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1 Glymes NPRM_EO 12866_2010-04-08.doc 

2 

3 EO12866-Documentation_Glymes-NPRM_Revised-v-Submitted_2011-05-27.docx 

4 

5 Revised to address Interagency Comments received under EO 12866 Review Draft as 

6 submitted. 

7 

8 BILLING CODE 6560–50–P

9 

10 ENVIRONMENTAL PROTECTION AGENCY 

11 40 CFR Part 721 

12 [EPA–HQ–OPPT–2009–0767; FRL–XXXX–X] 

13 RIN 2070–AJ52

14 Glymes; Proposed Significant New Use Rule 

15 AGENCY: Environmental Protection Agency (EPA).

16 ACTION: Proposed rule. 

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

18 Toxic Substances Control Act (TSCA) for the 14 glymes identified in this proposed rule. This 

19 action would require persons who intend to manufacture, import, or process these chemical 

20 substances for an activity that is designated as a significant new use by this proposed rule to 

21 notify EPA at least 90 days before commencing that activity. The required notification would 

22 provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or 

23 limit that activity before it occurs. 

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

25 publication in the Federal Register]. 

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

27 HQ–OPPT–2009–0767, by one of the following methods: 

28 • • Federal eRulemaking Portal: http://www.regulations.gov.http://www.regulations.gov. 

29 Follow the on-line instructions for submitting comments. 

30 

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

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

33 20460–0001. 

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

35 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ–

36 OPPT–2009–0767. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding 
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37 legal holidays. The telephone number for the DCO is (202) 564–8930. Such deliveries are only 

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

39 for deliveries of boxed information. 

40 Instructions: Direct your comments to docket ID number EPA–HQ–OPPT–2009–0767. 

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

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

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

44 Business Information (CBI) or other information whose disclosure is restricted by statute. Do 

45 not submit information that you consider to be CBI or otherwise protected through 

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

47 means EPA will not know your identity or contact information unless you provide it in the body 

48 of your comment. If you send an e-mail comment directly to EPA without going through 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

69 the building and returned upon departure. 

70 FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 

71 Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of 

72 Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 

73 NW., Washington, DC 20460–0001; telephone number: (202) 554–1404; e-mail address: 

74 TSCA-Hotline@epa.gov.

75 For technical information contact: Amy Breedlove, Chemical Control Division (7405M), 

76 Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 

77 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 202-564-9823; e78 mail address: breedlove.amy@epa.gov. 
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79 For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., 

80 Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: TSCA81 Hotline@epa.gov.

82 

83 SUPPLEMENTARY INFORMATION: 

84 

85 I. General Information 

86 A. Does this Action Apply to Me? 

87 You may be potentially affected by this action if you manufacture, import, or process the 

88 chemicals listed in Unit II.A.III.A. Potentially affected entities may include, but are not limited 

89 to:

90 

91 Potentially affected entities may include, but are not limited to:

92 • Manufacturers, importers, or processors of one or more of subject chemical substances 

93 (North American Industrial Classification System (NAICS) codes 325 and 324110), e.g., 

94 chemical manufacturing and petroleum refineries; 325199 – All other basic organic chemical 

95 manufacturing; 325910 – Printing ink manufacturing; 325510 – Paint and Coating 

96 Manufacturing; 325520 – Adhesive Manufacturing; 335912 – Principle Battery Manufacturing;

97 and 336340 – Motor Vehicle Brake System Manufacturing.

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

99 • Printing ink manufacturing (NAICS 325910); 

100 • Paint and Coating Manufacturing (NAICS 325510); 

101 • Adhesive Manufacturing (NAICS 325520); 

102 • Principle Battery Manufacturing (NAICS 335912); and 

103 • Motor Vehicle Brake System Manufacturing (NAICS 336340).

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

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

106 could also be affected. The NAICS codes have been provided to assist you and others in 

107 determining whether this action might apply to certain entities. To determine whether you or 

108 your business may be affected by this action, you should carefully examine the applicability 

109 provisions in 40 CFR 721.5. Also consult Unit II. If you have any questions regarding the 

110 applicability of this action to a particular entity, consult the technical person listed under FOR 

111 FURTHER INFORMATION CONTACT. 

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

113 export notification rules under TSCA. Persons who import any chemical substance governed by 

114 a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification 

115 requirements and the corresponding regulations at 19 CFR 12.118 through 12.127 and; see also

116 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance 
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117 complies with all applicable rules and orders under TSCA, including any SNUR requirements. 

118 The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In 

119 addition, any persons who export or intend to export a chemical substance that is the subject of 

120 this proposed rule on or after [insert date 30 days after the date of publication in the FR] are 

121 subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 

122 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, 

123 subpart D. 

124 

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

126 

127 1. Submitting CBI. Do not submit thisconfidential business information (CBI) to EPA 

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

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

130 the disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and 

131 then identify electronically within the disk or CD-ROM the specific information that is claimed 

132 as CBI. In addition to one complete version of the comment that includes information claimed 

133 as CBI (i.e., a sanitized version), a, a redacted copy of the comment that does not contain the 

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

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

136 

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

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

139 heading, Federal Register date and page number). 

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

141 organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 

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

143 your requested changes. 

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

145 used. 

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

147 sufficient detail to allow for it to be reproduced. 

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

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

150 threats. 

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

152 II. Background 

153 A. What Action is the Agency Taking? 
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154 EPA is proposing a significant new use rule under section 5(a)(2) of TSCA where the 

155 designated significant new use for the chemicals in Table 1 of this unit would be “use in a 

156 consumer product,” with the exception of the ongoing uses which are the excluded uses listed 

157 under “Proposed Excluded Consumer Uses,” and where the designated significant new use for 

158 the chemicals in Unit II.A.1 would be “any use.” “Consumer product” is defined at 40 CFR 

159 721.3 as: “a chemical substance that is directly, or as part of a mixture, sold or made available to 

160 consumers for their use in or around a permanent or temporary household or residence, in or 

161 around a school, or in recreation.” Persons would be required to notify EPA at least 90 days 

162 before commencing the manufacture, import, or processing of the listed substances for the 

163 designated significant new uses. The objectives and rationale for this proposed SNUR are 

164 explained in Unit IV.

165 

166 Table 1 – Chemicals with Use in a Consumer Product as the Proposed Significant New Use 

167 and Proposed Excluded Consumer Uses [moved table]

168 

169 What is the Agency's Authority for taking this Action? 

170 

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

172 of a chemical substance is a "“significant new use.".” Since on-going uses are by definition, not 

173 new, they are identified and excluded from the SNUR. EPA must make thisthe determination of 

174 a “significant new use” by rule after considering all relevant factors, including those listed in 

175 TSCA section 5(a)(2). The relevant factors to be considered are: 

176 

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

178 

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

180 environment to a chemical substance. 

181 

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

183 beings or the environment to a chemical substance. 

184 

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

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

187 

188 • In addition to the factors enumerated in TSCA section 5(a)(2), the statute authorizes 

189 EPA to consider any other relevant factors. 

190 

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

192 section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at 

193 least 90 days before they manufacture, import, or process the chemical substance for that use (15 

194 U.S.C. 2604(a)(1)(B)). As described in Unit II.CVII., the general SNUR provisions are found at 

195 40 CFR Part 721, Subpart A. 

196 

197 Section 26(c) of TSCA (15 U.S.C. Applicability of General Provisions

198 

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

200 provisions describe persons subject to the rule, recordkeeping requirements, exemptions to 
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201 reporting requirements, and applicability of the rule to uses occurring before the effective date of 

202 the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 

203 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA 

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

205 5(a)(1)(A). In particular, these requirements include the information submissions requirements 

206 of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 

207 (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA 

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

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

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

211 

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

213 SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations 

214 that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons who import a 

215 chemical substance identified in a final SNUR are subject to the TSCA section 13 import 

216 certification requirements, codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such 

217 persons must certify that the shipment of the chemical substance complies with all applicable 

218 rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of 

219 import certification appears at 40 CFR part 707, subpart B.

220 

221 III. Summary of Exposure and Hazard Information on the Glymes 

222 

223 A. What are the Chemicals included in the SNUR?

224 

225 The glymes in the category include the 142625(c)) authorizes EPA to take action 

226 under other sections of TSCA with respect to categories of chemical substances shown in Table 

227 1 of the regulatory text. .

228 

229 B. What areWhy is the Uses of these Chemicals? Agency taking this Action?

230 

231 To identify the ongoing consumer uses of these glymes, as well as potential industrial 

232 uses, EPA used information submitted under the 2006 Inventory Update Reporting (IUR) rule, 

233 contacted manufacturers, searched business periodicals, and searched other available sources. 

234 

235 Monoglyme is used in consumer products in electrolyte solutions for sealed lithium 

236 batteries. Industrial uses include printed circuit board manufacturing; in reactions with strong 

237 bases; in mixtures where solvent separation and recovery is necessary; as an inert special solvent; 

238 and as a solvent in pharmaceutical production (Ref. 1, pg. 9).

239 

240 Diglyme is used as a solvent in printing inks for consumer products and industrially as a solvent 

241 in a variety of processes (Ref. 1, pg. 10).

242 

243 Triglyme is used in consumer products in consumer brake fluids, as a solvent in consumer

244 adhesives, as a component of consumer paint and graffiti removers and in consumer paints. 

245 Industrial uses include generation of chemicals, use as a reaction solvent, and use as a binding 

246 agent in porcelain powders (Ref. 1, pg. 11).

247 
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248 Tetraglyme is used in consumer products as a solubilizing agent for consumer printing inks, as a 

249 coalescing agent in consumer paints, and as an HFC/CFC lubricant which may be used in 

250 consumer air conditioners. Industrial uses include use as a solubilizing agent in textiles and 

251 plastics, as a dye fixation additive for cotton textiles, as a fungicide process solvent, and as a gas 

252 scrubbing agent (Ref. 1, pg. 12). 

253 

254 Polyglyme is used in consumer paint strippers. Industrial uses include use as special, high 

255 boiling solvents for chemical reactions, use as a solubilizing agent for plastic, textile, and paper 

256 processes, and use as a gas scrubbing agent (Ref. 1, pg. 13).

257 

258 Ethyldiglyme, butyldiglyme, tetraethylene glycol dibutyl ether, ethylglyme, tetraethylene glycol 

259 diethyl ether, pentaethylene glycol diethyl ether, and polyethylene glycol dibutyl ether, have no 

260 known uses in consumer products. Industrial uses of these glymes can include use: as a high261 boiling solvent for nitrocellulose, resins, and lacquers; as a solubilizer in organic synthesis; as a 

262 solvent in the production of plastic resins and compounds, rubber chemicals; as a solvent for 

263 conductive printing ink; in the production of printed circuit etchants; in the preparation of and 

264 reaction with Grignard reagents; in metal extractions; as a solvent in pharmaceutical syntheses;

265 in the production of coatings; and as a gas scrubbing liquid (Ref. 1, pgs. 14-19).

266 

267 The chemicals listed in Unit II.A.1., pentaethylene glycol dibutyl ether and butyltriglyme,

268 have no known uses (Ref. 1, pg. 19).

269 

270 C. What are the Production Levels of these Chemicals? 

271 

272 The 2006 Inventory Update Reporting (IUR) regulation required manufacturers and 

273 importers of certain chemical substances included on the TSCA Chemical Substance Inventory 

274 to report site and manufacturing information for chemicals manufactured (including imported) in 

275 amounts of 25,000 pounds or greater at a single site. Table 2 summarizes 2006 and prior year 

276 IUR data for the 14 glymes. For monoglyme and diglyme, EPA expects that production will 

277 continue. For triglyme and ethylglyme, predicting future production is infeasible, although 

278 ethylglyme production appears to be increasing. For ethyldiglyme, butyldiglyme, and 

279 tetraglyme, EPA expects that production will remain at the previous levels. Production of 

280 pentaethylene glycol diethyl ether appears to be steadily increasing. For polyglyme, EPA 

281 expects that production will continue to decrease and/or remain below the reporting level. For 

282 tetraethylene glycol dibutyl ether, tetraethylene glycol diethyl ether, polyethylene glycol dibutyl 

283 ether, pentaethylene glycol dibutyl ether, and butyltriglyme, EPA expects that production of 

284 these chemical substances, if any, will remain below reporting levels. 

285 

286 Table 2 – Production Reporting Amounts to IUR 1986-2006 (Ref. 1) [moved table] 

287 

288 Monoglyme, diglyme, ethyldiglyme, triglyme, butyldiglyme, and ethylglyme are 

289 included in the category of chemicals reported as “certain glycol ethers” under the ID number 

290 N230 in the Toxics Release Inventory (TRI) (Ref. 2). The total release reported to the TRI in 

291 2007 from all reporting sites was 18,476,420 pounds. This total includes air releases of 

292 16,416,033 pounds from on-site fugitive and point sources, in addition to on-site water releases 

293 of 87,035 pounds. Most of the remaining volume of release was deep-well injected, sent to land 

294 treatment, transferred for energy recovery or transferred to a POTW. Release information about 
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295 the individual glymes within the larger glycol ether category is not known (Ref. 3). 

296 Manufacturers, importers, or processors are required to report releases of chemicals on the TRI 

297 when total manufacturing, imports or processing by a facility equals 25,000 pounds/year for the 

298 chemicals combined. 

299 

300 Ethylglyme was found in the US EPA Office of Water STORET database indicating 

301 potential environmental exposure since this chemical was found in ground water and/or surface 

302 water (Ref. 3). 

303 

304 Monitoring data indicate that the general population may be exposed to diglyme and 

305 ethyldiglyme via inhalation of vehicle exhaust and ingestion of contaminated drinking water 

306 (Refs. 4 and 5). Diglyme was listed as a contaminant found in drinking water (Ref. 4). 

307 

308 Diglyme has been detected in diluted vehicle exhaust from a light-duty truck using 

309 different fuel types (Ref. 4). 

310 

311 Industrial manufacture and processing may result in the release of glymes to the 

312 environment through various waste streams (Ref. 4). Diglyme, ethyldiglyme, and ethylglyme 

313 have been found at measurable concentrations in industrial wastewater treatment systems (Refs. 

314 4, 5, and 6). Wastewater treatment systems discharge to either surface waters or publicly owned 

315 treatment works. Either of these two discharge options could result in exposures for the general 

316 population and the environment to these chemicals.

317 

318 Ethyldiglyme has been qualitatively detected in drinking water from Cincinnati, OH; in 

319 ground water from the Hipps Road Landfill in Jacksonville, FL; in trench leachates from Maxey 

320 Flats, KY and West Valley, NY low-level radioactive waste disposal sites and in advanced waste 

321 treatment water from Lake Tahoe, CA, Pomona, CA, and Blue Plains, Washington, DC (Ref. 5). 

322 

323 Ethylglyme has been detected in western Cleveland, OH wastewater influents at 140 

324 μg/L and it was identified in Chicago Central water works water (treated and untreated) at 2 

325 μg/L (Ref. 6). 

326 

327 Monitoring data for ethylglyme indicates that the general population may be exposed to 

328 the chemical through releases from manufacturing facilities. The general population can then be 

329 exposed via inhalation of ambient air, ingestion of drinking water, and dermal contact with these 

330 substances and other products containing these chemicals. Evidence of releases from industrial 

331 manufacturing and processing is demonstrated by concentrations of 400 mg/L of diglyme which 

332 have been found in activated sludge from the waste treatment facility of the industry producing 

333 the chemical (Ref. 6). 

334 

335 For the remaining chemicals in Table 1 or Unit II.A.1., little or no release information 

336 was found. 

337 

338 EPA’s Source Ranking Databank (Ref. 7) shows metal polish and polishing cloths and 

339 papers as containing ethylglyme. Most of the entries into this databank for consumer products 

340 are from the late 1990s and therefore may not still be current. If ethylglyme is still found in 

341 these products, however, there is potential that consumers and children might be exposed to this 
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342 chemical from these consumer products. Furthermore, production of ethylglyme appears to be 

343 increasing. 

344 

345 Based on IUR data and communications with manufacturers, EPA believes that 

346 monoglyme is used as a component of lithium batteries and diglyme is used in printing inks, both 

347 of which are consumer applications of monoglyme. It is believed that disposal of the lithium 

348 batteries containing monoglyme and paper with printing inks containing diglyme could present 

349 the potential for release of these chemicals to environmental media and subsequent exposure to 

350 humans and ecological receptors. 

351 

352 Occupational exposure

353 

354 Occupational exposure to these chemicals may occur through inhalation and dermal 

355 contact at workplaces where the chemicals are produced or used. Monoglyme, diglyme, 

356 ethylglyme, ethyldiglyme, triglyme, and tetraethylene glycol diethyl ether all have vapor 

357 pressures high enough to potentially result in significant exposures to workers if they are near the 

358 chemical (Refs. 8, 9, 3, and 10). Based on IUR data, ethyldiglyme, butyldiglyme, tetraglyme, 

359 pentaethylene glycol diethyl ether, and polyglyme are manufactured in liquid forms, and worker 

360 exposures through dermal contact are possible (Ref. 10). These chemicals do not have 

361 Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (Refs. 8, 

362 9, and 3). Ferro Corporation, in their publications, recommended a Threshold Limit Value 

363 (TLV) for glycol ethers of 5 ppm (Time Weighted Average (TWA)) with a Short Term Exposure 

364 Limit (STEL) of 25 ppm. The 15-minute STEL should not be achieved more than 4 times in 8 

365 hours. For women of child-bearing potential, Ferro recommended a TLV of 1 ppm with a STEL 

366 of 5 ppm (Ref. 11). Based on the 2006 IUR reports, the maximum total number of potentially 

367 exposed industrial workers to monoglyme and ethylglyme during manufacturing and industrial 

368 processing and use is less than 100 each, and the maximum total number of workers likely to be 

369 exposed to diglyme was between 100 and 999 workers. There may, however, be additional 

370 potentially exposed industrial workers who are not included in these estimates since not all 

371 production volume may have been accounted for in the IUR (production below 25,000 pounds at 

372 a site does not have to be reported to the IUR), and commercial workers may be exposed as well 

373 (Refs. 8, 9, and 12).

374 

375 E. What are the Potential Health Effects of these Chemicals?

376 

377 Toxicology studies in laboratory animals have shown that exposure to monoglyme 

378 results in hemolytic (blood) effects, and developmental and reproductive toxicity. The acute 

379 toxicity of monoglyme is low via oral, dermal and inhalation routes of exposure. The potential 

380 toxicity from repeated exposure to monoglyme was assessed using a major metabolite, 2-

381 methoxyethanol (CASRN 109-86-4). Oral 90-day studies of 2-methoxyethanol in rats and mice 

382 showed testicular degeneration and adverse effects on the process of blood cell formation. The

383 lowest observed adverse effect level (LOAEL) in rats was 70 mg/kg-day; the LOAEL in mice 

384 was 300 mg/kg-day. An oral prenatal developmental toxicity study of monoglyme in rats 

385 showed fetal mortality at doses as low as 60 mg/kg-day, and edema at doses as low as 30 mg/kg386 day. An oral prenatal developmental toxicity study of monoglyme in mice showed reduced fetal 

387 body weight and increased skeletal defects at 250 mg/kg-day. Available data also suggest that 

388 monoglyme has the potential to be genotoxic (Ref. 13).
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389 

390 Toxicology studies in laboratory animals have shown that exposure to diglyme results in 

391 hemolytic (blood) effects, and developmental and reproductive toxicity. The acute toxicity of 

392 diglyme to rats via the oral and inhalation routes of exposure is low. The toxicity profile 

393 following repeated exposures to diglyme is similar to the profile for monoglyme. Rats showed 

394 testicular degeneration and hemolytic effects following inhalation exposure to diglyme for two 

395 weeks at concentrations as low as 0.6 mg/L-day; a NOAEL was not established. An inhalation 

396 dominant-lethal study in rats showed a reduced pregnancy rate at 5.5 mg/L-day. An oral prenatal 

397 developmental toxicity study in mice showed effects on fetal growth and viability, and an 

398 increase in malformations at 125 mg/kg-day; the NOAEL was 62.5 mg/kg-day. In vitro gene 

399 mutation and in vivo chromosomal aberration tests were negative (Ref. 14).Toxicology studies in 

400 laboratory animals have shown that exposure to ethylglyme results in developmental toxicity. 

401 The acute toxicity of ethylglyme is low in rats. Oral prenatal developmental toxicity studies of 

402 ethylglyme in mice and rabbits showed a significant decrease in fetal body weight and viability, 

403 and a significant increase in malformations; the NOAEL for developmental toxicity was 50 

404 mg/kg-day in mice and 25 mg/kg-day in rabbits (Ref. 6).

405 

406 Based on a review of the literature, there is insufficient information available to arrive at 

407 any health effects related conclusions for the remaining chemicals in Table 1 or Unit II.A.1. 

408 

409 IV. Rationale and Objectives

410 A. Rationale

411 

412 EPA has concerns about the 14 glymes listed in this SNUR, all of which have similar 

413 chemical structures. EPA is concerned about the reproductive and/or developmental toxicity of 

414 monoglyme, diglyme, and ethylglyme and believes that individuals could suffer adverse effects 

415 from their use. In addition, EPA has concerns about the remaining 11 glymes due to the lack of 

416 available use, exposure, and toxicity information. Currently, exposure to monoglyme in lithium 

417 batteries is very limited since the batteries are sealed. The amount of exposure to diglyme in 

418 printing inks is less certain, but any additional use would increase the existing exposure to the 

419 chemical. Ethylglyme currently has no consumer uses but has been found in water sources, its 

420 production level appears to be increasing, and given its toxicity, EPA would be concerned if this 

421 chemical became prevalent in consumer products. EPA further believes that the use of any of 

422 these chemicals in consumer products, beyond the limited, on-going current uses, wcould 

423 significantly increase the magnitude and duration of exposure to humans and the environment 

424 over that which would otherwise exist and that such increase should not occur without 

425 opportunity for EPA review. Finally, for pentaethylene glycol dibutyl ether and butyltriglyme, 

426 which presently show no reported production to the IUR or any ongoing uses, EPA believes that 

427 any use of these chemicals would significantlycould be a significant increase in the magnitude 

428 and duration of exposure to humans and the environment over that which currently occursexist. 

429 

430 On March 18, 2008, EPA published risk based prioritization related documents on 

431 monoglyme and diglyme (Refs. 8, 9, 13, and 14), which indicated that it appeared these two 

432 chemicals are used in consumer products and also indicated EPA’s concerns about the potential 

433 health effects of these two chemicals. Studies on monoglyme and diglyme indicate adverse 

434 health effects concerning reproductive and developmental toxicity, as well as on blood and 
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435 blood-forming organs. Studies on ethylglyme show developmental toxicity as well as potential 

436 for gene mutation. Several manufacturers initially responded that, with the exception of 

437 monoglyme use in sealed lithium batteries, there are no consumer uses. Follow up contact with 

438 manufacturers revealed some additional potential consumer uses and raised questions about 

439 some of the other uses. For monoglyme, diglyme, and ethylglyme, as well as the remaining 11 

440 chemicals, the level of toxicity is uncertain and/or the type and extent of the use of the chemical 

441 is unclear. EPA is proposing to issue this SNUR to require notification prior to any new 

442 manufacturing, importing, or processing of these chemicals for consumer uses (with specified 

443 exceptions), or in some cases all uses. EPA intends to continue to monitor production, use and 

444 other relevant information on the subject substances and, where appropriate, initiate further 

445 action. 

446 

447 EPA previously published a SNUR on November 29, 2005, (70 FR 71401), (FRL 7740-

448 7), on a major metabolite of monoglyme, 2-methoxyethanol (2-ME), CASRN 109-86-4, 

449 requiring notice to the Agency before 2-ME is used in a consumer product (40 CFR 721.10001) 

450 (Ref. 15). 

451 

452 B. Objectives

453 

454 Based on the considerations in Unit III., EPA wants to achieve the following objectives with 

455 regard to the significant new use(s) that are designated in this proposed rule:

456 

457 1. EPA would receive notice of any person’s intent to manufacture, import, or process the 

458 glymes listed in Table 1 and Unit II.A.1. for the described significant new uses before that 

459 activity begins.

460 

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

462 SNUN before the notice submitter begins manufacturing, importing or processing of

463 the glymes listed in Table 1 and Unit II.A.1. for the described significant new uses.

464 

465 3. EPA would be able to regulate prospective uses of the glymes listed in Table 1 and Unit 

466 II.A.1. before the described significant new uses of the chemical substance occur, provided that 

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

468 

469 V. Significant New Use Determination 

470 

471 A. What Chemicals are included in this SNUR?

472 

473 The proposed category of glymes to be regulated by this SNUR consists of the 14 

474 chemical substances shown in Table 1 and Table 2. Specifically, the designated significant new 

475 use for the glymes chemicals in Table 1 of this unit would be “use in a consumer product,” with 

476 the exception of the ongoing uses which are the excluded uses listed under “Proposed Excluded 

477 Consumer Uses,” and where the designated significant new use for the chemicals in Table 2

478 would be “any use.” “Consumer product” is defined at 40 CFR 721.3 as: “a chemical substance 

479 that is directly, or as part of a mixture, sold or made available to consumers for their use in or 

480 around a permanent or temporary household or residence, in or around a school, or in 

481 recreation.” 
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482 

483 While hazard data are only currently available for 3 of the 14 chemical substances in this 

484 category (see Unit IV.D.), EPA is proposing to designate significant new uses for all 14 chemical 

485 substances listed in Tables 1 and 2 on the basis of the available information. Consistent with its 

486 authority under TSCA section 26(c), EPA is proposing to make all 14 chemical substances 

487 subject to the significant new use rule based on similarities in the molecular structures, physical 

488 and chemical properties, uses, and potential uses of the chemical substances in the category. 

489 EPA acknowledges that there are differences in the ongoing uses of the 14 chemical substances, 

490 and has accounted for those differences by varying the proposed significant new use designations 

491 for the chemical substances, as shown in Tables 1 and 2. Nonetheless, EPA believes that the 

492 chemicals are sufficiently similar such that it is appropriate, for purposes of this SNUR, to act on 

493 them together. EPA solicits public comment on the scope of the chemical substances to be 

494 subject to this SNUR. Specifically, whether any of the chemical substances included in the 

495 category are sufficiently dissimilar from the rest that they should be removed from the category,

496 or whether any additional chemical substances are sufficiently similar that they should be added 

497 to the category.

498 

499 Table 1 – Chemicals with Use in a Consumer Product as the Proposed Significant New Use 

500 and Proposed Excluded Consumer Uses

501 

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

503 a significant new use must be made after consideration of all relevant factors including:

CAS Registry 

Number 

(CASRN)

CA Index Name Common Name Proposed Excluded 

Consumer Uses

110-71-4 Ethane, 1,2-

dimethoxyMonoglyme or Monoethylene glycol 

dimethyl ether 

in electrolyte solutions for 

sealed lithium batteries

111-96-6 Ethane, 1,l'-oxybis[2-

methoxyDiglyme or Diethylene glycol dimethyl ether 

as a solvent in printing inks 

for consumer products

112-36-7 Ethane, 1,l'-oxybis[2-

ethoxyEthyldiglyme or Diethylene glycol diethyl 

ether

112-49-2 2,5,8,11-

Tetraoxadodecane 

Triglyme or Triethylene 

glycol dimethyl ether 

-as a solvent in consumer 

adhesives

-as a component of 

consumer brake fluids

-as a component of 

consumer paint/graffiti 

removers

-in consumer paints 

112-73-2 Butane, 1,1'-

[oxybis(2,1-

ethanediyloxy)]bisButyldiglyme or 

Diethylene glycol dibutyl 

ether 

112-98-1 5,8,11,14,17-

Pentaoxaheneicosane

Tetraethylene glycol 

dibutyl ether
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143-24-8 2,5,8,11,14-

Pentaoxapentadecane 

Tetraglyme or 

Tetraethylene glycol 

dimethyl ether

-as an HFC/CFC lubricant

-as a solubilizing agent for 

consumer printing inks

-as a coalescing agent in 

consumer paints

629-14-1 Ethane, 1,2-diethoxy- Ethylglyme or Ethylene 

glycol diethyl ether 

4353-28-0 3,6,9,12,15-

Pentaoxaheptadecane

Tetraethylene glycol 

diethyl ether

23601-39-0 3,6,9,12,15,18-

Hexaoxaeicosane

Pentaethylene glycol 

diethyl ether

24991-55-7 Poly(oxy-l,2-

ethanediyl), .alpha.-

methyl-.omega.-

methoxyPolyglyme or 

Polyethylene glycol 

dimethyl ether

use in consumer paint 

strippers

31885-97-9 Poly(oxy-1,2-

ethanediyl), .alpha.-

butyl-.omega.-

butoxyPolyethylene glycol 

dibutyl ether

504 

505 Table 2 – Chemicals with “Any Use” as the Proposed Significant New Use

CAS Registry 

Number 

(CASRN)

CA Index Name Common Name

51105-00-1 5,8,11,14,17,20-Hexaoxatetracosane Pentaethylene glycol dibutyl ether

63512-36-7 5,8,11,14-Tetraoxaoctadecane Butyltriglyme or Triethylene glycol 

dibutyl ether

506 

507 B. What Relevant Factors were Considered for this SNUR?

508 

509 

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

511 

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

513 or the environment to a chemical substance. 

514 

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

516 human beings or the environment to a chemical substance. 

517 

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

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

520 

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

522 to consider any other relevant factors. 

523 

524 To develop its preliminary determination of what would constitute a significant new use 
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525 of the glymes listed in Table 1 and Unit II.A.1.,Table 2, EPA considered relevant information 

526 about the toxicity of these substances, likely human exposures and environmental releases 

527 associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA. and Unit 

528 II.A. of this proposed SNUR. 

529 

530 The latest information available to EPA, which is summarized in Unit IV. of this SNUR, 

531 indicates that based on historical production levels of five of these chemicals, any production or 

532 commencement of IUR reporting would be considered a significant change. For the two 

533 chemicals which currently do not appear to be in production or use, commencement of 

534 production for any use could result in a significant increase in the type and form of exposure to 

535 both humans and the environment. For the seven chemicals which currently do not have ongoing 

536 consumer uses, any commencement of use in a consumer product would change the type of 

537 exposure to humans from indirect to direct exposure and the form of exposure from primarily 

538 inhalation to both inhalation and skin exposure. 

539 

540 EPA believes that any shift from a status of no uses in a consumer product to any use in a 

541 consumer product would increase the magnitude and duration of exposure to consumers than 

542 would otherwise exist since use of a consumer product could result in more frequent, direct, and 

543 longer exposures than the infrequent or indirect exposures that currently exist. Additional 

544 workers are also likely to be exposed, as is the surrounding environment at manufacturing or 

545 processing sites, due to possible increases in releases which could contribute additional glymes 

546 into the environment. Finally, EPA believes that any changes in the reasonably anticipated 

547 manner and methods of manufacturing, processing, distribution in commerce, or disposal of 

548 these glymes could contribute to the type, form, magnitude and duration of exposure to humans 

549 and the environment. 

550 

551 Based on these relevant factors mentioned in this unit, and addressed in this SNUR, ,

552 EPA has preliminarily determined that the manufacture, import, or processing of ethyldiglyme, 

553 butyldiglyme, tetraethylene glycol dibutyl ether, ethylglyme, tetraethylene glycol diethyl ether, 

554 pentaethylene glycol diethyl ether, and polyethylene glycol dibutyl ether for any use in a 

555 consumer product is a significant new use. EPA has also primarily determined that the 

556 manufacture, import, or processing of monoglyme, diglyme, triglyme, tetraglyme, polyglyme for 

557 any use in a consumer product, other than for the ongoing uses listed in Table 1, is a significant 

558 new use. In addition, EPA has primarily determined that the manufacture, import, or processing 

559 of pentaethylene glycol dibutyl ether and butyltriglyme for any use is a significant new use. 

560 

561 VI. RequestC. What are EPA Objectives for Public Comment

562 

563 EPA welcomes comments on any aspect of this SNUR. Information available about toxicity and 

564 exposure would assist EPA to evaluate the level of risk posed by all of the chemicals. This unit 

565 also describes the specific use information for which EPA would find comments especially

566 helpful.?

567 

568 EPA wants to achieve the following objectives with regard to the significant new use(s) 

569 that are designated in this proposed rule:

570 

571 1. EPA would receive notice of any person’s intent to manufacture, import, or process 
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572 the glymes listed in Table 1 and Table 2 for the described significant new uses before that 

573 activity begins.

574 

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

576 SNUN before the notice submitter begins manufacturing, importing or processing of

577 the glymes listed in Table 1 and Table 2 for the described significant new uses.

578 

579 3. EPA would be able to regulate prospective uses of the glymes listed in Table 1 and 

580 Table 2 before the described significant new uses of the chemical substance occur, provided that 

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

582 

583 IV. Summary of Relevant Available Information on the Glymes 

584 

585 A. What are the Ongoing Uses of these Chemicals? 

586 

587 1. Known Ongoing Uses of Glymes. 

588 

589 To identify the ongoing consumer uses of these glymes, as well as potential industrial 

590 uses, EPA used information submitted under the 2006 Inventory Update Reporting (IUR) rule, 

591 contacted manufacturers, searched business periodicals, and searched other available sources. 

592 

593 Monoglyme is used in consumer products in electrolyte solutions for sealed lithium 

594 batteries. Industrial uses include printed circuit board manufacturing; in reactions with strong 

595 bases; in mixtures where solvent separation and recovery is necessary; as an inert special solvent; 

596 and as a solvent in pharmaceutical production (Ref. 1, pg. 9).

597 

598 Diglyme is used as a solvent in printing inks for consumer products and industrially as a 

599 solvent in a variety of processes (Ref. 1, pg. 10).

600 

601 Triglyme is used in consumer products in consumer brake fluids, as a solvent in 

602 consumer adhesives, as a component of consumer paint and graffiti removers and in consumer 

603 paints. Industrial uses include generation of chemicals, use as a reaction solvent, and use as a 

604 binding agent in porcelain powders (Ref. 1, pg. 11).

605 

606 Tetraglyme is used in consumer products as a solubilizing agent for consumer printing 

607 inks, as a coalescing agent in consumer paints, and as an HFC/CFC lubricant which may be used 

608 in consumer air conditioners. Industrial uses include use as a solubilizing agent in textiles and 

609 plastics, as a dye fixation additive for cotton textiles, as a fungicide process solvent, and as a gas 

610 scrubbing agent (Ref. 1, pg. 12). 

611 

612 Polyglyme is used in consumer paint strippers. Industrial uses include use as special, 

613 high boiling solvents for chemical reactions, use as a solubilizing agent for plastic, textile, and 

614 paper processes, and use as a gas scrubbing agent (Ref. 1, pg. 13).

615 

616 Ethyldiglyme, butyldiglyme, tetraethylene glycol dibutyl ether, ethylglyme, tetraethylene 

617 glycol diethyl ether, pentaethylene glycol diethyl ether, and polyethylene glycol dibutyl ether, 

618 have no known uses in consumer products. Industrial uses of these glymes can include use: as a 
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619 high-boiling solvent for nitrocellulose, resins, and lacquers; as a solubilizer in organic synthesis; 

620 as a solvent in the production of plastic resins and compounds, rubber chemicals; as a solvent for 

621 conductive printing ink; in the production of printed circuit etchants; in the preparation of and 

622 reaction with Grignard reagents; in metal extractions; as a solvent in pharmaceutical syntheses; 

623 in the production of coatings; and as a gas scrubbing liquid (Ref. 1, pgs. 14-19).

624 

625 The chemicals listed in Table 2, pentaethylene glycol dibutyl ether and butyltriglyme, 

626 have no known uses (Ref. 1, pg. 19).

627 

628 2. Potential for Other Ongoing Uses of Glymes.

629 

630 In order to ascertain if there are any ongoing uses of these glymes, EPA used information 

631 submitted under the IUR rule, contacted manufacturers, searched business periodicals, and 

632 searched other available sources. In some instances, EPA could confirm the existence of an 

633 ongoing use in a consumer product from the information reviewed. In other instances, the results 

634 of EPA’s search were unclear, and EPA could not confirm whether certain reported consumer 

635 product uses were actual ongoing uses. 

636 

637 Therefore, EPA is requesting public comment on whether any of the additional 

638 unconfirmed uses listed in this unit are actual, ongoing uses in a consumer product, and whether 

639 there are any other ongoing uses in a consumer product of the chemicals listed in Table 1. For 

640 pentaethylene glycol dibutyl ether and butyltriglyme, EPA is requesting public comment on 

641 whether there are any ongoing uses at all (consumer or industrial). EPA does not anticipate that 

642 it will add additional exclusions to the final rule, beyond those listed in Table 1, except where 

643 public comment adequately substantiates the existence of sucha claimed additional ongoing use. 

644 

645 Table 3 – Reported Consumer Uses of Glymes that are Unconfirmed 

646 

Common Name Additional Unconfirmed Reports of Use 

(In addition to any confirmed ongoing consumer uses listed in Table 1) 

Monoglyme Treat aluminum surfaces to ensure surfaces are less reactive, inner and 

outer layer etching of printed circuit board manufacturing. 

Diglyme Component in automotive care products, a component of brake fluid, a 

component in paints and coatings, and a component in adhesives and 

sealants. 

Ethyldiglyme Component in paint and paint varnishes, use in coatings manufacturing, 

use in adhesives manufacturing, and as a solvent in printing 

Triglyme None in consumer products 

Butyldiglyme None in consumer products 

Tetraethylene glycol 

dibutyl ether 

Use as an ingredient in consumer brake fluid 

Tetraglyme Use in fabrics, textiles and apparel 

Ethylglyme Use as a solvent in consumer paint production, use as an adhesive 

solvent, use as a polycarbonate swelling agent, use in consumer polishes 

and related products 

Tetraethylene glycol Use as an ingredient in consumer brake fluid 
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diethyl ether 

Pentaethylene glycol 

diethyl ether 

Use as an ingredient in consumer brake fluid, use in the soldering of 

electronic circuit boards 

Polyglyme Use in adhesive removers, use in fragrance production, use in anti-fog 

compounds, use in brake fluid, use in automotive care products, and use 

in paper products 

Polyethylene glycol 

dibutyl ether 

Use in the production of gel laundry detergents 

Pentaethylene glycol 

dibutyl ether 

None 

Butyltriglyme None 

647 

648 B. What are the Estimated Production Levels of these Chemicals? 

649 

650 The 2006 Inventory Update Reporting (IUR) regulation required manufacturers and 

651 importers of certain chemical substances included on the TSCA Chemical Substance Inventory 

652 to report site and manufacturing information for chemicals manufactured (including imported) in 

653 amounts of 25,000 pounds or greater at a single site. For monoglyme and diglyme, EPA expects 

654 that current production levels will continue. For triglyme and ethylglyme, predicting future 

655 production is infeasible, although ethylglyme production appears to be increasing. For 

656 ethyldiglyme, butyldiglyme, and tetraglyme, EPA expects that production will remain at the 

657 previous levels. Production of pentaethylene glycol diethyl ether appears to be steadily 

658 increasing. For polyglyme, EPA expects that production will continue to decrease and/or remain 

659 the same. For tetraethylene glycol dibutyl ether, tetraethylene glycol diethyl ether, polyethylene 

660 glycol dibutyl ether, pentaethylene glycol dibutyl ether, and butyltriglyme, EPA expects that 

661 production of these chemical substances, if any, will remain below reporting levels. Previous 

662 IUR reporting rules required that chemicals produced at amounts of 10,000 pounds or greater be 

663 reported. Table 3 summarizes 2006 and prior year IUR data for the 14 glymes. The projected 

664 trends are based on the IUR data from 1986-2006. The projections may not be precise since the 

665 IUR data does not reflect 100% of chemicals and their production and requirements for reporting 

666 have varied over time. 

667 

668 Table 4 – Production Reporting Amounts to IUR 1986-2006 (Ref. 1)

669 

Common Name 2006 IUR Reporting Prior IUR Reporting

Monoglyme >1M - <10M lbs 1986: >10K-<500K lbs

1990-2002: >1M - <10M lbs each year

Diglyme >1M - <10M lbs 1986-2002: >1M - <10M lbs each year

Ethyldiglyme >10K - <500K lbs 1986-2002: >10K – <500K lbs each year

Triglyme No report 1994-2002: >10K - <500K lbs each year

Butyldiglyme >10K - <500K lbs 1990-2002: >10K - <500K lbs each year

Tetraethylene glycol 

dibutyl ether

No report No reports 1986-2002

Tetraglyme >10K - <500K lbs 1986-2002: >10K - <500K lbs each year

Ethylglyme >10K - <500K lbs 1986-2002 : no reports

Tetraethylene glycol No report No reports 1986-2002
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diethyl ether

Pentaethylene glycol 

diethyl ether

>1M - <10M lbs 1986 & 1990: >10K - <500K lbs each year

1994: no report

1998: >500K - <1M lbs

2002: >1M - <10M lbs

Polyglyme 10-500K 1986: >1M - <10M lbs 

1994: no report; 

1998, 2002: >10K - <500K lbs each year 

Polyethylene glycol 

dibutyl ether

No report No reports 1986-2002

Pentaethylene glycol 

dibutyl ether

No report No reports 1986-2002

Butyltriglyme No report No reports 1986-2002

670 

671 C. What are the Potential Routes and Sources of Exposure for these Chemicals? 

672 

673 The following are summaries of the potential routes and sources of exposure for these 

674 chemicals considering ongoing current uses. More detailed information can be found in the 

675 Exposure Characterization documents for monoglyme and diglyme (Refs. 8, 9) and in the 

676 description of ethylglyme in the Hazardous Substances Data Bank (Ref. 6). 

677 

678 1. Potential exposures to the environment, consumers, and general population. 

679 

680 The exposures described in this unit reflect the actual and/or potential indirect exposures 

681 to the environment, consumers, and the general population resulting from ongoing industrial and 

682 commercial uses of these glymes. Consumer uses, however, also potentially allow for the direct 

683 exposure to skin from product handling and more immediate inhalation exposures resulting from 

684 proximity to the product. However, little to no data is available for those types of use scenarios. 

685 

686 Monoglyme, diglyme, ethyldiglyme, triglyme, butyldiglyme, and ethylglyme are 

687 included in the category of chemicals reported as “certain glycol ethers” under the ID number 

688 N230 in the Toxics Release Inventory (TRI) (Ref. 2). The total release reported to the TRI in 

689 2007 from all reporting sites was 18,476,420 pounds. This total includes air releases of 

690 16,416,033 pounds from on-site fugitive and point sources, in addition to on-site water releases 

691 of 87,035 pounds. Most of the remaining volume of release was deep-well injected, sent to land 

692 treatment, transferred for energy recovery or transferred to a POTW. Release information about 

693 the individual glymes within the larger glycol ether category is not known (Ref. 3). 

694 Manufacturers, importers, or processors are required to report releases of chemicals on the TRI 

695 when total manufacturing, imports or processing by a facility equals 25,000 pounds/year for the 

696 chemicals combined. 

697 

698 Ethylglyme was found in the US EPA Office of Water STORET database indicating 

699 potential environmental exposure since this chemical was found in ground water and/or surface 

700 water (Ref. 3). 

701 

702 Monitoring data indicate that the general population may be exposed to diglyme and 

703 ethyldiglyme via inhalation of vehicle exhaust and ingestion of contaminated drinking water
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704 (Refs. 4 and 5). Diglyme was listed as a contaminant found in drinking water (Ref. 4). 

705 

706 Diglyme has been detected in diluted vehicle exhaust from a light-duty truck using 

707 different fuel types (Ref. 4). 

708 

709 Industrial manufacture and processing may result in the release of glymes to the 

710 environment through various waste streams (Ref. 4). Diglyme, ethyldiglyme, and ethylglyme 

711 have been found at measurable concentrations in industrial wastewater treatment systems (Refs. 

712 4, 5, and 6). Wastewater treatment systems discharge to either surface waters or publicly owned 

713 treatment works. Either of these two discharge options could result in exposures for the general 

714 population and the environment to these chemicals.

715 

716 Ethyldiglyme has been qualitatively detected in drinking water from Cincinnati, OH; in 

717 ground water from the Hipps Road Landfill in Jacksonville, FL; in trench leachates from Maxey 

718 Flats, KY and West Valley, NY low-level radioactive waste disposal sites and in advanced waste 

719 treatment water from Lake Tahoe, CA, Pomona, CA, and Blue Plains, Washington, DC (Ref. 5). 

720 

721 Ethylglyme has been detected in western Cleveland, OH wastewater influents at 140 

722 μg/L and it was identified in Chicago Central water works water (treated and untreated) at 2 

723 μg/L (Ref. 6). 

724 

725 Monitoring data for ethylglyme indicates that the general population may be exposed to 

726 the chemical through releases from manufacturing facilities. The general population can then be 

727 exposed via inhalation of ambient air, ingestion of drinking water, and dermal contact with these 

728 substances and other products containing these chemicals. Evidence of releases from industrial 

729 manufacturing and processing is demonstrated by concentrations of 400 mg/L of diglyme which 

730 have been found in activated sludge from the waste treatment facility of the industry producing 

731 the chemical (Ref. 6). 

732 

733 For the remaining chemicals in Table 1 or Table 2, little or no release information was 

734 found. 

735 

736 EPA’s Source Ranking Databank (Ref. 7) shows metal polish and polishing cloths and 

737 papers as containing ethylglyme. Most of the entries in this databank for consumer products are 

738 from the late 1990s and therefore may not still be current. If ethylglyme is still found in these 

739 products, however, there is potential that consumers and children might be exposed to this 

740 chemical from these consumer products. Furthermore, production of ethylglyme appears to be 

741 increasing. 

742 

743 Based on IUR data and communications with manufacturers, EPA believes that 

744 monoglyme is used as a component of lithium batteries and diglyme is used in printing inks, both 

745 of which are consumer applications of monoglyme. It is believed that disposal of the lithium 

746 batteries containing monoglyme and paper with printing inks containing diglyme could present 

747 the potential for release of these chemicals to environmental media and subsequent exposure to 

748 humans and ecological receptors. 

749 

750 2. Potential occupational exposure.
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751 

752 Occupational exposure to these chemicals may occur through inhalation and dermal 

753 contact at workplaces where the chemicals are produced or used. Monoglyme, diglyme, 

754 ethylglyme, ethyldiglyme, triglyme, and tetraethylene glycol diethyl ether all have vapor 

755 pressures high enough to potentially result in significant exposures to workers if they are near the 

756 chemical (Refs. 8, 9, 3, and 10). Based on IUR data, ethyldiglyme, butyldiglyme, tetraglyme, 

757 pentaethylene glycol diethyl ether, and polyglyme are manufactured in liquid forms, and worker 

758 exposures through dermal contact are possible (Ref. 10). 

759 

760 These chemicals do not have Occupational Safety and Health Administration (OSHA) 

761 Permissible Exposure Limits (PELs) (Refs. 8, 9, and 3). Ferro Corporation, in their publications, 

762 recommended a Threshold Limit Value (TLV) for glycol ethers of 5 ppm (Time Weighted 

763 Average (TWA)) with a Short Term Exposure Limit (STEL) of 25 ppm. The 15-minute STEL 

764 should not be achieved more than 4 times in 8 hours. For women of child-bearing potential, 

765 Ferro recommended a TLV of 1 ppm with a STEL of 5 ppm (Ref. 11). 

766 

767 Based on the 2006 IUR reports, the maximum total number of potentially exposed 

768 industrial workers to monoglyme and ethylglyme during manufacturing and industrial processing 

769 and use is less than 100 each, and the maximum total number of workers likely to be exposed to 

770 diglyme was between 100 and 999 workers. There may, however, be additional potentially 

771 exposed industrial workers who are not included in these estimates since not all production 

772 volume may have been accounted for in the IUR (production below 25,000 pounds at a site does 

773 not have to be reported to the IUR), and commercial workers may be exposed as well (Refs. 8, 9,

774 and 12).

775 

776 D. What are the Potential Health Effects of these Chemicals?

777 

778 The following are summaries of the potential health effects of these chemicals

779 considering ongoing current uses. More detailed information can be found in the Hazard 

780 Characterization documents for monoglyme and diglyme (Refs. 13, 14) and in the description of 

781 ethylglyme in the Hazardous Substances Data Bank (Ref. 6). 

782 

783 Toxicology studies in laboratory animals have shown that exposure to monoglyme results 

784 in hemolytic effects (destruction of red blood cells), and developmental and reproductive 

785 toxicity. The acute toxicity of monoglyme is low via oral, dermal and inhalation routes of 

786 exposure. Monoglyme’s chronic adverse health effects generally fall into the moderate to high 

787 hazard range based on the classification ranges used in the Globally Harmonized System for 

788 Classification and Labeling of Chemicals (GHS). The potential toxicity from repeated exposure 

789 to monoglyme was assessed using a major metabolite, 2-methoxyethanol (CASRN 109-86-4). 

790 Oral 90-day studies of 2-methoxyethanol in rats and mice showed testicular degeneration and 

791 adverse effects on the process of blood cell formation. The lowest observed adverse effect level 

792 (LOAEL) in rats was 70 mg/kg-day; the LOAEL in mice was 300 mg/kg-day. An oral prenatal 

793 developmental toxicity study of monoglyme in rats showed fetal mortality at doses as low as 60 

794 mg/kg-day, and edema at doses as low as 30 mg/kg-day. An oral prenatal developmental 

795 toxicity study of monoglyme in mice showed reduced fetal body weight and increased skeletal 

796 defects at 250 mg/kg-day. Available data also suggest that monoglyme has the potential to be 

797 genotoxic (Ref. 13).
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798 

799 Toxicology studies in laboratory animals have shown that exposure to diglyme results in 

800 hemolytic effects (destruction of red blood cells), and developmental and reproductive toxicity. 

801 The acute toxicity of diglyme to rats via the oral and inhalation routes of exposure is low. The 

802 chronic adverse health effects of diglyme generally fall into the moderate to high hazard range 

803 based on the classification ranges used in the GHS. The toxicity profile following repeated 

804 exposures to diglyme is similar to the profile for monoglyme. Rats showed testicular 

805 degeneration and hemolytic effects following inhalation exposure to diglyme for two weeks at 

806 concentrations as low as 0.6 mg/L-day; a NOAEL was not established. An inhalation dominant807 lethal study in rats showed a reduced pregnancy rate at 5.5 mg/L-day (5.5 ppm in air). An oral 

808 prenatal developmental toxicity study in mice showed effects on fetal growth and viability, and 

809 an increase in malformations at 125 mg/kg-day; the NOAEL was 62.5 mg/kg-day. In vitro gene 

810 mutation and in vivo chromosomal aberration tests were negative (Ref. 14).

811 

812 Toxicology studies in laboratory animals have shown that exposure to ethylglyme results 

813 in developmental toxicity. The acute toxicity of ethylglyme is low in rats. Oral prenatal 

814 developmental toxicity studies of ethylglyme in mice and rabbits showed a significant decrease 

815 in fetal body weight and viability, and a significant increase in malformations; the NOAEL for 

816 developmental toxicity was 50 mg/kg-day in mice and 25 mg/kg-day in rabbits (Ref. 6), both 

817 falling into the high chronic hazard range based on the GHS.

818 

819 Based on a review of the literature, there is insufficient information available to arrive at any 

820 health effects related conclusions for the remaining chemicals in Table 1 or 

821 VIITable 2. 

822 

823 V. Alternatives Considered for this SNUR 

824 

825 Before proposing this SNUR, EPA considered promulgating a TSCA section 8(a) 

826 reporting rule for these glymes. Under a TSCA section 8(a) rule, EPA could, among other 

827 things, generally require persons to report information to the Agency when they intend to 

828 manufacture, import, or process a listed chemical for a specific use or any use. However, for 

829 these glymes, the use of TSCA section 8(a) rather than SNUR authority would have several 

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

831 section 5(a), EPA would not have the opportunity to review human and environmental hazards 

832 and exposures associated with the proposed significant new use and, if necessary, take 

833 immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) to prohibit or limit the 

834 activity before it begins. In addition, EPA may not receive important information from small 

835 businesses, because such firms generally are exempt from TSCA section 8(a) reporting 

836 requirements. In view of the level of health and environmental concerns about monoglyme, 

837 diglyme, and ethylglyme if used for the proposed significant new use, and the lack of 

838 information to be able to judge exposure for the remaining glymes, EPA believes that a TSCA 

839 section 8(a) rule for this substance would not meet EPA's regulatory objectives. 

840 

841 VIIIVI. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule 

842 

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

844 that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant 
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845 new use as of the date of publication of the proposed rule rather than as of the effective date of 

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

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

848 person could defeat the SNUR by initiating the proposed significant new use before the rule 

849 became final, and then argue that the use was ongoing as of the effective date of the final rule. 

850 Thus, persons who begin commercial manufacture, import, or processing of the chemical 

851 substance(s) that would be regulated through this proposed rule, if finalized, would have to cease 

852 any such activity before the effective date of the rule if and when finalized. To resume their 

853 activities, these persons would have to comply with all applicable SNUR notice requirements 

854 and wait until the notice review period, including all extensions, expires. EPA has promulgated 

855 provisions to allow persons to comply with this SNUR before the effective date. If a person 

856 were to meet the conditions of advance compliance under section 721.45(h), that person would 

857 be considered to have met the requirements of the final SNUR for those activities. 

858 

859 VIXI. Applicability of General Provisions

860 

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

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

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

864 the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 

865 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA 

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

867 5(a)(1)(A). In particular, these requirements include the information submissions requirements 

868 of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 

869 (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA 

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

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

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

873 

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

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

876 regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons 

877 who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 

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

879 127.28. Such persons must certify that the shipment of the chemical substance complies with all 

880 applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in 

881 support of import certification appears at 40 CFR part 707, subpart B.

882 

883 VIII. Test Data and Other Information 

884 

885 EPA recognizes that TSCA section 5 does not require developing any particular test data 

886 before submission of a SNUN. PersonsThere are two exceptions: 1) development of test data is 

887 required where the chemical substance subject to the SNUR is also subject to a test rule under 

888 TSCA section 4 (see TSCA section 5(b)(1)); and 2) development of test data may be necessary 

889 where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 

890 5(b)(2)). In the absence of a section 4 test rule or a section 5(b)(4) listing covering the chemical 

891 substance, persons are required only to submit test data in their possession or control and to 
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892 describe any other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 

893 CFR 721.25)., and 40 CFR 720.50). However, as a general matter, EPA recommends that 

894 SNUN submitters include data that would permit a reasoned evaluation of risks posed by the 

895 chemical substance during its manufacture, import, processing, use, distribution in commerce, or 

896 disposal. EPA encourages persons to consult with the Agency before submitting a SNUN. As 

897 part of this optional pre-notice consultation, EPA would discuss specific data it believes may be 

898 useful in evaluating a significant new use. SNUNs submitted for significant new uses without 

899 any test data may increase the likelihood that EPA will take action under TSCA section 5(e) to 

900 prohibit or limit activities associated with this chemical. 

901 

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

903 provide detailed information on: 

904 

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

906 uses of the chemical substances. 

907 2. Potential benefits of the chemical substances. 

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

909 potential substitutes. 

910 

911 XIX. SNUN Submissions 

912 

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

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

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

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

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

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

919 as described in 40 CFR 720.50. SNUNs must be submitted to EPA, on EPA Form No. 7710-25 

920 in accordance with the procedures set forth in 40 CFR 721.25 and 720.40. 

921 

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

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

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

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

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

927 information are also available electronically at 

928 Readers are reminded that EPA published a final rule at 75 FR 773 on January 6, 2010, that 

929 established standards and requirements for the use of the electronic-PMN (e-PMN) software and 

930 EPA's Central Data Exchange (CDX) to electronically submit these notices. The Agency is 

931 introducing electronic reporting via CDX using the e-PMN in three phases over a two-year 

932 period. The effective date of the rule was April 6, 2010. During the first year following the 

933 effective date of the final rule, submissions will be permitted via CDX, optical disc, or paper. 

934 After April 6, 2011, paper submissions will no longer be accepted. After April 6, 2012, all 

935 submissions will be required to be submitted electronically via CDX. Regardless of the delivery 

936 method, after April 6, 2010, EPA requires that all submissions be generated using the new e937 PMN software. For additional information and instructions go to: 

938 http://www.epa.gov/opptintr/newchems//epmn/epmn-index.htm.
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939 XI. Until April 6, 2012, SNUNs may still be mailed to the Environmental Protection Agency, 

940 OPPT Document Control Office (7407M), 1200 Pennsylvania Avenue, NW., Washington, DC 

941 20460-0001. 

942 

943 X. Economic Analysis 

944 

945 A. SNUNs

946 

947 EPA has evaluated the potential costs of establishing SNUR reporting requirements for 

948 potential manufacturers, importers, and processors of the chemical substances included in this 

949 proposed rule. While most businesses are subject to a $2,500 user fee required by 40 CFR 

950 700.45(b)(2)(iii), small businesses with annual sales of less than $40 million when combined 

951 with those of the parent company (if any) are subject to a reduced user fee of $100 (40 CFR 

952 700.45(b)(1)). The costs of submission of SNUNs will not be incurred by any company unless a 

953 company decides to pursue a significant new use as defined in this proposed SNUR. 

954 Furthermore, EPA believes that the expense of submitting a notice (approximately $6,000 plus 

955 the user fee) is unlikely to discourage innovations of high potential value. EPA's complete 

956 economic analysis is available in the public docket for this proposed rule (Ref. 16). 

957 

958 B. Export Notification

959 

960 Under section 12(b) of TSCA and the implementing regulations at 40 CFR part 707, 

961 subpart D, exporters must notify EPA if they export or intend to export a chemical substance or 

962 mixture for which, among other things, a rule has been proposed or promulgated under TSCA 

963 section 5. For persons exporting a substance the subject of a SNUR, a one-time notice must be 

964 provided for the first export or intended export to a particular country. EPA estimates the one965 time cost to be approximately $937 per exporter including mailing costs. The total costs of 

966 export notification will vary by chemical, depending on the number of required notifications 

967 (i.e., the number of countries to which the chemical is exported). Because EPA is unable to 

968 make an estimate of the likely number of export notifications for the chemicals covered in this 

969 proposed SNUR, a total export notification cost is not available. 

970 

971 XI. Request for Public Comment 

972 

973 EPA welcomes comment on all aspects of this proposed rule. In addition, EPA is 

974 particularly interested in receiving stakeholder input on a number of issues that were identified 

975 for public comment earlier in this proposed rule. Please provide comments on the following 

976 issues:

977 

978 1. Scope of the chemical substances to be subject to this SNUR. While hazard data are 

979 only currently available for 3 of the 14 chemical substances in the glymes chemical category 

980 identified in this proposed rule (see Unit IV.D.), EPA is proposing to designate significant new 

981 uses for all 14 chemical substances listed in Tables 1 and 2 in Unit III.A. on the basis of the 

982 available information. As discussed in Unit III.A. of this document, EPA believes that the 

983 chemicals are sufficiently similar such that it is appropriate, for purposes of this SNUR and 

984 consistent with TSCA section 26(c), to act on them together. However, EPA would be interested 

985 in hearing whether any of the chemical substances included in the category are sufficiently 
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986 dissimilar from the rest such that they should be removed from the category, or whether any 

987 additional chemical substances are sufficiently similar such that they should be added to the 

988 category.

989 

990 2. Ongoing uses. EPA solicits comment on whether any of the additional unconfirmed 

991 uses listed in this proposed rule are actual ongoing uses in a consumer product, and whether 

992 there are any other ongoing uses in a consumer product of the chemicals listed in Table 1 in Unit 

993 III.A. For pentaethylene glycol dibutyl ether and butyltriglyme, EPA is soliciting comment on 

994 whether there are any ongoing uses at all (consumer or industrial). In providing comments on 

995 ongoing uses, it would be most helpful if you provide sufficient information for EPA to 

996 adequately substantiate the existence of a claimed additional ongoing use.

997 

998 XII. References 

999 

1000 The sources listed in this unit were used as references for this SNUR and are included in the 

1001 public docket for this action, EPA-HQ-OPPT-2009-0767.

1002 

1003 The following is a list of the documents that are specifically referenced in this proposed 

1004 rule and placed in the public docket that was established under Docket ID No. EPA-HQ-OPPT1005 2009-0767. The docket includes information considered by EPA in developing this proposed

1006 rule. In addition, interested parties should consult documents that are referenced in the 

1007 documents that EPA has placed in the public docket, regardless of whether these referenced 

1008 documents are physically located in the public docket. 

1009 

1010 1. Wilson, Kimberly; Tome, Alice; and Narayan, Tulika, Abt Associates, Inc. 

1011 “Memorandum to EPA, Nishkam Agarwal, ‘Actual and Potential Uses of Fourteen Selected 

1012 Glymes,’” September 9, 2009. 

1013 

1014 2. US EPA. TRI Website. http://www.epa.gov/ttn/atw/glycol2000.pdf 

1015 

1016 3. US EPA,. Exposure Characterization for Ethylglyme, November 6, 2009. 

1017 

1018 4. Hazardous Substances Data Bank (HSDB, 2008.). Hazardous Substances Data Bank. 

1019 Entry for diglyme. Accessed October 30, 2009. http://toxnet.nlm.nih.gov. 

1020 

1021 5. Hazardous Substances Data Bank (HSDB), http://toxnet.nlm.nih.gov.). Entry for 

1022 CASRN 112-36-7,. Accessed on October 28, 2009. http://toxnet.nlm.nih.gov.

1023 

1024 6. Hazardous Substances Data Bank, http://toxnet.nlm.nih.gov. (HSDB). Entry for 

1025 Ethylene glycol diethyl ether, CASRN 629-14-1. Accessed on October 30, 2009. 

1026 http://toxnet.nlm.nih.gov.

1027 

1028 7. The Source Ranking Database is an EPA database that performs a systematic 

1029 screening-level review of over 12,000 potential indoor pollution sources to identify high-priority 

1030 product and material categories for further evaluation. It can also identify the products that have 

1031 contained a specific chemical. May, 1997. 

1032 http://www.epa.gov/oppt/exposure/pubs/srd_apdx.pdfhttp://www.epa.gov/oppt/exposure/pubs/sr
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1033 d_apdx.pdf. 

1034 

1035 8. US EPA,. Screening-Level Exposure Characterization of High Production Volume 

Chemicals: 1,2-Dimethoxyethane (CAS No. 110-71-4), [9th 1036 CI Name: Ethane, 1,2-dimethoxy-], 

1037 March 2008., page 21. 

1038 http://www.epa.gov/chemrtk/hpvis/rbp/Monoglyme.110714.Web.SupportDocs.31408.pdf

1039 

1040 9. US EPA,. Screening-Level Exposure Characterization of High Production Volume 

Chemicals: Diglyme (CAS No. 111-96-6), [9th 1041 CI Name: Bis(2-methoxyethyl) Ether], March 

1042 2008., page 16.

1043 http://www.epa.gov/chemrtk/hpvis/rbp/Diglyme.111966.Web.SupportDocs.031808.pdf

1044 

1045 10. US EPA, EETD/EAB. Physical-Chemical Properties and Fate Characterization: 

1046 Glycol Ethers. Washington, DC: U.S. EPA/OPPT/EETD/EAB. August 2009. 

1047 

1048 11. Ferro Corporation. 1,2-Dimethoxyethane US EPA HPV Challenge Program 

1049 Submission,. December 2001, pages 7-8 of 93. 

1050 

1051 12. US EPA. IUR database search results for number of workers exposed to ethylglyme, 

1052 http://cfpub.epa.gov/iursearch/2006_iur_natlcheminfo.cfm?id=3975, accessed on October 21, 

1053 2009. 

1054 

1055 13. US EPA,. Screening-Level Hazard Characterization of High Production Volume 

Chemicals: 1,2-Dimethoxyethane (CAS No. 110-71-4), [9th 1056 CI Name: Ethane, 1,2-dimethoxy-], 

1057 February 2008. , page 6. 

1058 http://www.epa.gov/chemrtk/hpvis/rbp/Monoglyme.110714.Web.SupportDocs.31408.pdf

1059 

1060 14. US EPA,. Screening-Level Hazard Characterization of High Production Volume 

Chemicals: Diglyme (CAS No. 111-96-6), [9th 1061 CI Name: Bis(2-methoxyethyl) Ether], February 

1062 2008., page 6. 

1063 http://www.epa.gov/chemrtk/hpvis/rbp/Diglyme.111966.Web.SupportDocs.031808.pdf

1064 

1065 15. US EPA. “2-ethoxyethanol, 2-ethoxyethanol acetate, 2-methoxyethanol, and 2-

1066 methoxyethanol acetate; Significant New Use Rule.” 70 FR 71401, November 29, 2005. 

1067 

1068 16. US EPA 2010. Economic Analysis of the Proposed Significant New Use Rule for 14 

1069 Glymes. Washington, DC: U.S. EPA/OPPT/EETD/EPAB, January 12, 2010. 

1070 

1071 XIII. Statutory and Executive Order Reviews 

1072 A. Executive Order 12866:

1073 A. Regulatory Planning and Review 

1074 

1075 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

1076 October 4, 1993), the Office of Management and Budget (OMB) has determined thatdesignated

1077 this proposed SNUR is a ‘‘“significant regulatory action,’’ because it meets the criteria in ”

1078 under section 3(f) of the Executive Order. Accordingly, this action was submitted to the OMB 

1079 for review under Executive Order 12866 and any changes made based onin response to OMB 
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1080 recommendations have been documented in the public docket for this rulemaking as required by 

1081 section 6(a)(3)(E) of the Executive Order. 

1082 

1083 B. Paperwork Reduction Act 

1084 

1085 According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency 

1086 may not conduct or sponsor, and a person is not required to respond to a collection of 

1087 information that requires OMB approval under the PRA, unless it has been approved by OMB 

1088 and displays a currently valid OMB control number. The OMB control numbers for EPA's 

1089 regulations in Title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR, 

1090 part 9, and included on the related collection instrument, or form, if applicable. The information 

1091 collection requirements related to this action have already been approved by OMB pursuant to 

1092 the PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action does not 

1093 impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to 

1094 the Agency, the annual burden is estimated to average 110 hours per response. This burden 

1095 estimate includes the time needed to review instructions, search existing data sources, gather and 

1096 maintain the data needed, and complete, review, and submit the required SNUN. Send any 

1097 comments about the accuracy of the burden estimate, and any suggested methods for minimizing 

1098 respondent burden, including through the use of automated collection techniques, to the Director, 

1099 Collection Strategies Division, Office of Environmental Information (2822T), Environmental 

1100 Protection Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 20460-0001. Please 

1101 remember to include the OMB control number in any correspondence, but do not submit any 

1102 completed forms to this address. 

1103 

1104 C. Regulatory Flexibility Act Small Entity Impacts

1105 

1106 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (), 5 U.S.C. 601 et 

1107 seq.),., the Agency hereby certifies that promulgation of this SNUR wouldaction will not have a 

1108 significant adverse economic impact on a substantial number of small entities. The rationale 

1109 supporting Under RFA, small entities include small businesses, small organizations, and small 

1110 governmental jurisdictions. For purposes of assessing the impacts of this conclusionproposed 

1111 rule on small entities, small entity is defined in accordance with RFA section 601 as follows. : 

1112 

1113 1. A small business as defined by the Small Business Administration’s (SBA)

1114 regulations at 13 CFR 121.201.

1115 2. A small governmental jurisdiction that is a government of a city, county, town, school 

1116 district or special district with a population of less than 50,000.

1117 3. A small organization that is any not-for-profit enterprise which is independently 

1118 owned and operated and is not dominant in its field. 

1119 

1120 A SNUR applies to any person (including small or large entities) who intends to engage 

1121 in any activity described in the rule as a “significant new use.” By definition of the word “new” 

1122 and based on all information currently available to EPA, it appears that no small or large entities 

1123 presently engage in such activity. Since this proposed SNUR would require a person who 

1124 intends to engage in such activity in the future to first notify EPA by submitting a SNUN, no 

1125 economic impact will occur unless someone files a SNUN to pursue a significant new use in the 

1126 future or forgoes profits by avoiding or delaying the significant new use. Although some small 
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1127 entities may decide to conduct such activities in the future, EPA cannot presently determine how 

1128 many, if any, there may be. However, EPA's experience to date is that, in response to the 

1129 promulgation of over 1,000 SNURs, the Agency receives on average only 5 notices per year. Of 

1130 those SNUNs submitted, only one appears to be from a small entity in response to any SNUR. 

1131 Therefore, EPA believes that the potential economic impact of complying with this SNUR is not 

1132 expected to be significant or adversely impact a substantial number of small entities. In a SNUR 

1133 that published as a final rule on August 8, 1997 (62 FR 42690)(FRL-5735-4), the Agency 

1134 presented its general determination that proposed and final SNURs are not expected to have a 

1135 significant economic impact on a substantial number of small entities, which was provided to the 

1136 Chief Counsel for Advocacy of the Small Business Administration. 

1137 

1138 D. Unfunded Mandates Reform Act 

1139 

1140 Based on EPA’s experience with proposing and finalizing SNURs, State, local, and 

1141 Tribal governments have not been impacted by these rulemakings, and EPA does not have any 

1142 reason to believe that any State, local, or Tribal government would be impacted by this 

1143 rulemaking. As such, EPA has determined that this regulatory action would not impose any 

1144 enforceable duty, contain any unfunded mandate, or otherwise have any effect on small 

1145 governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded 

1146 Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).), 2 U.S.C. 1531-1538.

1147 

1148 E. Executive Order 13132: Federalism 

1149 

1150 This action would not have a substantial direct effect on States, on the relationship 

1151 between the national government and the States, or on the distribution of power and 

1152 responsibilities among the various levels of government, as specified in Executive Order 13132, 

1153 entitled Federalism (64 FR 43255, August 10, 1999). 

1154 

1155 F. Executive Order 13175: Consultation and Coordination with Indian Tribal 

1156 GovernmentsTribal Implications

1157 

1158 This proposed rule would not have Tribal implications because it is not expected to have 

1159 substantial direct effects on Indian Tribes. This proposed rule would not significantly or 

1160 uniquely affect the communities of Indian Tribal governments, nor would it involve or impose 

1161 any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 

1162 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, 

1163 November 9, 2000), do not apply to this proposed rule. 

1164 

1165 G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety 

1166 RisksChildren’s Health Protections 

1167 

1168 This action is not subject to Executive Order 13045, entitled Protection of Children from 

1169 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not 

1170 an economically significant regulatory action as defined by Executive Order 12866, and this 

1171 action does not address environmental health or safety risks disproportionately affecting 

1172 children. 

1173 
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1174 H. Executive Order 13211: Actions that Significantly Affect Affect on Energy Supply, 

1175 Distribution, or Use 

1176 

1177 This proposed rule is not subject to Executive Order 13211, entitled Actions Concerning 

1178 Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 

1179 22, 2001), because this action is not expected to affect energy supply, distribution, or use. 

1180 

1181 I. National Technology Transfer Advancement Act Technical Standards

1182 

1183 SinceBecause this action does not involve any technical standards;, section 12(d) of the 

1184 National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 

1185 section 12(d) (15 U.S.C. 272 note), does not apply to this action. 

1186 

1187 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

1188 Populations and Low-Income Populations

1189 

1190 This action does not entail special considerations of environmental justice related issues 

1191 as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental 

1192 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 

1193 

1194 

1195 List of Subjects in 40 CFR Part 721

1196 

1197 Environmental protection, Chemicals, Hazardous substances, Reporting and 

1198 recordkeeping requirements.

1199 

1200 Dated: _______________________

1201 

1202 ________________

1203 Click -- Insert Title will be OPPT/OD

1204 

1205 ____________________________________

1206 Director, Office of Pollution Prevention and Toxics.

1207 

1208 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 

1209 PART 721- [Amended] 

1210 1. The authority citation for part 721 continues to read as follows: 

1211 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 

1212 

1213 2. By adding new § 721.xxxxx to subpart E to read as follows:

1214 § 721.xxxxx Glymes. 

1215 

1216 (a) Chemical substances and significant new uses subject to reporting. (1) The chemical 
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1217 substances identified in Table 1 are subject to reporting under this section for the significant new 

1218 uses described in Table 1, Column 3 “Significant New Use.” 

1219 

1220 Table 1 – Chemicals Subject to Reporting and Designated Significant New Uses 

1221 

CAS Registry 

Number 

(CASRN) 

CA Index Name Significant New Use 

110-71-4 Ethane, 1,2-dimethoxy- Any use in a consumer product except 

in electrolyte solutions for sealed 

lithium batteries 

111-96-6 Ethane, 1,l'-oxybis[2-methoxy- Any use in a consumer product except 

as a solvent in printing inks for 

consumer products 

112-36-7 Ethane, 1,l'-oxybis[2-ethoxy- Any use in a consumer product 

112-49-2 2,5,8,11-Tetraoxadodecane Any use in a consumer product except 

-as a solvent in consumer adhesives 

-as a component of consumer brake 

fluids 

-as a component of consumer 

paint/graffiti removers 

-in consumer paints 

112-73-2 Butane, 1,1'-[oxybis(2,1-

ethanediyloxy)]bisAny use in a consumer product 

112-98-1 5,8,11,14,17-

Pentaoxaheneicosane 

Any use in a consumer product 

143-24-8 2,5,8,11,14-

Pentaoxapentadecane 

Any use in a consumer product except 

-as an HFC/CFC lubricant 

-as a solubilizing agent for consumer 

printing inks 

-as a coalescing agent in consumer 

paints 

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

4353-28-0 3,6,9,12,15-

Pentaoxaheptadecane 

Any use in a consumer product 

23601-39-0 3,6,9,12,15,18-

Hexaoxaeicosane 

Any use in a consumer product 

24991-55-7 Poly(oxy-l,2-ethanediyl), 

.alpha.-methyl-.omega.-

methoxyAny use in a consumer product except 

in consumer paint strippers 

31885-97-9 Poly(oxy-1,2-ethanediyl), 

.alpha.-butyl-.omega.-butoxyAny use in a consumer product 

51105-00-1 5,8,11,14,17,20-

Hexaoxatetracosane 

Any use 

63512-36-7 5,8,11,14-Tetraoxaoctadecane Any use 

1222 
*** EO 12866 Review Deliberative - Do Not Cite, Quote, or Release During Review *** 

Page 31 of 31 [RIN 2070-AJ52] 

1223 [FR Doc. 09–????? Filed ??–??–09; 8:45 am]

1224 BILLING CODE 6560–50–S