*** EO 12866 Review Draft – Do Not Cite, Quote or Release During Review ***

October 28, 2010 

EO12866_PBDE Test Rule_NPRM_EA_10-28-2010.doc 

—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 

Washington, D.C. 20460 

Economic Analysis for the Proposed Section 4 Test Rule 

 for c-Pentabromodiphenyl Ether, 

 c-Octabromodiphenyl Ether, and 

c-Decabromodiphenyl Ether 
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ii

1 

2 Contributors 

3 

4 The EPA analyst responsible for this report was Timothy Lehman. Analytical and draft preparation support 

5 was provided by Abt Associates Inc. under EPA Contract No. EP-W-08-0100. 

6 

7 
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iii

8 Contents 

9 Chapter 1 – Introduction .........................................................................................................................................1-7

10 1.1 Statutory Authority .......................................................................................................................................1-7 

11 1.2 Regulatory and Programmatic Background .................................................................................................1-7 

12 1.3 Summary of Analytic Approach ...................................................................................................................1-8 

13 1.4 Organization of This Report .........................................................................................................................1-8 

14 Chapter 2 - Affected Entities ...................................................................................................................................2-1

15 2.1 Chemicals Subject to the Proposed Rule ......................................................................................................2-1 

16 2.2 Uses of PBDEs .............................................................................................................................................2-1 

17 2.3 Regulated Community ..................................................................................................................................2-2 

18 Chapter 3 –Tests Required by the Proposed Rule .................................................................................................3-1

19 3.1 Introduction ..................................................................................................................................................3-1 

20 3.2 Description of Tests Required by the Proposed Rule ...................................................................................3-1 

21 3.3 Specific Test Requirements for each Chemical in the Proposed Rule ..........................................................3-2 

22 Chapter 4 Industry Compliance Costs ....................................................................................................................4-1

23 4.1 Introduction ..................................................................................................................................................4-1 

24 4.2 Unit Costs .....................................................................................................................................................4-1 

25 4.3 Total Industry Compliance Costs .................................................................................................................4-6 

26 Chapter 5 – Agency Costs ........................................................................................................................................5-1

27 5.1 Introduction ..................................................................................................................................................5-1 

28 5.2 EPA Costs ....................................................................................................................................................5-1 

29 Chapter 6 - Social Costs ...........................................................................................................................................6-1

30 6.1 Total Social Costs .........................................................................................................................................6-1 

31 6.2 Chemical Level Costs ...................................................................................................................................6-1 

32 6.3 Annualized Costs ..........................................................................................................................................6-1 

33 Chapter 7 – Small Entity Impact Analysis .............................................................................................................7-2

34 7.1 Identify the Affected Population ..................................................................................................................7-2 

35 7.2 Select a Relevant Small Business Definition ...............................................................................................7-2 

36 7.3 Identifying Small Businesses .......................................................................................................................7-3 

37 7.4 Cost-to-Sales Ratio .......................................................................................................................................7-3 

38 Chapter 8 – Benefits .................................................................................................................................................8-1

39 8.1 Use Values ...................................................................................................................................................8-1 

40 8.2 Non-Use Values ...........................................................................................................................................8-2 

41 8.3 Potential Users of Information Generated by the Proposed Rule .................................................................8-2 

42 Chapter 9 – Other Impact Analyses ........................................................................................................................9-6

43 9.1 Paperwork Reduction Act ............................................................................................................................9-2 

44 9.2 Unfunded Mandates Reform Act..................................................................................................................9-3 

45 9.3 Executive Order 13132 – Federalism ...........................................................................................................9-3 

46 9.4 Executive Order 13175 – Consultation and Coordination with Indian Tribal Governments........................9-4 

47 9.5 Executive Order 13045 - Children’s Health .................................................................................................9-4 

48 9.6 Executive Order 13211 – Energy Supply, Distribution, or Use ...................................................................9-4 

49 9.7 National Technology Transfer and Advancement Act .................................................................................9-4 

50 9.8 Executive Order 12898 – Environmental Justice .........................................................................................9-5 

51 9.9 Executive Order 12630 – Property Rights ....................................................................................................9-5 

52 9.10 Executive Order 12988- Civil Justice Reform .............................................................................................9-5 

53 Chapter 10 – References ........................................................................................................................................ 10-5

54 Appendix A Wage Rate Calculations .............................................................................................................. A-5

55 Appendix B Costs ............................................................................................................................................. B-4

56 
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57 Exhibits 

58 

59 Exhibit 2-1 : Chemicals Included in the Proposed Test Rule .................................................................... 2-1

60 Exhibit 2-2 : U.S. Manufacturers and Importers of DecaBDE in 2006 ..................................................... 2-4

61 Exhibit 2-3: NAICS Codes for decaBDE Importers .................................................................................. 2-4

62 Exhibit 3-1: Tests Required under the Proposed Test Rule ....................................................................... 3-1

63 Exhibit 3-2: Test Requirements for Chemicals Included in the Proposed Rule ......................................... 3-2

64 Exhibit 4-1: EPA Estimates of Laboratory Costs of Proposed Tests (2009$) ........................................... 4-1

65 Exhibit 4-2: Total Laboratory Test Costs per Chemical ............................................................................ 4-3

66 Exhibit 4-3: Costs for Analytical Methodology Validation, per Test ........................................................ 4-4

67 Exhibit 4-4: Derivation of Loaded Hourly Rates by Labor Category ........................................................ 4-5

68 Exhibit 4-5: Industry Reporting Cost and Burden Estimate for the Proposed Rule (2009$) ..................... 4-5

69 Exhibit 4-6: Summary of Total Industry Compliance Costs Triggered by the Proposed Rule (2009$) .... 4-6

70 Exhibit 5-1: Estimated Government Costs for the Proposed Rule (2009$) ............................................... 5-1

71 Exhibit 6-1: Summary of Total Social Costs Triggered by the Proposed Rule (2009$) ............................ 6-1

72 Exhibit 6-2: Summary of Total Social Costs by Chemical (2009$, unadjusted) ....................................... 6-1

73 Exhibit 6-3: Annualized Costs Under Low- and High-Cost Scenarios (Total for All Chemicals) ($2009) 6-

74 2

75 Exhibit 7-1: Employee and Sales Information for Potentially Impacted Companies Included in the 

76 Analysis ............................................................................................................................................... 7-2

77 Exhibit 9-1: Reporting Burden Estimate for the Proposed Rule ................................................................ 9-2

78 Exhibit 9-2: Total Industry Burden Hour Estimate for the Proposed Rule ................................................ 9-3

79 Exhibit 9-3: Estimated Government Burden for the Proposed Test Rule .................................................. 9-3

80 Exhibit A-1: Detail of Labor Categories Used in the Analysis ................................................................. A-2

81 Exhibit A-2: Derivation of Loaded Wage Rates ....................................................................................... A-4

82 Exhibit B-1: Industry Compliance and Government Costs, Low-Cost Scenario ...................................... B-4

83 Exhibit B-2: Industry Compliance and Government Costs, High-Cost Scenario ..................................... B-2

84 Exhibit B-3: Annualized Social Costs ...................................................................................................... B-2

85 Exhibit B-4: Annualized Industry Compliance Costs ............................................................................... B-3

86 
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87 Executive Summary 

88 

89 The United States Environmental Protection Agency (EPA) is proposing a chemical test rule under 

90 section 4(a)(1)(A) of the Toxic Substances Control Act (TSCA) that applies to three commercial mixtures 

91 of polybrominated diphenyl ethers (PBDEs): c-pentrabromodiphenyl ether (c-pentaBDE), c92 octabromodiphenyl ether (c-octaBDE), and c-decabromodiphenyl ether (c-decaBDE), and would require 

93 manufacturers, importers and processors to conduct testing on these mixtures,as described below. This 

94 report estimates the costs and benefits of the proposed test rule. 

95 

96 C-pentaBDE and c-octaBDE are no longer manufactured in or imported into the United States, and there 

97 is no evidence to indicate their manufacture in any other countries, suggesting no domestic import of 

98 articles containing the chemicals. In addition, as a result of negotiations with EPA, the major U.S. 

99 manufacturers and importer of c-decaBDE have agreed to phase out its manufacture, import, and sale for 

100 all uses, except military and transportation uses, by December 31, 2012, and to phase out all uses by 

101 December 31, 2013 (U.S. EPA, 2010b). 

102 

103 If there is any ongoing manufacture, import, or processing of these mixtures for any use, including in 

104 articles, after December 31, 2012 (December 31, 2013 for military and transportation uses of c-decaBDE) 

(the dates specified in the proposed rule1 105 ), the mixture(s) will be subject to the test rule. The test rule 

106 would require companies that engage in these activities to perform testing in order to obtain data on the 

107 aquatic toxicity, mammalian toxicity, and chemical fate of the subject mixtures . If the manufacture, 

108 import, and processing of these,mixtures has ceased by December 31, 2012 (December 31, 2013 for 

109 military and transportation uses of c-decaBDE), any future manufacturing, import, or processing of the 

110 mixture will instead be subject to a Significant New Use Rule (SNUR), which is being proposed 

111 concurrently with the test rule. 

112 

113 C-PBDEs have been used as flame retardants in a variety of applications, including flexible polyurethane 

114 foam for mattresses, furniture, and automotive applications (c-pentaBDE); acrylonitrile-butadiene-styrene 

115 (ABS) plastic for electronics applications (c-octaBDE); and high-impact polystyrene (HIPS)-based 

116 products such as textiles, electronic equipment, and building and construction materials (c-decaBDE). 

117 The EPA is proposing a test rule because EPA has determined that the manufacture, import, processing, 

118 and use of the subject PBDE mixtures may present an unreasonable risk of injury to health or the 

119 environment. Neurobehavioral effects are a critical endpoint of concern, and c-decaBDE exhibits 

120 “suggestive evidence of carcinogenic potential.” EPA has also made preliminary findings that there is 

121 insufficient data to determine the health and environmental effects of the manufacture, processing, and 

122 use of the subject mixtures. 

123 

124 The proposed test rule specifies fourteen test methods covering health effects testing, ecotoxicity testing, 

125 and chemical fate testing. For one of these tests, EPA is proposing the use of a guideline that the agency 

126 has developed to test for photolytic degradation. This report estimates various costs associated with the 

127 proposed test rule, discusses benefits of the rule qualitatively, and presents several additional impact 

128 analyses. The average compliance cost per chemical is $3.23 million under the low-cost scenario and 

129 $5.03 million under the high-cost scenario. These costs include laboratory testing costs, analytical 

130 method validation costs, and administrative costs. The analysis does not consider export notification 

131 costs, because pentaBDE and octaBDE are already subject to a SNUR, and the economic analysis 

132 prepared for the SNUR amendment proposal includes an analysis of the export notification costs of c-

 

1

 According to the proposed rule preamble, EPA believes that a reasonable date by which all activities with c-pentaBDE, coctaBDE, and c-decaBDE can cease, including the activities of processors, is December 31, 2012 (December 31, 2013 for 

military and transportation uses of c-deca BDE). 
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133 decaBDE. The total government costs for the proposed rule are estimated to be approximately $12,538. 

134 The total estimated social costs of the proposed rule are the sum of the industry and EPA costs. 

135 This report also includes a small entity impact analysis to estimate the per-company cost incurred through 

136 the proposed rule. Such an analysis is particularly relevant for small businesses. This analysis determines 

137 that the proposed rule will not affect any companies identified as small under the Small Business 

138 Administration’s definitions. 

139 
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140 Chapter 1 – Introduction 

141 This report assesses the costs and benefits expected to result from EPA’s proposed test rule for 

142 commercial pentabromodiphenyl ether (c-pentaBDE), commercial octabromodiphenyl ether (c-octaBDE), 

143 and commercial decabromodiphenyl ether (c-decaBDE). The proposed rule would require anyone who 

144 manufactures, imports, or processes c-pentaBDE, c-octaBDE, or c-decaBDE, including in articles, after 

145 December 31, 2012 (December 31, 2013 for military and transportation uses of c-deca BDE) to conduct 

146 testing to obtain data on health effects, environmental effects, and chemical fate. This chapter provides 

147 background information on EPA’s statutory authority for requiring this testing, regulatory background, a 

148 brief summary of the methodology used in the analysis, and a description of the organization of the 

149 remainder of this report. 

150 1.1 Statutory Authority 

151 Under the Toxic Substances Control Act (TSCA), the U.S. EPA can impose information reporting and 

152 other requirements on producers, importers, processors, users, distributors, and disposers of chemical 

153 substances or mixtures to ensure the safe management of toxic chemical substances or mixtures. Under 

154 TSCA Section 4, EPA is authorized to require by rule that manufacturers and/or processors of chemical 

155 substances or mixtures conduct testing to determine the effect of chemical substances or mixtures on 

156 human health and the environment. In particular, the Administrator requires that testing be conducted if 

157 the Agency finds that: 

158 (A) (i) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or 

159 mixture, or any combination of such activities, may present an unreasonable risk of injury to health or the 

160 environment, 

161 (ii) there are insufficient data and experience upon which the effects of such manufacture, distribution in 

162 commerce, processing, use, or disposal of such substance or mixture or of any combination of such 

163 activities on health or the environment can reasonably be determined or predicted, and 

164 (iii) testing of such substance or mixture with respect to such effects is necessary to develop such data; or 

165 (B) (i) a chemical substance or mixture is or will be produced in substantial quantities, and (I) it enters or may 

166 reasonably be anticipated to enter the environment in substantial quantities or (II) there is or may be 

167 significant or substantial human exposure to such substance or mixture, 

168 (ii) there are insufficient data and experience upon which the effects of the manufacture, distribution in 

169 commerce, processing, use, or disposal of such substance or mixture or of any combination of such 

170 activities on health or the environment can reasonably be determined or predicted, and 

171 iii) testing of such substance or mixture with respect to such effects is necessary to develop such data. 

172 1.2 Regulatory and Programmatic Background 

173 In 2004, domestic manufacture of c-pentaBDE and c-octaBDE ceased when the Great Lakes Chemical 

174 Corporation (now Chemtura) voluntarily phased out its production of these commercial mixtures (U.S. 

175 EPA, 2009a). EPA promulgated a TSCA Section 5 Significant New Use Rule (SNUR) in 2006 (71 FR 

176 34015, June 13, 2006) to require any person intending to manufacture or import any one or more of six 

177 polybrominated diphenyl ethers (PBDEs), including pentaBDE and octaBDE, to notify EPA at least 90 

178 days prior to commencement of these activities. EPA is currently proposing amendments to this SNUR in 

179 order to 1) subject processors of all six PBDEs to the SNUR, 2) subject manufacturers, importers, and 

180 processors of decaBDE to the SNUR, and 3) rescind an article exemption from the 2006 SNUR, and 
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181 therefore subject the manufacturing, import, and processing of articles containing the PBDEs after 

December 31, 2012 (December 31, 2013 for military and transportation uses of deca BDE) to the SNUR.2 182 

183 EPA included pentaBDE, octaBDE, and decaBDE in the Voluntary Children’s Chemical Evaluation 

184 Program (VCCEP) in 2000. This program developed industry-sponsored screening level risk assessments 

185 for these c-pentaBDE, c-octaBDE, and c-decaBDE to evaluate the risks of potential exposure to PBDEs 

186 in children and prospective parents. With the manufacture of c-pentaBDE and c-octaBDE ceasing in 

187 2004, industry ended sponsorship of pentaBDE and octaBDE in this program in 2005 (U.S. EPA, 2010a). 

188 In May 2008, because of a lack of adequate data submission, EPA decided to terminate decaBDE’s 

189 sponsorship in VCCEP and proposed the development of a test rule, while allowing companies to submit 

190 a proposal to pursue an enforceable consent agreement (ECA) to develop the required data. In September 

191 2008, the Brominated Flame Retardants Industry Panel (BRFIP) agreed to submit additional data, based 

192 on which EPA agreed to temporarily suspend its plans to develop a test rule for decaBDE and work with 

193 the BRFIP to develop an ECA (U.S. EPA, 2009b). 

194 The U.S. manufacture and import of c-pentaBDE and c-octaBDE was phased out in 2004, and there is no 

195 evidence of any global production, and so no reason to suggest any import of articles containing the 

196 chemicals (see Section 2.3.1). EPA understands that the major U.S. manufacturers and importer of c197 decaBDE intend to phase out production, importation, and sales of c-decaBDE by the end of 2012, and 

198 phase out all uses by the end of 2013 (U.S. EPA, 2009a). EPA is proposing a test rule in order to predict 

199 the health effects, environmental effects, and chemical fate of c-pentaBDE, c-octaBDE, and c-decaBDE 

200 in the event that their production, import, and use does not cease. 

201 1.3 Summary of Analytic Approach 

202 This analysis seeks to quantify, to the extent possible, the costs to society of the proposed test rule, if 

203 finalized, by identifying the costs to industry associated with performing the required tests and the costs 

204 to EPA of administering the rule. Costs to industry include the costs incurred by the laboratory testing of 

205 the three commercial mixtures, as well as analytical methodology validation costs, administrative costs, 

206 and costs to comply with the export notification requirement in the rule. Agency costs include reviewing 

207 and processing the data received as a result of the rule. Data sources for this analysis include test costs 

208 estimated by laboratories and burden estimates derived from information collection requests for similar 

209 regulations. Because the specific tests required for each mixture may be different, costs are presented for 

210 each individual mixture and aggregated to show the cost of the rule as a whole. 

211 This report also presents a small entity impact analysis that assesses the effect of the proposed rule, if 

212 finalized, on small entities. The methodology includes reviewing the list of chemical manufacturers and 

213 importers to identify small businesses (using a sales-based and a revenue-based definition) with parent214 company data from Dun & Bradstreet. For each small entity, a ratio was calculated to compare the cost 

215 of the rule with the company’s annual revenue. 

216 Additionally, this report qualitatively discusses the benefits of the proposed action, based on the value of 

217 the information it will provide. The benefits analysis was undertaken to address the implicit call for cost218 benefit balancing contained in TSCA, as well as the requirements of Executive Order 12866. 

219 1.4 Organization of This Report 

220 This report presents EPA’s economic analysis for this proposed rule. Regulated mixtures and companies 

221 are characterized in Chapter 2. Chapter 3 explains the tests that are required by this testing rule. Costs to 

222 industry, including laboratory and administrative, are reported in Chapter 4. Agency costs are shown in 

223 Chapter 5. Total social costs (industry plus agency) are presented in Chapter 6. The small entity impact 

 

2

 There is no evidence to indicate the manufacture of appreciable quantities of c-pentaBDE or c-octaBDE anywhere 

in the world, suggesting there is any domestic import of articles containing the chemicals (see Section 2.3.1 for more 

details). 
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224 analysis for the proposed rule, as mandated by the Regulatory Flexibility Act (RFA), and amended by the 

225 Small Business Regulatory Enforcement Fairness Act (SBREFA), is presented in Chapter 7. Chapter 8 

226 qualitatively addresses the benefits of the proposed rule, if finalized. Several additional impact analyses 

227 are presented in Chapter 9. Cited references are listed in Chapter 10. 

228 Note that all dollar amounts in this analysis are reported in 2009 dollars. For cost inputs that were 

229 estimated prior to 2009, EPA applied the most relevant adjustment factor to ensure that all costs were 

230 comparable. 
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231 Chapter 2 - Affected Entities 

232 

233 2.1 Chemical Mixtures Subject to the Proposed Rule 

234 This chapter presents information about the production and use of the three chemical mixtures included in 

235 the proposed rule: c-pentaBDE, c-octaBDE, and c-decaBDE. To be included in this proposed rule, EPA 

236 has made preliminary findings for these chemical mixtures under TSCA section 4(a)(1)(A) that: 

237 • their manufacture, distribution in commerce, processing, use, or disposal may cause an 

238 unreasonable risk of injury to health or the environment; 

239 • existing data are insufficient to determine or predict their health and environmental effects; and 

240 • testing is necessary to develop such data. 

241 Exhibit 2-1 provides the common mixture names of the three mixtures included in the proposed rule and 

242 the predominant PBDE congener components (and their Chemical Abstracts Service Registry Number 

243 (CASRN) assigned by the Chemical Abstracts Service (CAS)) of each mixture 

244 Exhibit 2-1 : Mixtures Included in the Proposed Test Rule 

Common Mixture Name Predominant Congeners in Mixture and CASRNs 

Commercial 

Pentabromodiphenyl Ether 

(c-PentaBDE) 

tetrabromodiphenyl ether (CASRN 40088–47–9; Benzene, 1,1′-oxybis-, tetrabromo deriv.), 

pentabromodiphenyl ether (CASRN 32534-81-9; Benzene, 1,1’-oxybis-, pentabromo deriv.), 

and hexabromodiphenyl ether (CASRN 36483–60–0; Benzene, 1,1′-oxybis-, hexabromo 

deriv.)

Commercial 

Octabromodiphenyl Ether 

(c-OctaBDE) 

heptabromodiphenyl ether (CASRN 68928–80–3; Benzene, 1,1′-oxybis-, heptabromo 

deriv.), octabromodiphenyl ether (CAS No. 32536-52-0; Benzene, 1,1’-oxybis-, octabromo 

deriv.), and nonabromodiphenyl ether (CASRN 63936–56–1; Benzene, pentabromo 

(tetrabromophenoxy)-)

Commercial 

Decabromodiphenyl Ether 

(c-DecaBDE) 

component with the highest percent composition is decabromodiphenyl ether (CASRN 1163-

19-5; Benzene, 1,1’-oxybis[2,3,4,5,6-pentabromo-), aka BDE-209

245 

246 2.2 Uses of PBDEs 

247 Historically, PBDEs have been added to materials to reduce the risk of fires and to increase escape time 

248 when a fire occurs. They have been widely used in textiles, plastics, and polyurethane foam. PBDE249 treated articles have been used in the home, in business settings, and in the transportation sector. Articles 

250 that have often been treated with PBDEs include carpets, upholstery fabric, cushions, and plastics used as 

251 components in electrical appliances and equipment (U.S. EPA, 2009a). 

252 The following sections describe the specific known uses of each of the three mixtures, including articles 

253 that may contain the mixtures, and the potentially affected industry sectors. 

254 2.2.1 Uses of c-PentaBDE 

255 C-pentaBDE is one of the major brominated flame retardants. Because there has been no new 

256 manufacture of c-pentaBDE in the United States since 2004, no import since 2006, and there is no 

257 evidence of the import of any articles containing c-pentaBDE, it is expected that there are no current uses 

258 of the mixture (or articles containing the mixture) domestically (U.S. EPA, 2009a). 

259 Historically, c-pentaBDE was used primarily as an additive flame retardant in flexible polyurethane 

260 foams (95 percent of c-pentaBDE’s historical consumption in the United States) (ERG, 2002). A minor 

261 amount was consumed in rigid foams (ERG, 2002). Articles treated with c-pentaBDE were most 

262 commonly used in the upholstery and furniture markets, though treated articles were also used in other 

263 applications including automotive seat cushions and padding, mattress foam padding, furniture foam 
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264 padding, and pillows (ERG, 2002). A 2002 study estimated that 80 percent of c-pentaBDE was used in 

265 foam for furniture and mattresses, while the remaining amount was used in automotive applications 

266 (ERG, 2002). Minor amounts were also used in textiles. 

267 2.2.2 Uses of c-OctaBDE 

268 C-octaBDE is a brominated flame retardant that has applications in the plastics industry. Because there 

269 has been no new manufacture of c-octaBDE in the United States since 2004 no import since 2006, and 

270 there is no evidence of the import of any articles containing c-octaBDE, it is expected that there are also 

271 no current uses of the mixture (or articles containing the mixture) domestically (U.S. EPA, 2009a). 

272 Historically, c-octaBDE was used in acrylonitrile-butadiene-styrene (ABS) plastic, which was used as 

273 casing for certain electric and electronic devices that are used in both offices and home. For example, in 

274 Switzerland, 70 percent of c-octaBDE was used in electronic goods, 40 percent was used in TVs, 20 

275 percent in cars and 10 percent in building materials (Alvarez, 2008). Similar information was not 

276 available for the United States. One industry contact thought c-octaBDE was mostly used in ABS plastics 

277 for automotive applications because c-octaBDE gives the plastic a good quality finish that lends itself to 

278 high quality paint work (Dawson, 2009). Finished products typically contained five to 30 percent c279 octaBDE by weight (Alvarez, 2008). 

280 2.2.3 Uses of c-DecaBDE 

281 While uses of c-pentaBDE and c-octaBDE have been restricted in the United States and phased out 

282 internationally, c-decaBDE is still widely used. C-decaBDE is considered the most effective of the 

283 brominated flame retardants. Because relatively small quantities are required for outstanding flame 

284 retardant properties, c-decaBDE has minimal influence on the physical and mechanical properties of the 

285 flame-retarded product (Abt Associates, 2009). 

286 C-decaBDE’s main use is in high-impact polystyrene (HIPS), and has a variety of applications, including 

287 textiles, electronic equipment, and building and construction materials. According to 2006 reporting year 

288 submissions under the Inventory Update Reporting (IUR) rule, c-decaBDE is used as a flame retardant by 

289 the following industry sectors: Adhesive Manufacturing; Automobile and Light Duty Motor Vehicle 

290 Manufacturing; Computer and Peripheral Equipment Manufacturing; Major Appliance Manufacturing; 

291 Textile and Fabric Finishing Mills; and Wiring Device Manufacturing. IUR product categories include 

292 adhesives and sealants, electrical and electronic products, paints and coatings, rubber and plastic products 

293 (U.S. EPA, 2009c).

294 2.3 Regulated Community 

295 Entities potentially affected by the proposed test rule include those that manufacture, import, or process c296 pentaBDE, c-octaBDE, or c-decaBDE, including in articles. 

297 However, EPA notes that the proposed test rule addressed by this economic analysis is being proposed 

298 concurrently with an amendment to an existing SNUR (see 74 FR 34015, June 13, 2006). If manufacture, 

299 import, and processing of pentaBDE, octaBDE, and decaBDE, including in articles has ceased by 

300 December 31, 2012 (December 31, 2013 for military and transportation uses of decaBDE), the SNUR will 

301 apply and no company may enter or reenter the market without submitting a SNUN to EPA for the 

302 chemical. If any company manufactures, imports, or processes any of the three mixtures for any use, 

303 including in articles, after December 31, 2012 (December 31, 2013 for military and transportation uses of 

304 c-decaBDE), the mixture(s) will be subject to the test rule, and the costs and benefits described in this 

305 analysis would apply. 

306 The following sections describe the manufacturers, importers, or processors of the subject mixtures and 

307 articles.

308 2.3.1 Manufacturers and Importers of c-PentaBDE and c-OctaBDE 
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309 C-pentaBDE and c-octaBDE are no longer produced or imported into the United States. The sole 

310 domestic producer, Great Lakes Chemical (now Chemtura) voluntarily phased out the production of these 

311 mixtures in 2004. There are no other known U.S. manufacturers of these mixtures (U.S. EPA, 2009a). In 

312 2006, EPA issued a SNUR requiring anyone who intends to manufacture or import pentaBDE or 

313 octaBDE to notify the Agency at least 90 days in advance in order to provide EPA with the opportunity to 

314 evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. The SNUR 

315 did not cover the processing or the manufacture, import, or processing of articles treated with these 

chemicals. However, there is no evidence to suggest that appreciable quantities of pentaBDE3 316 or 

octaBDE4 317 are manufactured anywhere in the world. As a result, the Agency does not believe that any 

318 articles containing pentaBDE or octaBDE are being imported into the United States. 

319 If a company manufactures or imports the mixtures (or articles containing them) after December 31, 2012 

(the date specified in the proposed rule5 320 ), the company would be subject to the test rule. Given the fact 

321 that there are currently no known manufacturers or importers of the mixtures (or articles containing 

322 them), we assume that no companies will be engaged in these activities after December 31, 2012. We 

323 therefore do not consider any manufacturers or importers of c-pentaBDE and c-octaBDE in this test rule 

economic analysis.6 324 

325 2.3.2 Manufacturers and Importers of c-DecaBDE 

326 EPA acquired chemical manufacturer and importer information for c-decaBDE from submissions 

327 required by the TSCA IUR Revisions rule (70 FR 75059, December 19, 2005). According to the publicly 

328 available 2006 IUR data, c-decaBDE was manufactured or imported by four companies in the United 

329 States (U.S. EPA, 2009c). This figure may not include all potentially affected entities because, for 

330 example, companies that manufactured or imported less than 25,000 pounds of a subject mixture at an 

331 individual site in 2006 are not required to comply with IUR reporting. Further, the data are from 2006 

332 and may not be current. Therefore, EPA investigated other sources to obtain manufacturer information. 

333 The Directory of World Chemical Producers is a proprietary database containing over 18,000 worldwide 

334 producers of more than 150,000 chemicals, used to search for producers of chemicals and bulk 

335 pharmaceuticals. EPA used the directory to identify any U.S. producers of c-decaBDE subject to the 

336 proposed test rule that were not already identified based on IUR reporting. This resulted in one additional 

337 company producing one or more of the subject mixtures (DWCP, 2009). Another importer of c-decaBDE 

338 was identified through its involvement in EPA’s DecaBDE Phase-Out Initiative (U.S. EPA, 2010b). The 

339 list of identified manufacturers and importers of c-decaBDE is presented in Exhibit 2-2 below; this list 

340 likely overestimates the expected number of c-decaBDE manufacturers after December 31, 2012, because 

 

3

 A few Chinese manufacturers list pentaBDE as one of the chemicals they can produce, but any production of pentaBDE is 

probably on a to-order basis and not produced on a large scale (Buzcek, 2009). Several industry contacts agreed that if 

pentaBDE is being produced anywhere, it would likely be in China (Dawson, 2009; Buzcek, 2009; Campbell, 2009). One 

industry contact thought some pentaBDE might also be produced in India (Campbell, 2009). 4

 The production of octaBDE was recently phased out in the EU, Norway, Switzerland, Canada and the United States, and there 

is no information indicating that octaBDE is being produced in developing countries (Alvarex, 2008). In addition, none of the 

major global manufacturers produce octaBDE (Campbell, 2009; Dawson, 2009; Buzcek, 2009). However, if it produced 

anywhere in the world, it might be in China (Dawson, 2009). 5

 According to the proposed rule preamble, EPA believes that a reasonable date by which all activities with pentaBDE, 

octaBDE, and decaBDE can cease, including the activities of processors, is December 31, 2012 (December 31, 2013 for the 

military and transportation uses of decaBDE). . 

6

 If the Agency is incorrect in this assumption, and foreign companies manufacture c-pentaBDE and c-octaBDE,, companies 

that import articles treated with the mixtures would be subject to this test rule. Given the known uses of the mixture, if 

articles treated with c-pentaBDE were being imported into the United States, they would likely fall under the following 

NAICS codes: 337121 (upholstered office furniture); 337910 (mattresses); and 337214 (non-wood office furniture) (PFA, 

2006). However, given the broad range of products and lack of certainty over whether imported goods do contain the 

mixtures, we are unable to identify the importers of these articles that could be affected by this test rule. 
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341 the principal manufacturers and importer of c-decaBDE have committed to phase out the manufacture, 

342 import and sales of c-decaBDE starting in 2010. 

343 Ordinary production, import and sales of c-decaBDE would cease no later than December 31, 2012. 

344 Certain uses such as transportation uses or military applications may require an additional year to phase 

345 out. In any case, the companies would cease sales for these uses no later than December 31, 2013. EPA 

346 intends to encourage other importers of c-decaBDE to join this effort; however, the commitment under 

347 discussion would not affect articles made with c-decaBDE (U.S. EPA, 2009a). 

348 Exhibit 2-2 : U.S. Manufacturers and Importers of c-DecaBDE in 2006 

Company City State Company 

Type Data Source 

Albemarle Corporation Magnolia AR Manufacturer 

IUR, U.S. EPA, 

2009c Chemtura Corporation El Dorado AR [Data claimed 

as CBI] 

Sojitz Corporation of America New York NY Importer 

The Goodyear Tire & Rubber Company Marysville OH Importer 

Tiarco Chemicals Dalton GA Manufacturer DWCP, 2009 

ICL Industrial Products Tel Aviv-Jaffa Israel Importer U.S. EPA, 

2010b 

349 

350 According to the Directory of World Chemical Producers, c-decaBDE is produced in seven countries 

351 outside of the United States. Imported articles that may be treated with c-decaBDE fall under the NAICS 

352 codes listed in Exhibit 2-3:

353 Exhibit 2-3: NAICS Codes for c-decaBDE Importers 

NAICS Code Designation

313210 Broadwoven fabrics 

314121 Curtain draperies 

337121 Upholstered office furniture 

337214 Office furniture (without wood) 

337910 Mattresses 

334111 Electronic computers 

334220 Radio and television broadcasting and wireless communications equipment 

334310 Audio and video equipment 

335931 Current-carrying wiring devices 

335929 Communication and energy wire 

354 

355 Given the broad range of products and lack of certainty over whether imported goods do contain thec356 decaBDE, we are unable to identify the specific importers of these articles that could be affected by this 

357 test rule. 

358 2.3.3 Chemical Processors 

359 According to the proposed rule, processors of the three subject mixtures are assigned “Tier 2” status, 

360 meaning they are “persons not initially required to comply.” Therefore, while they would legally be 

361 subject to the proposed test rule, processors of a subject mixture would be required to comply with the 

362 requirements of the rule only if they are directed to do so by EPA in a future Federal Register notice. 

363 Because the proposed rule requires only that the required test results be obtained once for each mixture, 

364 EPA would only require processors to test if no manufacturer has submitted a notice of its intent to 

365 conduct testing, or if a problem occurs with the initiation, conduct, or completion of the required testing 

366 or the submission of the required data to EPA. Because there are three identified manufacturers of the 

367 subject mixture c-decaBDE and several importers, the Agency assumes that for c-decaBDE at least one 

368 such person will submit a letter of intent to conduct the required testing and that person will conduct such 
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369 testing and will submit the test data to EPA if c-decaBDE is still being manufactured or imported after 

370 December 31, 2012 (December 31, 2013 for military and transportation uses of c-deca BDE). Because 

371 processors would not need to comply with the proposed rule initially, this economic analysis does not 

372 address processors. Furthermore, we assume that there are no processors of c-pentaBDE or c-octaBDE in 

373 the United States, because the mixtures are not manufactured or imported into the United States (other 

374 than processing of articles containing one or more of the mixtures as impurities). 
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375 Chapter 3 –Tests Required by the Proposed Rule 

376 

377 3.1 Introduction 

378 EPA is concerned about the potential exposure to c-PBDEs, and their reported health and ecological 

379 effects. Based on the evidence of the human and environmental hazards of c-pentaBDE, c-octaBDE, and 

380 c-decaBDE, and the potential for human and environmental exposure to these mixtures, EPA believes that 

381 testing c-pentaBDE, c-octaBDE, and c-decaBDE is necessary to develop data to be able to reasonably 

382 determine and predict the effects of the manufacture, distribution in commerce, and processing of these 

383 mixtures on the environment, because current data is insufficient to do so. 

384 Data collected and/or developed under a final rule based on this proposal, when combined with 

385 information about exposure and uses, will allow the Agency and others to better assess the potential risk 

386 to health and the environment from these mixtures. EPA intends to make the information collected under 

387 the final rule available to the public, other Federal agencies, and any other interested parties. As 

388 appropriate, this information will be used to ensure a scientifically sound basis for risk 

389 assessment/management actions. This effort will serve to further the Agency’s goal of identifying and 

390 controlling human and environmental risks as well as providing greater protection and knowledge to the 

391 public. 

392 3.2 Description of Tests Required by the Proposed Rule 

393 EPA has specified fourteen test methods that provide data on the ecotoxicity (aquatic toxicity), 

394 mammalian toxicity, and chemical fate of the mixtures subject to the proposed rule. For one of these 

395 tests, EPA is proposing the use of a guideline that the agency developed (to test for photolytic 

396 degradation). Exhibit 3-1 provides a description of the tests that would be required for mixtures under the 

397 proposed rule. 

398 Exhibit 3-1: Tests Required under the Proposed Test Rule 

Protocol Name Protocol Number(s) Description 

Test 

Code 

(used in 

this 

analysis)

CATEGORY A: ECOTOXICITY / AQUATIC TOXICITY

Sediment toxicity to 

invertebrates 

ASTM E 1706-05e1 

and ASTM E 1391-

03 

Evaluate the toxicity to freshwater invertebrates of the test 

mixture when associated with whole sediments A1 

Soil toxicity and 

bioaccumulation 

ASTM E 1676-04 

and ASTM E 1391-

03 

Evaluate the adverse effects on earthworms (Eisenia 

fetida) and potworms (Enchytraeus albidu) of the test 

mixture when associated with soils 

A2 

Sediment toxicity to 

polychaetous annelids 

ASTM E 1611-00 

and ASTM E 1391-

03 

Evaluate the toxicity to polychaetous annelids of the test 

mixture when associated with sediment A3 

Soil toxicity to 

nematodes 

ASTM E 2172-01, 

ASTM E 1676-04 

and ASTM E 1391-

03 

Evaluate the adverse effects on nematodes 

(Caenorhabditis elegans) of the test mixture when 

associated with soils 

A4 

Sediment toxicity to 

estuarine or marine 

organisms 

ASTM E 1367-03, 

and ASTM E 1391-

03 

Evaluate the toxicity to estuarine or marine organisms of 

the test mixture when associated with whole sediments A5 
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Protocol Name Protocol Number(s) Description 

Test 

Code 

(used in 

this 

analysis)

CATEGORY B: MAMMALIAN TOXICITY 

Prenatal 

developmental toxicity 

in rabbits 

40 CFR 799.9370 

Provide general information concerning the effects of 

exposure to the test mixture on the pregnant test animal 

and on the developing organism 

B1 

Two-generation 

reproductive toxicity 

with satellite group for 

body burden 

determinations 

40 CFR 799.9380 

Provide general information concerning the effects of 

exposure to the test mixture on the integrity and 

performance of the male and female reproductive systems, 

and on the growth and development of offspring 

B2 

Immunotoxicity 40 CFR 799.9780 

Provide information on suppression of the immune system 

which might occur as a result of repeated exposure to the 

test mixture 

B3 

Neurotoxicity 

screening battery, 

acute and subchronic 

40 CFR 799.9620 

Provide information on gross functional deficits, level of 

activity, and histopathological changes in the central and 

peripheral nervous systems of the test animals as a result 

of acute and subchronic exposure to the test mixture 

B4 

Developmental 

neurotoxicity 40 CFR 799.9630 

Develop data on the potential functional and morphological 

hazards to the nervous system which may arise in the 

offspring from exposure of the mother to the test mixture 

during pregnancy and lactation 

B5 

Chronic 

toxicity/Carcinogenicity 40 CFR 799.9430 

Identify the majority of chronic and carcinogenetic effects 

and determine dose-response relationships in a 

mammalian species following prolonged and repeated 

exposure to the test mixture 

B6 

CATEGORY C: CHEMICAL FATE 

Anaerobic aquatic 

metabolism 

799.XXXX(i)(2) 

(modified 835.4400)

Assess transformation of test mixture in anaerobic aquatic 

sediment systems C1 

Biodegradation in 

Anaerobic Digester 

Sludge 

799.XXXX(i)(3) 

(modified 835.3280)

Simulate digester sludge and assess primary and ultimate 

biodegradability of test mixture discharged to wastewater C2 

Photolytic degradation 

in the indoor 

environment 

799.XXXX(i)(4) Assess potential sources of test mixture in indoor 

environment C3 

Source: U.S. EPA, 2010c 

399 

400 3.3 Specific Test Requirements for each Mixture in the Proposed Rule 

401 EPA has determined that neurobehavioral effects are a critical endpoint of concern for PBDEs, and that 

402 for c-decaBDE, there is “suggestive evidence of carcinogenic potential.” EPA has also made preliminary 

403 findings that there is insufficient data to determine the effects on health and the environment of the 

404 manufacture, processing, and use of the subject mixtures. Tests required for each mixture included in the 

405 proposed rule are summarized in Exhibit 3-2. 

406 Exhibit 3-2: Test Requirements for Mixtures Included in the Proposed Rule 

Mixture Name Required Tests

(See Test Codes in Exhibit 3-1) 

c-Pentabromodiphenyl Ether 

(c-PentaBDE) A1, A2, A3, A4, A5, B1, B2, B3, B4, B5, B6 

c-Octabromodiphenyl Ether 

(c-OctaBDE) A1, A2, A3, A4, A5, B1, B2, B3, B4, B5, B6 
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3-3 

Mixture Name Required Tests

(See Test Codes in Exhibit 3-1) 

c-Decabromodiphenyl Ether 

(c-DecaBDE) 

A1, A2, A3, A4, A5, B1, B2, B3, B4, B5, C1, C2, 

C3 
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4-1 

407 Chapter 4 Industry Compliance Costs 

408 

409 4.1 Introduction 

410 This chapter presents estimates of the costs that industry (entities who manufacture, import, or process c411 pentaBDE, c-octaBDE, or c-decaBDE, including in articles, after December 31, 2012 (December 31, 

412 2013 for military and transportation uses of c-deca BDE)) may incur due to the requirements included in 

413 the proposed rule, and discusses the method used to measure each. Industry may incur costs related to 

414 laboratory testing requirements (Section 4.2.1), analytical methodology validation (Section 4.2.2), 

415 administrative activities (Section 4.2.3), and export notification requirements (Section 4.2.4). Total 

416 industry compliance costs are summarized in Section 4.3. 

417 4.2 Unit Costs 

418 The following sections describe, on a per-unit basis, the types of costs that would be incurred by industry 

419 to comply with the proposed test rule. 

420 4.2.1 Laboratory Testing Costs 

421 Individual Test Cost Estimates 

422 EPA obtained test cost estimates by contacting nine or fewer laboratories known to perform each test and 

423 requesting pricing information, or, when such direct estimates were not available, by obtaining a best 

424 professional estimate from industry experts. Although the rule requires that testing be conducted in 

425 accordance with the specified mandatory and enforceable requirements in the ASTM or §799 guidelines 

426 (see Section 3.2), the cost estimates used in this analysis may also be based on OECD or other EPA 

427 protocols, which are representative of the desired testing endpoint (as summarized in Exhibit 4-1). 

428 Testing cost estimates generally include direct labor, overhead, other direct costs such as laboratory 

429 supplies, and general and administrative services. 

430 Estimating the potential testing costs for each mixture pursuant to requirements contained in the proposed 

431 rule is complicated in that industry may have choices associated with the doses, durations, species and/or 

432 route of administration used in a particular test; or preliminary results during a protocol may require 

433 additional steps or repetitions. Therefore, to obtain consistent costing results, all laboratories contacted for 

434 pricing information were provided with a study outline for the test specifying any variables that may 

435 affect the cost of the test. The most standard protocols were used. Furthermore, laboratories were asked 

436 to provide a range of cost estimates with a low-cost estimate and a high-cost estimate for each test. 

437 Individual estimates of test costs will vary across testing laboratories based upon factors such as labor 

438 costs, profit margins, and other concerns. The “low-cost” estimate used in this analysis is the average of 

439 all of the low-cost estimates received for the test, and the “high-cost” estimate is the average of all of the 

440 high-cost estimates received. 

441 Exhibit 4-1 presents the protocols required by the rule, the basis for the cost estimate, and final cost 

442 estimates used in the analysis. 

443 Exhibit 4-1: EPA Estimates of Laboratory Costs of Proposed Tests (2009$) 

Test 

Code 

Protocol Name Required Protocol 

Number(s) 

Basis for Cost 

Estimate1,2 Source 

Cost Estimate

2009$1

Low High

A1 Sediment toxicity to 

invertebrates 

ASTM E 1706-05e1 and 

ASTM E 1391-031 nine or fewer 

laboratories Abt, 2010b $26,060 $45,733 

A2 Soil toxicity and 

bioaccumulation 

ASTM E 1676-04 and 

ASTM E 1391-031 best professional 

estimation Abt, 2010c $23,100 $53,850 

A3 Sediment toxicity to 

polychaetous annelids 

ASTM E 1611-00 and 

ASTM E 1391-031 nine or fewer 

laboratories Abt, 2010b $14,742 $30,577 
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4-2 

Test 

Code 

Protocol Name Required Protocol 

Number(s) 

Basis for Cost 

Estimate Source 

Cost Estimate 

2009$1

Low High 

A4 Soil toxicity to nematodes 

ASTM E 2172-012

, 

ASTM 1676-04 and 

ASTM E 1391-031

nine or fewer 

laboratories Abt, 2010b $10,767 $30,425 

A5

Sediment toxicity to 

estuarine or marine 

organisms 

ASTM E 1367-03, and 

ASTM E 1391-031 nine or fewer 

laboratories Abt, 2010b $26,500 $41,581 

B1 Prenatal developmental 

toxicity in rabbits 40 CFR 799.9370 

nine or fewer 

laboratories, using 

40 CFR 870.3700 

Abt, 2010a $122,547 $210,760

B2

Two-generation 

reproductive toxicity with 

satellite group for body 

burden determinations 

40 CFR 799.9380 

nine or fewer 

laboratories, using 

40 CFR 870.3800 

Abt, 2010a $270,213 $516,400

B3 Immunotoxicity 40 CFR 799.9780 

nine or fewer 

laboratories, using 

40 CFR 870.7800 

Abt, 2010a $61,221 $63,608 

B4

Neurotoxicity screening 

battery, acute and 

subchronic 

40 CFR 799.9620 

nine or fewer 

laboratories, using 

40 CFR 870.6200 

Abt, 2010a $336,418 $407,999

B5 Developmental 

neurotoxicity 40 CFR 799.9630 

nine or fewer 

laboratories, using 

40 CFR 870.6300 

Abt, 2010a $702,500 $702,500

B6 Chronic 

toxicity/Carcinogenicity 40 CFR 799.9430 nine or fewer 

laboratories Abt, 2010b $1,260,850 $2,564,000

C1 Anaerobic aquatic 

metabolism 

799.XXXX(i)(2) 

(modified 835.4400) 

nine or fewer 

laboratories, using 

40 CFR 835.4400 

Abt, 2010a $72,663 $141,786

C2

Biodegradation in 

Anaerobic Digester 

Sludge 

799.XXXX(i)(3) 

(modified 835.3280) 

nine or fewer 

laboratories Abt, 2010b $82,750 $151,100

C3 Photolytic degradation in 

the indoor environment 799.XXXX(i)(4)2 nine or fewer laboratories Abt, 2010b $100,000 $150,000

Notes: 

1 The basis for the cost estimate for ASTM E 1391-03 is the best professional estimate of an industry expert. 2

 The basis for the cost estimate for ASTM E 2172-01 and 799.XXXX(i)(4) is a single laboratory; it is uncertain of how representative 

the estimate is for the whole industry.

444 

445 Total Test Costs per Mixture 

446 The proposed rule requires only that the required test results be obtained once for each mixture; each 

447 entity is not required to do the tests separately. Therefore, in order to obtain the total test costs under the 

448 proposed rule, EPA assumes that a required test will be performed only once per mixture. The costs of the 

449 tests required for each mixture were summed for all mixtures, and then the total cost per mixture was 

450 summed across all the mixtures included in the proposed rule. Exhibit 4-2 shows the laboratory test costs 

451 for each mixture.. ach 
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4-3 

452 chemical under the proposed rule. 

453 Exhibit 4-2: Total Laboratory Test Costs per Mixture 

Mixture Name 

Laboratory Testing Cost

(Test Requirements as listed in Exhibit 3-2) 

Low-Cost Scenario High-Cost Scenario 

1 c-PentaBDE $2,854,919 $4,667,433 

2 c-OctaBDE $2,854,919 $4,667,433 

3 c- DecaBDE $1,849,482 $2,546,319 

 Total $7,559,319 $11,881,186

454 

455 As shown in Exhibit 4-2, the total laboratory cost for testing the mixtures included in the proposed rule is 

456 estimated to range from approximately $7.56 million under the low-cost scenario to approximately $11.9 

457 million under the high-cost scenario. These estimates may overstate the true testing burden because they 

458 are based on the assumption that each mixture is tested independently. If more than one mixture is tested 

459 at a time (for example, if all three mixtures were to be tested at the same laboratory at the same time), 

460 testing costs could be lower due to economies of scale (for example, the test’s quality control procedures 

461 can be performed by batch, making the per-mixture cost lower). 

462 4.2.2 Analytical Method Validation Costs 

463 When conducting tests, laboratories perform analytical method validation to ensure that proper dose 

464 concentrations are used in toxicity studies. An analytical method validation approach assumes that an 

465 acceptable analytical method is available for a particular chemical or mixture and that the method is 

466 directly related to the matrix used for the test. When analytical methods are not suitable or known, they 

467 must be developed or modified. 

468 Analytical method validation includes all of the procedures that demonstrate that a particular method used 

469 for quantitative measurement of analytes in a given matrix is reliable and reproducible for the intended 

470 use. The fundamental parameters for this validation include (1) accuracy, (2) precision, (3) selectivity, 

471 (4) sensitivity, (5) reproducibility, and (6) stability. Validation involves documenting, through the use of 

472 specific laboratory investigations, that the performance characteristics of the method are suitable and 

473 reliable for the intended analytical applications. The acceptability of analytical data corresponds directly 

474 to the criteria used to validate the method. 

475 Factors that may increase the cost of analytical method development and validation costs include 

476 (1) testing new chemicals or mixtures that lack any established method or historical analytical data to use 

477 as a starting point, and (2) testing chemicals or mixtures that present challenging conditions or possess 

478 characteristics that require special or additional procedures during sample preparation and analysis. If 

479 previous testing on a chemical or mixture of interest has been conducted by either a laboratory or client, 

480 information may be available that can assist with sample preparation and analytical testing. This can help 

481 to minimize the costs of method development and validation. 

482 Analytical method development and analytical costs can also vary depending on characteristics of the test 

483 substance or mixture. Characteristics of chemicals or mixtures that may impact the cost of analytical 

484 method development and validation include mixture stability, mixture properties, and matrix properties 

485 and interactions with the mixture. For example, mixtures are not always stable under every test or 

486 analysis condition, and a mixture could decompose or transform into a different mixture or chemicals 

487 under testing conditions, which will invalidate the test results. Such mixtures will require additional 

488 effort to identify alternate conditions or matrices for testing to eliminate the potential for stability issues to 

489 affect the testing results. Certain properties may also affect the costs of analytical method development. 
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490 Some mixtures may interact with the dosing matrix and require special or even different handling and 

491 processing procedures that can impact the level of method development efforts. 

492 Once analytical methodology validation is completed for a specific mixture, however, it need not be 

493 repeated for tests of a similar nature (e.g., tests using the same dosing matrix), provided testing is done at 

494 the same laboratory. Therefore, the cost of analytical methodology validation is counted only once per 

495 testing category, for each mixture. 

496 For this proposed rule, EPA follows the methodology outlined in EPA’s Economic Analysis for the 

497 Proposed Section 4 Test Rule for High Production Volume Chemicals (U.S. EPA, 2009d) and estimates 

498 analytical methodology validation cost as listed in Exhibit 4-3 for aquatic toxicity tests. For mammalian 

499 toxicity and chemical fate tests required under this testing rule, laboratories recommended specific 

500 alternate analytical validation costs (Abt Associates, 2010a). These costs are also shown in Exhibit 4-3. 

501 Exhibit 4-3: Costs for Analytical Methodology Validation, per Test 

Testing Category Test Symbol Cost Estimate

2009$ 

Aquatic Toxicity A $6,000

Mammalian Toxicity B $17,500 

Chemical Fate C $22,500

Source: U.S. EPA, 2009d; Abt Associates, 2010a. 

502 

503 4.2.3 Administrative Costs 

504 In addition to laboratory costs, entities subject to the proposed test rule will also incur expenses associated 

505 with the administration of the testing program itself. Administrative activities include “reporting 

506 activities,” such as preparing letters of intent, study plans, and final reports, and “non-reporting 

507 activities,” such as soliciting laboratory bids, selecting laboratories, monitoring tests under progress, 

508 developing cost-sharing agreements, and auditing the laboratories for compliance with EPA’s Good 

509 Laboratory Practice (GLP) standards. Total administrative costs are calculated as the sum of the costs of 

510 reporting and non-reporting activities. This section discusses the methods and data employed to estimate 

511 reporting and non-reporting costs. 

512 Reporting costs include costs associated with submitting letters of intent, study plans, final reports, and 

513 exemption applications. The analysis assumes that one letter of intent and one set of study plans will be 

514 submitted for each mixture, resulting in 3 letters of intent and 3 study plans submitted to EPA. In 

515 addition, one final report is assumed to be required for each test conducted for each mixture. To estimate 

516 the total number of final reports, the total number of tests required for each mixture is summed across all 

517 mixtures, which results in an estimated 35 final reports that will be submitted to EPA in response to this 

518 rule. 

519 Finally, respondents may choose to develop and submit robust summaries of the full, final toxicological 

520 study reports. The robust summaries should contain technical information to adequately describe the 

521 study and results, and should be written such that the information provided is sufficient to allow a 

522 technically qualified person to evaluate study results without needing to review an entire study report. 

523 Typically, a robust summary would include a description of the test substance, methods, results, 

524 conclusions, data quality description, and references associated with the full study. Based on professional 

525 judgment, EPA estimates that 8 to 16 hours of technical time are needed to develop and review a robust 

526 summary, depending on the type of study conducted. Therefore, for this analysis, EPA assumes an 

527 average of 12 hours of technical time to prepare a robust summary. Because submission of robust 

528 summaries is voluntary, EPA does not expect that many companies will undertake this activity. EPA 

529 estimates that 10 percent of full, final toxicological study reports may include a robust summary. 

530 Therefore, EPA expects approximately 3.5 robust summaries. 
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531 EPA estimates that it takes a respondent 40 hours to prepare a letter of intent and study plan, and 73 hours 

532 to write a final report. These unit labor hours were derived from previous information collection requests 

533 and are believed to reflect the burdens that will be incurred for the proposed test rule (U.S. EPA, 2002b). 

534 Wage rates associated with the predominant skill level (managerial, technical, and clerical) required to 

535 complete each of the reporting activities described in this section are presented in Exhibit 4-4. These 

536 wage rates have been estimated following the method described in a memorandum titled, “Wage Rates for 

537 Economic Analyses of the Toxics Release Inventory Program” (U.S. EPA, 2002a). This method uses 

538 average December 2009 wages, benefits, and total compensation data extracted from the Employer Costs 

539 for Employee Compensation Summary available from the BLS Web site. Appendix A provides detailed 

540 information on the estimation of these wage rates. 

541 Exhibit 4-4: Derivation of Loaded Hourly Rates by Labor Category 

Labor Category 2009 Wage Rate 

2009 Benefits and 

Overhead 

Loading Factor 

2009 Loaded 

Hourly Wage Rate 

Managerial $42.36 1.61 $68.24 

Technical $35.96 1.65 $59.49 

Clerical $17.21 1.64 $28.31 

Source: Methodology from “Wage Rates for Economic Analyses of the Toxics Release Inventory Program” (U.S. 

EPA, 2002a). Wage rates and benefits extracted from the Employer Costs for Employee Compensation Summary, 

Bureau of Labor Statistics (BLS, 2010); assumed overhead rate of 17% applied to wage rates based on 

assumptions in U.S. EPA, 2002a and U.S. EPA 2002b. 

542 

543 Exhibit 4-5 details the respondents’ reporting cost and burden estimates. As shown, the total reporting 

544 cost and burden estimates are approximately $140,555 and 2,717 hours, respectively. 

545 Exhibit 4-5: Industry Reporting Cost and Burden Estimate for the Proposed Rule (2009$) 

Reporting Activity 

Unit Labor Annual Items 

Submitted 

Total

Category1 Hours/ 

Item 

Wage 

Rate 

Cost/ 

Item Hours Cost 

Letter of Intent and 

Study Plan T 40 $59.49 $2,380 3 120 $7,139 

Final Report 

 Record & Prepare Test 

for Submission 

 Laboratory Review 

 Corporate Review 

 Type & Print Results 

 Record Keeping 

T 

T 

M 

C 

C 

40 

6 

6 

20 

1 

$59.49 

$59.49 

$68.24 

$28.31 

$28.31 

$2,380 

$357 

$409 

$566 

$28 

35 

35 

35 

35 

35 

1,400 

210 

210 

700 

35 

$83,286 

$12,493 

$14,330 

$19,817 

$991 

Robust Summaries T 12 $59.49 $714 3.5 42 $2,499 

TOTAL 2,717 $140,555 1

Labor categories are as follows: T = Technical; M = Managerial; C = Clerical. 

546 

547 Non-Reporting Activities. In addition to reporting activities, manufacturers need to conduct a number of 

548 non-reporting activities. In January 2007, EPA conducted a brief study to investigate the types of non549 reporting activities manufacturers conduct and the magnitude of associated costs (U.S. EPA, 2007). The 

550 non-reporting activities identified include soliciting laboratory bids, selecting laboratories, monitoring 

551 tests in progress, developing cost-sharing agreements, and auditing the laboratories for compliance with 

552 EPA’s GLP standards. These activities, in addition to identifying manufacturers, arranging meetings, and 

553 employing toxicologists who may be hired to provide testing expertise for the testing, are considered to 

554 represent the costs of managing the testing activities. While these costs will vary based on a number of 

555 circumstances, the report suggests that managing the testing activities is equivalent, on average, to 15 

556 percent of the chemical testing costs, which is the assumption used in this analysis. Based on the study, 

557 an additional 10 percent of the testing costs are estimated to cover the costs of the technical expert, 
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558 including that expert’s study review and site visits to the laboratory. Therefore, total non-reporting 

559 administrative costs are assumed to equal an additional 25 percent of the total testing costs. Because 

560 laboratory-testing costs are estimated as $7.56 million under the low-cost scenario and $11.9 million 

561 under the high-cost scenario, non-reporting costs are approximately $1.89 million and $2.97 under the 

562 low- and high-cost scenarios, respectively. 

563 Total Administrative Costs. As stated previously, total administrative costs pursuant to the proposed 

564 rule are estimated as the sum of reporting and non-reporting costs. Thus, total administrative costs are 

565 estimated to be $2.03 million under the low-cost scenario and $3.11 million under the high-cost scenario. 

566 4.2.4 Export Notification Costs 

567 TSCA Section 12(b) export notification requirements apply to manufacturers who intend to export a 

568 chemical or mixture subject to various TSCA sections (40 CFR §707.60 through 75), including test rules 

569 promulgated under TSCA Section 4 such as this proposed rule. Under the Section 12(b) requirements, all 

570 exporters of regulated chemicals or mixtures must notify EPA about each country to which a chemical or 

571 mixture rule is shipped. 

572 However, as mentioned earlier in this report, two of the mixtures that are subject to the proposed test rule, 

573 c-pentaBDE and c-octaBDE, are already subject to a SNUR (71 FR 34015, June 13, 2006) and the 

574 associated export notification costs. EPA is concurrently proposing a modification to that SNUR that 

575 would also regulate c-decaBDE. The economic analysis prepared for the SNUR amendment proposal 

576 (also found in the docket for this rulemaking) already takes into account the Section 12(b) TSCA export 

577 notification requirements. Therefore, export notification costs are not included in this analysis. 

578 4.3 Total Industry Compliance Costs 

579 The total compliance costs borne by the regulated industry are summarized in Exhibit 4-6. These costs 

580 would only be incurred by entities who manufacture, import, or process c-pentaBDE, c-octaBDE, or c581 decaBDE, including in articles, after December 31, 2012 (December 31, 2013 for military and 

582 transportation uses of c-deca BDE). The total industry compliance costs potentially triggered by the 

583 proposed rule are estimated to equal $9.68 million under the low-cost assumption and $15.1 million under 

584 the high-cost assumption. These estimates include laboratory, method validation, administrative, and 

585 export notification costs. Laboratory costs may be overestimated due to the economies of scale that could 

586 arise if multiple mixtures are tested together or multiple tests are conducted on the same mixture. Total 

587 compliance costs may also be overestimated to the extent that firms can claim tax deductions for some of 

588 these costs. 

589 Exhibit 4-6: Summary of Total Industry Compliance Costs Triggered by the Proposed Rule (2009$) 

Compliance Cost Category 

Cost ($ million, unadjusted) 

Low-Cost 

Scenario 

High-Cost 

Scenario 

Laboratory costs (Section 4.2.1) $7.56 $11.9 

Analytical methodology validation costs (Section 4.2.2) $0.09 $0.09 

Administrative costs (Section 4.2.3) $2.03 $3.11 

Total industry compliance costs (Section 4.3) $9.68 $15.1 

Average compliance cost per mixture $3.23 $5.03 
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590 Chapter 5 – Agency Costs 

591 5.1 Introduction 

592 EPA would also incur costs resulting from the proposed rule, if there is anyone who manufactures, 

593 imports, or processes c-pentaBDE, c-octaBDE, or c-decaBDE, including in articles, after December 31, 

594 2012 (December 31, 2013 for military and transportation uses of c-deca BDE). If data are collected and 

595 submitted by industry, EPA must review and process letters of intent, study plans, final reports, robust 

596 summaries, and exemption applications for completeness, adherence to protocols, and findings. 

597 5.2 EPA Costs 

598 EPA assumes that, on average, a Federal GS-13, Step 1, full-time equivalent (FTE), equivalent to 2,080 

599 hours per year, would conduct its collection procedures under the proposed rule. The annual 2009 fully 

600 loaded salary for a GS-13, Step 1, FTE is $139,083. This includes a base salary of $86,927 plus 60 

percent for overhead and benefits (i.e., $52,146).7 601 Dividing the fully loaded annual salary by 2,080 (i.e., 

602 the number of hours in a work year) yields an hourly wage rate of $66.87 for the FTE. 

603 As explained earlier in Section 4.2.3, approximately 3 letters of intent and study plans, 35 final reports, 

604 and 3.5 robust summaries are estimated to be filed in response to the proposed rule. Based on best 

605 professional judgment, it is estimated that it takes on average 3 hours to process a letter of intent and 

606 study plan, 5 hours to process a final report, 1 hour to review a robust summary, and 1 hour to review 

607 each exemption application. Exhibit 5-1 presents the estimated total government costs based on these 

608 assumptions. As shown, the total government costs for the proposed rule are estimated to be 

609 approximately $12,538. 

610 Exhibit 5-1: Estimated Government Costs for the Proposed Rule (2009$) 

Item Unit Labor Total 

Hours Rate Cost/Item Items Hours Cost

Letter of Intent and Study Plans 3 $66.87 $200.60 3 9 $602 

Final Reports 5 $66.87 $334.33 35 175 $11,702 

Robust Summaries 1 $66.87 $66.87 3.5 3.5 $234 

TOTAL 187.5 $12,538

611 

 

7 The unloaded Federal GS-13 Step 1 salary ($86,927, effective January 2009), from the Office of Personnel Management 

salary table for Washington-Baltimore-Northern Virginia (OPM, 2009). The 60 percent fringes-and-overhead rate is from an 

EPA/OPPE guide (U.S. EPA, 1992). 
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612 Chapter 6 - Social Costs 

613 6.1 Total Social Costs 

614 The estimated total social costs of the proposed rule are the sum of industry and EPA costs (Exhibit 6-1). 

615 The total social costs under the low- and high-cost scenarios are $9.70 million and $15.1 million, 

616 respectively. Industry compliance costs are presented before tax. As with any costs, tax deductions 

617 would lower the portion borne by industry, but the amount deducted would still represent a cost to society 

618 because the costs borne by the government will increase. Similarly, some costs may be passed on to 

619 customers, suppliers, and/or workers in the form of changed prices and wages. However, a detailed 

620 analysis of such cost redistribution is beyond the scope of this report. 

621 These costs would only be incurred if there are entities who manufacture, import, or process c-pentaBDE, 

622 c-octaBDE and c-decaBDE, including in articles, after December 31, 2012 (December 31, 2013 for 

623 military and transportation uses of c-deca BDE). 

624 Exhibit 6-1: Summary of Total Social Costs Triggered by the Proposed Rule (2009$) 

Cost Category 

Cost ($ million) 

Low-Cost 

Scenario High-Cost Scenario 

Total industry compliance costs (unadjusted)a $9,682,703 $15,085,037 

Total government costs (unadjusted) $12,538 $12,538 

Total social costs triggered by the proposed rule (unadjusted) $9,695,240 $15,097,574 a

 Total industry compliance costs include laboratory, analytical methodology validation, administration, and export 

notification costs. 

625 

626 6.2 Mixture Level Costs 

627 The estimated total social costs per mixture are presented in the table below. The average (mean) total 

628 social cost per mixture is $3.23 million under the low-cost scenario and $5.03 million under the high-cost 

629 scenario. 

630 These costs would only be incurred if there are entities that manufacture, import, or process any of the 

631 mixtures , including in articles, after December 31, 2012 (December 31, 2013 for military and 

632 transportation uses of c-deca BDE). 

633 Exhibit 6-2: Summary of Total Social Costs by Mixture (2009$, unadjusted) 

Mixture Name Total Social Costs per Chemical 

Low-Cost Scenario High-Cost Scenario 

1 Pentabromodiphenyl Ether (PentaBDE) $3,640,410 $5,906,054 

2 Octabromodiphenyl Ether (OctaBDE) $3,640,410 $5,906,054 

3 Decabromodiphenyl Ether (DecaBDE) $2,414,420 $3,285,467 

 Total $9,695,240 $15,097,574

 Average $3,231,747 $5,032,525

634 

635 Mixture-specific estimates of laboratory, analytical methodology validation, administration, export 

636 notification, and government costs under the low- and high-cost scenarios can be found in Appendix B of 

637 this report. 

638 6.3 Annualized Costs 

639 Costs associated with this test rule if there are entities who manufacture, import, or process any of the 

640 mixtures, including in articles, after December 31, 2012 (December 31, 2013 for military and 

641 transportation uses of c-deca BDE), are expected to occur over the several years during which the actual 
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642 testing occurs and EPA reviews studies. A three-year time period is assumed for this analysis. Thus, 

643 total social costs of the rule have been annualized over three years. 

644 The issues involved in selecting the appropriate social discount rate are complex and subject to 

645 considerable debate in the economics literature. This literature largely focuses on the appropriate 

646 treatment of displaced private investment, often referred to as the private rate of return to capital, and 

647 displaced consumption, often referred to as the consumption rate of interest. The literature and EPA’s 

648 economic guidance document suggest that the appropriate rate to use for environmental actions is usually 

649 the consumption rate of interest. Historical rates of return on relatively risk-free investments, adjusted for 

650 taxes and inflation, suggest that a consumption rate of interest of 2 to 3 percent is appropriate (U.S. EPA, 

651 2000). A three percent discount rate is used for the primary analysis in this report, following common 

652 EPA convention. EPA guidance also recommends following OMB’s basic guidance on discount rates for 

653 regulatory and other analyses provided in OMB Circular A-4 (OMB, 2003). The OMB suggests using 

654 both a 3 and a 7 percent discount rate, in real terms. Therefore, results are presented for the 3 percent and 

655 7 percent discount rates. 

656 The standard formula for annualizing a lump sum cost is given by: 

A = I Χ [I(1 + i)n / ((1 + i)n 657 - 1)] 

658 where A equals the annualized amount, I is the initial lump sum investment cost (equal to the one-time 

659 cost to comply with the rule), i is the discount rate, and n is the useful life of the investment (equal to the 

660 financial life of the affected company). 

661 The initial lump sum costs to comply with the proposed rule under the low- and high-cost scenarios are 

662 presented in Exhibit 6-3. 

663 As shown, total annualized social costs under the low-cost scenario range from $3.42 to $3.69 million 

664 using a 3 percent and a 7 percent discount rate, respectively. Total annualized social costs under the high665 cost scenario range from $5.34 to $5.75 million using a 3 percent and a 7 percent discount rate, 

666 respectively. 

667 Exhibit 6-3: Annualized Costs Under Low- and High-Cost Scenarios (Total for All Mixtures) ($2009) 

Category 

Cost ($ million) 1

Low-Cost Scenario High-Cost Scenario

3% Discount 

Rate 

7% Discount 

Rate 

3% Discount 

Rate 

7% Discount 

Rate 

Annualized Industry Compliance Costs $3,423,129 $3,689,610 $5,333,018 $5,748,178 

Annualized Government Costs $4,432 $4,777 $4,432 $4,777 

TOTAL ANNUALIZED SOCIAL COSTS $3,427,562 $3,694,387 $5,337,451 $5,752,956 

Notes: 

1

 All costs were annualized over a 3-year time horizon.

668 Chapter 7 – Small Entity Impact Analysis 

669 

670 This chapter assesses the impact of the proposed test rule on the manufacturers of mixtures subject to the 

671 rule. In Chapter 4 the total industry costs were presented, and in this chapter EPA estimates the per672 company cost incurred if this proposed rule is finalized. Such an analysis is particularly relevant for small 

673 businesses, as defined by the U.S. Small Business Administration (SBA). This analysis satisfies the 

674 requirements of the Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business 

675 Regulatory Enforcement Act (SBREFA) of 1996. 
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676 7.1 Identify the Affected Population 

677 As described in Chapter 2, there are no known manufacturers, importers, or processors of c-pentaBDE or 

678 c-octaBDE, so this analysis focuses on manufacturers and importers of c-decaBDE only. For each 

679 manufacturer/importer identified in section 2.3.2, EPA identified the ultimate parent company and 

680 obtained sales and employment data, and six-digit North American Industry Classification System 

(NAICS) codes, using the Dun & Bradstreet Market Identifier (Dun & Bradstreet, 2010).8 681 

682 The search identified six affected global ultimate parent companies as defined by their global DUNS 

683 number or the highest parent level found in other sources. Sales and employment data could be found for 

684 all six of the global ultimate parent companies. Exhibit 7-1 provides summary statistics of the available 

685 data for the companies. As shown in Exhibit 7-1, potentially impacted companies vary widely as 

686 measured by both number of employees and annual sales. 

687 Exhibit 7-1: Employee and Sales Information for Potentially Impacted Companies Included in the 

688 Analysis 

Statistical Measure Number of 

Employees Annual Sales ($) 

Minimum Value 450 1,400,000 

Maximum Value 74,700 56,311,383,800 

Median Value 7,692 9,421,000,000 

Mean Value 18,698 15,947,979,767 

Standard Deviation 28,082 21,281,072,246 

Source: Dun & Bradstreet, 2010.

689 

690 7.2 Select a Relevant Small Business Definition 

691 The RFA relies on the definition of “small business” found in the Small Business Act, which authorizes 

692 the Small Business Administration to develop definitions for “small business” based upon a sales or 

693 employment level. The Small Business Administration provides a table of size standards in the Small 

694 Business Size Regulations, 13 CFR 121.201. These definitions for small business are provided for the 

695 six-digit NAICS codes, based on employment thresholds or annual sales volume (U.S. SBA, 2008). 

696 Throughout the remainder of this report, this definition is referred to as the “SBA definition.” 

697 For the NAICS codes corresponding with the global parent ultimate companies identified in section 7.2 

698 (Dun & Bradstreet, 2010) these size standards range from 100 employees to 1,000 employees, or 

699 $7,000,000 in revenue (U.S. SBA, 2008). 

700 For this analysis, EPA also considered an alternative definition based upon the TSCA definition for the 

701 sensitivity analysis. Under this definition, a manufacturer or importer is defined as small, as under 40 

702 CFR 704.3, if it meets either of the following criteria: 

703 (1) Total annual sales of the company, combined with those of any parent company, are below 

704 $40 million and annual production volume or importation volume at the facility is less than or equal 

705 to 100,000 lbs.; or 

 

8 Dun and Bradstreet is a New York-based company that provides business information through a global 

commercial database. It assigns DUNS numbers to identify businesses around the world. These numbers are 

required for many U.S. federal government transactions and therefore are widely used and assigned. DUNS 

numbers are also frequently used in corporate research. Database entries provide legal and trade names, physical 

and mailing addresses, geographical descriptions, product and industry descriptors, sales and number of 

employees for three years and associated growth rates, as well as up to 40 vital statistics about each organization. 

While the reporting year varied by company, company sales and employment data were primarily retrieved from 

the database in April 2010. 
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706 (2) Total annual sales of the company, combined with those of any parent company, are below 

707 $4 million. 

708 7.3 Identifying Small Businesses 

709 Parent company sales data, collected as explained in section 7.1, were used to identify companies that 

710 qualified for “small business” status, per both the employment-based and the sales-based definitions 

711 specified above. Based on the employment criteria, one company was identified as small under the TSCA 

712 definitions. No companies were considered small under the SBA definition. 

713 7.4 Cost-to-Sales Ratio 

714 As explained in Chapter 4, the industry compliance costs (the sum of laboratory costs, method 

715 development costs, administration costs, and export notification costs) were computed under low- and 

716 high-cost scenarios. For this small entity analysis, the costs were annualized over a 15-year time horizon 

717 using a 7 percent discount rate. The total annualized compliance costs for decaBDE was approximately 

$264,582 under the low-cost scenario and approximately $360,218 under the high-cost scenario.9 718 To 

719 determine the size of the adverse impact of the rule, these compliance costs were then compared to each 

720 company’s total sales. 

721 The cost-to-sales ratios under either scenario are greater than 3 percent for the one small business 

722 identified (under the TSCA definition of small business). With the company’s approximate annual sales 

723 of $1.40 million, the cost-to-sales ratios are 18.9 percent and 25.7 percent, under the low- and high-cost 

724 scenarios, respectively. However, the actual costs borne by this small business may not be so extreme, for 

725 the following reasons: 

726 • The costs would only be incurred if the company manufactures, imports, or processes c-decaBDE 

727 after December 31, 2012 (December 31, 2013 for military and transportation uses of c-deca 

728 BDE); given that most companies have agreed to phase out these activities before that date, it 

729 seems unlikely that the proposed rule will apply. 

730 • It is unlikely that, if manufacture, import, or processing continues, one company would bear the 

731 entire cost of testing for the mixture. In other economic analyses for Section 4 test rules (see for 

732 example, U.S. EPA, 2009d), EPA assumes that the cost of performing mixture-specific testing is 

733 borne by companies in proportion to their production and/or importation volume, and each 

734 company’s share of compliance costs are calculated. However, because production volumes are 

735 not available for c-decaBDE manufacturers, we were not able to estimate the proportion of the 

736 small business’ costs. Given the relatively low sales volume, we would assume that the company 

737 manufactures a relatively low percentage of the mixture. In fact, the small business accounts for 

approximately 1.46 x 10-4 738 of the total sales for all the identified manufacturers/importers. 

739 • Given the company’s small size, it may be that the manufacture of the mixture is for research and 

740 development purposes only, in which case the company would be in Tier 2 and would not be 

741 required to respond initially to the final rule, but would be responsible for cost reimbursement to 

742 the company that actually does the testing.. 

 

9

 Note that these figures include only the industry compliance cost and not the cost to the government. 
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743 Chapter 8 – Benefits 

744 The proposed rule targets c-pentaBDE, c-octaBDE, and c-decaBDE, for which certain toxicological 

745 (hazard) and chemical fate information is unavailable and requires testing of these chemicals to provide 

746 information on their effects on human health and the environment. The benefits of the testing 

747 requirement will result from the development of hazard information on these mixtures and the use of this 

748 information by the public, industry, and government. The information developed because of the proposed 

749 rule will be made publicly available and is expected to yield benefits resulting from the direct use of the 

750 information (use value). In addition, there may be non-use benefits because of the value that society 

751 places on just knowing that the test data exist, regardless of whether they ever use the information (non752 use value). This chapter discusses the use value of the proposed rule qualitatively. The non-use values 

753 are only discussed briefly; due to the scientific nature of the information that would result from the 

754 proposed rule, if finalized, non-use benefits are not likely to comprise a large percentage of the total 

755 benefits. 

756 8.1 Use Values 

757 The proposed rule will increase the publicly available data about a mixture(s)’s risks and consequently is 

758 likely to result in (a) a reduction in the costs of risk-based decisions about the mixture(s), ,and (b) an 

759 improvement in the expected outcome of the decisions (U.S. EPA, 2006). 

760 Reduced cost of risk-based decision making. By making new information about toxic mixtures available 

761 to the public (including EPA and other government agencies), this proposed rule can serve to replace 

762 other information-gathering, management, and dissemination activities related to the regulated mixtures. 

763 Once the data are publicly available, information users and decision makers will avoid the time and 

764 resource costs required to individually perform these activities. In effect, the proposed rule increases the 

765 efficiency (and strength) of the decision-making process. 

766 Improved outcome of decisions. Information-based policies contribute to better decisions by redirecting 

767 resources toward their most highly valued uses. With incomplete information regarding toxicchemicals 

768 and mixtures, public and private decision makers are not able to adequately assess the benefits and costs 

769 of actions that involve these chemicals and mixtures. For example, EPA decisions regarding whether, 

770 when, and how to target chemicals and mixtures for further risk assessment can be misdirected if basic 

771 risk-screening information is unavailable or inadequate. With more information, EPA can better direct its 

772 limited resources toward high-priority risks. It is also likely that once detailed toxicological and chemical 

773 fate information is available on these mixtures, producers and users of these mixtures will adjust the 

774 volume of production and use to minimize adverse effects. Improved information can therefore help lead 

775 to more socially optimal reductions in risks to humans and the environment. 

776 This chapter discusses the use benefits of the test rule qualitatively. Quantification of the benefits of the 

777 proposed rule would require more specific information about each user’s use patterns and preferences, 

778 and the changes in these that would result from the additional information made available under the 

779 proposed rule. These data are not readily available; to collect such data would be cost-prohibitive. For 

780 example, one approach would be to conduct a national willingness-to-pay (WTP) survey of the general 

781 public to determine the value that the public places on the availability of the information resulting from 

782 the test rule. However, such a survey (or one for similar information) has not been conducted. 

783 Furthermore, the exact nature and scope of the benefits resulting from this proposed rule would depend on 

784 the outcome of the tests that would be performed; to the extent that the test results did indicate a potential 

785 health or environmental risk from a chemical, the benefits related to understanding and avoiding this risk 

786 would be greater. 
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787 8.2 Non-Use Values 

788 The value that society places on the information resulting from this proposed rule may go beyond what 

789 people experience through the use of the data. Specifically, members of society may experience a “non790 use” value associated with just knowing that the test data exist regardless of whether they ever use the 

791 information. Non-use values have also been referred to as “existence” or “intrinsic” values and 

792 encompass a variety of motivations. For example, individuals may place a value on the availability of the 

793 test data for others to use in the current time period (vicarious consumption), or place value on preserving 

794 or ensuring the availability of the data (or the decisions or policies that result from the information) for 

795 the benefit of family and others in the future (bequest value). However, a quantitative discussion of these 

796 benefits is not provided here, as measuring non-use values can be extremely difficult for several reasons. 

797 First, there is no market equivalent to accurately reflect these values. Second, non-use values are not 

798 associated with easily observable behaviors. Third, non-use values may be held by both users and non799 users of a resource, and non-users may be less familiar with particular services provided by the resources 

800 in question. 

801 8.3 Potential Users of Information Generated by the Proposed Rule 

802 As discussed above, a wide range of groups are expected to benefit from the availability of this 

803 information, including consumers, workers, scientists, industry representatives, government 

804 organizations, public health officials, the medical community, and foreign interests. By incorporating 

805 new hazard data on these mixtures into their decision-making processes, users will achieve benefits 

806 resulting from improved decision-making processes, and ultimately risk reduction. 

807 The data would be made available to the public, and may be incorporated into numerous databases and 

808 sources that contain toxicological information. A few examples of these sources include the Hazardous 

809 Substances Data Bank (HSDB), Registry of Toxic Effects of Chemical Substances (RTECS), Integrated 

810 Risk Information System (IRIS), the Toxic Substances Control Act Test Submissions (TSCATS), and 

811 Toxicology Information Online (TOXLINE). These databases provide a variety of toxicological 

812 information in the form of study abstracts, information on effects, and more comprehensive information 

813 combining hazard and exposure information to provide risk information (e.g., IRIS). The U.S. National 

814 Library of Medicine (NLM) houses TOXLINE, a bibliographic database that includes the toxicological 

815 effects of drugs and other chemicals. Users can access TOXLINE through the Internet. NLM estimates 

816 that a single month’s access to the database (February 2009) consisted of 72,552 searches via the Internet 

817 (U.S. NLM, 2009b). 

818 The distribution of TSCATS user accounts purchased through a past vendor, Oxford Molecular Group 

(OMG),10 819 indicates that the users of toxicological data are diverse. In 1998, a representative of OMG 

820 suggested that 6 percent of account holders were government, 38 percent were the private sector, 4 

821 percent were academic organizations, 40 percent were foreign interests, and 11 percent were 

822 nonsubscribers (estimates may not add due to rounding) (CIS, 1998). The current vendor, National 

823 Information Services Corp. (NISC), does not track this information. However, it does track the 

824 subscribers and non-subscribers to whom NISC supplies copies of toxicological studies cited in the 

825 TSCATS database. NISC supplies approximately 38 percent of the copies to U.S. industrial entities, 27 

826 percent to U.S. non-industrial entities, 19 percent to non-U.S. governments, 7 percent to U.S. consultants, 

827 and 11 percent to international consultants (CIS, 2003). 

828 Clearly, there is a wide variety of users of toxicological data. It is expected that there will be similar uses 

829 for the data generated as a result of this proposed test rule, and that some of these data may be 

830 incorporated into these databases. Users of, and the benefits they derive from, toxicological information 

831 are discussed in more detail below. 

 

10 Oxford Molecular Group’s Chemical Information System, which housed TSCATS, was acquired by National Information 

Services Corp. (NISC) in 2000. 
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832 8.3.1 Consumers/Buyers 

833 Economic theory maintains that competitive markets provide goods and services to the extent that the 

834 marginal benefit of the good or service to consumers is more than or equal to the marginal cost of 

835 production. Underlying this conclusion are two assumptions: that both consumers and producers have 

836 perfect information, and that the cost of conducting a market transaction is negligible. The need for 

837 chemical and mixture testing information stems from the fact that, in some cases, neither producers nor 

838 consumers have perfect information regarding the hazards associated with certain chemicals and 

839 mixtures. If basic information on chemical and mixture hazards were known, consumers might alter the 

840 amount they would be willing to pay for the chemical or mixture. Therefore, in the absence of complete 

841 information, the private market may be misallocating resources to the production of the chemical or 

842 mixture. 

843 Thus, one advantage of mandatory testing and dissemination of test results is that consumers can make 

844 better choices about products containing chemicals or mixtures if they are better aware of the potential 

845 hazards. Consumers can respond to additional information by changing their purchasing decisions (i.e., 

846 increasing or decreasing consumption, as appropriate); by reducing the amount they are willing to pay for 

847 the product; or by changing the way they handle, store, use, or dispose of the product. This may move the 

848 market toward a more efficient allocation of resources. Thus, the role of toxicity information in resolving 

849 uncertainties can be particularly valuable. 

850 8.3.2 Workers 

851 Hazard information can play a role in guiding workers’ employment decisions and work practices. If 

852 workers are aware of workplace hazards (e.g., the hazard associated with chemicals or mixtures to which 

853 they are exposed), they may choose not to work at a particular facility. If they decide to work there, 

854 informed workers can make better decisions about the precautions, if any, they should take to reduce their 

855 exposure to that chemical or mixture. These precautions may include taking proper care while handling 

856 and using certain chemicals and mixtures or wearing protective clothing. Alternatively, a worker may 

857 seek a wage premium to compensate for increased workplace risk. Viscusi and O’Connor (1984) 

858 conclude that the value of new information to the worker can be measured by the increase in the wage 

859 premium (differential) as a greater understanding of workplace risk is gained. Thus, workers can seek a 

860 risk premium or take averting actions to protect themselves if information is available about the health 

861 effects of the chemicals and mixtures they come into contact with at work. EPA expects the potential 

862 benefits to workers to be large for mixtures included in the proposed rule since they are manufactured 

863 and processed in large volumes. 

864 8.3.3 Science and Health Communities 

865 Chemical and mixture toxicity information is useful to a variety of scientific and health communities. For 

866 example, medical professionals are concerned about the health of patients exposed to chemicals and 

867 mixtures, poison control centers distribute information on toxicity and treatment associated with 

868 poisoning, and scientists use toxicity information to characterize the effects of chemicals and mixtures 

869 and to assess risks of chemical or mixture exposure. The literature includes specific examples where 

870 toxicity data have been summarized and interpreted: Kapp et al. (1996) summarize the results of TSCA 

871 Section 4 test rule studies for isopropanol, Glickman et al. (1995) report the results of aquatic toxicity 

872 studies for cumene (isopropyl benzene), and Bogdanffy et al. (1990) present results of subchronic 

873 inhalation tests for vinyl fluoride. 

874 In addition, several published studies also rely on information from the RTECS database. RTECS is a 

875 database of toxicological information compiled, maintained, and updated by the National Institute of 

876 Occupational Safety and Health (NIOSH). Numerous vendors currently offer access to the database. 

877 RTECS currently covers more than 152,000 chemicals and provides data on mutagenic effects, 

878 reproductive effects, tumorgenic effects, and acute toxicity effects, for example (NIOSH, 2005). 

879 Examples of published scientific literature using this particular database include Ruder et al. (1990) and 
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880 Jones et al. (1998). The former study uses toxicity data available from the RTECS database to compute 

881 national estimates of occupational exposure to animal bladder tumorigens, while the latter study uses 

882 toxicological data from the RTECs database to compute relative potency factors for chemical compounds 

883 associated with increased risk of atherosclerosis to humans. 

884 The test results generated by the proposed rule are also expected to be used by scientists to increase the 

885 understanding of the health and environmental effects of these mixtures to which people may be exposed 

886 in the places where they live, work, study, and play. 

887 8.3.4 The General Public 

888 In addition to its impact on consumers of chemicals or products, the production or use of a chemical or 

889 mixture may impose external costs on society in the form of increased health risks to the general public 

890 and increased risks to the physical environment. If these external costs are known, individuals can take 

891 averting actions to protect themselves. However, if the adverse impacts are unknown to the public, 

892 inefficiencies in the production and consumption of the chemical or mixture will persist.

893 The proposed test rule is valuable because the health and environmental data it would generate would 

894 provide a better understanding of the external costs involved in the production and use of the mixtures. 

895 Because the information will be made publicly available, members of the general public will then be 

896 empowered to help address the market failure through individual actions they may take to protect 

897 themselves from exposure to the mixtures (averting behaviors) or activities designed to pressure firms or 

898 governments to reduce the externalities associated with production (e.g., lobbying activities). 

899 One can expect that if reliable test data are disseminated to the public, community and public, interest 

900 groups can initiate a dialogue with the manufacturers of hazardous chemicals and mixtures and encourage 

901 them to improve their safety measures and assess their environmental management plans. 

902 8.3.5 Firms and their Shareholders 

903 As noted earlier, industry is an important user of chemical hazard information. Toxicological, human 

904 health, and chemical fate information is used to better develop the handling and safety procedures for 

905 chemicals and mixtures, develop emergency preparedness plans, follow principles of the Responsible 

906 Care® Initiative of the American Chemistry Council (ACC), and competitively participate in today’s 

907 chemical market. Toxicity data help to screen the chemicals and mixtures for which such precautions are 

908 most important. 

909 The ACC’s Responsible Care® Initiative includes as guiding principles the following: 

910 • “To design and develop products that can be manufactured, transported, used and disposed of or 

911 recycled safely”; 

912 • “To work with customers, carriers, suppliers, distributors, and contractors to foster the safe and secure 

913 use, transport, and disposal of chemicals and provide hazard and risk information that can be accessed 

914 and applied in their operations and products;” 

915 • “To promote pollution prevention, minimization of waste and conservation of energy and other 

916 critical resources at every stage of the life cycle of our products”; and 

917 • “To support education and research on the health, safety, and environmental effects of our products 

918 and processes” (ACC, 2010). 

919 Consideration of these principles supports the need for toxicological information on chemical products 

920 used and manufactured by this industry. The Chemical Industry Institute of Toxicology (CIIT), a 

921 research institute sponsored by ACC, government, and industry, notes that chemical research has helped 

922 companies ensure safety in manufacturing, use, and disposal of chemicals (CIIT, 1998 and CIIT, 2001). 

923 Thus, companies are more likely to avoid potential liability concerns from inappropriate handling of 
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924 chemicals. Similar advantages are expected from the information developed as a result of the proposed 

925 rule. 

926 Corporate shareholders also benefit from the data developed in the rule. Basic microeconomic theory 

927 assumes that the primary objective of any firm, whether privately or publicly held, is to maximize profits. 

928 When a firm is incorporated and its shares are traded on the stock market, maximizing a firm’s profits is 

929 analogous to maximizing shareholder value. There are a number of ways in which the provision of 

930 information regarding the production practices and output of a firm can affect shareholder value. First, 

931 production processes and output that result in adverse consequences to human health and the environment 

932 may eventually result in substantial liabilities to the firm. Therefore, any new information regarding 

933 potential threats to human health or the environment may cause investors to re-evaluate the potential 

934 future liabilities (and hence profitability) of a firm. Second, when an investor who prefers providing 

935 capital to environmentally benign companies discovers that a firm’s use of toxics is inconsistent with his 

936 or her preferences, he or she may move investment funds toward other, more environmentally friendly 

937 firms. 

938 There is a growing body of empirical literature evaluating the effects of environmental information 

939 disclosures on firms and their shareholders. In an effort to estimate the economic cost of hazardous waste 

940 mismanagement, Muoghalu and Rogers (1992) modeled the effect of Superfund lawsuit announcements 

941 on firms’ stock values. The authors estimated that stock values dropped an average of $30.7 million 

942 when news of a new Superfund lawsuit was made public. Blacconiere and Patten (1994) examined the 

943 effect of the 1984 Union Carbide chemical leak in Bhopal, India, on other chemical firms’ stock prices. 

944 They found that firms in which chemical operations made up a larger portion of total revenue experienced 

945 greater losses in stock value immediately following the leak. 

946 Thus, some evidence suggests that investors respond to new information regarding a firm’s potential 

947 environmental liabilities by reassessing the value of the firm’s stock. If test results are disseminated to 

948 the public, shareholders can better consider the importance placed on the firm’s manufacture or use of 

949 particular chemicals or mixtures and may encourage the firm to address shareholder concerns regarding 

950 chemical production and use to avoid potential losses in the capital markets. It is clear that, while 

951 beneficial to shareholders, this information may also cost the company if share values drop. These costs 

952 would offset some of the benefits to shareholders. 

953 8.3.6 Government 

954 The information developed in response to the proposed rule will benefit society by reducing costs and 

955 improving the quality of government decision and policy making. EPA itself is a user of TSCA Section 4 

956 test results in three primary ways. First, EPA can use the chemical-specific or mixture-specific 

957 information acquired through a test rule to help identify hazards of concern and to screen and prioritize 

958 regulatory activities, including identifying areas where regulatory intervention is not required. Second, 

959 EPA can serve its “clients” by providing these test results to other agencies within the federal government 

960 as well as to public agencies at other levels of government. Finally, EPA can use information-reporting 

961 rules as an alternative to other forms of regulation. Each of these uses is discussed below. 

962 Support EPA Regulatory Activities. When developing risk management strategies, EPA must decide 

963 whether or not to regulate the use of a chemical substance or mixture to protect society. Basic toxicity 

964 data are not available for many chemicals and mixtures, but exposure controls have no environmental 

965 value if these chemicals or mixtures are not a concern. The lack of data on health and environmental 

966 effects can affect sound decision making by government and others (Wehmeier, 2001). Regulating most 

967 certainly involves costs to both EPA (e.g., resources required to develop, promulgate, and enforce a 

968 regulation) and to society at large (e.g., foregone benefits derived from the use of the chemical or mixture, 

969 resources diverted from other uses). Although not regulating avoids these costs, society will face a 

970 welfare loss if the chemical or mixture turns out to harm human health and the environment. 
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971 Taylor et al. (1993) considered the value of test information in supporting decisions about the control of 

972 chemicals whose cancer potency is untested or unknown. While not specifically addressing the value of 

973 the basic toxicity testing data required by this proposed rule, their results suggest there is value to (cancer) 

974 testing information, particularly at intermediate levels of anticipated human exposure to a chemical. The 

975 authors contend that information (from cancer testing) may be less valuable where very high levels of 

976 exposure are expected because no test can perfectly distinguish carcinogens from non-carcinogens. 

977 In the EPA context, the probability that a chemical or mixture poses a risk depends on the chemical’s or 

978 mixture’s toxicological properties, exposure pathways, dose-response relationships, and other factors. 

979 Testing rules help resolve some of these uncertainties. Thus, test information can help EPA decision 

980 makers avoid over-regulating a relatively safe chemical or mixture and under-regulating a risky chemical 

981 or mixture. 

982 Provide Information to Other Government Agencies. Under TSCA Section 4, EPA has the authority to 

983 require firms to conduct tests of specific chemicals and mixtures to determine the potential risk posed by 

984 these substances. However, other governmental agencies, such as the Food and Drug Administration, 

985 Consumer Product Safety Commission, NIOSH, and Occupational Safety and Health Administration, 

986 share regulatory authority over chemical substances, mixtures, or products containing them, or, in the case 

987 of NIOSH, compile summaries of available information and recommend exposure limits. Therefore, EPA 

988 serves as a conduit for chemical hazard information between the chemical producers and these other 

989 agencies. In addition to providing test results on chemical and mixtures to other federal agencies, EPA 

990 may make this information available to other interested parties such as state, local, and tribal government 

991 agencies, which can use the data to inform their own decision making. 

992 Information Provision as an Alternative to Traditional Regulation. Publicly disclosing TSCA Section 4 

993 chemical test results also provides an alternative to traditional regulation. As described above, the 

994 provision of chemical pollution and hazard information can be used to, among other things, empower 

995 individuals to take actions that they deem appropriate in response to chemical risks. In addition to 

996 fulfilling democratic notions of “right-to-know” information, regulations provide a low-cost avenue for 

997 pollution and hazard control when regulatory resources are scarce due to the large number of substances 

998 to be controlled (Tietenberg, 1998). 

999 8.3.7 Foreign Interests 

1000 The toxicity data developed as a result of the test rule are also expected to save other countries the 

1001 expense of collecting and interpreting toxicological data. At the United Nations Conference on 

1002 Environment and Development in 1992, delegates adopted Agenda 21 of Chapter 19, which discusses 

1003 chemical safety and includes program areas. One program area is international assessments of chemical 

1004 risks, part of which includes the assessment of chemical hazards. The International Forum on Chemical 

1005 Safety (IFCS) was formed in 1994 and has developed priorities for action in the implementation of 

1006 Agenda 21. These include recognition of the activities sponsored by OECD in the area of chemical 

1007 management and encouragement of the use of OECD as a means to carry out activities on chemical safety 

1008 (IFCS, 1998). Other countries will benefit from the development of these data and can use the data 

1009 without having to independently develop the information. Such information exchange will result in cost 

1010 savings to other countries and will enable their governments to more effectively manage chemicals and 

1011 mixtures for safety as pledged under Agenda 21.

1012 Chapter 9 – Other Impact Analyses 

1013 Several statutes and executive orders (EOs) pertain to the proposed test rule. This chapter presents 

1014 statements discussing unfunded mandates, environmental justice, children’s health, and paperwork 

1015 burden, among others. 
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1016 9.1 Paperwork Reduction Act 

1017 The Paperwork Reduction Act mandates that federal agencies estimate the recordkeeping and reporting 

1018 burden of a proposed rule. In this context, the term “burden” is interpreted as the total time, effort, or 

1019 financial resources expended by people to generate, maintain, retain, disclose, or provide information to 

1020 or for a federal agency. This includes the time needed by regulated entities to review instructions and to 

1021 develop, acquire, install, and use technology and systems to collect, validate, verify, and disclose 

1022 information. Time taken to adjust existing ways to comply with any previously applicable instructions 

1023 and requirements and to train personnel to respond to the information collection task is also included. In 

1024 this section, burden hours for both the industry respondents and the government are estimated. 

1025 9.1.1 Industry Burden 

1026 In this report, total industry burden hours represent the sum of time spent on reporting and on other 

1027 administrative activities. Industry respondents will spend time on reporting activities associated with 

1028 TSCA Section 4 test rules: preparing letters of intent and study plans, preparing test results for submission 

1029 to EPA, recording test results, preparing laboratory reviews, preparing corporate reviews, conducting 

1030 associated clerical work for final report preparation, conducting recordkeeping activities, and applying for 

1031 exemptions. Under this proposed rule, respondents are also asked to submit robust summaries on a 

1032 voluntary basis. In addition to the reporting burden, respondents will spend additional time on other, non1033 reporting administrative activities such soliciting laboratory bids, selecting laboratories, monitoring tests 

1034 under progress, developing cost-sharing agreements, and auditing the laboratories for compliance with 

1035 EPA’s Good Laboratory Practice (GLP) standards. The procedure for estimating the total industry burden 

1036 is described below. 

1037 Estimate the Reporting Burden. As shown in Section 4.2.3 of this report, EPA estimates that the 

1038 regulated community will submit three letters of intent and study plans, resulting in 34 final reports. 

1039 Additionally, it is estimated that 10 percent of final test reports will be accompanied by a robust summary 

1040 of results. EPA estimated that it takes a respondent 40 hours to prepare a letter of intent and study plan, 

1041 73 hours to write a final report for a short-term study, 12 hours to prepare a robust summary, and 2 hours 

1042 to prepare an exemption application. The unit labor hours are derived from the previous information 

1043 collection requests and are believed to reflect the burden that will be incurred for the proposed rule (U.S. 

1044 EPA, 2002b). The reporting burden estimates for this rule are detailed in Exhibit 9-1. The total reporting 

1045 burden generated by the rule is estimated to be approximately 2,717 hours. 

1046 Exhibit 9-1: Reporting Burden Estimate for the Proposed Rule 

Item Hours per Item Total Items Total Hours

Letter of Intent and Study Plans 40 3 120 

Final Reports 73 35 2,555 

Robust Summaries 12 3.5 42 

TOTAL 2,717

Source: U.S. EPA, 2002b.

1047 

1048 Estimate the Other Administrative Burden. Respondents also spend time on other administrative 

1049 activities including soliciting laboratory bids, selecting laboratories, monitoring tests under progress, 

1050 developing cost-sharing agreements, and auditing the laboratories for compliance with EPA’s Good 

1051 Laboratory Practice (GLP) standards. EPA has calculated the costs and burdens of these activities as 25 

1052 percent of the total laboratory testing costs. Based on this calculation, other administrative costs 

1053 associated with laboratory testing are estimated to amount to $1.89 million and $2.97 million under the 

1054 low- and high-cost scenarios, respectively. These costs are translated into burden estimates using an 

1055 average labor cost of $55.01 per hour, which is based on a labor mix that is 20 percent managerial, 60 

1056 percent technical, and 20 percent clerical. The estimated other administrative burden based on this 

1057 approach is 34,357 (54,000) hours under the low (high)-cost assumption. 
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1058 Estimate the Total Industry Burden. The total industry burden is the sum of the total administrative 

1059 burden and the export notification burden. Total industry burden estimates are summarized in Exhibit 

1060 9-2. The total industry burden is estimated to equal 37,074 hours (56,717 hours) in the low (high)-cost 

1061 scenario. The average burden per chemical is estimated to be 12,358 (18,906) hours in the low (high)-

cost scenario.11 1062 

1063 Exhibit 9-2: Total Industry Burden Hour Estimate for the Proposed Rule 

Activity Low-Cost Scenario

(Hours) 

High-Cost Scenario

(Hours) 

Reporting Activities 2,717 2,717 

Other Administrative Activities 34,357 54,000 

Total Industry Burden 37,074 56,717 

Average Burden Per Chemical (3 chemicals) 12,358 18,906 

1064 

1065 9.1.2 Government Burden 

1066 The government will also spend time processing, reviewing, and analyzing the information that will be 

1067 collected under the proposed test rule. As explained in Section 5.2 of Chapter 5, this work is assumed to 

1068 be performed by a GS-13, Step 1, FTE employee. 

1069 It is further assumed that three letters of intent and study plans, 35 final reports, and 3.5 robust 

1070 summaries, will be filed in response to this rule. The estimated unit government burden for processing 

1071 letters of intent and study plans (3 hours), final reports (5 hours), and robust summaries and exemption 

1072 applications (1 hour each) is derived from the previous information collection requests. Exhibit 9-3 

1073 presents the estimated government burden hours based on these assumptions. The total government 

1074 burden is estimated to equal 187.5 hours.

1075 Exhibit 9-3: Estimated Government Burden for the Proposed Test Rule 

Item Hours per Item Total Items Total Hours

Letter of Intent and Study Plans 3 3 9 

Final Reports 5 35 175 

Robust Summaries 1 3.5 3.5 

TOTAL 187.5

1076 

1077 9.2 Unfunded Mandates Reform Act 

1078 Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104–4, EPA 

1079 has determined that the proposed rule does not contain a Federal mandate that may result in expenditures 

1080 of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in 

1081 any 1 year. It is estimated that the total aggregate costs of this proposed rule to the private sector would 

1082 be $15.1 million (high-cost scenario). The total annualized costs of this proposed rule to the private 

1083 sector are estimated to be $5.34 and $5.75 million using a 3 percent and 7 percent discount rate over 3 

1084 years (high-cost scenario). In addition, since EPA does not have any information to indicate that any 

1085 State, local, or tribal government manufactures or processes the mixtures covered by this action such that 

1086 the final rule would apply directly to State, local, or tribal governments, EPA has determined that this 

1087 proposed rule would not significantly or uniquely affect small governments. Accordingly, this proposed 

1088 rule is not subject to the requirements of sections 202, 203, 204, and 205 of UMRA. 

1089 9.3 Executive Order 13132 – Federalism 

1090 Under Executive Order 13132, “Federalism” (64 FR 43255, August 10, 1999), EPA has determined that 

1091 the proposed rule does not have “federalism implications” because it will not have substantial direct 

 

11 The per-panel cost assumes that the export notification burden is distributed evenly across all panels. 
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1092 effects on the states, on the relationship between the national government and the states, or on the 

1093 distribution of power and responsibilities among the various levels of government, as specified in the 

1094 Executive Order. The proposed rule establishes testing and recordkeeping requirements that apply to 

1095 manufacturers (including importers) and processors of certain chemicals. Because EPA has no 

1096 information to indicate that any state or local government manufactures or processes the mixtures covered 

1097 by this action, the proposed rule does not apply directly to states and localities and will not affect state 

1098 and local governments. Thus, EO 13132 does not apply to the proposed rule. 

1099 9.4 Executive Order 13175 – Consultation and Coordination with Indian Tribal 

1100 Governments 

1101 Under Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 

1102 67249, November 9, 2000), EPA has determined that the proposed rule does not have tribal implications 

1103 because it will not have any effect on tribal governments, on the relationship between the Federal 

1104 Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal 

1105 Government and Indian tribes, as specified in the Executive Order. As indicated previously, EPA has no 

1106 information to indicate that any tribal government manufactures or processes the mixtures covered by this 

1107 action. Thus, Executive Order 13175 does not apply to this proposed rule. 

1108 9.5 Executive Order 13045 - Children’s Health 

1109 This proposed rule is not subject to Executive Order 13045, “Protection of Children from Environmental 

1110 Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it does not establish an 

1111 environmental standard intended to mitigate health or safety risks, will not have an annual effect on the 

1112 economy of $100 million or more, nor does it otherwise have a disproportionate effect on children. The 

1113 proposed test rule would establish testing and recordkeeping requirements that apply to manufacturers 

1114 (including importers) and processors of certain mixtures , and would result in the development of data 

1115 about those mixtures that can subsequently be used to assist the Agency and others in determining 

1116 whether the mixtures in the proposed test rule present potential risks, allowing the Agency and others to 

1117 take appropriate action to investigate and mitigate those risks. 

1118 9.6 Executive Order 13211 – Energy Supply, Distribution, or Use 

1119 This proposed rule is not subject to Executive Order 13211, “Actions Concerning Regulations That 

1120 Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is 

1121 unlikely to have any significant adverse effect on the supply, distribution, or use of energy. 

1122 9.7 National Technology Transfer and Advancement Act 

1123 Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 

1124 104–113 (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory 

1125 activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary 

1126 consensus standards are technical standards (e.g., materials specifications, test methods, sampling 

1127 procedures, and business practices) that are developed or adopted by voluntary consensus standards 

1128 bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency 

1129 decides not to use available and applicable voluntary consensus standards. 

1130 This proposed rule involves technical standards because it proposes to require the use of particular test 

1131 methods. If the Agency makes findings under TSCA section 4(a), EPA is required by TSCA section 4(b) 

1132 to include specific standards or test methods that are to be used for the development of the data required 

1133 in the test rules issued under TSCA section 4. For some of the testing that would be required by this rule, 

1134 EPA is proposing the use of voluntary consensus standards issued by ASTM and ISO that evaluate the 

1135 same type of toxicity as the TSCA 799 test guidelines and OECD test guidelines, where applicable. 

1136 Copies of the ASTM standards referenced in the proposed regulatory text at § 799.XXXX(h)(2)(i) 

1137 through (v) have been placed in the docket for this proposed rule. Interested parties may obtain copies of 
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1138 the ASTM standards from the American Society for Testing and Materials, 100 Bar Harbor Dr., West 

1139 Conshohocken, PA 19428–2959. In the final rule, EPA intends to seek approval from the Director of the 

1140 Federal Register for the incorporation by reference of the ASTM standards used in the final rule in 

1141 accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 

1142 EPA is not aware of any potentially applicable voluntary consensus standards which evaluate prenatal 

1143 developmental toxicity, two-generation reproductive toxicity, developmental neurotoxicity, 

1144 immunotoxicity, or chronic toxicity/carcinogenicity, or screen for neurotoxicity which could be 

1145 considered in lieu of the TSCA 799 test guidelines, 40 CFR 799.9370, 799.9380, 799.9630, 799.9780, 

1146 799.9430, and 799.9620, respectively, upon which the test standards in the proposed rule are based. 

1147 EPA is also not aware of any potentially applicable voluntary consensus standards which evaluate 

1148 anaerobic aquatic metabolism, biodegradation in anaerobic digester sludge, or photolytic degradation in 

1149 the indoor environment. As a result, EPA is proposing the use of three guidelines which are published in 

1150 full in the proposed regulatory text at § 799.XXXX (h)(3) (ii) through (iv). 

1151 The Agency invites comment on the potential use of voluntary consensus standards in the proposed test 

1152 rule, and, specifically, invites the public to identify potentially applicable consensus standard(s) and to 

1153 explain why such standard(s) should be used here. 

1154 9.8 Executive Order 12898 – Environmental Justice 

1155 Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and 

1156 Low Income Populations” (59 FR 7629, February 16, 1994), requires each agency to address and identify 

1157 “disproportionally high and adverse human health or environmental effects of its programs, policies, and 

1158 activities on minority and low-income populations.” 

1159 The proposed rule does not have an adverse impact on the environmental and health conditions in low1160 income and minority communities that require special consideration by the Agency under EO 12898. The 

1161 Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and 

1162 others in determining the potential hazards and risks associated with the mixtures covered by the rule. 

1163 Although not directly impacting environmental justice-related concerns, this information will enable the 

1164 Agency to better protect human health and the environment, including in low-income and minority 

1165 communities. 

1166 9.9 Executive Order 12630 – Property Rights 

1167 EPA has complied with Executive Order 12630, “Government Actions and Interference with 

1168 Constitutionally Protected Property Rights (Takings)” (53 FR 8859, March 15, 1988), by examining the 

1169 takings implications of this proposed rule in accordance with the “Attorney General’s Supplemental 

1170 Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the 

1171 Executive Order. 

1172 

1173 9.10 Executive Order 12988- Civil Justice Reform 

1174 In issuing the proposed rule, EPA has taken the necessary steps to eliminate drafting errors and 

1175 ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as 

1176 required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 

1177 1996). 

1178 Chapter 10 – References 

1179 
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1180 71 FR 34015, Certain Polybrominated Diphenylethers; Significant New Use Rule, Federal Register, 

1181 Volume 71, June 13, 2006. Available in docket EPA-HQ-OPPT-2004-0085 at 

1182 <http://www.regulations.gov>. 

1183 Abt Associates Inc., 2009. Pentabromodiphenyl Ether, Octabromodiphenyl Ether and 

1184 Decabromodiphenyl Ether Market Profile. October 20, 2009. 

1185 Abt Associates Inc., 2010a. Data Requirement Test Cost Estimates for Part 158 Spreadsheet Deliverable. 

1186 (Cost estimations performed for EPA’s Office of Pesticide Programs). April 6, 2010. 

1187 Abt Associates Inc., 2010b. Test Costs Deliverable for PBDEs Test Rule Proposal. (Cost estimations 

1188 performed for EPA’s OPPT). June 2, 1010. 

1189 ACC, 2010. American Chemistry Council, Responsible Care® Guiding Principles. 2010. 

1190 <http://www.americanchemistry.com/s_rctoolkit/sec.asp?CID=1787&DID=7265> (Accessed 7 

1191 May 2010). 

1192 Alvarez, Jacqueline. Draft Risk Management Evaluation for Commercial Octabromodiphenyl Ether. 

1193 Stockholm Convention on Persistent Organic Pollutants. April, 2008. 

1194 Blacconiere and Pattern, 1994. Blacconiere, W. G., and D. M. Patten. “Environmental Disclosures, 

1195 Regulatory Costs, and Changes in Firm Value.” Journal of Accounting and Economics 1994 

1196 18:357-377. 

1197 Bogdanffy et al, 1990. Bogdanffy, M. S., C. R. Kee, D. P. Kelly, M. C. Carakostas, and G. P. Sykes. 

1198 “Subchronic Inhalation Study with Vinyl Fluoride: Effects on Hepatic Cell Proliferation and 

1199 Urinary Fluorise Excretion.” Fundamental Applied Toxicology 1990 15(2): 394-406. 

1200 BLS, 2006. U.S. Bureau of Labor Statistics (BLS). Employer Costs for Employee Compensation: 

1201 Changes to NAICS and SOC, Table 2. ECEC Occupational Comparability between SOC and 

1202 OCS. 2006. 

1203 BLS, 2010. U.S. Bureau of Labor Statistics (BLS). Employer Costs for Employee Compensation 

1204 Supplemental Tables Historical Data December 2006 – December 2009. Supplemental Table 2, 

1205 Private manufacturing industry workers, by occupational group. Wages and Salaries: 

1206 Management, Business and Financial Occupations; Professional and Related Occupations; and 

1207 Office and Administrative Support Occupations. <http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf>. 

1208 March 12, 2009. (Accessed 16 April, 2009). 

1209 CIIT, 1998. Chemical Industry Institute of Toxicology. Business Impact from CIIT. 1998 

1210 <www.ciit.org/busimp/busimp.html>. 

1211 CIIT,2001.Chemical Industry Institute of Toxicology. “2001 Annual Report. CIIT Centers for Health 

1212 Research. 25 Years of Excellence in Science.” 2001. 

1213 <http://www.ciit.org/about/pdfs/2001CIITAnnualReport.pdf>. 

1214 CIS, 1998. Chemical Information System., “Distribution of TSCATS users”., November 12, 1998. 

1215 Personal communication between Hoffman, M. A, CIS and Brooks Depro, Research Triangle 

1216 Institute. November 12, 1998. 
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1217 CIS, 2003. Chemical Information System. Personal communication between Earle, B, CIS and Jason 

1218 Sacks, Abt Associates. December 2, 2003. 

1219 Dawson, Ray. Albemarle. Personal communication with Brian Segal of Abt Associates via telephone. 

1220 August 17, 2009. 

1221 Directory of World Chemical Producers (DWCP). 2009. 

1222 Dun & Bradstreet. 2010. Dun’s Market Identifier Database [computer file]. New York, NY: Dialog 

1223 Corporation. 

1224 ERG, 2002. Market Analysis for the use of Polybrominated Diphenyl Etheres (PBDEs) as Flame 

1225 Retardants – Focusing on Pentabromodiphenyl Ether (pentaBDE). October 3, 2002. 

1226 Glickman et al, 1995. Glickman, A. H., H. C. Alexander, R. J. Buccafusco, C. R. Morris, B. O. Francis, 

1227 D. C. Surprenant, and T. J. Ward. “An Evaluation of the Aquatic Hazard of Cumene”. 

1228 Ecotoxicology and Environmental Safety 1995 31(3): 287-289. 

1229 Hoffman, et al, 2003. Hoffman, D. J., B.A. Rattner, G. A. Burton Jr. Handbook of Ecotoxicology, 2nd Ed; 

1230 CRC Press., 2003 

1231 IFCS, 1998. International Forum on Chemical Safety. “Resolution on Priorities for Action in 

1232 Implementing Environmentally Sound Management of Chemicals. Intergovernmental Forum on 

1233 Chemical Safety”. 1998. <http://www.who.int/ifes/fs_res2.htm>. 

1234 Jones, et al, 1998. Jones T. D., M. D. Morris, and S. R. Basavaraju. “Atherosclerotic Risks from 

1235 Chemicals: Part II. A RASH Analysis of In Vitro and In Vivo Bioassay Data to Evaluate 45 

1236 Potentially Hazardous Compounds.” Archives of Environmental Contamination and Toxicology

1237 1998 35(1):165-177. 

1238 Kapp, et al. 1996. Kapp R. W., C. Bevan, T. H. Gardiner, M. I. Banton, T. R. Tyler, and G. A. Wright. 

1239 “Isopropanol: Summary of TSCA Test Rule Studies and Relevance to Hazard Identification.” 

1240 Regulatory Toxicology and Pharmacology 1996. 23(3): 183-92. 

1241 Muoghalu and Rogers, 1992, Muoghalu, M. and J. E. Rogers. “The Economic Impact of Superfund’s 

1242 Litigation on the Value of the Firm: An Empirical Analysis.” Journal of Economics and Finance

1243 1992 16(3): 73-87. 

1244 NIOSH, 2005. National Institute for Occupational Safety and Health. “Registry of Toxic Effects of 

1245 Chemical Substances (RTECS).” 2005. <http://www.cdc.gov/niosh/rtecs.html> 

1246 NIST, 2009. National Institute of Standards and Technology. WebBook. 2009. 

1247 <http://webbook.nist.gov/chemistry/> (Accessed October 2009). 

1248 OMB, 2003. US Office of Management and Budget. “Circular A-4. Washington, DC”. 2003. 

1249 <http://www.whitehouse.gov/omb/circulars/a004/a-4.html> 
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10-4 

1250 OPM, 2009. Office of Personnel Management. 2009 General Schedule Locality Pay Table for 

1251 Washington-Baltimore, DC-MD-VA-WV. Effective January 2009. <

1252 <http://www.opm.gov/oca/09tables/pdf/DCB.pdf > 

1253 PFA, 2006. Polyurethane Foam Association. Letter US EPA Re: Docket Number OPPT-2004-0085; 

1254 Proposed Significant New Use Rule. Polyurethane Foam Association. March 10, 2006. 

1255 Ruder et al, 1990. Ruder, A. M., L. J. Fine, and D. S. Sundin. “National Estimates of Occupational 

1256 Exposure to Animal Bladder Tumorigens.” Journal of Occupational Medicine 1990 32(9): 797-

1257 805. 

1258 Taylor, et al, 1993. Taylor A. C., J. S. Evans and T. E. McKone. “The Value of Animal Test Information 

1259 in Environmental Control Decisions.” 1993. Risk Analysis 13(4):403-412. 

1260 Tietenberg, 1998. Tietenberg, T. “Disclosure Strategies for Pollution Control.” Environmental and 

1261 Resource Economics 1998 11:587-602. 

1262 U.S. EPA, 2006. TCNC Dossier-Alternative to Solvents. Preventing Exposures to Polybrominated 

1263 Diphenyl Ethers (PBDEs). 

1264 U.S. EPA, 1992. U.S. Environmental Protection Agency, Office of Policy, Planning and Evaluation 

1265 (OPPE) Instructions for Preparing Information Collection Requests (ICRs.), 1992. 

1266 U.S. EPA, 2000. U.S. Environmental Protection Agency Guidelines for Preparing Economic Analyses. 

1267 EPA 240-R-00-003. 2000. 

1268 U.S. EPA, 2002a.U.S. Environmental Protection Agency (U.S. EPA), Office of Pollution Prevention and 

1269 Toxics, Economic and Policy Analysis Branch. Revised Economic Analysis for the Amended 

1270 Inventory Update Rule: Final Report. 2002. 

1271 U.S. EPA, 2002b. U.S. Environmental Protection Agency (U.S. EPA), Office of Pollution Prevention and 

1272 Toxics, Economic and Policy Analysis Branch. Wage Rates for Economic Analyses of the Toxics 

1273 Release Inventory Program. 2002. 

1274 U.S. EPA, 2003. U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 

1275 Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use 

1276 Rules for 65 Chemical Substances. 2003. EPA-HQ-OPPTS-2002-0078. 

1277 U.S. EPA, 2006. U.S. Environmental Protection Agency Office of Pollution Prevention and Toxics, 

1278 Economic and Policy Analysis Branch. Economic Assessment for the Proposed ATSDR Test Rule 

1279 for Four Chemicals. 2006. 

1280 U.S. EPA, 2007.U.S. Environmental Protection Agency (U.S. EPA). Administrative Costs Associated 

1281 with TSCA Test Rules and Voluntary Chemical Testing; Industry Response to Interview 

1282 Questions, January 2007. 2007. 

1283 U.S. EPA 2009a. U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 

1284 Polybrominated Diphenyl Ethers (PBDEs) Action Plan. 30 December 2008. 
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10-5 

1285 <http://www.epa.gov/oppt/existingchemicals/pubs/pbdes_ap_2009_1230_final.pdf> (Accessed 

1286 27 April 2010). 

1287 U.S. EPA, 2009b. Voluntary Children’s Chemical Evaluation Program (VCCEP). Site last updated on 

1288 May 6, 2009. <http://www.epa.gov/oppt/vccep/index.html> (Accessed 20 October 2009). 

1289 U.S. EPA, 2009c. Non-confidential 2006 IUR Company/Chemical Records. 

1290 <http://www.epa.gov/iur/index.htm> (Accessed October 15, 2009). 

1291 U.S. EPA, 2009d. U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics. 

1292 Economic Analysis for the Proposed Section 4 Test Rule for High Production Volume Chemicals. 

1293 December 16, 2009. Found in the docket at EPA-HQ-OPPT-2009-0112-0015. 

1294 U.S. EPA, 2010a. U.S. Environmental Protection Agency (U.S. EPA). Office of Pollution Prevention and 

1295 Toxics. VCCEP Pilot Chemicals, Sponsors, and their Status. 2010. 

1296 <http://www.epa.gov/oppt/vccep/pubs/chemmain.html> (Accessed May 2010). 

1297 U.S. EPA, 2010b. U.S. Environmental Protection Agency (U.S. EPA). Office of Pollution Prevention 

1298 and Toxics. DecaBDE Phase-Out Initiative. 2010. 

1299 <http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/deccadbe.html> (Accessed May 

1300 2010). 

1301 U.S. EPA, 2010c. Office of Pollution Prevention and Toxics. Significant New Use Rule and Test Rule for 

1302 Certain Polybrominated Diphenyl Ethers. Draft version, May 14, 2010. 

1303 U.S. NLM, 2009a. U.S. National Library of Medicine. ChemIDplusLite. 2009. 

1304 <http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp> (Accessed October 2009). 

1305 U.S. NLM, 2009b. U.S. National Library of Medicine. Personal communication P. Thomas, National 

1306 Library of Medicine and Adam Smolinksy, Abt Associates, Inc. Re: TOXLINE queries. March 

1307 2009. 

1308 U.S. SBA, U.S. Small Business Administration (U.S. SBA). 2008. Table of Small Business Standards 

1309 Matched to North American Industry Classification System Codes. Effective August 22, 2008. 

1310 <http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablexls.xls> 

1311 (Accessed May 2010). 

1312 Viscusi and O’Conner, 1984. Viscusi, W. K. and C. J. O’Connor. “Adaptive Responses to Chemical 

1313 Labeling: Are Workers Bayesian Decision Makers?” American Economic Review. 1984. 74(5): 

1314 942-956. 

1315 Wehmeier, 2001. Whmeier Helge. As quoted in “CIIT and LRI will Help Close ‘Knowledge Gap’”. 

1316 Centers for Health Research. 2001. 

1317 <http://www.ciit.org/news_events/news_01/release2001_10_12.htm>. 

1318 Weinstein, et al, 2004. Weinstein Harriet G and Mark A. Loewenstein. 2004. “Comparing Current and 

1319 Former Industry and Occupation ECEC Series.” U.S. Bureau of Labor Statistics. 

1320 <http://www.bls.gov/opub/cwc/cm20040823ar01p1.htm>. 

1321 Appendix A – Wage Rate Calculations 
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A-2 

1322 This appendix describes the derivation of the fully loaded labor rates and inflation factors used in 

1323 calculating costs of labor, materials, and other inputs. All cost estimates are presented in 2009 dollars. 

1324 A.1 Derivation of Loaded Wage Rates 

1325 The fully loaded unit labor cost for managerial, professional/technical, and clerical labor in the regulated 

1326 industry and for EPA staff is estimated by adding fringe benefits and overhead costs to the hourly wage or 

1327 annual salary for each category following the method described in Wage Rates for Economic Analysis of 

1328 the Toxics Release Inventory Program (U.S. EPA, 2002b). This appendix describes the method 

1329 employed to estimate the fully loaded unit labor costs for each labor category, and presents the results of 

1330 the analysis. 

1331 Labor categories used in the analysis correspond to the U.S. Bureau of Labor Statistics (BLS) Standard 

1332 Occupational Classification (SOC) system. In March 2004, BLS began using the North American 

1333 Industry Classification System (NAICS) instead of the Standard Industrial Classification (SIC) System, 

1334 and the Standard Occupational Classification (SOC) system instead of the Occupational Classification 

1335 System (OCS). Exhibit A-1 summarizes the crosswalk between old and new occupational titles, and lists 

1336 the SOC titles that correspond to the managerial, professional/technical, and clerical labor categories used 

1337 in this analysis. 

1338 Exhibit A-1: Detail of Labor Categories Used in the Analysis 

Labor Category Used in the 

Analysis BLS Old 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 

Sources: BLS, 2006, Table 2 and Weinstein, 2004 

1339 

1340 A.1.1 Derivation of Unit Labor Rates for Managerial, Professional/Technical, and Clerical 

1341 Industry Employees 

1342 Wages and fringe benefit data for managerial, professional/technical, and clerical labor are from the BLS 

1343 Employer Costs for Employee Compensation (ECEC) historical data, for December 2009 (BLS, 2010, 

Table 2).12 1344 

1345 The costs of fringe benefits such as paid leave and insurance, specific to each labor category, are taken 

1346 from the same BLS report (BLS, 2010). Fringe benefits as a percentage of wages are calculated 

1347 separately for each labor category. For example, for December 2009, the average wage rate for 

professional/technical labor was $35.96, and the average fringe benefit was $17.42.13 1348 Therefore, fringe 

1349 benefits as a percentage of wages were $17.42/$35.96, or approximately 48 percent (see Exhibit A-2). 

 

12 Past economic analyses used ECEC data series specific to white-collar workers in the manufacturing sector. 

However, those data sets were discontinued in March 2007, and these historical data were the best alternative. In 

a phone conversation (February 11, 2009), a BLS employee could not identify a better data set to use. 13 Past economic analyses have used the term “technical” labor. Here the category is called “professional/technical” 

labor, to make clear how it relates to BLS categories. In 2004, BLS changed from the Occupational Classification 

System, OCS, to the Standard Occupational Classification system, SOC. In the process, the “Professional 

specialty and technical” category became the “Professional and related” category. However, the coverage of the old and new 

occupational groups is approximately the same. See the BLS article, “Comparing Current and Former Industry and 

Occupation ECEC Series” (Weinstein, 2004). 
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A-3 

An additional loading factor of 17 percent is applied to wages to account for overhead.14 1350 This approach is 

1351 used for consistency with Office of Pollution Prevention and Toxics (OPPT) economic analyses for two 

1352 major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program, June 

1353 10, 2002 (U.S. EPA, 2002b), and the Revised Economic Analysis for the Amended Inventory Update 

1354 Rule: Final Report, August 2002 (U.S. EPA, 2002a). This overhead loading factor is added to the 

1355 benefits loading factor, and the total is then applied to the base wage to derive the fully loaded wage. For 

1356 example, the December 2009 fully loaded wage for professional/technical labor is $35.96 × (1+ 0.484 + 

1357 0.17) = $59.49. 

1358 Fully loaded costs for managerial and clerical labor are calculated in a similar manner, as shown in 

1359 Exhibit A-2. 

1360 A.1.2 Derivation of Unit Labor Rates for EPA Staff 

1361 Unit labor rates for EPA staff are calculated based on annual federal salaries for the Washington1362 Baltimore area published by the Office of Personnel Management (OPM) and effective January 2009 

1363 (OPM, 2009). The average salary for one full-time equivalent (FTE) staff member is estimated as the 

1364 salary for a GS-13 Step 1 employee, which is $86,927 annually without fringe benefits and overhead 

1365 costs. In order to derive the fully loaded salary, EPA multiplied the annual salary by an assumed loading 

1366 factor of 1.6 to reflect federal fringe benefits and overhead, which results in a fully loaded annual salary 

1367 of $139,083. 

1368 The Agency loading factor of 1.6 is from an EPA guide entitled Instructions for Preparing Information 

1369 Collection Requests (ICRs) (U.S. EPA, 1992, page 30, footnote 9). The 60 percent assumption was 

1370 labeled “the benefits multiplication factor” in the EPA guide, but has been used in many EPA Office of 

1371 Pollution Prevention and Toxics ICRs to reflect both fringe benefits and overhead for federal staff. For 

1372 example, it was used in an August 2000 document supporting ICR No. 1139.06, with the following 

1373 explanation: 

1374 The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits 

1375 multiplication factor). The multiplication factor used is recommended in EPA’s Office of Policy, 

1376 Planning, and Evaluation’s Instructions for Preparing Information Collection Requests (ICRs)

1377 (June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl 

1378 Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits 

1379 but also overhead. 

 

14 The change was used in the 2003 PMN SNUR economic analysis (U.S. EPA, 2003). In some earlier reports, the 17 percent 

had been applied to wages-plus-fringe benefits. 
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1380 Exhibit A-2: Derivation of Loaded Wage Rates 

Labor Category Data Source for Wage Information Date Wage Fringe Benefit Fringes as % wage Overhead as % wage1 

(a) (b) (c)=(b)/(a) (d) (e

Managerial 

BLS ECEC, Private Manufacturing industries,“Management, business, and financial occupations”2 

Dec-09 $42.36 $18.68 44.10% 17% 

Professional/ Technical 

BLS ECEC, Private Manufacturing industries, 

“Professional and related occupations“2 Dec-09 $35.96 $17.42 48.44% 17% 

Clerical BLS ECEC, Private Manufacturing industries, “Office and administrative support occupations”2 Dec-09 $17.21 $8.17 47.47% 17% EPA staff FTE 

Annual federal staff cost: OPM WashingtonBaltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-13 Step 1 pay rates, with 60% overhead.3 

Jan-09 

$86,927 

(annual) -- [Included in 60% 

overhead] 

60% 

$41.79 

(hourly) -- 

Notes: 1An overhead rate of 17% was used based on assumptions in U.S. EPA, 2002a and U.S. EPA, 2002b. 2 BLS (2010, Supplemental Table 2). 3 The federal salary is the unloaded federal GS-13 Step 1 salary ($86,927 for 2009), from the OPM salary table for Washington-Baltimore-Northern Virginia (O

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

divided by 2,080 hours.

1381 1382 Appendix B – Costs 1383 Exhibit B-1: Industry Compliance and Government Costs, Low-Cost Scenario 

Mixture Name Testing Cost 

Analytical 

Methodology 

Validation 

Cost 

Total 

Administrative 

Cost1

Total Industry 

Compliance 

Cost2

Government 

Cost 

To

1 Pentabromodiphenyl Ether (PentaBDE) $2,854,919 $23,500 $758,040 $3,636,458 $3,952 $2 Octabromodiphenyl Ether (OctaBDE) $2,854,919 $23,500 $758,040 $3,636,458 $3,952 $3 Decabromodiphenyl Ether (DecaBDE) $1,849,482 $46,000 $514,304 $2,409,786 $4,634 $

TOTAL $7,559,319 $93,000 $2,030,384 $9,682,703 $12,538 $

 1 1384 Total administrative cost includes both reporting and non-reporting administrative costs. 
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B-2 

 2 1385 Total industry compliance cost includes testing cost, analytical methodology validation cost, administrative cost, and export notificati 3 1386 Total social cost includes total industry compliance cost and government cost. 

1387 1388 Exhibit B-2: Industry Compliance and Government Costs, High-Cost Scenario 

Mixture Name Testing Cost 

Analytical 

Methodology 

Validation 

Cost 

Total 

Administrative 

Cost1

Total Industry 

Compliance 

Cost2

Government 

Cost 

To

1 Pentabromodiphenyl Ether (PentaBDE) $4,667,433 $23,500 $1,211,169 $5,902,102 $3,952 $2 Octabromodiphenyl Ether (OctaBDE) $4,667,433 $23,500 $1,211,169 $5,902,102 $3,952 $3 Decabromodiphenyl Ether (DecaBDE) $2,546,319 $46,000 $688,514 $3,280,833 $4,634 $

TOTAL $11,881,186 $93,000 $3,110,851 $15,085,037 $12,538 $

1 1389 Total administrative cost includes both reporting and non-reporting administrative costs. 2 1390 Total industry compliance cost includes testing cost, analytical methodology validation cost, administrative cost, and export notificati

 3 1391 Total social cost includes total industry compliance cost and government cost. 

1392 

 Exhibit B-3: Annualized Social Costs1 1393 

Mixture Name 

Low-Cost Scenario High-Cost Scenario

3 years, 3% 3 years, 7% 3 years, 3% 3 years

1 Pentabromodiphenyl Ether (PentaBDE) $1,286,996 $1,387,184 $2,087,969 $2,2502 Octabromodiphenyl Ether (OctaBDE) $1,286,996 $1,387,184 $2,087,969 $2,2503 Decabromodiphenyl Ether (DecaBDE) $853,571 $920,019 $1,161,512 $1,251

TOTAL $3,427,562 $3,694,387 $5,337,451 $5,752

1 1394 Total social cost includes total industry compliance cost and government cost. Total social costs are discounted over three years because these co

1395 expected to occur over the few years during which the actual testing occurs and EPA reviews studies. Discount rates of both 3 and 7 percent are p1396 following OMB Guidance contained in Circular A-4 (OMB, 2003). 
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B-3 

1397 

 Exhibit B-4: Annualized Industry Compliance Costs1 1398 

Mixture Name 

Low-Cost Scenario High-Cost Scenario

15 years, 7% 7 years, 7% 15 years, 7% 7 year

1 Pentabromodiphenyl Ether (PentaBDE) $399,264 $674,757 $648,019 $1,0952 Octabromodiphenyl Ether (OctaBDE) $399,264 $674,757 $648,019 $1,0953 Decabromodiphenyl Ether (DecaBDE) $264,582 $447,144 $360,218 $608

TOTAL $1,063,109 $1,796,657 $1,656,256 $2,799

 1 1399 Total industry compliance cost includes testing cost, analytical methodology validation cost, administrative cost, and export notification cost. Tot

1400 compliance costs are annualized at a 7 percent discount rate, which reflects the opportunity cost of capital, and over 15 years, which represents th1401 chemical. Results are also presented using a discounting timeline of 7 years to test the sensitivity of results to a shorter chemical lifetime, as some 1402 included in the proposed rule may have a lifetime that is less than 15 years. Industry compliance costs are used in the analysis of impacts of the ru1403 companies and the discount period differs from that used to calculate social costs.