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### EO 12866/13563 Review Draft – As Submitted Revised 11/19/14 12/3/2014 1 Rin2070-AJ73_EO12866_3-Chemical-SNUR_FRM_FR Document_Redlined_2014-12-03.docxRin2070- 2 AJ73_EO12866_3-Chemical-SNUR_FRM_FR Document_2014-08-15-Redlined_2014-11-19.docx 3

__________________________________________________________________________________________ 4 BILLING CODE 6560-50-P 5 ENVIRONMENTAL PRO TECTION AGENCY 6 40 CFR Parts 9 and 721 7 [EPA-HQ-OPPT-2010-0573; FRL -xxxx-x-9915-60 ] 8 RIN 2070-AJ73 9 Benzidine-Based Chemical Substances; Di- n -pentyl Phthalate (DnPP); and Alkanes, C 12– 10
13 , Chloro; Significant New Use Rule 11 AGENCY: Environmental Protection Agency (EPA). 12 ACTION: Final rule

. 13 SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is promulgating a 14 significant new use rule (SNUR) to add nine benzid ine-based chemical substances to the existing 15 SNUR on benzidine-based chemical substan ces. With respect to both the newly-added 16 benzidine-based chemical substances and the previously-listed benzidine-based chemical 17 substances, this rule makes inapplicable the exemption relating to persons that import or process 18 substances as part of an article. EPA is al so promulgating a SNUR fo r di-n-pentyl phthalate 19 (DnPP) and a SNUR for alkanes, C 12-13 , chloro (CAS No. 71011-12- 6). These actions require 20 persons who intend to manufacture (defined by st atute to include import) or process these 21 chemical substances for an activity that is desi gnated as a significant new use to notify EPA at 22 least 90 days before commencing such manufacture or processing. The required notifications 23 will provide EPA with the opportunity to evaluate activities associated with a significant new use 24 and, if necessary based on the information avai lable at that time, an opportunity to protect 25 against potential unreasonable risk s, if any, from that activity before it occurs. EPA is also 26*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 2 of 72 making a technical amendment to the codified li st of control numbers for approved information 27 collection activities so that it includes the cont rol number assigned by th e Office of Management 28 and Budget (OMB) to the info rmation collection activities contained in this rule. 29 DATES: This final rule is effective [ insert date 60days after date of publication in the Federal 30 Register ]. 31 ADDRESSES: The docket for this action, identifiedby docket identificat ion (ID) number EPA32 HQ-OPPT-2010-0573, is available at http://www.regulations.gov or at the Office of Pollution 33 Prevention and Toxics Docket (OPPT Docket), EPA Docket Center (EPA/DC), EPA West Bldg., 34 Rm. 3334, 1301 Constitution Ave., NW., Washingt on, DC. The Public Reading Room is open 35 from 8:30 a.m. to 4:30 p.m., Monday through Frid ay, excluding legal ho lidays. The telephone 36 number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT 37 Docket is (202) 566-0280. Please review the visito r instructions and addi tional information about 38 the docket available at http://www.epa.gov/dockets

. 39 FOR FURTHER INFORMATION CONTACT: For technical information contact : Sara 40 Kemme, National Program Chemicals Division (7404T), Office of Pollution Prevention and 41 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 42 20460-0001; telephone number: (202 ) 566-0511; email address: kemme.sara@epa.gov

. 43 For general information contact : The TSCA-Hotline, ABVI-Goodwill, 422 South 44 Clinton Ave., Rochester, NY 14620; telephon e number: (202) 554-1404; email address: TSCA45 Hotline@epa.gov

. 46 SUPPLEMENTARY INFORMATION: 47 I. Executive Summary 48 A. Does this Action Apply to Me? 49*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 3 of 72 These three different SNURs may apply to different entities. The North American 50 Industrial Classification System (NAICS) codes have been provide d to assist you and others in 51 determining whether this action might apply to certain entities. 52
1. Benzidine-based chemical substances . You may be potentially affected by this action if 53 you manufacture (defined by statute to include import), or process, in cluding as part of an article, 54 any of the benzidine-based chemical substances liste d in Tables 1 and 2 of the regulatory text in 55 this document. Potentially affected entities may include, but are not limited to: 56 • Manufacturers or processors of one or mo re of the subject chemical substances. 57 • Entities which plan to use the listed chemi cal substances in conjunction with apparel 58 and other finished products made from fabr ics, leather, and similar materials. 59 • Entities which plan to use the listed chemical substances in conjunction with paper and 60 allied products. 61 • Manufacturers or processors of the subjec t chemical substances in printing inks. 62 These entities may include those described by the NAICS codes 325-ch emical manufacturing, 63 31-textile manufacturers, 316-leather and al lied products manufacturers, 322-paper 64 manufacturers, 4243-apparel, piece goods, and notions wholesalers, or 443-clothing and 65 accessories stores. 66 2. DnPP . You may be potentially affected by th is action if you manufacture (defined by 67 statute to include import), or pr ocess DnPP. Potentially affected entities may include, but are not 68 limited to: Chemical industry – plastic ma terial and resins (NAICS code 325211). 69 3. Alkanes, C 12-13 , chloro (CAS No. 71011-12-6) . You may be potentially affected by this 70 action if you manufacture or proc ess the following short-chaine d chlorinated paraffin (SCCP): 71 Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). Potentiall y affected entities may include, but are 72 not limited to: Manufacturers of SCCPs (NAICS codes 325 and 325998), chemical 73*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 4 of 72 manufacturing; including mis cellaneous chemical product and preparation manufacturing; and 74 processors of SCCPs (NAICS codes 324 and 324191), petroleum lubricating oil and grease 75 manufacturing. 76 This action may also affect certain entitie s through pre-existing import certification and 77 export notification rule s under TSCA. Persons who import any chemical substance governed by 78 a final SNUR are subject to the TSCA sec tion 13 (15 U.S.C. 2612) import certification 79 requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 80 CFR 127.28. Those persons must certify that the sh ipment of the chemical substance complies 81 with all applicable rules and orders under TS CA, including any SNUR requirements. The EPA 82 policy in support of import cert ification appears at 40 CFR part 707, subpart B. In addition, any 83 persons who export or intend to e xport a chemical substance that is the subject of a proposed or 84 final SNUR are subject to the export notification provi sions of TSCA section 12(b) (15 U.S.C. 85 2611(b)) (see 40 CFR 721.20) and must comply with the export notification requirements in 40 86 CFR part 707, subpart D. 87 To determine whether you or your business may be affected by this action, you should 88 carefully examine the applicability provision s in 40 CFR 721.5 for SNUR-related obligations 89 and with respect to benzidine-based chemical s ubstances, the applicability provisions in Unit V. 90 If you have any questions regarding the applicability of this action to a particular entity, consult 91 the technical person listed under FOR FURTHER INFORMATION CONTACT

. 92 B. What Is the Agency's Aut hority for Taking this Action? 93 Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use 94 of a chemical substance is a “significant new us e.” EPA must make this determination by rule 95 after considering all rele vant factors, including those listed in TSCA sec tion 5(a)(2). Once EPA 96 determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) 97*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 5 of 72 requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before 98 they manufacture or process the chemical subs tance for that use (15 U.S.C. 2604(a)(1)(B)). As 99 described in Unit V., the general SNUR provi sions are found at 40 CFR Part 721, Subpart A. 100 C. What Action is the Agency Taking? 101 In a single Federal Registernotice on of March 28, 2012 (77 FR 18752) (FRL-8865-2), 102 EPA proposed three chemical specific SNURs being addressed in this final rule (Ref. 1). EPA’s 103 response to public comments received on the propose d rule appears in Unit X. Please consult the 104 March 28, 2012 Federal Register document (Ref. 1) for further background information for this 105
final rule. 106 These final SNURs will require persons to notify EPA at least 90 days before commencing 107 the manufacture (including import) or processing of: 108 • The nine benzidine-based chemical substances identified in Table 1, which are being added 109 to § 721.1660 with a designation of any use as a significant new use; 110 • DnPP with a designation of any use other than as a chemical standard for analytical 111 experiments as a significant new use; and 112 • Alkanes, C12-13, chloro (CAS No. 71011-12-6) with a designation of any use as a 113 significant new use. 114 In addition, this final rule amends the SNUR at § 721.1660 to make inapplicable the 115 exemption at § 721.45(f) for persons that import or process benzidine-based chemical substances as 116 part of an article. For the benzidine-based chemical substances, the elimination of the article 117 exemption at 40 CFR 721.45(f) will require person s to notify EPA at least 90 days before 118 commencing processing or importing as part of an article any of the newly-added benzidine-based 119 chemical substances, as well as those already covered (61 FR 52287, October 7, 1996 (FRL–5396– 120 6), codified at 40 CFR 721.1660). 121 D. Why is the Agency Taking this Action? 122*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 6 of 72 These SNURs are necessary to ensure that EPA receives timely advance notice of any future 123 manufacturing and processing of these chemical substances for new uses that may produce changes 124 in human and environmental exposures. The rationale and objectives for this SNUR are explained in 125 Unit III. 126 E. What are the Estimated Incremental Impacts of this Action? 127 EPA has evaluated the potential costs of establishing SNUR reporting requirements for 128 potential manufacturers and processors of the chemical substances included in this final rule. This 129 analysis, which is available in the docket, is disc ussed in Unit IX., and is briefly summarized here. 130 In the event that a SNUN is submitted, costs are estimated to be less than $8,700 per SNUN 131 submission for large business submitters and $6,300 for small business submitters. These estimates 132 include the cost to prepare and submit the SNUN and the payment of a user fee. In addition, for 133 persons exporting a substance that is the subject of a SNUR, a one-time notice must be provided for 134 the first export or intended export to a particular country, which is estimated to cost less than $100 on 135 average per notification. The rule may also affect firms that import or process articles that may 136 contain benzidine-based chemicals, because, while not required by the SNUR, these parties may take 137 additional steps to determine whether benzidine-based chemicals are part of the articles that they are 138 considering to import or process. Since EPA is unable to predict whether anyone might engage in 139 future activities that would require reporting, potential total costs were not estimated. 140 II. Overview of the Chemical Substances Subject to this Rule 141 The SNURs in this final rule involve certain benzidine-based chemical substances in the 142 existing SNUR at 40 CFR 721.1660 ( 77 FR 18752, 18756 (FRL-8865-2)), the nine benzidine143 based chemical substances lis ted in Table A, DnPP (CAS No . 131-18-0), and alkanes, C12-13, 144 chloro (CAS No. 71011-12-6). 145*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 7 of 72 Table A.—Newly Added Benzidine-Based Chemical Substances 146 CAS or accession number C.I. name C.I. number Chemical name

117-33-9 Not a v a il ab le Not a v a il ab le 1,3-N aphth a lenedisulfonic acid, 7-hyd r oxy8-[2-[4'-[2-(4-hydroxyphenyl)diazenyl][1,1'- biphenyl]-4-yl]diazenyl]- 65150-87-0 Not a v a il ab le Not a v a il ab le 1,3,6-N aphth a lenetr isulfonic acid, 8- hydroxy-7-[2-[4'-[2-(2-hydroxy-1- naphthalenyl)diazenyl][1,1'-biphenyl]-4- yl]diazenyl]-, lithium salt (1:3) 68214-82-4 Direct N a vy BH Not a v a il ab le 2,7-N aphth a lenedisulfonic acid, 5- amino-3- [2-[4'-[2-(7-amino-1-hydroxy-3-sulfo-2- naphthalenyl)diazenyl][1,1'-biphenyl]-4- yl]diazenyl]-4-hydroxy-, sodium salt (1:2) 72379-45-4 Not a v a il ab le Not a v a il ab le 2,7-N aphth a lenedisulfonic acid, 4- amino-5- hydroxy-3-[2-[4'-[2-[2-hydroxy-4-[(2- methylphenyl)amino] phenyl]diazenyl][1,1'- biphenyl]-4-yl]diazenyl]-6-(2- phenyldiazenyl)- Accession No. 21808 CAS No. CBI (NA) CBI CBI 2,7-Naphthalenedisu lfonic acid, 4-amino-5- hydroxy [[[(substituted phenylamino)] substituted phenylazo] diphenyl]azo-, phenylazo-, disodium salt. (generic name) Accession No. 24921 CAS No. CBI (NA) CBI CBI 4-(Substituted n aphth a lenyl) a zo diphenylyl azo-substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (generic name) Accession No. 26256 CAS No. CBI (NA) CBI CBI 4-(Substituted phenyl) a zo biphenylyl a zosubstituted carbopolycycloazo benzenesulfonic acid, sodium salt. (generic name) Accession No. 26267 CAS No. CBI (NA) CBI CBI 4-(Substituted phenyl) a zo biphenylyl a zo - substituted carbopolycycle azo benzenesulfonic acid, so dium salt. (generic name) Accession No. 26701 CAS No. CBI (NA) CBI CBI Phenyl a zo aminohy d r oxyn aphth a lenyl a zobiph enylazo substituted benzene sodium sulfonate. (generic name)
147 CAS = Chemical Abstracts Services. CBI = Confidential Business Information. CBI (NA) = 148 Confidential Business Information (Not Available). C.I. = Chemical Index. 149 III. Rationale and Objectives 150 A. Rationale 151*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 8 of 72 Consistent with EPA’s past practice for issuing SNURs under TSCA section 152 5(a)(2), EPA’s decision to issue a SNUR for a particular chemical use need not be based on an 153 extensive evaluation of the hazard, exposure, or potential risk asso ciated with that use. Rather, 154 the Agency’s action is based on EPA’s determinati on that if the use begins or resumes, it may 155 present a risk that EPA should evaluate under TS CA before the manufacturing or processing for 156 that use begins. Since the new use does not curren tly exist, deferring a deta iled consideration of 157 potential risks or hazards re lated to that use is an effective use of resources. If a person decides to 158 begin manufacturing or processing the chemical fo r the use, the notice to EPA allows EPA to 159 evaluate the use according to the specific parameters and circumstances surrounding that 160 intended use. 161
1. Benzidine-based chemical substances. As described in the proposal (77 FR 18752, 162 March 28, 2012) (FRL 8865-2), EPA is concer ned about potential carcinogenic effects on 163 workers and consumers from the manufacture, pro cessing, or use of these substances. Consumers 164 exposed via dermal exposure to consumer produc ts containing the benzidine-based chemical 165 substances are a particular concern because enzymes present in the human body and in bacteria 166 on the skin aid in the reduction of these chemical substances to the benzid ine unit, an established 167 human carcinogen (Ref. 2). The main consumer produc ts that could result in dermal exposure if 168 containing these chemical substances include tex tiles and leather products because they are in 169 prolonged contact with human skin. 170 During the review of information on be nzidine-based chemical substances, EPA 171 determined that the newly identified chemical substances that are being added to 40 CFR 172 721.1660 by this final rule present th e same concerns (Ref. 3) as those of the benzidine-based 173 chemical substances already listed in the rule (61 FR 52287, October 7, 1996 (FRL–5396–6), 174 codified at 40 CFR 721.1660). EPA does not believ e there is any current use of these nine 175*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 9 of 72 benzidine-based chemical substances within or outside the United States. This conclusion is 176 based on a review of EPA’s own Inventory U pdate Reporting (IUR) data, and more recent 177 Chemical Data Reporting (CDR) data as well as other sources including the Colour Index 178 International, published by the Society of Dyers and Colourists and American Association of 179 Textile Chemists and Colorists; IHS Chemi cal Economics Handbook, Dyes; and ICIS Directory 180 of World Chemical Producers. 181 In addition, as discussed earlier, although some of the benzidine-based chemical 182 substances subject to the 1996 SNUR may be manufactured or proces sed outside the United 183 States, an analysis of the benzidine-based chemical substances market (Ref. 3) revealed no 184 information indicating import of articles contai ning benzidine-based chemical substances for 185 non-excluded purposes. 186 Although it appears there is no ongoing domestic manufacture of the nine newly added 187 benzidine-based chemical substances, or import for a non-excluded use of articles containing any 188 benzidine-based chemical substances, the manufacture (including import) or processing of the 189 nine newly added benzidine-based chemical subs tances and the import or processing of articles 190 containing any benzidine-based ch emical substances may begin atany time, without prior notice 191 to EPA. Thus, EPA is concerned that commencem ent of the manufacture (including import) or 192 processing for any new uses, including resumption of past uses, of benzidine-based chemical 193 substances could significantly in crease the magnitude and duration of exposure to humans over 194 that which would otherwise exist currently. EPA is concerned that such an increase should not 195 occur without an opportunity for the Agency to ev aluate activities associat ed with a significant 196 new use and an opportunity to protect against pot ential unreasonable risks, if any, from exposure 197 to the chemical substance. 198*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 10 of 72 Accordingly, EPA is finalizing a SNUR for th e nine benzidine-based chemical substances 199 by adding them to those curren tly listed at § 721.1660, and maki ng inapplicable the article 200 exemption at § 721.45(f) for those chemical substa nces newly added in this rulemaking as well 201 as for those already listed at § 721.1660. This fi nal rule will require persons who intend to 202 manufacture (including import) or process any of the benzidine-ba sed chemical substances for a 203 non-excluded use, including importing or pro cessing any listed benzidine-based chemical 204 substance for a non-excluded use as part of an article, to submit a SNUN. 205
2. DnPP. As described in the proposal (77 FR 18752, March 28, 2012) (FRL 8865-2), 206 EPA has concerns regarding potential adverse hu man health and environmental effects that may 207 be caused by DnPP. EPA has directinformation from animal studi es that DnPP specifically can 208 elicit developmental/repr oductive effects that are relevant to human health and also indicate 209 potential effects in wildlife. EPA also is c oncerned that due to its general structure and 210 categorization as a phthalate thatDnPP may elicit adverse environm ental effects similar to those 211 described for other phthalates. EPA is concerne d that any manufacturing (including import) or 212 processing of DnPP, beyond that for its limited ongoing use as a chemical standard for laboratory 213 use, could significantly increase the magnitude and duration of exposure to humans over that 214 which would otherwise exist currently. EPA is c oncerned that such an increase should not occur 215 without an opportunity to eval uate activities associated witha significant new use and an 216 opportunity to protect agai nst potential unreasonable risks, if any, from exposure to the chemical 217 substance. Accordingly, EPA is finalizing a SNUR for DnPP that would designate, as a 218 significant new use, any use of the chemical substa nce other than use as a chemical standard for 219 analytical experiments. A person who intends to manufacture or process Dn PP for use other than 220 use as a chemical standard for analytical e xperiments would be required to submit a SNUN. 221*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 11 of 72 3. Alkanes, C12-13, chloro (CAS No. 71011-12-6). As described in the proposal (77 FR 222 18752, March 28, 2012) (FRL 8865-2), EPA has a primary concern regarding adverse 223 environmental effects that may be caused by alkanes, C12-13, chloro (CAS No. 71011-12-6), 224 one type of SCCP. For example, alkanes, C12–13, ch loro, have been shown to be highly toxic to 225 aquatic invertebrates followi ng acute and chronic exposures and to fish following chronic 226 exposures. EPA also has concerns about the persistence and bioaccumulation potential of 227 SCCPs, including alkanes, C12–13, chloro, since these substances have been measured in a 228 variety of biota (i.e., freshwat er aquatic species, marine mamm als, and avian and terrestrial 229 wildlife) and have also been measured in human breast milk from Canada and the United 230 Kingdom. The mechanisms or pathways by whic h SCCPs, including alkanes, C12-13, chloro 231 (CAS No. 71011-12-6), move into and through the environment and humans are not fully 232 understood, but are likely to include releases from manufacturing of the chemicals, 233 manufacturing of products like plastics or textil es, aging and wear of products like sofas and 234 electronics, and releases at the end of product life (e.g., disposal, recycling). 235 EPA believes that all manufacture and processing into the United States of alkanes, C12- 236 13, chloro (CAS No. 71011-12-6) has ceased. Given that EPA has no evidence to suggest that 237 there is any manufacture or pro cessing of this chemical substance in the United States, and 238 taking into consideration the negative commercia l and regulatory environment associated with 239 this chemical internationally (including the European Union (EU) and Canadian ban on 240 marketing) and use of the alkanes, C12-13, chloro (CAS No. 71011-12-6) domestically, EPA 241 does not expect to find such activity. However, EPA is concerned that commencement of the 242 manufacture or processing for any new uses , including resumption of past uses, could 243 significantly increase the magnitude and duration of exposure to humans over that which would 244 otherwise exist. EPA is concerne d that such an incr ease should not occur w ithout an opportunity 245*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 12 of 72 to evaluate activities associated with a significa nt new use and an opportunity to protect against 246 potential unreasonable risks, if any, from exposur e to the chemical substance. Accordingly, EPA 247 is finalizing a SNUR for alkanes, C12-13, chlo ro (CAS No. 71011-12-6) that designates as a 248 significant new use any use of the chemical subs tance. This SNUR requires a person who intends 249 to manufacture or process alkanes, C12-13, chlo ro (CAS No.71011-12-6) for any use to submit a 250
SNUN. 251 B. Objectives 252 Based on the considerations described in the proposal (77 FR 18752, March 28, 2012) 253 (FRL 8865-2) and in the response to public co mments, EPA expects to achieve the following 254 objectives with regard to the significant new uses that are designated in this final rule: 255 1. EPA will receive notice of any person’s intent to manufacture or process the specified 256 chemicals for the described significant ne w uses before that activity begins; 257 2. EPA will have an opportunity to review and evaluate data submitted in the SNUN 258 before the notice submitter begins manufacturing or processing of the specified chemicals for the 259 described significant new use; 260 3. EPA will be able to regulate prospective uses of the specified chemicals before the 261 described significant new uses o ccur, provided that regulation is warranted pursuant to TSCA 262 sections 5(e), 5(f), 6 or 7; and 263 4. EPA would receive a notice alerting the Agen cy to a reversal of an industry trend 264 toward deselecting for a chemical. 265 IV. Significant New Use Determination 266 Section 5(a)(2) of TSCA states that EPA’ s determination that a use of a chemical 267 substance is a significant new us e must be made after consider ation of all relevant factors 268 including: 269*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 13 of 72 • The projected volume of manufacturing and processing of a ch emical substance. 270 • The extent to which a use changes the type or form of exposure of human beings or the 271 environment to a chemical substance. 272 • The extent to which a use increases the magnitude and duration of exposure of human 273 beings or the environment to a chemical substance. 274 • The reasonably anticipated manner a nd methods of manufacturing, processing, 275 distribution in commerce, and disp osal of a chemical substance. 276 In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes 277 EPA to consider any other relevant factors. 278 To determine what constitutes a significant new use of the benzidine-based chemical 279 substances, DnPP, and alkanes, C12-13, chloro (C AS No. 71011-12-6) subject to this rule, EPA 280 considered relevant information about the toxicity of these su bstances, likely human exposures 281 and environmental releases associated with possi ble uses, and the four f actors listed in section 282 5(a)(2) of TSCA. EPA has dete rmined that the manufacture or processing, of any of the 283 benzidine-based chemical substances subject to the 1996 SNUR or being newly added to 40 CFR 284 721.1660 by this final rule, except for ongoing uses specified in 40 CFR 721.1660(a)(2)(i) of the 285 regulatory text in this document , is a significant new use. EPA has also determined that the 286 manufacture or processing of DnPP for any use other than use as a chemical standard for 287 analytical experiments is a signi ficant new use, and the manufacture or processing of alkanes, 288 C12-13, chloro (CAS No. 71011-12-6) for any use is a significant new use. 289 V. Applicability of the General Provisions 290 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 291 provisions describe persons subject to the rule , recordkeeping requirements, exemptions to 292*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 14 of 72 reporting requirements, and applicability of the rule to uses occurring before the effective date of 293 the final rule. 294 Provisions relating to user fees appearat 40 CFR part 700. According to § 721.1(c), 295 persons subject to SNURs must comply with the same notice requirements and EPA regulatory 296 procedures as submitters of Premanufacture Notic es (PMNs) under TSCA section 5(a)(1)(A). In 297 particular, these requirements include the in formation submissions requirements of TSCA 298 section 5(b) and 5(d)(1), the ex emptions authorized by TSCA sect ion 5(h)(1), (h)(2), (h)(3), and 299 (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take 300 regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the activities on which it has 301 received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to 302 explain in the Federal Register its reasons for not taking action. 303 However, § 721.45(f) (which generally ex empts persons importing or processing a 304 substance as part of an article) will not apply to the benzidine-based chemical substances listed at 305 40 CFR 721.1660 and those added by this final rule. Therefore, a person who imports or 306 processes as part of an article a benzidine-based chemical substan ce that is covered by this rule 307 would not be exempt from submitting a SNUN. 308 Persons who export or intend to export a ch emical substance identified in a proposed or 309 final SNUR are subject to th e export notification provisions of TSCA section 12(b). The 310 regulations that interpre t TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons who 311 import a chemical substance identified in a fi nal SNUR are subject to the TSCA section 13 312 import certification requirements, codifiedat 19 CFR 12.118 through 12.127; see also 19 CFR 313 127.28. Those persons must certify that the shipmentof the chemical substance complies with all 314 applicable rules and orders under TSCA, includi ng any SNUR requirements. The EPA policy in 315 support of import certification appear s at 40 CFR part 707, subpart B. 316*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 15 of 72 VI. Applicability of the Final Rule to Uses Oc curring Before the Effective Date of the Final 317
Rule 318 As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided 319 that the intent of section 5(a)(1)(B) of TSCA is best served by designa ting a use as a significant 320 new use as of the date of publication of the proposedrule rather than as of the effective date of 321 the final rule. If uses begun af ter publication of the proposed rule were considered ongoing rather 322 than new, it would be difficult for EPA to establish SNUR notice requirements, because a person 323 could defeat the SNUR by initiating the proposedsignificant new use before the rule became 324 final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, 325 persons who begin the commercial manufacture or pr ocessing of a covered substance as a 326 significant new use have to cease any such activity as of the effective date of the rule if and when 327 finalized. To resume their activities, these pers ons would have to comply with all applicable 328 SNUR notice requirements and wait until the no tice review period, including all extensions, 329 expires. If a person were to meet the condi tions of advance compliance under 40 CFR 721.45(h), 330 that person would be considered to have met the requirements of the final SNUR for those 331 activities. 332 VII. Test Data and Other Information 333 EPA recognizes that TSCA sec tion 5 does not require developi ng any particular test data 334 before submission of a SNUN. There are two excep tions: 1) development of test data is required 335 where the chemical substance subject to the SNURis also subject to a test rule under TSCA 336 section 4 (see TSCA section 5(b)(1)) and 2) deve lopment of test data may be necessary where 337 the chemical substance has been listed under TS CA section 5(b)(4) (see TSCA section 5(b)(2)). 338 In the absence of a section 4 test rule or a sectio n 5(b)(4) listing covering the chemical substance, 339 persons are required only to submit test data in their possession or contro l and to describe any 340*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 16 of 72 other data known to or reas onably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, 341 and 40 CFR 720.50). However, as a general matte r, EPA recommends that SNUN submitters 342 include data that would permit a reasoned evalua tion of risks posed by the chemical substance 343 during its manufacture, import, processing, use, distribution in commerce, or disposal. EPA 344 encourages persons to consult with the Agency before submitting a SNUN. As part of this 345 optional pre-notice consultation, EPA would discuss sp ecific data it believes may be useful in 346 evaluating a significant new use. SNUNs submitted fo r significant new uses w ithout any test data 347 may increase the likelihood that EPA would take action under TSCA secti on 5(e) to prohibit or 348 limit activities associated with this chemical. SNUN submitters should be aware that EPA will be 349 better able to evaluate SNUNs that provide detailed information on: 350 1. Human exposure and environmental releases that may result from the significant new 351 uses of the chemical substance. 352 2. Potential benefits of the chemical substance. 353 3. Information on risks posed by the chemical substances compared to risks posed by 354 potential substitutes. 355 VIII. SNUN Submissions 356 According to 40 CFR 721.1(c), persons subm itting a SNUN must comply with the same 357 notice requirements and EPA regulatory procedures as persons submitting a PMN, including 358 submission of test data on h ealth and environmental effect s as described in 40 CFR 720.50. 359 SNUNs must be on EPA Form No. 7710–25, genera ted using e-PMN software, and submitted to 360 the Agency in accordance with the proce dures set forth in 40 CFR 721.25 and 720.40. E-PMN 361 software is available electronically at http://www.epa.gov/opptintr/newchems

. 362 IX. Economic Analysis 363
A

. SNUNs 364*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 17 of 72 EPA has evaluated the potential cost s of establishing SNUR reporting 365 requirements for potential manufacturers and processors of thes e chemicals and for 366 articles containing any of the benzidine-based chemical substances included in the 1996 367 SNUR and those newly added by this final rule when imported or processed as part of an 368 article. These economic analyses, which are briefly summarized here, are available in the 369 docket for this rule. EPA adde d additional information to th e economic analysis for the 370 benzidine-based chemical substances in response to public comments. 371
The costs of submission of a SNUN would be incurred when a company decides to 372 pursue a significant new use of one of these ch emicals. In the event that a SNUN is submitted, 373 costs are estimated at approximately $8,600 per SNUN submission, and include the cost for 374 preparing and submitting the SNUN, recordkeeping, and the payment of a user fee. Businesses 375 that submit a SNUN are either subject to a $2,500 user fee required by 40 CFR 376 700.45(b)(2)(iii), or, if they are a small busin ess with annual sales of less than $40 million 377 when combined with those of the parent company (if any), a reduced user fee of $100 (40 CFR 378 700.45(b)(1)). In its evaluation of this final ru le, EPA also consideredthe potential costs a 379 company might incur by avoiding or delaying th e significant new use in the future, but these 380 costs have not been quantified. 381
B

. Export Notification 382 EPA regulations under TSCA section 12(b) (15 U.S.C. 2611(b)) at 40 CFR part 707, 383 subpart D require that, for chem icals subject to a proposed or final SNUR, a company notify 384 EPA of the first export or intended export to a particular country of an affected chemical 385 substance. EPA estimated that the one-time co st of preparing and submitting an export 386 notification to be $84. The total costs of export notification woul d vary per chemical, depending 387 on the number of required notifications (i.e., number of countries to which the chemical is 388*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 18 of 72 exported). 389 C. Import or Processing Benzidine-based Ch emical Substances as Part of an Article 390
In the case of the benzidine-based chemical substances, this rule makes inapplicable the 391 exemption relating to persons that import or process substances as part of an article. In the 392 proposal EPA preliminarily determined, based on the Agency’s market research, that there was 393 no ongoing manufacturing (including import) or processing of th ese chemical substances for 394 significant new uses as part of articles or othe rwise. For the nine newly-added benzidine-based 395 chemical substances, EPA found no evidence of ma nufacture either domestically or abroad, and 396 thus also no evidence of importati on or processing of these chemical substances as part of 397 articles (Ref. 1). For the majority of the 24 previously listed be nzidine-based chemical 398 substances, EPA found no evidence of manufacture, either domes tically or abroad. While, EPA 399 found that some of the previously listed benzid ine-based were being manufactured domestically 400 for discrete uses that are not subject to this SNUR, EPA found no evidence that these chemical 401 substances were being imported or processed as part of articles (Ref. 1). EPA received no public 402 comments indicating otherwise. Based on the gl obal trend away from using these chemical 403 substances, the fact that they are regulated in numerous jurisdictions, a nd the absence of public 404 comments indicating their ongoing use for si gnificant new uses, EPA is finalizing its 405 determination that these benzidine-based chemical substances are not being manufactured 406 (including import) or processed for a significant new use as part of articles or otherwise. 407 Therefore However , the rule may affect firms that pl an to import or process types of 408 articles that benzidine-based chemicals are potentially a part of. Some firms have an 409 understanding of the contents of the articles they import or process. However, EPA 410 acknowledges that importers and processors of articles may have varying levels of knowledge 411 about the chemical content of the articles that they import or pro cess. These parties may need to 412*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 19 of 72 become familiar with the requirements of the ru le. And, while not required by the SNUR, these 413 parties may take additional steps to determine whether benzidine-based chemicals are part of 414 the articles that they are cons idering to import or process. This determination may involve 415 activities such as gath ering information from suppliers al ong the supply chain, and/or testing 416 samples of the article itself. Costs vary across the activities chosen and the extent of familiarity 417 a firm has regarding the articles it imports or processes. Cost range s are presented in the 418 Economic Analysis of the Final Significant New Use Rule for Nine Benzidine Based Chemical 419 Substances (Ref. 3). Given existing regul atory limitations on certain benzidine-based substances 420 both internationally and within the U.S., indus try-wide processes, resources that support 421 companies in understanding and managing their supply chains, and evidence showing minimal 422 worldwide availability of the dyes regulatedunder the SNUR, EPA believes that article 423 importers that choose to invest igate their products would incur costs at the lower end of the 424 ranges presented in the Economic Analysis as a result of this rule. For those companies 425 choosing to undertake actions to assess the compos ition of the articles they import or process, 426 EPA expects that in all likelihood, these importers and processors would take actions that are 427 commensurate with the company’s perceived like lihood that a chemical substance might level 428 of risk (of a chemical to be a part of an article they intend to import into the United States) that 429 each company perceives , and the resources it has available. 430 X. Response to Public Comment 431 The Agency reviewed and considered all comm ents received related to the proposed rule. 432 Copies of all non-CBI comments ar e available in the docket for th is action. A discussion of the 433 major comments germane to the rulemaking and the Agency’s responses follow 434 A. Legal Authority to Make Inapplicable the Exemption for Persons who Import or Process 435 Chemical Substances as Part of Articles. 436*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 20 of 72 One commenter suggests that if chemical subs tances are not exempted from the SNUR at 437 the point they are incorporated into articl es, then EPA should consider whether it is 438 inappropriately regulating “arti cles under the chemical manage ment authorities of TSCA,” 439 (emphasis original) inconsistentwith Congressional intent in enacting TSCA. The commenter 440 argues further that the regulation of articles is not the primary purpose of TSCA and that such 441 regulation should be addressed by other agencies operating under other st atutes such as the 442 Occupational Safety and Health Act of 1970 and the Consumer Product Safety Act of 1972. 443 Another comment raises similar issues. 444 EPA responded that the SNUR for benzidin e-based chemical substances does not 445 regulate articles per se, but rather persons who manufacture or process these chemical 446 substances, including when the chemical substances are present as part of articles. TSCA clearly 447 contemplates such regulation, as certain article s are expressly removed from TSCA jurisdiction 448 at TSCA section 3(2). Indeed, EPA has a long hist ory of regulating chemical substances as part 449 of articles under TSCA. For polyc hlorinated biphenyls (the only chemical substance specifically 450 addressed in TSCA as it was originally enacted) , section 6(e) of TSCA provides authority for 451 EPA to promulgate rules related to polychlorinated biphenyls in articles, such as electrical 452 transformers. Other examples include the regulation of asbestos (40 CFR 763.160) and 453 regulation of manufacturers of consumer products intended for use by children who also 454 manufacture (including import) lead (40 CFR 716.21(a)(8)). 455 TSCA section 5 provides EPA with authority to regulate chemical substances, including 456 chemical substances that are part of articles. 1 Under this section, EPA has previously regulated 457

1 It should be noted that there is no general SNUN exemp tion for uses of a chemical substances involving articles and EPA routinely defines significant new uses to include use in articles. The exemption at 40 CFR 721.45(f) relates to a different question: whether the SNUR applies to persons who process or import a chemical substance by processing or importing the substance as part of an article.*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 21 of 72 persons that import or process chemical substa nces as part of articles, including articles 458 containing erionite fiber ( 40 CFR 721.2800) and mercury ( 40 CFR 721.10068). This is in 459 keeping with the statutory langua ge authorizing the Administrato r to designate a “use of a 460 chemical substance as a significant new use” an d to require SNUN submissions from persons 461 that intend to manufacture or process a chemical for a designated significant new use. 462 The commenter is incorrect in suggesting that regulation to address chemical substances 463 in articles is beyond the origina lly intended functions of TSCA. When TSCA was being drafted, 464 legislators characterized it as “a mechanism to protect against dangerous chemical materials 465 contained in consumer and indus trial products”; by way of exampl e, the drafters cited “the 466 presence of mercury in such consumer products as paint, home ther mometers, sponges, and a 467 variety of other products.” S. Rep. No. 94-698, 94th Cong., 2d Sess., 5-6 (1976). 468 Furthermore, this application of the regulations (to persons who manufacture or process 469 the chemical substance as part of articles) is consistent with le gislators’ observation, in drafting 470 this section, that: 471 [T]he most desirable time to determine th e health and environmental effects of a 472 substance, and to take action to protect ag ainst any potential adverse effects, occurs 473 before commercial production begins. No t only is human and environmental harm 474 avoided or alleviated, but the cost of any regulatory action in terms of loss of jobs and 475 capital investment is minimized. 476 H.R. Rep. 94-1679, 94th Cong., 2d Sess., 65 (1976). 477 When a chemical substance is domestically pr oduced, the substance generally exists in non478 article form at the earliest point of commercial production in the United States. When a chemical 479 substance is imported, however, it may in many instan ces already be part of an article, even at 480 the earliest point that it enters U.S. commerce. By this action, EPA makes importers of specific 481 chemical substances subject to the same SNUNrequirements as domestic manufacturers of the 482 same substance, irrespective of whether such im port is as part of an article. This action is 483*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 22 of 72 consistent with the plain text of TSCA 5(a)(1)( B) (generally, “no person may . . . manufacture or 484 process” for a significant new us e without proper notice) and with one of the intended goals of 485 TSCA: to hold importers to “the same res ponsibilities and obliga tions as domestic 486 manufacturers,” H.R. Rep. No. 94-1341, 94th Cong. 2d. Sess., 12-13 (1976). This action is also 487 consistent with EPA’s identified concerns regard ing benzidine-based chemical substances when 488 they are present as part of an article (See 77 FR 18752, 18756, March 28, 2012 (FRL-8865-2)). 489 Moreover, when originally promulgating the presumptive SNUN submission exemption 490 for persons who import or process chemical subs tances as part of ar ticles (40 CFR 721.45(f)), 491 EPA did so based on a belief that people and the environment would generally not be exposed to 492 chemical substances in articles. To address th ose cases where the assumption may not be valid, 493 EPA specifically noted that, “EPA may decide to eliminate one or all of these . . . exemptions 494 [including the exemption for importers and processo rs of chemicals as partof articles] if EPA 495 decides that review under a SNUR is warranted for specific substan ces . . . in articles.” (49 FR 496 35014, September 5, 1984) (FRL-2541-8). Thus, while EPA clearly has stat utory authority to 497 subject importers and processors of chemical substances in arti cles to SNUN requirements, they 498 are presumptively excluded by rule at 40 CFR 721.45(f), based on an assumption that people and 499 the environment will generally not be exposed to substances in articles. (49 FR 35014, 500 September 5, 1984) (FRL-2541-8). To the extent thatpotential exposure to a chemical substance 501 as part of an article contribut es to the EPA’s determination pursuant to the factors in section 502 5(a)(2) of TSCA that the new use is significant (i.e., EPA has reason to anticipate that use as part 503 of an article would raise importa nt questions, related to potentia l exposure, that EPA should have 504 an opportunity to review before su ch use could resume or occur), it is appropriate to make the 505 exemption inapplicable. 506 EPA notes that one of the commente rs appears to have conflated the Federal Register 507*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 23 of 72 notice establishing the article importers’ a nd article processors’ exemption from PMN 508 requirements (48 FR 21726, May 13, 1983) (FRL 2998-5), discussing 40 CFR 720.22(b)) with 509 another Federal Register notice establishing the compar able exemptions from SNUR 510 requirements ((49 FR 35014, September 5, 1984) (FRL-2541-8)), discussing 40 CFR 721.45(f)). 511 While EPA recognizes that Parts 720 and 721 deal with many similar issues, they are also 512 distinct from each other in important respects. Itis significant that in the 1984 action, whereby 513 EPA established the article importers’ and articl e processors’ exemption for SNURs, it did not 514 simply mirror the 1983 rationale for the compar able exemption from PMN obligations. For 515 PMNs, EPA noted the difficulties associated with determining the identity and Inventory status 516 of each chemical substance in imported artic les (e.g., automobiles) (48 FR 21726, May 13, 1983) 517 (FRL 2998-5)). But for SNURs, EPA placed speci al emphasis on its assumption that import of 518 the substance as part of an article would not affect human or environmental exposure to the 519 substance, while taking particular care to rese rve ongoing discretion to re vise its assumption as 520 warranted in the case of specific substances. EP A had reason to differentiate between the two 521 rationales. SNURs are for specified chemical substances for which EPA has identified exposure522 based concerns for the defined significant new us e (per the TSCA section 5(a)(2) factors). By 523 contrast, PMNs are required for all new chemical s (i.e., those not on the TSCA inventory), not a 524 specified set of chemicals. 525 Finally, there is no basis for the commente r’s suggestion that EPA should decline to 526 review significant new uses, in deference to th e Occupational Safety a nd Health Administration 527 (OSHA) or the Consumer Product Safety Commi ssion (CPSC), simply because a significant new 528 use notice would be submitted by a person who impor ts or processes the chemical substance as 529 part of an article. Neither th e Occupational Safety and HealthAct of 1970 nor the Consumer 530 Product Safety Act of 1972 contains a comparab le mechanism to ensure advance notice and 531*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 24 of 72 opportunity to review significant new uses of ch emical substances, as part of articles or 532 otherwise. 533 B. Development of a Separate Policy Framewor k for Making Inapplicable the Exemption for 534 Persons who Import or Process Chemical Substances as Part of Articles 535 1. Comment. Some commenters suggest that before finalizing a rulemaking to make the 536 “articles exemption” inapplicab le to the benzidine-based chem ical substances, the EPA should 537 complete a separate public comment process to develop a general “policy framework for the 538 issuance of article SNURs.” Co mmenters suggest that this po licy framework should include 539 science based criteria, feasibility criteria, costs, and other factors. 540 One comment suggests that, in formulating th e “policy framework” or criteria for making 541 the exemption for importers and processors of chemical substances as part of articles 542 inapplicable, EPA should addr ess the following questions: 543

 Can the risk posed by the chemical of c oncern be addressed through the standard 544 regulation? 545

 Why is the standard approach for SNURs that exempts articles not sufficient? 546

 What conditions make direct re gulation of artic les necessary? 547

 What gaps in health and environmental prot ection are likely to occur if a SNUR only 548 regulates chemicals and mixtures? 549 1. Response. The comments conflate two separate issues: the determination of a 550 significant new use under TSCA section 5(a)(2), and the decision to make the regulatory 551 exemption at 40 CFR 721.45(f) inapplicable. (40 CFR 721.45(f) provides that persons who 552 import or process a chemical substance as part of an article are not subject to the notification 553 requirements at 40 CFR 721.25; this exemption is referred to as the “articles exemption” by 554 some commenters). EPA first makes a determinati on on whether a use of a chemical substance is 555*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 25 of 72 a significant new use considering the factors listed in TSCA section 5(a)(2). Once that 556 determination is made, EPA separately determines whether it would be a ppropriate to revoke the 557 regulatory exemption at 40 CFR 721.45(f) for persons who import or process a chemical 558 substance as part of an article. 559 EPA notes that there may be a variety of cases in which it may be appropriate for EPA to 560 include persons who import or pr ocess the chemical s ubstance as part of an article among the 561 persons subject to SNUN submission obligations . Knowledge regarding chemical exposures 562 from articles has evolved since the Agency es tablished the exemption at 40 CFR 721.45(f) in 563 1984, and there has been a steady increase in international trad e of chemicals in articles. 564 Accumulated data illustrate that SNURs (and s ection 5(e) consent orde rs) that include the 565 exemption for persons who import or process a ch emical substance as part of an article are 566 sometimes insufficient to appropriately flag significant new exposures from downstream uses. 567 For example, there have been instances in which a section 5(e) consent order for a new chemical 568 substance was issued, prohibiting the release of the chemical substance to water, and yet the 569 chemical substance at issue was later found in th e environment and biota. The presence of the 570 chemical substance in the environment and in biota then appears to be asso ciated with the use of 571 the substance in articles (Ref. 4). There are also documented e xposures (and resulting toxicity) of 572 children to lead and cadmi um and their compounds from a variety of articles, such as toys (Ref. 573 5), and exposures to other heavy metals from arti cles, as measured in in door air and house dust 574 samples, which are direct routes of exposure a ccounting for children’s leve ls and toxicity (Ref. 575 6). Other well-documented examples are the pr esence of brominated flame retardants (e.g., 576 polybrominated diphenyl ethers and brominated phthalates and benzoates) in samplings of 577 articles, indoor air, people, and house dust. The lo w exchange rate of indoor air and house dust to 578 sources outside the home support th e flame retardant release from articles postulate. Likewise, 579*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 26 of 72 other semi-sealed environments, such as autom obiles, have demonstrated migration of flame 580 retardants from treated articles to interior surfaces and indoorair, as no other source was 581 possible. In addition, high flame re tardant levels have been observedin biota raised in proximity 582 to articles and living near article recyling sites. Fu rther, observed flame re tardant levels in biota 583 and in the environment at locations remote from manufacturing sites suggest transport of these 584 non-volatile chemical substances on associated particulate matter from distributed treated 585 articles, which strongly suggest release from articles as one potential source (Ref. 7-11). 586 The information discussed above – the well-documented exposures (and resulting 587 toxicity) of children to lead, cadmium, and other metals from a variety of articles; the data on 588 other chemicals used in articles; and the pres ence in the environment and biota of certain 589 brominated flame retardants (e.g., polybrominat ed diphenyl ethers and brominated phthalates 590 and benzoates) – all illustrate that there can be exposure to the chemicals associated with their 591 presence in articles (Refs. 5-11). 592 The scope of the suggested criteria (whi ch the commenters suggest EPA should now 593 develop to govern its exercise of its author ity to make the exemption at 40 CFR 721.45(f) 594 inapplicable) is incommensurate with the level of analysis supporting th e original development 595 of the exemption. EPA notes that TSCA sec tion 5(a)(1) establishes a general prohibition on 596 manufacturing or processing a chemical substanc e for a significant new use without prior notice 597 to EPA. 40 CFR 721.45(f) establishes an exempti on from this prohibition, but it is based on a 598 fairly minimal rationale: “EPA believes peopl e and the environment will generally not be 599 exposed to substances in articles.” (49 FR 35014, September 5, 1984) (FRL-2541-8). EPA 600 counterbalanced its reliance on this generalized assumption (about all chemicals that exist as part 601 of articles) with a broad re servation of case-by-case disc retion to make the exemption 602 inapplicable as “warranted for specific s ubstances.” (49 FR 35014, September 5, 1984) (FRL- 603*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 27 of 72 2541-8). 604 EPA does not think that development of a “policy framework” is necessary before 605 reaching the conclusion, with respect to benzidin e-based chemical substances, that persons who 606 import or process these substances as part of articles should be subj ect to the notification 607 provisions of 40 CFR 721.25. Derm al exposure can occur from the leaching of the benzidine608 based chemical substances by sweat in cont act with the dyed textiles (77 FR 18756, March 28, 609 2012) (FRL 8865-2). In addition, data indicate that exposure to othe r chemicals in materials such 610 as textiles and foam can result from the dust that is generated from abrasion and/or degradation 611 of the materials (Ref. 12). EPA notes that the commenter did not offer data to undercut the 612 conclusion that such exposure can occur. Becau se of this information, and other information 613 described in Unit III.E. of the proposal ( 77 FR 18756, March 28, 2012) (FRL 8865-2) (Ref. 1), 614 EPA does not assume that new types or forms of exposure associated with new use of benzidine615 based chemical substances would be insignifican t merely because the chemical substance is 616 imported or processed as part of an article. Thus, EPA does notbelieve the default assumption 617 used to support 40 CFR 721.45(f) (that people and the environment will generally not be exposed 618 to substances in articles) holds with respectto benzidine-based chemical substances. 619 2. Comment. Comments also suggest that EPA anal yze the “variety of products” that 620 could be construed as articles, the “practical questions that will arise” if the import and 621 processing of such products were not exempt from SNURs, and the “unique channels of trade,” 622 through which different varietie s of products move. Commenters encouraged EPA to develop 623 and articulate publicly a policy framework, c onsidering the following factors on an article624 specific basis, before proceeding to revoke the article exemption with respect to a particular 625 chemical substance: 626

• Whether there is, or will be, direct exposure to the chemic al substance in the article 627*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 28 of 72 during the course of the article’s use. 628

• Whether there is, or will be, a release of the regulated substance, or a metabolite or 629 breakdown product from the substance, during subsequent processing, distribution, use or 630 disposal of the article. 631

• Whether there is, or will be, a link between import or export of an article and cross632 border exposure to the U.S. population. 633 2. Response. Given the variety of substances and uses addressed under SNUR 634 regulations, EPA believes it is more efficient to ad dress article-specific issues as they actually 635 arise within each regulatory action than to develop, as suggested by the commenter, an 636 anticipatory “policy framework” document. 637 The importers and processors of chemical s ubstances present in articles are generally in 638 the best position to know which chemical substan ces are used in which types of articles. When 639 EPA identifies a particular chemical substan ce in a SNUR, such stakeholders have an 640 opportunity to identify, in their public comments, any article-specific issu es that concern them. 641 Furthermore, these issues are likely to be mo re accurately identified and more appropriately 642 addressed in connection with the development of a SNUR for particular chemical substances 643 than they would be if they were reviewed gene rically. In this case, co mmenters did not raise any 644 issues specific to certain articles. 645
C. A Compelling Basis Standard for Making Inapplic able the Exemption fo r Persons who Import 646 or Process Chemical Substances as Part of Articles 647 1. Comment. Some commenters made the point that revocation of the exemption at 40 648 CFR 721.45(f) should not be a presumed component of all SNURs. This was part of a broader 649 comment that EPA should not make this exemption inapplicable unless there was a “compelling 650 basis" to do so. One commenter was concerned that if EPA proceeds on a case-by-case basis, 651*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 29 of 72 following reasoning that “could be applied to many chemicals,” then elimination of the 652 exemption would come to be a “ kind of ‘d e fault’ step” in future SNURs. One commenter also 653 argues that, where the SNUN submi ssion requirement is to apply to importers and processors of 654 substances as part of articles, the TSCA sec tion 5(a)(2) criteria re quire EPA to undertake a 655 compelling analysis of how the use and distribution of the “specific articles or article categories,” 656 would “contribute to potential exposures of concern.” 657 1. Response. As an initial matter, the comments conflate two separate issues: the 658 determination of a significant new use under TSCA section 5(a)(2), and th e decision to make the 659 regulatory exemption at 40 CFR 721.45(f) inappli cable. The TSCA section 5(a)(2) factors do not 660 impose a “compelling analysis” requirement on the elimination of the 40 CFR 721.45(f) 661 exemption because (among other reasons) these tw o actions concern two discrete issues. The 662 section 5(a)(2) factors speak to the significant new use itself. 40 CFR 721.45(f) speaks to who is 663 required to notify EPA of the significant new use. 664 In this case, EPA identified its reasons, under the TSCA section 5(a)(2 ) factor analysis, to 665 anticipate that the new use would pose important new questions relate d to the substances’ 666 potential to threaten health or the en vironment (77 FR 18752, 18756, March 28, 2012 (FRL667 8865-2)), and that EPA should have an opportunity to consider those questions before such use 668 could occur. (In essence, a SNUR puts a partic ular set of uses on the same footing as a new 669 chemical, which is subject to automatic re view under TSCA section 5(a)(1) unless EPA 670 specifically excludes it from such review.) EPA also identified a basis, specific to benzidine671 based chemical substances, to question the a ssumption that people and the environment will 672 generally not be exposed to the chemical substances in articles . Therefore, EPA is also making 673 inapplicable the exemption at 40 CFR 721.45(f) fo r persons who import or process a chemical 674 substance as part of an article. No commenter provided data or other information to undercut the 675*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 30 of 72 factual basis for either decision. 676 Neither TSCA nor the implementing regulations for SNURs establish a separate 677 “compelling basis” standard, either with respect to the determination of a significant new use or 678 with respect to the decision to make the exem ption at 40 CFR 721.45(f) inapplicable. Nor have 679 commenters identified a persuasive basis for EPA to adopt such a standard under either scenario. 680 EPA’s specific action with respect to benzid ine-based chemical substances is not, as 681 commenters suggest, tantamount to the pres umptive revocation of the SNUN submission 682 exemption for importers and processors of chemical substances as part of articles in all future 683 instances. EPA has not proposed to globally mo dify or eliminate the SNUR exemption for 684 persons who import or process chemical substances as part of articles. EPA need not presently 685 address the merits of an action it is not presently taking, and did not previously propose to take. 686 TSCA sections 5(a)(2)(B) and (C) require EP A to consider the extent to which a new use 687 “changes the type or form of exposure” or “increases the magnitude and duration of exposure” 688 before making a determination that a particular use is a “significant new use.” EPA disagrees 689 that it must therefore, as one commenter suggest s, conduct a multiplicity of separate significant 690 new use analyses whenever the use under consid eration involves an article (i.e., one for each 691 specific article or article categor y, comparing the relative signifi cance of each particular article 692 or article category). In partic ular, the commenter’s interpreta tion of TSCA section 5(a)(2) 693 misconstrues the baseline against which the “new ness” and the “significance” of a significant 694 new use are evaluated. As EPA has long maintained, the single analytical ba seline is the set of 695 uses that were ongoing “as of the date of publi cation” of the SNUR pr oposal. (See e.g., 77 FR 696 18760, March 28, 2012 (FRL 8865-2)). 697 Furthermore, the particular analytical standards the commenter suggests are not 698 commensurate with the establishment of a one-tim e notice requirement intended to give EPA an 699*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 31 of 72 opportunity to later evaluate th e need for testing or other regulatory action under TSCA. 700 Requiring upfront answers to the very questions EPA would evaluate afte r receiving a significant 701 new use notice, as a pre-condition of requiri ng the notices, would unde rmine the statutory 702 authorization to issue SNURs in the first pl ace. EPA’s decision to propose a SNUR for a 703 particular chemical use and to make the exem ption at 40 CFR 721.45(f) inapplicable to that 704 SNUR need not be based on an extensive evalua tion of the hazard, exposure, or potential risk 705 associated with that use. Rather, the Agency is acting because it has reason to anticipate that such 706 use would raise important new questions related to the substance’s potential to threaten health or 707 the environment, and that EPA should have an o pportunity to consider those questions before 708 such use could occur. Since the use designated as a significant new use does not currently exist, 709 deferring a detailed consideration of potential risks or h azards related to that use is an effective 710 use of resources. If a person decides to begin ma nufacturing or processing the chemical for the 711 significant new use, in articles or otherwise, th e notice to EPA allows EPA to evaluate the use 712 according to the specific parameters and ci rcumstances surrounding that intended use. 713 Even if it were appropriate to construe the decision to make the 40 CFR 721.45(f) 714 exemption inapplicable as a subcomponent of the significant new use determination under 715 section 5(a)(2) (rather than as a subsequent determination), EPA adequately considered the 716 section 5(a)(2) factors. 717 The first factor is the “projected volume of manufacturing and processing of a chemical 718 substance” (TSCA section 5(a)(2)(A)). EPA pr ojects that these substances will not be 719 manufactured or processed at any volume for th e new uses in question and notes that for the 720 newly proposed nine benzidine-based chemical substances, data reported to EPA for the 2012, 721 2006, 2002, and 1998 reporting cycles, as required by the TSCA IUR rule, indicate no evidence 722 of manufacture (including import) (Ref. 13) . (77 FR 18755, March 28, 2012) (FRL 8865-2). Any 723*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 32 of 72 increase in the projected volum e of manufacturing (including import) or processing of these 724 substances, beyond the very limited uses curren tly ongoing, would reflect a significant departure 725 from prior trends. Given that these chemical s ubstances are anticipated to metabolize to the 726 parent benzidine molecule, which is a known human carcinogen, EPA anticipates that 727 information presented in the SNUN on the qua ntities manufactured (including imported) and 728 processed of benzidine based chemical subs tances would be important to EPA’s overall 729 evaluation of whether the new use may present an unreasonable risk to human health or the 730 environment. The necessary increase in volume of this substance from any new use weighs in 731 favor of determining that the ne w use is a significant new use. 732 The second factor is "the exte nt to which a use changes the type or form of exposure of 733 human beings or the environment to a chemical substance” (TSCA section 5(a)(2)(B)). For the 734 newly added benzidine-based chem ical substances, a general market review on these chemical 735 substances indicates no current manufacture with in or outside the United States. Although some 736 of the chemical substances subject to the 1996 SNUR may still have certain limited ongoing uses 737 (e.g., as a test reagent, lab standard, or microscopy stain), such uses are expected to be confined 738 to limited laboratory or technical applications that are not expect ed to represent an appreciable 739 amount of overall exposure. Furthermore, EPA did not find evidence of actual ongoing 740 importation or domestic production for these us es. No comments provided evidence of ongoing 741 manufacture (including import) or pr ocessing of these chemical substances as part of articles or 742 otherwise. Thus, EPA believes that there is no, oralmost no, current expos ure to these chemical 743 substances in the United States. 744 Should a significant new use be planned, EP A anticipates that the new use would raise 745 important new questions such as the following: 746

• To what extent would the use be expected to involve dermal contact with the substance? 747*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 33 of 72 • Would the substance be used in a setting where oral exposure is likely (e.g., would 748 young children be able to mouth the article)? 749

• How would potential occupati onal exposures and releases to the environment over the 750 substance’s lifecycle be expected to be managed? 751 Given that these chemical substances are anticipated to metabolize to the parent 752 benzidine molecule, which is a known human car cinogen, EPA anticipates that the answers to 753 such questions would be important to EPA’s ev aluation of whether the new use may present an 754 unreasonable risk to human health or the environment. The potential for a new use to change the 755 type or form of exposure weighs in favor of de termining that the new use is a significant new 756

use. 757 The third factor is "the ex tent to which a use increases the magnitude and duration of 758 exposure of human beings or the environmen t to a chemical substance” (TSCA section 759 5(a)(2)(C)). Should one of the de signated significant new uses be planned, EPA anticipates that 760 the planned new use would raise important new que stions relating to the concentration in which 761 the substance would be used, the potential for re peated exposure, and the potential for continuous 762 exposure. Given these chemical substances are an ticipated to metabolize to the parent benzidine 763 molecule, which is a known human carci nogen, EPA anticipates that the answers to these 764 questions would be important to EPA’s overall evaluation of whether the new use may present 765 an unreasonable risk to human health or the en vironment. EPA also notes that dermal exposure 766 can occur from the leaching of the chemical substa nces by sweat in contact with the dyed textiles 767 (77 FR 18756, March 28, 2012) (FRL 8865-2). Because of this information, and the information 768 described in Unit III.E. of the proposal (77 FR 18756, March 28, 2012) (FRL 8865-2), EPA does 769 not assume that new types or forms of exposure associated with new use of these substances 770 would be insignificant merely because they relate to new use in an article or because the 771*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 34 of 72 pertinent manufacturing or processi ng of the substance occurred as part of an article. The 772 potential for activities related to a new use to increase the ma gnitude and duration of exposure 773 weighs in favor of determining that a ny non-ongoing use is a significant new use. 774 The fourth factor is “the reasonably anticipated manner and methods of manufacturing, 775 processing, distribution in comm erce, and disposal of a chemical substance” (TSCA section 776 5(a)(2)(D)). EPA anticipates th at any new use, beyond the very limited uses currently ongoing, 777 would raise important new questi ons such as the following: 778

• To what extent can the anticipated ma nufacturing, processing, distribution in 779 commerce, and disposal of the chemical substance be expected to result in worker exposure, user 780 exposure, or release of the chemical substance to the environment? 781

• What potential controls are available to limit such releases? 782 Given these chemical substances are anticipat ed to metabolize to the parent benzidine 783 molecule, which is a known human carci nogen, EPA anticipates that the answers to these 784 questions would be important to EPA’s overall evaluation of whether the new use “may present 785 an unreasonable risk to human health or th e environment.” The potential for manufacturing, 786 processing, distribution in commerce or disposal of these benzidin e-based chemical substances to 787 change the overall exposure picture weighs in favor of determining that consumer textile use is a 788 significant new use. 789 After considering each of th e four TSCA 5(a)(2) factors, EPA has concluded that the 790 factors taken together weigh in favor of determining that manufacture or processing of these 791 benzidine-based chemical substances for a ny non-ongoing use would be a significant new use 792 such that the Agency should have an opportunity to analyze the new use before such use (and 793 potential exposures) occurs. This determination woul d still hold even if one were to consider the 794 40 CFR 721.45(f) exemption as a subcomponent of the significant new use determination under 795*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 35 of 72 section 5(a)(2). 796 D. Narrowing the Scope of SNURs where the Exemption for Importers and Processors of 797 Chemical Substances as Part of Articles is M ade Inapplicable 798 Some comments suggest that significant new uses should not be “open-ended” but 799 instead must be targeted to specific articles, particularly in cases where the exemption at 40 CFR 800 721.45(f) is made inapplicable. The concern expresse d is that if the SNUN applies to “any use of 801 a substance, then regulated parties and the EPA would be obligated to proceed through the 802 SNUR process for an article that would have litt le relevance to the perceived hazard that drove 803 the original SNUR.” The commente r further writes that “open-e nded article SNUR’s can trigger 804 reviews for articles that may have no relationship to the ha zard or exposure concerns that 805 motivated EPA’s decision to initiate the rule.” 806 EPA’s concern with these benzidine-based dyes is not limited to certain exposure 807 pathways to specific articles. EP A’s concern is specific to the be nzidine-based dyes and thus to 808 the range of exposures that could occur for th ese chemical substances. The preamble of the 809 proposed rule notes multiple potential routes a nd sources of exposure in cluding inhalation, skin 810 absorption via dyed textiles, and inges tion. (77 FR 18752, 18756, March 28, 2012) (FRL-8865- 811 2). Furthermore, SNURs need not be narrowly fo cused on the mitigation of currently foreseeable 812 exposure scenarios—it is proper that they will also ensure EPA has timely notice of future (and 813 currently unforeseeable) exposure scenarios. An additional requirement to make targeted 814 predictions of the particular uses that "may be proposed in the future" would undermine this 815 intended function of the SNUR. 816 More generally, an exhaustive lis t of all applications that could possibly fall within the 817 ambit of a significant new use definition is not a prerequisite for issuing a SNUR. Since the 818 significant new use does not currently exist, defe rring a detailed consider ation of potential risks 819*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 36 of 72 related to the importation or pr ocessing of these chemical subs tances (including as part of 820 articles) is an effective use of resources. If a person decides to begin importing or processing the 821 chemical, as part of an article or otherwise, the notice to EPA allows EPA to evaluate the 822 significant new use according to the specific pa rameters and circumstances surrounding that 823 intended use. 824 E. EPA Should Have a Reasonable Basis to Concl ude that Identified Articles Would be 825 Distributed in the United States 826 One comment states that “EPA presents an exposure-based rationale for why certain 827 articles could be a concern, but in dicates that there is no current expectation that these chemical 828 substances will be used in such articles.” The co mmenter believes that be fore issuing an article 829 SNUR, EPA should have a reasonable basis to conclude that identif ied articles of concern would 830 be distributed in the United States. The commen ter contends that EPA should identify an article 831 containing such a chemical that is currently in global commerce and explain why it is likely to be 832 distributed in the United States. The commenter be lieves that it might also be possible to identify 833 an article at the research and development st age that is likely to proceed to commercial 834 development. Without such findings, however, th e commenter is concerned that EPA would be 835 issuing an article SNUR for a situation that presen ts no current or likely future threats to health 836 or the environment, and thus that the rule would be a wast e of public resources. Another 837 comment raises similar issues, arguing that EPA should provide even more specific information 838 on how the significant new uses contribute to risk. 839 Alternatively, the first commenter sugge sts that EPA include a specific provision 840 suspending enforcement of the SNUR until a determination is made that there is a reasonable 841 basis to believe that an article containing the spec ific chemical had been, or would be, distributed 842 in the United States. 843*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 37 of 72 EPA disagrees with the s uggestion to limit the applic ation of SNUN submission 844 requirements for importers and processors of the chemical substances as part of articles to 845 situations where importation or processing as part of an article is known to be imminent. SNURs 846 address situations in which EPA is concerned ab out the potential for us e to commence without 847 prior opportunity for review and risk management action where appropriate. For purposes of 848 SNURs, EPA cannot be expected to predict specific situations wh ere new uses may be imminent, 849 or how those specific uses may contribute to ri sk, before designating significant new uses. The 850 purpose of a SNUR is to obtain such information so that EPA can evaluate risks associated with, 851 and take risk management action where appropriate regarding, any notified activities. These rules 852 serve the important function of alerting EPA wh en a significant new use is intended. Without 853 them, EPA would have no expectation of timely id entification of new uses of these chemicals. 854 Notice relating to the import or proc essing of articles is particularly important in this case, as the 855 proposal specifically identified a concern related to the potential for dermal exposure via dyed 856 articles (i.e., from the leaching of the benzidin e-based chemical substances by sweat in contact 857 dyed articles, such as textiles). (77 FR 18756, March 28, 2012) (FRL 8865-2). 858 It would not be an efficient use of governme nt resources for EPA to continually monitor 859 global commerce to try to predict which chemicals are about to be imported as part of articles 860 (but have not yet been imported) into the Un ited States. Persons who wish to manufacture 861 (including import) or process these chemical substa nces for a significant ne w use, as part of an 862 article or otherwise, are in a better position than EPA to evaluate when they are about to initiate 863 a particular significant new use. 864 Given that SNURs cannot be issued for ongoi ng uses, the commenter’s suggestion (that 865 EPA must itself make an upfront demons tration that a particular new use is about to begin , to 866 secure the opportunity to be notified of wh en significant new uses involving importation or 867*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 38 of 72 processing of chemical substances as part of articles are about to begin) is impracticable. It 868 would likely result in a scenario in which an ot herwise significant new us e would be allowed to 869 commence prior to the issuance of a SNUR proposal, thereby placi ng that use outside of EPA’s 870 SNUR authority. Furthermore, EPA has alrea dy considered and reje cted (in 2006, following 871 public comment on a 2004 proposal) the position th at it must defer revocation of the 40 CFR 872 721.45(f) exemption for a SNUR until it appears lik ely “that these chemical substances will be 873 imported as part of articles.” (69 FR 70409, December 6, 2004) (FRL 7633-1). EPA concluded 874 in 2006, after a re-evalua tion of the issue prompted by public comments, that “if the subject 875 substances when imported as a part of articles are not subject to the SNUR, EPA could miss the 876 opportunity to obtain notifications that would provide informati on of potential regulatory and 877 assessment value.” (71 FR 34018, June 13, 2006) (F RL 7743-2) (ultimately declining to make 878 the exemption inapplicable, based on a separate concern that the use withrespect to articles 879 appeared to be already ongoing). 880 Finally, for essentially the same reasons as set forth above, EPA believes it would be 881 inappropriate to follow one commenter’s alternat ive suggestion: to promulgate a SNUR without 882 the exemption for importers and processors of ch emical substances as part of articles, while 883 somehow “suspending enforcement” until the precise moment that manufacture or processing for 884 a significant new use as part of an artic le is about to begin, but has not yet begun. 885 In sum, EPA believes commente r’s suggestions would turn th e regulatory process on its 886 head. EPA would likely need to already have a SNUR in place in order to obtain the kind of 887 timely information about significant new use that th e commenter asserts should be prerequisite to 888 issuing the SNUR in the first place. 889 F. Intended Coverage of the Benzidin e-Based Chemical Substances SNUR 890 1. Comment. One commenter writes that “A proposedrule offering a clear explanation of 891*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 39 of 72 what uses EPA intends to cover, including an explan ation of the alternatives if certain situations 892 are unclear, will greatly increase th e chances that useful informa tion about business practices and 893 common terms of art in an industr y will be identified.” EPA should define the scope of the uses 894 to be regulated as clearly and precisely as possible. 895 The commenter also contended that solic iting public comment on the appropriate scope 896 of new uses to be regulated, for a specific chemical substance, constitu tes “an abdication of the 897 role that EPA should be undertaking.” The comm enter suggests that before soliciting public 898 comments, EPA should have first pursued an in formal coordination with downstream industries 899 and (as necessary) an exercise of its “ample authority under TSCA, either through regulatory 900 action under section 8 or order authority under secti on 11 (c).” Finally, the commenter suggests 901 that to the extent the proposed significant ne w uses admit ambiguity or potential need for 902 adjustment in response to public comment, that is evidence that EPA “should have learned more 903 about the uses” before issuing the proposal and is improperly seeking “to shift the responsibility 904 to stakeholders.” 905
1. Response. The description of the scope of the significant new uses in the benzidine906 based chemical substances proposed SNUR a nd the Agency’s basis for the proposal were 907 explicit. The SNUR proposal fairly apprised stak eholders as to the chemical at issue and the 908 particular concerns driving th e proposed action. It further indi cated that based on information 909 available to EPA, the significant new uses id entified are not currently on-going. Stakeholders 910 had an opportunity to oppose any of these pr eliminary findings by s upplying countervailing 911 information thorough the rulemaking process itsel f. Grafting additional pre-proposal steps onto 912 the SNUR rulemaking process would be unnece ssarily time-consuming and an unsound use of 913 agency resources. The timelier, less resource-int ensive, and more transparent process is for 914 interested stakeholders, through the public comment process it self, to simply provide any 915*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 40 of 72 pertinent countervailing informati on they wish to add to the initi al collection of information EPA 916 presented in the proposal. 917 As noted earlier, TSCA section 5(a)(2) does not compel nor contemplate an article by 918 article analysis to identify every conceivable si gnificant new use of a chemical substance. EPA 919 evaluates whether a new use is “s ignificant” consistent with the evidence of Congressional intent 920 underlying the enactment of TSCA. See H.R. Re p. No. 94-1341 at 24 (1976) (“[B]ecause of the 921 nature of a substance, it is possi ble that any new use of it will be significant. Thus, a potentially 922 dangerous substance which is manufactured for a particular use may, if manufactured for a 923 different use present additional health or envi ronmental problems and consequently there should 924 be notice of the intent to ma nufacture it for such different use.” H.R. Rep. No 94-1679 at 66 925 (1976) (“[T]he conferees intend that any potential threats to health or the environment from the 926 manufacture, processing, distribut ion in commerce, or disposal of a substance associated with a 927 new use be considered by the Administrator when determining the signifi cance of a new use.”) 928 Finally, a broad construction of th e significant new use is particul arly appropriate where (as in 929 the case of benzidine-based dyes) any increase in the projected vol ume of manufacturing 930 (including import) or processing of these subs tances, beyond the very limited uses currently 931 ongoing, would reflect a significant departure from prior trends. 932
2. Comment. “It does not make sense to issue article SNUR’s [ sic ] for full size machines 933 or structures. An article S NUR should focus on the specific components of more complex 934 machines or structures that involve the chemical of concern.” 935 2. Response. The commenter neither explains what the commenter means by “full size,” 936 nor offers any specific evidence to support their general view that new uses of chemical 937 substances in “full size machines or structures ,” are any less likely to be significant than new 938 uses of chemical substances in “specific co mponents.” Nor does the commenter indicate why 939*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 41 of 72 persons who import or process chemical substances as part of articles would be more likely to be 940 importing or processing the chemical substances for use in “full size” articles. Attempting to 941 define and distinguish between “full size” article uses and other uses, and correlating such 942 distinctions to whether persons are importing or processing these ch emical substances as part of 943 articles, would delay the rulemaking and increase its complexity, in a manner that does not seem 944 warranted on the basis of the limited information supplied in the comment. 945 3. Comment. “Chemicals used in articles may sometimes be incorporated into 'internal' 946 mechanisms of the article that are unlikely to come into contact with people or be released into 947 the environment during normal use of the article.” 948 3. Response. The commenter does not explain why the basis for a SNUR should be 949 limited to those exposures that occur concurrent with the article fulfilling its intended function, 950 when TSCA section 5(a)(2)(D) contemplates that EPA will consider the value of ensuring it has 951 a future opportunity to review the whole life -cycle impact (e.g., “m anufacturing, processing, 952 distribution in commerce, and disp osal”) of a significant new use of a chemical substance. The 953 exposure to the chemical substance, including when it is in an article, may be larger during 954 disposal or recycling than during the “normal use” of the chemical. Further, chemical substances 955 that are ‘internal’ to an article may still result in exposure if the chemical substance has certain 956 physical- chemical properties (e.g., a relatively volatile chemical used as a plasticizer in interior 957 automobile parts) or due to abrasion of the article (e.g., a dye incorporated into furniture 958 covering.) 959 Nor does the commenter indicate why pe rsons who import or process chemical 960 substances as part of articles would be more lik ely than any other manufacturers or processors to 961 be manufacturing or processing for use in the in ternal mechanisms of articles. Attempting to 962 define and meaningfully disti nguish between “internal” arti cle uses and other uses, and 963*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 42 of 72 correlating such distinctions to whether manufactur ing or processing of the substance occurs as 964 part of an article, would delay the rulemaking and increase its complexity, in a manner that does 965 not seem warranted on the basis of the lim ited information supplied in the comment. 966 4. Comment. “EPA should clarify whether the SNUR applies to articles containing the 967 chemical of concern in a solid, li quid, particle or gaseous form.” 968 4. Response. This SNUR applies to the chemical substances regardless of form. To the 969 extent the commenter seeks to continue some aspect of the exemption at 40 CFR 721.45(f), 970 depending on the form of the chemical substan ce in the article that is being imported or 971 processed, the commenter has not offered any specific support for that proposition, either 972 generally or in any particular ca se. In the SNUR at issue, EPA does not believe it is prudent to 973 limit the application of the rule based on the form (solid, liquid, or gaseous) of the chemical 974 substances at issue. Chemicals that may have be en used in one form during the manufacture of 975 the article may be released from the article in a different physical form. Also, fluids and particles 976 are not covered under the applicable definiti on of article at 40 CFR 704.3. EPA received no 977 comments suggesting that use of these chemicals in one form or another may not be significant 978 based on the TSCA section 5(a)(2) factors. Moreover , information relevant to a specific form of 979 a chemical substance can be submitted in a SNUN and may be considered by EPA in review of 980 that SNUN in determining whether follow-up action is warranted, and may support EPA’s 981 amendment of the SNUR to limit its scope. 982
5. Comment. “[A] chemical may be present at a very low concentration that is unlikely to 983 be associated with a risk warranting EPA risk management action. . . . EPA should consider 984 whether it can establish a de minimus exclusion [from the SNUR].” 985 5. Response. EPA notes that the SNUR already contains a general exemption for 986 unintentionally present impurities at 40 CFR 721.45(d). To the extent chemical substances are 987*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 43 of 72 intentionally added to articles at very low concentrations, the question of whether the substance 988 warrants risk management action is one that EPA can address upon receipt of the SNUN, not an 989 analytical prerequisite to d eciding whether it should receive the SNUN in the first place. 990 G. Screening for Benzidine- Based Chemical Substances 991 Some commenters faulted the proposal for not identifying precise scre ening operations to 992 be taken in response to the SNUR, and for not conducting additional analyses of the cost and 993 feasibility of such screening ope rations. One commenter suggests, in particular, th at an article 994 importer should be deemed in compliance with th e SNUR if the chemical is present below an 995 established de minimis level (based on mass or concentration) , or if it simply does not know the 996 article’s content after co nducting a reasonable inquiry for such information. 997 With respect to processors, given the requi rements of 40 CFR 721.5(a )(2), a processor of 998 the chemical substance should have received noti fication that the chemi cal substance is the 999 subject of a SNUR. A processo r is not required to submit a SNUN for its unknowing processing 1000 of a chemical substance subject to a SNUR if (upon obtaining knowle dge) the processor can 1001 document that when the past processing occurr ed, the processor neither knew the chemical 1002 identity of the substance it was processing nor kn ew that substance was subject to a SNUR. See 1003 40 CFR 721.5(c). EPA would generally expect that processors woul d only fail to be aware of the 1004 presence of a chemical subject to a SNUR if the manufacturer (incl uding importer) or upstream 1005 processor of the chemical substa nces failed to meet their obliga tions under 40 CFR 721.5(a)(2). 1006 With respect to importers, EPA disagrees that it would be appropriate or necessary for the 1007
SNUR itself to define screening procedures to be employed for compliance purposes. The 1008 Agency did not propose to require a particul ar screening procedure and, for the following 1009 reasons, it does not agree that particular sc reening procedures s hould be specified and 1010 incorporated into the final rule. 1011*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 44 of 72 First, EPA believes that adding these sort of screening-effort exemptions, specifically for 1012 importers of chemical substances as part of ar ticles, would be especia lly difficult to reconcile 1013 with the general statutory prohibition (under TSCA section 5(a)(1)) on manufacturing or 1014 processing a chemical substance for a significant ne w use without prior notice to EPA. The issue 1015 under the statute is whether or not an importer actually imports a substance. This is a separate 1016 question from the importers’ level of knowledge or level of effort to obtain knowledge respecting 1017 the content of the imports. 2 With respect to SNURs, EPA notes that its direct rulemaking 1018 authority is to identify significant new uses under section 5(a)(2). The Agency has been 1019 appropriately cautious in exercising its implicit ru lemaking authority to limit the applicability of 1020 section 5(a)(1). EPA recognizes th at it did previously exercise su ch implicit rulemaking authority 1021 when establishing 40 CFR 721.45(f). However, as noted above, the exemption at 40 CFR 1022 721.45(f) was established along with a broad reservation of authority to withdraw the exemption 1023 where, as here, it is inaccurat e to assume that there would not be exposure to the substance 1024 simply because it is present as part of an article. And a screening-effort exemption is especially 1025 difficult to reconcile with the statute in the case of importers. With importers, unlike with 1026 processors, there are no upstream entities with a duty under TSCA to no tify importers of the 1027 presence of a chemical substance subject to a SNUR. 1028 Second, establishing a safe-harbor for impor ters based on lack of knowledge would 1029 create incentives for foreign suppliers to delibe rately withhold information from importers. This 1030 could greatly reduce the efficacy of this SNUR. Cu rrently, when an importer wishes to import a 1031 substance it knows would be subjec t to notification requirements, but for which the chemical 1032

2 The limiting clause in the definition of “principal importer” at 40 CFR 721.3—“knowing that a chemical substance will be imported”—is a limit based on the person’s knowledge th at he or she is engaged in an import transaction, not a limit based on the person’s knowledge of a particularchemical’s identity and regulatory status. (48 FR 21727, May 13, 1983) (FRL 2998-5).*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 45 of 72 identity is claimed as CBI by a foreign ma nufacturer, EPA’s longsta nding practice when 1033 reviewing PMNs and SNUNs is to accept the releva nt information on chemical identity directly 1034 from the foreign manufacturer. See, 48 FR 21726, May 13, 1983 (FRL 2998-5) (“[t]he principal 1035 importer need not know the specific chemical iden tity of the imported substance” and “may have 1036 its foreign manufacturer or supplier, or some other person, report the chemical identity to EPA.”) 1037 Offering an outright regulatory exemption to an importer simply because it is ignorant of the 1038 existence of a SNUR-regulated substance in the imported article (after conducting a prescribed 1039 inquiry) would allow foreign suppli ers to short-circuit this proce ss simply by refusing to divulge 1040 to the importer whether the import contains a chemical substance subject to SNUR. 1041 Third, to the extent the chemical substance subject to the SNUR is only “unintentionally 1042 present” at the point of forei gn manufacture, it is already exem pt from reporting by the importer 1043 as an imported impurity. See 40 CFR 721.3 (chapeau), 40 CFR 720.3(m), and 40 CFR 721.45(d). 1044 Thus, importers are not required to submit a SNUN for a substance based simply on that 1045 substance’s presence as an impurity (i.e., a ch emical substances unintentionally present with 1046 another chemical substance). 1047 Fourth, whether and how it may appropriate fo r importers to screen for benzidine-based 1048 chemical substances will depend on many factor s, including their curr ent state of knowledge 1049 about the articles that they import and the poten tial risk of unknowingly importing articles that 1050 contain these chemical substances. The releva nt factors are largely impossible for EPA to 1051 establish at this time, given that there is curr ently no on-going import of these substances for the 1052 designated significant new uses. 1053 Finally, EPA did conduct additional analysis of potential screening burden to explore 1054 commenters’ concerns. As de scribed below, EPA acknowledges the costs of the various 1055 activities that certain enti ties may choose to undertake, in response to this rule, to ensure that the 1056*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 46 of 72 chemicals they import or process as part of articles do not trigger SNUN submission 1057 requirements (Ref. 14). Based on EPA’s economic analysis and the responses to the proposed 1058 rule, EPA does not believe that these costs wi ll be significant for any individual entity. 1059 H. Costs Associated with Maki ng the Exemption for Persons that Import or Process Chemical 1060 Substances as Part of Articles Inapplicable 1061 Some comments note that the economic analys is, which focuses on the cost of filing a 1062 SNUN, does not include any analysis of the costs that might be asso ciated with screening articles 1063 to determine whether these SNURs would apply. On e comment also notes that “the preambles to 1064 the proposed rules do not discuss what, if any oblig ations companies have to screen articles for 1065 the chemicals included in the SNUR’s.” 1066 With respect to processors: existing SNURregulations already provide that the 1067 unknowing processing of a chemical substance does not itself trigger SNUN requirements if the 1068 processor can (upon obtaining knowledge) document th at when the past processing occurred, the 1069 processor neither knew the chemical identity of the substance it was processing nor knew that 1070 substance was subject to a SNUR. See 40 CFR 721.5(c). 1071 With respect to importers: based on an a ssessment of current market activity in the 1072 economic analysis, EPA believes that the chemical s subject to the final SNUR are not currently 1073 being imported into the United States for the identified significant new uses in articles. EPA 1074 received no public comments on the proposed SNURthat indicate that importation of these 1075 benzidine-based chemical substances for the fi nalized significant new us es, in articles or 1076 otherwise, is ongoing. However, because this SNUR makes inapplicable the exemption for 1077 persons that import or process chemical substanc es as part of articles, companies may take 1078 actions to ensure that they do not import any arti cles containing the subject chemical substances 1079 after promulgation of this rule, by such means th ey deem appropriate. This is not necessarily a 1080*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 47 of 72 new consideration for importers given that importe rs of mixtures have needed to be aware of 1081 chemical substances subject to a SNUR that ma y be a component of imported mixtures. Whether 1082 and how companies respond will depend on many f actors, including their current state of 1083 knowledge about articles that they import and their own assessment s of the potential risk of 1084 unknowingly importing articles thatcontain these chemicals. As noted above, EPA did conduct 1085 additional analysis of burdens that may be asso ciated with activities en tities may undertake to 1086 ensure the chemicals they import or process as part of articles do not trigger SNUN submission 1087 requirements (Ref. 14). 1088 In any event, EPA did not propose to mandate any particular leve l of screening of 1089 imported or processed articles. The preamble to the proposed SNUR did no t discuss the precise 1090 steps that an importer or processor must take in this regard because ther e is no precise level of 1091 screening by which the manufacturer or processor could be separate ly liable under the rule (if not 1092 performed) or by which a manufact urer or processor could obtain “safe harbor” from what would 1093 otherwise be a violation of the rule. While EPA might potentially take screening practices into 1094 consideration when evaluating a particular instance in which the SNUR was nevertheless 1095 violated, that would be as a matter of enforcemen t policy, not as a provision of the rule itself. 1096 EPA has included estimates for some ac tivities that importers may undertake (e.g., 1097 supplier inquiries) in order to evaluate the likelihood of chemicals being imported as part of 1098 articles. These costs will vary for individual companies and their experience with suppliers. 1099 Awareness of article components and constituen ts is becoming more commonplace as companies 1100 frequently operate on a global scale and are su bject to numerous regulatory requirements around 1101 the world that affect product st ewardship responsibilities. Existi ng requirements that may compel 1102 a company to investigate an article’s compone nts include the Consumer Product Safety Act, 1103 California’s Proposition 65, and th e EU’s regulation on Registration, Evaluation, Authorization 1104*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 48 of 72 and Restriction of Chemical (REACH), which re quires customer notifica tion about the presence 1105 of certain chemical in articles that a compa ny distributes. U.S. importing companies may already 1106 be familiar with the process of determining whethe r the articles they impo rt contain restricted 1107 chemical substances, if they are subject to the requirements cited above or various U.S. 1108 regulations, such as the Product Safety Im provement Act (CPSIA) of 2008, Washington’s 1109 Children’s Safe Product Act, and Maine’s Act to Protect Children’s Health and the Environment 1110 from Toxic Chemicals in Toys and Children’s Products (Ref. 14). 1111 Given the existing regulatory limitations on certain chemicals both internationally and 1112 within the United States, regulated industries ha ve begun to develop industry-wide processes and 1113 other resources to obtain information on chemical substances in articles. Policies and procedures 1114 could include supplier agreements, such as Hewl ett Packard’s requirement that suppliers meet 1115 their General Specifications fo r the Environment (GSE) (Ref. 15) and Walmart’s requirement 1116 that suppliers participate in International Comp liance Information Exchange (iCiX) to manage 1117 and share compliance information throughout the s upply chain (Ref. 16). More extensive policies 1118 and procedures could even include product te sting. Companies may choose to use existing 1119 procedures or develop new ones that could range from document review, to supplier agreements, 1120 to product testing. 1121 Additional analysis conducted by EPA on activities that companies may choose to 1122 undertake to ensure that the chemicals they import or process as part of articles do not trigger 1123 requirements of the SNUR shows a wide range of potential activities and associated costs. The 1124 conduct of these activities and associated costs are at the discretion of the company. Table B 1125 shows EPA’s estimated a range of costs associatedwith some of these potential activities for 1126 importers of articles. 1127*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 49 of 72 Table B: Range of Costs Associated with an Importer’s Identification of Chemicals Subject 1128 to SNURs in Articles 1129 Activity Cost US ($) Notes Per Rule Costs 1. Rule familiarization $55 Cost typically already included in SNUR Economic Analyses 2. Identify the type of imported articles that potentially contain the restricted substances $130 to $1,550 Actual costs may vary based on number of articles imported and the complexity of the article itself (number of components) 3. Identify all suppliers involved $950 Actual costs may vary depending on the number of articles imported, number of suppliers, and frequency of supplier changes 6. Recordkeeping $10 Cost typically already included in SNUR Economic Analyses Article-Related Costs 4. Collect data from suppliers $5 to $515 per article reviewed. $0 if no data collected. Actual costs only apply to those companies that choose to collect data from suppliers. They will vary depending on the specific data collection method chosen. Total costs depend on considerations incl uding the number of articles imported, number of suppliers, and frequency of supplier changes. 5. Chemical testing $130 per article tested. $0 if no testing. Actual costs only apply to those companies that choose to collect data from suppliers. Total costs per company will depend on considerations including the number of articles tested, which may be affected by the number of suppliers and risk associated with each, and frequency of supplier changes. 1130 Should processors of articles need to demonstrate compliance with a SNUR, it is 1131 expected that they could use the shipping or labe ling documents received with the article in the 1132 ordinary course of business. As these documents would be received and stored anyway, as per 1133 standard business practices, the elimination of the exemption in the SNUR for persons that 1134 import or process chemical substances as part of articles would be unlikely to lead such persons 1135 to incur significant additional costs. To the exte nt that processors choos e to undertake more steps 1136 to identify regulated chemicals as part of articles , the costs of these activities would be similar to 1137*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 50 of 72 those in Table B for importers of similar size, supply chain complexity, and level of compliance 1138 with other chemical regulations. 1139 There are a number of regulations, incl uding California’s Proposition 65 and the EU’s 1140 REACH that currently restrict orotherwise affect the use of cer tain benzidine-based substances, 1141 particularly in their use as dyes in textiles and leather. Califor nia’s Proposition 65 Chemical List 1142 includes benzidine-based dyes as a potential carc inogen and requires that firms provide a clear 1143 and reasonable warning before knowingly and intentionally exposing anyone to a listed 1144 chemical. This warning may include the labe ling of consumer products (Refs. 17-18). 1145 The EU has banned, in textile and leather articles which may come into direct and 1146 prolonged contact with humans, th e use of azo dyes which can break down to release any of 22 1147 listed carcinogenic aromatic amines (including be nzidine and its congeners) in amounts above 30 1148 ppm (Ref. 19). The European Commission’s Directorate Gene ral for Health and Consumers 1149 maintains the RAPEX database that member countries can use to report dangerous products and 1150 the measures they have taken to prevent or re strict those products. Despite the EU ban, small 1151 numbers of products containing such azo dyes ha ve recently been listed on RAPEX. The 1152 products are typically voluntarily withdrawn from the market and/or destroyed by the importer or 1153 have been placed under an order by the authoritie s to cease sales (Refs. 20, 21). Therefore, azo 1154 dyes in imported articles still remain a potential issue in the EU. Other countries have also 1155 banned the manufacture and use of the azo dyes in textiles. Currently th e manufacture of azo 1156 dyes is banned in South Korea and Japan (Ref. 22). Use of these chemicals is banned by Egypt, 1157 India, China, South Korea, Taiwan and Vietna m (Ref. 23), and Indonesia has banned the use of 1158 the dyes in children’s and baby’s clothing (Ref. 24). In 2012, the Japanese textiles and leather 1159 industry announced voluntary restrictions of the chemicals (Refs. 23, 24). Canada has also 1160 expressed concern about the poten tial release of benzidine or its congeners from azo dyes and is 1161*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 51 of 72 evaluating potential approaches for addressing azo dyes (Ref. 25). Organizations, such as the 1162 American Apparel & Footwear Association (AAFA), have devel oped a comprehensive 1163 Restricted Substances List (RSL) as a referenc e for companies and have developed a toolkit to 1164 help apparel and footwear companies to better manage chemicals throughout the supply chain. 1165 Given the current level of international and domestic regulation and attention to benzidine1166 related chemicals, EPA believes that importers and processors of artic les may already have 1167 undertaken a number of ac tivities to manage chemicals within their supply chains and generally 1168 to deselect for these chemicals. Therefore, EP A expects that companies that could potentially 1169 commence importing or processing be nzidine-based chemicals as part of articles may already 1170 have some knowledge of the chemicals within their supply chain and would undertake few of the 1171 activities listed in Table B and would fall toward the lower end of th e cost range for any 1172 activities undertaken. More detailed informa tion is included in EPA’s economic analysis. 1173 EPA does not believe that the subject ch emicals are entering the United States in 1174 imported articles for the significant new uses defined by the final regulation. However, 1175 companies may screen or initiate other activities to determine if articles they import in the future 1176 contain chemicals included in this SNUR. EPA notes that no commenters provided data that 1177 could be used to estimate what, if any, costs mi ght be associated with continued assurance that 1178 imported articles are free from the chemical subs tances subject to this SNUR. The number of 1179 companies that may take such actions is not know n, nor is the level of action that may be taken 1180 by a particular company. Based on EPA’s economic analysis and the resp onses to the proposed 1181 rule, EPA does not believe that these costs will be significant for any individual entity. 1182 I. Import and Export Regulati ons for Chemical Substances as Part of Articles 1183 One comment noted that EPA is not propos ing to change the way in which TSCA’s 1184 export and import rules (pursuant to TSCA sections 12(b) and 13, respectively) apply to articles 1185*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 52 of 72 containing these chemical substances. The commen t indicates that (under the status quo of the 1186 import rules) the U.S. Customs and Border Protec tion (CBP) will not be screening articles for the 1187 chemical substances in the proposed SNURs. 1188 EPA agrees that the TSCA import rules ar e important TSCA compliance mechanisms and 1189 that 19 CFR 12.119 allows EPA to establish sect ion 13 import certification requirements for 1190 chemicals in articles. However, declining to su bject importers to one notice requirement (section 1191 13 import certification) does not render anothe r notice requirement (section 5 SNUN submission) 1192 unenforceable. 1193 In this case, EPA did not pr opose to require section 13 impor t certification or section 12 1194 export notification for the subject chemical substances when part of articles. This is consistent 1195 with EPA’s past practice of making the exemp tion at 40 CFR 721.45(f) inapplicable without also 1196 requiring import certification or ex port notification for these chemical substances as part of 1197 articles (40 CFR 721.28 00; 40 CFR 721.10068). However, the Agency continues to study this 1198 issue and has not ruled out a later proposal to require import certifi cation and/or export 1199 notification for these chemical subs tances as part of articles. 1200 With or without an import certification requirement, it is the importer that is “responsible 1201 for insuring that chemical importation complies with TSCA just as dom estic manufacturers are 1202 responsible for insuring that chemical manufacture compliance with TSCA.” 40 CFR 1203 707.20(b)(1). 1204 J. Distinguishing Between Chemicals in Non-Article Form and Other Products 1205 One comment contends that the rule, as pr oposed, “would not allow [EPA] to distinguish 1206 between a chemical being brought into the United States in its raw form and a chemical being 1207 brought in on a shift as a dye or finish.” The comment goes on to state that treating them the 1208 same way is unrealistic a nd scientifically unsound. 1209*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 53 of 72 EPA disagrees with the comment and notes th at it was not proposing to eliminate all 1210 distinctions, in all regu latory provisions under TSCA, between import of a chemical substance in 1211 non-article form, and import of a chemical substa nce as part of an article. The rule simply 1212 removes one particular distinction between pers ons who import or proce ss a chemical substance 1213 in non-article form and persons who import or proce ss a chemical substance as part of an article. 1214 Thus, while the raw chemical manufacturer and the article importer may both be required to 1215 submit a SNUN, EPA would be able distinguish between the two scenarios, as appropriate, in its 1216 review of the SNUN. The SNUN review proce ss will allow case-by-cas e analysis of each 1217 circumstance. 1218 With respect to the commenter’s comparison of the volume at which these chemical 1219 substances are currently manu factured in non-article form and the volume at which these 1220 chemical substances are currently manufactured in article form (i.e., via import of a chemical 1221 substance as part of an article), EPA’s conclusion, with respect to the significant new uses, is that 1222 the two volumes are currently the same. This is because EPA has concluded that there is no 1223 current manufacture of these chemical substanc es for the significant new uses, either through 1224 domestic manufacture of the substances in non- article form, or through import of articles 1225 containing the substances. Thus, both production volumes are currently zero. 1226 K. Provisions for Processors 1227 In a comment submitted after the closing of the public comment period, one commenter 1228 questions the utility of a provision for proces sors at 40 CFR 721.5(c), as applied to notice 1229 requirements under this rule. The commenter st ates that 40 CFR 721.5(c) would not protect 1230 companies unless they could docum ent lack of knowledge that a SNUR applies. The commenter 1231 believes that this requirement is therefore impossi ble to meet, explaining th at it is impossible to 1232 document what one does not know. 1233*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 54 of 72 EPA will respond to this comment, although it was submitted after the closing of the 1234 public comment period for this action, because it relates closely to the timely submitted 1235 comments. EPA disagrees that applying 40 CFR 721.5(c) is impo ssible or impracticable. The 1236 provisions at 40 CFR 721.5(c) pr ovide that the unknowing proce ssing of a chemical substance 1237 does not itself trigger SNUN submission requiremen ts, subject to meeting certain documentation 1238 requirements. Upon obtaining knowledge that it prev iously engaged in ac tivities covered by the 1239 SNUR, a processor can at that time assemble evidence relating to the period when the past 1240 processing occurred. Specifical ly, this would be evidence be aring on whether the processor 1241 previously knew the chemical identity of the s ubstance it was processing orpreviously knew that 1242 that substance was subject to a SNUR. Evidenceto establish a prior lack of knowledge could 1243 include items such as a purchase order and, wher e applicable, an material safety data sheet 1244 (MSDS) that indicates neither the relevant chemical identity nor the presence of a chemical 1245 subject to a SNUR. Another type of evidence would be the affida vit of a person in a position of 1246 appropriate authority swearing to the prior lack of knowledge. EP A would generally consider the 1247 wording on a purchase order and, where applicab le, an MSDS, along with an affidavit as 1248 described above, in determining whether there is sufficiently clear documentation for purposes of 1249 40 CFR 721.5(c). However, if there was also co ntrary documentary evidence, indicative of the 1250 prior possession of knowledge (e.g. , receipt of a notice given to the processor pursuant to 40 1251 CFR 721.5(a)(1)(i)) then the overall documentary ev idence would not allow th e processor to take 1252 advantage of the provisions of 40 CFR 721.5(c). 1253 L. Potential Ongoing Use of DnPP 1254 One commenter identified a potential ongoi ng use of DnPP in grease in automotive 1255 switches. The commenter requested that EP A exclude the identified use from the SNUR. 1256 After investigation, EPA has determined that there is no ongoing use of DnPP in grease 1257*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 55 of 72 in automotive switches. 1258 The commenter states that “[b]ased on cu rrent use information . . . [the commenter] 1259 believes that DnPP is being used in grease in some automotive switches.” The proposal stated 1260 that EPA "welcome[d] specific information thatdocuments [ongoing] use.” Yet the commenter 1261 does not provide any current use information to subs tantiate this belief. When raising a potential 1262 ongoing use, it is generally preferable to include in formation substantiating that use, especially 1263 where the entity raising that use is not an actu al manufacturer (including importer) or processor 1264 of that chemical substance for that use and thus would not be anticipated to have direct 1265 knowledge of that use. 1266 In order to determine whether there is an ongoing use of DnPP in grease in automotive 1267 switches, EPA performed targeted searches of sources including IHS Chemical Economics 1268 Handbook, MSDS search tools such as Seton’ s MSDS Hazard Communication Library and 1269 patent searches and was unable to substantia te this use as an ongoing use of DnPP. EPA 1270 reviewed several grease MSDS, and no grease MS DS listed any phthalate in its composition. 1271 EPA’s DfE alternatives analysis also has not iden tified use in grease in automotive switches as 1272 an ongoing use of DnPP. 1273 EPA also conducted patent searches for gr ease in automotive switches, and dampening 1274 greases in general. A patent search found men tions of the term phthalates with electronic 1275 components, but not DnPP specifically for automo tive switches. However, one patent gave a 1276 very broad alkyl range that re lease of phthalates C4 and C8 were observed during the vacuum 1277 burn pretreatment of electronic components [disc dr ives]. This process is routine treatment to 1278 remove volatiles from electronic components, including electronic switches (Vacuum baking 1279 process USP 6,051,169 and Electric switches USP 3,694,601). EPA does not believe the 1280 existence of this information is indicative of current use of DnPP in grease in automotive 1281*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 56 of 72 switches because, patents do not necessarily indica te current use. As noted in the proposed rule 1282 (77 FR 18756, March 28, 2012) (FRL 8865-2), no IU R production volume data were reported for 1283 DnPP during the 2006, 2002, 1998 and 1994 reporting cy cles. In addition, no production volume 1284 data were reported fo r the 2012 CDR (Ref. 13) 1285 Accordingly, EPA is declining to exclude use “in grease in automotive switches” from 1286 the significant new uses of DnPP. 1287 M. Reliance on Inventory Update Rule (IUR) Data in Assessing Ongoing Use of DnPP 1288 One commenter suggests that EPA relied sole ly on the IUR data for determining ongoing 1289 uses of DnPP, and that such reliance may be misleading or incomplete. The commenter notes 1290 that ongoing uses below the IUR reporting thresh old of 10,000 lbs would not be reported to EPA 1291 through the IUR process. 1292 EPA uses IUR data to identify ongoing uses of chemical substances. However, this is not 1293 the sole source of information relied upon to su pport the SNUR. EPA firs t identified a SNUR as 1294 a regulatory alternative for DnPP in the Phthalat es Action Plan because EPA found that the most 1295 recent IUR data contained no reports of DnPP be ing produced in or imported into the United 1296 States. In proposing the SNUR, EPA prepared the Economic Analysis of the Proposed 1297 Significant New Use Rule for Di-n-pentyl Phthalate (DnPP) (Ref. 25) and conducted internet 1298 queries in order to ascertain wh ether there were any ongoing uses of DnPP at levels below the 1299 IUR reporting threshold. During the course of th is research EPA identified several companies 1300 which either use or sell DnPP as a chemical stan dard for use in phthalates testing. Accordingly, 1301 the significant new uses of DnPP does not include use of DnPP as a chemical standard for 1302 analytical experiments as a significant new use. 1303 N. Design for the Environment (DfE) Assessment for Phthalates 1304 One commenter noted that EPA has undertak en a DfE project focused on phthalates, 1305*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 57 of 72 including but not limited to, DnPP. The commente r believes that the DfE phthalates alternative 1306 assessment will provide valuable information about potential alternatives to industries using 1307 phthalates. The commenter recommends that EPA refrain from further action on any phthalate 1308 until the DfE project is finalized. 1309 EPA disagrees that finalization of the Dn PP SNUR should be delayed until the DfE 1310 project is complete. (To the extent the commen t is discussing the timing of other potential EPA 1311 actions to address phthalates, it is out side the scope of this proposal.) 1312 The comment states that the final DfE report would identify alternatives, their viability as 1313 substitutes, and EPA’s comparativ e hazard information. EPA disagrees that this report is likely 1314 to provide information relevant to this SNUR. When defining th e “significant new use,” EPA is 1315 limited to uses of the chemical substance that are not ongoing. The DfE repor t is not expected to 1316 identify alternatives for chemical substances th at are generally no longer in use. It is already 1317 clear that there are many alternatives to DnPP use, because there are almost no ongoing uses of 1318 DnPP. Furthermore, the DfE report is not expectedto suggest DnPP itself as an alternative to 1319 another phthalate because of its toxicity relative to other phthalates. Even if the DfE report were 1320 to identify a significant new use of DnPP as an al ternative to some other chemical substance, 1321 then EPA would have the opportunity to consider that information at such time as it received the 1322 significant new use notice for DnPP. 1323 EPA notes that it is a regul ar practice to finalize SNURs fo r chemical substances that 1324 have not undergone a DfE assessment. Given that the DfE report is unlikely to provide additional 1325 information relevant to EPA’s significant new us e determination for DnPP, that newly available 1326 information respecting any particular use of DnPPcould be included in the significant new use 1327 notice itself, and that further delay would incr ease regulatory uncertaint y, EPA disagrees that it 1328 would be appropriate to delay issuance of the SNUR on DnPP pending the release of the DfE 1329*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 58 of 72 report. 1330 XI. References 1331 The following is a listing of the documents that are specifically referenced in this action. 1332 The docket includes these documents and other information considered by EPA, including 1333 documents that are referenced within the documents that are in the docket, even if the referenced 1334 document is not physically located in the doc ket. For assistance in locating these other 1335 documents, please consult the technical person listed under FOR FURTHER INFORMATION 1336 CONTACT

. 1337 1. U.S. EPA. Proposed Rule; Benzidin e-Based Chemical Substances; Di- n -pentyl 1338 phthalate (DnPP); and Alkanes, C12–13, Ch loro; Significant New Use Rules. 77 FR 18752, 1339 March 28, 2012 (FRL-8865-2). 1340 2. U.S. EPA, 2010. U.S. Environmental Pr otection Agency. Chemical Substances 1341 Derived from Benzidin e and Its Congeners, 1342 http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/DCB%20Action%20Plan_062320 1343 10.noheader.pdf (Accessed January 24, 2011). 1344 3. U.S. EPA. Economics and Policy Branc h, USEPA/OCSPP/ Economics, Exposure, and 1345 Technology Division. “Economic Analysis to Support the Final SNURfor Benzidine and 1346 Benzidine-based Chemical substances.” 1347 4. Testimony of James J. Jones, Acting Assi stant Administrator Office of Chemical 1348 Safety and Pollution Prevention, U.S. Environmental Protection Agency before the Committee 1349 on Environment and Public Works and th e Subcommittee on Superfund, Toxic and 1350 Environmental Health United States Senate, July 24, 2012, available at 1351 http://www.epa.gov/ocir/heari ngs/pdf/2012_jjone s_testimony1.pdf

. 1352*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 59 of 72 5. CPSC, 2011. Staff Briefing Package. Pe tition HP 10-2. Reques ting Restriction of 1353 Cadmium in Toy Jewelry (Consumer Product Safety Commission (February 9, 2011). Staff 1354 Report, Cadmium in Children’s Metal Jewelry. Toxicity Review of Cadmium. TAB B pp19-39 1355 http://www.cpsc.gov/PageFiles/96192/cadmiumtoy.pdf (October 14, 2010). 1356 6. Danish Environmental Protection Agenc y, Survey of Chemical Substances in 1357 Consumer Products Survey No. 25 2003, Mapping the Liberation of Organic Tin Compounds in 1358 Mattress Pads, To Mattresses, and Baby/Junior Duvets. 1359 7. Stapleton, et al., 2008, Alternate and New Brominated Flame Retardants Detected in 1360 U.S. House Dust, Environ. Sci. Technol

. 1361 8. CPSC Staff Preliminary Risk Assessmen t of Flame Retardant [FR] Chemicals in 1362 Upholstered Furniture Foam, December 21, 2006. 1363 9. Muller, et al., 2011, Car Indoor Air Pollu tion- Analysis of Potential Sources, Journal 1364 of Occupations Medicine and Toxicology 2011, 6:33. 1365 10. Wu, et al., 2009, Residues of Polybrom inated Diphenyl Ethers in Frogs ( Rana 1366 limnocharis ) from a Contaminated Site, South China: Tissue Distribution, Biomagnification, and 1367 Maternal Transfer, Environ. Sci. Technol. 2009, 42: 5212-5217. 1368 11. Gaylor, et al. 2012, House Cr ickets Can Accumulate Pol ybrominated Diphenyl Ethers 1369 (PBDEs) Directly from Polyurethane Foam Common in Consumer Products, Chemosphere, 1370 2012, 86: 500-505. 1371 12. Covaci, et al. 2006, Hexabromocyclodode canes (HBCDs) in the Environment and 1372 Humans: A Review. Environ. Sci. Technol. 2006, 40: 3679-3688. 1373 13. U.S. EPA, Chemical Data Access Tool (CDAT), 1374 http://java.epa.gov/oppt_chemical_search/

. 1375 14. U.S. EPA, Understanding the Costs Associated with Eliminating Exemptions for 1376*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 60 of 72 Articles in SNURs, May 1, 2013. 1377 15. Hewlett-Packard Development Company, LP . (2010). “Internationa l Material Data 1378 System.” Retrieved from http://www.mdsystem.com/

. 1379 16. Wal-Mart. (2012). Become a Supplier: Requirements. Retrieved from 1380 http://www.walmartstores.com/Suppliers/248.aspx

. 1381 17. CAEPA, 2013a. State of California Environmental Protection Agency. Chemicals 1382 Known to the State to Cause C ancer or Reproductive Toxicity. Office of Environmental Health 1383 Hazard Assessment, 04 February 2013. 1384 http://oehha.ca.gov/prop65/prop65_list/files/P65list020813.pdf. 1385 18. CAEPA, 2013b. State of California Envir onmental Protection Agency. Proposition 65 1386 in Plain Language! Febuary 2013. http://oehha.ca.gov/prop65/ background/p65plain.html. 1387 19. European Commission. 2009. Commissi on Regulation EC No. 552/2009 Commission 1388 Regulation (EC) No 552/2009 of 22 June 2009 am ending Regulation (EC) No 1907/2006 of the 1389 European Parliament and of the Council on REACH as regards Annex XVII. 1390 20. European Commission. 2010. RAPEX – Latest Notifications . Directorate General for 1391 Health and Consumers. http://ec.europa.eu/consumers/dy nex/rapex/rapex_achives_en.cfm

. 1392 21. IARC, 2012. International Agency for the Research on Cancer. IARC Monographs on 1393 the Evaluation of Carcinogenic Risks to Humans—Benzidine. Volume 100F: 53-63. 1394 22. Textination, 2012. Textination “Textile and Apparel Weekly June, 8 2012”. 1395 http://textination.de/en/tiw/2012/TIW08062012.pdf

. 1396 23. Intertek, 2013. Intertek, “Requirements of Azo dyes and Formaldehyde content in 1397 fabric for babies and children clothing in Indonesia” Jan 4, 2013. 1398 24. Intertek, 2013. Intertek, “Requirements of Azo dyes and Formaldehyde content in 1399 fabric for babies and children clothing in Indonesia” Jan 4, 2013. 1400*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 61 of 72 25. Environment Canada. 2009. Strategic options for the manage ment of toxic substances 1401 benzidine and 3,3-di chlorobenzidine . Available at: 1402 http://www.ec.gc.ca/toxics/docs/sor/bdine/EN/sum.cfm (Accessed 10 September, 2009). 1403 26. U.S. EPA. Economics and Policy Br anch, USEPA/OCSPP/ Economics, Exposure, 1404 and Technology Division. “Econo mic Analysis of the Final Significant New Use Rule for Di- n 1405 pentyl phthalate (DnPP).” 1406
27. U.S. EPA. Economics and Policy Bran ch, USEPA/OCSPP/ Economics, Exposure, 1407 and Technology Division. “Economic Analysis of the Final Significant New Use Rule for 1408 Alkanes, C 12-13 , chloro (CAS RN: 71011-12-6).” 1409 XII. Statutory and Executive Order Reviews 1410
A

. Executive Order 12866: Regulatory Planning a nd Review and Executive Order 13563: 1411 Improving Regulation and Regulatory Review 1412 This final rule has been designated by OMB as a “significant regulatory action” under 1413 section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993). Accordingly, EPA 1414 submitted this action to OMB for review under Executive Order 12866 and 13563 (76 FR 3821, 1415 January 21, 2011), and any changes made in response to OMB recommendations are documented 1416 in the docket. 1417
B

. Paperwork Reduction Act (PRA) 1418 This action does not impose any new inform ation collection burden under the PRA, 44 1419 U.S.C. 3501 et seq. Burden is defined in 5 CF R 1320.3(b). The informati on collection activities 1420 associated with existing chemical SNURs ar e already approved by OMB under OMB control 1421 number 2070-0038 (EPA ICR No. 1 188); and the information colle ction activities associated 1422 with export notifica tions are already approved by OMB under OMB control number 2070-0030 1423 (EPA ICR No. 0795). If an entity were to s ubmit a SNUN to the agency, the annual burden is 1424*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 62 of 72 estimated to be less than 100 hours per respon se, and the estimated burden for an export 1425 notifications is less than 1.5 hours per notification. In both cases, burden is estimated to be 1426 reduced for submitters who have already register ed to use the electronic submission system. 1427 Additional burden, estimated to be less than 10 h ours, could be incurred where additional record 1428 keeping requirements are specified under 40 CFR §721.125(a), (b), and (c). 1429 An Agency may not conduct or sponsor, a nd a person is not required to respond to a 1430 collection of information that requires OMB approval under the PRA, unless it has been 1431 approved by OMB and displays a currently valid OMB control number. The OMB control 1432 numbers for EPA’s regulations in Title 40 of the CFR, after appearing in the Federal Register , 1433 are listed in 40 CFR part 9 and included on th e related collection instrument, or form, if 1434 applicable. EPA is amending the table in 40 CFR part 9 to list this S NUR. This listing of the 1435 OMB control numbers and their subsequent co dification in the CFR satisfies the display 1436 requirements of the PRA and OMB's implementi ng regulations at 5 CFR part 1320. Since the 1437 existing OMB approval was previously subjec t to public notice and comment before OMB 1438 approval, and given the technica l nature of the table, EPA finds that further notice and 1439 comment to amend the table is unnecessary. As a result, EPA finds thatthere is “good cause” 1440 under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to 1441 amend this table without further notice and comment. 1442
C

. Regulatory Flexibility Act (RFA) 1443 Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I hereby certify that 1444 promulgation of this SNUR will not have a significant economic impact on a substantial number 1445 of small entities. The rationale suppor ting this conclusion is as follows. 1446 EPA generally finds that proposed and final SNURs are not exp ected to have a significant 1447 economic impact on a substantia l number of small entities (See, e.g., Ref. 34). Since these 1448*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 63 of 72 SNURs will require a person who intends to engage in such activity in the future to first notify 1449 EPA by submitting a SNUN, no economic impact will occur unless someone files a SNUN to 1450 pursue a significant new use in the future or forgoes profits by avoiding or delaying the 1451 significant new use. Although some small entities may decide to engage in su ch activities in the 1452 future, EPA cannot presently determine how ma ny, if any, there may be. However, EPA’s 1453 experience to date is that, in response to the promulgation of SNURs covering over 1,000 1454 chemical substances, the Agency receives only a handful of notices per year. During the six year 1455 period from 2005-2011, only three submitters self-ide ntified as small in their SNUN submission 1456 (Refs. 5, 32, 33). EPA believes the cost of submi tting a SNUN is relatively small compared to 1457 the cost of developing and marketing a chemical new to a firm and that the requirement to 1458 submit a SNUN generally does not have a significant economic impact. 1459 A SNUR applies to any person (including small or large enti ties) who intends to engage 1460 in any activity described in the ru le as a “significant new use.” In the proposed SNUR EPA 1461 preliminarily determined, based in part, on the Ag ency’s market research, that these chemical 1462 substances are not being manuf actured (including imported) or processed for a significant new 1463 use. In the case of the benzidine-based dyes, this preliminary determination also included 1464 importation and processing of these chemical s ubstances as part of articles (Ref. 1). EPA 1465 received no public comment indicating any ongoing importation of the benzidine-based chemical 1466 substances as part of articles or otherwise. Th erefore, EPA is finalizing its determination that 1467 these uses, including the importation and processing of benzidine-based dyes as part of articles, 1468 are new and not ongoing. Thus no small entities presently engage in a significant new use. By 1469 definition of the word “new” and based on all info rmation currently available to EPA, it appears 1470 that no small or large entities presently engage in such activities. Sin ce these SNURs will require 1471 a person who intends to engage in such activity in the future to first notify EPA by submitting a 1472*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 64 of 72 SNUN, no economic impact will occur unless some one files a SNUN to pursue a significant new 1473 use in the future or forgoes profits by avoi ding or delaying the signi ficant new use. Although 1474 some small entities may decide to engage in su ch activities in the futu re, EPA cannot presently 1475 determine how many, if any, there may be. Howeve r, EPA’s experience to date is that, in 1476 response to the promulgation of SNURs coveri ng over 1,000 chemical substances, the Agency 1477 receives only a handful of notices per year . During the six year period from 2005-2011, only 1478 three submitters self-identif ied as small in their SNUN su bmission (Refs. 3, 26, 27). EPA 1479 believes the cost of submitting a SNUN is relatively small compared to the cost of developing 1480 and marketing a chemical new to a firm and th at the requirement to submit a SNUN generally 1481 does not have a significant economic impact. 1482 Therefore, EPA believes that the potential economic impact of complying with this 1483 SNUR is not expected to be significant or adversely impact a substantial number of small 1484 entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735- 1485 4), the Agency presented its general determin ation that proposed and final SNURs are not 1486 expected to have a significant economic impact on a substantial number of small entities, which 1487 was provided to the Chief Counsel for Advo cacy of the Small Business Administration. 1488
D

. Unfunded Mandates Reform Act (UMRA) 1489 Based on EPA’s experience with proposing and finalizing SNURs, State, local, and Tribal 1490 governments have not been impact ed by these rulemakings, and EPA does not have any reason to 1491 believe that any State, local, or Tribal governme nt would be impacted by this rulemaking. As 1492 such, EPA has determined that this regulatory action would not impose any enforceable duty, 1493 contain any unfunded mandate, or otherwise have any effect on small governments subject to the 1494 requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538. 1495 E. Executive Order 13132: Federalism 1496*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 65 of 72 This action does not have a substantial direct effect on States, on the relationship between 1497 the national government and the States, or on th e distribution of powerand responsibilities 1498 among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, 1499 August 10, 1999). 1500 F. Executive Order 13175: Consultation and Coor dination with Indian Tribal Governments 1501 This action does not have Tribal implications because it will not have any effect (i.e., 1502 there will be no increase or decr ease in authority or jurisdictio n) on Tribal governments, on the 1503 relationship between the Federal government and the Indian tribes, or on the distribution of 1504 power and responsibilities between the Federal g overnment and Indian tribes. Thus, Executive 1505 Order 13175 (65 FR 67249, November 9, 2000) , does not apply to this action. 1506
G

. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety 1507 Risks 1508 This action is not subject to Executi ve Order 13045 (62 FR 19885, April 23, 1997), 1509 because this action is not intende d to address environmental healthor safety risks for children. 1510
H

. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy 1511 Supply, Distribution, or Use 1512 This action is not subject to Executi ve Order 13211 (66 FR28355, May 22, 2001), 1513 because it is not expected to affect energy supply, distribution, or use. 1514
I

. National Technology Transfer and Advancement Act (NTTAA) 1515 Since this action does not i nvolve any technical standards, section 12(d) of NTTAA, 1516 15 U.S.C. 272 note, does not apply to this action. 1517
J

. Executive Order 12898: Federal Actions to Ad dress Environmental Justice in Minority 1518 Populations and Low-Income Populations 1519 This action does not entail special considerations of environmental justice related issues 1520*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 66 of 72 as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has 1521 determined that this action will not have disproportionately high and adverse human health or 1522 environmental effects on minority or low-inco me populations. This action does not affect the 1523 level of protection provided to human health or the environment. 1524
K. Congressional Review Act (CRA) 1525 Pursuant to the CRA, 5 U.S.C. 801 et seq., EPA will submit a report containing this rule 1526 and other required information to the U.S. Senate , the U.S. House of Representatives, and the 1527 Comptroller General of the United States prior to publication of the rule in the Federal Register

. 1528 This action is not a “major rule” as defined by 5 U.S.C. 804(2). 1529 List of Subjects 1530
40 CFR Part 9 1531 Environmental protectio n, Reporting and recor dkeeping requirements. 1532
40 CFR Part 721 1533 Environmental protection, Chemicals, Hazardous substances, Reporting and 1534 recordkeeping requirements. 1535 Dated: 1536

1537

___________________________________________ 1538 Director, Office of Po llution Prevention and Toxics

. 1539*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 67 of 72 Therefore, 40 CFR parts 9 a nd 721 are amended as follows: 1540 PART 9--[AMENDED] 1541 1. The authority citation for part 9 continues to read as follows: 1542 Authority: 7 U.S.C. 135 et seq ., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601- 1543 2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq ., 1311, 1313d, 1314, 1544 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1545 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 1546 300g-4, 300g-5, 300g-6, 300j-1, 300j- 2, 300j-3, 300j-4, 300j-9, 1857 et seq ., 6901-6992k, 7401- 1547 7671q, 7542, 9601-9657, 11023, 11048. 1548 2. In § 9.1, add the following sections in numeri cal order under the undesignated center 1549 heading “Significant New Uses of Chemi cal Substances” to read as follows: 1550 § 9.1 OMB approvals under the Paperwork Reduction Act. 1551
* * * * * 1552 40 CFR citation OMB control No.

* * * * * Significant New Uses of Chemical Substances
* * * * * 721.10226 2070-0038
721.10227 2070-0038

* * * * *
1553
* * * * * 1554 PART 721--[AMENDED] 1555 3. The authority citation for part 721 continues to read as follows: 1556*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 68 of 72 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 1557 1558 4. Revise § 721.1660 to read as follows: 1559 1560 § 721.1660 Benzidine-based ch emical substances. 1561 1562 (a) Chemical substances and significant new uses subject to reporting . (1) The 1563 benzidine-based chemical substances listed in Tabl e 1. and Table 2. of this section are subject to 1564 reporting under this secti on for the significant new uses descri bed in paragraph (a)(2) of this 1565 section. 1566 Table 1.— Benzidine-Based Chemical Substances 1567 1568 CAS or accession number C.I. name C.I. number Chemical name

117-33-9 Not a v a il ab le Not a v a il ab le 1,3-N aphth a lenedisulfonic acid, 7-hyd r oxy8-[2-[4'-[2-(4-hydroxyphenyl)diazenyl][1,1'- biphenyl]-4-yl]diazenyl]- 65150-87-0 Not a v a il ab le Not a v a il ab le 1,3,6-N aphth a lenetr isulfonic acid, 8- hydroxy-7-[2-[4'-[2-(2-hydroxy-1- naphthalenyl)diazenyl][1,1'- biphenyl]-4- y l]di a zen y l]-, lithium s a lt ( 1:3 ) 68214-82-4 Direct N a vy BH 22590 2,7-N aphth a lenedisulfonic acid, 5- a mino-3- [2-[4'-[2-(7-amino-1-hydroxy-3-sulfo-2- naphthalenyl)diazenyl][1,1'-biphenyl]-4- yl]diazenyl]-4-hydroxy-, sodium salt (1:2) 72379-45-4 Not a v a il ab le Not a v a il ab le 2,7-N aphth a lenedisulfonic acid, 4- a mino-5- hydroxy-3-[2-[4'-[2-[2-hydroxy-4-[(2- methylphenyl)amino]phenyl]diazenyl][ 1,1'- biphenyl]-4-yl]diazenyl]-6-(2- phenyldiazenyl)- Accession No. 21808 CAS No. CBI (NA) CBI CBI 2,7-Naphthalenedisu lfonic acid, 4-amino-5- hydroxy [[[(substituted phenylamino)] substituted phenylazo] diphenyl]azo-, phenylazo-, disodium salt. (generic name) Accession No. 24921 CAS No. CBI CBI 4-(Substituted n aphth a lenyl ) a zo diphenylyl azo-substituted carbopolycycle azo benzenesulfonic acid, so dium salt. (generic name)*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 69 of 72 Accession No. 26256 CAS No. CBI (NA) CBI CBI 4-(Substituted phenyl) a zo biphenylyl a zosubstituted carbopolycycloazo benzenesulfonic acid, sodium salt. (generic name) Accession No. 26267 CAS No. CBI (NA) CBI CBI 4-(Substituted phenyl) a zo biphenylyl a zo - substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (generic name) Accession No. 26701 CAS No. CBI (NA) CBI CBI Phenylazoaminohydroxynaphthalenylazobip h enylazo substituted benzene sodium sulfonate. (generic name)

1569 Table 2.—Benzidine-Based Chemical Substances 1570 1571 CAS number C.I. name C.I. number Chemical name 92–87–5 Benzidine Not available [1,1’-Biphenyl]-4,4’-diamine 531–85–1 Benzidine · 2HCl Not a v a il ab le [1,1’-Biphenyl]-4,4’-diamine, 573–58–0 C.I. Direct R e d 28 22120 1- N aphth a lenesulfonic acid, 3,3'-[[1,1'- biphenyl]-4,4'-diylbis(azo)]bis[4-amino-, disodium s a lt 1937–37–7 C.I. Direct Blac k 38 30235 2,7-N aphth a lenedisulfonic acid, 4- amino-3- [[4’-[(2,4-diaminophenyl) azo][1,1’- biphenyl]-4- yl]azo]-5-hydroxy-6- (phenylazo)-, disodium salt 2302–97–8 C.I. Direct R e d 44 22500 1-N aphth a lenesulfonic acid, 8,8’-[[1,1’- biphenyl]-4,4’-diylbis(azo)]bis[7-hydroxy-, disodium salt 2429–73–4 C.I. Direct Blue 2 22590 2,7-N aphth a lenedisulfonic acid, 5- amino-3- [[4’-[(7-amino-1-hydroxy-3-sulfo-2- naphthalenyl)azo][1,1’-biphenyl]-4-yl]azo]- 4- hydroxy-, trisodium salt 2429–79–0 C.I. Direct Orange 8 22130 Be n zoic aci d , 5-[[4’-[(1- a mino-4-sulfo-2- naphthalenyl) azo][1,1’-biphenyl]-4- yl]azo]-2- hydroxy-, disodium salt 2429–81–4 C.I. Direct Brown 31 35660 Benzoic acid, 5-[[4’-[[2,6-diamino-3-[[8- hydroxy-3,6-disulfo-7-[(4-sulfo-1- naphthalenyl)azo]-2- naphthalenyl]azo]-5- methylphenyl]azo][1,1’- biphenyl]-4-yl]azo]- 2-hydroxy-, tetrasodium salt 2429–82–5 C.I. Direct Brown 2 22311 Be n zoic aci d , 5-[[4’-[(7- a mino-1-hy d r oxy-3- sulfo-2-naphthalenyl) azo][1,1’-biphenyl]-4- yl]azo]-2- hydroxy-, disodium salt*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 70 of 72 2429–83–6 Direct Blac k 4 30245 2,7-N aphth a lenedisulfonic acid, 4- amino-3- [[4’-[(2,4-diamino-5-methylphenyl)azo][1,1’

- biphenyl]-4-yl]azo] -5-hydroxy-6- ( p hen y l a zo ) -, disodium s a lt 2429–84–7 C.I. Direct R e d 1 22310 Be n zoic aci d , 5-[[4’-[(2- a mino-8-hy d r oxy-6- sulfo-1-naphthalenyl)azo][1,1’-biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt 2586–58–5 C.I. Direct Brown 1:2 30110 Be n zoic aci d , 5-[[4’-[[2,6-di a mino-3- m ethyl5-[(4-sulfophenyl)azo]phenyl]azo][1,1’- biphenyl]-4- yl]azo]-2-hydroxy-, disodium 2602–46–2 C.I. Direct Blue 6 22610 2,7-N aphth a lenedisulfonic acid, 3,3’-[[1,1’- biphenyl]-4,4’-diylbis(azo)]bis[5- amino-4- hydroxy-, tetrasodium salt 2893–80–3 C.I. Direct Brown 6 30140 Benzoic acid, 5-[[4’-[[2,4-dihydroxy-3-[(4- sulfophenyl) azo]phenyl]azo][1,1’- biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt 3530–19–6 C.I. Direct R e d 37 22240 1,3-N aphth a lenedisulfonic acid, 8-[[4’-[(4- ethoxyphenyl) azo][1,1’-biphenyl]-4-yl]azo]-7-hydroxy-, disodium salt 3567–65–5 C.I. Acid R ed 85 22245 1,3-N aphth a lenedisulfonic acid, 7-hyd r oxy-8

- [[4’-[[4-[[(4-methylphenyl) sulfonyl]oxy]phenyl]azo][1,1’-biphenyl]-4- yl]azo]-, disodium salt 3626–28–6 C.I. Direct Gree n 1 30280 2,7-N aphth a lenedisulfonic acid, 4- amino-5- hydroxy-3-[[4’-[(4- hydroxyphenyl)azo][1,1’- biphenyl]-4- yl]azo]-6-(phenylazo)-, disodium salt 3811–71–0 C.I. Direct Brown 1 30045 Be n zoic aci d , 5-[[4’-[[2,4-di a mino-5-[(4- sulfophenyl) azo]phenyl]azo][1,1’ biphenyl]-4- yl]azo]-2-hydroxy-, disodium s a lt 4335–09–5 C.I. Direct Gree n 6 30295 2,7-N aphth a lenedisulfonic acid, 4- amino-5-hydroxy-6-[[4’-[(4- hydroxyphenyl)azo][1,1’- biphenyl]- 4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium s a lt 6358–80–1 C.I. Acid Blac k 94 30336 2,7-N aphth a lenedisulfonic acid, 4- amino-5- hydroxy-3-[[4’-[[4-hydroxy-2-[(2- methylphenyl)amino]phenyl]azo] [1,1’- biphenyl]-4-yl]azo]-6-[(4-sulfophenyl) azo]-, trisodium salt*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 71 of 72 6360–29–8 C.I. Direct Brown 27 31725 Benzoic acid, 5-[[4’-[[4-[(4-amino-7-sulfo-1- naphthalenyl)azo]-6-sulfo-1- naphthalenyl]azo][1,1’-biphenyl]-4-yl] azo]-2- hydroxy-, trisodium salt 6360–54–9 C.I. Direct Brown 154 30120 Benzoic acid, 5-[[4’-[[2,6-diamino-3-methyl5-[(4-sulfophenyl)azo]phenyl] azo][1,1’- biphenyl]-4- yl]azo]-2- hydroxy-3-methyl-, disodium salt 8014–91–3 C.I. Direct Brown 74 36300 Benzoic acid, 3,3’-[(3,7-disulfo-1,5- naphthalenediyl)bis [azo(6- hydroxy-3,1- phenylene)azo[6(or7)-sulfo-4,1- naphthalenediyl]azo[1,1’- biphenyl]-4,4’- diylazo]]bis[6- h y d r ox y - , hex a sodium s a lt 16071–86–6 C.I. Direct Brown 95 30145 Cupr a te(2-), [5-[[4’-[[2,6-dihy d r oxy-3-[(2- hydroxy-5-sulfophenyl)azo]phenyl] azo][1,1’- biphenyl]-4-yl]azo]-2-hydroxybenzoato(4-)]-, disodium salt 1572 1573 (2) The significant new uses are: 1574 (i) For each of the chemical substances lis ted in Table 2, any use other than use as a 1575 reagent to test for hydrogen peroxide in milk; a reagent to test for hydrogen sulfate, hydrogen 1576 cyanide, and nicotine; a stain in microscopy; a reagent for detecting blood; an analytical 1577 standard; and, additionally for Co lour Index (C.I.) Direct Red 28 (Congo Red) (CAS No. 573-58- 1578 0), an indicator dye. 1579 (ii) For the chemical substances listed in Table 1: Any use. 1580 1581 (b) Specific requirements . The provisions of subpart A of th is part apply to this section 1582 except as modified by this paragraph (b). 1583 (1) Revocation of certain notification exemptions. The provisions of § 721.45(f) do not 1584 apply to this section. A person who imports or processes a chemical s ubstance identified in 1585 paragraph (a)(1) of this secti on as part of an article for a significant new use described 1586 in paragraph (a)(2) of this section is not exempt from submitting a significant new use notice. 1587 (2) [Reserved] 1588*** EO12866/13563 Review – Do not Cite, Quote, or Release During the Review*** (RIN 2070-AJ73)

Page 72 of 72 5. Add § 721.10226 to subpart E to read as follows: 1589 § 721.10226 Di- n -pentyl phthalate (DnPP). 1590 (a) Chemical substance and significant new uses subject to reporting . (1) The chemical 1591 substance identified as di- n -pentyl phthalate (DnPP) (1,2-benz enedicarboxylic acid, 1,2-dipentyl 1592 ester) (CAS No. 131-18-0) is subj ect to reporting under this secti on for the significant new uses 1593 described in paragraph (a )(2) of this section. 1594 (2) The significant new use is: any use other than use as a chemical standard for 1595 analytical experiments

. 1596 (b) [Reserved] 1597 1598 6. Add § 721.10227 to subpart E to read as follows: 1599 § 721.10227 Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). 1600 (a) Chemical substance and significant new uses subject to reporting. (1) The chemical 1601 substance identified as alkanes, C 12-13 , chloro (CAS No. 71011-12-6 ) is subject to reporting 1602 under this section for the signif icant new uses described in para graph (a)(2) of this section. 1603 (2) The significant new use is: Any use. 1604 (b) Specific requirements . The provisions of subpart A of th is part apply to this section 1605 except as modified by this paragraph. 1606 (1) Persons who must report . § 721.5 applies to th is section except for 1607 § 721.5(a)(2). A person who inte nds to manufacture for comm ercial purposes a substance 1608 identified in paragraph (a)(1) of this section a nd intends to distribute the substance in commerce 1609 must submit a signifi cant new use notice. 1610 (2) [Reserved] 1611

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