## Economic Analysis of t he Pro posed Significant New Use Rule for Nine Benzidine Based Dyes (EPA Docket EPA

- HQ

- OPPT

- 2010

- 0573 RIN 2070

- AJ73 ) FINAL



## — Does not contain TSCA CBI

—

Prepared by:

Economic and Policy Analysis Branch Economics, Exposure and Technology Division Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, DC 20460Economic Analysis of Proposed SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes i Economic and Policy Analysis Branch CONTRIBUTORS

The EPA analyst responsible for this report was Lynne Blake

- Hedges

. Analytical and draft preparation support w as provided by Abt Associ ates Inc. under EPA Contract No. EP

- W

- 08

- 010.Economic Analysis of Proposed SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes ii Economic and Policy Analysis Branch ABSTRACT

This report estimates the costs of the U.S. Environmental Protection Agency (EPA)’s proposed Significant New Use Rule (SNUR) that adds the nine benzidine

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

- based chemical substances at 40 CFR section 721.1660 The proposed rule also revoke s the article e xemption described in 40 CFR section 721.45(f) for the chemical substances included in 40 CFR 721.1660(a)(1) (see Appendix A) as well as the nine chemicals in the proposed rule

. 1

Table 1 : Benzidine

- Based Dyes S ubject to Proposed 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 nam es 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 precursors in the synthesis of dyes. These dyes (called azo dyes) have historically been used in the production of textiles, paints, printing inks, paper, and pharmaceuticals. Because they have the potential to metabolize to

carc inogenic amines both in and on the human body, EPA is concerned about the potential risk from exposure to products containing benzidine

- based dyes.

The most recent data from the Toxic Substances Control Act (TSCA ) Inventory Update Reporting (IUR) database (2006 reporting) indicates no evidence of production of the nine new benzidine

- based dyes subject to the proposed rule (EPA 2006 a )

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

- CBI dyes listed in Table 1

. In addition, no manufacturers of any of the dyes subject to the proposed rule were listed in the Colour Index or identified through internet queries. 2

1 The proposed rule does not revoke the exemptions granted in 40 CFR section 721.1660(a)(2) for laboratory stains and other analytical reagents. However, global and domestic manufacturers for several of the dyes specified at 40 CFR section 721.1660 were id entified; a lthough

, information is

2 The Colour Index is an international directory of manufacturers of pigments and dyes published by the UK Society of Dyers and Colourists (SDC) and the American Association of Textile Chemists and Colorists (AATCC).Economic Analysis of Proposed SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes iii Economic and Policy Analysis Branch insufficient to determine if the current ly manufactured dyes are being importe d and/or processed domestically as part of arti cles

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

. The proposed rule would require persons to notify EPA at least 90 days bef ore commencing the manufacture, import, or process ing o f any of the dyes specified in Table 1

. It would also make inapplicable the article exemption at 40 CFR section 721.45(f), requiring notification of the import and/ or processing as part of an article any of t he dyes s ubject to the proposed rule or specified at 40 CFR section 721.1660. A firm intending to engage in these activities would be required to submit a Signi ficant New Use Notice (SNUN). While EPA is encouraged by the di scontinuation of the use of the dyes subject to the proposed rule , it is concerned that the manufacture, import , and processing of these dyes and the articles containing them could be reinitiat ed in the future. EPA is also concerned that articles containing the dyes specified at 40 CFR section 721.1660 could be available for human exposure or eventual release to the environment. The SNUN provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs

. When submitting a SNUN, a firm incurs a modest submission cost of $ 8, 112 and potentially other minor
costs

. While no firms were identified that manufacture, import, process or import or process as part of an article the dyes subject to the proposed rule, global and domestic manufacturers of several of the dyes specified at 40 CFR section 721.1660 were identified. However, there is there is insufficient information to conclud e that these currently manufactured dyes are being imported or processed domestically as part of articles. As a result, EPA does not expect that any firm will incur a cost of submitting a SNUN as the result of the proposed rule

. EPA does not require the de velopment 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 data. 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 proposed SNUR.

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

.
However, costs are estimated at the firm level and reflect the burden of a SNUR on firms that may make a SNUN submission.Economic Analysis of Proposed SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes iv Economic and Policy Analysis Branch TABLE OF CON TENTS

CONTRIBUTORS

................................ ................................ ................................ ................................ ......... i
ABSTRACT

................................ ................................ ................................ ................................ .................. ii
1. INTRODUCTION

................................ ................................ ................................ ................................ 1 1.1 Background

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

................................ ................................ ................................ ................... 2 Health Effects

................................ ................................ ................................ ............................. 3 Environmental Expo sure

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

................................ ................................ ................................ ............... 3 1.2 Statutory Authority

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

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

................................ ................................ ................................ ........ 4
2. INDUSTRY COMPLIANCE COSTS

................................ ................................ ................................ .. 5 2.1 Wage Rates

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

................................ ................................ ................................ . 6 2.2.1 Rule Familiarization

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

................ 7 2.2.3 Form Completion and Submission Fee

................................ ................................ .......... 8 2.2.4 Recordkeeping

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

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

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

................................ ................................ ......................... 12 2.4 Likelihood of a SNUN Submission

................................ ................................ .......................... 13 2.5 Potential for Subsequent Regulatory Action

................................ ................................ ............ 14
3. AGENCY COSTS

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

................................ ................................ ................................ ........ 15 3. 2 SNUN Processing Costs

................................ ................................ ................................ ........... 16 3.3 Export Notification Cost

................................ ................................ ................................ ........... 1 9
4. ADDITIONAL ANALYSES

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

................................ ................................ ................................ ........ 20 4. 2 Unfunded Mandates Reform Act

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

................................ ................................ ................................ ......... 20 4.4 National Technology Transfer and Advancement Act

................................ ............................. 21 4.5 Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations

................................ ................................ ............... 21 4.6 Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

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

................................ ................................ ......................... 21 4.8 Executive Order 13 175: Consultation and Coordination with Indian Tribal Governments

.... 21 4.9 Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use

................................ ................................ ................................ ................................ .................. 21
5. Benefits

................................ ................................ ................................ ................................ ............... 22
6. REFERENCES

................................ ................................ ................................ ................................ .... 23
7. Appendix A

– Be nzidine

- Based Dyes Specified at 40 CFR section 721.1660

................................ ... 27Economic Analysis of Proposed SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes v Economic and Policy Analysis Branch LIST OF TABLES Table 1: Benzidine

- Based Dyes Subject to Proposed SNUR

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

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

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

- Time Submitters

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

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

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

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

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

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

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

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

................................ .. 18 Table 13: TSCA 1 2(b) Export Notification Cost: Agency Burden per Activity (2009$)

........................... 19 Table 14: Benzidine

- Based Dyes Specified at 40 CFR Section 721.1660

................................ .................. 27Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 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 co sts incurred as a result of a proposed Significant New Use Rule (SNUR) that adds the nine benzidine

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

. EPA is also proposing to revoke the a r ticle e xemption at 40 CFR section 721. 45(f) for the chemical substances included in 40 CFR 721.1660(a)(1) (see Appendix A) as well as the nine chemicals included in the proposed rule. However, the proposed r ule does not revoke the exemptions granted in 40 CFR section 271.1660(a)(2) for uses as laboratory stains and other analytical reagents.

Table 1 : Benzidine

- Based Dyes S ubject to Proposed 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

- hyd roxy

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

- based dyes subject to the proposed rule or any import or processing of articles containing them or the dyes specified at 40 CFR section 721.1660

. 3

. 4

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

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

- based dyes as part of an article would not be required to provide export notification. E PA promulgates a

4 Section 5(h)(3) of TSCA, 15 USC 2604(h) exempts substances that are manufactured in small quantities solely for research and development (R&D) from the section 5(a) notice requirements. No application is re quire d for the exemption for R&D und er section 5(h)(3) (U.S. EPA 1986)

.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 2 Economic and Policy Analysis Branch 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

O ccupational exposure to some azo dyes has been regulated for many years; however, the potential for consumer exposure to products containing these dyes i s still a potential concern. The European Union (E.U.) has banned

, in textile and leather articles which may come into direct an d prolonged contact with humans

, the use of azo dyes which can break down to release any of 22 listed carcin ogenic aromatic amin es (including benzidine and its congeners) in amounts above 30 ppm (European Commission 2009). 5

Canada has also expressed concern about the potential release of be nzidine or its congeners from azo dyes and is evaluating potential approaches for addressing azo dyes (Environment Canada 2009). In addition, the American Apparel and Footwear Association (AAFA), the national trade association representing apparel, footwea r and other sewn products companies and their suppliers, which compete in the global market, includes benzidine on its Restricted Substances List (AAFA 2010). The European Commission’s Directorate General for Health and Consumers maintains the RAPEX database that member countries can use to report dangerous products and the measures they have taken to prevent or restrict those products. Despite the E.U. ban, products containing such azo dyes have recently been listed on RAPEX. The products are typically voluntarily withdrawn from the market and/or destroyed by the im porter or have been placed under an order to cease sales by the authorities (E uropean C ommission , 2010). Therefore, azo dyes in imported articles still remain a potential issue in the E.U.

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

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

- based substances ; however, EPA recognized that additional substances would need to be added. The f our 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 i n and on the human body

. The Action Plan summarized readily available use, exposure, and hazard i nform ation for forty

- eight azo dyes; 6

Uses and Substitutes considered which authorities provided under TSCA and other statutes could be used to address potential
concerns; and desc ribed various courses of actions available to EPA to address the concerns (EPA 2009 c )

. 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

- base d dyes.

Azo dyes are used in the production of textiles, paints, printing inks, paper, and pharmaceuticals. T hey are also used as reagents and biological stains in laboratories, and in the food indus tries (Dapson

, 2009). As mentioned above, the 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 dy es (E uropean C ommission , 2010). A s a result, it is believed that there are readil y available substitutes for the benzidine

- based dyes subject to th e proposed SNUR

.

5 See Restriction 43 in REACH Annex XVII.
6 The four non

- CBI benzidine

- based dyes listed inTable 1, and forty

- four benzidine congener

- based dyes not subject to the proposed SNUR. The f ive CBI dyes listed in Table 1 were identified by Agency chemists from an inventory of CBI chemicals which also had the potential to metabolize into benzidine.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 3 Economic and Policy Analysis Branch Health Effects
The 1980 EPA Preliminary Risk Assessment on derivatives of benzidine and its congeners established that the primary hazard concern was for the carcinogenic effects to humans from exposure to specific metabolites of the dyes (EPA 1980). Azo dyes are biologically active through their metabolites. Azoreduction of these compounds occur s in humans by an enzyme

- mediated reaction. Azoreductases are found in the liver, in gut bacteria, and in skin bacteria. The result of this azoreduction is the release of the carcinogenic aromatic amine from the dye. Studies have demonstrated that the azor eduction 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 is early life susceptibility to benzidine carcinogenesis. Cancer potency for benzidine was substantially increased when the dose was given in early life as compared to adults (EPA 2005a).
Environmental Exposure
The primary route of consumer exposure to azo dyes is dermal absorption from wearing azo

- dyed clothing or footwear

. 7

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. B iodegra dation studies indicate that azo dyes would 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. However, i t is unclear whether metabolites from these reductions would be available in large concentrations or locations to be of concern to the general population. Other products are either not available to consumers (laboratory chemicals) or would not likely be readily accessible in significant quantities (printing ink or LCD displays) to present
exposure concern. Oral ingestion is an additional route for babies and young children who suck on clothing, blankets, and other non

- food products which might contain azo dyes. Inhalat ion exposure is a more prevalent route in occup ational 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 a dditional potential source of
exposure (Zeilmaker et al. 1999; Zeilmaker et al. 2000).

Current Manufacturing
Dye production in the United States has been steadily declining for the past decade, largely due to the increase in imported finished textiles from less developed countries like China and India which may have less stringent regulations on dye intermediates (Dapson 2009). The most recent data from the TSCA IUR database (200 6 reporting) did not indicate any domestic manufacture or import of the dyes subject to th e proposed SNUR

. 8 Table 1 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 list ed in

. In addition, none of the dyes subject to th e proposed SNUR were found in the Colour Index or during internet que ries for manufacturers

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

7 The main factors determining dye releases from textiles to the skin include the type of dyed t extile, contact with other substrates, amount of dye applied to the textile, and number of previous washings (Zeilmaker et al. 1999; Zeilmaker et al. 2000).
8 The IUR compiles production data from manufacturers and importers of certain chemical substances listed on the TSCA Chemical Substance Inventory. Sites are only required to submit IUR data if they manufacture or import more that 25,000 pounds of a chemical during the reporting year. As a result, it is possible that some ongoing manufacture and import of the dyes could occur at sites not meeting this threshold. While it is not known how many sites fall into this latter category, the Agency believes it likely to be very few if any.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 4 Economic and Policy Analysis Branch section 721.1660

. 9

, 10

1.2 Statutory Authority Nine of which were also manufactured domestically. However, w ithout further information, it is not possible to verify whether the currently manufactured dye s are being imported and/or processed domestically as part of articles. Because the remaining 10 dyes specified at 40 CFR section 721.1660 are no longer man ufactured anywhere in the world it is expected that they are not used in articles imported into the United States.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, i ncluding those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a Significant New Use Notice ( SNUN ) to EPA at least 90 days before manufactur ing, importing, or processing the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)).
The general SNUR provisions are found at 40 CFR Part 721, Subpart A.

1.3 Summary of Methodology
This analysis quantifies, to the extent possible, the costs to society of the proposed rule by identifying the costs to industry associated with performing the required reporting and recordkeeping, and the costs to EPA of administering the rule. Industry costs may consist of rule familiarization; registration with the Central Data Exchange (CDX) electronic reporting tool; collection, compilation, and submission of required information for significant new uses of the subject chemicals; export notification; and recordkeeping. Agency costs include reviewing and processing the dat a 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 suppleme ntary market research.

1.4 Organization of this Report
The remainder of this report provides EPA’s economic analysis in support of the proposed rule. Section 2 presents estimates of the costs incurred by manufacturers

, importers, and/or processors under the SNUR options. Section 3 shows estimates of the government costs associated with the administration of the proposed rule. Chapter 4 p re sents an analysis of other impacts, as required by various statutes and executive orders

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

.

9 There were three dyes for which there was some information suggesting current production; however, it was not possible to verify this information.
10 In some cases, company product lists contained common names for dyes. C ommon names are not unique identifi ers 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 soley by common name may not be the same chemical subject to the SNUR.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 5 Economic and Policy Analysis Branch 

### 2. INDUSTRY COMPLIANCE COSTS

The proposed SNUR discussed in this report specifies that significant new use s of the benzidine

- based dyes 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 proposed rule revokes the article exemption described in 40 CFR section 721.45(f) for the chemicals spe cifie d in 40 CFR 721.1660(a)(1) (see Appendix A) as well the nine chemicals in the proposed rule. Th erefore

, a firm intending to manufacture, import, or process the dyes subject to the proposed rule for any non

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

. The firm

, therefore

, has two options:

**•** Option 1: Submit a SNUN

. A SNUN indicates to EPA that the firm would like to manufacture, import, and/or process the chemical (s) for a significant new use , which, in this case, means the manufacture, import, an d/or p rocessing of the dyes subject to the proposed rule for any use excluding as laboratory stains and other analytical reagents , and/or any import and processing of articles containing dyes subject to the proposed rule or specified at 40 CFR section 721.1660

. 11

. 12

2.2.6 The firm must submit the SNUN to EPA at least 90 days before it plans to commence t hese activities ; the SNUN provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. If EPA al lows for a significant new use, then the costs associated with this option are the costs of submitting the SNUN (including a user fee) plus

, if there is any export of these products

, the export notification costs that result from TSCA Section 12(b) require ments that are automatically triggered for chemicals regulated under TSCA Section 5 (see Section for details)

. Because there is no evidence to suggest that the currently manufactured dyes are being imported and/or processed domestically, EPA expects no fir ms will choose this option.

**•** Option 2: Decide not to manu facture, import, and/or process the chemical

. The firm may decide simply not to proceed to manufacture, import, or process the dyes subject to the proposed rule, or import or process articles containing the se dyes or those specified at 40 CFR section 721.1660 . While this option avoids the costs of submitting a SNUN, it entails the ‘hi dden’ cost of the profit that will be foregone as a result of not engaging in the commercial activity originally planned. Similarly, if the firm would have used a given amount of the dye in the production of another p roduct, and must substitute to more cos tly substance, it will incur those additional “ hidden ” costs of production. However, these hidden costs are expected to be minimal, if not zero, because there is no evidence to suggest that the current domestic manufacturers of the dyes specified at 40 CFR section 721.1660 use the dyes in artic les

. If the firm elects to produce the dye for research and development (R&D) purposes only ( an exemption for R&D purposes is provided in 40 CFR §721.47), it may have costs associated with R&D recordkeeping.

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

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

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

.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 6 Economic and Policy Analysis Branch Becaus e there is no evidence to suggest that the currently manufactured dyes are being imported and/or processed domestically as part of articles

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

. The remainder of this chapter estimates the quantified portion of costs

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

.

2.1 Wage Rates

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

Loaded wage rates for managerial, technical, and clerical personnel are derived by combining data on wages and fringe benefits with estimates of overhead rates, following the methodology described in “Wage Rates for Economic Analysis of the Toxics Release Inventory Program” ( EPA 2002b ). Wage data for each labor category in December 2009 are provided by the Employer Costs for Employee Compensation (ECEC) Supplemental Tables available on the BLS website ( BLS 2010 a ). The loaded wage rate for managerial labor is $68.24; for technical labor, $59.49; and for clerical labor, $28.31. Table 2 presents the basic data used to calculate the loaded wage rates for all three labor categories.

Table 2 : Loaded Industry Wage Rates, December 2009

Labor Category Data Sources Wage (2009$) Fringe Benefit (2009$) Fringes as %
wage Over

head %

wage 2 Fringe + overhead

factor Loaded Wages 1 (2009$) (a) (b) (c) =(b)/(a) (d) (e)=(c)+ (d)+1 (f)=(a) x (e)

Managerial BLS ECEC , Private Manufacturing industries

, “Mgt, Business, and Financial” 3 $42.36 $18.68 44.10% 17% 1.61 $68.24

Professional/

Technical BLS ECEC , Private Manufacturing industries

, “Professional and related“ 3 $35.96 $17.42 48.44% 17% 1.65 $59.49

Clerical BLS ECEC , Private Manufacturing industries, “Office and Administrative Support” 3 $17.21 $ 8.17 47.47% 17% 1.64 $28.31

1 Wage data are rounded to the nearest cent pennies in this table.
2 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program ( EPA 2002b ), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report ( EPA, 2002a ).
3 Employer Costs for Employee Compensation Supplementary Tables: Decem ber 200 9

. US Bureau of Labor Statistics, March 1 0

, 20 1

- (BLS 20 10a ).

2.2 Unit Industry Compliance CostsEconomic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 7 Economic and Policy Analysis Branch 

### 2.2.1 Rule Familiarization

The proposed rule requires submitters and their staff to become familiar with the SNUR and its various requirements. The per company burden associated with r ule familiarization is approximately 0.55 hours of technical labor and 0.27 hours of managerial labor, as described in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule ( EPA 2009a )

. As shown in Table 3 the total labor cost associated with rule familiarization by a first

- time reporter is $50.92.

Table 3 : Rule Familiarization Burden and Cost for SNUR Submitters

Reporting Activity Clerical Labor (at $28.31/hour) Technical Labor (at $59.49/hour) Managerial Labor (at $68.24/hour) Total Labor Cost

Burden (hours) Cost (2009$) Burden (hours) Cost (2009$) Burden (hours) Cost (2009$) Burden (hours) Cost (2009$) Rule Familiarization 0.00 $0.00 0.55 $32.72 0.27 $18.20 0.82 $50.92 Total 0.00 $0.00 0.55 $32.72 0.27 $18.20 0.82 $50.92 Source : BLS 2010 a (labor rates) ; EPA 2009a (burden hours)



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

The proposed SNUR requires first

- time submitters (that is, those companies who have not submitted information to EPA through CDX before) to register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E

- payment account

. 13

**•** CDX registration: EPA estimates that companies will spend approximately 0.18 hours per employee to register with CDX, and that an average of four technical staff members and one manager will need to register for each company, totaling approximately 0.92 hours of burden per
company. Thes e activities are only required of first

- time submitters (companies already registered with CDX would not need to re

- register for the purposes of complying with the proposed SNUR) . The burdens associated with these activities were estimated in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule ( EPA, 2009a ) and are described in more detail below :

**•** CDX electronic signature: EPA estimates that companies will spend 0.25 hours preparing, submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA per employee

. This burden will apply to four technical staf f members and one manager per company, totaling to 1.25 hours of burden per company

. In addition, EPA estimates that a manager will spend an additional 0.50 hours accessing, preparing, and submitting verification forms (Verification of Authorization) for a ll authorized submitters to EPA

. The total burden incurred by companies submitting and then verifying electronic signature agreements is 1.75 hours

. Note that this burden does not include any additional time required to contact EPA’s CDX help desk to notif y a change of submitter status, should one occur.

Filing the electronic signature agreement requires an additional mailing cost of $2.30 per company (including five $0.44 stamps and five $0.02 business envelopes) (USPS 2010)

.

13 Although the proposed rule does not specifically require submitters to establish and use a Pay.gov account, the burden estimates in this analysis are higher

- en d insofar as to include the use of Pay.gov as a required activity

.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 8 Economic and Policy Analysis Branch **•** Payment via Pay.gov account : EPA estimates that one manager per company will spend approximately 0.13 hours setting up a Pay.gov ID account, logging into the system, finding the appropriate form, and filling it out

. This burden does not include the time required to click ‘submit’ on the form and wait for payment processing.

As shown in Table 4

, the cost associated with CDX registration, CDX electronic signature, and Pay.gov account setup is $17 8

. 2 1 , and this cost is only incurred by a first

- time submitter.

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

- Time Submitters

Reporting Activity Clerical Labor (at $28.31/hour) Technical Labor (at $59.49/hour) Managerial Labor (at $68.24/hour) Total Cost

Burden (hours) Cost (2009$) Burden (hours) Cost (2009$) Burden (hours) Cost (2009$) Burden (hours) Cost (2009$) CDX Registration 0.00 $0.00 0.73 $43.63 0.18 $12.51 0.92 $56.13 CDX Electronic Signature 0.00 $0.00 1.00 $59.49 0.75 $51.18 1.75 $110.67 Mailing Cost $2.30 E

- Payment ( Pay.gov ID) 0.00 $0.00 0.00 $0.00 0.13 $9.10 0.13 $9.10 Total 0.00 $0.00 1.73 $103 1.07 $72.79 2.80 $17 8

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



### 2.2.3 Form Completion and Submission Fee

Respondents are required to gather and submit information regarding the data elements identified in the applicable SNUN reporting form

. The methodology and calculations used in this analysis assume that the employee responsible for collecting, filling out, and submitting the requested information has a reasonable level of fam iliarity 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 an d do not require additional familiarization or training beyond the basic rule familiarization described above

. In addition, this analysis focuses on the marginal costs of submitting information for the proposed rule and not the total costs for the company to comply with a range of other Federal and State environmental, health, and safety regulations or accounting requirements that rely on this type of information.
Estimates of the costs of completing a Significant New Use Notice (SNUN) form are based on the costs of completing a Premanufacture Notification ( PMN ) submission, since the data requirements are the same and the same form is used for both

. The PMN submission costs are based on EPA's 1994 Regulatory Impact Analysis of Amendments to Regulations for T SCA Section 5 Premanufacture Notifications and the updates to this estimates in 2009 ( EPA 2009a ). The original 1994 estimates relied on industry estimates of the effort needed to collect and compile all data required for a PMN submission, prepare the form, submit the form and data to EPA, and mainta in a file of the submission (EPA 1994 )

. 14

14 Table III

- 2 and pages III

- 11,

- 12, and

- 13

. The 1994 estimates were based on a survey conducted by the Chemical Manufacturers Association ( CMA 1991 ), which became the American Chemistry Council

. These burdens “ include the time spent reading and becoming familiar with the form, gathering the required information and preparing the report, producing sanitized responses for items claimed as confidential business informatio n, and maintaining a file of the submission” ( EPA,Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 9 Economic and Policy Analysis Branch 1994 )

. 15 The burden associated with SNUN submission and preparation has been adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that requires the electr onic submission of all TSCA section 5 notices

. Electronic submission of SNUN forms is expected to remove all clerical burden associated with preparing a SNUN ( EPA 2009a ) 16

. In addition, electronic

su bmission is expected to generate an additional 0.18 hours of technical burden, for the completion of the User Fee Payment Identification Number and e mail a ddress data elements on the electronic SNUN form.

SNUN form completion and electronic submission is estimated to require 7 3

. 68 hours of technical labor and 18 .00 hours of managerial labor

. Table 5 combines the estimated reporting burden and loaded wage rates for all three labor categories to estimate the per

- SNUN cost of form completion

. The labor cost incurred by a SNUN submission for both large and small business submitters is $5, 6 12

.

Table 5 : Industry Cost Estimate to Complete the SNUN Form

Reporting Activity Clerical Labor (at $28.31/hour) Technical Labor (at $59.49/hour) Managerial Labor (at $68.24/hour) Total Labor Cost

Burden (hours) Cost (2009$) Burden (hours) Cost (2009$) Burden (hours) Cost (2009$) Burden (hours) Cost (2009$) Form Completion 0.00 $0.00 73.68 $4,414 18.00 $1,228 9 1.68 $5, 6 12 Source : 1 Loaded wages include fringe benefits and overhead. Wage rates presented in this table are rounded values; however, unrounded values are used to calculate total labor costs. For this reason, total labor costs may not equal the product of rounded values.
2 The estimate of no clerical burden is taken from the Economic Analysis of the Premanufacture Notice Electronic Reporting Final Rule (EPA, 2009a, page 7)
3 T echnical an d 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 Elec tronic SNUN form (EPA, 2009a page 15).
In addition, each submitting large business must pay a $2,500 per

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

- SNUN submission fee

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

. The total cost of a SNU N submission is $8,112 for large business submitters and $5,7 12 for small busine ss submitters.

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

Reporting Population Labor Cost Submission Fee Total Cost (2009 $ ) Large Business Submitters $5, 6 12 $2,500 $8, 1 12 Small Business Submitters $5, 6 12 $100 $5, 7 12 Source : EPA, 2009a

.

15 p. III 11

- 13 16 The Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009 a ) estimates a 0.5 hour clerical burden and a 0.5 hour technical burden associated with recordkeeping in addition to the burden estimates from the 1994 RIA, which include the burden for recordkeeping ( EPA, 1994 , p. III

- 14) . T hese burden estimates are based on the recordkeeping bu rden for polymer exceptions and not the recordkeeping burden associated with PMN submissions. Therefore

, for this analysis we assume that any reduction in recordkeeping burden is captured in the reduction of the clerical burden, and we do not consider the one hour recordkeeping burden from the ePMN EA in order to avoid double counting

.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 10 Economic and Policy Analysis Branch 

### 2.2.4 Recordkeeping

Companies submitting a SNUN must keep records under 40 CFR §721.40. Some EPA reports have assumed that SNUN recordkeeping hours would be five percent of SNUN submission hours, or about five to six hours

. For this report, the SNUN recordkeeping hours were included in the SNUN submission hours (see Section 2.2.3 ) and were not separately estimated

. 17



### 2.2.5 Import Ce rtification

In general, promulgation of a final SNUR triggers a TSCA Section 13 import certification requirement and the corresponding regulations at 19 CFR 12.118 to 12.127 and 19 CFR 127.28 for all imports of the relevant chemical substances

. Thus, any U.S. manufacturer, importer, or processor receiving an imported shipment of chemicals subject to the proposed SNUR would have to certify that all chemical substances in the shipment either comply with all applicable rules and orders under TSCA or that all chemical substances in the shipment are not subject to TSCA. 18

In practice, import certification is fulfilled by checking a box on an invoice or entry document and generally imposes no additional burden or cost on the importer ( EPA 2009b )

. Any potential burden associated with a submitter’s familiarization with this requirement is assumed to be included in the more general SNUR familiarization burden discussed above. The statement must be on or attached to a commercial invoice or entry document belonging to the imported shipment.



### 2.2.6 Export Notification

Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical or an article subject to various TSCA sections ( 40 CFR §707.60 through 75 )

. 19 For TSCA 5(a)(2) (the section under which EPA promulgates significant new use rules) and certain other TSCA sections, this is

a one

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

. 20

17 SNUN submission costs estimated in Section After receiving a notification from a firm, EPA notifies the importing country and the U

. S

. State Department ( 40 CFR §707.70 )

. To calculate the burden associated with making export notifications, EPA first estimated the average annual number of export notifications made by an exporter

. EPA then derived the annu al and per notification burden associated with preparing and submitting an export notification.

2.2.3 of this report were based on PM N 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 inc luded 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 EP A 1994) included recordkeeping hours.
18 The exact statements are as follows: For imports of chemical substances subject to TSCA, “I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am no t offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.” For imports of chemical substances not subject to TSCA (e.g., pesticides), “I certify that all chemicals in this shipment are not subject to TSCA.” ( 40 CFR 707.20 )
19 While companies which manufacture or process the benzidine

- based dyes subject to the proposed SNUR solely for export are exempt from the notification requirements of 40 CFR 721.25 if the chemical is labeled in accordance with TSCA section 12(a)(1)(B), the y are required to submit export notifications under section 12(b).
20 On November 14, 2006, EPA revised the export notification requirement for chemicals subject to TSCA §5(a)(2), 5(b), 5(e)(1) and 5(e)(2) from an annual to a one

- time requirement per destin ation country for each exporter ( November 14, 2006, 71 FR 66234 ).Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 11 Economic and Policy Analysis Branch Exporter Costs 21

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

one

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



### The per

- notification cost was calculated based on the assumption that the average exporter ma k es 12 notifications per year

. These costs include the cost to the exporter of compiling a list of their products that are subject to TSCA Section 12(b) requirements, wr iting or revising an export notification letter to EPA, checking the outgoing shipments, and sending the notification letters with the associated shipping costs

.

23

Estimated Submission (Mailing) Costs

. Regulated companies will incur mailing costs for export notifications delivered to EPA

. Notifications are assumed shipped via the U.S. Postal Service (USPS) as first

- class registered mail with a return receipt ( USPS 2010)

. The estimated per

- shipment and annual mailing costs incurred by individual submitters are detailed in Exporters making more notifications per year may benefit from economies of scale and have lower costs per notification; those making fewer notifications may have higher costs per notification.

Table 7

.

Table 7 : Derivation of Total Mailing Cost for 12 Notices

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

Postal services costs Registered mail, regular, with $0 declared value $10.60 Return receipt, requested at time of mailing (receive by mail) $2.30 Postage, regular First Class, up to 1 ounce $0.44 Cost per export notice

– Subtotal $13.34
Source : Mailing rates are from the US Postal Service web site as of April 2010 ( http://www.usps.com/prices/)

. The mailing method comes from the Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements , November 2005 ( EPA, 2005), as clarified in a later SNUR economic analysis ( EPA, 2007 a , Table 8 ).
Compile and Maintain the List of Products

. Since TSCA §12(b) information collection activity has been in place for twenty yea rs, most respondents will have already developed a list of their products subject to TSCA §12(b) export notification. Respondents need only check for new regulations promulgated and any
new pr oducts exported by the company. Updating the list is estimated to take an average of one hour of technical time, which may also include some proportion of legal time ( EPA 2009b ). The total burden can vary from two hours per year up to two hours per mont h, depending on the number of products exported by the company and the number of their products subject to TSCA §12(b) ( EPA 2009b ).
Write or Revise Export Notification

. Companies that export chemicals subject to TSCA §12(b) reporting must prepare an export no tification to send to EPA when export shipments are made

. Time for initial preparation of the export notice may vary depending on whether the company has prior experience with this requirement

. This step is estimated to take an average of one hour of techn ical time (which may also include some proportion of legal time) per firm per year for 12 notifications per year , or 0.08 hours per

21 Most underlying data in this section come from the 2009 TSCA Section 12(b) ICR, ICR No.: 0795.13 [Information Collection Request for] Notification of Chemical Exports

- TSCA Section 12(b) Supporting Statement for Request for OMB Review under the Paperwork Reduction Act (EPA 2009b), with updating for inflation.
22 page 11, Table 3
23 EPA calculated the average number of export notifications per exporter in the 2009 TSCA Section 12(b) ICR ( EP A 2009b) by dividing the estimated number of submitted notifications (3,500) by the estimated number of exporters (300 ).Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 12 Economic and Policy Analysis Branch notification ( EPA 2009b ). EPA has no evidence to suggest that the current domestic manufacturers of the dyes specified at 40 CFR section 721.1660 strictly export the m or articles containing them and do es not expect that this will start.
Check Orders and Send Notifications

. Companies that export chemicals subject to TSCA §12(b) reporting must check outgoing shipments against the list of their products described above

. A form letter notifying EPA and providing the required data must be printed and mailed within the required time period

. This process is estimated to take an average one half hour of clerical time per export notifica tion ( EPA 2009b ).
The burdens and associated costs for each notification activity are provided in Table 8 below.

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

Technical Clerical Total
$/Hr Hours 2009$ $/Hr Hours 2009$ 2009$ Hours Compile list $59.49 0.78 $46.08

-- -- -- $46.08 0.78 Write letter $59.49 0.08 $4.96

-- -- -- $4.96 0.08 Check order and send notice -- -- -- $28.31 0.50 $14.17 $14.17 0.50
Mailing cost 1

-- -- -- $13.34

- Total per n otification 0.86 $51.04 0.50 $14.15 $78.5 4 1.36 Notes:
1 Mailing costs reflect April 20 10 USPS rates and can be found in Table 7

. 2 Per notification costs are based on a n average facility submitting 12 export notifications per year. Source: ICR No.: 0795.13 [Information Collection Request for] Notification of Chemical Exports

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

, and are updated to 2009 dollars.

2.3 Industry Costs of SNUR, by O ption
The number of firms affected by not making submissions to EPA is not known; therefore, costs are not aggregated across the affected entities. Table 9 summarizes the costs to comply with the proposed rule, as described in more detail in section 2.2 above.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 13 Economic and Policy Analysis Branch Table 9 : Compliance Options and As sociated Costs Incurred by a Firm Due to the Proposed SNUR
Option 1 Costs Qua ntified Costs per Chemical (2009 $) 2

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

. Costs of e lectronically submitting a SNUN, including rule familiarization, CDX registration (for companies that are first

- time submitters), form completion, user fee, export notification cost ( if relevant )

. Rarely, a firm may choose to conduct toxicity or fate testing to support the SNUN, but such testing is not $50.92 rule familiarization cost; $8, 112 submission cost (including SNUN recordkeeping and $2,500 fee). EPA usually receives well under ten SNUNs per year. Based on review of recent SNUNs, it appears that firms rarely conduct toxicity or fate testing to support a SNUN (such testing would be voluntary). 3 Export notificatio ns costs are estimated at $78.54 per notificatio n; total cost per company will vary based on the number of countries of export

. Those submitting information electronically through CDX for the first time w ould incur $178 for CDX registration and associated activities. required by law

.

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 exp ort notification costs. Opportunity costs are not quantified. Other
costs including rule familiarization ($50.92), and export notification costs ($78 .54 p e r notification if the chemical is exported only ) would apply.

Notes:
1 Firms may experience costs related to both options at once since submission of a SNUN results in profits foregone as a result of not manufacturing, importing, or processing the dyes subject to the proposed rule, or importing or processing articles containing these dyes or those spec ified at 40 CFR section 721.1660. Additionally, export notification costs are somewhat independent of the option because the production of benzidine

- based dyes subject to the proposed rule for export purposes only does not require notification under 40 CFR 721.25.
2 Quantified costs are attributable to the SNUR only if a firm would not otherwise follow the specified practices. Costs are detailed in Section 2.2

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

2.4 Likelihood of a SNUN Submission
The domestic manufacture, import and processing of the dyes specified in Table 1 and the articles containing them have been phased out. Additionally, there appears to be no production of the majority of the dyes specified at 40 CFR section 721.1660 either domestically or globally. Of those that ap p ear to remain in production either 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 .) 24

The E.U. has banned the use of azo d yes which can break down to release any of 22 listed carcinogenic aromatic amines (including benzidine and its congeners) in amounts above 30 ppm in textile and leather articles which may come into direct and prolonged contact with humans (European Commiss ion 2009). .

25

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

- reviewed literature. Therefore, dyes listed as available soley by common name may not be the same chemical subject to the SNUR. Despite the E.U. ban, products are occasionally found in articles meant for import (European

25 See Restriction 43 in REACH Annex XVII.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 14 Economic and Policy Analysis Branch Commission, 2010) and certain azo dyes in articles may remain an ongoing issue

. However, t here is not sufficient information to conclude that articles containing the specific dyes specified at 40 CFR section 721.1660 are currently imported into the US.

Canada has also expressed concern about the potential release of benzidine or its congeners from azo dyes and is evaluating potential approaches for addressing azo dyes (Environment Canada 2009). In addition, the American Apparel and Footwear Association (AAFA), the national trade association representing apparel, footwear and other sewn products companies and their suppliers, which compete in the global market, includes benzidine on its Restricted Substances List (AAFA 2010

. Clearly, benzidine

- based dyes are a c oncern internationally to governments and industry. M any of the dyes , including those listed in Table 1, have been phased out of production. Given the international concern for these chemicals

, market ree mergence o f those not current ly manufactured or impo rted is not expected. While research identified global and domestic manufacturers of several of the dyes specified at 40 CFR section 721.1660 there is no evidence to suggest that these dyes are being used in non

- exempt uses or are being imported and/or pr ocessed domestically as part of articles (see section 1.1 )

. Therefore

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

.

2.5 Potential for Subs equent Regulatory Action
EPA recognizes that if submission of a SNUN does result from the proposed SNUR, the Agency may take a dditional regulatory actions under TSCA. These additional regulatory actions might be necessary to further evaluate an intended ne w use and associated activities, or to prohibit or limit that activity before it occurs to prevent unreasonable risk of injury to human health or the environment. It is not known what specific subsequent regulatory actions, if any, the Agency may determine are necessary after reviewing a SNUN. Any such actions are highly dependent on the circumstances surrounding the individual SNU N (e.g., available information and scientific understanding of the chemical and its risks at the time the SNUN is being reviewed ).
Should EPA’s review of the SNUN result in further regulatory actions, the Agency will initiate and follow the appropriate procedures for taking those actions

. Included in those procedures would be an assessment of the costs and benefits of those action s.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 15 Economic and Policy Analysis Branch 

### 3. AGENCY COSTS

As described in the following sections, EPA’s costs to review and process SNUN submissions are assumed to be the same as EPA costs to review PMNs.

3.1 Labor Rates for EPA Staff

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

- Baltimore area published by the Office of Personnel Management effective January 200 9 (OPM 200 9 ) . EPA assumes that, on average, a federal GS

- 13, Step 5 full

- time equivalent (FTE) will conduct its collection and administrative activities under the proposed rule. 26

Table 10 The average salary for a GS

- 13 Step 5 employee was $ 98,518 in 2009 without fringe benefits and overhead costs

. In order to derive the fully loaded salary, EPA multiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and overhead, which results in a fully loaded annual salary of $157,629 (see ). Divi ding the fully load ed annual salary by 2,080 hours (i.e., the number of hours in a work year) yields an hourly FTE compensation wage rate of $ 75.78.
The Agency loading factor of 1.6 is from an EPA guide entitled Instructions for Preparing Information Collection Requests (ICR s) ( EPA 1992 ). 27

The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits multiplication factor)

. The multiplication fa ctor used is recommended in EPA’ s Office of Policy, Planning, and Evaluation’s Instructions for Preparing Information Collection Requests (ICRs) (June 1, 1992)

. An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits but also overhead

. The 60 percent assumption was labeled “the benefits multiplication factor” in the EPA guide, but has been used in many EPA OPPT ICRs to reflect both fringe benefits and overhead for federal staff. For example, it was used in a document supp orting EPA ICR No. 1139.06 ( EPA 2000 ), with the following explanation:

Fully loaded costs for Agency labor are shown in Table 10

.

26 The GS

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

- 12 Step 1 and GS

- 12 Step 10 salaries.
27 page 30, footnote 9.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 16 Economic and Policy Analysis Branch Table 10 : Derivation of Loaded Agency Wage Rates

Labor Category Data Source for Wage Information Date Wage Fringe Benefit Fringes as % wage Overhead as % wage Fringe + overhead

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

EPA staff FTE Annual federal staff cost: OPM Washington

Baltimore

- Northern Virginia, DC

- MD

- PA

VA

- WV, area, GS

- 13 Step 1 pay rates a Dec

09 $98,518 (annual)

-- [Included in 60% overhead] 60% b 1.60 $157,629 (annual)

$47.36 (hourly) $75.78 (hourly)

Notes :

a The Agency salary is the unloaded federal GS

- 13 Step 5 salary ($98,518 for 2009), from the OPM salary table for the Washington

- Baltimore

- Northern Virginia Locality Pay Area ( OPM 2009 )

. Hourly rates are based on annual salary divided by 2,080 hours.
b The 60% fringes

- and

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

3.2 SNUN Processing Costs
The list of review steps, estimates of extramural costs, and the percent of c hemicals requiring a particular review step are derived from the costs for processing PMN submissions in a1994 EPA report entitled, Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications ( EPA 1994 ). 28 The Age ncy burden associated with processing a PMN has been adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices . Electronic submission of SN UN forms is expected reduce Agency burden by 16.5 percent ( EPA, 2009a )

. 29

For each review step, the “EPA staff” cost is calculated by multiplying the number of FTEs (in the first column) by the fully loaded hourly salary. This shows EPA staff cost for chemi cals requiring the selected review step.
The Extramural Cost column shows costs for contractor support and other outside purchases for chemicals requiring the selected review step is inflated from 1993 prices using the Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) data (BLS 2010b). T he not seasonally adjusted E CI for total compensation of private industry professional and related workers (Series ID CIU2010000120000I ) is used because it is the only series with continuous data since 1985 , a nd that includes professional and technical labor, which perform the majority of Agency extramural activities. Table 11 , below contains the derivation of inflation factors for Agency extramural costs.

28 Table VII

- 1.
29 p. 28.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 17 Economic and Policy Analysis Branch Table 11 : Derivation of Inflation Factors for Agency Extramural Costs

Item Inflation index source Starting
year Index for starting

year

(a) Index for 2009

(b) Inflation factor (b)/(a) 2

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

, 4 th Q [BLS 2010d] 4 1993 67.0 111.4 1.663

Source: Bureau of Labor Statistics

. Employment Cost Index

– Total Compensation: Professional and Related Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I) , extracted April 12, 2010 (BLS 2010b).

The Percent of Cases column in Table 12 is a weighting factor applied to reflect the fact that not all chemicals require each review step. For example, in the PMN process, all chemicals require Administrative Prescreening, but not all chemicals 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 would be submitted

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

- 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 1 6.5 percent to account for burden savings generated electronic submission. A s shown in Table 12

, t h is calculation yields total Agency costs of $4,934, per SNUN, for submission review and processing

.Economic Analysis of SNUR for 18 U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes Economic and Policy Analysis Branch Table 12 : Agency Costs for SNUN and Other Submission Review and Processing

Review Steps EPA staff (FTE) Cost Extramural Cost 2 Unweighted Cost Pct. of Cases Weighted Cost 3 ePMN Burden Reduction 4 Weighted Cost with ePMN Burden Reduction FTE fraction Cost per FTE 1 FTE Total ($2009) 1993 dollars 2009 dollars (a) (b) (c)=(a)*(b) (d) (e) (f)=(c)+(e) (g) (h)=(f)*(g) (i) (j)=(h)*(1

- (i)) Pre

- notice consultation 0.0024 $157,629 $378 $4.00 $6.65 $385 41% $158 0.165 $132 Administrative prescreen/ notice receipt/user fee 0.0024 $157,629 $378 $92.00 $152.97 $531 100% $531 0.165 $444
CRSS (Chemical Review and Search Strategy) 0.0025 $157,629 $394 $268.00 $445.60 $840 100% $840 0.165 $701
SAT (Structure Activity Team) 0.0006 $157,629 $94.58 $14.00 $23.28 $118 100% $118 0.165 $98.41
Engineering/Exposure 0.0015 $157,629 $236 $56.00 $93.11 $330 100% $330 0.165 $275 Exposure/Fate 0.0008 $157,629 $126 $0.00 $0.00 $126 100% $126 0.165 $105
Focus 0.0009 $157,629 $142 $23.00 $38.24 $180 100% $180 0.165 $150 Standard Review Functions 0.0219 $157,629 $3,452 $511.00 $849.63 $4,302 29% $1,247 0.165 $1,042 Division Directors Meeting 0.0129 $157,629 $2,033 $113.00 $187.88 $2,221 15% $333 0.165 $278 Order Development/Negotiation Review 0.0171 $157,629 $2,695 $22.00 $36.58 $2,732 3% $81.96 0.165 $68.44

Post Order Data Review 0.0886 $157,629 $13,966 $0.00 $0.00 $13,966 3% $419 0.165 $350
Order Modification 0.2167 $157,629 $34,158 $0.00 $0.00 $34,158 3% $1,025 0.165 $856
New Chemical SNUR Development 0.0277 $157,629 $4,366 $85.00 $141.33 $4,508 7% $316 0.165 $263

Notices of Commencement 0.0012 $157,629 $189 $40.00 $66.51 $256 31% $79 0.165 $66.18 FOIA (Freedom of Information Act) Requests 0.0333 $157,629 $5,249 $287.00 $477.19 $5,726 1% $57 0.165 $47.81
CBI (Confidential Business Information) Substantiation 0.0004 $157,629 $63.05 $3.00 $4.99 $68.04 100% $68.04 0.165 $56.81

TOTAL $5,909 0.165 $4,934
Notes:
1 GS

- 13 Step 5 salaries loaded with benefits and overhead. See Table 10 for derivation.
2 Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993 prices using the factors presented in Table 11

. 3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values 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). Sources: FTEs per review step, 1993 extramural costs, and percents of cases are from EPA, 1994 Table VII

- 1, GS

- 13 salaries are from OPM 2009.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 19 Economic and Policy Analysis Branch 3.3 Export Notification Cost The Agency burden and cost due to TSCA §12(b) export notification result s from three tasks. In the first task, EPA receives export notificat ions from companies that inten d to export one of the chemicals subject to TSCA §12(b) ( EPA 2009b ). In the second task, EPA staff prepares separate notification letters that are subsequently reviewed and delivered to importing countries, their embassies, or representatives, and to the importing country’s US embassies ( EPA 2009b ). 30

Because domestic manufacture, import and processing of the dyes specified in The third task is comprised of EPA staff responses to public inquiries and other TSCA 12(b) activities. The work of responding to non

- routine requests for information and clarifica tion from industry and importing countries, and of handling other tasks associated with the TSCA §12(b) program, was esti mated to require roughly 400 hours per year ( EPA 2009b ).

Table 1 and the articles containing them have been phased out, and there is no evidence to suggest that the currently manufactured dyes specified at 40 CFR section 721.1660 are being imported and/or processed as part of articles, EPA does not expect to receive or send any export notifications. Nevertheless, should there be any notifications as a result of the current rulemaking, the cost s to the Agency are presented per activity. The burden for the first two Agency activities is provided in Table 13 below. To estimate the Agency cost, hourly burdens are multiplied by the loaded wage rate of a GS

- 13, Step 5 (see Table 10 )

.

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

Agency Activity Hours per Activity FTE per Activity 1 Loaded Mailing Cost Total Agency Cost per Activity GS

- 13, Step 5 FTE Wage Rate (a) (b) = (a)/2,080 (c) (d) (e) = ((b)*(c))+(d) Process an incoming notification from an exporting compan y 0.1 0 0.000048 $157,629 $0.00 $7.58

P repare and mail a notification to an importing countr y 0.5 0 0.000240 $157,629 $13.34 $ 51.23

Notes : 1 The burden associated with an Agency activity is the burden for the Agency to process one incoming notification, or to prepar e and mail an outgoing notification Source: Table 10 of this report derives Agency labor costs. Mailing costs are from Table 7 of this report

. Other burdens a re from EPA 2009 b , updated for inflation.

30 See Table 7 for the cost of mailing one notification

.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 20 Economic and Policy Analysis Branch 

### 4. ADDITIONAL ANALYSES

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

4.1 Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et. seq.), as amended by the Small Business Regulatory Enforcement Fairness Act, requires regulators to consider the impact of regulations on small entities, in particular small businesses

. EPA ’ s experienc e to date is that, in response to the promulgation of SNUR s covering over 1,000 chemicals, the Agency receives only a handful of notices per year

. For

ex ample, the number of SNUNs was four in Federal fiscal yea r 2005, eight in FY2006, six in FY2007, eight in FY2008, and seven in FY2009. 31 During this five

- year period, three small e ntities submitted a SNUN

- t he criteria for ‘ small business ’ was that the company checked the box on the PMN form, page 2, statin g that it was a small business for the purpose of paying the $100 fee instead of the normal fee

. 32

, 33

4.2 Unfunded Mandates Reform Act

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not expect that any State, local, or Tribal government would be impacted by this rulemaking.

4.3 Paperwork Reduction Act

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OM B and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR, part 9, and included on the related collection instrument, or form, if applicable. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070

- 0038 (EPA ICR No. 1188).

If an entity were to submit a SNUN to the Agency, the annual burden i s estimated to averag e 97 hours per response

– 0.82 hours for rule familiarization (Section 2.2.1 ), 2.80 hours for CDX registration, CDX electronic signature, and pay.gov account setup (Section 2.2.2 ), 91.68 hours for form completion and submission ( Section 2.2.3 ), and 1.36 hours for export notification ( Section 2.2.5 )

,

31 February 5, 2009 email from Carol Rawie, EPA Office of Pollution Prevention and Toxics, to Tulika Narayan and Kimberly Wilson, Abt Associates. The counts include both “valid” and “invalid” SNUNs. SNUN numbering is according to Federal fiscal year, ending September 30.
32 February 5, 2009 email from Carol Rawie, EPA Office of Pollution Prevention and Toxics to Tulika Narayan and Kimberly Wilson, Abt Associates.
33 In order to submit SNUN as a “small business” a company needs to be classified as small using the TSCA based definition of annual revenue of less than $4,000,000 per year. This definition is not consistent with the definition of a small business using Small Business Administration (SBA) NAICs based definitions.Economic Analysis of SNUR for U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes 21 Economic and Policy Analysis Branch 4.4 National Technology Transfer and Advancement Act

The proposed SNUR does not involve any technical standards; therefore

, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104

– 113, section 12(d) (15 U.S.C. 272 note), does not apply.

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

- Income Populations

The proposed SNUR does not involve special consid er ations of environmental justice

- related issues as required by Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low

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

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

Th e proposed SNUR does not address environmental health or safety risks dispropo rtionately affecting children.

4.7 Executive Order 13132: Federalism

Th e proposed SNUR is not expected to have a su bstantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government as specified in Executive Order 13132, entitled Federalism (6 4 FR 43255, August 10, 1999).

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

This proposed SNUR would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly or uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requireme nts that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), do not apply

.

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

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

### 5. BE NEFITS

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 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 A gency deems harmful to the environment or human health. The proposed SNUR allows EPA to evaluate the use of, or exposure to these chemicals and allow the Agency to take preventive action to limit or prohibit any Significant New Use. EPA also expects the
pr oposed rule may restrict future uses or exposure to the chemicals, as a company may choose modify planned uses, and worker exposures the chemical is such a way that does not trigger a SNUR, as opposed to submitting a SNUN. Therefore, the proposed SNUR may limit future exposure to the chemicals

. Quantification of the benefits of the proposed rule would require more specific information about each user’s use patterns and preferences as well as the changes in these patterns and preferences that would result f rom the additional information made available under the proposed r ule. These data are not readily available and collecting such data would be cost

- prohibitive.Economic Analysis of SNUR for 23 U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes Economic and Policy Analysis Branch 

### 6. REFERENCES

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

– 113, Section 12(d).

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

, Part 12, Title 19, August 1, 1983

.
40 CFR 707, Chemical Imports and Exports , Code of Federal Regulations

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

40 CFR 720

, Premanufacture Notification , Code of Federal Regulations

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

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

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

59 FR 7629, Fede ral Actions to Address Environmental Justice in Minority Populations and Low

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

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

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

, Volume 62, April 23, 1997.

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

66 FR 28355, Actions Concerning R egulations that Significantly Affect Energy Supply, Distribution, or Use , Federal Register, Volume 66, May 22, 2001.

71 FR 66234

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

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

- HQ

- OPPT

- 2005

- 0058 at http://www.regulations.gov

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

Am erican 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, Nov ember 2010).

BLS, 2010a. U.S. Bureau of Labor Statistics. “Employer Costs for Employee Compensation Supplementary Tables December 2009

. ” (March 10 , 2010) at http://www.b ls.gov/ncs/ect/sp/ecsuptc13.pdf . (Note: The BLS report title and content is updated periodically to include more recent data, on the same website.)

BLS, 2010 b . Bureau of Labor Statistics. Employment Cost Index

– Total Compensation: Professional and R elated Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I )

, extracted April 12, 2010.Economic Analysis of SNUR for 24 U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes Economic and Policy Analysis Branch CMA, 1991. Chemical Manufacturers Association. Responses to Questions on Burden Associated with PMN Submissions

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

Dapson, R.W. 2009. Benzidine

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

- 100.

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

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

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

- 560/11

- 80

- 019, June 1980.

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

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

EPA, 1994. U

. S

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

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

EPA, 200 0

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

EPA, 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 Pr evention and Toxics, Economic and Policy Analysis Branch. Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Washington, DC , June 10, 2002

.
EPA, 2003

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

. Washington, DC, 2003. Available in docket EPA

- HQ

- OPPTS

- 2002

- 0078 at

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

- 03/003F, March 2005. http://www.regulations.gov

.

EPA, 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) Expo rt NotificationEconomic Analysis of SNUR for 25 U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes Economic and Policy Analysis Branch Requirements, November 2005, available from the Federal Docket Management System as EPA

HQ

- OPPT

- 2005

- 005 8

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

EPA, 2006a. Inventory Update Reporting (IUR): Non

- Confidential 2006 TSCA Inve ntory Update Rule (I UR) Records. Available at: http://cfpub.epa.gov/iursearch/index.cfm?s=chem

. As cited in the Benzidine Dyes Action Plan (EPA, 2009c).

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

- 2006

- 0898 ), August 17, 2007

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

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

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

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

. (EPA

- HQ

- OPPT

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- 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/existingchemi cals/pubs/actionplans/benzidine.html

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

European Commission. 20 10. RAPEX

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

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

- 210.

OPM , 2009 . Office of Personnel Management, Salary Table 2009

- DCB, Wa shington

- Baltimore / Northern Virginia, DC

- MD

- PA

- VA

- WV

. Accessed from http://www.opm.gov/oca/ 09tables/pdf/DCB.pdf

Rawie, Carol

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

- mail

. February 5 , 2009.

Simpsons UK LTD. 2010. "Product Catalogue." Accessed November 18, 2010. Available at: http://www.dyemakers.com/Economic Analysis of SNUR for 26 U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes Economic and Policy Analysis Branch Standard Dyes, Inc. 2010. "Product Catalogue." Acc essed November 18, 2010. Available at: http://www.standarddyes.com/

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

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

USPS, 2010

. U.S. Postal Service Mailing and postage rates. <http://www.usps.com /prices >. Accessed 16 August 20 10

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

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

- chemical.com/

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

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

.Economic Analysis of SNUR for 27 U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes Economic and Policy Analysis Branch



### 7. APPENDIX A

– BENZIDINE

- BASED DYES SPECIFIED AT 40 CFR SECTION 72 1.1660

Table 14 provides a list of the benzidine

- based dyes specified at 40 CFR section 721.1660

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

Table 14 : Benzidine

- Based Dyes Specified at 40 CFR Section 721.1660

CAS No. Chemical Name 1 Current Manufacture? 92

- 87

- 5 [1,1 ′

- Biphenyl]

- 4,4 ′

- diamine [ CI Azoic Diazo Component 112 ] N 531

- 85

- 1 [1,1 ′

- Biphenyl]

- 4,4 ′

- diamine, dihydrochloride N

573

- 58

- 0 1

- Naphthalenesulfonic acid, 3,3 ′

- [[1,1 ′

- biphenyl]

- 4,4 ′

- diylbis(azo)]bis[4

- amino

- , disodium salt [ CI Direct Red 28 ] Domestic

1937

- 37

- 7 2,7

- Naphthalenedisulfonic acid, 4

- amino

- 3

- [[4 ′

- [(2, 4

- diaminophenyl)azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 5

- hydroxy

- 6

- (phenylazo)

- , disodium salt [ CI Direct Black 38 ] Domestic

2302

- 97

- 8 1

- Naphthalenesulfonic acid, 8,8 ′

- [[1,1 ′

- biphenyl]

- 4,4 ′

- diylbis(azo)]bis[7

- hydroxy

- , disodium salt [ CI Direct Red 44 ] N

2429

- 73

- 4 2,7

- Naphthalenedisulfonic acid, 5

- amino

- 3

- [[4 ′

- [(7

- amino

- 1

- hydroxy

- 3

- sulfo

- 2

- naphthalenyl)azo][ 1,1 ′

- biphenyl]

- 4

- yl]azo]

- 4

- hydroxy

- , trisodium salt [ CI Direct Blue 2 ] Domestic

2429

- 79

- 0 Benzoic acid, 5

- [[4 ′

- [(1

- amino

- 4

- sulfo

- 2

- naphthalenyl)azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 2

- hydroxy

- , disodium salt [ CI Direct Orange 8 ] Domestic

2429

- 81

- 4 Benzoic acid, 5

- [[4 ′

- [[2,6

- diamino

- 3

- [[8

- hydroxy

- 3,6

- disulfo

- 7

- [(4

- sulfo

- 1

- naphthalenyl)azo]

- 2

- 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

- sulfophe nyl)azo]phenyl]azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 2

- hydroxy

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

2602

- 46

- 2 2,7

- Naphthalenedisulfonic acid, 3,3 ′

- [[1,1 ′

- biphenyl]

- 4,4 ′

- diylbis(azo)]bis[5

- amino

4

- hydroxy

- , tetrasodium salt [ CI Direct Blue 6 ] Domestic

2893

- 80

- 3 Benzoic acid, 5

- [[4 ′

- [[2,4

- dihydroxy

- 3

- [(4

- sulfophenyl)azo]phenyl]azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 2

- hydroxy

- , disodium salt [ CI Direct Brown 6 ] N

3530

- 19

- 6 1,3

- Naphthalenedisulfonic acid, 8

- [[4 ′

- [(4

- ethoxyphenyl)azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 7

- hydroxy

- , disodium salt [ CI Direct Red 37 ] Global

3567

- 65

- 5 1,3

- Naphthalenedisulfonic acid, 7

- hydroxy

- 8

- [[4 ′

- [[4

- [[(4

- methylphenyl)sulfonyl]oxy]phenyl]azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- , disodium salt [ 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 ] N

4335

- 09

- 5 2,7

- Naphthalenedisulfonic acid, 4

- amino

- 5

- hydroxy

- 6

- [[4 ′

- [(4

- hydroxyphenyl)azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 3

- [(4

- nitrophenyl)azo]

- , disodium salt [ CI Direct Green 6 ] DomesticEconomic Analysis of SNUR for 28 U.S. EPA Office of Pollution Prevention and Toxics Nine Benzidine Based Dyes Economic and Policy Analysis Branch

6358

- 80

- 1 2,7

- Naphthalenedisulfonic acid, 4

- amino

- 5

- hydroxy

- 3

- [[4 ′

- [[4

- hydroxy

- 2

- [(2

- methylphenyl)amino]phenyl]azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 6

- [(4

- sulfophenyl)azo]

- , trisodium salt [ CI Acid Black 94 ] N

6360

- 29

- 8 Benzoic acid, 5

- [[4 ′

- [[4

- [(4

- amino

- 7

- sulfo

- 1

- naphthalenyl)azo]

- 6

- sulfo

- 1

- naphthalenyl]azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 2

- hydroxy

- , trisodium salt [ CI Direct Brown 27 ] N

6360

- 54

- 9 Benzoic acid, 5

- [[4 ′

- [[2,6

- diamino

- 3

- methyl

- 5

- [(4

- sulfophenyl)azo]phenyl]azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 2

- hydroxy

- 3

- methyl

- , disodium salt [ CI Direct Brown 154 ] Domestic

8014

- 91

- 3 Benzoic acid, 3,3 ′

- [(3,7

- disulfo

- 1,5

- naphthalenediyl)bis[azo(6

- hydroxy

- 3,1

- phenylene)azo[6(or7)

- sulfo

- 4,1

- naphthalenediyl]azo[1,1 ′

- biphenyl]

- 4,4 ′

- diylazo]]bis[6

- hydroxy

- , hexasodium salt [ CI Direct Brown 74 ] N

16071

- 86

- 6 Cuprate(2

- ), [5

- [[4 ′

- [[2,6

- dihydroxy

- 3

- [(2

- hydroxy

- 5

- sulfophenyl)azo]phenyl]azo][1,1 ′

- biphenyl]

- 4

- yl]azo]

- 2

- hydroxybenzoato(4

- )]

- , disodium [ CI Direct Brown 95] Domestic

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

- reviewed literature.