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1 EO 12866/13563 Review Draft – As Submitted Revised 12/11/2014

2 Rin2070-AJ91_EO12866_TDI SNUR_NPRM_FRN_MASTER_REDLINE_2014-12-

3 11.docxRin2070-AJ91_EO12866_TDI-SNUR_NPRM_FRdocument_2014-08-15.docx

4 

5 BILLING CODE 6560-50-P 

6 ENVIRONMENTAL PROTECTION AGENCY 

7 40 CFR Part 721 

8 [EPA-HQ-OPPT-2011-0976; FRL-XXXX9915-X62]

9 RIN 2070-AJ91 

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

11 AGENCY: Environmental Protection Agency (EPA). 

12 ACTION: Proposed rule. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

28 publication in the Federal Register]. 

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

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

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

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

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

34 disclosure is restricted by statute. 

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

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

37 Washington, DC 20460-0001. 

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

39 boxed information, please follow the instructions at 

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

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

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

43 FOR FURTHER INFORMATION CONTACT: For technical information contact: 

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

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

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

47 sleasman.katherine@epa.gov. 

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

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

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

52 I. Executive Summary 

53 A. Does this Action Apply to Me?

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

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

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

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

58 applies to them. Potentially affected entities may include: 

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

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

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

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

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

64 • Building and construction polyurethane foam products (NAICS code 

65 32615031).

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

67 32615091). 

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

69 • Consumer and institutional polyurethane foam products (NAICS code 

70 32615051).

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

72 • Elastomers (NAICS code 326199).

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

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

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

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

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

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

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

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

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

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

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

85 CFR part 707, subpart D. 

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

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

88 INFORMATION CONTACT. 

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

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

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

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

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

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

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

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

97 general SNUR provisions are found at 40 CFR Ppart 721, Ssubpart A. 

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

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

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

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

103 in Table 1 of Unit II.A.; and any use in a consumer product of any chemical listed in 

104 Table 2 of Unit II.A. (except for use in coatings, elastomers, adhesives, binders, and 

105 sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer 

106 product). 

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

108 in this unit that EPA believes are not ongoing at the time of this proposed rule. EPA is 

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

110 understanding of ongoing uses for the chemicals identified in Table 1 of Unit II.A and 

111 Table 2 of Unit II.A. in consumer products. EPA is particularly interested in whether 

112 there are any ongoing uses of these chemicals in consumer products of which the Agency 

113 is currently unaware and would welcome specific documentation of any such ongoing 

114 uses. A consumer product is defined at 40 CFR 721.3 as: a chemical substance that is 

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

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

117 recreational settings. 

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

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

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

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

122 proposed rule, EPA is proposing that the general SNUR article exemption at 40 CFR 
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123 721.45(f) for persons who import or process chemical substances as part of an article 

124 would not apply. The article exemption at 40 CFR 721.45(f) is based on an assumption 

125 that people and the environment will generally not be exposed to chemical substances in 

126 articles (see September 5, 1984; 49 FR 35014; FRL-2541-8 September 5, 1984)(Ref. 1). 

127 However, TDI and related compounds are volatile and as such could migrate out of 

128 articles that contain them. For instance, studies of TDI in polyurethane products reported 

129 that after the reaction between an isocyanate and an alcohol to form polyurethane 

130 products, residual levels of isocyanates were detected on the surface of the products, (e.g. 

131 flexible foams), which if used could lead to exposure (Refs. 2 and 3). Because TDI and 

132 related compounds are known to be volatile chemical substances, have been reported to 

133 migrate from products, are sensitizers, and would be expected to present a higher 

134 potential for exposure if the TDI in the article were a consumer product, EPA would like 

135 the opportunity to evaluate such potential uses in consumer products for any associated 

136 risks or hazards that might exist before those uses would begin. 

137 D. Why Is the Agency Taking this Action? 

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

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

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

141 objectives for this SNUR are explained in Unit III. 

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

143 EPA has evaluated the potential costs of establishing SNUR reporting 

144 requirements for potential manufacturers and processors of the chemical substances 

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

146 discussed in Unit IX., and is briefly summarized here. In the event that a SNUN is 
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147 submitted, costs are estimated to be less than $8,700 589 per SNUN submission for large 

148 business submitters and $6,300 189 for small business submitters. These estimates 

149 include the cost to prepare and submit the SNUN and the payment of a user fee. The 

150 proposed SNUR would require first-time submitters of any TSCA section 5 notice to 

151 register their company and key users with the CDX reporting tool, deliver a CDX 

152 electronic signature to EPA, and establish and use a Pay.gov E-payment account before 

153 they may submit a SNUN, for a cost of $200 per firm. However, these activities are only 

154 required of first-time submitters of section 5 notices. In addition, for persons exporting a 

155 substance that is the subject of a SNUR, a one-time notice must be provided for the first 

156 export or intended export to a particular country, which is estimated to cost less than 

157 $100 on average be $84.22 per notification. The rule may also affect firms that plan to 

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

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

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

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

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

163 II. Chemical Substances Subject to this Proposed Rule 

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

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

166 Table 1 of this unit and Table 2 of this unit in consumer products. Diisocyanates contain 

167 free isocyanate functional groups (-N=C=O). Diisocyanates are combined with other 

168 compounds that contain free hydroxyl functional groups (i.e., –OH), typically called 

169 “polyols.” These two-part components react and begin to form polyurethane polymers. 

170 This chemical reaction is completed when all of the isocyanate functional groups are 
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171 bound within the polymer network. This process is commonly referred to as “curing.” 

172 Products that contain free isocyanate functional groups are intended to react further and 

173 undergo “curing” in the process of use. The chemical substances subject to this proposed 

174 SNUR contain free isocyanate functional groups and are by definition uncured. Prior to 

175 complete curing, consumers and bystanders can potentially be exposed to isocyanates 

176 through both dermal and respiratory routes. Exposures to uncured isocyanates could lead 

177 to sensitization.

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

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

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

181 Reporting under the CDR indicated no consumer uses of TDI or related compounds. 

182 However, during conversations between EPA personnel and manufacturers and 

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

184 residual TDI of no more than 0.1 percent by weight, as noted in Table 2 of this unit (Ref. 

185 4). This was also confirmed by review of published literature and SDS for consumer 

186 adhesives and sealants available in retail outlets. It is EPA’s understanding that any TDI 

187 present in a coating, adhesive, elastomer, binder or sealant consumer product is at levels 

188 of no more than 0.1 percent by weight and would typically be considered residual 

189 diisocyanate remaining from the manufacture of a polyurethane polymer, a concentration 

190 which is above the detection level (Ref. 5). EPA believes that other consumer products do 

191 not contain TDI or related compounds at any level. 

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

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

194 

Chemical Name Chemical Abstracts Index Name Chemical 

Abstracts Service 
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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 

195 

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

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

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

199 Consumer Product)” 

200 

Chemical Name Chemical Abstracts Index Name Chemical 

Abstracts Service 

Registry Number 

(CASRN)

2,6-Toluene diisocyanate Benzene, 1,3-diisocyanato-2-

methyl91-08-7

2,4-Toluene diisocyanate Benzene, 2,4-diisocyanato-1-

methyl- 584-84-9 

Toluene diisocyanate 

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

201 

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

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

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

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

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

207 foam is used mainly for insulation (Ref. 6). Approximately 90 percent of TDI, typically a 

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

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

210 sectors of TDI include coatings, adhesives, elastomers, binders, and sealants. These 
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211 products may be sold and used, most often in a mixture of formulated product, in an 

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

213 used in products intended for industrial use only (Ref. 7). In contrast, EPA believes 

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

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

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

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

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

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

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

221 C. What Are the Potential Health Effects of TDI and Related Compounds? 

222 In acute, subacute, and chronic animal exposure studies for TDI, the respiratory 

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

224 and effects becoming more severe with increasing concentration (Ref. 8). TDI is 

225 uniformly distributed throughout the body, following inhalation exposure (Refs. 8 and 9). 

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

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

228 inhalation routes of exposure in animals (Ref. 8). 

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

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

231 in the Toluene Diisocyanate and Related Compounds Action Plan (Ref. 10), 

232 diisocyanates, including TDI and related compounds, are well-known dermal, eye, and 

233 inhalation irritants and sensitizers based on worker data. They have been documented in 

234 the workplace to cause asthma and respiratory problems, such as hypersensitivity 
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235 pneumonitis, an inflammation of the lungs. In severe cases, there have been reported fatal 

236 reactions. 

237 Isocyanate exposure has been identified as the leading attributable cause of work238 related asthma, and prevalence in the exposed workforce has been estimated at 1-20 

239 percent (Refs. 11 and 12). Once a worker is sensitized to diisocyanates, subsequent 

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

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

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

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

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

245 exposure to isocyanates that can elicit sensitization responses or asthma is unknown. In 

246 addition, immune response and subsequent disease in humans can vary significantly 

247 between individuals (Ref. 6). Fatalities linked to diisocyanate exposures in sensitized 

248 persons have been reported (Refs. 13 and 14). 

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

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

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

252 for the carcinogenicity of TDI in experimental animals (Ref. 15). TDI has also been 

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

254 concerns for humans owing to possible carcinogenic effects”) (Ref. 16) and by the United 

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

256 carcinogen” (Ref. 17). National Institutes for Occupational Safety and Health (NIOSH) 

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

258 the lowest feasible levels (Ref 18). 
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259 There are very few reports available regarding non-occupational health effects 

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

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

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

263 products (Ref. 19). A specific, potential concern for consumer products is exposures to 

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

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

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

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

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

269 may settle could potentially receive higher doses of inhaled toxicants than adults present 

270 in the same room (Ref. 20).

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

272 Compounds? 

273 There is available information on worker exposures to industrial products 

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

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

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

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

278 settings where TDI is present (Ref. 7). Because of the high volatility of TDI, exposure 

279 can occur in all phases of its use, even in the final product (Ref.17), and it is unknown to 

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

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

282 where overexposures have been documented is floor finishing in both personal and area 
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283 samples in one NIOSH evaluation (Ref. 21). Exposure data for professional workers may 

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

285 contain residual TDI. 

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

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

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

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

290 increase in the number of isocyanate-containing products used by consumers (Ref. 6). In 

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

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

293 more of their own home renovation and repair work, as well as from craftsmen and 

294 consumers generally continuing to use adhesives (Ref. 22). Most consumers would be 

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

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

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

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

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

300 literature, including emissions of TDI from concrete patio sealants (Refs. 23 and 24) and 

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

302 coat wood floors (Ref. 25). It is possible that lower level exposures could occur when 

303 conducting comparable activities using similar types of consumer products containing 

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

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

306 are addressed. Of particular concern is the fact that children may have a greater potential 
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307 for exposure if they use or are bystanders to the use of consumer products containing 

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

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

310 when they are experiencing symptoms of exposure. 

311 III. Rationale and Objectives 

312 A. Rationale

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

314 work-related asthma worldwide (Ref. 26). In the past, consumer exposures have not been 

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

316 consumers were generally exposed to products containing only completely cured 

317 polyurethanes, which have been generally considered to have low toxicity (Ref. 2). 

318 However, an increase in consumer use of polyurethane products that may further react 

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

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

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

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

323 bystanders when products are used by others (Refs. 2 and 3). In sensitized individuals, 

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

325 like asthma and severe breathing difficulties (Ref. 6). EPA believes that the use of any of 

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

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

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

329 chemicals listed in Table 2 of Unit II.A., based on Safety Data Sheets (SDS) information 

330 that coating-, adhesive-, elastomer-, binder-, or sealant-consumer products may contain 
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331 residual TDI of no more than 0.1 percent by weight, EPA believes that these consumer 

332 products do not contain residual TDI of more than 0.1 percent by weight. EPA believes 

333 that other consumer products do not contain TDI or related compounds at any level. 

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

335 5(a)(2), EPA's decision to propose a SNUR for a particular chemical use need not be 

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

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

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

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

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

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

342 the chemical for the use, the notice to EPA allows EPA to evaluate the use according to 

343 the specific parameters and circumstances surrounding that intended use. 

344 B. Objectives 

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

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

347 rule:

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

349 TDI or its related compounds (see Table 1 of Unit II.A and Table 2 of Unit II.A.) for the 

350 described significant new use before that activity begins. 

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

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

353 compounds (see Table 1 of Unit II.A. and Table 2 of Unit II.A.) for the described 

354 significant new use. 
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355 3. EPA would be able to regulate prospective manufacturers or processors of TDI 

356 or its related compounds (see Table 1 of Unit II.A. and Table 2 of Unit II.A.) before the 

357 described significant new use of the chemical substance occurs, provided that regulation 

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

359 IV. Significant New Use Determination

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

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

362 including: 

363 •1. The projected volume of manufacturing and processing of a chemical 

364 substance. 

365 •2. The extent to which a use changes the type or form of exposure of human 

366 beings or the environment to a chemical substance. 

367 •3. The extent to which a use increases the magnitude and duration of exposure 

368 of human beings or the environment to a chemical substance.

369 

370 •4. The reasonably anticipated manner and methods of manufacturing, 

371 processing, distribution in commerce, and disposal of a chemical substance. 

372 

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

374 authorizes EPA to consider any other relevant factors. 

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

376 compounds subject to this proposed rule, as discussed in this unit, EPA considered 

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

378 environmental releases associated with possible uses, and the four factors listed in section 
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379 5(a)(2) of TSCA. EPA has preliminarily determined as the significant new uses: any use 

380 in a consumer product for any chemical listed in Table 1 of Unit II.A.; and any use in a 

381 consumer product for any chemical listed in Table 2 of Unit II.A. (except for use in 

382 coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 

383 0.1 percent by weight of TDI in a consumer product). 

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

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

386 September 5, 1984; 49 FR 35014,; September 5, 1984)(Ref. 1).. However, TDI and 

387 related compounds are volatile and as such could migrate out of articles that contain 

388 them. For instance, studies of TDI in polyurethane products reported that after the 

389 reaction between an isocyanate and an alcohol to form polyurethane products, residual 

390 levels of isocyanates were detected on the surface of the products, which if used could 

391 lead to exposure (Refs. 2 and 3). Because TDI and related compounds are known to be 

392 volatile chemical substances, have been reported to migrate from products, are 

393 sensitizers, and would be expected to present a higher potential for exposure if the TDI in 

394 the article were a consumer product, EPA would like the opportunity to evaluate such 

395 potential uses in consumer products for any associated risks or hazards that might exist 

396 before those uses would begin. 

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

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

399 considerations, EPA has preliminarily determined that importing or processing 

400 substances in Table 1 of Unit II.A. and Table 2 of Unit II.A. as part of articles warrants 

401 making inapplicable the article exemption at 40 CFR 721.45(f) for the significant new 

402 uses identified in the tables in Unit II.A.. 
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403 V. Importers and Processors of These Chemical Substances as Part of Articles 

404 Once the determination of a significant new use under TSCA section 5(a)(2) has 

405 been made, EPA may separately determine whether it would be appropriate to make the 

406 regulatory exemption for some or all persons who import or process a chemical substance 

407 as part of an article (40 CFR 721.45(f)) inapplicable to a SNUR. In this case, EPA 

408 believes that the assumption underpinning this exemption, that people and the 

409 environment will generally not be exposed to chemical substances as part of articles, does 

410 not hold true. See Unit IV. for a discussion of why EPA believes this assumption is 

411 incorrect. Thus EPA is proposing to make this exemption inapplicable to importers or 

412 processors of the TDI and related compounds as part of an article for the identified 

413 significant new uses. EPA is requesting comment on the potential for exposure to these 

414 chemical substances via these articles and for comments on the ongoing uses of the TDI 

415 and related compounds as part of an article. EPA is not proposing to make this 

416 exemption inapplicable to processors of these chemical substances as part of an article. 

417 VI. Applicability of General Provisions 

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

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

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

421 effective date of the final rule. However, for this action, EPA is proposing that 40 CFR 

422 721.45(f) (which generally exempts persons importing or processing a substance as part 

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

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

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

426 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice 
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427 requirements and EPA regulatory procedures as submitters of Premanufacture Notices 

428 (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the 

429 information submissions requirements of TSCA section 5(b) and 5(d)(1), the exemptions 

430 authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 

431 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under 

432 TSCA section 5(e), 5(f), 6 or 7 to control the activities on which it has received the 

433 SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain 

434 in the Federal Register its reasons for not taking action. 

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

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

437 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 

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

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

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

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

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

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

444 import certification appears at 40 CFR part 707, subpart B. The TSCA section 13 import 

445 certification requirement applies to articles containing a chemical substance or mixture if 

446 so required by the Administrator by a specific rule under TSCA. At this time EPA is not 

447 proposing to require import certification for these chemical substances as part of articles.

448 VII. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule 

449 As discussed in the Federal Register of April 24, 1990 (55 FR 17376; FRL450 3658-5)(Ref. 27),, EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best 
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451 served by designating a use as a significant new use as of the date of publication of the 

452 proposed rule rather than as of the effective date of the final rule. If uses begun after 

453 publication of the proposed rule were considered ongoing rather than new, it would be 

454 difficult for EPA to establish SNUR notice requirements, because a person could defeat 

455 the SNUR by initiating the proposed significant new use before the rule became final, 

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

457 persons who begin commercial manufacture or processing of the chemical substance(s) 

458 that would be regulated through this proposed rule, if finalized, would have to cease any 

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

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

461 requirements and wait until the notice review period, including all extensions, expires. 

462 Uses arising after the publication of the proposed rule are distinguished from uses that 

463 exist at publication of the proposed rule. The former would be new uses, the latter 

464 ongoing uses, except that uses that are ongoing as of the publication of the proposed rule 

465 would not be considered ongoing uses if they have ceased by the date of issuance of a 

466 final rule. To the extent that additional ongoing uses are found in the course of 

467 rulemaking, EPA would exclude those specific chemical substances for those specific 

468 uses from the final SNUR. EPA has promulgated provisions to allow persons to comply 

469 with the final SNUR before the effective date. If a person were to meet the conditions of 

470 advance compliance under 40 CFR 721.45(h), that person would be considered to have 

471 met the requirements of the final SNUR for those activities. 

472 VIII. Test Data and Other Information 

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

474 particular test data before submission of a SNUN. There are two exceptions: 
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475 1). dDevelopment of test data is required where the chemical substance subject 

476 to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 

477 5(b)(1)); and 

478 2). dDevelopment of test data may be necessary where the chemical substance 

479 has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). 

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

481 substance, persons are required to submit only test data in their possession or control and 

482 to describe any other data known to or reasonably ascertainable by them (15 U.S.C. 

483 2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA 

484 recommends that SNUN submitters include data that would permit a reasoned evaluation 

485 of risks posed by the chemical substance during its manufacture, processing, use, 

486 distribution in commerce, or disposal. EPA encourages persons to consult with the 

487 agency before submitting a SNUN. As part of this optional pre-notice consultation, EPA 

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

489 SNUNs submitted for significant new uses without any test data may increase the 

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

491 activities associated with this chemical. 

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

493 SNUNs that provide detailed information on: 

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

495 significant new uses of the chemical substance, 

496 •2. Potential benefits of the chemical substance, and 

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

498 posed by potential substitutes. 
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499 VIIIIX. SNUN Submissions 

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

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

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

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

504 section 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice 

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

506 submission of test data on health and environmental effects as described in section 40 

507 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e508 PMN software, and submitted to the Agency in accordance with the procedures set forth 

509 in sections 40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available 

510 electronically at http://www.epa.gov/opptintr/newchems. 

511 IX. Economic Analysis 

512 A. SNUNs 

513 EPA has evaluated the potential costs of establishing SNUR reporting 

514 requirements for potential manufacturers and processors of the chemical substances 

515 included in this proposed rule, including as part of articles (Ref. 28). In the event that a 

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

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

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

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

520 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than 

521 $40 million when combined with those of the parent company (if any), a reduced user fee 

522 of $100 (40 CFR 700.45(b)(1)). EPA's complete economic analysis is available in the 
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523 public docket for this proposed rule (Ref. 28). 

524 B. Export Notification

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

526 707, subpart D, exporters must notify EPA if they export or intend to export a chemical 

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

528 promulgated under TSCA section 5. For persons exporting a substance that is the subject 

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

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

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

532 the chemical is exported). While EPA is unable to make any estimate of the likely 

533 number of export notifications for the chemical covered in this proposed SNUR. , as 

534 stated in the accompanying EA of this proposed SNUR, the estimated cost of the export 

535 notification requirement on a per unit basis is $84.22. 

536 

537 C. Import or Processing Chemical Substances as Part of an Article

538 In proposing to make inapplicable the exemption relating to persons that import or 

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

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

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

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

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

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

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

546 determine whether the subject chemical substances are part of the articles that they are 
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547 considering to import or process. This determination may involve activities such as 

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

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

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

551 “Understanding the Costs Associated with Eliminating Exemptions for Articles in 

552 SNURs” (Ref. 29). Based on available information, EPA believes that article importers 

553 that choose to investigate their products would incur costs at the lower end of the ranges 

554 presented in the Economic Analysis. For those companies choosing to undertake actions 

555 to assess the composition of the articles they import or process, EPA expects that in all 

556 likelihood, these importers and processors would take actions that are commensurate with 

557 the level of risk (of company’s perceived likelihoond that a chemical to substance might 

558 be a part of an article) that each company perceives, and the resources it has available.

559 Example activities and their costs are provided in the accompanying Economic Analysis 

560 of this Rule (Ref. 28). 

561 XI. Alternatives 

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

563 action: 

564 A. Promulgate a TSCA Section 8(a) Reporting Rule

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

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

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

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

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

570 EPA would not have the opportunity to review human and environmental hazards and 
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571 exposures associated with the proposed significant new use and, if necessary, take 

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

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

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

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

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

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

578 regulatory objectives. 

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

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

581 Under the SNUR exemption provision at 40 CFR 721.45(f), a person who 

582 imports or processes a chemical substance covered by a SNUR identified in 40 CFR part 

583 721, subpart E, as part of an article is not generally subject to the notification 

584 requirements of 40 CFR 721.25 for that chemical substance. However, EPA is concerned 

585 that exempting TDI and related compounds as part of articles would render the SNUR 

586 less effective because of the possibility that articles could be imported or processed for 

587 uses subject to this proposed SNUR without the submission of a SNUN. This proposed 

588 rule would not include the exemption at 40 CFR 721.45(f). 

589 XII. Request for Comment 

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

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

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

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

594 To confirm EPA’s understanding, the Agency is requesting public comment on the 
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595 EPA’s understanding that coating, adhesive, elastomer, binder, or sealant consumer 

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

597 Table 2 of Unit II.A.. EPA believes that other consumer products do not contain TDI or 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

615 forth in 40 CFR part 2, subpart B.

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

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

618 (subject heading, Federal Register date, and page number). 
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619 ii. Follow directions. The agency may ask you to respond to specific questions or 

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

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

622 language for your requested changes. 

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

624 that you used. 

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

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

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

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

629 personal threats. 

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

631 identified. 

632 XIII. References 

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

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

635 EPA, including documents that are referenced within the documents that are in the 

636 docket, even if the referenced document is not physically located in the docket. For 

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

638 FOR FURTHER INFORMATION CONTACT. 

639 1. U.S. EPA. Significant New Uses of Chemical Substances; Certain Chemicals. 

640 49 FR 35014, September 5, 1984 (FRL-2541-8). 

641 2. Krone, C., and Klinger, T. (2005). Isocyanates, polyurethane and childhood 

642 asthma. Pediatric Allergy and Immunology 16, 378-379. 
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643 3. Bello, D., Herrick, C. A., Smith, T. J., Woskie, S. R., Streicher, R. P., Cullen, 

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

645 Concern. Environmental Health Perspectives 115. 

646 4. BASF Corporation. (2011). Project Summary Report Requested Industrial 

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

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

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

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

651 5. Vangronsveld, E, Berckmans, S., and Spence, M. (2013). Comparison of 

652 Solvent/Derivatization Agent Systems for Determination of Extractable Toluene 

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

654 640-649. 

655 6. Redlich, C. A., Bello, D., and Wisnewski, A. (2006). Isocyanate exposures and 

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

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

658 7. DOW (2009). Product Safety Assessment DOW Modified Toluene 

659 Diisocyanate (TDI) Products. July 16 2010. 

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

661 ctsay/pdfs/noreg/233-00617.pdf&fromPage=GetDoc. 

662 8. Collins, M.A. (2002). Toxicology of Toluene Diisocyanate. Applied 

663 Occupational and Environmental Hygiene 17, 846-855.

664 9. Gledhill, A. Wake, A., Hext, P., Leiobold, E., and Shiotsuka, R. (2005). 

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

666 methylenediphenyl diisocyanate in the male rat. Xenobiotica 35, 273-292.
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667 10. EPA. 2011. Toluene Diisocyanate (TDI) and Related Compounds Action 

668 Plan. Available online at: 

669 http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/tdi.pdf. 

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

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

672 Review Toxicology 33, 1-59. 

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

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

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

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

677 13. NIOSH (1996). National Institute for Occupational Safety and Health. 

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

679 14. American Chemistry Council (ACC) (2005). TSCA Section 8(e) Notice of 

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

681 15. IARC. (1999).Toluene Diisocyanates. WHO. p. 865-879. 

682 16. Environment Canada. (2008). Screening Assessment for the Challenge: 

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

684 17. NTP (2011). National Toxicology Program. Report on Carcinogens, Twelfth 

685 Edition; U.S. Department of Health and Human Services, Public Health Service. 

686 Substance Profile, Toluene Diisocyanates. http://ntp.niesh.nih.gov?objectid=03C9AF75-

687 E1BF-FF40-DBA9EC0928DF8B15.

688 18. NIOSH (2005). National Institute of Occupational Safety and Health. NIOSH 

689 Pocket Guide to Chemical Hazards July 16, 2010. 

690 http://www.cdc.gov/NIOSH/npg/npgdcas.html.
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691 19. De Zotti (2000). De Zotti, R., Muran, A., and Zambon, F. (2000). Two cases 

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

693 Environmental Medicine 57, 837-839. 

694 20. Agency for Toxic Disease Registry (ATSDR) (2002). Case Studies in 

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

696 ATSDR-HE-CD-2002-0002. 

697 21. NIOSH (2004). National Institute for Occupational Safety and Health. A 

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

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

700 22. Pianoforte, K. (2009). Adhesives and sealants market update, November 1, 

701 2009. In Coatings World. 

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

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

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

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

706 Occupational Environmental Hygiene 17, 491-494. 

707 25. NYC-DOHMH (2010). New York City Department of Health and Mental 

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

709 http://www.nyc.gov/html/doh/html/epi/mcufact.shtml.

710 26. NIOSH (2006). National Institute for Occupational Safety and Health. 

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

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

713 149/default.html. 

714 27. U.S. EPA. Significant New Uses of Certain Chemical Substances. 
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715 55 FR 173776, April 24, 1990 (FRL-3658-5). 

716 28. EPA. Economic Analysis of the Significant New Use Rule for Toluene 

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

718 29. EPA, Understanding the Costs Associated with Eliminating 

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

720 30. U.S. EPA. Modifications of Significant New Use Rules for Certain 

721 Substances 62 FR 42690, August 8, 1997 (FRL-5735-4).

722 XIIIXIV. Statutory and Executive Order Reviews 

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

724 Improving Regulation and Regulatory Review 

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

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

727 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted this action to OMB for 

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

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

730 B. Paperwork Reduction Act (PRA) 

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

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

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

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

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

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

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

738 response, and the estimated burden for an export notifications is less than 1.5 hours per 
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739 notification. In both cases, burden is estimated to be reduced for submitters who have 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

756 comment. 

757 C. Regulatory Flexibility Act (RFA) 

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

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

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

761 follows. 

762 EPA generally finds that proposed and final SNURs are not expected to have a 
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763 significant economic impact on a substantial number of small entities (See, e.g., Ref. 30). 

764 Since these proposed SNURs would require a person who intends to engage in such 

765 activity in the future to first notify EPA by submitting a SNUN, no economic impact 

766 would occur unless someone files a SNUN to pursue a significant new use in the future or 

767 forgoes profits by avoiding or delaying the significant new use. Although some small 

768 entities may decide to engage in such activities in the future, EPA cannot presently 

769 determine how many, if any, there may be. However, EPA’s experience to date is that, in 

770 response to the promulgation of SNURs covering over 1,000 chemical substances, the 

771 Agency receives only a handful of notices per year. During the six year period from 

772 2005-2011, only three submitters self-identified as small in their SNUN submission (Ref. 

773 28). EPA believes the cost of submitting a SNUN is relatively small compared to the cost 

774 of developing and marketing a chemical new to a firm and that the requirement to submit 

775 a SNUN generally does not have a significant economic impact.

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

777 engage in any activity described in the rule as a “significant new use.” EPA has 

778 preliminarily determined, based in part, on the Agency’s market research, that these 

779 chemical substances are not being manufactured (including imported) or processed for a 

780 significant new use. This preliminary determination also includes importation and 

781 processing of these chemical substances as part of articles for the significant new use 

782 (Unit IV). Therefore, based on current knowledge, EPA has preliminarily determined that 

783 these uses, including the importation of these chemical substances as part of articles, are 

784 not ongoing, and that no small entities presently manufacture or import for the significant 

785 new uses addresses in this proposed rule. EPA will consider information received during 

786 the comment period that might indicate that this preliminary determination is incorrect. 
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787 By definition of the word “new” and based on all information currently available to EPA, 

788 it appears that no small or large entities presently engage in such activities. Since this 

789 proposed SNUR will would require a person who intends to engage in such activity in 

790 the future to first notify EPA by submitting a SNUN, no economic impact will occur 

791 unless someone files a SNUN to pursue a significant new use in the future or forgoes 

792 profits by avoiding or delaying the significant new use. Although some small entities may 

793 decide to conduct such activities in the future, EPA cannot presently determine how 

794 many, if any, there may be. However, EPA’s experience to date is that, in response to the 

795 promulgation of SNURs covering over 1,000 chemical substances, the Agency receives 

796 on average only a handful of notices per year. During the six year period from 2005-

797 2011, only three submitters self-identified as small in their SNUN submission (Ref. 26). 

798 EPA believes the cost of submitting a SNUN is relatively small compared to the cost of 

799 developing and marketing a chemical new to a firm and that the requirement to submit a 

800 SNUN generally does not have a significant economic impact. 

801 EPA believes that there will be minimal impact to processors and importers of 

802 these chemical substances subject to the final SNUR as part of an articles from this 

803 proposed SNUR. The SNUR does not require processors and importers of articles that 

804 contain the chemicals subject to the proposed SNUR to conduct specific activities to 

805 ascertain if they are importing or processing an article that uses a chemical subject to the 

806 proposed rule. EPA expects importers would take actions that are commensurate with 

807 their perceived likelihood of a chemical substance subject to the SNUR being part of an 

808 article, and the resources it has available. EPA has no reason to believe that a firm would 

809 voluntarily incur substantial costs to comply with the SNUR, but rather EPA believes 
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810 each firm will choose the most efficient route to identify whether it is importing the 

811 subject chemical substances in articles.

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

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

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

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

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

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

818 Small Business Administration.

819 D. Unfunded Mandates Reform Act (UMRA) 

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

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

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

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

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

825 E. Executive Order 13132: Federalism 

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

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

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

829 13132 (64 FR 43255, August 10, 1999). 

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

831 Governments 

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

833 have any effect (i.e., there will be no increase or decrease in authority or jurisdiction) on 
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834 Tribal governments, on the relationship between the Federal government and the Indian 

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

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

837 2000), does not apply to this action. 

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

839 Safety Risks 

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

841 1997), because this action is not intended to address environmental health or safety risks 

842 for children. 

843 H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect 

844 Energy Supply, Distribution, or Use 

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

846 22, 2001), because this action is not expected to affect energy supply, distribution, or use. 

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

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

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

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

851 Populations and Low-Income Populations 

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

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

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

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

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

857 environment. 
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858 

859 

860 

861 

862 

863 

864 

865 List of Subjects in 40 CFR Part 721

866 Environmental protection, Chemicals, Hazardous substances, Reporting and 

867 recordkeeping requirements.

868 

869 

870 Dated: _______________________ 

871 

872 

873 ____________________________________________ 

874 

875 

876 

877 

878 Director, Office of Pollution Prevention and Toxics. 
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879 Therefore, it is proposed that 40 CFR part 721chapter I be amended as follows: 

880 PART 721--[AMENDED]

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

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

883 2. Add §721. xx 10789 to subpart E to read as follows:

884 §721.10xxx 10789 Toluene Ddiisocyanates and Rrelated Ccompounds. 

885 3. Add § 721.xx as follows: 

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

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

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

889 this section. 

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

891 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 

892 

893 

894 

895 

896 

897 

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

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

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

901 Consumer Product)
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902 

903 

Chemical Name Chemical Abstracts Index Name Chemical 

Abstracts Service 

Registry Number 

(CASRN)

2,6-Toluene diisocyanate Benzene, 1,3-diisocyanato-2-

methyl91-08-7

2,4-Toluene diisocyanate Benzene, 2,4-diisocyanato-1-

methyl- 584-84-9 

Toluene diisocyanate 

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

904 

905 (2) The significant new uses are: 

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

907 the chemical substance in consumer products. 

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

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

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

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

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

913 section except as modified by this paragraph (b):

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

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

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

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

918 significant new use notice. 

919 (2) [Reserved]