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1 EO 12866/13563 Review Draft – As Submitted 

2 Rin2070-AJ52_EO12866_Ethylene Glycol Ethers-SNUR_FRM_FRdocument_2014-08-15.docx 

3 

4 BILLING CODE 6560-50-P 

5 ENVIRONMENTAL PROTECTION AGENCY 

6 40 CFR Parts 9 and 721 

7 EPA-HQ-OPPT-2009-0767; FRL-XXXX-X

8 RIN 2070-AJ52 

9 Ethylene Glycol Ethers; Significant New Use Rule

10 AGENCY: Environmental Protection Agency (EPA). 

11 ACTION: Final Rule. 

12 SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is promulgating a 

13 significant new use rule (SNUR) for seven ethylene glycol ethers (also known as 

14 glymes). This rule will require persons who intend to manufacture (including import) or 

15 process any of the seven ethylene glycol ethers for an activity that is designated as a 

16 significant new use by this rule to notify EPA at least 90 days before commencing such 

17 manufacture or processing. The required notifications would provide EPA with the 

18 opportunity to evaluate the intended use and, if necessary based on the information 

19 available at that time, an opportunity to protect against potential unreasonable risks, if 

20 any, from that activity before it occurs. EPA is also making a technical amendment to the 

21 codified list of control numbers for approved information collection activities so that it 

22 includes the control number assigned by the Office of Management and Budget (OMB) 

23 to the information collection activities contained in this rule. 

24 DATES: This final rule is effective [insert date 60 days after date of publication in the

25 Federal Register]. 

26 ADDRESSES: The docket for this action, identified by docket identification (ID) 
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27 number EPA-HQ-OPPT-2009-0767, is available at http://www.regulations.gov or at the 

28 Office of Pollution Prevention and Toxics Docket (OPPT Docket), EPA Docket Center 

29 (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave., 

30 NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., 

31 Monday through Friday, excluding legal holidays. The telephone number for the Public 

32 Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is 

33 (202) 566-0280. Please review the visitor instructions and additional information about 

34 the docket available at http://www.epa.gov/dockets. 

35 FOR FURTHER INFORMATION CONTACT: For technical information contact: 

36 Kirsten Hesla, Chemical Control Division (7405M), Office of Pollution Prevention and 

37 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, 

38 DC 20460-0001; telephone number: 202-564-2984; e-mail address: 

39 hesla.kirsten@epa.gov. 

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

41 Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: 

42 TSCA-Hotline@epa.gov. 

43 SUPPLEMENTARY INFORMATION: 

44 I. Executive Summary 

45 A. Does this Action Apply to Me? 

46 You may be potentially affected by this action if you manufacture (including 

47 import) or process any of the chemical substances covered by this final rule. The North 

48 American Industrial Classification System (NAICS) codes identified are not intended to 

49 be exhaustive, but rather provides a guide to help readers determine whether this 

50 document applies to them. Potentially affected entities may include: 
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51 • Manufacturers of one or more of subject chemical substances (NAICS codes 

52 325 and 324110); e.g., chemical manufacturing and petroleum refineries;

53 • All other basic organic chemical manufacturing (NAICS code 325199);

54 • Printing ink manufacturing (NAICS code 325910);

55 • Paint and coating manufacturing (NAICS code 325510); 

56 • Adhesive manufacturing (NAICS code 325520); and 

57 • Motor vehicle brake system manufacturing (NAICS code 336340). 

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

59 certification and export notification rules under TSCA. Persons who import any 

60 chemical substance are subject to the TSCA section 13 (15 U.S.C. 2612) import 

61 certification requirements and the corresponding regulations at 19 CFR 12.118 through 

62 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the 

63 chemical substance complies with all applicable rules and orders under TSCA, including 

64 any SNUR requirements. The EPA policy in support of import certification appears at 40 

65 CFR part 707, subpart B. In addition, any persons who export or intend to export a 

66 chemical substance that is the subject of this rule are subject to the export notification 

67 provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must 

68 comply with the export notification requirements in 40 CFR part 707, subpart D. 

69 To determine whether you or your business may be affected by this action, you 

70 should carefully examine the applicability provisions in 40 CFR 721.5 and 40 CFR 

71 721.10299. If you have any questions regarding the applicability of this action to a 

72 particular entity, consult the technical person listed under FOR FURTHER 

73 INFORMATION CONTACT. 

74 B. What is the Agency's Authority for Taking this Action? 
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75 Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that 

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

77 determination by rule after considering all relevant factors, including those listed in 

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

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

80 new use notice (SNUN) to EPA at least 90 days before they manufacture or process the 

81 chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit V., the 

82 general SNUR provisions are found at 40 CFR Part 721, Subpart A. 

83 C. What Action is the Agency Taking? 

84 In the Federal Register of July 12, 2011 (76 FR 40850) (FRL-8877-8), EPA 

85 proposed a SNUR for 14 ethylene glycol ethers (Ref. 1). EPA’s response to public 

86 comments received on the proposed rule appears in Unit X. Please consult the July 12, 

87 2011 Federal Register document for further background information for this final rule. 

88 This final SNUR applies to seven of the 14 ethylene glycol ethers identified in 

89 the proposed rule. EPA is not finalizing the SNUR for the other seven ethylene glycol 

90 ethers proposed because the Agency believes that these chemicals are not sufficiently 

91 similar to the seven chemicals subject to this SNUR and therefore do not raise the same 

92 concern for potential exposure to these chemicals. (See Unit X.A. for more information.) 

93 This final SNUR will require persons to notify EPA at least 90 days before commencing 

94 the manufacture (including import) or processing of: 

95 • ethylene glycol dimethyl ether (monoglyme, CASRN 110-71-4) for any use in a 

96 consumer product; 

97 • diethylene glycol dimethyl ether (diglyme, CASRN 111-96-6) for any use in a 

98 consumer product; 
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99 • ethylene glycol diethyl ether (ethylglyme, CASRN 629-14-1) for any use in a 

100 consumer product; 

101 • diethylene glycol diethyl ether (ethyldiglyme, CASRN 112-36-7) for any use in 

102 a consumer product, except as a component of inks, coatings and adhesives, and as a 

103 component of paint/graffiti removers; 

104 • triethylene glycol dimethyl ether (triglyme, CASRN 112-49-2) for any use in a 

105 consumer product, except as a solvent in consumer adhesives, in brake fluid, as a 

106 component of consumer paint/graffiti removers, and in consumer paints; 

107 • diethylene glycol dibutyl ether (butyl diglyme, CASRN 112-73-2) for any use in 

108 a consumer product, except as a component of inks, coatings and adhesives, and as a 

109 component in soldering compounds; or 

110 • triethylene glycol dibutyl ether (butyltriglyme, CASRN 63512-36-7) for any 

111 use. 

112 D. Why is the Agency Taking this Action?

113 This SNUR is necessary to ensure that EPA receives timely advance notice of any 

114 future manufacturing and processing of these ethylene glycol ethers for new uses that 

115 may produce changes in human and environmental exposures. The rationale and 

116 objectives for this SNUR are explained in Unit III. 

117 E. What are the Estimated Incremental Impacts of this Action?

118 EPA has evaluated the potential costs of establishing SNUR reporting 

119 requirements for potential manufacturers and processors of the chemical substances 

120 included in this final rule. This analysis, which is available in the docket, is discussed in 

121 Unit IX., and is briefly summarized here. 

122 In the event that a SNUN is submitted, costs are estimated to be less than $8,700 
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123 per SNUN submission for large business submitters and $6,300 for small business 

124 submitters. These estimates include the cost to prepare and submit the SNUN and the 

125 payment of a user fee. In addition, for persons exporting a substance that is the subject of 

126 a SNUR, a one-time notice must be provided for the first export or intended export to a 

127 particular country, which is estimated to cost less than $100 on average per notification. 

128 Since EPA is unable to predict whether anyone might engage in future activities that 

129 would require reporting, potential total costs were not estimated. 

130 II. Overview of the Chemical Substances Subject to this Rule 

131 The ethylene glycol ethers and the significant new use for each chemical 

132 substance subject to this SNUR are identified in Table 1. 

133 Table 1. Chemicals with Significant New Use(s) 

Chemical Name Chemical Abstracts 

(CA) Index Name 

Chemical 

Abstracts 

Service Registry 

No. (CASRN) 

Significant New Use(s) 

Monoethylene 

glycol dimethyl 

ether or 

monoglyme 

Ethane, 1,2,-

dimethoxy110-71-4 Any use in a consumer product 

Diethylene 

glycol dimethyl 

ether or diglyme 

Ethane, 1,1’-

oxybis[2-methoxy111-96-6 Any use in a consumer product 

Diethylene 

glycol diethyl 

ether or 

ethyldiglyme 

Ethane, 1,1’-

oxybis[2-ethoxy112-36-7 Any use in a consumer product except as a 

component of inks, 

coatings and adhesives, 

and as a component of 

paint/graffiti removers 

Triethylene 

glycol dimethyl 

ether or triglyme 

2,5,8,11-

Tetraoxadodecane 

112-49-2 Any use in a consumer 

product, except as a 

solvent in consumer 

adhesives, in brake fluid, 

as a component of 

consumer paint/graffiti 

removers, and in 

consumer paints 

Diethylene 

glycol dibutyl 

Butane, 1,1’-

[oxybis(2,1-

112-73-2 Any use in a consumer 

product except as a 
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ether or butyl 

diglyme 

ethanediyloxy)]bis- solvent in consumer inks, 

coatings and adhesives, 

and as a component in 

soldering compounds 

Ethylene glycol 

diethyl ether or 

ethylglyme 

Ethane, 1,2-diethoxy 629-14-1 Any use in a consumer 

product 

Triethylene 

glycol dibutyl 

ether or butyl 

triglyme 

5,8,11,14-

Tetraoxaoctadecane 

63512-36-7 Any use 

134 

135 EPA notes that the seven chemical substances that are the subjects of this SNUR 

136 are not the only ethylene glycol ethers that are of concern based on toxicity. EPA has 

137 described the ethylene glycol ethers category more broadly under the TSCA New 

138 Chemicals Program and under Emergency Planning and Community Right-To-Know Act 

139 (EPCRA) section 313. (See the TSCA New Chemicals Program Chemical Categories 

140 document (Ref. 2) and the EPCRA section 313 List of Toxic Chemicals “Certain Glycol 

141 Ethers” category at 40 CFR 372.65(c) (Ref. 3). Both categories are based on a 

142 consideration of structural similarity and hazard.) These categories are broader than the 

143 category that is subject to this SNUR. For this rulemaking, EPA considered past and 

144 current patterns of use as one factor in determining which ethylene glycol ethers would 

145 be included within the scope of this SNUR. EPA believes that the seven ethylene glycol 

146 ethers that are the subjects of this SNUR have and/or had similar use patterns and can be 

147 anticipated to have at least some similar new uses. Thus, given the potential for similar 

148 uses and the potential impact that these will have on type, duration, and magnitude of 

149 exposure, EPA believes it is appropriate to focus on these seven ethylene glycol ethers. 

150 III. Rationale and Objectives for this Final Rule 

151 A. Rationale

152 EPA is concerned about the potential of the seven ethylene glycol ethers that are 
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153 the subjects of this SNUR to cause reproductive and/or developmental toxicity, 

154 genotoxicity and toxicity to blood and blood forming organs and believes that individuals 

155 could suffer adverse effects from their use (Refs. 1-4). This concern is based on a 

156 combination of data and structure-activity relationships. While a specific hazard 

157 evaluation is not required by TSCA section 5(a)(2), EPA considered hazard in 

158 designating this category of ethylene glycol ethers. In deciding to focus on these 

159 chemical substances, EPA considered use patterns as well as toxicity data and structure160 activity relationships. EPA considered these factors in conjunction with the statutory 

161 factors provided in section 5(a)(2). In designating the significant new uses for these 

162 chemical substances, EPA will have the opportunity to evaluate and control, where 

163 appropriate, activities associated with those uses, if such manufacturing or processing for 

164 the significant new uses were to start or resume. The required notification provided by a 

165 SNUN will provide EPA with the opportunity to evaluate activities associated with a 

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

167 which may occur from exposure to these chemical substances. 

168 Consistent with EPA's past practice for issuing SNURs under TSCA section 

169 5(a)(2), EPA's decision to issue a SNUR for a particular chemical use need not be based 

170 on an extensive evaluation of the hazard, exposure, or potential risk associated with that 

171 use. Rather, the Agency's action is based on EPA's determination that if the use begins or 

172 resumes, it may present a risk that EPA should evaluate under TSCA before the 

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

174 exist, deferring a detailed consideration of potential risks or hazards related to that use is 

175 an effective use of resources. If a person decides to begin manufacturing or processing 

176 the chemical for the use, the notice allows EPA to evaluate the use according to the 
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177 specific parameters and circumstances surrounding that intended use. 

178 B. Objectives 

179 Based on the considerations in Unit III.A., EPA will achieve the following 

180 objectives with regard to the significant new uses that are designated in this rule: 

181 1. EPA will receive notice of any person’s intent to manufacture or process any of 

182 the chemical substances listed in Table 1 for the described significant new use before that 

183 activity begins. 

184 2. EPA will have an opportunity to review and evaluate data submitted in a 

185 SNUN before the notice submitter begins manufacturing or processing the chemical 

186 substances listed in Table 1 for the described significant new use. 

187 3. EPA will be able to regulate the prospective manufacture or processing of the 

188 chemical substances before the described significant new use of the chemical substance 

189 listed in Table 1 occurs, provided that regulation is warranted pursuant to TSCA sections 

190 5(e), 5(f), 6 or 7. 

191 IV. Significant New Use Determination

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

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

194 including: 

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

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

197 or the environment to a chemical substance. 

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

199 human beings or the environment to a chemical substance. 

200 • The reasonably anticipated manner and methods of manufacturing, processing, 
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201 distribution in commerce, and disposal of a chemical substance. 

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

203 authorizes EPA to consider any other relevant factors. 

204 To determine what would constitute a significant new use of the chemical 

205 substances subject to this rule, as discussed herein, EPA considered relevant information 

206 about the potential toxicity of these substances, the range of uses for these chemicals and 

207 the four factors listed in section 5(a)(2) of TSCA. 

208 EPA believes that potential new consumer uses could change the type and form of 

209 exposure and/or the magnitude and duration of exposure to humans and the environment 

210 relative to what currently exists. Use in consumer products could result in different types 

211 of exposure, e.g., inhalation exposure through spray applications, dermal exposure if the 

212 consumer product is meant to be hand-applied to an object, than currently exist. Use in 

213 different consumer products can also change the duration of exposure, which will depend 

214 upon the type of consumer product in which the chemical substance is used. Also, new 

215 uses of any of these chemical substances would likely result in an increase of the 

216 magnitude of exposure relative to current exposures given that these uses would be in 

217 addition to ongoing uses. Consumers use a variety of products; thus, their potential 

218 exposures to a chemical substance in multiple consumer products would likely be 

219 additive. 

220 New uses in consumer products would also result in differences in the processing 

221 of the chemical substances that are the subject of this SNUR because these chemical 

222 substances may be mixed with other chemicals and may be made part of consumer 

223 products with different properties, e.g., different viscosities from existing consumer 

224 products. Based on these considerations of the statutory factors, EPA has determined that 
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225 the uses identified in Table 1 are significant new uses. In addition, because there are no 

226 current uses of triethylene glycol dibutyl ether, any new use would result in a change in 

227 the volume of manufacturing and processing of this chemical substance, as well as the 

228 type, form, magnitude and duration of exposure, and the manner and methods of 

229 manufacturing, processing, distribution in commerce, and disposal of this chemical 

230 substance. 

231 V. Applicability of General Provisions 

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

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

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

235 effective date of the final rule. 

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

237 721.1(c), persons subject to SNURs must comply with the same notice requirements and 

238 EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under 

239 TSCA section 5(a)(1)(A). In particular, these requirements include the information 

240 submissions requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized 

241 by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 

242 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 

243 5(e), 5(f), 6 or 7 to control the activities on which it has received the SNUN. If EPA does 

244 not take action, EPA is required under TSCA section 5(g) to explain in the Federal 

245 Register its reasons for not taking action. 

246 Persons who export or intend to export a chemical substance(s) identified in a 

247 proposed or final SNUR are subject to the export notification provisions of TSCA section 

248 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 
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249 subpart D. Persons who import a chemical substance are subject to the TSCA section 13 

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

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

252 complies with all applicable rules and orders under TSCA, including any SNUR 

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

254 707, subpart B. 

255 VI. Applicability of the Rule to Uses Occurring Before Effective Date of the Final 

256 Rule 

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

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

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

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

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

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

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

264 was ongoing as of the effective date of the final rule. Thus, persons who may have begun 

265 commercial manufacture or processing of the chemical substance(s) subject to this rule

266 after the proposal was published on July 12, 2011, must cease such activity before the 

267 effective date of this final rule. To resume their activities, these persons will have to 

268 comply with all applicable SNUR notice requirements and wait until the notice review 

269 period, including all extensions, expires. Uses arising after the publication of the 

270 proposed rule are distinguished from uses that exist at publication of the proposed rule. 

271 The former would be new uses, the latter ongoing uses. To the extent that additional 

272 ongoing uses were found in the course of rulemaking, EPA has excluded these uses from 
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273 the final SNUR. EPA promulgated provisions to allow persons to comply with this 

274 SNUR before the effective date. If a person were to meet the conditions of advance 

275 compliance under section 721.45(h), that person would be considered to have met the 

276 requirements of the final SNUR for those activities. 

277 VII. Test Data and Other Information 

278 EPA recognizes that TSCA section 5 does not usually require developing any 

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

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

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

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

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

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

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

286 known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and 

287 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters 

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

289 substance during its manufacture (including import), processing, use, distribution in 

290 commerce, or disposal. EPA encourages persons to consult with the Agency before 

291 submitting a SNUN. As part of this optional pre-notice consultation, EPA would discuss 

292 specific data it believes may be useful in evaluating a significant new use. SNUNs 

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

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

295 with this chemical substance. 

296 SNUN submitters should be aware that EPA will be better able to evaluate 
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297 SNUNs that provide detailed information on: 

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

299 significant new uses of the chemical substance. 

300 2. Potential benefits of the chemical substance. 

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

302 by potential substitutes. 

303 VIII. SNUN Submissions 

304 EPA recommends that entities consult with the Agency prior to submitting a 

305 SNUN to discuss what data may be useful in evaluating a significant new use. 

306 Discussions with the Agency prior to submission can afford ample time to conduct any 

307 tests that might be helpful in evaluating risks posed by the intended use of the chemical 

308 substance. According to section 721.1(c), persons submitting a SNUN must comply with 

309 the same notice requirements and EPA regulatory procedures as persons submitting a 

310 PMN, including submission of test data on health and environmental effects as described 

311 in § 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e312 PMN software, and submitted to the Agency in accordance with the procedures set forth 

313 in §§ 721.25 and 720.40. E-PMN software is available electronically at 

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

315 IX. Economic Analysis 

316 A. SNUNs 

317 EPA has evaluated the potential costs of establishing SNUR reporting 

318 requirements for potential manufacturers and processors of the chemical substance 

319 included in this rule (Ref. 5). In the event that a SNUN is submitted, costs are estimated 

320 at approximately $8,589 per SNUN submission for large business submitters and $6,189 
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321 for small business submitters. These estimates include the cost to prepare and submit the 

322 SNUN, and the payment of a user fee. Businesses that submit a SNUN would be subject 

323 to either a $2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small 

324 business with annual sales of less than $40 million when combined with those of the 

325 parent company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). The costs of 

326 submission of SNUNs will not be incurred by any company unless a company decides to 

327 pursue a significant new use as defined in this SNUR. EPA's complete economic 

328 analysis is available in the public docket for this rule (Ref. 5) 

329 B. Export Notification 

330 Under section 12(b) of TSCA and the implementing regulations at 40 CFR part 

331 707, subpart D, exporters must notify EPA if they export or intend to export a chemical 

332 substance or mixture for which, among other things, a rule has been proposed or 

333 promulgated under section 5. For persons exporting a substance that is the subject of a 

334 SNUR, a one-time notice must be provided for the first export or intended export to a 

335 particular country. The total costs of export notification will vary by chemical substance, 

336 depending on the number of required notifications (i.e., the number of countries to which 

337 the chemical substance is exported). EPA is unable to make any estimate of the likely 

338 number of export notifications for the chemical substances covered in this SNUR. 

339 X. Response to Comments 

340 The Agency reviewed and considered all comments received related to the 

341 proposed rule. Copies of all non-CBI comments are available in the docket for this action 

342 (EPA-HQ-OPPT-2009-0767). A discussion of the major comments germane to the 

343 rulemaking and the Agency’s responses follow. Responses to all germane comments 

344 received are in the document titled: Response to Comments on the Proposed Ethylene 
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345 Glycol Ethers (Glymes) Significant New Use Rule (SNUR) (Ref. 6), which is also 

346 available in the docket. 

347 A. Scope of Ethylene Glycol Ethers Category. 

348 Comment 1: One commenter contends that the term glymes, while technically 

349 correct, is a less well-known term for these ethylene glycol ethers. The commenter 

350 asserts it may not have been clear to many what chemicals are subject to this rulemaking. 

351 Response 1: EPA disagrees that it was unclear what chemical substances were 

352 the subjects of the proposed SNUR. Even if an individual manufacturer or processor 

353 were unfamiliar with the term EPA used to designate the category (“glymes”), all of the 

354 chemical substances proposed to be included in the SNUR were also individually 

355 identified by their CASRN, CA Index Name, and ethylene glycol ether common name. 

356 Notice of the proposal was adequate; there were several ways in which stakeholders 

357 could have determined which chemical substances were the subjects of the proposal. 

358 However, to increase clarity, EPA will list the “ethylene glycol ether” name instead of the 

359 name “glymes” to characterize the chemicals subject to this SNUR. 

360 Comment 2: One commenter contends that while the ethylene glycol ethers are 

361 structurally similar, they vary in molecular weight, in the number of ethylene glycol 

362 groups, and in the length of the terminal alkyl groups. The commenter asserts that the 

363 presence of characteristics, such as longer terminal alkyl groups and more ethylene glycol 

364 groups act to reduce the developmental and reproductive toxicity of the higher molecular 

365 weight ethylene glycol ethers, as compared to the lower molecular weight ethylene glycol 

366 ethers. The commenter states that there is a decrease in ethylene glycol ether toxicity 

367 with increasing terminal alkyl length and/or increasing ethylene glycol groups, and that 

368 the category should be limited to monoglyme, diglyme and ethylglyme. Another 
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369 commenter contends that the category should be limited based on a consideration of 

370 metabolism. The commenter contends that the category should be limited to monoglyme, 

371 diglyme, ethyl diglyme and triglyme because only these will be metabolized in the body 

372 to chemical substances that have toxicity characteristics of ethylene glycol monomethyl 

373 ether and ethylene glycol monoethyl ether. The commenter contends that none of the 

374 other ethylene glycol ethers exhibit developmental or reproductive toxicity similar to that 

375 of these four chemical substances. 

376 Response 2: A specific evaluation of hazard is not required by TSCA section 

377 5(a)(2) to issue a SNUR. Nonetheless, EPA has based this SNUR in part on 

378 considerations of toxicity, so toxicity considerations are relevant in this instance. 

379 EPA believes that based on both toxicity data and structure-activity relationships 

380 (Refs. 1-4) ethylene glycol ethers that consist of 1, 2 or 3 glycol ether groups and 

381 terminal alkyl groups of 1 to 4 carbons can be anticipated to cause developmental and 

382 reproductive toxicity and/or hemolytic toxicity. Based on these same data and structure383 activity relationships, EPA agrees with commenters that chemical substances with more 

384 than 3 repeating glycol ether units should not be included in the category because the 

385 toxicity of such substances is dissimilar from the remaining members of the category. 

386 Therefore, EPA removed seven of the proposed category members from the final rule. 

387 While there is evidence that the toxicity is reduced going from methyl to butyl 

388 ether and with increasing number of ethylene glycol groups, toxicity is still observed 

389 (Refs. 3, 4). Indeed, data provided by one commenter demonstrate the developmental 

390 toxicity of six of the seven ethylene glycol ethers (Ref. 7). Among the seven substances 

391 listed in Table 1, EPA disagrees that the relevant evidence establishes sufficient variation 

392 in degree of toxicity to cull any further substances from the group. Differing doses at 
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393 which toxicity occurs does not equate with lack of toxicity. Thus, EPA disagrees with 

394 the commenter that the category should be further limited to only those chemicals which 

395 induce toxicity at the lowest doses. Inclusion in the category is appropriately predicated 

396 on similarity of toxicity. (EPA notes also that the commenters’ individual lists are not in 

397 agreement with respect to ethylene glycol ethers that they consider to be the most 

398 developmentally toxic, and that there is only partial overlap between these two lists.) 

399 Further, ethylene glycol ethers cause adverse effects in addition to reproductive 

400 and developmental toxicity. Data for other toxic effects of ethylene glycol ethers with 

401 terminal alkyl groups of one to four carbons do not indicate a trend toward decreasing 

402 toxicity with increasing alkyl chain length (Ref. 4). Hemolysis has been reported in 

403 varying degrees for ethylene glycol ethers of one to five carbons in the alkyl chains (Ref. 

404 4). Hemolysis is associated with chain length, and a chain length of four carbons causes 

405 this type of toxicity at the lowest dose (Ref. 4). 

406 One commenter contends that “the lower glymes that are generally considered to 

407 be toxic following repeated exposure are: monoglyme, diglyme and ethylglyme. The 

408 higher glymes that are less toxic following repeated exposure are triglyme, tetraglyme, 

409 polyglyme, ethyldiglyme and butyldiglyme” (Ref. 7). EPA disagrees that molecular 

410 weight can be appropriately applied, by itself, to establish which substances are 

411 sufficiently similar to be included in the SNUR. EPA notes that some level of variation 

412 within chemical categories is inevitable when placing similar chemicals into groups, and 

413 therefore, variation is expected. The similarity in the toxicity of the chemical substances 

414 that are the subject of this SNUR is not primarily based on molecular weight but as 

415 discussed above is based on both toxicity data and structure-activity relationships (Refs 

416 1-4). Ethylene glycol ethers that consist of 1, 2 or 3 glycol ether groups and terminal 
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417 alkyl groups of 1 to 4 carbons can be anticipated to cause developmental and 

418 reproductive toxicity and/or hemolytic toxicity. Based on these toxicity considerations, 

419 EPA notes that it did, in fact remove some of the higher molecular weight ethylene glycol 

420 ethers from the final rule. But EPA disagrees that varying molecular weight, in itself, 

421 should be a deciding factor in eliminating a chemical substance from a category of 

422 similar chemical substances. While the commenter provides limited data on 

423 developmental and reproductive toxicity, they provide no data with respect to other 

424 toxicity endpoints of concern (including toxicity to blood and blood forming organs, and 

425 potential for gene mutation) and the commenter does not speculate on possible 

426 similarities or differences among the chemical substances with respect to these endpoints 

427 (Ref. 7). 

428 Comment 3: Several commenters contend that the ethylene glycol ether category 

429 is too broad. While the chemical substances in the category are similar because they have 

430 one or more repeating glycol ether groups and terminal alkyl chains, structural similarity 

431 is not sufficient to predict toxicity. One commenter further states that structural 

432 similarities alone should not be the basis for toxicity determinations, risk assessment and 

433 subsequent regulation. 

434 Response 3: EPA acknowledges the commenters’ assertions that the category of 

435 ethylene glycol ethers in the proposed SNUR was too broad, and is finalizing this SNUR 

436 for only seven of the original 14 chemicals. 

437 The commenters’ remaining arguments (about the relevance of structural 

438 similarities to risk assessment, and subsequent regulation) are premature. This SNUR is 

439 not based on a risk assessment, and it does not establish that subsequent regulation of the 
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440 ethylene glycol ethers would be necessary in the event EPA receives a significant new 

441 use notice after promulgating this rule. 

442 While EPA did consider toxicity in deciding to focus on these chemical 

443 substances, under TSCA section 5(a)(2), EPA is neither required to determine that a 

444 particular new use of any chemical substance presents, nor even that it may present, an 

445 unreasonable risk to human health or the environment. Rather, EPA issues a SNUR for a 

446 particular new use of a substance if it has reason to anticipate that the use would raise 

447 significant questions related to potential exposure, so that it should have an opportunity to 

448 review the use before such use could occur. EPA bases this judgment on a consideration 

449 of all relevant factors, including the specific factors identified at section 5(a)(2). EPA 

450 considered similarities in toxicity and potential toxicity among these chemical 

451 substances, similarities in uses and considered the extent to which the significant new 

452 uses that are the subject of this SNUR could result in changes to the processing of these 

453 chemical substances and the type, duration and magnitude of exposures to these 

454 chemicals. 

455 B. Use. 

456 Comment 4: Two commenters request clarification on whether automobiles are 

457 considered consumer products. These commenters point to the definition of consumer 

458 product at section 3(a)(5) of the Consumer Product Safety Act (CPSA), which excludes 

459 motor vehicles. These commenters contend that the EPA definition at 40 CFR 721.3 

460 should be clarified to be consistent with CPSA and exclude motor vehicles. 

461 Response 4: CPSA is a different statute from TSCA. For purposes of significant 

462 new use rules issued pursuant to TSCA, consumer product is defined at 40 CFR 721.3 as 

463 “...a chemical substance that is directly, or as part of a mixture, sold or made available to 
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464 consumers for their use in or around a permanent or temporary household or residence, in 

465 or around a school, or in recreation.” This is the pertinent regulatory text and it contains 

466 no exclusion for automobiles. 

467 However, EPA would not consider ethylene glycol ethers to have been “sold or 

468 made available to consumers for their use” merely because they have been sold or made 

469 available to automobile manufacturers or commercial auto service establishments (for 

470 their use in manufacturing or maintaining customers’ motor vehicles). By contrast, 

471 ethylene glycol ethers that are sold or made available to a consumer, for the consumer’s 

472 own use in maintaining his or her own motor vehicle (e.g., as part of an aftermarket brake 

473 fluid) would fall within the definition of “consumer product.” 

474 Comment 5: One commenter asks that EPA clarify the status of brake fluid 

475 contained in a new or used motor vehicle at point of sale. 

476 Response 5: EPA would not consider an ethylene glycol ether to have been “sold 

477 or made available to consumers for their use,” merely because it has been made available 

478 to motor vehicle manufacturers (as part of a brake fluid mixture for their use in 

479 manufacturing customers’ motor vehicles) or used car dealers. By contrast, ethylene 

480 glycol ethers that are sold or made available to a consumer, for the consumer’s own use 

481 in maintaining his or her own motor vehicle (e.g., as part of an aftermarket brake fluid) 

482 would fall within the definition of “consumer product.” 

483 Comment 6: One commenter requested that EPA clarify how aftermarket 

484 components are addressed in this rulemaking. 

485 Response 6: An aftermarket component is any product offered for sale or 

486 installation in or on a motor vehicle after such vehicle has left the manufacturer's 

487 production line. Use in an aftermarket component would qualify as use in a consumer 
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488 product if the chemical substances in an aftermarket component are “sold or made 

489 available to consumers for their use in or around a permanent or temporary household or 

490 residence, in or around a school, or in recreation.” 40 CFR 721.3. 

491 Comment 7: Two commenters request that EPA modify the listed ongoing use 

492 for monoethylene glycol dimethyl ether (monoglyme) listed in the proposed rule - “any 

493 use in a consumer product except in electrolyte solution in sealed lithium batteries” to 

494 “any use in a consumer product except in electrolyte solutions for primary and secondary 

495 sealed lithium batteries” - because this would clarify that the ongoing use of monoglyme 

496 is in all primary and secondary batteries. 

497 Response 7: For purposes of defining the scope of the significant new use, EPA 

498 has determined that the use of ethylene glycol ethers in sealed lithium batteries (whether 

499 primary or secondary) is not use in a consumer product. An ethylene glycol ether is not 

500 being “sold or made available to consumers for their use,” 40 CFR 721.3, merely because 

501 it is contained in the electrolyte of sealed lithium batteries, which are themselves used by 

502 consumers. With this clarification, EPA is finalizing the significant new use for 

503 monoethylene glycol dimethyl ether as “any use in a consumer product.” 

504 XI. References 

505 The following is a listing of the documents that are specifically referenced in this 

506 document. The docket includes these documents and other information considered by 

507 EPA in developing this rule, including the documents referenced within the documents 

508 that are in the docket, even if the referenced document is not physically located in the 

509 docket. For assistance in locating these other documents, please consult the technical 

510 person listed under FOR FURTHER INFORMATION CONTACT. 

511 1. US EPA. Glymes; Proposed Significant New Use Rule. 76 FR 40850, July 12, 
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512 2011. 

513 2. US EPA. TSCA New Chemicals Program (NCP) Chemical Categories. Last 

514 revised August 2010, pages 68 – 69. 

515 http://www.epa.gov/oppt/newchems/pubs/npcchemicalcategories.pdf.

516 3. US EPA. Glycol Ethers Category; Toxic Chemical Release Reporting; 

517 Community Right-To-Know. 58 FR 36180, July 6, 1993. 

518 4. US EPA. Glycol Ethers Category; Toxic Chemical Release Reporting; 

519 Community Right-To-Know. 59 FR 34386, July 5, 1994. 

520 5. US EPA. Economic Analysis of the Significant New Use Rule for Seven 

521 Ethylene Glycol Ethers. Prepared by Nishkam Agarwal and Abt Associates Inc. 

522 September 30, 2013. 

523 6. US EPA. Response to Comments on the Proposed Ethylene Glycol Ethers 

524 (Glymes) Significant New Use Rule (SNUR). October 30, 2013. 

525 7. Novolyte Technologies. Attachment 1: Categorization of Glymes Based on 

526 Toxicology and Structural Characteristics. October 12, 2011, pages 1-21. 

527 XII. Statutory and Executive Order Reviews 

528 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: 

529 Improving Regulation and Regulatory Review 

530 This final rule has been designated by OMB as a “significant regulatory action” 

531 under section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993). 

532 Accordingly, EPA submitted this action to OMB for review under Executive Orders 

533 12866 and 13563 (76 FR 3821, January 21, 2011) and any changes made in response to 

534 OMB recommendations have been documented in the docket for this action. 

535 B. Paperwork Reduction Act (PRA) 
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536 This action does not impose any new information collection burden under the 

537 PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b). The information 

538 collection activities associated with existing chemical SNURs are already approved by 

539 OMB under OMB control number 2070-0038 (EPA ICR No. 1188); and the information 

540 collection activities associated with export notifications are already approved by OMB 

541 under OMB control number 2070-0030 (EPA ICR No. 0795). If an entity were to submit 

542 a SNUN to the Agency, the annual burden is estimated to be less than 100 hours per 

543 response, and the estimated burden for an export notifications is less than 1.5 hours per 

544 notification. In both cases, burden is estimated to be reduced for submitters who have 

545 already registered to use the electronic submission system. Additional burden, estimated 

546 to be less than 10 hours, could be incurred where additional record keeping requirements 

547 are specified under 40 CFR §721.125(a), (b), and (c). 

548 An agency may not conduct or sponsor, and a person is not required to respond to 

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

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

551 control numbers for EPA's regulations in Title 40 of the CFR, after appearing in the 

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

553 instrument, or form, if applicable. EPA is amending the table in 40 CFR part 9 to list this 

554 SNUR. This listing of the OMB control numbers and their subsequent codification in the 

555 CFR satisfies the display requirements of the PRA and OMB's implementing regulations 

556 at 5 CFR part 1320. Since the existing OMB approval was previously subject to public 

557 notice and comment before OMB approval, and given the technical nature of the table, 

558 EPA finds that further notice and comment to amend the table is unnecessary. As a 

559 result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the 
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560 Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further 

561 notice and comment. 

562 C. Regulatory Flexibility Act (RFA) 

563 Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I hereby certify that 

564 promulgation of this SNUR will not have a significant economic impact on a substantial 

565 number of small entities. The rationale supporting this conclusion is as follows. 

566 A SNUR applies to any person (including small or large entities) who intends to 

567 engage in any activity described in the rule as a “significant new use.” By definition of 

568 the word “new” and based on all information currently available to EPA, it appears that 

569 no small or large entities presently engage in such activities. Since this SNUR will 

570 require a person who intends to engage in such activity in the future to first notify EPA 

571 by submitting a SNUN, no economic impact will occur unless someone files a SNUN to 

572 pursue a significant new use in the future or forgoes profits by avoiding or delaying the 

573 significant new use. Although some small entities may decide to engage in such 

574 activities in the future, EPA cannot presently determine how many, if any, there may be. 

575 However, EPA’s experience to date is that, in response to the promulgation of SNURs 

576 covering over 1,000 chemical substances, the Agency receives only a handful of notices 

577 per year. During the six year period from 2005-2011, only three submitters self578 identified as small in their SNUN submission (Ref. 5). EPA believes the cost of 

579 submitting a SNUN is relatively small compared to the cost of developing and marketing 

580 a chemical new to a firm and that the requirement to submit a SNUN generally does not 

581 have a significant economic impact. 

582 Therefore, EPA believes that the potential economic impact of complying with 

583 this SNUR is not expected to be significant or adversely impact a substantial number of 
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584 small entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) 

585 (FRL-5735-4), the Agency presented its general determination that proposed and final 

586 SNURs are not expected to have a significant economic impact on a substantial number 

587 of small entities, which was provided to the Chief Counsel for Advocacy of the Small 

588 Business Administration. 

589 D. Unfunded Mandates Reform Act (UMRA) 

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

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

592 have any reason to believe that any State, local, or Tribal government would be impacted 

593 by this rulemaking. As such, EPA has determined that this regulatory action would not 

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

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

596 of UMRA, 2 U.S.C. 1531-1538. 

597 E. Executive Order 13132: Federalism 

598 This action does not have a substantial direct effect on States, on the relationship 

599 between the national government and the States, or on the distribution of power and 

600 responsibilities among the various levels of government, as specified in Executive Order 

601 13132 (64 FR 43255, August 10, 1999). 

602 F. Executive Order 13175: Consultation and Coordination with Indian Tribal 

603 Governments 

604 This rule does not have Tribal implications because it will not have any effect 

605 (i.e., there will be no increase or decrease in authority or jurisdiction) on Tribal 

606 governments, on the relationship between the Federal government and the Indian tribes, 

607 or on the distribution of power and responsibilities between the Federal government and 
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608 Indian tribes. Thus, Executive Order 13175 (65 FR 67249, November 9, 2000) does not 

609 apply to this action. 

610 G. Executive Order 13045: Protection of Children from Environmental Health Risks and 

611 Safety Risks 

612 This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 

613 1997), because this action is not intended to address environmental health or safety risks 

614 for children. 

615 H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, 

616 or Use 

617 This rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), 

618 because this action is not expected to affect energy supply, distribution, or use. 

619 I. National Technology Transfer Advancement Act (NTTAA) 

620 Since this action does not involve any technical standards, NTTAA section 12(d), 

621 15 U.S.C. 272 note, does not apply to this action. 

622 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

623 Populations and Low-Income Populations 

624 This action does not entail special considerations of environmental justice related 

625 issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because 

626 EPA has determined that this action will not have disproportionately high and adverse 

627 human health or environmental effects on minority or low-income populations. This 

628 action does not affect the level of protection provided to human health or the 

629 environment. 

630 XIII. Congressional Review Act (CRA) 

631 Pursuant to the CRA, 5 U.S.C. 801 et seq., EPA will submit a report containing 
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632 this rule and other required information to the U.S. Senate, the U.S. House of 

633 Representatives, and the Comptroller General of the United States prior to publication of 

634 the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 

635 804(2). 

636 List of Subjects 

637 40 CFR Part 9 

638 Environmental protection, Reporting and recordkeeping requirements. 

639 40 CFR Part 721

640 Environmental protection, Chemicals, Hazardous substances, Reporting and 

641 recordkeeping requirements.

642 Dated: _______________________ 

643 

644 _______________________________________________ 

645 Director, Office of Pollution Prevention and Toxics. 
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646 Therefore, 40 CFR parts 9 and 721 are amended as follows: 

647 PART 9--[AMENDED] 

648 1. The authority citation for part 9 continues to read as follows: 

649 Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 

650 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 

651 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 

652 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 

653 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 

654 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048. 

655 2. In § 9.1, add the following sections in numerical order under the undesignated 

656 center heading “Significant New Uses of Chemical Substances” to read as follows: 

657 § 9.1 OMB approvals under the Paperwork Reduction Act.

658 * * * * * 

40 CFR citation OMB control No. 

* * * * *

Significant New Uses of Chemical Substances

* * * * *

721.10229 2070-0038

* * * * * 

659 

660 * * * * * 

661 PART 721--[AMENDED]

662 3. The authority citation for part 721 continues to read as follows: 

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

664 4. Add §721.10229 to subpart E to read as follows:
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665 §721.10229 Ethylene Glycol Ethers.

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

667 substances identified in Table 1 are subject to reporting under this section for the 

668 significant new uses described in Table 1 

669 Table 1. Ethylene glycol ethers and significant new uses subject to reporting. 

Chemical Name Chemical Abstracts 

Index Name 

Chemical 

Abstracts Service 

Registry No. 

(CASRN) 

Significant New Use(s) 

Monoethylene 

glycol dimethyl 

ether or 

monoglyme 

Ethane, 1,2,-

dimethoxy110-71-4 Any use in a consumer product 

Diethylene glycol 

dimethyl ether or 

diglyme 

Ethane, 1,1’-

oxybis[2-methoxy111-96-6 Any use in a consumer product 

Diethylene glycol 

diethyl ether or 

ethyldiglyme 

Ethane, 1,1’-

oxybis[2-ethoxy112-36-7 Any use in a consumer product except as a 

component of inks, coatings 

and adhesives, and as a 

component of paint/graffiti 

removers 

Triethylene glycol 

dimethyl ether or 

triglyme 

2,5,8,11-

Tetraoxadodecane 

112-49-2 Any use in a consumer 

product, except as a solvent 

in consumer adhesives, in 

brake fluid, as a component 

of consumer paint/graffiti 

removers, and in consumer 

paints 

Diethylene glycol 

dibutyl ether or 

butyldiglyme 

Butane, 1,1’-

[oxybis(2,1-

ethanediyloxy)]bis112-73-2 Any use in a consumer 

product except as a solvent 

in consumer inks, coatings 

and adhesives, and as a 

component in soldering 

compounds 

Ethylene glycol 

diethyl ether or 

ethylglyme 

Ethane, 1,2-

diethoxy 

629-14-1 Any use in a consumer 

product 

Triethylene glycol 

dibutyl ether or 

butyltriglyme 

5,8,11,14-

Tetraoxaoctadecane 

63512-36-7 Any use 

670