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1 EO 12866/13563 Review Draft – Revisions 11/21/2014

2 Rin2070-AJ91_EO12866_TDI SNUR_NPRM_FR Document_Redlined_2014-11-21.docx

3

4 BILLING CODE 6560-50-P

5 ENVIRONMENTAL PROTECTION AGENCY

6 40 CFR Part 721

7 [EPA-HQ-OPPT-2011-0976; FRL-9915-62]

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 subject 

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

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

84 707, 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 of Unit II.A.; and any use in a consumer product of any chemical listed in Table 

103 2 of Unit II.A. (except for use in coatings, elastomers, adhesives, binders, and sealants 

104 that results in less than or 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 in this unit 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 Table 1 of Unit II.A and 

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

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

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

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

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

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

115 recreational settings. 

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

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

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

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

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

121 721.45(f) for persons who import or process chemical substances as part of an article 
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122 would not apply. The article exemption at 40 CFR 721.45(f) is based on an assumption 

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

124 articles (see September 5, 1984; 49 FR 35014; FRL-2541-8 ) (Ref. 1). However, TDI and 

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

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

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

128 levels of isocyanates were detected on the surface of the products (e.g. flexible foams),

129 which if used could lead to exposure (Refs. 2 and 3). Because TDI and related 

130 compounds are known to be volatile chemical substances, have been reported to migrate 

131 from products, are sensitizers, and would be expected to present a higher potential for 

132 exposure if the TDI in the article were a consumer product, EPA would like the 

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

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

135 D. Why Is the Agency Taking this Action?

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

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

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

139 objectives for this SNUR are explained in Unit III. 

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

141 EPA has evaluated the potential costs of establishing SNUR reporting 

142 requirements for potential manufacturers and processors of the chemical substances 

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

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

145 submitted, costs are estimated to be $8,589 per SNUN submission for large business 
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146 submitters and $6,189 for small business submitters. These estimates include the cost to 

147 prepare and submit the SNUN and the payment of a user fee. The proposed SNUR would 

148 require first-time submitters of any TSCA section 5 notice to register their company and 

149 key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and 

150 establish and use a Pay.gov E-payment account before they may submit a SNUN, for a 

151 cost of $200 per firm. However, these activities are only required of first-time submitters 

152 of section 5 notices. In addition, for persons exporting a substance that is the subject of a 

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

154 particular country, which is estimated to be $84.22 per notification. The rule may also 

155 affect firms that plan to import or process articles that contain TDI and related 

156 compounds, because, while not required by the SNUR, these parties may take additional 

157 steps to determine whether TDI and related compounds are part of the articles that they

158 are considering to import or process. Since EPA is unable to predict whether anyone 

159 might engage in future activities that would require reporting, potential total costs were 

160 not estimated.

161 II. Chemical Substances Subject to this Proposed Rule

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

163 This proposed SNUR would apply to TDI and its related compounds listed in Table 1 of 

164 this unit and Table 2 of this unit in consumer products. Diisocyanates contain free 

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

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

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

168 This chemical reaction is completed when all of the isocyanate functional groups are 

169 bound within the polymer network. This process is commonly referred to as “curing.” 
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170 Products that contain free isocyanate functional groups are intended to react further and 

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

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

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

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

175 to sensitization. 

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

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

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

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

180 However, during conversations between EPA personnel and manufacturers and

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

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

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

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

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

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

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

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

189 not contain TDI or related compounds at any level.

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

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

192

Chemical Name Chemical Abstracts Index Name Chemical 

Abstracts Service 

Registry Number 

(CASRN)
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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

193

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

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

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

197 Consumer Product)”

198

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-

methyl584-84-9 

Toluene diisocyanate

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

199

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

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

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

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

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

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

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

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

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

209 products may be sold and used, most often in a mixture of formulated product, in an 
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210 uncured form. Because of its hazards, some industry representatives assert that TDI is 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

232 the workplace to cause asthma and respiratory problems, such as hypersensitivity

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

235 Isocyanate exposure has been identified as the leading attributable cause of work236 related asthma, and prevalence in the exposed workforce has been estimated at 1-20 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

256 the lowest feasible levels (Ref 18).

257 There are very few reports available regarding non-occupational health effects 
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258 from exposures to TDI products. However, there are case reports suggesting that 

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

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

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

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

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

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

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

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

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

268 in the same room (Ref. 20).

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

270 Compounds?

271 There is available information on worker exposures to industrial products

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

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

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

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

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

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

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

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

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

281 samples in one NIOSH evaluation (Ref. 21). Exposure data for professional workers may
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282 provide an indication of possible exposures if consumer products and articles were to 

283 contain residual TDI. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

301 conducting comparable activities using similar types of consumer products containing 

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

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

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

305 for exposure if they use or are bystanders to the use of consumer products containing 
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306 even residual amounts of TDI, because they may not have fully developed judgment for 

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

308 when they are experiencing symptoms of exposure.

309 III. Rationale and Objectives

310 A. Rationale

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

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

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

314 consumers were generally exposed to products containing only completely cured 

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

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

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

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

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

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

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

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

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

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

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

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

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

328 that coating-, adhesive-, elastomer-, binder-, or sealant-consumer products may contain 

329 residual TDI of no more than 0.1 percent by weight, EPA believes that these consumer 
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330 products do not contain residual TDI of more than 0.1 percent by weight. EPA believes 

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

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

333 5(a)(2), EPA's decision to propose a SNUR for a particular chemical use need not be 

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

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

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

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

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

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

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

341 the specific parameters and circumstances surrounding that intended use.

342 B. Objectives

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

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

345 rule:

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

347 TDI or its related compounds (see Tables 1 and 2 of Unit II.A.) for the described 

348 significant new use before that activity begins.

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

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

351 compounds (see Tables 1 and 2 of Unit II.A.) for the described significant new use.

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

353 or its related compounds (see Table 1 of Unit II.A. and Table 2 of Unit II.A.) before the 
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354 described significant new use of the chemical substance occurs, provided that regulation 

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

356 IV. Significant New Use Determination

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

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

359 including:

360 1. The projected volume of manufacturing and processing of a chemical 

361 substance.

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

363 beings or the environment to a chemical substance. 

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

365 human beings or the environment to a chemical substance. 

366 4. The reasonably anticipated manner and methods of manufacturing, processing,

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

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

369 authorizes EPA to consider any other relevant factors. 

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

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

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

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

374 5(a)(2) of TSCA. EPA has preliminarily determined as the significant new uses: any use 

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

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

377 coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 
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378 0.1 percent by weight of TDI in a consumer product).

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

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

381 49 FR 35014; September 5, 1984) (Ref. 1). However, TDI and related compounds are 

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

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

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

385 detected on the surface of the products, which if used could lead to exposure (Refs. 2 and 

386 3). Because TDI and related compounds are known to be volatile chemical substances, 

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

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

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

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

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

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

393 considerations, EPA has preliminarily determined that importing or processing

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

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

396 uses identified in the tables.

397 V. Applicability of General Provisions

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

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

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

401 effective date of the final rule. However, for this action, EPA is proposing that 40 CFR
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402 721.45(f) (which generally exempts persons importing or processing a substance as part 

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

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

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

406 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice 

407 requirements and EPA regulatory procedures as submitters of Premanufacture Notices 

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

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

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

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

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

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

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

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

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

417 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 

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

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

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

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

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

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

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

425 certification requirement applies to articles containing a chemical substance or mixture if 
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426 so required by the Administrator by a specific rule under TSCA. At this time EPA is not 

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

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

429 As discussed in the Federal Register of April 24, 1990 (55 FR 17376; FRL430 3658-5) (Ref. 27), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best 

431 served by designating a use as a significant new use as of the date of publication of the 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

449 with the final SNUR before the effective date. If a person were to meet the conditions of 
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450 advance compliance under 40 CFR 721.45(h), that person would be considered to have 

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

452 VII. Test Data and Other Information

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

454 particular test data before submission of a SNUN. There are two exceptions: 

455 1. Development of test data is required where the chemical substance subject to 

456 the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)); 

457 and 

458 2. Development of test data may be necessary where the chemical substance has 

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

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

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

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

463 2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA 

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

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

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

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

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

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

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

471 activities associated with this chemical. 

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

473 SNUNs that provide detailed information on: 
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474 • Human exposure and environmental releases that may result from the 

475 significant new uses of the chemical substance, 

476 • Potential benefits of the chemical substance, and

477 • Information on risks posed by the chemical substances compared to risks posed 

478 by potential substitutes. 

479 VIII. SNUN Submissions 

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

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

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

483 tests that might be helpful in evaluating risks posed by the substance. According to 40 

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

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

486 submission of test data on health and environmental effects as described in 40 CFR

487 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN 

488 software, and submitted to the Agency in accordance with the procedures set forth in 40 

489 CFR 721.25 and 40 CFR 720.40. E-PMN software is available electronically at 

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

491 IX. Economic Analysis

492 A. SNUNs

493 EPA has evaluated the potential costs of establishing SNUR reporting 

494 requirements for potential manufacturers and processors of the chemical substances

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

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

497 for large business submitters and $6,189 for small business submitters. These estimates 
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498 include the cost to prepare and submit the SNUN, and the payment of a user fee. 

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

500 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than 

501 $40 million when combined with those of the parent company (if any), a reduced user fee 

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

503 public docket for this proposed rule (Ref. 28).

504 B. Export Notification

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

506 707, subpart D, exporters must notify EPA if they export or intend to export a chemical 

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

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

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

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

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

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

513 export notifications for the chemical covered in this proposed SNUR, as stated in the 

514 accompanying EA of this proposed SNUR, the estimated cost of the export notification 

515 requirement on a per unit basis is $84.22

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

517

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

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

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

521 substance. Some firms have an understanding of the contents of the articles they import 
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522 or process. However, EPA acknowledges that importers and processors of articles may

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

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

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

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

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

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

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

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

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

532 (Ref.29). Based on available information, EPA believes that article importers that choose 

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

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

535 composition of the articles they import or process, EPA expects that importers would take 

536 actions that are commensurate with the company’s perceived likelihood that a chemical 

537 substance might be a part of an article, and the resources it has available. Example 

538 activities and their costs are provided in the accompanying Economic Analysis of this 

539 Rule (Ref. 28).

540 X. Alternatives

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

542 action: 

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

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

545 require persons to report information to the agency when they intend to manufacture or 
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546 process a listed chemical for a specific use or any use. However, for TDI, the use of 

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

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

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

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

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

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

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

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

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

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

557 regulatory objectives. 

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

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

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

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

562 721, subpart E, as part of an article is not generally subject to the notification 

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

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

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

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

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

568 XI. Request for Comment

569 A. Do you have comments or information about ongoing uses?
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570 EPA welcomes comment on all aspects of this proposed rule. EPA based its 

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

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

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

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

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

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

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

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

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

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

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

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

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

584 provided, unless a comment includes information claimed to be CBI or other information 

585 whose disclosure is restricted by statute. Do not submit this information to EPA through 

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

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

588 outside of the disk or CD ROM that you mail to EPA as CBI and then identify

589 electronically within the disk or CD ROM the specific information that is claimed as 

590 CBI. In addition to one complete version of the comment that includes information 

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

592 CBI must be submitted for inclusion in the public docket. Information so marked will not 

593 be disclosed except in accordance with procedures set forth in 40 CFR part 2, subpart B.
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594 2. Tips for preparing your comments. When submitting comments, remember to:

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

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

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

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

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

600 language for your requested changes.

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

602 that you used.

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

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

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

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

607 personal threats.

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

609 identified.

610 XII. References

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

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

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

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

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

616 FOR FURTHER INFORMATION CONTACT. 

617 1. U.S. EPA. Significant New Uses of Chemical Substances; Certain Chemicals. 
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618 49 FR 35014, September 5, 1984 (FRL-2541-8).

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

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

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

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

623 Concern. Environmental Health Perspectives 115.

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

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

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

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

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

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

630 Solvent/Derivatization Agent Systems for Determination of Extractable Toluene 

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

632 640-649.

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

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

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

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

637 Diisocyanate (TDI) Products. July 16 2010.

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

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

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

641 Occupational and Environmental Hygiene 17, 846-855.
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642 9. Gledhill, A. Wake, A., Hext, P., Leiobold, E., and Shiotsuka, R. (2005).

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

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

645 10. EPA. 2011. Toluene Diisocyanate (TDI) and Related Compounds Action 

646 Plan. Available online at: 

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

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

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

650 Review Toxicology 33, 1-59. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

665 E1BF-FF40-DBA9EC0928DF8B15.
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666 18. NIOSH (2005). National Institute of Occupational Safety and Health. NIOSH 

667 Pocket Guide to Chemical Hazards July 16, 2010. 

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

669 19. De Zotti (2000). De Zotti, R., Muran, A., and Zambon, F. (2000). Two cases 

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

671 Environmental Medicine 57, 837-839.

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

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

674 ATSDR-HE-CD-2002-0002. 

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

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

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

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

679 2009. In Coatings World. 

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

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

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

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

684 Occupational Environmental Hygiene 17, 491-494.

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

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

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

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

689 Preventing Asthma and Death from MDI Exposure During Spray-on Truck Bed Liner 
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690 and Related Applications: NIOSH Alert. http://www.cdc.gov/niosh/docs/2006-

691 149/default.html. 

692 27. U.S. EPA. Significant New Uses of Certain Chemical Substances. 

693 55 FR 173776, April 24, 1990 (FRL-3658-5).

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

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

696 29. EPA, Understanding the Costs Associated with Eliminating

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

698 XIII. Statutory and Executive Order Reviews

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

700 Improving Regulation and Regulatory Review

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

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

703 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted this action to OMB for 

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

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

706 B. Paperwork Reduction Act (PRA)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

732 comment.

733 C. Regulatory Flexibility Act (RFA)

734 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 

735 et seq.), the agency hereby certifies that promulgation of this SNUR would not have a 

736 significant adverse economic impact on a substantial number of small entities. The 

737 rationale supporting this conclusion is as follows.
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738 A SNUR applies to any person (including small or large entities) who intends to 

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

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

741 no small or large entities presently engage in such activities. Since this proposed SNUR 

742 would require a person who intends to engage in such activity in the future to first notify

743 EPA by submitting a SNUN, no economic impact will occur unless someone files a 

744 SNUN to pursue a significant new use in the future or forgoes profits by avoiding or 

745 delaying the significant new use. Although some small entities may decide to conduct 

746 such activities in the future, EPA cannot presently determine how many, if any, there 

747 may be. However, EPA's experience to date is that, in response to the promulgation of 

748 SNURs covering over chemical substances, the agency receives on average only a 

749 handful of notices per year. During the six year period from 2005-2011, only three 

750 submitters self-identified as small in their SNUN submission (Ref. 26). EPA believes the 

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

752 marketing a chemical new to a firm and that the requirement to submit a SNUN generally 

753 does not have a significant economic impact.

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

755 chemical substance subject to the final SNUR as part of an article. The SNUR does not 

756 require processors and importers of articles that contain the chemicals subject to the 

757 proposed SNUR to conduct specific activities to ascertain if they are importing or 

758 processing an article that uses a chemical subject to the rule. EPA expects importers 

759 would take actions that are commensurate with their perceived likelihood of a chemical 

760 substance subject to the SNUR being part of an article, and the resources it has available. 

761 EPA has no reason to believe that a firm would voluntarily incur substantial costs to 
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762 comply with the SNUR, but rather EPA believes each firm will choose the most efficient 

763 route to identify whether it is importing the subject chemical substances in articles

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

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

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

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

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

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

770 Small Business Administration.

771 D. Unfunded Mandates Reform Act (UMRA)

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

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

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

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

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

777 E. Executive Order 13132: Federalism

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

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

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

781 13132 (64 FR 43255, August 10, 1999).

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

783 Governments

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

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

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

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

789 2000), does not apply to this action. 

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

791 Safety Risks

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

793 1997), because this action is not intended to address environmental health or safety risks 

794 for children.

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

796 Energy Supply, Distribution, or Use

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

798 22, 2001), because this action is not expected to affect energy supply, distribution, or use.

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

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

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

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

803 Populations and Low-Income Populations

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

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

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

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

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

809 environment. 
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810
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811 List of Subjects in 40 CFR Part 721

812 Environmental protection, Chemicals, Hazardous substances, Reporting and 

813 recordkeeping requirements.

814

815 Dated: _______________________

816

817

818

819 ____________________________________________

820

821

822 Director, Office of Pollution Prevention and Toxics.
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823 Therefore, it is proposed that 40 CFR chapter I be amended as follows:

824 PART 721--[AMENDED]

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

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

827 2. Add §721.10789 to subpart E to read as follows:

828 §721.10789 Toluene diisocyanates and related compounds.

829

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

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

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

833 this section. 

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

835 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

836

837

838

839

840

841

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

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

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

845 Consumer Product)
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846

847

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-

methyl584-84-9 

Toluene diisocyanate 

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

848

849 (2) The significant new uses are: 

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

851 the chemical substance in consumer products.

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

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

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

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

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

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

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

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

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

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

862 significant new use notice. 

863 (2) [Reserved]