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### EO 12866/13563 Review Draft – As Submitted 1 Rin2070-AJ91_EO12866_TDI-SNUR_NPR M_FRdocument_2014-08-15.docx 2 3 BILLING CODE 6560-50-P 4 ENVIRONMENTAL PRO TECTION AGENCY 5 40 CFR Part 721 6 EPA-HQ-OPPT-2011-0976; FRL- XXXX-X 7 RIN 2070-AJ91 8 Toluene Diisocyanates (TDI) and Relate d Compounds; Significant New Use Rule 9 AGENCY: Environmental Protection Agency (EPA). 10 ACTION: Proposed rule. 11 SUMMARY: Under the Toxic Substance Control Act (TSCA), EPA is proposing a 12 significant new use rule (SNUR) for 2,4-toluen e diisocyanate, 2,6-toluene diisocyanate, 13 toluene diisocyanate unspecified isomers (the se three chemical substances are hereafter 14 referred to as toluene diisocyanates or TDI) and related compounds as identified in this 15 proposed rule. The proposed significant new use is any use in a consumer product, with a 16 proposed exception for use of certain chemi cal substances in coatings, elastomers, 17 adhesives, binders, and sealants that results in less than orequal to 0.1 percent by weight 18 of TDI in a consumer product. In addition, EP A is also proposing that the general SNUR 19 article exemption for persons who import or proc ess these chemical substances as part of 20 an article would not apply. Pers ons subject to the SNUR would be required to notify EPA 21 at least 90 days before commencing any manufacturing or processing. The required 22 notification would provide EPA w ith the opportunity to evaluate the intended use and, if 23 necessary based on the information available at that time, an opportunity to protect 24 against potential unreasonable risks, if any, from that activity before it occurs. 25*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 2 of 35 DATES: Comments must be recei ved on or before [ insert date 60 days after date of 26 publication in the Federal Register ]. 27 ADDRESSES: Submit your comments, identified by docket identification (ID) number 28 EPA-HQ-OPPT-2011-0976, by one of the following methods: 29

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the online 30 instructions for submitting comments. Do not submit electronically any information you 31 consider to be Confidential Business Info rmation (CBI) or other information whose 32 disclosure is restricted by statute. 33

• Mail : Document Control Office (7407M), Office of Pollution Prevention and 34 Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 35 Washington, DC 20460-0001. 36

• Hand Delivery : To make special arrangements fo r hand delivery or delivery of 37 boxed information, please follow the instructions at 38 http://www.epa.gov/dockets/contacts.html

. 39 Additional instructions on commenting or visiting the docket, along with more 40 information about dockets ge nerally, is available at http://www.epa.gov/dockets

. 41 FOR FURTHER INFORMATION CONTACT: For technical information contact : 42 Katherine Sleasman, Chemical Control Divisi on (7405M), Office of Pollution Prevention 43 and Toxics, Environmental Protectio n Agency, 1200 Pennsylvania Ave., NW., 44 Washington, DC 20460-0001; telephone number: 202-564-7716; e-mail address: 45 sleasman.katherine@epa.gov

. 46 For general information contact : The TSCA-Hotline, ABVI-Goodwill, 422 South 47 Clinton Ave., Rochester, NY 14620; telephon e number: (202) 554–1404; e-mail address: 48 TSCA-Hotline@epa.gov

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Page 3 of 35 SUPPLEMENTARY INFORMATION: 50 I. Executive Summary 51 A. Does this Action Apply to Me? 52 You may be potentially affected by this action if you manufacture, process, or 53 distribute in commerce chemical substances and mixtures. The following list of North 54 American Industrial Classification System (NAICS) codes is not intended to be 55 exhaustive, but rather provides a guide to he lp readers determine whether this document 56 applies to them. Potentially affected entities may include: 57

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

• Petroleum Refining (NAI CS code 325 and 32411). 59

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

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

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

• Building and construction polyuretha ne foam products (NAICS code 63 32615031). 64

• Products made of foam other than polys tyrene or polyurethane (NAICS code 65 32615091). 66

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

• Consumer and institutional polyurethane foam products (NAICS code 68 32615051 ). 69

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

• Elastomers (NAICS code 326199). 71 This action may also affect certai n entities through pre-existing import 72 certification and export notification rule s under TSCA. Persons who import any 73*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 4 of 35 chemical substance governed by a final SNURare subject to the TSCA section 13 (15 74 U.S.C. 2612) import certification requiremen ts and the corresponding regulations at 19 75 CFR 12.118 through 12.127; see also 19 CFR 1 27.28. Those persons must certify that 76 the shipment of the chemical substance complies with all applicable rules and orders 77 under TSCA, including any SNUR requirements. The EPA policy in support of import 78 certification appears at 40 CF R part 707, subpart B. In addition, any persons who export 79 or intend to export a chemical substance that is the subject of this proposed rule on or 80 after [insert date 30 days after the date of publication in the Federal Register] are 81 subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), 82 (see 40 CFR 721.20), and must comply with th e export notification requirements in 40 83 CFR part 707, subpart D. 84 If you have any questions regarding the appl icability of this action to a particular 85 entity, consult the technical in formation contact listed under FOR FURTHER 86 INFORMATION CONTACT

. 87 B. What Is the Agency's Aut hority for Taking this Action? 88 Section 5(a)(2) of TSCA (15 U.S. C. 2604(a)(2)) authorizes EPA to determine that 89 a use of a chemical substance is a “si gnificant new use.” EPA must make this 90 determination by rule after c onsidering all releva nt factors, includi ng those listed in 91 TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a 92 significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant 93 new use notice (SNUN) to EPA at least 90 days before they manufacture or process the 94 chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit V., the 95 general SNUR provisions are found at 40 CFR Part 721, Subpart A. 96 C. What Action Is the Agency Taking? 97*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 5 of 35 EPA is proposing a SNUR for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, 98 toluene diisocyanate unspecified isomers (the se three chemical substances are hereafter 99 referred to as toluene diisocyanates or TDI) and related compounds. The proposed 100 significant new use is: any use in a consumer product of any chemical substance listed in 101 Table 1; and any use in a consumer product of any chemical listed in Table 2 (except for 102 use in coatings, elastomers, adhesives, binders , and sealants that results in less than or 103 equal to 0.1 percent by weight of TDI in a consumer product). 104 This proposed significant new use rule woul d apply to the uses EPA has identified 105 herein that EPA believes are not ongoing atthe time of this proposed rule. EPA is 106 requesting public comment on this propos al, and specifically on the Agency’s 107 understanding of ongoing uses for the chemicals identified in Tables 1 and 2 in consumer 108 products. EPA is particularly interested in whether there are any ongoing uses of these 109 chemicals in consumer products of which the Agency is currently unaware and would 110 welcome specific documentation of any such ongoing uses. A consumer product is 111 defined at 40 CFR 721.3 as: a chem ical substance that is directl y, or as part of a mixture, 112 sold or made available to consumers for thei r use in or around a permanent or temporary 113 household or residence, in or around a school, or in recreational settings. 114 This proposed SNUR would require persons that manufacture (including import) 115 or process any of the chemicals for a si gnificant new use, consistent with the 116 requirements at 40 CFR 721.25, to notify EPA atleast 90 days before commencing such 117 manufacture or process of the chemical subs tance for a significant new use. For this 118 proposed rule, EPA is proposing that the ge neral SNUR article exemption at 40 CFR 119 721.45(f) for persons who import or process chemical substances as part of an article 120 would not apply. The article exemption at 40 CFR 721.45(f) is based on an assumption 121*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 6 of 35 that people and the environmen t will generally not be exposed to chemical substances in 122 articles (see 49 FR 35014; September 5, 1984). However, TDI and related compounds are 123 volatile and as such could migrat e out of articles that contai n them. For instance, studies 124 of TDI in polyurethane products reported that after the r eaction between an isocyanate 125 and an alcohol to form polyurethane produc ts, residual levels of isocyanates were 126 detected on the surface of the products, which if used could lead to exposure (Refs. 1 and 127 2). Because TDI and related compounds are known to be volatile chemical substances, 128 have been reported to migrate from products, are sensitizers, and would be expected to 129 present a higher potential for e xposure if the TDI in the arti cle were a consumer product, 130 EPA would like the opportunity to evaluate su ch potential uses in consumer products for 131 any associated risks or hazards that mightexist before those uses would begin. 132 D. Why Is the Agency Taking this Action? 133 These SNURs are necessary to ensure th at EPA receives timely advance notice of 134 any future manufacturing and processing of TD I and related compounds for new uses that 135 may produce changes in human and envir onmental exposures. The rationale and 136 objectives for this SNUR ar e explained in Unit III. 137 E. What are the Estimated Incremental Impacts of this Action? 138 EPA has evaluated the potential co sts of establishing SNUR reporting 139 requirements for potential manufacturers and pr ocessors of the chemical substances 140 included in this proposed rule. This analys is, which is available in the docket, is 141 discussed in Unit IX., and is briefly summarized here. In the event that a SNUN is 142 submitted, costs are estimated to be less than $8,700 per SNUN submission for large 143 business submitters and $6,300 for small business submitters. These estimates include the 144 cost to prepare and submit the SNUN and th e payment of a user fee. In addition, for 145*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 7 of 35 persons exporting a substance that is the s ubject of a SNUR, a one-time notice must be 146 provided for the first export or intended expor t to a particular count ry, which is estimated 147 to cost less than $100 on average per notification. The rule may also affect firms that plan 148 to import or process articles that contain TDI and related compounds, because, while not 149 required by the SNUR, these parties may take additional steps to determine whether TDI 150 and related compounds are part of the articles that they are considering to import or 151 process. Since EPA is unable to predict whether anyone might engage in future activities 152 that would require reporting, potential total costs were not estimated. 153 II. Chemical Substances Subject to this Proposed Rule 154
A. What Chemicals Are Included in the Proposed SNUR? 155 This proposed SNUR would apply to TD I and its related compounds listed in 156 Table 1 and Table 2 in consumer products . Diisocyanates cont ain free isocyanate 157 functional groups (-N=C=O). Diisocyanates are combined with other compounds that 158 contain free hydroxyl functiona l groups (i.e., –OH), typically called “polyols.” These 159 two-part components react and begin to form polyurethane polymers. This chemical 160 reaction is completed when all of the isoc yanate functional groups are bound within the 161 polymer network. This process is commonly refe rred to as “curing.” Pr oducts that contain 162 free isocyanate functional groups are intended to react further a nd undergo “curing” in 163 the process of use. The chemical substances subject to this propos ed SNUR contain free 164 isocyanate functional groups and are by definition uncured. 165 To ascertain if TDI and related compounds are used in consumer products, EPA 166 reviewed published literature, the most rece nt data from EPA’s Chemical Data Reporting 167 program (CDR), and communicated directly with manufacturers and processors. 168 Reporting under the CDR indicated no consum er uses of TDI or related compounds. 169*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 8 of 35 However, during conversations between EPA personnel and manufacturers and 170 processors, it was revealed that in some cases consumer products may still contain 171 residual TDI of no more than 0.1 percent by weight, as noted in Table 2 (Ref. 3). This 172 was also confirmed by review of published l iterature and SDS for consumer adhesives 173 and sealants available in reta il outlets. It is EPA’s understand ing that any TDI present in a 174 coating, adhesive, elastomer, binder or sealan t consumer product is at levels of no more 175 than 0.1 percent by weight and would typica lly be considered residual diisocyanate 176 remaining from the manufacture of a polyur ethane polymer, a concentration which is 177 above the detection level (Ref. 4). EPA be lieves that other consumer products do not 178 contain TDI or related compounds at any level. 179 Table 1 – Toluene Diisocyanate Related Comp ounds Subject to this Action with a 180 Proposed Significant New Use of “Any Use in a Consumer Product” 181 182 Chemical Name Chemical Abstracts Index Name Chemical Abstracts Service Registry Number (CASRN) Toluene diisocyanate trimer Benzene, 1,3-diisocyanatomethyl-, trimer 9019-85-6 Poly(toluene diisocyanate) Ben zene, 1,3-diisocyanatomethyl-, homopolymer 9017-01-0 Toluene diisocyanate dimer 1,3-Diazetidine-2,4-dione, 1,3bis(3- isocyanatomethylphenyl)- 26747-90-0 Toluene diisocyanate “cyclic” trimer 1,3,5-Triazine-2,4,6(1H,3H,5H)- trione, 1,3,5-tris(3- isocyanatomethylphenyl)- 26603-40-7
183 Table 2 – Toluene Diisocyanates Subject to this Action with a Proposed Significant 184 Use of “Any Use in A Consumer Product (Except for use in Coatings, Adhesives, 185 Elastomers, Binders, and Sealants at Less than or Equal to 0.1 Percent in a 186 Consumer Product)” 187 188 Chemical Name Chemical Abstracts Index Name Chemical Abstracts Service Registry Number (CASRN) 2,6-Toluene diisocyanate Benzene, 1,3-diisocyanato-2- 91-08-7*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 9 of 35methyl2,4-Toluene diisocyanate Benzene, 2,4-diisocyanato-1- methyl- 584-84-9 Toluene diisocyanate unspecified isomer Benzene, 1,3-diisocyanatomethyl- 26471-62-5 189
B. What Are the Production Volumes and Us es of TDI and Related Compounds? 190 TDI and the related compounds are genera lly high production volume chemicals, 191 predominantly used in the production of polyurethanes. There are many types of 192 polyurethane products in the marketplace, with foams representing th e largest sector of 193 the polyurethane industry. Flexible foam is primarily used for cushioning, while rigid 194 foam is used mainly for insulation (Ref. 5). Approximately 90 percent of TDI, typically a 195 mixture of toluene diisocyanate isomers, is used in the production of flexible foams, 196 which are designed to be fully cured in a final product. Non-foam polyurethane use 197 sectors of TDI include coatings, adhesives, elastomers, binders, and sealants. These 198 products may be sold and used, most often in a mixture of formulated product, in an 199 uncured form. Because of its hazards, some i ndustry representatives assert that TDI is 200 used in products intended for industrial us e only (Ref. 6). In contrast, EPA believes 201 coatings, adhesives, elastomers, binders, and sealants used by general consumers contain 202 residual TDI of no more than 0.1 percent by weight. Due to th e projected growth of the 203 market for such use in consumer products as discussed further in Unit II.D., EPA is 204 concerned that consumer products in the future might contain amounts of TDI above 205 these levels. Therefore, EPA is proposing th is action to provide the Agency with an 206 opportunity to evaluate such potential uses in consumer products for any associated risks 207 or hazards that might exist be fore those uses would begin. 208
C. What Are the Potential Health Ef fects of TDI and Related Compounds? 209*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 10 of 35 In acute, subacute, and chronic animal e xposure studies for TDI, the respiratory 210 tract was the target organ, with nasal irri tation evident at concen trations above 0.1 ppm 211 and effects becoming more severe with in creasing concentratio n (Ref. 7). TDI is 212 uniformly distributed throughout the body, followi ng inhalation exposure (Refs. 7 and 8). 213 TDI causes skin, eye, and lung irritation, progr essive impairment of lung function with 214 long-term inhalation exposure and is a resp iratory sensitizer via both the dermal and 215 inhalation routes of exposur e in animals (Ref. 7). 216 Most data on human health hazards resu lting from diisocyanate exposures are 217 from occupational populations ra ther than exposures to consumer products. As discussed 218 in the Toluene Diisocyanate and Related Comp ounds Action Plan (Ref. 9), diisocyanates, 219 including TDI and related compounds, are well-known dermal, eye, and inhalation 220 irritants and sensitizers based on worker data. They have been documented in the 221 workplace to cause asthma and respiratory problems, such as hypersensitivity 222 pneumonitis, an inflammation of the lungs. In se vere cases, there have been reported fatal 223 reactions. 224 Isocyanate exposure has been identified as the leading attributable cause of work225 related asthma, and prevalen ce in the exposed workforce has been estimated at 1-20 226 percent (Refs. 10 and 11). Once a worker is sensitized to diisoc yanates, subsequent 227 exposures can trigger severe as thma attacks. Spray applica tion and heated processes are 228 associated with higher incidences of asthmathan other application methods because they 229 can generate airborne isocyanate vapors and mists, which lead to worker exposure via the 230 respiratory and dermal routes. Most worker s who develop diisocyanate asthma have 231 experienced long periods of exposure (mont hs or longer); however, the minimum 232 exposure to isocyanates that can elicit sens itization responses or asthma is unknown. In 233*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 11 of 35 addition, immune response and subsequent disease in humans can vary significantly 234 between individuals (Ref. 5). Fatalities linke d to diisocyanate exposures in sensitized 235 persons have been reported (Refs. 12 and 13). 236 The International Agency for Research on Cancer (IARC) classified toluene 237 diisocyanates as “possibly carcinogenic to hum ans” (Carcinogenicity Group 2B), based 238 on inadequate evidence for the carcinogenicity of TDI in humans and sufficient evidence 239 for the carcinogenicity of TDI in experiment al animals (Ref. 14). TDI has also been 240 classified by the European Commission (EC) as Category 3 for carcinogenicity (“causes 241 concerns for humans owing to possible carci nogenic effects”) (Ref. 15) and by the United 242 States National Toxicology Pr ogram (NTP) as “reasonably anticipated to be a human 243 carcinogen” (Ref. 16). National Institutes for Occupational Safety and Health (NIOSH) 244 considers TDI to be an occupational carci nogen and recommends exposure reduction to 245 the lowest feasible levels (Ref 17). 246 There are very few reports available re garding non-occupatio nal health effects 247 from exposures to TDI products. However, there are case reports suggesting that 248 paraoccupational (brought outside of the wo rkplace) asthma may have resulted from 249 incidental exposure to TDI, one of which involved incidental exposure to varnishing 250 products (Ref. 18). A specific, potential concern for consumer products is exposures to 251 children. Children exposed to the same leve ls of TDI vapor as adults may receive a 252 larger dose because they have greater l ung surface area to body weight ratios and 253 increased respiratory minute volumes to weight ratios. TDI vapor is heavier than air and 254 may layer close to the floor; therefore, childre n who crawl, roll, or sit on surfaces treated 255 with chemicals (i.e. carpets and floors) and play with objects such as toys where residues 256 may settle could potentially receive higher doses of inhaled toxicants than adults present 257*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 12 of 35 in the same room (Ref. 19). 258
D. What Are the Potential Route and Sources of Exposure to TDI and Related 259 Compounds? 260 There is available information on work er exposures to industrial products 261 containing TDI, such as coatings, adhesives, and sealants. Exposures resulting from the 262 use of these industrial products may indicate potential but lower level exposures that may 263 result for users conducting similar activities with consumer products containing residual 264 TDI. There is a potential for worker exposure to TDI in al l industrial and commercial 265 settings where TDI is present (Ref. 6). Becau se of the high volatility of TDI, exposure 266 can occur in all phases of its use, even inthe final product (Ref.16), and it is unknown to 267 what extent factors such as appli cation techniques, product composition, and 268 environmental conditions influence the availa bility of TDI in products. One activity 269 where overexposures have been documented is floor finishing in both personal and area 270 samples in one NIOSH evaluation (Ref. 20). E xposure data for professional workers may 271 provide an indication of possible exposures if consumer products and articles were to 272 contain residual TDI. 273 As previously discussed, TDI is used in coatings, adhesives, sealants, and other 274 polyurethane products. TDI is used in the ma nufacturing process of the polymer and as a 275 result, a small percentage of TDI may be pr esent in consumer produc ts, including articles. 276 Further, researchers looking at workplace e xposures to diisocyanates have noted an 277 increase in the number of isocyanate-contai ning products used by consumers (Ref. 5). In 278 addition, consumer use of adhesives and sealants is a potential growth sector as seen in 279 the increasing numbers of “Do It Yourself ” (DIY), energy-conscious homeowners doing 280 more of their own home renovation and repa ir work, as well as from craftsmen and 281*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 13 of 35 consumers generally continuing to use adhe sives (Ref. 21). Most consumers would be 282 unaware of the potential hazards of consumer products, including articles, containing TDI 283 or other diisocyanates. Consequently, insu fficient and inadequate hazard communication 284 may lead to incorrect use and increased c onsumer and bystander exposures, particularly 285 for sensitive groups, such as children. For ex ample, exposures to bystanders and building 286 occupants (including children) to TDI in industrial products have been reported in the 287 literature, including emissions of TDI from c oncrete patio sealants (Refs. 22 and 23) and 288 detection of TDI in building air samples fo llowing use of urethanes containing TDI to 289 coat wood floors (Ref. 24). It is possible that lower level exposures could occur when 290 conducting comparable activitie s using similar types of consumer products containing 291 residual TDI. Even if consumers are aware of such potential hazards, they may not take 292 appropriate precautions or research the appropr iate resources in which these precautions 293 are addressed. Of particular concern is the fact that children may ha ve a greater potential 294 for exposure if they use or are bystanders to the use of consumer products containing 295 even residual amounts of TDI, because they may not have fully developed judgment for 296 following labeling instructions and safety precautions and may not cease activity even 297 when they are experiencing symptoms of exposure. 298 III. Rationale and Objectives 299 A. Rationale 300 Diisocyanates are potent dermal and lung se nsitizers and an attributable cause of 301 work-related asthma worldwide (Ref. 25). In th e past, consumer expos ures have not been 302 a focus of concern with respect to diisoc yanates, because it had been assumed that 303 consumers were generally exposed to pr oducts containing only completely cured 304 polyurethanes, which have been generally c onsidered to have low toxicity (Ref. 1). 305*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 14 of 35 However, an increase in consumer use of polyurethane products that may further react 306 and undergo “curing” could occur if consumer products, such as coatings, elastomers, 307 adhesives, and sealants contained TDI in am ounts greater than residual amounts. In such 308 instances, TDI and related compounds that are not completely reacted upon their 309 application can provide potential exposures both to the consumeras the direct user or to 310 bystanders when products are used by others (Refs. 1 and 2). In sensitized individuals, 311 exposure to even small amounts of diisocyanate s may cause allergic respiratory reactions 312 like asthma and severe breathing difficulties (R ef. 5). EPA believes that the use of any of 313 these chemical substances in consumer produc ts above current levels could significantly 314 increase human exposure, and that such in crease should not occur without an opportunity 315 for EPA review and control as appropriate. As discussed in Unit II, regarding the 316 chemicals listed in Table 2, based on Safety Data Sheets (SDS) information that coating-, 317 adhesive-, elastomer-, binder-, or sealant-c onsumer products may c ontain residual TDI of 318 no more than 0.1 percent by weight, EPA belie ves that these consumer products do not 319 contain residual TDI of more than 0.1 pe rcent by weight. EPA believes that other 320 consumer products do not contain TDI or related compounds at any level. 321 Consistent with EPA's past practice for issuing SNURs under TSCA section 322 5(a)(2), EPA's decision to propose a SNUR fo r a particular chemical use need not be 323 based on an extensive evaluation of the hazard, e xposure, or potential ri sk associated with 324 that use. Rather, the Agency action is based on EPA's determination that if the use begins 325 or resumes, it may present a risk that EP A should evaluate under TSCA before the 326 manufacturing or processing for that use be gins. Since the new use does not currently 327 exist, deferring a detailed consideration of potenti al risks or hazards related to that use is 328 an effective use of resources. If a person d ecides to begin manufacturing or processing 329*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 15 of 35 the chemical for the use, the notice to EPA allows EPA to evaluate the use according to 330 the specific parameters and circumst ances surrounding that intended use. 331 B. Objectives 332 Based on the considerations in Unit III. A., EPA wants to achieve the following 333 objectives with regard to the significant new use(s) that are designated in this proposed 334 rule: 335 1. EPA would receive notice of any pers on’s intent to manufacture or process 336 TDI or its related compounds (see Table 1 and Table 2) for the described significant new 337 use before that activity begins. 338 2. EPA would have an opportunity to review and evaluate data submitted in a 339 SNUN before the notice submitter begins manufacturing or processing TDI or its related 340 compounds (see Table 1 and Table 2) for the described significant new use. 341 3. EPA would be able to regulate prosp ective manufacturers or processors of TDI 342 or its related compounds (see Table 1 and Tabl e 2) before the described significant new 343 use of the chemical substance occurs, provide d that regulation is warranted pursuant to 344 TSCA sections 5(e), 5(f), 6 or 7. 345 IV. Significant New Use Determination 346 Section 5(a)(2) of TSCA states that EPA' s determination that a use of a chemical 347 substance is a significant new us e must be made after consider ation of all relevant factors 348 including: 349 • The projected volume of manufacturing and processing of a ch emical substance. 350 • The extent to which a use changes the type or form of exposure of human beings 351 or the environment to a chemical substance. 352

• The extent to which a use increases th e magnitude and duration of exposure of 353*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 16 of 35 human beings or the environment to a chemical substance. 354 • The reasonably anticipated manner a nd methods of manufacturing, processing, 355 distribution in commerce, and disposal of a chemical substance. 356 In addition to these factors enumerated in TSCA section 5(a)(2), the statute 357 authorizes EPA to consider a ny other relevant factors. 358 To determine what would constitute a si gnificant new use of TDI or its related 359 compounds subject to this proposed rule, as discussed herein, EPA considered relevant 360 information about the toxicity of thes e substances, likely human exposures and 361 environmental releases associated with possibl e uses, and the four f actors listed in section 362 5(a)(2) of TSCA. EPA has preliminarily dete rmined as the significant new uses: any use 363 in a consumer product for any chemical liste d in Table 1; and any use in a consumer 364 product for any chemical listed in Table 2 (except for use in co atings, elastomers, 365 adhesives, binders, and sealants that results in less than orequal to 0.1 percent by weight 366 of TDI in a consumer product). 367 The article exemption at 40 CFR 721.45(f) is based on an assumption that people 368 and the environment will generally not be exposedto chemical substances in articles (see 369 49 FR 35014; September 5, 1984). However, TD I and related compounds are volatile and 370 as such could migrate out of articles that c ontain them. For instance, studies of TDI in 371 polyurethane products reported that after the reaction betw een an isocyanate and an 372 alcohol to form polyurethane products, residual levels of isocyanates were detected on 373 the surface of the products, which if usedcould lead to exposure (Refs. 1 and 374 2). Because TDI and related compounds are known to be volatile chemical substances, 375 have been reported to migrate from products, are sensitizers, and would be expected to 376 present a higher potential for e xposure if the TDI in the arti cle were a consumer product, 377*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 17 of 35 EPA would like the opportunity to evaluate su ch potential uses in consumer products for 378 any associated risks or hazards that mightexist before those uses would begin. 379 EPA believes any new use of TDI and related compounds as part of articles would 380 increase the duration and magn itude of human exposure to th e substance. Based on these 381 considerations, EPA has preliminarily de termined that importing or processing 382 substances in Table 1 and 2 as part of articles warrants making inapplicable the article 383 exemption at 40 CFR 721.45(f) for the si gnificant new uses identified above. 384 V. Applicability of General Provisions 385 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 386 provisions describe persons subject to the ru le, recordkeeping requirements, exemptions 387 to reporting requirements, and applicability of the rule to uses occurring before the 388 effective date of the final rule. However, for this action, EPA is proposing that § 389 721.45(f) (which generally exempts persons im porting or processing a substance as part 390 of an article) will not apply and a person who imports or processes a chemical substance 391 as part of an article would not be exempt from submitting a SNUN. 392 Provisions relating to user fees appe ar at 40 CFR part 700. According to 393 § 721.1(c), persons subject to SNURs must co mply with the same notice requirements 394 and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under 395 TSCA section 5(a)(1)(A). In particular, th ese requirements include the information 396 submissions requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized 397 by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 398 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 399 5(e), 5(f), 6 or 7 to control the activities on which it has received the SNUN. If EPA does 400 not take action, EPA is required under TSCA section 5(g) to explain in the Federal 401*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 18 of 35 Register its reasons for not taking action. 402 Persons who export or intend to exporta chemical substa nce identified in a 403 proposed or final SNUR are s ubject to the export notificati on provisions of TSCA section 404 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 405 subpart D. In accordance with 40 CFR 707.60(b) this proposed SNUR does not trigger 406 export notification for articles. Persons who import a chemical substance identified in a 407 final SNUR are subject to the TSCA s ection 13 import certifi cation requirements, 408 codified at 19 CFR 12.118 through 12.127; s ee also 19 CFR 127.28. Those persons must 409 certify that the shipment of the chemical s ubstance complies with al l applicable rules and 410 orders under TSCA, including any SNUR requirements. The EPA policy in support of 411 import certification appears at 40 CFR part 707, subpart B. 412 VI. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule 413 As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has 414 decided that the intent of s ection 5(a)(1)(B) of TSCA is best served by designating a use 415 as a significant new use as of the date of publication of the pr oposed rule rather than as of 416 the effective date of the final rule. If us es begun after publication of the proposed rule 417 were considered ongoing rather than new, it would be difficult for EPA to establish 418 SNUR notice requirements, because a person could defeat the SNUR by initiating the 419 proposed significant new use before the rule became final, and then argue that the use 420 was ongoing as of the effective date of the final rule. Thus, persons who begin 421 commercial manufacture or pro cessing of the chemical s ubstance(s) that would be 422 regulated through this proposed rule, if fina lized, would have to cease any such activity 423 before the effective date of the rule if a nd when finalized. To resume their activities, 424 these persons would have to comply with al l applicable SNUR notice requirements and 425*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 19 of 35 wait until the notice review peri od, including all extensions, expi res. Uses arising after 426 the publication of the proposed rule are disti nguished from uses that exist at publication 427 of the proposed rule. The former would be new uses, the latter ongoing uses, except that 428 uses that are ongoing as of the publication of the proposed rule would not be considered 429 ongoing uses if they have ceased by the date of issuance of a final rule. To the extent that 430 additional ongoing uses are found in the cour se of rulemaking, EPA would exclude those 431 specific chemical substances for those specific uses from the final SNUR. EPA has 432 promulgated provisions to allow persons to comply with the final SNUR before the 433 effective date. If a person were to meet the conditions of advance compliance under 40 434 CFR 721.45(h), that person would be considered to have met the requirements of the final 435 SNUR for those activities. 436 VII. Test Data and Other Information 437 EPA recognizes that TSCA section 5 doe s not usually require developing any 438 particular test data before submission of a SNUN. There are two exceptions: 1) 439 development of test data is re quired where the chemical substance subject to the SNUR is 440 also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)); and 2) 441 development of test data may be necessary wh ere the chemical substance has been listed 442 under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a section 4 443 test rule or a section 5(b)(4) listing covering the chemical s ubstance, persons are required 444 to submit only test data in their possession or control and to describe any other data 445 known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and 446 40 CFR 720.50). However, as a general matte r, EPA recommends that SNUN submitters 447 include data that would permit a reasoned evaluation of risks posed by the chemical 448 substance during its manufacture, processing, use, distribution in commerce, or disposal. 449*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 20 of 35 EPA encourages persons to consult with the agency before submitting a SNUN. As part 450 of this optional pre-notice c onsultation, EPA would discuss specific data it believes may 451 be useful in evaluating a si gnificant new use. SNUNs submitted for significant new uses 452 without any test data may increase the lik elihood that EPA will ta ke action under TSCA 453 section 5(e) to prohibit or limit activitie s associated with this chemical. 454 SNUN submitters should be aware thatEPA will be better able to evaluate 455 SNUNs that provide deta iled information on: 456 1. Human exposure and environmenta l releases that may result from the 457 significant new uses of the chemical substance, 458 2. Potential benefits of the chemical substance, and 459 3. Information on risks posed by the ch emical substances compared to risks 460 posed by potential substitutes. 461 VIII. SNUN Submissions 462 EPA recommends that submitters consult with the Agency prior to submitting a 463 SNUN to discuss what data may be usef ul in evaluating a significant new use. 464 Discussions with the Agency prior to submission can afford ample time to conduct any 465 tests that might be helpful in evaluating risks posed by the substance. According to 466 section 721.1(c), persons submitting a SNUN must comply with the same notice 467 requirements and EPA regulatory procedures as persons submitting a PMN, including 468 submission of test data on health and envi ronmental effects as described in section 469 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN 470 software, and submitted to the Agency in acco rdance with the procedures set forth in 471 sections 721.25 and 720.40. E-PMN software is available electronically at 472 http://www.epa.gov/opptintr/newchems

. 473*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 21 of 35 IX. Economic Analysis 474 A. SNUNs 475 EPA has evaluated the potential co sts of establishing SNUR reporting 476 requirements for potential manufacturers and pr ocessors of the chemical substances 477 included in this proposed rule, in cluding as part of articles (Ref. 26). In the event that a 478 SNUN is submitted, costs are estimated at approximately $8,589 per SNUN submission 479 for large business submitters and $6,189 for small business submitters. These estimates 480 include the cost to prepare and submit th e SNUN, and the payment of a user fee. 481 Businesses that submit a SNUN would be subj ect to either a $2,500 user fee required by 482 40 CFR 700.45(b)(2)(iii), or, if they are a sm all business with annual sales of less than 483 $40 million when combined with those of the parent company (if any), a reduced user fee 484 of $100 (40 CFR 700.45(b)(1)). EPA's complete economic analysis is available in the 485 public docket for this proposed rule (Ref. 26). 486 B. Export Notification 487 Under section 12(b) of TSCA and the implementing regulations at 40 CFR part 488 707, subpart D, exporters must notify EPA if th ey export or intend to export a chemical 489 substance or mixture for which, among othe r things, a rule has been proposed or 490 promulgated under section 5. For persons expor ting a substance the subject of a SNUR, a 491 one-time notice must be provided for the first export or intended e xport to a particular 492 country. The total costs of export notification will vary by chemical, depending on the 493 number of required notifications (i.e., the number of countries to which the chemical is 494 exported). EPA is unable to make any estimate of the likely number of export 495 notifications for the chemical c overed in this proposed SNUR. 496
C. Import or Processing Chemical Su bstances as Part of an Article 497*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 22 of 35 In proposing to make inapplicable the ex emption relating to persons that import or 498 process certain chemical substances as part of an article, this action may affect firms that 499 plan to import or process types of articles that may c ontain the subject chemical 500 substance. Some firms have an understanding of the contents of the articles they import 501 or process. However, EPA acknowledges that importers and proce ssors of articles may 502 have varying levels of knowledge about the chemical content of the articles that they 503 import or process. These parties may need to become familiar with the requirements of 504 the rule. And, while not required by the SNUR, these parties may take additional steps to 505 determine whether the subject chemical substanc es are part of the articles that they are 506 considering to import or process. This de termination may involve activities such as 507 gathering information from suppliers along th e supply chain, and/or testing samples of 508 the article itself. Costs vary across the activities chosen and the extent of familiarity a 509 firm has regarding the articles it imports or processes. Cost ranges are presented in the 510 Understanding the Costs Associated with Elimin ating Exemptions for Articles in SNURs 511 (Ref.27). Based on available information, EPA be lieves that article importers that choose 512 to investigate their products w ould incur costs at the lower end of the ranges presented in 513 the Economic Analysis. For those companies ch oosing to undertake actions to assess the 514 composition of the articles they import or process, EPA expects that in all likelihood, 515 these importers and processors would take ac tions that are commensurate with the level 516 of risk (of a chemical to be a part of an article) that each company perceives, and the 517 resources it has available. 518 X. Alternatives 519 Before proposing this SNUR, EPA consider ed the following alternative regulatory 520 action: 521*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 23 of 35 A. Promulgate a TSCA Section 8(a) Reporting Rule 522 Under a TSCA section 8(a) rule, EP A could, among other things, generally 523 require persons to report information to th e agency when they intend to manufacture or 524 process a listed chemical for a specific use or any use. However, for TDI, the use of 525 TSCA section 8(a) rather than SNUR authorit y would have several li mitations. First, if 526 EPA were to require reporting under TSCA s ection 8(a) instead of TSCA section 5(a), 527 EPA would not have the opportunity to revi ew human and environmental hazards and 528 exposures associated with the proposed si gnificant new use and, if necessary, take 529 immediate follow-up regulatory action under TSCA sections 5(e) or 5( f) to prohibit or 530 limit the activity before it begins. In addition, EPA may notreceive important 531 information from small businesses, because su ch firms generally are exempt from TSCA 532 section 8(a) reporting requireme nts (see TSCA sections 8(a)(1)(A) and 8(a)(1)(B)). In 533 view of the level of health concerns about TDI if used for the proposed significant new 534 use, EPA believes that a TSCA section 8(a) ru le for this substance would not meet EPA's 535 regulatory objectives. 536 B. Allow the Exemption for Persons Who Import or Process TDI and Related 537 Compounds as Part of Articles That W ould Be Subject to the Proposed SNUR 538 Under the SNUR exemption provision at § 721.45(f), a person who imports or 539 processes a chemical substance covered by a SNUR identified in 40 CFR part 721, 540 subpart E, as part of an arti cle is not generally subject to the notification requirements of 541 § 721.25 for that chemical substance. Howeve r, EPA is concerned that exempting TDI 542 and related compounds as part of articles would render the SNUR less effective because 543 of the possibility that articles could be imported or processed for uses subject to this 544 proposed SNUR without the submission of a SNUN. This proposed rule would not 545*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 24 of 35 include the exemption at § 721.45(f). 546 XI. Request for Comment 547 A. Do you have comments or information about ongoing uses? 548 EPA welcomes comment on all aspects of this proposed rule. EPA based its 549 understanding of the use profile of these ch emicals on the publishe d literature, the 2012 550 CDR submissions, market research, discussi ons with manufacturers, and product SDSs. 551 To confirm EPA’s understanding, the Agency is requesting public comment on the 552 EPA’s understanding that coating, adhesive, elastomer, binder, or sealant consumer 553 products do not contain residual TDI of more than 0.1 percent by weight, as noted in 554 Table 2. EPA believes that other consumer products do not cont ain TDI or related 555 compounds at any level. In providing comme nts on the concentration of TDI and related 556 compounds in the consumer product, it woul d be helpful if you provide sufficient 557 information for EPA to substantiate any assertions of use and concentrations. 558 B. What Should I Consider as I Prepare my Comments for EPA? 559 1. Submitting CBI . It is EPA's policy to include all comments received in the 560 public docket without change or further no tice to the commenter and to make the 561 comments available on-line at www.regulations .gov, including any personal information 562 provided, unless a comment includes informati on claimed to be Confidential Business 563 Information (CBI) or other information whose di sclosure is restricted by statute. Do not 564 submit this information to EPA through regula tions.gov or e-mail. Clearly mark the part 565 or all of the information that you claim to be CBI. For CBI information in a disk or CD 566 ROM that you mail to EPA, mark the outside of the disk or CD ROM that you mail to 567 EPA as CBI and then identify electronically within the disk or CD ROM the specific 568 information that is claimed as CBI. In addi tion to one complete version of the comment 569*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 25 of 35 that includes information claimed as CBI, a copy of the comment that does not contain 570 the information claimed as CBI must be submitted for inclusion in the public docket. 571 Information so marked will not be disclosed except in accordance with procedures set 572 forth in 40 CFR part 2, subpart B. 573 2. Tips for preparing your comments . When submitting comments, remember to: 574 i. Identify the document by docket ID number and other identifying information 575 (subject heading, Federal Register date, and page number). 576 ii. Follow directions. The agency may ask you to respond to specific questions or 577 organize comments by referencing a CFR part or section number. 578 iii. Explain why you agree or disagree ; suggest alternatives and substitute 579 language for your requested changes. 580 iv. Describe any assumptions and pr ovide any technical info rmation and/or data 581 that you used. 582 v. If you estimate potential costs or burdens, explain how you arrived at your 583 estimate in sufficient detail to allow for it to be reproduced. 584 vi. Provide specific examples to illu strate your concerns a nd suggest alternatives. 585 vii. Explain your views as clearly as possible, avoiding th e use of profanity or 586 personal threats. 587 viii. Make sure to submit your comments by the comment period deadline 588 identified. 589 XII. References 590 The following is a listing of the documents that are specifically referenced in this 591 document. The docket includes these documen ts and other information considered by 592 EPA, including documents that are referencedwithin the documents that are in the 593*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 26 of 35 docket, even if the referenced document is not physically located in the docket. For 594 assistance in locating these other documents, please consult techni cal person listed under 595 FOR FURTHER INFORMATION CONTACT

. 596 1. Krone, C., and Klinger, T. (2005). Is ocyanates, polyurethane and childhood 597 asthma. Pediatric Allergy and Immunology 16, 378-379. 598 2. Bello, D., Herrick, C. A., Smith, T. J., Woskie, S. R., Streicher, R. P., Cullen, 599 M. R., Liu, Y., and Redlich, C. A. (2007). Sk in Exposure to Isocyanates: Reasons for 600 Concern. Environmental Health Perspectives 115. 601 3. BASF Corporation. (2011). Project Summary Report Requested Industrial 602 Hygiene personal and Area Monitoring for Iden tified Airborne Chemical Hazards of 603 MDI and/or TDI Associated with Isocya nate-Containing Product Use Scenarios for 604 Identified Construction Sealants and/or Basecoat Products (Sanitized Version). JKInc

. 605 Report #: 111-11, 1- 6. 606 4. Vangronsveld, E, Berckmans, S., a nd Spence, M. (2013). Comparison of 607 Solvent/Derivatization Agent Systems for Determination of Extractable Toluene 608 Diisocyanate from Flexible Polyurethane Foam. Annals of Occupational Hygiene 57(5), 609 640-649. 610 5. Redlich, C. A., Bello, D., and Wisnewsk i, A. (2006). Isocyanate exposures and 611 health effects. In Environmental and Occupational Medicine (W. Rom, and S. 612 Markowitz, Eds.), pp. 502-516. Lippincott W illiams & Wilkins Philadelphia, PA. 613 6. DOW (2009). Product Safety Asse ssment DOW Modified Toluene 614 Diisocyanate (TDI) Products. July 16 2010. 615 http://www.dow.com/PublishedLit erature/dh_034d/0901b8038034d515.pdf?filepath=pru 616 ctsay/pdfs/noreg/233-00617.pdf&fromPage=GetDoc. 617*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 27 of 35 7. Collins, M.A. (2002). Toxicology of Toluene Diisocyanate. Applied 618 Occupational and Environmental Hygiene 17, 846-855. 619 8. Gledhill, A. Wake, A., Hext, P., Leiobold, E., and Shiotsuka, R. (2005). 620 Absorption, distribution, metabolism and excr etion of an inhalation does of 14C 4,4' 621 methylenediphenyl diisocyanate in the male rat. Xenobiotica 35, 273-292. 622 9. EPA. 2011. Toluene Diisocyanate (T DI) and Related Compounds Action Plan. 623 Available online at: http://www.epa.gov/oppt/existingche micals/pubs/actionplans/tdi.pdf. 624 10. Ott, M.G., Diller, W.F., and Jolly, A.T. (2003). Respiratory effects of toluene 625 diisocyanates in the workplace; a discu ssion of exposure-response relationships. Critical 626 Review Toxicology 33, 1-59. 627 11. Bello, D., Woskie, S. R., Streicher, R. P., Liu, Y., Stowe, M. H., Eisen, E. A. 628 Ellenbecker, M. J., Sparer, J., Youngs, F., Cullen, M. R., and Redlich, C. A. (2004). 629 Polyisocyanates in occupational environments: a critical review of exposure limits and 630 metrics. American Journal Industrial Medicine 46, 480-491. 631 12. NIOSH (1996). National Institute for Occupational Safety and Health

. 632 Preventing asthma and death from diisocya nate exposure: NIOSH Alert. (DHHS, Ed.). 633 13. American Chemistry Council (ACC) (2005). TSCA Section 8(e) Notice of 634 Substantial Risk 8EHQ-0905-16225 Fatalities linked to diisocyanates. EPA. 635 14. IARC. (1999). Toluene Diisocyanates . WHO. p. 865-879. 636 15. Environment Canada. (2008). Screen ing Assessment for the Challenge: 637 Toluene Diisocyanate. http://www.ec.gc.ca/ese-ees/ default.asp?lang=En&n=69A64ACA

. 638 16. NTP (2011). National Toxicology Program . Report on Carcinogens, Twelfth 639 Edition; U.S. Department of Health and Human Services, Public Health Service. 640*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 28 of 35 Substance Profile, Toluene Diisocyanates. http://ntp.niesh.nih.gov?objectid=03C9AF75- 641 E1BF-FF40-DBA9EC0928DF8B15. 642 17. NIOSH (2005). National Institute of O ccupational Safety and Health . NIOSH 643 Pocket Guide to Chemical Hazards July 16, 2010. 644 http://www.cdc.gov/NIOSH/npg/npgdcas.html

. 645 18. De Zotti (2000). De Zotti, R., Muran, A., and Zambon, F. (2000). Two cases 646 of paraoccupational as thma due to toluene diisocyanate (TDI). Occupational and 647 Environmental Medicine 57, 837-839. 648 19. Agency for Toxic Disease Registry (ATSDR) (2002). Case Studies in 649 Environmental Medicine: Pediatric Envir onmental Health. ATSDR Publication No. 650 ATSDR-HE-CD-2002-0002. 651 20. NIOSH (2004). National Institute for Occupational Safety and Health . A 652 Summary of Health Hazard Evaluations: I ssues Related to Occupational Exposure to 653 Isocyanates 1989-2002. (D. o. H. a. H. Serv ices, Ed.), pp. 1-42, Cincinnati, OH 654 21. Pianoforte, K. (2009). Adhesives a nd sealants market update, November 1, 655 2009. In Coatings World. 656 22. Kelly, T. J., Myers, J. D., and Hold ren, M. W. (1999). Testing of Household 657 Products and Materials for Emission of Toluene Diisocyanate. Indoor Air 9, 117-124. 658 23. Jarand, C. W., Akapo, S. O., Swenson, L. J., and Kelman, B. J. (2002). 659 Diisocyanate emission from a paint product: a preliminary analysis. Applied 660 Occupational Environmental Hygiene 17, 491-494. 661 24. NYC-DOHMH (2010). New York City Department of Health and Mental 662 Hygiene . Moisture Cure Urethanes (MCU). July 16, 2010. 663 http://www.nyc.gov/html/doh/ html/epi/mcufact.shtml. 664*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 29 of 35 25. NIOSH (2006). National Institute fo r Occupational Safety and Health. 665 Preventing Asthma and Death from MDI Exposure During Spray-on Truck Bed Liner 666 and Related Applications: NIOSH Alert. http://www.cdc.gov/niosh/docs/2006- 667 149/default.html

. 668 26. EPA. Economic Analysis of the Si gnificant New Use Rule for Toluene 669 Diisocyanate (TDI) and Rela ted Compounds. April 2, 2014. 670 27. EPA, Understanding the Cost s Associated with Eliminating 671 Exemptions for Articles in SNURs. May 1, 2013. 672 XIII. Statutory and Executive Order Reviews 673 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: 674 Improving Regulation and Regulatory Review 675 This proposed SNUR has been designated by the Office of Management and 676 Budget (OMB) as a ‘‘significan t regulatory action ’’ under section 3(f) of Executive Order 677 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted this action to OMB for 678 review under Executive Orders 12866 a nd 13563 (76 FR 3821, January 21, 2011), and 679 any changes made in response to OMB recommendations are documented in the docket. 680 B. Paperwork Reduction Act (PRA) 681 This action does not impose any new in formation collection burden under the 682 PRA, 44 U.S.C. 3501 et seq. Burden is defi ned in 5 CFR 1320.3(b). The information 683 collection activities associated with exis ting chemical SNURs are already approved by 684 OMB under OMB control number 2070-0038 (EPA ICR No. 1188); and the information 685 collection activities a ssociated with export notifications are already approved by OMB 686 under OMB control number 2070-0030 (EPA ICR N o. 0795). If an entity were to submit 687 a SNUN to the Agency, the annual burden is estimated to be less than 100 hours per 688*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 30 of 35 response, and the estimated burden for an e xport notifications is less than 1.5 hours per 689 notification. In both cases, burden is estimatedto be reduced for submitters who have 690 already registered to use the electronic submission system. Additional burden, estimated 691 to be less than 10 hours, coul d be incurred where additional record keeping requirements 692 are specified under 40 CFR §721.125(a), (b), and (c). 693 An agency may not conduct or sponsor, and a person is not required to respond to 694 a collection of information that requires OM B approval under the PRA, unless it has been 695 approved by OMB and displays a currentl y valid OMB control number. The OMB 696 control numbers for EPA's regulations in Titl e 40 of the CFR, after appearing in the 697 Federal Register , are listed in 40 CFR, part 9, a nd included on the related collection 698 instrument, or form, if applicable. EPA is amen ding the table in 40 CFR part 9 to list this 699 SNUR. This listing of the OMB control numbers and their subsequent codification in the 700 CFR satisfies the display requirements of the PRA and OMB's implementing regulations 701 at 5 CFR part 1320. Since the existing OMB approval was previously subject to public 702 notice and comment before OMB approval, and given the technical nature of the table, 703 EPA finds that further notice and comment to amend the table is unnecessary. As a result, 704 EPA finds that there is “good cause” under se ction 553(b)(3)(B) of the Administrative 705 Procedure Act (5 U.S.C. 553(b)(3)(B)) to am end this table without further notice and 706

comment. 707 C. Regulatory Flexibility Act (RFA) 708 Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq ., I hereby certify that 709 promulgation of this SNUR would not have a significant economic impact on a 710 substantial number of small entities. The rationale supporti ng this conclusion is as 711 follows. 712*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 31 of 35 A SNUR applies to any pers on (including small or large entities) who intends to 713 engage in any activity describe d in the rule as a “significan t new use.” By definition of 714 the word “new” and based on all information cu rrently available to EPA, it appears that 715 no small or large entities presently engage in such activities. Since this SNUR will 716 require a person who intends to engage in such activity in the future to first notify EPA 717 by submitting a SNUN, no economic impact will occur unless someone files a SNUN to 718 pursue a significant new use in the future or forgoes profits by avoiding or delaying the 719 significant new use. Although some small entitie s may decide to conduc t such activities 720 in the future, EPA cannot presently determin e how many, if any, there may be. However, 721 EPA’s experience to date is that, in res ponse to the promulgation of SNURs covering 722 over 1,000 chemical substances, the Agency rece ives only a handful of notices per year. 723 During the six year period from 2005-2011, only three submitters self -identified as small 724 in their SNUN submission (Ref. 26). EPA be lieves the cost of submitting a SNUN is 725 relatively small compared to the cost of de veloping and marketing a chemical new to a 726 firm and that the requirement to submit a SN UN generally does not have a significant 727 economic impact. 728 Therefore, EPA believes that the potentia l economic impact of complying with 729 this proposed SNUR is not expected to be si gnificant or adversely impact a substantial 730 number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 731 FR 42690) (FRL-5735-4), the Agency presented its general determination that proposed 732 and final SNURs are not expect ed to have a significant ec onomic impact on a substantial 733 number of small entities, which was provide d to the Chief Counsel for Advocacy of the 734 Small Business Administration. 735 D. Unfunded Mandates Reform Act (UMRA) 736*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 32 of 35 Based on EPA’s experience with proposi ng and finalizing SNURs, State, local, 737 and Tribal governments have not been imp acted by these rulemakings, and EPA does not 738 have any reason to believe that any State, lo cal, or Tribal government would be impacted 739 by this rulemaking. As such, the requirem ents of sections 202, 203, 204, or 205 of 740 UMRA, 2 U.S.C. 1531-1538, do not apply to this action. 741 E. Executive Order 13132: Federalism 742 This action will not have a substantial di rect effect on States, on the relationship 743 between the national government and the Stat es, or on the distribution of power and 744 responsibilities among the various levels of government, as specified in Executive Order 745 13132 (64 FR 43255, August 10, 1999). 746 F. Executive Order 13175: Consultation and Coordination with Indian Tribal 747
Governments 748 This proposed rule does not have Tribal implications because it is not expected to 749 have any effect (i.e., there will be no increase or decrease in author ity or jurisdiction) on 750 Tribal governments, on the relationship betw een the Federal government and the Indian 751 tribes, or on the distribution of power and responsibilities between the Federal 752 government and Indian tribes. Thus, Ex ecutive Order 13175 (65 FR 67249, November 9, 753 2000), does not apply to this action. 754 G. Executive Order 13045: Protection of Childre n from Environmental Health Risks and 755 Safety Risks 756 This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 757 1997), because this action is not intended to ad dress environmental health or safety risks 758 for children. 759 H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect 760*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 33 of 35 Energy Supply, Distribution, or Use 761 This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 762 22, 2001), because this action is not expected to affect energy supply, distribution, or use. 763 I. National Technology Transfer and Advancement Act (NTTAA) 764 Since this action does not involve any technical standards, section 12(d) of 765 NTTAA, 15 U.S.C.272 note, does no t apply to this section. 766 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 767 Populations and Low-Income Populations 768 This proposed rule does not invoke special consideration of environmental justice 769 related issues as delineated by Executiv e Order 12898 (59 FR 7629, February 16, 1994), 770 because EPA has determined that this action will not have disproportionately high and 771 adverse human health or environmental eff ects on minority or low-income populations. 772 This action does not affect th e level of protection provide d to human health or the 773 environment. 774 List of Subjects in 40 CFR Part 721 775 Environmental protection, Chemicals, Hazardous substances, Reporting and 776 recordkeeping requirements. 777 Dated: _______________________ 778
779

____________________________________________ 780 Director, Office of Pollution Prevention and Toxics. 781*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 34 of 35 Therefore, it is proposed that 40 CF R part 721 be amended as follows: 782 PART 721--[AMENDED] 783 1. The authority citation for part 721 continues to read as follows: 784 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 785 2. Add §721. xx to subpart E to read as follows : 786 §721.10xxx Toluene Diisocyanates and Related Compounds 787 3. Add § 721.xx as follows: 788 (a) Chemical substances and significant new uses subject to reporting. (1) The 789 chemical substances listed in Table 1 and Table 2 of this para graph are subject to 790 reporting under this section for the significant new uses described in paragraph (a)(2) of 791 this section. 792 Table 1.—Toluene Diisocyanates ad Rela ted Compounds Subject to Reporting for 793 Any Use in a Consumer Product 794 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) Ben zene, 1,3-diisocyanatomethyl-, homopolymer 9017-01-0 Toluene diisocyanate dimer 1,3-Diazetidine-2,4-dione, 1,3bis(3- isocyanatomethylphenyl)- 26747-90-0 Toluene diisocyanate “cyclic” trimer 1,3,5-Triazine-2,4,6(1H,3H,5H)- trione, 1,3,5-tris(3- isocyanatomethylphenyl)- 26603-40-7 795 Table 2.—Toluene Diisocyanates ad Rela ted Compounds Subject to Reporting for 796 Any Use in A Consumer Product (Except for use in Coatings, Adhesives, 797 Elastomers, Binders, and Sealants at Less than or Equal to 0.1 Percent in a 798 Consumer Product) 799 Chemical Name Chemical Abstracts Index Name Chemical Abstracts Service Registry Number (CASRN) 2,6-Toluene diisocyanate Benzene, 1,3-diisocyanato-2- 91-08-7*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 35 of 35methyl2,4-Toluene diisocyanate Benzene, 2,4-diisocyanato-1- methyl- 584-84-9 Toluene diisocyanate unspecified isomers Benzene, 1,3-diisocyanatomethyl- 26471-62-5 800 (2) The significant new uses are: 801 (i) For the chemical substances listed inTable 1 of paragraph (a)(1), any use of 802 the chemical substance in consumer products. 803 (ii) For the chemical substances listed inTable 2 of paragraph (a)(1), any use of 804 the chemical substance in a consumer produc t (except for use in coatings, adhesives, 805 elastomers, binders, and sealants, that resu lts in less than or equal to 0.1 percent by 806 weight of such chemical substa nce in the consumer product). 807 (b) Specific requirements. The provisions of subpart A of this part apply to this 808 section except as modified by this paragraph: 809 (1) Revocation of certain notification exemptions. The provisions of § 721.45(f) 810 do not apply to this section. A person who im ports or processes a chemical substance 811 identified in paragraph (a)(1) of this section as part of an article for a significant new use 812 described in paragraph (a)(2) of this sec tion is not thereby exempt from submitting a 813 significant new use notice. 814 (2) [Reserved] 815