# Economic Analysis of Expedited Significant New Use Rules for 15 Chemical Substances
(EPA DOCKET EP A-HQ-OPPT-2008-0918 )



## August 26, 2009

—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 Expedited SNURs, Docket OPPT-2008-0918 i August 26, 2009 CONTRIBUTORS

The EPA analyst responsible for this report was Carol Rawie. An alytical and draft preparation support was provided by Abt Associates In c. under EPA Contract No. EP-W08-010.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 ii August 26, 2009 ABSTRACT

This Economic Analysis estimates the poten tial costs of Significant New Use Rules (SNURs) covering 15 chemicals that have been the subject of TSCA premanufacture notices (PMNs). The SNURs are being published unde r the rulemaking docket number EPA-HQOPPT-2008-0918 as direct final rules. The SNURs define “Significant New Uses” that trigger EPA notice requirements. To submit a Si gnificant New Use Notice or request a SNUR modification, a firm incurs a modest submission cost, plus costs of any additional data generated to support the submission. By avoiding a Signifi cant New Use, a firm can avoid submission costs, but may incur other compliance costs. Fo r example, it may incu r costs of restricting chemical releases to water or preventing worker exposure.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 iii August 26, 2009 TABLE OF CONTENTS

CONTRIBUTORS................................................................................................................... ........ i ABSTRACT....................................................................................................................... ............. ii TABLE OF CONTENTS.............................................................................................................. .iii LIST OF TABLES................................................................................................................. ........ iv 1.0 INTRODUCTION .............................................................................................................. 1 2.0 COSTS OF A SIGNIFICANT NEW USE RULE (SNUR), BY OPTION ........................ 4 2.1 Comply with SNUR Limits (Option 1)........................................................................... 4 2.2 Request Modification or Revoca tion of a SNUR (Option 2)........................................ 12 2.3 Submit SNUN (Option 3) ............................................................................................. 15 2.4 Request Equivalency Determination (Option 4)........................................................... 17 2.5 Decide Not to Produce Chemical (Option 5)................................................................ 17 2.6 Summary of Costs for Each Option.............................................................................. 18 3.0 EXPORT NOTIFICATION COSTS ................................................................................ 19 4.0 AGENCY COSTS ............................................................................................................ 21 5.0 ADDITIONAL ANALYSES............................................................................................ 22 5.1 Regulatory Flexibility Act (RFA)................................................................................. 22 5.2 Unfunded Mandates Reform Act (UMRA) .................................................................. 23 5.3 Paperwork Reduction Act (PRA).................................................................................. 23 5.4 Executive Order 12866, Regulator y Planning and Review .......................................... 23 5.5 Executive Order 13132, Federalism ............................................................................. 23 5.6 Executive Order 12898, Environmental Justice............................................................ 24 5.7 Executive Order 13045, Protection of Children ........................................................... 24 5.8 Executive Order 13175, Tribal Governments............................................................... 24 5.9 Executive Order 13211, Energy Supply, Distribution, or Use ..................................... 24 APPENDIX A LIST OF PMNs AND THEIR CHEMICAL NAMES ................................... A-1 APPENDIX B INFLATORS AND WAGE RATES .............................................................. B-1 B.1 Derivation of Loaded Wage Rates.............................................................................. B-1 B.2. Derivation of Inflation Factors.................................................................................... B-5 APPENDIX C COSTS OF HAZARD COMMUNICATION, PROTECTION IN THE WORKPLACE, AND RECORDKE EPING REQUIREMENTS............................................... C-1 C.1 Modifying the Hazard Communication Program ....................................................... C-1 C.2 Protection in the Workplace........................................................................................ C-6 C.3 Recordkeeping .......................................................................................................... C-19 APPENDIX D COSTS OF TESTING .................................................................................... D-1 D.1 Testing Guidelines ...................................................................................................... D-1 D.2 Test Costs by Guideline.............................................................................................. D-7 D.3 Testing Costs by Chemical ....................................................................................... D-11 APPENDIX E COSTS FOR SNUN, MODIFICATION/REVOCATION, OR EQUIVALENCY DETE RMINATION.......................................................................................E-1 APPENDIX F AGENCY COSTS ...........................................................................................F-1 APPENDIX G REFERENCES ............................................................................................... G-1Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 iv August 26, 2009 LIST OF TABLES

Table 1 Compliance Options and Associated Costs Incurred by a Firm due to SNUR.................. 3 Table 2 Production and Use Re strictions/Requirements ................................................................ 6 Table 3 Annual Costs of Hazard Communication Requirements................................................... 7 Table 4 Annual Costs of Wor kplace Protection Requirement........................................................ 9 Table 5 Sample Costs of Workplace Protection ........................................................................... 10 Table 6 Annual Costs of Recordkeeping Requirements (40 CFR §721.125)............................... 12 Table 7 Sample Costs of Recommended Testing ......................................................................... 13 Table 8 Costs of Requirement to Modify/Revoke SNUR or Submit SNUN................................ 14 Table 9 Derivation of Total Mailing Cost for 24 Notices............................................................ 20 Table 10 TSCA 12(b) Export Notification Cos t: Annual Burden per Respondent Facility ......... 21 Table A-1 PMNs and Chemical Names Refe renced in this Economic Analysis ....................... A-1 Table B-1 Derivation of Loaded Wage Rates............................................................................. B-4 Table B-2 Derivation of I ndustrial Hygienist Wage Rate (NAICS 31, 32, 33).......................... B-5 Table B-3 Derivation of Inflation Factors .................................................................................. B-7 Table C-1 Annual Costs of Labeling for Dist ribution in Commerce [40 CFR §721.72(b)(2)].. C-3 Table C-2 Annual Costs of Labeling for Us e in Workplace [40 CFR §721.72(b)(1)] ............... C-4 Table C-3 Annual Costs for Material Safety Data Sheets (MSDSs) [40 CFR §721.72(c)]........ C-5 Table C-4 Annual Costs for Employee Trai ning, Per Chemical [40 CFR §721.72(d)].............. C-5 Table C-5 Annual Costs for Dermal Protec tion Selection [40 CFR §721.63(a)(1)] .................. C-6 Table C-6 Annual Costs of Impermeabil ity Testing [40 CFR §721.63(a)(3)] ........................... C-8 Table C-7 Annual Cost of Glove s [40 CFR §721.63(a)(2)(i)].................................................... C-9 Table C-8 Annual Cost of Protective Ey ewear [40 CFR §721.63(a)(2)(iii)] ............................. C-9 Table C-9 Annual Cost of Protectiv e Clothing [40 CFR §721.63(a)(2)] ................................. C-10 Table C-10 Crosswalk Between S NUR Text and Respirator Type s at 40 CFR §721.63(a)(5) C-12 Table C-11 Annual Per-Chemical Costs for Re spiratory Protection [40 CFR §721.63(a)(4)]. C-14 Table C-12 Respirator Pr ices and Average Costs in 1997, by NIOSH Type ........................... C-16 Table C-13 Recordkeeping Estimates from Kearney 1988a and 1988b................................... C-21 Table C-14 Annual Per-Chemical Costs of R ecordkeeping Requirement [40 CFR 721.125] . C-23 Table D-1 Cost Estimates for Test Guidelines Cited in SNURs ................................................ D-3 Table D-2 Default Parameters for Species, Route, and Study Type.......................................... D-8 Table D-3 Persistent Bioaccumulative Toxic (PBT) Tiered Testing Requirements................. D-10 Table E-1 Burden for SNUN, Request to Modify SNUR, or Equivalency Determination .........E-1 Table F-1 Agency Costs for SNUN and Othe r Submission Review and Processing ..................F-3Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 1 August 26, 2009 1.0 INTRODUCTION

This report presents the U.S. Environmen tal Protection Agency (EPA), Office of Pollution Prevention and Toxics’ (OPPT ’s) analysis of the potential costs incurred as a result of direct final Significant New Use Rules (SNURs) being promulgated for 15 chemical substances which have gone through prema nufacture notice (PMN) review. 1 The SNURs are being published under the rulemaking docket number OPPT-2008-0918. Appendix A lists the generic or specific chemical name and CAS numb er (if non-confidential) for each PMN.

EPA may promulgate a SNUR for a substance wh en 1) the substance is the subject of a section 5(e) Consent Order (40 CFR §721.160) or 2) the Agency determines that activities other than those described in the PMN may result in significant changes in human exposure or environmental release levels and/or that conc ern exists about the s ubstance’s health or environmental effects (40 CFR §721.170). In co ntrast to PMN requirements, which apply mainly to manufacturers and importers (T SCA § 5(a)(1)(A), 40 CFR §720.22), the SNUR applies to processors as well as to manufactur ers and importers (TSCA § 5(a)(1)(B), 40 CFR §721.5).

Each substance analyzed here was the subj ect of at least one premanufacture notice submitted under the Toxic Substances Control Act (TSCA), and is now being regulated as a result of PMN review. For the current rulemaking, 14 of the 15 chemicals have commenced commercial manufacture or import and so are listed on the TSCA Inventory; they are no longer "new" chemicals. For chemicals in this type of rulemaking, SNUR requirements are sometimes based on past Consent Orders entered into w ith a PMN or SNUN submitter under TSCA Section 5(e). For the current rulemaki ng, SNUR requirements for 3 of the 15 substances are based on prior Consent Orders.

EPA promulgates a signi ficant new use rule (SNUR) to designate specific activities involving the chemical substance that EPA has determined constitute a "significant new use." No person may manufacture or process a chemical su bstance for a significant new use, unless they submit a significant new use notice (SNUN) to EPA at least 90 days in advance. Examples of typical "significant new uses" that can trigger the requirement to submit a SNUN (if EPA has promulgated a SNUR applying these require ments to a specific chemical) include:

• Domestic manufacture in the United States

• Manufacture of a particular aggregate or annual volume

• Use other than that specified in the PMN

1 This report covers chemicals that went through PMN review and are part of an expedited rulemaking. The relevant Office of Management and Budget Information Collection Request number is ICR No. 0574 (OMB Control Number 2070-0012). EPA also promulgates SNURs through conventional rulemaking that are covered by ICR No. 1188 (OMB Control Number 2070-0038).Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 2 August 26, 2009 • Releases to water resulting in a surface water concentration exceeding a specified

amount

• Handling the chemical without employing specified personal protective equipment (e.g., gloves, goggles, respirators) or h azard communication measures (e.g., label, MSDS, worker training)

If EPA does not promulgate a SNUR for a given chemical, then these requirements would not apply (unless they apply to a PMN submitter via a §5(e) Consent Order). If EPA has promulgated a SNUR containing these types of significant new use designations, as long as the person does not engage (nor intend to engage) in any activities defined by the SNUR as a significant new use, then that person may proceed to handle the chemical without submitting a SNUN.

The options available to a firm considering the manufacture, impo rt, and/or processing of a chemical covered under a SNUR, and the types of associated costs to the firm, are summarized in Table 1.

Table 1 and later tables list various costs. However, often such costs may be incurred for reasons other than the SNUR. The co sts of avoiding a Significant New Use are attributable to the SNUR only if, in the absence of the SNUR, the firm would have adopted a different approach. For example, a SNUR may define any use other than that described in the PMN as a Significant New Use. If the PMN submitter would have conformed to the uses described in the PMN even without the SNUR, then any associated costs of adhering to the PMN uses would not be due to the SNUR. Costs to a PMN submitter of practices required by a TSCA Section 5(e) Consent Order would be attributable to the Consent Order, not the S NUR. If a processor would have workers wear gloves even without SNUR requirements, then the gloves costs would not be attributable to the SNUR. The costs in Ta ble 1 are attributable to the SNUR only if the firm adopts a different approach due to th e Significant New Use Rule.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 3 August 26, 2009 Table 1 Compliance Options and Associated Costs Incurred by a Firm due to SNUR

Option 1 Costs Quantified Costs per Chemical ($2008) 2

1 Manufacture, import, or process in a way that avoids a Significant New Use, such as limiting water releases, engaging in PMN uses only, importing only, limiting volumes, providing workplace protection, or providing hazard communications. All SNUR chemicals require ongoing recordkeeping. In addition, many SNUR chemicals may involve costs of complying with water release restrictions and foregoing non-PMN uses; these costs were not quantified for this report. Costs for worker protection and hazard communication apply to relatively few chemicals, but are quantified. Typically, annual costs for recordkeeping are under $1,133. For the few SNUR chemicals where these apply, annual costs for worker protection may be $35,760 or more and for haz-comm are $1,020.

2 Submit a request for modification or revocation of the SNUR (§721.185). Costs of submitting a request for modification or revocation, including costs of developing supporting data (e.g., testing, if needed). $5,955 submission cost plus any testing costs. 3 EPA receives very few such requests, typically 0-3 per

year. 3 Submit 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 submitting a SNUN (including SNUN recordkeeping and user fee 4 ) plus ongoing recordkeeping. Rarely, a firm may choose to conduct toxicity or fate testing to support the SNUN, but such testing is not required by law. $8,455 submission cost (including SNUN recordkeeping and $2,500 fee) 4,5 plus ongoing recordkeeping costs of under $1,133. EPA usually
receives well under ten SNUNs in a 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). 4 Petition EPA for an equivalency determination to consider alternative controls to prevent release or exposure that are equivalent to those identified in the SNUR (§721.30). Costs of submitting a request for equivalency determination. $5,955 one-time submission cost.

5 Do not manufacture, import, or process the subs tance except for R&D (the R&D exemption is covered in 40 CFR §721.47). Cost of profits foregone due to delaying or avoiding commercial activity that would otherwise be pursued. R&D recordkeeping costs if manufacture for R&D. Costs not quantified.

Notes: Section numbers refer to 40 CFR §721 (in the Code of Federal Regulations). Costs come from Table 3 through Table 8.

1 Firms may follow multiple Options simultaneously

2 Quantified costs are attributable to the SNUR Significan t New Use definition only if a firm would not otherwise follow the specified practices. $35,760 is the annual cost for dermal protection selection; impermeability testing, heavy-duty gloves, and a lower-cost respirator (see Tabl e 5). Some firms may have export notification costs (see Section 3 of this report).

3 See Appendix D for costs of individual test s recommended in current and recent SNURs.

4 EPA charges a nominal flat fee of $2,500 for a PMN or SNUN submission.

5 SNUR chemicals not on the TSCA Inventory are “new” ch emicals requiring a PMN, so some firms may need to make a submission before commercial production or import, even in the absence of a SNUR (see Section 2.3 of this report).Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 4 August 26, 2009 In previous economic analyses of SNUR s, EPA identified those requirements under Subparts A, B, C, and D of 40 CFR §721 that may indirectly impose costs on manufacturers, importers, and processors of PMN substances (e .g., RIB, 1989). Some of these costs, such as providing personal protective equipment unde r §721.63, were estimated in earlier SNUR economic analyses and are presented as part of this analysis. Resources were not available to quantify other costs, such as for limiting releases to water, avoiding uses not listed in the PMN, or keeping production below a specified le vel; they are described only qualitatively.

It was not feasible within available resources to aggregate costs, or to estimate how often costs are actually incurred as a result of SNURs, except for costs of SNUN submissions.

The remainder of this report estimates the quantified portion of costs potentially associated with SNURs such as those included in this rulemaking. Secti on 2 presents estimates of the costs that could be incurred by manuf acturers, importers, and/or processors under the SNUR options in Table 1. Section 3 addresses export notif ication costs. Section 4 addresses costs to EPA of administering the SNURs, while Section 5 presents an analysis of other impacts, as required by various statutes and executive or ders. Appendix B provide s the wage rates and inflators used in this analysis. Other appendice s give cost estimation details and references.

2.0 COSTS OF A SIGNIFICANT NEW USE RULE (SNUR), BY OPTION

A SNUR specifies requirements a firm must meet if it choose s to manufacture, import, or process a PMN chemical without engaging in a Significant New Use that would trigger notification to EPA. A SNUR also requires r ecordkeeping for anyone manufacturing, importing, or processing the SNUR chemical. A SNUR r ecommends testing, but do es not require testing. EPA rarely receives results of tests performed specifically to support a SNUN

. Table 1 sets forth possible responses to a SNUR. A fi rm may select more than one course of action. For example, it may produce in a way that avoids a Significant New Use, while simultaneously submitting a Significant New Use Notice for a proposed new us e. These options are described below along with their costs.

2.1 Comply with SNUR Limits (Option 1)

A firm can avoid engaging in a Significan t New Use and submitting a SNUN by meeting all applicable SNUR requirements. The firm may also pursue this option temporarily by complying with SNUR restrictions while al so pursuing other options such as making a submission to EPA. If it does avoid engaging in a Significant New Use (and if the chemical is on the TSCA Inventory or if the firm has already submitted a PMN), no notice to EPA is required. 2 Table 2 below shows the types of requirement s a firm must meet to avoid engaging in a Significant New Use.

2 Under the Toxic Substances Control Act § 3(9), if a chemical is not on the TSCA Inventory, it is a “new chemical.” Prior to manufacture or import of a new chemical for genera l commercial use, a notice mu st be filed with EPA under Section 5(a)(1)(A) of TSCA (40 CFR §720.3 and 40 CFR §720.22).Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 5 August 26, 2009 The Significant New Use designation in a SNUR for a specific chemical reflects either the use scenario described in the PMN for th at chemical (what the submitter was already planning to do) or the requirements in the 5(e) Consent Order resulting from the PMN submission. Thus, it is likely that the typi cal PMN submitter will incur no added costs of complying with the SNUR requirements so as to avoid a Significant New Use.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 6 August 26, 2009 Table 2 Production and Use Restrictions/Requirements

40 CFR Reference (Code of Federal

Regulations) Restriction/Requirement No. of Chemicals Affected 1 Sample Costs Per Chemical

($2008)

§721.63 Workpl ace protection 3 $11,882 to $35,760 2 §721.72 Hazard communication 0 $1,020 Industrial Commercial, and Cons umer Activities (§721.80) §721.80(a, b, c) Enclosed use only 0 Not quantified §721.80(d, e) Use at site only 0 Not quantified §721.80(f) Import only (do not manufacture) 3 Not quantified §721.80(g, h, i) Use only as intermediate 0 Not quantified

§721.80(j, k) Engage only in uses listed in PMN or Consent Order 8 Not quantified

§721.80(l, m, n, o) Limits non-industrial uses 0 Not quantified §721.80(p, q, s, t) Limit production volume 1 Not quantified §721.80(r, u) Volume-triggered testing 0 Not quantified §721.80(v, w, x, y) Restricts physical form of chemical 0 Not quantified Disposal, water release, recordkeeping §721.85 Disposal 0 Not quantified §721.90 Limit releases to water 5 Not quantified

§721.125 3 Recordkeeping for all manufacturers, importers, and processors 15 Up to $1,133

Notes:

1 Some chemicals have more than one type of restriction.

2 $11,882, is the annual cost for dermal protection selection and heavy duty gloves. $35,760 is the annual cost for dermal protection selection; heavy duty gloves, impermeability testing/evaluation of manufacturer specifications, and a lower-cost respirator (see Table 5).

3 This excludes SNUN recordkeeping under §721.40. See the recordkeeping discussion in Appendix C. Source : Costs are summarized in Table 3, Table 4, and Table 6, and derived in Appendix C.

The costs of meeting the hazard communicati on (haz-comm), protective equipment, and recordkeeping requirements are qua ntified for this report. Appendi x C presents a more detailed derivation of these costs. Complying with requir ements to avoid a Significant New Use also may result in additional costs that affect a significant number of the chemicals, such as costs associated with limiting releases to water, that were not quantifie d for this report; these costs are also summarized below.

Hazard Communication

Requirements. Each SNUR may require firms that manufacture, import, or process one of the PMN substances to implement a haz-comm program for the applicable chemical, or else submit a SNUN. For purposes of the economic analys is, it is assumed that each facility has in place a haz-comm program consistent with th at required by OSHA’s Hazard Communication standard (29 CFR 1910; November 25, 1983). Much of the haz-comm cost methodology used in this analysis came fr om a 1989 EPA report, Economic Analysis of Final Significant New UseEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 7 August 26, 2009 Rules: General Provisions for New Chemical Followup (RIB, 1989). The cost estimates provided here are for one chemical produced at one site assumed to have 25 exposed workers and roughly a 10,000 kilogram annual shipment volume. Higher volumes would increase costs, although not necessarily proportionately. The major elements of a haz-comm program that could apply to a SNUR chemical, based on the requirements in §721.72, are:

• Revision of the existing written haz-comm pr ogram to incorporate information about the chemical [§721.72(a)];

• Creation of labels and application of labe ls to containers used for distributing the chemical in commerce [§721.72(b)];

• Creation of labels or signage and posting of hazard data in areas of the facility where the chemical is used or stored [§721.72(b)];

• Creation and distribution of material safety data sheet s (MSDSs) [§721.72(c)]; and

• Employee awareness training on where and how the chemical is used, the hazards associated and availability of hazard info rmation about the chemical, and protective equipment and other measures in place to reduce and minimize exposure to the chemical [§721.72(d)].

Costs. The annual costs of compliance with the haz-comm requirements for PMN substances subject to haz-comm requirements appear in Table 3. Further, the costs are for substances with full haz-comm requiremen ts, and may overstate haz-comm costs for substances with partial requirements. Appe ndix C gives the detailed cost derivation.

Table 3 Annual Costs of Hazard Communication Requirements

Cost Requirement ($2008) 1,2 Hours

Update written program $192 4 Labeling Distribution in commerce $132 0.5 Use in the workplace $365 1.5 MSDS preparation $128 2.25 Employee training $202 6.75 TOTAL $1,020 15

Notes:

1 Figures are rounded to whole dollars. Substances not subject to all of these requirements may have lower costs. See Table C-1 through Table C-4, and section C.1.1 for derivations.

2 Hourly labor costs are derived in Table B-1.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 8 August 26, 2009 Protection in the Workplace

Requirements. Under 40 CFR §721.63, manufacturers, importers, or processors must comply with worker protection requirements as specified in the SNUR on the regulated chemical, or else submit a SNUN. The core comp onents of the worker protection requirements include provision of personal protective equipm ent (PPE) such as gloves, goggles, protective clothing, and respirators.

In some cases, EPA specifies the type of PPE required. In other cases, EPA requires adequate dermal protection but does not specify particular PPE. Instead, it requires the employer to evaluate worker exposure conditions and haza rds, and select appropriate PPE. Generally the employer is also required to determine that de rmal PPE is impervious to the PMN substance by one or both of the following methods: (1) perfor m impermeability testing on the PPE under the expected conditions of exposure, and/or (2) re ly on equipment manufacturers' specifications. Employers not already providing adequate dermal protection would need to do so.

Costs. Annual costs for worker protection items are shown in Table 4 below. The derivation of the sample minimum and maximum annual costs for worker protection is found in Table 5. The costs of worker protection were originally estimated in an 1989 EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Follow-Up (RIB, 1989), as a range of costs, depending on the assumed number of worker-days of exposure. This report uses the high end of th e assumptions about worker-day exposure, updated to adjust for inflation. The estimates are for one chemical at one site with 25 exposed workers; actual costs would vary with th e number of workers. Appendix C gives the detailed cost derivation.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 9 August 26, 2009 Table 4 Annual Costs of Wor kplace Protection Requirement

Personal Protective Equipment an d Requirement Citation at 40 CFR Unit Cost ($2008) 1 Quantity Required 1 Total Annual Cost 2 ($2008)

Dermal Protection Selection §721.63(a)(1) 10 hours industrial hygienist (IH) time $47.99 10 $480 Impermeability Testing §721.63(a)(3) Impermeability Test $1,261 1 $1,261 Evaluation of Manufacturer's Specifications $192 1 $192
Gloves §721.63(a)(2)(i) Standard (disposable) $0.58 6,250 $3,605 Heavy-duty butyl $46 250 $11,402 Protective clothing §721.63(a)(2) [ii] - Full-body (coverall with hood) $82 75 $6,157 [iv] - Coverall (no hood) $49 75 $3,647 Eyewear §721.63(a)(2)(iii) Standard goggles $5 75 $407 Heavy-duty goggles $8 75 $609

Respirator Types 3

Supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight -fitting full facepiece. [simila r to §721.6 3(a)(5)(ii)] $1,079 25 $26,964

Supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-f itting facepiece (either half- or full-face). [similar to §721.63( a)(5)(iii)] $1,250 25 $31,261

Air-purifying respirator equipped with a tight-fitting full facepiece and High Efficiency Particulate Air (HEPA) f ilters.[similar to §721.63(a)(5)(iv)] $897 25 $22,425

Air-purifying, tight-fitting respirator (e ither half- or full-face) equipped with N100 (if aerosols absent), R100, or P100 filters. [similar to §721.63(a)(5)(iv)] $897 25 $22,425

Powered air-purifying, tight-fitting full-f ace respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. [similar to §721.63(a)(5)(v)] $3,223 25 $80,569

Powered air-purifying respirator eq uipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters. [similar to §721.63(a)(5)(v)] $3,223 25 $80,569

Powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters. [similar to §721.63(a)(5)(vi)] $2,508 25 $62,711

Notes:

1 Quantities assume: 1) 25 workers exposed 250 days per year; 2) standard gloves replaced daily and heavy-duty gloves replaced every 25 days; 3) respirator units replaced annually and cartridge sets repl aced every five days (50 cartridges sets per year); 4) goggles and protective clothing replaced three times yearly.

2 Total annual costs were calculated using unrounded unit cost estimates, and may not equal the product of the rounded estimates shown in this table.

3 This table lists respirator choices that typically would sati sfy SNUR requirements for a particular chemical, for current and recent SNURs. Future SNURs may list different choices. The citations in brackets refer to respirator types listed at 40 CFR. While the SNURs no longer reference the §721.63(a)( 5) categories, costs in this analysis are based on costs estimated in 1997 for the §721.63(a)(5) categories. See Table C-10 for the crosswalk between respirator types in SNURs and in this table. The respirator “unit cost” is per worker. Total respirator costs include costs of the respirator plus the costs of any add-on items such as hoods, helmets, cartridges, filters, and caps, if these items are required for a particular respirator. Source: Appendix C, Tables Table C-5 through Table C-11.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 10 August 26, 2009 The costs of purchasing protec tive equipment are derived in Appendix C, and have been annualized based on the assumptions listed above regarding their use and lifetime in the workplace. Costs for evaluating hazards when PPE is not specified in the SNUR are based on estimates of the reasonable time required for a sa fety professional to perform such evaluations. Costs for conducting impermeability testing are ba sed on consultation with PPE vendors, as described in Appendix C. Table 4 summarizes the annual costs associated with protection in the workplace, including the PPE itself, as well as selecting required dermal protection, and performing impermeability testing and/or evaluating manufacturer's information.

Table 5 shows a sample of the minimum and maximum annual cost of workplace protection, assuming 25 workers who are exposed for 250 hours per year. The minimum cost includes the cost of heavy-duty butyl gloves, and 10 hours of an industrial hygienist’s time for dermal protection selection. The maximum cost is includes the cost of gloves, dermal protection, impermeability testing, and the annual co st of the least expensive respirator and filters for 25 workers.

Table 5 Sample Costs of Workplace Protection

Cost Element Annual Cost ($2008)
Example #1: Gloves and Dermal Protection Selection Heavy-duty butyl Gloves $11,402 Dermal Protection Selection $480 Total per site with 25 workers $11,882 Example #2: Gloves , Testing, and Respirator Heavy-duty butyl Gloves $11,402
Dermal Protection Selection $480 Impermeability Test $1,261
Evaluation of Manufactur er's Specifications $192 Least Cost Respirator $22,425 Total per site with 25 workers $35,760
Source : Table 4

In cases where the SNUR specifies the type of protective gear, the estimates assume workers would not otherwise wear adequate prot ective equipment. To the extent that workers would otherwise be adequately protected (as a result of the company's own safety program related to other chemical hazards, or to comply with OSHA's PPE standards), these costs may be an overestimate of the actual costs.

In some cases, the SNUR requires dermal prot ection but does not sp ecify any particular gear, allowing regulated companie s to make that determination. Table 4 shows costs of assessing needs and demonstrating impermeability. These co st estimates would reflect a situation where the dermal protection is alrea dy in place but the manufacturer must demonstrate that it is adequate. If companies also have to purchase additional protective ge ar, incremental costs attributable to the SNUR would include the added items. For example, if a firm already providing gloves and goggles determined that it would have to add protective clothing to avoid engaging inEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 11 August 26, 2009 a Significant New Use, this would increase costs ev en if particular prot ective clothing is not specified in the SNUR.

Recordkeeping

Requirements. Under 40 CFR §721.40, recordkeep ing is required fo r SNUN submitters. This recordkeeping cost was included in the SNUN submission cost and is not separately estimated here. 3

In addition, the SNURs specify recordkeeping requirements for manufacturers, importers, and processors, by identifying paragraphs sele cted from 40 CFR §721.125(a) through (k). These recordkeeping requirements apply even if the fi rm does not engage in a reportable New Use or make a submission to EPA, so long as it manufact ures, imports, or proc esses the chemical. The recordkeeping requirements vary by chemical. For example, only chemicals that must establish a Hazard Communications program to avoid a Sign ificant New Use would be required to keep records documenting their haz-comm program. (For firms producing under the R&D exemption, R&D recordkeeping would be needed. R&D recor dkeeping costs were not estimated for this report.)

SNUR recordkeeping requirements essentia lly involve copying and filing relevant records, including those related to manufacturin g, importing, or processing volumes; shipment amounts and customer information; clothing impermeability determinations; the hazard communication program incl uding labels and MSDS copies; co mpliance with disposal and water discharge limitations; and/or compliance with rest rictions on volumes, nature of manufacture or use, or on the chemical’s physical form (powder, liquid etc.).

Costs. Annual costs for compliance with 40 CFR §721.125 recordkeeping requirements are low, but do potentially apply to all SNUR ch emicals, and the recordkeeping could continue for years. Costs are presented in Table 6 and de rived in Appendix C. They are estimated for one chemical at one site, and incl ude technical and cler ical labor time, photocopying charges, and costs for records storage.

Table 6 summarizes recordkeeping costs by re quirement at 40 CFR §721.125. The totals in Table 6 provide the cost if all recordkeeping requirements in paragraphs §721.125 (a) through (k) were required; this would seldom, if ever, be the case for a single chemical.

3 For example, OPPT’s Informat ion Collection Request (ICR) for TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (Renewal), October 11, 2005, estimated SNUN recordkeeping costs at 5.67 hours (ICR 1188.08, page 12).Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 12 August 26, 2009 Table 6 Annual Costs of Recordkeeping Requirements (40 CFR §721.125)
40CFR §721.1252 Cost Element Cost ($2008) 1 Hours
(a)(b)(c) Volumes & sales/transfer data $320 7.11

(d)(e) Protective clothing [§721.63] and impermeability [§721.63(a)(3)] $13 0.29

(f) Haz com program [§721.72] $165 3.67 (g) Label copies [§721.72(b)] $3 0.07 (h) MSDS copies [§721.72(c)] $3 0.07 (i) Use limitations compliance [§721.80] $165 3.67 (j) Disposal compliance [§721.80] $396 8.80 (k) Water discharge compliance [§721.90] $66 1.47
TOTAL $1,133 25.15

Notes:

1 Recordkeeping applies to all SNUR chemicals. This table does not cover recordkeeping for SNUN submissions. See Appendix C Table C-14 for derivations.

PMN uses, production volume limits, import- only, releases to water and disposal

Several types of costs that may be incurred by complying with the significant new use designations are not quantified in this report.

Release to water, disposal, and other use rest rictions may result in costs not quantified for this report. For example:

• A producer could incur costs of determining whether discharges to water would constitute a Significant New Use and of li miting releases in order to avoid the Significant New Use.

• Keeping production volume below specified li mits to avoid a Signi ficant New Use could result in a decrease in prof its; a potential “hidden” cost. A firm producing for sale may have to restrict its sales of the chemical. If th e chemical is for intern al use, it may have to substitute to a less cost-effective chemical.

• Similarly, avoiding uses not liste d in the original PMN could re sult in “hidden” costs of foregone profits if the firm cannot market th e chemical for certain applications. If the firm wants to use the chemical for internal use, it may have to substitute to other chemicals or technologies that cost more or have lesser performance resulting in higher production costs.

• Importing could be costlier than ma nufacturing a PMN substance in the United States.

2.2 Request Modification or Revoc ation of a SNUR (Option 2)

Under 40 CFR §721.185, EPA may modify or revoke a SNUR upon review of a submittal from a manufactur er, importer, or processor. Conseque ntly, the second option for a firmEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 13 August 26, 2009 is to request modification or revocation of th e SNUR. According to New Chemical Program records, EPA receives few modify/revoke request s (typically 0-3 per year) due to SNURs.

This option may have some or all of the following associated costs:

• One-time costs of testing to develop health a nd environmental effects data for a chemical subject to the SNUR;

• One-time costs of submitting a request for modification or revocation;

• Ongoing costs of complying with SNUR restri ctions (Option 1 in this report) or of avoiding production while the modification request is bei ng processed (Option 5). The firm may also incur costs of complying w ith any SNUR restrictions that are not ultimately revoked or may incur hidden costs of avoiding production altogether.

These costs are discussed below.

Costs of Developing and Submitting Testing Data

40 CFR §721.185(b)(1) requires that a modi fication request include “information sufficient to support the request.” For each PMN substance, the SNUR identifies health, ecological, and/or fate/transport/ transformation testing that woul d help characterize the risks associated with the substance. However, there is no requirement for a requester to perform the recommended tests or even to perform testing at all. It is possi ble that some of the recommended tests, or other tests, would be performed by the submitter to support a request for modification and revocation of a SNUR. For info rmational purposes, costs for various tests recommended in SNURs over the years are listed in Appendix D. If no additional testing is performed to support a modification request, costs may be similar to costs of a SNUN – discussed later in this section – minus the user fee.

Table 7 below provides an example of poten tial costs if a firm were to perform a standard set of basic ecotoxicity tests to support a request to modify or revoke a SNUR.

Table 7 Sample Costs of Recommended Testing

Estimated Cost Test Guideline Test description ($2008)
Ecotoxicity Base Set OPPTS 850.5400 Algal Toxicity, Tiers I and II $17,209 OPPTS 850.1010 Daphnid Acute Toxicity $14,804 OPPTS 850.1075 Fish Acute Toxicity $20,402 Sample TOTAL Testing Cost: $52,415

Notes:

1 Costs are from Table D-1Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 14 August 26, 2009 Costs for Submitting a Request for Modi fication or Revocation of a SNUR

The costs associated with submitting a request for modification and revocation of a SNUR (or of submitting a SNUN) are estimated to be similar to the costs for preparing a PMN submission, except that there is no user fee for the modify/revoke request. In its Regulatory Impact Analysis for the amendments to the PMN regulations, EPA relied on industry estimates of the effort needed to collect and compile al l data required for a PMN submission, prepare the form, submit the form and data to EPA, and main tain a file of the subm ission (RIB, 1994, pages III-11 through III-13, and Appendix B). These estimates, based on five responses to a 1991 survey conducted by the Chemical Manufacturers Association, indica te that the average effort required to prepare and submit a PMN is betw een 95 and 114 hours. This analysis uses the average of the estimated hours for each step, re sulting in the cost shown in Table 9. The costs associated with these labor time es timates are derived in Appendix E.

Other Costs

EPA’s review of the submitter's request may cause dela ys in the start of manufacturing or processing activities. Such dela ys could cause the company to forego opportunities to earn profits for the duration of the review period. Alternatively, the submitter may elect to produce under the constraints of the SNUR during the review period, so as to avoid a Significant New Use. EPA may not revoke all SNUR provisions as a result of the request. If the company is allowed to continue production a nd chooses to do so, it would bear costs of complying with any SNUR restrictions that are not revoked. Costs of complying w ith SNUR restrictions pending EPA modification or revocation were discussed under Option 1.

Table 8 Costs of Requirement to Modify/Revoke SNUR or Submit SNUN

Request to Modify/Revoke SNUR (Option 2) ($2008) Submit a SNUN (Option 3)

($2008) Request Equivalency Determination

(Option 4)

($2008)

Costs of preparing submission (105 labor hours) $5,955 $5,955 $5,955

User fees NONE $2,500 NONE TOTAL $5,955 $8,455 $5,955

Test Costs Sometimes Rarely

Notes: Figures are rounded to whole dollars (see Appendix E, Table E-1, for derivation). Costs include recordkeeping in support of the submission.

Total Costs for Option 2

The total costs associated with requesti ng a modification or revocation of a SNUR include the costs of generating ne w supporting data plus the admini strative cost of preparing the submission.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 15 August 26, 2009 2.3 Submit SNUN (Option 3)

Under 40 CFR §721.5, manufacturers, importers , or processors who would like to undertake a Significant New Use of a substance listed in a SNUR are required to submit a Significant New Use Notice (SNUN) at least 90 days before the firm plans to commence the manufacture, import, or processing of the substa nce. For example, they could submit a SNUN if they wish to produce above the volume limit listed in the SNUR for a given chemical, since any production beyond that volume would be defined as a Significant New Use.

The SNUN provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit th at activity before it occurs. Th e notice form used to submit a SNUN is the same as that fo r a PMN, and the costs of subm itting a SNUN are estimated based on the costs incurred to submit a PMN.

This option could have the following costs:

• One-time costs of the SNUN and $2,500 user fee. (However, in some cases, a notification may be needed for reasons ot her than the SNUR; see the “SNUR ‘New’ Chemicals” discussion below.)

• Ongoing costs of complying with SNUR restrictions to avoid engaging in a Significant New Use (Option 1 in this re port) or of avoidi ng production while the SNUN is being processed (Option 5); cost s of recordkeeping, and of complying with any restrictions resul ting from the SNUN review.

• Rarely, the SNUN submitter may elect to perform some of the testing recommended in the SNUR as a way to characterize effects of a chemical. These tests are not mandatory, and firms do not usually conduct testing to support a SNUN, so any such costs are likely to be zero or low.

This observation is based on an analysis of the 18 SNUNs submitted over a three-year period, from 2005 through 2007. A list of human h ealth tests submitted to EPA with PMNs and SNUNs was also available from a confiden tial database maintained by EPA’s Office of Pollution Prevention and Toxics Risk Asse ssment Division. Only one SNUN described toxicity or environmental fate testing that seem ed reasonably likely to have been performed to support a SNUN. In that case, two relatively lo w-cost tests (fish acute toxicity and daphnid acute toxicity) may have been conducted to s upport a SNUN, although it is also possible that the testing was done for some other reason not apparent in the SNUN itself.

A substantial portion of the SNUNs did provide or reference test results. However, in almost all cases, the testing appeared to have been conducted for reason s other than a SNUR. For example, the SNUN might include laboratory reports that had already been submitted for a PMN for the same chemical.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 16 August 26, 2009 SNUR “New” Chemicals

If a SNUR chemical is not on the TSCA Inventory and a potential manufacturer or importer has not yet filed a PMN, submission cost s may be incurred but are not attributable to the SNUR.

All SNUR chemicals in this rulemaking were the subject of at least one PMN. For PMN chemicals to be added to the TSCA Inve ntory, manufacturing (or import) must have commenced, with notification to EPA through a Notice of Commencement, or NOC. Thus, SNUR chemicals not yet in commercial ma nufacture (or import) are not on the TSCA Inventory. They legally remain “new” ch emicals subject to PMN requirements.

For “new” chemicals, firms wh o have not yet submitted a PM N must notify EPA 90 days before manufacturing/importing th e chemical for commercial purposes. This submission is still designated a PMN but may contain information de monstrating the submitter intends to engage in a significant new use. Either way, the firm uses the same submission form and provides the data listed at 40 CFR §720.45. Consequently, for this special situation, the submission cost is incurred due to PMN requirements, not due to the SNUR. (See EPA's 1997 Chemistry Assistance Manual for Premanufac ture Notification Submitters for an overview of New Chemicals requirements [EPA, 1997]).

Advance Compliance Exemption

Another option available to firms before the S NUR is promulgated is to seek an advance compliance exemption under 40 CFR §721.45(h). The submission cost for this option is the same as that for a SNUN, but by negotiating an advance complian ce agreement with EPA a firm might diminish any loss of profits due to delay. This option is not available after the SNUR is promulgated.

Costs for Submitting a SNUN

As with Option 2 above (Request Modificati on or Revocation of a SNUR), the costs for submitting a SNUN are estimated to be equivalent to the costs of completing a PMN submission. If the SNUN is submitted at the same time as a request to modify a SNUR (Option 2), the added cost would be less than shown here due to overla p in information in the two submissions. Table 8 shows the costs of preparing a SNUN; details are in Appendix E.

Potential for Subsequent Regulatory Actions

The Agency recognizes that if submission of a SNUN does result from a SNUR, the Agency may take additional regulatory actions under TSCA. These additional regulatory actions might be necessary to further evaluate an inte nded new use and associated activities, or to prohibit or limit that activity befo re it occurs to prevent unreas onable risk of injury to human health or the environment. It is not known wh at specific subsequent regulatory actions, if any, the Agency may determine are ne cessary after reviewi ng a SNUN. Any such actions are highlyEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 17 August 26, 2009 dependent on the circumstances surrounding the individual SNUN (e.g., available information and scientific understanding about the chemical and its risks at the time the SNUN is being reviewed).

Should the Agency’s review of the SNUN result in further regulatory actions, the Agency will initiate and follow the appropriate procedur es for taking those actions. Included in those procedures would be an assessment of th e costs and benefits of those actions.

Subsequent regulatory action may be a Consent Order under TSCA Section 5(e). Assessments of costs and benefits for a Cons ent Order would be limited, similar to those supporting PMN reviews leading to Consent Orders, in contrast to the in-depth benefit-cost analyses prepared under some other TSCA Sections.

The description above was adapted from text in Economic Analysis of the Significant New Use Rule for Chloranil , January 8, 2008, Section 2.4; and Economic Analysis of the Final Significant New Use Rule for 183 Perfluoroalkyl Sulfonates , August 20, 2007, Section 3.4. Both reports are from the U.S. EPA Office of Po llution Prevention and Toxics, Economic and Policy Analysis Branch. The nature of the follow-up regulatory action and benefit/cost analysis may differ between SNUNs for newer chemicals submitte d as a result of a direct final rulemaking such as this one, and SNUNs for older chemical s such as chloranil and most perfluoroalkyl sulfonates.

2.4 Request Equivalency De termination (Option 4)

Under 40 CFR §721.30, EPA may review appl ications from facilities who propose alternative methods of controlling or preventing exposures or releases to those specified in the SNUR. In these cases, EPA evaluate s the alternatives using an a bbreviated review process. As shown in Table 8, the costs of submitting an e quivalency determination request are expected to be the same as those for submitting a SNUN except that no user fee is required.

For this option the EPA review period is 45 days compared to 90 days for a SNUN, therefore any potential loss of pr ofits due to delays may be le ss than for a SNUN under Option 3.

In addition to the costs of submitting the equivalency determination request, each submitter will also incur costs to develop data to support the request. However, total costs of the equivalency option should be no mo re than the costs of complying with controls in the SNUR to avoid a significant new use -- for example, c ontrols related to workplace protection or environmental release. Otherwise, presumably there would be no incentive for the submitter to choose this alternative. Finally, to produce th e chemical following EPA review, the submitter would incur costs from recordk eeping and from any re strictions not waived (see Option 1).

2.5 Decide Not to Produce Chemical (Option 5)

Some firms may find that the costs of meeting the SNUR requirements and/or restrictions (Option 1) or preparing a SNUN or other s ubmission (Options 2, 3, or 4) are financiallyEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 18 August 26, 2009 unattractive. In these cases, the firm could choose not to manufacture, import, or process the PMN substance.

While this option avoids the costs of meeting the specifications in the SNUR or submitting a request for some alternative, it entails the “hidden” cost of the profit that will be foregone as a result of not engaging in the comme rcial activity originally planned. For example, if the firm does not produce the SNUR substan ce, then it will forego the profit it would have achieved by producing it. That forego ne profit is a potential “hidde n” cost of Option 5. Similarly, if the firm would have used the SNUR substan ce in the production of another product and must substitute to a more costly substance, it will in cur those additional costs of production. If the firm elects to produce for R&D purposes only, it may ha ve costs associated with R&D recordkeeping attributable to the SNUR.

2.6 Summary of Costs for Each Option

Table 1, above, gave an overview of co mpliance options. Table 3 through Table 6 summarized the quantified portion of potential cost s of either following restrictions to avoid engaging in a Significant New Use, or of making a submission to EPA. Table 7 presented sample testing costs. Costs are for one chemical at one site, and – where volume is relevant – are based on standard assumptions that incl ude 25 exposed workers per site a nd, for haz-comm costs, annual shipments of about 10,000 kilograms per site. Costs are not otherwis e adjusted for the nature of the chemical or process, volume, location, or ot her firm-specific or chemical-specific factors.

As mentioned above, costs are estimated for one chemical at one site, not for aggregate production. Resources were not ava ilable to estimate aggregate co sts. Among other things, it is not known how many firms are affected by the S NURs. EPA receives a handful of Significant New Use Notices per year due to SNURs. However, if a SNUR chemical is on the TSCA Inventory, a firm may use the chemical in a wa y that avoids a Signifi cant New Use (Option 1), and never make a submission. It is not known how many firms are affected but do not make a submission. Also, it is not known whether firms avoid the chemical altogether specifically due
to the SNUR. However, at least for the years immedi ately following SNUR promulgation, these numbers are likely to be small. Th is is because the chem icals in this type of SNUR rulemaking are still relatively new – as APPENDIX A indicates, most were subm itted to EPA as PMNs in the past four Federal fiscal years – and, in additi on, often have confidential chemical identities.

• For firms manufacturing, importing, or processi ng within SNUR restrictions to avoid a Significant New Use (Option 1), quantifiable costs can range from a few hundred dollars (if the only added cost is for recordkeepi ng) to over $30,000 per chemical if the firm must add worker protection measures such as gloves, protective cl othing, and respirators that it would not otherwise use . Most chemicals are also subject to costs that could be significant but are not quantified in this report , such as restrictions on releases to water or on other aspects of use.

• For submissions to EPA (Options 2, 3, and 4) , the basic one-time submission cost is estimated at $5, 955, including recordkeeping for the submission. For the SNUN (Option 3), EPA also collects a $2,500 fee.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 19 August 26, 2009 • One objective of the rule is that EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs , provided that regulation is warranted pursuant to TSCA sections 5( e), 5(f), 6 or 7. Consequentl y, after submitting a SNUN, the firm may need to comply with restrictions as a result of the SNUN review process, possibly leading to further cost s similar to those in Option 1.

• Rarely firms may choose to perform toxicity and/or environmental fate testing to support a SNUN (Option 3). Such testing is not mandatory. Costs for such testing are expected to be zero for most SNUNs and expected to be low for the few SNUNs for which a submitter might voluntarily perform such testing.

• Companies that might have manufactured, im ported, or processed a chemical in the absence of the SNUR may incur “hidden” costs, such as loss of profits from delayed or foregone sales, if they avoid the chemical altogether (Option 5). These costs were not quantified.

• Companies may incur costs from more than one Option, for example if they temporarily produce in conformance with SNUR restri ctions while submitting a SNUN and waiting the required 90 days plus any extensions.

For some firms, costs may be attributable to EPA’s New Chemicals review process, but not to the SNUR itself. For example, a firm may already be bound by a TSCA Section 5(e) Consent Order following review of its PMN, so that the SNUR based on the 5(e) order imposes no added costs for that firm. As another example, in rulemakings where a SNUR chemical is not on the TSCA Inventory, firms that have not ye t submitted a PMN must s ubmit one to EPA before commercial production/import, w ith or without the SNUR (s ee Section 2.3, SNUR “New” Chemicals).

If the SNUR reflects the PMN use scenari o, and the PMN submitter would stick to the PMN uses even in the absence of a SNUR, th en there would be no added costs for the PMN submitter attributable to the SNUR. Also, firms may also incur worker protection, haz-comm and other costs for reasons other than the SNUR, so that SNUR requirements may impose no added

costs. 4

3.0 EXPORT NOTIFICATION COSTS

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

4 Earlier SNUR economic analyses calcu lated possible haz-comm, worker protection, testing, and other costs for each PMN chemical (EPAB, 2007a, Tabl es 9, 10, D-4). The chemical-specifi c tables were dropped from a later SNUR economic analysis (EPAB, 2007b). They reflected SNUR requirements and “recommended” testing, but were not otherwise tailored to the particular situation, and so were unreliable predictors of actual SNUR costs.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 20 August 26, 2009 5(a)(2) and certain other TSCA sections, this is a one-time notification requirement 5 per each destination country for each expor ter of a chemical substance. TSCA 5(a)(2) is the section under which EPA promulgates Significant New Use ru les. After receiving a notification from a firm, EPA notifies the importing country and the United States State Department (40 CFR §707.70).

Notifications from firms must include the e xporter's name and address, the chemical name, the date(s) of export or intended export, the importing country (o r countries), and the section of TSCA under which EPA has taken action.

An EPA report, Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements (EPAB, 2005, page 19, Table 2-9), estimated the annual export notification cost for an exporter under the one-time ex port notification requirement. These costs include the cost to the exporter of co mpiling a list of their pr oducts that are subject to TSCA Section 12(b) requirements, writing or revising an export notific ation letter to EPA, checking the outgoing shipments, and sending the notification letters with the associated shipping costs.

Table 9 Derivation of Total Mailing Cost for 24 Notices

Dates that the rates were verified on United States Postal Service web site: Nov '05 June '09

Postal services costs Registered mail, regular, with $0 declared value $7.50 $10.60 Return receipt, requested at time of mailing (receive by mail) $1.75 $2.30 Postage, regular First Class, up to 1 ounce $0.37 $0.44 Cost per export notice - Subtotal $9.62 $13.34

× 24 × 24 Total Mailing Cost for 24 Notices $230.88 $320.16

Notes: Information in italics shows the exact postal services assumed for cost purposes in the November 2005 report, Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements (EPAB, 2005, p.17). November 2005 costs are in cluded for easy comparison with co sts in the source report. Source: Mailing rates are from the US Postal Service web site as of November 2005 and June 2009 (http://www.usps.com/prices/)

In order to estimate the costs of these activities for an exporter making notifications, EPA estimated that there would be 24 notif ications per year for an exporter making notifications. 6 This includes both notifications resulting from SNURs and notifications resulting from other

5 On November 14, 2006, EPA revised the export notifica tion requirement for chemicals subject to TSCA §5(a)(2), 5(b), 5(e)(1) and 5(e)(2) from an annual to a one-time requirement per destination country for each exporter (November 14, 2006, 71 FR 66234).

6 This applies to years after the first year following pr omulgation of the November 2006 rule, i.e. starting in November 2007. For those later years, EPA calculated the number of export notifications per exporter by dividing the estimated number of submitted notifications (7, 125) by the estimated number of exporters (296).Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 21 August 26, 2009 TSCA activities. The percent of these notifica tions due to PMN SNURs has not been estimated for this report.

Table 9 summarizes the derivation of mailing costs from EPAB, 2005. Table 10 presents the annual costs of the one-time e xport notification requirement for an exporter making 24 export notifications per year.

Table 10 TSCA 12(b) Export Notification Cost: Annual Burden per Respondent Facility

Technical Clerical Total
$/Hr Hours $2008 $/Hr Hours $2008 $2008 Hours Compile list $58.84 9.4 $553 -- -- -- $553 9.4
Write letter $58.84 1 $59 -- -- -- $59 1
Check order and send notice -- -- -- $28.48 12 $342 $342 12

Mailing cost 1 -- -- -- -- -- -- $320 - Total per facility 2 10.4 $612 12 $342 $1,274 22.4

Notes:

1 Mailing costs reflect June 2009 USPS rates and can be found in Table 9.

2 An average facility is assumed to s ubmit 24 export notifications per year Source: Appendix B of this report derives technical and clerical hourly labor costs. Other costs are from Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements (EPAB, 2005)

After receiving a notification from a firm, EP A notifies the importing country and the U.S. State Department (40 CFR §707.70). Not all inco ming notices from firms require that a notification be sent out by EPA. For an esti mated 7,125 incoming notifications from exporters and 980 outgoing notifications from EPA, total Agency costs were estimated at $134,570 per year before inflation (EPAB, 2005, pages 19-20 and Table 2.12). This includes notifications triggered by activities under several TS CA sections, not just by SNURs.

4.0 AGENCY COSTS

EPA’s costs to review and pr ocess industry submissions (S NUNs, requests to modify or revoke the SNUR, and requests for equivalency dete rminations) are assumed to be the same as EPA costs to review PMNs. These costs are es timated at $5,693 per case, as shown in Appendix F, Table F-1. The required Agency steps, full-tim e equivalent (FTE) staff needs, and extramural costs such as for contractor support are derived in Appendix F from EPA's analysis of the Agency costs of processing PMN submissions (RIB , 1994), with adjustments to reflect inflation and changes in Agency staff grade levels. The orig inal EPA analysis used a range of salaries, but this analysis uses one typical salary.

The PMN costs reflect estimates made in 1994, in Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (RIB, 1994). The average cost to review a SNUN may be different from that estimated for PMNs, both because of differences between PMNs and SNUNs, and b ecause the PMN review hours may have changed since 1994. Resources were not av ailable to re-estimate costs for SNUNs. See Appendix F for details.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 22 August 26, 2009 5.0 ADDITIONAL ANALYSES

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

5.1 Regulatory Flexibility Act (RFA)

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et. seq.), as amended by the Small Business Regulatory Enforcement Fairness Act, requi res regulators to consider the impact of regulations on small entities, in particular small bus inesses. EPA's experience to date is that, in response to the promulgation of SNURS coveri ng over 1,000 chemicals, the Agency receives only a handful of notices per year. For example, the number of SNUNs was 4 in Federal fiscal year in 2005, 8 in FY2006, 6 in FY2007 and 8 in FY2008. 7 During this four-year period, one SNUN was submitted by a small entity. 8 The criteria for 'small business' was that the company checked the box on the PMN form, page 2, stating that it was a small business for the purpose of paying the $100 fee instead of the normal fee.

This leaves open the question of how many small businesses are affected but do not submit SNUNs. For example, businesses may change their behavior in order to use a chemical in a manner that avoids triggering Significant New Use notification requirements, and make no submission to EPA. Data and resources were not available to estimate the number of such small businesses affected by the current rule. However, a 1989 analysis suggested that few small businesses would be affected by SNURs fo r chemicals that have undergone PMN review. The 1989 report estimated that 9% of firms subject to SNURs would be small businesses, based on the portion of PMN submitters who were small businesses (RIB, 1989). The threshold to be considered a “small business” was $40 million in sales, which is consistent with the definition used at 40 CFR §700.43 to set PMN fees.

Past bona fide submissions also suggest that few firms other than possibly some PMN submitters will be affected. 9 EPA has received few bona fides indicating interest in manufacturing or importing chemi cals subject to past SNURs. EP A also has received few public comments during rulemaking on SNURs covering PMN chemicals. For example, a SNUR published in the spring of 2003 covering 62 chem icals resulted in industry comments on only three PMNs, none from small businesses (EPA, 2003).

7 February 5, 2009 email from Carol Rawie, EPA Office of Pollution Prevention and T oxics, to Tulika Narayan and Kimberly Wilson, Abt Associates. The counts include both “valid” and “invalid ” SNUNs. SNUN numbering is a ccording to Federal fiscal year, ending September 30.

8 February 5, 2009 email from Carol Rawi e, EPA Office of Pollution Prevention and Toxics to Tulika Narayan and Kimberly Wilson, Abt Associates.

9 Bona fides are submitted to EPA by manufacturers and importers to determine a chemical's TSCA Chemical Inventory and regulatory statusEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 23 August 26, 2009 It remains possible that some small businesse s are affected by S NURs without EPA being aware, for example if the firms have made no su bmissions or comments to EPA. However, even if a small business were interested in supplying a SNUR chemical, the SNUR's impact on profits is generally expected to be minor. For example, the firm may have a small expense of keeping records and/or of changing wor kplace practices to comply with restrictions. If modifying practices would be overly costly, the sma ll business may instead forego production, thus sacrificing profits. The lost profits, if any, were not quantified for this report, but EPA expects them to be low. This is because SNUR chemical s are unlikely to be central to a firm’s business because they are relatively new and few compar ed to the many thousands of chemicals on the TSCA Inventory.

Based on these considerations and on the lim ited data available, EPA expects that any compliance with a SNUR w ill not have a significant economic impact on a substantial number of small entities.

5.2 Unfunded Mandates Reform Act (UMRA)

EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small gover nments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

5.3 Paperwork Reduction Act (PRA)

According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., an agency may not conduct or sponsor, and a pers on is not required to respond, to a collection of information that requires Office of Management and Budge t (OMB) approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The information collection requirements related to this action ha ve already been approved by OMB pursuant to the PRA under OMB control number 2070-0012 (E PA ICR No. 574). This action does not impose any additional burden requiring OMB approval.

5.4 Executive Order 12866, Regulatory Planning and Review

Executive Order 12866, Regulatory Planning and Review, requires OMB review for rules with an impact on the economy of $100 million or more, or with any other potential significant impact. OMB has previously determined that these types of SNURs are not a “significant regulatory action” that w ould require OMB review under this Executive Order.

5.5 Executive Order 13132, Federalism

Executive Order 13132, Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “m eaningful and timely i nput by State and local officials in the development of re gulatory policies that have federa lism implications.” This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distributi on of power and responsibilities among the variousEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 24 August 26, 2009 levels of government, as specified in Execu tive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).

5.6 Executive Order 12898, Environmental Justice

This action does not involve special considera tions 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).

5.7 Executive Order 13045, Protection of Children

Executive Order 13045, Protection of Children from En vironmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), requires EPA to iden tify and assess environmental health and safety risks that ma y disproportionately affect childr en. This type of analysis is required for rules that will have an impact of $100 million or more only. The impact of these SNURs will be less than $100 millio n and therefore no analysis of such impacts on children is required.

5.8 Executive Order 13175, Tribal Governments

Executive Order 13175 is Consultation and Coordination with Indian Tribal
Governments (59 FR 22951, November 6, 2000). This rule does not have Tribal implications because it is not expected to have substa ntial direct effects on Indian Tribes.

5.9 Executive Order 13211, Energy Supply, Distribution, or Use

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

LIST OF PMNs AND THEIR CHEMICAL NAMESEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 A- August 26, 2009 1 APPENDIX A LIST OF PMNs AND THEIR CHEMICAL NAMES

Table A-1 PMNs and Chemical Names Referenced in this Economic Analysis

No PMN 1 CAS RN 2 Name 2

1 P-03-141 5614-37-9 Cyclopentane, methoxy2 P-03-197 Not available Polyoxyethylene polyalkylarylphenylether sulfate ammonium salt (generic)

3 P-03-285 141914-99-0 1-Hbenz(e)indolium, 1,1,2,3-tetramethyl, 4-methylbenzenesulfonic acid (1:1) 4 P-03-633 Not available Alkylamide derivative (generic)5 P-03-793 35077-00-0 Silanamine,1,1,1-triethoxy-N,N-diethyl6 P-04-139 691401-28-2 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, Npeanut-oil acyl derivs., inner salts

7 P-04-141 691400-36-9 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3- sulfo-, N-(C12-18 and C18-unsatd. acyl) derivs., inner salts 8 P-04-144 691400-76-7 Amides, peanut-oil, N-[3-(dimethylamino)propyl] 9 P-04-153 13990-54-0 Phosphoric acid, yttrium(3+) salt (1:1)

10 P-04-319 642928-30-1 Distillates (Fischer-Tropsch), hydroisomerized middle, C10-13-branched alkane fraction 11 P-04-346 Not available Copolymers of phenol and aromatic hydocarbon (generic) 12 P-04-347 Not available Copolymers of phenol and aromatic hydocarbon (generic) 13 P-04-692 Not available Trifunc tional acrylic ester (generic) 14 P-07-453 Not available Halide salt of an alkylamine (generic) 15 P-07-601 754-12-1 2,3,3,3-Tetrafluoroprop-1-ene Key: PMN = Premanufacture Notice. CAS RN = Chemical Abstract Service Registry Number.

Notes:

1 The order of chemicals in this table reflects the order in the draft Federal Register notice and may differ from the order of c hemicals in the published Federal Register notice. The PMN number reflec ts the Federal Fiscal Year a nd sequence of submission. For example, those starting “P-07” were submitted in the twelve months ending September 31, 2007.

2 If a CAS RN is identified as “Not available” and/or the chemical name is indicated to be “generic” than the chemical identity is indicated to be confidential.APPENDIX B

INFLATORS AND WAGE RATESEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 B-1 August 26, 2009 APPENDIX B INFLATORS AND WAGE RATES

This appendix describes the derivation of the fully lo aded labor rates and inflation factors used in calculating costs of labor, materials, and other in puts. Costs for this report are for year-end 2008.

B.1 Derivation of Loaded Wage Rates

Unit labor costs are calculated by adding fringe benefits a nd overhead to the wage or salary to derive a fully loaded labor cost. The basic method is described in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (Rice, 2002). The resulting loaded labor rates are given in Table B-1. Cost s are calculated for several labor categories: Managerial, Professional/ Techni cal, Clerical, Production Worker s, Industrial Hygienists, and EPA staff.

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

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

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

Clerical Administrative support, including clerical Office and administrative support

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

B.1.1 Derivation of Labor Rates for Manageri al, Professional/Technical, Clerical, and Production Labor

Wages and fringe benefits for managerial, professional/technical, clerical and production labor were taken from the Bur eau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data, 10 for December, for manufacturing industries. 11

10 This follows the approach introduced in Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances: EPA Docket OPPT-2003-0063 (EPAB, 2007a). In earlier PMN SNUR economic analyses, such as EPAB, 2003, wage rates for production workers came from the BLS National Employment, Hours, and Earnings, Average Hourly Earnings of Production Workers, while fringe benefits were taken from the ECEC data. Here, as in EPAB, 2007a, both wages and fringes for producti on workers come from ECEC data, for better consistency with the method of estimating labor costs for other labor categories.

11 Employer Costs for Employee Compen sation Supplementary Tables: Histori cal Data December 2006 – December 2008. (BLS, 2009a). This follows the approach introduced in EPAB, 2007a. Earlier PMN SNUR economic analyses, such as EPAB, 2003, used ECEC data for “A ll Goods Producing” sectors (manufacturing, mining, and construction). However, the manufacturing sector data seem more relevant since the SNURs mainly affect the chemicals industry.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 B-2 August 26, 2009 The cost of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same ECEC series. Fringe benefits as a percent of wages are calculated separately for each labor categor y. For example, for December 2008, the average wage rate for professional/technical 12 labor was $35.29; the aver age fringe benefit was $17.55. Fringe benefits as a percent of wages were $17.55/$35.29, or approximately 49.7 percent.

An additional loading factor of 17 percent is applied to wages to account for overhead. This approach is used for consistency with O ffice of Pollution Prevention and Toxics economic analyses for two major rulemakings: Wage Rates for Economic Analys es of the Toxics Release Inventory Program (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPAB, 2002). This overhead loading factor is added to the benefits loading factor, and the total is th en applied to the base wage to derive the fully loaded wage. For example, the December 2008 fully loaded wage for professional/technical labor is $35.29 × (1+0.4973 + 0.17) = $58.84.

Fully loaded costs for managerial, clerical , and production labor ar e calculated in a similar manner, as shown in Table B-1.

B.1.2 Derivation of Labor Rates for Industrial Hygienists

For industrial hygienists, wages were based on another BLS data series, Occupational Employment Statistics [OES], National Industry -Specific Occupational Employment and Wage
Estimates. OES data were used because ECEC data were not available for very specific occupations. However, the OES data covers only wages, not fringe benefits. Therefore, the Industrial Hygienist fringe benefits continue to be based on ECEC data. 13

The wage rate for Industrial Hygienists is a weighted average of the hourly mean wage for Occupational Health and Safety Specialists, Standard Occupational Classification (SOC) 29- 9011, and Occupational Health and Safety Technicians, SOC 29-9012, in Manufacturing. The wage rate for each occupation was weighted by employment for the occupation. The North American Industry Classificati on System (NAICS) codes for Manufacturing are 31, 32, and 33 (BLS, 2005). The calculations are shown in Table B-2.

As with other labor categor ies, the fringe benefits factor came from the BLS Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006 – December 2008 (BLS, 2009a). Benefits for “professional specialty and technical” occupations

12 This follows terminology introduced in EPAB, 2007a. Ea rlier SNUR economic analyses used the term “technical” labor. Here the category is called “professional/technical” la bor, to make clear how it relates to BLS categories. In 2004, BLS changed from the Occupational Classification System, OCS, to the Standard Occupational Classification system, SOC. In the process, the “P rofessional specialty and technical” category became the “Professional and related” category. However, the coverage of the old and new occupational groups is approximately the same. See the BLS article, C omparing Current and Former Industry and Occupation ECEC Series (Weinstein, 2004 ).

13 This follows the approach for calculating Industry Hygi enist wages introduced in EP AB, 2007a and is a change from the method used in earlier PMN SNUR economic reports such as EPAB, 2003, which used data from a 1997 professional journal salary survey.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 B-3 August 26, 2009 were used, and loaded wages were calculated as for other types of labor. An additional loading factor of 17 percent of wages was applied for overhead. Calculat ions are shown in Table B-1.

B.1.3 Derivation of Labor Rates for EPA Staff Agency labor costs are calculated based on a nnual Federal salaries for the WashingtonBaltimore area published by the Office of Personnel Management effective January 2008 (OPM, 2008). The average salary for one Full Time Equivale nt (FTE) staff is estimated as the salary for a GS-13 Step 5 employee. 14

Multiplying the annual pay by an assumed loading factor of 1.6 to reflect Federal fringe benefits and overhead, the load ed annual salary of EPA staff was calculated to be $150,440.

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

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

14 The GS-13 Step 5 is consistent with ICR No. 0574.14 (12/18 /2007), which covers PMN SNURs. Use of this grade level follows the approach introduced in EPAB, 2007a. That repor t represented a change from th e earlier PMN SNUR economic analysis (EPAB, 2003), which used an average of GS-12 Step 1 and GS-12 Step 10 salaries.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 B-4August 26, 2009Table B-1 Derivation of Loaded Wage RatesWageFringeBenefitFringes as% wageOver-head %wage2Fringe +overheadfactorLoadedWages1EPAB LaborCategoryData SourcesDate(a) (b) (c) =(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a) x (e)ManagerialBLSECEC, PrivateManufacturingindustries,“Mgt, Business, andFinancial”3Dec-08 $43.22 $19.46 45.03% 17% 1.62 $70.03Professional/TechnicalBLSECEC, PrivateManufacturingindustries, “Professional andrelated“3Dec-08 $35.29 $17.55 49.73% 17% 1.67 $58.84ClericalBLSECEC, PrivateManufacturingindustries,“Office andAdministrative Support”3Dec-08 $17.22 $8.33 48.37% 17% 1.65 $28.48ProductionWorkerBLSECEC, PrivateManufacturingindustries, “Production, transport,and material moving.”3Dec-08 $16.11 $8.71 54.07% 17% 1.71 $27.56IndustrialHygienistWage: BLS OES Occupat. Employ.and Wages,forManufacturing(NAICS 31, 32, 33), average of wagesforOccup. Health/ Safety Specialists(SOC 29-9011) andOccup.Health/Safety Technicians(SOC 29-9012), weighted by employment.4Fringes: BLSECEC, PrivateManufacturing industries,“Professional and related”3Wage:May-08Fringe:Dec-08$28.78 -- 49.73% 17% 1.67 $47.99Dec-08 $94,025(annual) --[Includedin 60%overhead]60% 1.6 $150,440EPA staffFTEAnnual Federal staff cost: OPMWashington-Baltimore-NorthernVirginia, DC-MD-PA-VA-WV, area,GS-13 Step 5 pay rates, with 60%overhead.5(annual)Notes:1Wage data are rounded to the closest penniesin this table; however, in calculationsusing these numbers for this report, unrounded values were used.2An overhead rate of 17% was used based on assumptions inWage Rates for Economic Analyses of the Toxics Release Inventory Program(Rice, 2002), and theRevised EconomicAnalysis for the Amended Inventory Update Rule: Final Report(EPAB, 2002).3Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006 – December 2008.US Bureau of Labor Statistics, March 12, 2009 (BLS,2009a).4Employment and unweighted wages are from BLSOccupational EmploymentStatistics (National Industry-SpecificEmployment and Wage Estimates),May 2008.5The salary is unloaded Federal GS-13 Step5 salary for calendar 2008, from the Officeof Personnel Management salary table forWashington-Baltimore-Northern Virginia (OPM,2008). The 60% fringes-and-overhead rate is from an EPA guide,Instructions for Preparing Information Collection Requests (ICRs)(OPPE, 1992, page 30, footnote 9).Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 B-5 August 26, 2009 Table B-2 Derivation of Industrial Hygienist Wage Rate (NAICS 31, 32, 33)

Employment Mean hourly wage Weight Weighted Wage 1 Occupation Title (SOC code)
(a) (b) (c) (d)=(c) X (b)

Occupational Health & Safety Specialists (29-9011) 7,520 $30.03 0.836 $25.09

Occupational Health & Safety Technicians (29-9012) 1,480 $22.45 0.164 $3.69

Industrial Hygienist (w eighted average) 9,000 -- 1 $28.78

Notes:

1 Wage data are rounded to the closest pennies in this tabl e; however, in calculations using these numbers for this report, unrounded values were used. Source: Employment and unweighted wages are for manufacturing (NAICS 31, 32, 33) from BLS Occupational Employment Statistics (Occupational Employment and Wages) , for May 2008 (BLS, 2 009b). The most recent published OES data when this report was prepared in June, 2009, was for May 2008.

B.2 Derivation of Inflation Factors

Costs of equipment and supplies were infl ated using the Consumer Price Index – All Urban Consumers; wages were inflated using the appropriate Employment Cost Index (ECI). Where both labor and equipment/supplies were involve d, we used the inflation factor corresponding to the dominant cost cate gory. For example, test costs include a mix of labor, equipment, and supplies. Assuming that the largest component of test costs comes from labor, we used the ECI for private indu stry, all workers. Complete information on the derivation of the inflation factor s used is given in Table B-3 below.

In 2006, the Bureau of Labor Statistics (BLS) made several changes to the Employment Cost Index. The changes ar e described on a BLS web page, “Change has come to the ECI,” (BLS, 2006c) and in several April 2006 Monthly Labor Review articles posted on the BLS web site: “Changes affecting the Employment Cost Index: an overview” (Caroll 2006); “Employment Cost Index Pub lication Plans” (Sleemi, 2006); and “Seasonal adjustment in the ECI and the convers ion to NAICS and SOC” (Branch, 2006).

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

In addition to changing the industry and o ccupational classification systems, in 2006, BLS rebased the ECI from June 1989 = 100 to December 2005 = 100 for all current and historical non-seasonally adju sted series, including the NAICS and SIC based series. (Seasonally adjusted indices, includ ing those in Table B-3 of this report, may not exactly equal 100 for December 2005 as a result of the seasonal adjustment. Seasonal adjustments are explained in Branch, 2006.)Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 B-6 August 26, 2009 According to BLS, the official ECI for th e years 1975-2005 is the SIC-OCS based series, and for subsequent years, the official ECI is the NAICS-SOC based series (Sleemi, 2006, p.8). 15

“Starting year” indices in Tabl e B-3 continue to be SIC-SOC based. Current year indices are NAICS-SOC based. We use indices from both the NAICS-SOC and the SIC-OCS based ECI series because neither series spans the entire period over which testing and other costs need to be inflated.

15 BLS has been publishing the NIACS-SOC ba sed ECI series since March 2001 and it be came official in March 2006. The SICOCS based series and NAICS-SOC series ha ve different series ID numbers, even wh en they describe essentially the same population. For example the series ID fo r seasonally adjusted total compensation for all private industry workers is ECS10002I

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

.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 B-7 August 26, 2009 Table B-3 Derivation of Inflation Factors

Item Inflation index source 1 Starting

year Index for starting

year (a) Index for 2008

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

Chemical testing (toxicity, ecological effects etc.) BLS ECI, SA, Total comp, Private industry , All Workers , 4 th Q [BLS 2006d and 2008b] varies varies 109.1 varies

White collar/other labor mix; equipment; supplies. Example for test costed in 1993 1993 66.5 109.1 1.641

Tests were first costed out in various years, depending on the test; inflation factors vary depending original cost date. Example for test costed in 2000 2000 83.8 109.1 1.302

Impermeability testing of gloves and other gear 3 BLS ECI, SA, Total comp, Private industry , All Workers , 4 th Q [BLS 2006d and 2008b] 1997 74.9 109.1 1.457

Export notification BLS ECI, SA, Total comp, Private industry, White Collar , 4 th Q [BLS 2006d and 2008c] 1992 63.2 109.4 1.731

Agency Extramural costs White collar labor; equipment; supplies BLS ECI, SA, Total comp, Private industry, White Collar , 4 th Q [BLS 2006d and 2008c] 1993 65.5 109.4 1.670

Labels, placards, gloves, eyewear, clothing, respirators, file cabinet BLS CPI, All urban consumers, not SA. CUUR0000SA0, Annual [BLS 2008a] 1997 160.5 215.303 1.341

Photocopies Record keeping materials BLS CPI, All urban consumers, not SA. CUUR0000SA0, Annual [BLS 2008a] 1988 118.3 215.303 1.820

Notes:

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

“Starting year” ECI indices are SIC-OCS based: ECS10002I for pr ivate industry All Workers, and ECS11102I for private industry White Collar Workers. The indices are Seasonally Adjusted (SA).

After 2006, ECI indices are NAICS-SOC based: CIS2010000000000I for private industry All Workers, and CIS2010000W00000I for private industry White Collar Workers. The indices are Seasonally Adjusted

. 2 Inflation factors are rounded to three decimal places in this ta ble, but calculations in this report use the unrounded values. BLS CPI values were published with one decimal place through 2006 and with th ree decimal places after that.

3 We began using the ECI for Private Industry All Workers in EPAB, 2007a, to better reflect the labor mix for impermeability testing. Earlier PMN SNUR economic anal yses used the ECI for Private Industry White Collar Workers.APPENDIX C

COSTS OF HAZARD COMMUNICATION, PR OTECTION IN TH E WORKPLACE, AND RECORDKEEPING REQUIREMENTSEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-1 August 26, 2009 APPENDIX C COSTS OF HAZARD COMMUNICAT ION, PROTECTI ON IN THE WORKPLACE, AND RECORDKEEPING REQUIREMENTS

Section 2.1 of the main text of this report discusses cost s of worker protection, hazard communication (haz-comm), and recordkeeping for SNURs. This appendix presents dollar costs and labor hours of these requirements, for one chemical at one site. Some requirements listed here may not be cited in the current rulemaking, but have been cited in past SNUR rulemakings.

The haz-comm costs reflect th e annual costs of updating th e written program, labeling for chemical distribution and storage, creating and di stributing material safety data sheets (MSDS), and employee training. The persona l protective equipment (PPE) costs reflect the annualized costs of providing required equipment (i.e., glov es, goggles, clothing, or re spirators), assessing dermal protection needs associated with the chemical, and performing required impermeability testing, and/or evaluating manufacturer’s inform ation. Finally, the annual recordkeeping costs include labor, photocopying, a nd record storage costs.

To estimate the costs of haz-comm, worker protection, and recordkeeping requirements, a number of assumptions were made, based on th e original EPA analysis for generic SNUR provisions, Economic Analysis of Final Significant Ne w Use Rule: General Provisions for New Chemical Followup (RIB, 1989). In that report, EPA estim ated that the number of workers exposed to any one substance would range from 10 to 25, and that a worker potentially would be exposed to a substance for a minimum of 50 days per year to a maximum of 250 days per year. The current analysis uses the high ends of those two ranges. Thus, each site is assumed to have 25 chemically-exposed workers requiring training and/or protective equipment, with each of them assumed to be exposed for 250 days per year.

Labor costs are derived from the United States Bureau of Labor Statistics sources as described in Appendix B. Mate rial costs were primarily obtained from a national safety equipment supply house catalog (LSS, 1997) and ar e inflated as described in Appendix B.

Costs of haz-comm, workplace protection, and recordkeeping are discussed in Sections C.1, C.2, and C.3, respectively. Table 4 and Table 6 in the main text summarize these costs by SNUR requirement.

C.1 Modifying the Hazard Communication Program

As mentioned in Section 2.1, it is assumed that each facility has in place a haz-comm program consistent with that required by OSHA’s Hazard Communication standard (29 CFR 1910; November 25, 1983), so that costs attributable to the S NUR are costs of adding one chemical to the program. Much of the haz-co mm methodology and assumptions came from the EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Followup (RIB, 1989), which in turn reli ed partly on the 1983 OSHA study, Final Regulatory Impact and Regulatory Flexibility An alyses of the Hazard Communication Standard OSHA, 1983).Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-2 August 26, 2009 It was assumed that the haz-comm costs woul d be incurred each year. For example, there would be worker turnover and need for refreshe r training, the MSDS would need revision due to changing information, placards would wear out (RIB , 1989). To the extent that some steps would not need repeating each year, costs could be lower than estimated here. The hazard communication costs summarized in Table 3 above are detailed here.

C.1.1 Updating the Written Program

If the SNUR cites 40 CFR §721.72(a), then to avoid engaging in a Significant New Use, which would trigger other SNUR requirements, manufacturers must update their written hazcomm program to incorporate information about th e chemical. The written part of the program includes data and information about hazardous chem icals present in the workplace, the hazards associated with such chemicals, procedures for employees who routinely work with or around such chemicals, procedures for non-routine task s that may involve exposure (e.g., tank cleaning), and personal protective equipment requirements wh en working with or around such chemicals.

While material safety data sheets may provide much of the information needed to update the written haz-comm program, many employers may perform a more detailed assessment of exposure risks associated with the chemical a nd develop more site-specific procedures for workers potentially exposed to such chemicals. For purposes of the economic analysis, EPA assumes that each employer will engage the servi ces of a professional industrial hygienist (IH), either in-house or on a consulting basis, for f our hours to perform such an assessment. Loaded hourly rates for IH services we re calculated based on Bureau of Labor Statistics data, as described in tables B-1 and B-2. Costs for th e written haz-comm program , in 2008 dollars, are as follows 16

4 hours Industrial Hygienist time × $47.99 per hour = $192

The estimates of IH hours to update the prog ram come from a 1998 EP A report (EPAB, 1998).

C.1.2 Labeling

If the SNUR cites 40 CFR §721.72(b), then to avoid engaging in a Significant New Use, manufacturers must ensure that co ntainers used to distribute the PMN substance in commerce are labeled with the necessary hazardous substance wa rnings and procedures. In addition, containers used in the workplace must bear similar labels or, alternatively, the employer must provide equivalent signage, operating pr ocedures, or other written ma terial to communicate hazard information to workers. The cost of providing such labeling was estimat ed in a 1989 EPA report (RIB, 1989) and has been updated here using more recent cost information.

Standard formats are assumed to be used fo r creating labels or other signage, and the information required for the labels is assumed to be already available from the MSDS for the chemical (see below).

16 Figures presented here are rounded.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-3 August 26, 2009 C.1.2.1 Chemicals Distributed in Commerce

For chemicals distributed in commerce, the labeling process is assumed to require 0.5 hours of technical labor time per ch emical to compile label information. It is assumed to require 480 labels per chemical. The assumption of 480 la bels per chemical is from a 1989 EPA report (RIB, 1989), and is based on the assumption that, on average, each chemical is shipped twice monthly to 20 customers. This is consistent with roughly 10,000 kilograms of chemical per year shipped in 40 five-gallon c ontainers per month (RIB, 1989). 17

Technical labor is fully loaded with fri nge benefits and overhead, as described in Appendix B. Labeling materials costs were obtai ned from a national safety equipment supply house catalog (LSS, 1997) and were inflated as de scribed in Appendix B. The resulting costs of labeling for chemicals distributed in commerce, pe r chemical substance at one site, are shown in Table C-1.

Table C-1 Annual Costs of Labeling for Distribution in Commerce [40 CFR §721.72(b)(2)]

Cost Element Unit Cost (1997 Dollars) Inflation Factor Unit Cost (2008 Dollars) Hours Total Cost

0.5 hours technical time -- -- $58.84 per hour 0.5 $29 480 labels $0.16 per label 1.341 $0.21 per label -- $103
TOTAL 0.5 $132

Note: Total costs were calculated using unrounded unit cost valu es and inflation factors (s ee Appendix B), so results may differ from calculations using the rounded values shown in this table. Source: 1997 label cost, EPAB 1998, LSS 1997; cost elements, quantities, RIB 1989; inflators, labor, Table B-1 and Table B-3.

C.1.2.2 Chemicals Used in the Workplace
Workplace labeling requirements are costed by assuming the facility purchases six large (14" × 10") signs, priced at $38 .30 each in 1997 dollars (LSS, 1997; EPAB, 1998). Costs of these signs were inflated as describe d in Appendix B. These signs will be mounted in areas where the chemicals are used or formulated. For example, a placard might be posted at each of six vessels: a mixing tank, a reactor, two se parators, and two storage vesse ls (RIB, 1989). The labeling process is also assumed to require 0.5 hours of technical time to compile label information and 10 minutes of production worker time to post each placard. Technical labor costs include wages, fringe benefits, and overhead, as described in Appendix B.

The resulting per chemical, per site costs of labeling for chemicals in the workplace are shown in Table C-2.

17 Data on PMN notices suggest that some PMN submitters expected to produce less than 10,000 kilograms per year of the SNUR chemicals, but many expected to produce much more. It is not known whether volumes listed in the PMNs were realized in practice. Production volumes of secondary suppliers affected by th e SNUR are also unknown. Annual volumes significantly greater than 10,000 kg could lead to higher haz-comm costs than those estimated here.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-4 August 26, 2009 Table C-2 Annual Costs of Labeling for Use in Workplace [40 CFR §721.72(b)(1)]

Cost Element Unit Cost (1997 Dollars) Inflation Factor Unit Cost (2008 Dollars) Hours Total Cost
0.5 hours technical time -- -- $58.84 per hour 0.5 $29

6 labels or placards (14" x 10") $38.30 per item 1.341 $51.38 per item -- $308

10 minutes per label/placard production worker time -- -- $27.56 per hour 1.0 $28

TOTAL 1.5 $365

Note: Total costs were calculated using unrounded unit cost valu es and inflation factors (s ee Appendix B), so results may differ from calculations using the rounded values shown in this table. Source: 1997 placard cost, EPAB, 1998, LSS, 1997; cost elements an d quantities, RIB, 1989; inflator s and labor unit costs, Table B-1 and Table B-3.

C.1.3 Preparing Material Safety Data Sheet (MSDS) Information

If the SNUR cites 40 CFR §721.72(c), then to avoid engaging in a Significant New Use, each facility is required to create, post, and dist ribute material safety data sheets (MSDSs). Based on estimates in OSHA 1983, the 1989 EPA report (R IB, 1989) has estimated that creation of an MSDS for a chemical substance requires 2.0 hours of technical la bor time and 0.25 hours of clerical time. Further, EPA assumes that the manufacturer provides 20 co pies of the MSDS to customers and retains 20 copies for use onsite, for a total of 40 copies (RIB, 1989). The loaded hourly wage rates and the inflator used in estimating unit photocopy costs are derived in Appendix B. The resulting cost of MSDS preparation is shown in Table C-3.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-5 August 26, 2009 Table C-3 Annual Costs for Material Safety Data Sheets (MSDSs) [40 CFR §721.72(c)]

Cost Element Unit Cost (1988 Dollars) Inflation Factor Unit Cost (2008 Dollars) Hours Total Cost

2.0 hours technical time -- -- $58.84 per hour 2 $118

0.25 hours clerical time -- -- $28.48 per hour 0.25 $7

40 copies $0.05 1.820 $0.09 per copy -- $4
TOTAL 2.25 $128

Note: Total costs were calculated using unrounded unit cost valu es and inflation factors (s ee Appendix B), so results may differ from calculations using the rounded values shown in this table. Source: Cost elements, quantities, and 1988 copy cost, RIB 1989 ; inflators and labor unit costs, Table B-1 and Table B3 C.1.4 Employee Training

The final required component of the haz-co mm program is employee training, based on 40 CFR §721.72(d). The 1989 EPA report, Economic Analysis of Fi nal Significant New Use Rules: General Provisions for New Chemical Follow-up (RIB, 1989), assumes that a training program currently is in place, but the existing pr ogram must be modified to add new information pertaining to the PMN substance. Subsequentl y, the training program must be expanded to include such material each time the training cour se is presented. Costs of modifying the program and presenting the modified program are mainly labor costs for the trainer and the trainees.

Inserting the new information about the PMN substance into the training program and conducting the revised training is assumed to require 0.5 hours of the trainer’s time. An additional 0.25 hours per trainee is estimated to be required, and an average of 25 affected workers is assumed per facility (RIB, 1989). If additional production workers needed to be trained, for example because they might come into contact with the chemical due to spills or leaks, training costs could be highe r than estimated here (RIB, 1989).

Labor rates for training are based on the loaded rates derived in Appendix B for chemical technicians and chemical industry production work ers. The total cost of the employee training requirement is shown in Table C-4.

Table C-4 Annual Costs for Employee Trai ning, Per Chemical [40 CFR §721.72(d)]

Cost Element Unit Cost (2008 Dollars) Hours Total Cost

0.5 hours technical time (trainer) $58.84 per hour 0.5 $29 0.25 hours per production employee X average of 25 workers per plant = 6.25 hours $27.56 per hour 6.25 $172

TOTAL 6.75 $202

Note: Total costs were calculated using unrounded values from (see Appendix B), so results may differ from calculations using the rounded values shown in this table. Source: Cost elements and quantities, RIB, 1989; labor unit costs, Table B-1.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-6 August 26, 2009 C.2 Protection in the Workplace

The following section estimates costs of a ssessing needs for dermal protection and evaluating protective gear for impermeability, as we ll as the costs of glove s, goggles, protective clothing, and respirators.

C.2.1 Dermal Protection Selection

If the SNUR cites 40 CFR §721.63(a)(1), then to avoid engaging in a Significant New Use, the employer must ensure that each person who is likely to experience dermal exposure to a PMN chemical, must be provided with and is re quired to wear personal protective equipment (e.g., gloves) that will prevent dermal exposure to the substance. The equipment must be selected and used in accordance with 29 CFR § § 1910.132 and 1910.133 (promulgated by the Occupational Safety and Health Administration, OSHA). The se lection and administration of this dermal protection is estimated to require 10 hours labor by an industrial hygienist, annually (EPAB, 1999). The wage rate of the hygienist wa s calculated as described in Appendix B. The cost calculations for the dermal protection sele ction requirement are given in Table C-5. This covers only costs of selecting the dermal protect ion needed, not costs of the items themselves. For costs of purchasing dermal protective items , see the sections below on costs of gloves, eyewear, and clothing.

Table C-5 Annual Costs for Dermal Protection Selection [40 CFR §721.63(a)(1)]

Cost Element Unit Cost (2008 Dollars) Hours Total Cost 1

10 hours industrial hygienist (IH) time $47.99 per hour 10 $480

Notes: Total costs were calculated using unrounded values (see Appendix B), so results may differ from calculations using the rounded values shown in this table. Source: Labor rates, Table B-1; cost elements and quantities, EPAB, 1999.

C.2.2 Impermeability Testing
As part of the workplace protection requi rements specified under 40 CFR §721.63(a)(3), to avoid engaging in a Significant New Use, the SNUR may require that employers demonstrate that each item of protective equipment provided (e.g., gloves) provides an impervious barrier, to protect employees from dermal exposure. Re quirements outlined in §721.63(a)(3) are provided in two parts, §721 .63(a)(3)(i) and (ii). The employe r may use a combination of (i) testing and/or (ii) evaluating manufacturer specifications . The following discussion is based on the Economic Analysis of Expedited Significant Ne w Use Rules for 168 Chemical Substances and Background Support Document for Economic Analysis of Significant New Use Rules (EPAB, 1998) and assumes that the manufacturer uses both testing and evaluation of manuf acturer specifications. The analysis assumes that costs are incurred annually.

The first step, described at 40 CFR §721.63(a)(3)(i), is to perform actual impermeability testing. To determine the costs of impermeab ility testing compliance, Best ManufacturingEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-7 August 26, 2009 Company, a leading manufacturer and tester of chemical resistant articles, was consulted (Best, 1997).

As described in EPAB, 1998, Best used one of two methodologies for impermeability testing. In the first method, chemical samples were submitted to Best with a specific article to be tested for impermeability. This method was cheaper, costing $200 per chemical, but the burden of finding an appropriate article of protection lay with the chem ical manufacturer. In the second method, the chemical manufacturer simply submitted chemical samples to Best, who in turn determined the most appropriate product, even if a competitor manufactured the product. This method was more costly at $800 per chemical.

The second method of impermeability testing is favored in this analysis for several reasons. First, the burden of finding and submitting an article of protection is shifted from the chemical manufacturer to the testing company, who would have greater experience in Personal Protective Equipment (PPE) selection. Second, should the article submitted fail the impermeability test, other articles may have to be submitted until satisfactory test results are obtained. Furthermore, substances subject to SNURs may include new and/or rare chemicals, which may have undiscovered or unknown propertie s. This uncertainty may impede chemical manufacturers’ ability to effec tively submit appropriate PPE articl es for testing. Finally, the first method is essentially a pass-fail test. If an ar ticle passes the impermeability test, then it is acceptable. In the second method, several articles may be tested and compared, and, while one or more acceptable articles may result, the most impe rmeable article is always determined for the chemical. To obtain the best article rather than merely a sati sfactory article of protection, the second method of testing is more appropriate. For these reasons, unit costs of $800 per chemical (1997 dollars) are assumed for impermeability testi ng. The cost of the impermeability testing is assumed to be driven by labor costs of the comp any performing the testing, thus test costs were inflated with an Employment Cost Index as desc ribed in Appendix B. The administration of this test would also require two hours of i ndustrial hygienist la bor (EPAB, 1999).

The second step to compliance with th e workplace protection requirements at §721.63 (a)(3)(ii) is the evaluation of specifications from the ma nufacturer or supplier of the protective equipment. This requirement helps ensure that the protective equipment will be impervious to the PMN chemical(s). The evalua tion of manufacturer sp ecifications requires an estimated four hours of industrial hygienist labor.

Annual costs of the impermeability testing requirements are presented in Table C-6.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-8 August 26, 2009 Table C-6 Annual Costs of Impermeability Testing [40 CFR §721.63(a)(3)]

Cost Element Unit Cost (1997 Dollars) Inflation Factor Unit Cost (2008 Dollars) Hours Total Cost 1 Impermeability Testing [§721.63(a)(3)(i)] Impermeability Test $800 per chemical 1.457 $1,165 per chemical $1,165

$47.99 per hour 2 $96 Industrial Hygienist time

Subtotal 2 $1,261

Evaluation of Manufacturer's Specifications [§721.63(a)(3)(ii)]

$47.99 per hour 4 $192 Industrial Hygienist time

Subtotal 4 $192 TOTAL 6 $1,453

Notes:

1 Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded values shown in this table. Source: 1997 costs, Best, 1997; cost elements and quantities, EPAB, 1998 and EPAB, 1999; inflators and labor rates, Table B-1 through Table B-3.

C.2.3 Gloves

If the SNUR cites 40 CFR §721.63(a)(2)(i), then gloves must be worn to avoid engaging in a Significant New Use. Gloves may also be acquired as a result of the dermal protection selection at §721.63 (a)( 1). If standard, disposable medical-grade gloves are used, they are assumed to be worn and discarded by th e worker following each day of exposure. Each site is assumed to have 25 workers, each of them exposed 250 days per year. This reflects the high-side assumptions in RIB, 1989 (page 25) for the number of workers and exposure days. Each pair was estimated to cost $0.43 in 1997 (LSS, 1997); the cost has been inflated as described in Appendix B. Total annual costs of providing disposable gloves are developed by applying the assumptions above regarding the nu mber of workers exposed (25 per site) and frequency of replacement (one pair per worker per day of exposure H 250 days of exposure per year). For some chemicals, heavy-duty gloves may be used. They are generally not disposed of daily, but are more expensive. The estimated costs of gloves purchased in compliance with SNUR Personal Protective Equipment requirement s are presented below in Table C-7. The cost estimates for each chemical assume that the more expensive heavy-duty gloves are used in cases where the SNUR explicitly requires gloves.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-9 August 26, 2009 Table C-7 Annual Cost of Gloves [40 CFR §721.63(a)(2)(i)]

Cost Element Unit Cost ($1997 per pair) Inflation Factor Unit Cost ($2008 per pair) Number of Pairs Required 1 Total Cost ($2008) 2

Disposable nitrile gloves (replaced daily) $0.43 1.341 $0.58 6,250 $3,605

Heavy duty butyl gloves (replaced every 25 work days) $34.00 1.341 $45.61 250 $11,402

Notes:

1 The analysis assumes that 25 work ers who are exposed 250 days/year repl ace disposable gloves daily and replace heavy duty gloves every 25 work days.

2 Total costs were calculated using unrounded unit cost values and inflation factors (Table B-3), so results may differ from calculations using the rounded values shown in this table. Source: 1997 item costs, LSS, 1997; item type and quantity, EPAB, 1998; inflator, Table B-3.

C.2.4 Eyewear

If the SNUR cites 40 CFR § 721.63(a)(2)(iii), then to avoid engaging in a Significant New Use, employer must provide eye protection. Eye protection may also be acquired as a result of the dermal protection selection at §721.63 (a)( 1). Protective goggles are expected to be used at a rate of one set per worker and replaced every four months. Each site is assumed to have 25 workers, each of them exposed 250 days per year . The SNUR may not specify the exact type of eyewear required. OSHA guidelines in 29 CFR § 1910.133 (b)( 1), however, state that protective eye and face devices purchased af ter July 5, 1994 shall comply with ANSI Z87.1- 1989. To determine the cost of goggles that meet this standard, EPA consulted with eyewear specialists at equipment supplier LSS. A sta ndard pair of goggles that meets the ANSI Z87.1- 1989 specification was priced at $4.05 per pa ir in 1997 (LSS, 1997; RIB, 1998). A price estimate for a heavy-duty pair of goggles compliant with the ANSI standard is also included in Table C-8.

The cost estimates for each chemical assu me that the more expensive heavy-duty goggles are used in cases wher e the SNUR explicitly requires goggles. Costs of protective eyewear were inflated as described in Appe ndix B and are presented in Table C-8 below.

Table C-8 Annual Cost of Protective Eyewear [40 CFR §721.63(a)(2)(iii)]

Cost Element Unit Cost ($1997 per pair) Inflation Factor Unit Cost ($2008 per pair) Number of Pairs Required 1 Total Cost 2

Standard Goggles $4.05 1.341 $5.43 75 $407
Heavy duty chemical-splash/impact goggles $6.05 1.341 $8.12 75 $609

Notes:

1 The analysis assumes 25 workers repl acing goggles three times per year.

2 Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded values shown in this table. Source: 1997 item costs, LSS, 1997; item type and quantity, EPAB, 1998; Inflator, Table B-3.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-10 August 26, 2009 C.2.5 Clothing

Costs for a standard coverall clothing set, estimated at $36.25 in 1997 (LSS, 1997), were
inflated as described in A ppendix B and are shown in Table C-9 below. Costs for full-body protective clothing are based on the coverall clothing set with a hood (LSS, 1997) as shown in Table C-9.

If the SNUR cites 40 CFR §721.63(a)(2)(ii) or (iv), then to avoid engaging in a Significant New Use, employers must provide protective clothi ng. Protective clothing may also be acquired as a result of the dermal protecti on selection at §721.63(a)(1 ). Protective clothing, (a)(2)(iv), and full-body chemical resistant clothing, (a)(2 )(ii), are assumed to last four months. Each site is assumed to have 25 workers, each of them exposed 250 days per year.

Table C-9 shows estimated costs, after infl ating as described in Appendix B, for a standard coverall clothing set that cost $36.25 in 1997 (LSS, 1997) and for full-body protective clothing – the coverall clothing set with a hood – costing $61.20 in 1997 (LSS, 1997).

Table C-9 Annual Cost of Protective Clothing [40 CFR §721.63(a)(2)]

Cost Element Unit Cost ($1997 per set) Inflation Factor Unit Cost ($2008 per set) Number Required 1 Total Cost 2

Coverall with hood [full-body clothing] §721.63(a)(2)(ii) $61.20 1.341 $82.10 75 $6,157

Coverall §721.63(a)(2)(iv) $36.25 1.341 $49.63 75 $3,647

Notes:

1 The analysis assumes 25 workers repl acing coverall three times per year.

2 Totals were calculated using unrounded unit cost values and inflation factors (see Table B-3), so results may differ from calculations using the rounded values shown in this table. Source: 1997 item costs, LSS, 1997; item type and quantity, EPAB, 1998; inflation factor, Table B-3.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-11 August 26, 2009 C.2.6 Respirators

For some PMN chemicals, to avoid enga ging in a Significant New Use, the SNUR requires either the use of re spirators or compliance with a New Chemical Exposure Limit (NCEL). Both requirements differ by chemical. 18 18 For costing purposes, this analysis assumes that respirators are used. Earlier, PMN SNUR s referenced specific paragraphs at 40 CFR §721.63 (a)(5) that identified fifteen types of NI OSH-approved respirator units. However, with rulemaking docket OPPT-2003-0063 (EPAB, 2007a), PMN SNURs began to describe respirator choices directly. Costs of the SNUR respirator choices were estimated based on the costs of the respirator in §721.63 (a)(5) that appeared to best match the SNUR descriptions.

18 EPA’s website at http://www.epa.gov/oppt/newchems/pubs/ncelmain.htm explains that in Consent Orders and subsequent SNURs, EPA can require respirators unle ss workplace air measurements show that air-borne concentrations of the chemical are below a New Chemical Exposure Limit established by EPA to protect health. NCEL provisions are modeled after Occupational Safety an d Health Administration Permissible Exposure Limits (PELs), and also cover sampling and analytical methods, monitoring, respiratory protection, and recordkeeping.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-12 August 26, 2009 Table C-10 Crosswalk Between SNUR Text a nd Respirator Types at 40 CFR §721.63(a)(5)

Respirator types at 40 CFR §721.63 (a)(5) 1 Requirement Stated in SNUR (exact SNUR wording may differ)

(ii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting facepiece.

Some SNURs may specify “full” facepiece

Some SNURs may specify “or other positive pressure mode” Supplied-air respirator oper ated in pressure demandor continuous flow mode and equipped with a tightfitting full facepiece.

Supplied-air respirator oper ated in pressure demand or other positive pressure mode and equipped with a tight-fitting full facepiece

(iii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-fitting facepiece.

Some SNURs may specify “half” or “full” facepiece. Supplied-air respirator oper ated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-fitting facepiece (either half- or full-face).

(iv) Category 21C air-purifying respirator equipped with a full facepiece and high effici ency particulate filters.

Some SNURs may specify a “half" or "full" facepiece.

Some SNURs may specify “if oil aerosols absent” or other restrictions related to oil aerosols. Air-purifying respirator equipped with a tight-fitting full facepiece and High Effi ciency Particulate Air (HEPA) filters.

Air-purifying, tight-fitting respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters (either half- or full-face).

Air-purifying, tight-fitting re spirator (either half- or full-face) equipped with N100 (if oil aerosols absent), R100 (restricted use when oil aerosols present), or P100 (appropriate when oil aerosols present) filters

. Air-purifying, ti ght-fitting full facepiece respirator equipped with combination organic gas/vapor P100cartridges (organic vapor, acid gas, or substancespecific).
(v) Category 21C powered air-purifying respirator equipped with a tight-fitting facepiece and high efficiency particulate filters.

Some SNURs may specify a “half" or "full" facepiece. Powered air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.

Powered air-purifying respirator equipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters.

(vi) Category 21C powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate filters. Powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters.

Notes:

1 The table specifies respirator types at 40 CFR §721.63 (a)(5) that are most similar to the equipment described in the SNUR text for the current and recent SNUR rulemakings. Any significant differences between the specified respirator type at 40 CFR §721.63 (a)(5) and the SNUR text respirator type are noted in italics.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-13 August 26, 2009 Table C-11 gives average costs of various respirator types, both as originally estimated in 1997 and after applying inflation factors from Table B-3. It also estimates costs per plant site for a ch emical requiring respirators.

The respirators specified in the SNURs are typically comprised of a respirator unit and any number of the following: special cartr idges (such as high efficiency particulate filters, organic vapor cartridges, and paint, lacquer, and enamel filters), hoods or helmets, and filter caps. The costs for each site of providing respirator s to chemically-exposed workers, shown in Table 4 of Section 2 of the report, are calculated based on the assumptions stated there, that (1) there are 25 chemically-exposed workers requiring protective equipment, (2) respirators are replaced once a year, and (3) car tridges (and cartridge filters and caps) are replaced at a rate of one pair (two cartridges) every five of the 250 days that workers are exposed, or 50 times per year. For example, fo r the respirator type described at 40 CFR §721.63(a)(5)(xv), the annual cost per worker in 1997 dollars would be as follows:

$10.83 per respirator + ($8.94 per cartridge × 50 cartridges/year) = $457.83 per worker.

The 1997 cost was adjusted for inflation as shown in Table C-11.

Typically a SNUR describes more than one type of respirator, but only one type of respirator is needed to comply with the workplace protection requirements.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-14August 264, 2009Table C-11 Annual Per-Chemical Costs forRespiratory Protection [40 CFR §721.63(a)(4)]Annual Average Costs(1997 Dollars)Annual Average Costs(2008 Dollars)1§721.63(a)(5)par.NIOSH approval type at 40 CFR §721.63 (a)(5)(See Table C-10 for cross-walk to respirators in SNUR)RespiratorUnitCartridgeSetPerWorker2InflationFactorAnnual PerWorkerAnnual Per Site(25 workers)3(i)19C Type C Supplied-air with full facepiece$804 $0.00 $804 1.341 $1,079 $26,964(ii)19C Type C Supplied-airwith tight-fitting facepiece$804 $0.00 $804 1.341 $1,079 $26,964(iii)19C Type C Supplied-airwith hood or helmetor tight-fitting facepiece$932 $0.00 $932 1.341 $1,250 $31,261(iv)21C Air-purifying with full facepiece andhigh efficiency particulate filters(HEPAs)$181 $9.76 $669 1.341 $897 $22,425(v)21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs$627 $35.50 $2,402 1.341 $3,223 $80,569(vi)21C PAPR with loose hood or helmet and HEPAs$525 $26.89 $1,870 1.341 $2,508 $62,711(vii)21C Air-purifying with HEPA and disposable respirators$12.53 $7.00 $363 1.341 $486 $12,158(viii)23C air-purifying with full facepieceand combination cartridges approvedfor paints, lacquers and enamels (PLE)$192 $15.71 $978 1.341 $1,311 $32,782(ix)23C PAPR with tight-fitting facepieceand combination cartridges approvedPLE$627 $35.50 $2,402 1.341 $3,223 $80,569(x)23C PAPR with loose-fitting hood or helmet and combination cartridges forPLE$525 $26.88 $1,869 1.341 $2,508 $62,694(xi)23C Air-purifying with combination cartridges for PLE, includingdisposable respirators$14.30 $8.90 $459 1.341 $616 $15,403(xii)23C Air-purifying with full-facepieceand organic gas/vapor cartridges$192 $10.47 $716 1.341 $960 $23,996(xiii)23C PAPR with tight-fitting facepieceand organic gas/vapor cartridges$826 $41.15 $2,884 1.341 $3,869 $96,715(xiv)23C PAPR with a loose-fitting hood or helmet and organic gas/vaporcartridges$640 $41.15 $2,697 1.341 $3,618 $90,457(xv)23C Air-purifying with organic gas/vapor cartridges, including disposablecartridges$10.83 $8.94 $458 1.341 $614 $15,354Notes:1Annual average costs were inflated asdescribed in Table B-3.2“Respirator unit” costs include both the respirator and any required add-ons such as hoods and helmets. A “cartridge set” includes two cartridges and any filters or capsrequired. Assumes cartridge sets are replaced every five days (50 times during 250 exposure days) so that each worker requiresone respirator unit and 50 cartridge sets per year.3Totals were estimated from unrounded unit costs and inflation factors, so results may differ from calculations using the rounded values shown in this table.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-15 August 26, 2009 Table C-12 shows how the average costs per NIOSH-type respirat or were calculated, based on prices of respirators lis ted in a 1997 catalog. To calculate the cost of respirators that meet the NIOSH criteria, the prices of all units in the supplier cat alog (LSS, 1997) that meet each NIOSH criteria were averaged. Costs of additiona l items such as hoods, helmets, cartridges, and filter caps were also obtained. These are added to th e cost of the basic respirator unit if they are required under the SNUR regulation and if th e unit does not already include the item. For example, §721.63(a)(5)(x) requires a hood or helmet. One model in the catalog that satisfies the requirement already includes a hood, while anot her unit requires that a separate hood be purchased. The cost of the hood was added to th e unit cost and the combined cost was then averaged with the model with integrated hood.

Many respirator specifications also require cartridges. The co sts of the cartridges listed in LSS (1997) were averaged for the correspondi ng requirements. In some instances, certain cartridges or filters require a secondary cartridge to function properly (e.g. , some paint, lacquer and enamel filters required the organic vapors cartridges and filter retainer caps). These additional items were priced and added to the cost for the basic cartridge before averages were taken.

Some cartridge prices were unavailable fr om LSS (1997). For instance, §721.63(a)(5)(ix) and (x) require a powered air-purifying respirator (PAPR) with a paint, lacquer and enamel cartridge. The only cartridges available for these models of respirators in LSS (1997) are HEPA cartridges. In these cases the costs of a paint, l acquer, and enamel cartridge are assumed to be the same as for a HEPA cartridge.

The 1997 purchase costs of the varying types of respiratory protective equipment are shown in Table C-12.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-16 August 26, 2009 Table C-12 Respirator Prices and Average Costs in 1997, by NIOSH Type

40CFR 1997 Average Cost 2

§ 721.63

(a)(5) NIOSH Type Catalog Item Number Description 1 1997 Cost Respirator Unit Cartrid g e Set 19C Type C Supplied-air with full facepiece $804 -- 7A-24506 Allegro Economical Full- Face Airline Kits, p144 $758.95 (i) 7A-32366 311Survivair Supplied Air Respirator Kits, p144 $849.10 19C Type C Supplied-air with tight-fitting facepiece $80 -- 7A-24506 Allegro Economical Full- Face Airline Kits, p144 $758.95 (ii) 7A-32366 Survivair Supplied Air Respirator Kits, p144 $849.10 19C Type C Supplied-air with hood or helmet or tight-fitting facepiece $932 -- (iii) 7A-29363 Allegro Hood Systems, p144 $932.15 21C Air-purifying with full fa cepiece and high efficiency particulate filters (HEPAs) $181 $10 7A-9838 North Full-Face Respirator, p114 $210.10 7A-7122 North HEPA Cartridge, p115 $11.15
7A-12338 Willson Fu ll-Face Silicone Respirat or, p116 $215.10 7A-7526 Willson HEPA Cartridge, p117 $11.75
7A-10516 3M 7800 Fu ll-Facepiece Respirator , p118 $202.10 7A-11839 3M HEPA Cartridge, p118 $7.00
7A-33446 Pro-Tech Full-Face Respirator, p122 $106.45 7A-3070-1 Pro-Tech HEPA Cartridge, p123 $9.87
7A-3195 Willson 1600/1700 Se ries Full-Face Respirators, p124 $215.10

7A-3202 Willson HEPA Cartridge, p125 $12.50

7A-23959 AO7Star Fu ll-Face Respirator (Silicone), p126 $203.25 7A-9940 AO7Star HEPA Cartridge, p127 $9.44 7A-24158 MSA Advantage 1000 Full- Face Respirator, p1 34 $112.60 (iv)

7A-29946 MSA HEPA Cartridge, p134 $6.60 21C Powered air-purifying (PAPR) with ti ght fitting facepiece and HEPAs $627 $36 7A-13599 3M Face-Mounted PAPR System, p142 $720.00 7A-13601 3M HEPA Replacement Cartridge, p142 $36.50 7A-32505 RACAL Powerflow PAPR, p142 $534.90 (v)

7A-11936 RACAL Replacement Cartridge, p142 $34.50 21C PAPR with loose hood or helmet and HEPAs $525 $27 7A-32506 RACAL Air-Mate PAPR 12, p143 $411.05 7A-24505 RACAL HEPA Replacemen t Cartridge, p143 $24.65 7A-32477 RACAL Breathe-Easy HEPA Cartridges and Turbo Unit, p141 $548.50

7A-12838 RACAL HEPA Repl acement Cartridge $29.12 (vi)

7A-12840 RACAL Breathe-Easy 10 Tyvek Hood, p140 $91.30 21C Air-purifying with HEPA and disposable respirators $13 $7 7A-15255 3M 6000 Series Low-Maintenance Respirator, p135 $10.90 7A-12518P 3M Adaptor, p135 $1.63 (vii) 7A-11839 3M HEPA Cartridge, p135 $7.00Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-17 August 26, 2009 40CFR 1997 Average Cost 2

§ 721.63

(a)(5) NIOSH Type Catalog Item Number Description 1 1997 Cost Respirator Unit Cartrid g e Set 23C air-purifying with full facepiece and combination cartridges approved for

p aints, lacquers and enamels (PLE) $192 $16

7A-9838 North Full-Face Respirator, p114 $210.10 7A-7117 North Organic Vapors Cartridge, p115 $10.50 7A-7125 North Paint Spray/Mists Prefilter, p115 $2.38 7A-7125-2 North Filter Covers, p115 $4.35
7A-12338 Willson Fu ll-Face Silicone Respirat or, p116 $215.10 7A-7527 Willson Organic Vapors Cartridge, p117 $10.25
7A-7531 Willson Dusts/Mists/Pe sticides/Paint Spray Prefilter, p117 $2.52

7A-7532 Willson Retainer Caps, p117 $4.00
7A-10516 3M 7800 Fu ll-Facepiece Respirator , p118 $202.10 7A-9279 3M Organic Vapors Cartridge, p119 $8.91 7A-9284 3M Paint Spray Prefilter, p119 $2.37 7A-9292 3M Retainer Caps, p119 $3.90
7A-33446 Pro-Tech Full-Face Respirator, p122 $106.45 7A-955-4 Pro-Tech Organic Vapors Cartridge, p123 $9.27 7A-9605 Pro-Tech Paint Sp ray Prefilter, p123 $1.95
7A-3195 Willson 1600/1700 Se ries Full-Face Respirators, p124 $215.10

7A-3197 Willson Organic Vapors Cartridge, p125 $11.22 7A-3203 Willson Pesticides/Paint Spray Prefilter, p125 $3.36 7A-3858 Willson Retainer Caps, p125 $4.27
7A-23959 AO7Star Fu ll-Face Respirator (Silicone), p126 $203.25 7A-9935 AO7Star Organic Vapors Cartridge, p127 $8.76 7A-10043 AO7Star Dusts/Mists/Paint Spray Prefilter, p127 $3.07 (viii)

7A-10044 AO7Star Retainer Clips, p 127 $3.20 23C PAPR with tight-fitting facepiece and comb ination cartridges approved PLE $627 $36 7A-13599 3M Face-Mounted PAPR System, p142 $720.00 --- Paint, Lacquer, Enamel Cartridge 3 $36.50 7A-32505 RACAL Powerflow PAPR, p142 $534.90 (ix)

--- Paint, Lacquer, Enamel Cartridge 3 $34.50 23C PAPR with loose-fitting hood or helmet an d combination cartridges for PLE $525 $27 7A-32506 RACAL Air-Mate PAPR 12, p143 $411.05 --- Paint, Lacquer, Enamel Cartridge 3 $24.65 7A-32477 RACAL Breathe-Easy HEPA Cartridges and Turbo Unit, p141 $548.50

7A-12840 RACAL Breathe-Easy 10 Tyvek Hood, p140 $91.30 (x)

--- Paint, Lacquer, Enamel Cartridge 3 $29.10 23C Air-purifying with combination cartridges for PLE, including disposable respirators $14 $9

7A-12711 Willson Freedom 2000 Series Organic Vapors Respirator, p136 $17.85

7A-7531 Willson Dusts/Mists/Paint Spray/Pesticides Prefilter, p136 $2.52 (xi)

7A-13509 Willson Retainer Caps, p136 $2.03Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-18 August 26, 2009 40CFR 1997 Average Cost 2

§ 721.63

(a)(5) NIOSH Type Catalog Item Number Description 1 1997 Cost Respirator Unit Cartrid g e Set 7A-33826 Moldex 8000 Series Half-Mask Respirator, p139 $10.75 7A-22751 Moldex Organic Vapors Cartridge, p139 $8.03 7A-22753 Moldex Paint Spray/Pe sticides Prefilter, p139 $2.56 7A-22754 Moldex Retainer Caps, p139 $2.65 23C Air-purifying with fu ll-facepiece and organic gas/ vapor cartridges $192 $10 7A-9838 North Full-Face Respirator, p114 $210.10 7A-7117 North Organic Vapors Cartridge, p115 $10.50
7A-12338 Willson Fu ll-Face Silicone Respirat or, p116 $215.10 7A-7527 Willson Organic Vapors Cartridge, p117 $10.25
7A-10516 3M 7800 Fu ll-Facepiece Respirator , p118 $202.10 7A-9279 3M Organic Vapors Cartridge, p119 $8.91 7A-9292 3M Retainer Caps, p119 $3.90
7A-33446 Pro-Tech Full-Face Respirator, p122 $106.45 7A-955-4 Pro-Tech Organic Vapors Cartridge, p123 $9.27
7A-3195 Willson 1600/1700 Se ries Full-Face Respirators, p124 $215.10

7A-3197 Willson Organic Vapors Cartridge, p125 $11.22
7A-23959 AO7Star Fu ll-Face Respirator (Silicone), p126 $203.25 (xii)

7A-9935 AO7Star Organic Vapors Cartridge, p127 $8.76 23C PAPR with tight-fitting facepiece and or ganic gas/vapor cartridges $826 $41 7A-32473 RACAL Breathe-Easy Organic Vapors and Turbo Unit, p141 $548.50

7A-12844 RACAL Breathe-Easy 7 Full Face, p140 $277.90 (xiii)

7A-12830 RACAL Organic Vapors Replacement Cartridges, p141 $41.15

23C PAPR with a loose-fitting hood or helmet and organic gas /vapor cartridges $640 $41 7A-32473 RACAL Breathe-Easy Organic Vapors and Turbo Unit, p141 $548.50

7A-12840 RACAL Breathe-Easy 10 Tyvek Hood, p140 $91.30 (xiv)

7A-12830 RACAL Organic Vapors Replacement Cartridges, p141 $41.15

23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges $11 $9

7A-15255 3M 6000 Series Low-Maintenance Respirator, p135 $10.90 7A-15256 3M Organic Vapors Cartridge, p135 $9.85 7A-33826 Moldex 8000 Series Half-Mask Respirator, p139 $10.75 (xv)

7A-22751 Moldex Organic Vapors Cartridge, p139 $8.03

Notes:

1 See Table C-10 for the cross-walk between respirator ty pes in the SNUR and in this table .

2 Average costs presented in this table are rounded to the nearest dollar figure, so results may differ from calculations using the rounded values shown in this table.

3 Paint, lacquer and enamel (PLE) ca rtridges for PAPRs were not listed in the catalog. The costs for PLE cartridges are assumed to be the same as HEPA cartridges. Source: LSS 1997; EPAB 1999Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-19 August 26, 2009 C.3 Recordkeeping

There are two main types of recordkeeping re quirements for the substances listed in the current SNURs: those for companies submitting a SNUN, and those for all companies that manufacture, import or process SNUR-regulated substances, regardless of whether they have made a submission to EPA.

SNUN submitters

Companies submitting a SNUN must keep records under 40 CFR §721.40. Some EPA reports have assumed that SNUN recordkeeping hours would be 5 percent of SNUN submission hours, or about 5 to 6 hours. 19 For this report, the SNUN reco rdkeeping hours were included in the SNUN submission hours (see Appendix E) and the SNUN recordkeeping cost was not separately estimated. 20

All manufacturers, importers, and processors

Whether or not they submit a SNUN, firms that manufacture, import, or process the SNUR substance must keep records based on 40 CFR §721.125(a) throug h (k), to document compliance with SNUR conditions for avoiding a Significant New Use. (For firms producing under the R&D exemption, R&D recordkeeping w ould be needed. R&D recordkeeping costs were not estimated for this report.)

Recordkeeping requirements vary between PMN chemicals, reflecting differences in SNUR restrictions. For all chemicals in the current SNURs, manufact urers, importers, and processors must keep record s on quantities supplied or pur chased under 40 CFR §721.125(a), (b), and (c). For chemicals with water discha rge restrictions, compan ies must keep records concerning water discharge compliance, under §721.125(k). For chemicals with other use restrictions, or for those few chemicals w ith workplace protection or hazard communication restrictions, companies must keep records under other 40CFR §721.125 paragraphs, to document compliance.

All recordkeeping requirements essentially involve copying and filing relevant records, including those related to: manufacturing, impor ting, or processing volumes; shipment amounts and customer information; clothing impermeability determinations; the hazard communication

19 For example, OPPT’s Information Collection Request (ICR) for TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (Renewal), October 11, 2005, estimates SNUN reco rdkeeping costs at 5.67 hours (ICR 118.08, page 12).

20 SNUN submission costs estimated in Appendix E of this report were based on PMN submission costs from a 1994 report, Regulatory Impact Analysis of Amendments to Regu lations for TSC Section 5 Premanufacture Notifications (RIB, 1994). Page III-14 of the 1994 report refers to “the normal records kept with a PMN submission which are included in the estimates for submission costs.” Page III-12 identifies “maintaining a file of the submission” as part of the labor hours for the PMN reporting form. These statements imply that the 95 to 114 total hours for a PMN submission (page III-10 of RIB 1994) included recordkeeping hours.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-20 August 26, 2009 program including labels and MSDS copies; comp liance with other use restrictions; and/or compliance with disposal and release to water lim itations. Records must be maintained for five years from the date of their creation.

Costs for compliance with the recordkeeping requirements for substances subject to a SNUR are based on the approach in Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Followup (RIB, 1989) which in turn was based on Recordkeeping Costs for a Generic SNUR , prepared for EPA in 1988 by Kearney/Centaur (Kearney, 1988a). These reports drew on recordkeeping costs es timated for the Comprehensive Assessment Information Rule, CAIR. Industry re cordkeeping costs for CAIR compliance were estimated in reports Kearney prepared for EPA, including Estimated Cost of the Final Comprehensive Assessment Information Rule , June 1, 1988 (Kearney, 1988b, pages 63 to 65).

This report uses the basic Kearney (1988a and 1988b) esti mates and assumptions to estimate recordkeeping costs for SNUR requirements. 21 Unlike Kearney (1988a), this report presents costs for each §721.125 recordkeeping require ment separately. This report also avoids minor rounding errors by cal culating from unrounded data. However, the underlying methodology is identical to the Kearney 1988a/RIB 1989 reports, resulting in identical costs per chemical except for differences due to inflat ion and rounding. The paragraphs that follow describe estimates and assumptions used from Kearney (1988a and 1988b).

Cost per page

Recordkeeping costs are based on cost per pa ge. Kearney (1988a) assumes that the ratios of labor hours to page count for each labor categor y, file drawer space to page count, and cost of miscellaneous supplies such as folders and labels to page count, are the same as the per-page ratios estimated for EPA’s Comprehensive Assessment and Reporting Rule. The CAIR estimates are given in the 1988 report, Estimated Cost of the Final Comprehensive Assessment Information Rule , June 1, 1988, page 65 (Kearney, 1988b). Table C-13 summarizes estimates from Kearney 1988a and the CAIR report (Kearn ey, 1988b). It also shows the derivation of costs from these estimates, after in flation. The method is as follows:

• Technical labor was estimated at 1 hour fo r 750 pages in the CAIR report (Kearney, 1988b, page 65), or .00133 hours per page. The analysis estimates a cost per hour and per page using fully loaded labor rates from Table B-1.

• Clerical labor was estimated at 10 hours for 750 pages in the CAIR report (Kearney, 1988b, page 65), or .01333 hours per page. The analysis estimates a cost per hour and per page using fully loaded labor rates from Table B-1.

21 This report follows the method in Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances (EPA Docket OPPT-2003-0063) , (EPAB, 2007a), which used the Kearney data to calculate the cost breakdown by recordkeeping requirement.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-21 August 26, 2009 • The photocopying cost from Kearney 1988a ( $0.05 per page) was inflated using an
inflation factor from Table B-3.

• File space for CAIR was estimated at 1⁄4 of a four-drawer file cabinet for 750 pages (Kearney, 1988b, page 65) or 0.000333 of a cabinet per page. A standard, four-drawer, full-suspension file cabinet was priced from a national office products supplier at $195 in 1997 (BT Office Products, 1997; Item #LGM-2 02401; EPAB, 1998). This results in $0.065 per page cost for file space, before inflation ($195 × 0.25 file cabinet/750 pages). The cost per page was inflated using an inflation factor from Table B-3.

• Miscellaneous materials costs were estimated at $10.00 for 750 pages in the CAIR report (Kearney, 1988b, page 65), or $0.0133/page before inflation. This cost per page was inflated using an inflatio n factor from Table B-3.

Table C-13 Recordkeeping Estimates from Kearney 1988a and 1988b

Kearney Estimates for CAIR Rule (1988b) Adjusted for inflation Per page cost - $2008 Labor Costs
Hours CAIR Pages Hours Per Page Cost Per Hour Cost Per Page

Technical 1 750 0.00133 $58.84 $0.0785

Clerical 10 750 0.01333 $28.48 $0.3797

Total Labor 0.01467 $0.4582

Kearney Estimates for CAIR Rule (1988a) ($1998 ) Adjusted for inflation Per page cost - $2008 Materials Costs
Estimate CAIR Pages Cost Per Page Inflation Factor Cost Per Page Photocopying $0.05 1 $0.050 1.820 $0.0910

File Cabinet 2 1/4 of cabinet priced at $195 750 $0.065 1.341 $0.0872
Misc. Materials $10 total 750 $0.013 1.820 $0.0243

Total Materials 0.1283 $0.2025 Total Cost per Page $0.6606

Note: Per-page labor hours and materials costs were originally estimated in Kearney 1988b for the CAIR rule. The CAIR per-page costs were then used to estimate SNUR recordkeeping per-page costs in Kearney 1988a. This clarifies the method by which the original CAIR per-page co sts and hours were calculated. It also adjusts costs for inflation using labor rates from Table B-1 and inflation factors from Table B-3.

Pages per chemical at one site

In order to estimate recordkeeping costs, th e analysis multiplies the costs per page for each recordkeeping element estimated in Table C-13 by the number of pages required for each SNUR recordkeeping requirement at 40 CFR §7 21.125 as estimated by Kearney (1998a). The Kearney data was used by EPA in its original expedited-SNUR economic analysis (RIB, 1989). For example, maintaining MSDS copies as required at §721.125(h) would require 5 pages. The following estimates from Kearney (1988a) are also used:Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-22 August 26, 2009 • Manufacture and import volume, and sales and tr ansfer data require 485 pages of records per year. This reflects 40 invoices per m onth (see haz-comm Section C.1 above), 480 for sales/transfer and 5 for manuf acturer/import (Kearney, 1988a, p.11).

• Disposal compliance records, if required, co ver items such as wa ste production, shipping manifests, permits, and transfer receipts. The 600 disposal compliance pages assume 50 pages per month (Kearney, 1988a, p.11).

(This report uses slightly different terminology from RIB, 1989: “Protective clothing” instead of “protective gloves,” “haz-comm” in stead of “employee information and training.” Recordkeeping for “impermeability determination” was not separately costed out in RIB, 1989. This report assumes it is included under “protective clothing” recordkeeping.)

Cost per chemical

Table C-14 shows annual recordkeeping activit ies at one site for one SNUR chemical, by CFR requirement. If all recordkeeping requi rements at 40 CFR §721.125 applied to a single chemical, there would be costs for 2.3 hours of technical time, 23 hours of clerical time, 1,715 photocopies, approximately one-half of a four-d rawer file cabinet, and other miscellaneous materials such as folders. However, in reality, few if any chemicals will have all of the recordkeeping requirements listed in Table C- 14. Recordkeeping costs would be lower for chemicals with relatively few SN UR restrictions because fewer pages would be needed to document SNUR compliance.

Table C-14 does not include costs of record keeping resulting from a SNUN submission; those costs were included in the SNUN submission cost.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 C-23 August 26, 2009 Table C-14 Annual Per-Chemical Costs of Recordkeeping Requirement [40 CFR 721.125]

40CFR §721.125 2 Requirement Pages 3 Labor and materials cost 1 ($2008) Hours

(a) Per Page (b) Per Chemical (c)=(a)*(b) Per Page (d) Per Chemical (e)=(a)*(d) (a)(b)(c) Volumes & sales/transfer data 485 $0.6606 $320 0.01467 7.11 (d)(e) Protective clothing [§721.63] and impermeability [§721.63(a)(3)] 20 $0.6606 $13 0.01467 0.29 (f) Haz-comm program [§721.72] 250 $0.6606 $165 0.01467 3.67 (g) Label copies [§721.72(b)] 5 $0.6606 $3 0.01467 0.07 (h) MSDS copies [§721.72(c)] 5 $0.6606 $3 0.01467 0.07 (i) Use limitations compliance [§721.80] 250 $0.6606 $165 0.01467 3.67 (j) Disposal compliance [§721.80] 600 $0.6606 $396 0.01467 8.80 (k) Release to water compliance [§721.90] 100 $0.6606 $66 0.01467 1.47
TOTAL 1,715 $0.6606 $1,133 0.01467 25.15

Notes:

1 This table multiplies cost per page estimates from Table C-13 by the number of pages estimated for each recordkeeping cost element. (This table does not include recordkeeping for SNUN submissions required by 40 CFR §721.40.) Total costs are calculated from unrounded values and may not equal the sum and/or product of rounded values.

2 40 CFR 721.125(a) through (k) list recordkeeping that may be specified in the SNUR. The recordkeeping specified depends on which 40 CFR §721 provisions [in brackets] were used by the SNUR to define reportable New Uses (§721.63, §721.72, §721.80, an d/or §721.90). Few if any SNUR chemicals would require all of the recordkeeping costs listed above since few if any chemicals ar e subject to all of the requirements (a) through (k).

3 Pages count estimates for each SNUR requirement are from Kearney, 1988a.APPENDIX D

COSTS OF TESTINGEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-1 August 26, 2009 APPENDIX D COSTS OF TESTING

EPA recognizes that TSCA Section 5 does not require developing any particular test data before submission of a Significant New Use Notice. Persons are required onl y to submit test data in their possession or control and to describe any other data know n to or reasonably ascertainable by them. (Upon review of a SNUN, the Agency has the authority to require appropriate testing, but that is a cost of regulatory follow-up, not of the SNUN submission itself.) For informational purposes, the SNURs describe tests recommended by EPA to provide sufficient information to evaluate the chemical substance. However, as was explained in the discussion of SNUNs earlier in this report, it appears that firms rarely el ect to do these recomme nded tests to support a SNUN, and especially not the higher-cost tests. For informational pu rposes, this appendix presents estimated costs for testing often recomme nded for chemicals that have been the subject of PMNs and are subject to Signi ficant New Use Rules (SNURs).

D.1 Testing Guidelines

In the SNURs, EPA identifies a set of tests for each PMN chemical that can be used by firms making Significant New Use Notice or other submissions to EPA to characterize risks of the chemical. The tests are recommended in the SNUR, not mandatory. They are identified by guideline numbers which can be used to look up pub lished test protocols. Table D-1 lists test guidelines cited in the current a nd recent SNUR rulemakings, and their associated costs, Table D-2 presents certain assumptions used in the analysis, and Table D-3 presents Persistent Bioaccumulative Toxic (PBT) tiered testing requirem ents. The types of guidelines are described below.

• OPPTS Harmonized . Most SNUR tests are identif ied by their OPPTS number from the series of OPPTS Harmonized Test Guidelines and OPPTS harmonized public drafts not yet promulgated as OPPTS guide lines. These guidelines blended testing guidance from OPPT (published in the Code of Federal Regulations), EPA's Office of Pesticide Programs, the Organization fo r Economic Cooperation and Development (OECD), and other sources. The harmonized guidelines fall into several categories, including the following:

Series 835--Fate, Transport and Transformation Test Guidelines Series 850--Ecological E ffects Test Guidelines Series 870--Health Effects Test Guidelines

They are available electronically on EPA’ s website (OPPT, 2006). Cross-references for health effects guidelines ar e listed at 63 FR 41847, August 5, 1998.

• CFR . SNUR tests may also come from the Code of Federal Regulations, identified for example as “40 CFR 799.9370” or just “ 799.9370.” In addition, in costing out testEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-2 August 26, 2009 guidelines, this report sometimes uses cost s for a CFR guideline when costs have not been developed for the equivalent OPPT S harmonized guideline. 40 CFR parts 795 through 798 include pre-harmonization test guidelines, typically updated before 1990. 40 CFR part 799 includes more recent TSCA test guidelines, based on harmonized test guidelines. (63 FR 41845, August 5, 1998).

• OECD . A few SNUR tests are identified by their OECD number. The OECD guidelines may have OPPTS equivalents. For example, OECD 407 28-Day Oral Toxicity in Rats is essentia lly equivalent to OPPTS 870.3050.

• PBT Category . For some chemicals, the SNUR cites tiered testing according to a testing strategy published in the Federal Register (FR), Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999 (64 FR 60194), which in turn refers to a number of tests by OPPTS or OECD guideline number.

• ASTM, NTIS, and other sources . Test guidelines may also come from the American Society for Testing and Mate rials (for example, ASTM D2035-80 Modified Coagulation-flocculation Jar Te st of Water) (www.astm.org) or other sources. The guideline for a neurotoxicit y functional observational battery, NTIS PB 91-154617, is available from the National Technical Information Service (www.ntis.gov).Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-3August 26, 2009Table D-1 Cost Estimates for Test Guidelines Cited in SNURsGuideline Test Species Route/MethodCost$2008HoursProduct properties830.6315 Flammability NA NA $7205*830.7050 (796.1050/OECD101)Absorption in Aqueous Solution: ultraviolet/visiblespectraNA NA $1,623 15830.7200 (OECD 102) Melting Point / Melting Range NA 8-test average $1,627 13830.7550 (OECD 107) Partition Coefficient (n-Octanol/Water) NAShake FlaskMethod$7,926 50830.7560 (796.1720) Partition Coefficient (n-Oct/Water) NA Generator Column $4,014 39830.7570 (796.1570) Partition Coefficient (n-Oct/Water) NALiquidChromatography$2,920 28Karel Vershueren Handbook,odor and taste testOdor and taste test (in Handbook of EnvironmentalData on Organic Chemicals, by Karel Vershueren,4thEd,Vol. 1, Page 22)NA NA * *Fate, Transport, Transformation835.1110 Activated Sludge Sorption Isotherm NA NA $11,978 81835.1220 Sediment and Soil Adsorption/Desorption Isotherm NA NA $29,299 106835.2110 Hydrolysis as a Function of pH NA NA $57,565 130835.2130 Hydrolysis as a Function of pH and Temperature NA NA * *835.2210 (796.3700) Photolysis in Aqueous Solution in Sunlight NA NA $115,153 985835.3100 (796.3100) Aerobic Aquatic Biodegradation NA NA $15,808 174835.3110 Ready Biodegradation NAAverage of sixmethods$12,352 112835.3120 Sealed-Vessel CO2 Production Test NA NA $7,660 62835.3170 Shake Flask Die-Away Test NA NA $50,367 88835.3180 Sediment/Water Microcosm Biodegradation NA Flow-through $131,699 1496835.3200 (796.3360) Inherent Biodegradation: Modified Zahn-Wellens NA NA * *835.3220 Porous Pot Test NA NA $49,460 539835.3400 Anaerobic Biodegradabilityof Organic Chemicals NA NA $12,159 99835.5045 (OECD 302A) Inherent Biodegradability: Modified SCAS Test NA NA $14,049 143835.5270 (795.7000)Sunlight Photolysis in Waters ContainingDissolved Humic Substances(Indirect PhotolysisScreening Test)NA NA $24,288 218Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-4August 26, 2009Guideline Test Species Route/MethodCost$2008HoursD2035-80 (ASTM D 2035-80)Standard Practice for Coagulation-Flocculation JarTest of WaterNA NA $4,195 25OECD 303ASimulation Test - Aerobic Sewage Treatment, withmeasurement of loss of the parentNA NA * *OECD 307 Aerobic and Anaerobic Transformation in Soil NA Flow-through $277,042 3510OECD 307 Aerobic and Anaerobic Transformation in Soil NABio-meter typeflasks$11,978 3279OECD 308Anaerobic transformation in aquatic sedimentsystemsNA NA * *OECD 311 (835.3400)Anaerobic biodegradability of organic compoundsin digested sludgeNA NA * *Ecological Effects850.1010 (797.1300) Daphnid Acute Toxicity Daphnid Flow-through $14,804 54850.1010 (797.1300) Daphnid Acute Toxicity Daphnid Static $14,609 53850.1075 (797.1400) Fish Acute Toxicity Fathead Minnow Flow-through $20,402 65850.1075 (797.1400) Fish Acute Toxicity NA Static $16,524 84850.1085 Fish Acute Toxicity Test mitigated by humic acid Fathead Minnow Static $17,224 74850.1300 Daphnid Chronic Toxicity Test Daphnid Flow-through $42,379 173850.1400 Fish Early Life Stage Toxicity Rainbow Trout Flow-through $67,622 432850.1400 Fish Early Life Stage Toxicity Fathead Minnow Flow-through $45,715 291850.1730 Fish BCF Fathead Minnow Flow-through $74,937 775850.1925 Site-Specific Aquatic Microcosm Test NA NA * *850.1950 Field testing for Aquatic Organisms3NA NA * *OECD 218(795.1350/850.1790)Chironomid Sediment Toxicity Midge Flow-through $103,093 949850.5400 Algal Toxicity, Tiers I and II4-speciesaverageNA $17,209 60Health Effects870.1100 Acute Oral Toxicity Rats Gavage $8,198 44870.1300 Acute Inhalation Toxicity Rats4Inhalation $25,368 200870.3100 90-Day Oral Toxicity Rats Gavage $150,419 834870.34651Subchronic Inhalation Toxicity Rats Inhalation $415,796 2,458Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-5August 26, 2009Guideline Test Species Route/MethodCost$2008Hours870.3465 (mod)Subchronic Inhalation Toxicity (w/ 60 dayrecovery group)Rats Inhalation $241,482 2,882870.3465 (OECD 413)1Subchronic Inhalation Toxicity (90-dayexposure/180-day retention)Rats Inhalation $421,909. 3,657870.3700 Prenatal Developmental Toxicity {2 species} Rats Gavage $123,167 1,157870.3800Reproduction/Fertility Effects (2-GenerationReproduction)Rats Gavage $650,181 5,024870.4200 Carcinogenicity {2 species} (24 months) Rats Gavage $978,613 8,275870.5100 Bacterial reverse mutation test NA Direct plate $13,483 48870.5265Salmonella typhimurium Reverse Mutation Assay(Ames Test)NAAverage of directplate and Azoreduction$12,810 48870.5395In Vivo Mammalian Bone Marrow CytogeneticsTests: Erythrocyte Micronucleus Assay (Averageof 1 and 3 day dosings)MiceGavage (Average of1 and 3 day)$21,724 114870.5395In Vivo Mammalian Bone Marrow CytogeneticsTests: Erythrocyte Micronucleus Assay (Averageof 1 and 3 day dosings)MiceIntravenous (Twotest average)$21,724 114870.5550Unscheduled DNA Synthesis in Mammalian Cellsin CultureRat Hepatocytes NA $22,434 199870.6100Delayed Neurotoxicity of OrganophosphorusSubstances (Acute)Hens Gavage (Acute) $38,355 261870.6100Delayed Neurotoxicity of OrganophosphorusSubstances (Subchronic 28-day)HensGavage(Subchronic)$76,081 618870.6200Neurotoxicity Screening Battery (Acute)RatsGavage$119,856925ASTM D F739 -91 (ASTMD F739)2Standard Test Method for Resistance of ProtectiveClothing Materials to Permeation by Liquids orGases Under Conditions of Continuous ContactNAAverage (Gases andLiquids)$14,63940OECD 407 (870.3050)Repeated dose 28-day oral toxicity study in rodentsRatsGavage (28 Days)$56,945328OECD 421 (870.3550)Reproduction/developmental toxicity screeningtestsRatsGavage$66,792445OECD 422 (870.3650)Combined RepeatedDose Study withReproductive/Developmental Toxicity ScreenRats Gavage $136,339. 1,146Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-6August 26, 2009Guideline Test Species Route/MethodCost$2008HoursOECD 422 (mod)Combined RepeatedDose Study withReproductive/Developmental Toxicity Screen (90days w/ histopathology)Rats Gavage $250,309 2,152OECD 425 Acute Oral toxicity: Up-and-down Procedure Rats Gavage $5,897 19Source:EPA OPPTS Economic and Policy Analysis Branch cost estimates. Many costs were estimated in the 1990s or earlier. All have beeninflated (see TableB-1 and Table B-3 for inflation index). Dollar costs include $3,924 or $9,531 for analytical method validation; where applicable (see text). Species and route ormethod may be specified in SNURs or may be unspecified but assumed in this table for costing purposes.Notes:* Indicates this cost has notbeen calculated for this report.1For some PMNs, recommended testing under guideline 870.3465 would involve an additional 3 month recovery group, as well as other evaluationbeyond the standard requirements in the test guideline.These activities would raise testing cost substantially.2The recommended testing for some PMN chemicals may include a glove permeation test following ASTM F739 and F1194-99 guidelines.ASTMF1194-99 is a standard guide for documenting the results of chemical permeation tests (seewww.astm.org). The additional costs of following ASTM F1194-99(average of gases and liquids) were not estimated for this report.3Costs for field testing will be site-specific, with a wide rangeof actual costs. A report fromEPA's Office of Pesticide Programs estimated an averagetest cost of $600,000 for guideline 850.1950, for simulated or actual field testing for aquatic organisms (OPP, 2008, AppendixC).4Performing the test on species other than rats may change the test costs. For example, testing on rabbits is likely to increase costs.5Test cost is from a Eurofins Product Safety Laboratory 2009 price schedule published on the company website athttp://www.productsafetylabs.com/media/645697/price%20schedule-2009%20revised.pdf.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-7 August 26, 2009 D.2 Test Costs by Guideline

Table D-1 gives dollar cost and hours fo r each test, based on assumptions and adjustments discussed below. This section desc ribes the development of individual test costs.

EPA’s Office of Pollution Prevention a nd Toxics, Economic and Analysis Branch, regularly develops cost estimates of test gu idelines to support TSCA rule development. Estimates are based on assumptions about specie s, route of administration, study duration, and other aspects of methodology. Costs are calculat ed based on costs of labor, materials, and equipment needed to perform testing, with ove rhead and fee. Many of the test costs were developed in the 1990s. Test costs have been in flated using Employment Cost Index inflators from the Bureau of Labor Statistics (see Appendi x B). However, generally they have not been updated to reflect subsequent chan ges in laboratory technologies.

Testing laboratories perform analytical method validation to ensure that proper dose concentrations are used in toxicity studies (E PAB 2005, p. 3-9). This analysis assumes that for health effects tests (e.g. 870 series guidelines), tests of up to 90 days in duration have method validation costs of $3,500, and longer-term tests have validation costs of $8,500 in 2004 dollars. Using the inflation rates found in Appendix B, validation costs are $3,924 and $9,531 in 2008 dollars. For simplicity, the method validation cost for ecological effects tests (e.g. 850 series guidelines) was assumed to be $3,924 for each test.

In cases where costs have not been estimated for the specified guideline, EPA uses the cost from an approximately equivalent guide line (listed in Table D-1 and Table D-3 in parentheses). Many of these equivalents are listed in the Federal Register at 63 FR 41847, August 5, 1998. In some cases the test protocol itself states that it is essentially equivalent to another test upon which it was based. Sometimes judgment was needed to select the closest equivalent(s)

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In some cases, EPA has not costed out the te st for the species, route, duration, and/or other method listed in the SNUR, or the SNUR sp ecifies a guideline but does not specify these details. In such cases, EPA has made the adju stments described below. The adjustments were selected based on discussions with EPA scie ntists and on SNUR language, published test guidelines, assumptions underlying the cost estimate s in EPAB's test cost database, EPA review and Consent Order history for specific PMNs, or other sources.

Default Parameters

Costs for many of the guidelines have been estimated for different combinations of species, route, length of study and other aspects of methodology, but in some cases the SNUR may not specify all of these variables. Wher e this occurs, EPA has used certain default parameters, listed in Table D-2.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-8 August 26, 2009 Table D-2 Default Parameters fo r Species, Route, and Study Type

Variable Default

Species Mammals Fish Invertebrates Algae Rats Fathead minnow 1 Daphnids [Four species -- see text]

Route/Method Mammalian Fish Invertebrates Gavage Flow-through Flow-through

Notes: 1 For guideline 850.1400 tests also in PBT tier tests, rain bow trout is the default sp ecies. (See PBT discussion below.)

SNUR Testing Tiers

A SNUR may recommend tiered testing. In su ch cases, costs are lower if only the firsttier tests are performed, and higher if all tests listed for the chem ical are performed. Testing is “tiered” if later tests are contingent on the re sults of earlier tests, a nd/or if some tests are contingent on the firm reaching a certain chemical volume or time limit. Some tiers are explicit in the SNUR text; others result because the S NUR references the tiered PBT Category testing described at 64 FR 60194.

Test Cost Assumptions and Comments

This section explains treatment of certain te sts listed in this or past SNUR rulemakings.

• A SNUR may recommend algal acute toxic ity testing according to OPPTS Guideline 850.5400. This guideline has been previously costed by EPA for four separate algal species ( Navicula pelliculosa, Skeletonema costatum, Anabaena flos-aquae, and Selenastrum capricornutum ). If a SNUR does not specify the algal species to be used, the average costs of the four algal species tests are used.

• For OPPTS test guideline 835.3100 (Aerobic Aquatic Biodegra dation), a SNUR may call for an additional analytical methodology to identify the isononyl phenol degradation product, which may be a substantial add-on to the basic cost. Tabl e D-1 gives costs for 835.3100 but not for the extended test.

• A SNUR may recommend a “modified” vers ion of ASTM test guideline D2035-80 (Coagulation-Flocculation Jar Test of Water). Table D- 1 gives costs for D2035-80 but not for the additional analytical methodology.

• For test guideline OECD 422 (Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Sc reening), a SNUR may recommend extended histopathology. Although the OECD 422 prot ocol does include hi stopathology, it is possible that extending the hist opathology would increase the cost beyond that shown in Table D-1.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-9 August 26, 2009 • A SNUR may recommend two variations of test guideline OECD 218 (Chironomid Sediment Toxicity), one usi ng the acute portion of the sedi ment and the other using the chronic portion. Costs were not determined fo r these two variants. The cost of the test performed on midge under flow th rough conditions was used for both.

• A SNUR may recommend “a fish acute toxici ty test, freshwater and marine (OPPTS 850.1075 test guideline)”. “Freshwater and marine” refers to the name of the test, not the number of species required by EPA. The cost estimates assume only one species is used.

Persistent Bioaccumulative Toxic (PBT) tiered testing

A SNUR may cite tiered testing for Pe rsistent Bioaccumulative Toxic chemical substances (PBTs) according to the testing strategy in EPA’s New Chemicals Program PBT Category document, published in the Federal Register notice, Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999, at 64 FR 60194.

In 64 FR 60194, there are three ti ers of testing. The results of Tier 1 determine whether Tier 2 testing is needed and the results of Tier 2 testing determine whether Tier 3 testing is needed. Table D-3 lists the tests in the PBT cat egory document. These tests are also listed in Table D-1.

To obtain a cost estimate for SNURs that ci te PBT Category testing (64 FR 60194), costs of individual tests from 64 FR 60194 would have to be added up as appropriate, depending on the specific SNUR language. The test list w ould also need to be adjusted to avoid double counting tests listed in the SNUR both explicitly by guideline nu mber, and implicitly due to their inclusion in PBT Category tiers.

Other assumptions related to PB T testing are described below:

• The PBT category tests at 64 FR 60194 specify rainbow trout as the species for the chronic fish toxicity test, 850.1400. For S NURs that recommend PBT Category testing, 850.1400 costs would be based on using rai nbow trout. If 850.1400 is recommended without PBT testing, costs would be based on using fathead minnows.

• For PBT Tier 1 ready biodegradability tests, firms may either choose among six methods in test guideline 835.3110 or follow test guideline 835.3120. The cost of 835.3110 is calculated as the average cost of its six possible methods. Th e cost estimates assume an equal chance of using either 835.3110 or 835.3120.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-10 August 26, 2009 Table D-3 Persistent Bioaccumulative Toxic (PBT) Tiered Testing Requirements

PBT Tier Guideline Test Cost $2008

1 OPPTS 830.7560*

-orOPPTS 830.7570* Partition Coefficient (n-Oct/Water), Generator Column method

-orPartition Coefficient (n-Oct/Water), Liquid Chromatography method Average $4,014

$2,920 $3,467 1 OPPTS 835.2110 Hydrolysis as a Function of pH $57,565

1 OPPTS 835.3110

-orOPPTS 835.3120 Ready Biodegradability (choose one of 6 methods; cost is average of the 6)

-or- [Ready biodegradability] Sealed-vessel CO 2 Production Test Average $12,352

$7,660 $10,006
2 OPPTS 835.3170 Shake-flask Die-away Test [measures biodegradability] $50,367 2 OPPTS 850.1730 Fish Bioconcentration $74,937 3 OPPTS 835.3180 Sediment/Water Microcosm Biodegradation $131,699

3 40CFR 797.1330 or 850.1300** Daphnid Chronic Toxicity Test $42,379

3 40CFR 797.1600 or 850.1400** Fish Early Life Stage Toxicity (in rainbow trout) $67,622

3 OECD 422 Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Screening (in rats) $136,339

Total cost, all tiers (assuming all tests a re conducted) $574,381
Source: 64 FR 60194, Category for Persistent, Bioaccumulati ve, and Toxic New Chemical Substances , November 4, 1999, at http://www.epa.gov/EPA-TOX/1999/November/Day-04/t28888.htm . Tests costs are from Table D-1.

*The PBT FR notice cites 830.7560 and 830.7570. This ta ble used costs for similar tests 796.1720 and 796.1570, respectively. Tests 830.7550 (Partition Coefficient using Shake Flask method) and “the new ‘slow-stir’ method currently under development by the OECD” are also mentioned as options for determining the Oct/Water partition coefficient, in the PBT FR notice Response to Comments but not in the main Testing Strategy discussion.

** PBT FR notice cites both tests as equivalents. This table uses costs for 850.1300 and 850.1400 since they were costed out more recently by EPA.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 D-11 August 26, 2009 D.3 Testing Costs by Chemical

Test costs attributable to a SNUN are likely to be much lower than the costs that would be implied by adding up costs of all of the testi ng recommended in the SNUR for that chemical, and usually are zero. 22 See the main text of this report for a discussion of testing.

22 A prior SNUR economic analysis cal culated chemical-specific test cost s (EPAB, 2007a, Table D-4). The chemical-specific table was dropped from a later SNUR economic analysis (EPAB 2007b).APPENDIX E

COSTS FOR SNUN, MODI FICATION/REVOCATION, OR EQUIVALENCY DETERMINATIONEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 E-1 August 26, 2009 APPENDIX E COSTS FOR SNUN, MODIFI CATION/REVOCATION, OR EQUIVALENCY DETERMINATION

Estimates of the costs of completing a Significant New Use Notice (SNUN) form are based on the costs of completing a PMN submissi on, since the data requirements are the same and the same form is used for both. The PMN submission costs came from EPA's 1994 Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications, which relied on industry estimates of the effort needed to collect and compile all data required for a PMN submission, prepare the form, submit the form and data to EPA, and maintain a file of the submission (RIB, 1994, Tabl e III-2 and pages III-11, -12, and -13). The 1994 estimates were based on a survey conducte d by the Chemical Manufacturers Association (CMA, 1991), which became the American Chemistry Council.

In the 1994 EPA report, the average effort required to prepare and submit a PMN was 95 to 114 hours. This included recordkeeping for the submission, but the recordkeeping cost was not broken out. For this analysis, the costs of a preparing a SNUN were derived using the averages of the hours for each type of labor from the 1994 report. The method of calculating hourly loaded labor costs is described in Appendix B.

As shown in Table E-1, the cost of submitting a request to modify or revoke a SNUR is the same as the cost for an equivalency determ ination. The cost of submitting a SNUN is $2,500 higher due to EPA's notif ication user fee.

Table E-1 Burden for SNUN, Request to Mo dify SNUR, or Equivalency Determination
Total Labor Cost (loaded wage X hours)

Labor Category Hours Range 1 Average Hours Loaded Wage Rate 2 ($2008) Request to Modify SNUR (Option 2) SNUN (Option 3) Equivalency Determination (Option 4)

Clerical 12 - 14 13 $28.48 $370 $370 $370

Technical 67 - 80 73.5 $58.84 $4,325 $4,325 $4,325

Managerial 16 - 20 18 $70.03 $1,260 $1,260 $1,260

Subtotal 95 - 114 104.5 $5 ,955 $5,955 $5,955 User fees (SNUN only) $0 $2,500 $0
TOTAL $5,955 $8,455 $5,955

Notes:

1 Hours range for each labor category is from th e PMN Amendments RIA (RIB, 1994, Table III-2).

2 Loaded wages include fringe benefits and overhead. See Appendix B of this report for derivation. Wage rates presented in this table are rounded values; however, unrou nded values are used to calculate total labor costs. For this reason, total labor costs may not equal the product of rounded values.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 E-2 August 26, 2009 In addition to submission costs, there may be testing costs if the submitter believes performing the tests will help its submission. EPA believes such testing costs are ze ro for most SNUNs, as explained in the discussion of SNUNs in the main text of this report.

The Agency may also take additional regu latory actions after submission of a SNUN, such as a TSCA Section 5(e) Consent Order. The subsequent regulator y action would involve a limited assessment of benefits and costs comparab le to such assessments for regulation following PMN review. Followon restrictions could invo lve worker protection, hazard communication, or testing triggered by reaching a specified produc tion volume, among other possibilities. These costs are discussed in Appendix C (worker pr otection, hazard communication) and Appendix D (testing). Other possible restri ctions have not been costed out for this analysis.APPENDIX F

AGENCY COSTSEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 F-1 August 26, 2009 APPENDIX F AGENCY COSTS

EPA submission review costs are presented in Table F-1. Costs to review and process industry submissions – SNUNs, requests to m odify a SNUR, and requests for equivalency determination – are assumed to be si milar to EPA costs to review PMNs. 23

The list of review steps, estimates of staff- year full-time equivalents (FTEs), estimates of extramural costs, and the percent of chemicals requir ing a particular review st ep are derived from the costs for processing PMN submissions in Table VII-1 of a 1994 EPA report, Regulatory Impact Analysis of Amendments to Regulations fo r TSCA Section 5 Premanufacture Notifications (RIB, 1994). The GS levels used for Agency staff reflect the judgment of Agency staff familiar with the PMN/SNUN review process. The salary of a Fu ll Time Equivalent EPA staff was calculated using GS-13 Step 5 salary data (OPM, 2008). The original PMN cost estimates were for GS 12 and were presented as low and high estimates, based on the most junior (Step 1) and th e most senior (Step 10) GS-12 pay rates, respectively. However, this an alysis uses the higher GS-13 staff level and, for simplicity, a single intermediate pay rate (Step 5) within that GS le vel. A loading factor of 1.6 was applied to the salary to reflect fringe benefits and overhead (OPPE, 1992). The loaded salary calculations are descri bed in Appendix B.

For each review step, the “EPA staff” cost is calculated by multiplying the number of FTEs (in the first column) by the fully loaded average sa lary. This shows EPA staff cost for chemicals requiring the selected review step.

The Extramural Cost column shows costs for co ntractor support and ot her outside purchases for chemicals requiring the selected review step, inflated from 1993 prices, as explained in Appendix
B

.
The Percent of Cases is a weigh ting factor applied to reflect th e fact that not all chemicals require each review step. For example, in the PMN process, all chemicals require Administrative Prescreening, but not all chemical s require the intensive scrutiny of “Standard Review.” The three types of submissions resulting from a SNUR may ha ve weighting factors that differ from each other and from the weighting factors for PMNs. Change s in weighting factors c ould cause actual review costs to be higher or lower than calculated here. For example, some SNUNs require little review because they are determined to be “invalid” – i.e. not required in the first place. However, often a SNUN may take more Agency time than a typical PMN because of factors such as the need to retrieve old PMN records from archives, and the likelihood that more data requiring EPA review is submitted with a SNUN than would be submitted on average with a PMN. Resources were not available to update the review hour s to reflect the current review process or to tailor the cost

23 For an overview of the PMN review process, see the Chemistry Assistance Manual for Premanufacture Notification Submitters, EPA, 1997.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 F-2 August 26, 2009 estimates to SNUNs. Therefore, for this anal ysis, 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 Unweighted Costs (EPA staff cost plus extramural costs) by the percentage of cases requiring this review step. This calculation yields total Agency costs for submission review and processing shown in Table F-1.Economic Analysis of Expedited SNURs, Docket OPPT-2008-0918 F-3 August 26, 2009 Table F-1 Agency Costs for SNUN and Ot her Submission Review and Processing

EPA staff (FTE) Cost Extramural Cost 2

FTE fraction Cost per FTE 1 FTE Total ($2008) 1993 dollars 2008 dollars Unweighted Cost Pct. of Cases Weighted Cost 3 Review Steps

(1) (2) (3)=(1)*(2) (4) (5) (6)=(3)+(5) (7) (8)=(6)*(7)

Prenotice consultation 0.0024 $150,440 $361 $4 $7 $368 41% $151

Administrative prescreen/ notice receipt/user fee 0.0024 $150,440 $361 $92 $154 $515 100% $515

CRSS (Chemical Review and Search Strategy) 0.0025 $150,440 $376 $268 $448 $824 100% $824

SAT (Structure Activity Team) 0.0006 $150,440 $90 $14 $23 $114 100% $114

Engineering/Exposure 0.0015 $150,440 $226 $56 $94 $319 100% $319 Exposure/Fate 0.0008 $150,440 $120 $0 $0 $120 100% $120 Focus 0.0009 $150,440 $135 $23 $38 $174 100% $174
Standard Review Functions 0.0219 $150,440 $3,295 $511 $853 $4,148 29% $1,203

Division Directors Meeting 0.0129 $150,440 $1,941 $113 $189 $2,129 15% $319

Order Development/Negotiation Review 0.0171 $150,440 $2,573 $22 $37 $2,609 3% $78

Post Order Data Review 0.0886 $150,440 $13,329 $0 $0 $13,329 3% $400 Order Modification 0.2167 $150,440 $32,600 $0 $0 $32,600 3% $978

New Chemical SNUR Development 0.0277 $150,440 $4,167 $85 $142 $4,309 7% $302

Notices of Commencement 0.0012 $150,440 $181 $40 $67 $247 31% $77

FOIA (Freedom of Information Act) Requests 0.0333 $150,440 $5,010 $287 $479 $5,489 1% $55

CBI (Confidential Business Information) Substantiation 0.0004 $150,440 $60 $3 $5 $65 100% $65

TOTAL $5,693

Notes:

1 GS-13 Step 5 salaries loaded with benefits and overhead. See Table B-1 derivation.

2 Extramural costs consist of contracting support and other purcha ses directly attributable to the PMN review process inflated from 1993 prices as described in Appendix B.

3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values shown in this table. Sources: FTEs per review step, 1993 extramural costs, and percents of cases are from RIB, 1994, Table VII-1. GS-13 salaries are from OPM, 2008.APPENDIX G

REFERENCESEconomic Analysis of Expedited SNURs, Docket OPPT-2008-0918 G-1 August 26, 2009 APPENDIX G REFERENCES

29 CFR 1910. Occupational Safety and Health Standards. Code of Federal Regulations, Part 1910, Title 29, November 25, 1983.

63 FR 41847. Test Guidelines; Notice of Availability, Federal Register, Vo lume 63, August 5, 1998.

64 FR 60914. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, Federal Register, Volume 64, November 8, 1999.

71 FR 6733. Export Notification; Proposed Change to Reporting Requirements, Federal Register, Volume 71, February 9, 2006. Available from the Federal Docket Management System as docket EPA-HQ-OPPT-2005-005 8 at http://www.regulations.gov

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ASTM. American Society for Standards and Materials. http://www.astm.org

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Best, 1997. Personal communication between Tom DeCoff of East ern Research Group, Lexington, MA and Best Manufacturing Co. te chnical support serv ices, Austin, TX, December 1997.

BLS, 2006a. U.S. Bureau of Labor Statistics, Employer Costs for Employee Compensation: Changes to NAICS and SOC, Table 2. ECEC Occupationa l Comparability between SOC and OCS. Downloaded February 2006 from http://www.bls.gov/ncs/ect/sp/ecsm0003 .htm.

BLS, 2006b. U.S. Bureau of Labor Statistics, Employment Cost Index News Release Text: Employment Cost Index, March 2006 (April 28, 2006), at http://www.bls.gov

.

BLS, 2006c. U.S. Bureau of Labor Statistics. Change has Come to the ECI (June 14, 2006) at http://www.bls.gov/nc s/ect/sp/ecsm0001.htm

BLS, 2006d. Bureau of Labor Statistics. Employment Cost Index, Hist orical Listing Current-Dollar 1975-2005 (May 10, 2006) at http://www.bls.gov/web/ecconst.pdf

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