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### EO 12866/13563 Review **D raft**  **– Revisions 11/21/2014**  1 Rin2070 - AJ91_EO12866_TDI SNUR_NPRM_FR Document_Redlined _2014 - 11 - 21 .docx 2 3 BILLING CODE 6560 - 50 - P 4 **ENVIRONMENTAL PROTECTION AGENCY** 5 **40 CFR Part 721**  6 **[ EPA**  **- HQ**  **- OPPT**  **- 201**  **1 -**  **0976 ; FRL**  **- 9915**  **- 62]**  7 **RIN 2070**  **- AJ**  **91** 8 **Toluene Diisocyanates (TDI) and Related Compounds ;**  **Significant New Use Rule** 9 **AGENCY:** Environmental Protection Agency (EPA). 10 **ACTION:** Proposed rule. 11 **SUMMARY:** Un der the Toxic Substance Control Act (TSCA) , EPA is proposing a 12 significant new use rule (SNUR) for 2,4 - toluene diisocyanate, 2,6 - toluene diisocyanate, 13 toluene diisocyanate unspecified isomers (these 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 ce rtain chemical substance s in coatings, elastomers, 17 adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight 18 of TDI in a consumer product. Inaddition, EPA is also proposing that the general SNUR 19 article exemption for per sons who import or process the se chemical substances as part of 20 an article would not apply. P ersons subject to the SNUR would be required to notify EPA 21 at least 90 day s before commencing any manufacturing or processing . The required 22 notification would prov ide EPA with 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

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Page 2 of 38 **DATES:** Comments must be received 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 - 20 11 - 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 electronicall y any information you 31 consider to be Confidential Business Information (CBI) or other information whose 32 disclosure is restricted b y s tatute. 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 for 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 doc kets generall y, is available at http://www.epa.gov/dockets . 41 **FOR FURTHER INFORMATION CONTACT:** For technical information contact : 42 Katherine Sleasman , Chemical Control Division (7405M), Office of Pollution Prevention 43 and Toxics, Environmental Protection 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; telephone number: (202) 554

– 1404; e - mail address: 48 TSCA -Hotline@epa.gov . 49* ** EO 12866/13563 Review

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Page 3 of 38 **SUPPLEMENTARY INFORMATION:** 50 **I. E**  **xecutive Summary** 51 A. Does this Action Apply to Me? 52 You may

be potentiall y affected b y this action if you manufacture, process, or 53 distribute in commerce chemical substances and mixtures. The following list of North 54 American Industrial Classification Sy stem (NAI CS) codes is not intended to be 55 exhaustive, but rather provides a guide to help readers determine whether this document 56 applies to them. Potentiall y affected entities may include : 57

**•** Chemical and Allied Products Manufacturers (NAI CS code 32411). 58

**•** Petrol eum Refining (NAI CS code 325 and 32411). 59

**•** Paints, coatings and adhesives manufacturing (NAI CS code 3255). 60

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

**•** Transportation pol yurethane foam products (NAICS code 32615011) . 62

**•** Building and construction poly urethane foam products (NAICS code 63 32615031) . 64

**•** Products made of foam other than poly styr ene or poly urethane (NAICS code 65 32615091) . 66

**•** All other miscellaneous poly urethane foam products (NAICS code 32615061) . 67

**•** Consumer and institutional poly urethane foam products (NAICS code 68 32615051 ) . 69

**•** Packing pol yurethane foam products (NA IC S code 32615021) . 70

**•** Elastomers (NAICS code 326199). 71 This action may also affect certain entities through pre - existing import 72 certification and export notification rules under TSCA. Persons who import any 73* ** EO 12866/13563 Review

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Page 4 of 38 chemical substance governed b y a final SNUR are subject to the TSCA section 13 (15 74 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 75 CFR 12.118 through 12.1 27; see also 19 CFR 127.28. 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 CFR 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 subject 81 to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 82 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 83 707, subpart D. 84 If you have any questions regarding the applicability of this action to a particular 85 entity , consult the technical information contact listed under **FOR FURTHER** 86 **INFORMATION CONTACT** . 87 B. W

hat Is the Agency's Authority 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 “significant new use.” EPA must make this 90 determination by

rule after considering all relevant factors, including those listed in 91 TSCA secti on 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 day s before they manufacture or process the 94 chemical su

bstance 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 p art 721, s ubpart A. 96 C. W

hat Action Is the Agency Taking? 97* ** EO 12866/13563 Review

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Page 5 of 38 EPA is proposing a SNUR for 2,4 - toluene diisocyanate, 2,6 - toluene diisocyanate, 98 toluene diisocyanate unspecified isomers (these 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 of Unit II.A. ; and any use in a consumer product of any chemical listed in Table 102 2 of Unit II.A. ( except for use in coatings, elastomers, adhesives, binders, and sealants 103 that result s in less than or equal to 0.1 percent by weight of TDI in a consumer product) . 104 This proposed significant new use rule would apply to the uses EPA has identified 105 in this unit that EPA believes are not ongoing at the time of this proposed rule. EPA is 106 requesting public comment on this proposal, and specificall y on the Agency’s 107 understanding of ongoing uses for the chemicals identified in Table 1 of Unit II.A and 108 Table 2 of Unit II.A. in consumer products. EPA is particularl y interested in whether 109 there are any ongoing uses of these chemicals in consumer products of which the Agency 110 is currentl y unaware and would welcome specific documentation of any such ongoing 111 uses. A c onsumer product is defined at 40 CFR 721.3 as: a chemical substance that is 112 directly , or as part of a m ixture, sold or made available to consumers for their use in or 113 around a permanent or temporary household or residence, in or around a school, or in 114 recreational settings. 115 Th is proposed SNUR would require persons that manufacture (including import) 116 or process any of the chemicals for a significant new use, consistent with the 117 requirements at 40 CFR 721.25, to notify EPA at least 90 day s before commencing such 118 manufacture or process of the chemical substance for a significant new use. For this 119 propose d rule, EPA is proposing that the general SNUR article exemption at 40 CFR 120 721.45(f) for persons who import or process chemical substances as part of an article 121* ** EO 12866/13563 Review

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Page 6 of 38 would not apply . The article exemption at 40 CFR 721.45(f) is based on an assumption 122 that peopl e and the environment will generall y not be exposed to chemical substances in 123 articles (see September 5, 1984 ; 49 FR 35014; FRL - 2541 - 8 ) (Ref. 1 ) . However, TDI and 124 related compounds are volatile and as such could migrate out of articles that c ontain 125 them. For instance, studies of TDI in pol yurethane products reported that after the 126 reaction between an isocyanate and an alcohol to form poly urethane product s , residual 127 levels of isocyanates were detected on the surface of the products (e.g. flex ible foams) , 128 which if used could le a d to exposure (Refs. 2 and 3 ). Because TDI and related 129 compounds are known to be volatile chemical substances, have been reported to migrate 130 from products, are sensitizers , and would be expected to present a higher potential for 131 exposure if the TDI in the article were a consumer product, EPA would like the 132 opportunity

to evaluate such potential uses in consumer products for any associated risks 133 or hazards that might exist b efore those uses would begin. 134 D. Why Is the Agency Taking this Action? 135 These SNURs are necessary to ensure that EPA receives timely advance notice of 136 any

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

produce change s in human and environmental exposures. The rationale and 138 objectives for this SNUR are explained in Unit III. 139 E. W

hat are the Estimated Incremental Impacts of this Action? 140 EPA has evaluated the potential costs of establishing SNUR reporting 141 requirements f

or potential manufacturers and processors of the chemical substances 142 included in this proposed rule. This anal ys is, which is available in the docket, is 143 discussed in Unit IX., and is briefly summarized here. In the event that a SNUN is 144 submitted, costs are estimated to be $8, 589 per SNUN submission for large business 145* ** EO 12866/13563 Review

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Page 7 of 38 submitters and $6, 189 for small business submitters. These estimates include the cost to 146 prepare and submit the SNUN and the pay ment of a user fee. The proposed SNUR would 147 require first - time submitters of any TSCA section 5 notice to register their company and 148 key

users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and 149 establish and use a Pay .gov E - pay ment account before they may submit a SNUN, for a 150 cost of $200 per firm. However, these activities are only required of first - time submitters 151 of section 5 notices. In addition, for persons exporting a substance that is the subject of a 152 SNUR, a one - time notice must be provided for the first export or intended export to a 153 particular country , which is estimated to be $84.22 per notification. The rule may also 154 affect firms that plan to import or process articles that contain TDI and related 155 compounds, bec ause, while not required by the SNUR, these parties may take additional 156 steps to determine whether TDI and related compounds are part of the articles that they 157 are considering to import or process. Since EPA is unable to predict whether anyone 158 might engage in future activities that would require reporting, potential total costs were 159 not estimated. 160 **II. Chemical Substances Subject to this Proposed Rule**  161 A. What C

hemicals A re I

ncluded in the Proposed SNUR? 162 This proposed SNUR would apply to TDI and its related compounds listed in Table 1 of 163 this unit and Table 2 of this unit in consumer products . Diisocyan ates contain free 164 isocyanate functional groups ( -N=C=O). D iisocyanates are combined with other 165 compounds that contain free hydrox ylfunctional groups (i.e. , –OH), typically called 166

“polyol s . ” These two - part components react and begin to form poly urethane poly

mers. 167 This chemical reaction is completed when all of the isocyanate functional groups are 168 bound within the poly mer network. This process is commonly referred to as “curing.” 169* ** EO 12866/13563 Review

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Page 8 of 38 Products that contain free isocyanate functional groups are intended to react further and 170 undergo “curing” in the process of use. The chemical substances subject to this proposed 171 SNUR contain free isocyanate functional gro ups and are b y definition uncured. Prior to 172 complete curing, consumers and b ys tanders can potentially be exposed to isocyanates 173 through both dermal and respiratory routes. Exposures to uncured isocyanates could lead 174 to sensitization. 175 To ascertain if TDI and related compounds are used in consumer products , EPA 176 reviewed published literature, the most recent data from EPA’s Chemical Data Reporting 177 program (CDR) , and communicated direct ly with manufacturers and processors . 178 Reporting under the CDR indicated no consumer uses of TDI or related compounds . 179 However, d

uring conversations between EPA personnel and manufacturers and 180 processors , it was revealed that in some cases consumer products may still contain 181 residual TDI of no more than 0.1 percent by weight , as noted in Table 2 of this unit (Ref. 182 4 ) . This was also confirmed by review of published literature and SDS for consumer 183 adhesives and sealants available in retail outlets. Itis EPA’s understanding that any TDI 184 present in a coating, adhesive, elastomer, binder or sealant consumer product is at levels 185 of no more than 0.1 percent by weight and would ty

picall y be considered residual 186 diisocyanate remaining from the manufa cture of a poly urethane pol ym er, a concentration 187 which is above the detection level (Ref. 5 ) . EPA believes that other consumer products do 188 not contain TDI or related compounds at any level. 189 **Table 1 –**  **Toluene Diisocyanate Related Compounds Subject to this**  **Action with a**  190 **Proposed Significant New Use of “**  **Any U**  **se in a**  **Consumer Product**  **”** 191 192 Chemical Name Chemical Abstract s Index Name Chemical Abstract s Service Registry Number (CASRN)* ** EO 12866/13563 Review

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Page 9 of 38 Toluene diisocyanate trimer Benzene, 1,3 - diisocyanatomethyl - , trimer 9019 - 85 - 6 Poly(toluene diisocyanate) Benzene, 1,3 - diisocyanatomethyl - , homopoly

mer 9017 - 01 - 0 Toluene diisocyanate dimer 1,3 - Diazetidine - 2,4 - dione, 1,3 bis(3 - isocyanatomethylphenyl) - 26747 - 90 - 0 Toluene diisocyanate “cyclic” trimer 1,3,5 - Triazine - 2,4,6(1H,3H,5H) - trione, 1,3,5 - tris(3 - isocyanatomethylphenyl) - 26603 - 40 - 7 193 **Table 2 –**  **Toluene Diisocyanates Subject to this Action with a Proposed Significant**  194 **Use of “ A**  **ny Use in A Consumer Product**  **( Except for use in**  **Coatings, Adhesives,** 195 **Elastomers, Binders, and S ealants**  **at Less**  **than or Equal to**  **0.1 Percent in a**  196 **Consumer Product )**  **”** 197 198 Chemical Name Chemical Abstract s Index Name Chemical Abstract s Service Registry Number (CASRN) 2,6 - Toluene diisocyanate Benzene, 1,3 - diisocyanato - 2 - methyl 91 - 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 - 5 199 B. What Are the Production V olumes and U

ses of TDI and R elated C ompounds? 200 TDI and the related compounds are generall y high production volume chemicals, 201 predominantly

used in the production of pol yurethanes. There are many typ es of 202 poly

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

urethane industry. Flexible foam is primarily u sed for cushioning, while rigid 204 foam is used mainly for insulation (Ref. 6 ). Approximately 90 percent of TDI, ty

pically a 205 mixture of toluene diisocyanate isomers, is used in the production of flexible foams , 206 which are designed to be fully cured in a final product . Non - foam pol yurethane use 207 sectors of TDI include coatings, adhesives, elastomers, binders, and sealants. These 208 products may

be sold and used, most often in a mixture of formulated product, in an 209* ** EO 12866/13563 Review

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Page 10 of 38 uncured form . Because of its hazards, some industry representative s assert that TDI is 210 used in products intended for industrial use only (Ref. 7 ). In contrast, EPA believes 211 coatings, adhesives, elastomers, binders, and sealants used by general consumers contain 212 residual TDI of no more than 0.1 percent by weight. Due to the projected growth of the 213 market for such use in consumer products as discussed further in Unit II .D., EPA is 214 concerned that consumer products in the future might contain amounts of TDI above 215 these levels. Therefore, EPA is propos i ng this action to provide the A genc y with an 216 opportunity

to evaluate such potential uses in consumer products for any associated risks 217 or hazards that might exist before those uses would begin. 218 C. What Are the Potential Health Effects of TDI and Related Compo unds ? 219 In acute, subacute, and chronic animal exposure studies for TDI, the respiratory 220 tract was the target organ, with nasal irritation evident at concentrations above 0.1 ppm 221 and effects becoming more severe with increasing concentration (Ref. 8 ). TDI is 222 uniformly

distributed throughout the body , following inhalation exposure (Refs. 8 and 9 ). 223 TDI causes skin, eye, and lung irritation, progressive impairment of lung function with 224 long - term inhalation exposure and is a respiratory sensitizer via both the dermal and 225 inhalation routes of exposure in animals (Ref. 8 ). 226 Most data on human health hazards resulting from diisocyanate exposures are 227 from occupational populations rather than exposures to consumer products. As discussed 228 i n the Toluene Diiso cyanate and Related Compounds Action Plan (Ref. 10 ) , 229 diisocyanates , including TDI and related compounds, are well - known dermal, eye, and 230 inhalation irritants and sensitizers based on worker data . They have been documented in 231 the workplace to cause asthma and respiratory problems , such as h ypersensitivity 232 pneumonitis, an inflammation of the lungs. In severe cases, there have been reported fatal 233* ** EO 12866/13563 Review

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Page 11 of 38 reactions. 234 Isocyanate exposure has been identified as the leading attributable cause of work 235 related asthma, and p revalence in the exposed workforce has been estimated at 1 - 20 236 percent (Refs. 1 1 and 1 2 ). Once a worker is sensitized to diisocyanates, subsequent 237 exposures can trigger severe asthma attacks. Spray application and heated processes are 238 associated with hi gher incidences of asthma than other application methods because they 239 can generate airborne isocyanate vapors and mists, which lead to worker exposure via the 240 respiratory

and dermal routes. Most workers who develop diisocyanate asthma have 241 experienced long periods of exposure (months or longer); however, the minimum 242 exposure to isocyanates that can elicit sensitization responses or asthma is unknown. In 243 addition, immune response and subsequent disease in humans can vary significantly 244 between individuals (Re f. 6 ). Fatalities linked to diisocyanate exposures in sensitized 245 persons have been reported (Refs. 1 3 and 1 4 ). 246 The International Agency for Research on Cancer (IARC) classified toluene 247 diisocyanates as “possibly carcinogenic to humans” (Carcinogenicity Group 2B), based 248 on inadequate evidence for the carcinogenicity of TDI in humans and sufficient evidence 249 for the carcinogenicity of TDI in experimental animals (Ref. 1 5 ). TDI has also been 250 classified by

the European Commission (EC) as Category 3 for carcinogenicity

(“causes 251 concerns for humans owing to possible carcinogenic effects”) (Ref. 1 6 ) and by the United 252 States National Toxicology Program (NTP) as “reasonably anticipated to be a human 253 carcinog en” (Ref. 1 7 ). National Institutes for Occupational Safety and Health (NI OSH ) 254 considers TDI to be an occupational carcinogen and recommends exposure reduction to 255 the lowest feasible levels (Ref 1 8 ) . 256 There are very few reports available regarding non - occupational health effects 257* ** EO 12866/13563 Review

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Page 12 of 38 from exposures to TDI products . H owever, there are case reports suggesting that 258 paraoccupational (brought outside of the workplace) asthma may have resulted from 259 incidental exposure to TDI , one of which involved incidental exposure to varnishing 260 products (Ref. 19 ) . A specific, potential concern for consumer products is exposures to 261 children. Children exposed to the same levels of TDI vapor as adults may receive a 262 larger dose because they have greater lung surface area to body weight ratios and 263 increased respiratory minute volumes to weight ratios. TDIvapor is heavier than air and 264 may

layer cl ose to the floor ; therefore , c hildren who crawl , roll , or sit on surfaces treated 265 with chemicals (i.e. carpets and floors ) and play with objects such as toy s where residues 266 may

settle could potentially receive higher doses of inhaled toxicants than adults present 267 in the same room ( Ref . 20 ). 268 D. What Are the Potential R oute and S ources of E

xposure to TDI and Related 269 Compounds? 270 There is available information on worker exposures to industrial products 271 containing TDI, such as coatings, adhesives, and sealants. Exposures resulting from the 272 use of these industrial products may indicate potential but lower level exposures that may 273 result for users conducting similar activities with consumer products containing residual 274 TDI. There is a potential for work er exposure to TDI in all industrial and commercial 275 settings where TDI is present (Ref. 7 ). Because of the high volatility of TDI, exposure 276 can occur in all phases of its use , even in the final product ( Ref. 1 7 ) , and i t is unknown to 277 what extent factors such as application techniques, product composition, and 278 environmental conditions influence the availability of TDI in products . One activity 279 where o verexposures have been documented is floor finishing in both personal and area 280 samples in one NIOSH evaluation (Ref. 2 1 ). E xposure data for professional workers may 281* ** EO 12866/13563 Review

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Page 13 of 38 provide an indication of possible exposures if consumer products and articles were to 282 contain residual TDI. 283 As previously dis cussed, TDI is use d in coatings, adhesives, sealants, and other 284 poly

urethane products. TDI is used in the manufacturing process of the poly mer and as a 285 result, a small percentage of TDI may be present in consumer products , including articles . 286 Further, rese archers looking at workplace exposures to diisocyanates have noted an 287 increase in the number of isocyanate - containing products used by consumers (Ref. 6 ). In 288 addition, consumer use of adhesives and sealants is a potential growth sector as seen in 289 the increasing numbers of “Do It Yourself” (DIY), energy- conscious homeowners doing 290 more of their own home renovation and repair work , as well as from craftsmen and 291 consumers generall y continuing to use adhesives (Ref. 2 2 ). M ost consumers would be 292 unaware of the potential hazards of consumer products , including articles , containing TDI 293 or other diisocyanates. Consequently , insufficient and inadequate hazard communication 294 may

lead to incorrect use and increased consumer and by stander exposures, particularl y 295 fo r sensitive groups , such as children. For example, e xposures to by standers and building 296 occupants (including children) to TDI in industrial products have been reported in the 297 literature, including emissions of TDI from concrete patio sealants (Refs. 2 3 and 2 4 ) and 298 detection of TDI in building air samples following use of urethanes containing TDI to 299 coat wood floors (Ref. 2 5 ) . It is possible that lower level exposures could occur when 300 conducting comparable activities using similar ty pes of consumer p roducts containing 301 residual TDI. Even if consumers are aware of such potential hazards, they may not take 302 appropriate precautions or research the appropriate resources in which these precautions 303 are addressed. Of particular concern is the fact that c hildren may have a greater potential 304 for exposure if they use or are b ys tanders to the use of consumer products containing 305* ** EO 12866/13563 Review

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Page 14 of 38 even residual amounts of TDI , because they may not have fully

developed judgment for 306 following labeling instructions and safety precautions and may not cease activity

even 307 when they

are experiencing s ymptoms of exposure. 308 **I II**  **. Rationale and Objectives** 309 A. Rationale 310 Diisocyanates are potent dermal and lung sensitizers and an attributable cause of 311 work - related asthma worldwide (Ref. 2 6 ). In the past, consumer exposures have not been 312 a focus of concern with respect to diisocyanates, because it had been assumed that 313 co nsumers were generally exposed to products containing onl y completel y cured 314 poly

urethanes, which have been generally considered to have low toxicity (Ref. 2 ). 315 However, an increase in consumer use of pol yurethane products that may further react 316 and undergo “curing” could occur if consumer p roducts , such as coatings, elastomers, 317 adhesives, and sealants contained TDI in amounts greater than residual amounts . Insuch 318 instances, TDI and related compounds that are not completely reacted upon their 319 application can provide potential exposures both to the consumer as the direct user or to 320 by standers when products are used by others (Refs. 2 and 3 ) . In sensitized individuals, 321 exposure to even small amounts of diisocyanates may cause allergi c respiratory reactions 322 like asthma and severe breathing difficulties (Ref. 6 ) . EPA believes that the use of any of 323 these chemical substances in consumer products above current levels could significantl y 324 increase human exposure, and that such incre ase should not occur without an opportunity 325 for EPA review and control as appropriate . As discussed in Unit I I , regarding the 326 chemicals listed in Table 2 of Unit II.A. , based on Safety Data Sheets (S DS ) information 327 that coating - , adhesive - , elastomer - , binder - , or sealant - consumer products may contain 328 residual TDI of no more than 0.1 percent by weight , EPA believes that these consumer 329* ** EO 12866/13563 Review

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Page 15 of 38 products do not contain residual TDI of more than 0.1 percent b y weight . EPA believes 330 that other consumer products do not contain TDI or related compounds at any level. 331 Consistent with EPA's past practice for issuing SNURs under TSCA section 332 5(a)(2), EPA's decision to propose a SNUR for a particular chemical use need not be 333 based on an extensive evaluation of the hazard, exposure, or potential risk associated with 334 that use. Rather, the A gency action is based on EPA's determination that if the use begins 335 or resumes, it may present a risk that EPA should evaluate under TSCA before the 336 manufacturing or processing for that use b egins. Since the new use does not currentl y 337 exist, deferring a detailed consideration of potential risks or hazards related to that use is 338 an effective use of resources. If a person decides to begin manufacturing or processing 339 the chemical for the use, the notice to EPA allows EPA to evaluate the use according to 340 the specific parameters and circumstances surrounding that intended use. 341 B. Objectives 342 Based on the considerations in Unit I II .A., EPA wants to achieve the following 343 objectives with regard to the significant new use(s) that are designated in this proposed 344 rule: 345 1. EPA would receive notice of any person’s intent to manufacture or process 346 TDI or its related compounds (see Table s 1 and 2 of Unit II.A. ) for the described 347 significant new use before that activity begins. 348 2. EPA would have an opportunity to review and evaluate data submitted in a 349 SNUN before the notice submitter begins manufacturing or processing TDI or its related 350 compounds (see Table s 1 and 2 of Unit II.A. ) for the described significant new use. 351 3. EPA would be able to regulate prospective manufacturers or processors of TDI 352 or its related compounds (see Table 1 of Unit II.A. and Table 2 of Unit II.A. ) before the 353* ** EO 12866/13563 Review

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Page 16 of 38 described significant new use of the chemical substance occurs, provided that regulation 354 is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7. 355 **I V. Significant New Use Determination**  356 Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical 357 substance is a significant new use must be made after consideration of all relevant factors 358 including: 359 1. The projected volume of manufacturing and processing of a chemical 360 substance. 361 2. The extent to which a use changes the ty pe or form of exposure of human 362 beings or the environment to a chemical substance. 363 **3.** The extent to which a use increases the magnitude and duration of exposure of 364 human beings or the environment to a chemical substance. 365 4. The reasonabl y anticipated manner and methods of manufacturing, processing, 366 distribution in commerce, and disposal of a chemical substance. 367 In addition to these factors enumerated in TSCA section 5(a)(2), the statute 368 authorizes EPA to consider any other relevant factors. 369 To determine what would constitute a significant new use of TDIor its related 370 compounds subject to this proposed rule, as discussed in this unit , EPA considered 371 relevant information about the toxicity of these substances, likel y human exposures and 372 environmental releases associated with possible uses, and the four factors listed in section 373 5(a)(2) of TSCA. EPA has preliminarily determined as the significant new uses : any use 374 in a consumer product for any chemical listed in Table 1 of Unit II.A. ; and any use in a 375 consumer product for any chemical listed in Table 2 of Unit II.A. ( except for use in 376 coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 377* ** EO 12866/13563 Review

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Page 17 of 38 0.1 percent by

weight of TDI in a consumer product) . 378 The article exemption at 40 CFR 721.45(f) is based on an assumption that people 379 and the environment will generall y not be exposed to chemical substances in articles (see 380 49 FR 35014; September 5, 1984 ) (Ref. 1 ) . However, TDI and related compounds are 381 volatile and as such could migrate out of articles that contain them. For instance, studies 382 of TDI in pol yurethane products reported that after the reaction between an isocyanate 383 and an alcohol to form poly urethane product s , residual levels of isocyanates were 384 detected o n the surface of the products, which if used could le a d to exposure (Refs. 2 and 385 3 ). Because TDI and related compounds are known to be volatile chemical substances, 386 have been reported to migrate from products, are sensitizers, and would be expected to 387 p resent a higher potential for exposure if the TDI in the article were a consumer product, 388 EPA would like the opportunity to evaluate such potential uses in consumer products for 389 any

associated risks or hazards that might exist before those uses would begin . 390 EPA believes any new use of TDI and related compounds as part of articles would 391 increase the duration and magnitude of human exposure to the substance. Based on these 392 considerations, EPA has preliminarily determined that importing or processing 393 substance s in Table 1 of Unit II.A. and Table 2 of Unit II.A. as part of articles warrants 394 making inapplicable the article exemption at 40 CFR 721.45(f) for the significant new 395 uses identified in the tables . 396 **V . Applicability of General Provisions**  397 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 398 provisions describe persons subject to the rule, recordkeeping requirements, exemptions 399 to reporting requirements, and applicability of the rule to uses occurring before the 400 effective date of the final rule. However, for this action, EPA is proposing that 40 CFR 401* ** EO 12866/13563 Review

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Page 18 of 38 721.45(f) (which generally exempts persons importing or processing a substance as part 402 of an article) will not apply and a person who imports or processes a chemical substance 403 as part of an article would not be exempt from submitting a SNUN. 404 Provisions relating to user fees appear at 40 CFR part 700. According to 405 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice 406 requirements and EPA regulatory procedures as submitters of Premanufacture Notices 407 (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the 408 information submissi ons requirements of TSCA section 5(b) and 5(d)(1), the exemptions 409 authorized by

TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 410 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory

action under 411 TSCA section 5(e), 5(f) , 6 or 7 to control the activities on which it has received the 412 SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain 413 in the Federal Register its reasons for not taking action. 414 Persons who export or intend to export a chem ical substance identified in a 415 proposed or final SNUR are subject to the export notification provisions of TSCA section 416 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, 417 subpart D. In accordance with 40 CFR 707.60(b) this proposed SNUR does not trigger 418 export notification for articles. Persons who import a chemical substance identified in a 419 final SNUR are subject to the TSCA section 13 import certification requirements, 420 codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must 421 certify

that the shipment of the chemical substance complies with all applicable rules and 422 orders under TSCA, including any SNUR requirements. The EPA policy in support of 423 import certification appears at 40 CFR part 707, subpart B. The TSCA section 13 import 424 certification requirement applies to articles containing a chemical substance or mixture if 425* ** EO 12866/13563 Review

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Page 19 of 38 so required b y the Administrator by a specific rule under TSCA. At this time EPA is not 426 proposing to require import certification for these chemical substances as part of articles. 427 **VI. Applicability of Rule to Uses Occurring**  **B efore Effective Date of the Final Rule**  428 As discussed in the **Federal Register** of April 24, 1990 (55 FR 17376 ; FRL 429 3658 - 5 ) (Ref. 27 ) , EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best 430 served b y designating a use as a significant new use as of the date of publication of the 431 proposed rule rather than as of the effective date of the final rule. If uses begun after 432 publication of the proposed rule were considered ongoing rather than new, it would be 433 difficult for EPA to establish SNUR notice requirements, because a person could defeat 434 the SNUR by

initiating the proposed significant new use before the rule became final, 435 and then argue that the use was ongoing as of the eff ective date of the final rule. Thus, 436 persons wh o begin commercial manufacture or processing of the chemical substance(s) 437 that would be regulated through this proposed rule, if finalized, would have to cease any 438 such activity

befor e the effective date of the rule if and when finalized. To resume their 439 activities, these persons would have to compl y with all applicable SNUR notice 440 requirements and wait until the notice review period, including all extensions, expires. 441 Uses arising af

ter the publication of the proposed rule are distinguished from uses that 442 exist at pub lication of the proposed rule. The former would be new uses, the latter 443 ongoing uses, except that uses that are ongoing as of the publication of the proposed rule 444 would n ot be considered ongoing uses if they have ceased b y the dat e of issuance of a 445 final rule. To the extent that additional ongoing uses are found in the course of 446 rulemaking, EPA would exclude those specific chemical substances for those specific 447 uses from the final SNUR. EPA has promulgated provisions to allow persons to comply 448 with the final S NUR before the effective date. If a person were to meet the conditions of 449* ** EO 12866/13563 Review

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Page 20 of 38 advance compliance under 40 CFR 721.45(h), that person would be considered to have 450 met the requirements of the final SNUR for those activities. 451 **VII . Test Data and Other Information**  452 EPA recognizes that TSCA section 5 does not usually require developing any 453 particular test data before submission of a SNUN. There are two exceptions: 454 1 . D evelopment of test data is required where the chemical substance subject to 455 the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)); 456 and 457 2 . D evelopment of test data may be necessary

where the chemical substance has 458 been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). 459 Inthe absence of a section 4 test rule or a section 5(b)(4) listing covering the chemical 460 substance, persons are required to submit only test data in their possession or control and 461 to describe any other data known to or reasonabl y ascertainable b y them (15 U.S.C. 462 2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA 463 recommends that SNUN submitters in clude data that would permit a reasoned evaluation 464 of risks posed b y the chemical substance during its manufacture, processing, use, 465 distribution in commerce, or disposal. EPA encourages persons to consult with the 466 agency before submitting a SNUN. As part of this optional pre - notice consultation, EPA 467 would discuss specific data it believes may be useful in evaluating a significant new use. 468 SNUNs submitted for significant new uses without any test data may

increase the 469 li kelihood that EPA will take action under TSCA section 5(e) to prohibit or limit 470 activities associated with this chemical. 471 SNUN submitters should be aware that EPA will be better able to evaluate 472 SNUNs that provide detailed information on: 473* ** EO 12866/13563 Review

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Page 21 of 38 • Human exposure and environmental releases that may result from the 474 significant new uses of the chemical substance , 475

• P otential benefits of the chemical substance , and 476

• Information on risks posed by the chemical substances compared to risks posed 477 by potential substitutes. 478 **VIII .**  **SNUN Submission s**  479 EPA recommends that submitters consult with the A gency prior to submitting a 480 SNUN to discuss what data may be useful in evaluating a significant new use. 481 Discussions with the A gency prior to submission can afford ample time to conduct any 482 tests that might be helpful in evaluating risks posed by the substance. According to 40 483 CFR 721.1(c), persons submitting a SNUN must comply with the same notice 484 requirements and EPA regulat ory procedures as persons submitting a PMN, including 485 submission of test data on health and environmental effects as described in 40 CFR 486 720.50. SNUNs must be submitted on EPA Form No. 7710 - 25, generated using e - PMN 487 software, and submitted to the A gency in accordance with the procedures set forth in 40 488 CFR 721.25 and 40 CFR 720.40. E - PMN software is available electronically at 489 http://www.epa.gov/opptintr/newchems . 490 **I X. Economic Analysis**  491 A. SNUNs 492 EPA has evaluated the potential costs of establishing SNUR reporting 493 requirements for potential manufacturers and processors of the chemical substance s 494 i ncluded in this proposed rule , including as part of articles (Ref. 2 8 ). In the event that a 495 SNUN is submitted, costs are estimated at approxim ately $ 8,589 per SNUN submission 496 for larg e business submitters and $ 6,189 for small business submitters. These estimates 497* ** EO 12866/13563 Review

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Page 22 of 38 include the cost to prepare and submit the SNUN, and the pay ment of a user fee. 498 Businesses that submit a SNUN would be subject to eithe r a $2,500 user fee required b y 499 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than 500 $40 million when combined with those of the parent company (if any), a reduced user fee 501 of $100 (40 CFR 700.45(b)(1)). EPA's complete economic anal ys is is available in the 502 public docket for this proposed rule (Ref. 2 8 ). 503 B. Export Notification 504 Under section 12(b) of TSCA and the implementing regulations at 40 CFR part 505 707, subpart D, exporters must notify EPA if they

export or intend to export a chemical 506 substance or mixture for which, among other things, a rule has been proposed or 507 promulgated under TSCA section 5. For persons exporting a substance that is the subject 508 of a SNUR, a one - time notice must be provided for the first export or intended export to a 509 particular country . The total costs of export notification will vary by chemical, depending 510 on the number of required notifications (i.e., the number of countries to which the 511 chemical is exported). While EPA is unable to make any estimate of the likely number of 512 export noti fications for the chemical covered in this proposed SNUR , a s stated in the 513 accompanyi ng EA of this proposed SNUR, the estimated cost of the export notification 514 requirement on a per unit basis is $84.22 515 C. Import or Processing Chemical Substances as Part of an Article 516 517 In proposing to make inapplicable the exemption relating to persons that import or 518 process certain chemical substances as part of an article, this action may affect firms that 519 plan to import or process ty pes of articles that may

contain th e subject chemical 520 substance. Some firms have an understanding of the contents of the articles they import 521* ** EO 12866/13563 Review

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Page 23 of 38 or process. However, EPA acknowledges that importers and processors of articles may 522 have varying levels of knowledge about the chemical content of the articles that they 523 import or process. These parties may need to become familiar with the requirements of 524 the rule. And, while not required b y the SNUR, these parties may take additional steps to 525 determine whether the subject chemical substances are part of the articles that they are 526 considering to import or process. This determination may involve activities such as 527 gathering information from suppliers along the supply chain, and/or testing samples of 528 the article itself. Costs vary across the activities c hosen and the extent of familiarity a 529 firm has regarding the articles it imports or processes. Cost ranges are presented in the 530 Understanding the Costs Associated with Eliminating Exemptions for Articles in SNURs 531 (Ref. 29 ). Based on available information, EPA believes that article importers that choose 532 to investigate their products would incur costs at the lower end of the ranges presented in 533 the Economic Anal ys is. For those companies choosing to undertake actions to assess the 534 composition of the articles they import or process , EPA expects that importers would take 535 actions that are commensurate with the company’ s perceived likelihood that a chemical 536 substance might be a part of an article , and the resources it has available. Example 537 activities and their costs are provided in the accompanying Economic Analy sis of this 538 Rule (Ref. 2 8 ). 539 **X . Alternatives**  540 Before proposing this SNUR, EPA considered the following alternativ e regulatory 541 action: 542 A. Promulgate a TSCA Section 8(a) Reporting Rule 543 Under a TSCA section 8(a) rule, EPA could, among other things, generall y 544 require persons to report information to the agency when they intend to manufacture or 545* ** EO 12866/13563 Review

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Page 24 of 38 process a listed chemical for a specific use or any use. However, for TDI , the use of 546 TSCA section 8(a) rather than SNUR authority would have several limitations. First, if 547 EPA w ere to require reporting under TSCA section 8(a) instead of TSCA section 5(a), 548 EPA would not have the opportunity to review human and environmental hazards and 549 exposures associated with the proposed significant new use and, if necessary , take 550 immediate follow - up regulatory action under TSCA sections 5(e) or 5(f) to prohibit or 551 limit the activity

before it begins. In addition, EPA may not receive important 552 information from small businesses, because such firms generall y are exempt from TSCA 553 section 8(a) reporting requirements (see TSCA sections 8(a)(1)(A) and 8(a)(1)(B)) . In 554 view of the level of health concerns about TDI if used for the proposed significant new 555 use, EPA believes that a TSCA section 8(a) rule for this substance would not meet EPA's 556 regulatory

objectives. 557 B. Allow the Exemption for Persons W ho Import or Process T

DI and Related 558 Compounds as Part of Articles That W ould Be Subject to the Proposed SNUR 559 Under the SNUR exemption provision at 40 CFR 721.45(f), a person who 560 imports or processes a chemical substance covered by a SNUR identified in 40 CFR part 561 721 , subpart E, as part of an article is not generally subject to the notification 562 requirements of 40 CFR 721.25 for that chemical substance. However, EPA is concerned 563 that exemp ting TDI and related compounds as part of articles would render the SNUR 564 less effective because of the possibility that articles could be imported or processed for 565 uses subject to this proposed SNUR without the submission of a SNUN. This proposed 566 rule woul d not include the exemption at 40 CFR 721.45(f). 567 **X I. Request for Comment**  568 A. Do you have comments or information about ongoing uses? 569* ** EO 12866/13563 Review

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Page 25 of 38 EPA welcomes comment on all aspects of this proposed rule. EPA based its 570 understanding of the use profile of these chemicals on the published literature, the 2012 571 CDR submissions, market research, discussions with manufacturers, and product SDSs. 572 To confirm EPA’s understanding, the A gency is requesting public comment on the 573 EPA’s understanding that coating, adhesive, elastomer, binder, or sealant consumer 574 products do not contain residual TDI of more than 0.1 percent b y weight , as noted in 575 Table 2 of Unit II.A . EPA believes that other consumer products do not contain TDI or 576 related compounds at any level. In providing comments on the concentration of TDI and 577 related compounds in the consumer product, it would be helpful if you provide sufficient 578 information for EPA to substantiate any assertions of use and concentrations. 579 B . W

hat Should I Consider as I Prepare m y Comments for EPA? 580 1. Submitting CBI . Itis EPA's policy

to include all comments received in the 581 public docket without change or further notice to the commenter and to make the 582 comments available on - line at www.regulations.gov, including any personal information 583 provided, unless a comment includes information claimed to be CBI or other information 584 whose disclosure i s restricted by statute. Do not submit this information to EPA through 585 regulations.gov or e - mail. Clearly mark the part or all of the information that you claim 586 to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the 587 outside of the disk or CD ROM that you mail to EPA as CBI and then identify 588 electronically

within the disk or CD ROM the specific information that is claimed as 589 CBI. In addition to one complete version of the comment that includes information 590 claimed as CBI, a cop y of the comment that does not contain the information claimed as 591 CBI must be submitted for inclusion in the public docket. Information so marked will not 592 be disclosed except in accordance with procedures set forth in 40 CFR part 2 , subpart B . 593* ** EO 12866/13563 Review

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Page 26 of 38 2. Tips fo r preparing your comments . When submitting comments, remember to: 594 i. I dentify

the document by

docket ID number and other identifying information 595 (subject heading, **Federal Register** date, and page number). 596 ii. Follow directions. The agency may ask yo u to respond to specific questions or 597 organize comments by referencing a CFR part or section number. 598 iii. Explain why you agree or disagree; suggest alternatives and substitute 599 language for your requested changes. 600 iv. Describe any assumptions and provide any technical information and/or data 601 that you used. 602 v. If you estimate potential costs or burdens, explain how you arrived at your 603 estimate in sufficient detail to allow for it to be reproduced. 604 vi. Provide specific examples to illustrate your concerns and suggest alternatives. 605 vii. Explain your views as clearl y as possible, avoiding the use of profanity or 606 personal threats. 607 viii. Make sure to submit your comments by the comment period deadline 608 identified. 609 **XII. References** 610 The following is a listing of the documents that are specifically referenced in this 611 document. The docket includes these documents and other information considered b y 612 EPA, including documents that are referenced with in the documents that are in the 613 docket, even if the referenced document is not phy sicall y located in the docket. For 614 assistance in locating these other documents, please consult technical person listed under 615 **FOR FURTHER INFORMATION CONTACT** . 616 1 . U.S. EPA. Significant New Uses of Chemical Substances; Certain Chemicals. 617* ** EO 12866/13563 Review

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Page 27 of 38 49 FR 35014, September 5, 1984 (FRL - 2541 - 8). 618 2 . Krone, C., and Klinger, T. (2005). Isocyanates, poly urethane and childhood 619 asthma. Pediatric Allergy and Immunology 16, 378 - 379. 620 3 . Bello, D., Herrick, C. A., Smith, T. J., Woskie, S. R., Streicher, R. P., Cullen, 621 M. R., L iu, Y., and Redlich, C. A. (2007). Skin Exposure to Isocyanates: Reasons for 622 Concern. Environmental Health Perspectives 115. 623 4 . BASF Corporation. (2011). Project Summary Report Requested Industrial 624 Hygiene personal and Area Monitoring for Id entified Airborne Chemical Hazards of 625 MDIand/or TDI Associated with I socyanate - Containing Pro duct Use Scenarios for 626 Id entified Construction Sealants and/or Basecoat Products (Sanitized Version). JKInc . 627 Report #: 111 - 11, 1 - 6. 628 5 . Vangronsveld, E, Berckmans, S., and S pence, M. (2013). Comparison of 629 Solvent/Derivatization Agent S ys tems for Deter mination of Extractable Toluene 630 Diisocyanate from Flexible Poly urethane Foam. Annals of Occupational Hygiene 57(5), 631 640 - 649 . 632 6 . Redlich, C. A., Bello, D., and Wisnewski, A. (2006). Isocyanate exposures and 633 health effects. In Environmental and Occupational Medicine (W. Rom, and S. 634 Markowitz, Eds.), pp. 502 - 516. Lippincott Williams & Wilkins Philadelphia, PA. 635 7 . DOW (2009). Product Safety Assessment DOW Modified Toluene 636 Diisocyanate (TDI) Products. July 16 2010. 637 http://www.dow.com/PublishedLiterature/dh_034d/0901b8038034d515.pdf?filepath=pru 638 ctsay/pdfs/noreg/233 - 00617.pdf &f romPage=GetDoc . 639 8 . Collins, M.A. (2002). Toxicology of Toluene Diisocyanate. Applied 640 Occupational and Environmental Hygiene 17, 846 - 855. 641* ** EO 12866/13563 Review

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Page 28 of 38 9 . Gledhill, A. Wake, A., Hext, P., Leiobold , E., and Shiotsuka, R. (2005). 642 Absorption, distribution, metabolism and excretion of an inhalation does of 14C 4,4' 643 methylenediphenyl diisocyanate in the male rat. Xenobiotica 35, 273 - 292. 644 10 . EPA. 2011. Toluene Diisocyanate (TDI) and Related Compounds Action 645 Plan. Available online at : 646 http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/tdi.pdf . 647 1 1 . Ott, M.G. , Diller, W.F., and Jolly , A.T. (2003). Respiratory effects of toluene 648 diisocyanates in the workplace; a discussion of exposure - response relationships. Critical 649 Review Toxicology 33, 1 - 59. 650 1 2 . Bello, D., Woskie, S. R., Streicher, R. P., L iu, Y., Stowe, M. H., Eisen, E. A. 651 Ellenbecker, M. J., Sparer, J., Youngs, F., Cullen, M. R., and Redlich, C. A. (2004). 652 Polyisocyanates in occupational environments: a critical review of exposure limits and 653 metrics. American Journal Industrial Medicine 46, 480 - 491. 654 1 3 . NIOSH (1996). National Institute for Occupational Safety and Health . 655 Preventing asthma and death from diisocyanate exposure: NI OSH Alert. (DHHS, Ed.). 656 1 4 . American Chemistry Council (ACC) (2005). TSCA Section 8(e) Notice of 657 Substantial Risk 8EHQ - 0905 - 16225 Fatalities linked to diisocyanates. EPA. 658 1 5 . IARC. (1999). Tolu ene Diisocyanates . WHO. p. 865 - 879. 659 1 6 . Environment Canada. (2008). Screening Assessment for the Challenge: 660 Toluene Diisocyanate . http://www.ec.gc.ca/ese - ees/default.asp?lang=En& n=69A64ACA . 661 1 7 . NTP (2011). National Toxicology Program . Report on Carcinogens, Twelfth 662 Edition ; U.S. Department of Health and Human Services, Public Health Service. 663 Substance Profile, Toluene Diisocyanates. http://ntp.niesh.nih.gov?objectid=03C9AF75 - 664 E1BF

-FF40 -DBA9EC0928DF8B15 . 665* ** EO 12866/13563 Review

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Page 29 of 38 1 8 . NI OSH (2005). National Institute of Occupational Safety and Health . N I O SH 666 Pocket Guide to Chemical Hazards July 16, 2010. 667 http://www.cdc.gov/NIOSH/npg/npgdcas.html . 668 1 9 . De Zotti (2000). De Zotti, R., Muran, A., and Zambon, F. (2000). Two cases 669 of paraoccupational asthma due to toluene diisocyanate (TDI). Occupational and 670 Environmental Medicine 57, 837 - 839. 671 20 . Agency for Toxic Disease Registry (ATSDR) ( 2002 ) . Case Studies in 672 Environmental Medicine: Pediatric Environmental Health. ATSDR Publication No. 673 ATSDR - HE - CD - 2002 - 0002. 674 2 1 . NI OSH (2004). Nationa l Institute for Occupational Safety and Health . A 675 Summary

of Health Hazard Evaluations: I ssues Related to Occupational Exposure to 676 Isocyanates 1989 - 2002. (D. o. H. a. H. Services, Ed.), pp. 1 - 42, Cincinnati, OH 677 2 2 . Pianoforte, K. (2009). Adhesives and sealants market update, November 1, 678 2009. In Coatings World. 679 2 3 . Kelly , T. J., Myers, J. D., and Holdren, M. W. (1999). Testing of Household 680 Products and Materials for Emission of Toluene Diisocyanate. Indoor Air 9, 117 - 124. 681 2 4 . Jarand, C. W., Akapo, S. O., Swenson, L . J., and Kelman, B. J. (2002). 682 Diisocyanate emission from a paint product: a preliminary analy sis. Applied 683 Occupational Environmental Hygiene 17, 491 - 494. 684 2 5 . NYC - DOHMH (2010). New York City Department of Health and Mental 685 Hygiene . Moisture Cure Urethanes (MCU). July 16 , 2010 . 686 http://www.nyc.gov/html/doh/html/epi/mcufact.shtml. 687 2 6 . NI OSH (2006). National Institute for Occupational Safety and Health. 688 Preventing Asthma and Death from MDI Exposure During Spray- on Truck Bed Liner 689* ** EO 12866/13563 Review

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Page 30 of 38 and Related Applications: NI OSH Alert. http://www.cdc.gov/niosh/docs/2006- 690 149/default.html . 691 27. U.S. EPA. Significant New Uses of Certain Chemical Substances. 692 55 FR 173776 , April 24, 1990 (FRL - 3658 - 5) . 693 2 8 . EPA. Economic Analy sis of the Significant New Use Rule for Toluene 694 Diisocyanate (TDI) and Related Compounds . April 2, 2014 . 695 2 9 . EPA, Understanding the Co sts Associated with Eliminating 696 E xemptions for Articles in SNURs. May 1, 2013. 697 **XI II**  **. Statutory and Executive Order Reviews** 698 A. Executive Order 12866 : Regulatory Planning and Review and Executive Order 13563 : 699 Improving Regulation and Regulatory Review 700 This prop osed SNUR has been designated b y the Office of Management and 701 Budget (OMB) as a ‘‘significant regulatory action’’ under section 3(f) of Exe cutive Order 702 (58 FR 51735, October 4, 1993) . Accordingl y, EPA submitted this action to OMB for 703 review under Executive Order s 12866 and 13563 (76 FR 3821, January 21, 2011) , and 704 any

c hanges made in response to OMB recommendations are documented in the docket . 705 B. Paperwork Reduction Act (PRA) 706 This action does not impose any new information collection burden under the 707 PRA, 44 U.S.C. 3501 et seq . Burden is defined in 5 CFR 1320.3(b). The information 708 collection activities associated with existing chemical SNURs are already approved b y 709 OMB under OMB control number 2070 - 0038 (EPA I CR No. 1188); and the information 710 collection a ctivities associated with export notifications are already approved by

OMB 711 under OMB control number 2070 - 0030 (EPA IC R No. 0795). If an entity were to submit 712 a SNUN to the Agency , the annual burden is estimated to be less than 100 hours per 713* ** EO 12866/13563 Review

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Page 31 of 38 response, and the estimated burden for an export notifications is less than 1.5 hours per 714 notification. In both cases, burden is estimated to be reduced for submitters who have 715 already registered to use the electronic submission sy stem. Additional burden, estimated 716 to b e less than 10 hours, could be incurred where additional record keeping requirements 717 are specified under 40 CFR 721.125(a), (b), and (c). 718 An agency may not conduct or sponsor, and a person is not required to respond to 719 a collection of information that req uires OMB approval under the PRA, unless it has been 720 approved b y OMB and displays a currently valid OMB control number. The OMB 721 control numbers for EPA's regulations in Title 40 of the CFR, after appearing in the 722 **Federal Register** , are listed in 40 CFR, part 9, and included on the related collection 723 instrument, or form, if applicable. EPA is amending the table in 40 CFR part 9 to list this 724 SNUR. This listing of the OMB control numbers and their subsequent codification in the 725 CFR satisfies the display requirements of the PRA and OMB's implementing regulations 726 at 5 CFR part 1320. Since the existing OMB approval was previousl y subject to public 727 notice and comment before OMB approval, and given the technical nature of the table, 728 EPA finds that further notice and comment to amend the table is unnecessary . As a result, 729 EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative 730 Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and 731 comment. 732 C. Regulatory Flexibility Act (RFA) 733 Pursuant to section 605(b) of the Regulatory Flexibility

Act ( RFA ) ( 5 U.S.C. 601 734 et seq .), the agency hereby certifies that promulgation of this SNUR would not have a 735 significant adverse economic impact on a substantial number of small entities. The 736 rationale supporting this conclusion is as follows. 737* ** EO 12866/13563 Review

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Page 32 of 38 A SNUR applies to any

person (including small or large entities) who intends to 738 engage in any activity described in the rule as a “significant new use.” By definition of 739 the word “new” and based on all information currently available to EPA, it appears that 740 no small or large entities presentl y engage in such activities. Since this proposed SNUR 741 would require a person who intends to engage in such activity in the future to first notify 742 EPA by

submitting a SNUN, no economic impact will occur unless someone files a 743 SNUN to pursue a significant new use in the future or forgoes profits by avoiding or 744 delaying the significant new use. Although some small entities may decide to co nduct 745 such activities in the future, EPA cannot presentl y determine how many, if any, there 746 may

be. However, EPA's experience to date is that, in response to the promulgation of 747 SNURs covering over chemical substances, the agency receives on average only a 748 handful of notices per ye ar. During the six year period from 2005 - 2011, only three 749 submitters self

- identified as small in their SNUN submission (Ref. 26). EPA believes the 750 cost of submitting a SNUN is relativel y small compared to the cos t of developing and 751 marketing a chemical new to a firm and that the requirement to submit a SNUN generall y 752 does not have a significant economic impact. 753 EPA believes that there will be minimal impact to processors and importers of the 754 chemical substance subject to the final SNUR as part of an article. The SNUR does not 755 require processors and importers of articles that contain the chemicals subject to the 756 proposed SNUR to conduct specific activities to ascertain if they are importing or 757 processing an artic le that uses a chemical subject to the rule. EPA expects importers 758 would take actions that are commensurate with their perceived likelihood of a chemical 759 substance subject to the SNUR being part of an article, and the resources it has available. 760 EPA has no reason to believe that a firm would voluntarily incur substantial costs to 761* ** EO 12866/13563 Review

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Page 33 of 38 comply with the SNUR, but rather EPA believes each firm will choose the most efficient 762 route to identify

whether it is importing the subject chemical substances in articles 763 Therefo re, EPA believes that the potential economic impact of compl yi ng with 764 this proposed SNUR is not expected to be significant or adversel y impact a substantial 765 number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 766 FR 42690 )( FRL - 5735 - 4), the Agency presented its general determination that proposed 767 and final SNURs are not expected to have a significant economic impact on a substantial 768 number of small entities, which was provided to the Chief Counsel for Advocacy of the 769 Small Business Administration. 770 D. Unfunded Mandates Reform Act (UMRA) 771 Based on EPA’s experience with proposing and finalizing SNURs, State, local, 772 and Tribal governments have not been impacted by these rulemakings, and EPA does not 773 have any reason to believe that any State, local, or Tribal government would be impacted 774 by this rulemaking. As such, the requirements of sections 202, 203, 204, or 205 of 775 UMRA , 2 U.S.C. 1531 - 1538 , do not apply to this action. 776 E. Executive Order 13132 : Federalism 777 This action will not have a substantial direct effect on States, on the relationship 778 between the national government and the States, or on the distribution of power and 779 responsibilities among the various levels of government, as specified in Executive Order 780 13132 (64 FR 43255, August 10, 1999) . 781 F. Executive Order 13175 : Consultation and Coordination with Indian Tribal 782 Governments 783 This proposed rule does not have Tribal implications because it is not expected to 784 have any effect ( i.e., there will be no increase or decrease in authority or jurisdiction) on 785* ** EO 12866/13563 Review

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Page 34 of 38 Tribal governments, on the relationship between the Federal government and the Indian 786 tribes, or on the distribution of power and responsibilities between the Federal 787 government and Indian tribes. Thus , Exe cutive Order 13175 (65 FR 67249, November 9, 788 2000), do es not appl y to this action . 789 G. Executive Order 13045 : Protection of Children from Environmental Health Risks and 790 Safety Risks 791 This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 792 1997), because this action is not intended to address environmental health or safety risks 793 for children. 794 H. Executive Order 13211 : Actions Concerning Regulations that Significantly Affect 795 Energy Supply, Distribution, or Use 796 This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 797 22, 2001), because this action is not expected to affect energy suppl y, distribution, or use. 798 I. National Technology Transfer and Advancement Act (NTTAA) 799 S ince this action does not invo lve any technical standards, section 12(d) of 800 NTTAA, 15 U.S.C. 272 note , does not apply to this section. 801 J. Executive Order 12898 : Federal Actions to Address Environmental Justice in Minority 802 Populations and Low -Income Populations 803 This proposed rule does not invoke special consideration of environmental justice 804 related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994) , 805 because EPA has determined that this action will not have disproportionately high and 806 adverse human health or environmental effects on minority or low - income populations . 807 This action does not affect the level of protection provided to human health or the 808 environment. 809* ** EO 12866/13563 Review

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Page 35 of 38 810* ** EO 12866/13563 Review

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Page 36 of 38 **List of Subjects in 40 CFR Part 721**  811 Environmental protection, Chemicals, Hazardous substances, Reporting and 812 recordkeeping requirements . 813 814 Dated: _______________________ 815 816 817 818

**____________________________________________** 819 820 821 Director, Office of Pollution Prevention and Toxics. 822* ** EO 12866/13563 Review

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Page 37 of 38 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 823 **PART 721**  **-- [AMENDED]**  824 1. The authority citation for part 721 continues to read as follows: 825 **Authority:** 15 U.S.C. 2604, 2607, and 2625(c) . 826 2. Add §721. **10789** to subpart E to read as follows **:** 827 **§721. 10**  **789 Toluene**  **d iisocyanates**  **and r**  **elated c**  **ompounds .**  828 829 (a) Chemical substances and significant new uses subject to reporting. (1) The 830 chemical substances listed in Table 1 and Table 2 of this paragraph are subject to 831 reporting under this section for the significant new uses described in paragraph (a)(2) of 832 this section. 833 **Table 1**  **. —** **Toluene Diisocyanates ad Related Compounds Subject to Repo**  **rting for**  834 **Any Use in a Consumer Product** 835 Chemical Name Chemical Abstracts Index Name Chemical Abstract s Service Registry (CASRN) Toluene diisocyanate trimer Benzene, 1,3 - diisocyanatomethyl - , trimer 9019 - 85 - 6 Poly(toluene diisocyanate) Benzene, 1,3 - diisocyanatomethyl - , homopoly

mer 9017 - 01 - 0 Toluene diisocyanate dimer 1,3 - Diazetidine - 2,4 - dione, 1,3 bis(3 - isocyanatomethylphenyl) - 26747 - 90 - 0 Toluene diisocyanate “cyclic” trimer 1,3,5 - Triazine - 2,4,6(1H,3H,5H) - trione, 1,3,5 - tris(3 - isocyanatomethylphenyl) - 26603 - 40 - 7 836 837 838 839 840 841 **Table 2 .**  **— Toluene Diisocyanates ad Related Compounds Subject to Reporting for**  842 **Any Use in A Consumer Product (Except for use in Coatings, Adhesives,** 843 **Elastomers, Binders, and S ealants**  **at Less than or Equal to 0.1 Percent in a** 844 **Consumer Product)** 845* ** EO 12866/13563 Review

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Page 38 of 38 846 847 Chemical Name Chemical Abstract s Index Name Chemical Abstract s Service Registry Number (CASRN) 2,6 - Toluene diisocyanate Benzene, 1,3 - diisocyanato - 2 - methyl 91 - 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 - 5 848 (2) The significant new use s are: 849 ( i ) For the chemi cal substances listed in Table 1 of paragraph (a)(1), any use of 850 the chemical substance in consumer products . 851 (ii) For the chemical substance s listed in Table 2 of paragraph (a)(1), any use of 852 the chemical substance in a consumer product ( except for use in coatings, adhesives, 853 elastomers, binders, and sealants, that re sult s in less than or equal to 0.1 percent b y 854 weight of such chemical substance in the consumer product). 855 (b) Specific requirements. The provisions of subpart A of this part appl y to this 856 section except as modified by this paragraph (b) : 857 (1 ) Revocation of certain notification exemptions . The p rovisions of § 721.45 (f ) 858 do not a

pp l y to this s ec tion. A p er son who impo rts or p ro ce ss e s a c h e mi c al subst an ce 859 i d enti f

i e d in p aragr a

ph ( a)( 1) o f this s ec tion a s p art of an arti c le f or a s i gni f

i c ant n ew u s e 860 d es crib ed in p aragr a ph ( a)( 2) of th i s s ec tion is not thereb y exempt from submitting a 861 s i gni f

i cant n ew use noti ce . 862 (2) [Reserved] 863