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1 EO12866_HBCD SNUR_NPRM_Redline_Revisions_2012-02-03.docx 

2 

3 Revised to address Interagency Comments received under EO 12866 Review.

4 BILLING CODE 6560-50-P 

5 ENVIRONMENTAL PROTECTION AGENCY 

6 40 CFR Part 721 

7 [EPA–HQ–OPPT–2011–0489; FRL–XXXX–X] 

8 RIN 2070-AJ88 

9 Significant New Use Rule for Hexabromocyclododecane and 1,2,5,6,9,10-

10 hexabromocyclododecane 

11 AGENCY: Environmental Protection Agency (EPA). 

12 ACTION: Proposed rule. 

13 SUMMARY: EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) 

14 of the Toxic Substances Control Act (TSCA) for two chemicals: 

15 hexabromocyclododecane (CASRN 25637-99-4) and 1,2,5,6,9,10-

16 hexabromocyclododecane (CASRN 3194-55-6), hereinafter collectively referred to as 

17 HBCD. This proposed rule would designate “use in consumer textiles, other than for use 

18 in motor vehicles” as a significant new use. This action would require persons who 

19 intend to manufacture (including import) or process HBCD for use in covered consumer 

20 textiles to notify EPA at least 90 days before commencing that activity. The required 

21 notification would provide EPA with the opportunity to evaluate the intended use and, if 

22 appropriate, to prohibit or limit that activity before it occurs. For this proposed rule, the 

23 general SNUR exemption at 40 CFR § 721.45(f) for persons who import or process 

24 chemical substances as part of an article would not apply. 

25 DATES: Comments must be received on or before [insert date 60 days after date of
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26 publication in the Federal Register]. 

27 ADDRESSES: Submit your comments, identified by docket identification (ID) number 

28 EPA-HQ-OPPT-2011-0489, by one of the following methods: 

29 • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line 

30 instructions for submitting comments. 

31 • Mail: Document Control Office (7407M), Office of Pollution Prevention and 

32 Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

33 Washington, DC 20460-0001. 

34 • Hand Delivery: OPPT Document Control Office (DCO), EPA East, Rm. 6428, 

35 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ36 OPPT-2011-0489. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, 

37 excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such 

38 deliveries are only accepted during the DCO’s normal hours of operation, and special 

39 arrangements should be made for deliveries of boxed information. 

40 Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2011-

41 0489. EPA’s policy is that all comments received will be included in the docket without 

42 change and may be made available on-line at http://www.regulations.gov, including any 

43 personal information provided, unless the comment includes information claimed to be 

44 Confidential Business Information (CBI) or other information whose disclosure is 

45 restricted by statute. Do not submit information that you consider to be CBI or otherwise 

46 protected through regulations.gov or e-mail. The regulations.gov website is an 

47 “anonymous access” system, which means EPA will not know your identity or contact 

48 information unless you provide it in the body of your comment. If you send an e-mail 

49 comment directly to EPA without going through regulations.gov, your e-mail address 
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50 will be automatically captured and included as part of the comment that is placed in the 

51 docket and made available on the Internet. If you submit an electronic comment, EPA 

52 recommends that you include your name and other contact information in the body of 

53 your comment and with any disk or CD-ROM you submit. If EPA cannot read your 

54 comment due to technical difficulties and cannot contact you for clarification, EPA may 

55 not be able to consider your comment. Electronic files should avoid the use of special 

56 characters, any form of encryption, and be free of any defects or viruses. 

57 Docket: All documents in the docket are listed in the docket index available at 

58 http://www.regulations.gov. Although listed in the index, some information is not 

59 publicly available, e.g., CBI or other information whose disclosure is restricted by statute. 

60 Certain other material, such as copyrighted material, will be publicly available only in 

61 hard copy. Publicly available docket materials are available electronically at 

62 http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The 

63 OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West 

64 Bldg., 1301 Constitution Ave., NW, Washington, DC. The EPA/DC Public Reading 

65 Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 

66 legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 

67 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket 

68 visitors are required to show photographic identification, pass through a metal detector, 

69 and sign the EPA visitor log. All visitor bags are processed through an X-ray machine 

70 and subject to search. Visitors will be provided an EPA/DC badge that must be visible at 

71 all times in the building and returned upon departure. 

72 FOR FURTHER INFORMATION CONTACT: For technical information contact: 

73 Sue Slotnick, National Program Chemicals Division, Office of Pollution Prevention and 
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74 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, 

75 DC 20460-0001; telephone number: (202) 566-1973; e-mail address: 

76 slotnick.sue@epa.gov.

77 For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 

78 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; e-mail 

79 address: TSCA-Hotline@epa.gov. 

80 SUPPLEMENTARY INFORMATION: 

81 I. General Information 

82 A. Does this Action Apply to Me? 

83 You may be potentially affected by this action if you manufacture (defined by 

84 statute to include import) or process HBCD for consumer textiles. Potentially affected 

85 entities may include, but are not limited to organizations identified by the following 

86 North American Industry Classification System (NAICS) codes: 

87 • 238320 - Painting and Wall Covering Contractors 

88 • 313312 - Textile and Fabric Finishing (except Broadwoven Fabric) Mills 

89 • 314121 - Curtain and Drapery Mills 

90 • 314129 - Other Household Textile Product Mills 

91 • 314999 - All Other Miscellaneous Textile Product Mills 

92 • 337121 - Upholstered Household Furniture Manufacturing 

93 • 337125 - Household Furniture (except Wood and Metal) Manufacturing 

94 • 337910 - Mattress Manufacturing 

95 • 337920 - Blind and Shade Manufacturing 

96 • 423210 - Furniture Merchant Wholesalers 
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97 • 423220 - Home Furnishing Merchant Wholesalers 

98 • 811420 - Reupholstery and Furniture Repair 

99 In addition, entities within NAICS code 325 (Chemical Manufacturing) may be 

100 affected by the proposed rule. This listing is not intended to be exhaustive, but rather 

101 provides a guide for readers regarding entities likely to be affected by this action. Other 

102 types of entities not listed in this unit could also be affected. The North American 

103 Industrial Classification System (NAICS) codes have been provided to assist you and 

104 others in determining whether this action might apply to certain entities. To determine 

105 whether you or your business may be affected by this action, you should carefully 

106 examine the applicability provisions in 40 CFR 721.5. If you have any questions 

107 regarding the applicability of this action to a particular entity, consult the technical person 

108 listed under FOR FURTHER INFORMATION CONTACT. 

109 This action may also affect certain entities through pre-existing import 

110 certification and export notification rules under TSCA. Chemical importers are subject 

111 to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated 

112 at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28 (the corresponding EPA 

113 policy appears at 40 CFR part 707, subpart B). Chemical importers must certify that 

114 shipments of chemical substances comply with all applicable rules and orders under 

115 TSCA, including SNURs. In addition, any persons who export or intend to export a 

116 chemical substance(s) that is the subject of this proposed rule on or after [insert date 30 

117 days after date of publication in the Federal Register] are subject to the export 

118 notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), 

119 and must comply with the export notification requirements in 40 CFR part 707, subpart 

120 D. 
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121 B. What Should I Consider as I Prepare My Comments for EPA? 

122 1. Submitting CBI. Do not submit this information to EPA through 

123 regulations.gov or e-mail. Clearly mark the part or all of the information that you claim 

124 to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the 

125 outside of the disk or CD-ROM as CBI and then identify electronically within the disk or 

126 CD-ROM the specific information that is claimed as CBI. In addition to one complete 

127 version of the comment that includes information claimed as CBI, a copy of the comment 

128 that does not contain the information claimed as CBI must be submitted for inclusion in 

129 the public docket. Information so marked will not be disclosed except in accordance with 

130 procedures set forth in 40 CFR part 2. 

131 2. Tips for preparing your comments. When submitting comments, remember to: 

132 i. Identify the document by docket ID number and other identifying information 

133 (subject heading, Federal Register date and page number). 

134 ii. Follow directions. The Agency may ask you to respond to specific questions or 

135 organize comments by referencing a Code of Federal Regulations (CFR) part or section 

136 number. 

137 iii. Explain why you agree or disagree; suggest alternatives and substitute 

138 language for your requested changes. 

139 iv. Describe any assumptions and provide any technical information and/or data 

140 that you used. 

141 v. If you estimate potential costs or burdens, explain how you arrived at your 

142 estimate in sufficient detail to allow for it to be reproduced. 

143 vi. Provide specific examples to illustrate your concerns and suggest alternatives. 

144 vii. Explain your views as clearly as possible, avoiding the use of profanity or 
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145 personal threats. 

146 viii. Make sure to submit your comments by the comment period deadline 

147 identified. 

148 II. Background 

149 A. What Action is the Agency Taking? 

150 EPA is proposing a significant new use rule for HBCD which would require 

151 persons to notify EPA at least 90 days before commencing the manufacture (including 

152 import), or processing of HBCD for use in consumer textiles other than for use in motor 

153 vehicles. EPA is considering future regulatory action on additional uses of HBCD. 

154 B. What is the Agency’s Authority for Taking this Action? 

155 Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that 

156 a use of a chemical substance is a “significant new use.” EPA must make this 

157 determination by rule after considering “all relevant factors including: 

158 • The projected volume of manufacturing and processing of a chemical substance 

159 • The extent to which a use changes the type or form of exposure of human 

160 beings or the environment to a chemical substance 

161 • The extent to which a use increases the magnitude and duration of exposure of 

162 human beings or the environment to a chemical substance, and 

163 • The reasonably anticipated manner and methods of manufacturing, processing, 

164 distribution in commerce, and disposal of a chemical substance.” 

165 In addition to these factors enumerated in TSCA section 5(a)(2), the statute 

166 authorizes EPA to consider any other relevant factors. 

167 Once EPA determines that a use of a chemical substance is a significant new use, 

168 TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) 
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169 to EPA at least 90 days before they manufacture or process the chemical substance for 

170 that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit II.C., the general SNUR 

171 provisions are found at 40 CFR Part 721, subpart A. 

172 C. Applicability of General Provisions

173 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 

174 provisions describe persons subject to the rule, recordkeeping requirements, exemptions 

175 to reporting requirements, and applicability of the rule to uses occurring before the 

176 effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 

177 700. Additional provisions appear at 40 CFR 721.1(c) which describe how persons 

178 subject to SNURs must comply with the same notice requirements and EPA regulatory 

179 procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 

180 5(a)(1)(A). In particular, these requirements include the information submission 

181 requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA 

182 section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once 

183 EPA receives a SNUN, the Agency may take regulatory action under TSCA section 5(e), 

184 5(f), 6, or 7 to control the activities on which it has received the SNUN. If EPA does not 

185 take action, the Agency is required under TSCA section 5(g) to explain in the Federal 

186 Register its reasons for not taking action. 

187 EPA proposes that a person who imports or processes HBCD as part of an article 

188 for use in consumer textiles (except for use in motor vehicles) would not be exempt from 

189 submitting a Significant New Use Notification (SNUN). (See rationale at Section VI. C.) 

190 For this reason, 40 CFR 721.45(f), which exempts persons importing or processing a 

191 substance as part of an article, would not apply to this proposed SNUR. 

192 Persons who export or intend to export a chemical substance(s) identified in a 
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193 proposed or final SNUR are subject to the export notification provisions of TSCA section 

194 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 

195 subpart D. Persons who import chemical substances are subject to the TSCA section 13 

196 import certification requirements, codified at 19 CFR 12.118 through 12.127; see also 19 

197 CFR 127.28. Such persons must certify that the shipment of the chemical substance(s) 

198 comply with all applicable rules and orders under TSCA, including any SNUR 

199 requirements. The EPA policy in support of import certification appears at 40 CFR part 

200 707, subpart B. 

201 III. Overview of HBCD 

202 A. What Chemicals Are Included in the Proposed SNUR? 

203 This proposed SNUR would apply to two chemical substances: 

204 hexabromocyclododecane (CASRN 25637-99-4) and 1,2,5,6,9,10-

205 hexabromocyclododecane (CASRN 3194-55-6). Hexabromocyclododecane is 

206 manufactured by adding bromine to technical grade 1,5,9-cyclododecatriene to make a 

207 chemical substance where the positions of the six bromine atoms are not specified on the 

208 cyclododecane ring, corresponding to CASRN 25637-99-4. The specific 1,2,5,6,9,10-

209 hexabromocyclododecane isomer (CASRN 3194-55-6) is the major component of 

210 CASRN 25637-99-4. Throughout this notice, the term “HBCD” represents both 

211 chemical substances, unless a specific CASRN is also noted. 

212 B. What is the Production Volume of HBCD? 

 The Inventory Update Rule (IUR)1 213 submissions to EPA reported annual U.S. 

214 import/production volumes of 10-50 million pounds in both 2002 and 2006 for CASRN 

 

1

 As of August 2, 2011, the Inventory Update Rule (IUR) was renamed “Chemical Data Reporting rule 

(CDR).” 
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215 3194-55-6 (U.S. EPA, 2006). IUR submissions to EPA reported annual U.S. 

216 import/production volumes of 10,000 to 500,000 pounds in 2002 for CASRN 25637-99-

217 4; no import/production was reported in 2006 (U.S. EPA, 2006). 

218 C. What Are the Uses of HBCD? 

219 Based on information gathered from research, industry, and government, EPA 

220 believes that HBCD is not used in consumer textiles other than for use in motor vehicles. 

221 The major use of HBCD is in polystyrene foam insulation boards used in construction. It 

222 is also used to a minor extent in high impact polystyrene in electronic products and in 

223 textile coatings in carpets, vehicles, furniture, and upholstery, such as draperies (Posner, 

224 2006). In the IUR data, one manufacturer/importer of HBCD (CASRN 3194-55-6) 

225 reported the use of the substance under the NAICS code for textile and fabric finishing 

226 mills (U.S. EPA, 2006). For this use, 1 percent of the total production volume of the 

227 substance was in consumer and commercial products. However, the reporting does not 

228 distinguish between commercial and consumer use. (U.S. EPA, 2006). 

229 Information available to EPA indicates that the use of HBCD in textiles is as a 

230 backcoating to function as a flame retardant. EPA conducted preliminary research to 

231 determine whether HBCD was used in textile applications for end products sold to 

232 consumers. In 2010, an HBCD expert with the Consumer Product Safety Commission 

233 (CPSC) expressed to EPA his understanding that HBCD is used only in non-consumer 

234 textiles such as firefighters’ suits (Babich, 2010). In 2011, EPA requested information 

235 from current and former manufacturers of HBCD. The responses indicate that only one 

236 manufacturer sells HBCD for textile uses. The company does not know whether the end 

237 use of any of those textiles is a consumer article. (Jackson Morrill,2011), (LG Chem 

238 America, 2011). Additionally, a representative of the furniture manufacturing company 
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239 Herman Miller told EPA that HBCD is not in their products (Gabe Wing, 2011). EPA 

240 also received information from a group of textile formulators that the end uses of HBCD241 containing textiles are for military, institutional, and aviation uses only (Friddle, 2011). 

242 EPA solicits comment on whether any of these uses could be considered consumer textile 

243 uses. (See definition of “consumer textile” at §721.______ in the regulatory language at 

244 the end of this proposed rule). 

245 EPA found that a small amount of HBCD is used in floor mats, headliners, and 

246 possibly other interior fabrics in motor vehicles made in the U.S., including passenger 

247 vehicles. The automotive industry plans to phase out these uses in 2015. This phase-out 

248 is consistent with the addition of HBCD to the Annex XIV List of Substances Subject to 

249 Authorisation under the European Union’s Registration, Evaluation, Authorisation and 

250 Restriction of Chemical Substances (REACH) regulations. (See 

251 http://echa.europa.eu/reach_en.asp.) The REACH regulations are expected to effectively 

252 ban the use of HBCD by major U.S. automotive companies unless authorized for use in 

253 the EU after July 21, 2015. The companies are not likely to manufacture a different set 

254 of products for sale in the EU and for sale in the U.S. Because the use of HBCD in 

255 textiles in motor vehicles is currently ongoing, that use is not included in this proposed 

256 rule. 

257 Based on the sum of available information, EPA believes HBCD is not used in 

258 consumer textiles other than those used in motor vehicles. The Agency also believes 

259 HBCD could potentially be used in the future in consumer textiles in the U.S. because the 

260 chemical: 1) is used in non-consumer textile applications in the U.S. including 

261 institutional, military, and aviation uses, 2) is used in textiles in motor vehicles in the 

262 U.S., and 3) has been used in residential consumer textile applications. See more 
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263 information on uses of HBCD in EPA’s Draft Economic Analysis of the Proposed 

264 Significant New Use Rule for Hexabromocyclododecane (HBCD) (U.S. EPA, 2011). 

265 D. What are the Potential Health and Environmental Effects of HBCD? 

266 1. Human health effects

267 Repeated exposure of HBCD to rats showed disturbances in thyroid hormone 

268 system and effects on the thyroid in males and females (Chengelis, 2001). A study by 

269 Eriksson, et al. (2006), concluded that neonatal exposure of HBCD to mice affected 

270 spontaneous motor behavior, learning and memory processes in adult mice. However, 

271 this study was not conducted according to established Organization for Economic 

272 Cooperation and Development Test Guidelines. 

273 In a recently conducted, more robust, two-generation reproductive toxicity study 

274 in rats conducted according to established test guidelines, HBCD showed treatment275 related reproductive effect (a significant decrease in the number of primordial follicles in 

276 the F1 females) (Ema, et al., 2008). Although this decrease in ovarian follicles did not 

277 affect any reproductive parameters in this study, this effect is suggestive of potential 

278 reproductive toxicity. Developmental effects were observed including delays in eye 

279 opening in the second (F2) generation and transient changes in learning and memory in 

280 F1 males, but exposure did not cause any changes in spontaneous behavior. In addition, 

281 there was high and dose-dependent pup mortality during lactation (Ema, et al., 2008). 

282 2. Environmental effects 

283 Laboratory studies have shown that HBCD is capable of producing adverse 

284 effects in a variety of organisms including algae, fish, invertebrates and soil-dwelling 

285 organisms at environmentally relevant concentrations. HBCD is toxic to algae and 

286 acutely toxic to fish embryos (Desjardins, et al., 2004; Deng, et al., 2009). A number of 
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287 sub-lethal effects (e.g., altered thyroid status, protein metabolism, oxidative stress, 

288 reproductive activity) have also been observed in fish (Palace, et al., 2008; Kling and 

289 Förlin, 2009; Zhang, et al., 2008; Ronisz, et al., 2004). Drottar and Krueger (1998) 

290 reported a reduced number and size of daphnid offspring in first and second generations. 

291 Thyroid hormone-dependent developmental effects were observed in tadpoles (Xenopus 

292 laevis) exposed to HBCD (Schriks, et al., 2006). HBCD has been reported to reduce egg 

293 production and lower biomass in soil dwelling organisms (Lumbriculus variegatus) 

294 (Oetken, et al., 2001). HBCD administered to chicken (Gallus domesticus) embryonic 

295 hepatocytes in vitro resulted in significant alterations in expression of genes (mRNA) 

296 associated with liver and thyroid function (Crump, et al., 2008). Thinner egg shells were 

297 measured in American kestrels exposed to a combination of PBDEs and HBCD (Fernie, 

298 et al., 2009). 

299 E. What are the Potential Sources and Routes of Exposure to HBCD? 

300 Because HBCD is not chemically bound to its substrate (the protected textile 

301 material), there is potential for HBCD to be released at any point in the lifecycle. There 

302 is potential for release when the HBCD is initially manufactured, when it is being 

303 formulated into the material that is commonly used in textile back coatings, as well as 

304 when it is being combined with the textile material to which it is added. In addition, 

305 HBCD can be released during the service life of the textile material containing it, 

306 including release into water used to wash the treated textiles or into the air via dust 

307 particulates. Workers and the general population can be exposed to HBCD through direct 

308 contact as it migrates across land, in air, and in water by diffusion or environmental 

309 transport. Other opportunities for release can occur at the end of the lifecycle of the 

310 consumer articles when they are transported as waste and disposed of, although 
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311 incineration at high temperatures destroys the HBCD. (Posner, 2006). 

312 Evidence strongly suggests there is potential for exposure to the general 

313 population from HBCD in the environment and also from products and dust in the home 

314 and workplace. HBCD is found world-wide in the environment and wildlife. Human 

315 exposure is evidenced from its presence in breast milk, adipose tissue, and blood. 

316 (Covaci, et al., 2006). The chemical bioaccumulates and biomagnifies in food chains. 

317 The frequent detection of HBCD over a large geographic area, with increasing exposure 

318 in remote locations such as the Arctic, where no demonstrable local sources exist that can 

319 account for these exposures, suggest that HBCD is persistent and undergoes long-range 

320 transport. (UNEP, 2007). 

321 To the extent HBCD is present in household applications (e.g., building foam, 

322 furniture upholstery, carpeting), children could be exposed, especially given children’s 

323 increased exposure via dust and the hand-to-mouth ingestion pathway. In vitro

324 experiments conducted to demonstrate leaching of HBCD from textiles showed that the 

325 presence of simulated biological fluids (sweat, saliva) and fruit juices enhances the 

326 leaching of HBCD from back-coated samples (Ghanem, 2009). Children’s exposure to 

327 HBCD from mouthing of textiles and from ingestion of dust has been estimated (EC, 

328 2008). 

329 HBCD has been measured in air and sediment in Scandinavian countries, North 

330 America and Asia (Covaci, et al., 2006; Arnot, et al., 2009). HBCD has also been 

331 measured in marine and arctic mammals, freshwater and marine fish, aquatic 

332 invertebrates, birds and bird eggs, and one plant species (Covaci, et al., 2006; Arnot, et 

333 al., 2009). HBCD has been detected in Arctic air in northern Scandinavia and in Arctic 

334 birds and bird eggs, Arctic fish, ringed seals and polar bears (UNEP, 2009). It has been 
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335 detected in freshwater, marine, and avian organisms, and in upper trophic-level mammals 

336 (polar bears and seals). 

337 For more information on HBCD concerning its physical-chemical properties, fate, 

338 releases, and human and environmental exposure, see U.S. EPA’s 

339 “Hexabromocyclododecane (HBCD) Action Plan” dated August 18, 2010 at 

340 www.epa.gov/oppt/existingchemicals/pubs/actionplans/hbcd.html. 

341 IV. Summary of Proposed Rule 

342 EPA is proposing to designate as a significant new use the any use of HBCD in 

343 consumer textiles other than for use in motor vehicles. EPA believes the only current use 

344 of HBCD for consumer textiles is in motor vehicles. Thus any use of HBCD in consumer 

345 textiles (other than for textiles in motor vehicles) would be a significant new use. A 

346 proposed definition of “consumer textile” can be found at 40 CFR 721.______ of the 

347 regulatory text at the end of this proposed rule. The proposed definition of “motor 

vehicle” refers to 40 CFR 85.1703.2 348 

349 This proposed rule would add a section to 40 CFR 721 to require persons who 

350 intend to manufacture (including import) or process HBCD for an activity preliminarily 

 

2

 The definition at 40 CFR § 85.1703 is: “a vehicle which is self-propelled and capable of 

transporting a person or persons or any material or any permanently or temporarily affixed 

apparatus shall be deemed a motor vehicle, unless any one or more of the criteria set forth below 

are met, in which case the vehicle shall be deemed not a motor vehicle and excluded from the 

operation of the [Clean Air] Act:

(1) The vehicle cannot exceed a maximum speed of 25 miles per hour over level, paved surfaces; 

or

(2) The vehicle lacks features customarily associated with safe and practical street or highway 

use, such features including, but not being limited to, a reverse gear (except in the case of 

motorcycles), a differential, or safety features required by state and/or federal law; or(

3) The vehicle exhibits features which render its use on a street or highway unsafe, impractical, or 

highly unlikely, such features including, but not being limited to, tracked road contact means, an 

inordinate size, or features ordinarily associated with military combat or tactical vehicles such as 

armor and/or weaponry.

b) The Administrator will, from time to time, publish in the Federal Register a list of vehicles 

which have been determined to be excluded. This list will be in appendix VI of 40 CFR part 85. 

http://www.gpo.gov/fdsys/pkg/CFR-2000-title40-vol12/xml/CFR-2000-title40-vol12-sec85-1703.xml
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351 designated as a significant new use by this action to notify EPA at least 90 days before 

352 commencing that activity. The required notification would provide EPA with the 

353 opportunity to evaluate the intended use and, if appropriate, to prohibit or limit that 

354 activity before it occurs. For this proposed rule, the general SNUR exemption for 

355 persons that import or process chemical substances as part of an article at 40 CFR 

356 721.45(f) would not apply. (See discussion at Unit VI.C.) 

357 V. Significant New Use Determination 

358 A. Rationale 

359 As summarized in Unit III.D. and E., EPA has concerns regarding the potential 

360 exposure to and human health and environmental effects of HBCD. EPA believes that 

361 HBCD could be manufactured or processed for consumer textiles other than for use in 

362 motor vehicles in the future. Accordingly, EPA wants the opportunity to evaluate and 

363 control, where appropriate, activities associated with that use, if such manufacturing or 

364 processing were to be commenced in the future. The required notification provided by a 

365 SNUN would provide EPA with the opportunity to evaluate activities associated with the 

366 significant new use and an opportunity to protect against unreasonable risks, if any, from 

367 exposure to HBCD. 

368 Consistent with EPA’s past practice for issuing SNURs under TSCA Section 

369 5(a)(2), EPA’s decision to propose a SNUR for a particular chemical use need not be 

370 based on an extensive evaluation of the hazard, exposure, or potential risk associated with 

371 that use. Rather, the Agency’s action is based on EPA’s determination that if the use 

372 begins or resumes, it may present a risk that EPA should evaluate before the 

373 manufacturing or processing for that use begins. Since the new use does not currently 

374 exist, deferring a detailed consideration of potential risks or hazards related to that use is 
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375 an effective use of resources. If a person decides to begin manufacturing or processing 

376 the chemical for the new use, the notice to EPA allows EPA to evaluate the use according 

377 to the specific parameters and circumstances surrounding that intended use. 

378 B. Objectives 

379 Based on the considerations in Unit V.A., EPA has the following objectives with 

380 regard to the significant new use that is preliminarily designated in this proposed rule: 

381 1. EPA would receive notice of any person’s intent to manufacture (including 

382 import) or process HBCD for the described significant new use before that activity 

383 begins. 

384 2. EPA would have an opportunity to review and evaluate data submitted in a 

385 SNUN before the notice submitter begins manufacturing or processing of HBCD for the 

386 described significant new use. 

387 3. EPA would be able to regulate prospective manufacturers or processors of 

388 HBCD before the described significant new use of the chemical substance(s) occur, 

389 provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7. 

390 C. Relevant Factors Considered for this Proposed SNUR

391 TSCA states that EPA’s determination that a use of a chemical substance is a 

392 significant new use must be made after consideration of all relevant factors, including 

393 those listed at TSCA Section 5(a)(2) (see list at Unit II. B.). EPA has preliminarily 

394 determined that manufacturing or processing of HBCD for use in consumer textiles other 

395 than for use in motor vehicles is a significant new use. This determination is based 

396 primarily on the following factor listed at TSCA Section 5(a)(2): “the extent to which a 

397 use increases the magnitude and duration of exposure of human beings or the 

398 environment to a chemical substance.” The latest information available to EPA indicates 
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399 that the only ongoing use of HBCD in consumer textiles is for use in motor vehicles. 

400 Initiation of new uses of HBCD in consumer textiles could increase the magnitude and 

401 duration of exposure to the general population from HBCD in the environment and from 

402 products and dust in the home and workplace. Workers could be exposed to HBCD at 

403 facilities of all types involved in the lifecycle of the products, as described in greater 

404 detail in Unit III. E. Releases to the environment are expected to occur during the service 

405 life of the textiles containing HBCD. Such increase in releases could contribute 

406 additional HBCD to the atmosphere, long-range transport, and greater concentrations in 

407 water, which could be detrimental to overall environmental and human health. Thus, 

408 EPA believes that initiating the use of HBCD in consumer textiles other than for use in 

409 motor vehicles would increase the magnitude and duration of exposure to humans and the 

410 environment over that which would otherwise exist. 

411 D. Request for Comment 

412 EPA welcomes comment on all aspects of this proposed rule, including: 

413 • the basis for the significant new use determination presented for this 

414 proposed rule, and 

415 • information about any ongoing manufacture, import, or processing of 

416 HBCD for use in consumer textiles. 

417 VI. Alternative Regulatory Approaches 

418 Before proposing this SNUR, EPA considered the following alternative regulatory 

419 actions: 

420 A. Promulgate a TSCA Section 8(a) Reporting Rule 

421 Under a TSCA section 8(a) rule, EPA could, among other things, generally 

422 require persons to report information to the Agency when they intend to manufacture or 
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423 process a listed chemical for a specific use or any use. However, for HBCD in consumer 

424 textiles, the use of TSCA section 8(a) rather than SNUR authority would have several 

425 limitations. First, if EPA were to require reporting under TSCA section 8(a) instead of 

426 TSCA section 5(a), EPA would not have the opportunity to review human and 

427 environmental hazards and exposures associated with the use in consumer textiles and, if 

428 necessary, take immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) 

429 to prohibit or limit the activity before it begins, if warranted. In addition, EPA might not 

430 receive important information from small businesses, because such firms generally are 

431 exempt from TSCA section 8(a) reporting requirements. In view of health and 

432 environmental concerns related to HBCD, if used for the proposed significant new use, 

433 EPA believes that a TSCA section 8(a) rule for these substances would not meet EPA’s 

434 regulatory objectives. 

435 B. Regulate HBCD in Consumer Textiles under TSCA Section 6 

436 EPA may regulate under TSCA section 6 if “the Administrator finds that there is a 

437 reasonable basis to conclude that the manufacture, processing, distribution in commerce, 

438 use or disposal of a chemical substance or mixture . . . presents or will present an 

439 unreasonable risk of injury to health or the environment.” (TSCA section 6(a)). EPA 

440 concluded that risk management action under TSCA section 6 is not necessary at this 

441 time because EPA: 1) believes HBCD is not being used in consumer textiles in the 

442 United States other than for use in motor vehicles, 2) has not determined as of this date 

443 that use of HBCD in motor vehicles presents unreasonable risk, and 3) expects the use in 

444 motor vehicles to end within a few years. This proposed SNUR would allow the Agency 

445 to address the potential risks associated with the proposed significant new use. 

446 C. Allow the Exemption for Persons Who Import or Process HBCD as Part of Articles 
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447 that Would be Subject to the Proposed SNUR 

448 Under the SNUR exemption provision at 40 CFR 721.45(f), a person who imports 

449 or processes a substance covered by a SNUR identified in subpart E of part 721 as part of 

450 an article is not generally subject to the notification requirements of 40 CFR 721.25 for 

451 that substance. However, EPA is concerned that exempting HBCD as part of articles 

452 would render the SNUR less effective because of the possibility that consumer textile 

453 articles containing HBCD, the primary concern of EPA associated with this rulemaking, 

454 could be imported or processed for uses subject to this proposed SNUR without the 

455 submission of a SNUN. Thus, EPA is proposing to promulgate this rule without the 

456 exemption at 40 CFR 721.45(f). 

457 VII. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule 

458 As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has 

459 decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use 

460 as a significant new use as of the date of publication of this proposed rule rather than as 

461 of the effective date of the final rule. If uses begun after publication of the proposed rule 

462 were considered ongoing rather than new, it would be difficult for EPA to establish 

463 SNUR notice requirements, because a person could defeat the SNUR by initiating the 

464 proposed significant new use before the rule became final, and then argue that the use 

465 was ongoing as of the effective date of the final rule. Thus, persons who begin 

466 commercial manufacture or processing of the chemical substance(s) (including 

467 manufacturing or processing the chemical substance(s) as part of an article) for a use that 

468 would be regulated through this proposed rule, if finalized, would have to cease any such 

469 activity before the effective date of the rule if and when finalized. To resume their 

470 activities, these persons would have to comply with all applicable SNUR notice 
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471 requirements and wait until the notice review period, including all extensions, expires. 

472 EPA has promulgated provisions (40 CFR 721.45(h)) to allow persons to submit a SNUN 

473 before the effective date of the SNUR. If a person were to meet the conditions of 40 CFR 

474 section 721.45(h), that person would be considered to have met the requirements of the 

475 final SNUR for those activities. If persons who begin commercial manufacture, import, 

476 or processing of the substance between publication of the proposal and the effective date 

477 of the final SNUR do not meet the conditions of advance compliance, they must cease 

478 that activity before the effective date of the final rule. To resume their activities, these 

479 persons would have to comply with all applicable SNUN requirements and wait until the 

480 notice review period, including all extensions, expires. 

481 VIII. Test Data and Other Information 

482 EPA recognizes that TSCA section 5 does not require the development of any 

483 particular test data before submission of a SNUN. There are two exceptions: 1) 

484 development of test data is required where the chemical substance subject to the SNUR is 

485 also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)); and 2) 

486 development of test data may be necessary where the chemical substance has been listed 

487 under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a section 4 

488 test rule or a section 5(b)(4) listing covering the chemical substance, persons are required 

489 only to submit test data in their possession or control and to describe any other data 

490 known to or reasonably ascertainable by them (TSCA section 5(d); 40 CFR 721.25 and 

491 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters 

492 include data that would permit a reasoned evaluation of risks posed by the chemical 

493 substance during its manufacture, processing, use, distribution in commerce, or disposal. 

494 EPA encourages persons to consult with the Agency before submitting a SNUN. As part 
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495 of this optional pre-notice consultation, EPA would discuss specific data it believes may 

496 be useful in evaluating a significant new use. SNUNs submitted for significant new uses 

497 without any test data may increase the likelihood that EPA will take action under TSCA 

498 section 5(e) to prohibit or limit activities associated with this chemical. 

499 SNUN submitters should be aware that EPA will be better able to evaluate 

500 SNUNs that provide detailed information on: 

501 1. Human exposure and environmental releases that may result from the 

502 significant new use of the chemical substance. 

503 2. Potential benefits of the chemical substance. 

504 3. Information on risks posed by the chemical substances compared to risks 

505 posed by potential substitutes. 

506 IX. SNUN Submissions 

507 According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the 

508 same notice requirements and EPA regulatory procedures as persons submitting a PMN, 

509 including submission of test data on health and environmental effects as described in 40 

510 CFR 720.50. SNUNs must be on EPA Form No. 7710–25, generated using e-PMN 

511 software, and submitted to the Agency in accordance with the procedures set forth in 40 

512 CFR 721.25 and 720.40. The e-PMN software is available electronically at 

513 http://www.epa.gov/opptintr/newchems. 

514 X. Economic Analysis 

515 EPA has evaluated the potential costs of establishing SNUR reporting 

516 requirements for potential manufacturers and processors of HBCD in consumer textiles. 

517 The evaluation is in the Draft Economic Analysis of the Proposed Significant New Use 

518 Rule for Hexabromocyclododecane (HBCD) (U.S. EPA, 2011). It is briefly summarized 
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519 here and is available in the docket for this proposed rule. 

520 Because there appears to be no use of HBCD in consumer textiles in the U.S. at 

521 the current time, other than for use in motor vehicles, EPA expects very few, if any, 

522 entities would submit a SNUN. As a result, the economic impact of this rule is 

523 anticipated to be either zero or very low. 

524 In the event that a SNUN is submitted, costs are estimated at approximately 

525 $8,300 per SNUN submission for large businesses and $5,900 for small businesses, and 

526 include the cost to prepare and submit the SNUN and the payment of a user fee. 

527 Businesses that submit a SNUN would be subject to either a $2,500 user fee required by 

528 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than 

529 $40 million when combined with those of the parent company (if any), a reduced user fee 

530 of $100 (40 CFR 700.45(b)(1)). In its evaluation of this proposed rule, EPA also 

531 considered the potential costs a company might incur by avoiding or delaying the 

532 significant new use in the future, but these costs have not been quantified. 

533 XI. References 

534 The following documents are specifically referenced in the preamble for this 

535 rulemaking. In addition to these documents, other materials may be available in the 

536 docket established for this rulemaking under Docket ID No. EPA-HQ-OPPT-2011-0489, 

537 which you can access through http://www.regulations.gov. Those interested in the 

538 information considered by EPA in developing this proposed rule, should also consult 

539 documents that are referenced in the documents that EPA has placed in the docket, 

540 regardless of whether the other documents are physically located in the docket. 

541 1. U.S. EPA, 2006. Inventory Update Reporting (IUR): Non-Confidential 2006 

542 TSCA Inventory Update Rule (IUR) Records. Available at: 
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543 http://cfpub.epa.gov/iursearch/index.cfm (accessed July 22, 

544 2011).http://cfpub.epa.gov/iursearch/index.cfm?s=chem. 

545 2. Posner, 2006. Survey and technical assessment of alternatives to TBBPA and 

546 HBCDD. Kemi PM. January 2006. 

547 3. Babich, 2010. Personal communication with Michael Babich, Chemist, 

548 United States Consumer Product Safety Commission. March 16, 2010. 

549 4. Jacson Morrill, 2011. Personal communication with Jackson Morrill, 

550 Director of Chemical Products of the American Chemistry Council. February 

551 25, 2011. 

552 5. Gabe Wing, 2011. Personal communication with Gabe Wing of Herman 

553 Miller, Inc. March 30, 2011. 

554 6. John Friddle, 2011. Personal communication with John Friddle, President of 

555 Eagle Performance Products. March 3, 2011. 

556 7. U.S. EPA, 2011. Draft Economic Analysis of the Proposed Significant New 

557 Use Rule for Hexabromocyclododecane (HBCD), Washington, D.C. 

558 OPPT/EETD/EPAB, July 8, 2011. 

559 8. Chengelis, 2001. An oral (gavage) 90 day toxicity study of HBCD in rats. 

560 Study No. WIL-186012. WIL Research Laboratories, Inc., Ashland, Ohio, 

561 USA. 

562 9. Eriksson, et al., 2006. Impaired behaviour, learning and memory, in adult 

563 mice neonatally exposed to hexabromocyclododecane (HBCDD). Environ. 

564 Toxicol. Pharmacol. May 2006, 21(3), 317–322. 
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565 10. Ema, M., et al., 2008. Two-generation reproductive toxicity study of the 

566 flame retardant hexabromcyclododecane in rats. Reprod. Toxicol.. Apr 2008, 

567 25(3), 335-351. 

568 11. Desjardins, et al., 2004. Hexabromocyclododecane (HBCD): A 72-hour 

569 toxicity test with the marine diatom (Skeletonema costatum). Final Report. 

570 Wildlife International, Ltd., Easton, Maryland, USA. 66 p. 

571 12. Deng, et al., 2009. Hexabromcyclododecane-induced developmental toxicity 

572 and apoptosis in zebrafish embryos. Aquatic Toxicol. June 2009, 93(1), 29-

573 36. 

574 13. Palace, et al., 2008. Biotransformation enzymes and thyroid axis disruption 

575 in juvenile rainbow trout (Oncorhynchus mykiss) exposed to 

576 hexabromocyclododecane diastereoisomers. Environ. Sci. Technol. Feb 2008, 

577 42(6), 1967-1972. 

578 14. Kling, et al., 2009. Proteomic studies in zebrafish liver cells exposed to the 

579 brominated flame retardants HBCD and dTBBPA. Ecotoxicol. Environ. Saf. 

580 2009, 72, 985-1993. 

581 15. Zhang, et al., 2008. Induction of hepatic enzymes and oxidative stress in 

582 Chinese rare minnow (Gobiocypris rarus) exposed to waterborne 

583 hexabromocyclododecane (HBCD). Aquatic Toxicol. Jan 2008, 86(1) 4-11. 

584 16. Ronisz, et al., 2004. Sublethal effects of the flame retardants 

585 hexabromocyclododecane (HBCDD), and tetrabromobisphenol A (TBBPA), 

586 on hepatic enzymes and other biomarkers in juvenile rainbow trout and feral 

587 eelpout. Aquatic Toxicol. Aug 2004, 69(3), 229-245. 
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588 17. Drottar, et al., 1998. Hexabromocyclododecane (HBCD): A flow-through 

589 life-cycle toxicity test with the cladoceran (Daphnia magna). Final report. 

590 439A-108, Wildlife International, Ltd, Easton, Maryland, USA. 1998. 78 p. 

591 18. Schriks, et al., 2006. Disruption of thyroid hormone-mediated Zenopus laevis 

592 tadpole tail tip regression by hexabromocyclododecane (HBCD) and 

593 2,2’,3,3’,4,4’,5,5’, 6-nona brominated diphenyl ether (BDE206). 

594 Chemosphere. Dec 2006, 65(10), 1904-1908.

595 19. Oetken, et al., 2001. Validation of the preliminary EU-concept of assessing 

596 the impact of chemicals to organisms in sediment by using selected 

597 substances. UBA-FB 299 67 411, Institute of Hydrobiology, Dresden 

598 University of Technology, Dresden, Germany. 2001, 97 p. 

599 20. Crump, et al., 2008. Effects of hexabromocyclododecane and polybrominated 

600 diphenyl ethers on mRNA expression in chicken (Gallus domesticus) 

601 hepatocytes. Toxicol. Sci. Dec 2008, 106(2), 479-487. 

602 21. Fernie, et al., 2009. Environmentally relevant concentrations of DE-71 and 

603 HBCD alter eggshell thickness and reproductive success of American 

604 kestrels. Environ. Sci. Technol. Mar 2009, 43(6), 2124-30. 

605 22. Covaci, et al., 2006. Hexabromocyclododecanes (HBCDs) in the 

606 Environment and Humans: A Review. Environ. Sci. Technol. May 2006, 

607 40(12), 3679-3688. 

608 23. UNEP, 2007. Stockholm Convention on Persistent Organic Pollutants. 

609 Persistent Organic Pollutants Review Committee, Third meeting, Geneva, 

610 19-23 November 2007, Item 7 of the provisional agenda, Presentation on 

611 environmental transport and modeling. The OECD screening tool for overall 
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612 persistence and long-range transport potential. 

613 UNEP/POPS/POPRC.3/INF/7. 

614 24. Ghanem, R., 2009. Kinetics of Thermal and Photolytic Segregation of 

615 Hexabromocyclododecane in Backcoated Textile Samples. Jordan J Chem. 

616 Apr 2009, 4(2), 171-181. 

617 25. EC, 2008. European Commission (EC). Risk Assessment: 

618 Hexabromocyclododecane CAS-No.: 25637-99-4 EINECS-No.: 247-148-4, 

619 Final Report. Office for Official Publications of the European Communities: 

620 Luxembourg. May 2008. 

621 26. Arnot, et al., 2009. An evaluation of hexabromocyclododecane (HBCD) for 

622 Persistent Organic Pollutant (POP) properties and the potential for adverse 

623 effects in the environment. Submitted to European Brominated Flame 

624 Retardant Industry Panel (EBFRIP). May 2009. 

625 27. UNEP, 2009. Stockholm Convention on Persistent Organic Pollutants. 

626 Summary of the proposal for the listing of hexabromocyclododecane 

627 (HBCDD) in Annex A to the Convention. July 2008. 

628 28. HBCD Action Plan, 2010. EPA’s Hexabromocyclododecane (HBCD) Action 

629 Plan. August 2010. Available at 

630 http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/RIN2070-

631 AZ10_HBCD%20action%20plan_Final_2010-08-09.pdf (accessed July 22, 

632 2011). 

633 XII. Statutory and Executive Order Reviews 

634 A. Regulatory Planning and Review

635 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
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636 51735, October 4, 1993), this action has been designated a “significant regulatory 

637 action.” Accordingly, EPA submitted this action to OMB for review under Executive 

638 Orders 12866 and 13563, entitled Improving Regulation and Regulatory Review (76 FR 

639 3821, January 21, 2011), and any changes made in response to OMB recommendations 

640 have been documented in the docket for this action as required by section 6(a)(3)(E) of 

641 the Executive Order. 

642 EPA has prepared an economic analysis of this action, entitled Draft Economic 

643 Analysis of the Proposed Significant New Use Rule for Hexabromocyclododecane 

644 (HBCD) (USEPA, 2011). A copy of the document is available in the docket for this 

645 proposed rule and is summarized in Unit X. 

646 B. Paperwork Reduction Act

647 According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an 

648 Agency may not conduct or sponsor, and a person is not required to respond to a 

649 collection of information that requires OMB approval under the PRA, unless it has been 

650 approved by OMB and displays a currently valid OMB control number. The OMB 

651 control numbers for certain EPA regulations in title 40 of the CFR, after appearing in the 

652 Federal Register, are listed in 40 CFR part 9, and included on the related collection 

653 instrument, or form, if applicable. 

654 The information collection requirements related to this action have already been 

655 approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA 

656 ICR No. 1188). This action does not impose any burden requiring additional OMB 

657 approval. If an entity were to submit a SNUN to the Agency, the annual burden is 

658 estimated to average 97 hours per response. This burden estimate includes the time 

659 needed to review instructions; search existing data sources; gather and maintain the data 
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660 needed; and complete, review, and submit the required SNUN. 

661 Send any comments about the accuracy of the burden estimate, and any suggested 

662 methods for minimizing respondent burden to the Director, Collection Strategies 

663 Division, Office of Environmental Information (2822T), Environmental Protection 

664 Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 20460-0001. Please 

665 remember to include the OMB control number in any correspondence, but do not submit 

666 any completed forms to this address. 

667 C. Small Entity Impacts

668 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 

669 et seq.), the Agency hereby certifies that promulgation of this SNUR would not have a 

670 significant adverse economic impact on a substantial number of small entities. The 

671 rationale supporting this conclusion is as follows. 

672 Under the RFA, small entities include small businesses, small organizations, and 

673 small governmental jurisdictions. Small entity is defined in accordance with section 601 

674 of the RFA as: a small business as defined by the Small Business Administration’s (SBA) 

675 regulations at 13 CFR 121.201; a small governmental jurisdiction that is a government of 

676 a city, county, town, school district or special district with a population of less than 

677 50,000; and a small organization that is any not-for-profit enterprise which is 

678 independently owned and operated and is not dominant in its field. For purposes of 

679 assessing the impacts of this proposed rule on small entities, EPA has determined that 

680 this proposed rule is not expected to impact any small not-for-profit organizations or 

681 small governmental jurisdictions. As such, the Agency estimated potential impacts on 

682 small business. 

683 A SNUR applies to any person (including small or large entities) who intends to 
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684 manufacture, import, or process a chemical substance for a use the EPA has designated as 

685 a “significant new use.” By definition of the word “new,” and based on information 

686 currently available to EPA, it appears that no small or large entities presently engage in 

687 such activity. Since this proposed SNUR would require a person who intends to engage 

688 in such activity in the future to first notify EPA by submitting a SNUN, no economic 

689 impact will occur unless someone files a SNUN to pursue a significant new use in the 

690 future or forgoes profits by avoiding or delaying the significant new use. Although some 

691 small entities may decide to conduct such activities in the future, EPA cannot presently 

692 determine how many, if any, there may be. However, EPA’s experience to date is that, in 

693 response to the promulgation of SNURs covering over 1,000 chemicals, the Agency 

694 receives only a handful of notices per year. For example, the number of SNUNs was four 

695 in Federal fiscal year 2005, eight in FY2006, six in FY2007, eight in FY2008, and seven 

696 in FY2009. During this five-year period, three small entities submitted a SNUN. 

697 Therefore, EPA believes that the potential economic impact of complying with a SNUR 

698 is not expected to be significant or adversely impact a substantial number of small 

699 entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690)(FRL700 5735-4), the Agency presented its general determination that proposed and final SNURs 

701 are not expected to have a significant economic impact on a substantial number of small 

702 entities, which was provided to the Chief Counsel for Advocacy of the Small Business 

703 Administration. 

704 D. Unfunded Mandates 

705 Based on EPA’s experience with proposing and finalizing SNURs, State, local, 

706 and Tribal governments have not been impacted by these rulemakings, and EPA does not 

707 have any reason to believe that any State, local, or Tribal government would be impacted 
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708 by this rulemaking. As such, EPA has determined that this regulatory action would not 

709 impose any enforceable duty, contain any unfunded mandate, or otherwise have any 

710 effect on small governments subject to the requirements of sections 202, 203, 204, or 205 

711 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538). 

712 E. Federalism

713 This action would not have federalism implications because it is not expected to 

714 have a substantial direct effect on States, on the relationship between the national 

715 government and the States, or on the distribution of power and responsibilities among the 

716 various levels of government, as specified in Executive Order 13132, entitled Federalism

717 (64 FR 43255, August 10, 1999). 

718 F. Indian Tribal Governments

719 This action would not have tribal implications as specified in Executive Order 

720 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 

721 67249, November 9, 2000). This action is not expected to have substantial direct effects 

722 on Indian Tribes, would not significantly or uniquely affect the communities of Indian 

723 Tribal governments, and would not involve or impose any requirements that affect Indian 

724 Tribes. Thus, Executive Order 13175 does not apply to this action. 

725 G. Protection of Children 

726 This action is not subject to Executive Order 13045, entitled Protection of 

727 Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 

728 1997), because this is not an economically significant regulatory action as defined by 

729 Executive Order 12866, and this action does not address environmental health or safety 

730 risks disproportionately affecting children. 

731 H. Effect on Energy Supply, Distribution, or Use
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732 This action is not a “significant energy action” as defined in Executive Order 

733 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, 

734 Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not likely to 

735 have a significant adverse effect on the supply, distribution, or use of energy. 

736 I. Technical Standards

737 Because this action would not involve any technical standards, section 12(d) of 

738 the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 

739 272 note), does not apply to this action. 

740 J. Environmental Justice 

741 This action would not entail special considerations of environmental justice 

742 related issues as delineated by Executive Order 12898, entitled Federal Actions to 

743 Address Environmental Justice in Minority Populations and Low-Income Populations (59 

744 FR 7629, February 16, 1994). 

745 List of Subjects in 40 CFR Part 721 

746 Environmental protection, Chemicals, Hazardous substances, Reporting and 

747 recordkeeping requirements. 

748 Dated: ____________________ 

749 

750 __________________________________________ 

751 Director, Office of Pollution Prevention and Toxics 

752 
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753 Therefore, it is proposed that 40 CFR part 721 be amended as follows: 

754 1. The authority citation for part 721 would continue to read as follows: 

755 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 

756 2. By adding new § 721.______ to read as follows:

757 721.[number to be added] Hexabromocyclododecane and 1,2,5,6,9,10-

758 hexabromocyclododecane 

759 (a) Chemical substances and significant new uses subject to reporting. (1) The 

760 chemical substances identified as hexabromocyclododecane (CASRN 25637-99-4) and 

761 1,2,5,6,9,10-hexabromocyclododecane (CASRN 3194-55-6) are subject to reporting 

762 under this section for the significant new use described in paragraph (a)(2) of this section. 

763 (2) The significant new use is use in consumer textiles, other than for use in 

764 motor vehicles. 

765 (b) Specific requirements. The provisions of subpart A of this part apply to this 

766 section except as modified by this paragraph. 

767 (1) Definitions. The definitions in § 721.3 apply to this section. In addition, the 

768 following definitions apply: 

769 Consumer textile means any cloth, fabric or other item produced during the milling 

770 process (including spinning, weaving, knitting, felting, or finishing), consisting in whole 

771 or in part as a product that is sold to or made available to a private individual who uses 

772 the product in or around a permanent or temporary household or residence, during 

773 recreation, or for any personal use or enjoyment. Consumer textiles include, but are not 

774 limited to, upholstered household furniture, mattresses, and draperies. 

775 Motor vehicle has the meaning found at 40 CFR 85.1703. 

776 (2) Revocation of article exemption. The provisions of § 721.45(f) do not apply to 
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777 this section. A person who imports or processes the chemical substances identified in 

778 paragraph (a)(1) of this section as part of an article for the significant new use described 

779 in paragraph (a)(2) of this section must submit a significant new use notice. 

780 [FR Doc. ??–????? Filed ??–??–??; ?:?? a.m.]