*** EO 12866 Review DRAFT – Do Not Cite, Quote or Release During the Review ***

1 Glymes NPRM_EO 12866_2010-04-08.doc 1

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EO 12866 Review Draft as submitted. 3

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ENVIRONMENTAL PRO TECTION AGENCY 5

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40 CFR Part 721 7

8 [EPA–HQ–OPPT–2009–0767; FRL–XXXX–X] 9

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RIN 2070–AJ52 11

12 Glymes; Proposed Significant New Use Rule 13

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AGENCY: Environmental Protection Agency (EPA). 15

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ACTION: Proposed rule. 17

SUMMARY: EPA is proposing a significant new use rule (SNUR) under section 18 5(a)(2) of the Toxic Substances Control Ac t (TSCA) for 14 glymes. This action would 19 require persons who intend to ma nufacture, import, or process these chemical substances 20

for an activity that is designated as a significant new use by this proposed rule to notify 21 EPA at least 90 days before commencing that activity. The requi red notification would 22 provide EPA with the opportunity to evalua te the intended use and, if necessary, to 23 prohibit or limit that ac tivity before it occurs. 24

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DATES: Comments must be re ceived on or before [ insert date [60 ] days after date of 26 publication in the Federal Register ]. 27

ADDRESSES: Submit your comments, identified by docket identification (ID) number 28 EPA–HQ–OPPT–2009

– 0767, by one of the following methods: 29

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line 30 instructions for submitting comments. 31

• Mail : Document Control Office (7407M), Offi ce of Pollution Prevention and Toxics 32 (OPPT), Environmental Protection Agenc y, 1200 Pennsylvania Ave., NW., Washington, 33

DC 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– 36 HQ–OPPT–2009

– 0767. The DCO is open from 8 a.m. to 4 p.m., Monday through 37 Friday, excluding legal holidays. The te lephone number for the DCO is (202) 564–8930. 38 Such deliveries are only accepted during the DCO’s normal hours of operation, and 39 special arrangements should be made for deliveries of boxed information. 40*** Internal Deliberative – Do Not Cite, Quote or Release ***

2 Instructions : Direct your comments to doc ket ID number EPA–HQ–OPPT– 41 2009–0767. EPA's policy is that all comments received will be included in the docket 42 without change and may be made available on-line at http://www.regulations.gov

, 43 including any personal information provided, unless the comment includes information 44

claimed to be Confidential Business Info rmation (CBI) or other information whose 45 disclosure is restricted by st atute. Do not submit informati on that you consider to be CBI 46 or otherwise protected through regulations.gov or e-mail. The regulations.gov website is 47 an “anonymous access” system, which means EP A will not know your identity or contact 48 information unless you provide it in the body of your comment. If you send an e-mail 49 comment directly to EPA without going through regulations.gov, your e-mail address 50 will be automatically captured and included as part of the comment that is placed in the 51

docket and made available on the Internet. If you submit an electronic comment, EPA 52 recommends that you include your name and other contact information in the body of 53 your comment and with any disk or CD-ROM you submit. If EPA cannot read your 54

comment due to technical difficulties and cannot contact you for clarification, EPA may 55 not be able to consider your comment. El ectronic files should a void the use of special 56 characters, any form of encryption, and be free of any defects or viruses. 57

Docket : All documents in the docket ar e listed in the docket index 58

available at http://www.regulations.gov . Although listed in the index, some information is 59 not publicly available, e.g., CBI or other information whose disclosure is restricted by 60 statute. Certain other material, such as c opyrighted material, will be publicly available 61 only in hard copy. Publicly av ailable docket materials are av ailable electronically at 62 http://www.regulations.gov , or, if only available in hard copy, at the OPPT Docket. The 63

OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West 64 Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading 65 Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 66 legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 67 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Docket 68 visitors are required to show photographic id entification, pass through a metal detector, 69 and sign the EPA visitor log. All visitor bags are proce ssed through an X-ray machine 70 and subject to search. Visitors will be provi ded an EPA/DC badge that must be visible at 71 all times in the building a nd returned upon departure. 72

FOR FURTHER INFORMATION CONTACT: For general information contact : 73 Colby Lintner, Regulatory C oordinator, Environmental Assistance Division (7408M), 74

Office of Pollution Prevention and Toxics , Environmental Protection Agency, 1200 75 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 554– 76 1404; e-mail address: TSCA-Hotline@epa.gov

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For technical information contact : Amy Breedlove

, Chemical Control Division 78 (7405M) , Office of Pollution Prevention and Toxi cs, Environmental Protection Agency, 79 1200 Pennsylvania Ave., NW., Washingt on, DC 20460–0001; telephone number: 202- 80 564-9823; e-mail address: breedlove.amy @epa.gov

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SUPPLEMENTARY INFORMATION: 82

83*** Internal Deliberative – Do Not Cite, Quote or Release ***

3 I. General Information 84

A. Does this Action Apply to Me? 85

You may be potentially affected by th is action if you manufacture, import, or 86 process the chemicals listed in Unit II.A. 87

88 Potentially affected entities may include, but are not limited to: 89

• Manufacturers, importers, or processors of one or more of subject chemical 90 substances (North American Industrial Cl assification System (NAICS) codes 325 and 91 324110), e.g., chemical manufacturing and pe troleum refineries; 325199 – All other basic 92 organic chemical manufacturing; 325910 – Printing ink manufacturing; 325510 – Paint 93 and Coating Manufacturing; 325520 – Adhe sive Manufacturing; 335912 – Principle 94 Battery Manufacturing; and 336340 – Moto r Vehicle Brake System Manufacturing

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This listing is not intended to be exhausti ve, but rather provides a guide for readers 96 regarding entities likely to be affected by this action. Other types of entities not listed in 97

this unit could also be affected. The NAICS codes have been provided to assist you and 98 others in determining whether this action might apply to certain entities. To determine 99 whether you or your business may be aff ected by this action, you should carefully 100 examine the applicability provisions in 40 CFR 721.5. Also consult Unit II. If you have 101 any questions regarding the applicability of th is action to a particular entity, consult the 102 technical person listed under FOR FURTHER INFORMATION CONTACT

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This action may also affect certain entit ies through pre-existing import certification 104 and export notification rules under TSCA. Pe rsons who import any chemical substance 105 governed by a final SNUR are subject to th e TSCA section 13 (15 U.S.C. 2612) import 106 certification requirements and the corres ponding regulations at 19 CFR 12.118 through 107 12.127 and 19 CFR 127.28. Those persons must certify that the shipment of the chemical 108 substance complies with all applicable rules and orde rs under TSCA, including any 109 SNUR requirements. The EPA policy in s upport of import certific ation appears at 40 110 CFR part 707, subpart B. In addition, a ny persons who export or intend to export a 111 chemical substance that is the subject of this proposed rule on or after [insert date 30 112 days after the date of publication in the FR] are subject to the export notification 113 provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must 114 comply with the export notification requi rements in 40 CFR part 707, subpart D. 115

116 B. What Should I Consider as I Prepare My Comments for EPA? 117

1. Submitting CBI . Do not submit this information to EPA through 118 regulations.gov or e-mail. Clearly mark the pa rt or all of the information that you claim 119

to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the 120

outside of the disk or CD-ROM that you mail to EPA, mark the outside of the disk or 121 CD-ROM as CBI and then identify electro nically within the disk or CD-ROM the 122 specific information that is claimed as CBI. In addition to one complete version of the 123

comment that includes information claimed as CBI (i.e., a sanitized version), a copy of 124*** Internal Deliberative – Do Not Cite, Quote or Release ***

4 the comment that does not contain the information claimed as CBI must be submitted for 125 inclusion in the public docket. Information so marked will not be disclosed except in 126 accordance with procedures se t forth in 40 CFR part 2. 127

2. Tips for preparing your comments . When submitting comments, remember to: 128

i. Identify the document by docket ID nu mber and other identifying information 129 (subject heading, Federal Register date and page number). 130

ii. Follow directions. The Agency may ask you to respond to specific questions or 131 organize comments by referencing a Code of Federal Regulations (C FR) part or section 132

number. 133

iii. Explain why you agree or disagree; suggest alternatives and substitute 134 language for your requested changes. 135

iv. Describe any assumptions and provid e any technical information and/or data 136 that you used. 137

v. If you estimate potential costs or bu rdens, explain how you arrived at your 138 estimate in sufficient detail to allow for it to be reproduced. 139

vi. Provide specific examples to illustra te your concerns and suggest alternatives. 140

vii. Explain your views as clearly as possible, avoidi ng the use of profanity or 141 personal threats. 142

viii. Make sure to submit your comments by the comment period deadline 143

identified. 144

II. Background 145

A. What Action is the Agency Taking? 146

EPA is proposing a significant new use rule under section 5(a)(2) of TSCA where 147 the designated significant new use for the chemi cals in Table 1 of this unit would be “use 148 in a consumer product,” with the excepti on of the ongoing uses which are the excluded 149 uses listed under “Proposed Excluded C onsumer Uses,” and where the designated 150 significant new use for the chemicals in Un it II.A.1 would be “any use.” “Consumer 151 product” is defined at 40 CFR 721.3 as: “a chemical substan ce that is directly, or as part 152 of a mixture, sold or made available to c onsumers for their use in or around a permanent 153 or temporary household or residence, in or around a school, or in recreation.” Persons 154 would be required to notify EPA at least 90 days before commencing the manufacture, 155 import, or processing of the listed substan ces for the designated significant new uses. 156 The objectives and rationale for this pr oposed SNUR are explained in Unit IV. 157

158

Table 1 – Chemicals with Use in a Consumer Product as the Proposed Significant New 159 Use and Proposed Excluded Consumer Uses 160*** Internal Deliberative – Do Not Cite, Quote or Release ***

5 161 CAS Registry

Number (CASRN) CA Index Name Common Name Proposed Excluded

Consumer Uses

110-71-4 Ethane, 1,2-dimethoxy- Monoglyme 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
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-diet hoxy- 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.- Polyglyme or Polyethylene glycol dimethyl ether use in consumer paint strippers*** Internal Deliberative – Do Not Cite, Quote or Release ***

6methoxy31885-97-9 Poly(oxy-1,2- ethanediyl), .alpha.-butyl-.omega.-butoxyPolyethylene glycol dibutyl ether

162

163 1. Chemicals with “any use” as th e proposed significant new use: 164

165 - CASRN 51105-00-1, CA Index Na me: 5,8,11,14,17,20-Hexaoxatetracosane, 166 and Common Name: Pentaethylene glycol dibutyl ether; and, 167

168 - CASRN 63512-36-7; CA Index Name : 5,8,11,14-Tetraoxaoctadecane; and 169 Common Name: Butyltriglyme or Tr iethylene glycol dibutyl ether. 170

171 B. What is the Agency's Authority for taking this Action? 172

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a )(2)) authorizes EPA to determine that 173

a use of a chemical substance is a "si gnificant new use." EPA must make this 174 determination by rule after c onsidering all releva nt factors, includi ng those listed in 175 TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a 176 significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant 177 new use notice (SNUN) to EPA at least 90 da ys before they manufacture, import, or 178 process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)) . As described in 179 Unit II.C., the general SNUR provisions are found at 40 CFR Part 721, Subpart A. 180

181 C. Applicability of General Provisions 182

183 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 184 provisions describe persons subject to the ru le, recordkeeping requirements, exemptions 185 to reporting requirements, and applicability of the rule to uses occurring before the 186

effective date of the final rule. Provisions re lating to user fees a ppear at 40 CFR part 187 700. According to 40 CFR 721.1(c), persons su bject to SNURs must comply with the 188 same notice requirements and EPA regulatory procedures as submitters of 189 Premanufacture Notices (PMNs) under TSCA section 5(a)(1)( A). In particular, these 190 requirements include the information submi ssions requirements of TSCA section 5(b) 191 and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and 192 (h)(5), and the regulations at 40 CFR pa rt 720. Once EPA receives a SNUN, EPA may 193 take regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the activities on 194

which it has received the SN UN. If EPA does not take action, EPA is required under 195 TSCA section 5(g) to explain in the Federal Register its reasons for not taking action. 196

197 Persons who export or intend to export a chemical substance id entified in a proposed 198 or final SNUR are subject to the export notification provisio ns of TSCA section 12(b). 199 The regulations that interpret TSCA section 12( b) appear at 40 CFR part 707, subpart D. 200 Persons who import a chemical substance iden tified in a final SNUR are subject to the 201 TSCA section 13 import certification require ments, codified at 19 CFR 12.118 through 202*** Internal Deliberative – Do Not Cite, Quote or Release ***

7 12.127 and 19 CFR 127.28. Such persons must certi fy that the shipment of the chemical 203 substance complies with all applicable rules and orde rs under TSCA, including any 204 SNUR requirements. The EPA policy in s upport of import certific ation appears at 40 205 CFR part 707, subpart B. 206

207 III. Summary of Exposure and Hazard Information on the Glymes 208

209

A. What are the Chemicals included in the SNUR? 210

211 The glymes in the category include the 14 chemical substances shown in Table 1 212 of the regulatory text. 213
214 B. What are the Uses of these Chemicals? 215

216 To identify the ongoing consumer uses of these glymes, as well as potential 217 industrial uses, EPA used information submitted under the 2006 Inventory Update 218 Reporting (IUR) rule, contacted manufacturers, searched business periodicals, and 219

searched other available sources. 220

221 Monoglyme is used in consumer products in electrolyte solutions for sealed lithium 222 batteries. Industrial uses include printed ci rcuit board manufacturing; in reactions with 223 strong bases; in mixtures where solvent separa tion and recovery is necessary; as an inert 224 special solvent; and as a solvent in pharmaceutical production (Ref. 1, pg. 9). 225

226 Diglyme is used as a solvent in printing inks for consumer products and industrially 227 as a solvent in a variety of processes (Ref. 1, pg. 10). 228

229 Triglyme is used in consumer products in consumer brake fluids, as a solvent in 230 consumer adhesives, as a component of consumer paint and graffiti removers and in 231 consumer paints. Industrial uses include generation of chemical s, use as a reaction 232 solvent, and use as a binding agen t in porcelain powders (Ref. 1, pg. 11). 233

234 Tetraglyme is used in consumer products as a solubilizing agent for consumer 235 printing inks, as a coalescing agent in cons umer paints, and as an HFC/CFC lubricant 236 which may be used in consumer air conditi oners. Industrial uses include use as a 237 solubilizing agent in textiles and plastics, as a dye fixation additive for cotton textiles, as 238 a fungicide process solvent, and as a gas scrubbing agent (Ref. 1, pg. 12). 239

240 Polyglyme is used in consumer paint strippers. Industrial uses includ e use as special, 241 high boiling solvents for chemical reactions, use as a solubilizing agent for plastic, 242 textile, and paper processes, and use as a gas scrubbing agent (Ref. 1, pg. 13). 243

244 Ethyldiglyme, butyldiglyme, tetraethylene glycol di butyl ether, ethylglyme, 245 tetraethylene glycol diethyl et her, pentaethylene glycol di ethyl ether, and polyethylene 246 glycol dibutyl ether, have no known uses in consumer products. Indus trial uses of these 247 glymes can include use: as a high-boiling solv ent for nitrocellulose, resins, and lacquers; 248 as a solubilizer in organic synthesis; as a so lvent in the production of plastic resins and 249*** Internal Deliberative – Do Not Cite, Quote or Release ***

8 compounds, rubber chemicals; as a solvent for conductive prin ting ink; in the production 250 of printed circuit etchants; in the preparati on of and reaction with Grignard reagents; in 251 metal extractions; as a solvent in pharmaceutic al syntheses; in the production of coatings; 252 and as a gas scrubbing li quid (Ref. 1, pgs. 14-19). 253

254 The chemicals listed in Unit II.A.1., pe ntaethylene glycol dibutyl ether and 255 butyltriglyme, have no known uses (Ref. 1, pg. 19). 256

257 C. What are the Production Levels of these Chemicals? 258

259 The 2006 Inventory Update Reporting (IUR) regulation required manufacturers and 260 importers of certain chemical substances included on the TSCA Chemical Substance 261 Inventory to report site a nd manufacturing information for chemicals manufactured 262 (including imported) in amounts of 25,000 pounds or greater at a single site. Table 2 263 summarizes 2006 and prior year IUR data for the 14 glymes. For monoglyme and 264 diglyme, EPA expects that production will continue. For triglyme and ethylglyme, 265 predicting future production is infeasible, although ethylglym e production appears to be 266 increasing. For ethyldiglym e, butyldiglyme, and tetraglyme, EPA expects that 267 production will remain at the previous levels. Production of pentaethylene glycol diethyl 268 ether appears to be steadily increasing. For polyglyme, EPA expects that production will 269

continue to decrease and/or remain below the reporting level. For tetraethylene glycol 270 dibutyl ether, tetraethylene glycol diethyl ether, polyeth ylene glycol dibutyl ether, 271 pentaethylene glycol dibutyl ether, and but yltriglyme, EPA expect s that production of 272 these chemical substances, if any, will remain below reporting levels. 273

274 Table 2 – Production Reporting Amounts to IUR 1986-2006 (Ref. 1) 275

276

Common Name 2006 IUR Reporting Previous 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 lb s 1986-2002: >10K - <500K lbs each year Ethylglyme >10K - <500K lbs 1986-2002 : no reports Tetraethylene glycol No report No reports 1986-2002*** Internal Deliberative – Do Not Cite, Quote or Release ***

9 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 No report 1986: >1M - <10M lbs 1994: 0; 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

277 D. What are the Potential Routes and Sources of Exposure? 278

279 Exposures to the environment, consumers, and general population 280

281 Monoglyme, diglyme, ethyldiglyme, trig lyme, butyldiglyme, and ethylglyme are 282 included in the category of chemicals reporte d as “certain glycol ethers” under the ID 283 number N230 in the Toxics Release Inventory (TRI) (Ref. 2). The total release reported 284

to the TRI in 2007 from all reporting sites was 18,476,420 pounds. This total includes air 285 releases of 16,416,033 pounds from on-site fugitive and point sources, in addition to on286

site water releases of 87,035 pounds. Most of the remaining volume of release was deep287 well injected, sent to land treatment, transf erred for energy recovery or transferred to a 288

POTW. Release information about the individua l glymes within the larger glycol ether 289 category is not known (Ref. 3). Manufacturers, importers, or processors are required to 290 report releases of chemicals on the TRI when total manufacturing, imports or processing 291 by a facility equals 25,000 pounds/year for the chemicals combined. 292

293 Ethylglyme was found in the US EPA Office of Water STORET database 294 indicating potential environmental exposur e since this chemical was found in ground 295 water and/or surface water (Ref. 3). 296

297 Monitoring data indicate that the gene ral population may be exposed to diglyme 298 and ethyldiglyme via inhalation of vehicle exhaust and ingestion of contaminated 299 drinking water (Refs. 4 and 5). Diglyme was listed as a contaminant found in drinking 300

water (Ref. 4). 301

302 Diglyme has been detected in diluted vehicle exhaust from a light-duty truck 303 using different fuel types (Ref. 4). 304

305 Industrial manufacture and processing may re sult in the release of glymes to the 306 environment through various waste streams (Ref. 4). Diglyme, ethyldiglyme, and 307*** Internal Deliberative – Do Not Cite, Quote or Release ***

10 ethylglyme have been found at measurable concentrations in industrial wastewater 308 treatment systems (Refs. 4, 5, and 6). Wastew ater treatment systems discharge to either 309 surface waters or publicly owned treatment work s. Either of these two discharge options 310 could result in exposures for the general population and the environment to these 311

chemicals. 312

313 Ethyldiglyme has been qualit atively detected in drinki ng water from Cincinnati, 314 OH; in ground water from the Hipps Road Landfill in Jacksonville, FL; in trench 315 leachates from Maxey Flats, KY and West Valley, NY low-level radioactive waste 316 disposal sites and in advanced waste trea tment water from Lake Tahoe, CA, Pomona, 317 CA, and Blue Plains, Washington, DC (Ref. 5). 318

319 Ethylglyme has been detected in wester n Cleveland, OH wastew ater influents at 320 140 μg/L and it was identified in Chicago Central water works water (treated and 321 untreated) at 2 μg/L (Ref. 6). 322

323 Monitoring data for ethylglyme indicate s that the general population may be 324 exposed to the chemical through releases fr om manufacturing facilities. The general 325 population can then be exposed via inhalation of ambient air, ingestion of drinking water, 326

and dermal contact with these substances and other products containing these chemicals. 327

Evidence of releases from industrial manuf acturing and processing is demonstrated by 328 concentrations of 400 mg/L of diglyme whic h have been found in activated sludge from 329 the waste treatment facility of the indu stry producing the chemical (Ref. 6). 330

331 For the remaining chemicals in Table 1 or Unit II.A.1., little or no release 332

information was found. 333

334 EPA’s Source Ranking Databank (Ref. 7) s hows metal polish and polishing cloths 335 and papers as containing ethylglyme. Most of the entries into this databank for consumer 336 products are from the late 1990s and therefore may not still be current. If ethylglyme is 337 still found in these products, however, there is potential that consumers and children 338 might be exposed to this chemical from these consumer products. Furthermore, 339 production of ethylglyme app ears to be increasing. 340

341 Based on IUR data and communications with manufacturers, EPA believes that 342 monoglyme is used as a compone nt of lithium batteries and di glyme is used in printing 343 inks, both of which are consumer applications of monoglyme. It is believed that disposal 344 of the lithium batteries containing monoglyme and paper with printing inks containing 345 diglyme could present the potential for release of these chemicals to environmental media 346 and subsequent exposure to human s and ecological receptors. 347

348 Occupational exposure 349

350 Occupational exposure to these chemi cals may occur thr ough inhalation and 351 dermal contact at workplaces where the ch emicals are produced or used. Monoglyme, 352 diglyme, ethylglyme, ethyldiglyme, triglyme, and tetraethylene glycol diethyl ether all 353*** Internal Deliberative – Do Not Cite, Quote or Release ***

11 have vapor pressures high enough to potentially result in significant exposures to workers 354 if they are near the chemical (Refs. 8, 9, 3, and 10). Based on IUR data, ethyldiglyme, 355 butyldiglyme, tetraglyme, pentaethylene glycol diethyl ethe r, and polyglyme are 356 manufactured in liquid forms, and worker e xposures through dermal contact are possible 357 (Ref. 10). These chemicals do not have Occ upational Safety and Health Administration 358 (OSHA) Permissible Exposure Limits (Refs. 8, 9, and 3). Ferro Corporation, in their 359 publications, recommended a Threshold Limit Value (TLV) for glycol ethers of 5 ppm 360 (Time Weighted Average (TWA )) with a Short Term Exposure Limit (STEL) of 25 ppm. 361

The 15-minute STEL should not be achieved more than 4 times in 8 hours. For women of 362 child-bearing potential, Ferro recommended a TLV of 1 ppm with a STEL of 5 ppm (Ref. 363 11). Based on the 2006 IUR reports, the maxi mum total number of potentially exposed 364 industrial workers to monoglyme and ethyl glyme during manufactur ing and industrial 365 processing and use is less than 100 each, and the maximum total number of workers 366 likely to be exposed to diglyme was between 100 and 999 workers. There may, however, 367 be additional potentially expos ed industrial workers who are not included in these 368 estimates since not all production volume ma y have been accounted for in the IUR 369 (production below 25,000 pounds at a site does not have to be reported to the IUR), and 370 commercial workers may be exposed as well (Refs. 8, 9, and 12). 371

372

E

. What are the Potential Health Effects of these Chemicals? 373
374 Toxicology studies in laboratory an imals have shown that exposure to 375 monoglyme results in hemolytic (blood) eff ects, and developmental and reproductive 376 toxicity. The acute toxicity of monoglyme is low via oral, dermal and inhalation routes 377 of exposure. The potential toxicity from repeated exposure to monoglyme was assessed 378 using a major metabolite, 2-methoxyethanol (C ASRN 109-86-4). Oral 90-day studies of 379 2-methoxyethanol in rats and mice showed te sticular degeneration and adverse effects on 380 the process of blood cell formation. The lowest observed adverse eff ect level (LOAEL) in 381 rats was 70 mg/kg-day; the LOAEL in mi ce was 300 mg/kg-day. An oral prenatal 382 developmental toxicity study of monoglyme in ra ts showed fetal mortality at doses as low 383 as 60 mg/kg-day, and edema at doses as low as 30 mg/kg-day. An oral prenatal 384 developmental toxicity study of monoglyme in mice showed reduced fetal body weight 385 and increased skeletal defects at 250 mg/kg- day. Available data also suggest that 386 monoglyme has the potential to be genotoxic (Ref. 13). 387

388 Toxicology studies in labor atory animals have shown that exposure to diglyme 389 results in hemolytic (blood) effects, and developmental a nd reproductive toxicity. The 390 acute toxicity of diglyme to ra ts via the oral and inhalation routes of exposure is low. 391 The toxicity profile following re peated exposures to diglyme is similar to the profile for 392 monoglyme. Rats showed testicular dege neration and hemolytic effects following 393 inhalation exposure to diglyme for two weeks at concentrations as low as 0.6 mg/L-day; a 394

NOAEL was not established. An inhalation dominant-lethal study in rats showed a 395 reduced pregnancy rate at 5.5 mg/L-day. An oral prenatal developmental toxicity study 396 in mice showed effects on fetal growth and viab ility, and an increase in malformations at 397 125 mg/kg-day; the NOAEL was 62.5 mg/kg-day. I n vitro gene mutation and in vivo 398 chromosomal aberration tests were negative (Ref. 14). 399

400*** Internal Deliberative – Do Not Cite, Quote or Release ***

12 Toxicology studies in laboratory an imals have shown that exposure to 401 ethylglyme results in developmental toxicity. The acute toxicity of ethylglyme is low in 402 rats. Oral prenatal developmental toxicity studies of ethylglyme in mice and rabbits 403 showed a significant decrease in fetal body weight and viability, and a significant 404 increase in malformations; the NOAEL for deve lopmental toxicity was 50 mg/kg-day in 405 mice and 25 mg/kg-day in rabbits (Ref. 6). 406

407 Based on a review of the literature, there is insufficient information available to 408 arrive at any health effects related conclusi ons for the remaining chemicals in Table 1 or 409

Unit II.A.1. 410

411 IV. Rationale and Objectives 412

A. Rationale 413

414 EPA has concerns about the 14 glymes lis ted in this SNUR, all of which have 415

similar chemical structures. EPA is concerned about the reproductive and/or 416 developmental toxicity of monoglyme, di glyme, and ethylglyme and believes that 417

individuals could suffer advers e effects from their use. In addition, EPA has concerns 418 about the remaining 11 glymes due to the lack of available use, exposure, and toxicity 419

information. Currently, exposure to monogl yme in lithium batteries is very limited since 420

the batteries are sealed. Th e amount of exposure to diglyme in printing inks is less 421 certain, but any additional us e would increase the existing exposure to the chemical. 422 Ethylglyme currently has no consumer uses but has been found in water sources and 423 given its toxicity, EPA would be concerne d if this chemical became prevalent in 424 consumer products. EPA further believes that the use of any of these chemicals in 425 consumer products, beyond the limited, current uses, would significantly increase the 426 magnitude and duration of exposure to humans and the environment over that which 427

would otherwise exist and that such increase should not occur without opportunity for 428 EPA review. Finally, for pentaethylene gl ycol dibutyl ether a nd butyltriglyme, EPA 429

believes that any use of these chemicals would significantly increase the magnitude and 430 duration of exposure to humans and the envi ronment over that which currently occurs. 431

432 On March 18, 2008, EPA published risk base d prioritization related documents on 433 monoglyme and diglyme (Refs. 8, 9, 13, and 14), which indicated that it appeared these 434 two chemicals are used in consumer products and also indicated EPA’s concerns about 435 the potential health effects of these two chemicals. Studies on monoglyme and diglyme 436

indicate adverse health eff ects concerning reproductive and developmental toxicity, as 437 well as on blood and blood-forming organs. Studies on ethylglyme show developmental 438 toxicity as well as potential for gene muta tion. Several manufacturers initially responded 439 that, with the exception of monoglyme use in sealed lith ium batteries, there are no 440 consumer uses. Follow up contact with manuf acturers revealed some additional potential 441 consumer uses and raised questions about some of the other uses. For monoglyme, 442 diglyme, and ethylglyme, as well as the remain ing 11 chemicals, the le vel of toxicity is 443 uncertain and/or the type and extent of the use of the chemical is unclear. EPA is 444 proposing to issue this SNUR to require notification prior to any new manufacturing, 445 importing, or processing of these chemical s for consumer uses (with specified 446*** Internal Deliberative – Do Not Cite, Quote or Release ***

13 exceptions), or in some cases all uses. EP A intends to continue to monitor production, 447

use and other relevant information on the subject substances and, where appropriate, 448

initiate further action. 449

450 EPA previously published a SNUR on November 29, 2005, (70 FR 71401), (FRL 451 7740-7), on a major metabolite of monoglyme, 2-methoxyethanol (2-ME), CASRN 109- 452 86-4, requiring notice to the Agency before 2- ME is used in a consumer product (40 CFR 453 721.10001) (Ref. 15). 454

455 B. Objectives 456

457 Based on the considerations in Unit III., EP A wants to achieve the following objectives 458 with regard to the signifi cant new use(s) that are desi gnated in this proposed rule: 459

460 1. EPA would receive notice of any pers on’s intent to manufacture, import, or 461 process the glymes listed in Table 1 and Unit II.A.1. for the described significant new 462 uses before that activity begins. 463

464 2. EPA would have an opportunity to review and evaluate data submitted in a 465 SNUN before the notice submitter begins manufacturing, importing or processing of 466 the glymes listed in Table 1 and Unit II. A.1. for the described significant new uses. 467

468 3. EPA would be able to regulate prospectiv e uses of the glymes listed in Table 1 and 469 Unit II.A.1. before the described significant ne w uses of the chemical substance occur, 470 provided that regulation is wa rranted pursuant to TSCA sec tions 5(e), 5(f), 6 or 7. 471

472 V. Significant Ne w Use Determination 473

474 Section 5(a)(2) of TSCA states that EPA' s determination that a use of a chemical 475 substance is a significant new us e must be made after consider ation of all relevant factors 476 including: 477

478 • The projected volume of manufacturing and processing of a ch emical substance. 479

480 • The extent to which a use changes the t ype or form of exposure of human beings 481

or the environment to a chemical substance. 482

483

• The extent to which a use increases th e magnitude and duration of exposure of 484 human beings or the environment to a chemical substance. 485

486 • The reasonably anticipated manner and methods of manufacturing, processing, 487 distribution in commerce, and dispos al of a chemical substance. 488

489

In addition to these factors enumerated in TS CA section 5(a)(2), the statute authorizes 490 EPA to consider any othe r relevant factors. 491

492*** Internal Deliberative – Do Not Cite, Quote or Release ***

14 To develop its determination of what woul d constitute a significant new use of the 493 glymes listed in Table 1 and Unit II.A.1.

, EPA considered relevant information about the 494 toxicity of these substances, likely hu man exposures and environmental releases 495 associated with possible uses, and the four factors listed in sec tion 5(a)(2) of TSCA. 496

497

Based on the relevant factors mentioned in this unit, and addressed in this SNUR, 498 EPA has determined that the manufacture, import, or processing of ethyldiglyme, 499 butyldiglyme, tetraethylene glyc ol dibutyl ether, et hylglyme, tetraethyle ne glycol diethyl 500 ether, pentaethylene glycol diethyl ether, and polyet hylene glycol dibutyl ether for any 501 use in a consumer product is a significant ne w use. EPA has also determined that the 502 manufacture, import, or processing of m onoglyme, diglyme, triglyme, tetraglyme, 503 polyglyme for any use in a consumer product, othe r than for the uses lis ted in Table 1, is 504 a significant new use. In addition, EPA has de termined that the manufacture, import, or 505 processing of pentaethylene gl ycol dibutyl ether and butyl triglyme for any use is a 506 significant new use

. 507

508 VI. Request for Public Comment 509

510 EPA welcomes comments on any aspect of this SNUR. Information available 511 about toxicity and exposure would assist EPA to evaluate the level of risk posed by all of 512

the chemicals. This unit also describes the specific use information for which EPA 513 would find comments especially helpful. 514

515

In order to ascertain if there are a ny ongoing uses of these glymes, EPA used 516 information submitted under the IUR rule, c ontacted manufacturers, searched business 517 periodicals, and searched othe r available sources. In some instances, EPA could confirm 518 the existence of an ongoing use in a consumer product from the information reviewed. In 519 other instances, the results of EPA’s search were unclear, and EPA could not confirm 520 whether certain reported consumer pr oduct uses were actual ongoing uses. 521

522 Therefore, EPA is requesting public co mment on whether any of the additional 523

unconfirmed uses listed in this unit are actua l, ongoing uses in a consumer product, and 524 whether there are any other ongoing uses in a consumer product of th e chemicals listed in 525 Table 1. For pentaethylene gl ycol dibutyl ether and butyl triglyme, EPA is requesting 526 public comment on whether there are any ongoing uses at all (consumer or industrial). 527 EPA does not anticipate that it will add a dditional exclusions to the final rule, beyond 528 those listed in Table 1, except where public comment adequately substantiates the 529 existence of such ongoing use. 530

531 Table 3 – Reported Consumer Uses of Glymes that are Unconfirmed 532

533

Common Name Additional Unc onfirmed 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*** Internal Deliberative – Do Not Cite, Quote or Release ***

15 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 diethyl ether Use as an ingredient in consumer brake fluid

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

534

VII. Alternatives 535

536 Before proposing this SNUR, EPA consider ed promulgating a TSCA section 8(a) 537 reporting rule for these glymes. Under a TSCA section 8(a) rule, EPA could, among 538 other things, generally require persons to report information to the Agency when they 539 intend to manufacture, import, or process a listed chemical for a specific use or any use. 540 However, for these glymes, the use of TSCA section 8(a) rather than SNUR authority 541 would have several limitations. First, if EPA was to require reporting under TSCA 542 section 8(a) instead of TSCA section 5(a), EPA would not have the opportunity to review 543 human and environmental hazards and exposures associated with th e proposed significant 544 new use and, if necessary, take immediat e follow-up regulatory action under TSCA 545 sections 5(e) or 5(f) to prohibit or limit the activity before it begins. In addition, EPA 546 may not receive important information from small businesses, because such firms 547 generally are exempt from TSCA section 8(a) reporting requirements. In view of the 548

level of health and environmental concerns about monoglyme, diglyme, and ethylglyme 549*** Internal Deliberative – Do Not Cite, Quote or Release ***

16 if used for the proposed significant new use, a nd the lack of information to be able to 550 judge exposure for the remaining glymes, EPA be lieves that a TSCA section 8(a) rule for 551

this substance would not meet EPA's regulatory objectives. 552

553 VIII. Applicability of Rule to Uses O ccurring Before Effective Date of the Final 554

Rule 555

556 As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has 557

decided that the intent of s ection 5(a)(1)(B) of TSCA is best served by designating a use 558 as a significant new use as of the date of publication of the pr oposed rule rather than as of 559

the effective date of the final rule. If us es begun after publication of the proposed rule 560 were considered ongoing rather than new, it would be difficult for EPA to establish 561 SNUR notice requirements, because a person could defeat the SNUR by initiating the 562 proposed significant new use before the rule became final, and then argue that the use 563 was ongoing as of the effective date of th e final rule. Thus, persons who begin 564 commercial manufacture, import, or processing of the chemical substance(s) that would 565 be regulated through this proposed rule

, if finalized

, would have to cease any such 566 activity before the effective date of the rule if and when finalized. To resume their 567 activities, these persons w ould have to comply with all applicable SNUR notice 568 requirements and wait until the notice review pe riod, including all extensions, expires. 569 EPA has promulgated provisions to allow persons to comply with this SNUR before the 570 effective date. If a person were to m eet the conditions of advance compliance under 571 section 721.45(h), that person would be consid ered to have met the requirements of the 572

final SNUR for those activities. 573

574

IX. Test Data and Other Information 575

576 EPA recognizes that TSCA section 5 does not require developing any particular test 577

data before submission of a SNUN. Persons ar e required only to submit test data in their 578 possession or control and to desc ribe any other data known to or reasonably ascertainable 579 by them (15 U.S.C. 2604(d); 40 CFR 721.25). However, as a general matter, EPA 580

recommends that SNUN submitters include da ta that would permit a reasoned evaluation 581 of risks posed by the chemical substance duri ng its manufacture, import, processing, use, 582 distribution in commerce, or disposal. EPA encourages persons to consult with the 583 Agency before submitting a SNUN. As part of this optional pre- notice consultation, EPA 584 would discuss specific data it believes may be useful in evaluating a significant new use. 585 SNUNs submitted for significant new uses without any test data may increase the 586

likelihood that EPA will take action under TSCA section 5(e) to prohibit or limit 587

activities associated with this chemical. 588

589

SNUN submitters should be aware that EP A will be better able to evaluate SNUNs 590 that provide detailed information on: 591

592 1. Human exposure and environmental rele ases that may result from the significant 593

new uses of the chemical substances. 594

2. Potential benefits of the chemical substances. 595*** Internal Deliberative – Do Not Cite, Quote or Release ***

17 3. Information on risks posed by the chemi cal substances compared to risks posed 596 by potential substitutes. 597

598

X. SNUN Submissions 599

600 EPA recommends that submitters consult with the Agency prior to submitting a 601 SNUN to discuss what data may be usef ul in evaluating a significant new use. 602 Discussions with the Agency prior to submission can afford ample time to conduct any 603 tests that might be helpful in evaluating ri sks posed by the substance. According to 40 604 CFR 721.1(c), persons submitting a SNUN must comply with the same notice 605 requirements and EPA regulatory procedures as persons submitting a PMN, including 606

submission of test data on health and envi ronmental effects as described in 40 CFR 607

720.50. 608

609

SNUNs must be mailed to the Environm ental Protection Agency, OPPT Document 610 Control Office (7407M), 1200 Pennsylvania Avenue, NW., Washington, D.C. 20460- 611

0001. Information must be submitted in the fo rm and manner set forth in EPA Form No. 612

7710-25. This form is available from the Environmental Assistance Division (7408M), 613 1200 Pennsylvania Avenue, NW., Washingt on, D.C. 20460-0001 (see 40 CFR 721.25 614 and 720.40). Forms and information are also available electronically at 615 http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm

. 616

XI. Economic Analysis 617

A. SNUNs 618

619 EPA has evaluated the potential costs of establishing SNUR reporting requirements 620 for potential manufacturers, importers, and processors of the chemical substances 621 included in this proposed rule. While most businesses are subject to a $2,500 user fee 622 required by 40 CFR 700.45(b)(2)(iii), small businesses with annua l sales of less than $40 623 million when combined with those of the pa rent company (if any) are subject to a 624 reduced user fee of $100 (40 CFR 700.45(b)(1)). The costs of submission of SNUNs will 625 not be incurred by any company unless a comp any decides to pursue a significant new 626 use as defined in this proposed SNUR. Furt hermore, EPA believes that the expense of 627 submitting a notice (approximately $6,000 plus th e user fee) is unlikely to discourage 628 innovations of high potential value. EPA's complete economic an alysis is available in the 629 public docket for this proposed rule (Ref. 16). 630

631 B. Export Notification 632

633 Under section 12(b) of TSCA and the im plementing regulations at 40 CFR part 634 707, subpart D, exporters must notify EPA if th ey export or intend to export a chemical 635 substance or mixture for which, among othe r things, a rule has been proposed or 636 promulgated under TSCA section 5. For pers ons exporting a substan ce the subject of a 637 SNUR, a one-time notice must be provided for the first export or intended export to a 638 particular country. EPA estimates the one -time cost to be approximately $937 per 639 exporter including mailing costs. The total costs of export notification will vary by 640*** Internal Deliberative – Do Not Cite, Quote or Release ***

18 chemical, depending on the number of requi red notifications (i.e., the number of 641 countries to which the chemical is exported). Because EPA is unable to make an estimate 642 of the likely number of expor t notifications for the chemicals covered in this proposed 643 SNUR, a total export notificati on cost is not available. 644

645

XII. References 646

647

The sources listed in this unit were used as references for this SNUR and are included 648 in the public docket for this action, EPA-HQ-OPPT-2009-0767

. 649

650 1. Wilson, Kimberly; Tome, Alice; and Na rayan, Tulika, Abt Associates, Inc. 651 “Memorandum to EPA, Nishkam Agarwal, ‘A ctual and Potential Uses of Fourteen 652 Selected Glymes,’” September 9, 2009. 653

654

2. US EPA TRI Website. http://www.epa.gov/ttn/atw/glycol2000.pdf 655

656 3. US EPA, Exposure Characterizati on for Ethylglyme, November 6, 2009

. 657

658 4. HSDB, 2008. Hazardous Substances Data Bank. Entry for diglyme. Accessed 659 October 30, 2009. http://toxnet.nlm.nih.gov

. 660

661 5. Hazardous Substances Data Bank (HSDB), http://toxnet.nlm.nih.gov . Entry for 662 CASRN 112-36-7, Accessed on October 28, 2009. 663

664 6. Hazardous Substances Data Bank, http://toxnet.nlm.nih.gov . Entry for Ethylene 665 glycol diethyl ether, CASRN 629- 14-1. Accessed on October 30, 2009. 666

667 7. The Source Ranking Database is an EP A database that performs a systematic 668 screening-level review of over 12,000 potential indoor pollution sources to identify high669 priority product and material categories for fu rther evaluation. It can also identify the 670 products that have contained a specific chemical. May, 1997. 671 http://www.epa.gov/oppt/exposure/pubs/srd_apdx.pdf

. 672

8. US EPA, Screening-Level Exposure Ch aracterization of High Production Volume 673 Chemicals: 1,2-Dimethoxyeth ane (CAS No. 110-71-4), [9 th CI Name: Ethane, 1,2- 674 dimethoxy-], March 2008. 675

676 9. US EPA, Screening-Level Exposure Ch aracterization of High Production Volume 677 Chemicals: Diglyme (CAS No. 111-96-6), [9 th CI Name: Bis(2-methoxyethyl) Ether], 678

March 2008. 679

680 10. US EPA, EETD/EAB. Physical-Chemical Properties and Fate Characterization: 681 Glycol Ethers. August 2009. 682

683 11. Ferro Corporation. 1,2-Dimethoxyeth ane US EPA HPV Challenge Program 684 Submission, December 2001, pages 7-8 of 93. 685

686*** Internal Deliberative – Do Not Cite, Quote or Release ***

19 12. US EPA. IUR database sear ch results for number of wo rkers exposed to ethylglyme, 687 http://cfpub.epa.gov /iursearch/2006_iur_na tlcheminfo.cfm?id=3975 , accessed on October 688 21, 2009. 689

690 13. US EPA, Screening-Level Hazard Characterization of High Production Volume 691 Chemicals: 1,2-Dimethoxyeth ane (CAS No. 110-71-4), [9 th CI Name: Ethane, 1,2- 692 dimethoxy-], February 2008. 693

694 14. US EPA, Screening-Level Hazard Char acterization of High Production Volume 695 Chemicals: Diglyme (CAS No. 111-96-6), [9 th CI Name: Bis(2-methoxyethyl) Ether], 696 February 2008. 697

698 15. US EPA. “2-ethoxyethanol, 2-ethoxyethanol acetate, 2-methoxyethanol, and 2- 699 methoxyethanol acetate; Significant New Use Rule.” 70 FR 71401, November 29, 2005. 700

701 16. US EPA 2010. Economic Analysis of the Proposed Significant New Use Rule for 14 702 Glymes. Washington, DC: U.S. EPA/OPPT/EETD/EPAB, January 12, 2010. 703

704 XIII. Statutory and Executive Order Reviews 705

A. Executive Order 12866: Regulatory Planning and Review 706

707

Under Executive Or der 12866, entitled Regulatory Planning and Review (58 FR 51735, 708 October 4, 1993), the Office of Management a nd Budget (OMB) has determined that this 709 proposed SNUR is a ‘‘significant regulatory action,’’ because it meets the criteria in 710 section 3(f) of the Executive Order. Accord ingly, this action was submitted to the OMB 711

for review under Executive Order 12866 and any changes made based on OMB 712

recommendations have been documented in the public docket for this rulemaking as 713 required by section 6(a)(3)(E ) of the Executive Order. 714

715 B. Paperwork Reduction Act 716

717 According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency 718 may not conduct or sponsor, and a person is not required to res pond to a collection of 719 information that requires OMB approval unde r the PRA, unless it has been approved by 720 OMB and displays a currently valid OMB c ontrol number. The OMB control numbers for 721 EPA's regulations in Title 40 of the CFR, after appearing in the Federal Register , are 722 listed in 40 CFR, part 9, and included on the related collection inst rument, or form, if 723 applicable. The information collection require ments related to this action have already 724 been approved by OMB pursuant to th e PRA under OMB control number 2070-0038 725 (EPA ICR No. 1188). This action does not impose any burden requiring additional OMB 726 approval. If an entity were to submit a SNUN to the Agency, the annual burden is 727 estimated to average 110 hours per response. This burden estimate includes the time 728

needed to review instructions , search existing data sources, gather and maintain the data 729 needed, and complete, review, and submit the required SNUN. Send any comments 730 about the accuracy of the burden estimate, and any suggested methods for minimizing 731 respondent burden, including through the use of automated collection techniques, to the 732*** Internal Deliberative – Do Not Cite, Quote or Release ***

20 Director, Collection Strategi es Division, Office of Envir onmental Information (2822T), 733 Environmental Protection Agency, 1200 Pe nnsylvania Ave., NW., Washington, D.C. 734 20460-0001. Please remember to include the OMB control number in any 735 correspondence, but do not submit any co mpleted forms to this address. 736

737 C. Regulatory Flexibility Act 738

739 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), 740 the Agency hereby certifies that promulgation of this SNUR would not have a significant 741 adverse economic impact on a substantial number of small entities. The rationale 742 supporting this conclusion is as follows. A SNUR applies to any person (including small 743 or large entities) who intends to engage in any activity described in the rule as a 744 “significant new use.” By de finition of the word “new” and based on all information 745 currently available to EPA, it appears that no small or large entities presently engage in 746 such activity. Since this proposed SNUR w ould require a person who intends to engage 747 in such activity in the future to first notify EPA by submitting a SNUN, no economic 748 impact will occur unless someone files a S NUN to pursue a significant new use in the 749 future or forgoes profits by avoiding or de laying the significant ne w use. Although some 750 small entities may decide to conduct such act ivities in the future, EPA cannot presently 751 determine how many, if any, there may be. Howeve r, EPA's experience to date is that, in 752 response to the promulgation of over 1,000 SNUR s, the Agency receives on average only 753 5 notices per year. Of those SNUNs submitted, only one appears to be from a small entity 754 in response to any SNUR. Therefore, EPA belie ves that the potential economic impact of 755 complying with this SNUR is not expected to be significant or adversely impact a 756

substantial number of small en tities. In a SNUR that publis hed as a final rule on August 757 8, 1997 (62 FR 42690)(FRL-5735-4), the Agency pr esented its general determination that 758 proposed and final SNURs are not expected to have a significant economic impact on a 759

substantial number of sma ll entities, which was provide d to the Chief Counsel for 760 Advocacy of the Small Business Administration. 761

762 D. Unfunded Mandates Reform Act 763

764 Based on EPA’s experience with proposing a nd finalizing SNURs, State, local, and 765 Tribal governments have not been impact ed by these rulemakings, and EPA does not 766 have any reason to believe that any State, lo cal, or Tribal government would be impacted 767 by this rulemaking. As such, EPA has determin ed that this regulat ory action would not 768 impose any enforceable duty, contain any unfunded mandate, or otherwise have any 769 effect on small governments subject to th e requirements of sections 202, 203, 204, or 205 770 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 771

772

E. Executive Order 13132: Federalism 773

774

This action would not have a substantial di rect effect on States, on the relationship 775 between the national government and the Stat es, or on the distribution of power and 776 responsibilities among the various levels of government, as specified in Executive Order 777 13132, entitled Federalism (64 FR 43255, August 10, 1999). 778*** Internal Deliberative – Do Not Cite, Quote or Release ***

21 779

F. Executive Order 13175: Consultation and Coordination with Indian Tribal 780

Governments 781

782 This proposed rule would not have Tribal imp lications because it is not expected to have 783

substantial direct effects on Indian Tribes. This proposed rule woul d not significantly or 784 uniquely affect the communities of Indian Tr ibal governments, nor would it involve or 785 impose any requirements that affect Indian Tribes. Accordingly, the requirements of 786 Executive Order 13175, entitled Consultation and Coordination with Indian Tribal 787

Governments (65 FR 67249, November 9, 2000), do not apply to this proposed rule. 788

789 G. Executive Order 13045: Protection of Childre n from Environmental Health Risks and 790 Safety Risks 791

792 This action is not subject to Executive Order 13045, entitled Protection of Children from 793 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this 794 is not an economically significant regulato ry action as defined by Executive Order 12866, 795

and this action does not address environmental health or safety risks disproportionately 796 affecting children. 797

798 H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, 799

or Use 800

801 This proposed rule is not subj ect to Executive Order 13211, entitled Actions Concerning 802 Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 803 May 22, 2001), because this action is not expect ed to affect energy supply, distribution, 804

or use. 805

806 I. National Technology Transfer Advancement Act 807

808

Since this action does not invol ve any technical standards; section 12(d) of the National 809 Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 810 section 12(d) (15 U.S.C. 272 note), does not apply to this action. 811

812

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 813 Populations and Low-Income Populations 814

815 This action does not entail special considerations of environmental justice related issues 816 as delineated by Executive Order 12898, entitled Federal Actions to Address 817 Environmental Justice in Minority Po pulations and Low-Income Populations (59 FR 818 7629, February 16, 1994). 819

820

821 List of Subjects in 40 CFR Part 721 822

823*** Internal Deliberative – Do Not Cite, Quote or Release ***

22 Environmental protection, Chemicals, Hazardous substances, Reporting and 824 recordkeeping requirements. 825

826 Dated: ________ 827

828

________________ 829

Click -- Insert Title will be OPPT/OD 830

831

832 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 833

PART 721- [Amended] 834

1. The authority citation for part 721 continues to read as follows: 835

Authority: 15 U.S.C. 2604, 2607, and 2625(c). 836

837 2. By adding new § 721.xxxxx to subpart E to read as follows: 838

§ 721.xxxxx Glymes. 839

840 (a) Chemical substances and significant new uses subject to reporting . (1) The 841

chemical substances identified in Table 1 ar e subject to reporting under this section for 842 the significant new uses described in Table 1, Column 3 “Significant New Use.” 843

844 Table 1 – Chemicals Subject to Repor ting and Designated Significant New Uses 845

846 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-met hoxy- Any use in a consumer product except as a solvent in printing inks for consumer products 112-36-7 Ethane, 1,l'-oxybis[2-eth oxy- 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*** Internal Deliberative – Do Not Cite, Quote or Release ***

23 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

847

848 [FR Doc. 09–????? Filed ??–??–09; 8:45 am] 849

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