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1 EO12866_PBDE SNUR-Test_NPRM_2010-12-08.doc 

2 

3 BILLING CODE 6560–50–P

4 

5 ENVIRONMENTAL PROTECTION AGENCY 

6 

7 40 CFR Parts 721 and 799 

8 

9 EPA–HQ–OPPT–2009-0357; FRL–XXXX–X] 

10 

11 RIN 2070–AJ08

12 

13 Certain Polybrominated Diphenylethers; Significant New Use Rule (SNUR) and Test Rule 

14 

15 AGENCY: Environmental Protection Agency (EPA). 

16 ACTION: Proposed rule. 

17 SUMMARY: The Agency is proposing to amend the Toxic Substances Control Act (TSCA) 

18 section 5(a) Significant New Use Rule (SNUR), at 40 CFR 721.10000, that requires any person 

19 who intends to manufacture or import tetrabromodiphenyl ether (CASRN 40088–47–9; 

20 Benzene, 1,1′-oxybis-, tetrabromo deriv.) (tetraBDE), pentabromodiphenyl ether (CASRN 

21 32534-81-9; Benzene, 1,1’-oxybis-, pentabromo deriv.) (pentaBDE), hexabromodiphenyl ether 

22 (CASRN 36483–60–0; Benzene, 1,1′-oxybis-, hexabromo deriv.) (hexaBDE), 

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

24 (heptaBDE), octabromodiphenyl ether (CASRN 32536-52-0; Benzene, 1,1’-oxybis-, octabromo 

25 deriv.) (octaBDE), or nonabromodiphenyl ether (CASRN 63936–56–1; Benzene, pentabromo 

26 (tetrabromophenoxy)-) (nonaBDE), or any combination of these substances resulting from a 

27 chemical reaction, for any use on or after January 1, 2005, to notify EPA at least 90 days in 

28 advance. EPA is proposing to amend the SNUR by: (1) designating processing of the six 

29 polybrominated diphenyl ethers (PBDE)s, or any combination of these substances resulting from 

30 a chemical reaction, for any use as a significant new use, (2) designating manufacturing, 

31 importing, and processing of a seventh PBDE, decabromodiphenyl ether (CASRN 1163-19-5; 

32 Benzene, 1,1’-oxybis[2,3,4,5,6-pentabromo-)(decaBDE) for any use after December 31, 2012, 

33 except military and transportation uses, and for any use including military and transportation 

34 uses after December 31, 2013 as a significant new use, and (3) making inapplicable the article 

35 exemption at 721.45(f) for this action. Any person who intends to import or process any 

36 chemical substance subject to the proposed SNUR, as part of an article would be subject to 

37 significant new use reporting. The purpose of amending the existing SNUR is to ensure that the 

38 Agency has an opportunity to review and, if necessary, take action to restrict or prohibit a new 

39 use, such as resumption of discontinued uses of PBDEs before they resume. EPA expects all 

40 manufacture and processing of PBDEs, except as impurities, to be discontinued by the dates 

41 specified above. EPA is also proposing a test rule under section 4(a) of TSCA that would require 

42 any person who manufactures or processes commercial pentaBDE (c-pentaBDE), commercial 

43 octaBDE (c-octaBDE), or commercial decaBDE (c-decaBDE), including in articles, for any use 

44 after December 31, 2012, except for military and transportation uses of c-decaBDE, or after 

45 December 31, 2013 for any use including military and transportation uses of c-decaBDE to 
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46 conduct testing to obtain data on health effects, environmental effects, and chemical fate. The 

47 proposed test rule specifies that testing of c-pentaBDE, c-octaBDE, and c-decaBDE be 

48 conducted on a representative commercial product of each. The required testing would provide 

49 EPA with data necessary to determine the effects of manufacture, distribution in commerce, 

50 processing, use, and disposal of c-pentaBDE, c-octaBDE, and c-decaBDE or any combination of 

51 such activities on health or the environment. EPA is proposing to designate all discontinued uses 

52 of PBDEs as significant new uses. The test rule would only be promulgated if there are persons 

53 manufacturing, importing, or processing c-pentaBDE, c-octaBDE, or c-decaBDE for any use, 

54 except as impurities, after the dates specified above. 

55 

56 DATES: Comments must be received on or before [insert date 60 days after date of publication 

57 in the Federal Register]. 

58 ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–

59 HQ–OPPT–2009-0357, by one of the following methods: 

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

61 instructions for submitting comments. 

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

63 (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

64 20460–0001. 

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

66 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ–

67 OPPT–2009-0357. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding 

68 legal holidays. The telephone number for the DCO is (202) 564–8930. Such deliveries are only 

69 accepted during the DCO’s normal hours of operation, and special arrangements should be made 

70 for deliveries of boxed information. 

71 Instructions: Direct your comments to docket ID number EPA–HQ–OPPT–2009-0357. 

72 EPA's policy is that all comments received will be included in the docket without change and 

73 may be made available on-line at http://www.regulations.gov, including any personal 

74 information provided, unless the comment includes information claimed to be Confidential 

75 Business Information (CBI) or other information whose disclosure is restricted by statute. Do not 

76 submit information that you consider to be CBI or otherwise protected through regulations.gov 

77 or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA 

78 will not know your identity or contact information unless you provide it in the body of your 

79 comment. If you send an e-mail comment directly to EPA without going through 

80 regulations.gov, your e-mail address will be automatically captured and included as part of the 

81 comment that is placed in the docket and made available on the Internet. If you submit an 

82 electronic comment, EPA recommends that you include your name and other contact information 

83 in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read 

84 your comment due to technical difficulties and cannot contact you for clarification, EPA may not 

85 be able to consider your comment. Electronic files should avoid the use of special characters, 

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

87 Docket: All documents in the docket are listed in the docket index available at 
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88 http://www.regulations.gov. Although listed in the index, some information is not publicly 

89 available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other 

90 material, such as copyrighted material, will be publicly available only in hard copy. Publicly 

91 available docket materials are available electronically at http://www.regulations.gov, or, if only 

92 available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 

93 Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, 

94 DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 

95 through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading 

96 Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. 

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

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

99 subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in 

100 the building and returned upon departure. 

101 FOR FURTHER INFORMATION CONTACT: For technical information regarding the 

102 SNUR contact: John Bowser, Chemical Control Division, Office of Pollution Prevention and 

103 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

104 20460–0001; telephone number: 202-564-8082; e-mail addresses: bowser.john@epa.gov. 

105 For technical information regarding the test rule contact: Catherine Roman, Chemical Control 

106 Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 

107 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 202-564-8708; e108 mail addresses: roman.catherine@epa.gov.

109 For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., 

110 Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: TSCA111 Hotline@epa.gov. 

112 SUPPLEMENTARY INFORMATION:

113 I. General Information 

114 A. Does this Action Apply to Me? 

115 You may be affected by this action if you manufacture or process tetraBDE, pentaBDE, 

116 hexaBDE, heptaBDE, octaBDE, nonaBDE, or decaBDE, or intend to, including as part of a 

117 mixture or article. TSCA defines manufacture to include import. Unless otherwise noted in this 

118 preamble, use of the term “manufacture” includes import. Manufacturers and processors in 

119 certain industries to whom this action may apply include, but are not limited to: 

120 • Manufacturers and processors of subject chemical substances and mixtures with North 

121 American Industry Classification System (NAICS) codes 325 and 324110,, e.g., chemical 

122 manufacturing and petroleum refineries. 

123 • textile manufacturers and processors (NAICS codes 313, 314, and 315), 

124 • furniture manufacturers (NAICS code 337), 
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125 • manufacturers and processors of polyurethane foam (NAICS code 326150), 

126 • manufacturers of high impact polystyrene (HIPS) and acrylonitrile-butadiene-styrene (ABS) 

127 plastics (NAICS codes 325, 326140, and 3261), and 

128 • manufacturers of electronics equipment (NAICS codes 334 and 335). 

129 This listing is not intended to be exhaustive, but rather provides a guide for readers 

130 regarding entities likely to be affected by this action. Other types of entities not listed in this unit 

131 could also be affected. The North American Industrial Classification System (NAICS) codes 

132 have been provided to assist you and others in determining whether this action might apply to 

133 certain entities. If you have any questions regarding the applicability of this action to a particular 

134 entity, consult the technical person listed under FOR FURTHER INFORMATION 

135 CONTACT. 

136 This action may also affect certain entities through pre-existing import certification and 

137 export notification rules under TSCA. Persons who import any chemical substance identified in 

138 a final SNUR are subject to the TSCA section 13 import requirements, codified at 19 CFR 

139 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of 

140 the chemical substance complies with all applicable rules and orders under TSCA, including any 

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

142 707, subpart B. In addition, any persons who export or intend to export a chemical substance 

143 that is the subject of the proposed SNUR on or after [insert date 30 days after the date of 

144 publication in the Federal Register] are subject to the export notification provisions of TSCA 

145 section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must comply with the export 

146 notification requirements in 40 CFR part 707, subpart D. Persons who export or intend to export 

147 a chemical substance or mixture identified in the proposed test rule will be subject to the export 

148 notification provisions of TSCA section 12(b) if the test rule is finalized. However, persons who 

149 export or intend to export articles containing chemical substances or mixtures subject to a final 

150 test rule would not be required to submit notice of export. 

151 

152 B. What Should I Consider as I Prepare My Comments for EPA? 

153 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e154 mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI 

155 information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD156 ROM as CBI and then identify electronically within the disk or CD-ROM the specific 

157 information that is claimed as CBI. In addition to one complete version of the comment that 

158 includes information claimed as CBI, a copy of the comment that does not contain the 

159 information claimed as CBI must be submitted for inclusion in the public docket. Information so 

160 marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 

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

162 i. Identify the document by docket ID number and other identifying information (subject 

163 heading, Federal Register date and page number). 

164 ii. Follow directions. The Agency may ask you to respond to specific questions or 
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165 organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 

166 iii. Explain why you agree or disagree; suggest alternatives and substitute language for 

167 your requested changes. 

168 iv. Describe any assumptions and provide any technical information and/or data that you 

169 used. 

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

171 sufficient detail to allow for it to be reproduced. 

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

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

174 threats. 

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

176 II. Background 

177 A. What Action is the Agency Taking? 

178 The Agency is proposing to amend the SNUR at 40 CFR section 721.10000 (Ref. 1) that 

179 requires any person who intends to manufacture or import tetraBDE, pentaBDE, hexaBDE, 

180 heptaBDE, octaBDE, or nonaBDE, or any combination of these chemical substances that results 

181 from a chemical reaction, for any use on or after January 1, 2005, to notify EPA at least 90 days 

182 in advance. EPA is proposing to amend the SNUR by: (1) designating processing of any of the 

183 six PBDEs after December 31, 2012 for any use a significant new use, (2) designating 

184 manufacturing, importing, and processing of a seventh PBDE, decabromodiphenyl ether 

185 (decaBDE) (CAS No. 1163-19-5) for any use except military and transportation uses after 

186 December 31, 2012, and manufacture and processing of decaBDE for any use including military 

187 and transportation after December 31, 2013, as significant new uses, and (3) making inapplicable 

188 the article exemption at 721.45(f). A person that imports or processes any of the chemical 

189 substances identified in the proposed SNUR as part of an article would not be exempt from the 

190 significant new use notification requirements. No person would be able to begin manufacturing, 

191 importing, or processing any of the chemical substances identified in the proposed SNUR for a 

192 significant new use without first submitting a significant new use notification (SNUN) to EPA. 

193 

194 In this notice EPA is also proposing to issue a test rule under section 4(a) of the TSCA 

195 that would require any person who manufactures, imports, or processes c-pentaBDE or c196 octaBDE including in articles for any use after December 31, 2012; or manufactures, imports, or 

197 processes c-decaBDE for any use except military and transportation uses including in articles 

198 after December 31, 2012; or manufactures, imports, or processes c-decaBDE for any use, 

199 including military and transportation uses, including in articles, after December 31, 2013 to 

200 conduct testing of such commercial PBDE mixtures to obtain data on health effects, 

201 environmental effects, and chemical fate in accordance with the test rule. Hereafter, Dec 31, 

202 2012 and December 31, 2013, will be referred to as the relevant effective dates; see 799.xxxx(k). 

203 The proposed test rule specifies that testing of c-pentaBDE, c-octaBDE, and c-decaBDE be 
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204 conducted on representative forms of the relevant commercial mixtures. The commercial 

205 mixture, c-pentaBDE, typically contains tetraBDE, pentaBDE and hexaBDE as the predominant 

206 components; the commercial mixture, c-octaBDE, typically contains hexaBDE, heptaBDE, 

207 octaBDE and nonaBDE as the predominant components; and the commercial mixture, c208 decaBDE, typically contains decaBDE in the highest percent composition. 

209 

210 If EPA finds that the proposed significant new uses have not ceased by the specified 

211 dates, EPA will promulgate a final test rule to require persons who manufacture or process c212 pentaBDE, c-octaBDE, or c-decaBDE to conduct testing to obtain data on health effects, 

213 environmental effects, and chemical fate of those mixtures. The required testing would provide 

214 EPA with data necessary to determine the effects on health and the environment if the 

215 manufacture and processing of those mixtures and the associated use, distribution in commerce 

216 and disposal are not discontinued. 

217 

218 EPA is seeking public comment on both the proposed SNUR and test rule. Comments 

219 may address any aspect of the actions being proposed today. Unit XI of this notice contains a list 

220 of specific issues for which the Agency is seeking comment. The actions EPA is proposing 

221 today are generally described in the PBDE Action Plan released December 30, 2009 

222 (www.epa.gov/oppt/existingchemicals/pubs/actionplans/pbde.html). 

223 

224 

225 B. Why is the Agency Taking this Action? 

226 

227 

228 

229 EPA is concerned about the effects PBDEs may have on human health and the 

230 environment. As discussed in Unit III and the PBDE Action Plan (Ref. 66), there is evidence that 

231 PBDEs may be toxic to both humans and wildlife. PBDEs have been found in human tissue, 

232 wildlife and the environment. However, there is insufficient data to fully evaluate the 

233 significance of observed exposures. 

234 

235 EPA is also concerned that the PBDEs included in these proposed actions are highly 

236 persistent in the environment. Some lower brominated PBDEs are both toxic and highly 

237 bioaccumulative. Other, more highly brominated forms such as decaBDE may debrominate to 

238 the more toxic and bioaccumulative lower brominated forms. However, the overall impact of 

239 debromination of decaBDE as a source of the lower brominated PBDE congeners in the 

240 environment has not been fully characterized. DecaBDE has been found at high levels in 

241 predators such as peregrine falcons. The environmental significance of such accumulations of 

242 decaBDE has not been fully characterized. The exact mechanisms or pathways by which the 

243 PBDEs move into and through the environment and allow humans and wildlife to become 

244 exposed are not fully understood. The data produced by some of the tests included in the 

245 proposed test rule would be necessary to determine the effects on the environment if manufacture 

246 and processing of c-pentaBDE, c-octaBDE, and c-decaBDE and their associated use, distribution 

247 in commerce and disposal are not discontinued. 

248 

249 In December 2009, EPA received voluntary commitments from the principal 

250 manufacturers and importer of c-decaBDE to phase out manufacture and import for all uses by 
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251 December 31, 2013. The phase out of decaBDE will be accomplished in two steps. No later 

252 than December 31, 2012, the manufacturers and the importer of c-decaBDE would cease 

253 manufacture and import for all uses, including in articles, with the exception of military and 

254 transportation uses. No later than December 31, 2013, they would cease manufacture and import 

255 for all uses including military and transportation uses, including in articles. The principal 

256 manufacturers and importer of c-decaBDE stated that the additional time required for phasing 

257 out military and transportation uses was due to the stringent engineering requirements and risks 

258 associated with these applications as well as the multiple levels of testing and certification 

259 required for such product changes. EPA believes these activities will cease by the specified 

260 dates and is proposing to use its authority under section 5 of TSCA to designate them as 

261 significant new uses. Once an activity has been determined, by rule, to be a significant new use, 

262 persons may not manufacture or process the chemical substance for that activity without first 

263 submitting a significant new use notice (SNUN) to EPA. The Agency would then have an 

264 opportunity to review and if necessary take action to restrict or prohibit the new use. 

265 

266 C. Why is EPA Proposing both a SNUR and a Test Rule?

267 EPA has found no evidence of manufacture or processing of c-pentaBDE or c-octaBDE 

268 except as impurities. The principal manufacturers and importer of c-decaBDE have informed the 

269 Agency that they intend to phase out manufacture and import of the chemical no later than 

270 December 31, 2013. EPA believes that other manufacturers and importers of decaBDE will also 

271 cease their activities by that date. EPA is proposing to amend the SNUR to ensure that after 

272 these activities have been discontinued, no one resumes them without notifying EPA in advance, 

273 thereby providing EPA with an opportunity to review the new uses before they commence. 

274 Before promulgating the amended SNUR, EPA will verify through comments on this action, or 

275 by other means, that the proposed significant new uses have ceased. EPA seeks comment on 

276 whether anyone intends to import or process articles containing pentaBDE, octaBDE, or 

277 decaBDE except as impurities for any of the proposed significant new uses. 

278 

279 In the event that the activities proposed as significant new uses of pentaBDE, octaBDE, 

280 or decaBDE do not cease by the projected dates, EPA is proposing a test rule to obtain 

281 information to assess the effects on humans and the environment of the continued manufacture 

282 and processing of c-pentaBDE, c-octaBDE, and c-decaBDE and the associated use, distribution 

283 in commerce and disposal. 

284 

285 D. Why does the proposed test rule include three commercial PBDE mixtures while the SNUR 

286 includes seven PBDE congeners?

287 

288 The test rule is designed to provide the Agency with data relevant to commercial PBDE 

289 products actually in use or intended for use. There are three commercial PBDE products: c290 pentaBDE, c-octaBDE, and c-decaBDE. The test rule proposes that testing be conducted on a 

291 representative form of each commercial mixture to better understand their potential effects on 

292 health and the environment. Some of the data obtained by the test rule would address unmet data 

293 needs identified by EPA through the Voluntary Children’s Chemical Evaluation Program 

294 (VCCEP). All three of the commercial PBDE products are mixtures, but have different 

295 predominant components. Other PBDE congeners may be present in the mixtures in lesser 

296 amounts. 
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297 

298 The SNUR is designed to provide the Agency with advance notice of manufacture or 

299 processing of any one or any combination of the seven PBDEs for a significant new use. Since 

300 the composition of any future commercial PBDE products may vary in terms of congener 

301 composition, the Agency determined that it would be more effective to include all seven of the 

302 individual PBDE congeners in the SNUR. Thus, all congeners in any future commercial PBDE 

303 product would be subject to the SNUR reporting requirements. 

304 

305 E. Will EPA Promulgate both the SNUR and the Test Rule?

306 

307 EPA expects that the manufacture and processing of the c-PBDEs identified in this 

308 proposed action, except as impurities, including these c-PBDEs when contained in articles, will 

309 have been discontinued by the dates indicated in the proposed amendments to the SNUR. EPA 

310 intends to promulgate amendments to the SNUR designating manufacture and processing for any 

311 use, including discontinued uses, as a significant new use. 

312 

313 If EPA were to learn through comments on the proposed amendments to the SNUR or 

314 test rule, or through other means, that a person who would be subject to the test rule intended to 

315 continue, resume, or commence manufacture or processing of c-pentaBDE, c-octaBDE, or c316 decaBDE after the relevant dates specified in the proposed test rule in 799.xxxx(k), EPA would 

317 promulgate the test rule. However, if EPA were to learn that the only persons that would be 

318 subject to the test rule would be persons that process c-pentaBDE, c-octaBDE, or c-decaBDE as 

319 impurities contained in articles, EPA would not require testing because EPA has not determined 

320 whether this activity alone may present an unreasonable risk of injury to health or the 

321 environment. 

322 

323 EPA could promulgate both the test rule the SNUR for the corresponding PDBE 

324 congeners, i.e., pentaBDE, octaBDE, and decaBDE. If a person indicates his intention to 

325 continue to engage in an activity proposed as a significant new use for pentaBDE, octaBDE, or 

326 decaBDE, EPA intends to promulgate the proposed amendments to the SNUR designating all 

327 other uses of that PBDE as significant new uses, but would exclude the ongoing use from the 

328 SNUR. In that situation, EPA would also promulgate the test rule. Persons that manufacture or 

329 process that PBDE for the ongoing use after the dates specified in the test rule would be subject 

330 to the test rule. 

331 

332 F. What is the Agency's Authority for Taking this Action? 

333 

334 1. Significant New Use Rules (SNURs). Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) 

335 authorizes EPA to determine that a use of a chemical substance is a "significant new use." EPA 

336 must make this determination by rule after considering all relevant factors, including those listed 

337 in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a 

338 significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use 

339 notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical 

340 substance for that use (15 U.S.C. 2604(a)(1)(B)). 

341 

342 2. Test Rule. TSCA section 4(a)(1)(A) (15 U.S.C. 2603(a)(1)(A)) directs EPA to require 

343 by rule that manufacturers and/or processors of chemical substances and mixtures conduct 
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344 testing, if the EPA Administrator finds that:

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

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

347 environment, 

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

349 commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on 

350 health or the environment can reasonably be determined or predicted, and 

351 (iii) testing of such substance or mixture with respect to such effects is necessary to develop such data [.]

352 

353 Once the EPA Administrator has made a finding under TSCA section 4(a)(1)(A), EPA 

354 may require any type of health or environmental effects testing necessary to address unanswered 

355 questions about the effects of the chemical substance or mixture that are relevant to whether the 

356 manufacture, distribution in commerce, processing, use, or disposal of the chemical substance or 

357 mixture, or any combination of such activities, presents an unreasonable risk of injury to health 

358 or the environment. EPA need not limit the scope of testing required to the factual basis for the 

359 TSCA section 4(a)(1)(A)(i) findings. This approach is explained in more detail in EPA’s TSCA 

360 section 4(a)(1)(B) Final Statement of Policy (B Policy) (Ref. 2). 

361 In this proposed test rule, EPA would use its TSCA section 4(a) authority to obtain data 

362 necessary to determine whether the manufacture, processing, distribution in commerce, use, or 

363 disposal of any or all of the three commercial PBDE mixtures, i.e., c-pentaBDE, c-octaBDE, and 

364 c-decaBDE, present an unreasonable risk of injury to health or the environment. 

365 

366 EPA is also proposing to use its authority under TSCA section 12(a)(2) to require testing 

367 of mixtures named in this proposed test rule which would otherwise be exempted from TSCA 

368 under 12(a)(1). TSCA 12(a)(1) exempts from TSCA the manufacture, processing, or distribution 

369 in commerce of a mixture for export from the United States in certain situations. Such testing 

370 would be for the purpose of determining whether or not the mixture presents an unreasonable 

371 risk of injury to health within the United States or to the environment of the United States 

372 

373 G. Applicability of General Provisions. 

374 

375 1. SNUR. General provisions for SNURs appear under 40 CFR part 721, subpart A. 

376 These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to 

377 reporting requirements, and applicability of the rule to uses occurring before the effective date of 

378 the final rule. However, part 721.45(f) would not apply to this proposed SNUR. A person who 

379 imports or processes a chemical substance that would be covered by this action as part of an 

380 article would not be exempt from submitting a significant new use notice. A person who 

381 manufactures or processes a PBDE only as an impurity would be exempt from the SNUR under 

382 part 721.45(d). 

383 

384 Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 

385 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA 

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

387 5(a)(1)(A). In particular, these requirements include the information submissions requirements 

388 of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 
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389 (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA 

390 may take regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the activities on 

391 which it has received the SNUN. If EPA does not take action, EPA is required under TSCA 

392 section 5(g) to explain in the Federal Register its reasons for not taking action. 

393 

394 Persons who export or intend to export a chemical substance identified in a proposed or 

395 final SNUR are subject to the export notification provisions of TSCA section 12(b). The article 

396 exemption at 40 CFR part 707.60(b) would apply to this rule. Persons who export or intend to 

397 export articles containing chemical substances subject to this proposed rule would not be 

398 required to submit notice of export. The regulations that interpret TSCA section 12(b) appear at 

399 40 CFR part 707, subpart D. Also, see Unit VII. 

400 

401 Persons who import a chemical substance identified in a final SNUR are subject to the 

402 TSCA section 13 import requirements, codified at 19 CFR 12.118 through 12.127; see also 19 

403 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies 

404 with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA 

405 policy in support of import certification appears at 40 CFR part 707, subpart B. Also, see Unit 

406 VIII. 

407 

408 2. Test Rule. General provisions for test rules appear under 40 CFR part 790 (subparts A, 

409 B, C, and E), part 791, part 792, and part 799 (subpart A). These provisions describe persons 

410 subject to the rule, procedures for developing test rules, implementation, enforcement, and 

411 modification of test rules, exemption from testing, data reimbursement, and good laboratory 

412 practice standards. Section 791.48(b) would not apply to this proposed test rule for the purpose 

413 of defining production volume to determine fair reimbursement shares. Production volume 

414 would be defined as including amounts of the test chemical imported in bulk form, in mixtures, 

415 in articles, and the total domestic production of the chemical including that produced as a 

416 byproduct or as an impurity. See 799.xxxx(f) of the proposed rule. Also, persons described in 

417 part 790.2 as subject to a test rule include, among others, importers and processors of a chemical 

418 substance or mixture as part of an article. Submission of a SNUN would not affect a person’s 

419 obligations under a test rule.

420 

421 Persons who export or intend to export a chemical substance or mixture identified in a 

422 final test rule are subject to the export notification provisions of TSCA section 12(b). However, 

423 persons who export or intend to export articles containing chemical substances or mixtures 

424 subject to a final test rule would not be required to submit notice of export. The regulations that 

425 interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Also, see Unit VII. 

426 

427 III. Overview of PBDEs

428 

429 A. Chemistry of PBDEs. 

430 

431 The polybrominated diphenyl ethers (PBDEs) are a family of chemicals with a common 

432 structure of a brominated diphenyl ether molecule which may have anywhere from one to ten 

433 bromine atoms attached. (Figure 1). 

434 

435 Figure 1. Brominated diphenyl molecule 
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436 

O

Br x Br y

437 x + y = 4 - 10

438 

439 Each individual PBDE variant, distinguished from others by both the number of bromine 

440 atoms and the placement of those atoms, is referred to as a congener. For example, there are 42 

441 tetrabromodiphenyl ether congeners, each with four bromine atoms in different configurations. 

442 Specific congeners, also known as isomers, in which both the number and location of bromine 

443 atoms is specified are given numbers, e.g., BDE-47. In theory, there could be as many as 209 

444 PBDE congeners, but a much smaller number of congeners are commonly found in the 

445 commercial PBDE products and in measurements of PBDEs in humans and the environment 

446 (Table 1). Scientific studies, particularly those measuring presence of PBDEs in tissues and the 

447 environment, often report their findings by BDE number. 

448 

449 PBDE congeners can be grouped as homologs i.e., according to the number of bromine 

450 atoms present in the molecule. TSCA inventory listings and regulations for PBDEs are based on 

451 these homolog groups. (Table 1). The PBDE homologs used in flame retardants have between 

452 four and ten bromine atoms. EPA regulations of PBDEs generally apply to congeners grouped 

453 according to homolog groups rather than specific congener/isomers designated by BDE number. 

454 

455 There are three types of commercial PBDE (c-PBDE) products, c-pentaBDE, c-octaBDE, 

456 and c-decaBDE; each commercial product is a mixture of PBDE congeners (see Table 2). 

457 

Table 1. PBDE Homolog Groups

Common Name CAS Index Name CASRN Number 

Br atoms 

TetraBDE Benzene, 1,1'-oxybis-, tetrabromo derivative 40088-47-9 4 

PentaBDE Benzene, 1,1'-oxybis-, pentabromo derivative 32534-81-9 5 

HexaBDE Benzene, 1,1'-oxybis-, hexabromo derivative 36483-60-0 6 

HeptaBDE Benzene, 1,1'-oxybis-, heptabromo derivative 68928-80-3 7 

OctaBDE Benzene, 1,1'-oxybis-, octabromo derivative 32536-52-0 8 

NonaBDE Benzene, 1,1’-oxybis-, nonabromo derivative 63936-56-1 9 

DecaBDE. Benzene, 1,1'-oxybis[2,3,4,5,6-pentabromo- 1163-19-5 10 

458 

Table 2. Congeners In Commercial PBDE Mixtures

Commercial Mixture Major components Minor components 

c-pentaBDE tetraBDE 

pentaBDE 

hexaBDE 

c-octaBDE heptaBDE 

octaBDE 

hexaBDE 

nonaBDE 

decaBDE 

c-decaBDE decaBDE nonaBDE 

459 
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460 B. Actions taken to understand and limit risk from use of PBDEs. 

461 

462 EPA has been concerned about the reported health and environmental effects of PBDEs 

463 and potential exposure to PBDEs for some time, and has taken several actions to fully understand 

464 their effects and to reduce exposure to them. Of particular note are the VCCEP, which was 

465 announced in 2000 (Ref. 65), and the 2006 PBDE SNUR (Ref. 1). 

466 

467 C-PentaBDE, c-octaBDE, and c-decaBDE were among the chemicals evaluated in 

468 VCCEP. That Program was designed to collect health effects information on chemicals to which 

469 children had a high likelihood of being exposed and to characterize the risk to children from that 

470 exposure. Sponsors in VCCEP provided health effects and exposure information on a voluntary 

471 basis. Through VCCEP the Agency identified data needs for all three c-PBDEs that were 

472 beyond what was provided by the sponsors in the initial chemical assessments. The sponsors of 

473 c-pentaBDE and c-octaBDE, however, declined to conduct testing to address the identified data 

474 needs because of plans to discontinue manufacture of these chemicals in 2004. Later the 

475 sponsors of c-decaBDE also declined to conduct testing to provide the data needs identified 

476 through VCCEP and subsequently decided to phase out their activities with c-decaBDE. As a 

477 result, the sponsoring companies did not meet the additional data needs identified through 

478 VCCEP for any of the three c-PBDEs. Tests addressing those data needs are among the tests 

479 proposed for c-pentaBDE, c-octaBDE, and c-decaBDE in this action. 

480 

481 C-pentaBDE and c-octaBDE had been widely used as additive flame retardants in a 

482 number of applications until their sole U.S. manufacturer, the Great Lakes Chemical Corporation 

483 (now Chemtura Corporation) voluntary phased out their production in 2004. C-PentaBDE was 

484 used primarily in flexible polyurethane foams. C-OctaBDE was used in acrylonitrile-butadiene485 styrene (ABS) plastic which was used in applications such as casing for certain electric and 

486 electronic devices used in both offices and homes. . When manufacture of c-pentaBDE and c487 octaBDE was discontinued, EPA promulgated a SNUR (74 FR 34015, June 13, 2006) which 

488 requires that any person who intends to manufacture or import a chemical substance containing 

489 any of the congeners present in c-pentaBDE or c-octaBDE (namely tetraBDE, pentaBDE, 

490 hexaBDE, heptaBDE, octaBDE, and nonaBDE), or any combination of these substances 

491 resulting from a chemical reaction, to notify EPA at least 90 days in advance of manufacture or 

492 import for any use on or after January 1, 2005. The SNUR does not address processing of 

493 PBDEs, nor does it apply to import of articles which contain any of the congeners present in c494 pentaBDE or c-octaBDE. 

495 

496 C-DecaBDE is still manufactured and widely used in the United States as an additive 

497 flame retardant. The three major product categories in which c-decaBDE is used are: textiles, 

498 electronic equipment, and building and construction materials. Its primary use is in high impact 

499 polystyrene (HIPS) based products. However as a result of the voluntary phase-out announced 

500 on December 17, 2009, EPA expects all uses of c-decaBDE except for military and 

501 transportation uses to be discontinued in the United States by December 31, 2012, and all 

502 remaining uses including military and transportation uses to be discontinued by the end of 2013. 

503 Other actions EPA has taken with PBDEs include (1) supporting he inclusion in 

504 voluntary consensus standards of criteria restricting PBDE use as a product component (e.g., in 

505 carpets, electronics, and furniture or use in manufacturing processes, and (2) working with and 
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506 through programs (i.e., Furniture Flame Retardancy Partnership and the Green Suppliers 

507 Network) to identify environmentally safer approaches to meeting fire standards and to improve 

508 awareness of concerns related to PBDEs. 

509 C. Human Health Effects. 

510 

511 In 2008, EPA published peer-reviewed toxicological reviews of tetraBDE (BDE-47), 

512 pentaBDE (BDE-99), hexaBDE (BDE-153), and decaBDE (BDE-209) (Refs. 3-6), to support 

513 summary information on EPA's Integrated Risk Information System (IRIS) database 

514 (www.epa.gov/iris/). Developmental neurotoxicity was identified as the critical effect for each 

515 of the four chemicals. EPA also concluded that the database for decaBDE (BDE-209) provides 

516 “suggestive evidence of carcinogenic potential” (Ref. 6). 

517 

518 Through EPA’s Voluntary Children’s Chemical Evaluation Program (VCCEP), industry519 sponsored screening level risk assessments for c-pentaBDE, c-octaBDE and c-decaBDE were 

520 developed to evaluate the potential risks to children and prospective parents from PBDE 

521 exposures (Ref. 7). Adverse neurobehavioral effects following exposure to PBDEs during the 

522 postnatal period are believed to be the most sensitive health endpoint. Repeated-dose toxicity 

523 studies for c-pentaBDE showed changes in liver enzyme activity, increased liver weight and 

524 histologic changes in liver. Changes in thyroid hormone T4 levels and thyroid hyperplasia were 

525 noted in oral adult rat studies. In limited prenatal developmental studies, decreases in T4 levels 

526 were reported for dams and offspring. The repeated-dose toxicity studies for c-octaBDE showed 

527 changes in liver enzyme activity and increased liver weights. In prenatal developmental studies, 

528 decreased maternal and pup bodyweight and decreases in T4 levels were reported for rat dams 

529 and their offspring. Evidence of developmental and reproductive effects was noted but 

530 additional studies are needed to better characterize potential risks to children (Ref. 48). EPA 

531 through VCCEP identified two-generation reproductive toxicity studies with a satellite group for 

532 body burden determinations as a data need for both c-pentaBDE and c-octaBDE (Ref. 48). Also 

533 through VCCEP, EPA identified anaerobic debromination in aquatic sediments, anaerobic 

534 debromination in sludge digesters, and photolysis in the indoor environment as data needs for c535 decaBDE to better understand the chemical fate and thereby the potential exposure to decaBDE 

536 and lower brominated congeners (Ref. 49). 

537 

538 D. Environmental Hazard. 

539 

540 Laboratory studies have shown that c-pentaBDE is capable of producing adverse effects 

541 in a variety of organisms including birds, mammals, fish, and invertebrates (Refs. 8-19). In some 

542 cases, these effects were observed at exposure levels similar to levels found in the environment 

543 

544 E. Environmental Releases and Fate. 

545 

546 The exact mechanisms or pathways by which the PBDEs move into and through the 

547 environment and allow humans to become exposed are not fully understood, but are likely to 

548 include releases from manufacturing of the chemicals, processing c-PBDEs into products like 

549 plastics or textiles, aging and wear of products like sofas and electronics, and releases at the end 

550 of product life (disposal or recycling). In general, levels of PBDE congeners in humans and the 

551 environment are higher in North America than in other regions of the world, which may be 
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552 attributed to the greater use of c-PBDEs in North America (Ref. 20). The concentration and 

553 distribution of congeners detected in the environment appear to depend on the proximity to a 

554 source of the congener and the media tested. (Ref. 74) 

555 

556 PBDE congeners with four to ten bromine atoms are highly persistent, based on a large 

557 body of environmental monitoring data in both the United States and abroad (Refs 21-23). 

558 Available data also indicate that the tetra-, penta-, hexa- and heptaBDE congeners are highly 

559 bioaccumulative (Ref. 24). After reviewing the available information, EPA has concluded that 

560 decaBDE is a likely contributor to the formation of bioaccumulative and/or potentially 

561 bioaccumulative transformation products, such as lower brominated PBDEs, in organisms and in 

562 the environment see, e.g., (Refs 25-28), but the overall impact of this process as a source of the 

563 more toxic, lower brominated PBDE congeners has not been fully characterized. DecaBDE 

564 undergoes photolytic and possibly microbial debromination under certain conditions (Refs. 22 

565 and 28). Photolysis is expected to be a significant transformation process for decaBDE 

566 whenever the substance is significantly exposed to light. For example, it has been found that 

567 decaBDE undergoes photolytic debromination in house dust (Ref. 29). DecaBDE would also be 

568 exposed to light when waste sludge containing PBDEs is used as a soil amendment, albeit only 

569 on the soil surface (Ref. 30). Studies have shown that photodegradation of decaBDE may result 

570 in PBDEs from tri- to nona-, although most photolysis studies were done under conditions that 

571 do not allow direct extrapolation to environmental conditions. Metabolism of decaBDE in 

572 organisms results predominantly in nona-, octa- and heptaBDE formation (as reviewed in Ref. 

573 22). Stapleton (Ref. 28) summarized the effects of decaBDE debromination, noting that the 

574 formation potential for the pentaBDE and lower congeners was low, but that the formation of the 

575 hepta, octa and nonaBDE congeners was environmentally relevant. 

576 

577 The atmosphere and marine currents can transport PBDEs over relatively long distances 

578 (> 1,000 km). Evidence for this comes from the presence of PBDEs in the tissues of deep ocean579 dwelling whales and other marine mammals far from anthropogenic sources (Ref. 23), as well as 

580 from modeling (Ref. 30). The body burdens of PBDE congeners in a wide variety of biota, 

581 indigenous to geographical areas ranging from the equator to the poles also substantiate the 

582 PBDE propensity for long-range transport (LRT), and constitute evidence of environmental 

583 persistence (Ref. 24).

584 

585 F. Human Exposure. 

586 

587 The use of c-PBDEs as flame retardants in consumer products is believed to be a source 

588 of exposure. Dermal exposure may occur through direct contact with c-PBDE-containing 

589 products such as computer housings and textiles (Ref. 31). The lower brominated tetra- and 

590 penta- congeners have also been detected in the vapor phase of air samples while the higher 

591 brominated congeners are found in associated particulate matter, including house dust (Refs. 32 

592 and 33). Lorber (Ref.33) and EPA (Ref. 31) reported that a significant source of human 

593 exposures to PBDEs appears to be their use in commercial products that are part of the indoor 

594 environment (computer circuitry, foam cushions, fabrics in curtains, etc). They found that 

595 food/water ingestion and inhalation explained less than 20% of the body burden, based upon the 

596 estimate of total exposure derived using a pharmacokinetic model. They stated that the remainder 

597 of the estimated exposure likely came from house dust through the pathways of ingestion and 

598 dermal contact, or some other, unknown source. Other literature indicates that inhalation may be 
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599 a significant potential route of exposure for the general population (Ref. 31). In addition, PBDE 

600 exposure can occur by ingestion of foods that are contaminated (Ref. 35). PBDEs have been 

601 detected in human tissue, blood (usually serum), and breast milk (Ref. 36). Exposures to PBDEs 

602 in some occupational settings, such as in computer recycling, can be higher than those of the 

603 general population (Ref. 37). PBDE use as flame retardants in many household products, and 

604 subsequent exposure to indoor house dust containing PBDEs, coupled with the elevated 

605 ingestion potential due to increased intakes of food, water, and air per pound of body weight, as 

606 well as childhood-specific exposure pathways such as breast milk consumption and increased 

607 contact with the floor, make children especially vulnerable. 

608 

609 Recent human biomonitoring data on PBDEs are available in CDC’s “Fourth National 

610 Report on Human Exposure to Environmental Chemical” (http://www.cdc.gov/exposurereport/). 

611 The PBDE data have also been published in the peer-reviewed literature (Ref. 38). The data 

612 were obtained from samples from participants in the 2003-2004 National Health and Nutrition 

613 Examination Survey (Ref. 39). Ten PBDE congeners (containing from three to seven bromines) 

614 were included in the analysis: BDE-17, BDE-28, BDE-47, BDE-66, BDE-85, BDE-99, BDE615 100, BDE-153, BDE-154 and BDE-183; decaBDE was not included. Participants were aged 12 

616 years and older. BDE-47 was detected in serum from almost all of the participants and it was 

617 highest in 12-19 years old, and those over 59 years old. Furthermore, serum levels were highest 

618 in 12-19 year olds for other lower brominated congeners. In addition, these congeners were 

619 significantly correlated with each other--concentration of individual congeners and total PBDE 

620 content in blood serum steadily increased annually over a five year period, suggesting a similar 

621 pathway of exposure via diet, or via direct inhalation or dermal contact (Ref. 38). 

622 

623 G. Environmental Exposure. 

624 

625 The food chain is likely a large contributor to environmental exposures. In general, 

626 PBDE concentrations are highest in sediment samples collected downstream from 

627 industrial/urban areas, outfalls from sewage treatment plants, and urban locations without heavy 

628 industries. The lowest PBDE concentrations are generally found in sediments collected in 

629 remote and agricultural areas. DecaBDE (BDE-209) appears to dominate congener profiles of 

630 aquatic sediments. Researchers have determined concentrations of PBDEs in waterways, 

631 sediments, and biota from various locations such as the Great Lakes, the San Francisco Bay, and 

632 near unnamed polyurethane foam manufacturing facility for which PBDE contamination was 

633 known or suspected. (Ref. 31) 

634 

635 Some studies show evidence that concentrations of PBDEs in biota have doubled every 3 

636 to 6 years, the doubling time depending on species, life stage, and location. PBDE levels in trout 

637 from the Great Lakes rose from non-detectable in 1975, to approximately 50 nanograms/gram 

638 (ng/g) in 1990, and to approximately 200 ng/gm in 2000 (Ref. 40). PBDE concentrations in 

639 marine biota in North America are the highest in the world, and are increasing (Ref. 23). After 

640 reviewing the available information, EPA has concluded that the extent of accumulation of 

641 congeners in biota is directly related to dietary levels of PBDEs. Observed differences in PBDE 

642 congener profiles in marine mammals from California, Alaska, and the Gulf of Mexico indicate 

643 that diet is a significant source of PBDE exposure in marine wildlife (Ref.23). 

644 

645 DecaBDE has been found at high levels in predators such as peregrine falcons (Ref. 41). 
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646 Biomonitoring studies of wild mink from the Great Lakes region revealed that margins of safety 

647 for mink are small, and that PBDE concentrations in mink from Hamilton Harbor exceeded the 

648 no observed adverse effect concentrations (Ref. 15).

649 

650 Biomagnification is the process in which the concentration of a chemical in an organism 

651 achieves a level that exceeds that in the organism’s diet, due to dietary absorption (Ref. 42). 

652 Biomagnification occurs as predators up the food chain ingest the accumulated PBDEs in the 

653 bodies of their prey (Refs. 23, 43-45). Environment Canada concluded that the greatest potential 

654 risks from PBDEs in the Canadian environment are the secondary poisoning of wildlife from the 

655 consumption of prey containing elevated concentrations of PBDEs, and effects on benthic 

656 organisms that may result from elevated concentrations of certain PBDEs in sediments (Ref. 24). 

657 Biomagnification of PBDEs has been observed in fish; PBDE levels in sediment were directly 

658 related to increases and decreases in the PBDE levels measured in fish (Ref. 46). Environment 

659 Canada concluded that decaBDE is available for uptake in organisms, and may accumulate to 

660 high and potentially problematic levels in certain species such as birds of prey or mammalian 

661 predators (Ref. 22). 

662 

663 Although not conclusive, some data suggests that PBDEs may debrominate in the bodies 

664 of wild birds. Park, et al., (Ref. 40) found that younger peregrine falcons had higher levels of 

665 BDE-209 and other highly brominated congeners, whereas older birds had higher levels of the 

666 less brominated (hexa) BDE-153, which could not be explained by the BDE-153 levels in diet. 

667 Further, in eggs that were collected yearly from the same bird, PBDE congener concentrations 

668 changed yearly, with levels of BDE-209 decreasing, and levels of BDE 153 increasing in the two 

669 last years relative to the former four years (but no such obvious changes in polychlorinated 

670 biphenyl (PCB) levels). The chemical measurements and comparison in this study are valuable 

671 because a similar laboratory study would take many years in similar long-lived avian species 

672 (peregrines live 7-15 years or longer), and environmental variables that affect PBDE uptake and 

673 biomagnifications, including exposure to other chemicals, might be difficult to simulate. Similar 

674 evidence of debromination of decaBDE has been observed in carp (Refs. 28 and 47) and British 

675 starlings (Ref. 47).

676 

677 IV. Proposed Findings 

678 A. SNUR. 

679 Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical 

680 substance is a significant new use must be made after consideration of all relevant factors 

681 including: 

682 

683 • The projected volume of manufacturing and processing of a chemical substance. 

684 

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

686 or the environment to a chemical substance. 

687 

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

689 human beings or the environment to a chemical substance. 

690 
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691 • The reasonably anticipated manner and methods of manufacturing, processing, 

692 distribution, in commerce, and disposal of a chemical substance. 

693 

694 To determine what would constitute a significant new use of PBDEs, EPA also 

695 considered other relevant factors including information about the toxicity of PBDEs as well as 

696 exposures and environmental presence resulting from past use. 

697 

698 As discussed in Unit III, there is evidence that PBDEs may be toxic to humans and 

699 wildlife. However, there is insufficient data to fully evaluate the significance of observed 

700 exposures. EPA is also concerned that the PBDEs included in these proposed amendments to the 

701 SNUR are highly persistent in the environment. Some lower brominated PBDEs are highly 

702 bioaccumulative, and others may debrominate to the lower brominated forms. In general, levels 

703 of PBDEs in humans and the environment are higher in North America than in other regions of 

704 the world, which may be attributed to the greater use of PBDE in North America. Some 

705 monitoring data show a steady increase from non-detectable levels when PBDEs first came into 

706 use to current levels. The exact mechanisms or pathways by which the PBDEs move into and 

707 through the environment and allow humans and wildlife to become exposed are not fully 

708 understood, but are likely to include releases from manufacturing of the chemicals, processing 

709 PBDEs into products like plastics or textiles, aging and wear of products like sofas and 

710 electronics, and releases at the end of product life (disposal or recycling). 

711 

712 Once the manufacture and processing of PBDEs have been discontinued, EPA expects 

713 their presence in humans and the environment to decline over time as has been observed in the 

714 past when production and use of other persistent chemicals has ceased. 

715 

716 EPA is concerned that if manufacture and processing of PBDEs were to resume, the 

717 anticipated decline in levels in humans and the environment will be disrupted as PBDEs are 

718 introduced into the environment at levels greater than would otherwise occur. The result would 

719 be that the magnitude and duration of exposure of humans and the environment in the future 

720 would likely increase. 

721 

722 B. Test Rule. 

723 Based on the data cited in Unit III.C. through III.G. of this preamble, EPA has made the 

724 following preliminary determinations. First, c-pentaBDE, c-octaBDE, and c-decaBDE may 

725 present a hazard to human health. C-pentaBDE, c-octaBDE and c-decaBDE were all reviewed 

726 under EPA’s VCCEP program. Members of the peer consultation panel for c-pentaBDE and c727 octaBDE noted that there are indications of thyroid toxicity in some rodent studies, and thyroid 

728 toxicity can have adverse effects on reproductive success and fetal development (Ref. 48). For 

729 c-decaBDE, VCCEP identified anaerobic debromination in aquatic sediments, anaerobic 

730 debromination in sludge digesters, and photolysis in the indoor environment as a potential source 

731 of human and environmental exposure to lower brominated congeners (Ref. 49). Debromination 

732 of decaBDE to form lower brominated, more toxic congeners is potentially relevant to effects on 

733 both human health and the environment. EPA’s IRIS database indicates that neurobehavioral 

734 effects are critical endpoints of concern for components of c-pentaBDE and c-decaBDE. EPA 

735 has also concluded that there is suggestive evidence of carcinogenic potential for decaBDE 

736 (BDE-209), which is the main component of c-decaBDE. 
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737 Second, c-pentaBDE and c-decaBDE may present a hazard to the environment. 

738 Laboratory studies have shown that c-pentaBDE is capable of producing adverse effects in a 

739 variety of organisms including birds, mammals, fish, and invertebrates. In some cases these 

740 effects were observed at exposure levels similar to levels found in the environment. C-decaBDE 

741 may contribute to these levels by debrominating to lower, more toxic brominated congeners in 

742 the environment. 

743 Third, pentaBDE, octaBDE, and decaBDE congeners, which are among the predominant 

744 components of c-pentaBDE, c-octaBDE, and c-decaBDE respectively, are ubiquitous in soil, 

745 sediments and living organisms (Ref. 50). PentaBDE, octaBDE, and decaBDE congeners have 

746 been found in human tissue, blood and breast milk (Ref. 51). These chemicals persist in the 

747 environment and accumulate in organisms that ingest or inhale them. For example, high levels 

748 of decaBDE have been found in high trophic level animals, e.g., predatory animals such as the 

749 peregrine falcon. However, the predominant congeners present in living organisms tend to be 

750 the lower brominated, more toxic forms, which include pentaBDE (Refs. 52 and 53). Infants and 

751 children, as well as people who are occupationally exposed, may be exposed at higher levels than 

752 the general public. 

753 Based on the evidence of human and environmental exposure to pentaBDE, octaBDE, 

754 and decaBDE congeners, which derive from c-pentaBDE, c-octaBDE, and c-decaBDE, coupled 

755 with the evidence of human and/or environmental hazard of c-pentaBDE, c-octaBDE, and c756 decaBDE, EPA preliminarily finds under TSCA section 4(a)(1)(A)(i) that the manufacture, 

757 processing, distribution in commerce, use, and disposal of c-pentaBDE, c-octaBDE, and c758 decaBDE, or any combination of such activities, may present an unreasonable risk of injury to 

759 human health and the environment. 

760 

761 Through the testing of c-pentaBDE and c-octaBDE in VCCEP, EPA identified two762 generation reproductive toxicity studies with a satellite group for body burden determinations as 

763 a data need for c-pentaBDE and c-octaBDE (Ref. 48). For c-decaBDE, VCCEP identified 

764 anaerobic debromination in aquatic sediments, anaerobic debromination in sludge digesters, and 

765 photolysis in the indoor environment as data needs (Ref. 49). Therefore, EPA also preliminarily 

766 finds under TSCA section 4(a)(1)(A)(ii) that there are insufficient data upon which the effects of 

767 such manufacture, processing, distribution in commerce, use, and disposal of c-pentaBDE, c768 octaBDE, and c-decaBDE, or any combination of such activities, on health or the environment 

769 can reasonably be determined or predicted. Under TSCA section 4(a)(1)(A)(iii), EPA 

770 preliminarily finds that testing of c-pentaBDE, c-octaBDE, and c-decaBDE with respect to these 

771 and other toxic effects is necessary to develop such data. 

772 

773 EPA has determined in accordance with section 4(a)(2) of TSCA that the effects of the 

774 mixtures, c-pentaBDE, c-octaBDE, and c-decaBDE, may be reasonably and more efficiently 

775 determined by testing the commercial products themselves rather than the individual chemical 

776 substances which comprise these mixtures. EPA believes that testing of the individual chemical 

777 substances that are present in the commercial mixtures at different percentages would be a less 

778 efficient mechanism to determine the effects of the commercial mixtures than testing of 

779 representative forms of commercial products as they are manufactured. 

780 
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781 V. Proposed Amendments to the SNUR 

782 A. Summary of proposed amendments to the SNUR. 

783 This proposed rule would amend the significant new use rule at 40 CFR part 721.10000. 

784 Under the existing SNUR, any person who intends to manufacture certain PBDEs must notify 

785 EPA at least 90 days before commencing the manufacture of any one or more of those chemical 

786 substances after January 1, 2005 for any use. The following chemicals substances are subject to 

787 reporting under the existing SNUR: tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, and 

788 nonaBDE, or any combination of these substances resulting from a chemical reaction. 

789 

790 Among other activities, the use of a PBDE in the manufacture of an article is considered 

791 processing of the PBDE. In the existing SNUR, the Agency did not designate processing of the 

792 subject PBDEs as a significant new use because it believed that such activities were ongoing. 

793 The Agency now believes that processing of these chemical substances has been discontinued 

794 and therefore is proposing to amend the SNUR to include processing as a significant new use. 

795 EPA believes that resumption of the practice of processing PBDEs would increase exposure to 

796 PBDEs and releases of PBDEs to the environment. 

797 

798 On December 19, 2009 the principle U.S. manufacturers and importers of decaBDE 

799 committed to end production, and importation of decaBDE in the United States for all uses 

800 except military uses and transportation uses by December 31, 2012, and for all uses including 

801 military and transportation uses by the end of 2013. The Agency also expects all other 

802 manufacturers to discontinue manufacture and use of decaBDE by the end of 2013. Therefore, 

803 the Agency is proposing to amend the SNUR by adding decaBDE to the list of chemicals subject 

804 to reporting and by designating manufacture and processing of decaBDE for any use except 

805 military and transportation use after December 31, 2012 a significant new use. The Agency is 

806 proposing to designate manufacture and processing of decaBDE for any use, including military 

807 and transportation uses, after December 31, 2013, a significant new use. Military use means use 

808 by the armed forces of the United States, or preparation of an article for use by the armed forces 

809 of the United States. Transportation use means preparation of an article for use as an integral 

810 component of a moving vehicle such as a car, truck, train, ship, or aircraft. 

811 

812 EPA’s immediate objective in proposing these amendments to the PBDE SNUR is to 

813 enable the Agency to review and, if necessary, limit or prohibit resumption of any activities 

814 which could result in increasing the amount of PBDEs in commerce in the United States. 

815 

816 Under the general SNUR exemption provisions at 40 CFR 721.45, a person that imports 

817 or processes a substance covered by a SNUR identified in subpart E of part 721 is not generally 

818 subject to the notification requirements of § 721.25 for that substance, if the person imports or 

819 processes the substance as part of an article. However, EPA is concerned that if PBDEs 

820 contained in articles are exempt, they could be imported without a notification and thereby 

821 increase the amount of PBDEs in commerce in the United States without a review by EPA. 

822 Therefore, the Agency is proposing that the article exemption at § 721.45(f) not apply to this 

823 action. 

824 

825 
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826 B. Alternatives to the Significant New Use Rule. 

827 Before proposing these amendments to the PBDE SNUR, EPA considered the following 

828 alternative regulatory actions: 

829 

830 1. Promulgate a TSCA section 8(a) reporting rule. Under a TSCA section 8(a) rule, 

831 EPA could, among other things, generally require persons to report information to the Agency 

832 when they intend to manufacture or process a listed chemical for a specific use or any use. 

833 However, for polybrominated diphenyl ethers the use of TSCA section 8(a) rather than SNUR 

834 authority would have several limitations. First, if EPA was to require reporting under TSCA 

835 section 8(a) instead of TSCA section 5(a), EPA would not have the opportunity to review human 

836 and environmental hazards and exposures associated with the proposed significant new uses and, 

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

838 prohibit or limit the activity before it begins. In view of the level of health and environmental 

839 concerns about the chemicals subject to this proposed rule, if they were used for the proposed 

840 significant new uses, EPA believes that a TSCA section 8(a) rule for this substance would not 

841 meet EPA's regulatory objectives. 

842 

843 2. Regulate under TSCA section 6. EPA may regulate under TSCA section 6 if "the 

844 Administrator finds that there is a reasonable basis to conclude that the manufacture, processing, 

845 distribution in commerce, use or disposal of a chemical substance or mixture “ . . presents or will 

846 present an unreasonable risk of injury to health or the environment." (TSCA section 6(a)). 

847 Given that the chemicals named in this proposed rule are no longer being manufactured or 

848 processed for the proposed significant new uses, or the activities are scheduled to be 

849 discontinued, EPA concluded that risk management action under TSCA section 6 is not 

850 necessary at this time. These proposed amendments to the SNUR would allow the Agency to 

851 address the potential risks associated with the proposed significant new use. If the manufacture 

852 and processing of pentaBDE or octaBDE, including in articles, resumes after December 12, 

853 2012, or if the manufacture and processing of decaBDE, including in articles, does not cease as 

854 anticipated, EPA is proposing to require that persons engaging in those activities conduct testing 

855 in accordance with the proposed test rule which accompanies these proposed amendments to the 

856 SNUR. The Agency may pursue additional regulatory action as appropriate. 

857 

858 C. Applicability of the Significant New Use Rule to Uses Occurring before the Effective Date of 

859 the Final Rule

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

861 that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant 

862 new use as of the date of publication of the proposed rule rather than as of the effective date of 

863 the final rule. If uses begun after publication of the proposed rule were considered ongoing rather 

864 than new, it would be difficult for EPA to establish SNUR notice requirements, because a person 

865 could defeat the SNUR by initiating the proposed significant new use before the rule became 

866 final, and then argue that the use was ongoing as of the effective date of the final rule. EPA has 

867 decided that a similar interpretation is appropriate for a SNUR that is premised in part on all uses 

868 ceasing between proposal and promulgation of a final rule. Thus, persons who begin commercial 

869 manufacture or processing of the chemical substance(s), or articles containing those chemical 

870 substances that would be regulated through this proposed rule, if finalized, would have to cease 
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871 any such activity before the effective date of the rule if and when finalized. This applies to all 

872 entities that do not currently engage in these activities; it does not apply to entities that are 

873 currently engaged in these activities -- i.e., the entities EPA expects to terminate such activities 

874 by the proposed significant new use dates of the SNUR. To resume their activities, these 

875 persons would have to comply with all applicable SNUR notice requirements and wait until the 

876 notice review period, including all extensions, expires. EPA has promulgated provisions to 

877 allow persons to comply with this SNUR before the effective date. If a person were to meet the 

878 conditions of advance compliance under section 721.45(h), that person would be considered to 

879 have met the requirements of the final SNUR for those activities. 

880 

881 D. Test Data and Other Information

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

883 particular test data before submission of a SNUN, however EPA is also proposing a test rule for 

884 pentaBDE, octaBDE, and decaBDE under TSCA section 4(a). If a chemical is subject to a test 

885 rule, persons submitting a significant new use notice are required to comply with data 

886 submission requirements under TSCA 5(b)(1). In the absence of a test rule or a section 5(b)(4) 

887 rule (see section 5(b)(2)) covering the chemical substance, persons are required to submit test 

888 data in their possession or control and to describe any other data known to or reasonably 

889 ascertainable by them (see section 720.50). As a general matter, EPA recommends that SNUN 

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

891 substance during its manufacture, processing, or use. EPA encourages persons to consult with 

892 the Agency before submitting a SNUN. As part of this optional pre-notice consultation, EPA 

893 would discuss specific data it believes may be useful in evaluating a significant new use. 

894 SNUNs submitted for significant new uses without any test data may increase the likelihood that 

895 EPA will take action under TSCA section 5(e) to prohibit or limit activities associated with this 

896 chemical. 

897 

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

899 provide detailed information on: 

900 

901 1. Human exposure and environmental releases that may result from the significant new 

902 uses of the chemical substance. 

903 2. Potential benefits of the chemical substance. 

904 3. Information on risks posed by the chemical substances resulting from the significant new 

905 use compared to risks posed by potential substitutes. 

906 

907 E. SNUN Submissions.

908 EPA recommends that submitters consult with the Agency prior to submitting a SNUN to 

909 discuss what data may be useful in evaluating a significant new use. Discussions with the 

910 Agency prior to submission can afford ample time to conduct any tests that might be helpful in 

911 evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a 

912 SNUN must comply with the same notice requirements and EPA regulatory procedures as 

913 persons submitting a PMN, including submission of test data on health and environmental effects 

914 as described in 40 CFR 720.50. 

915 
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916 SNUNs must be mailed to the Environmental Protection Agency, OPPT Document 

917 Control Office (7407M), 1200 Pennsylvania Avenue, NW., Washington, D.C. 20460-0001. 

918 Information must be submitted in the form and manner set forth in EPA Form No. 7710-25. This 

919 form is available from the Environmental Assistance Division (7408M), 1200 Pennsylvania 

920 Avenue, NW., Washington, D.C. 20460-0001 (see 40 CFR 721.25 and 720.40). Forms and 

921 information are also available electronically at 

922 http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm. 

923 VI. Proposed Test Rule 

924 A. What Testing is Being Proposed in this Action? 

925 EPA is proposing specific testing and reporting requirements for c-pentaBDE, c926 octaBDE, and c-decaBDE. These requirements are presented in Table 3 of this unit. 

927 Table 3: Proposed Testing and Reporting Requirements for PentaBDE, OctaBDE, and DecaBDE 

Proposed Test Proposed Test 

Guideline 

Test Proposed for: Deadline for 

submitting 

final report 

(Number of 

months 

after the 

relevant 

effective 

date in 

799.xxxx(k))

cpenta 

BDE 

cocta 

BDE

cdeca 

BDE 

Toxicity to freshwater 

invertebrates of sedimentassociated contaminants 

ASTM E 1706-05e1 

and ASTM E 1391-

031

 X X X 12 

Laboratory soil toxicity and 

bioaccumulation tests with 

the lumbricid earthworm 

Eisenia fetidaand the 

enchytraeid potworm 

Enchytraeus albidu 

ASTM E 1676-04 

and ASTM E 1391-

032

 X X X 12 

Toxicity to polychaetous 

annilids of sedimentassociated contaminants 

ASTM E 1611-00 

and ASTM E 1391-

031

 X X X 12 

Laboratory soil toxicity to 

nematode Caenorhabditis 

elegans 

ASTM E 2172-01 

and ASTM E 1391-

032

 X X X 12 
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Toxicity to estuarine and 

marine invertebrates of 

sediment-associated 

contaminants 

ASTM E 1367-03, 

ASTM E 1676-043

and ASTM E 1391-

031

 X X X 12 

Prenatal developmental 

toxicity in rabbits 

40 CFR 799.9370 X X X 12 

Two-generation 

reproductive toxicity with 

satellite group for body 

burden determinations 

40 CFR 799.9380 X X X 29 

Immunotoxicity 40 CFR 799.9780 X X X 12 

Neurotoxicity screening 

battery, acute and 

subchronic 

40 CFR 799.9620 X X X 21 

Developmental 

neurotoxicity 

40 CFR 799.9630 X X X4 21 

Chronic 

toxicity/Carcinogenicity 

40 CFR 799.9430 X X 60 

Anaerobic aquatic 

metabolism 

799.XXXX(i)(2) 

(modified 835.4400) 

 X 60 

Biodegradation in 

Anaerobic Digester Sludge 

799.XXXX(i)(3) 

(modified 835.3280) 

 X 24 

Photolytic degradation in 

the indoor environment 

799.XXXX(i)(4) X 24 

928 1. ASTM E 1391-03 provides guidance on the collection, storage, characterization, and manipulation of sediments 

929 when toxicity to various organisms of sediment-associated contaminants is tested. 

930 2. ASTM E 1391-03 provides general guidance. 

931 3. ASTM E 1676-04 provides guidance for collecting laboratory soil. 

932 4. A developmental neurotoxicity study of decaBDE (Ref. 54) conducted according to OECD Guideline 426 and 

933 sponsored by the Bromine Science and Environmental Forum (BSEF) was submitted to EPA. If EPA considers the 

934 study to be adequately conducted and the study requirements of OECD 426 comparable to the study requirements 

935 of 40 CFR 799.9630, EPA will most likely accept the study and not finalize the proposed requirement to conduct 

936 developmental neurotoxicity testing of c-decaBDE. 

937 The proposed testing requirements are listed in § 799.XXXX(h) and (i) of the proposed 

938 regulatory text and include the specification of test methods covering health effects testing, 

939 ecotoxicity testing, and chemical fate testing. EPA's TSCA 799 test guidelines (40 CFR part 
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940 799, subpart H) and Office of Chemical Safety and Pollution Prevention (OCSPP) 835 series 

941 guidelines have been harmonized with the OECD test guidelines. However, EPA is specifying 

942 that the TSCA 799 test guidelines and OCSPP 835 guidelines, as well as American Society for 

943 Testing and Materials International (ASTM International) standards, be used rather than OECD 

944 test guidelines because the language in the TSCA 799 test guidelines, the OCSPP 835 series 

945 guidelines, and the ASTM International standards makes clear which steps are mandatory and 

946 which steps are only recommended. Accordingly, in order to comply with the testing required 

947 by a final rule, EPA is proposing that testing must be conducted in accordance with the specified 

948 TSCA 799, OCSPP series 835, and ASTM International test guidelines. In addition, EPA is 

949 proposing a guideline developed by the Agency to test for photolytic degradation. 

950 Most of the proposed testing requirements for a particular endpoint are specified in one test 

951 standard. In the case of certain endpoints, however, additional guidance is provided in a second 

952 guideline and possibly a third guideline (e.g., ASTM E 1391-03 provides guidance in the 

953 collection, storage, characterization, and manipulation of sediments when toxicity to various 

954 organisms of sediment-associated contaminants is tested). The following testing endpoints and 

955 test standards are proposed to be required for one or more of the test substances in this rule. 

956 1. Ecotoxicity: 

957 a. Toxicity to freshwater invertebrates of sediment-associated contaminants conducted 

958 in accordance with ASTM E 1706-05e1 (Ref. 55) and following the guidance of ASTM E 1391-

959 03 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the toxicity to freshwater 

960 invertebrates of the test substance when associated with whole sediments. 

961 b. Laboratory soil toxicity and bioaccumulation tests with the lumbricid earthworm 

962 Eisenia fetida and the enchytraeid potworm Enchytraeus albidu conducted in accordance with 

963 ASTM E 1676-04 (Ref. 57) and following the general guidance of ASTM E 1391-03 (Ref. 56). 

964 EPA proposes this guideline as appropriate to evaluate the adverse effects and bioaccumulation 

965 in earthworms and potworms of the test substance when associated with soils. 

966 c. Toxicity to polychaetous annilids of sediment-associated contaminants conducted in 

967 accordance with ASTM E 1611-00 (Ref. 58) and following the guidance of ASTM E 1391-03 

968 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the toxicity to polychaetous 

969 annelids of the test substance when associated with sediment. 

970 d. Laboratory soil toxicity to nematode Caenorhabditis elegans conducted in 

971 accordance with ASTM E 2172-01 (Ref. 59) and following the general guidance of ASTM E 

972 1391-03 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the adverse effects on 

973 nematodes of the test substance when associated with soils. 

974 e. Toxicity to estuarine and marine invertebrates of sediment-associated contaminants 

975 conducted in accordance with ASTM E 1367-03 (Ref. 60) and following the guidance of ASTM 

976 E 1391-03 (Ref. 56). EPA proposes this guideline as appropriate to evaluate the toxicity to 

977 estuarine or marine organisms of the test substance when associated with whole sediments. 

978 2. Mammalian toxicity:
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979 a. Prenatal developmental toxicity in rabbits conducted in accordance with 40 CFR 

980 799.9370. EPA proposes this guideline as appropriate to provide general information concerning 

981 the effects of exposure to the test substance on the pregnant test animal and on the developing 

982 organism. 

983 b. Two-generation reproductive toxicity with a satellite group for body burden 

984 determinations conducted in accordance with 40 CFR 799.9380. EPA proposes this guideline as 

985 appropriate to provide general information concerning the effects of exposure to the test 

986 substance on the integrity and performance of the male and female reproductive systems, and on 

987 the growth and development of the offspring. 

988 c. Immunotoxicity conducted in accordance with 40 CFR 799.9780. EPA proposes this 

989 guideline as appropriate to provide information on suppression of the immune system which 

990 might occur as a result of repeated exposure to a test chemical. 

991 d. Neurotoxicity screening battery, acute and subchronic, conducted in accordance with 

992 40 CFR 799.9620. EPA proposes this guideline as appropriate to provide information on gross 

993 functional deficits, level of activity, and histopathological changes in the central and peripheral 

994 nervous systems of the test animals as a result of acute and subchronic exposure to a test 

995 chemical. 

996 e. Developmental neurotoxicity conducted in accordance with 40 CFR 799.9630. EPA 

997 proposes this guideline as appropriate to develop data on the potential functional and 

998 morphological hazards to the nervous system which may arise in the offspring from exposure of 

999 the mother during pregnancy and lactation. 

1000 f. Chronic toxicity/Carcinogenicity conducted in accordance with 40 CFR 799.9430. 

1001 EPA proposes this guideline as appropriate to identify the majority of chronic and carcinogenic 

1002 effects and determine dose-response relationships in a mammalian species following prolonged 

1003 and repeated exposure to a test substance. 

1004 3. Chemical Fate: 

1005 a. Anaerobic aquatic metabolism conducted in accordance with OCSPP 835.4400 as 

1006 modified for c-decaBDE in section 799.XXXX(i)(2). EPA proposes this guideline as appropriate 

1007 to assess transformation of decaBDE in anaerobic aquatic sediment systems. 

1008 b. Biodegradation in anaerobic digester sludge conducted in accordance with OCSPP 

1009 835.3280 as modified for c-decaBDE in section 799.XXXX (i)(3). EPA proposes this guideline 

1010 as appropriate to assess biotransformation in anaerobic digester sludge. 

1011 c. Photolytic degradation of c-decaBDE conducted in accordance with an EPA1012 developed method in section 799.XXXX(i)(4). EPA proposes this guideline as appropriate to 

1013 assess whether PBDEs can migrate out of plastics/fabrics by volatilization; and if photolytic 

1014 degradation can take place on the surfaces of plastics and fabrics. 

1015 B. When Would any Testing Proposed by this Rule Begin? 

1016 The testing requirements contained in this proposed rule are not effective until and unless 
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1017 the Agency issues a final rule. If any manufacturer or processor of c-pentaBDE or c-octaBDE is 

1018 subject to the test rule after December 31, 2012, the test sponsor may plan the initiation of any 

1019 required testing as appropriate to submit the required final report by the deadline indicated as the 

1020 number of months, shown in § 799.XXX(j) of the proposed regulatory text, after December 31, 

1021 2012. If any manufacturer or processor of c-decaBDE is subject to the test rule after Dec 31, 

1022 2012, the test sponsor need not begin testing until it is known whether there are manufacturers or 

1023 processors of c-decaBDE for military and transportation uses that will be subject to the test rule 

1024 after December 31, 2013. The test sponsor will then know whether there are additional persons 

1025 subject to the rule after December 31, 2013, from the letters of intent to test or exemption 

1026 applications which would have to be filed by the deadline of January 30, 2014 (30days after the 

1027 relevant effective date of December 31, 2013). After December 31, 2013, all the test sponsor(s) 

1028 for decaBDE may plan the testing as appropriate to submit the required final reports by the 

1029 deadlines indicated as the number of months, shown in § 799.XXXX(j) of the final regulatory 

1030 text, after December 31, 2013. 

1031 C. How Would the Studies Proposed under this Test Rule be Conducted? 

1032 Persons required to comply with the final rule would have to conduct the necessary 

1033 testing in accordance with the testing and reporting requirements established in the regulatory 

1034 text of the final rule, with 40 CFR Part 790—Procedures Governing Testing Consent 

1035 Agreements and Test Rules (except for paragraphs (a), (d), (e), and (f) of § 790.45; § 790.48; 

1036 paragraph (a)(2) and paragraph (b) of § 790.80; paragraph (e)(1) of § 790.82; and § 790.85), and 

1037 with 40 CFR Part 792—Good Laboratory Practice Standards. 

1038 D. What Forms of Test Mixtures Would be Tested Under this Rule? 

1039 The test rule proposes that the test mixtures be the representative forms of pentaBDE1040 containing commercial mixtures, octaBDE-containing commercial mixtures, and decaBDE1041 containing commercial mixtures. To fully describe the three test mixtures, the percentage of 

1042 each of the seven congeners present in each of the three test mixtures must be identified by the 

1043 test sponsor(s). 

1044 

1045 Each of the three proposed test mixtures is described by its predominant components. C1046 pentaBDE) is a mixture predominantly comprised of pentaBDE, tetraBDE, and hexaBDE. C1047 octaBDE is a mixture predominantly comprised of octaBDE, hexaBDE, heptaBDE, and 

1048 nonaBDE. C-decaBDE is a mixture with decaBDE being present in the highest percentage. 

1049 EPA believes that the proposed testing of c-pentaBDE, c-octaBDE, and c-decaBDE will provide 

1050 EPA with data necessary to determine the effects of commercial PBDE products on human 

1051 health and the environment. EPA is seeking comment on whether testing of c-pentaBDE, c1052 octaBDE and c-decaBDE should be conducted with the pure congener or each congener in each 

1053 mixture instead of the commercial products. EPA is also seeking comment on whether its 

1054 descriptions of the commercial mixtures to be tested accurately predict what commercial forms 

1055 of pentaBDE, octaBDE, and decaBDE might be produced. Finally, EPA solicits comment on 

1056 whether more than one commercial form each of c-pentaBDE, c-octaBDE, and c-decaBDE 

1057 should be tested. 

1058 

1059 E. Would I Be Required to Test Under this Rule? 
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1060 Under TSCA section 4(a)(1)(A)(ii), EPA has made preliminary findings that there are 

1061 insufficient data and experience to reasonably determine or predict health and environmental 

1062 effects resulting from the manufacture, processing, use, and distribution in commerce of the 

1063 mixtures listed in this proposed rule. As a result, under TSCA section 4(b)(3)(B), manufacturers 

1064 and processors of mixtures listed in this proposed rule, and those who intend to manufacture or 

1065 process them, would be subject to the rule with regard to those listed mixtures which they 

1066 manufacture or process. 

1067 1. Would I be subject to this rule? You would be subject to this rule and may be required 

1068 to test if you manufacture (which is defined by statute to include import) or process, or intend to 

1069 manufacture or process, one or more mixtures listed in this proposed test rule during the time 

1070 period discussed in Unit VI.E.2. You would also be subject to this rule if you manufacture or 

1071 process the subject mixtures for export from the United States. For this rule, importers of articles 

1072 which include c-pentaBDE, c-octaBDE, or c-decaBDE would be considered manufacturers and 

1073 subject to this rule. If you do not know or cannot reasonably ascertain that you manufacture or 

1074 process a listed test rule mixture (based on all information in your possession or control, as well 

1075 as all information that a reasonable person similarly situated might be expected to possess, 

1076 control, or know, or could obtain without unreasonable burden), you would not be subject to the 

1077 rule for that listed mixtures. 

1078 2. When would my manufacture or processing (or my intent to do so) cause me to be 

1079 subject to this rule? You would be subject to this rule if you manufacture or process, or intend to 

1080 manufacture or process, a mixture listed in the rule at any time from the relevant effective date in 

1081 799.xxxx(k) of the final test rule to the end of the test data reimbursement period. The term 

1082 “reimbursement period” is defined at 40 CFR 791.3(h) and may vary in length for each mixture 

1083 to be tested under a final TSCA section 4(a) test rule, depending on what testing is required and 

1084 when testing is completed. See Unit VI.E.4. 

1085 3. Would I be required to test if I were subject to the rule? It depends on the nature of 

1086 your activities. All persons who would be subject to this TSCA section 4(a) test rule, which, 

1087 unless otherwise noted in the regulatory text, incorporates EPA’s generic procedures applicable 

1088 to TSCA section 4(a) test rules (contained within 40 CFR part 790), would fall into one of two 

1089 groups, designated here as Tier 1 and Tier 2. Persons in Tier 1 (those who would have to 

1090 initially comply with the final rule) would either: 

1091 • Submit to EPA letters of intent to conduct testing, conduct this testing, and submit the 

1092 test data to EPA, or 

1093 • Apply to and obtain from EPA exemptions from testing. 

1094 Persons in Tier 2 (those who would not have to initially comply with the final rule) would 

1095 not need to take any action unless they are notified by EPA that they are required to do so 

1096 (because, for example, no person in Tier 1 had submitted a letter of intent to conduct testing), as 

1097 described in Unit VI.E.3.d. Note that both persons in Tier 1 who obtain exemptions and persons 

1098 in Tier 2 would nonetheless be subject to providing reimbursement to persons who actually 

1099 conduct the testing, as described in Unit VI.E.4. 

1100 a. Who would be in Tier 1 and Tier 2? All persons who would be subject to the final rule 
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1101 are considered to be in Tier 1 unless they fall within Tier 2. Table 4 of this unit describes who is 

1102 in Tier 1 and Tier 2. 

Table 4.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2

Tier 1 (Persons initially required to 

comply) 

Tier 2 (Persons not initially required to comply) 

Persons who manufacture (as 

defined at TSCA section 3(7)), or 

intend to manufacture, a test rule 

mixture and who are not listed 

under Tier 2. Importers of articles 

containing PBDEs are 

manufacturers. 

A. Persons who manufacture (as defined at TSCA 

section 3(7)) or intend to manufacture a test rule 

mixture solely as one or more of the following: 

--As a byproduct (as defined at 40 CFR791.3(c)); 

--As an impurity (as defined at 40 CFR 790.3); 

--As a naturally occurring chemical substance (as 

defined at 40 CFR 710.4(b); 

--As a non-isolated intermediate (as defined at 40 

CFR 704.3); 

--As a component of a Class 2 substance (as 

described at 40 CFR 720.45(a)(1)(i)); 

--In amounts of less than 500 kg (1,100 lbs.) 

annually (as described at 40 CFR 790.42(a)(4)); or 

--In small quantities solely for research and 

development (R and D) (as described at 40 CFR 

790.42(a)(5)). 

B. Persons who process (as defined at TSCA 

section 3(10)) or intend to process a test rule 

mixture including in articles (see 40 CFR 

790.42(a)(2)). 

1103 

1104 Under 40 CFR 790.2, EPA may establish procedures applying to specific test rules that 

1105 differ from the generic procedures governing TSCA section 4(a) test rules in 40 CFR part 790. 

1106 For purposes of this proposed rule, EPA is proposing to establish certain requirements that differ 

1107 from those under 40 CFR part 790. 

1108 In this proposed test rule, EPA has configured the tiers in 40 CFR 790.42 as in certain 

1109 previous test rules. In addition to processors, manufacturers of less than 500 kg (1,100 lbs.) per 

1110 year (‘‘small-volume manufacturers’’), and manufacturers of small quantities for research and 

1111 development (‘‘R&D manufacturers’’), EPA has added the following persons to Tier 2: 

1112 Manufacturers of byproducts, manufacturers of impurities, manufacturers of naturally occurring 

1113 chemical substances, manufacturers of non-isolated intermediates, and manufacturers of 

1114 components of Class 2 chemical substances. The Agency took administrative burden and 

1115 complexity into account in determining who was to be in Tier 1 in this proposed rule. EPA 

1116 believes that those persons in Tier 1 who would conduct testing under this proposed rule, when 

1117 finalized, would generally be large chemical manufacturers who, in the experience of the 

1118 Agency, have traditionally conducted testing or participated in testing consortia under previous 

1119 TSCA section 4(a) test rules. 
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1120 The Agency also believes that manufacturers of byproducts, impurities, naturally 

1121 occurring chemical substances, manufacturers of non-isolated intermediates, and manufacturers 

1122 of components of Class 2 chemical substances historically have not themselves participated in 

1123 testing or contributed to reimbursement of those persons who have conducted testing. EPA 

1124 understands that these manufacturers may include persons for whom the marginal transaction 

1125 costs involved in negotiating and administering testing arrangements are deemed likely to raise 

1126 the expense and burden of testing to a level that is disproportional to the additional benefits of 

1127 including these persons in Tier 1. Therefore, EPA is not proposing to burden these persons with 

1128 Tier 1 requirements (e.g., submitting requests for exemptions). Nevertheless, these persons, 

1129 along with all other persons in Tier 2, would be subject to reimbursement obligations to persons 

1130 who actually conduct the testing, as described in Unit VI.E.4. 

1131 TSCA section 4(b)(3)(B) requires all manufacturers and/or processors of a mixture to test 

1132 that mixture if EPA has made findings under TSCA sections 4(a)(1)(A)(ii) or 4(a)(1)(B)(ii) for 

1133 that mixture, and issued a TSCA section 4(a) test rule requiring testing. However, practicality 

1134 must be a factor in determining who is subject to a particular test rule. Thus, persons who do not 

1135 know or cannot reasonably ascertain that they are manufacturing or processing a mixture subject 

1136 to this proposed rule, e.g., manufacturers or processors of a mixture as a trace contaminant who 

1137 are not aware of or cannot reasonably ascertain these activities, would not be subject to the rule. 

1138 See Unit VI.E.1.and §799.XXXX(b)(2) of the proposed regulatory text. 

1139 EPA believes it is possible that there will be no persons in Tiers 1 and 2A that will be 

1140 subject to the test rule. If EPA learns that the only persons that would be subject to the rule 

1141 would be persons that process c-pentaBDE, c-octaBDE, or c-decaBDE as impurities contained in 

1142 articles, EPA will not require testing because EPA has not determined whether this activity alone 

1143 may present an unreasonable risk of injury to health or the environment. EPA is seeking 

1144 comment on whether the Agency should address persons who manufacture or process PBDEs as 

1145 impurities whether or not they are contained in articles, and whether such persons should be 

1146 required to conduct testing. 

1147 

1148 b. Subdivision of Tier 2 entities. The Agency is proposing to prioritize which persons in 

1149 Tier 2 would be required to perform testing, if needed. Specifically, the Agency is proposing 

1150 that Tier 2 entities be subdivided into: 

1151 i. Tier 2A–manufacturers, i.e., those who manufacture, or intend to manufacture, a test 

1152 rule chemical substance including in articles solely as one or more of the following: A 

1153 byproduct, an impurity, a naturally occurring chemical substance, a non-isolated intermediate, a 

1154 component of a Class 2 chemical substance, in amounts less than 1,100 lbs. annually, or in small 

1155 quantities solely for research and development. 

1156 ii. Tier 2B–processors, i.e., those who process, or intend to process, a test rule mixture in 

1157 any form including in articles. The terms ‘‘process’’ and ‘‘processor’’ are defined by TSCA 

1158 sections 3(10) and 3(11), respectively. 

1159 If the Agency needs testing from persons in Tier 2, EPA would seek testing from persons 

1160 in Tier 2A before proceeding to Tier 2B. It is appropriate to require manufacturers in Tier 2A to 

1161 submit letters of intent to test or exemption applications before processors are called upon 

1162 because the Agency believes that testing costs are traditionally passed along by manufacturers to 
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1163 processors, enabling them to share in the costs of testing (Ref. 61). In addition, ‘‘[t]here are 

1164 [typically] so many processors [of a given test rule chemical] that it would be difficult to include 

1165 them all in the technical decisions about the tests and in the financial decisions about how to 

1166 allocate the costs’’ (Ref. 62, 48 FR 31786, July 11, 1983). 

1167 c. When would it be appropriate for a person who would be required to comply with the 

1168 rule to apply for an exemption rather than to submit a letter of intent to conduct testing? You 

1169 may apply for an exemption if you believe that the required testing will be performed by another 

1170 person (or a consortium of persons formed under TSCA section 4(b)(3)(A)). You can find 

1171 procedures relating to exemptions in 40 CFR 790.80 through 790.99, and § 799.XXXX(c)(2), 

1172 (c)(5), (c)(7), and (c)(11) of the proposed regulatory text. In this proposed rule, EPA would not 

1173 require the submission of equivalence data (i.e., data demonstrating that your chemical substance 

1174 or mixture is equivalent to the chemical substance or mixture actually being tested) as a 

1175 condition for approval of your exemption. Therefore, 40 CFR 790.82(e)(1) and 40 CFR 790.85 

1176 would not apply to this proposed rule. 

1177 d. What would happen if I submitted an exemption application? EPA believes that 

1178 requiring the collection of duplicative data is unnecessarily burdensome. As a result, if EPA has 

1179 received a letter of intent to test from another source or has received (or expects to receive) the 

1180 test data that would be required under this rule, the Agency would conditionally approve your 

1181 exemption application under 40 CFR 790.87. 

1182 The Agency would terminate conditional exemptions if a problem occurs with the 

1183 initiation, conduct, or completion of the required testing, or with the submission of the required 

1184 data to EPA. EPA may then require you to submit a notice of intent to test or an exemption 

1185 application. See 40 CFR 790.93 and § 799.XXXX(c)(8) of the proposed regulatory text. In 

1186 addition, the Agency would terminate a conditional exemption if no letter of intent to test has 

1187 been received by persons required to comply with the rule. See, e.g., § 799.XXXX(c)(6) of the 

1188 proposed regulatory text. Note that the provisions at 40 CFR 790.48(b) have been incorporated 

1189 into the regulatory text of this proposed rule; thus, persons subject to this rule are not required to 

1190 comply with 40 CFR 790.48 itself (see § 799.XXXX(c)(4) through (c)(7) and § 799.XXXX(d)(3) 

1191 of the proposed regulatory text). Persons who obtain exemptions or receive automatic 

1192 conditional exemptions would nonetheless be subject to providing reimbursement to persons 

1193 who do actually conduct the testing, as described in Unit VI.E.4. 

1194 e. What would my obligations be if I were in Tier 2? If you are in Tier 2, you would be 

1195 subject to the rule and you would be responsible for providing reimbursement to persons in Tier 

1196 1, as described in Unit VI.E.4. There is no difference whether you are in Tier 2A or Tier 2B as 

1197 regards reimbursement. EPA is not aware of any circumstances in which test rule Tier 1 entities 

1198 have sought reimbursement from Tier 2 entities either through private agreements or by 

1199 soliciting the involvement of the Agency under the reimbursement regulations at 40 CFR part 

1200 791. 

1201 Concerning testing, if you are in Tier 2, you are considered to have an automatic 

1202 conditional exemption. You would not need to submit a letter of intent to test or an exemption 

1203 application unless you are notified by EPA that you are required to do so. As previously noted, 

1204 Tier 2A manufacturers would be notified to test before Tier 2B processors (Unit VI.E.3.ii.). 
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1205 If a problem occurs with the initiation, conduct, or completion of the required testing, or 

1206 with the submission of the required data to EPA, the Agency may require you to submit a notice 

1207 of intent to test or submit an exemption application. See 40 CFR 790.93 and §

1208 799.XXXX(c)(10) of the proposed regulatory text. 

1209 In addition, you would need to submit a notice of intent to test or an exemption 

1210 application if: 

1211 • No manufacturer in Tier 1 has notified EPA of its intent to conduct testing, and 

1212 • EPA has published a Federal Register document directing persons in Tier 2 to submit 

1213 to EPA letters of intent to conduct testing or exemption applications. See § 799.XXXX(c)(4), 

1214 (c)(5), (c)(6), and (c)(7) of the proposed regulatory text. The Agency would conditionally 

1215 approve an exemption application under 40 CFR 790.87, if EPA has received a letter of intent to 

1216 test or has received (or expects to receive) the test data required under this rule. 

1217 f. What would happen if no one submitted a letter of intent to conduct testing? EPA 

1218 anticipates that, if there were manufacturers or processors of those chemical substances subject 

1219 to the final rule, it would receive letters of intent to conduct testing for all of the tests specified 

1220 for each mixture from one of those persons. However, in the event it does not receive a letter of 

1221 intent for one or more of the tests required by the final rule for any of the mixtures in the final 

1222 rule within 30 days after the publication of a Federal Register document notifying Tier 2 

1223 processors of the obligation to submit a letter of intent to conduct testing or to apply for an 

1224 exemption from testing, EPA would notify all manufacturers and processors of the mixture of 

1225 this fact by certified letter or by publishing a Federal Register document specifying the test(s) 

1226 for which no letter of intent has been submitted. This letter or Federal Register document 

1227 would additionally notify all manufacturers and processors that all exemption applications 

1228 concerning the test(s) have been denied, and would give them an opportunity to take corrective 

1229 action. If no one has notified EPA of its intent to conduct the required testing of the mixture 

1230 within 30 days after receipt of the certified letter or publication of the Federal Register

1231 document, all manufacturers and processors subject to the final rule with respect to that mixture 

1232 who are not already in violation of the final rule would be in violation of the final rule. 

1233 4. How do the reimbursement procedures work? In the past, persons subject to test rules 

1234 have independently worked out among themselves their respective financial contributions to 

1235 those persons who have actually conducted the testing. However, if persons are unable to agree 

1236 privately on reimbursement, they may take advantage of EPA’s reimbursement procedures at 40 

1237 CFR part 791, promulgated under the authority of TSCA section 4(a). These procedures include: 

1238 The opportunity for a hearing with the American Arbitration Association; publication by EPA of 

1239 a document in the Federal Register concerning the request for a hearing; and the appointment of 

1240 a hearing officer to propose an order for fair and equitable reimbursement. The hearing officer 

1241 may base his or her proposed order on the production volume formula set out at 40 CFR 791.48, 

1242 but is not obligated to do so. The hearing officer’s proposed order may become the Agency’s 

1243 final order, which is reviewable in Federal court (40 CFR 791.60). Under this proposed rule, for 

1244 the purpose of determining fair reimbursement shares if the hearing officer chooses to use a 

1245 formula based on production volume, the total production volume will include amounts of a 

1246 mixture produced as an impurity and amounts imported in articles. 
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1247 F. What Reporting Requirements are Proposed Under this Test Rule? 

1248 If you were required to test, you would be required to submit a final report for a specific 

1249 test by the deadline indicated in Table 3 in Unit VI.A of this preamble as the number of months 

1250 after the relevant effective date of the final rule; this deadline is also shown in § 799.XXXX(j) of 

1251 the proposed regulatory text. 

1252 EPA is also proposing that a robust summary of the final report for each specific test be 

1253 required to be submitted electronically in addition to and at the same time as the final report. 

1254 The term “robust summary” is used to describe the technical information necessary to adequately 

1255 describe an experiment or study and includes the objectives, methods, results, and conclusions of 

1256 the full study report which can be either an experiment or in some cases an estimation or 

1257 prediction method. Guidance for the compilation of robust summaries is described in a 

1258 document entitled “Draft Guidance on Developing Robust Summaries” (Ref. 63). 

1259 G. What Would I Need to Do if I Cannot Complete the Testing Required by the Final Rule? 

1260 A person who submits a letter of intent to test under the final rule and who subsequently 

1261 anticipates difficulties in completing the testing by the deadline set forth in the final rule may 

1262 submit a modification request to the Agency, pursuant to 40 CFR 790.55. EPA will determine 

1263 whether modification of the test schedule is appropriate, and may first seek public comment on 

1264 the modification. 

1265 H. Would There be Sufficient Test Facilities and Personnel to Undertake the Testing Proposed 

1266 Under this Test Rule? 

1267 EPA’s most recent analysis of laboratory capacity (Ref. 64) indicates that available test 

1268 facilities and personnel would adequately accommodate the testing proposed in this rule. 

1269 I. Might EPA Seek Further Testing of the Chemicals in this Proposed Test Rule? 

1270 If EPA determines that it needs additional data regarding any of the chemical substances 

1271 included in this proposed rule, the Agency would seek further health and/or environmental 

1272 effects testing for these mixtures. Should the Agency decide to seek such additional testing via a 

1273 test rule, EPA would initiate a separate action for this purpose. 

1274 VII. Export Notification 

1275 A. SNUR 

1276 Any person who exports, or intends to export decaBDE will be subject to the export 

1277 notification requirements in TSCA section 12(b)(2) and at 40 CFR part 707, subpart D when the 

1278 rule is proposed. Any person who exports, or intends to export, tetraBDE, pentaBDE, hexaBDE, 

1279 heptaBDE, octaBDE, and nonaBDE became subject to those requirements with the proposal of 

1280 the SNUR in 2004 (Ref. 7). Export notification is generally not required for articles under a 

1281 SNUR, as provided by 40 CFR 707.60(b), and for these proposed amendments to the SNUR, the 

1282 article exemption for export notification would apply. 

1283 

1284 B. Test Rule
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1285 Any person who exports, or intends to export, one of the mixtures contained in this 

1286 proposed test rule would be subject to the export notification requirements in TSCA section 

1287 12(b)(1) and at 40 CFR part 707, subpart D, but only after the final rule is promulgated and only 

1288 if the mixture is contained in the final rule. Export notification would not be required for 

1289 articles under the proposed test rule. 

1290 VIII. Import Certification 

1291 Persons who import a chemical substance identified in a final SNUR are subject to the 

1292 TSCA section 13 import requirements, codified at 19 CFR 12.118 through 12.127; see also 19 

1293 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies 

1294 with all applicable rules and orders under TSCA, including any SNUR requirements. Chemical 

1295 substances contained in articles are exempt from import certification. The EPA policy in support 

1296 of import certification appears at 40 CFR part 707, subpart B. 

1297 

1298 IX. The Dates that the SNUR, Proposed Amended SNUR, and Proposed Test Rule 

1299 Requirements Apply to the Seven PBDEs and the Three Commercial Mixtures

1300 

1301 The SNUR that became effective on August 14, 2006, requires that persons that intend to 

1302 manufacture any of six PBDEs (tetraBDE, pentaBDE, hexaBDE, heptaBDE, octaBDE, and 

1303 nonaBDE) for any use after January 1, 2005, submit a SNUN to EPA at least 90 days in advance. 

1304 EPA believes that all import and processing of these six PBDEs for any use including as part of 

1305 an article have been discontinued. These proposed amendments to the SNUR would designate 

1306 processing for any use after December 31, 2012, a significant new use. The proposed amended 

1307 SNUR would also make inapplicable the article exemption at 40 CFR 721.45(f). Therefore, a 

1308 person who intends to import or process any of the six PBDEs as part of an article after 

1309 December 31, 2012, would not be exempt from submitting a significant new use notice. EPA 

1310 will promulgate the amended SNUR after it has verified that the proposed significant new uses 

1311 have been discontinued. 

1312 

1313 Any person who manufactures or processes or intends to manufacture or process c1314 pentaBDE, c-octaBDE, or c-decaBDE after the relevant proposed effective dates would be 

1315 subject to the test rule. For a discussion of applicability of the significant new use rule to uses 

1316 occurring before the effective date of the final rule see Unit V.C.

1317 

1318 On December 2009, the principal manufacturers and importer of decaBDE announced 

1319 their intent to phase out their activities with decaBDE and committed to do so by December 31, 

1320 2012 for all uses, except military and transportation, and by December 31, 2013, for all uses 

1321 including military and transportation, with possibly an additional 6 months to sell remaining 

1322 inventory of decaBDE. The Agency does not believe that manufacturers would need additional 

1323 time to sell remaining inventory or that processors would require any additional time to use 

1324 existing stocks, and has not proposed any additional time in this action. EPA is seeking 

1325 comment on this in Unit XI.A.2. 

1326 

1327 With this Proposed SNUR-Test Rule, EPA is proposing to amend the 2006 PBDE SNUR 

1328 by designating manufacture and processing of decaBDE for any use except military and 

1329 transportation uses including in articles after December 31, 2012, and manufacture and 
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1330 processing of decaBDE for all uses including military and transportation uses, including in 

1331 articles after December 31, 2013, significant new uses that would require the submission of a 

1332 SNUN to EPA at least 90 days before commencing such activity. If any persons engage in such 

1333 activities with decaBDE after the relevant significant new use dates, EPA would promulgate the 

1334 test rule and they would be subject to the test rule requirements. 

1335 

1336 Table 5 presents the date when the requirements of the existing SNUR applied to 

1337 activities with certain PBDEs and the dates when the requirements of the proposed amendments 

1338 to the SNUR and test rule, if promulgated, would apply to the manufacture and processing of the 

1339 seven PBDEs depending on whether those activities are ongoing or have ceased. 

1340 

1341 

1342 Table 5: The Date SNUR, Amended SNUR, or Test Rule Requirements Apply to the 

1343 Seven PBDEs and the Three Commercial Mixtures

1344 

PBDE On or After 

Jan 1, 2005 

After Dec 31, 2012 After Dec 31, 2013 

SNUR applies 

to nonongoing: 

Amended 

SNUR would 

apply to nonongoing: 

Test Rule 

would apply 

to ongoing: 

Amended 

SNUR 

would apply 

to nonongoing: 

Test Rule 

would apply 

to ongoing: 

tetraBDE 

hexaBDE 

heptaBDE 

nonaBDE 

pentaBDE 

octaBDE 

Manufacture 

for any use. 

Processing 

for any use. 

Manufacture 

and 

processing 

including in 

articles for 

any use. 

 

decaBDE Manufacture 

and 

processing 

for any use, 

except 

military and 

transportation 

uses, 

including in 

articles. 

 Manufacture 

and 

processing 

for any use, 

including 

military and 

transportation 

uses, 

including in 

articles. 

cpentaBDE 

and coctaBDE 

 Manufacture 

and 

processing 

for any use 

including in 

 
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articles. 

cdecaBDE  Manufacture 

and 

processing 

for any use, 

except 

military and 

transportation 

uses, 

including in 

articles. 

 Manufacture 

and 

processing 

for any use, 

including 

military and 

transportation 

uses, 

including in 

articles. 

1345 

1346 

1347 X. Economic Considerations

1348 

1349 A. SNUR

1350 

1351 The proposed amendment to the SNUR would require persons intending to engage in 

1352 significant new use to submit a Significant New Use Notice (SNUN), incurring an estimated 

1353 submission cost of $8,143 per chemical, plus other costs (Ref. 72). In addition to the firms that 

1354 make a SNUN submission, the proposed amendments to the SNUR may also impact firms that 

1355 do not make a submission. By avoiding a significant new use, a firm can avoid submission and 

1356 testing costs but may incur other compliance costs. The firm may also incur “hidden” costs; for 

1357 example, it could forego profitable opportunities to use the chemical in an application that would 

1358 be a significant new use or limit production volume to avoid a significant new use. Costs are 

1359 estimated at the firm level and reflect the burden of a SNUR on the firms that make a 

1360 submission. The hidden costs to the firms that do not make a submission are not quantified. 

1361 EPA receives only a handful of SNUNs per year due to SNURs. However, the number of firms 

1362 affected by not making submissions to EPA is not known; therefore, costs are not aggregated 

1363 across the affected entities. 

1364 

1365 B. Test Rule 

1366 EPA has prepared an economic assessment entitled Economic Impact Analysis for the 

1367 Proposed Section 4 Test Rule for c-Pentabromodiphenyl Ether, c-Octabromodiphenyl Ether, and 

1368 c-Decabromodiphenyl Ether (Ref. 73), a copy of which has been placed in the docket for this 

1369 rulemaking. The economic analysis evaluates the costs associated with the testing that would be 

1370 required by a final test rule. The analysis looks at costs due to testing all three mixtures and to 

1371 each mixture separately. The total costs to industry of compliance, including testing and 

1372 administrative costs, for all three mixtures are estimated under the low- and high-cost scenarios 

1373 to be $9.68 million and $15.1 million, respectively. The testing cost (not including 

1374 administrative costs) to comply with the test rule requirements for c-pentaBDE or c-octaBDE 

1375 under the low- and high-cost scenarios would be $2.8 million and $4.7 million, respectively. 

1376 The testing cost (not including administrative costs) to comply with the test rule requirements for 

1377 c-decaBDE under the low- and high-cost scenarios would be $1.8 million and $2.5 million, 

1378 respectively. (Ref. 73) These costs would only be incurred if there were entities that 
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1379 manufacture or process c-pentaBDE, c-octaBDE, or c-decaBDE, including in articles, after the 

1380 relevant dates specified in the proposed test rule in §799.xxxx(k) of December 31, 2012 and 

1381 December 31, 2013. 

1382 

1383 Currently, there are no known entities that manufacture or process c-pentaBDE or c1384 octaBDE in the United States except as impurities, so an economic impact analysis could not be 

1385 done for these two chemicals. 

1386 

1387 EPA has identified six ultimate parent companies that manufacture or import c-decaBDE 

1388 in the United States. The total annualized compliance costs for decaBDE are estimated to be, 

1389 under low- and high-cost scenarios, $264,582 and $360,218, respectively. To evaluate the 

1390 potential for an adverse economic impact of testing on manufacturers and importers of c1391 decaBDE, EPA employed an initial screening approach that estimated the impact of testing 

1392 requirements as a percentage of c-decaBDE’s sale price. This measure compares annual 

1393 revenues from the sale of a mixture to the annualized compliance cost for that mixture to assess 

1394 the percentage of testing costs that can be accommodated by the revenue stream generated by 

1395 that mixture over a number of years. Compliance costs include costs of testing and 

1396 administering the testing, as well as reporting costs. In addition, they include the estimated cost 

1397 of the TSCA section 12(b) export notification requirements, which, under the final rule, would 

1398 be required for the first export to a particular country of a mixture subject to the rule, estimated 

1399 to range from $26.86 per notice to $85.70 per notice (Ref. 72). These export notification 

1400 requirements (included in the total and annualized cost estimates) that would be triggered by the 

1401 final rule are expected to have a negligible impact on exporters. 

1402 

1403 Annualized compliance costs divide testing expenditures into an equivalent, constant 

1404 yearly expenditure over a longer period of time. To calculate the percent price impact, testing 

1405 costs (including laboratory and administrative expenditures) are annualized over 15 years using a 

1406 7% discount rate. These annualized testing costs are then divided by the estimated annual 

1407 revenue of the mixture to derive a cost-to-sales ratio. 

1408 

1409 For five companies manufacturing or importing c-decaBDE, the cost-to-sales ratios is 3 

1410 percent or less. One company was identified as a small business by TSCA’s employment-based 

1411 definition and has a cost-to-sales ratio greater than 3 percent. Mixtures for which the price 

1412 impact is expected to exceed 1% of the revenue from that chemical have a higher potential for 

1413 adverse economic impact. However, EPA also compared the annualized cost of testing c1414 decaBDE to company revenue because, in some cases, companies may choose to use revenue 

1415 sources other than the profits from the individual mixture to pay for testing. EPA estimates that 

1416 the costs of testing will exceed 1% of company revenue for only one of the affected companies, 

1417 i.e., the company identified as a small business. 

1418 

1419 While processors are legally subject to this test rule if they process c-decaBDE after 

1420 December 31, 2012, processors of c-decaBDE would be required to comply with the 

1421 requirements of the rule only if they are directed to do so by EPA as described in 

1422 §799.XXXX(c)(6) and (c)(8) of the proposed regulatory text. EPA would only require 

1423 processors to test if no subject person in Tier 1 or Tier 2A has submitted a notice of its intent to 

1424 conduct testing, or if under 40 CFR 790.93, a problem occurs with the initiation, conduct, or 

1425 completion of the required testing or the submission of the required data to EPA. Because 
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1426 processors would not need to comply with the proposed rule initially if there are persons in Tiers 

1427 1 or 2A subject to the rule, the economic assessment does not address processors. 

1428 

1429 The benefits resulting from this proposed test rule are discussed qualitatively in 

1430 Economic Impact Analysis for the Proposed Section 4 Test rule for c-Pentabromodiphenyl Ether, 

1431 c-Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether (Ref. 73). EPA believes the major 

1432 benefits of the test rule will be the development of hazard information on these chemicals and the 

1433 use of this information by the public, industry, and government. 

1434 

1435 XI. Request for Public Comment 

1436 A. Solicitation of Comments on the proposed amendments to the SNUR. 

1437 

1438 (1) EPA welcomes comments on any aspect of the proposed amendments to the SNUR, but is 

1439 especially interested in comments regarding the designation of a new use of decaBDE as (1) 

1440 manufacture and processing of decaBDE for any use except military and transportation uses 

1441 including in articles after December 31, 2012, and (2) manufacture and processing of decaBDE 

1442 for any use including military and transportation uses, including in articles after December 31, 

1443 2013. 

1444 

1445 (2) EPA is projecting that processors will discontinue their activities by December 31, 2013. 

1446 Should EPA assume that processors will continue their activities beyond that date? For example, 

1447 should EPA assume that processors will continue their activities for six months after 

1448 manufacture of decaBDE ceases? Should EPA designate processing of decaBDE after June 30, 

1449 2014, or some other date, a significant new use? 

1450 

1451 (3) EPA welcomes comments on the designation of a significant new use of tetraBDE, 

1452 pentaBDE, hexaBDE, heptaBDE, octaBDE, and nonaBDE as manufacture and processing for 

1453 any use including in articles after December 31, 2012. 

1454 

1455 (4) In this action, EPA is proposing to make inapplicable the article exemption for SNURs at 40 

1456 CFR part 721.45(f). A person who intends to process a chemical substance identified in this 

1457 section as part of an article, other than as an impurity, would not be exempt from submitting a 

1458 significant new use notice. EPA welcomes comment on this proposed course of action. 

1459 

1460 (5) EPA requests comment on when to finalize the proposed amendments to the SNUR. Should 

1461 they be finalized before or after the phase-out dates of decaBDE? 

1462 

1463 (6) EPA requests comment on whether the proposed significant new uses are still ongoing and 

1464 will be ongoing on the relevant dates of December 31, 2012 and December 31, 2013. 

1465 

1466 B. Solicitation of Comments on the Proposed Test Rule. 

1467 (1) EPA is soliciting comment regarding additional information pertaining to potential exposure 

1468 of the general population, consumers, and workers to c-pentaBDE, c-octaBDE, and c-decaBDE. 

1469 Also, the Agency solicits comment regarding additional information pertaining to environmental 

1470 releases of any of these three PBDE mixtures. 
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1471 (2) EPA is soliciting comments which identify existing studies that may satisfy the data needs 

1472 identified in the proposed test rule. To the extent that data relevant to the testing specified in this 

1473 proposed rule are known to exist, EPA strongly encourages the submission of this information as 

1474 comments to the proposed rule. Such data submitted to EPA must be in the form of full copies of 

1475 unpublished studies or full citations of published studies, and accompanied by a robust summary 

1476 (Ref. 63). To the extent that studies proposed in this action are currently available, and the data 

1477 are judged sufficient by EPA, testing for the endpoint/mixture combination will not be required 

1478 in a final test rule. 

1479 (3) EPA is soliciting comment on what test substances should be required for pentaBDE, 

1480 octaBDE, and decaBDE. EPA is proposing that the test substances be the representative 

1481 commercial forms with the percent congener composition identified by the test sponsor(s). 

1482 Instead, should the test substances be the 99% pure pentaBDE, octaBDE, and decaBDE with an 

1483 isomer composition identified for each? 

1484 (4) EPA is soliciting comment on whether a purity level of 99% or greater can be attained for 

1485 pentaBDE, octaBDE, and decaBDE. 

1486 (5) EPA is soliciting comment on whether the descriptions in section 799.XXXX(a) of the 

1487 commercial mixtures to be tested adequately encompass the range of commercial forms of 

1488 pentaBDE, octaBDE, and decaBDE that might be produced. 

1489 

1490 (6) EPA is soliciting comment on whether, for the purpose of the testing proposed in this action, 

1491 a single commercial form each of pentaBDE, octaBDE, and decaBDE can be representative of 

1492 the possible variations of those commercial mixtures. If not, should more than one commercial 

1493 form each of pentaBDE, octaBDE, and decaBDE be tested? How should those forms be 

1494 determined? 

1495 

1496 (7) EPA is soliciting comment on whether testing should be required of tetraBDE, pentaBDE, 

1497 hexaBDE, heptaBDE, octaBDE, nonaBDE, and decaBDE comparable to that proposed for c1498 pentaBDE, c-octaBDE, and c-decaBDE if they are present in commercial PBDE products. 

1499 (8) EPA is also soliciting comment on the proposed test methods, the proposed requirement for 

1500 submission of robust summaries, the proposed deadlines to submit final reports, and the 

1501 economic impact analysis detailing the burdens and costs that would result from complying with 

1502 a final test rule. 

1503 (9) The Agency invites comment on the potential use of voluntary consensus standards in the 

1504 proposed test rule, and, specifically, invites the public to identify potentially applicable 

1505 consensus standard(s) and to explain why such standard(s) should be used here. 

1506 (10) EPA is interested in receiving comments on whether the Agency should consider 

1507 establishing an alternate definition for small business to use in the small entity impact analyses 

1508 for future TSCA section 4(a) test rules, and what size cutoff may be appropriate. 

1509 

1510 (11) EPA is soliciting comment on whether, in a future rulemaking, persons who manufacture or 

1511 process c-PBDEs contained in articles as impurities should be required to conduct testing. EPA 

1512 also solicits comment on whether persons who manufacture or process c-PBDEs as impurities 
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Page 39 of 83 

1513 not contained in articles should be required to test. 

1514 

1515 XII. References 

1516 As indicated under ADDRESSES, a docket has been established for this rulemaking 

1517 under docket ID number EPA–HQ–OPPT–2009–0357. The following is a listing of the 

1518 documents that have been placed in the docket for this rulemaking. The docket includes 

1519 information considered by EPA in developing this proposed rule, including the documents listed 

1520 in this unit, which are physically located in the docket. In addition, interested parties should 

1521 consult documents that are referenced in the documents that EPA has placed in the docket, 

1522 regardless of whether these referenced documents are physically located in the docket. For 

1523 assistance in locating documents that are referenced in documents that EPA has placed in the 

1524 docket, but that are not physically located in the docket, please consult either technical person 

1525 listed under FOR FURTHER INFORMATION CONTACT. The docket is available for 

1526 review as specified under ADDRESSES. 

1527 1. EPA. Significant New Use Rule for Certain Polybrominated Diphenylethers. 40 CFR 

1528 721.10000. 

1529 2. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy. Notice. Federal Register 

1530 (58 FR 28736 at 28738–28739, May 14, 1993). 

1531 3. EPA, 2008a. Toxicological Review of 2,2',4,4' -Tetrabromodiphenyl Ether (BDE-47), 

1532 EPA/635/R-07/005F, June 2008. 

1533 4. EPA, 2008b. Toxicological Review of 2,2',4,4',5-Pentabromodiphenyl Ether (BDE1534 99), EPA/635/R-07/006F, June 2008. 

1535 5. EPA, 2008c. Toxicological Review of 2,2',4,4',5,5’-Hexabromodiphenyl Ether (BDE1536 153), EPA/635/R-07/007F, June 2008. 

1537 6. EPA, 2008d. Toxicological Review of Decabromodiphenyl Ether (BDE-209), 

1538 EPA/635/R-07/008F, June 2008. 

1539 7. EPA. Certain Polybrominated Diphenyl Ethers; Proposed Significant New Use Rule. 

1540 69 FR70404, December 6, 2004. 

1541 8. Arkoosh MR, Boylen D, Dietrich J, Anulacion BF, Ylitalo G, Bravo CF, Johnson LL, 

1542 Loge FJ, Collier TK, Disease susceptibility of salmon exposed to polybrominated diphenyl 

1543 ethers (PBDEs). Aquatic Toxicology 98(1): 51-59. (2010) 

1544 

1545 9. McKernan MA, Rattner BA, et al. Toxicity of Polybrominated Diphenyl Ethers (De1546 71) In Chicken (Gallus gallus), Mallard (Anas platyrhynchos), and American Kestrel (Falco 

1547 sparverius) Embryos and Hatchlings. Environmental Toxicology and Chemistry 28(5):1007-

1548 1017. 2009. 

1549 10. Fernie KJ, Mayne G, Shutt LJ, Pekarick C, Grasman KA, Letcher RJ, Drouillard KG. 

1550 Evidence of immunomodulation in nestling American kestrels (Falco sparverius) exposed to 
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1551 environmentally relevant PBDEs. Environmental Pollution. 138:485-493. 2005a. 

1552 11. Fernie KJ, Shutt LJ, Mayne G, Hoffman DJ, Letcher RJ, Drouillard KG, Richie IJ. 

1553 Exposure to polybrominated diphenyl ethers (PBDEs): Changes in thyroid, vitamin A, 

1554 glutathione homeostasis, and oxidative stress in American kestrels (Falco sparverius). 

1555 Toxicological Sciences. 88:375-383. 2005b. 

1556 12. Fernie K, Shutt L, et al. The effects of exposure to polybrominated diphenyl ethers on 

1557 reproductive performance and immune function in captive American Kestrels. Journal of 

1558 Ornithology. 147(5): 92-92. 2006. 

1559 13. Fernie KJ, Marteinson S, Shutt JL, Bird DM, Letcher RJ, Ritchie JI. In ovo DE-71 

1560 exposure of male American kestrels: Reproductive and behavioral effects. Presented at the 10th 

1561 Workshop on Brominated Flame Retardants in the Environment. 2008.

1562 14. Fernie, KJ, Shutt JL, Letcher RJ, Ritchie IJ, and Bird DM. Environmentally Relevant 

1563 Concentrations of DE-71 and HBCD Alter Eggshell Thickness and Reproductive Success of 

1564 American Kestrels. Environmental Science & Technology. 43(6):2124-2130. 2009. 

1565 15. Zhang S, Bursian SJ, Martin PA, Chan HM, Tomy G, Palace VP, Mayne GJ, Martin 

1566 JW. Reproductive and developmental toxicity of a pentabrominated diphenyl ether mixture, DE1567 71, to ranch mink (Mustela vison) and hazard assessment for wild mink in the Great Lakes 

1568 region. Toxicological Sciences. 110 (1):107-116. 2009.

1569 16. Timme-Laragy AR, Levin DE, Di Giulio RT. Developmental and behavioral effects 

1570 of embryonic exposure to the polybrominated diphenylether mixture DE-71 in the killifish 

1571 (Fundulus heteroclitus). Chemosphere. 62:1097-1104. 2006

1572 17. Lema SC, Schultz IR, Scholz NL, Incardona PJ, Swanson P. Neural defects and 

1573 cardiac arrhythmia in fish larvae following embryonic exposure to 2,2’,4,4’-tetrabromodiphenyl 

1574 ether (PBDE 47). Aquatic Toxicology. 82: 296-307. 2007. 

1575 18. Kuiper RV, Vethaak AD, Cantón RF, Anselmo H, Dubbeldam M. Toxicity of 

1576 analytically cleaned pentabromodiphenylether after prolonged exposure in estuarine European 

1577 flounder (Platichthys flesus), and partial life-cycle exposure in fresh water zebrafish (Danio 

1578 rerio). Chemosphere. 73:195-202. 2008. 

1579 19. Nakari and Huhtala 2008. EPA, 2006. Polybrominated Diphenyl Ethers (PBDEs) 

1580 Project Plan. March, 2006. Available at http://www.epa.gov/oppt/pbde/pubs/proj-plan32906a.pdf 

1581 (accessed Dec. 15, 2009). 

1582 20. Vonderheide AP, Mueller KE, et al. Polybrominated diphenyl ethers: Causes for 

1583 concern and knowledge gaps regarding environmental distribution, fate and toxicity. Science of 

1584 the Total Environment. 400(1-3): 425-436. 2008. 

1585 21. Environment Canada. Ecological State of the Science Report on Decabromodiphenyl 

1586 Ether (decaBDE) Bioaccumulation and Transformation. 2010. Available from: 

1587 http://www.ec.gc.ca/lcpe-cepa/documents/substances/decabde/ess_report_decabde-eng.pdf
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1588 22. Shaw SD, Kannan K. Polybrominated diphenyl ethers in marine ecosystems of the 

1589 American continents: foresight from current knowledge. Reviews on Environmental Health. 

1590 24:157-229. 2009. 

1591 23. Environment Canada. Ecological Screening Assessment Report on Polybrominated 

1592 Diphenyl Ethers (PBDEs). 2006. Available from: 

1593 http://www.ec.gc.ca/CEPARegistry/documents/subs_list/PBDE_SAR/PBDEs_SAR_EC_June_2

1594 006_%28en%29.pdf. 

1595 24. Thuresson K, Bergman A, Jakobsson K. Occupational Exposure to Commercial 

1596 Decabromodiphenyl Ether in Workers Manufacturing or Handling Flame-Retarded Rubber. 

1597 Environmental Science & Technology. 39:1980-1986. 2005. 

1598 25. Tokarz JA, Ahn MY, Leng J, Filley TR, Nies L. Reductive Debromination of 

1599 Polybrominated Diphenyl Ethers in Anaerobic Sediment and a Biomimetic System. 

1600 Environmental Science & Technology. 42:1157-1164. 2008. 

1601 26. La Guardia MJ, Hale RC, Harvey E. Evidence of Debromination of 

1602 Decabromodiphenyl Ether (BDE-209) in Biota from a Wastewater Receiving Stream. 

1603 Environmental Science & Technology. 41(19):6663-6670. 2007. 

1604 27. Stapleton HM. Brominated flame retardants: assessing the decaBDE debromination in 

1605 the environment. Health and Environmental Alliance (formerly the EPHA Environmental 

1606 Network (EEN)). May 2006. 

1607 28. Stapleton HM, Dodder NG. Photodegradation of decabromodiphenyl ether in house 

1608 dust by natural sunlight. Environmental Toxicology and Chemistry. 27:306-312. 2008 

1609 29. Wania F, Dugani CB. Assessing the long-range transport potential of polybrominated 

1610 diphenyl ethers: a comparison of four multimedia models. Environmental Toxicology and 

1611 Chemistry. 22:1252–1261. 2003. 

1612 30. ATSDR. Agency for Toxic Substances and Disease Registry. Toxicological Profile 

1613 for Polybrominated Diphenyl Ethers and Polybrominated Biphenyls. 2004. 

1614 www.atsdr.cdc.gov/toxprofiles/tp68.html. 

1615 31. EPA. An exposure assessment of polybrominated diphenyl ethers. National Center 

1616 for Environmental Assessment, Washington, DC; EPA/600/R-08/086F. 2010. Available from the 

1617 National Technical Information Service, Springfield, VA, and online at 

1618 http://www.epa.gov/ncea. 

1619 

1620 32. Allen JG, McClean MD, Stapleton HM, Webster TF. Critical factors in assessing 

1621 exposure to PBDEs via house dust. Environment International. 34(8):1085-1091. November 

1622 2008. 

1623 33. Lorber M. Exposure of Americans to polybrominated diphenyl ethers. Journal of 

1624 Exposure Science and Environmental Epidemiology. 18:2-19. 2008. 

1625 34. Jones-Otazo HA, Clarke J, Diamond ML, Archbold J, Ferguson G, Harner T, 
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1626 Richardson SM, Jakeryan J, and Wilford BY. Is House Dust the Missing Exposure Pathway for 

1627 PBDEs? An Analysis of the Urban Fate and Human Exposure to PBDEs. Environmental Science 

1628 & Technology. 39: 5121-5130. 2005 

1629 35. Hites RA. Polybrominated Diphenyl Ethers in the Environment and in People: A 

1630 Meta-Analysis of Concentrations. Environmental Science & Technology. 38: 945. 2004 

1631 36. Cal/EPA PBDE Workgroup. Polybrominated Diphenyl Ethers: Recommendations to 

1632 Reduce Exposure in California. California Environmental Protection Agency, Sacramento, 

1633 California. February 2006. Available at: http://oeha.ca.gov/pdf/PBDEWrkgrpRptFeb06.pdf. 

1634 37. Sjodin A, Wong LY, Jones RS, Park A, Zhang Y, Hodge C, Dipietro E, McClure C, 

1635 Turner W, Needham LL and Patterson DG. Serum concentrations of polybrominated diphenyl 

1636 ethers (PBDEs) and polybrominated biphenyl (PBB) in the United States population: 2003-2004. 

1637 Environmental Science & Technology. 42:1377-1384. 2008. 

1638 38. NHANES. Centers for Disease Control and Prevention, Atlanta (GA). December 

1639 2009. Available at: http://www.cdc.gov/exposurereport/faq.html

1640 39. Environment Canada. Flame Retardants: A threat to the environment? Science & the 

1641 Environment Bulletin. 30:5. May/June 2002. Available at: http://dsp1642 psd.pwgsc.gc.ca/Collection/En1-28-1-2002-03E.pdf

1643 40. Park JS, Holden A, et al. Time-Trends and Congener Profiles of PBDEs and PCBs in 

1644 California Peregrine Falcons (Falco peregrinus). Environmental Science & Technology.

1645 43(23):8744-8751. 2009. 

1646 41. Gobas FAPC and Morrison HA. Bioconcentration and biomagnification in the aquatic 

1647 environment. In Handbook of Property Estimation Methods for Chemicals. Environmental and 

1648 Health Sciences. pp. 189-231. RS Boethling and DMackay, Eds,. Lewis/CRC, Boca Raton, FL 

1649 USA. 2000. 

1650 42. Chen D, Mai B, Song J, Sun Q, Luo Y, Luo X, Zeng EY, Hale RC. Polybrominated 

1651 diphenyl ethers in birds of prey from Northern China. Environmental Science & Technology. 

1652 41:1828-1833. 2007. 

1653 43. Voorspoels S, Covaci A, Lepom P, Jaspers VLB, Neels H, Schepens P. 

1654 Biomagnification of PBDEs in three small terrestrial food chains. Environmental Science & 

1655 Technology. 41:411–-416. 2007. 

1656 44. Stapleton HM, Baker JE. Comparing polybrominated diphenyl ether and 

1657 polychlorinated biphenyl bioaccumulation in a food web in Grand Traverse Bay, Lake Michigan. 

1658 Archives of Environmental Contamination and Toxicology. 45:227–234. 2003. 

1659 45. Gandhi et.al. Development of a Multichemical Food Web Model: Application to 

1660 PBDEs in Lake Ellasjøen, Bear Island, Norway. Environmental Science & Technology. 

1661 40(15):4714–4721. 2006. 

1662 46. Stapleton HM, Alaee M, Letcher RJ, Baker JE. Debromination of the flame retardant 
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1663 decabromodiphenyl ether by juvenile carp (Cyprinus carpio). Environmental Science & 

1664 Technology. 38:112-119. 2004. 

1665 47. Van den Steen E, Covaci A, Jaspers VLB, Dauwe T, Voorspoels S, Eens M, 

1666 Pinxten R. Accumulation, tissue-specific distribution and biotransformation of BDE 209 in 

1667 European starlings (Sturnus vulgaris). Environmental Pollution. 148:648-653. 2007.

1668 48. EPA. Voluntary Children’s Chemical Evaluation Program: Data Needs Decision 

1669 Document for Pentabromodiphenyl Ether and Octabromodiphenyl Ether. Prepared by Risk 

1670 Assessment Division, OPPT. June 2005. 

1671 49. EPA. Voluntary Children’s Chemical Evaluation Program: Data Needs Decision 

1672 Document for Decabromodiphenyl Ether. Prepared by Risk Assessment Division, OPPT. June 

1673 2005. 

1674 50. Darnerud PO. Toxic effects of brominated flame retardants in man and in wildlife. 

1675 Environment International. 29:841-853. 2003. 

1676 51. Harley KG, et al. PBDE Concentrations in Women’s Serum and Fecundability. 

1677 Environmental Health Perspectives. 118(5): 699-704. May 2010. 

1678 52. Costa LG, et al. Polybrominated diphenyl ether (PBDE) flame retardants: 

1679 environmental contamination, human body burden and potential adverse health effects. Acta 

1680 Biomed. 79:172-183. 2008. 

1681 53. Herbstman JB, et al. Prenatal Exposure to PBDEs and Neurodevelopment. 

1682 Environmental Health Perspectives. 118(5):712-719. May 2010. 

1683 54. Bromine Science and Environmental Forum. An Oral (gavage) Developmental 

1684 Neurotoxicity Test of Decabromodiphenyl Oxide in Rats. Submitted to EPA on May 19, 2010. 

1685 55. ASTM. Standard test method for measuring the toxicity of sediment-associated 

1686 contaminants with freshwater invertebrates. ASTM E 1706-05e1. 

1687 56. ASTM. Standard guide for collection, storage, characterization, and manipulation of 

1688 sediments for toxicological testing and for selection of samplers used to collect benthic 

1689 invertebrates. ASTM E 1391-03. 

1690 57. ASTM. Standard guide for conducting laboratory soil toxicity or bioaccumulation 

1691 tests with the Lumbricid Earthworm Eisenia Fetida and the Enchytraeid Potworm Enchytraeus 

1692 albidus. ASTM E 1676-04. 

1693 58. ASTM. Standard guide for conducting sediment toxicity tests with Polychaetous 

1694 Annelids. ASTM E 1611-00. 

1695 59. ASTM. Standard guide for conducting laboratory soil toxicity tests with the 

1696 Nematode Caenorhabditis elegans. ASTM E 2172-01. 

1697 60. ASTM. Standard test method for measuring the toxicity of sediment-associated 
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1698 contaminants with estuarine and marine invertebrates. ASTM E 1367-03. 

1699 61. EPA. Toxic Substances; Test Rule Development and Exemption Procedures; Interim 

1700 Final Rule. Federal Register (50 FR 20652, May 17, 1985). 

1701 62. EPA. Toxic Substances Control Act; Data Reimbursement; Final Rule. Federal 

1702 Register (48 FR 31786, July 11, 1983). 

1703 63. EPA. OPPT. Draft Guidance on Developing Robust Summaries. October 22, 1999. 

1704 Available on-line at http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm. 

1705 64. EPA. Analysis of Laboratory Capacity to Support U.S. EPA Chemical Testing 

1706 Program Initiatives. Economic and Policy Analysis Branch. Washington, DC. August 2004. 

1707 65. EPA. VCCEP Web site home page. (www.epa.gov/oppt/vccep). 

1708 66. EPA, 2009. Polybrominated Diphenyl Ethers (PBDEs) Action Plan. Available at: 

1709 http://www.epa.gov/oppt/existingchemicals/pubs/pbdes_ap_2009_1230_final.pdf 

1710 67. Chemtura. Letter from Robert Campbell to Jim Willis, Director, CCD, OPPT, 

1711 USEPA. January 6, 2006. 

1712 68. Albermarle Corporation. Letter from David W. Clary, Albemarle Corp. to Lisa P. 

1713 Jackson, USE EPA. EPA-Industry DecaBDE Phase-Out Initiative. Dec 15, 2009. 

1714 69. Chemtura Corporation. Letter from Craig A. Rogerson, Chemtura Corp. to Lisa P. 

1715 Jackson, US EPA. DecaBDE Phase-Out Initiative. Dec 17, 2009. 

1716 70. ICL Industrial Products. Letter from Nissim Adar to Lisa P. Jackson, US EPA. 

1717 Voluntary Phase-Out of DecaBDE. Dec 15, 2009. 

1718 71. Arnold & Porter LLP. Letter from Lawrence Culleen to Ward Penberthy, CCD, 

1719 EPA. June 25, 2010. 

1720 72. EPA. Economic Analysis of the Proposed Significant New Use Rule for 

1721 Polybrominated Diphenyl Ethers. Prepared by Timothy Lehman and Abt Associates Inc. 

1722 September 30, 2010. 

1723 73. EPA. Economic Impact Analysis for the Proposed Section 4 Test Rule for c1724 Pentabromodiphenyl Ether, c-Octabromodiphenyl Ether, and c-Decabromodiphenyl Ether. 

1725 Prepared by Timothy Lehman and Abt Associates Inc. September 30, 2010. 

1726 74. Kimbrough KL, Johnson WE, Lauenstein GG, Christensen JD, and Apeti DA. An 

1727 Assessment of Polybrominated Diphenyl Ethers (PBDEs) in Sediments and Bivalves of the U.S. 

1728 Coastal Zone. NOAA Technical Memorandum NOS NCCOS 94. 2009. 

1729 

1730 XIII. Statutory and Executive Order Reviews 

1731 A. Executive Order 12866 
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1732 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

1733 October 4, 1993), this action has been designated a “significant regulatory action” by the Office 

1734 of Management and Budget (OMB). Accordingly, EPA submitted this action to OMB for review 

1735 and any changes made in response to OMB recommendations have been documented in the 

1736 docket for this action. 

1737 

1738 In addition, EPA has prepared two economic analyses of the potential impacts associated 

1739 with this action. A copy of these economic analyses, entitled Economic Impact Analysis for the 

1740 Proposed Section 4 Test Rule for c-Pentabromodiphenyl Ether, c-Octabromodiphenyl Ether, and 

1741 c-Decabromodiphenyl Ether (Ref. 73) and Economic Analysis of the Proposed Significant New 

1742 Use Rule for Polybrominated Diphenyl Ethers (Ref. 72), are available in the docket for this 

1743 proposed rule and are summarized in Unit X. of this preamble. 

1744 

1745 B. Paperwork Reduction Act 

1746 This proposed rule does not impose any paperwork collection requirements that would 

1747 require additional review and/or approval by OMB under the Paperwork Reduction Act (PRA), 

1748 44 U.S.C. 3501 et. seq. The information collection requirements related to the proposed SNUR 

1749 (i.e., the submission of a SNUN) have been approved by OMB pursuant to the PRA under OMB 

1750 control number 2070-0038 (EPA ICR No. 1188). The information collection requirements 

1751 related to the proposed test rule have been approved by OMB pursuant to the PRA under OMB 

1752 control number 2070-0033 (EPA ICR No. 1139). Although the test rule information collection 

1753 activities are approved, the additional burden associated with this test rule is not yet covered by 

1754 the approved ICR until the final rule is effective. In the context of developing a new test rule, 

1755 the Agency must determine whether the total annual burden covered by the approved ICR needs 

1756 to be amended to accommodate the burden associated with the new test rule. If so, the Agency 

1757 must submit an Information Correction Worksheet (ICW) to OMB and obtain OMB approval of 

1758 an increase in the total approved annual burden in the OMB inventory. 

1759 

1760 The information collection activities related to export notification under TSCA section 

1761 12(b)(1) are already approved under OMB control number 2070–0030 (EPA ICR No. 0795). 

1762 This rulemaking does not propose any new or changes to the export notification requirements, 

1763 and is not expected to result in any substantive changes in the burden estimates for EPA ICR No. 

1764 0795 that would require additional review and/or approval by OMB. 

1765 

1766 Under the PRA, an agency may not conduct or sponsor, and a person is not required to 

1767 respond to, a collection of information that is subject to approval under the PRA, unless it 

1768 displays a currently valid OMB control number. The OMB control numbers for the EPA 

1769 regulations codified in chapter 40 of the CFR, after appearing in the preamble of the final rule, 

1770 are listed in 40 CFR part 9, displayed either by publication in the Federal Register or by other 

1771 appropriate means, such as on the related collection instrument or form, if applicable. The 

1772 display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9. 

1773 

1774 To submit a SNUN, EPA estimates that the industry burden hours per chemical to be 92 

1775 hours. (Ref. 72). The standard chemical testing program involves the submission of letters of 

1776 intent to test (or exemption applications), study plans, semi-annual progress reports, test results, 

1777 and administrative costs. For this proposed rule, EPA estimates the total industry burden hours 
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1778 for all three mixtures to be 37,074 hours (56,717 hours) for the low (high) cost scenario. 

1779 Average industry burden hours per mixture are estimated to be 12,358 hours (18,906 hours) in 

1780 the low (high) cost scenario. (Ref. 72). 

1781 

1782 The estimated burden of the information collection activities related to export notification 

1783 is estimated to average 1 burden hour for each mixture/country combination for an initial 

1784 notification and 0.5 hours for each subsequent notification (Ref. 72). In estimating the total 

1785 burden hours approved for the information collection activities related to export notification, the 

1786 Agency has included sufficient burden hours to accommodate any export notifications that may 

1787 be required by the Agency’s issuance of final test rules. As such, EPA does not expect to need to 

1788 request an increase in the total burden hours approved by OMB for export notifications. 

1789 

1790 As defined by PRA and 5 CFR 1320.3(b), ‘‘burden’’ means the total time, effort, or 

1791 financial resources expended by persons to generate, maintain, retain, or disclose or provide 

1792 information to or for a Federal agency. This includes the time needed to: Review instructions; 

1793 develop, acquire, install, and utilize technology and systems for the purposes of collecting, 

1794 validating, and verifying information, processing and maintaining information, and disclosing 

1795 and providing information; adjust the existing ways to comply with any previously applicable 

1796 instructions and requirements; train personnel to be able to respond to a collection of 

1797 information; search data sources; complete and review the collection of information; and 

1798 transmit or otherwise disclose the information. 

1799 

1800 Comments are requested on the Agency’s need for this information, the accuracy of the 

1801 provided burden estimates, and any suggested methods for minimizing respondent burden, 

1802 including through the use of automated collection techniques. Send comments to EPA as part of 

1803 your overall comments on this proposed action in the manner specified under ADDRESSES. In 

1804 developing the final rule, the Agency will address any comments received regarding the 

1805 information collection requirements contained in this proposal. 

1806 

1807 C. Regulatory Flexibility Act

1808 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 

1809 after considering the potential economic impacts of this proposed rule on small entities, the 

1810 Agency hereby certifies that this proposed rule does not have a significant adverse economic 

1811 impact on a substantial number of small entities. The factual basis for the Agency’s 

1812 determination is presented in the small entity impact analysis prepared as part of the economic 

1813 analyses for this proposed rule (Refs. 72 and 73), which are summarized in Unit X. of this 

1814 document, and copies of which are available in the docket for this rulemaking. The following is 

1815 a brief summary of the factual basis for this certification. 

1816 

1817 Under the RFA, small entities include small businesses, small organizations, and small 

1818 governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small 

1819 entities, small entity is defined in accordance with the RFA as: 1) A small business as defined 

1820 by the Small Business Administration’s (SBA) regulations at 13 CFR 121.201; 2) A small 

1821 governmental jurisdiction that is a government of a city, county, town, school district, or special 

1822 district with a population of less than 50,000; and 3) A small organization that is any not-for1823 profit enterprise which is independently owned and operated and is not dominant in its field. 
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1824 

1825 Based on the industry profile that EPA prepared as part of the economic analysis for this 

1826 rulemaking (Ref. 73), EPA has determined that this proposed rule is not expected to impact any 

1827 small not-for-profit organizations or small governmental jurisdictions. As such, the Agency’s 

1828 analysis presents only the estimated potential impacts on small business. 

1829 

1830 Two factors are examined in EPA’s small entity impact analysis (Ref. 73) in order to 

1831 characterize the potential small entity impacts of this proposed rule on small business: 1) The 

1832 size of the adverse economic impact (measured as the ratio of the cost-to-sales or cost-to1833 revenue), and 2) The total number of small entities that experience the adverse economic 

1834 impact. 

1835 

1836 Section 601(3) of the RFA establishes as the default definition of “small business” the 

1837 definition used in section 3 of the Small Business Act, 15 U.S.C. 632, under which the Small 

1838 Business Administration (SBA) establishes small business size standards (13 CFR 121.201). For 

1839 this rulemaking, EPA has analyzed the potential small business impacts using the size standards 

1840 established under this default definition. The SBA size standards, which are primarily intended 

1841 to determine whether a business entity is eligible for government programs and preferences 

1842 reserved for small businesses (13 CFR 121.101), “seek to ensure that a concern that meets a 

1843 specific size standard is not dominant in its field of operation.” (13 CFR 121.102(b)). See 

1844 section 632(a)(1) of the Small Business Act. In analyzing potential impacts, the RFA recognizes 

1845 that it may be appropriate at times to use an alternate definition of small business. As such, 

1846 section 601(3) of the RFA provides that an agency may establish a different definition of small 

1847 business after consultation with the SBA Office of Advocacy and after notice and an opportunity 

1848 for public comment. Even though the Agency has used the default SBA definition of small 

1849 business to conduct its analysis of potential small business impacts for this proposed rule, EPA 

1850 does not believe that the SBA size standards are generally the best size standards to use in 

1851 assessing potential small entity impacts with regard to TSCA section 4(a) test rules. 

1852 

1853 The SBA size standard is generally based on the number of employees an entity in a 

1854 particular industrial sector may have. For example, in the chemical manufacturing industrial 

1855 sector (i.e., NAICS 325 and NAICS 324110), approximately 98% of the firms would be 

1856 classified as small businesses under the default SBA definition. The SBA size standard for 75% 

1857 of this industry sector is 500 employees, and the size standard for 23% of this industry sector is 

1858 either 750, 1,000, or 1,500 employees. When assessing the potential impacts of test rules on 

1859 chemical manufacturers, EPA believes that a standard based on total annual sales may provide a 

1860 more appropriate means to judge the ability of a chemical manufacturing firm to support 

1861 chemical testing without significant costs or burdens. 

1862 

1863 EPA is currently determining what level of annual sales would provide the most 

1864 appropriate size cutoff with regard to various segments of the chemical industry usually 

1865 impacted by TSCA section 4(a) test rules, but has not yet reached a determination. As stated 

1866 above, therefore, the factual basis for the RFA determination for this proposed rule is based on 

1867 an analysis using the default SBA size standards. Although EPA is not currently proposing to 

1868 establish an alternate definition for use in the analysis conducted for this proposed rule, the 

1869 analysis for this proposed rule also presents the results of calculations using a standard based on 

1870 total annual sales (40 CFR 704.3). EPA is interested in receiving comments on whether the 
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1871 Agency should consider establishing an alternate definition for small business to use in the small 

1872 entity impact analyses for future TSCA section 4(a) test rules, and what size cutoff may be 

1873 appropriate. 

1874 

1875 The SBA has developed 6 digit NAICS code-specific size standards based on 

1876 employment thresholds. These size standards range from 500 to 1,500 employees for the various 

1877 6 digit NAICS codes that are potentially impacted (Ref. 73). For a conservative estimate of the 

1878 number of small businesses affected by this rule, the Agency chose an employment threshold of 

1879 less than 1,500 employees for all businesses regardless of the NAIC-specific threshold to 

1880 determine small business status. 

1881 

1882 For manufacturers and importers of decaBDE covered by this proposed rule, six parent 

1883 companies (ultimate corporate entity, or UCE) were identified and sales and employment data 

1884 were obtained for companies where data were publicly available. Parent company sales data 

1885 were used to identify companies that qualified as a “small business” for purposes of the RFA 

1886 analysis. Based on the TSCA employment standard (1,500 employees or less), one company 

1887 was identified as small. This company had cost-to-sales ratios of greater than 3% under both the 

1888 low- and high-cost scenarios. Given these results, the Agency has determined that there is not a 

1889 significant economic impact on a substantial number of small entities as a result of this proposed 

1890 rule, if finalized. 

1891 

1892 The estimated cost of the TSCA section 12(b)(1) export notification, which, as a result of 

1893 the final rule, would be required for the first export to a particular country of a mixture subject to 

1894 the rule, is estimated to be $85.70 for the first time that an exporter must comply with TSCA 

1895 section 12(b)(1) export notification requirements, and $26.86 for each subsequent export 

1896 notification submitted by that exporter (Ref. 72). EPA has concluded that the costs of TSCA 

1897 section 12(b)(1) export notification would have a negligible impact on exporters of the mixtures 

1898 in the final rule, regardless of the size of the exporter. 

1899 

1900 Any comments regarding the impacts that this action may impose on small entities, or 

1901 regarding whether the Agency should consider establishing an alternate definition of small 

1902 business to be used for analytical purposes for future test rules and what size cutoff may be 

1903 appropriate, should be submitted to the Agency in the manner specified under ADDRESSES. 

1904 

1905 D. Unfunded Mandates Reform Act 

1906 This action does not contain any Federal mandates for State, local, or tribal governments 

1907 or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act 

1908 (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory action will not result in 

1909 annual expenditures of $100 million or more for State, local, and tribal governments, in the 

1910 aggregate, or for the private sector. For the private sector, it is estimated that the total aggregate 

1911 costs of this proposed rule would be $15.1 million. The total annualized costs of this proposed 

1912 rule to the private sector are estimated to be $5.34 and 5.75 million using a 3% and 7% discount 

1913 rate over 3 years (high cost scenario). In addition, since EPA does not have any information to 

1914 indicate that any State, local, or tribal government manufactures or processes the mixtures 

1915 covered by this action such that this rule would apply directly to State, local, or tribal 

1916 governments, EPA has determined that this proposed rule would not significantly or uniquely 
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1917 affect small governments. Accordingly, this proposed rule is not subject to the requirements of 

1918 sections 202, 203, 204, and 205 of UMRA. 

1919 

1920 E. Executive Order 13132 

1921 Under Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), 

1922 EPA has determined that this proposed rule does not have “federalism implications” because it 

1923 will not have substantial direct effects on the States, on the relationship between the national 

1924 government and the States, or on the distribution of power and responsibilities among the various 

1925 levels of government, as specified in the Executive Order. The proposed test rule would 

1926 establish testing and recordkeeping requirements that apply to manufacturers (including 

1927 importers) and processors of certain mixtures. The proposed amendments to the SNUR would 

1928 establish notification and submission requirements that apply to manufacturers (including 

1929 importers) before certain chemicals may be manufactured or imported. Because EPA has no 

1930 information to indicate that any State or local government manufactures or processes the 

1931 chemical substances and mixtures covered by this action, the proposed SNUR-Test Rule does not 

1932 apply directly to States and localities and will not affect State and local governments. Thus, 

1933 Executive Order 13132 does not apply to this proposed rule. 

1934 F. Executive Order 13175 

1935 Under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal 

1936 Governments (65 FR 67249, November 9, 2000), EPA has determined that this proposed rule 

1937 does not have tribal implications because it will not have any affect on tribal governments, on the 

1938 relationship between the Federal Government and the Indian tribes, or on the distribution of 

1939 power and responsibilities between the Federal Government and Indian tribes, as specified in the 

1940 Executive Order. As indicated previously, EPA has no information to indicate that any tribal 

1941 government manufactures or processes the chemical substances or mixtures covered by this 

1942 action. Thus, Executive Order 13175 does not apply to this proposed rule. 

1943 G. Executive Order 13045 

1944 EPA interprets Executive Order 13045, entitled Protection of Children from 

1945 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 

1946 those regulatory actions that concern health or safety risks, such that the analysis required under 

1947 section 5-501 of Executive Order 13045 has the potential to influence the regulation. This action

1948 is not subject to Executive Order 13045 because it does not establish an environmental standard 

1949 intended to mitigate health or safety risks. Nevertheless, the information obtained by this 

1950 proposed rule could inform the Agency’s decision-making process regarding mixtures to which 

1951 children may be disproportionately exposed. The proposed test rule would establish testing and 

1952 recordkeeping requirements that apply to manufacturers (including importers) and processors of 

1953 certain mixtures, and would result in the development of data about those mixture substances 

1954 that can subsequently be used to assist the Agency and others in determining whether the 

1955 mixtures in the proposed test rule present potential risks, allowing the Agency and others to take 

1956 appropriate action to investigate and mitigate those risks. Similarly, the proposed amendments 

1957 to the SNUR would allow EPA to review available information to identify and take action to 

1958 address potential risk because it would require manufacturers to submit notification and hazard 

1959 information in the form of a SNUN to EPA before a chemical may be manufactured or imported. 
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1960 H. Executive Order 13211 

1961 This action is not a “significant energy action” as defined in Executive Order 13211, 

1962 entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or 

1963 Use (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on 

1964 the supply, distribution, or use of energy as described in the Order. 

1965 I. National Technology Transfer and Advancement Act 

1966 Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA), 15 

1967 U.S.C. 272 note, directs EPA to use voluntary consensus standards in its regulatory activities 

1968 unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary 

1969 consensus standards are technical standards (e.g., materials specifications, test methods, 

1970 sampling procedures, and business practices) that are developed or adopted by voluntary 

1971 consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, 

1972 explanations when the Agency decides not to use available and applicable voluntary consensus 

1973 standards. 

1974 The proposed test rule involves technical standards because it proposes to require the use 

1975 of particular test methods. If the Agency makes findings under TSCA section 4(a), EPA is 

1976 required by TSCA section 4(b) to include specific standards or test methods that are to be used 

1977 for the development of the data required in the test rules issued under TSCA section 4. For 

1978 some of the testing that would be required by the final rule, EPA is proposing the use of 

1979 voluntary consensus standards issued by ASTM International and ISO which evaluate the same 

1980 type of toxicity as the TSCA 799 test guidelines and OECD test guidelines, where applicable. 

1981 Copies of the ASTM International standards referenced in the proposed regulatory text at §

1982 799.XXXX (h)(2)(i) through (v) have been placed in the docket for this proposed rule where they 

1983 are available for reading, but not copying. You may obtain copies of the ASTM International 

1984 standards from the American Society for Testing and Materials International, 100 Bar Harbor 

1985 Dr., West Conshohocken, PA 19428–2959. In the final rule, EPA intends to seek approval from 

1986 the Director of the Federal Register for the incorporation by reference of the ASTM 

1987 International and ISO standards used in the final rule in accordance with 5 U.S.C. 552(a) and 1 

1988 CFR part 51. 

1989 EPA is not aware of any potentially applicable voluntary consensus standards which 

1990 evaluate prenatal developmental toxicity, two-generation reproductive toxicity, developmental 

1991 neurotoxicity, immunotoxicity, or chronic toxicity/carcinogenicity, or screen for neurotoxicity 

1992 which could be considered in lieu of the TSCA 799 test guidelines, 40 CFR 799.9370, 799.9380, 

1993 799.9630, 799.9780, 799.9430, and 799.9620, respectively, upon which the test standards in the 

1994 proposed rule are based. 

1995 EPA is also not aware of any potentially applicable voluntary consensus standards which 

1996 evaluate anaerobic aquatic metabolism, biodegradation in anaerobic digester sludge, or 

1997 photolytic degradation in the indoor environment. As a result, EPA is proposing the use of three 

1998 guidelines which are published in full in the proposed regulatory text at § 799.XXXX (h)(3) (ii) 

1999 through (iv). 

2000 The Agency invites comment on the potential use of voluntary consensus standards in the 
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2001 proposed test rule, and, specifically, invites the public to identify potentially applicable 

2002 consensus standard(s) and to explain why such standard(s) should be used here. 

2003 J. Executive Order 12898 

2004 This proposed rule does not have an adverse impact on the environmental and health 

2005 conditions in low-income and minority communities that require special consideration by the 

2006 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 

2007 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 

2008 The Agency believes that the information collected under this proposed rule, if finalized, will 

2009 assist EPA and others in determining the potential hazards and risks associated with the mixtures 

2010 covered by this proposed rule. Although not directly impacting environmental justice-related 

2011 concerns, this information will enable the Agency to better protect human health and the 

2012 environment, including in low-income and minority communities. 

2013 K. Executive Order 12630

2014 EPA has complied with Executive Order 12630, entitled Government Actions and 

2015 Interference with Constitutionally Protected Property Rights (Takings) (53 FR 8859, March 15, 

2016 1988), by examining the takings implications of this proposed rule in accordance with the 

2017 “Attorney General’s Supplemental Guidelines for the Evaluation of Risk and Avoidance of 

2018 Unanticipated Takings” issued under the Executive Order. 

2019 L. Executive Order 12988

2020 In issuing this proposed rule, EPA has taken the necessary steps to eliminate drafting 

2021 errors and ambiguity, minimize potential litigation, and provide a clear legal standard for 

2022 affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice 

2023 Reform (61 FR 4729, February 7, 1996). 

2024 List of Subjects in 40 CFR Part 721 

2025 Environmental protection, Chemicals, Hazardous substances, Premanufacture 

2026 notification, Reporting and recordkeeping requirements. 

2027 List of Subjects in 40 CFR Part 799. 

2028 

2029 Environmental protection, Chemicals, Hazardous substances, Laboratories, Reporting 

2030 and recordkeeping requirements. 

2031 Dated: __________________ 

2032 

2033 _____________________________ 

2034 Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
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2035 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 

2036 

2037 PART 721---[AMENDED] 

2038 1. The authority citation for part 721 continues to read as follows: 

2039 Authority: [15 U.S.C. 2604, 2607, and 2625(c).]. 

2040 

2041 2. By amending 721.10000 to read as follows: 

2042 § 721. 10000 Certain Polybrominated Diphenylethers. 

2043 

2044 (a) Definitions. The definitions in § 721.3 apply to this section. In addition, the following 

2045 definitions apply: 

2046 (1) Military use means use by the armed forces of the United States. 

2047 (2) Transportation use means preparation of an article for use as an integral component 

2048 of a moving vehicle such as a car, truck, train, ship, or aircraft. 

2049 (b) Chemical substances subject to significant new use reporting. 

2050 (1) The chemical substances identified as tetrabromodiphenyl ether (CAS No. 40088–47–

2051 9; Benzene, 1,1′-oxybis-, tetrabromo deriv.), pentabromodiphenyl ether (CAS No. 32534–81–9; 

2052 Benzene, 1,1′-oxybis-, pentabromo deriv.), hexabromodiphenyl ether (CAS No. 36483–60–0; 

2053 Benzene, 1,1′-oxybis-, hexabromo deriv.), heptabromodiphenyl ether (CAS No. 68928–80–3; 

2054 Benzene, 1,1′-oxybis-, heptabromo deriv.), octabromodiphenyl ether (CAS No. 32536–52–0; 

2055 Benzene, 1,1′-oxybis-, octabromo deriv.), and nonabromodiphenyl ether (CAS No. 63936–56–1; 

2056 Benzene, pentabromo(tetrabromophenoxy)-), or any combination of these substances resulting 

2057 from a chemical reaction are subject to reporting under this section for the significant new uses 

2058 described in paragraph (c)(2) of this section. 

2059 (2) Decabromodiphenyl ether (CAS No. 1163-19-5; Benzene, 1,1'-oxybis[2,3,4,5,6-

2060 pentabromo-) 

2061 (c) Significant new uses. 

2062 (1) The significant new uses for chemicals identified in paragraph (b)(1) of this section 

2063 are: 

2064 (i) Manufacture or import for any use on or after January 1, 2005, and 

2065 (ii) Processing for any use after December 31, 2012. 

2066 (2) The significant new uses for the chemical identified in paragraph (b)(2) of this section 

2067 are: 

2068 (i) Manufacture, import or processing for any use except military and transportation uses 

2069 after December 31, 2012, and 

2070 (ii) Manufacture, import or processing for any use including military or transportation 

2071 uses after December 31, 2013.

2072 (d) Specific requirements. The provisions of subpart A of this part apply to this section 

2073 except as modified by this paragraph. 

2074 (1) Revocation of certain notification exemptions. The provisions of § 721.45(f) do not 

2075 apply to this section. A person who imports or processes a chemical substance identified in this 

2076 section as part of an article is not exempt from submitting a significant new use notice. 

2077 (2) [Reserved] 
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2078 

2079 PART 799---[AMENDED] 

2080 3. The authority citation for part 799 continues to read as follows: 

2081 Authority: 15 U.S.C. 2603, 2611, 2625 

2082 

2083 4. By adding § 799.XXXX to subpart D to read as follows: 

2084 § 799.XXXX Certain polybrominated diphenylethers.

2085 (a) What mixtures will be tested under this section? The chemical mixtures that must be 

2086 tested under this section are three representative commercial forms of pentabromodiphenyl ether, 

2087 octabromodiphenyl ether, and decabromodiphenyl ether, as follows: 

2088 (1) commercial pentabromodiphenyl ether (c-pentaBDE), whose predominant components are 

2089 tetrabromodiphenyl ether (CASRN 40088–47–9; Benzene, 1,1′-oxybis-, tetrabromo deriv.), 

2090 pentabromodiphenyl ether (CASRN 32534-81-9; Benzene, 1,1’-oxybis-, pentabromo deriv.), and 

2091 hexabromodiphenyl ether (CASRN 36483–60–0; Benzene, 1,1′-oxybis-, hexabromo deriv.), 

2092 

2093 (2) commercial octabromodiphenyl ether (c-octaBDE), whose predominant components are 

2094 heptabromodiphenyl ether (CASRN 68928–80–3; Benzene, 1,1′-oxybis-, heptabromo deriv.), 

2095 octabromodiphenyl ether (CAS No. 32536-52-0; Benzene, 1,1’-oxybis-, octabromo deriv.), and 

2096 nonabromodiphenyl ether (CASRN 63936–56–1; Benzene, pentabromo (tetrabromophenoxy)-), 

2097 and 

2098 

2099 (3) commercial decabromodiphenyl ether (c-decaBDE), whose component with the highest 

2100 percent composition is decabromodiphenyl ether (CASRN 1163-19-5; Benzene, 1,1’-

2101 oxybis[2,3,4,5,6-pentabromo-), aka BDE-209. 

2102 

2103 The test sponsor(s) must identify the percentage of each of the seven PBDE congeners present in 

2104 each of the representative commercial mixtures that will be tested. 

2105 

2106 (b) Am I subject to this section? (1) If you manufacture (including import) or process c2107 pentaBDE or c-octaBDE for any use including in articles at any time after December 31, 2012; 

2108 or manufacture or process c-decaBDE for any use except for military and transportation uses 

2109 including in articles at any time after December 31, 2012; or manufacture (including import) or 

2110 process c-decaBDE for any use including military or transportation uses including in articles at 

2111 any time after December 31, 2013, until the end of the test data reimbursement period as defined 

2112 in 40 CFR 791.3(h), you are subject to this section with respect to that mixture. You are also 

2113 subject to this rule if you manufacture (including import) or process c-pentaBDE, c-octaBDE, or 

2114 c-decaBDE for export from the United States. For this rule, importers of articles containing c2115 pentaBDE, c-octaBDE, or c-decaBDE are considered manufacturers and are subject to this rule. 

2116 (2) If you do not know or cannot reasonably ascertain that you manufacture or process a 

2117 mixture listed in paragraph (a) of this section during the time period described in paragraph 

2118 (b)(1) of this section (based on all information in your possession or control, as well as all 

2119 information that a reasonable person similarly situated might be expected to possess, control, or 

2120 know, or could obtain without unreasonable burden), you are not subject to this section with 
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2121 respect to that mixture. 

2122 (c) If I am subject to this section, when must I comply with it? (1) (i) Persons subject to 

2123 this section are divided into two groups, as set forth in Table 1 of this paragraph: Tier 1 (persons 

2124 initially required to comply) and Tier 2 (persons not initially required to comply). If you are 

2125 subject to this section, you must determine if you fall within Tier 1 or Tier 2, based on Table 1 of 

2126 this paragraph. 

2127 Table 1.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2

Tier 1 (Persons initially required to comply) Tier 2 (Persons not initially required to 

comply) 

Persons who manufacture (as defined at TSCA 

section 3(7)), or intend to manufacture, a test rule 

mixture and who are not listed under Tier 2. 

Importers of articles containing PBDEs are 

considered manufacturers. 

A. Persons who manufacture (as defined 

at TSCA section 3(7)) or intend to 

manufacture a test rule mixture solely as 

one or more of the following: 

--As a byproduct (as defined at 40 

CFR791.3(c)); 

--As an impurity (as defined at 40 CFR 

790.3); 

--As a naturally occurring chemical 

substance (as defined at 40 CFR 

710.4(b)); 

--As a non-isolated intermediate (as 

defined at 40 CFR 704.3); 

--As a component of a Class 2 substance 

(as described at 40 CFR 720.45(a)(1)(i)); 

--In amounts of less than 500 kg (1,100 

lbs.) annually (as described at 40 CFR 

790.42(a)(4)); or 

--In small quantities solely for research 

and development (R and D) (as described 

at 40 CFR 790.42(a)(5)). 

B. Persons who process (as defined at 

TSCA section 3(10)) or intend to process 

a test rule mixture, including in articles 

(see 40 CFR 790.42(a)(2)). 

2128 

2129 (ii) Table 1 of paragraph (c)(1)(i) of this section expands the list of persons in Tier 2, that 

2130 is those persons specified in § 790.42(a)(2), (a)(4) and (a)(5) of this chapter, who, while legally 

2131 subject to this section, must comply with the requirements of this section only if directed to do so 

2132 by EPA under the circumstances set forth in paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) 

2133 of this section. 

2134 (2) If you are in Tier 1 with respect to a mixture listed in paragraph (a) of this section, 
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2135 you must, for each test required under this section for that mixture, either submit to EPA a letter 

2136 of intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the 

2137 exemption application must be received by EPA no later than 30 days after the relevant effective 

2138 date in paragraph (k) of this section. 

2139 (3) If you are in Tier 2 with respect to a mixture listed in paragraph (a) of this section, 

2140 you are considered to have an automatic conditional exemption and you will be required to 

2141 comply with this section with regard to that mixture only if directed to do so by EPA under 

2142 paragraphs (c)(5), (c)(7), or (c)(10) of this section. 

2143 (4) If no person in Tier 1 has notified EPA of its intent to conduct one or more of the tests 

2144 required by this section on any mixture listed in paragraph (a) of this section within 30 days after 

2145 the relevant effective date in paragraph (k) of this section, EPA will publish a Federal Register

2146 document that would specify the test(s) and the mixture (s) for which no letter of intent has been 

2147 submitted and notify manufacturers in Tier 2A of their obligation to submit a letter of intent to 

2148 test or to apply for an exemption from testing. 

2149 (5) If you are in Tier 2A (as specified in Table 1 in paragraph (c) of this section) with 

2150 respect to a chemical substance listed in paragraph (a) of this section, and if you manufacture, or 

2151 intend to manufacture, this chemical substance after the relevant effective date in paragraph (k) 

2152 of this section, or within 30 days after publication of the Federal Register document described 

2153 in paragraph (c)(4) of this section, you must, for each test specified for that chemical substance 

2154 in the document described in paragraph (c)(4) of this section, either submit to EPA a letter of 

2155 intent to test or apply to EPA for an exemption from testing. The letter of intent to test or the 

2156 exemption application must be received by EPA no later than 30 days after publication of the 

2157 Federal Register document described in paragraph (c)(4) of this section. 

2158 (6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its intent to conduct one 

2159 or more of the tests required by this section on any chemical substance listed in paragraph (a) of 

2160 this section within 30 days after the publication of the Federal Register document described in 

2161 paragraph (c)(4) of this section, EPA will publish another Federal Register document that 

2162 would specify the test(s) and the chemical substance(s) for which no letter of intent has been 

2163 submitted, and notify processors in Tier 2B of their obligation to submit a letter of intent to test 

2164 or to apply for an exemption from testing. 

2165 (7) If you are in Tier 2B (as specified in Table 1 in paragraph (c) of this section) with 

2166 respect to a mixture listed in paragraph (a) of this section, and if you process, or intend to 

2167 process, this mixture after the relevant effective date in paragraph (k) of this section, or within 30 

2168 days after publication of the Federal Register document described in paragraph (c)(6) of this 

2169 section, you must, for each test specified for that mixture in the Federal Register document 

2170 described in paragraph (c)(6) of this section, either submit to EPA a letter of intent to test or 

2171 apply to EPA for an exemption from testing. The letter of intent to test or the exemption 

2172 application must be received by EPA no later than 30 days after publication of the Federal 

2173 Register document described in paragraph (c)(6) of this section. 

2174 (8) If no manufacturer or processor has notified EPA of its intent to conduct one or more 

2175 of the tests required by this section for any of the mixtures listed in paragraph (a) of this section 

2176 within 30 days after the publication of the Federal Register document described in paragraph 
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2177 (c)(6) of this section, EPA will notify all manufacturers and processors of those mixtures of this 

2178 fact by certified letter or by publishing a Federal Register document specifying the test(s) for 

2179 which no letter of intent has been submitted. This letter or Federal Register document will 

2180 additionally notify all manufacturers and processors that all exemption applications concerning 

2181 the test(s) have been denied, and will give the manufacturers and processors of the mixture (s) an 

2182 opportunity to take corrective action. 

2183 (9) If no manufacturer or processor has notified EPA of its intent to conduct one or more 

2184 of the tests required by this section for any of the mixtures listed in paragraph (a) of this section 

2185 within 30 days after receipt of the certified letter or publication of the Federal Register

2186 document described in paragraph (c)(8) of this section, all manufacturers and processors subject 

2187 to this section with respect to that mixture who are not already in violation of this section will be 

2188 in violation of this section. 

2189 (10) If a problem occurs with the initiation, conduct, or completion of the required testing 

2190 or the submission of the required data with respect to a mixture listed in paragraph (a) of this 

2191 section, under the procedures in §§ 790.93 and 790.97 of this chapter, EPA may initiate 

2192 termination proceedings for all testing exemptions with respect to that mixture and may notify 

2193 persons in Tier 1 and Tier 2 that they are required to submit letters of intent to test or exemption 

2194 applications within a specified period of time. 

2195 (11) If you are required to comply with this section, but your manufacture or processing 

2196 of, or intent to manufacture or process, a mixture listed in paragraph (a) of this section begins 

2197 after the applicable compliance date referred to in paragraphs (c)(2), (c)(5), or (c)(7) of this 

2198 section, you must either submit a letter of intent to test or apply to EPA for an exemption. The 

2199 letter of intent to test or the exemption application must be received by EPA no later than the day 

2200 you begin manufacture or processing. 

2201 (d) What must I do to comply with this section? (1) To comply with this section you 

2202 must either submit to EPA a letter of intent to test, or apply to and obtain from EPA an 

2203 exemption from testing. 

2204 (2) For each test with respect to which you submit to EPA a letter of intent to test, you 

2205 must conduct the testing specified in paragraphs (h) and (i) of this section and submit the test 

2206 data to EPA. 

2207 (3) You must also comply with the procedures governing test rule requirements in part 

2208 790 of this chapter, as modified by this section, including the submission of letters of intent to 

2209 test or exemption applications, the submission of study plans prior to testing, the conduct of 

2210 testing, and the submission of data; Part 792—Good Laboratory Practice Standards of this 

2211 chapter; and this section. The following provisions of 40 CFR part 790 do not apply to this 

2212 section: Paragraphs (a), (d), (e), and (f) of § 790.45; § 790.48; paragraph (a)(2) and paragraph (b) 

2213 of § 790.80; paragraph (e)(1) of § 790.82; and § 790.85. 

2214 

2215 (e) If I do not comply with this section, when will I be considered in violation of it? You 

2216 will be considered in violation of this section as of 1 day after the date by which you are required 

2217 to comply with this section. 
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2218 (f) How are EPA’s data reimbursement procedures affected for purposes of this section? 

2219 If persons subject to this section are unable to agree on the amount or method of reimbursement 

2220 for test data development for one or more mixtures included in this section, any person may 

2221 request a hearing as described in 40 CFR part 791. In the determination of fair reimbursement 

2222 shares under this section, if the hearing officer chooses to use a formula based on production 

2223 volume, the total production volume amount will include amounts of a mixture manufactured 

2224 and processed as impurities and amounts imported in articles. 

2225 (g) Who must comply with the export notification requirements? Any person who 

2226 exports, or intends to export, a mixture listed in paragraph (a) of this section is subject to part 

2227 707, subpart D, of this chapter except when the mixture is in articles. 

2228 (h) How must I conduct my testing of c-pentaBDE and c-octaBDE? The tests that are 

2229 required for c-pentaBDE and c-octaBDE and the test methods that must be followed are listed in 

2230 subparagraphs (1) through (11) of paragraph (h) of this section. All tests must be conducted in 

2231 accordance with the requirements described in 40 CFR Part 792—Good Laboratory Practice 

2232 Standards. 

2233 (1) toxicity to freshwater invertebrates of sediment-associated contaminants conducted in 

2234 accordance with ASTM E 1706-05e1 and following the guidance of ASTM E 1391-03, 

2235 (2) Laboratory soil toxicity and bioaccumulation tests with the lumbricid earthworm 

2236 Eisenia fetidaand the enchytraeid potworm Enchytraeus albidu conducted in accordance with 

2237 ASTM E 1676-04 and following general guidance in ASTM E 1391-03, 

2238 (3) toxicity to polychaetous annilids of sediment-associated contaminants conducted in 

2239 accordance with ASTM E 1611-00 and following the guidance of ASTM E 1391-03, 

2240 (4) laboratory soil toxicity to nematode Caenorhabditis elegans conducted in accordance 

2241 with ASTM E 2172-01 and following guidance for collecting laboratory soil in ASTM E 1676-

2242 04, and following general guidance in ASTM E 1391-03, 

2243 (5) toxicity to estuarine and marine invertebrates of sediment-associated contaminants 

2244 conducted in accordance with ASTM E 1367-03 and following the guidance of ASTM E 1391-

2245 03, 

2246 (6) prenatal developmental toxicity in rabbits conducted in accordance with 40 CFR 

2247 799.9370, 

2248 (7) two-generation reproductive toxicity with a satellite group for body burden 

2249 determinations conducted in accordance with 40 CFR 799.9380, 

2250 (8) immunotoxicity conducted in accordance with 40 CFR 799.9780, 

2251 (9) neurotoxicity screening battery, acute and subchronic, conducted in accordance with 

2252 40 CFR 799.9620, 

2253 (10) developmental neurotoxicity conducted in accordance with 40 CFR 799.9630, 
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2254 (11) chronic toxicity/carcinogenicity conducted in accordance with 40 CFR 799.9430. 

2255 (i) How must I conduct my testing of c-decaBDE? The tests that are required for c2256 decaBDE and the test methods that must be followed are listed in subparagraphs (1) through (4) 

2257 of paragraph (i) of this section. The use of the term “test substance” in the guidelines listed in 

2258 subparagraphs (2) through (4) of paragraph (i) of this section, should be understood to mean c2259 decaBDE or test mixture where appropriate. All tests must be conducted in accordance with the 

2260 requirements described in 40 CFR Part 792—Good Laboratory Practice Standards. 

2261 (1) The tests and test methods listed in paragraphs (h)(1) through (h)(10) of this section. 

2262 (2) anaerobic aquatic metabolism conducted in accordance with the following guideline: 

2263 (i) Title. Decabromodiphenyl ether: Anaerobic Aquatic Metabolism 

2264 (ii) Source. U.S. Environmental Protection Agency, Series 835 – Fate, Transport and 

2265 Transformation Test Guidelines, OCSPP Guideline 835.4400—Anaerobic Aquatic Metabolism. 

2266 (iii) Introduction. Chemicals can enter shallow or deep surface waters by a wide variety 

2267 of routes including direct application, run-off, groundwater seepage drainage, waste disposal, 

2268 industrial or agricultural effluent and atmospheric deposition. This study plan describes a 

2269 proposed laboratory test method to assess transformation of the test substance in anaerobic 

2270 aquatic sediment systems. 

2271 

2272 (iv) Objectives. The objectives of the study are to 1) measure the rate of transformation 

2273 of the test substance, decabromodiphenyl ether; 2) identify and quantify all detectable 

2274 degradation products; 3) identify and quantify the transformation pathways and rate of formation 

2275 and degradation of intermediate products in the water, vapor and sediment phases; and 4) 

2276 measure the distribution of the test substance and degradation products and intermediates within 

each phase in the test system. 

14

2277 C-labeled decabromodiphenyl ether shall be used to help ensure 

2278 mass balance over time. 

2279 

2280 (v) Experimental design. The test shall be conducted using six sediments and their 

associated waters at two concentrations (one trace; the other significantly higher), using 

14

2281 C2282 labeled test substance. Sediments shall be selected to include a variety of sediment types and 

2283 shall include sediments known to contain polybrominated diphenyl ethers (PBDEs) and 

2284 polychlorinated biphenyls (PCBs). 

2285 Untreated live and killed controls and test substance-dosed biotic and abiotic systems 

2286 shall be prepared for each sediment type. Based on published studies on the biodegradation of 

2287 decabromodiphenyl ether in sediments, the half-life of decabromodiphenyl ether may be long. 

2288 Tokarz (2008) reported sediment half-lives ranging from 6-50 years with an average of 14 years. 

2289 Therefore, it is expected that untreated control, test substance-dosed live, and killed control 

2290 systems will be incubated at approximately 20°C for at least 36 months. However, the actual 

2291 study duration shall be dependent on the analytical results for initial sampling periods. The total 

2292 duration and interval for later samples may be changed depending on the observed rate of 

2293 degradation. 

2294 Duplicate test vessels for each treatment (i.e. treated and control) option, each test 
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2295 substance concentration and each sediment shall be sacrificed at appropriate time intervals. Test 

2296 substance-dosed systems shall be used for quantification of parent material and degradation 

2297 products. Untreated controls shall be used to determine background levels of the parent material 

2298 and other PBDEs over time. Sampling shall be performed at time zero and seven times 

2299 thereafter. Additional sample vessels may be prepared for additional analyses, if necessary. 

2300 These vessels shall be sampled at the request of the sponsor in consultation with EPA. 

2301 Additional untreated chambers shall be prepared for use as matrix fortification samples, water2302 sediment characterizations and viability controls, as necessary. 

2303 

2304 (vi) Materials and methods. (A) The test system and study conditions are selected to 

2305 comply with the Fate, Transport and Transformation Test Guidelines, OCSPP 835.4400 (at 

2306 paragraph (i)(2)(xii)(B) of this section) with appropriate modifications, if any, for decaBDE. 

2307 

2308 (B) Test substance. Information on the characterization of test, control or reference 

2309 substances is required by Good Laboratory Practice (GLP) Standards and Principles. Ringlabeled, 

14

2310 C-labeled test substance shall be used. The Sponsor is responsible for providing the 

2311 test substance and verification that it has been characterized according to GLP requirements prior 

2312 to its use in the study. If verification of GLP test substance characterization is not provided, it 

2313 shall be noted in the compliance statement of the final report. The Sponsor is responsible for all 

2314 information related to the test substance including the following descriptions of the radiolabeled 

2315 form of the test substance: name, lot number, specific activity, radiochemical purity, sample 

2316 form, solubility in water, and storage conditions. For the nonlabeled form of the test substance, 

2317 the Sponsor is responsible for the following descriptions: name, lot number, purity, sample form, 

2318 solubility in water, and storage conditions. The Sponsor must agree to accept any unused test 

2319 substance and/or test substance containers remaining at the end of the study. 

2320 

2321 (C) Test substance preparation and administration. A dispersal powder of test substance 

2322 shall be prepared using an inert carrier (e.g. silica gel, quartz sand). Radiolabeled test substance 

2323 shall be placed in a round bottom flask and dissolved with an appropriate solvent (i.e., 

2324 tetrahydrofuran). The inert carrier shall be added to the flask and the solvent shall be evaporated 

2325 using a rotary evaporator until the carrier is dry. This method of creating a dispersal powder is 

2326 an appropriate route of administration for poorly water-soluble materials. Prior to the test, 

2327 characteristics of sorption of the test substance on various carriers shall be evaluated. 

2328 

2329 (D) Sediments and associated waters. Sediments and associated water shall be obtained 

2330 from at least six different sites known or suspected to be contaminated with polybrominated 

2331 diphenyl ethers including, but not limited to decabromodiphenyl ether, and PCBs. Selection and 

2332 approval of the collection sites shall be the responsibility of the study Sponsor and must be 

2333 approved by EPA. 

2334 Sediments shall be collected and handled using strict anaerobic procedures (for example 

2335 see Loveley and Phillips (1986) at paragraph (i)(2)(xii)(A) of this section). They shall be 

2336 immediately sealed under nitrogen and transported and stored to maintain anaerobic conditions. 

2337 All collection containers shall be stored in a nitrogen atmosphere until and during use. In 

2338 addition, the containers shall be purged with nitrogen in the field after collection. The anaerobic 

2339 sediment and associated waters shall be taken from the same location. The reduction potential or 

2340 Redox potential (Eh) of the sediment shall be measured prior to collection and should be less 

2341 than –150 mV. The dissolved oxygen concentration of the overlying water shall be measured 
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2342 and should be less than 0.5 mg/L. The sediments and water shall be transported to the lab under 

2343 anaerobic conditions. The sediments and associated waters may be stored at room temperature 

2344 in sealed containers for up to 7 days. If longer storage is necessary, the sediments and associated 

2345 waters may be stored in sealed containers in a refrigerator for up to 4 weeks. Prior to use, the 

2346 sediment shall be settled, then separated from the water by decanting. The settled sediment shall 

2347 be wet-sieved using a 2 mm sieve. All handling of anaerobic sediment after collection and prior 

2348 to testing shall be performed under a constant flow of nitrogen. 

2349 At a minimum, the following properties of the sediment shall be determined: 

2350 • Particle size (i.e., percentage of sand, silt and clay) 

2351 • Organic carbon content 

2352 • Microbial biomass 

2353 • Nitrate, sulfate and iron species 

2354 • Percent water 

2355 • Microbial biomass (fumigation extraction method) 

2356 • pH 

2357 • Concentration of humic material 

2358 • Concentrations of electron acceptors including methane, nitrate, nitrite, sulfate, sulfide, 

2359 and iron species. 

2360 Similar characterization of the aqueous phase shall be performed prior to the start of the 

2361 test. Prior to the test, resazurin shall be added to the water at a nominal concentration of 1 mg/L. 

2362 The water shall be sparged with nitrogen until a light pink color is obtained and the dissolved 

2363 oxygen concentration is less than 0.1 mg/L. Redox conditions in the test vessels shall be 

2364 monitored by measuring dissolved hydrogen gas and Eh at each sampling. The test vessels shall 

2365 be stored under nitrogen or other inert atmosphere throughout the test. 

2366 

2367 (E) Test apparatus and conditions. The test vessels shall be 1-L glass bottles sealed with 

2368 butyl rubber septa and screw caps. Prior to beginning the study, the integrity of the test vessels 

2369 and caps and their ability to maintain anaerobic conditions and prevent leakage of H2 and other 

2370 gas species for long periods shall be verified. The test vessels shall be identified by project 

2371 number, test substance ID, test concentration, and a unique identifier. The test vessels shall be 

2372 incubated under an atmosphere of nitrogen at approximately 20°C in a anaerobic glove box. Test 

2373 temperatures shall be recorded each working day using a min/max thermometer. The need for 

2374 venting of the test systems shall be evaluated prior to the start of the study. The procedure for 

2375 venting and frequency shall be added to the study protocol, if necessary, prior to beginning the 

2376 study. 

2377 

2378 (F) Preparation of the test chambers and acclimation. Test chambers shall be prepared 

2379 in an anaerobic glove box or under a constant flow of nitrogen. Appropriate amounts of sediment 

2380 and water shall be added to each test chamber so the resulting water:sediment volume ratio is 

2381 between approximately 1:3 and 1:4. The depth of the sediment layer shall depend upon the 

2382 characteristics of the specific sediment. As a practical example, 200 g dry weight equivalent of 

2383 sediment and 250 mL of associated water typically result in a sediment layer of 6.5 cm and a 

2384 water layer of 2.5 cm. Amounts of sediment and water to be added may be determined prior to 

2385 the preparation of the test chambers. The sediment/water samples shall be acclimated under the 

2386 same conditions as in the test for at least 7 days prior to the start of the test. 

2387 

2388 (G) Characterization of water-sediment systems. The pH, total organic carbon 
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2389 concentration, dissolved oxygen concentration, redox potential of the water and sediment 

2390 (including microbial biomass), and other parameters characteristics of the water-sediment media 

2391 in the test vessels shall be measured at each sampling period noted in Table 1 of this paragraph. 

2392 The sediment and water shall be kept anaerobic with a redox potential lower than –100 mV. 

2393 

2394 Table 1: Measurements at Various Stages of the Test Procedure 

2395 

Parameter 

 Stage of Test Procedure 

Field 

Sampling 

PostHandling Start of 

Acclimation 

Start of 

Test During Test End of Test 

Water 

Origin/source X 

Temperature X 

pH X X X X X 

TOC X X X 

O2 concentration X X X X X 

Redox potential X X X X 

Sediment 

Origin/Source X 

Depth of layer X 

pH X X X X X 

Particle size X 

TOC X X X X 

Microbial biomass X X X 

Redox potential X X X X X 

2396 

2397 (H) Application of the test substance. Chambers containing the sediment/water systems 

2398 shall be fortified at the start of the test with the test substance by applying the test material to the 

2399 water layer. Methods for mixing the test material with sediment shall be evaluated prior to the 

2400 start of the test. Methods to be evaluated shall include but are not limited to mixing by hand and 

2401 the use of roller and tumbling mixers. 

2402 

2403 (I) Preparation of abiotic systems. Test substance-dosed abiotic controls shall be heat2404 sterilized (autoclaved three times at 120 °C for 60 minutes on three consecutive days). A 

2405 preliminary evaluation of the effects of heat sterilization on the test substance shall be conducted 

2406 prior to the start of the study. If this method is found to be unsatisfactory, irradiation shall be 

2407 used to sterilize the test systems. 

2408 

2409 (J) Sample collection. Proposed sampling intervals are day 0 and months 3, 6, 12, 18, 24, 

2410 30, and 36. If analysis of initial sampling results suggests more rapid degradation, the sampling 

2411 interval may be modified after consultation with EPA using procedures specified in the ECA. 

2412 The actual sampling intervals shall be documented in the study records and in the final report. 

2413 Duplicate test vessels for each treatment (i.e. treated and control) option, each test substance 

2414 concentration and each sediment shall be sacrificed at appropriate time intervals. 

2415 
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2416 (K) Headspace analysis. The headspace of the treated systems shall be analyzed for 

radiolabeled mineralization products including 

14

CO2- hydrocarbons and 

14

CO2 and 

14

2417 CH4 using 

2418 purge and trap methods. At each sampling time prior to extraction of the test system, the septum 

2419 shall be pierced using a needle connected to an appropriate trap and the vessel headspace shall be 

2420 purged and trapped using a hydrocarbon trap followed by a mineralization trapping apparatus. 

2421 The headspace within each of test chamber shall be continuously purged with a flow of nitrogen 

2422 for a minimum of 1 hour and passed through a gas collection system consisting of a hydrocarbon 

2423 trap and two sets of CO2 traps and a combustion apparatus. The displaced gases shall initially 

2424 pass through a sorption tube containing appropriate solid phase to trap any hydrocarbon 

2425 degradation products present, then one empty bottle followed by two more bottles, each 

2426 containing approximately 100 mL of 1.5N KOH (CO2 trapping solution), followed by another 

2427 empty bottle. The gas shall be combined with a flow of oxygen and channeled through a quartz 

2428 column that is packed with cupric oxide and maintained at approximately 800°C in a tube 

2429 furnace to combust methane to CO2. Because Br may poison the surface of the cupric oxide, a 

2430 preliminary experiment shall be run to test this, and the protocol adjusted if necessary. The gas 

2431 exiting the combustion column shall be passed through an empty bottle followed by two 

2432 additional CO2 traps. 

2433 

2434 (L) Sample processing and analysis for total radioactivity. After purging, the overlying 

2435 water shall be removed with minimal disturbance to the sediment and assayed for total 

2436 radioactivity by liquid scintillation counting (LSC). Sediment samples shall be analyzed using 

2437 combustion followed by LSC counting to determine to total amount of radioactivity associated 

2438 with the sediment. Water and sediment samples shall be extracted following aggressive methods 

2439 designed to extract the maximum amount of parent and degradation products from the sediment. 

2440 These shall be evaluated and verified and approved by EPA prior to the start of the study. These 

2441 methods shall be able to detect and quantify parent and degradates at least as well as those 

2442 reported in the literature for PBDE analysis. The extraction method shall be robust, for example 

2443 sequential extraction by solvent washing, soxhlet extraction and supercritical fluid extraction, but 

2444 shall not substantially change the test substance or degradation products, or the structure of the 

2445 matrix itself. Solvent extracts and extracted solids shall be analyzed to determine total residual 

2446 radioactivity. Untreated controls shall be extracted in the same manner as the test substance 

2447 treated systems. 

2448 

2449 (M) Characterization of extracted radioactivity. Water and sediment extracts from the 

2450 treated and untreated systems shall be analyzed for radiolabeled test substance and degradation 

2451 products using high performance liquid chromatography (HPLC) and gas chromatography (GC) 

2452 with mass spectrometry (MS) and radiochemical detection. Methods of analysis shall be verified 

2453 prior to the start of the study and shall be at least as sensitive and accurate as reported in the 

2454 literature for analysis of PBDEs and products. 

2455 

2456 (N) Quantification of test substance and degradation products. Water and sediment 

2457 extracts from the untreated controls and treated systems shall be analyzed for quantification of 

2458 BDE-209 (decaBDE) and trace level lower brominated diphenyl ethers including but not limited 

2459 to BDE-202 (octaBDE), BDE-197 (octaBDE), and BDE-201 (octaBDE), as well as, brominated 

2460 dibenzofurans. This analysis shall be conducted using gas chromatography/electron capture 

2461 negative chemical ionization mass spectrometry (GC/ECNI-MS). Expected limits of detection 

2462 (LOD) and quantitation (LOQ) for reasonably anticipated products shall be determined and 
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2463 reported to EPA prior to starting the test. All debromination products shall be measured in each 

2464 sample, including background and time zero samples, and both biotic systems and abiotic 

2465 (inhibited) controls. 

2466 

2467 (O) Viability controls. The assessment of the metabolic activity of untreated 

2468 sediment/water systems shall be conducted within one week of each sampling interval. 

2469 Duplicate incubation vessels for each sediment, which have been incubated in parallel under the 

2470 same conditions, shall be dosed at approximately 100 mg/kg sediment dry weight with a 

2471 combination of radiolabeled and nonlabeled substance suitable (i.e. glucose, benzoic acid) for 

2472 viability determination. The methods and procedures used shall be documented in study protocol 

2473 prior to beginning the study. 

2474 

2475 (P) Treatment of results. Total mass balance of radioactivity shall be calculated at each 

2476 sampling interval. Results shall be reported as total and percentage of added radioactivity. The 

2477 behavior of the test substance and major and minor metabolites in the whole system as well as 

2478 water, gas and sediment compartments shall be evaluated. Regression analysis of the percentage 

2479 of test substance and major metabolites as a function of time shall be performed and the time for 

2480 50% degradation (DT50) and the time for 90% degradation (DT90) of the test substance and 

2481 major metabolites shall be calculated, when possible. The ratio of BDE-209 (decaBDE) to all 

2482 detected degradation products shall be determined. All analytical results and all raw data shall 

2483 be submitted to EPA, including the mass of each analyte at each time. 

2484 

2485 (vii) Records to be maintained. Records to be submitted to EPA shall include, but are not 

2486 limited to, the following: 

2487 

2488 (A) The original signed protocol and any amendments. 

2489 

2490 (B) Identification and characterization of the test substance as provided by Sponsor. 

2491 

2492 (C) Experiment initiation and termination dates. 

2493 

2494 (D) Stock solution concentration calculations and solution preparation. 

2495 

2496 (E) Inoculum source and pretreatment data. 

2497 

2498 (F) Results of LSC and HPLC and/or other analysis (e.g. GC or GC/ECNI-MS). 

2499 

2500 (G) Temperature data recorded during test period. 

2501 

2502 (H) Copy of final report. 

2503 

2504 (viii) Final report. A final report of the results of the study shall be prepared and 

2505 submitted to EPA. The report shall include, but is not limited to the following, when applicable: 

2506 

2507 (A) Name and address of facility performing the study. 

2508 

2509 (B) Dates on which the study was initiated and completed. 
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2510 

2511 (C) Objectives and procedures stated in the approved protocol, including any changes in 

2512 the original protocol. 

2513 

2514 (D) Identification and characterization of the test substance as provided by Sponsor. 

2515 

2516 (E) A summary and analysis of the data and a statement of the conclusions drawn from 

2517 the analysis. 

2518 

2519 (F) A description of the transformations and calculations performed on the data. 

2520 

2521 (G) A description of the methods used and reference to any standard method employed. 

2522 

2523 (H) A description of the test system. 

2524 

2525 (I) A description of the preparation of the test solutions, the testing concentrations, and 

2526 the duration of the test. 

2527 

2528 (J) A description of sampling and analytical methods, including level of detection, level 

2529 of quantification, and references. 

2530 

2531 (K) A description of the test results including measured values for individual PBDE 

2532 congeners and PBDF homolog group. 

2533 

2534 (L) A description of all circumstances that may affect the quality or integrity of the data. 

2535 

2536 (M) The name of the study director, the names of other scientists or professionals, and the 

2537 names of all supervisory personnel involved in the study. 

2538 

2539 (N) The signed and dated reports of each of the individual scientists or other 

2540 professionals involved in the study, if applicable. 

2541 

2542 (O) The location where the raw data and final report are to be stored. 

2543 

2544 (P) A statement prepared by the Quality Assurance Unit listing the types of inspections, 

2545 the dates that the study inspections were made and the findings reported to the Study Director 

2546 and Management. 

2547 

2548 (Q) A copy of all raw data including but not limited to chromatograms, lab notebooks and 

2549 data sheets etc. 

2550 

2551 (ix) Changes to the final report. If it is necessary to make corrections or additions to the 

2552 final report after it has been accepted, such changes shall be made in the form of an amendment 

2553 issued by the Study Director. The amendment shall clearly identify the part of the study that is 

2554 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 

2555 Study Director and Laboratory QA officer. 

2556 
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2557 (x) Changes to the protocol. Planned changes to the protocol shall be in the form of 

2558 written amendments signed by the Study Director and approved by the Sponsor’s Representative 

2559 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 

2560 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 

2561 form of written deviations signed by the Study Director and filed with the raw data. All changes 

2562 to the protocol shall be indicated in the final report. Changes to the test standard require prior 

2563 approval from EPA using procedures in 40 CFR 790.55. 

2564 

2565 (xi) Good laboratory practices. This study shall be conducted in accordance with Good 

2566 Laboratory Practice Standards for EPA and shall be consistent with OECD Principles of Good 

2567 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 

2568 the facility’s quality assurance unit for compliance with Good Laboratory Practices, Standard 

2569 Operating Procedures, and the specified protocol. A statement of compliance with Good 

2570 Laboratory Practices shall be prepared for all portions of the study conducted by the testing 

2571 facility. The Sponsor is responsible for compliance with Good Laboratory Practices for 

2572 procedures that may be performed by other laboratories (e.g., residue analyses). Raw data for all 

2573 work performed at the testing facility and a copy of the final report shall be filed by project 

2574 number in archives located on the facility’s site or at an alternative location to be specified in the 

2575 final report. 

2576 

2577 (xii) Literature cited. 

2578 

2579 (A) Lovley DR, Phillips EJP. Organic matter mineralization with reduction of ferric iron 

2580 in anaerobic sediments. Applied Environmental Microbiology 51:683–689. 1986. 

2581 

2582 (B) U.S. Environmental Protection Agency. Series 835-Fate, Transport and 

2583 Transformation Test Guidelines. OCSPP Number 835.4400: Anaerobic Aquatic Metabolism. 

2584 EPA 712-C-08-019. June 2008. 

2585 

2586 (C) Tokarz JA, III, Ahn MY, Leng J, Filley TR, Nies L. Reductive debromination of 

2587 polybrominated diphenyl ethers in anaerobic-sediment and a biomimetic system. Environmental 

2588 Science & Technology 42:1157-1164. 2008. 

2589 (3) Biodegradation in anaerobic digester sludge conducted in accordance with the 

2590 following guideline: 

2591 (i) Title. Decabromodiphenyl ether: Biodegradation in Anaerobic Digester Sludge 

2592 

2593 (ii) Source. U.S. Environmental Protection Agency Series 835 - Fate, Transport and 

2594 Transformation Test Guidelines, OCSPP guideline 835.3280—Simulation test to assess primary 

2595 and ultimate biodegradability of chemicals discharged to wastewater: Mineralization and 

2596 transformation in digester sludge. 

2597 

2598 (iii) Introduction. Anaerobic digesters are commonly used in municipal wastewater 

2599 treatment plants to stabilize various plant sludges. The digestion process reduces the amount of 

2600 solids present in the sludge, destroys pathogenic bacteria and viruses, and removes the 

2601 biodegradable portion of the sludge. A test for biodegradation during anaerobic sludge digestion 
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2602 is particularly relevant for sorbing substances, which partition to primary and secondary sludge. 

2603 This test is useful for determining the concentration of a substance present in the sludge leaving a 

2604 treatment plant as well as demonstrating the potential for anaerobic biodegradation. The test is 

2605 characterized by reducing conditions, a high level of anaerobic biomass, and a level of test 

2606 substance based on expected wastewater concentrations and partitioning behavior. The test is 

2607 designed to assess the extent to which a substance can be degraded during anaerobic digestion. 

2608 This protocol describes the methods employed in determining the biodegradability of the test 

2609 substance in anaerobic digester sludge. 

2610 

2611 (iv) Objectives. The objective of the study is to assess the potential for mineralization 

2612 and transformation of decabromodiphenyl ether in anaerobic digester sludge, and the quantity 

2613 and identity of degradants (if present). 

2614 

2615 (v) Experimental design. The test shall be conducted using digester sludge from six 

2616 different sources. Untreated control and test substance-dosed systems shall be prepared for each 

2617 sludge source. Additionally, an abiotic control shall be prepared. The test substance treatment 

systems shall be dosed at two concentrations with 14 2618 C-labeled test or a combination of 

2619 radiolabeled and nonlabeled forms of the test substance. A very low concentration is used to 

2620 establish environmentally relevant transformation kinetics; whereas a higher concentration is 

2621 required to quantify product formation. The test systems shall be incubated at approximately 

2622 35°C for approximately 10 months; e.g. approximately 300 days. Studies using anaerobic 

2623 digester sludge normally involve incubating sludge for 60 days, which is about twice the normal 

2624 residence time of sludge in anaerobic digesters. The extended length of this study is based on a 

2625 half-life of the test substance in sludge without added primers of 1400 days as reported by 

2626 Gerecke et al. at paragraphs (i)(3)(xii)(A) and (B) of this section, and the general 

2627 recommendation that test duration be at least 20% of the anticipated half-life. 

2628 Based on the length of the study, bench-scale anaerobic reactor systems with semi2629 continuous feeding shall be used. A system consists of a 5-L glass reactor containing an 

2630 anaerobic digester sludge mixture incubated at 35° C and gas collection bladder. On a weekly 

2631 basis, supernatant shall be removed from the reactor and replaced with an anoxic mixture of 

2632 settled activated sludge solids (secondary sludge) and fresh anaerobic digester sludge solids. 

2633 Test substance-dosed systems shall be used for quantification of parent material and 

2634 degradation products. Untreated controls shall be used to determine background levels of the 

2635 parent material and other polybrominated diphenyl ethers. Sampling shall be performed at time 

2636 zero and seven times thereafter. 

2637 

2638 (vi) Materials and methods. The test system and study conditions are selected to comply 

2639 with the Fate, Transport and Transformation Test Guidelines, OCSPP 835.3280 at paragraph 

2640 (i)(3)(xii)(C) of this section. 

2641 (A) Test Substance. Information on the characterization of test, control or reference 

2642 substances is required by Good Laboratory Practice (GLP) Standards and Principles. The 

2643 Sponsor is responsible for providing verification that the test substance has been characterized 

2644 according to GLP requirements prior to its use in the study. If verification of GLP test substance 

2645 characterization is not provided, it shall be noted in the compliance statement of the final report. 

2646 The Sponsor is responsible for all information related to the test substance. Following are 

2647 descriptions of the radiolabeled form of the test substance: name, lot number, specific activity, 
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2648 radiochemical purity, radiolabel position, identities and percentages of all brominated 

2649 diphenylethers, sample form, solubility in water, and storage conditions. Following are 

2650 descriptions of the nonlabeled form of the test substance: name, lot number, purity, identities and 

2651 percentages of all brominated diphenyl ethers, sample form, solubility in water, and storage 

2652 conditions. The Sponsor must agree to accept any unused test substance and/or test substance 

2653 containers remaining at the end of the study. 

2654 (B) Test substance preparation and administration. A dispersal powder of test substance 

2655 shall be prepared using an inert carrier (e.g. silica gel, quartz sand). A combination of 

2656 radiolabeled and nonlabeled test substance shall be placed in a round bottom flask and dissolved 

2657 with an appropriate solvent (i.e. tetrahydrofuran). The inert carrier shall be added to the flask 

2658 and the solvent shall be evaporated using a rotary evaporator until the sediment is dry. This 

2659 method of creating a dispersal powder is an appropriate route of administration for poorly water2660 soluble materials. Prior to the test, the adsorption characteristics of the test substance on various 

2661 carriers shall be evaluated. 

2662 (C) Test inoculum. Anaerobic digester sludge shall be obtained from at least six different 

2663 sites. Selection of the collection sites shall be the responsibility of the study Sponsor, with 

2664 review and final approval by the EPA. All collection containers shall be purged with nitrogen 

2665 and immediately sealed prior to use. In addition, purging the containers with nitrogen in the field 

2666 after collection shall be performed if possible. Sludge shall be screened using a 2 mm mesh 

2667 screen to remove debris and may be held for up to 7 days prior to the start of the test. The total 

2668 solids level of the digester sludge shall be measured and should be in the range of 4-6% (40,000-

2669 60,000 mg/L). On the day the test is to start, the inoculum shall be diluted with mineral salts 

2670 solution to an initial solids level of approximately 25,000 mg/L. If the solids concentration is too 

2671 low, the solids can be allowed to settle, the supernatant decanted, and the sludge resuspended in 

2672 mineral salts solution. A final solids level and pH shall then be determined. All handling of 

2673 anaerobic sludge after collection and prior to testing shall be performed under a constant flow of 

2674 nitrogen or in an anaerobic glove box. 

2675 (D) Mineral salts solution. A mineral salts solution shall be prepared using high quality 

2676 water as described below. All chemicals used in the preparation of the solution shall be reagent 

2677 grade or better, if available. The solution shall be autoclaved for 30 min and allowed to cool 

2678 overnight in an anaerobic chamber or under an anaerobic atmosphere. The solution shall contain 

2679 the following constituents per liter of high quality water: 

2680 • Anhydrous potassium dihydrogen phosphate (KH2PO4) 0.27 g 

2681 • Disodium hydrogen phosphate dodecahydrate (Na2HPO4•12H2O) 1.12 g 

2682 • Ammonium chloride (NH4Cl) 0.53 g 

2683 • Calcium chloride dihydrate (CaCl2•2H2O) 0.075 g 

2684 • Magnesium chloride hexahydrate (MgCl2•6H2O) 0.10 g 

2685 • Iron (II) chloride tetrahydrate (FeC12•4H2O) 0.02 g 
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2686 • Resazurin (oxygen indicator) 0.001 g 

2687 • Sodium sulphide nonahydrate (Na2S•9H2O) 0.10 g 

2688 (E) Digester sludge feed. The source guideline for this study, OCSPP 835.3280, has no 

2689 provision for feeding. However, due to the length of the study, periodic feeding is needed. The 

2690 anaerobic digester sludge shall be fed an anoxic mixture of settled activated sludge solids 

2691 (secondary sludge) and fresh anaerobic digester sludge solids. Activated sludge shall be 

2692 collected from a sewage treatment plant receiving waste from predominantly domestic sources. 

2693 The sludge shall be sieved using a 2 mm mesh screen to remove debris, then dewatered using 

2694 filtration. A feed solution shall be prepared at a sludge solids concentration of approximately 50 

2695 g/L using mineral salts solution. The feed solution shall be stored under nitrogen and 

2696 refrigerated. In addition, freshly prepared solutions should be stored for at least 1 week prior to 

2697 use. 

2698 (F) Test apparatus and conditions. The test reactors shall be 5-L glass bottles and shall 

2699 be identified by project number, test substance ID, test concentration, and unique identifier. The 

2700 reactors shall be sealed with black rubber stoppers with stopcock ports and connections used for 

2701 the addition of feed sludge, sample removal and gas collection bag. The test reactors shall be 

2702 incubated at 35 ± 3 °C and in the dark. Reactor contents shall be mixed for at least 10 min every 

2703 day using a magnetic stirrer and test temperatures shall be measured each working day using a 

2704 min/max thermometer. 

2705 (G) Preparation of the test reactors. Working under a constant flow of nitrogen, 1.5 L of 

2706 anaerobic digester sludge (4-6% solids), mineral salts solution to achieve an initial solids level of 

2707 approximately 25,000 mg/L, and test substance dispersal powder shall be combined in the 

2708 reactor. The headspace in the reactor shall be purged with nitrogen, then the reactor sealed and 

2709 transferred to the incubator. 

2710 (H) Reactor maintenance, The contents of the reactors (anaerobic sludge and mineral 

2711 salts solution at a solids level of approx. 25,000 mg/L) shall be fed on a weekly basis. Prior to 

2712 mixing, approximately 75 mL of supernatant shall be removed from the reactor and replaced 

2713 with an equal volume of digester sludge feed solution. The solids added in this way are expected 

2714 to be approximately equivalent to 10% of the total digester solids reasonably expected to be 

2715 present. The amount of digester sludge feed solution added may be adjusted based on the 

2716 observed level of gas production. The activity of the supernatant removed shall be measured 

2717 using liquid scintillation counting (LSC). 

2718 (I) Abiotic control. An abiotic control shall be included. Biological activity is inhibited 

2719 in the abiotic control, which is used for estimating mineralization by difference, establishing 

2720 extraction efficiency and recovery of the test substance, and quantifying other loss processes 

2721 such as hydrolysis, oxidation, volatilization or sorption to test apparatus. The preparation of the 

2722 abiotic system is typically performed using a combination of chemical and heat sterilization. A 

2723 proven approach is to add mercuric chloride (1 g/l) to the sludge, which is then autoclaved for at 

2724 least 90 min. Typically the volume of medium is less than or equal to half the volume of the 

2725 container being autoclaved (e.g. 500 ml sludge in a 1-liter container). After cooling, the pH of 

2726 the abiotic system should be measured and adjusted to match that of the biologically active 

2727 system. Alternative approaches to deactivate the system can also be used. 
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2728 (J) Sample collection schedule. Proposed sampling times are day 0 and months 1, 2, 4, 6, 

2729 8, 9, and 10, but the actual sampling times shall be documented in the study records and in the 

2730 final report. The timing of the sampling may be altered at the discretion of the Study Director, 

2731 and more frequent sampling may be conducted. Based on the analytical method that is selected, 

2732 the minimum change in the initial concentration of the test substance that can be detected shall 

2733 be estimated, then applied to help determine the sampling schedule and assess the need for 

2734 additional samples. As an example, if the minimum reliably detectable change is 5% relative to 

2735 the starting concentration, and if this has already occurred at the first suggested sampling time (1 

2736 month), then measurements should be made monthly up to 10 months. The solids concentration 

2737 of sludge shall be measured at each sampling interval. 

2738 (K) Evolved gas and headspace analysis. The evolved gas and headspace of the treated 

systems shall be analyzed for radiolabeled mineralization products (14CO2 and 14 2739 CH4). At 

2740 intervals throughout the study, evolved gases shall be analyzed by passing the contents of the gas 

2741 collection bags through the mineralization apparatus described below. Reactor headspace 

2742 analysis shall be performed at the end of the study. The headspace gases within the reactor shall 

2743 be continuously purged with a flow of nitrogen for a minimum of 2 hours and passed through a 

2744 gas collection system consisting of two sets of CO2 traps and a combustion apparatus. The 

2745 displaced gases shall initially pass through one empty bottle followed by two bottles each 

2746 containing approximately 100 mL of 1.5N KOH (CO2 trapping solution) followed by another 

2747 empty bottle. The gas shall be combined with a flow of oxygen and channeled through a quartz 

2748 column that is packed with cupric oxide and maintained at approximately 800°C in a tube 

2749 furnace to combust methane to CO2. The gas exiting the combustion column shall be passed 

2750 through an empty bottle followed by two additional CO2 traps. 

2751 (L) Sample processing and analysis for total radioactivity. Treated digester sludge 

2752 samples shall be analyzed using a combination of LCS and combustion followed by LSC 

2753 counting to determine the total amount of radioactivity associated with the sludge. At each 

2754 sampling interval, replicate (minimum 3) one mL aliquots of well mixed digester sludge shall be 

2755 placed into microcentrifuge tubes and centrifuged at 10,000 x g for 15 min. The activity 

2756 associated with the supernatant shall be measured by LSC. Solids shall be analyzed using 

2757 combustion followed by LSC to determine to total amount of radioactivity associated with the 

2758 sludge solids. 

2759 Digester sludge shall be extracted following methods evaluated and verified prior to the 

2760 start of the study. These methods shall be able to detect and quantify parent and degradates at 

2761 least as well as those reported in the literature for PBDE analysis. The extraction method shall 

2762 be robust, for example sequential extraction by solvent washing, soxhlet extraction and 

2763 supercritical fluid extraction, but shall not substantially change the test substance or degradation 

2764 products, or the structure of the matrix itself. Solvent extracts and extracted solids shall be 

2765 analyzed to determine total radioactivity. Untreated controls shall be extracted in the same 

2766 manner as the test substance-treated systems, but will not be analyzed for radioactivity. 

2767 (M) Characterization of extracted radioactivity. Digester sludge extracts from the treated 

2768 systems shall be analyzed for radiolabeled test substance and degradation products using high 

2769 performance liquid chromatography with radiochemical detection. Methods of analysis shall be 

2770 verified prior to the start of the study. 
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2771 

2772 (N) Quantification of test substance and degradation products. Digester sludge extracts 

2773 from the untreated control, abiotic control and treated systems shall be analyzed for 

2774 quantification of BDE-209 (decaBDE) and trace level lower brominated diphenyl ethers 

2775 including but not limited to BDE-202 (octaBDE), BDE-197 (octaBDE), and BDE2776 201(octaBDE), as well as brominated dibenzofurans. 

2777 Methods for analysis shall be evaluated and verified prior to the start of the study and 

2778 shall reference available best practice techniques for the type of analyte. This analysis shall be 

2779 conducted using gas chromatography/electron capture negative chemical ionization mass 

2780 spectrometry (GC/ECNI-MS). Expected limits of detection (LOD) and quantitation (LOQ) for 

2781 reasonably anticipated products shall be determined and reported to EPA prior to starting the 

2782 test. 

2783 All debromination products shall be measured in each sample, including background and 

2784 time zero samples, and both biotic systems and abiotic (inhibited) controls. 

2785 

2786 (O) Treatment of results. Total mass balance of radioactivity shall be calculated at each 

2787 sampling interval. Results shall be reported as a percentage of added radioactivity. Regression 

2788 analysis of the percentage of test substance and major metabolites as a function of time shall be 

2789 performed and the time for 50% degradation (DT50) and the time for 90% degradation (DT90) of 

2790 the test substance and major metabolites shall be calculated, when appropriate. The ratio of 

2791 BDE-197 (octaBDE) to BDE-201 (octaBDE) shall be determined, if present. 

2792 (vii) Records to be maintained. Records to be maintained shall include, but are not 

2793 limited to, the following: 

2794 (A) The original signed protocol and any amendments. 

2795 (B) Identification and characterization of the test substance as provided by Sponsor. 

2796 (C) Experiment initiation and termination dates. 

2797 (D) Stock solution concentration calculations and solution preparation. 

2798 (E) Inoculum source and pretreatment data. 

2799 (F) Results of LSC and/or other (e.g. GC/ECNI-MS) analyses. 

2800 (G) Temperature data recorded during test period. 

2801 (H) Copy of final report. 

2802 (viii) Final report. A final report of the results of the study shall be prepared by the 

2803 testing facility. The report shall include, but is not limited to the following, when applicable: 

2804 (A) Name and address of facility performing the study. 

2805 (B) Dates on which the study was initiated and completed. 

2806 (C) Objectives and procedures stated in the approved protocol, including any changes in 
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2807 the original protocol. 

2808 (D) Identification and characterization of the test substance as provided by Sponsor. 

2809 (E) A summary and analysis of the data and a statement of the conclusions drawn from 

2810 the analysis. 

2811 (F) A description of the transformations and calculations performed on the data. 

2812 (G) A description of the methods used and reference to any standard method employed. 

2813 (H) A description of the test system. 

2814 (I) A description of the preparation of the test solutions, the testing concentrations, and 

2815 the duration of the test. 

2816 

2817 (J) A description of sampling and analytical methods, including level of detection, level 

2818 of quantification, and references. 

2819 

2820 (K) A description of the test results including measured values for individual PBDE 

2821 congeners and polybrominated dioxin/furan (PBDF) homolog group. 

2822 

2823 (L) A description of all circumstances that may affect the quality or integrity of the data. 

2824 (M) The name of the study director, the names of other scientists or professionals, and the 

2825 names of all supervisory personnel involved in the study. 

2826 

2827 (N) The signed and dated reports of each of the individual scientists or other 

2828 professionals involved in the study, if applicable. 

2829 (O) The location where the raw data and final report are to be stored. 

2830 (P) A statement prepared by the Quality Assurance Unit listing the types of inspections, 

2831 the dates that the study inspections were made and the findings reported to the Study Director 

2832 and Management. 

2833 

2834 (Q) A copy of all raw data including but not limited to chromatograms, lab notebooks, 

2835 and data sheets etc. 

2836 

2837 (ix) Changes to the final report. If it is necessary to make corrections or additions to the 

2838 final report after it has been accepted, such changes shall be made in the form of an amendment 

2839 issued by the Study Director. The amendment shall clearly identify the part of the study that is 

2840 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 

2841 Study Director and Laboratory QA officer. 

2842 (x) Changes to the protocol. Planned changes to the protocol shall be in the form of 

2843 written amendments signed by the Study Director and approved by the Sponsor's Representative 

2844 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 

2845 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 
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2846 form of written deviations signed by the Study Director and filed with the raw data. All changes 

2847 to the protocol shall be indicated in the final report. Changes to the test standard require prior 

2848 approval from EPA using procedures in 40 CFR 790.55. 

2849 (xi) Good laboratory practices. This study shall be conducted in accordance with Good 

2850 Laboratory Practice Standards for EPA and shall be consistent with OECD Principles of Good 

2851 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 

2852 the facility's quality assurance unit for compliance with Good Laboratory Practices, Standard 

2853 Operating Procedures, and the specified protocol. A statement of compliance with Good 

2854 Laboratory Practices shall be prepared for all portions of the study conducted by the testing 

2855 facility. The Sponsor is responsible for compliance with Good Laboratory Practices for 

2856 procedures that may be performed by other laboratories (e.g., residue analyses). Raw data for all 

2857 work performed at the testing facility and a copy of the final report shall be filed by project 

2858 number in archives located on the facility's site or at an alternative location to be specified in the 

2859 final report. 

2860 (xii) Literature cited: 

2861 (A) Gerecke AC, Hartmann PC, Heeb NV, Kohler H-PE, Giger W, Schmid P, Zennegg 

2862 M, Kohler M. Anaerobic degradation of decabromodiphenyl ether. Environmental Science & 

2863 Technology 39:1078-1083. 2005 

2864 

2865 (B) Gerecke AC, Giger W, Hartmann PC, Heeb NV, Kohler H-PE, Schmid P, Zennegg 

2866 M, Kohler M. Anaerobic degradation of brominated flame retardants in sewage sludge. 

2867 Chemosphere 64:311-317. 2006. 

2868 

2869 (C) U.S. Environmental Protection Agency. Series 835-Fate, Transport and 

2870 Transformation Test Guidelines. OCSPP Number 835.3280: Simulation test to assess primary 

2871 and ultimate biodegradability of chemicals discharged to wastewater: Mineralization and 

2872 transformation in digester sludge. 2008. 

2873 

2874 (4) photolytic degradation of decabromodiphenyl ether in the indoor environment in 

2875 accordance with the following guideline: 

2876 (i) Title: Photolytic Degradation Testing of Decabromodiphenyl Ether (CAS No. 1163-

2877 19-5) in the Indoor Environment. 

2878 

2879 (ii) Source. US EPA, based on a method in an article entitled “Photodegradation of 

2880 decabromodiphenyl ether in house dust by natural sunlight” by Stapleton and Dodder (2008) 

2881 reported in Environmental Toxicology and Chemistry 27:306–312. 

2882 

2883 (iii) Introduction. Recent studies have found elevated levels of polybrominated 

2884 diphenylethers (PBDEs) in indoor air and house dust, suggesting the presence of indoor sources. 

2885 It has also been observed that photolytic degradation of BDE-209 (decabromodiphenyl ether) can 

2886 take place in house dust when exposed to sunlight, forming debrominated products. It is not well 

2887 understood, however, how PBDEs are transferred from the sources to indoor media (e.g., house 

2888 dust) and whether photolytic degradation can occur under indoor lighting conditions. Most 

2889 Americans spend over 85% of their time indoors. Elderly and young children tend to stay indoors 
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2890 even longer. Therefore, understanding indoor exposure is a key to exposure assessment and risk 

2891 reduction. This guideline describes test methods to characterize potential sources of these 

2892 emerging contaminants in the indoor environment. 

2893 

2894 (iv) PBDE off-gassing and photolytic degradation.

2895 

2896 (A) Objectives. The objectives of this first part of the investigation are to determine (1) if 

2897 PBDEs can migrate out of plastics/fabrics by volatilization; and 

2898 

2899 (2) determine if photolytic degradation can take place on the surfaces of plastics and 

2900 fabrics and quantify these processes. 

2901 

2902 (B) Experimental Design. Accelerated aging tests shall be conducted in an 

2903 environmental chamber. PBDE off-gassing will be determined by taking integrated air samples 

2904 and potential photolytic degradation by taking wipe samples on the surface of test specimens. 

2905 The chamber system must meet the following criteria: 

2906 

2907 (1) It has uniform UV-A light irradiation sources; 

2908 

 (2) The light intensity is no less than 5 Watts per square meter (W/m2 2909 ) incident to the test 

2910 specimen; 

2911 

2912 (3) The chamber has a constant air flow to allow air sampling; and 

2913 

 (4) The moisture content in the air flow is no less than 10 g/m3 2914 (i.e., 50% relative 

2915 humidity at 23 °C). 

2916 

2917 (5) The light source shall be operated according to ASTM G 151-09, Standard Practice 

2918 for Exposing Nonmetallic Materials in Accelerated Test Devices that Use Laboratory Light 

2919 Sources. 

2920 

2921 (6) Window-filtered sunlight shall be simulated according to ASTM D 4459-06, 

2922 Standard Practice for Xenon-Arc Exposure of Plastics Intended for Indoor Applications. ASTM 

2923 D 4459-06 is intended to simulate the effects produced by exposure to solar irradiation through 

2924 glass. A chamber system conforming to D4459-06 can provide spectral irradiance of 

approximately 0.3 W/m2 2925 /nm at 340 nm (i.e., peak emission) when operated in the continuous 

2926 light-on mode without water spray. This light source satisfies the light intensity requirement of 5 

W/m2 2927 as specified above. 

2928 

2929 (C) Materials and methods.

2930 

2931 (1) Test specimens. The test specimens shall include BDE-209-containing high impact 

2932 polystyrene (HIPS) coupons and commercial fabric swatches. HIPS coupons shall be prepared 

2933 using typical commercial extrusion and injection molding conditions for the manufacture of 

2934 HIPS television cabinet backs. High purity (99% or greater) BDE-209 shall be used in making 

2935 the coupons. The high purity will assist in detection of any lower brominated diphenyl ethers 

2936 formed as degradants. The coupons shall be manufactured using high impact polystyrene resin, 
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2937 12 wt% BDE-209, antimony oxide (4% by weight), and the typical additives of television cabinet 

2938 backs (UV inhibitors, antioxidants, colorants, etc.). A total of 36 coupons shall be prepared for 

tests listed in Table 1. Each coupon shall have an area of at least 100 cm2 2939 (one-side). 

2940 Fabric swatches shall be obtained from a commercial source, depending on availability, or 

2941 manufactured using 99+% BDE-209 as the flame retardant. A total of 36 swatches shall be 

prepared for tests listed in Table 1. Each swatch shall have an area of at least 100 cm2 2942 (one2943 side). 

2944 

2945 (2) Test matrix.

2946 

2947 A total of six tests listed in Table 1 shall be conducted. 

2948 

2949 Table 1. Test matrix for PBDE off-gassing and photolytic degradation 

2950 

Test No. Material UV light Durations (h) 

1 HIPS coupons on 300, 600, 900 

2 HIPS coupons on 300, 600, 900 

3 HIPS coupons off 300, 600, 900 

4 Fabric swatches on 300, 600, 900 

5 Fabric swatches on 300, 600, 900 

6 Fabric swatches off 300, 600, 900 

2951 

2952 

2953 (3) Test procedure.

2954 

2955 (i) Prepare 12 identical coupons (or swatches) for an aging test 

2956 

2957 (ii) Put aside 3 coupons (or swatches) for taking wipe samples. These wipe samples 

2958 represent no-exposure conditions. To take a wipe sample of fabric, use the California roller 

2959 method per Ross, et al. (1991) in paragraph (i)(4)(xi)(F). 

2960 

2961 (iii) Clean the chamber by wiping the interior surfaces with ethanol-soaked paper towel 

2962 

 (iv) Take two wipe samples for chamber walls (100 cm2 2963 area each) 

2964 

2965 (v) Place three passive air samplers (PUF disks) on supporting cradle about half chamber 

2966 height and away from inlet air 

2967 

2968 (vi) Place the remaining 9 coupons (or swatches) on chamber floor or rack, depending on 

2969 the type of chamber used 

2970 

2971 (vii) Close chamber door and, for light-on tests, turn on the UV light, and start the test 

2972 

2973 (viii) At 300 elapsed hours, turn off the UV light and then open the chamber door 

2974 

2975 (ix) Remove three coupons (or swatches) from the chamber for taking wipe samples 
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2976 

2977 (x) Remove one PUF disk for determination of time-integrated air concentrations of 

2978 BDE-209, lower PBDE congeners, and polybrominated dibenzofurans (PBDFs) 

2979 

2980 (xi) Close chamber door and turn on the UV light 

2981 

2982 (xii) At 600 elapsed hours, turn off the UV light and then open the chamber door 

2983 

2984 (xiii) Remove three coupons (or swatches) from the chamber for taking wipe samples 

2985 

2986 (xiv) Remove one PUF disk for determination of time-integrated air concentrations of 

2987 BDE-209, lower PBDE congeners, and PBDFs 

2988 

2989 (xv) Close chamber door and turn on the UV light 

2990 

2991 (xvi) At 900 elapsed hours, turn off the UV light and then open the chamber door 

2992 

2993 (xvii) Remove the last three coupons (or swatches) from the chamber for taking wipe 

2994 samples 

2995 

2996 (xviii) Remove one PUF disk for determination of time-integrated air concentrations of 

2997 BDE-209, lower PBDE congeners, and PBDFs 

2998 

 (xix) Take two wipe samples for chamber walls (100 cm2 2999 area each) 

3000 

3001 (4) Sampling and analytical methods.

3002 

3003 (i) Surface sampling for HIPS coupons. ASTM D-6661, Standard Practice for Field 

3004 Collection of Organic Compounds from Surfaces Using Wipe Sampling, or an equivalent 

3005 method, shall be used for surface sampling on HIPS coupons. The wipe samples shall be 

3006 extracted (Stapleton et al. (2008) in paragraph (i)(4)(xi)(F) of this section) and then analyzed for 

3007 BDE-209, lower PBDE congeners, and PBDFs. 

3008 

3009 (ii) Surface sampling for fabric swatches. A modified ASTM D-6661 method, as 

3010 described below, shall be used for surface sampling on fabric swatches. Modified procedure: 

Use 10×10 cm2 3011 heavy filter paper instead of cotton gauze pad; Place the fabric swatch on pre3012 cleaned flat surface; Place the solvent-wetted filter paper on the fabric swatch; Place a 10×10 

cm2 3013 stainless steel (or aluminum) plate on the paper filter; Add additional weights on the plate 

3014 such that the total weight is 2 lbs; Wait for 5 minutes; Remove plate and weights; Extract the 

3015 paper filter. 

3016 

3017 (iii) Air sampling. Time-integrated air samples shall be collected by using passive air 

3018 samplers (PUF disks; see Harrad, et al, 2006 (in paragraph(i)(4)(xi)(D) of this section) and 

3019 references therein). 

3020 

3021 (iv) Analytical method. High sensitivity is a key factor in selecting the analytical method. 

3022 A method based on chromatography/mass spectrometry in electron capture negative ionization 
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3023 mode (GC/MS-ECNI) shall be used. The analytes shall include BDEs and PBDFs as listed in 

3024 Bezares-Cruz et al. 2004 in paragraph (i)(4)(xi)(B) of this section; Stapleton and Dodder 2008 in 

3025 paragraph (i)(4)(xi)(G) of this section; and Geller et al. 2006 in paragraph (i)(4)(xi)(C) of this 

3026 section. 

3027 

3028 (v) Accelerated aging tests for HIPS coupons and fabric swatches with house dust. 

3029 

3030 (A) Objectives. The objectives of this, second part of the investigation are to determine 

3031 (1) if PBDEs or PBDF can migrate from plastics/fabrics to settled house dust by direct 

3032 partitioning; and (2) determine if the particle-bound PBDEs are subject to photolytic degradation 

3033 and quantify these processes. 

3034 

3035 (B) Experimental design. HIPS coupons and used TV cabinets shall be subjected to 

3036 accelerated aging in a test chamber in the presence of standard house dust, National Institute of 

3037 Standards Technology, Standard Reference Material 2583 (NIST SRM 2583), free of BDE-209. 

3038 This investigation shall be performed as described in (iv) with the exception of the addition of 

3039 pre-cleaned house dust to the surface of the HIPS coupons and fabric swatches. Accelerated 

3040 aging under simulated sunlight and fluorescent lighting, exposure durations, and sample 

3041 collections shall be identical to those described in (iv), with the addition of collection and 

3042 analysis of the added house dust. This experiment requires that the coupons are sufficiently large 

(500 cm2 3043 or larger) that there is enough house dust for sampling while the dust layer is not too 

3044 thick. 

3045 The house dust can be deposited on test specimens by using a separate dust deposition 

3046 chamber or spiked manually on test specimens (Ashley et al. 2007 in paragraph (i)(4)(xi)(A) of 

3047 this section). The test samples and dust shall then be exposed to accelerated aging for 300, 600, 

3048 and 900 hours, the dust collected by vacuum, and analyzed for content of BDE-209, lower 

3049 BDEs, and PBDFs. 

3050 

3051 (C) Materials and methods.

3052 

3053 (1) Test specimens. HIPS coupons and used TV cabinets shall be used in this 

3054 investigation. The procedure for preparing HIPS coupons described in (iv)(C)(1) shall be 

followed except that the size of the coupon shall be at least 500 cm2 3055 , such that an adequate 

3056 amount of house dust can be spiked on the surface without forming a thick layer of dust. The 

target dust load is between 0.5 and 1 mg/cm2 3057 coupon. 

3058 Two used TV sets shall be vacuumed and the dust analyzed for PBDEs and PBDFs as 

3059 previously described. Samples of the backcover shall be analyzed by Fourier transform infrared 

3060 spectroscopy (FT-IR) to identify the plastic and the flame retardant. Ground samples shall be 

3061 prepared for determination of PBDE and PBDF content. 

3062 The requirements for the test chamber are the same as described in (iv)(B) unless indicated 

3063 otherwise. 

3064 

3065 (2) Test matrix. A total of five tests listed in Table 2 shall be conducted. 

3066 

3067 Table 2. Test matrix for PBDE migration from source to house dust and photolytic degradation 

3068 

Test No. Material UV light Durations (h) 
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1 HIPS coupons Off 300, 600, 900 

2 HIPS coupons Off 300, 600, 900 

3 HIPS coupons On 300, 600, 900 

4 TV cabinet 1a Off 600 

5 TV cabinet 1b On 600 

6 TV cabinet 2a Off 600 

7 TV cabinet 2b On 600 

3069 

3070 (3) Test procedure for HIPS coupons.

3071 

3072 (i) Prepare HIPS coupons 

3073 

3074 (ii) Determine PBDE content in test specimens by preparing and analyzing ground 

3075 samples 

3076 

3077 (iii) Evenly spike approximately 0.25 to 0.5 g NIST standard house dust SRM 2583 on 

3078 each of the six HIPS coupons. This can be done either manually (Ashley et al. 2007 in paragraph 

3079 (i)(4)(xi)(A) of this section) or in a particle deposition chamber. The targeted dust load is 

between 0.5 and 1 mg/cm2 3080 coupon 

3081 

3082 (iv) Clean the test chamber by wiping the interior surfaces with ethanol-soaked paper 

3083 towel 

3084 

 (v) Take two wipe samples from chamber walls (100 cm2 3085 area each); the PBDE and 

3086 PBDF content shall be below the method detection limit 

3087 

3088 (vi) Open the chamber door, place six coupons on chamber floor (or rack), and close the 

3089 door 

3090 

3091 (vii) Set the chamber temperature at 55 °C and air change rate between 0.3 to 0.5 air 

3092 changes per hour, or the lowest air change flow the chamber system allows 

3093 

3094 (viii) Close chamber door and start the test. 

3095 

3096 (ix) At 300 elapsed hours, remove 2 coupons for dust sampling, restart chamber 

3097 

3098 (x) Repeat the above step at 600 and 900 elapsed hours. 

3099 

3100 (4) Test procedure for used TV cabinets.

3101 

3102 (i) Open the TV set and collect settled dust from the interior surfaces (see Takigami et al. 

3103 (2008) in paragraph (i)(4)(xi)(I)). 

3104 

3105 (ii) Determine the PBDE and PBDF content in the settled dust 

3106 

3107 (iii) Clean the backcover by soft cloth and air jet; do not clean it with solvents 
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3108 

3109 (iv) Determine PBDE and PBDF content in test specimen by preparing and analyzing 

3110 ground samples 

3111 

3112 (v) Divide the backcover evenly into two pieces (designated a and b in Table 2), one for 

3113 test with light and the other without light 

3114 

3115 (vi) For each half, cut flat areas into rectangular panels for testing; the total area of the 

flat panels shall be no less than 1000 cm2 3116 

3117 

3118 (vii) Evenly spike NIST standard house dust SRM 2583 on the interior side of the 

backcover panels for a targeted dust load between 0.5 to 1 mg/cm2 3119 

3120 

3121 (viii) Clean the test chamber by wiping the interior surfaces with ethanol-soaked paper 

3122 towel 

3123 

 (ix) Take two wipe samples from chamber walls (100 cm2 3124 area each); the PBDE and 

3125 PBDF content shall be below the method detection limit 

3126 

3127 (x) Open the chamber door, place the half backcover with NIST house dust on chamber 

3128 floor (or rack) 

3129 

3130 (xi) Set the chamber temperature at 55 °C and air change rate between 0.3 to 0.5 air 

3131 changes per hour, or the lowest air change flow the chamber system allows 

3132 

3133 (xii) Close chamber door and start test 

3134 

3135 (xiii) At 600 elapsed hours, remove the backcover panels from chamber, collect and 

3136 extract dust samples 

3137 

3138 (5) Sampling and analytical methods. Dust samples shall be collected by micro3139 vacuuming (Ashley et al. 2007 in paragraph (i)(4)(xi)(A) of this section or ASTM 7114). 

3140 The method described by Stapleton and Dodder (2008) in paragraph (i)(4)(xi)(F) of this section 

3141 shall be used to determine the PBDE content in dust samples. Wipe and air sampling methods 

3142 are described in (iv)(C)(4). 

3143 

3144 (vi) Records to be maintained. Records to be submitted to EPA shall include, but are not 

3145 limited to, the following: 

3146 

3147 (A) The original signed protocol and any amendments. 

3148 

3149 (B) Identification and characterization of the test substance as provided by Sponsor. 

3150 

3151 (C) Experiment initiation and termination dates. 

3152 

3153 (D) Stock solution concentration calculations and solution preparation, if applicable. 

3154 
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Page 79 of 83 

3155 (E) Results of LSC and HPLC and/or other analysis (e.g. GC or GC/ECNI-MS). 

3156 

3157 (F) Data on temperature, air flow and inlet air moisture content. 

3158 

3159 (G) Copy of final report. 

3160 

3161 (vii) Final report. A final report of the results of the study shall be prepared and 

3162 submitted to EPA. The report shall include, but is not limited to the following, when applicable: 

3163 

3164 (A) Name and address of facility performing the study. 

3165 

3166 (B) Dates on which the study was initiated and completed. 

3167 

3168 (C) Objectives and procedures stated in the approved protocol, including any changes in 

3169 the original protocol. 

3170 

3171 (D) Identification and characterization of the test substance as provided by Sponsor. 

3172 

3173 (E) A summary and analysis of the data and a statement of the conclusions drawn from 

3174 the analysis. 

3175 

3176 (F) A description of the transformations and calculations performed on the data. 

3177 

3178 (G) A description of the methods used and reference to any standard method employed. 

3179 

3180 (H) A description of the test system and test chamber(s), including chamber type, 

3181 dimensions and light source; and spectral irradiance inside the chamber if applicable. 

3182 

3183 (I) A description of the preparation of the test solutions, the testing concentrations, and 

3184 the duration of the test. 

3185 

3186 (J) A description of sampling and analytical methods, including level of detection, level 

3187 of quantification, and references. 

3188 

3189 (K) A description of test specimens and test matrix. 

3190 

3191 (L) A description of the test results including measured values for individual PBDE 

3192 congeners and PBDF homolog group for each matrix, exposure condition, and exposure 

3193 duration. 

3194 

3195 (M) A description of all circumstances that may affect the quality or integrity of the data. 

3196 

3197 (N) The name of the study director, the names of other scientists or professionals, and the 

3198 names of all supervisory personnel involved in the study. 

3199 

3200 (O) The signed and dated reports of each of the individual scientists or other 

3201 professionals involved in the study, if applicable. 
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Page 80 of 83 

3202 

3203 (P) The location where the raw data and final report are to be stored. 

3204 

3205 (Q) A statement prepared by the Quality Assurance Unit listing the types of inspections, 

3206 the dates that the study inspections were made and the findings reported to the Study Director 

3207 and Management. 

3208 

3209 (R) A copy of all raw data including but not limited to chromatograms, lab notebooks and 

3210 data sheets etc. 

3211 

3212 (viii) Changes to the final report. If it is necessary to make corrections or additions to the 

3213 final report after it has been accepted, such changes shall be made in the form of an amendment 

3214 issued by the Study Director. The amendment shall clearly identify the part of the study that is 

3215 being amended and the reasons for the alteration. Amendments shall be signed and dated by the 

3216 Study Director and Laboratory QA officer. 

3217 

3218 (ix) Changes to the protocol . Planned changes to the protocol shall be in the form of 

3219 written amendments signed by the Study Director and approved by the Sponsor’s Representative 

3220 and submitted to EPA using procedures in 40 CFR 790.50. Amendments shall be considered as 

3221 part of the protocol and shall be attached to the final protocol. Any other changes shall be in the 

3222 form of written deviations signed by the Study Director and filed with the raw data. All changes 

3223 to the protocol shall be indicated in the final report. Changes to the test standard require prior 

3224 approval from EPA using procedures in 40 CFR 790.55. 

3225 

3226 (x) Good laboratory practices. This study shall be conducted in accordance with Good 

3227 Laboratory Practice Standards for EPA and shall be consistent with OECD Principles of Good 

3228 Laboratory Practice. Each study conducted by the testing facility shall be routinely examined by 

3229 the facility’s quality assurance unit for compliance with Good Laboratory Practices, Standard 

3230 Operating Procedures, and the specified protocol. A statement of compliance with Good 

3231 Laboratory Practices shall be prepared for all portions of the study conducted by the testing 

3232 facility. The Sponsor is responsible for compliance with Good Laboratory Practices for 

3233 procedures that may be performed by other laboratories (e.g., residue analyses). Raw data for all 

3234 work performed at the testing facility and a copy of the final report shall be filed by project 

3235 number in archives located on the facility’s site or at an alternative location to be specified in the 

3236 final report. 

3237 

3238 (xi) Literature cited.

3239 

3240 (A) Ashley K, Applegate GT, Wise TJ, Fernback JE, Goldcamp MJ. Evaluation of a 

3241 standardized micro-vacuum sampling method for collection of surface dust. Journal of 

3242 Occupational and Environmental Hygiene 4:215–223. 2007. 

3243 

3244 (B) Bezares-Cruz J, Jafvert CT, Hua I.. Solar photodecomposition of decabromodiphenyl 

3245 ether: products and quantum yield. Environmental Science & Technology 38:4149-4156. 2004 

3246 

3247 (C) Geller AM, Krüger HU, Palm WU, Zetsch C. Identification of polybrominated 

3248 dibenzofurans from photolysis of decabromodiphenyl ether by UV spectroscopy. Abstract from 
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Page 81 of 83 

3249 DIOXIN 2006, Oslo, Norway, August 21-24, 2006. 

3250 

3251 (D) Harrad S, Hazrati S, Ibarra C. Concentrations of polychlorinated biphenyls in indoor 

3252 air and polybrominated diphenyl ethers in indoor air and dust in Birmingham, United Kingdom: 

3253 implications for human exposure. Environmental Science & Technology 40:4633-4638. 2006. 

3254 

3255 (E) Ross, J.; Fong, H.; Thongsinthusak,T.: Margetich, S.; Krieger, R. Measuring 

3256 potential dermal transfer of surface pesticide residue generated from indoor fogger use: using the 

3257 CDFA roller method interim report II. Chemosphere 22:975-984. 1991. 

3258 

3259 (F) Stapleton HM, Kelly SM, Allen JG, McClean MD, Webster TF. Measurement of 

3260 polybrominated diphenyl ethers on hand wipes: estimating exposure from hand-to-mouth 

3261 contact. Environmental Science & Technology 42:3329–3334. 2008. 

3262 

3263 (G) Stapleton HM, Dodder NG. 2008. Photodegradation of decabromodiphenyl ether in 

3264 house dust by natural sunlight. Environmental Toxicology and Chemistry 27:306–312. 

3265 

3266 (H) Strandberg B, Dodder NG, Basu I, Hites RA. 2001. Concentrations and spatial 

3267 variations of polybrominated diphenyl ethers and other organohalogen compounds in Great 

3268 Lakes air. Environmental Science & Technolnology 35: 1078-(missing page). 

3269 

3270 (I) Takigami H, Suzuki G, Hirai Y, Sakai S. Transfer of brominated flame retardants 

3271 from components into dust inside television cabinets. Chemosphere 73:161–169. 2008. 

3272 (j) Reporting requirements. For c-pentaBDE and c-octaBDE, a final report for each 

3273 specific test for each subject mixture must be received by EPA by the number of months 

3274 designated for that test in this paragraph after December 31, 2012, unless an extension is granted 

3275 in writing pursuant to 40 CFR 790.55. For c-decaBDE, a final report for each specific test must 

3276 be received by EPA by the number of months designated for that test in this paragraph after 

3277 December 31, 2013, unless an extension is granted in writing pursuant to 40 CFR 790.55. 

3278 A robust summary of the final report for each specific test shall be submitted electronically in 

3279 addition to and at the same time as the final report. The term “robust summary” is used to 

3280 describe the technical information necessary to adequately describe an experiment or study and 

3281 includes the objectives, methods, results, and conclusions of the full study report which can be 

3282 either an experiment or in some cases an estimation or prediction method. Guidance for the 

3283 compilation of robust summaries is described in a document entitled “Draft Guidance on 

3284 Developing Robust Summaries” which is available on-line at: 

3285 http://www.epa.gov/chemrtk/pubs/general/robsumgd.htm. 

3286 (1) The final report on toxicity to freshwater invertebrates of sediment-associated 

3287 contaminants shall be received by EPA by (12 months after the relevant effective date in 

3288 paragraph (k) of this section). 

3289 (2) The final report on Laboratory soil toxicity and bioaccumulation tests with the 

3290 lumbricid earthworm Eisenia fetidaand the enchytraeid potworm Enchytraeus albidu shall be 

3291 received by EPA by (12 months after the relevant effective date in paragraph (k) of this section). 
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3292 (3) The final report on toxicity to polychaetous annilids of sediment-associated 

3293 contaminants shall be received by EPA by (12 months after the relevant effective date in 

3294 paragraph (k) of this section). 

3295 (4) The final report on toxicity to nematode Caenorhabditis elegans of sediment3296 associated contaminants shall be received by EPA by (12 months after the relevant effective date 

3297 in paragraph (k) of this section). 

3298 (5) The final report on toxicity to estuarine and marine invertebrates of sediment3299 associated contaminants shall be received by EPA by (12 months after the relevant effective date 

3300 in paragraph (k) of this section). 

3301 (6) The final report on prenatal developmental toxicity in rabbits shall be received by 

3302 EPA by (12 months after the relevant effective date in paragraph (k) of this section.). 

3303 (7) The final report on two-generation reproductive toxicity with a satellite group for 

3304 body burden shall be received by EPA by (29 months after the relevant effective date in 

3305 paragraph (k) of this section). 

3306 (8) The final report on immunotoxicity shall be received by EPA by (12 months after the 

3307 relevant effective date in paragraph (k) of this section). 

3308 (9) The final report on the neurotoxicity screening battery, acute and subchronic, shall be 

3309 received by EPA by (21 months after the relevant effective date in paragraph (k) of this section). 

3310 (10) The final report on developmental neurotoxicity shall be received by EPA by (21 

3311 months after the relevant effective date in paragraph (k) of this section). 

3312 (11) The final report for the chronic toxicity/carcinogenicity test shall be received by 

3313 EPA by (60 months after the relevant effective date in paragraph (k) of this section). 

3314 (12) The final report for anaerobic aquatic metabolism shall be received by EPA by (60 

3315 months after the relevant effective date in paragraph (k) of this section). 

3316 (13) The final report for biodegradation in anaerobic digester sludge shall be received by 

3317 EPA by (24 months after the relevant effective date in paragraph (k) of this section). 

3318 (14) The final report for photolytic degradation of c-decaBDE in the indoor environment 

3319 shall be received by EPA by (24 months after the relevant effective date in paragraph (k) of this 

3320 section). 

3321 (k) Effective date. This section is effective after: 

3322 (1) December 31, 2012 for manufacturers (including importers) and processors of c3323 pentaBDE and c-octaBDE except as impurities, including c-pentaBDE and c-octaBDE in 

3324 articles, for any use, and for manufacturers (including importers) and processors of c-decaBDE 

3325 except as impurities, including c-decaBDE in articles, for any use except military and 

3326 transportation uses. 
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3327 (2) December 31, 2013 for manufacturers (including importers) and processors of c3328 decaBDE except as impurities, including c-decaBDE in articles, for all uses including military 

3329 and transportation uses. 

3330 [FR Doc. ??–????? Filed ??–??–??; 8:45 am]