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### EO 12866/13563 Review Draft – As Submitted Revised 12/11/2014 1 Rin2070-AJ91_EO12866_TDI SNUR_N PRM_FRN_MASTER_REDLINE_2014-12- 2 11.docxRin2070-AJ91_EO12866_TDI-SNUR _NPRM_FRdocument_2014-08-15.docx 3 4 BILLING CODE 6560-50-P 5 ENVIRONMENTAL PRO TECTION AGENCY 6 40 CFR Part 721 7 [ EPA-HQ-OPPT-2011-0976; FRL- XXXX9915
- X62] 8 RIN 2070-AJ91 9 Toluene Diisocyanates (TDI) and Relate d 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-toluen e diisocyanate, 2,6-toluene diisocyanate, 14 toluene diisocyanate unspecified isomers (the se 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 chemi cal substances in coatings, elastomers, 18 adhesives, binders, and sealants that results in less than orequal to 0.1 percent by weight 19 of TDI in a consumer product. In addition, EP A is also proposing that the general SNUR 20 article exemption for persons who import or proc ess these chemical substances as part of 21 an article would not apply. Pers ons 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 w ith 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25 against potential unreasonable risks, if any, from that activity before it occurs. 26*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 2 of 39 DATES: Comments must be recei ved 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 Info rmation (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 Protect ion Agency, 1200 Pennsylvania Ave., NW., 36 Washington, DC 20460-0001. 37

• Hand Delivery : To make special arrangements fo r 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 ge nerally, is available at http://www.epa.gov/dockets

. 42 FOR FURTHER INFORMATION CONTACT: For technical information contact : 43 Katherine Sleasman, Chemical Control Divisi on (7405M), Office of Pollution Prevention 44 and Toxics, Environmental Protectio n 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; telephon e number: (202) 554–1404; e-mail address: 49 TSCA-Hotline@epa.gov

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Page 3 of 39 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 he lp 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 (NAI CS 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 polyuretha ne foam products (NAICS code 64 32615031). 65

• Products made of foam other than polys tyrene 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 certai n entities through pre-existing import 73 certification and export notification rule s under TSCA. Persons who import any 74*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 4 of 39 chemical substance governed by a final SNURare subject to the TSCA section 13 (15 75 U.S.C. 2612) import certification requiremen ts and the corresponding regulations at 19 76 CFR 12.118 through 12.127; see also 19 CFR 1 27.28. 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 CF R part 707, subpart B. In addition, any persons who export 80 or intend to export a chemical substance that is the subject of this proposed rule on or 81 after [ insert date 30 days after the date of publication in the Federal Register ] are 82 subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), 83 (see 40 CFR 721.20), and must comply with th e export notification requirements in 40 84 CFR part 707, subpart D. 85 If you have any questions regarding the appl icability of this action to a particular 86 entity, consult the technical in formation contact listed under FOR FURTHER 87 INFORMATION CONTACT

. 88 B. What Is the Agency's Aut hority 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 “si gnificant new use.” EPA must make this 91 determination by rule after c onsidering all releva nt factors, includi ng 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 Pp art 721, Ss ubpart A. 97 C. What Action Is the Agency Taking? 98*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 5 of 39 EPA is proposing a SNUR for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, 99 toluene diisocyanate unspecified isomers (the se three chemical substances are hereafter 100 referred to as toluene diisocyanates or TDI) and related compounds. The proposed 101 significant new use is: aA ny use in a consumer product of any chemical substance listed 102 in Table 1 of Unit II.A. ; and any use in a consumer produc t of any chemical listed in 103 Table 2 of Unit II.A. (except for use in coatings, el astomers, adhesives, binders, and 104 sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer 105 product). 106 This proposed significant new use rule woul d apply to the uses EPA has identified 107 in this unit that EPA believes are not ongoing at th e time of this proposed rule. EPA is 108 requesting public comment on this propos al, and specifically on the Agency’s 109 understanding of ongoing uses for the chemicals identified in Table 1 of Unit II.A and 110 Table 2 of Unit II.A. in consumer products. EPA is part icularly interested in whether 111 there are any ongoing uses of these chemicals in consumer products of which the Agency 112 is currently unaware and would welcome specific documentation of any such ongoing 113 uses. A consumer product is defined at 40 CFR 721.3 as: a chemical substance that is 114 directly, or as part of a mixt ure, sold or made available to consumers for their use in or 115 around a permanent or temporary household or residence, in or around a school, or in 116 recreational settings. 117 This proposed SNUR would require persons that manufacture (including import) 118 or process any of the chemicals for a si gnificant new use, consistent with the 119 requirements at 40 CFR 721.25, to notify EPA atleast 90 days before commencing such 120 manufacture or process of the chemical subs tance for a significant new use. For this 121 proposed rule, EPA is proposing that the ge neral SNUR article exemption at 40 CFR 122*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 6 of 39 721.45(f) for persons who import or process chem ical substances as part of an article 123 would not apply. The article exemption at 40 CFR 721.45(f) is based on an assumption 124 that people and the environmen t will generally not be exposed to chemical substances in 125 articles (see September 5, 1984; 49 FR 35014; FRL-2541-8 September 5, 1984 )(Ref. 1)

. 126 However, TDI and related compounds are vol atile and as such could migrate out of 127 articles that contain them. For instance, studies of TDI in polyurethane products reported 128 that after the reaction between an isocyana te and an alcohol to form polyurethane 129 products, residual levels of isocyanates we re detected on the surface of the products, (e.g. 130 flexible foams), which if used could lead to exposure (Refs. 2 and 3 ). Because TDI and 131 related compounds are known to be volatile chem ical substances, have been reported to 132 migrate from products, are sensitizers, a nd would be expected to present a higher 133 potential for exposure if the TDI in the arti cle were a consumer product, EPA would like 134 the opportunity to evaluate such potential uses in consumer products for any associated 135 risks or hazards that might exist before those uses would begin. 136 D. Why Is the Agency Taking this Action? 137 These SNURs are necessary to ensure th at EPA receives timely advance notice of 138 any future manufacturing and processing of TD I and related compounds for new uses that 139 may produce changes in human and envir onmental exposures. The rationale and 140 objectives for this SNUR ar e explained in Unit III. 141 E. What are the Estimated Incremental Impacts of this Action? 142 EPA has evaluated the potential co sts of establishing SNUR reporting 143 requirements for potential manufacturers and pr ocessors of the chemical substances 144 included in this proposed rule. This analys is, which is available in the docket, is 145 discussed in Unit IX., and is briefly summarized here. In the event that a SNUN is 146*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 7 of 39 submitted, costs are estimated to be less than $8, 700 589 per SNUN submission for large 147 business submitters and $6, 300 189 for small business submitters. These estimates 148 include the cost to prepare and submit the SNUN and the payment of a user fee. The 149 proposed SNUR would require first-time subm itters of any TSCA section 5 notice to 150 register their company and key users with the CDX re porting tool, deliver a CDX 151 electronic signature to EPA, and establis h and use a Pay.gov E-payment account before 152 they may submit a SNUN, for a cost of $200 per firm. However, these activities are only 153 required of first-time submitters of section 5 notices. In addition, for persons exporting a 154 substance that is the subject of a SNUR, a one -time notice must be provided for the first 155 export or intended export to a particul ar country, which is estimated to cost less than 156 $100 on average be $84.22 per notification. The rule may al so affect firms that plan to 157 import or process articles that contain TD I and related compounds, because, while not 158 required by the SNUR, these parties may take additional steps to determine whether TDI 159 and related compounds are part of the articles that they are considering to import or 160 process. Since EPA is unable to predict whet her anyone might engage in future activities 161 that would require reporting, potential total costs were not estimated. 162 II. Chemical Substances Subject to this Proposed Rule 163
A. What Chemicals Are Included in the Proposed SNUR? 164 This proposed SNUR would apply to TD I and its related compounds listed in 165 Table 1 of this unit and Table 2 of this unitin consumer products. Diisocyanates contain 166 free isocyanate functional groups (-N=C=O). Diisocyanates are co mbined with other 167 compounds that contain free hydroxyl functiona l groups (i.e., –OH), typically called 168 “polyols.” These two-part components react and begin to form polyurethane polymers. 169 This chemical reaction is completed when all of the isocyanate functional groups are 170*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 8 of 39 bound within the polymer network. This proce ss is commonly referred to as “curing.” 171 Products that contain free is ocyanate functional groups are intended to react further and 172 undergo “curing” in the process of use. The ch emical substances subject to this proposed 173 SNUR contain free isocyanate functiona l groups and are by definition uncured. Prior to 174 complete curing, consumers and bystanders can potentially be exposed to isocyanates 175 through both dermal and respiratory routes. Ex posures to uncured isocyanates could lead 176 to sensitization. 177 To ascertain if TDI and related compounds are used in consumer products, EPA 178 reviewed published literature, the most rece nt data from EPA’s Chemical Data Reporting 179 program (CDR), and communicated directly with manufacturers and processors. 180 Reporting under the CDR indicated no consum er uses of TDI or related compounds. 181 However, during conversations between EPA personnel and manufacturers and 182 processors, it was revealed that in some cases consumer products may still contain 183 residual TDI of no more than 0.1 per cent by weight, as noted in Table 2 of this unit (Ref. 184
4 ). This was also confirmed by review of published literature and SDS for consumer 185 adhesives and sealants availabl e in retail outlets. It is EP A’s understanding that any TDI 186 present in a coating, adhesive, elastomer, binde r or sealant consumer product is at levels 187 of no more than 0.1 percent by weight and would typically be considered residual 188 diisocyanate remaining from the manufactur e of a polyurethane polymer, a concentration 189 which is above the detection level (Ref. 5 ). EPA believes that other consumer products do 190 not contain TDI or related compounds at any level. 191 Table 1 – Toluene Diisocyanate Related Comp ounds Subject to this Action with a 192 Proposed Significant New Use of “Any Use in a Consumer Product” 193 194 Chemical Name Chemical Abstracts Index Name Chemical Abstracts Service*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 9 of 39 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)- 26603-40-7 195 Table 2 – Toluene Diisocyanates Subject to this Action with a Proposed Significant 196 Use of “Any Use in A Consumer Product (Except for use in Coatings, Adhesives, 197 Elastomers, Binders, and Sealants at Less than or Equal to 0.1 Percent in a 198 Consumer Product)” 199 200 Chemical Name Chemical Abstracts Index Name Chemical Abstracts Service Registry Number (CASRN) 2,6-Toluene diisocyanate Benzene, 1,3-diisocyanato-2-methyl91-08-7 2,4-Toluene diisocyanate Benzene, 2,4-diisocyanato-1- methyl- 584-84-9 Toluene diisocyanate unspecified isomer Benzene, 1,3-diisocyanatomethyl- 26471-62-5 201
B. What Are the Production Volumes and Us es of TDI and Related Compounds? 202 TDI and the related compounds are genera lly high production volume chemicals, 203 predominantly used in the production of polyurethanes. There are many types of 204 polyurethane products in the marketplace, with foams representing th e largest sector of 205 the polyurethane industry. Flexible foam is primarily used for cushioning, while rigid 206 foam is used mainly for insulation (Ref. 6 ). Approximately 90 percent of TDI, typically a 207 mixture of toluene diisocyanate isomers, is used in the production of flexible foams, 208 which are designed to be fully cured in a final product. Non-foam polyurethane use 209 sectors of TDI include coatings, adhesives, elastomers, binders, and sealants. These 210*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 10 of 39 products may be sold and used, most often in a mixture of formulated product, in an 211 uncured form. Because of its hazards, some i ndustry representatives assert that TDI is 212 used in products intended for industrial use only (Ref. 7 ). In contrast, EPA believes 213 coatings, adhesives, elastomers, binders, and sealants used by general consumers contain 214 residual TDI of no more than 0.1 percent by weight. Due to th e projected growth of the 215 market for such use in consumer products as discussed further in Unit II.D., EPA is 216 concerned that consumer products in the future might contain amounts of TDI above 217 these levels. Therefore, EPA is proposing th is action to provide the Agency with an 218 opportunity to evaluate such potential uses in consumer products for any associated risks 219 or hazards that might exist be fore those uses would begin. 220
C. What Are the Potential Health Ef fects of TDI and Related Compounds? 221 In acute, subacute, and chronic animal e xposure studies for TDI, the respiratory 222 tract was the target organ, with nasal irri tation evident at concen trations above 0.1 ppm 223 and effects becoming more severe wi th increasing concentration (Ref. 8 ). TDI is 224 uniformly distributed throughout the body, following inhalation exposure (Refs. 8 and 9 ). 225 TDI causes skin, eye, and lung irritation, progr essive impairment of lung function with 226 long-term inhalation exposure and is a resp iratory sensitizer via both the dermal and 227 inhalation routes of e xposure in animals (Ref. 8 ). 228 Most data on human health hazards resu lting from diisocyanate exposures are 229 from occupational populations ra ther than exposures to consumer products. As discussed 230 in the Toluene Diisocyanate and Re lated Compounds Action Plan (Ref. 10 ), 231 diisocyanates, including TD I and related compounds, are well-known dermal, eye, and 232 inhalation irritants and sensit izers based on worker data. They have been documented in 233 the workplace to cause asthma and respiratory problems, such as hypersensitivity 234*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 11 of 39 pneumonitis, an inflammation of the lungs. In se vere cases, there have been reported fatal 235 reactions. 236 Isocyanate exposure has been identified as the leading attributable cause of work237 related asthma, and prevalen ce in the exposed workforce has been estimated at 1-20 238 percent (Refs. 11 and 12 ). Once a worker is sensitized to diisocyanates, subsequent 239 exposures can trigger severe as thma attacks. Spray applica tion and heated processes are 240 associated with higher incidences of asthmathan other application methods because they 241 can generate airborne isocyanate vapors and mists, which lead to worker exposure via the 242 respiratory and dermal routes. Most worker s who develop diisocyanate asthma have 243 experienced long periods of exposure (mont hs or longer); however, the minimum 244 exposure to isocyanates that can elicit sens itization responses or asthma is unknown. In 245 addition, immune response and subsequent di sease in humans can vary significantly 246 between individuals (Ref. 6 ). Fatalities linked to diisocya nate exposures in sensitized 247 persons have been reported (Refs. 13 and 14 ). 248 The International Agency for Research on Cancer (IARC) classified toluene 249 diisocyanates as “possibly carcinogenic to hum ans” (Carcinogenicity Group 2B), based 250 on inadequate evidence for the carcinogenicity of TDI in humans and sufficient evidence 251 for the carcinogenicity of TDI in experimental animals (Ref. 15 ). TDI has also been 252 classified by the European Commission (EC) as Category 3 for carcinogenicity (“causes 253 concerns for humans owing to po ssible carcinogenic effects”) (Ref. 16 ) and by the United 254 States National Toxicology Pr ogram (NTP) as “reasonably anticipated to be a human 255 carcinogen” (Ref. 17 ). National Institutes for Occupational Safety and Health (NIOSH) 256 considers TDI to be an occupational carci nogen and recommends exposure reduction to 257 the lowest feasible levels (Ref 18 ). 258*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 12 of 39 There are very few reports available re garding non-occupatio nal health effects 259 from exposures to TDI products. However, there are case reports suggesting that 260 paraoccupational (brought outside of the wo rkplace) asthma may have resulted from 261 incidental exposure to TDI, one of which involved incidental exposure to varnishing 262 products (Ref. 19 ). A specific, potential concern for consumer products is exposures to 263 children. Children exposed to the same leve ls of TDI vapor as adults may receive a 264 larger dose because they have greater l ung surface area to body weight ratios and 265 increased respiratory minute volumes to weight ratios. TDI vapor is heavier than air and 266 may layer close to the floor; therefore, childre n who crawl, roll, or sit on surfaces treated 267 with chemicals (i.e. carpets and floors) and play with objects such as toys where residues 268 may settle could potentially receive higher doses of inhaled toxicants than adults present 269 in the same room (Ref. 20 ). 270
D. What Are the Potential Route and Sources of Exposure to TDI and Related 271 Compounds? 272 There is available information on work er exposures to industrial products 273 containing TDI, such as coatings, adhesives, and sealants. Exposures resulting from the 274 use of these industrial products may indicate potential but lower level exposures that may 275 result for users conducting sim ilar activities with consumer products containing residual 276 TDI. There is a potential for worker exposure to TDI in al l industrial and commercial 277 settings where TDI is present (Ref. 7 ). Because of the high volatility of TDI, exposure 278 can occur in all phases of its use, even in the final product (Ref. 17 ), and it is unknown to 279 what extent factors such as appli cation techniques, product composition, and 280 environmental conditions influence the availa bility of TDI in products. One activity 281 where overexposures have been documented is floor finishing in both personal and area 282*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 13 of 39 samples in one NIOSH evaluation (Ref. 21 ). Exposure data for professional workers may 283 provide an indication of possible exposures if consumer products and articles were to 284 contain residual TDI. 285 As previously discussed, TDI is used in coatings, adhesives, sealants, and other 286 polyurethane products. TDI is used in the ma nufacturing process of the polymer and as a 287 result, a small percentage of TDI may be pr esent in consumer produc ts, including articles. 288 Further, researchers looking at workplace e xposures to diisocyanates have noted an 289 increase in the number of isocyanate-c ontaining products used by consumers (Ref. 6 ). In 290 addition, consumer use of adhesives and sealants is a potential growth sector as seen in 291 the increasing numbers of “Do It Yourself ” (DIY), energy-conscious homeowners doing 292 more of their own home renovation and repa ir work, as well as from craftsmen and 293 consumers generally continui ng to use adhesives (Ref. 22 ). Most consumers would be 294 unaware of the potential hazards of consumer products, including articles, containing TDI 295 or other diisocyanates. Consequently, insu fficient and inadequate hazard communication 296 may lead to incorrect use and increased c onsumer and bystander exposures, particularly 297 for sensitive groups, such as children. For ex ample, exposures to bystanders and building 298 occupants (including children) to TDI in industrial products have been reported in the 299 literature, including emissions of TDI fr om concrete patio sealants (Refs. 23 and 24 ) and 300 detection of TDI in building air samples fo llowing use of urethanes containing TDI to 301 coat wood floors (Ref. 25 ). It is possible that lower level exposures could occur when 302 conducting comparable activitie s using similar types of consumer products containing 303 residual TDI. Even if consumers are aware of such potential hazards, they may not take 304 appropriate precautions or research the appropr iate resources in which these precautions 305 are addressed. Of particular concern is the fact that children may ha ve a greater potential 306*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 14 of 39 for exposure if they use or are bystanders to the use of consumer products containing 307 even residual amounts of TDI, because they may not have fully developed judgment for 308 following labeling instructions and safety precautions and may not cease activity even 309 when they are experiencing symptoms of exposure. 310 III. Rationale and Objectives 311 A. Rationale 312 Diisocyanates are potent dermal and lung se nsitizers and an attributable cause of 313 work-related asthma worldwide (Ref. 26 ). In the past, consumer exposures have not been 314 a focus of concern with respect to diisoc yanates, because it had been assumed that 315 consumers were generally exposed to pr oducts containing only completely cured 316 polyurethanes, which have been generally considered to have low toxicity (Ref. 2 ). 317 However, an increase in consumer use of polyurethane products that may further react 318 and undergo “curing” could occur if consumer products, such as coatings, elastomers, 319 adhesives, and sealants contained TDI in am ounts greater than residual amounts. In such 320 instances, TDI and related compounds that are not completely reacted upon their 321 application can provide potential exposures both to the consumeras the direct user or to 322 bystanders when products ar e used by others (Refs. 2 and 3 ). In sensitized individuals, 323 exposure to even small amounts of diisocyanate s may cause allergic respiratory reactions 324 like asthma and severe breathing difficulties (Ref. 6 ). EPA believes that the use of any of 325 these chemical substances in consumer produc ts above current levels could significantly 326 increase human exposure, and that such in crease should not occur without an opportunity 327 for EPA review and control as appropriate. As discussed in Unit II

. , regarding the 328 chemicals listed in Table 2 of Unit II.A. , based on Safety Data Sheets (SDS) information 329 that coating-, adhesive-, el astomer-, binder-, or sealant-consumer products may contain 330*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 15 of 39 residual TDI of no more than 0.1 percent by weight, EPA believes that these consumer 331 products do not contain residual TDI of more than 0.1 percent by weight. EPA believes 332 that other consumer products do not contain TDI or related compounds at any level. 333 Consistent with EPA's past practice for issuing SNURs under TSCA section 334 5(a)(2), EPA's decision to propose a SNUR fo r a particular chemical use need not be 335 based on an extensive evaluation of the hazard, e xposure, or potential ri sk associated with 336 that use. Rather, the Agency action is based on EPA's determination that if the use begins 337 or resumes, it may present a risk that EP A should evaluate under TSCA before the 338 manufacturing or processing for that use be gins. Since the new use does not currently 339 exist, deferring a detailed consideration of potenti al risks or hazards related to that use is 340 an effective use of resources. If a person d ecides to begin manufact uring or processing 341 the chemical for the use, the notice to EPA allows EPA to evaluate the use according to 342 the specific parameters and circumst ances surrounding that intended use. 343 B. Objectives 344 Based on the considerations in Unit III. A., EPA wants to achieve the following 345 objectives with regard to the significant new use(s) that are designa ted in this proposed 346 rule: 347 1. EPA would receive notice of any pers on’s intent to manufacture or process 348 TDI or its related compounds (see Table 1 of Unit II.A and Table 2 of Unit II.A. ) for the 349 described significant new use be fore that activity begins. 350 2. EPA would have an opportunity to review and evaluate data submitted in a 351 SNUN before the notice submitter begins manufacturing or processing TDI or its related 352 compounds (see Table 1 of Unit II.A. and Table 2 of Unit II.A. ) for the described 353 significant new use. 354*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 16 of 39 3. EPA would be able to regulate prosp ective manufacturers or processors of TDI 355 or its related compounds (see Table 1 of Unit II.A. and Table 2 of Unit II.A. ) before the 356 described significant new use of the chemical substance occurs, provided that regulation 357 is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7. 358 IV. Significant New Use Determination 359 Section 5(a)(2) of TSCA states that EPA' s determination that a use of a chemical 360 substance is a significant new us e must be made after consider ation of all relevant factors 361 including: 362 •1. The projected volume of manufactu ring and processing of a chemical 363 substance. 364 •2. The extent to which a use changes the type or form of exposure of human 365 beings or the environment to a chemical substance. 366 •3. The extent to which a use increases the magnitude and duration of exposure 367 of human beings or the environment to a chemical substance. 368 369 •4. The reasonably anticipated manne r and methods of manufacturing, 370 processing, distribution in commerce, and dispos al of a chemical substance. 371 372 In addition to these factors enumerated in TSCA section 5(a)(2), the statute 373 authorizes EPA to consider a ny other relevant factors. 374 To determine what would constitute a si gnificant new use of TDI or its related 375 compounds subject to this proposed rule, as discussed in this unit , EPA considered 376 relevant information about the toxicity of these substances, likel y human exposures and 377 environmental releases associated with possibl e uses, and the four f actors listed in section 378*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 17 of 39 5(a)(2) of TSCA. EPA has preliminarily dete rmined as the significant new uses: any use 379 in a consumer product for any chemical listed in Table 1 of Unit II.A. ; and any use in a 380 consumer product for any chemical listed in Table 2 of Unit II.A. (except for use in 381 coatings, elastomers, adhesives, binders, and seal ants that results in less than or equal to 382 0.1 percent by weight of TD I in a consumer product). 383 The article exemption at 40 CFR 721.45(f) is based on an assumption that people 384 and the environment will generally not be exposed to chemical substances in articles (see 385 September 5, 1984; 49 FR 35014 ,; September 5, 1984 ) (Ref. 1).. However, TDI and 386 related compounds are volatile and as such could migrate out of articles that contain 387 them. For instance, studies of TDI in pol yurethane products reported that after the 388 reaction between an isocyanate and an alcoho l to form polyurethane products, residual 389 levels of isocyanates were detected on the surface of the products, which if used could 390 lead to exposure (Refs. 2 and 3 ). Because TDI and relate d compounds are known to be 391 volatile chemical substances, have been reported to migrate from products, are 392 sensitizers, and would be expected to presen t a higher potential for exposure if the TDI in 393 the article were a consumer product, EPA w ould like the opportunity to evaluate such 394 potential uses in consumer products for any a ssociated risks or hazards that might exist 395 before those uses would begin. 396 EPA believes any new use of TDI and rela ted compounds as part of articles would 397 increase the duration and magn itude of human exposure to th e substance. Based on these 398 considerations, EPA has preliminarily de termined that importing or processing 399 substances in Table 1 of Unit II.A. and Table 2 of Unit II.A. as part of articles warrants 400 making inapplicable the arti cle exemption at 40 CFR 721.45(f ) for the significant new 401 uses identified in the tables in Unit II.A.

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

Page 18 of 39 V. Importers and Processors of These Chem ical Substances as Part of Articles 403 Once the determination of a significant new use under TSCA section 5(a)(2) has 404 been made, EPA may separately determine wh ether it would be appropriate to make the 405 regulatory exemption for some or all persons who import or process a chemical substance 406 as part of an article ( 40 CFR 721.45(f)) inapplicable to a SNUR. In this case, EPA 407 believes that the assumption underpinning this exemption, that people and the 408 environment will generally not be exposed to chemical substances as part of articles, does 409 not hold true. See Unit IV. for a discussion of why EPA believes this assumption is 410 incorrect. Thus EPA is proposing to make this exemption inapplicable to importers or 411 processors of the TDI and re lated compounds as part of an article for the identified 412 significant new uses. EPA is requesting comme nt on the potential for exposure to these 413 chemical substances via these articles a nd for comments on the ongoing uses of the TDI 414 and related compounds as part of an articl e. EPA is not proposing to make this 415 exemption inapplicable to processors of these ch emical substances as part of an article. 416 VI. Applicability of General Provisions 417 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 418 provisions describe persons subject to the ru le, recordkeeping requirements, exemptions 419 to reporting requirements, and applicability of the rule to uses occurring before the 420 effective date of the final rule. Howeve r, for this action, EPA is proposing that 40 CFR 421 721.45(f) (which generally exempts persons im porting or processing a substance as part 422 of an article) will not apply and a person who imports or processes a chemical substance 423 as part of an article would not be exempt from submitting a SNUN. 424 Provisions relating to user fees appe ar at 40 CFR part 700. According to 425 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice 426*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 19 of 39 requirements and EPA regulatory procedures as submitters of Premanufacture Notices 427 (PMNs) under TSCA section 5( a)(1)(A). In particular, th ese requirements include the 428 information submissions requirements of TSCA section 5(b) and 5(d)(1), the exemptions 429 authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 430 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under 431 TSCA section 5(e), 5(f), 6 or 7 to control the activities on which it has received the 432 SNUN. If EPA does not take action, EPA is re quired under TSCA section 5(g) to explain 433 in the Federal Register its reasons for not taking action. 434 Persons who export or intend to exporta chemical substa nce identified in a 435 proposed or final SNUR are s ubject to the export notificati on provisions of TSCA section 436 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 437 subpart D. In accordance with 40 CFR 707.60(b) this proposed SNUR does not trigger 438 export notification for articles. Persons who import a chemical substance identified in a 439 final SNUR are subject to the TSCA s ection 13 import certifi cation requirements, 440 codified at 19 CFR 12.118 through 12.127; s ee also 19 CFR 127.28. Those persons must 441 certify that the shipment of the chemical s ubstance complies with al l applicable rules and 442 orders under TSCA, including any SNUR requirements. The EPA policy in support of 443 import certification appears at 40 CFR part 707, subpart B. The TSCA section 13 import 444 certification requirement applies to articles co ntaining a chemical substance or mixture if 445 so required by the Administrator by a specific rule under TSCA. At this time EPA is not 446 proposing to require import certif ication for these chemical subs tances as part of articles. 447 VI I . Applicability of Rule to Uses Occurrin g Before Effective Date of the Final Rule 448 As discussed in the Federal Register of April 24, 1990 (55 FR 17376 ; FRL449 3658-5 ) (Ref. 27),, EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best 450*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 20 of 39 served by designating a use as a significant new use as of the date of publication of the 451 proposed rule rather than as of the effective date of the final rule. If uses begun after 452 publication of the proposed rule were consid ered ongoing rather than new, it would be 453 difficult for EPA to establish SNUR notice re quirements, because a person could defeat 454 the SNUR by initiating the proposed significan t new use before the rule became final, 455 and then argue that the use was ongoing as of the effective date of the final rule. Thus, 456 persons who begin commercial manufacture or processing of the chemical substance(s) 457 that would be regulated through this proposed rule, if finaliz ed, would have to cease any 458 such activity before the effective date of the rule if and when finalized. To resume their 459 activities, these persons w ould have to comply with all applicable SNUR notice 460 requirements and wait until the notice review pe riod, including all extensions, expires. 461 Uses arising after the publication of the propos ed rule are distinguished from uses that 462 exist at publication of the proposed rule. Th e former would be new uses, the latter 463 ongoing uses, except that uses that are ongoing as of the publication of the proposed rule 464 would not be considered ongoing uses if they have ceased by the date of issuance of a 465 final rule. To the extent that additional ongoing uses are found in the course of 466 rulemaking, EPA would exclude those specific chemical substances for those specific 467 uses from the final SNUR. EPA has promulga ted provisions to allow persons to comply 468 with the final SNUR before th e effective date. If a person we re to meet the conditions of 469 advance compliance under 40 CFR 721.45(h), that person would be considered to have 470 met the requirements of the final SNUR for those activities. 471 VII I . Test Data and Other Information 472 EPA recognizes that TSCA section 5 doe s not usually require developing any 473 particular test data before submissi on of a SNUN. There are two exceptions: 474*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 21 of 39 1 ). dD evelopment of test data is required where the chemical substance subject 475 to the SNUR is also subject to a test ru le under TSCA section 4 (see TSCA section 476 5(b)(1)); and 477
2 ). dD evelopment of test data may be necessary where the chemical substance 478 has been listed under TSCA section 5( b)(4) (see TSCA section 5(b)(2)). 479 In the absence of a section 4 test rule or a section 5(b)(4) listing covering the chemical 480 substance, persons are required to submit only te st data in their possession or control and 481 to describe any other data known to or r easonably ascertainable by them (15 U.S.C. 482 2604(d); 40 CFR 721.25, and 40 CFR 720.50). Ho wever, as a general matter, EPA 483 recommends that SNUN submitters include da ta that would permit a reasoned evaluation 484 of risks posed by the chemical substance during its manufacture, processing, use, 485 distribution in commerce, or disposal. EPA encourages persons to consult with the 486 agency before submitting a SNUN. As part of this optional pre- notice consultation, EPA 487 would discuss specific data it believes may be useful in evaluating a significant new use. 488 SNUNs submitted for significant new uses without any test data may increase the 489 likelihood that EPA will take action under TSCA section 5(e) to prohibit or limit 490 activities associated with this chemical. 491 SNUN submitters should be aware thatEPA will be better able to evaluate 492 SNUNs that provide deta iled information on: 493 •1. Human exposure and environmental releases that may result from the 494 significant new uses of the chemical substance, 495 •2. Potential benefits of the chemical substance, and 496 •3. Information on risks posed by the ch emical substances compared to risks 497 posed by potential substitutes. 498*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 22 of 39 VIIIIX . SNUN Submissions 499 EPA recommends that submitters consult with the Agency prior to submitting a 500 SNUN to discuss what data may be usef ul in evaluating a significant new use. 501 Discussions with the Agency prior to submission can afford ample time to conduct any 502 tests that might be helpful in evaluating risks posed by the substance. According to 503 section 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice 504 requirements and EPA regulatory procedures as persons submitting a PMN, including 505 submission of test data on health and environmental effects as described in section 40 506 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e507 PMN software, and submitted to the Agency in accordance with the procedures set forth 508 in sections 40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available 509 electronically at http://www.epa.gov/opptintr/newchems

. 510
I X. Economic Analysis 511 A. SNUNs 512 EPA has evaluated the potential co sts of establishing SNUR reporting 513 requirements for potential manufacturers and pr ocessors of the chemical substances 514 included in this proposed rule, incl uding as part of articles (Ref. 28 ). In the event that a 515 SNUN is submitted, costs are estimated at approximately $8,589 per SNUN submission 516 for large business submitters and $6,189 for small business submitters. These estimates 517 include the cost to prepare and submit th e SNUN, and the payment of a user fee. 518 Businesses that submit a SNUN would be subj ect to either a $2,500 user fee required by 519 40 CFR 700.45(b)(2)(iii), or, if they are a sm all business with annual sales of less than 520 $40 million when combined with those of the pa rent company (if any), a reduced user fee 521 of $100 (40 CFR 700.45(b)(1)). EPA's complete economic analysis is available in the 522*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 23 of 39 public docket for this proposed rule (Ref. 28 ). 523 B. Export Notification 524 Under section 12(b) of TSCA and the implementing regulations at 40 CFR part 525 707, subpart D, exporters must notify EPA if th ey export or intend to export a chemical 526 substance or mixture for which, among othe r things, a rule has been proposed or 527 promulgated under TSCA section 5. For persons exporting a substance that is the subject 528 of a SNUR, a one-time notice must be provided for the first export or intended export to a 529 particular country. The total costs of export notification will vary by chemical, 530 depending on the number of required notifications (i.e., the number of countries to which 531 the chemical is exported). While EPA is unable to make any estimate of the likely 532 number of export notificati ons for the chemical covered in this proposed SNUR. , as 533 stated in the accompanying EA of this propos ed SNUR, the estimated cost of the export 534 notification requirement on a per unit basis is $84.22. 535 536
C. Import or Processing Chemical Su bstances as Part of an Article 537 In proposing to make inapplicable the ex emption relating to persons that import or 538 process certain chemical substances as part of an article, this action may affect firms that 539 plan to import or process types of articles that may c ontain the subject chemical 540 substance. Some firms have an understanding of the contents of the articles they import 541 or process. However, EPA acknowledges that importers and proce ssors of articles may 542 have varying levels of knowledge about the chemical content of the articles that they 543 import or process. These parties may need to become familiar with the requirements of 544 the rule. And, while not required by the SNUR, these parties may take additional steps to 545 determine whether the subject chemical substanc es are part of the articles that they are 546*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 24 of 39 considering to import or process. This de termination may involve activities such as 547 gathering information from suppliers along th e supply chain, and/or testing samples of 548 the article itself. Costs vary across the activit ies chosen and the extent of familiarity a 549 firm has regarding the articles it imports or processes. Cost ranges are presented in the 550

“ Understanding the Costs Asso ciated with Eliminating Exemptions for Articles in 551 SNURs ” (Ref. 29 ). Based on available information, EP A believes that article importers 552 that choose to investigate their products woul d incur costs at the lo wer end of the ranges 553 presented in the Economic Analysis. For thos e companies choosing to undertake actions 554 to assess the composition of the articles th ey import or process, EPA expects that in all 555 likelihood, these importers and processors would take actions that are commensurate with 556 the level of risk (of comp any’s perceived likelihoo nd that a chemical to substance might 557 be a part of an article ) that each company perceives , and the resources it has available. 558 Example activities and their costs are provi ded in the accompanying Economic Analysis 559 of this Rule (Ref. 28). 560
X I . Alternatives 561 Before proposing this SNUR, EPA consider ed the following alternative regulatory 562 action: 563 A. Promulgate a TSCA Section 8(a) Reporting Rule 564 Under a TSCA section 8(a) rule, EP A could, among other things, generally 565 require persons to report information to th e agency when they intend to manufacture or 566 process a listed chemical for a specific use or any use. However, for TDI, the use of 567 TSCA section 8(a) rather than SNUR authorit y would have several li mitations. First, if 568 EPA were to require reporting under TSCA s ection 8(a) instead of TSCA section 5(a), 569 EPA would not have the opportunity to revi ew human and environmental hazards and 570*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 25 of 39 exposures associated with the proposed si gnificant new use and, if necessary, take 571 immediate follow-up regulatory action under TSCA sections 5(e) or 5( f) to prohibit or 572 limit the activity before it begins. In addition, EPA may notreceive important 573 information from small businesses, because su ch firms generally are exempt from TSCA 574 section 8(a) reporting requireme nts (see TSCA sections 8(a)(1)(A) and 8(a)(1)(B)). In 575 view of the level of health concerns about TDI if used for the proposed significant new 576 use, EPA believes that a TSCA section 8(a) ru le for this substance would not meet EPA's 577 regulatory objectives. 578 B. Allow the Exemption for Persons Who Import or Process TDI and Related 579 Compounds as Part of Articles That W ould Be Subject to the Proposed SNUR 580 Under the SNUR exemption provision at 40 CFR 721.45(f), a person who 581 imports or processes a chemical substance covered by a SNUR identified in 40 CFR part 582 721, subpart E, as part of an article is not generally subject to the notification 583 requirements of 40 CFR 721.25 for that chemical substance. However, EPA is concerned 584 that exempting TDI and related compounds as part of articles would render the SNUR 585 less effective because of the possibility that articles could be imported or processed for 586 uses subject to this proposed SNUR without the submission of a SNUN. This proposed 587 rule would not include the exemption at 40 CFR 721.45(f). 588
XI I . Request for Comment 589 A. Do you have comments or information about ongoing uses? 590 EPA welcomes comment on all aspects of this proposed rule. EPA based its 591 understanding of the use profile of these ch emicals on the publishe d literature, the 2012 592 CDR submissions, market research, discussi ons with manufacturers, and product SDSs. 593 To confirm EPA’s understanding, the Agency is requesting public comment on the 594*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 26 of 39 EPA’s understanding that coating, adhesive, elastomer, binder, or sealant consumer 595 products do not contain residual TDI of more than 0.1 percent by weight, as noted in 596 Table 2 of Unit II.A. . EPA believes that other consumer products do not contain TDI or 597 related compounds at any level. In providi ng comments on the concentration of TDI and 598 related compounds in the consumer product, it would be helpful if you provide sufficient 599 information for EPA to substantiate any assertions of use and concentrations. 600 B. What Should I Consider as I Prepare my Comments for EPA? 601 1. Submitting CBI . It is EPA's policy to include all comments received in the 602 public docket without change or further no tice to the commenter and to make the 603 comments available on-line at www.regulations .gov, including any personal information 604 provided, unless a comment include s information claimed to be Confidential Business 605 Information ( CBI ) or other information whose disclosure is restricted by statute. Do not 606 submit this information to EPA through regula tions.gov or e-mail. Clearly mark the part 607 or all of the information that you claim to be CBI. For CBI information in a disk or CD 608 ROM that you mail to EPA, mark the outside of the disk or CD ROM that you mail to 609 EPA as CBI and then identify electronically within the disk or CD ROM the specific 610 information that is claimed as CBI. In addi tion to one complete version of the comment 611 that includes information claimed as CBI, a copy of the comment that does not contain 612 the information claimed as CBI must be submitted for inclusion in the public docket. 613 Information so marked will not be disclosed except in accordance with procedures set 614 forth in 40 CFR part 2, subpart B. 615 2. Tips for preparing your comments . When submitting comments, remember to: 616 i. Identify the document by docket ID number and other identifying information 617 (subject heading, Federal Register date, and page number). 618*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 27 of 39 ii. Follow directions. The agency may ask you to respond to specific questions or 619 organize comments by referencing a CFR part or section number. 620 iii. Explain why you agree or disagree ; suggest alternatives and substitute 621 language for your requested changes. 622 iv. Describe any assumptions and pr ovide any technical info rmation and/or data 623 that you used. 624 v. If you estimate potential costs or burdens, explain how you arrived at your 625 estimate in sufficient detail to allow for it to be reproduced. 626 vi. Provide specific examples to illu strate your concerns a nd suggest alternatives. 627 vii. Explain your views as clearly as possible, avoiding th e use of profanity or 628 personal threats. 629 viii. Make sure to submit your comments by the comment period deadline 630 identified. 631
XII I . References 632 The following is a listing of the documents that are specifically referenced in this 633 document. The docket includes these documen ts and other information considered by 634 EPA, including documents that are referenced within the documents that are in the 635 docket, even if the referenced document is not physically located in the docket. For 636 assistance in locating these other documents, please consult techni cal person listed under 637 FOR FURTHER INFORMATION CONTACT

. 638 1. U.S. EPA. Significant New Uses of Ch emical Substances; Certain Chemicals. 639 49 FR 35014, September 5, 1984 (FRL-2541-8). 640
2 . Krone, C., and Klinger, T. (2005). Is ocyanates, polyurethane and childhood 641 asthma. Pediatric Allergy and Immunology 16, 378-379. 642*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 28 of 39 3 . Bello, D., Herrick, C. A., Smith, T. J., Wo skie, S. R., Streicher, R. P., Cullen, 643 M. R., Liu, Y., and Redlich, C. A. (2007). Sk in Exposure to Isocyanates: Reasons for 644 Concern. Environmental Health Perspectives 115. 645
4 . BASF Corporation. (2011). Project Summary Report Requested Industrial 646 Hygiene personal and Area Monitoring for Iden tified Airborne Chemical Hazards of 647 MDI and/or TDI Associated with Isocya nate-Containing Product Use Scenarios for 648 Identified Construction Sealants and/or Basecoat Products (Sanitized Version). JKInc

. 649 Report #: 111-11, 1- 6. 650 5 . Vangronsveld, E, Berckmans, S., a nd Spence, M. (2013). Comparison of 651 Solvent/Derivatization Agent Systems for Determination of Extractable Toluene 652 Diisocyanate from Flexible Polyurethane Foam. Annals of Occupational Hygiene 57(5), 653 640-649. 654
6 . Redlich, C. A., Bello, D., and Wisnewsk i, A. (2006). Isocyanate exposures and 655 health effects. In Environmental and Occupational Medicine (W. Rom, and S. 656 Markowitz, Eds.), pp. 502-516. Lippincott W illiams & Wilkins Philadelphia, PA. 657
7 . DOW (2009). Product Safety Asse ssment DOW Modified Toluene 658 Diisocyanate (TDI) Products. July 16 2010. 659 http://www.dow.com/PublishedLit erature/dh_034d/0901b8038034d515.pdf?filepath=pru 660 ctsay/pdfs/noreg/233-00617.pdf&fromPage=GetDoc. 661 8

. Collins, M.A. (2002). Toxicology of Toluene Diisocyanate. Applied 662 Occupational and Environmental Hygiene 17, 846-855. 663 9

. Gledhill, A. Wake, A., Hext, P., Leiobold, E., and Shiotsuka, R. (2005). 664 Absorption, distribution, metabolism and excr etion of an inhalation does of 14C 4,4' 665 methylenediphenyl diisocyanate in the male rat. Xenobiotica 35, 273-292. 666*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 29 of 39 10 . EPA. 2011. Toluene Diisocyanate (TDI) and Related Compounds Action 667 Plan. Available online at: 668 http://www.epa.gov/oppt/existingche micals/pubs/actionplans/tdi.pdf. 669
11 . Ott, M.G., Diller, W.F., and Jolly, A.T. (2003). Respiratory effects of toluene 670 diisocyanates in the workplace; a discu ssion of exposure-response relationships. Critical 671 Review Toxicology 33, 1-59. 672
12 . Bello, D., Woskie, S. R., Streicher, R. P., Liu, Y., Stowe, M. H., Eisen, E. A. 673 Ellenbecker, M. J., Sparer, J., Youngs, F., Cullen, M. R., and Redlich, C. A. (2004). 674 Polyisocyanates in occupational environments: a critical review of exposure limits and 675 metrics. American Journal Industrial Medicine 46, 480-491. 676 13 . NIOSH (1996). National Institute for Occupational Safety and Health

. 677 Preventing asthma and death from diisocya nate exposure: NIOSH Alert. (DHHS, Ed.). 678
14 . American Chemistry Council (ACC) (2005). TSCA Section 8(e) Notice of 679 Substantial Risk 8EHQ-0905-16225 Fatalities linked to diisocyanates. EPA. 680 15 . IARC. (1999). Toluene Diisocyanates . WHO. p. 865-879. 681 16 . Environment Canada. (2008). Screen ing Assessment for the Challenge: 682 Toluene Diisocyanate. http://www.ec.gc.ca/ese-ees/ default.asp?lang=En&n=69A64ACA

. 683 17 . NTP (2011). National Toxicology Program . Report on Carcinogens, Twelfth 684 Edition; U.S. Department of Health and Human Services, Public Health Service. 685 Substance Profile, Toluene Diisocyanates. http://ntp.niesh.nih.gov?objectid=03C9AF75- 686 E1BF-FF40-DBA9EC0928DF8B15. 687 18

. NIOSH (2005). National Institute of O ccupational Safety and Health . NIOSH 688 Pocket Guide to Chemical Hazards July 16, 2010. 689 http://www.cdc.gov/NIOSH/npg/npgdcas.html

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

Page 30 of 39 19 . De Zotti (2000). De Zotti, R., Muran, A., and Zambon, F. (2000). Two cases 691 of paraoccupational as thma due to toluene diisocyanate (TDI). Occupational and 692 Environmental Medicine 57, 837-839. 693 20 . Agency for Toxic Disease Registry (ATSDR) (2002). Case Studies in 694 Environmental Medicine: Pediatric Envir onmental Health. ATSDR Publication No. 695 ATSDR-HE-CD-2002-0002. 696
21 . NIOSH (2004). National Institute for Occupational Safety and Health . A 697 Summary of Health Hazard Evaluations: I ssues Related to Occupational Exposure to 698 Isocyanates 1989-2002. (D. o. H. a. H. Serv ices, Ed.), pp. 1-42, Cincinnati, OH 699
22 . Pianoforte, K. (2009). Adhesives and sealants market update, November 1, 700 2009. In Coatings World. 701 23 . Kelly, T. J., Myers, J. D., and Hold ren, M. W. (1999). Testing of Household 702 Products and Materials for Emission of Toluene Diisocyanate. Indoor Air 9, 117-124. 703
24 . Jarand, C. W., Akapo, S. O., Swenson, L. J., and Kelman, B. J. (2002). 704 Diisocyanate emission from a paint product: a preliminary analysis. Applied 705 Occupational Environmental Hygiene 17, 491-494. 706 25

. NYC-DOHMH (2010). New York City Department of Health and Mental 707 Hygiene . Moisture Cure Urethanes (MCU). July 16, 2010. 708 http://www.nyc.gov/html/doh/ html/epi/mcufact.shtml. 709 26 . NIOSH (2006). National Institute fo r Occupational Safety and Health. 710 Preventing Asthma and Death from MDI Exposure During Spray-on Truck Bed Liner 711 and Related Applications: NIOSH Alert. http://www.cdc.gov/niosh/docs/2006- 712 149/default.html

. 713 27. U.S. EPA. Significant New Uses of Certain Chemical Substances. 714*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 31 of 39 55 FR 173776, April 24, 1990 (FRL-3658-5). 715 28 . EPA. Economic Analysis of the Si gnificant New Use Rule for Toluene 716 Diisocyanate (TDI) and Rela ted Compounds. April 2, 2014. 717 29 . EPA, Understanding the Costs Associated with Eliminating 718 Exemptions for Articles in SNURs. May 1, 2013. 719 30. U.S. EPA. Modifications of Si gnificant New Use Rules for Certain 720 Substances 62 FR 42690, August 8, 1997 (FRL-5735-4). 721 XIIIXIV . Statutory and Executive Order Reviews 722 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: 723 Improving Regulation and Regulatory Review 724 This proposed SNUR has been designated by the Office of Management and 725 Budget (OMB) as a ‘‘significan t regulatory action ’’ under section 3(f) of Executive Order 726 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted this action to OMB for 727 review under Executive Orders 12866 a nd 13563 (76 FR 3821, January 21, 2011), and 728 any changes made in response to OMB recommendations are documented in the docket. 729 B. Paperwork Reduction Act (PRA) 730 This action does not impose any new in formation collection burden under the 731 PRA, 44 U.S.C. 3501 et seq . Burden is defined in 5 CFR 1320.3(b). The information 732 collection activities associated with exis ting chemical SNURs are already approved by 733 OMB under OMB control number 2070-0038 (EPA ICR No. 1188); and the information 734 collection activities a ssociated with export notifications are already approved by OMB 735 under OMB control number 2070-0030 (EPA ICR N o. 0795). If an entity were to submit 736 a SNUN to the Agency, the annual burden is estimated to be less than 100 hours per 737 response, and the estimated burden for an e xport notifications is less than 1.5 hours per 738*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 32 of 39 notification. In both cases, burden is estimated to be reduced for submitters who have 739 already registered to use the electronic submission system. Additional burden, estimated 740 to be less than 10 hours, coul d be incurred where additional record keeping requirements 741 are specified under 40 CFR 721.125(a), (b), and (c). 742 An agency may not conduct or sponsor, and a person is not required to respond to 743 a collection of information that requires OM B approval under the PRA, unless it has been 744 approved by OMB and displays a currentl y valid OMB control number. The OMB 745 control numbers for EPA's regulations in Titl e 40 of the CFR, after appearing in the 746 Federal Register , are listed in 40 CFR, part 9, a nd included on the related collection 747 instrument, or form, if applicable. EPA is amen ding the table in 40 CFR part 9 to list this 748 SNUR. This listing of the OMB control numbers and their subsequent codification in the 749 CFR satisfies the display requirements of the PRA and OMB's implementing regulations 750 at 5 CFR part 1320. Since the existing OMB a pproval was previously subject to public 751 notice and comment before OMB approval, and given the technical nature of the table, 752 EPA finds that further notice and comment to amend the table is unnecessary. As a result, 753 EPA finds that there is “good cause” under se ction 553(b)(3)(B) of the Administrative 754 Procedure Act (5 U.S.C. 553(b)(3)(B)) to am end this table without further notice and 755

comment. 756 C. Regulatory Flexibility Act (RFA) 757 Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq ., I hereby certify that 758 promulgation of this SNUR would not have a significant economic impact on a 759 substantial number of small entities. The rationale supporti ng this conclusion is as 760 follows. 761 EPA generally finds that pr oposed and final SNURs are not expected to have a 762*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 33 of 39 significant economic impact on a substantial nu mber of small entities (See, e.g., Ref. 30). 763 Since these proposed SNURs would require a person who intends to engage in such 764 activity in the future to first notify EPA by submitting a SNUN, no economic impact 765 would occur unless someone files a SNUN to pursu e a significant new us e in the future or 766 forgoes profits by avoiding or delaying the significant new use. Although some small 767 entities may decide to engage in such ac tivities in the future, EPA cannot presently 768 determine how many, if any, there may be. Howeve r, EPA’s experience to date is that, in 769 response to the promulgation of SNURs c overing over 1,000 chemical substances, the 770 Agency receives only a handful of notices per year. During the six year period from 771 2005-2011, only three submitters self-identified as small in their SNUN submission (Ref. 772 28). EPA believes the cost of submitting a SNUN is relatively small compared to the cost 773 of developing and marketing a chemical new to a firm and that the requirement to submit 774 a SNUN generally does not have a significant economic impact. 775 A SNUR applies to any pers on (including small or large entities) who intends to 776 engage in any activity de scribed in the rule as a “significant new use.” EPA has 777 preliminarily determined, based in part, on the Agency’s market research, that these 778 chemical substances are not being manufactur ed (including imported) or processed for a 779 significant new use. This preliminary dete rmination also includes importation and 780 processing of these chemical substances as part of articles for the significant new use 781 (Unit IV). Therefore, based on current knowledg e, EPA has preliminarily determined that 782 these uses, including the importation of these chem ical substances as part of articles, are 783 not ongoing, and that no small en tities presently manufacture or import for the significant 784 new uses addresses in this proposed rule. EPA will consider information received during 785 the comment period that might indicate that this preliminary determination is incorrect. 786*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 34 of 39 By definition of the word “new” and based on all information currently available to EPA, 787 it appears that no small or large entities pres ently engage in such activities. Since this 788 proposed SNUR will would require a person who intends to engage in such activity in 789 the future to first notify EPA by submitti ng a SNUN, no economic impact will occur 790 unless someone files a SNUN to pursue a signif icant new use in the future or forgoes 791 profits by avoiding or delaying the significant new use. Although some small entities may 792 decide to conduct such activ ities in the future, EPA cannot presently determine how 793 many, if any, there may be. However, EPA’s expe rience to date is that , in response to the 794 promulgation of SNURs covering over 1,000 chem ical substances, the Agency receives 795 on average only a handful of notices per year. During the six year period from 2005- 796 2011, only three submitters self-identified as small in their SNUN submission (Ref. 26). 797 EPA believes the cost of submitting a SNUN is relatively small compared to the cost of 798 developing and marketing a chemical new to a firm and that the requirement to submit a 799 SNUN generally does not have a significant economic impact. 800 EPA believes that there will be minimal impact to processors and importers of 801 the se chemical substance s subject to the final SNUR as part of an article s from this 802 proposed SNUR . The SNUR does not require proce ssors and importers of articles that 803 contain the chemicals subj ect to the proposed SNUR to conduct specific activities to 804 ascertain if they are importing or processing an article that uses a chemical subject to the 805 proposed rule. EPA expects importers would take actions that are commensurate with 806 their perceived likelihood of a chemical substance subject to the SNUR being part of an 807 article, and the resources it ha s available. EPA has no reason to believe that a firm would 808 voluntarily incur substantial costs to comply with the SNUR, but rather EPA believes 809*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 35 of 39 each firm will choose the most efficient rout e to identify whether it is importing the 810 subject chemical substances in articles

. 811 Therefore, EPA believes that the potentia l economic impact of complying with 812 this proposed SNUR is not expected to be si gnificant or adversely impact a substantial 813 number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 814 FR 42690) (FRL-5735-4), the Agency presented its general determination that proposed 815 and final SNURs are not expect ed to have a significant ec onomic impact on a substantial 816 number of small entities, which was provide d to the Chief Counsel for Advocacy of the 817 Small Business Administration. 818 D. Unfunded Mandates Reform Act (UMRA) 819 Based on EPA’s experience with proposi ng and finalizing SNURs, State, local, 820 and Tribal governments have not been imp acted by these rulemakings, and EPA does not 821 have any reason to believe that any State, lo cal, or Tribal government would be impacted 822 by this rulemaking. As such, the requirem ents of sections 202, 203, 204, or 205 of 823 UMRA, 2 U.S.C. 1531-1538, do not apply to this action. 824 E. Executive Order 13132: Federalism 825 This action will not have a substantial di rect effect on States, on the relationship 826 between the national government and the Stat es, or on the distribution of power and 827 responsibilities among the various levels of government, as specified in Executive Order 828 13132 (64 FR 43255, August 10, 1999). 829 F. Executive Order 13175: Consultation and Coordination with Indian Tribal 830
Governments 831 This proposed rule does not have Tribal implications because it is not expected to 832 have any effect (i.e., there will be no increase or decrease in author ity or jurisdiction) on 833*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 36 of 39 Tribal governments, on the relationship betw een the Federal government and the Indian 834 tribes, or on the distribution of power and responsibilities between the Federal 835 government and Indian tribes. Thus, Ex ecutive Order 13175 (65 FR 67249, November 9, 836 2000), does not apply to this action. 837 G. Executive Order 13045: Protection of Childre n from Environmental Health Risks and 838 Safety Risks 839 This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 840 1997), because this action is not intended to ad dress environmental health or safety risks 841 for children. 842 H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect 843 Energy Supply, Distribution, or Use 844 This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 845 22, 2001), because this action is not expected to affect energy supply, distribution, or use. 846 I. National Technology Transfer and Advancement Act (NTTAA) 847 Since this action does not involve any technical standards, section 12(d) of 848 NTTAA, 15 U.S.C.272 note, does no t apply to this section. 849 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 850 Populations and Low-Income Populations 851 This proposed rule does not invoke special consideration of environmental justice 852 related issues as delineated by Executiv e Order 12898 (59 FR 7629, February 16, 1994), 853 because EPA has determined that this action will not have disproportionately high and 854 adverse human health or environmental eff ects on minority or low-income populations. 855 This action does not affect th e level of protection provide d to human health or the 856 environment. 857*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 37 of 39 858 859 860 861 862 863 864 List of Subjects in 40 CFR Part 721 865 Environmental protection, Chemicals, Hazardous substances, Reporting and 866 recordkeeping requirements. 867 868 869 Dated: _______________________ 870 871 872

____________________________________________ 873 874 875 876 877 Director, Office of Pollution Prevention and Toxics. 878*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 38 of 39 Therefore, it is proposed that 40 CFR part 721chapter I be amended as follows: 879 PART 721--[AMENDED] 880 1. The authority citation for part 721 continues to read as follows: 881 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 882 2. Add §721. xx 10789 to subpart E to read as follows : 883 §721. 10xxx 10789 Toluene Dd iisocyanates and Rr elated Cc ompounds . 884 3. Add § 721.xx as follows: 885 (a) Chemical substances and significant new uses subject to reporting. (1) The 886 chemical substances listed in Table 1 and Table 2 of this para graph are subject to 887 reporting under this section for the significant new uses described in paragraph (a)(2) of 888 this section. 889 Table 1.—Toluene Diisocyanates ad Rela ted Compounds Subject to Reporting for 890 Any Use in a Consumer Product 891 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)- 26603-40-7 892 893 894 895 896 897 Table 2.—Toluene Diisocyanates ad Rela ted Compounds Subject to Reporting for 898 Any Use in A Consumer Product (Except for use in Coatings, Adhesives, 899 Elastomers, Binders, and Sealants at Less than or Equal to 0.1 Percent in a 900 Consumer Product) 901*** EO 12866/13563 Review – Do Not Cite, Qu ote or Release During the Review *** (RIN 2070-AJ91)

Page 39 of 39 902 903 Chemical Name Chemical Abstracts Index Name Chemical Abstracts Service Registry Number (CASRN) 2,6-Toluene diisocyanate Benzene, 1,3-diisocyanato-2-methyl91-08-7 2,4-Toluene diisocyanate Benzene, 2,4-diisocyanato-1- methyl- 584-84-9 Toluene diisocyanate unspecified isomers Benzene, 1,3-diisocyanatomethyl- 26471-62-5 904 (2) The significant new uses are: 905 (i) For the chemical substances listed in Table 1 of paragraph (a)(1), any use of 906 the chemical substance in consumer products. 907 (ii) For the chemical substances listed in Table 2 of paragraph (a)(1), any use of 908 the chemical substance in a consumer produc t (except for use in coatings, adhesives, 909 elastomers, binders, and sealants, that resu lts in less than or equal to 0.1 percent by 910 weight of such chemical substa nce in the consumer product). 911 (b) Specific requirements. The provisions of subpart A of this part apply to this 912 section except as modified by this paragraph (b) : 913 (1) Revocation of certain notification exemptions. The provisions of § 721.45(f) 914 do not apply to this section. A person who im ports or processes a chemical substance 915 identified in paragraph (a)(1) of this section as part of an article for a significant new use 916 described in paragraph (a)(2) of this sec tion is not thereby exempt from submitting a 917 significant new use notice. 918 (2) [Reserved] 919