Dyes Specified at 40 CFR section 721.1660

................................ ......... B

- 1Economic 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 Wage Rates, December 2011

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

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

- Time Submitters

................................ ................................ ................................ ................................ . 11 Table 5: Industry Cost Estimate to C omplete the SNUN Form

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

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

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

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

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

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

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

................................ .. 27 Table A

- 2: Derivation of Inflation Factors

................................ ................................ ............................... A

- 5 Table B

- 1: Benzidine

- Based Dyes Specified at 40 CFR Section 721.1660

................................ .............. B

- 1Economic 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 Protection Age ncy (EPA), Office of Pollution Prevention and Toxics ’ ( OPPT’s ) analysis of the potential costs incurred as a result of a final Significant New Use Rule (SNUR) that adds the nine benzidi ne

- based chemical substances listed in Table 1 to an existing SNUR at 40 CFR section 721.1660

. EPA is also proposing to revoke the a r ticle e xemption at 40 CFR section 721. 45(f) for the chemical substances included regulated under a 1996 S NUR at 40 CFR 721.1660(a)(1) (see Appendix A) as well as the nine chemicals included in the final rule

. However, the final rule does not revoke the significant new use exemptions granted in 40 CFR section 721 .1660(a)(2) for uses as laboratory stains and ot her analytical reagents.

Table 1 : Benzidine

- Based Chemicals S ubject 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

- substituted carbopolycycloazo benzenesulfonic

acid, sodium salt

21808 2,7

- Naphthalenedisulfonic acid, 4

- amino

- 5

- hydroxy[[[(substituted phenyl)amino]

substituted phenylazo]diphenyl]azo

- , phenylazo

- , disodium salt 1. Note that the CAS numbers and chemical names for the last 5 dyes are CBI; so Accession numbers and generic names have been used instead 2 . Common names are not unique identifi e r s as they may correspond to more than one CAS No.; however, they are frequently used, even in peer

- reviewed literature.

EPA is concerned that in the future benzidine

- based chemical substances may be incorporated in to articles and then imported into the United States

, which will increas e human and environmental exposure to the chemicals. There is potential for exposure to benzidine

- based chemicals incorporated into imported finished articles ; t herefore

, EPA is proposing to make the article exemption at §721.45(f) inapplicable to persons who import the benzidine

- dye chemical substances included in the rule as part of articles.

SNURs are proposed by EPA under the authority granted by Section 5(a)(2) of TSCA. The final SNUR will require persons to notif y EPA at least 90 days before commencing any manufacture, import, or
pr ocessi ng of the benzidine

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

- based substances specified at 40 C FR sectionEconomic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 2 Economic and Policy Analysis Branch 721.1660

. 4

. 5 E PA promulgates a SNUR for a substance when potential uses could result in increased exposure to
, or releases of

, the substance

, which in turn, could present an unreasonable risk to health or the environment

.
1.1 Background

In 1995, as part of a risk management strategy to reduce the risks associated with the manufacture and use of azo dyes in the United States, EPA proposed a SNUR for several benzidine

- based substances (FR 45119, 8/30/95). The final SNUR ( §721.1660) included 24 benzidin e

- based substances; however, EPA recognized that additional substances would need to be added. The four non

- CBI dyes specified in Table 1 were included in draft additions to §721.1660, but were never finalized (61 FR 52287, 10/7/96).
As part of a more recent effort to enhance the existing chemicals program under TSCA, EPA created a list of widely recognized chemicals for the development of an Action Plan . Azo dyes were selected because they have the potential to metabolize to carcinogenic amines both in and on the human body. The Action Plan summarized readily available use, exposure, and hazard information for forty

- eight azo dyes; 6 considered which auth orities provided under TSCA and other statutes could be used to address potential concerns; and described various courses of actions available to EPA to address the concerns (EPA 2009c). It is important to note that, unless specified, the following section s, which use information from the Action Plan, describe azo dyes in general, not just benzidine

- based dyes

.
Uses and Substitutes

The benzidine

- based chemical substances listed in Table 1 and regulated under a 1996 SNUR at 40 CFR 721.1660(a)(1) have predomi nately been used as a zo dyes in the production of textiles, paints, printing inks, paper, and pharmaceuticals. 7 T hey are also used as reagents and biological stains in laboratories, and in the food indus tries (Dapson

, 2009). The European Union (E .U. ) has ban ned certain azo dyes from use in textiles and leather that are in pr olonged 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 (E uropean C ommis sion , 2010). A s a result, it is believed that there are readil y available substitutes for the benzidine

- based dyes subject to th e final SNUR

. Health Effects
The 1980 EPA Preliminary Risk Assessment on derivatives of benzidine and its congeners established that the primary hazard concern was for the carcinogenic effects to humans from exposure to specific

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 fro m the TSCA section 12(b) notification requirements for exported articles ( see 40 CFR 707.60(b)) will remain in force. Thus, persons who export benzidine

- based dyes as part of an article will not be required to provide export notification.
5 Section 5(h)(3) of TSCA, 15 USC 2604(h) exempts substances that are manufactured in small quantities solely for research and development (R&D) from the section 5(a) notice requirements. No application is require d for the exemption for R&D und er 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, whic h 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.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 3 Economic and Policy Analysis Branch metabolites of azo dyes (EPA 1980). Azo dyes are biologically active through their metabolites. Azoreduction of these compounds occurs in humans by an enzy me

- mediated reaction. Azoreductases are found in the liver, in gut bacteria, and in skin bacteria. The result of this azoreduction is the release of the carcinogenic aromatic amine from the dye. Studies have demonstrated that the azoreduction of benzidine

based dyes occurs in the human body as well as on the skin (Golka et al. 2004). Therefore, the primary human health concern for consumers is exposure to azo dyes through oral, dermal, or inhalation routes. Evidence from animal studies suggests that there i s early life susceptibility to benzidine carcinogenesis. Cancer potency for benzidine was substantially increased when the dose was given in early life as compared to adults (EPA 2005a).
Environmental Exposure
The primary route of consumer exposure to azo dyes is dermal absorption from wearing azo

- dyed clothing or footwear

. 8 Other products are either not available to consumers (laboratory chemicals) or will not likely be readily accessible in significant quantities (printing ink or LCD displays) to present exposure

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

- food products

, which might contain azo dyes. Inhalat ion exposure is a more prevalent route in occupational settings; however , it can also occur from the use of azo

- dyed in ks during ‘air brushing’ or off

- gassing from azo

- dyed carpets to indoor air

. Contact with azo dyes entering the environment through the whole life cycl e of azo dyes in textiles is an additional potential source of
exposure (Zeilmaker et al. 1999; Zeilmaker et al. 2000).

T he problems of discharge of dye contents to wastewaters from textile and other industries have resulted in extensive research for biological methods to degrade dyes. Biodegra dation studies indicate that azo dyes will be expected to biodegrade a t negligible to slow rates in aerobic conditi ons, while in anaerobic soils the dyes are likely to under go azo reduction to benzidine and/congeners depending on structure. Howeve r, i t is unclear whether metabolites from these reductions will be available in large concentrations or locations to be of concern to the general population.
Current Manufacturing
Dye production in the United States has been steadily declining for the past decade, largely due to the increase in imported finished textiles from less developed countries like China and India

, which may have less stringent regulations on dye intermediates (Dapson 2009). The most recent data from the public TSCA CDR database ( 201 3 reporting) did not indicate any domestic manufacture or import of the benzidine

- based chemicals subject to th e final SNUR

. 9 EPA did not receive comment after the publication of the Benzidine Dyes Action Plan to indicat e any ongoing production of the four non

- CBI dyes listed in Table 1

. In addition, EPA received no comments indicating any ongoing domestic manufacture or uses after the promulgation of the proposed SNUR and n one of the chemicals subject to th e final SNUR were found in the Colour Index or during internet que ries for manufacturers

. However, domestic and/or international manufacturers were identified for 14 of the 24 benzidine

- based chemical substances

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

9 The CDR compiles produc tion data from manufacturers and importers of certain chemical substances listed on the TSCA Chemical Substance Inventory. Sites are only required to submit IUR data if they manufacture or import more that 25,000 pounds of a chemical during the reporting y ear. As a result, it is possible that some ongoing manufacture and import of the dyes could occur at sites not meeting this threshold. While it is not known how many sites fall into this latter category, the Agency believes it likely to be very few if any.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 4 Economic and Policy Analysis Branch specified at 40 CFR section 721.1660

. 10 Searches for informati on by Colour Index Number suggest that

n ine of the chemicals may be manufactured domestically. In order to confirm their domestic or global manufacture of the chemical substances specified at 40 CFR section 721.1660, EPA searched company websites for lists of products available for sale. However, i n some cases, company product lists contained common names for dyes. C ommon names are not unique identifiers for dy es as they may correspond to more than one CA SRN ; however, they are frequently used, even in peer

- reviewed literature. Therefore, dyes listed as available sole l y by common name may not be the same chemical subject to the SNUR

. W ithout further information, it is not possible to verify whether the currently manufactured dyes are being imported and/o r processed domestically as part of articles. Because the remaining 10 dyes specified at 40 CFR section 721.1660 are no longer man ufactured anywhere in the world it is expected that they are not used in articles imported into the United States.
Regulatory Environment
Occupational exposure to some azo colorants has been regulated for many years; however, the potential for consumer exposure to products containing these colorants is still a potential concern. California’s Proposition 65 Chemical List includes benzidine

- based dyes as a potential carcinogen and requires that firms provide a clear and reasonable warning before knowingly and intentionally exposing anyone to a listed chemical (CAEPA, 2013a and CAEPA, 2013b). This warning may include the labeling of consumer products (CAEPA, 2013b).
The European Union (E.U.) has banned, in textile and leather articles which may come into direct and prolonged contact with humans, the use of azo dyes which can break down to release any of 22 listed carcinogenic aromat ic amines (including benzidine and its congeners) in amounts above 30 ppm (European Commission 2009). 11 The European Commission’s Directorate General for Health and Consumers maintains the RAPEX database that member countries can use to report dangerous pro ducts and the measures they have taken to prevent or restrict those products. Despite the E.U. ban, small numbers of products containing such azo dyes have recently been listed on RAPEX. The products are typically voluntarily withdrawn from the market and /or destroyed by the importer or have been placed under an order by the authorities to cease sales (European Commission, 2010). Therefore, azo dyes in imported articles still remain a potential issue in the E.U.

Other countries have also banned the manufa cture and use of the azo dyes in textiles . C urrently the manufacture of azo dyes is banned in South Korea and Japan (IARC, 2012). Use of these chemicals is banned by Egypt, India, China, South Korea, Taiwan and Vietnam ( Textination, 2012) and Indonesia has banned the use of the dyes in children’s and baby’s clothing (Intertek, 2013). In 2012

, the Japanese textiles and leather industry announced voluntary restrictions of the chemicals (Textination, 2012 and HKTDC, 2012). Canada has also expressed concern about the potential release of benzidine or its congeners from azo dyes and is evaluating potential approaches for addressing azo dyes (Environment Canada 2009). In addition, the American Apparel and Footwear Association (AAFA), the national trade associat ion 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 ri sks associated with the manufacture and use of azo dyes in the United States, EPA proposed a SNUR for several benzidine

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

- based substances; however,

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

11 See Restriction 43 in REACH Annex XVII.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 5 Economic and Policy Analysis Branch EPA recognized that additional substances will need to be added. The four non

- CBI dyes specified in Table 1 were included in draft additions to §721.1660 , but were never finalized (61 F R 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 meta bolize to carcinogenic amines both in and on the human body. The Action Plan summarized readily available use, exposure, and hazard information for forty

- eight azo dyes; 12 considered which authorities provided under TSCA and other statutes could be used to address potential concerns; and described various courses of action available to EPA to address the concerns (EPA 2009c). It is important to note that, unless specified, the following sections, which use information from the Action Plan, describe azo dyes in general, not just benzidine

- based dyes.

1.2 Statutory Authority

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after conside ring all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a SNUN to EPA at least 90 days before manufacturi ng, 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

T his analysis quantifies, to the extent possible, the costs of the fina l 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 Cen tral Data Exchange (CDX) electronic reporting tool; collection, compilation, and submission of required information for significant new uses of the subject chemicals; export notification; and recordkeeping. Agency costs include reviewing and processing the data received as a result of the rule. Data sources for this analysis include burden estimates derived from previous information collection requests and economic analyses for related rules, compensation data acquired from government publications, and supp lementary market research.
In addition to estimated costs, this report qualitatively discusses the benefits of the final rule based on the value of the information it will provide

.
1.4 Organization of this Report

T he remainder of this report presents EPA’s economic analysis in support of the final rule. Chapter 2 contains estimates of the industry costs to comply with the final rule, and Chapter 3 shows estimates of the government costs associated with the administr ation of the final rule. Several additional impact analyses are presented in Chapter 4 , including: small entity impact analysis, as mandated by the Regulatory Flexibility Act (RFA); a burden hour analysis that responds to the requirements of the Paperwork Reduction Act (PRA); an analysis of unfunded mandates that pertains to the Unfunded Mandates Reform Act (UMRA); an analysis of environmental justice implications that addresses the

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 i nventory of CBI chemicals which also had the potential to metabolize into benzidine.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 6 Economic and Policy Analysis Branch requirements of Executive O rder 12898; and an analysis of children’s health pertinent to Executive Order 13045. Chapter 5 addresses the benefits of the final rule.
Note that all dollar amounts in this analysis are reported in December 20 11 dollars , except for U.S. Postal Service mailing rates, which were acquired in January 2012

.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics 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 use s of the benzidine

- based chemical substances specified in Table 1 that require reporting under section 5(a)( 2 )(A) of TSCA include the manufactur e , import, or pr ocessing of the chemicals , excluding use as laboratory stains and other analytical reagents

. In addition, the final rule revokes the article exemption described in 40 CFR section 721.45(f) for the chemicals regulated under a 1996 SNUR at 40 CFR 721.1660(a)(1) (see Appendix A)

, as well the nine chemicals in the final rule

. Th erefore

, a firm intending to manufacture, import, or process the chemicals subje ct to the final rule for any non

- exempt use
, or import or process articles containing chemicals subject to the final rule or specified at 40 CFR section 721.1660 , must submit a SNUN. Alternatively, a firm can decide not to manufacture, import, and/or process th e chemicals and articles containing them for a significant new use

. The firm

, therefore

, has two options:

 Option 1: Submit a SNUN

. A SNUN indicates to EPA that the firm would like to manufacture, import, and/or process the chemical(s) for a sign ificant new use, which, in this case, means the manufacture, import, and/or processing of the chemicals subject to the final rule for any use and/or any import and processing of chemicals subject to the rule (including those specified at 40 CFR section 721.1660 ) as part of an article. 13 14

. 15 The firm must submit the SNUN to EPA at least 90 days before it plans to commence these activities; the SNUN provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that ac tivity before it occurs. T he 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 a re automatically triggered for chemicals regulated under TSCA Section 5 (see Section 2.2.7 for details).

 Option 2: Decide not to manu facture 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 r ule or those specified at 40 CFR section 721.1660 as part of articles . While this option avoids the costs of submitting a SNUN, it entails the ‘hidden’ cost of the profit that will be foregone as a result of not engaging in the commercial activity original ly planned. Similarly, if the firm would have used a given amount of the chemical in the production of another product, and must substitute to more costly substance, it will incur those additional “hidden” costs of production. However, these hidden costs a re expected to be minimal, if not zero

, because EPA found no evidence to suggest that many of the dyes are available anywhere . It is believed that they have largely been substituted for , and EPA also has no

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

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

- based chemicals solely for export will be exempt from the notification requirements of 40 CFR 721.25, if when distributing the substance in commerce, it is labeled in accordance with TSCA section 12(a)(1)(B). Further, EPA notes that the exemption from the TSCA section 12(b) notification requirements for exported articles ( see 40 CFR 707.60(b)) will remain in force. Thus, persons who export benzidine

- based dyes as part of an article will not be required to provide export notification.
15 Section 5(h)(3) of TSCA, 15 USC 2604(h) exempts substances that are manufactured in small quantities solely for research and development (R&D) from the section 5(a) notice requirements. No application is require d for the exemption for R&D und er section 5(h)(3) (U.S. EPA 1986)

. 16 Under TSCA section 3(7), the definition of “ manufacture” means to “import..., produce or manufacture” and importers are responsible parties under the final SNUR.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 8 Economic and Policy Analysis Branch information that the regulated chemicals are part of articles imported into or processed within the U.S. If the firm elects to produce the chemical for research and development (R&D) purposes only (an exemption for R&D purposes is provided in 40 CFR §721.47), it may have costs associated with R&D recordk eeping

.

Because there is no evidence to suggest that the currently manufactured chemicals are being imported and/or processed domestically as part of articles

, EPA does not expect there to be compliance costs associated with either of the options

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

. Section 2.1 summarizes the wage rates used in this chapter. Section 2.2 provides the unit industry compliance costs, including the costs of rule familiarization, registration with the Central Data Exchange ( CDX ) electronic reporting tool, completing the SNUN form, submission fee, import certification, and export notification. Total costs under each option are presented in Section 2.3

2.1 Wage Rates

The final rule involves activities that may require efforts by employees in three labor classifications: managerial, technical, and clerical. Costs for each activity are calculated by estimating the labor hours required in each labor category and multiplying those burde ns by the wage rate for each labor category. This section presents the estimated wage rate in each labor category.

Loaded wage rates for managerial, technical, and clerical personnel are derived by combining data on wages and fringe benefits with estimate s of overhead rates, following the methodology described in “Wage Rates for Economic Analysis of the Toxics Release Inventory Program” ( EPA 2002b ). Wage data for each labor category in December 20 11 are provided by the Employer Costs for Employee Compensat ion (ECEC) Supplemental Tables available on the BLS website ( BLS 201 2 a ). The loaded wage rate for managerial labor is $ 70.72 ; for technical labor, $ 64.66 ; and for clerical labor, $ 29.63

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

Table 2 : Loaded Industry Wage Rates, December 20 11

Labor Category Data Sources Wage (20 11 $) Fringe

Benefit (20 11 $) Fringes

as %
wage Over

head %
wage 2 Fringe +

overhead factor Loaded

Wages 1 (20 11 $) (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

Clerical BLS ECEC , Private

Manufacturing industries, “Office and Administrative Support” 3 $17.69 $8.93 50.48% 17% 1.67 $29.63Economic 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 20 11

1 Wage data are rounded to the nearest cent pennies in this table.

2 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program ( EPA 2002b ), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report ( EPA, 2002a ).

3 Employer Costs for Employee Compensation Supplementary Tables: December 20 11

. US Bureau of Labor Statistics, March 1 4

, 20 1 2 (BLS 20 12 a ).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 rule, some chemical manufacturers and processors and importers and processors of articles and their staff will need to become familiar with the SNUR and its

va rious 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 3 , the total labor cost associated with rule f

amiliarization is estimated at $5 4.43

.

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

(20 11 $) Burden

(hours) Cost

(20 11 $) Burden

(hours) Cost

(20 11 $) Burden

(hours) Cost

(20 11 $) Rule Familiarization 0.00 $0.00 0.55 $3 5.56 0.27 $1 8.86 0.82 $5 4.43 Total 0.00 $0.00 0.55 $3 5.56 0.27 $18. 86 0.82 $5 4.43 Source : BLS 201 2 a (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

. F irst

- time submitters of any TSCA sect ion 5 notice (including Premanufacture Notices ( PMNs), SNUNs, Test Market Exemption (TME) applications, Low Volume Exemption (LVE) notices, Low Exposure/Low Release (LoREX) exemption notices, Biotechnology Notices for genetically modified microorganisms, N otices of Commencement of Manufacture or Import (NOCs), and support documents to Section 5 notices ) are required to register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E

- payment account. 17 These activities are only required of sites that have not previously register ed with CDX for other activities such as CDR reporting or the submission of other Section 5 notice s (PMNs, MCANs, etc. )

. These activities are estimated to req uire the following burden hours , based on the estimates presented in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a) :

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

.

 CDX electronic signature: EPA estimates that companies will spend 0.25 hours preparing, submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA per employee. This burden will apply to four technical staff members and one manager per company, totaling 1.25 hours of burd en per company. In addition, EPA estimates that a manager

17 Although the final rule does not require submitters to establish and use a Pay.gov account, the burden estimates in this analysis are conservative insofar as to include the use of Pay.gov as a required activity.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 11 Economic and Policy Analysis Branch 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 compani es submitting and then verifying electronic signature agreements is 1.75 hours. Note that this burden does not include any additional time required to contact EPA’s CDX help desk to notify a change of submitter status, should one occur. Filing the electron ic 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 burden does not include the time required to click ‘submit’ on the form and wait for payment processing.

As shown in Table 4

, the cost associated with CDX registratio n, 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

(20 11 $) Burden

(hours) Cost

(20 11 $) Burden

(hours) Cost

(20 11 $) Burden

(hours) Cost

(20 11 $) 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, 201 2 a (labor rates) ; EPA, 2009a (burden hours); USPS, 201 2 (mailing cost)



### 2.2.3 Form Completion and Submission Fee

Respondents who choose to submit a SNUN are required to gather and submit information regarding the data elements identified in the applicable SNUN reporting form. The methodology and calculations used in this analysis assume that the employee responsible for collecting, filling out, and submitting the requested information has a reasonable level of familiari ty with the company and knowledge of operations at the site. It is assumed that for most entities these tasks are similar to other employee duties that require familiarity with EPA, State, and other Federal agency requests for chemical information and do n ot require additional familiarization or training beyond the basic rule familiarization described above. In addition, this analysis focuses on the marginal costs of submitting information for the final rule and not the total costs for the company to comply with a range of other Federal and State environmental, health, and safety regulations or accounting requirements that rely on this type of information

.

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

19 Price for an envelope was determined based on the per unit price of a regular business envelope. See “ Staples® #10, Self

- Sealing Envelopes, 500/Box." Available at: http://www.staples.com/ (Accessed 1/25/2012).Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 12 Economic and Policy Analysis Branch Estimates of the costs of completing a SNUN form are based on the costs of completing a PMN submission, since the data requirements are the same and the same form is used for both. The PMN submission costs came from EPA's 1994 Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications, which relied on industry es timates of the effort needed to collect and compile all data required for a PMN submission, prepare the form, submit the form and data to EPA, and maintain a file of the submission (EPA, 1994, Table III

- 2 and pages III

- 11,

- 12, and

- 13). The 1994 estimates were based on a survey conducted by the Chemical Manufacturers Association, which became the American Chemistry Council. These burdens include “the time spent reading and becoming familiar with the form, gathering the required information and preparing th e 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 bur den 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 recordkeep ing 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 elem ents on the electronic SNUN for m.

SNUN form completion and electronic submission is estimated to require approximately 74 hours of technical labor and 18 hours of managerial labor (EPA, 2009a). Table 5 combines the estimated reporting burden and loaded wage rates for all three labor categories to estimate the per

- SNUN cost of form completion. The labor cost incurred by a SNUN submission for both large and small business submitters is estimated at $ 6,071

.

20 The Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a) reported a 0.5 hour clerical and a 0.5 hour technical burden associated with recordkeeping in addition to the burden estimates from the 1994 RIA (EPA, 1994, p. III

- 14). These burden estimates (the 0.5 for clerical burden and 0.5 for technical burden) are based on th e recordkeeping burden for polymer exceptions and not the recordkeeping burden associated with PMN submissions. Therefore, for this analysis, the 0.5 hour for clerical labor and the 0.5 hour for technical labor were removed. It is important to note that fo r this analysis, clerical burden changes are not applicable because the entire clerical burden is assumed to be eliminated under the electronic reporting requirements . In sum mary, we do not include the one hour recordkeeping burden (0.5 hour for clerical, 0.5 for technical) reported in the ePMN EA.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics 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 rates presented in this table are rounded values; however, unrounded values are used to calculate total labor costs. For this reason, total labor costs may not equal the product of rounded values.

2 The estimate of no clerical burden is take n from the Economic Analysis of the Premanufacture Notice Electronic Reporting Final Rule (EPA, 2009a, page 7)

3 T echnical and managerial labor burden is from the PMN Amendments RIA (EPA, 1994, Table III

- 2). An additional eleven minutes (0.18 hours) of technical burden is estimated to complete the User Fee Payment Identification Number and Email Address data elements on the Electronic SNUN form (EPA, 2009a page 15).
In addition, each submitting large business must pay a $2,500 per

- SNUN submission fee, a nd each submitting small business must pay a $100 per

- SNUN submission fee

. Table 6 adds the labor cost and submission fee to estimate the total cost o f a SNUN submission

. The total cost of a SNU N submission is $8,571 for large business submitters and $ 6,171 for small business submitters.

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

Reporting Population Labor Cost Submission Fee Total Cost ( 2011$ ) Large Business Submitters $6,071 $2,500 $8,571 Small Business Submitters $6,071 $100 $6,171 Source : EPA, 2009a

.



### 2.2.4 Recordkeeping

Companies submitting a SNUN must, under 40 CFR §721.40, keep records of the information contained in the SNUN. Some EPA reports have assumed that SNUN recordkeeping hours will be five percent of SNUN submission hours, or about five to six hours. For this report, the SNUN recordkeeping hours were included in the SNUN submission hours ( see Section 2.2.3 ) and the SNUN recordkeeping costs under 40 CFR §721.4 0 were not separately estimate d

. 21



### 2.2.5 C ustomer Notification

Manufacturers, processors, and importers of chemicals subject to SNURs and processors and importers of chemicals subject to the rule as part of articles must notify recipients of such chemicals of the SNUR or verify that knowledge of the SNUR has been otherwise acquired by recipien ts, or that the recipients are unable to engage in significant new uses. Since it is not expected that all such entities will have complete knowledge of all uses of any products subject to a SNUR

, it is generally assumed that manufacturers,

21 SNUN submission costs estimated in Section 2.2.3 of this report were based on PMN submission costs from a 1994 report, Regulatory Impact Analysis of Amendments to Regulations for TSC Section 5 Premanufacture Notifications ( EPA , 1994)

. Page III

- 14 of the 1994 report refers to “the normal records kept with a PMN submission which are included in the estimates for submission costs.” Page III

- 12 identifies “maintaining a file of the submission” as part of the labor hours for the PMN reporting form. These statements imply that the 95 to 114 total hours for a PMN submission (page III

- 10 of EPA 1994) included recordkeeping hours.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 14 Economic and Policy Analysis Branch processors, and importers will most often choose to notify their customers of SNUR regulatory activities. As this notification may be accomplished by simply annotating an MSDS, EPA estimates the associated burden to be about one hour of a technical employe e's time or $64.66 per manufacturer, processor, or importer per chemical. H owever , for this SNUR, the regulated chemicals are not used in the U.S.

, and therefore

, no manufacturer s , processor s , or importer s will be affected. Thus , customer notifications wil l not be necessary.



### 2.2.6 Import Certification

In general, promulgation of a SNUR triggers a TSCA Section 13 import certification requirement and the corresponding regulations at 19 CFR §12.118 to 12.127 and 19 CFR §127.28 for all imports of the relevant chem ical substances. Thus, any U.S. manufacturer, importer, or processor receiving an imported shipment of chemicals subject to the final SNUR will have to certify that all chemical substances in the shipment either comply with all applicable rules and orders under TSCA or that all chemical substances in the shipment are not subject to TSCA. 22 The statement must be on or attached to a commercial invoice or entry document belonging to the imported shipment.
Import certification is fulfilled by checking a box on an invoice or entry document and EPA assumes that it generally imposes no additional burden or cost on the importer. Any potential burden associated with submitter’s familiarization with this requirement is assumed to be included in the more general SNUR f amiliarization burden discussed above.



### 2.2.7 Export Notification

Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical subject to various TSCA sections (40 CFR §707.60 through 75). For TSCA 5(a)(2) (the section und er which EPA promulgates significant new use rules) and certain other TSCA sections, this is a one

- time notification requirement 23 per destination country for each exporter of a chemical substance. After receiving a notification from a firm, EPA notifies th e importing country and the United States State Department (40 CFR §707.70). However, t he percent of notifications resulting from SNURs in general is unknown, and it is assumed that there will be no notifications from this rulemaking as there are no U.S.

m anufacturers.



### 2.2.8 Article Importation and Processing

Certain SNUR s may require importers or processors who choose to import or process regulated chemical substances as part of articles to comply with notification requirements, such as notify ing EPA at least 90 days before commencing the import of any articles contain ing c hemicals 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

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

23 On November 14, 2006 , EPA revised the export notification requirement for chemicals subject to TSCA §5(a)(2), 5(b), 5(e)(1) and 5(e)(2) from an annual to a one

- time requirement per destination country for each exporter (November 14, 2006, 71 FR 66234).Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 15 Economic and Policy Analysis Branch SNUR. A number of potential activities that importers may choose to undertake to determine whether the articles they import contain regulated chemical substances are outlined in this paper. This determination may involve gathering information from suppliers in their supply chain, and/or testing samples of the article itself

. More in formation 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 v arying levels of knowledge about the chemical content of the articles they import, yet under TSCA the definition of “manufacture” means to “import..., produce or manufacture” 24 and importers are responsible parties under the final SNUR . In order to understand and monitor their liability, companies might undertake a range of activities to ensure that the articles they import do not violate existing regulations.

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

Table 7 c ontains examples NAICS codes for firms that may import or p rocess articles that use chemical substances subject to the SNUR. The benzidine

- based chemical substances subject to the rule have predominately been used as azo dyes in the production of textiles, paints, printing inks, paper, and pharmaceuticals. This is not meant to be an exhaustive list, but rather an example of the types of industries that may be impacted by the articles exemption. As shown in Table 7

, a wide variety of industries may import articles containing the dyes, including chemical, apparel, an d textile manufacturers, wholesalers, and retail stores.

24 TSCA section 3(7).Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Chemical Substances 16 Economic and Policy Analysis Branch

Table 7 : Examples of Industries that may Import or Process Articles Containing Benzid i ne Chemical Substances

NAICS Code Section Description

314 Textile Product Mills Industries in the Textile Product Mills subsector group establishments that make textile products (except apparel). With a few exceptions, processes used in these industries are generally cut and sew (i.e., purchasing fabric and cutting and sewing to make nonapparel textile products, such as sheets and towels).

315 Apparel Manufacturing Industries in the Apparel Manufacturing subsector group establishments with two distinct manufacturing processes: (1) cut and sew (i.e., purchasing fabric and cutting and sewing to make a garment), and (2) the manufacture of garments in establishments that first knit fabric and then cut and sew the fabric into a garment. The Apparel Manufacturing subsector includes a diverse range of establishments manufacturing full lines of ready

- to

- wear apparel and custom apparel: apparel contractors, performing cutting or sewing operations on materials owned by others; jobbers performing entrepreneurial functions involved in apparel manufacture; and tailors, manufacturing custom garments for individual clients are all included.

423 Merchant Wholesalers,

Durable Goods Industries 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 three years or more. Durable goods merchant wholesale trade establishments are engaged in wholesaling products, such as motor vehicles, furniture, construction materials, machinery and equipment (including household

- type appliance s), metals and minerals (except petroleum), sporting goods, toys and hobby goods, recyclable materials, and parts.

424 Merchant Wholesalers,

Nondurable Goods Industries in the Merchant Wholesalers, Nondurable Goods subsector sell nondurable goods to other businesses. Nondurable goods are items generally with a normal life expectancy of less than three years. Nondurable goods merchant wholesale trade establishments are engaged in wholesaling products, such as paper and paper products, chemicals and chemical products, drugs, textiles and textile products, apparel, footwear, groceries, farm products, petroleum and petroleum products, alcoholic beverages, books, magazines, newspapers, flowers and nursery stock, and tobacco products.

442 Furniture and Home

Furnishings Stores Industries in the Furniture and Home Furnishings Stores subsector retail new furniture and home furnishings from fixed point

- of

- sale locations. Establishments in this subsector usually operate from showrooms and have substantial areas for the presentation of their products.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Chemical Substances 17 Economic and Policy Analysis Branch

Table 7 : Examples of Industries that may Import or Process Articles Containing Benzid i ne Chemical Substances

NAICS Code Section Description

448 Clothing and Clothing

Accessories Stores Industries in the Clothing and Clothing Accessories Stores subsector retail new clothing and clothing accessories merchandise from fixed point

- of

- sale locations. Establishments in this subsector have similar display equipment and staff that is knowledgeable regarding fashion trends and the proper match of styles, colors, and combinations of clothing and accessories to the characteristics and tastes of th e customer.

449 Sporting Goods, Hobby,

Musical Instrument, and Book Stores Industries in the Sporting Goods, Hobby, Musical Instrument, and Book Stores subsector are engaged in retailing and providing expertise on the use of sporting equipment or other sp ecific leisure activities, such as needlework and musical instruments. Book stores are also included in this subsector.

450 General Merchandise

Stores Industries in the General Merchandise Stores subsector retail new general merchandise from fixed point

- of

- sale locations. Establishments in this subsector are unique in that they have the equipment and staff capable of retailing a large variety of goods from a single location. This includes a variety of display equipment and staff trained to provide i nformation on many lines of products. 451 Nonstore Retailers Industries in the Nonstore Retailers subsector retail merchandise using methods, such as the broadcasting of infomercials, the broadcasting and publishing of direct

- response advertising, the pub lishing of paper and electronic catalogs, door

- to

- door solicitation, in

- home demonstration, selling from portable stalls and distribution through vending machines. 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, except food). Establishments engaged in the direct sale (i.e., nonstore) of products, such as home heating oil dealers and

n ewspaper delivery service providers are included in this subsector.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 18 Economic and Policy Analysis Branch Potential Compliance Activities ( Article Importers)

T he rule does not prescribe steps that an importer must take to identify a chemical subject to the SNUR in articles ; therefore, there are a variety of potential actions that a company could take to identify specific substances in its articles

, should they choose to do so

. These activities range in cost ; however, costs incurred are at the discretion of any individual importer. EPA expects that in all likelihood, i mporters would take actions that are commensurate with each company ’s perceived likelihood that the regulated chemical is part of the article th ey intend to import , and the resources it has available. There is currently no single widely accepted standard procedure to identify regulated chemicals in the supply chain

. H owever, t here are a number of organizations that help provide information on the content of articles

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

. Import ers (or processors) subject to SNURs may refer to these sources for assistance in their own strategy to identify a chemical subject to a SNUR in articles. The American Apparel & Footwear Association (AAFA) RSL ( Restricted Substances List ) Management (AFIRM) Working Group has developed a toolkit to help apparel and footwear companies “to reduce the use and impact of harmful substances i n 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 subs tances that are of interest to the company. In addition, some agree ments specify that if testing identifies a restricted material, the supplier must cover all associated costs. ASTM International, formerly known as the American Society for Testing and Materials (ASTM), has developed a Standard Guide for Assessm ent of Materials and Products for Declarable Substances (“ASTM F2577”)

, w hich provides guidance for the decision process to assess materials and products for declarable substances. T he following list includes activities that an importer might perform to identify any restricted chemicals in imported articles. Any rule familiarization burden associated with the proposed SNUR for importers of articles is discussed in Section 2.2.1 of this report. This list is intended to capture the general types of activities that might be performed.
1) Understand applicable requirements ( p er - f irm c ost)

. All importers would read and understand the SNUR, within the context of the company’s products. This burden is derived in Section 2.2.1 of this report
2) Identify the type of imported ar ticles that potentially contain the chemicals subject to this SNUR ( p er - f

irm c ost)

. This determination may be done based on an understanding of the uses of the subject chemical substance s (e.g., those described in Section 1.1 of this analysis) and the application of any a priori knowledge of the material and its manufacture to assess the probability whether each regulated substance may be present.
3) Identify all sup pliers inv olved ( p er - f irm c ost). The importer may choose to identify all suppliers from whom the articles identified in the previous step are imported, and as appropriate

, to make them aware of the importer’s potential notice obligations respecting the regulated chemical substances.
4) Collect data from suppliers ( p er - a rticle c ost)

. Importers may choose to obtain verification from suppliers identified in step 3 that the regulated chemical substance is or is not found in the article. This may be accomplished through, for example, agreements with suppliers, declarations through databases or surveys, or by using a third

- party certification system.
5) Chemical testing ( p er - a rticle c ost)

. Importer s may choose to assess imported articles for chemical content. This could involve requiring suppliers to provide certificates of analysis/laboratory reports for a lot or batch of the material produced. Importers may performEconomic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Chemical Substances 19 Economic and Policy Analysis Branch their own laboratory testing of certain articles (or components of articles) to determine if they contain the restricted substance.
6) Recordkeeping ( p er - f irm c ost)

. The importer may choose to keep records confirming the activities completed.

Table 8 contains the cost ranges associated with the above activ ities . The activities and cost derivations are discussed in more detail in Understanding the Costs Associated with Eliminating Exempt ions for Articles in SNURs (EPA, 2013 b )

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

Nine Benzidine Chemical Substances 20 Economic and Policy Analysis Branch

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

Activity Cost (2011$) Notes
Per Rule Costs

Rule familiarization $55 Discussed in Section 2.2.1 of this document

Identify the type of imported articles that potentially contain the restricted substances $130 to $1,550 Actual costs may vary based on number of articles imported and the c omplexity of the article itself (number of components)

Identify all suppliers involved $ 9 5 0 Actual costs may vary depending on the number of articles imported, number of suppliers, and frequency of supplier changes
Recordkeeping $10 Actual costs may vary depending on recordkeeping system already in place Per Article

- Related Costs

Collect data from suppliers $5 to $ 5 15 per article reviewed. $0 if no data collected. Actual costs only apply to those companies that choose to collect data from suppliers. They will vary depending on the specific data collection method chosen. Total costs depend on considerations including the number of articles imported, number of suppliers, and frequency of supplier changes.

Chemical testing $130 per article tested. $0 if no testing. Actual costs only apply to those companies that choose to

collect data from suppliers. They will vary depending on the specific chemical being tested for; the complexity of the article and sample preparation required; and the exact fees of the laboratory chosen for the analysis. Total costs per company will depend on considerations including the number of articles tested, which may be affected by the number of suppliers and risk associated with each , and frequency of supplier changes. Source: EPA, 2013bEconomic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Chemical Substances 21 Economic and Policy Analysis Branch Variation in cost s associated with these activities would depend on a company’s level of activity to comply with other regulations on chemicals in articles , the complexity of the supply chains

, and the size of the company. Total costs per article importe r will further depend on the number of affected articles and the frequency of supplier change

. Total c osts associated with these activities to any article importer are not quantified, but are believed to be minimal for this particular SNUR because firms may already be taking actions to avoid certain azo dyes as part of articles they import and because the dyes are not as readily available and therefore are not expected to be widely used in articles.
Since the 1990s, the import, manufacture, export, and sale of many textile products made with certain azo dyes has been banned in a number of European companies. Also in the 1990s most European and North American members of the Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers vol untarily ceased manufacturing benzidine dyes and salts. Developing countries that manufacture dyes and produce leather and textiles with azo dyes were affected by the changes in the marketplace. Cost for textile exporters (in developing countries) to switc h to nonregulated azo substitutes have been high ; however

, compliance with European regulations seems high with a rate of over 96% for some samples tested for export to Europe (OECD, 2002).

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

use of certain azo dyes in fabrics and leather products and a general decline in the availability of certain azo dyes in the marketplace as many leather and textile producers have moved to substitute dyes (OECD, 2002)

. Because firms operating in countries and/or states where azo dyes are already regulated are expected to be complying with existing regulations, EPA also expects that they are more likely to use

non

- regulated substances, rather than have a separate p roduct stream that may only be used in certain countries or states

. Furthermore, f irms that have previously selected suppliers that have agreed to uphold certain standards

, or who have otherwise sufficiently demonstrated that they are not supplying benzidi ne

based chemicals

, would not likely incur any additional costs associated with these activities . Essentially, the product’s certification would allow importer s or processor s of articles to learn whether an article does or does not contain certain azo dyes or whether suppliers have agreed to upho ld certain production standards

. There are labeling systems for products in which independent entities ensure that the production of products does not utilize specific chemicals. For example, the European Union has developed a voluntary labeling system, called the EU Ecolabel. Producers, importers and retailers can voluntarily apply for the EU Ecolabel (EC, 2013). Labeled products signal to consumers that the product in question has a reduced environmental impact thr oughout the product’s life cycle, such as at the manufacturing stage and/or during the final product disposal. The criteria are specifically designed to focus on the stage of the life cycle where a product has the most environmental impact (EC, 2013). For textiles, the criteria are based on the manufacturing process when fabrics are dyed, printed, and bleached since this is the stage with the largest impact (EC, 2013). Another international association, OEKO

TEX® 25 set up an independent testing and certifica tion system specifically for textiles, called the OEKO

TEX® Standard 100 ( OEKO

- TEX®

, No Date b ) . The system looks at products at different stages of production, including, raw materials, intermediates, and end products. The label signals to customers that the textiles have been tested for (1) illegal substances, (2) legally regulated substances, (3) known harmful unregulated chemicals, and (4) parameters for healthcare

. The company also looks at the uses of the textile to see the intensity of contact betwee n the product and skin for their parameters. ( OEKO

- TEX®

, No Date b )

. Similarly, firms that operate in places where azo dyes are already regulated would presumably have mechanisms in place to identify the content of any articles they import

. Firms already subject to REACH

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

Nine Benzidine Chemical Substances 22 Economic and Policy Analysis Branch requirements could potentially rely on any article testing that may have been completed to comply with REACH to assess the likelihood of a chemical regulated under the SNUR being a constituent of an imported article. EPA beli eves that t he analytical testing standards listed under REACH that detect azo dyes that contain benzidine, are suitable for testing the benzidine

- based chemicals listed in Table 1 . This is because all chemicals regulated under the final SNUR will release benzidine when tested using the REACH requirements. Therefore

, any firm that is currently testing articles for benzidine prior to importation into the EU would not need to conduct additional testing to learn about the presence or absence of the chemicals covered by the SNUR

, as the results from the REACH test could be used to show the presence or absence of benzidine in an article.
Firms with less experience with other regulations that are planning to import articles that could potentially contain benzidine

- based chemicals may incur a larger burden should they choose to conduct some or all of the activities listed above to learn about the chemical content of those articles

. T hese firms may choose to reach out to a wide variety of upstream firms

, including subcontractors, accessory suppliers, dye mills, print mills, tanneries, and chemical suppliers

, to gather information on the chemical content of articles, for docu mentation

. Firms may also choose to conduct additional research on their suppliers to ensure that they are purchasing from reputable manufacturers and chemical suppliers who will provide necessary technical support and will use high quality dyes that meet customer color and quality

, as well as regulatory standards (AFIRM, 2011). Furthermore, a company could choose to have articles tested. If a company chooses to conduct testing

, they may also need to conduct additional research to ensure the laboratory is a ccre di ted, reliable and follows Good Laboratory Practices (GLP) (AFIRM, 2011).
There are no requirements in the SNUR for importers to develop any information regarding the content of the articles they import. Given existing regulatory limitations both int ernationally and within the U.S., industry

- wide processes

, resources that support companies in understanding and managing their supply chains

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

, EPA believes that a rticle im porters that choose to investigate their products would incur costs at the lower end of the ranges presented in Table 8

, as a result of this rule. For those companies choosing to undertake actions to assess the composition of the articles they import, EPA expects that in all likelihood, these importers would take actions that are commensurate with the perceived likelihood th at the regulated chemical is part of the article they intend to import , 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 sub stances who distribute the su bstance in commerce must notify the recipient, in writing, of the applicability of SNUR requirements, or document that the recipient has such knowledge or will not undertake any significant new use described in the rule. Theref ore, 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 Mater ial Safety Data Sheets, shipping or labeling documents, etc. that may provide information on the chemicals in the articles they process.
To the extent that processors desire extra certainty that the articles they process are not subject to a SNUR, they ma y undertake the steps to identify regulated chemicals outlined above for importers. However, as stated above

, given the international bans on the use of azo dyes in fabrics and leather products, it is unlikely that t hese chemicals will be imported into the United States as part of finished articles.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Chemical Substances 23 Economic and Policy Analysis Branch 2.3 Industry Costs of SNUR, by Option
The number of firms affected by not making submissions to EPA is not known; therefore, costs are not aggregated across the affected entities. Table 9 summarizes the costs to comply with the final rule , as described in more detail in S ection 2.2 abo ve

Table 9 : Compliance Options and Associated Costs Incurred by a Firm Due to the Final SNUR
Option 1 Costs Qua ntified 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 e lectronically submitting a SNUN, including rule familiarization, CDX registration (for companies that are first

- time submit ters), form completion, user fee, export notification cost (if relevant). Rarely, a firm may choose to conduct toxicity or fate testing to support the SNUN, but such testing is not required by law

. $54.43 rule familiarization cost; $8,571 submission cost (including SNUN recordkeeping under 40 CFR §721.40 and fee $2,500 for large businesses). EPA usually receives well under ten SNUNs per year. First time submitters will incur $190 for CDX registration and associated activities.

2. Decide not to manufacture, import, or process the chemical for any non

exempt 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 notificati on 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 ) recordk eeping ($ 1 0), collecting data from suppliers ($5

- $ 515 per article), and testing , if completed ($130 per article). Notes:

1 Firms may experience costs related to both options at once since submission of a SNUN results in profits foregone as a result of not manufacturing, importing, or processing the dyes subject to the final rule , or importing or processing articles containing these dyes or those specified at 4 0 CFR section 721.1660. Additionally, export notification costs are somewhat independent of the option because the production of benzidine

- based dyes subject to the final rule for export purposes only does not require notification under 40 CFR 721.25.

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

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

.

2.4 Likelihood of a SNUN Submission
The domestic manufacture, import and processing of the dyes specified in Table 1 and the articles containing them have been phased out. Additionally, there appears to be no production of the majority of the dyes specified at 40 CFR section 721.1660 either domestically or globally , although some may have appeared on websites of some companies 26

. Of those that ap p ear to remain in production either

26 Dyes may appear on website listings, however, actual availability is not confirmed.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Chemical Substances 24 Economic and Policy Analysis Branch domestically or globally, t here is insufficient information to identify the use (including non

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

.
The E.U. has banned the use of azo dyes which can break down to release any of 22 listed carcinogenic aromatic ami nes (including benzidine and its congeners) in amounts above 30 ppm in textile and leather articles which may come into direct and prolonged contact with humans (European Commission 2009). 28 Despite the E.U. ban, products are occasionally found in articles meant for import (European Commission, 2010) and certain azo dyes in articles may remain an ongoing issue

. However, EPA has found no information to support the conclusion that articles containing the specific dyes specified at 40 CFR section 721.1660 are c urrently imported into the US.
Canada has also expressed concern about the potential release of benzidine or its congeners from azo dyes and is evaluating potential approaches for addressing azo dyes (Environment Canada 2009). In addition, the American App arel and Footwear Association (AAFA), the national trade association representing apparel, footwear and other sewn products companies and their suppliers, which compete in the global market, includes benzidine on its Restricted Substances List (AAFA 2010

. Clearly, benzidine

- based dyes are a concern internationally to governments and industry. M any of the dyes , including those listed in Table 1, have been phased

- out of production. Exporters of textile and leather products that are located in developing 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 ree mergence o f those not

curren t ly manufactured or imported is not expected. While research identified global and domestic manufacturers that have listed availability of several of the dyes specified at 40 CFR section 721.1660 there is no evidence to suggest that these dyes are being u sed 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 dy es was not confirmed. Therefore

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

.

2.5 Potential for Subsequent Regulatory Action
The Agency recognizes that if submission of a SNUN does result from a SNUR, the Agency may take additional regulatory actions under TSCA. These additional regulatory actions might be necessary to further evaluate an intended new use and associated activities

. Any such actions are highly dependent on the circumstances surrounding the individual SNUN (e.g., avai lable information and scientific understanding about the chemical and its risks at the time the SNUN is being reviewed).
Should the Agency’s review of the SNUN result in further regulatory actions, the Agency w ill initiate and follow the appropriate proce dures for taking those actions. Included in those procedures , as appropriate,

w ill be an assessment of the cost s and benefits of those actions

.

27 In some cases, company product lists contained common names for dyes. C ommon names are not unique identifiers for dy es as they may correspond to more than one CA SRN ; however, they are frequently used, even in
peer

- reviewed literature. Theref ore, 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.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Chemical Substances 25 Economic and Policy Analysis Branch 

### 3. AGENCY COSTS

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

a ssumed to be the same as EPA costs to review PMNs.

3.1 Labor Rates for EPA Staff

A gency labor costs are calculated based on annual Federal salaries for the Washington

- Baltimore area published by the Office of Personnel Management effective January 2011 (OPM , 20 11 ). EPA assumes that, on average, a federal GS

- 13, Step 5 full

- time equivalent (FTE) will conduct its collection and administrative activities under the final rule. 29 The average salary for a GS

- 13 Step 5 employee was $100,904 in 2011 without fringe benefits and overhead costs. In order to derive the fully loaded salary, EPA multiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and overhead (EPA, 2009c) , which results in a fully loaded annu al salary of $161,446 ( see Table 10 ). Dividing the fully loaded annual salary by 2,080 hours (i.e., the number of hours in a work year) yields an estim ated hourly FTE wage rate of $77.62.

Fully loaded costs for Agency labor are shown in Table 10

.

Table 10 : Derivation of Loade d 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 Washington

Baltimore

- Northern Virginia, DC

- MD

- PA

VA

- 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 20 11 ), from the OPM salary table for the Washington

- Baltimore

- Northern Virginia Locality Pay Area ( OPM 20 11 )

. Hourly rates are based on annual salary divided by 2,080 hours.

b The 60% fringes

- and

- overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) ( EPA 1992 , page 30, footnote 9).

3.2 SNUN Processing Costs

T he list of review steps, estimates of extramural costs, and the percent of chemicals requiring a particular review step are derived from the costs for processing PMN submissions in Table VII

- 1 of a 1994 EPA report, Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994). The Agency burden associated with processing a PMN has been adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that

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

Nine Benzidine Chemical Substances 26 Economic and Policy Analysis Branch requires t he electronic submission of all TSCA section 5 notices. Electronic submission of SNUN forms is expected to reduce Agency burden by 16.5 percent (E PA, 2009a , p.28)

. For each review step, the “EPA staff” cost is calculated by multiplying the number of FTEs (in the first column) by the fully loaded hourly salary. This shows EPA staff cost for chemicals requiring the selected review step.
The Extramural Cost column shows costs for contractor support and other outside purchases for chemicals requiring the sele cted review step is inflated from 1993 prices using the Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) data (BLS 201 2 b). T he not seasonally adjusted E CI for total compensation of private industry professional and related workers (Series ID CI U2010000120000I ) is used because it is the only series with continuous data since 1985 , and that includes professional and technical labor, which perform the majority of Agency extramural activities. Table 11 , below contains the derivation of inflation factors for Agency extramural costs.

Table 11 : Derivation of Inflation Factors for Agency Extramural Costs

Item Inflation index source Starting
year Index

for starting
year (a) Index

for 20 11 (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 201 2b ] 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 201 2 b).

The Percent of Cases column in Table 12 is a weighting factor applied to reflect the fact that not all chemicals require each review step. For example, in the PMN process, all chemicals require Administrative Prescreening, but not all chemicals requi re the intensive scrutiny of “Standard Review.” The three types of submissions resulting from a SNUR may have weighting factors that differ from each other and from the weighting factors for PMNs. Changes in weighting factors could cause actual review costs to be higher or lo wer than calculated here. For example, some SNUNs require little review because they are determined to be “invalid”

– i.e. not required in the first place. However, often a SNUN may take more Agency time than a typica l PMN because of factors such as the need to retrieve old PMN records from archives, and the likelihood that more data requiring EPA review is submitted with a SNUN than will be submitted

, on average , with a PMN. Resources were not available to update the review hours to reflect the current review process or to tailor the cost estimates to SNUNs. Therefore, for this analysis, the review steps and weighting factors are assumed to be the same as those derived in 1994 for PMNs.
Values in the ‘Weighted Cost’ column are calculated by multiplying the un

- weighted costs (EPA staff cost plus extramural costs) by the percentage of cases requiring this review step. Weighted costs are then multiplied by the burden reduction of 16.5 percen t to account for burden savings generated electronic submission. A s shown in Table 12

, t h is calculation yields total Agency costs of $ 5,066 , per SNUN, for submission review and processing

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

Nine Benzidine Based Dyes Economic and Policy Analysis Branch Table 12 : Agency Costs for SNUN and Other Submission Review and Processing

Review Steps EPA staff (FTE) Cost Extramural Cost 2 Unweighted Cost Pct. of

Cases Weighted

Cost 3 ePMN

Burden Reduction 4 Weighted Cost

with ePMN Burden Reduction FTE fraction Cost per

FTE 1 FTE Total

($20 11 ) 1993

dollars 20 11

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

- (i)) Pre

- notice consultation 0.0024 $161,446 $387.47 $4.00 $6.91 $394 41% $161.70 0.165 $135 Administrative prescreen/ notice receipt/user fee 0.0024 $161,446 $387.47 $92.00 $158.87 $546 100% $546.34 0.165 $456

CRSS (Chemical Review and Search Strategy) 0.0025 $161,446 $403.62 $268.00 $462.80 $866 100% $866.42 0.165 $723
SAT (Structure Activity Team) 0.0006 $161,446 $96.87 $14.00 $24.18 $121 100% $121.04 0.165 $101
Engineering/Exposure 0.0015 $161,446 $242.17 $56.00 $96.70 $339 100% $338.87 0.165 $283 Exposure/Fate 0.0008 $161,446 $129.16 $0.00 $0.00 $129 100% $129.16 0.165 $108
Focus 0.0009 $161,446 $145.30 $23.00 $39.72 $185 100% $185.02 0.165 $154 Standard Review Functions 0.0219 $161,446 $3,535.68 $511.00 $882.43 $4,418 29% $1,281.25 0.165 $1,070 Division Directors Meeting 0.0129 $161,446 $2,082.66 $113.00 $195.14 $2,278 15% $341.67 0.165 $285 Order Development/Negotiation Review 0.0171 $161,446 $2,760.73 $22.00 $37.99 $2,799 3% $83.96 0.165 $70

Post Order Data Review 0.0886 $161,446 $14,304.15 $0.00 $0.00 $14,304 3% $429.12 0.165 $358
Order Modification 0.2167 $161,446 $34,985.43 $0.00 $0.00 $34,985 3% $1,049.56 0.165 $876
New Chemical SNUR Development 0.0277 $161,446 $4,472.07 $85.00 $146.78 $4,619 7% $323.32 0.165 $270

Notices of Commencement 0.0012 $161,446 $193.74 $40.00 $69.07 $263 31% $81.47 0.165 $68 FOIA (Freedom of Information Act) Requests 0.0333 $161,446 $5,376.17 $287.00 $495.61 $5,872 1% $58.72 0.165 $49
CBI (Confidential Business Information) Substantiation 0.0004 $161,446 $64.58 $3.00 $5.18 $70 100% $69.76 0.165 $58

TOTAL $6,067 0.165 $5,066
Notes:

1 GS

- 13 Step 5 salaries loaded with benefits and overhead. See Table 10 for derivation.

2 Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993 prices using the factors presented in Table 11

. 3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values show n in this table.

4 Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009 b , p. 28).Economic Analysis of SNUR for 28 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Dyes Economic and Policy Analysis Branch Sources: FTEs per review step, 199 3 extramural costs, and percent of cases are from EPA, 1994 Table VII

- 1, GS

- 13 salaries are from O PM 20 11

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

Nine Benzidine Based Chemical Substances 29 Economic and Policy Analysis Branch 3.3 Export Notification Cost

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

. S

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

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

, the Agency will not incur any costs associated with export notification as a result of the SNUR.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Chemical Substances 30 Economic and Policy Analysis Branch 

### 4. ADDITIONAL ANALYSES

This section presents additional analysis of other potential impacts of this rulemaking, as required under various statutes and executive orders.

4.1 Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The 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 significant new use. Where a use is new, by definition no small or large entities presently engage in such activities. Although some small entities may decide to manufacture or process a substance for the new use after the SNUR is promulgated, EPA receives very few SNUNs, and few of those are submitted by smal l entities. In response to the promulgation of SNURs covering over 1,000 chemical substances, the Agency receives only a handful of SNUNs per year. For example, the number of SNUNs was four in Federal fiscal year 2005, eight in FY2006, six in FY2007, eigh t in FY2008, seven in FY2009, two in 2010, and ten in 2011 (EPA, 2012), for an average of 6 per year from all SNURs. EPA has no reason to believe that this SNUR will alter the pattern of SNUN submissions that EPA has historically seen. In addition, the est imated reporting cost for submission of a SNUN is minimal regardless of the size of the firm, averaging about $8,600 including SNUN recordkeeping and reporting costs. The Agency currently offers some relief to certain small businesses with sales (including those of subsidiary/parent companies) of less than $40 million per year by reducing the SNUN submission fee from $2,500 to $100. This lower fee reduces the cost of submitting a SNUN to about $6,200 for smaller firms. During the six year period from 2005

- 2 010, only three submitters self

identified as small in their SNUN submission 30 (EPA, 2012). EPA believes the cost of submitting a SNUN is relatively small compared the cost of developing and marketing a chemical new to a firm and that the requirement to sub mit 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 an d importers of articles to conduct specific activities to ascertain if they are importing or processing chemicals regulated by the SNUR as part of an article

. Therefore

, processors and i mporters are , in all likelihood, expected to take actions that are com mensurate with the level their perceived likelihood that the regulated chemical is part of the article they intend to process or import , and the resources it has available. EPA has no reason
to believe that a firm would voluntarily incur substantial costs to evaluate its articles , but rather EPA believes each firm will choose the most efficient route to identify whether it is importing or processing the subject chemical substances as part of articles.

4.2 U nfunded Mandates Reform Act

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

.

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

30 The three “small” submitters wer e identified by review of actual SNUN submissions from the years 2005

- 2010.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Chemical Substances 31 Economic and Policy Analysis Branch sponsor, and a person is not required to r espond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB Control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in t he Federal Register , are listed in 40 CFR, part 9, and included on the related collection instrument, or form, if applicable. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB con trol numbers 2070

- 0038 (EPA ICR No. 1188) and 2070

- 0030 (EPA ICR No. 0795).

If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average 98.2 hours per response: 0.82 h ours for rule familiarization (Section 2.2.1 ) ; 2.80 hours for CDX registration, CDX electronic signature, and pay.gov account setup ( Section 2.2.2 ) ; 92.2 hours for form completion, submission and re cordkeeping under CFR §721.40 (Section s 2.2.3 and 2.2.4 ) ; 1 hour for consumer notifications (Section 2.2.5 ) ; and 1.36 hours for export notification ( Section 2.2.6 ). The burdens for rule familiarization, CDX registrat ion, CDX electronic signature, pay.gov account setup form completion, submission, and recordkeeping are approved under EPA ICR No. 1188 (OMB control number 2070

- 0038). The burden for export notification is approved under EPA ICR No. 0795 (OMB control numbe r 2070

- 0030).

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

- Income Populations

Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations” (59 FR 7629, February 16, 1994), establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their m ission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low

- income populations in the United States.

The inform ation collected under this final rule will assist EPA and others in determining the potential hazards and risks associated with various benzidine

- related chemicals . Although not directly impacting environmental justice

- related concerns, this information wi ll 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 o f Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), requires EPA to identify and assess environmental health and safety risks that may disproportionately affect children. This type of analysis is required for rules that will have an impact of $100 million or more only. The impact of this SNUR will be less than $100 million

.
4.6 Executive Order 13132: Federal ism

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federali sm implications.” Policies that have federalism implications are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distri bution of power and responsibilities among the various levels of government” (64 FR 43255, August 10, 1999).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 The final rule establishes reporting and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain c hemicals. EPA has no information to indicate that any state or local government manufactures or processes the chemical substances covered by this action.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Chemical Substances 33 Economic and Policy Analysis Branch 4.7 Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

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

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

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

4.9 Executive Order 13563, Improving Regulation and Reg ulatory Review

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

The proposed rule establishes reporting and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain chemicals. Consistent with EO 13563, this documen t qualitatively and quantitatively describes both the costs and benefits of the proposed rule as well as the underlying data used in the analyses. EPA chose the best available data to analyze the costs and benefits described in this document and the best a nalytic approaches given the available data and other constraints

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

Nine Benzidine Based Chemical Substances 34 Economic and Policy Analysis Branch 

### 5. BENEFITS

A SNUN submission provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. It allows the Agency to take immediate action to mitigate an activity that the Agency deems harmful to th e environment or human health. The final SNUR allows EPA to evaluate the use of, or exposure to these chemicals and allow the Agency to take preventive action to limit or pro hibit 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 benzidine

based dyes in the United States. A SNUN submission provides EPA with the opportunity to evalu ate the intended use and, if necessary, to prohibit or limit that activity before it occurs. It allows the Agency to take immediate action to mitigate an activity that the Agency deems harmful to the environment or human health. The final SNUR allows EPA t o evaluate the use of, or exposure to

, these chemicals and allow s 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 exposure s to the chemicals, as a compa ny may choose to modify planned uses of the chemical s order to not be subject to the SNUR, as opposed to submitting a SNUN. Therefore, the final SNUR may limit future exposure (e.g., worker, consumer) to the chemicals

. Quantification of the benefits of the final rule w ill require more specific information about each user’s use patterns and preferences

, as well as the changes in these patterns and preferences that will result from the additional information made available under the final r ule. 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 35 Economic and Policy Analysis Branch 

### 6. REFERENCES

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

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19 CFR 12

, Customs Duties: Special Classes of Merchandise, Code of Federal Regulations

, Part 12, Title 19, August 1, 1983

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, Part 707, Title 40, July 1, 2003.

40 CFR 720

, Premanufacture Notification , Code of Federal Regulations

, Part 720, Title 40, July 1, 2003.

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

, Part 721, Title 40, July 1, 2003.

59 FR 7629, Federal Actions to Address Environmental Justi ce in Minority Populations and Low

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

59 FR 22951, Consultation and Coordination with Indian Tribal Governments , Federal Register, Volume 59, November 6, 2000.

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

, Volume 62, April 23, 1997.

6 4 FR 43255, Federalism , Federal Register, Volume 65, August 10, 1999.

66 FR 28355, Actions Concerning Regulations that Significantly Af fect Energy Supply, Distribution, or Use , Federal Register, Volume 66, May 22, 2001.

71 FR 66234

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

, Volume 71, November 14, 2006. Available in docket EPA

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- 2005

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. Abbey Colour , 2010. “Table of Dyes.” Accessed November 23, 2010. Available at: http://www.abbeycolor.com/

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

American Association of Textile Chemists and Colorists, 2010. Colour Index International online. Fourth Edition. http://www.colour

- index.org/ (Accessed various dates, November 2010).

AFIRM , 2011. Apparel and Footwear International RSL Management. AFIRM Supplier Toolkit

. Retrieved from: http://www.afirm

- group.com/AFIRMSupplierToolkitFinalJune6.pdf

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BLS, 2012 a . U.S. Burea u of Labor Statistics. “Employer Costs for Employee Compensation Supplementary Tables December 2011.” ( Accessed on March 14, 2012.) Available at: http://www.bls.gov/ncs/ect/sp/ecsuptc21.pdf. (Note: The BLS report title and content is updated periodically t o include more recent data, on the same website.)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 BLS, 201 2 b. Bureau of Labor Statistics. Employment Cost Index

– Total Compensation: Professional and Related Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I (B)), extracted March 22, 2012. Available at: http:/data.bls.gov/cgi

- bin/srgate.

CAE PA, 2013 a . State of California Environmental Protection Agency. Chemicals Known to the State to Cause Cancer or Reproductive Toxicity. Office of Environmental Health Hazard Assessment, 04 February 2013. http://oehha.ca.gov/prop65/prop65_list/files/P65list0 20813.pdf

CAEPA , 2013 b . State of California Environmental Protection Agency. Proposition 65 in Plain Language! Febuary 2013. http://oehha.ca.gov/prop65/background/p65plain.html

CMA, 1991. Chemical Manufacturers Association. Responses to Questions on Burde n Associated with PMN Submissions

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

Dapson, R.W. 2009. Benzidine

- based dyes: effects on industrial practices, regulations, and world trade on the biological stains market . Biotechnic & Histochemistry 84(3): 95

- 100.

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

- dichlorobenzidine . Available at: http://www.ec.gc.ca/toxics/docs/sor/bdine/EN/sum.cfm Accessed 10 September, 2009.

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

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- 80

- 019, June 1980.

EPA, 1986. U.S. EPA, Office of Toxic Substances. New Chemical Information Bulletin: Exemptions for R esearch and Development and Test Marketing . Washington, D.C. November, 1986. Available
at: http://www.epa.gov/oppt/newchems/pubs/tmeranddbulletin.pdf

EPA, 1992. U.S. EPA, Office of Policy, Planning, and Evaluation. Instructions for Preparing Information C ollection Requests (ICRs). Washington, DC, June 1, 1992.

EPA, 1994. U

. S

. EPA, Office of Toxic Substances, Regulatory Impacts Branch. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications

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

EPA, 1999

. U.S. EPA

, Office of Pollution Prevention and Toxics, Economics, Exposure and Technology Division, Economic and Policy Analysis Branch Economic Analysis of the Final Rule to Modify Reporting of Persisten t Bioaccumulative Toxic Chemicals under EPCRA Section 313 . October 1999.

EPA, 200 0

. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1139.06. [Information Collection Request for] TSCA Existing Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Test Data Submissions: Supporting Statement for Request for OMB Review under the Paperwork Reduction Act . Attachment 5, Wage Rates Estimation, August 29, 2000.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 EPA, 2002 a

. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Washington, DC. August 2002

.
EPA, 2002 b

. U.S. EPA, Office of Pollution Preventi on and Toxics, Economic and Policy Analysis Branch. Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Washington, DC , June 10, 2002

.
EPA, 2003

. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branc h. Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances

. Washington, DC, 2003. Available in docket EPA

- HQ

- OPPTS

- 2002

- 0078 at http://www.regulations.gov

.
EPA, 2005a. U.S. EPA. Supplemental Guidance for Assessing the Susceptibi lity from Early Life Exposure to Carcinogens. EPA 630/R

- 03/003F, March 2005.

EPA, 2005 b

. U.S. EPA. Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements, November 2005, available from the Federal Docket Management System as EPA

HQ

- OPPT

- 2005

- 005 8

- 0017 at http://www.regulations.gov.

EPA, 2007 a . U.S. EPA, Office o f Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 38 Chemical Substances (EPA Docket OPPT

- 2006

- 0898 ), August 17, 2007

.

EPA, 2007b . U.S. EPA, Office of Pollution Prevention a nd Toxics

, ICR No. 0574.14. [Information Collection Request for] Pre

- Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances: Supporting Statement for a Requ est for OMB Review under The Paperwork Reduction Act , December 6, 2007.

EPA, 2009a . U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch . Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule

. (EPA

- HQ

- OPPT

- 2008

- 0296) . July 13, 2009.

EPA, 2009b . U.S. EPA, Office of Pollution Prevention and Toxics. ICR No.: 0795.13 [Information Collection Request for] Notification of Chemical Exports

- TSCA Section 12(b) Supporting Statement for Request for OMB Review under the Paperwork Reduction Act . March 6, 2009 at http://www.regulations.gov

.
EPA, 2009c . U.S. EPA, Office of Pollution Prevention and Toxics

. Benzidine Dyes Action Plan

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

EPA 2013 a

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

EPA, 2013b . U.S. E PA, Office of Pollution Prevention and Toxics. U nderstanding the Costs Associated with Eliminating Exemptions for Articles in SNURsEconomic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Chemical Substances 38 Economic and Policy Analysis Branch European Commission. 2009. Commission Regulation EC No. 552/2009 

### Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on REACH as regards Annex XVII.

European Commission. 20 10. RAPEX

– Latest Notificat ions . Directorate General for Health and Consumers. http://ec.europa.eu/consumers/dynex/rapex/rapex_achives_en.cfm Accessed on December 7, 2010.

European Commission (EC). 2013. “More about the EU Ecolabel.” Available at: http://ec.europa.eu/environment/ecolabel /the

- ecolabel

- scheme.html (Accessed June 5, 2013). Last updated March 25, 2013.

Galbraith® Laboratories, 2013

. Galbraith® Laboratories . Elemental Analysis Test Information http://www.galbraith.com/analyses.htm

Golka, K.; Kopps, S.; Myslak, Z.W. 2004. Carcinogenicity of azo colorants: influence of solubility and bioavailability. Tox Lett 151:203

- 210.

HKTDC, 2012. HKTDC Research “Japan Industry Stipulates Voluntary AZO Dyes Standard for Textile and Leather Products” May 22, 2012.

IARC, 2012. Internati onal Agency for the Research on Cancer. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans

— Benzidine. Volume 100F: 53

- 63.

Intertek, 2013. Intertek, “ Requirements of Azo dyes and Formaldehyde content in fabric for babies and children clothing in Indonesia” Jan 4, 2013.

OECD, 2002. Organisation for Economic Co

- operation and Development. The Deve lopmen t Dimension of Trade and Environment: Case Studies on Environmental Requirements and Market Access. Joint working Party on Trade and Environment. COM/ENV/TD(2002)86/FINAL. Nov. 19, 2002.

OEKO

- TEX® Association . No Date a . “ OEKO

- TEX® Association” Available at https://www.oeko

tex.com/en/manufacturers/philosophy/oeko_tex_association/oeko_tex_association.xhtml (Accessed June 6, 2013)

OEKO

- TEX® Association . No Date b . “ OEKO

- TEX® Standard 100 ” Available at https://www.oeko

tex.com/en/manufacturers/concept/oeko_tex_standard_100/oeko_tex_standard_100.xhtml (Accessed June 5, 2013)

OPM, 2011. Office of Personnel Management, Salary Table 2011

- DCB, Washington

- Baltimore

Northern

- Virginia, DC

- MD

- VA

- WV

- PA. Accessed from http://www.opm.gov/oca/11tables/pdf/DCB.pdf.

RPA, 2003. Risk and Policy Analysts Limited

. Assessment of the Business Impacts of New Regulations in the Chemicals Sector Phase 2: Substances in Articles. Prepared for European Commission

– Directorate

- G eneral Enterprise.

Rawie, Carol

. 2009. EPA Office of Pollution Prevention and Toxics . Personal communication with Tulika Narayan and Kimberly Wilson of Abt Associates via e

- mail

. February 5 , 2009.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Based Chemical Substances 39 Economic and Policy Analysis Branch Simpsons UK LTD. 2010. "Product Catalogue." Accessed Nove mber 18, 2010. Available at: http://www.dyemakers.com/

Standard Dyes, Inc. 2010. "Product Catalogue." Accessed November 18, 2010. Available at: http://www.standarddyes.com/

Taiheung D&C. 2010. “Products.” A ccessed November 22/23, 2010. Available at: http://www.taiheung.co.kr/eng/index.html

Textination, 2012. Textination “Textile and Apparel Weekly June, 8 2012”. http://textination.de/en/tiw/2012/TIW08 062012.pdf

U.S. SBA. 2010. United States Small Business Administration. Table of Small Business Size Standards Matched to North American Industry Classification System Codes. Available at: http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf

U.S. Postal Service (U.S. PS). 201 2 . “Prices” < http://www.usps.com/prices/ >. Accessed January 2012

. Vipul Dye Chem LTD. 2010. “Products.” Accessed November 22, 2010. Available at: http://www.vipuldyes.com/

Winchem Industrial Co. LTD. 2010. “Products.” Accessed November 22, 2010. Available at: http://www.win

- chemical.com/

Zeilmaker, M.J.; Rosese, E.D.; van Haperen, P.; van Veen, M.P.; Bremmer, H.J.; van Kranen, H.J.; Wouters, M.F.A.; Janus, J.A. 1999. Cancer risk assessment of azo dyes and aromatic amines from garmen t and footwear . RIVM Report 601503014. Netherlands

. Zeilmaker, M. J.; van Kranen, H.J.; van Veen, M.P.; Janus, J.A. 2000. Cancer risk assessment of azo dyes and aromatic amines from tattoo bands, folders of paper, toys, bed clothes

.APPENDIX A INFLATORS AND WAGE 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 R ATES

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

.
A.1 Derivation of Loaded Wage Rates
Unit labor costs are calculated by adding fringe benefits and overhead to the wage or salary to derive a fully loaded labor cost. The basic method is described in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (EPA, 2002b). The resulting loaded labor rates are given in Table A

- 1 . Costs are calculated for several labor categories: Managerial, Professional/Technical, Clerical, and EPA staff.
In March 2004, BLS began using the North American Industry Classification System (NAICS) codes instead of the Standard Industrial Classificat ion (SIC) System, and the Standard Occupational Classification (SOC) system instead of the Occupational Classification System (OCS). The following table shows the crosswalk between old and new occupational titles.

EPAB Reports Labor Category BLS Old Titl e (OCS) BLS New Title (SOC)
Managerial Executive, administrative, and managerial Management, business, and financial Professional/Technical Professional specialty and technical Professional and related

Clerical Administrative support, including clerical Office and administrative support

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

.

A.1.1 Derivation of Labor Rates for Managerial, Professional/Technical, Clerical, and Production Labor
Wages and fringe benefits for managerial, professional/technical, and clerical labor were taken from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data, 31 for December 2011, for manufacturing industries. 32

The cost of fringe benefits

, such as paid leave and insurance, specific to each labor category, are taken from the same ECEC series. Fringe benefits as a percent of wages are calculated separately for each labor category. For example, for December 2011, the average wage rate for professional/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 applied to wages to account for overhead. This approach is used for consistency with Office of Pollution Prevention and Toxics economic analyses for two major

31 This follows the approach introduced in Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances: EPA Docket OPPT

- 2003

- 0063 (EPAB, 2007 b )

. 32 Employe r Costs for Employee Compensation Supplementary Tables December 2011

. (BLS, 2012 a)

. 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, 2007 b . Earlier SNUR economic analyses used the term “technical” labor. Here the category is called “professional/technical” labor, to make clear how it relates to BLS categories

. In 2004, BLS changed from the Occupational Classification System, OCS, to the Standard Occupational Classification system, SOC

. In the proces s, the “Professional specialty and technical” category became the “Professional and related” category

. However, the coverage of the old and new occupational groups is approximately the same

. See the BLS article, C omparing Current and Former Industry and Oc cupation 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 rulemaki ngs: 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 fa ctor, 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 l abor are calculated in a similar manner, as shown in Table A

- 1

.
A.1.2 Derivation of Labor Rates for EPA Staff
Agency labor costs are calculated based on annual Federal salaries for the Washington

- Baltimore area published by the Office of Personnel Management effective January 2011 (OPM, 2011). The average salary for one FTE staff member is estimated as the salary for a GS

- 13 Step 5 employee. 34

Multiplying the ann ual 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 Collec tion Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 percent assumption was labeled “the benefits multiplication factor” in the EPA Guide, but has been used in many EPA Office of Pollution Prevention and Toxics ICRs to reflect both fringe benefits and overhead for Federal staff. For example, it was used in an August 2000 document supporting ICR No. 1139.06 (EPA, 2000), with the following explanation:

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

34 The GS

- 13 Step 5 is consistent with ICR No. 0574.14 (12/18/2007), which covers PMN SNURs. Use of this grade level follows the approach introduced in EPAB, 2007a. That report represented a change from the earlier P MN SNUR economic analysis (EPA, 2003), which used an average of GS

- 12 Step 1 and GS

- 12 Step 10 salaries.Economic Analysis of SNUR for A

- 3 U.S. EPA Office of Chemical Safety and Pollution Prevention

Nine Benzidine Chemical Substances Economic and Policy Analysis Branch Table A

- 1 : Derivation of Loaded Wage Rates

EPAB Labor Category Data Sources Date Wage Fringe Benefit Fringes as

% W age Over

head % W age 2 Fringe +

Overhead Factor Loaded Wages 1

(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 Dec

- 11 $43.01 $20.40 47.43% 17% 1.64 $70.72

Professional/ Technical BLS ECEC , Private Manufacturing

industries , “Professional and related“ 3 Dec

- 11 $38.48 $19.64 51.04% 17% 1.68 $64.66

Clerical BLS ECEC , Private Manufacturing

industries, “Office and Administrative Support” 3 Dec

- 11 $17.69 $8.93 50.48% 17% 1.67 $29.63

EPA staff FTE Annual Federal staff cost: OPM

Washington

- Baltimore

- Northern Virginia, DC

- MD

- PA

- VA

- WV, area, GS

- 13 Step 5 pay rates, with 60% overhead. 3 Jan

- 11 $48.51

-- [Included in 60% overhead] 60% 1.6 $77.62

Notes:

1 Wage data ar e rounded to the closest penny in this table; however, in calculations using these numbers for this report, unrounded values were used.

2 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program ( EPA, 2002b ), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002 a ).

3 The salary is unloaded Federal GS

- 13 Step 5 salary for calendar year 20 11 , from the Office of Personnel Management salary table for Washington

- Baltimore

- Northern Virginia (OPM, 20 11 ). The 60% fringes

- and

- overhead rate is from an EPA guide, Instructions for Preparin g 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 Eco nomic and Policy Analysis Branch A.2 Derivation of Inflation Factors
Detailed information on the derivation of the inflation factors used is presented in Table A

- 2 . In 2006, the Bureau of Labor Statistics (BLS) made several changes to the Employment Cost Index. The changes are described on a BLS web page, “Change has come to the ECI,” (BLS, 2006c) and in several April 2006 Monthly Labor Review articles posted on the BLS web site: “Changes affecting the Employment Cost Index: an overview” (Caroll, 2006); “Employment Cost Index Publication Plans” (Sleemi, 2006); and “Seasonal adjustment in the ECI and the conversion to NAICS and SOC” (Branch, 200 6).
Under a mandate from OMB, BLS changed its classification of industries and occupations from the Standard Industrial Classification (SIC) and Occupational Classification System (OCS) to the North American Industry Classification System (NAICS) and Stand ard Occupational Classification (SOC) system. In 2006, BLS adjusted all ECI series to reflect this change.
In addition to changing the industry and occupational classification systems, in 2006, BLS rebased the ECI from June 1989 = 100 to December 2005 = 1 00 for all current and historical non

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

- 2 of this report, may not exactly equal 100 for December 2005 as a result of the seasonal adjustment. Seasonal adjustments are explained in Branch, 2006.)
According to BLS, the official ECI for the years 1975

- 2005 is the SIC

- OCS based serie s, and for subsequent years, the official ECI is the NAICS

- SOC based series (Sleemi, 2006, p.8). 35
“Starting year” indices in Table A

- 2 continue to be SIC

- OCS based. Current year indices are NAICS

SOC based. We use indices from both the NAICS

- SOC and the SIC

- OCS based ECI series because neither series spans the entire period over which testing and other costs need to be inflated.

35 BLS has been publishing the NAICS

- SOC based ECI series since March 2001 and it became official in March 2006. The SIC

OCS based series and NAICS

- SOC series have different series ID numbers, even when they describe essentially the same population. For example the series ID for seasonally adjusted total compensation for all private industry workers is ECS10002I for the SIC

- OCS series and CIS201000000000 0I 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 Eco nomic and Policy Analysis Branch Table A

- 2 : Derivation of Inflation Factors

Item Inflation Index Source 1 Starting Y ear Index for

Starting Year (a) Index for

20 11 (b) Inflation

F actor (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 Cost Index. SA = Seasonally Adjusted. Total Comp = Total Compensation (wages/salaries and benefits). 4th Q = Fourth Quarter. “ECS10002I” etc. refer to BLS series Ids. Notes:

1 In 2006, Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) series “were rebased to December 2005 = 100 from June 1989 = 100.” The change is reflected in the indices in this table and explained on the BLS website, Employment Cost Index News Relea se Text: Employment Cost Index, March 2006 (BLS, 2006b). The Consumer Price Index (CPI) was not rebased. “Starting year” ECI indices are SIC

- OCS based: Seasonally Adjusted (SA) ECS10002I for private industry All Workers, and not SA ECU11122I for private i ndustry Professional and Related Workers. After 2006, ECI indices are NAICS

- SOC based: Seasonally Adjusted (SA) CIS2010000000000I for private industry All Workers, and not SA CIU2010000120000I (B) for private industry Professional, and Related workers.

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

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

- 2009

- 0922 (EPA, 2011b) we began to use the not

- seasonally adjusted CIU2010000120000I for private industry Professional, and Related workers, instead of SA CIS2010000W00000I for private industry white collar workers because BLS retired the “white

collar” series

.Economic Analysis of SNUR for B

- 1 U.S. EPA Office of Pollution Prevention and Toxics

Nine Benzidine Chemical Substances Eco nomic and Policy Analysis Branch 

### APPENDIX B

– BENZIDINE

- BASED DYES SPECIFIED AT 40 CFR SECTION 72 1.1660

Table B

- 1 provides a list of the benzidine

- based dyes specified at 40 CFR section 721.1660

. It also indicates whether or not EPA found evidence of current manufacture of the dye, and where that manufacture occurred.

Table B

- 1: Benzidine

- Based Dyes Specified at 40 CF R 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

- , disod ium salt [ CI Direct Orange 8 ] Domestic

2429

- 81

- 4 Benzoic acid, 5

- [[4′

- [[2,6

- diamino

- 3

- [[8

- hydroxy

- 3,6

- disulfo

- 7

- [(4

- sulfo

- 1

-

naphthalenyl)azo]

- 2

- naphthalenyl]azo]

- 5

- methylphenyl]azo][1,1′

- biphenyl]

- 4

- yl]azo]

- 2

- hydroxy

- , tetrasodium salt [ CI Direct Brown 31 ] Domestic

2429

- 82

- 5 Benzoic acid, 5

- [[4′

- [(7

- amino

- 1

- hydroxy

- 3

- sulfo

- 2

- naphthalenyl)azo][1,1′

-

biphenyl]

- 4

- yl]azo]

- 2

- hydroxy

- , disodium salt [ CI Direct Brown 2 ] Global

2429

- 83

- 6 2,7

- Naphthalenedisulfonic acid, 4

- amino

- 3

- [[4′

- [(2,4

- diamino

- 5

-

methylphenyl) azo][1,1′

- biphenyl]

- 4

- yl]azo]

- 5

- hydroxy

- 6

- (phenylazo)

- , disodium salt [ CI Direct Black 4 ] N

2429

- 84

- 7 Benzoic acid, 5

- [[4′

- [(2

- amino

- 8

- hydroxy

- 6

- sulfo

- 1

- naphthalenyl)azo][1,1′

-

biphenyl]

- 4

- yl]azo]

- 2

- hydroxy

- , disodium salt [ CI Direct Red 1 ] N

2586

- 58

- 5 Benzoic acid, 5

- [[4′

- [[2,6

- diamino

- 3

- methyl

- 5

- [(4

-

sulfophenyl)azo]phenyl]azo][1,1′

- biphenyl]

- 4

- yl]azo]

- 2

- hydroxy

- , disodium salt [ CI Direct Brown 1:2 ] Global

2602

- 46

- 2 2,7

- Naphthalenedisulfonic acid, 3,3′

- [[1,1′

- biphenyl]

- 4,4′

- diylbis(azo)]bis[5

-

amino

- 4

- h ydroxy

- , 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 [ C I 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 Eco nomic and Policy Analysis Branch Table B

- 1: Benzidine

- Based Dyes Specified at 40 CF R 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

- naphthalenediyl]azo[1,1′

- biphenyl]

- 4,4′

- diylazo]]bis[6

- hydroxy

- , hexasodium salt [ CI Direct Brown 74 ] N

16071

- 86

- 6 Cuprate(2

- ), [5

- [[4′

- [[2,6

- dihydroxy

- 3

- [(2

- hydroxy

- 5

-

sulfophenyl)azo]phenyl]azo][1,1′

- biphenyl]

- 4

- yl]azo]

- 2

- hydroxybenzoato(4

- )]

- , disodium [ CI Direct Brown 95] Domestic

1. Common names are not unique identifiers as they may correspond to more than one CAS No.; however, they are frequently used, even in peer

- reviewed literature.