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Page 1 of 34 EO12866_HBCD SNUR_RIN 2070-A J88_NPRM_FRN_2011-08-09.docx 1 2 EO 12866 Review DRAFT – 08/09/2011 3 BILLING CODE 6560-50-P 4 ENVIRONMENTAL PRO TECTION AGENCY 5 40 CFR Part 721 6 [EPA–HQ–OPPT–2011–0489; FRL–XXXX–X] 7 RIN 2070-AJ88 8 Significant New Use Rule for Hexabromocyclododecane and 1,2,5,6,9,10- 9 hexabromocyclododecane 10

AGENCY: Environmental Protection Agency (EPA). 11 ACTION: Proposed rule. 12 SUMMARY : EPA is proposing a significant new us e rule (SNUR) under section 5(a)(2) 13 of the Toxic Substances Control Act (TSCA) for two chemicals: 14 hexabromocyclododecane (C ASRN 25637-99-4) and 1,2,5,6,9,10- 15 hexabromocyclododecane (CASRN 3194-55-6), he reinafter collectively referred to as 16 HBCD. This proposed rule would designate “use in consumer textiles, other than for use 17 in motor vehicles” as a significant new use. This action would require persons who 18 intend to manufacture (including import) or process HBCD for use in covered consumer 19 textiles to notify EPA at least 90 days before commencing that activ ity. The required 20 notification would provide EPA w ith the opportunity to evaluate the intended use and, if 21 appropriate, to prohibit or limit that activity be fore it occurs. For this proposed rule, the 22 general SNUR exemption at 40 CFR § 721.45(f) for persons who import or process 23EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 2 of 34 chemical substances as part of an article would not apply. 24 DATES: Comments must be received on or be fore [insert date 60 days after date of 25 publication in the Federal Register ]. 26 ADDRESSES: Submit your comments, identified by docket identification (ID) number 27 EPA-HQ-OPPT-2011-0489, by one of the following methods: 28

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line 29 instructions for submitting comments. 30

• Mail : Document Control Office (7407M), Office of Pollution Prevention and 31 Toxics (OPPT), Environmental Protect ion Agency, 1200 Pennsylvania Ave., NW., 32 Washington, DC 20460-0001. 33

• Hand Delivery : OPPT Document Control Office (DCO), EPA East, Rm. 6428, 34 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ35 OPPT-2011-0489. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, 36 excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such 37 deliveries are only accepted during the DCO’s normal hours of operation, and special 38 arrangements should be made for deliveries of boxed information. 39 Instructions : Direct your comments to doc ket ID number EPA-HQ-OPPT-2011- 40 0489. EPA’s policy is that all comments recei ved will be included in the docket without 41 change and may be made available on-line at http://www.regulations.gov , including any 42 personal information provided, unless the comme nt includes information claimed to be 43 Confidential Business Information (CBI) or other information whose disclosure is 44 restricted by statute. Do not submit informa tion that you consider to be CBI or otherwise 45 protected through regulations.gov or e-mail. The regulations.gov website is an 46 “anonymous access” system, which means EPA will not know your identity or contact 47EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 3 of 34 information unless you provide it in the body of your comment. If you send an e-mail 48 comment directly to EPA without going through regulations.gov, your e-mail address 49 will be automatically captured and included as part of the comment that is placed in the 50 docket and made available on the Internet. If you submit an electronic comment, EPA 51 recommends that you include your name and other contact information in the body of 52 your comment and with any disk or CD-ROM you submit. If EPA cannot read your 53 comment due to technical difficulties and cannot contact you for clarification, EPA may 54 not be able to consider your comment. El ectronic files should a void the use of special 55 characters, any form of encryption, and be free of any defects or viruses. 56 Docket : All documents in the docket are list ed in the docket index available at 57 http://www.regulations.gov . Although listed in the index, some information is not 58 publicly available, e.g., CBI or other information whose disclosure is rest ricted by statute. 59 Certain other material, such as copyrighted material, will be publicly available only in 60 hard copy. Publicly available docket ma terials are available electronically at 61 http://www.regulations.gov , or, if only available in hard copy, at the OPPT Docket. The 62 OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West 63 Bldg., 1301 Constitution Ave., NW, Washington, DC. The EPA/DC Public Reading 64 Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 65 legal holidays. The telephone number of th e EPA/DC Public Reading Room is (202) 66 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket 67 visitors are required to show photographic id entification, pass through a metal detector, 68 and sign the EPA visitor log. All visitor bags are proce ssed through an X-ray machine 69 and subject to search. Visitors will be provi ded an EPA/DC badge thatmust be visible at 70 all times in the building a nd returned upon departure. 71EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 4 of 34 FOR FURTHER INFORMATION CONTACT: For technical information contact : 72 Sue Slotnick, National Program Chemicals Division, Office of Pollution Prevention and 73 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, 74 DC 20460-0001; telephone number: ( 202) 566-1973; e-mail address: 75 slotnick.sue @epa.gov. 76 For general information contact : The TSCA-Hotline, ABVI-Goodwill, 422 77 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; e-mail 78 address: TSCA-Hotline@epa.gov

. 79 SUPPLEMENTARY INFORMATION: 80 I. General Information 81 A. Does this Action Apply to Me? 82 You may be potentially affected by th is action if you manuf acture (defined by 83 statute to include import) or process HBCD for consumer tex tiles. Potentially affected 84 entities may include, but are not limited to organizations identified by the following 85 North American Industry Classifi cation System (NAICS) codes: 86

• 238320 - Painting and Wall Covering Contractors 87

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

• 314121 - Curtain and Drapery Mills 89

• 314129 - Other Household Textile Product Mills 90

• 314999 - All Other Miscellaneous Textile Product Mills 91

• 337121 - Upholstered Household Furniture Manufacturing 92

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

• 337910 - Mattress Manufacturing 94EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 5 of 34 • 337920 - Blind and Shade Manufacturing 95

• 423210 - Furniture Merchant Wholesalers 96

• 423220 - Home Furnishing Merchant Wholesalers 97

• 811420 - Reupholstery and Furniture Repair 98 In addition, entities within NAICS c ode 325 (Chemical Manufacturing) may be 99 affected by the proposed rule. This listing is not intended to be exhaustive, but rather 100 provides a guide for readers rega rding entities lik ely to be affected by this action. Other 101 types of entities not listed in this unit c ould also be affected. The North American 102 Industrial Classification Syst em (NAICS) codes have been provided to assist you and 103 others in determining whether this action might apply to certain entities. To determine 104 whether you or your business may be aff ected by this action, you should carefully 105 examine the applicability provisions in 40 CFR 721.5. If you have any questions 106 regarding the applicability of th is action to a particular enti ty, consult the technical person 107 listed under FOR FURTHER INFORMATION CONTACT

. 108 This action may also affect cert ain entities through pre-existing import 109 certification and export notification rules under TSCA. Chemical importers are subject 110 to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated 111 at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28 (the corresponding EPA 112 policy appears at 40 CFR part 707, subpart B). Chemical importers must certify that 113 shipments of chemical substances comply with all applicable rules and orders under 114 TSCA, including SNURs. In addition, any persons who export or intend to export a 115 chemical substance(s) that is the subj ect of this proposed rule on or after [ insert date 30 116 days after date of publication in the Federal Register ] are subject to the export 117 notification provisions of TS CA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), 118EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 6 of 34 and must comply with the export notificati on requirements in 40 CFR part 707, subpart 119 D. 120 B. What Should I Consider as I Prepare My Comments for EPA? 121 1. Submitting CBI . Do not submit this information to EPA through 122 regulations.gov or e-mail. Clearly mark the pa rt or all of the information that you claim 123 to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the 124 outside of the disk or CD-ROM as CBI and then identify electronically within the disk or 125 CD-ROM the specific information that is clai med as CBI. In addition to one complete 126 version of the comment that includes inform ation claimed as CBI, a copy of the comment 127 that does not contain the information claimed as CBI must be submitted for inclusion in 128 the public docket. Information so marked will not be disclosed except in accordance with 129 procedures set forth in 40 CFR part 2. 130 2. Tips for preparing your comments . When submitting comments, remember to: 131 i. Identify the document by docket ID number and other identifying information 132 (subject heading, Federal Register date and page number). 133 ii. Follow directions. The Agency may ask you to respond to specific questions or 134 organize comments by referencing a Code of Federal Regulations (C FR) part or section 135 number. 136 iii. Explain why you agree or disagree ; suggest alternatives and substitute 137 language for your requested changes. 138 iv. Describe any assumptions and provide any technical information and/or data 139 that you used. 140 v. If you estimate potential costs or burdens, explain how you arrived at your 141 estimate in sufficient detail to allow for it to be reproduced. 142EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 7 of 34 vi. Provide specific exampl es to illustrate your concer ns and suggest alternatives. 143 vii. Explain your views as clearly as possible, avoidi ng the use of profanity or 144 personal threats. 145 viii. Make sure to submit your comments by the comment period deadline 146 identified. 147 II. Background 148 A. What Action is the Agency Taking? 149 EPA is proposing a significant new us e rule for HBCD which would require 150 persons to notify EPA at least 90 days be fore commencing the manufacture (including 151 import), or processing of HBCD for use in c onsumer textiles other than for use in motor 152 vehicles. EPA is considering future re gulatory action on additional uses of HBCD. 153 B. What is the Agency’s Author ity for Taking this Action? 154 Section 5(a)(2) of TSCA (15 U.S.C. 2604( a)(2)) authorizes EPA to determine that 155 a use of a chemical substance is a “si gnificant new use.” EPA must make this 156 determination by rule after consideri ng “all relevant factors including: 157 • The projected volume of manufacturing and processing of a chemical substance 158 • The extent to which a use changes th e type or form of exposure of human 159 beings or the environment to a chemical substance 160

• The extent to which a use increases the magnitude and duration of exposure of 161 human beings or the environment to a chemical substance, and 162 • The reasonably anticipated manner a nd methods of manufacturing, processing, 163 distribution in commerce, and disp osal of a chemical substance.” 164 In addition to these factors enumerated in TSCA section 5(a)(2), the statute 165 authorizes EPA to consider any other relevant factors. 166EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 8 of 34 Once EPA determines that a use of a ch emical substance is a significant new use, 167 TSCA section 5(a)(1)(B) requi res persons to submit a significant new use notice (SNUN) 168 to EPA at least 90 days before they manuf acture or process the chemical substance for 169 that use (15 U.S.C. 2604(a)(1)(B)). As de scribed in Unit II.C., the general SNUR 170 provisions are found at 40 CFR Part 721, subpart A. 171 C. Applicability of General Provisions 172 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 173 provisions describe persons subject to the ru le, recordkeeping requirements, exemptions 174 to reporting requirements, and applicability of the rule to uses occurring before the 175 effective date of the final rule. Provisions re lating to user fees a ppear at 40 CFR part 176 700. Additional provisions appear at 40 CFR 721.1(c) which de scribe how persons 177 subject to SNURs must comply with the same notice requirements and EPA regulatory 178 procedures as submitters of Premanufact ure Notices (PMNs) under TSCA section 179 5(a)(1)(A). In particular, these require ments include the information submission 180 requirements of TSCA section 5(b) and 5(d )(1), the exemptions authorized by TSCA 181 section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at40 CFR part 720. Once 182 EPA receives a SNUN, the Agency may take regulatory action under TSCA section 5(e), 183 5(f), 6, or 7 to control the activities on whic h it has received the SNUN. If EPA does not 184 take action, the Agency is required under TSCA section 5(g) to explain in the Federal 185 Register its reasons for not taking action. 186 EPA proposes that a person who imports or processes HBCD as part of an article 187 for use in consumer textiles (except for use in motor vehicles) would not be exempt from 188 submitting a Significant New Use Notification (SNU N). (See rationale at Section VI. C.) 189 For this reason, 40 CFR 721.45(f), which exem pts persons importing or processing a 190EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 9 of 34 substance as part of an article, would not apply to this proposed SNUR. 191 Persons who export or intend to export a chemical substance( s) identified in a 192 proposed or final SNUR are s ubject to the export notificati on provisions of TSCA section 193 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 194 subpart D. Persons who import chemical subs tances are subject to the TSCA section 13 195 import certification requirements, codifi ed at 19 CFR 12.118 through 12.127; see also 19 196 CFR 127.28. Such persons must certify that th e shipment of the chemical substance(s) 197 comply with all applicab le rules and orders under TSCA, including any SNUR 198 requirements. The EPA policy in support of im port certification appears at 40 CFR part 199 707, subpart B. 200 III. Overview of HBCD 201 A. What Chemicals Are Incl uded in the Proposed SNUR? 202 This proposed SNUR would apply to two chemical substances: 203 hexabromocyclododecane (C ASRN 25637-99-4) and 1,2,5,6,9,10- 204 hexabromocyclododecane (CASRN 3194- 55-6). Hexabromocyclododecane is 205 manufactured by adding bromine to techni cal grade 1,5,9-cyclododecatriene to make a 206 chemical substance where the positions of th e six bromine atoms are not specified on the 207 cyclododecane ring, corresponding to CA SRN 25637-99-4. The specific 1,2,5,6,9,10- 208 hexabromocyclododecane isomer (CASRN 3194 -55-6) is the major component of 209 CASRN 25637-99-4. Throughout this notice, the term “HBCD” represents both 210 chemical substances, unless a specific CASRN is also noted. 211 B. What is the Production Volume of HBCD? 212EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 10 of 34 The Inventory Update Rule (IUR) 1 submissions to EPA reported annual U.S. 213 import/production volumes of 10-50 million pounds in both 2002 and 2006 for CASRN 214 3194-55-6 (U.S. EPA, 2006). IUR submissions to EPA reported annual U.S. 215 import/production volumes of 10,000 to 500,000 pounds in 2002 for CASRN 25637-99- 216 4; no import/production was reporte d in 2006 (U.S. EPA, 2006). 217 C. What Are the Uses of HBCD? 218 Based on information gathered from research, industry, and government, EPA 219 believes that HBCD is not used in consumer te xtiles other than for use in motor vehicles. 220 The major use of HBCD is in polystyrene foam insulation boards used in construction. It 221 is also used to a minor extent in high imp act polystyrene in elect ronic products and in 222 textile coatings in carpets, vehicles, furnitu re, and upholstery, such as draperies (Posner, 223 2006). In the IUR data, one manufactur er/importer of HBCD (CASRN 3194-55-6) 224 reported the use of the substance under the NAI CS code for textile and fabric finishing 225 mills (U.S. EPA, 2006). For this use, 1 pe rcent of the total production volume of the 226 substance was in consumer and commercial products. However, the reporting does not 227 distinguish between comme rcial and consumer use. (U.S. EPA, 2006). 228 Information available to EPA indicates thatthe use of HBCD in textiles is as a 229 backcoating to function as a flame retardan t. EPA conducted preliminary research to 230 determine whether HBCD was used in textil e applications for e nd products sold to 231 consumers. In 2010, an HBCD expert with the Consumer Produc t Safety Commission 232 (CPSC) expressed to EPA his understanding thatHBCD is used only in non-consumer 233 textiles such as firefighter s’ suits (Babich, 2010). In 2011, EPA requested information 234

1 As of August 2, 2011, the Inventory Update Rule (IUR) was renamed “Chemical Data Reporting rule (CDR).”EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 11 of 34 from current and former manufacturers of HBCD. The responses i ndicate that only one 235 manufacturer sells HBCD for textile uses . The company does not know whether the end 236 use of any of those textiles is a consum er article. (Jackson Morrill,2011), (LG Chem 237 America, 2011). Additionally, a representati ve of the furniture manufacturing company 238 Herman Miller told EPA that HBCD is not in their products (Gabe Wing, 2011). EPA 239 also received information from a group of tex tile formulators that th e end uses of HBCD240 containing textiles are for military, institutiona l, and aviation uses only (Friddle, 2011). 241 EPA solicits comment on whether any of these us es could be considered consumer textile 242 uses. (See definition of “consumer textile” at §721.______ in the regulatory language at 243 the end of this proposed rule). 244 EPA found that a small amount of HBCD is used in floor mats, headliners, and 245 possibly other interior fabrics in motor ve hicles made in the U.S., including passenger 246 vehicles. The automotive industry plans to ph ase out these uses in 2015. This phase-out 247 is consistent with the addition of HBCD to the Annex XIV List of Substances Subject to 248 Authorisation under the European Union’s Registration, Evaluati on, Authorisation and 249 Restriction of Chemical Substa nces (REACH) regulations. (See 250 http://echa.europa.eu/reach_en.asp .) The REACH regulations are expected to effectively 251 ban the use of HBCD by major U.S. automo tive companies unless authorized for use in 252 the EU after July 21, 2015. The companies ar e not likely to manuf acture a different set 253 of products for sale in the EU and for sale in the U.S. Because the use of HBCD in 254 textiles in motor vehicles is currently ongoing, that use is not incl uded in this proposed 255 rule. 256 Based on the sum of available informa tion, EPA believes HBCD is not used in 257 consumer textiles other than those used in motor vehicles. The Agency also believes 258EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 12 of 34 HBCD could potentially be used in the future in consumer textiles in the U.S. because the 259 chemical: 1) is used in non-consumer te xtile applications in the U.S. including 260 institutional, military, and aviation uses, 2) is used in textiles in motor vehicles in the 261 U.S., and 3) has been used in residential consumer textile applications. See more 262 information on uses of HBCD in EPA’s Draft Economic Analysis of the Proposed 263 Significant New Use Rule for Hexabromocyclododecane (HBCD) (U.S. EPA, 2011). 264 D. What are the Potential Health and Environmental Effects of HBCD? 265 1. Human health effects 266 Repeated exposure of HBCD to rats s howed disturbances in thyroid hormone 267 system and effects on the thyroid in male s and females (Chengelis, 2001). A study by 268 Eriksson, et al. (2006), concl uded that neonatal exposure of HBCD to mice affected 269 spontaneous motor behavior, learning and me mory processes in adult mice. However, 270 this study was not conducted according to established Organization for Economic 271 Cooperation and Development Test Guidelines. 272 In a recently conducted, more robust, tw o-generation reproductive toxicity study 273 in rats conducted according to established test guidelin es, HBCD showed treatment274 related reproductive effect (a significant decrease in the numbe r of primordial follicles in 275 the F1 females) (Ema, et al., 2008). Although th is decrease in ovarian follicles did not 276 affect any reproductive parameters in this study, this effect is suggestive of potential 277 reproductive toxicity. Developmental effect s were observed including delays in eye 278 opening in the second (F2) generation and tran sient changes in learning and memory in 279 F1 males, but exposure did not cause any chan ges in spontaneous behavior. In addition, 280 there was high and dose-dependent pup mortal ity during lactation (Ema, et al., 2008). 281 2. Environmental effects 282EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 13 of 34 Laboratory studies have shown that HBCD is capab le of producing adverse 283 effects in a variety of organisms including algae, fish, invertebrates and soil-dwelling 284 organisms at environmentally relevant con centrations. HBCD is toxic to algae and 285 acutely toxic to fish embryos (Desjardins, et al., 2004; Deng, et al., 2009). A number of 286 sub-lethal effects (e.g., altere d thyroid status, protein metabolism, oxidative stress, 287 reproductive activity) have also been observed in fish (Pal ace, et al., 2008; Kling and 288 Förlin, 2009; Zhang, et al., 2008; Ronisz, et al., 2004). Drottar and Krueger (1998) 289 reported a reduced number and size of daphnid of fspring in first and second generations. 290 Thyroid hormone-dependent developmental effects were observed in tadpoles (Xenopus 291 laevis ) exposed to HBCD (Schriks, et al., 2006). HBCD has b een reported to reduce egg 292 production and lower biomass in soil dwelling organisms ( Lumbriculus variegatus ) 293 (Oetken, et al., 2001). HBCD administered to chicken ( Gallus domesticus ) embryonic 294 hepatocytes in vitro resulted in significant alterations in expression of genes (mRNA) 295 associated with liver and thyr oid function (Crump, et al., 2008). Thinner egg shells were 296 measured in American kestrels exposed to a combination of PBDEs and HBCD (Fernie, 297 et al., 2009). 298 E. What are the Potential Sources an d Routes of Exposure to HBCD? 299 Because HBCD is not chemically bound to its substrate (the protected textile 300 material), there is potential for HBCD to be re leased at any point in the lifecycle. There 301 is potential for release when the HBCD is initially manufactured, when it is being 302 formulated into the material that is commonl y used in textile back coatings, as well as 303 when it is being combined with the textile material to wh ich it is added. In addition, 304 HBCD can be released during the service lif e of the textile material containing it, 305 including release into water used to wash th e treated textiles or into the air via dust 306EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 14 of 34 particulates. Workers and th e general population can be expo sed to HBCD through direct 307 contact as it migrates across land, in air, and in water by diffusion or environmental 308 transport. Other opportunities for release can occur at th e end of the lifecycle of the 309 consumer articles when they are trans ported as waste and disposed of, although 310 incineration at high temperatures de stroys the HBCD. (Posner, 2006). 311 Evidence strongly suggests there is po tential for exposure to the general 312 population from HBCD in the en vironment and also from pro ducts and dust in the home 313 and workplace. HBCD is found world-wide in the environment a nd wildlife. Human 314 exposure is evidenced from its presence in breast milk, adipose tissue, and blood. 315 (Covaci, et al., 2006). The chemical bioaccumu lates and biomagnifies in food chains. 316 The frequent detection of HBCD over a larg e geographic area, with increasing exposure 317 in remote locations such as the Arctic, where no demonstrable local sources exist that can 318 account for these exposures, suggest that H BCD is persistent and undergoes long-range 319 transport. (UNEP, 2007). 320 To the extent HBCD is present in household applications (e.g., building foam, 321 furniture upholstery, carpeting), children coul d be exposed, especially given children’s 322 increased exposure via dust and th e hand-to-mouth ingestion pathway. In vitro 323 experiments conducted to demonstrate leaching of HBCD from textil es showed that the 324 presence of simulated biological fluids (sw eat, saliva) and fruit juices enhances the 325 leaching of HBCD from back-coated sample s (Ghanem, 2009). Children’s exposure to 326 HBCD from mouthing of textil es and from ingestion of dus t has been estimated (EC, 327 2008). 328 HBCD has been measured in air and se diment in Scandinavian countries, North 329 America and Asia (Covaci, et al., 2006; Ar not, et al., 2009). HBCD has also been 330EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 15 of 34 measured in marine and arctic mammals, freshwater and marine fish, aquatic 331 invertebrates, birds and bird eggs, and one plant species (Covaci, et al., 2006; Arnot, et 332 al., 2009). HBCD has been detect ed in Arctic air in norther n Scandinavia and in Arctic 333 birds and bird eggs, Arctic fish, ringed seals and polar bears (UNEP, 2009). It has been 334 detected in freshwater, marine, and avian or ganisms, and in upper trophic-level mammals 335 (polar bears and seals). 336 For more information on HBCD concerning its physical-chemical properties, fate, 337 releases, and human and environm ental exposure, see U.S. EPA’s 338 “Hexabromocyclododecane (HBCD) Action Plan” dated August 18, 2010 at 339 www.epa.gov/oppt/existingchemical s/pubs/actionplans/hbcd.html

. 340 IV. Summary of Proposed Rule 341 EPA is proposing to designate as a si gnificant new use the use of HBCD in 342 consumer textiles other than for use in motor vehicles. A proposed definition of 343 “consumer textile” can be found at 40 CFR 721.______ of the regulatory text at the end 344 of this proposed rule. The proposed defin ition of “motor vehicle” refers to 40 CFR 345 85.1703. 2 346

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 associat ed with safe and practical street or highway use, such features including, but not being limit ed 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 us e 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 ordina rily 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.EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 16 of 34 This proposed rule would add a secti on to 40 CFR 721 to require persons who 347 intend to manufacture (including import) or process HBCD for an activity preliminarily 348 designated as a significant new use by this action to notify EPA at least 90 days before 349 commencing that activity. The required not ification would provide EPA with the 350 opportunity to evaluate the intended use a nd, if appropriate, to prohibit or limit that 351 activity before it occurs. For this pro posed rule, the general SNUR exemption for 352 persons that import or process chemical subs tances as part of an article at 40 CFR 353 721.45(f) would not apply. (See discussion at Unit VI.C.) 354 V. Significant Ne w Use Determination 355 A. Rationale 356 As summarized in Unit III.D. and E., EPA has concerns regarding the potential 357 exposure to and human health and environmen tal effects of HBCD. EPA believes that 358 HBCD could be manufactured or processed fo r consumer textiles other than for use in 359 motor vehicles in the future. Accordingl y, EPA wants the opportunity to evaluate and 360 control, where appropriate, activities associatedwith that use, if such manufacturing or 361 processing were to be commenced in the futu re. The required notif ication provided by a 362 SNUN would provide EPA with the opportunity to evaluate activities associated with the 363 significant new use and an opportunity to protec t against unreasonable risks, if any, from 364 exposure to HBCD. 365 Consistent with EPA’s past practice for issuing SNURs under TSCA Section 366 5(a)(2), EPA’s decision to propose a SNUR for a particular chemical use need not be 367 based on an extensive evaluation of the hazard, e xposure, or potential ri sk associated with 368 that use. Rather, the Agency’s action is ba sed on EPA’s determination that if the use 369
http://www.gpo.gov/fdsys/pkg/CFR-2000-title40-vo l12/xml/CFR-2000-title40-vol12-sec85-1703.xmlEO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 17 of 34 begins or resumes, it may present a risk that EPA should evaluate before the 370 manufacturing or processing for that use be gins. Since the new use does not currently 371 exist, deferring a detailed consideration of potenti al risks or hazards related to that use is 372 an effective use of resources. If a person decides to begin manufact uring or processing 373 the chemical for the new use, the notice to EPA allows EPA to evaluate the use according 374 to the specific parameters and circum stances surrounding that intended use. 375 B. Objectives 376 Based on the considerations in Unit V. A., EPA has the following objectives with 377 regard to the significant new use that is pr eliminarily designated in this proposed rule: 378 1. EPA would receive notice of any pe rson’s intent to manufacture (including 379 import) or process HBCD for the described significant new use before that activity 380 begins. 381 2. EPA would have an opportunity to review and evaluate data submitted in a 382 SNUN before the notice submitter begins ma nufacturing or processing of HBCD for the 383 described significant new use. 384 3. EPA would be able to regulate pros pective manufacturers or processors of 385 HBCD before the described si gnificant new use of the chem ical substance(s) occur, 386 provided that regulation is wa rranted pursuant to TSCA sec tions 5(e), 5(f), 6 or 7. 387 C. Relevant Factors Considered for this Proposed SNUR 388 TSCA states that EPA’s determination th at a use of a chemical substance is a 389 significant new use must be made after consid eration of all relevant factors, including 390 those listed at TSCA Secti on 5(a)(2) (see list at Unit II. B.). EPA has preliminarily 391 determined that manufacturing or processing of HBCD for use in consumer textiles other 392 than for use in motor vehicles is a significant new use. This determination is based 393EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 18 of 34 primarily on the following factor listed at TS CA Section 5(a)(2): “t he extent to which a 394 use increases the magnitude and duration of exposure of human beings or the 395 environment to a chemical substance.” The la test information availa ble to EPA indicates 396 that the only ongoing use of HBCD in consumer textiles is for use in motor vehicles. 397 Initiation of new uses of HBCD in consumertextiles could increase the magnitude and 398 duration of exposure to the ge neral population from HBCD in the environment and from 399 products and dust in the home and workplace. Workers could be exposed to HBCD at 400 facilities of all types involved in the lifecycle of the produc ts, as described in greater 401 detail in Unit III. E. Releases to the envi ronment are expected to occur during the service 402 life of the textiles containi ng HBCD. Such increase in releases could contribute 403 additional HBCD to the atmosphere, long-range transport, and greater concentrations in 404 water, which could be detrimental to overall environmental and human health. Thus, 405 EPA believes that initiating the use of HBCD in consumer textiles other than for use in 406 motor vehicles would increase the magnitude and duration of exposure to humans and the 407 environment over that whic h would otherwise exist. 408 D. Request for Comment 409 EPA welcomes comment on all aspects of this proposed rule, including: 410

• the basis for the significant new use determination presented for this 411 proposed rule, and 412

• information about any ongoing manufacture, import, or processing of 413 HBCD for use in consumer textiles. 414 VI. Alternative Regulatory Approaches 415 Before proposing this SNUR, EPA consider ed the following alternative regulatory 416 actions: 417EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 19 of 34 A. Promulgate a TSCA Section 8(a) Reporting Rule 418 Under a TSCA section 8(a) rule, EP A could, among other things, generally 419 require persons to report information to the Agency when they intend to manufacture or 420 process a listed chemical for a specific use or any use. However, for HBCD in consumer 421 textiles, the use of TSCA sec tion 8(a) rather than SNUR authority would have several 422 limitations. First, if EPA were to require reporting under TSCA section 8(a) instead of 423 TSCA section 5(a), EPA would not have the opportunity to review human and 424 environmental hazards and exposures associated with the use in consum er textiles and, if 425 necessary, take immediate follow-up regulatory action under TSCA secti ons 5(e) or 5(f) 426 to prohibit or limit the activity before it begi ns, if warranted. In addition, EPA might not 427 receive important information from small businesses, because such firms generally are 428 exempt from TSCA section 8(a) reporting requirements. In view of health and 429 environmental concerns related to HBCD, if used for the proposed significant new use, 430 EPA believes that a TSCA section 8(a) rule for these substances would not meet EPA’s 431 regulatory objectives. 432 B. Regulate HBCD in Consumer Textiles under TSCA Section 6 433 EPA may regulate under TSCA section 6 if “t he Administrator finds that there is a 434 reasonable basis to conclude th at the manufacture, processi ng, distribution in commerce, 435 use or disposal of a chemical substance or mixture . . . presents or will present an 436 unreasonable risk of injury to health or the environment.” (TSCA section 6(a)). EPA 437 concluded that risk management action under TSCA section 6 is notnecessary at this 438 time because EPA: 1) believes HBCD is not being used in consumer textiles in the 439 United States other than for use in motor vehicl es, 2) has not determined as of this date 440 that use of HBCD in motor ve hicles presents unreasonable ri sk, and 3) expects the use in 441EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 20 of 34 motor vehicles to end within a few years. This proposed SNUR would allow the Agency 442 to address the potential risk s associated with the proposed significant new use. 443 C . Allow the Exemption for Persons Who Import or Process HBCD as Part of Articles 444 that Would be Subject to the Proposed SNUR 445 Under the SNUR exemption provision at 40 CFR 721.45(f), a person who imports 446 or processes a substance covered by a SNUR iden tified in subpart E of part 721 as part of 447 an article is not generally subject to th e notification requirements of 40 CFR 721.25 for 448 that substance. However, EPA is concerned that exempting HBCD as part of articles 449 would render the SNUR less effective because of the possibility that consumer textile 450 articles containing HBCD, the primary concer n of EPA associated with this rulemaking, 451 could be imported or processed for uses s ubject to this propose d SNUR without the 452 submission of a SNUN. Thus, EPA is proposing to promulga te this rule without the 453 exemption at 40 CFR 721.45(f). 454 VII. Applicability of Rule to Uses Occurr ing Before Effective Date of the Final Rule 455 As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has 456 decided that the intent of s ection 5(a)(1)(B) of TSCA is best served by designating a use 457 as a significant new use as of the date of publication of this proposed rule rather than as 458 of the effective date of the fi nal rule. If uses begun after publication of the proposed rule 459 were considered ongoing rather than new, it would be difficult for EPA to establish 460 SNUR notice requirements, because a person could defeat the SNUR by initiating the 461 proposed significant new use before the rule became final, and then argue that the use 462 was ongoing as of the effective date of th e final rule. Thus, persons who begin 463 commercial manufacture or pr ocessing of the chemical substance(s) (including 464 manufacturing or processing the ch emical substance(s) as part of an article) for a use that 465EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 21 of 34 would be regulated through this proposed rule , if finalized, would have to cease any such 466 activity before the effective date of the rule if and when finalized. To resume their 467 activities, these persons w ould have to comply with all applicable SNUR notice 468 requirements and wait until the notice review pe riod, including all extensions, expires. 469 EPA has promulgated provisions (40 CFR 721.4 5(h)) to allow persons to submit a SNUN 470 before the effective date of th e SNUR. If a person were to meet the conditions of 40 CFR 471 section 721.45(h), that person would be consid ered to have met the requirements of the 472 final SNUR for those activities. If persons who begin commercial manufacture, import, 473 or processing of the substance between public ation of the proposal and the effective date 474 of the final SNUR do not meet the conditions of advance compliance, they must cease 475 that activity before the effective date of the final rule. To resume their activities, these 476 persons would have to comply with all app licable SNUN requirements and wait until the 477 notice review period, including all extensions, expires. 478 VIII. Test Data and Other Information 479 EPA recognizes that TSCA section 5 doe s not require the development of any 480 particular test data before submission of a SNUN. There are two exceptions: 1) 481 development of test data is re quired where the chemical substance subject to the SNUR is 482 also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)); and 2) 483 development of test data may be necessary wh ere the chemical substance has been listed 484 under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a section 4 485 test rule or a section 5(b)(4) listing covering the chemical s ubstance, persons are required 486 only to submit test data in their possession or control and to desc ribe any other data 487 known to or reasonably ascertainable by them (TSCA section 5(d); 40 CFR 721.25 and 488 40 CFR 720.50). However, as a general matte r, EPA recommends that SNUN submitters 489EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 22 of 34 include data that would permit a reasoned evaluation of risks posed by the chemical 490 substance during its manufacture, processing, use, distribution in commerce, or disposal. 491 EPA encourages persons to consult with the Agency before submitting a SNUN. As part 492 of this optional pre-notice c onsultation, EPA would discuss specific data it believes may 493 be useful in evaluating a si gnificant new use. SNUNs submitted for significant new uses 494 without any test data may increase the lik elihood that EPA will ta ke action under TSCA 495 section 5(e) to prohibit or limit activitie s associated with this chemical. 496 SNUN submitters should be aware thatEPA will be better able to evaluate 497 SNUNs that provide deta iled information on: 498 1. Human exposure and environmental releases that may result from the 499 significant new use of the chemical substance. 500 2. Potential benefits of the chemical substance. 501 3. Information on risks posed by the ch emical substances compared to risks 502 posed by potential substitutes. 503 IX. SNUN Submissions 504 According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the 505 same notice requirements and EPA regulatory procedures as persons submitting a PMN, 506 including submission of test da ta on health and environmental effects as described in 40 507 CFR 720.50. SNUNs must be on EPA Fo rm No. 7710–25, generated using e-PMN 508 software, and submitted to the Agency in accord ance with the procedures set forth in 40 509 CFR 721.25 and 720.40. The e-PMN software is available electronically at 510 http://www.epa.gov/opptintr/newchems

. 511 X. Economic Analysis 512 EPA has evaluated the potential co sts of establishing SNUR reporting 513EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 23 of 34 requirements for potential manufacturers and pro cessors of HBCD in consumer textiles. 514 The evaluation is in the Draft Economic Analysis of the Proposed Significant New Use 515 Rule for Hexabromocyclododecane (HBCD) (U.S. EPA, 2011). It is briefly summarized 516 here and is available in the docket for this proposed rule. 517 Because there appears to be no use of HBCD in consumer textiles in the U.S. at 518 the current time, other than for use in moto r vehicles, EPA expects very few, if any, 519 entities would submit a SNUN. As a result , the economic impact of this rule is 520 anticipated to be either zero or very low. 521 In the event that a SNUN is submitted, costs are estimated at approximately 522 $8,300 per SNUN submission for large busines ses and $5,900 for small businesses, and 523 include the cost to prepare and submit th e SNUN and the payment of a user fee. 524 Businesses that submit a SNUN would be subj ect to either a $2,500 user fee required by 525 40 CFR 700.45(b)(2)(iii), or, if they are a sm all business with annual sales of less than 526 $40 million when combined with those of the pa rent company (if any), a reduced user fee 527 of $100 (40 CFR 700.45(b)(1)). In its evalua tion of this proposed rule, EPA also 528 considered the potential costs a compa ny might incur by avoiding or delaying the 529 significant new use in the future, but th ese costs have not been quantified. 530 XI. References 531 The following documents are specifically referenced in the preamble for this 532 rulemaking. In addition to these documents, other materials may be available in the 533 docket established for this rulemaking under Docket ID No. EPA-HQ-OPPT-2011-0489, 534 which you can access through http:// www.regulations.gov . Those interested in the 535 information considered by EPA in developi ng this proposed rule, should also consult 536 documents that are referenced in the docum ents that EPA has placed in the docket, 537EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 24 of 34 regardless of whether the ot her documents are physically located in the docket. 538 1. U.S. EPA, 2006. Inventory Update Reporting (IUR): Non-Confidential 2006 539 TSCA Inventory Update Rule (IUR) Records. Available at: 540 http://cfpub.epa.gov /iursearch/index.cfm (accessed July 22, 541 2011).http://cfpub.epa.gov/iurs earch/index.cfm?s=chem. 542 2. Posner, 2006. Survey and technical assessment of alternatives to TBBPA and 543 HBCDD . Kemi PM. January 2006. 544 3. Babich, 2010. Personal communication with Michael Babich, Chemist, 545 United States Consumer Product Safety Commission. March 16, 2010. 546 4. Jacson Morrill, 2011. Personal communi cation with Jackson Morrill, 547 Director of Chemical Products of the American Chemistry Council. February 548 25, 2011. 549 5. Gabe Wing, 2011. Personal communicat ion with Gabe Wing of Herman 550 Miller, Inc. March 30, 2011. 551 6. John Friddle, 2011. Personal communicati on with John Friddle, President of 552 Eagle Performance Products. March 3, 2011. 553 7. U.S. EPA, 2011. Draft Economic Analysis of the Proposed Significant New 554 Use Rule for Hexabromocyclododecane (HBCD), Washington, D.C. 555 OPPT/EETD/EPAB, July 8, 2011. 556 8. Chengelis, 2001. An oral (gavage) 90 day toxi city study of HBCD in rats. 557 Study No. WIL-186012. WIL Research Labor atories, Inc., Ashland, Ohio, 558 USA. 559EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 25 of 34 9. Eriksson, et al., 2006. Impaired behavi our, learning and memory, in adult 560 mice neonatally exposed to hexabromocyclododecane (HBCDD). Environ. 561 Toxicol. Pharmacol . May 2006, 21(3) , 317–322. 562 10. Ema, M., et al., 2008. Two-generation reproductive toxicity study of the 563 flame retardant hexabromcyclododecane in rats. Reprod. Toxicol. . Apr 2008, 564 25(3) , 335-351. 565 11. Desjardins, et al., 2004. Hexabrom ocyclododecane (HBCD): A 72-hour 566 toxicity test with the marine diatom (Skeletonema costatum). Final Report. 567 Wildlife International, Ltd., Easton, Maryland, USA. 66 p. 568 12. Deng, et al., 2009. Hexabromcyclododecane-induced developmental toxicity 569 and apoptosis in zebrafish embryos. Aquatic Toxicol . June 2009, 93(1) , 29- 570 36. 571 13. Palace, et al., 2008. Biotransformation enzymes and thyroid axis disruption 572 in juvenile rainbow trout (O ncorhynchus mykiss) exposed to 573 hexabromocyclododecane diastereoisomers. Environ. Sci. Technol . Feb 2008, 574 42(6) , 1967-1972. 575 14. Kling, et al., 2009. Proteomic studies in zebrafish liver cells exposed to the 576 brominated flame retardants HBCD and dTBBPA. Ecotoxicol

. Environ. Saf

. 577 2009, 72, 985-1993. 578 15. Zhang, et al., 2008. Induction of hepatic enzymes and oxidative stress in 579 Chinese rare minnow (Gobiocypris rarus) exposed to waterborne 580 hexabromocyclododecane (HBCD). Aquatic Toxicol . Jan 2008, 86(1) 4-11. 581 16. Ronisz, et al., 2004. Sublethal eff ects of the flame retardants 582 hexabromocyclododecane (HBCDD), and tetrabromobisphenol A (TBBPA), 583EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 26 of 34 on hepatic enzymes and other biomarkers in juvenile rainbow trout and feral 584 eelpout. Aquatic Toxicol . Aug 2004, 69(3) , 229-245. 585 17. Drottar, et al., 1998. Hexabromocyc lododecane (HBCD): A flow-through 586 life-cycle toxicity test with the cladoceran (Da phnia magna). Final report. 587 439A-108, Wildlife International, Ltd, Easton, Maryland, USA. 1998. 78 p. 588 18. Schriks, et al., 2006. Disruption of th yroid hormone-mediated Zenopus laevis 589 tadpole tail tip regression by hexabromocyclododecane (HBCD) and 590 2,2’,3,3’,4,4’,5,5’, 6-nona brominat ed diphenyl ether (BDE206). 591 Chemosphere . Dec 2006, 65(10) , 1904-1908. 592 19. Oetken, et al., 2001. Validation of the preliminary EU-concept of assessing 593 the impact of chemicals to organisms in sediment by using selected 594 substances. UBA-FB 299 67 411, In stitute of Hydrobiology, Dresden 595 University of Technology, Dresden, Germany. 2001, 97 p. 596 20. Crump, et al., 2008. Effects of hexabr omocyclododecane and polybrominated 597 diphenyl ethers on mRNA expression in chicken (Gallus domesticus) 598 hepatocytes. Toxicol. Sci . Dec 2008, 106(2) , 479-487. 599 21. Fernie, et al., 2009. Environmentally re levant concentrations of DE-71 and 600 HBCD alter eggshell thickness and reproductive success of American 601 kestrels. Environ. Sci. Technol . Mar 2009, 43(6) , 2124-30. 602 22. Covaci, et al., 2006. Hexabromocyclododecanes (HBCDs) in the 603 Environment and Humans: A Review. Environ. Sci. Technol . May 2006, 604 40(12) , 3679-3688. 605 23. UNEP, 2007. Stockholm Convention on Persistent Organic Pollutants. 606 Persistent Organic Pollutants Review Committee, Third meeting, Geneva, 607EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 27 of 34 19-23 November 2007, Item 7 of the pr ovisional agenda, Presentation on 608 environmental transport and modeling. The OECD screening tool for overall 609 persistence and long-rang e transport potential. 610 UNEP/POPS/POPRC.3/INF/7. 611 24. Ghanem, R., 2009. Kinetics of Therma l and Photolytic Segregation of 612 Hexabromocyclododecane in Backcoated Textile Samples. Jordan J Chem

. 613 Apr 2009, 4(2) , 171-181. 614 25. EC, 2008. European Commission (EC). Risk Assessment: 615 Hexabromocyclododecane CAS-No.: 25637-99-4 EINECS-No.: 247-148-4, 616 Final Report. Office for Official Public ations of the European Communities: 617 Luxembourg. May 2008. 618 26. Arnot, et al., 2009. An evaluation of hexabromocyclododecane (HBCD) for 619 Persistent Organic Polluta nt (POP) properties and th e potential for adverse 620 effects in the environment. Submitted to European Brominated Flame 621 Retardant Industry Panel (EBFRIP). May 2009. 622 27. UNEP, 2009. Stockholm Convention on Persistent Organic Pollutants. 623 Summary of the proposal for the listing of hexabromocyclododecane 624 (HBCDD) in Annex A to the Convention . July 2008. 625 28. HBCD Action Plan, 2010. EPA’s Hexa bromocyclododecane (HBCD) Action 626 Plan. August 2010. Available at 627 http://www.epa.gov/oppt/existingc hemicals/pubs/actionplans/RIN2070- 628 AZ10_HBCD%20action%20plan_Final_2010- 08-09.pdf (accessed July 22, 629 2011). 630 XII. Statutory and Executive Order Reviews 631EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 28 of 34 A. Regulatory Planning and Review 632 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 633 51735, October 4, 1993), this action has been designated a “significant regulatory 634 action.” Accordingly, EPA submitted this action to OMB for review under Executive 635 Orders 12866 and 13563, entitled Improving Regulation and Regulatory Review (76 FR 636 3821, January 21, 2011), and any changes made in response to OMB recommendations 637 have been documented in the docket for this action as required by section 6(a)(3)(E) of 638 the Executive Order. 639 EPA has prepared an economic analysis of this action, entitled Draft Economic 640 Analysis of the Proposed Significant Ne w Use Rule for Hexabromocyclododecane 641 (HBCD) (USEPA, 2011). A copy of the document is available in the docket for this 642 proposed rule and is summarized in Unit X. 643 B. Paperwork Reduction Act 644 According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., an 645 Agency may not conduct or sponsor, and a pe rson is not required to respond to a 646 collection of information that requires OM B approval under the PRA, unless it has been 647 approved by OMB and displays a currentl y valid OMB control number. The OMB 648 control numbers for certain EPA regulations in title 40 of the CFR, af ter appearing in the 649 Federal Register , are listed in 40 CFR part 9, a nd included on the related collection 650 instrument, or form, if applicable. 651 The information collection requirements re lated to this action have already been 652 approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA 653 ICR No. 1188). This action does not impos e any burden requiri ng additional OMB 654 approval. If an entity were to submit a SNUN to the Agency, the annual burden is 655EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 29 of 34 estimated to average 97 hours per response. This burden estimate includes the time 656 needed to review instructions ; search existing data sources; gather and maintain the data 657 needed; and complete, review, a nd submit the required SNUN. 658 Send any comments about the accuracy of the burden estimate, and any suggested 659 methods for minimizing respondent burden to the Director, Coll ection Strategies 660 Division, Office of Environmental Inform ation (2822T), Environmental Protection 661 Agency, 1200 Pennsylvania Ave., NW ., Washington, D.C. 20460-0001. Please 662 remember to include the OMB control numbe r in any correspondence, but do not submit 663 any completed forms to this address. 664 C. Small Entity Impacts 665 Pursuant to section 605(b) of the Regul atory Flexibility Act (RFA) (5 U.S.C. 601 666 et seq .), the Agency hereby certifies that promulgation of this SNUR would not have a 667 significant adverse economic impact on a s ubstantial number of small entities. The 668 rationale supporting this conc lusion is as follows. 669 Under the RFA, small entities include sm all businesses, small organizations, and 670 small governmental jurisdictions. Small entity is defined in accordance with section 601 671 of the RFA as: a small business as defined by the Small Business Administration’s (SBA) 672 regulations at 13 CFR 121.201; a small government al jurisdiction that is a government of 673 a city, county, town, school district or special district with a p opulation of less than 674 50,000; and a small organization that is a ny not-for-profit ente rprise which is 675 independently owned and operated and is not dominant in its field. For purposes of 676 assessing the impacts of this proposed rule on small entities, EPA has determined that 677 this proposed rule is not expected to impact any small not-for-profit organizations or 678 small governmental jurisdictions. As suc h, the Agency estimated potential impacts on 679EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 30 of 34 small business. 680 A SNUR applies to any pe rson (including small or large entities) who intends to 681 manufacture, import, or process a chemical substance for a use the EPA has designated as 682 a “significant new use.” By definition of the word “new,” and based on information 683 currently available to EPA, it appears that no small or large entities presently engage in 684 such activity. Since this proposed SNUR w ould require a person who intends to engage 685 in such activity in the future to first notify EPA by submitting a SNUN, no economic 686 impact will occur unless someone files a S NUN to pursue a significant new use in the 687 future or forgoes profits by avoiding or de laying the significant ne w use. Although some 688 small entities may decide to conduct such act ivities in the future, EPA cannot presently 689 determine how many, if any, there may be. Howe ver, EPA’s experience to date is that, in 690 response to the promulgation of SNURs covering over 1,000 chemicals, the Agency 691 receives only a handful of notices per year. For example, the number of SNUNs was four 692 in Federal fiscal year 2005, eight in FY2006, six in FY2007, eight in FY2008, and seven 693 in FY2009. During this five-year period, three small entities submitted a SNUN. 694 Therefore, EPA believes that the potential ec onomic impact of complying with a SNUR 695 is not expected to be sign ificant or adversely impact a substantial number of small 696 entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690)(FRL697 5735-4), the Agency presented its general de termination that propos ed and final SNURs 698 are not expected to have a si gnificant economic impact on a substantial number of small 699 entities, which was provided to the Chief Counsel for Advocacy of the Small Business 700 Administration. 701 D. Unfunded Mandates 702 Based on EPA’s experience with proposi ng and finalizing SNURs, State, local, 703EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 31 of 34 and Tribal governments have not been imp acted by these rulemakings, and EPA does not 704 have any reason to believe that any State, lo cal, or Tribal government would be impacted 705 by this rulemaking. As such, EPA has determ ined that this regul atory action would not 706 impose any enforceable duty, contain any unfunded mandate, or otherwise have any 707 effect on small governments subject to th e requirements of sections 202, 203, 204, or 205 708 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538). 709 E. Federalism 710 This action would not have federalism imp lications because it is not expected to 711 have a substantial direct effect on Stat es, on the relationship between the national 712 government and the States, or on the distribut ion of power and res ponsibilities among the 713 various levels of government, as speci fied in Executive Order 13132, entitled Federalism 714 (64 FR 43255, August 10, 1999). 715 F. Indian Tribal Governments 716 This action would not have tribal implications as specified in Executive Order 717 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 718 67249, November 9, 2000). This action is not exp ected to have substa ntial direct effects 719 on Indian Tribes, would not significantly or uniquely affect the communities of Indian 720 Tribal governments, and would not involve or impose any requir ements that affect Indian 721 Tribes. Thus, Executive Order 13175 does not apply to this action. 722 G. Protection of Children 723 This action is not subject to Executive Order 13045, entitled Protection of 724 Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 725 1997), because this is not an economically si gnificant regulatory ac tion as defined by 726EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 32 of 34 Executive Order 12866, and this action does not a ddress environmental health or safety 727 risks disproportionately affecting children. 728 H. Effect on Energy Supply, Distribution, or Use 729 This action is not a “significant energy action” as defined in Executive Order 730 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, 731 Distribution, or Use (66 FR 28355, May 22, 2001), because th is action is not likely to 732 have a significant advers e effect on the supply, distribution, or use of energy. 733 I. Technical Standards 734 Because this action would not involve a ny technical standards, section 12(d) of 735 the National Technology Transfer and Adva ncement Act of 1995 (NTTAA) (15 U.S.C. 736 272 note), does not apply to this action. 737 J. Environmental Justice 738 This action would not entail special c onsiderations of e nvironmental justice 739 related issues as delineated by Executive Orde r 12898, entitled Federal Actions to 740 Address Environmental Justice in Minority Populations and Low-Income Populations (59 741 FR 7629, February 16, 1994). 742 List of Subjects in 40 CFR Part 721 743 Environmental protection, Chemicals, Hazardous substances, Reporting and 744 recordkeeping requirements. 745 Dated: ____________________ 746 747

__________________________________________ 748 Director, Office of Pollution Prevention and Toxics 749 750EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 33 of 34 Therefore, it is proposed that 40 CF R part 721 be amended as follows: 751 1. The authority citation for part 721 would continue to read as follows: 752 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 753 2. By adding new § 721.______ to read as follows : 754 721.[number to be added] Hexabromocyclododecane and 1,2,5,6,9,10- 755 hexabromocyclododecane 756 (a) Chemical substance s and significant new uses subject to reporting. (1) The 757 chemical substances identified as hexa bromocyclododecane (CASRN 25637-99-4) and 758 1,2,5,6,9,10-hexabromocyclododecane (CASRN 3 194-55-6) are subject to reporting 759 under this section for the signifi cant new use described in para graph (a)(2) of this section. 760 (2) The significant new use is use in consumer textiles, other than for use in 761 motor vehicles. 762 (b) Specific requirements. The provisions of subpart A of this part apply to this 763 section except as modified by this paragraph. 764 (1) Definitions. The definitions in § 721.3 apply to this section. In addition, the 765 following definitions apply: 766 Consumer textile means any cloth, fabric or other item produced during the milling 767 process (including spinning, weaving, knitting, felting, or finishing), consisting in whole 768 or in part as a product that is sold to or made available to a private individual who uses 769 the product in or around a permanent or te mporary household or residence, during 770 recreation, or for any personal use or enjoyment. Consumer textiles include, but are not 771 limited to, upholstered household furn iture, mattresses, and draperies. 772 Motor vehicle has the meaning found at 40 CFR 85.1703. 773 (2) Revocation of article exemption. The provisions of § 721.45( f) do not apply to 774EO 12866 Draft – Do Not Cite, Quote or Release during Review

Page 34 of 34 this section. A person who imports or proces ses the chemical substances identified in 775 paragraph (a)(1) of this section as part of an article for the significant new use described 776 in paragraph (a)(2) of this section mu st submit a significant new use notice. 777 [FR Doc. ??–????? Filed ??–??–??; ?:?? a.m.] 778