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1 EO 12866/13563 Review Draft – As Submitted 

2 Rin2070-AJ91_EO12866_TDI-SNUR_NPRM_FRdocument_2014-08-15.docx 

3 

4 BILLING CODE 6560-50-P 

5 ENVIRONMENTAL PROTECTION AGENCY 

6 40 CFR Part 721 

7 EPA-HQ-OPPT-2011-0976; FRL-XXXX-X

8 RIN 2070-AJ91 

9 Toluene Diisocyanates (TDI) and Related Compounds; Significant New Use Rule

10 AGENCY: Environmental Protection Agency (EPA). 

11 ACTION: Proposed rule. 

12 SUMMARY: Under the Toxic Substance Control Act (TSCA), EPA is proposing a 

13 significant new use rule (SNUR) for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, 

14 toluene diisocyanate unspecified isomers (these three chemical substances are hereafter 

15 referred to as toluene diisocyanates or TDI) and related compounds as identified in this 

16 proposed rule. The proposed significant new use is any use in a consumer product, with a 

17 proposed exception for use of certain chemical substances in coatings, elastomers, 

18 adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight 

19 of TDI in a consumer product. In addition, EPA is also proposing that the general SNUR 

20 article exemption for persons who import or process these chemical substances as part of 

21 an article would not apply. Persons subject to the SNUR would be required to notify EPA 

22 at least 90 days before commencing any manufacturing or processing. The required 

23 notification would provide EPA with the opportunity to evaluate the intended use and, if 

24 necessary based on the information available at that time, an opportunity to protect 

25 against potential unreasonable risks, if any, from that activity before it occurs. 
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26 DATES: Comments must be received on or before [insert date 60 days after date of 

27 publication in the Federal Register]. 

28 ADDRESSES: Submit your comments, identified by docket identification (ID) number 

29 EPA-HQ-OPPT-2011-0976, by one of the following methods: 

30 • Federal eRulemaking Portal: http://www.regulations.gov. Follow the online 

31 instructions for submitting comments. Do not submit electronically any information you 

32 consider to be Confidential Business Information (CBI) or other information whose 

33 disclosure is restricted by statute. 

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

35 Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

36 Washington, DC 20460-0001. 

37 • Hand Delivery: To make special arrangements for hand delivery or delivery of 

38 boxed information, please follow the instructions at 

39 http://www.epa.gov/dockets/contacts.html. 

40 Additional instructions on commenting or visiting the docket, along with more 

41 information about dockets generally, is available at http://www.epa.gov/dockets. 

42 FOR FURTHER INFORMATION CONTACT: For technical information contact: 

43 Katherine Sleasman, Chemical Control Division (7405M), Office of Pollution Prevention 

44 and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

45 Washington, DC 20460-0001; telephone number: 202-564-7716; e-mail address: 

46 sleasman.katherine@epa.gov. 

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

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

49 TSCA-Hotline@epa.gov. 
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50 SUPPLEMENTARY INFORMATION: 

51 I. Executive Summary 

52 A. Does this Action Apply to Me?

53 You may be potentially affected by this action if you manufacture, process, or 

54 distribute in commerce chemical substances and mixtures. The following list of North 

55 American Industrial Classification System (NAICS) codes is not intended to be 

56 exhaustive, but rather provides a guide to help readers determine whether this document 

57 applies to them. Potentially affected entities may include: 

58 • Chemical and Allied Products Manufacturers (NAICS code 32411). 

59 • Petroleum Refining (NAICS code 325 and 32411).

60 • Paints, coatings and adhesives manufacturing (NAICS code 3255).

61 • Urethane and other foam product manufacturing (NAICS code 326150).

62 • Transportation polyurethane foam products (NAICS code 32615011).

63 • Building and construction polyurethane foam products (NAICS code 

64 32615031).

65 • Products made of foam other than polystyrene or polyurethane (NAICS code 

66 32615091). 

67 • All other miscellaneous polyurethane foam products (NAICS code 32615061).

68 • Consumer and institutional polyurethane foam products (NAICS code 

69 32615051).

70 • Packing polyurethane foam products (NAICS code 32615021). 

71 • Elastomers (NAICS code 326199).

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

73 certification and export notification rules under TSCA. Persons who import any 
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74 chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 

75 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 

76 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that 

77 the shipment of the chemical substance complies with all applicable rules and orders 

78 under TSCA, including any SNUR requirements. The EPA policy in support of import 

79 certification appears at 40 CFR part 707, subpart B. In addition, any persons who export 

80 or intend to export a chemical substance that is the subject of this proposed rule on or 

81 after [insert date 30 days after the date of publication in the Federal Register] are 

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

83 (see 40 CFR 721.20), and must comply with the export notification requirements in 40 

84 CFR part 707, subpart D. 

85 If you have any questions regarding the applicability of this action to a particular 

86 entity, consult the technical information contact listed under FOR FURTHER 

87 INFORMATION CONTACT. 

88 B. What Is the Agency's Authority for Taking this Action? 

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

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

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

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

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

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

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

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

97 C. What Action Is the Agency Taking? 
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98 EPA is proposing a SNUR for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, 

99 toluene diisocyanate unspecified isomers (these three chemical substances are hereafter 

100 referred to as toluene diisocyanates or TDI) and related compounds. The proposed 

101 significant new use is: any use in a consumer product of any chemical substance listed in 

102 Table 1; and any use in a consumer product of any chemical listed in Table 2 (except for 

103 use in coatings, elastomers, adhesives, binders, and sealants that results in less than or 

104 equal to 0.1 percent by weight of TDI in a consumer product). 

105 This proposed significant new use rule would apply to the uses EPA has identified 

106 herein that EPA believes are not ongoing at the time of this proposed rule. EPA is 

107 requesting public comment on this proposal, and specifically on the Agency’s 

108 understanding of ongoing uses for the chemicals identified in Tables 1 and 2 in consumer 

109 products. EPA is particularly interested in whether there are any ongoing uses of these 

110 chemicals in consumer products of which the Agency is currently unaware and would 

111 welcome specific documentation of any such ongoing uses. A consumer product is 

112 defined at 40 CFR 721.3 as: a chemical substance that is directly, or as part of a mixture, 

113 sold or made available to consumers for their use in or around a permanent or temporary 

114 household or residence, in or around a school, or in recreational settings. 

115 This proposed SNUR would require persons that manufacture (including import) 

116 or process any of the chemicals for a significant new use, consistent with the 

117 requirements at 40 CFR 721.25, to notify EPA at least 90 days before commencing such 

118 manufacture or process of the chemical substance for a significant new use. For this 

119 proposed rule, EPA is proposing that the general SNUR article exemption at 40 CFR 

120 721.45(f) for persons who import or process chemical substances as part of an article 

121 would not apply. The article exemption at 40 CFR 721.45(f) is based on an assumption 
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122 that people and the environment will generally not be exposed to chemical substances in 

123 articles (see 49 FR 35014; September 5, 1984). However, TDI and related compounds are 

124 volatile and as such could migrate out of articles that contain them. For instance, studies 

125 of TDI in polyurethane products reported that after the reaction between an isocyanate 

126 and an alcohol to form polyurethane products, residual levels of isocyanates were 

127 detected on the surface of the products, which if used could lead to exposure (Refs. 1 and 

128 2). Because TDI and related compounds are known to be volatile chemical substances, 

129 have been reported to migrate from products, are sensitizers, and would be expected to 

130 present a higher potential for exposure if the TDI in the article were a consumer product, 

131 EPA would like the opportunity to evaluate such potential uses in consumer products for 

132 any associated risks or hazards that might exist before those uses would begin. 

133 D. Why Is the Agency Taking this Action? 

134 These SNURs are necessary to ensure that EPA receives timely advance notice of 

135 any future manufacturing and processing of TDI and related compounds for new uses that 

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

137 objectives for this SNUR are explained in Unit III. 

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

139 EPA has evaluated the potential costs of establishing SNUR reporting 

140 requirements for potential manufacturers and processors of the chemical substances 

141 included in this proposed rule. This analysis, which is available in the docket, is 

142 discussed in Unit IX., and is briefly summarized here. In the event that a SNUN is 

143 submitted, costs are estimated to be less than $8,700 per SNUN submission for large 

144 business submitters and $6,300 for small business submitters. These estimates include the 

145 cost to prepare and submit the SNUN and the payment of a user fee. In addition, for 
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146 persons exporting a substance that is the subject of a SNUR, a one-time notice must be 

147 provided for the first export or intended export to a particular country, which is estimated 

148 to cost less than $100 on average per notification. The rule may also affect firms that plan 

149 to import or process articles that contain TDI and related compounds, because, while not 

150 required by the SNUR, these parties may take additional steps to determine whether TDI 

151 and related compounds are part of the articles that they are considering to import or 

152 process. Since EPA is unable to predict whether anyone might engage in future activities 

153 that would require reporting, potential total costs were not estimated. 

154 II. Chemical Substances Subject to this Proposed Rule 

155 A. What Chemicals Are Included in the Proposed SNUR? 

156 This proposed SNUR would apply to TDI and its related compounds listed in 

157 Table 1 and Table 2 in consumer products. Diisocyanates contain free isocyanate 

158 functional groups (-N=C=O). Diisocyanates are combined with other compounds that 

159 contain free hydroxyl functional groups (i.e., –OH), typically called “polyols.” These 

160 two-part components react and begin to form polyurethane polymers. This chemical 

161 reaction is completed when all of the isocyanate functional groups are bound within the 

162 polymer network. This process is commonly referred to as “curing.” Products that contain 

163 free isocyanate functional groups are intended to react further and undergo “curing” in 

164 the process of use. The chemical substances subject to this proposed SNUR contain free 

165 isocyanate functional groups and are by definition uncured. 

166 To ascertain if TDI and related compounds are used in consumer products, EPA 

167 reviewed published literature, the most recent data from EPA’s Chemical Data Reporting 

168 program (CDR), and communicated directly with manufacturers and processors. 

169 Reporting under the CDR indicated no consumer uses of TDI or related compounds. 
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170 However, during conversations between EPA personnel and manufacturers and 

171 processors, it was revealed that in some cases consumer products may still contain 

172 residual TDI of no more than 0.1 percent by weight, as noted in Table 2 (Ref. 3). This 

173 was also confirmed by review of published literature and SDS for consumer adhesives 

174 and sealants available in retail outlets. It is EPA’s understanding that any TDI present in a 

175 coating, adhesive, elastomer, binder or sealant consumer product is at levels of no more 

176 than 0.1 percent by weight and would typically be considered residual diisocyanate 

177 remaining from the manufacture of a polyurethane polymer, a concentration which is 

178 above the detection level (Ref. 4). EPA believes that other consumer products do not 

179 contain TDI or related compounds at any level. 

180 Table 1 – Toluene Diisocyanate Related Compounds Subject to this Action with a 

181 Proposed Significant New Use of “Any Use in a Consumer Product” 

182 

Chemical Name Chemical Abstracts Index Name Chemical 

Abstracts Service 

Registry Number 

(CASRN)

Toluene diisocyanate 

trimer 

Benzene, 1,3-diisocyanatomethyl-, 

trimer 9019-85-6 

Poly(toluene diisocyanate) Benzene, 1,3-diisocyanatomethyl-, 

homopolymer 9017-01-0 

Toluene diisocyanate 

dimer 

1,3-Diazetidine-2,4-dione, 1,3bis(3-

isocyanatomethylphenyl)- 

26747-90-0 

Toluene diisocyanate 

“cyclic” trimer 

1,3,5-Triazine-2,4,6(1H,3H,5H)-

trione, 1,3,5-tris(3-

isocyanatomethylphenyl)- 

26603-40-7 

183 

184 Table 2 – Toluene Diisocyanates Subject to this Action with a Proposed Significant 

185 Use of “Any Use in A Consumer Product (Except for use in Coatings, Adhesives, 

186 Elastomers, Binders, and Sealants at Less than or Equal to 0.1 Percent in a 

187 Consumer Product)” 

188 

Chemical Name Chemical Abstracts Index Name Chemical 

Abstracts Service 

Registry Number 

(CASRN)

2,6-Toluene diisocyanate Benzene, 1,3-diisocyanato-2- 91-08-7
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methyl2,4-Toluene diisocyanate Benzene, 2,4-diisocyanato-1-

methyl- 584-84-9 

Toluene diisocyanate 

unspecified isomer Benzene, 1,3-diisocyanatomethyl- 26471-62-5 

189 

190 B. What Are the Production Volumes and Uses of TDI and Related Compounds? 

191 TDI and the related compounds are generally high production volume chemicals, 

192 predominantly used in the production of polyurethanes. There are many types of 

193 polyurethane products in the marketplace, with foams representing the largest sector of 

194 the polyurethane industry. Flexible foam is primarily used for cushioning, while rigid 

195 foam is used mainly for insulation (Ref. 5). Approximately 90 percent of TDI, typically a 

196 mixture of toluene diisocyanate isomers, is used in the production of flexible foams, 

197 which are designed to be fully cured in a final product. Non-foam polyurethane use 

198 sectors of TDI include coatings, adhesives, elastomers, binders, and sealants. These 

199 products may be sold and used, most often in a mixture of formulated product, in an 

200 uncured form. Because of its hazards, some industry representatives assert that TDI is 

201 used in products intended for industrial use only (Ref. 6). In contrast, EPA believes 

202 coatings, adhesives, elastomers, binders, and sealants used by general consumers contain 

203 residual TDI of no more than 0.1 percent by weight. Due to the projected growth of the 

204 market for such use in consumer products as discussed further in Unit II.D., EPA is 

205 concerned that consumer products in the future might contain amounts of TDI above 

206 these levels. Therefore, EPA is proposing this action to provide the Agency with an 

207 opportunity to evaluate such potential uses in consumer products for any associated risks 

208 or hazards that might exist before those uses would begin. 

209 C. What Are the Potential Health Effects of TDI and Related Compounds? 
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210 In acute, subacute, and chronic animal exposure studies for TDI, the respiratory 

211 tract was the target organ, with nasal irritation evident at concentrations above 0.1 ppm 

212 and effects becoming more severe with increasing concentration (Ref. 7). TDI is 

213 uniformly distributed throughout the body, following inhalation exposure (Refs. 7 and 8). 

214 TDI causes skin, eye, and lung irritation, progressive impairment of lung function with 

215 long-term inhalation exposure and is a respiratory sensitizer via both the dermal and 

216 inhalation routes of exposure in animals (Ref. 7). 

217 Most data on human health hazards resulting from diisocyanate exposures are 

218 from occupational populations rather than exposures to consumer products. As discussed 

219 in the Toluene Diisocyanate and Related Compounds Action Plan (Ref. 9), diisocyanates, 

220 including TDI and related compounds, are well-known dermal, eye, and inhalation 

221 irritants and sensitizers based on worker data. They have been documented in the 

222 workplace to cause asthma and respiratory problems, such as hypersensitivity 

223 pneumonitis, an inflammation of the lungs. In severe cases, there have been reported fatal 

224 reactions. 

225 Isocyanate exposure has been identified as the leading attributable cause of work226 related asthma, and prevalence in the exposed workforce has been estimated at 1-20 

227 percent (Refs. 10 and 11). Once a worker is sensitized to diisocyanates, subsequent 

228 exposures can trigger severe asthma attacks. Spray application and heated processes are 

229 associated with higher incidences of asthma than other application methods because they 

230 can generate airborne isocyanate vapors and mists, which lead to worker exposure via the 

231 respiratory and dermal routes. Most workers who develop diisocyanate asthma have 

232 experienced long periods of exposure (months or longer); however, the minimum 

233 exposure to isocyanates that can elicit sensitization responses or asthma is unknown. In 
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234 addition, immune response and subsequent disease in humans can vary significantly 

235 between individuals (Ref. 5). Fatalities linked to diisocyanate exposures in sensitized 

236 persons have been reported (Refs. 12 and 13). 

237 The International Agency for Research on Cancer (IARC) classified toluene 

238 diisocyanates as “possibly carcinogenic to humans” (Carcinogenicity Group 2B), based 

239 on inadequate evidence for the carcinogenicity of TDI in humans and sufficient evidence 

240 for the carcinogenicity of TDI in experimental animals (Ref. 14). TDI has also been 

241 classified by the European Commission (EC) as Category 3 for carcinogenicity (“causes 

242 concerns for humans owing to possible carcinogenic effects”) (Ref. 15) and by the United 

243 States National Toxicology Program (NTP) as “reasonably anticipated to be a human 

244 carcinogen” (Ref. 16). National Institutes for Occupational Safety and Health (NIOSH) 

245 considers TDI to be an occupational carcinogen and recommends exposure reduction to 

246 the lowest feasible levels (Ref 17). 

247 There are very few reports available regarding non-occupational health effects 

248 from exposures to TDI products. However, there are case reports suggesting that 

249 paraoccupational (brought outside of the workplace) asthma may have resulted from 

250 incidental exposure to TDI, one of which involved incidental exposure to varnishing 

251 products (Ref. 18). A specific, potential concern for consumer products is exposures to 

252 children. Children exposed to the same levels of TDI vapor as adults may receive a 

253 larger dose because they have greater lung surface area to body weight ratios and 

254 increased respiratory minute volumes to weight ratios. TDI vapor is heavier than air and 

255 may layer close to the floor; therefore, children who crawl, roll, or sit on surfaces treated 

256 with chemicals (i.e. carpets and floors) and play with objects such as toys where residues 

257 may settle could potentially receive higher doses of inhaled toxicants than adults present 
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258 in the same room (Ref. 19).

259 D. What Are the Potential Route and Sources of Exposure to TDI and Related 

260 Compounds? 

261 There is available information on worker exposures to industrial products 

262 containing TDI, such as coatings, adhesives, and sealants. Exposures resulting from the 

263 use of these industrial products may indicate potential but lower level exposures that may 

264 result for users conducting similar activities with consumer products containing residual 

265 TDI. There is a potential for worker exposure to TDI in all industrial and commercial 

266 settings where TDI is present (Ref. 6). Because of the high volatility of TDI, exposure 

267 can occur in all phases of its use, even in the final product (Ref.16), and it is unknown to 

268 what extent factors such as application techniques, product composition, and 

269 environmental conditions influence the availability of TDI in products. One activity 

270 where overexposures have been documented is floor finishing in both personal and area 

271 samples in one NIOSH evaluation (Ref. 20). Exposure data for professional workers may 

272 provide an indication of possible exposures if consumer products and articles were to 

273 contain residual TDI. 

274 As previously discussed, TDI is used in coatings, adhesives, sealants, and other 

275 polyurethane products. TDI is used in the manufacturing process of the polymer and as a 

276 result, a small percentage of TDI may be present in consumer products, including articles. 

277 Further, researchers looking at workplace exposures to diisocyanates have noted an 

278 increase in the number of isocyanate-containing products used by consumers (Ref. 5). In 

279 addition, consumer use of adhesives and sealants is a potential growth sector as seen in 

280 the increasing numbers of “Do It Yourself” (DIY), energy-conscious homeowners doing 

281 more of their own home renovation and repair work, as well as from craftsmen and 
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282 consumers generally continuing to use adhesives (Ref. 21). Most consumers would be 

283 unaware of the potential hazards of consumer products, including articles, containing TDI 

284 or other diisocyanates. Consequently, insufficient and inadequate hazard communication 

285 may lead to incorrect use and increased consumer and bystander exposures, particularly 

286 for sensitive groups, such as children. For example, exposures to bystanders and building 

287 occupants (including children) to TDI in industrial products have been reported in the 

288 literature, including emissions of TDI from concrete patio sealants (Refs. 22 and 23) and 

289 detection of TDI in building air samples following use of urethanes containing TDI to 

290 coat wood floors (Ref. 24). It is possible that lower level exposures could occur when 

291 conducting comparable activities using similar types of consumer products containing 

292 residual TDI. Even if consumers are aware of such potential hazards, they may not take 

293 appropriate precautions or research the appropriate resources in which these precautions 

294 are addressed. Of particular concern is the fact that children may have a greater potential 

295 for exposure if they use or are bystanders to the use of consumer products containing 

296 even residual amounts of TDI, because they may not have fully developed judgment for 

297 following labeling instructions and safety precautions and may not cease activity even 

298 when they are experiencing symptoms of exposure. 

299 III. Rationale and Objectives 

300 A. Rationale

301 Diisocyanates are potent dermal and lung sensitizers and an attributable cause of 

302 work-related asthma worldwide (Ref. 25). In the past, consumer exposures have not been 

303 a focus of concern with respect to diisocyanates, because it had been assumed that 

304 consumers were generally exposed to products containing only completely cured 

305 polyurethanes, which have been generally considered to have low toxicity (Ref. 1). 
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306 However, an increase in consumer use of polyurethane products that may further react 

307 and undergo “curing” could occur if consumer products, such as coatings, elastomers, 

308 adhesives, and sealants contained TDI in amounts greater than residual amounts. In such 

309 instances, TDI and related compounds that are not completely reacted upon their 

310 application can provide potential exposures both to the consumer as the direct user or to 

311 bystanders when products are used by others (Refs. 1 and 2). In sensitized individuals, 

312 exposure to even small amounts of diisocyanates may cause allergic respiratory reactions 

313 like asthma and severe breathing difficulties (Ref. 5). EPA believes that the use of any of 

314 these chemical substances in consumer products above current levels could significantly 

315 increase human exposure, and that such increase should not occur without an opportunity 

316 for EPA review and control as appropriate. As discussed in Unit II, regarding the 

317 chemicals listed in Table 2, based on Safety Data Sheets (SDS) information that coating-, 

318 adhesive-, elastomer-, binder-, or sealant-consumer products may contain residual TDI of 

319 no more than 0.1 percent by weight, EPA believes that these consumer products do not 

320 contain residual TDI of more than 0.1 percent by weight. EPA believes that other 

321 consumer products do not contain TDI or related compounds at any level. 

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

323 5(a)(2), EPA's decision to propose a SNUR for a particular chemical use need not be 

324 based on an extensive evaluation of the hazard, exposure, or potential risk associated with 

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

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

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

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

329 an effective use of resources. If a person decides to begin manufacturing or processing 
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330 the chemical for the use, the notice to EPA allows EPA to evaluate the use according to 

331 the specific parameters and circumstances surrounding that intended use. 

332 B. Objectives 

333 Based on the considerations in Unit III.A., EPA wants to achieve the following 

334 objectives with regard to the significant new use(s) that are designated in this proposed 

335 rule:

336 1. EPA would receive notice of any person’s intent to manufacture or process 

337 TDI or its related compounds (see Table 1 and Table 2) for the described significant new 

338 use before that activity begins. 

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

340 SNUN before the notice submitter begins manufacturing or processing TDI or its related 

341 compounds (see Table 1 and Table 2) for the described significant new use. 

342 3. EPA would be able to regulate prospective manufacturers or processors of TDI 

343 or its related compounds (see Table 1 and Table 2) before the described significant new 

344 use of the chemical substance occurs, provided that regulation is warranted pursuant to 

345 TSCA sections 5(e), 5(f), 6 or 7. 

346 IV. Significant New Use Determination

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

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

349 including: 

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

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

352 or the environment to a chemical substance. 

353 • The extent to which a use increases the magnitude and duration of exposure of 
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354 human beings or the environment to a chemical substance. 

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

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

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

358 authorizes EPA to consider any other relevant factors. 

359 To determine what would constitute a significant new use of TDI or its related 

360 compounds subject to this proposed rule, as discussed herein, EPA considered relevant 

361 information about the toxicity of these substances, likely human exposures and 

362 environmental releases associated with possible uses, and the four factors listed in section 

363 5(a)(2) of TSCA. EPA has preliminarily determined as the significant new uses: any use 

364 in a consumer product for any chemical listed in Table 1; and any use in a consumer 

365 product for any chemical listed in Table 2 (except for use in coatings, elastomers, 

366 adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight 

367 of TDI in a consumer product). 

368 The article exemption at 40 CFR 721.45(f) is based on an assumption that people 

369 and the environment will generally not be exposed to chemical substances in articles (see 

370 49 FR 35014; September 5, 1984). However, TDI and related compounds are volatile and 

371 as such could migrate out of articles that contain them. For instance, studies of TDI in 

372 polyurethane products reported that after the reaction between an isocyanate and an 

373 alcohol to form polyurethane products, residual levels of isocyanates were detected on 

374 the surface of the products, which if used could lead to exposure (Refs. 1 and 

375 2). Because TDI and related compounds are known to be volatile chemical substances, 

376 have been reported to migrate from products, are sensitizers, and would be expected to 

377 present a higher potential for exposure if the TDI in the article were a consumer product, 
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378 EPA would like the opportunity to evaluate such potential uses in consumer products for 

379 any associated risks or hazards that might exist before those uses would begin. 

380 EPA believes any new use of TDI and related compounds as part of articles would 

381 increase the duration and magnitude of human exposure to the substance. Based on these 

382 considerations, EPA has preliminarily determined that importing or processing 

383 substances in Table 1 and 2 as part of articles warrants making inapplicable the article 

384 exemption at 40 CFR 721.45(f) for the significant new uses identified above. 

385 V. Applicability of General Provisions 

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

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

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

389 effective date of the final rule. However, for this action, EPA is proposing that § 

390 721.45(f) (which generally exempts persons importing or processing a substance as part 

391 of an article) will not apply and a person who imports or processes a chemical substance 

392 as part of an article would not be exempt from submitting a SNUN. 

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

394 § 721.1(c), persons subject to SNURs must comply with the same notice requirements 

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

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

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

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

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

400 5(e), 5(f), 6 or 7 to control the activities on which it has received the SNUN. If EPA does 

401 not take action, EPA is required under TSCA section 5(g) to explain in the Federal 
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402 Register its reasons for not taking action. 

403 Persons who export or intend to export a chemical substance identified in a 

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

405 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 

406 subpart D. In accordance with 40 CFR 707.60(b) this proposed SNUR does not trigger 

407 export notification for articles. Persons who import a chemical substance identified in a 

408 final SNUR are subject to the TSCA section 13 import certification requirements, 

409 codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must 

410 certify that the shipment of the chemical substance complies with all applicable rules and 

411 orders under TSCA, including any SNUR requirements. The EPA policy in support of 

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

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

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

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

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

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

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

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

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

421 was ongoing as of the effective date of the final rule. Thus, persons who begin 

422 commercial manufacture or processing of the chemical substance(s) that would be 

423 regulated through this proposed rule, if finalized, would have to cease any such activity 

424 before the effective date of the rule if and when finalized. To resume their activities, 

425 these persons would have to comply with all applicable SNUR notice requirements and 
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426 wait until the notice review period, including all extensions, expires. Uses arising after 

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

428 of the proposed rule. The former would be new uses, the latter ongoing uses, except that 

429 uses that are ongoing as of the publication of the proposed rule would not be considered 

430 ongoing uses if they have ceased by the date of issuance of a final rule. To the extent that 

431 additional ongoing uses are found in the course of rulemaking, EPA would exclude those 

432 specific chemical substances for those specific uses from the final SNUR. EPA has 

433 promulgated provisions to allow persons to comply with the final SNUR before the 

434 effective date. If a person were to meet the conditions of advance compliance under 40 

435 CFR 721.45(h), that person would be considered to have met the requirements of the final 

436 SNUR for those activities. 

437 VII. Test Data and Other Information 

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

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

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

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

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

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

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

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

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

447 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters 

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

449 substance during its manufacture, processing, use, distribution in commerce, or disposal. 
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450 EPA encourages persons to consult with the agency before submitting a SNUN. As part 

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

452 be useful in evaluating a significant new use. SNUNs submitted for significant new uses 

453 without any test data may increase the likelihood that EPA will take action under TSCA 

454 section 5(e) to prohibit or limit activities associated with this chemical. 

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

456 SNUNs that provide detailed information on: 

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

458 significant new uses of the chemical substance, 

459 2. Potential benefits of the chemical substance, and 

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

461 posed by potential substitutes. 

462 VIII. SNUN Submissions 

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

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

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

466 tests that might be helpful in evaluating risks posed by the substance. According to 

467 section 721.1(c), persons submitting a SNUN must comply with the same notice 

468 requirements and EPA regulatory procedures as persons submitting a PMN, including 

469 submission of test data on health and environmental effects as described in section 

470 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN 

471 software, and submitted to the Agency in accordance with the procedures set forth in 

472 sections 721.25 and 720.40. E-PMN software is available electronically at 

473 http://www.epa.gov/opptintr/newchems. 
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474 IX. Economic Analysis 

475 A. SNUNs 

476 EPA has evaluated the potential costs of establishing SNUR reporting 

477 requirements for potential manufacturers and processors of the chemical substances 

478 included in this proposed rule, including as part of articles (Ref. 26). In the event that a 

479 SNUN is submitted, costs are estimated at approximately $8,589 per SNUN submission 

480 for large business submitters and $6,189 for small business submitters. These estimates 

481 include the cost to prepare and submit the SNUN, and the payment of a user fee. 

482 Businesses that submit a SNUN would be subject to either a $2,500 user fee required by 

483 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than 

484 $40 million when combined with those of the parent company (if any), a reduced user fee 

485 of $100 (40 CFR 700.45(b)(1)). EPA's complete economic analysis is available in the 

486 public docket for this proposed rule (Ref. 26). 

487 B. Export Notification

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

489 707, subpart D, exporters must notify EPA if they export or intend to export a chemical 

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

491 promulgated under section 5. For persons exporting a substance the subject of a SNUR, a 

492 one-time notice must be provided for the first export or intended export to a particular 

493 country. The total costs of export notification will vary by chemical, depending on the 

494 number of required notifications (i.e., the number of countries to which the chemical is 

495 exported). EPA is unable to make any estimate of the likely number of export 

496 notifications for the chemical covered in this proposed SNUR. 

497 C. Import or Processing Chemical Substances as Part of an Article
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498 In proposing to make inapplicable the exemption relating to persons that import or 

499 process certain chemical substances as part of an article, this action may affect firms that 

500 plan to import or process types of articles that may contain the subject chemical 

501 substance. Some firms have an understanding of the contents of the articles they import 

502 or process. However, EPA acknowledges that importers and processors of articles may 

503 have varying levels of knowledge about the chemical content of the articles that they 

504 import or process. These parties may need to become familiar with the requirements of 

505 the rule. And, while not required by the SNUR, these parties may take additional steps to 

506 determine whether the subject chemical substances are part of the articles that they are 

507 considering to import or process. This determination may involve activities such as 

508 gathering information from suppliers along the supply chain, and/or testing samples of 

509 the article itself. Costs vary across the activities chosen and the extent of familiarity a 

510 firm has regarding the articles it imports or processes. Cost ranges are presented in the 

511 Understanding the Costs Associated with Eliminating Exemptions for Articles in SNURs

512 (Ref.27). Based on available information, EPA believes that article importers that choose 

513 to investigate their products would incur costs at the lower end of the ranges presented in 

514 the Economic Analysis. For those companies choosing to undertake actions to assess the 

515 composition of the articles they import or process, EPA expects that in all likelihood, 

516 these importers and processors would take actions that are commensurate with the level 

517 of risk (of a chemical to be a part of an article) that each company perceives, and the 

518 resources it has available. 

519 X. Alternatives 

520 Before proposing this SNUR, EPA considered the following alternative regulatory 

521 action: 
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522 A. Promulgate a TSCA Section 8(a) Reporting Rule

523 Under a TSCA section 8(a) rule, EPA could, among other things, generally 

524 require persons to report information to the agency when they intend to manufacture or 

525 process a listed chemical for a specific use or any use. However, for TDI, the use of 

526 TSCA section 8(a) rather than SNUR authority would have several limitations. First, if 

527 EPA were to require reporting under TSCA section 8(a) instead of TSCA section 5(a), 

528 EPA would not have the opportunity to review human and environmental hazards and 

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

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

531 limit the activity before it begins. In addition, EPA may not receive important 

532 information from small businesses, because such firms generally are exempt from TSCA 

533 section 8(a) reporting requirements (see TSCA sections 8(a)(1)(A) and 8(a)(1)(B)). In 

534 view of the level of health concerns about TDI if used for the proposed significant new 

535 use, EPA believes that a TSCA section 8(a) rule for this substance would not meet EPA's 

536 regulatory objectives. 

537 B. Allow the Exemption for Persons Who Import or Process TDI and Related 

538 Compounds as Part of Articles That Would Be Subject to the Proposed SNUR 

539 Under the SNUR exemption provision at § 721.45(f), a person who imports or 

540 processes a chemical substance covered by a SNUR identified in 40 CFR part 721, 

541 subpart E, as part of an article is not generally subject to the notification requirements of 

542 § 721.25 for that chemical substance. However, EPA is concerned that exempting TDI 

543 and related compounds as part of articles would render the SNUR less effective because 

544 of the possibility that articles could be imported or processed for uses subject to this 

545 proposed SNUR without the submission of a SNUN. This proposed rule would not 
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546 include the exemption at § 721.45(f). 

547 XI. Request for Comment 

548 A. Do you have comments or information about ongoing uses? 

549 EPA welcomes comment on all aspects of this proposed rule. EPA based its 

550 understanding of the use profile of these chemicals on the published literature, the 2012 

551 CDR submissions, market research, discussions with manufacturers, and product SDSs. 

552 To confirm EPA’s understanding, the Agency is requesting public comment on the 

553 EPA’s understanding that coating, adhesive, elastomer, binder, or sealant consumer 

554 products do not contain residual TDI of more than 0.1 percent by weight, as noted in 

555 Table 2. EPA believes that other consumer products do not contain TDI or related 

556 compounds at any level. In providing comments on the concentration of TDI and related 

557 compounds in the consumer product, it would be helpful if you provide sufficient 

558 information for EPA to substantiate any assertions of use and concentrations. 

559 B. What Should I Consider as I Prepare my Comments for EPA?

560 1. Submitting CBI. It is EPA's policy to include all comments received in the 

561 public docket without change or further notice to the commenter and to make the 

562 comments available on-line at www.regulations.gov, including any personal information 

563 provided, unless a comment includes information claimed to be Confidential Business 

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

565 submit this information to EPA through regulations.gov or e-mail. Clearly mark the part 

566 or all of the information that you claim to be CBI. For CBI information in a disk or CD 

567 ROM that you mail to EPA, mark the outside of the disk or CD ROM that you mail to 

568 EPA as CBI and then identify electronically within the disk or CD ROM the specific 

569 information that is claimed as CBI. In addition to one complete version of the comment 
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570 that includes information claimed as CBI, a copy of the comment that does not contain 

571 the information claimed as CBI must be submitted for inclusion in the public docket. 

572 Information so marked will not be disclosed except in accordance with procedures set 

573 forth in 40 CFR part 2, subpart B.

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

575 i. Identify the document by docket ID number and other identifying information 

576 (subject heading, Federal Register date, and page number). 

577 ii. Follow directions. The agency may ask you to respond to specific questions or 

578 organize comments by referencing a CFR part or section number. 

579 iii. Explain why you agree or disagree; suggest alternatives and substitute 

580 language for your requested changes. 

581 iv. Describe any assumptions and provide any technical information and/or data 

582 that you used. 

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

584 estimate in sufficient detail to allow for it to be reproduced. 

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

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

587 personal threats. 

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

589 identified. 

590 XII. References 

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

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

593 EPA, including documents that are referenced within the documents that are in the 
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594 docket, even if the referenced document is not physically located in the docket. For 

595 assistance in locating these other documents, please consult technical person listed under 

596 FOR FURTHER INFORMATION CONTACT. 

597 1. Krone, C., and Klinger, T. (2005). Isocyanates, polyurethane and childhood 

598 asthma. Pediatric Allergy and Immunology 16, 378-379. 

599 2. Bello, D., Herrick, C. A., Smith, T. J., Woskie, S. R., Streicher, R. P., Cullen, 

600 M. R., Liu, Y., and Redlich, C. A. (2007). Skin Exposure to Isocyanates: Reasons for 

601 Concern. Environmental Health Perspectives 115. 

602 3. BASF Corporation. (2011). Project Summary Report Requested Industrial 

603 Hygiene personal and Area Monitoring for Identified Airborne Chemical Hazards of 

604 MDI and/or TDI Associated with Isocyanate-Containing Product Use Scenarios for 

605 Identified Construction Sealants and/or Basecoat Products (Sanitized Version). JKInc. 

606 Report #: 111-11, 1- 6. 

607 4. Vangronsveld, E, Berckmans, S., and Spence, M. (2013). Comparison of 

608 Solvent/Derivatization Agent Systems for Determination of Extractable Toluene 

609 Diisocyanate from Flexible Polyurethane Foam. Annals of Occupational Hygiene 57(5), 

610 640-649. 

611 5. Redlich, C. A., Bello, D., and Wisnewski, A. (2006). Isocyanate exposures and 

612 health effects. In Environmental and Occupational Medicine (W. Rom, and S. 

613 Markowitz, Eds.), pp. 502-516. Lippincott Williams & Wilkins Philadelphia, PA. 

614 6. DOW (2009). Product Safety Assessment DOW Modified Toluene 

615 Diisocyanate (TDI) Products. July 16 2010. 

616 http://www.dow.com/PublishedLiterature/dh_034d/0901b8038034d515.pdf?filepath=pru

617 ctsay/pdfs/noreg/233-00617.pdf&fromPage=GetDoc. 
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618 7. Collins, M.A. (2002). Toxicology of Toluene Diisocyanate. Applied 

619 Occupational and Environmental Hygiene 17, 846-855.

620 8. Gledhill, A. Wake, A., Hext, P., Leiobold, E., and Shiotsuka, R. (2005). 

621 Absorption, distribution, metabolism and excretion of an inhalation does of 14C 4,4' 

622 methylenediphenyl diisocyanate in the male rat. Xenobiotica 35, 273-292.

623 9. EPA. 2011. Toluene Diisocyanate (TDI) and Related Compounds Action Plan. 

624 Available online at: http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/tdi.pdf. 

625 10. Ott, M.G., Diller, W.F., and Jolly, A.T. (2003). Respiratory effects of toluene 

626 diisocyanates in the workplace; a discussion of exposure-response relationships. Critical 

627 Review Toxicology 33, 1-59. 

628 11. Bello, D., Woskie, S. R., Streicher, R. P., Liu, Y., Stowe, M. H., Eisen, E. A. 

629 Ellenbecker, M. J., Sparer, J., Youngs, F., Cullen, M. R., and Redlich, C. A. (2004). 

630 Polyisocyanates in occupational environments: a critical review of exposure limits and 

631 metrics. American Journal Industrial Medicine 46, 480-491. 

632 12. NIOSH (1996). National Institute for Occupational Safety and Health. 

633 Preventing asthma and death from diisocyanate exposure: NIOSH Alert. (DHHS, Ed.). 

634 13. American Chemistry Council (ACC) (2005). TSCA Section 8(e) Notice of 

635 Substantial Risk 8EHQ-0905-16225 Fatalities linked to diisocyanates. EPA. 

636 14. IARC. (1999).Toluene Diisocyanates. WHO. p. 865-879. 

637 15. Environment Canada. (2008). Screening Assessment for the Challenge: 

638 Toluene Diisocyanate. http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=69A64ACA.

639 16. NTP (2011). National Toxicology Program. Report on Carcinogens, Twelfth 

640 Edition; U.S. Department of Health and Human Services, Public Health Service. 
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641 Substance Profile, Toluene Diisocyanates. http://ntp.niesh.nih.gov?objectid=03C9AF75-

642 E1BF-FF40-DBA9EC0928DF8B15.

643 17. NIOSH (2005). National Institute of Occupational Safety and Health. NIOSH 

644 Pocket Guide to Chemical Hazards July 16, 2010. 

645 http://www.cdc.gov/NIOSH/npg/npgdcas.html.

646 18. De Zotti (2000). De Zotti, R., Muran, A., and Zambon, F. (2000). Two cases 

647 of paraoccupational asthma due to toluene diisocyanate (TDI). Occupational and 

648 Environmental Medicine 57, 837-839. 

649 19. Agency for Toxic Disease Registry (ATSDR) (2002). Case Studies in 

650 Environmental Medicine: Pediatric Environmental Health. ATSDR Publication No. 

651 ATSDR-HE-CD-2002-0002. 

652 20. NIOSH (2004). National Institute for Occupational Safety and Health. A 

653 Summary of Health Hazard Evaluations: Issues Related to Occupational Exposure to 

654 Isocyanates 1989-2002. (D. o. H. a. H. Services, Ed.), pp. 1-42, Cincinnati, OH 

655 21. Pianoforte, K. (2009). Adhesives and sealants market update, November 1, 

656 2009. In Coatings World. 

657 22. Kelly, T. J., Myers, J. D., and Holdren, M. W. (1999). Testing of Household 

658 Products and Materials for Emission of Toluene Diisocyanate. Indoor Air 9, 117-124. 

659 23. Jarand, C. W., Akapo, S. O., Swenson, L. J., and Kelman, B. J. (2002). 

660 Diisocyanate emission from a paint product: a preliminary analysis. Applied 

661 Occupational Environmental Hygiene 17, 491-494. 

662 24. NYC-DOHMH (2010). New York City Department of Health and Mental 

663 Hygiene. Moisture Cure Urethanes (MCU). July 16, 2010. 

664 http://www.nyc.gov/html/doh/html/epi/mcufact.shtml.
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665 25. NIOSH (2006). National Institute for Occupational Safety and Health. 

666 Preventing Asthma and Death from MDI Exposure During Spray-on Truck Bed Liner 

667 and Related Applications: NIOSH Alert. http://www.cdc.gov/niosh/docs/2006-

668 149/default.html. 

669 26. EPA. Economic Analysis of the Significant New Use Rule for Toluene 

670 Diisocyanate (TDI) and Related Compounds. April 2, 2014. 

671 27. EPA, Understanding the Costs Associated with Eliminating 

672 Exemptions for Articles in SNURs. May 1, 2013. 

673 XIII. Statutory and Executive Order Reviews 

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

675 Improving Regulation and Regulatory Review 

676 This proposed SNUR has been designated by the Office of Management and 

677 Budget (OMB) as a ‘‘significant regulatory action’’ under section 3(f) of Executive Order 

678 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted this action to OMB for 

679 review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011), and 

680 any changes made in response to OMB recommendations are documented in the docket. 

681 B. Paperwork Reduction Act (PRA) 

682 This action does not impose any new information collection burden under the 

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

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

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

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

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

688 a SNUN to the Agency, the annual burden is estimated to be less than 100 hours per 
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689 response, and the estimated burden for an export notifications is less than 1.5 hours per 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

705 EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative 

706 Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and 

707 comment. 

708 C. Regulatory Flexibility Act (RFA) 

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

710 promulgation of this SNUR would not have a significant economic impact on a 

711 substantial number of small entities. The rationale supporting this conclusion is as 

712 follows. 
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713 A SNUR applies to any person (including small or large entities) who intends to 

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

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

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

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

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

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

720 significant new use. Although some small entities may decide to conduct such activities 

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

722 EPA’s experience to date is that, in response to the promulgation of SNURs covering 

723 over 1,000 chemical substances, the Agency receives only a handful of notices per year. 

724 During the six year period from 2005-2011, only three submitters self-identified as small 

725 in their SNUN submission (Ref. 26). EPA believes the cost of submitting a SNUN is 

726 relatively small compared to the cost of developing and marketing a chemical new to a 

727 firm and that the requirement to submit a SNUN generally does not have a significant 

728 economic impact. 

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

730 this proposed SNUR is not expected to be significant or adversely impact a substantial 

731 number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 

732 FR 42690) (FRL-5735-4), the Agency presented its general determination that proposed 

733 and final SNURs are not expected to have a significant economic impact on a substantial 

734 number of small entities, which was provided to the Chief Counsel for Advocacy of the 

735 Small Business Administration. 

736 D. Unfunded Mandates Reform Act (UMRA) 
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737 Based on EPA’s experience with proposing and finalizing SNURs, State, local, 

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

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

740 by this rulemaking. As such, the requirements of sections 202, 203, 204, or 205 of 

741 UMRA, 2 U.S.C. 1531-1538, do not apply to this action. 

742 E. Executive Order 13132: Federalism 

743 This action will not have a substantial direct effect on States, on the relationship 

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

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

746 13132 (64 FR 43255, August 10, 1999). 

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

748 Governments 

749 This proposed rule does not have Tribal implications because it is not expected to 

750 have any effect (i.e., there will be no increase or decrease in authority or jurisdiction) on 

751 Tribal governments, on the relationship between the Federal government and the Indian 

752 tribes, or on the distribution of power and responsibilities between the Federal 

753 government and Indian tribes. Thus, Executive Order 13175 (65 FR 67249, November 9, 

754 2000), does not apply to this action. 

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

756 Safety Risks 

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

758 1997), because this action is not intended to address environmental health or safety risks 

759 for children. 

760 H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect 
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761 Energy Supply, Distribution, or Use 

762 This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 

763 22, 2001), because this action is not expected to affect energy supply, distribution, or use. 

764 I. National Technology Transfer and Advancement Act (NTTAA) 

765 Since this action does not involve any technical standards, section 12(d) of 

766 NTTAA, 15 U.S.C.272 note, does not apply to this section. 

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

768 Populations and Low-Income Populations 

769 This proposed rule does not invoke special consideration of environmental justice 

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

771 because EPA has determined that this action will not have disproportionately high and 

772 adverse human health or environmental effects on minority or low-income populations. 

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

774 environment. 

775 List of Subjects in 40 CFR Part 721

776 Environmental protection, Chemicals, Hazardous substances, Reporting and 

777 recordkeeping requirements.

778 Dated: _______________________ 

779 

780 ____________________________________________ 

781 Director, Office of Pollution Prevention and Toxics. 
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782 Therefore, it is proposed that 40 CFR part 721 be amended as follows: 

783 PART 721--[AMENDED]

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

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

786 2. Add §721. xx to subpart E to read as follows:

787 §721.10xxx Toluene Diisocyanates and Related Compounds 

788 3. Add § 721.xx as follows: 

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

790 chemical substances listed in Table 1 and Table 2 of this paragraph are subject to 

791 reporting under this section for the significant new uses described in paragraph (a)(2) of 

792 this section. 

793 Table 1.—Toluene Diisocyanates ad Related Compounds Subject to Reporting for 

794 Any Use in a Consumer Product 

Chemical Name Chemical Abstracts Index Name Chemical 

Abstracts Service 

Registry 

(CASRN) 

Toluene diisocyanate 

trimer 

Benzene, 1,3-diisocyanatomethyl-, 

trimer 9019-85-6 

Poly(toluene diisocyanate) Benzene, 1,3-diisocyanatomethyl-, 

homopolymer 9017-01-0 

Toluene diisocyanate 

dimer 

1,3-Diazetidine-2,4-dione, 1,3bis(3-

isocyanatomethylphenyl)- 

26747-90-0 

Toluene diisocyanate 

“cyclic” trimer 

1,3,5-Triazine-2,4,6(1H,3H,5H)-

trione, 1,3,5-tris(3-

isocyanatomethylphenyl)- 

26603-40-7 

795 

796 Table 2.—Toluene Diisocyanates ad Related Compounds Subject to Reporting for 

797 Any Use in A Consumer Product (Except for use in Coatings, Adhesives, 

798 Elastomers, Binders, and Sealants at Less than or Equal to 0.1 Percent in a 

799 Consumer Product) 

Chemical Name Chemical Abstracts Index Name Chemical 

Abstracts Service 

Registry Number 

(CASRN)

2,6-Toluene diisocyanate Benzene, 1,3-diisocyanato-2- 91-08-7
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methyl2,4-Toluene diisocyanate Benzene, 2,4-diisocyanato-1-

methyl- 584-84-9 

Toluene diisocyanate 

unspecified isomers Benzene, 1,3-diisocyanatomethyl- 26471-62-5 

800 

801 (2) The significant new uses are: 

802 (i) For the chemical substances listed in Table 1 of paragraph (a)(1), any use of 

803 the chemical substance in consumer products. 

804 (ii) For the chemical substances listed in Table 2 of paragraph (a)(1), any use of 

805 the chemical substance in a consumer product (except for use in coatings, adhesives, 

806 elastomers, binders, and sealants, that results in less than or equal to 0.1 percent by 

807 weight of such chemical substance in the consumer product). 

808 (b) Specific requirements. The provisions of subpart A of this part apply to this 

809 section except as modified by this paragraph:

810 (1) Revocation of certain notification exemptions. The provisions of § 721.45(f) 

811 do not apply to this section. A person who imports or processes a chemical substance 

812 identified in paragraph (a)(1) of this section as part of an article for a significant new use 

813 described in paragraph (a)(2) of this section is not thereby exempt from submitting a 

814 significant new use notice. 

815 (2) [Reserved]