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RIN 2070-AJ36 Page 1 of 50 Rin2070-AJ36_EO12866_3-Chemical-SNUR- NPRM_FRdocument_2011-06-24 1 EO 12866 REVIEW DRAFT – As submitted. 2 BILLING CODE 6560–50–P 3 ENVIRONMENTAL PRO TECTION AGENCY 4 40 CFR Part 721 5 EPA-HQ-OPPT-2010-0573; FRL-8865-2 6 RIN 2070–AJ36 7 Benzidine-Based Chemical Substances; Di- n -pentyl phthalate (DnPP); and Alkanes, C 12-13 , 8 Chloro; Proposed Significant New Use Rules 9 10 AGENCY: Environmental Protection Agency (EPA). 11 ACTION: Proposed rule. 12 SUMMARY: Under section 5(a)(2) of the Toxic Substances Control Act (TSCA), EPA is 13 proposing: to add nine benzidin e-based chemical substances to the Significant New Use Rule 14 (SNUR) at § 721.1660 on benzidine-based chemical substances; a SNUR for Di- n -pentyl 15 phthalate (DnPP) (1,2-Benzenedicarboxylic acid, 1,2-di pentyl ester) (CAS No. 131-18-0); and a 16 SNUR for Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). If fi nalized this rule would require 17 persons who intend to manufacture, import, orprocess these chemical substances for an activity 18 that is designated as a significant new use to notify EPA at least 90 days before commencing that 19 activity. In the case of the benz idine-based chemical substances, EPA is also proposing to make 20 inapplicable the exemption at § 721.45(f) relating to persons that import or process substances as 21 part of an article. If finalizedthis would require persons who intend to import or process all 22 listed benzidine-based chemical substances, i. e., the newly proposed nine benzidine-based 23 chemical substances as well as the currently list ed benzidine-based chemical substances, as part 24 of an article to notify EPA atleast 90 days before commenc ing that activity. The required 25 notification would provide EPA w ith the opportunity to evaluate activities associated with a 26*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 2 of 50 significant new use and an opportunity to protec t against potential unreas onable risks, if any, 27 from exposure to the chemical substance. 28 DATES: Comments must be recei ved on or before [ insert date [90] days after date of 29 publication in the Federal Register ]. 30 ADDRESSES: Submit your comments, identified by doc ket identification (ID) number EPA31 HQ-OPPT-2010 - 0573 by one of the following methods: 32

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line 33 instructions for submitting comments. 34

• Mail : Document Control Office (7407M), Offi ce of Pollution Prevention and Toxics 35 (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 36 20460-0001. 37

• Hand Delivery : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 38 1201 Constitution Ave., NW., Washington, DC. Atte ntion: Docket ID number EPA-HQ-OPPT39 2010 - 0573. The DCO is open from 8 a.m. to 4 p. m., Monday through Friday, excluding legal 40 holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only 41 accepted during the DCO’s normal hours of operati on, and special arrangements should be made 42 for deliveries of boxed information. 43

• Instructions : Direct your comments to docket ID number EPA-HQ-OPPT-2010 - 0573. 44 EPA's policy is that all comments received will be included in the docket without change and 45 may be made available on-line at http://www.regulations.gov , including any personal 46 information provided, unless the comment include s information claimed to be Confidential 47 Business Information (CBI) or other information whos e disclosure is restrict ed by statute. Do not 48 submit information that you consider to be CBI or otherwise protec ted through regulations.gov 49 or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA 50*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 3 of 50 will not know your identity or contact inform ation unless you provide it in the body of your 51 comment. If you send an e-mail comment directly to EPA without going through 52 regulations.gov, your e-mail address will be automati cally captured and included as part of the 53 comment that is placed in the docket and made available on the Internet. If you submit an 54 electronic comment, EPA recomme nds that you include your name and other contact information 55 in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read 56 your comment due to technical difficulties and cannot contact you for clarification, EPA may not 57 be able to consider your comment . Electronic files should avoid the use of special characters, 58 any form of encryption, and be fr ee of any defects or viruses. 59

• Docket : All documents in the docket are liste d in the docket index available at 60 http://www.regulations.gov . Although listed in the index, so me information is not publicly 61 available, e.g., CBI or other information whose disc losure is restricted by statute. Certain other 62 material, such as copyrighted material, will be publicly available only in hard copy. Publicly 63 available docket materials ar e available elect ronically at http://www.regulations.gov , or, if only 64 available in hard copy, at the OPPT Docket. Th e OPPT Docket is located in the EPA Docket 65 Center (EPA/DC) at Rm. 3334, EPA WestBldg., 1301 Constitution Ave., NW., Washington, 66 DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 67 through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading 68 Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. 69 Docket visitors are required to show photographic identification, pass through a metal detector , 70 and sign the EPA visitor log. All visitor bags are processe d through an X-ray machine and 71 subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in 72 the building and return ed upon departure. 73 FOR FURTHER INFORMATION CONTACT: For technical information contact: Sara 74*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 4 of 50 Kemme, National Program Chemicals Division (7404T), Envir onmental Protection Agency, 75 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 566-0511 76 e-mail address: sara.kemme@epa.gov

. 77 For general information contact : The TSCAHotline, ABVI-Goodwill, 422 South Clinton Ave., 78 Rochester, NY 14620; telephone numb er: (202) 554–1404; e-mail address: TSCA79 Hotline@epa.gov

. 80 SUPPLEMENTARY INFORMATION: 81 I. General Information 82 A. Does this Action Apply to Me? 83 These three different SNURs may apply to different entities. 84 1. Benzidine-based chemical substances. You may be potentially affected by this action 85 if you manufacture, import or process, including as part of an arti cle, any of the benzidine-based 86 chemical substances listed in Tables 1 and 2 of the regulatory text in this document. Potentially 87 affected entities may incl ude, but are not limited to: 88

• Manufacturers, importers, or processors of one or more of the subject chemical 89 substances. 90

• Entities which plan to use the listed chemi cal substances in conjunction with apparel 91 and other finished products made from fabrics, leather, and similar materials. 92

• Entities which plan to use the listed chemical substances in conjunction with paper 93 and allied products. 94

• Manufacturers, importers, or pr ocessors of the subject chemical substances in printing 95 inks. 96 These entities may include those desc ribed by the North Am erican Industrial 97 Classification System (NAICS) codes 325- chemi cal manufacturing, 313- te xtile manufacturers, 98*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 5 of 50 316 – leather and allied products manufacturers, 322- paper manufacturers, 4243- apparel, piece 99 goods, and notions wholesalers, or 4 43- clothing and accessories stores. 100 2. DnPP. For DnPP, you may be potentially affect ed by this action if you manufacture 101 (defined by statute to include import), or pro cess DnPP. Potentially affected entities may 102 include, but are not limited to: ch emical industry – plastic mate rial & resins (NAICS code 103 325211). 104 3. Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). You may be potentially affected by this 105 action if you manufacture, process, or import th e following short-chained chlorinated paraffin 106 (SCCP): alkanes, C 12-13 , chloro (CAS No. 71011-12-6). Potentia lly affected entities may include, 107 but are not limited to: Manufacturers (definedby statute to include importers) of SCCPs 108 (NAICS codes 325 and 325998), e.g., chemical manufacturing; including miscellaneous 109 chemical product and preparation manufacturing; and processors of SCCPs (NAICS codes 324 110 and 324191), e.g., petroleum lubricati ng oil and grease manufacturing. 111 This listing is not intended to be exhaustiv e, but rather provides a guide for readers 112 regarding entities likely to be aff ected by this action. Other types of entities not listed in this unit 113 could also be affected. The NAICS codes have been provided to assi st you and others in 114 determining whether this action might apply to certain entities. To determine whether you or 115 your business may be affected by this action, you should carefully examine the applicability 116 provisions in § 721.5 for SNUR-relate d obligations and withrespect to benzidine-based chemical 117 substances, the applicability provisions in Unit II.C. If you have any questions regarding the 118 applicability of this action to a particular entity, consult the tec hnical person listed under FOR 119 FURTHER INFORMATION CONTACT

. 120 This action may also affect certain entitie s through pre-existing import certification and 121 export notification rule s under TSCA. Persons who import any chemical substance governed by 122*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 6 of 50 a final SNUR are subject to the TSCA sec tion 13 (15 U.S.C. 2612) import certification 123 requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 124 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies 125 with all applicable rules and orders under TS CA, including any SNUR requirements. The EPA 126 policy in support of import certif ication appears at 40 CFR part 707, subpart B. In addition, any 127 persons who export or intend to e xport a chemical substance that is the subject of this proposed 128 rule on or after [ insert date 30 days after th e date of publication in the Federal Register ] are 129 subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see § 130 721.20), and must comply with the export notific ation requirements in 40 CFR part 707, subpart 131 D. 132 B. What Should I Consider as I Prepare My Comments for EPA? 133 1. Submitting CBI . Do not submit this information to EPA through regulations.gov or e134 mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI 135 information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD136 ROM as CBI and then identify electronically within the disk or CD-ROM the specific 137 information that is claimed as CBI. In additi on to one complete version of the comment that 138 includes information claimed as CBI, a copy of the comment that does not contain the 139 information claimed as CBI must be submitted for inclusion in the public docket. Information so 140 marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 141 2. Tips for preparing your comments . When submitting comments, remember to: 142 i. Identify the document by docket ID number and other identifying information (subject 143 heading, Federal Registerdate and page number). 144 ii. Follow directions. The Agency may ask you to respond to specific questions or 145 organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 146*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 7 of 50 iii. Explain why you agree or disagree; suggest alternatives and substitute language for 147 your requested changes. 148 iv. Describe any assumptions and provide a ny technical information and/or data that you 149 used. 150 v. If you estimate potential costs or burdens, explain how you arrived at your estimate in 151 sufficient detail to allow for it to be reproduced. 152 vi. Provide specific examples to illustrate your concerns and suggest alternatives. 153 vii. Explain your views as cl early as possible, avoiding the use of profanity or personal 154 threats. 155 viii. Make sure to submit your comments by the comment period deadline identified. 156 II. Background 157 A. What Action is the Agency Taking? 158 EPA is proposing to add nine chemical subs tances (see Table 1 in Unit III.A.) to the 159 existing SNUR for certain benzidine-based chemical substances at § 721.1660. That regulation 160 includes as significant new uses “a ny use other than as a reagent to test for hydrogen peroxide in 161 milk; a reagent to test for hydrogen sulfate, hydrogen cyanid e, and nicotine; a stain in 162 microscopy; a reagent for detecting blood; an an alytical standard; and also for Colour Index 163 (C.I.) Direct Red 28 (Congo Red, CAS No. 573-58- 0) as an indicator dye.” § 721.1660(a)(2). 164 For the nine newly-proposed be nzidine-based chemical subs tances, EPA is proposing to 165 designate any use as a significant new use. EPA requests comment on whether there are any 166 ongoing uses of these chemicals. 167 EPA is also proposing to amend the SNUR at § 721.1660 to make inapplicable the 168 exemption at § 721.45(f) for persons that import or process benzidine-based chemical substances 169 as part of an article. 170*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 8 of 50 Additionally, EPA is proposing a SNUR for DnPP that would designate, as a significant 171 new use, any use of the substance other than as a chemical standard for laboratory use. 172 EPA is also proposing a SNUR for alkanes, C 12-13 , chloro (CAS No. 71011-12-6) that 173 would designate any use of the substance as a si gnificant new use. Because any use of alkanes, 174 C 12-13 , chloro (CAS No. 71011-12-6) would be a new use, § 721.5(a)(2) would be inapplicable to 175 alkanes, C 12-13 , chloro (CAS No. 71011-12-6). 176 These proposed SNURs would re quire persons that manufactur e, process, or import any 177 of the chemicals for a significant new use, c onsistent with the requi rements at 40 CFR part 178 721.25, to notify EPA at least 90 days before comme ncing such manufacture, process, or import 179 of the chemical substance for a significant new use. For the benzidine-based chemical 180 substances, the proposed elimination of the arti cle exemption at § 721.45(f) would also require 181 persons to notify EPA at least 90 days before co mmencing processing or importing as part of an 182 article any of the currently-listed or newly-pr oposed benzidine-based ch emical substances. The 183 objectives and rationale for this prop osed SNUR are explained in Unit VI. 184 B. What is the Agency's Author ity for Taking this Action? 185 Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2 )) authorizes EPA to determine that a use 186 of a chemical substance is a "significant new use." EPA must make this determination by rule 187 after considering all rele vant factors, includi ng those listed in TSCA section 5(a)(2). These 188 factors include: 189 • The projected volume of manufacturing and processing of a ch emical substance. 190 • The extent to which a use changes the t ype or form of exposure of human beings 191 or the environment to a chemical substance. 192

• The extent to which a use increases the magnitude and duration of exposure of 193 human beings or the e nvironment to a chemical substance. 194*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 9 of 50 • The reasonably anticipated manner a nd methods of manufacturing, processing, 195 distribution in commerce, and disposal of a chemical substance. 196 Once EPA determines that a use of a chemi cal substance is a significant new use, TSCA 197 section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at 198 least 90 days before they manufacture, import, or process the chemical substance for that use (15 199 U.S.C. 2604(a)(1)(B)). The general SNUR provisions are found at 40 CFR part 721, subpart A. 200 C. Applicability of General Provisions 201 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 202 provisions describe persons subject to the rule , recordkeeping requirements, exemptions to 203 reporting requirements, and applicability of the rule to uses occurring before the effective date of 204 the final rule. 205 Provisions relating to user fees appearat 40 CFR part 700. According to § 721.1(c), 206 persons subject to SNURs must comply with the same notice requirements and EPA regulatory 207 procedures as submitters of Premanufacture Notic es (PMNs) under TSCA section 5(a)(1)(A). In 208 particular, these requirements include the in formation submissions requirements of TSCA 209 section 5(b) and 5(d)(1), the ex emptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and 210 (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a Significant New Use Notice 211 (SNUN), EPA may take regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the 212 activities on which it has received the SNUN. If EPA does nottake action, EPA is required under 213 TSCA section 5(g) to explain in the Federal Registerits reasons for not taking action. 214 However, § 721.45(f) (which generally ex empts persons importing or processing a 215 substance as part of anarticle) would not apply to benzidine-based chemi cal substances listed at 216 40 CFR 721.1660 and those added by this proposed rule. Therefore, a person who imports or 217 processes as part of an article a benzidine-based chemical subs tance that is covered by this 218*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 10 of 50 proposed rule would not be exempt from submitting a SNUN. 219 Persons who export or intend to export a ch emical substance identified in a proposed or 220 final SNUR are subject to th e export notification provisions of TSCA section 12(b). The 221 regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons 222 who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 223 import certification requirements, codifiedat 19 CFR 12.118 through 12.127; see also 19 CFR 224 127.28. Those persons must certify that the shipme nt of the chemical substance complies with 225 all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy 226 in support of import certification appear s at 40 CFR part 707, subpart B. 227 III. Overview of Benzidine-Ba sed Chemical Substances 228 A. What Additional Benzidine-Based Chemical Subs tances are Subject to this Proposed SNUR? 229 This proposed rule would add nine benzidine- based chemical substances to the list of 230 twenty four chemical substances currently regulated under § 721.1660. The nine benzidine-based 231 chemical substances covered by this proposed S NUR are listed in Table 1. The chemicals listed 232 in Table 1 are identified by Chemical Abstract Se rvice Registry Numbers (CAS number) or if the 233 chemical’s CAS number is claimed confidential business information (CBI), the chemical is 234 identified by an EPA Accession Number, al ong with its corresponding generic name. The 235 accession numbers are EPA assigned numbers used to identify chemicals in place of confidential 236 CAS numbers. Table 1 also indicates the availability of the Col our Index (C.I.) name and C.I. 237 number, which is either not available or CBI for some of the chemicals subject to this rule. 238 Persons who are interested in determining the pr ecise identity of the chemical designated by a 239 certain accession number and a generic name should submit a bonafide request to EPA that 240 complies with the information requi rements stipulated in § 721.11(b). 241 Table 1—Benzidine-Based Chemical Substances 242*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 11 of 50

CAS number C.I. name C.I. number Chemical name 117-33-9 Not available Not available 1,3- Naphthalenedisulfonic acid, 7-hydroxy8-[2-[4'-[2-(4-hydroxyp henyl)diazenyl][1,1'- biphenyl]-4-yl]diazenyl]- 65150-87-0 Not available Not available 1,3,6-Naphthalenetrisulfonic 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 Navy BH Not available 2,7-Naphthalenedisulfonic 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 available Not available 2,7- Naphthalenedisulfonic 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. 26267 CAS No. CBI (NA) CBI CBI 4-(Substituted phenyl)azo biphenylyl azo - substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (Generic Name) Accession No. 24921 CAS No. CBI (NA) CBI CBI 4-(Substituted naphthalenyl )azo diphenylyl azo-substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (Generic Name) Accession No. 26256 CAS No. CBI (NA) CBI CBI 4-(Substituted phenyl)azo biphenylyl azosubstituted carbopolycycloazo benzenesulfonic acid, sodium salt. (Generic Name) 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. 26701 CAS No. CBI (NA) CBI CBI Phenylazoami nohydroxynaphthalenylazobip henylazo substituted benzene sodium sulfonate. (Generic Name) 243 B. What Action has the Agency Previously Taken on Other Benzidine-Based Chemical 244 Substances? 245 In 1996, EPA promulgated a TSCA section 5(a)(2) SNUR for the benzidine-based 246 chemical substances listed at § 721.1660 (61 FR 52287, October 7, 1996). That rule considered 247*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 12 of 50 any use of the chemical substances except thos e listed in § 721.1660(a)(2 ) as a significant new 248 use that requires a SNUN to be submitted to the Agency prior to manufacture, import, or 249 processing of the listed chemical substances. Because they were id entified as ongoing, the 250 SNUR excluded as significant new uses the following uses: As a reagent to test for hydrogen 251 peroxide in milk; a reagent to te st for hydrogen sulfate, hydrogen cy anide, and nicotine; a stain in 252 microscopy; as a reagent for detecting blood; and as an analytical standard. In addition, for 253 Color Index (C.I.) Direct Red 28 (Congo Red) (C AS No. 573-58-0), use as an indicator dye was 254 excluded as a significant new use. The S NUR did not require a SNUN to be submitted by 255 persons that import or process a listed substance as part of an article. 256 C. What is the Production Volume of Newl y-Proposed and Currently-Listed Chemical 257 Substances? 258 For the newly proposed nine benzidine-base d chemical substances, data reported to EPA for 259 the 2006, 2002 and 1998 reporting cycles, as requir ed by the TSCA Inventory Update Reporting 260 (IUR) rule, indicate no evidence of production (i ncluding import). The IU R regulation requires 261 manufacturers and importers of certain chemical substances to report site and manufacturing 262 information for chemicals manufactured (inc luding imported) in amounts of 25,000 pounds or 263 greater at a single site (prior to 2006, reporting was for 10,000 pounds at a site). 264 In addition, four of these benzidine-based chemicals were included in EPA’s Benzidine265 based Dyes Action Plan. The addi tional five chemicals were found in the confidential TSCA 266 inventory. Designed as a part of a comprehensive approach to enhancing EPA’s Chemical 267 Management Program, Action Plans summarize h azard, exposure, and use information; outline 268 the potential risks that each chemical may pose; and identify the specific steps the Agency is 269 considering to address th ose concerns (Ref. 1). 270*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 13 of 50 EPA received no public comme nts (EPA-HQ-OPPT-2010-0570 at 271 http://www.regulations.gov ) on this Action Plan that woul d provide any indication of ongoing 272 manufacturing, importing, or processing of any of the nine benzidine-based chemical substances 273 that are proposed for addition to the exis ting SNUR at § 721.1660. Finally, a general market 274 review on these chemical substances indicates no current manufacture (Ref. 2) within or outside 275 the United States. 276 For the benzidine-based chemical substances currently listed at§ 721.1660, data reported 277 to EPA for the 2006, 2002 and 1998 reporting cycles , as required by the TSCA IUR rule, 278 indicate no evidence of domestic production (i ncluding import) at IUR reportable levels. 279 Further, EPA’s general market review on the currently listed benzidine-based chemical 280 substances suggests that the ma jority of these chemical subs tances are not currently being 281 manufactured domestically or ab road (Ref. 2). Although some of these substances appear to be 282 manufactured for allowable uses within the Unite d States at a level be low current IUR reporting 283 thresholds, and some substances appear to be manufactured outside the United States generally 284 and may therefore potentially be imported as part of an article, EPA does not have information to 285 suggest that the substances are being imported, for use as part of articles. In fact, the market 286 review did not find evidence of any import of articles containing benzidine-based chemical 287 substances. 288 D. What are the Uses of These Benz idine-Based Chemical Substances? 289 Historically, the benzidine-based chemical substances currently -listed at § 721.1660 were 290 used as reagents, biological stai ns in laboratories, and in food industries. Note that TSCA 291 section 3(2)(B)(vi) excludes foods, food additives, drugs, cosmetics or devices (as defined in the 292 Federal Food, Drug, and Cosmetic Act) from the statutory definition of a “chemical substance” 293 when such substances are manufactured, processe d, or distributed in commerce for use as a food, 294*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 14 of 50 food additive, drug, cosmetic, or device. Additiona lly, these previously listed bezidine-based 295 substances are believed to ha ve been historically used as dyes in the textile industry. 296 The nine newly-proposed benzidine-based chemi cal substances are believed to have been 297 used in the past in the production of textiles, paints, printing inks paper, and pharmaceuticals. 298 However, based on market information and the fact that the 2006 IUR ha d no production reports 299 for the any of the benzidine-based chemical substa nces, if these chemical substances are used at 300 all, they are likely used in small volumes, maki ng it difficult to access cu rrent production and use 301 information. 302 E. What are the Potential Health Effects of These Chemicals? 303 The 1980 EPA Preliminary Risk Assessment on de rivatives of benzidine established that 304 the primary hazard concern was for the carcinogenic effects to humans from exposure to specific 305 metabolites of the chemical substances (Ref. 3). There is potential for benzidine-based chemical 306 substances to metabolize to the parent benzidin e molecule, which is a known carcinogen (Refs. 307 4, 5, and 6). This metabolism occurs in humans by an enzyme-mediated reaction. These enzymes 308 are found in the liver, in gut bact eria, and in skin bacteria. The re sult of this enzymatically-aided 309 reduction is the release of the car cinogenic aromatic amine from the chemical substance. Studies 310 have demonstrated that the reduction of benzid ine-based chemical substances occurs in the 311 human body as well as on the skin (Ref. 7). Ther efore, the primary human health concern for 312 consumers is exposure to the benzidine-based ch emical substances through oral, dermal, or 313 inhalation routes. Evidence from an imal studies suggests that there is early life susceptibility to 314 benzidine carcinogenesis (Ref. 8). Cancer poten cy for benzidine was substantially increased 315 when the dose was given in early life as compared to adults (Ref. 8). For additional information 316

see Benzidine-Based Chemical Substances; Sign ificant New Uses of Certain Chemical 317 Substances; Final Rule (61 FR 52287, October 7, 1996). 318*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 15 of 50 F. What are the Potential R outes and Sources of Exposures to These Chemicals? 319 There are benzidine related exposure concerns as a result of the use of benzidine and 320 benzidine-based chemical substances. In 1996, EP A identified inhalation, skin absorption, and 321 ingestion as possible routes of exposure in a variety of settings where benzidine-based chemical 322 substances are either manufactured or us ed (61 FR 52287, October 7, 1996). Although EPA 323 estimated that the highest exposure would be to workers who were involved in dye 324 manufacturing, EPA determined that it was necessary to apply the SNUR to any use of the listed 325 benzidine-based chemical substances, with the exception of the limited uses mentioned in Unit 326 II.A. EPA listed all the benzidine-based chemical substances that it was able to identify on the 327 TSCA Inventory at that time. Since then, EPA ha s identified the nine additional benzidine-based 328 chemical substances listed as part of Table 1 and has similar concerns about potential consumer 329 and worker exposure to these substances. 330 Dermal exposure can occur from the leaching of the chemical substances by sweat in 331 contact with the dyed textiles (R ef. 7). Dermal exposure is also a concern since many of these 332 chemical substances can be directly absorbed by the skin to some extent. It is well established 333 that the enzymatically-aided dye reduction to th e carcinogenic benzidine unit occurs internally in 334 the liver and the gut (Refs. 9 a nd 10). Studies have shown that so me human skin bacteria possess 335 azo-reductases, the enzymes necessary to break down the benzidine-based chemical substances 336 to release the carcinogenic amines, which can be more readily absorbed (Ref. 11). 337 Consistent with the information on dermal absorption that EPA reviewed in developing 338 its recent Benzidine-based Chemical Substa nces Action Plan (E PA-HQ-OPPT-2010-0570 at 339 www.regulations.gov ), EPA identified the following main routes of consumer exposure to 340 benzidine-based chemical substances that are of concern: (1) Dermal absorption, the primary 341 route from wearing dyed clothing or footwear; (2) oral ingestion, an additional route for babies 342*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 16 of 50 and young children who suck on clothing, blanke ts, and other non-food products which might 343 contain any of the benzidine-base chemical substances; (3) inhalation exposure, a more prevalent 344 route in occupational settings; however, it can also occur from the use of dyed inks during "air 345 brushing" or from off-gassing from the dyed carpe ts to indoor air; and (4) contact with the 346 benzidine-based chemical substances entering th e environment, through the whole life cycle of 347 benzidine-based chemical substanc es in textiles (Ref. 12). 348 IV. Overview of DnPP 349 A. What Chemical is Incl uded in the Proposed SNUR? 350 This proposed SNUR would apply to DnPP (1,2-Benzenedicarboxylic acid, 1,2-dipentyl 351 ester), CAS No. 131-18-0, an ortho-phthalate (or phthalate ester). 352 B. What is the Production Volume of DnPP? 353 No IUR production volume data were reported for DnPP during the 2006, 2002, 1998, 354 and 1994 reporting cycles (Ref. 13) . The last reporting of DnPP production to the IUR occurred 355 in 1990 and corresponds to the lowest reportable production volume range (10,000 to 500,000 356 pounds) (Ref. 13). 357 DnPP was included in EPA’s Phthalates Ac tion Plan. As stated in Unit III.C., the 358 chemical action plans were designed as a part of a comprehensive approach to enhancing EPA’s 359 Chemical Management Program. These action pl ans summarize available hazard, exposure, and 360 use information; outline the risks that each chemi cal may present; and identify the specific steps 361 the Agency is considering to address those concerns. EPA received no public comments 362 submitted to the public docket for this Action Plan (EPA-HQ-OPPT-2010-0342 at 363 http://www.regulations.gov ) that would provide any i ndication of ongoi ng manufacturing, 364 importing or processing of DnPP (Ref. 14). Howeve r, subsequent internet queries performed by 365 EPA identified several companies that either us e or sell DnPP as a chemical standard for 366*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 17 of 50 laboratory use. As a result, EPA is proposing a SNUR for DnPP, excluding use of the substance 367 as a chemical standard for laboratory use. 368 C. What are the Uses of DnPP? 369 DnPP belongs to a broad category of chemi cals commonly referred to as phthalates. 370 Although a number of phthalates are in comm on use, EPA believes th e individual phthalate 371 DnPP is not in general use in the United States, and only has a limited application as a chemical 372 standard for laboratory use. As a chemical categor y, the major use of phthalates is as plasticizers 373 (Refs. 15-23) especially in pol yvinyl chloride (PVC) products, wh ere they are added to impart 374 flexibility and other desirable properties. Phthal ate-containing PVC products include a variety of 375 industrial and commercial products, as well as specialized medical and dental applications. The 376 particular phthalate or combin ation of phthalates used in a specific product’s formulation 377 depends on the properties the phthalates impart, as well as their cost. 378 D. What are the Potential Health and Environmental Effects of DnPP? 379 1. Human health effects. Exposures of some phthalates in animal studies resulted in 380 phthalate syndrome effects, which consist of changes in the fetal development of the 381 reproductive system (Refs. 15-22 and 24-35). The pht halates that are the most potent at causing 382 phthalate syndrome effects are ge nerally those with linear ester side chains having 4-6 carbons 383 (Ref. 24). DnPP has a linear carbon chain length of 5 carbons. Of the phthalates studied, DnPP is 384 the most potent in producing testicular toxi city in pubertal animals (Ref. 24). 385 Developmental oral exposure s in rats to DnPP showed in creased resorptions, increased 386 fetal mortality, and decreased fetal testicular testosterone production (Refs. 36 and 37); and 387 reduced anogenital distance in male rat offsprin g (Ref. 38). Effects noted in adult mice exposed 388 to DnPP include decreased body weight; increase d liver weights; decr eased kidney weights; 389 decreases in the weights of the epididymis, cauda epididymis, testes, and seminal vesicles; 390*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 18 of 50 complete absence of detectable sperm; shorter average estrous cycle length in females; and 391 decreased fertility (Refs. 39 and 40). Gross a nd microscopic evidence of degenerative changes 392 have been observed in the testes and epididym is (including testicular atrophy, interstitial cell 393 hyperplasia, degeneration of the se miniferous tubules, and accumul ation of fluid and degenerated 394 cells in the epididymis) of rodents (Refs. 39 a nd 40). There are no subchronic or chronic animal 395 studies of DnPP exposure th rough any exposure route. 396 There are no known human studies of expos ure to DnPP. However, due to the data 397 discussed in this section and Dn PP’s general structure and categorization as a phthalate, EPA is 398 concerned that human health effects of DnPP expo sure may be similar to that observed for some 399 other phthalates. Several human studies have reported associati ons of exposure of some other 400 phthalates with adverse reproductive outcomes and developmental effects si milar to those in the 401 rat, although no causal link ha s been established (Refs. 24 and 41-50). The reproductive 402 developmental effects of some phthalates obs erved in humans include shortened anogenital 403 distance observed in newborn boys, shortened pr egnancy, lower sex and thyroid hormones, and 404 reduced sperm quality in adults; however, some studies failed to show these effects (Ref. 42). 405 Since the pathway for sexual differentiation in the fetus is highly conserved in all mammals, the 406 reproductive and developmental effects observed in the rat studies are potentially relevant to 407 humans. 408 Studies in animals evaluating the cumulativ e effects of combinations of phthalates on 409 testosterone fetal mortality, and male and fema le reproductive development later in life have 410 demonstrated all mixtures were cumulative for all endpoints (Ref s. 36-37 and 51-55). The 411 reproductive effects of DnPP observed in animal studies, the reproducti ve effects of other 412 phthalates observed in humans, and the data on th e cumulative effects of mi xtures of phthalates, 413 support EPA’s concern for potential human h ealth hazards following exposure to DnPP. 414*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 19 of 50 2. Environmental effects. EPA does not know of any studies of the environmental 415 effects of DnPP. Due to the general structure of DnPP, its behavior in an aquatic environment 416 similar to the close analog mono 2- ethylhexyl phthalate, its log K ow, and water solubility 417 measurements, and its categorization as a phthalate, EPA is concerned that the environmental 418 effects of DnPP may be similar to those of other phthalates studied. Other phthalates studied 419 have been shown to have biolog ical effects in all st udied animal groups and have been observed 420 at environmentally relevant exposures in th e nanogram/liter to microgram/liter range. The 421 combination of the inherent toxicity, variable solubility, log of the octanol-water coefficient 422 values, and bioconcentration fact or (BCF) values among the studiedphthalates el icit both acute 423 and chronic toxicity to aquatic and terrestrial wildlife by targeting thyroid function, liver 424 function, reproduction, and other physiological mechanisms (Refs. 31-35, 56 and 57). 425 E. What are the Potential Routes and Sources of Exposure to DnPP? 426 1. Human exposure. Data from the National Health and Nutrition Examination Survey 427 (NHANES) indicates widespread ex posure of the general population to various phthalates (Ref. 428 58). Phthalates are used in a wide array of plastic products and may be released into the 429 environment during use and disposal of these products (Ref. 58). Bi omonitoring data from 430 amniotic fluid and urine have demonstrated th at humans are exposed to various phthalates in 431

utero , as infants, during puberty, and in adult lif e; and that people are exposed to several 432 phthalates at once. The urinary metabolites of DnPP were not specifically included in the 4 th 433 National Report on Human Exposure to Environm ental Chemicals (2010), so EPA cannot draw 434 conclusions as to the current exposure of the ge neral population in the Un ited States to DnPP. 435 2. Environmental exposure. Due to phthalates pervasive use and release, as well as their 436 propensity for global transport, various phthalate s may be found in most environmental media, 437 including ambient air, surface water, soil, and sediment (Refs. 25-32 and 34-35). Fish and other 438*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 20 of 50 aquatic organisms, as well as terrestrial an imals have evidenced exposure to a common 439 phthalate: di-(2-ethylhexyl) phtha late (DEHP) (Refs. 34 and 57). EPA does not have available 440 data on environmental exposures to DnPP. 441 V. Overview of Alkanes, C 12-13 , Chloro (CAS No. 71011-12-6) 442 A. What Chemical is Included in the Proposed SNUR? 443 This proposed SNUR would cover alkanes, C 12-13 , chloro (CAS No. 71011-12-6), one 444 type of short-chain chlorinated para ffin (SCCP). This consists of C 12 and C 13 alkanes with 445 varying degrees of chlorination. 446 B. What is the Production Volume of Alkanes, C12-13 , chloro (CAS No. 71011-12-6)? 447 No production volumes for alkanes, C 12-13 chloro (CAS No. 71011- 12-6) were reported to 448 the IUR during the 2006, 2002, 1998 and 1994 reporting cycles, and EPA found no additional 449 evidence of any importation or manufacturing of the chemical. 450 Alkanes, C 12-13 , chloro (CAS No. 71011-12- 6) was included in EPA’s Short-Chain 451 Chlorinated Paraffins (SCCPs) and Other Chlorinated Paraffins Action Plan (Ref. 59) . As stated in 452 Unit III.C., the chemical action plans were design ed as a part of a comprehensive approach to 453 enhancing EPA’s Chemical Management Progr am. These action plans summarize available 454 hazard, exposure, and use information; outline th e risks that each chemical may present; and 455 identify the specific steps the Agency is consid ering to address those concerns. EPA received no 456 public comments submitted to the public doc ket for this Action Plan (EPA-HQ-OPPT-2010- 457 0334 at http://www.regulations.gov ) that would provide any indication of ongoing 458 manufacturing, importing or processing of Alkanes, C 12-13 , chloro (CAS No. 71011-12-6) (Ref. 459 59). 460 C. What Were the Uses of this SCCP? 461 Alkanes, C 12-13 , chloro (CAS No. 71011-12-6) is an individual chemical substance that 462*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 21 of 50 belongs to a category of chemicals referred to as short-chain chlorina ted paraffins (SCCPs). 463 There are many different chemical substances that are members of the SCCP category. 464 Generally these SCCPs have between 10 a nd 13 carbon atoms and contain 40 – 70 percent 465 chlorine by weight. Of the diffe rent SCCPs that are listed on the TSCA Inventory, EPA believes 466 the SCCP named “Alkanes, C 12-13 , chloro (CAS No. 71011-12-6)” is not in use in the United 467 States and EPA has found no inform ation that indicates it has ever been used. All of the data 468 discussed in this section associated with th e SCCPs general category would pertain to any 469 individual member of that category, including alkanes, C 12-13 , chloro (CAS No. 71011-12-6). 470 D. What are the Potential Environmental Effects of Alkanes, C12-13 , chloro (CAS No. 71011-12- 471 6)? 472 The primary concern for SCCPs is ecotoxi city. There are data specifically on the 473 ecotoxicity of alkanes, C 12-13 , chloro (CAS No. 71011-12-6). Alkanes, C 12-13 , chloro (CAS No. 474 71011-12-6) are highly toxic to aq uatic invertebrates following acute and chronic exposures. In 475 fish, this high toxicity is associated with chronic exposures, but not for acute exposures. For 476 aquatic plants, there is high toxicity associatedwith both acute and chronic exposures to SCCPs 477 in general (Ref. 60). 478 Both Health Canada and Environment Ca nada have characteri zed all chlorinated 479 paraffins (short chain chlorinated paraffins, medium chain chlo rinated paraffins, and long chain 480 chlorinated paraffins), which include the chemi cal substance covered by this proposed rule, as 481 “toxic” under the Canadian Environmental Protec tion Act (CEPA) (Ref. 61). Their assessment 482 found that these SCCPs have or may have an immediate or long term harmful effect on the 483 environment or its biological dive rsity; and that they are persiste nt, bioaccumulative, inherently 484 toxic and present in the environment primarily as a result of human activity (Ref. 61). 485 E. What are the Potential Routes and Sources of Exposure to Alkanes, C 12-13 , Chloro (CAS No. 486*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 22 of 50 71011-12-6)? 487 The mechanisms or pathways by whic h the SCCPs, including alkanes, C 12-13 , chloro 488 (CAS No. 71011-12-6), move into and through the environment and humans are not fully 489 understood, but are likely to include releases from manufacturing of the chemicals, 490 manufacturing of products like plastics or textil es, aging and wear of products like sofas and 491 electronics, and releases atthe end of product life (e.g., disposal, recycling). 492 EPA has concerns regarding the environmenta l fate and the exposure pathways that lead 493 to any SCCP presence, including C12 and C13 SCCPs (for example, Alkanes, C 12-13 , Chloro 494 (CAS No. 71011-12-6)), in a vari ety of biota, including freshw ater aquatic species, marine 495 mammals, and avian and terrestrial wildlife (R ef. 60). In addition, SCCPs, including C12 and 496 C13 SCCPs, have been detected in samples of human breast milk from Canada and the United 497 Kingdom, as well as in a variety of food items from Japan and various regions of Europe (Ref. 498 60). SCCPs are routinely found in soil and sediment samples. EPA also has concerns about the 499 persistence, bioaccumulation, and toxi city (PBT) of SCCPs (Ref. 60). 500 VI. Rationale and Objectives 501 A. Rationale 502 Consistent with EPA’s past practice for issuing SNURs under TS CA Section 5(a)(2), 503 EPA’s decision to propose a SNUR for a particul ar chemical use need not be based on an 504 extensive evaluation of the hazard, exposure, or potential risk asso ciated with that use. Rather, 505 the Agency’s action is based on EPA’s determinati on that if the use begins or resumes, it may 506 present a risk that EPA should evaluate under TS CA before the manufacturing or processing for 507 that use begins. Since the new use does not curren tly exist, deferring a deta iled consideration of 508 potential risks or hazards related to that use is an effective us e of resources. If a person decides 509 to begin manufacturing or processing the chemical for the use, the notice to EPA allows EPA to 510*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 23 of 50 evaluate the use according to the specific parameters and circumstances surrounding that 511 intended use. 512 1. Benzidine-based Chemical Substances. As summarized in Unit III, EPA is concerned 513 about potential carcinogenic effects on workers and consum ers from the manufacture, 514 processing, importing, or use of these substances . Consumers exposed via dermal exposure to 515 consumer products containing the benzidine-based chemical substances are a particular concern 516 because enzymes present in the human body and in bacteria on the skin aid in the reduction of 517 these chemical substances to th e benzidine unit, an establishe d human carcinogen (Ref. 8). The 518 main consumer products that could result in dermal exposure if containing these chemical 519 substances include textiles and leather products because they are in prolonged contact with 520 human skin. 521 During the review of information on be nzidine-based chemical substances, EPA 522 determined that the newly identified chemical substances covered by this proposed rule present 523 the same concerns (Ref. 1) as those of the benz idine-based chemical substances currently listed 524 under § 721.1660. However, based on a review of IU R data and a separate market review, EPA 525 does not believe there is any cu rrent manufacture of these ni ne benzidine-based chemical 526 substances within or outsid e the United States. 527 In addition, as discussed earlier , although some of the curre ntly listed be nzidine-based 528 chemical substances may be manufactured or processed outside the United States, EPA does not 529 have specific information that suggests they are entering into the United States in imported 530 articles (Ref. 4). In fact, an analysis of the be nzidine-based chemical substances market (Ref. 2) 531 revealed no information indicating import of articles containing benzidine-based chemical 532 substances for non-excluded purposes. Supporting a conclusion that there is no import of textile 533 articles containing benzidine-ba sed chemical substances, the American Apparel and Footwear 534*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 24 of 50 Association, the national trade association re presenting apparel, footwear, and other sewn 535 products companies and their suppliers, which co mpete in the global market, includes benzidine 536 on its Restricted Substances List (RSL) (Ref. 62). The RSL is a compilation of chemicals, 537 regulated or banned, that are used by apparel and footwear industries. 538 Although it appears there is no ongoing manuf acture of the nine newly proposed 539 benzidine-based chemical substances, or import for a non-excluded use of articles containing any 540 benzidine-based chemical substances, the manufacture (including import) or processing of the 541 nine newly proposed benzidine-based chemical substances and the import or processing of 542 articles containing any benzidine-based chemical substances may begin at any time, without 543 prior notice to EPA. Thus, EPA is concerned that commencement of the manufacture, import or 544 processing for any new uses, including resumption of past uses, of benzidine-based chemical 545 substances could significantly in crease the magnitude and duration of exposure to humans over 546 that which would otherwise exist currently. EPA is concerned that such an increase should not 547 occur without an opportunity to ev aluate activities associated witha significant new use and an 548 opportunity to protect agai nst potential unreasonable risks, if any, from exposure to the chemical 549 substance. 550 Therefore, EPA is proposing a SNUR for the nine benzidine-based chemical substances 551 by adding them to those curren tly listed at 40 CFR § 721.1660, and to make inapplicable the 552 article exemption at 40 CFR § 721. 45(f) for those chemical substa nces newly proposed in this 553 rulemaking as well as for those already listed at 40 CFR § 721.1660. If finalized, a person who 554 intends to manufacture (includi ng import) or process any of the benzidine-based chemical 555 substances for a non-excluded use, or to import or process any listed benzidine-based chemical 556 substance for a non-excluded use, would be required to submit a SNUN. 557*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 25 of 50 2. DnPP. As summarized in Unit IV., EPA has concerns regarding potential adverse 558 human health and environmental effects that may be caused by DnPP. EPA has direct 559 information from animal studies that DnPP sp ecifically can elicit developmental/reproductive 560 effects that are relevant to human health and also indicate potential effects in wildlife. EPA also 561 is concerned that due to its ge neral structure and categorization as a phthalate that DnPP may 562 elicit adverse environmental effects similar to those described for other phthalates. EPA is 563 concerned that any manufacturing (including import) or processi ng of DnPP, beyond that for its 564 limited ongoing use as a chemical standard for la boratory use, could sign ificantly increase the 565 magnitude and duration of exposure to humans overthat which would otherwise exist currently. 566 EPA is concerned that such an increase shoul d not occur without an opportunity to evaluate 567 activities associated with a significant new use and an opportunity to pr otect against potential 568 unreasonable risks, if any, from exposure to the chemical substance. Therefore, EPA is 569 proposing a SNUR for DnPP that would designate, as a significant new use, any use of the 570 chemical substance other than as a chemical stan dard for laboratory use. If finalized, a person 571 who intends to manufacture, import or process Dn PP for use other than as a chemical standard 572 for laboratory use would be required to submit a SNUN. 573 3. Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). The mechanisms or pathways by 574 which the SCCPs, including alkanes, C 12-13 , chloro (CAS No. 71011-12-6), move into and 575 through the environment and humans are not fully understood, but are likely to include releases 576 from manufacturing of the chemi cals, manufacturing of products like plastics or textiles, aging 577 and wear of products like sofas and electronics, and releases at the end of product life (e.g., 578 disposal, recycling). 579 EPA believes that all manufacture, proce ssing, and import into the United States of 580 alkanes, C 12-13 , chloro (CAS No. 71011-12-6) has ceased. Given EPA has no evidence to 581*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 26 of 50 suggest that there is any manuf acture, processing, or importation of this chemical substance in 582 the United States, and taking into considera tion the negative comme rcial and regulatory 583 environment associated with this chemical inte rnationally (including th e EU and Canadian ban 584 on marketing) and use of the alkanes, C 12-13 , chloro (CAS No. 71011-12-6) domestically, EPA 585 does not expect to find such activity. However, EPA is concerned that commencement of the 586 manufacture, import or processing for any new us es, including resumption of past uses, could 587 significantly increase the magnitude and duration of exposure to humans over that which would 588 otherwise exist. EPA is concerne d that such an incr ease should not occur w ithout an opportunity 589 to evaluate activities associated with a significa nt new use and an opportunity to protect against 590 potential unreasonable risks, if any, from exposure to the chemical substance. Therefore, EPA is 591 proposing a SNUR for alkanes, C 12-13 , chloro (CAS No. 71011-12-6) that would designate as a 592 significant new use any use of the chemical subs tance. If finalized, a person who intends to 593 manufacture, import or process alkanes, C 12-13 , chloro (CAS No. 71011-12-6) for any use would 594 be required to submit a SNUN. 595 EPA is requesting comment on whether any of the significant new uses identified are 596 currently ongoing. However, if EPA determines , based on comments on this proposed rule or on 597 other information the Agency id entifies, that any proposed sign ificant new use of any of the 598 chemical substances has been ongoing (includin g, in the case of benzidine-based chemical 599 substances, that an article containing benzidin e-based chemical substances was being imported 600 or processed) prior to date of publication of the final rule, EP A would exclude such ongoing uses 601 from the final SNUR and consider pursui ng other regulatory acti on, as appropriate. 602 B. Objectives 603 Based on the considerations in Unit VI .A.1-3, EPA wants to achieve the following 604 objectives with regard to the significant new us e(s) that are designated in this proposed rule: 605*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 27 of 50 1. EPA would receive notice of any person’ s intent to manufacture or process the 606 specified chemicals for the described significan t new uses before that activity begins; 607 2. EPA would have an opportunity to review and evaluate data submitted in a 608 SNUN before the notice submitter begins manufactu ring or processing of the specified chemicals 609 for the described significant new use; and 610 3. EPA would be able to regulate prospective uses of the specified chemicals before the 611 described significant new uses o ccur, provided that regulation is warranted pursuant to TSCA 612 sections 5(e), 5(f), 6 or 7. 613 VII. Significant New Use Determination 614 Section 5(a)(2) of TSCA states that EPA' s determination that a use of a chemical 615 substance is a significant new us e must be made after consider ation of all relevant factors 616 including: 617 • The projected volume of manufacturing and processing of a ch emical substance. 618 • The extent to which a use changes the type or form of exposure of human beings or the 619 environment to a chemical substance. 620

• The extent to which a use increases the ma gnitude and duration of exposure of human 621 beings or the environment to a chemical substance. 622 • The reasonably anticipated manner a nd methods of manufacturing, processing, 623 distribution in commerce, and dispos al of a chemical substance. 624 In addition to these factors enumerated in TS CA section 5(a)(2), the statute authorizes 625 EPA to consider any othe r relevant factors. 626 To determine what would constitute a significant new use of the benzidine-based 627 chemical substances subject to this proposed rule, DnPP and the alkanes, C 12-13 , chloro (CAS No. 628 71011-12-6), as discussed herein, EPA considered relevant information about the toxicity of 629*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 28 of 50 these substances, likely human exposures and en vironmental releases as sociated with possible 630 uses, and the four factors listed in section 5(a)(2) of TSCA. EPA has preliminarily determined 631 that the manufacture, import, processing, or import or processing as part of an article of any of 632 the benzidine-based chemical substances subj ect to this proposed rule, except ongoing uses 633 specified in § 721.1660(a)(2)(i) of th e regulatory text in this docume nt, is a significant new use. 634 EPA has also preliminarily determined that the manufacture, import, or processing of DnPP for 635 any use other than as a chemical standard for laboratory use is a significant new use, and the 636 manufacture, processing, or import of alkanes, C 12-13 , chloro (CAS No. 71011-12-6) for any use 637 is a significant new use. 638 VIII. Request for Public Comment 639 EPA welcomes comments on any aspect of th is proposed SNUR. Information available 640 about environmental effects, health eff ects, and exposure would be beneficial. EPA is also 641 requesting public comment on whether there are a ny ongoing uses of any of these chemicals for 642 the proposed significant new uses, and would welc ome specific information that documents such 643

uses. 644 IX. Alternatives 645 Before proposing these SNURs, EPA consid ered the following alternative regulatory 646 actions: 647 A. Promulgate a TSCA Section 8(a) Reporting Rule 648 Under a TSCA section 8(a) rule, EPA c ould, among other things, generally require 649 persons to report information to the Agency when they intend to manufactur e, import, or process 650 a listed chemical for a specific use or any use. However, for the chemical substances subject to 651 this proposed rule, the use of TS CA section 8(a) rather than S NUR authority would have several 652 limitations. First, if EPA were to require re porting under TSCA section 8(a) instead of TSCA 653*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 29 of 50 section 5(a), EPA would not have the opportunity to review human and environmental hazards 654 and exposures associated with the proposed significant new use and, if necessary, take 655 immediate follow-up regulatory action under TSCA sec tions 5(e) or 5(f) to prohibit or limit the 656 activity before it begins. In addition, EPA may not receive important information from small 657 businesses, because such firms generally ar e exempt from TSCA section 8(a) reporting 658 requirements. In view of the level of health and environmental concerns about the chemicals 659 subject to this proposed rule if used for the proposed significant new uses, EPA believes that a 660 TSCA section 8(a) rule for this substance would not meet EPA's regulatory objectives. 661 B. Regulate Under TSCA Section 6 662 EPA may regulate under TSCA s ection 6 if "the Administra tor finds that there is a 663 reasonable basis to conclude thatthe manufacture, processing, di stribution in commerce, use or 664 disposal of a chemical substance or mixture pres ents or will present anunreasonable risk of 665 injury to health or the environmen t." (TSCA section 6(a)). Given that the benzidine-based 666 chemical substances subject to this proposed rule are no longer being usedexcept as provided in 667 the regulatory text of this doc ument, DnPP is no longer being used except as a chemical standard 668 for laboratory use, and alkanes, C 12-13 , chloro (CAS No. 71011-12-6) is no longer used in the 669 United States, EPA concluded that risk mana gement action under TS CA section 6 is not 670 necessary at this time. This proposed SNUR would allow the Ag ency to address the potential 671 risks associated with the proposed significant new uses. If EPA lear ns that these chemicals are in 672 use, EPA may reconsider this decision and pur sue additional regulatory action as appropriate. 673 X. Applicability of Proposed Rule to Uses Occurring Before Effective Date of the Final 674 Rule 675 As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided 676 that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant 677*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 30 of 50 new use as of the date of publication of the proposedrule rather than as of the effective date of 678 the final rule. If uses begun af ter publication of the proposed rule were considered ongoing rather 679 than new, it would be difficult for EPA to establish SNUR notice requirements, because a person 680 could defeat the SNUR by initiating the proposedsignificant new use before the rule became 681 final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, 682 persons who begin the comm ercial manufacture, import, or pr ocessing of a covered substance as 683 a significant new use have to cease any such activity as of the effective date of the rule if and 684 when finalized. To resume their activities, th ese persons would have to comply with all 685 applicable SNUR notice requirements and wait until the notice review period, including all 686 extensions, expires. EPA has pr omulgated provisions to allow persons to comply with this 687 SNUR before the effective date. If a person we re to meet the conditions of advance compliance 688 under 40 CFR § 721.45(h), that person would be considered to have met the requirements of the 689 final SNUR for those activities. 690 XI. Test Data and Other Information 691 EPA recognizes that TSCA sec tion 5 does not require developi ng any particular test data 692 before submission of a SNUN. There are two excepti ons: 1) Development of te st data is required 693 where the chemical substance subject to the SNURis also subject to a test rule under TSCA 694 section 4 (see TSCA section 5(b)(1)); and 2) de velopment of test data may be necessary where 695 the chemical substance has been listed under TS CA section 5(b)(4) (see TSCA section 5(b)(2)). 696 In the absence of a section 4 test rule or a sectio n 5(b)(4) listing covering the chemical substance, 697 persons are required only to submit test data in their possession or contro l and to describe any 698 other data known to or reas onably ascertainable by them ( 15 U.S.C. 2604(d); § 721.25, and 699 §720.50). However, as a general matter, EPA reco mmends that SNUN submitters include data 700 that would permit a reasoned evaluation of risk s posed by the chemical substance during its 701*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 31 of 50 manufacture, import, processing, use, distributi on in commerce, or disposal. EPA encourages 702 persons to consult with the Agency before s ubmitting a SNUN. As part of this optional pre703 notice consultation, EPA would disc uss specific data it believes may be useful in evaluating a 704 significant new use. SNUNs submitted for signifi cant new uses without any test data may 705 increase the likelihood that EPA w ould take action under TSCA section 5(e) to prohibit or limit 706 activities associated with this chemical. 707 SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that 708 provide detailed information on: 709 1. Human exposure and environmental releas es that may result from the significant new 710 uses of the chemical substance. 711 2. Potential benefits of the chemical substance. 712 3. Information on risks posed by the chemical substances compared to risks posed by 713 potential substitutes. 714 XII. SNUN Submissions 715 According to 40 CFR § 721.1(c), persons subm itting a SNUN must comply with the same 716 notice requirements and EPA regulatory procedures as persons submitting a PMN, including 717 submission of test data on h ealth and environmental effects as described in § 720.50. SNUNs 718 must be on EPA Form No. 7710–25, generated us ing e-PMN software, and submitted to the 719 Agency in accordance with the procedures set forth in §§ 721.25 and 720.40. E-PMN software is 720 available electronically at http://www.epa.gov/opp tintr/newchems. 721 XIII. Economic Analysis 722 A. SNUNs 723 EPA has evaluated the potential costs of establishing S NUR reporting requirements for 724 potential manufacturers and processors of these ch emicals and for articles containing any of the 725*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 32 of 50 benzidine-based chemical substances included in this proposed rule. These economic analyses, 726 which are briefly summarized here, are available in the docket for this proposed rule. 727 The costs of submission of a SNUN woul d be incurred when a company decides to 728 pursue a significant new use of one of these chemicals. In the event that a SNUN is submitted, 729 costs are estimated at approximately $8,112 pe r SNUN submission, and include the cost for 730 preparing and submitting the SNUN, recordkeeping, and the payment of a user fee. Businesses 731 that submit a SNUN are either subject to a $2,50 0 user fee required by § 700.45(b)(2)(iii), or, if 732 they are a small business with annual sales of le ss than $40 million when combined with those of 733 the parent company (if any), a reduced user fee of $100 (§ 700.45(b)(1)). In its evaluation of this 734 proposed rule, EPA also considered the potenti al costs a company might incur by avoiding or 735 delaying the significant new use in the future, but these costs have not been quantified. 736 B. Export Notification 737 EPA regulations under TSCA section 12(b) (15 U.S.C. 2611(b)) at § 707 subpart D 738 require that, for chemicals subject to a proposedor final SNUR, a company notify EPA of the 739 first export or intended export to a particular country of an aff ected chemical substance. EPA 740 estimated that the one-time cost of prepari ng and submitting an export notification to be $78.54. 741 The total costs of export notif ication would vary per chemi cal, depending on the number of 742 required notifications (i.e., number of countries to which the chemical is exported). 743 XIV. References 744 As indicated under ADDRESSES , a docket has been established for this proposed rule 745 under docket ID number EPA–HQ–OPPT–2010-0573. The following is a listing of the 746 documents that have been placed in the docket for this proposed rule. The docket includes 747 information considered by EPA in developing this proposed rule, including the documents listed 748 in this unit, which are physica lly located in the docket. In addition, interested parties should 749*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 33 of 50 consult documents that are referenced in the documents that EPA has placed in the docket, 750 regardless of whether these referenced documents are physically located in the docket. For 751 assistance in locating documents that are referenc ed in documents that EPA has placed in the 752 docket, but that are not physica lly located in the docket, please consult either technical person 753 listed under FOR FURTHER INFORMATION CONTACT . The docket is available for 754 review as specified under ADDRESSES

. 755 1. U.S. EPA, 2010. U.S. Environmental Protection Agency. Chemical Substances Derived from 756 Benzidine and Its Congeners, 757 http://www.epa.gov/oppt/existingchemicals/ pubs/actionplans/DCB%20Action%20Plan_06232010.no 758 header.pdf (Accessed January 24, 2011). 759 2. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/ Economics, Exposure, and 760 Technology Division. “Economic Anal ysis to Support the Propos ed SNUR for Benzidine and 761 Benzidine-based Chemical substances,'' (May 24, 2011). 762 3. EPA. 1980. Preliminary Risk Assessment: Phas e I. Benzidine, its congeners, and their 763 derivative dyes and pigments. EPA-560/11-80-019, June 1980. 764 4. IARC (1982). Some industrial chemicals and dyestuffs. IARC monographs on the evaluation 765 of carcinogenic risk of chemicals to humans, Suppl.7, International Agency for Research on 766 Cancer, Lyon, France. 767 5. IARC (1987). Overall evaluation of carcinogeni city. IARC monographs on the evaluation of 768 carcinogenic risk of chemicals to humans, vol.29, International Agency fo r Research on Cancer 769 6. Report on Carcinogens, 11 thed. (2008). http://ntp.niehs.nih.gov/?objectid=035E5806-F735- 770 FE81-FF769DFE5509AF0A 771 7. Golka, K., Kopps, S., Myslak, Z.W. 2004. Carc inogencitiy of azo colorants: influence of 772 solubility and bioavailability. Tox Lett 151:203-210. 773*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 34 of 50 8. EPA. 2005. Supplemental Guidance for Asse ssing Susceptibility from Early Life Exposure 774 to Carcinogens. EPA 630/R-03/003F, March 2005. 775 9. Levine, W.G. (1991). Metabolism of azo dyes: implication for detoxification and activation. 776 Drug Metab. Rev. 23(3&4):253-309. 777 10. Platzek, T., Lang, C.; Grohmann, G., Giu, -S.; Baltes, W. (1999). Formation of a 778 carcinogenic aromatic amine from an azo dye by human skin bacteria in vitro

. Human & 779 Experimental Toxicology , 18: 552-559. 780 11. Stingley, R., Zou, W., Heinze, T., Chen, H. and Cerniglia, C. 2009. Metabolism of azo dyes 781 by human skin microbiota. J Med Microbiol(2009), DOI: 10.1099/jmm.0.012617-0 782 12. NIOSH, Special Occupational Hazard Re view for Benzidine-Based Dyes (1980). 783 13. U.S. EPA, 2009. U.S. Environmental Protecti on Agency. Inventory Update Reporting IUR: 784 Non Confidential IUR Production Vo lume Data 1986-2002. Available at: 785 http://www.epa.gov/oppt/iur/tools/data/2002-vol.html(Updated October 26, 2009). 786 14. U.S. EPA, 2010. U.S. Environmental Prot ection Agency. Phthal ates Action Plan. 787 http://www.epa.gov/oppt/existingchemica ls/pubs/actionplans /phthalates.html (Accessed January 788 24, 2011). 789 15. Australian Government, 2008a. Existing Chemical Hazard Assessment Report for 790 Butylbenzyl Phthalate . Department of Health and Ag eing, National Industrial Chemicals 791 Notification and Assessment Scheme (NIC NAS): Sydney, Australia. Available at: 792 http://www.nicnas.gov.au/Publica tions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 793 16. Australian Government, 2008b. Existing Chemical Hazard A ssessment Report for Dibutyl 794 Phthalate . Department of Health and Ageing, Nati onal Industrial Chemi cals Notification and 795 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 796 http://www.nicnas.gov.au/Publica tions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 797*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 35 of 50 17. Australian Government, 2008c. Existing Chemical Hazard Assessment Report for 798 Diethylhexyl Phthalate . Department of Health and Agei ng, National Industrial Chemicals 799 Notification and Assessment Scheme (NIC NAS): Sydney, Australia. Available at: 800 http://www.nicnas.gov.au/Publica tions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 801 18. Australian Government, 2008d. Existing Chemical Hazard A ssessment Report for Diisobutyl 802 Phthalate . Department of Health and Ageing, Nati onal Industrial Chemi cals Notification and 803 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 804 http://www.nicnas.gov.au/Publica tions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 805 19. Australian Government, 2008e. Existing Chemical Hazard Assessment Report for Diisodecyl 806 Phthalate . Department of Health and Ageing, Nati onal Industrial Chemi cals Notification and 807 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 808 http://www.nicnas.gov.au/Publica tions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 809 20. Australian Government, 2008f. Existing Chemical Hazard A ssessment Report for Diisonoyl 810 Phthalate . Department of Health and Ageing, Nati onal Industrial Chemi cals Notification and 811 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 812 http://www.nicnas.gov.au/Publica tions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 813 21. Australian Government, 2008g. Existing Chemical Hazard Assessment Report for Di-n-octyl 814 Phthalate . Department of Health and Ageing, Nati onal Industrial Chemi cals Notification and 815 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 816 http://www.nicnas.gov.au/Publica tions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 817 22. Australian Government, 2008h. Phthalates Hazard Comp endium. A Summary of 818 Physicochemical and Human Health Hazard Data for 24 Ortho-Phthalate Chemicals

. 819 Department of Health and Ageing, National Indu strial Chemicals Notification and Assessment 820 Scheme (NICNAS): Sydney, Australia. Available at: 821*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 36 of 50 www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 822 23. HSDB, 2009. Hazardous Substance Data Bank. U. S. National Library of Medicine TOXNET 823 System. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB (accessed Aug 13, 2009). 824 24. NAS, 2008. National Academy of Sciences. Ph thalates and Cumulative Risk Assessment: 825 The Tasks Ahead. 826 25. NTP-CERHR, 2003a. Monograph on the Poten tial Human Reproductive and Developmental 827 Effects of Di- n -Butyl Phthalate (DBP). U.S. Departme nt of Health and Human Services. 828 Available at: http://cerhr.niehs.nih.gov/ evals/phthalates/dbp/dbp.html 829 26. NTP-CERHR, 2003b. National Toxicology Program - Center for the Evaluation of Risks to 830 Human Reproduction. Monograph on the Potentia l Human Reproductive and Developmental 831 Effects of Butyl Benzyl Phthalate (BBP); NIH Pub. No. 03-4487; U.S. Department of Health and 832 Human Services. Available at: http://cerhr.niehs.nih.gov/eva ls/phthalates/bb-phthalate/bb833 phthalate.html

. 834 27. NTP-CERHR, 2003c. National Toxicology Program - Center for the Evaluation of Risks to 835 Human Reproduction. Monograph on the Potentia l Human Reproductive and Developmental 836 Effects of Di-n-Octyl Phthalate (DnOP); NIH P ub. No. 03-4488; U.S. Department of Health and 837 Human Services. Available at: http://cerhr.niehs.nih.gov /evals/phthalates/dnop/dnop.html

. 838 28. NTP-CERHR, 2003d. National Toxicology Program - Center for the Evaluation of Risks to 839 Human Reproduction. Monograph on the Potentia l Human Reproductive and Developmental 840 Effects of Diisononyl Phthalate (DINP); U.S. Department of Health and Human Services. 841 Available at: http://cerhr.niehs.nih.gov/ evals/phthalates/dinp/dinp.html

. 842 29. NTP-CERHR, 2003e. National Toxicology Program - Center for the Evaluation of Risks to 843 Human Reproduction. Monograph on the Potentia l Human Reproductive and Developmental 844 Effects of Di-Isodecyl Phthalate (DIDP); NIH P ub. No. 03-4485; U.S. Department of Health and 845*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 37 of 50 Human Services. Available at: http://cerhr.niehs.nih.gov/eva ls/phthalates/didp/didp.html

. 846 30. NTP-CERHR, 2006. National Toxi cology Program - Center for the Evaluation of Risks to 847 Human Reproduction. Monograph on the Potentia l Human Reproductive and Developmental 848 Effects of Di-(2-ethylhexyl) Phthalate (DEHP) ; NIH Pub. No. 06-4476; U. S. Department of 849 Health and Human Services. Available at: 850 http://cerhr.niehs.nih.gov/evals/phthalates/dehp/dehp.html

. 851 31. EC, 2003a. European Commission. Europe an Union Risk Assessment Report: 1,2- 852 Benzenedicarboxylic Acid, Di-C8-10-BranchedAlkyl Esters, C9-R ich And Di-“Isononyl” 853 Phthalate [DINP], CAS-Nos. 68515-48-0, 28553-12-0. Vol. 35; EUR 20784EN; Office for 854 Official Publications of the EuropeanCommunities: Luxembourg. Available at: 855 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing856 Chemicals/RISK_ASSESSMENT/REPORT/dinpreport046.pdf

. 857 32. EC, 2003b. European Commi ssion. European Union Risk Assessment Report: 1,2- 858 Benzenedicarboxylic Acid, Di-C9-11-Branched Alkyl Esters, C10-Rich And Di-“Isodecyl” 859 Phthalate [DIDP], CAS-Nos 68515-49-1 and 26 761-40-0. Vol. 36; EUR 20785EN; Office for 860 Official Publications of the EuropeanCommunities: Luxembourg. Available at: 861 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing862 Chemicals/RISK_ASSESSMENT/REPORT/didpreport041.pdf

. 863 33. EC, 2004. European Commi ssion. European Union Risk Assessment Report: Dibutyl 864 Phthalate [DBP], CAS-No. 84-74- 2. Vol. 29; EUR 19840EN; Office fo r Official Publications of 865 the European Communities: Luxembourg. Available at: 866 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing867 Chemicals/RISK_ASSESSMENT/REPORT /dibutylphthalatereport003.pdf

. 868 34. EC, 2008a. European Commission. Europe an Union Risk Assessment Report Bis(2- 869*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 38 of 50 Ethylhexyl) Phthalate (DEHP), CAS-No. 117-81-7. Vol. 80; EUR 23384EN; Office for Official 870 Publications of the European Communities: Luxembourg. Available at: 871 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing872 Chemicals/RISK_ASSESSMENT/REPORT/dehpreport042.pdf

. 873 35. EC, 2008b EC. 2008b. Eu ropean Commission. European Union Risk Assessment Report 874 Benzyl Butyl Phthalate (BBP), CASNo. 85-68-7. Vol. 76; EUR 22773EN; Luxembourg: Office 875 for Official Publications of the European Communities, 876 36. Howdeshell, K.L.; Rider, C.V.; Wilson, V.S.; Gray, L.E. Jr. 2008a. Mechanisms of action of 877 phthalate esters, individually and in combin ation, to induce abnormal reproductive development 878 in male laboratory rats. Environ Res . 108(2):168-76. 879 37. Howdeshell K.L., Wilson V.S., Furr J., Lamb right C.R., Rider C.V., Blystone C.R., 880 Hotchkiss A.K., Gray L.E. Jr. 2008b. A mixture of fi ve phthalate esters inhi bits fetal testicular 881 testosterone production in the sprague-dawley rat in a cumulative, dose-additive manner. Toxicol 882 Sci. 105(1):153-65. 883

38. Liu et al., 2005. Liu, K; Lehmann, KP; Sar, M; et al. (2005) Gene expression profiling 884 following in utero exposure to ph thalate esters reveals new gene targets in the etiology of 885 testicular dysgenesis . Biol Reprod 73(1):180–192. 886 39. Heindel et al.,1989. Heindel, JJ ; Gulati, DK; Mounce, RC; et al. (1989) Reproductive toxicity 887 of three phthalic acid esters in a continuous breeding protocol. Fundam Appl Toxicol12(3):508– 888 518. 889 40. NTP, 1985. NTP (National Toxicology Progra m). (1985) Di-n-pentyl phthalate: reproduction 890 and fertility assessment in CD-1 mice when admini stered in feed. Research Triangle Park, NC: 891 National Toxicology Program. PB86-118999. 892*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 39 of 50 41. Swan et al, 2005. an, S. H.; Main, K. M.; Stewart, S. L.; Kruse, R. L.; Calafat, A. M.; Mao, 893 C. S.; Redmon, J. B.; Ternand, C. L.;Sullivan, S.; Teague. J. L. 2005. Study for Future Families 894 Research Team. Decrease in Anoge nital Distance among male Infa nts with Prenatal Phthalate 895 Exposure. Environ. Health Perspect . Aug 2005, 113(8) , 1056–61. 896 42. Huang, P.C.; Kuo, P.L.; Chou, Y.Y.; Lin, S.J.; Lee, C.C. 2009. Association between 897 prenatal exposure to phthalates a nd the health outcome of newborns. Environ. Int. 35(1):14–20. 898 43. Meeker, J.D.; Calafat, A.M.; Hauser, R. 2007. Di(2-ethylhexyl) phthalate metabolites may 899 alter thyroid hormone levels in men. Environ Health Perspect . 115(7):1029-34. 900 44. Qiao, L.; Zheng, L.; Cai, D. 2007. Study on th e di-n-butyl phthalate and di-2-ethylhexyl 901 phthalate level of girl serum related with precocious puberty in Shanghai. Wei Sheng Yan Jiu

. 902 36(1): 93-5 903 45. Hauser, R.; Williams, P.; Altshul, L.; Calafat, A.M. 2005. Evidence of interaction between 904 polychlorinated biphenyls and phthalate s in relation to human sperm motility. Environ Health 905 Perspect . 113(4):425-30. 906 46. Hauser, R.; Meeker, J.D.; Duty, S,; Silva, M. J.; Calafat, A.M. 2006. Altered semen quality 907 in relation to urinary concen trations of phthalate monoest er and oxidative metabolites. 908 Epidemiology . 17(6):682-91. 909 47. Hauser, R.; Meeker, J.D.; Singh, N.P.; Silva, M.J.; Ryan, L.; Duty, S.; Calafat, A.M. 2007. 910 DNA damage in human sperm is related to urinar y levels of phthalate monoester and oxidative 911 metabolites. Hum Reprod. 22(3):688-95. 912 48. Duty, S.M.; Calafat, A.M.; Silva, M.J.; Ryan , L.; Hauser, R. 2005. Phthalate exposure and 913 reproductive hormones in adult men. Hum Reprod . 20(3):604-10. 914 49. Colón, I.; Caro, D,; Bourdony, C.J.; Rosario, O. 2000. Identification of phthalate esters in 915 the serum of young Puerto Rican girls w ith premature breast development. Environ Health 916*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 40 of 50 Perspect . 108(9):895-900. 917 50. Latini, G.; De Felice, C.; Presta, G.; Del Vecch io, A.; Paris, I.; Ruggieri, F.; Mazzeo, P. 918 2003. Exposure to Di(2-ethylhexyl)phthalate in hu mans during pregnancy. A preliminary report. 919 Biol Neonate . 83(1):22-4. 920 51. Rider, C.V.; Furr, J.; Wilson, V.S.; Gray, L. E. Jr. 2008. A mixture of seven antiandrogens 921 induces reproductive malformations in rats. Int J Androl . 31(2):249-62. 922 52. Rider, C.V.; Wilson, V.S.; Howdeshell, K.L.; Hotchkiss, A.K.; Furr, J.R.; Lambright, C.R.; 923 Gray, LE Jr. 2009. Cumulative effects of in utero administration of mixtur es of "antiandrogens" 924 on male rat reproductive development. Toxicol Pathol . 37(1):100-13. 925 53. Howdeshell, K.L.; Furr, J.; Lambright, C.R.; Rider, C.V.; Wilson, V.S.; Gray, L.E. Jr. 2007. 926 Cumulative effects of dibutyl phtha late and diethylhexyl phthalat e on male rat reproductive tract 927 development: altered fetal st eroid hormones and genes. Toxicol Sci . 99(1):190-202. 928 54. Gray, L.E. Jr; Wilson, V.S.; Stoker, T.; Lambright, C.; Furr, J.; Noriega, N.; Howdeshell, K.; 929 Ankley, G.T.; Guillette, L. 2006. Adverse effects of environmental antiandrogens and 930 androgens on reproductive development in mammals. Int J Androl . 29(1): 96-108. 931 55. Hotchkiss, A.K.; Parks-Saldutti. L.G.; Ostby, J.S.; Lambright, C.; Furr, J.; Vandenbergh, 932 J.G.; Gray, L.E. Jr. 2004. A mixture of the "a ntiandrogens" linuron and but yl benzyl phthalate 933 alters sexual differentiation of the male rat ina cumulative fashion. Biol Reprod . 71(6):1852-61. 934 56. Oehlmann et al., 2008. Oehlmann, J.; Schulte -Oehlmann, U.; Werner, K.; Jagnytsch, O.; 935 Lutz, I.; Kresten, K.; Wollenberger, L.; Santos, E. .; Paull, G. C.; Van Look, K. J. W.; Tyler, C. 936 R. 2008. A Critical Analysis of the Biologi cal Impacts of las ticizers on Wildlife. Philos. Trans. 937 R. Soc ., B: Biol. Sci. 2008, 364(1526) , 2047–2062. 938 57. Staples et al., 1997. Staples, C. A.; Adams, W. J.; Parkerton, T. F.; Gorsuch, J. W.; 939 Biggingers, G. R.; Reiner, K. H. 1997. Aquatic Toxicity of Eighteen Phthalate Esters. Environ. 940*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 41 of 50 Toxicol. Chem . 1997, 16 (5) , 875–891. 941 58. CDC, 2009. Centers for Dis ease Control and Prevention. Fourth National Report on Human 942 Exposure to Environmental Chemicals. Nationa l Health and Nutriti on Examination Survey 943 (NHANES), Centers for Diseas e Control and Prevention, A tlanta (GA). Available at: 944 http://www.cdc.gov/exposurereport/faq.html

. 945 59. U.S. EPA, 2010. U.S. Environmental Protection Agency. Short-Chain Chlorinated Paraffins 946 (SCCPs) and Other Chlorinated Para ffins Action Plan. Available at: 947 http://www.epa.gov/oppt/existingchemi cals/pubs/actionplans/sccps.html(Accessed March 7, 948 2011). 949 60. UNEP. 2009. United Nations Environmen t Programme. Stockholm Convention on 950 Persistent Organic Pollutants (POPs). Persis tent Organic Pollutants Review Committee. 951 Revised Draft Risk Profile: Short-Chained Chlorinated Paraffins . 9 July 2009. 952 UNEP/POPS/POPRC.5/2. Available at: 953 http://chm.pops.int/Convention/POPsRevi ewCommittee/hrPOPRCMeetings/POPRC5/POPR 954 5Documents/tabid/592/language/en-US/Default.aspx . Accessed December 11, 2009. 955 61. Government of Canada. 2008. Order Adding Toxic Substances to Schedule 1 to the Canadian 956 Environmental Protection Act, 1999 . Canada Gazette. September 20, 2008, 142 (38). 957 62. American Apparel and Footwear Association (AAFA) Restricted Substance List (RSL), 958 September, 2010. 959 XV. Statutory and Executive Order Reviews 960 A. Regulatory Planning and Review 961 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 962 October 4, 1993), the Office of Management a nd Budget (OMB) has determined that this 963 proposed SNUR this action is a “significant regulatory action” under section 3(f) of the 964*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 42 of 50 Executive Order. Accordingly, EPA submitted this action to OMB for review under Executive 965 Order 12866 and 13563, entitled Improving Regulation and Regulatory Review(76 FR 3821, 966 January 21, 2011). Changes made in response to OMB recommendations have been documented 967 in the docket for this rulemaking as required by section 6(a)(3)(E) of the Executive Order. 968 B. Paperwork Activities 969 According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., an Agency 970 may not conduct or sponsor, and a person is not required to res pond to a collection of 971 information that requires OMB approval under the PRA, unless it has been approved by OMB 972 and displays a currently valid OMB control number. The OMB control numbers for EPA's 973 regulations in Title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR, 974 part 9, and included on the related collecti on instrument, or form, if applicable. 975 The information collection requirements re lated to this action have already been 976 approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 977 1188). This action does not impose any burden requi ring additional OMB appr oval. If an entity 978 were to submit a SNUN to the Agency, the annu al burden is estimated to average 97 hours per 979 response. This burden estimate includes the time needed to review instructions, search existing 980 data sources, gather and maintain the data need ed, and complete, review, and submit the required 981 SNUN. 982 Send any comments about the accuracy of the burden estimate, and any suggested 983 methods for minimizing respondent burden, includi ng through the use of automated collection 984 techniques, to the Director, Co llection Strategies Division, Offi ce of Environmental Information 985 (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 986 20460-0001. Please remember to include the OMB c ontrol number in any correspondence, but 987 do not submit any completed forms to this address. 988*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 43 of 50 C. Small Entity Impacts 989 Pursuant to section 605(b) of the Regul atory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), 990 the Agency hereby certifies that promulgation of this SNUR would not have a significant adverse 991 economic impact on a substantial number of sm all entities. The rationale supporting this 992 conclusion is as follows. 993 Under the RFA, small entities include small businesses, small organizations, and small 994 governmental jurisdictions. Small entity is defi ned in accordance with section 601of the RFA as: 995 A small business as defined by the Small Busi ness Administration’s (SBA) regulations at 13 996 CFR 121.201; A small governmental jurisdiction thatis a government of a city, county, town, 997 school district or special district with a population of less th an 50,000; and A small organization 998 that is any not-for-profit enterprise which is independently owned a nd operated and is not 999 dominant in its field. 1000 For purposes of assessing the impacts of this proposed rule on small entities, EPA has 1001 determined that this proposed rule is not expected to impact any small not-for-profit 1002 organizations or small governmental jurisdictio ns. As such, the Agency estimated potential 1003 impacts on small business. A SNUR applies to any person (including sma ll or large entities) 1004 who intends to engage in any act ivity described in the rule as a “significant new use.” By 1005 definition of the word “new” and based on all info rmation currently available to EPA, it appears 1006 that no small or large entities presently engage insuch activity. Since th is action would require a 1007 person who intends to engage in such activity in the future to first notify EPA by submitting a 1008 SNUN, no economic impact would occur unless someone files a SNUN to pursue a significant 1009 new use in the future or forgoes profits by avoiding or delaying the significant new use. 1010 Although some small entities may decide to conduc t such activities in the future, EPA cannot 1011 presently determine how many, if any, there may be. 1012*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 44 of 50 EPA's experience to date is that, in re sponse to the promulgation of over 1,000 SNURs, 1013 the Agency receives on average only 5 notices per year. Of those SNUNs submitted, only one 1014 appears to be from a small entity in response to any SNUR. Therefore, EPA believes that the 1015 potential economic impact of complying with this SNUR is not expected to be significant or 1016 adversely impact a substantial number of small enti ties. In a SNUR that pub lished as a final rule 1017 on August 8, 1997 (62 FR 42690) (FRL-5735-4), the Ag ency presented its general determination 1018 that proposed and final SNURs are not expected to have a significant economic impact on a 1019 substantial number of small entities, which wa s provided to the Chief Counsel for Advocacy of 1020 the Small Business Administration. 1021 D. State, Local, and Tribal Governments 1022 In EPA’s experience with proposing and fina lizing SNURs since 1980, no State, local, or 1023 Tribal government has initiated the manufacture of a chemical for a new use. Furthermore, EPA 1024 does not have any reason to believe that any State, local, or Tribal government would do so for the 1025 chemicals in this rulemaking. Fo r that reason, EPA has determined that this action does not have 1026 federalism implications as specifi ed in Executive Order 13132, entitled Federalism (64 FR 43255, 1027 August 10, 1999), or Tribal implications as specified in Executiv e Order 13175, entitled 1028 Consultation and Coordination wi th Indian Tribal Governments (65 FR 67249, November 9, 1029 2000). 1030 In addition, this action does not impose any enforceable duty or contain any unfunded 1031 mandate for State, local, or tribal governments under the provisions of Title II of the Unfunded 1032 Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538. Nor does it otherwise have any effect on 1033 small governments, or estimated impacts on the private sector that might exceed $100 million in 1034
any year. 1035 Thus, sections 202, 203, 204, or 205 of UM RA, Executive Order 13132, and Executive 1036*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 45 of 50 Order 13175 do not apply to this action. 1037 E. Protection of Children 1038 This action is not subject to Executive Order 13045, entitled Protection of Children from 1039 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this action 1040 is not an economically signifi cant regulatory action as defi ned by Executive Order 12866, and it 1041 is not intended to address environmenta l health or safety risks for children. 1042 F. Effect on Energy Supply, Distribution, or Use 1043 This action is not subject to Executive Order 13211, entitled Actions Concerning 1044 Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 1045 22, 2001), because this action is not an economically significant regulatory action as defined by 1046 Executive Order 12866, and it is not expected to affect energy supply, distribution, or use. 1047 G. Technical Standards 1048 Since this action does not invol ve any technical standards, section 12(d) of the National 1049 Technology Transfer and Advancement Act (NTT AA), 15 U.S.C. 272 note, does not apply to 1050 this action. 1051 H. Environmental Justice 1052 This action does not entail speci al considerations of environmental justice related issues 1053 as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental 1054 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 1055 1056 List of Subjects in 40 CFR Part 721 1057 Environmental protection, Chemicals, Hazardous substances, Reporting and 1058 recordkeeping requirements. 1059 Dated: ________ 1060*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 46 of 50 Director, Office of Pollution Prevention and Toxics. 1061 Therefore, it is proposed that 40 CFR Part 721 be amended as follows: 1062 [AMENDED] 1063 1. The authority citation for part 72 1 continues to read as follows: 1064 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 1065 2. In § 721.1660, revise paragraph (a) and (b) to read as follows: 1066 §721.1660 Benzidine-based Chemical Substances. 1067 (a) Chemical substances and significant new uses subject to reporting . (1) The 1068 benzidine-based chemical substances listed in Tabl e 1 and Table 2 of this section are subject to 1069 reporting under this section for the significant ne w uses described in paragraph (a)(2) of this 1070 section. 1071 Table 1. Benzidine-Based Chemical Substances 1072

CAS number C.I. name C.I. number Chemical name 117-33-9 Not available Not available 1,3-Naphthalenedisulfonic aci d, 7-hydroxy-8-[2-[4'- [2-(4-hydroxyphenyl)diazenyl][1,1'-biphenyl]-4- yl]diazenyl]- 65150-87-0 Not available Not available 1,3,6-Naphthalenetrisulfonic 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 Navy BH 22590 2,7-Naphthalenedisulfonic acid, 5-amino-3-[2-[4'-[2- (7-amino-1-hydroxy-3-sulfo-2- naphthalenyl)diazenyl][1,1'-b iphenyl]-4-yl]diazenyl]- 4-hydroxy-, sodium salt (1:2) 72379-45-4 Not available Not available 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy3-[2-[4'-[2-[2-hydroxy-4-[(2-methylphenyl)amino] phenyl]diazenyl][1,1'-biphenyl ]-4-yl]diazenyl]-6-(2- phenyldiazenyl)- Accession No. 26267 CAS. No. CBI (NA) CBI CBI 4-(Substituted phenyl)azo biphenylyl azo - substituted carbopolycycle azo benzenesulf onic acid, sodium salt. (Generic Name) Accession No. 24921 CAS No. CBI CBI 4-(Substituted naphtha lenyl )azo diphenylyl azosubstituted carbopolycycle azo benzenesulfonic acid, sodium salt. (Generic Name)*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 47 of 50 CBI (NA) Accession No. 26256 CAS CBI (NA) CBI CBI 4-(Substituted phenyl)azo bi phenylyl azo-substituted carbopolycycloazo benzenesulfonic acid, sodium salt. (Generic Name) Accession No. 21808 CAS No. CBI (NA) CBI CBI 2,7-Naphthalenedisulf onic acid, 4-amino-5-hydroxy [[[(substituted phenylamino] substituted phenylazo] diphenyl]azo-, phenylazo-, di sodium salt. ( Generic Name) Accession No. 26701 CAS No. CBI (NA) CBI CBI Phenylazoaminohydrox ynaphthalenylazobiphenylazo substituted benzene sodium sulfonate. (Generic Name)

1073 Table 2.—Benzidine-Based Chemical Substances 1074 1075

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 available [1,1 ’-Biphenyl]-4,4’-diamine, dihydrochloride 573–58–0 C.I. Direct Red 28 22120 1- Naphthale nesulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'- diylbis(azo)]bis[4-amino-, disodium salt 1937–37–7 C.I. Direct Black 38 30235 2,7-Naphthalenedisulfonic ac id, 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 Red 44 22500 1-Naphthalenesu lfonic acid, 8,8’-[[1,1’-biphenyl]-4,4’- diylbis(azo)]bis[7-hydro xy-, disodium salt 2429–73–4 C.I. Direct Blue 2 22590 2,7-Naphthalene disulfonic acid, 5-amino-3-[[4’-[(7- amino-1-hydroxy-3-sulfo-2- naphthalenyl)azo][1,1’- biphenyl]-4-yl]azo]-4-hy droxy-,trisodium salt 2429–79–0 C.I. Direct Orange 8 22130 Benzoic acid, 5-[[4’-[(1-amino-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-methyl phenyl]azo][1,1’-biphenyl]- 4-yl]azo]-2-hydroxy-,tetrasodium salt 2429–82–5 C.I. Direct Brown 2 22311 Benzoic acid, 5-[[4’-[(7-amino-1-hydroxy-3-sulfo-2- naphthalenyl) azo][1,1’-biphe nyl]-4-yl]azo]-2-hydroxy-, disodium salt 2429–83–6 Direct Black 4 C.I. 30245 2,7-Naphthalene disulfonic acid, 4-amino-3-[[4’-[(2,4- diamino-5-methylphenyl)azo ][1,1’-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)-,disodium salt 2429–84–7 C.I. Direct Red 1 22310 Benzoic ac id, 5-[[4’-[(2-amino-8-hydroxy-6-sulfo1-naphthalenyl)azo][1,1’-biphenyl]-4-yl]azo]-2- hydroxy-, disodium salt*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 48 of 50 2586–58–5 C.I. Direct Brown 1:2 30110 Benzoic acid, 5-[[4’-[[2,6-diamino-3-methyl-5-[(4- sulfophenyl)azo]phenyl]azo][1,1’-biphenyl]-4-yl]azo]- 2-hydroxy-, disodium salt 2602–46–2 C.I. Direct Blue 6 22610 2,7-Naphthale nedisulfonic acid, 3,3’-[[1,1’-biphenyl]- 4,4’-diylbis(azo)]bis[5-am ino-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 Red 37 22240 1,3-Naphtha lenedisulfonic acid, 8-[[4’-[(4- ethoxyphenyl) azo][1,1’-biphenyl]-4-yl]azo ]-7-hydroxy-,disodium salt 3567–65–5 C.I. Acid Red 85 22245 1,3-Naphthalene disulfonic acid, 7-hydroxy-8-[[4’-[[4- [[(4-methylphenyl) sulf onyl]oxy]phenyl]azo][1,1’- biphenyl]-4-yl]azo]-, disodium salt 3626–28–6 C.I. Direct Green 1 30280 2,7-Naphthalenedisulfonic 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 Benzoic acid, 5-[[4’-[[2,4-diamino-5-[(4-sulfophenyl) azo]phenyl]azo][1,1’-biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt 4335–09–5 C.I. Direct Green 6 30295 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6- [[4’-[(4-hydroxyphenyl)azo][1,1’-biphenyl]-4-yl] azo]- 3-[(4-nitrophenyl)azo]-,disodium salt 6358–80–1 C.I. Acid Black 94 30336 2,7-Naphthale nedisulfonic 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 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-h ydroxy-,trisodium salt 6360–54–9 C.I. Direct Brown 154 30120 Benzoic acid, 5-[[4’-[[2,6-diamino-3-methyl-5-[(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-disul fo-1,5-naphthalenediyl)bis [azo(6-hydroxy-3,1-phenylene)azo[6(or7)-sulfo-4,1- naphthalenediyl]azo[1,1’-bi phenyl]-4,4’-diylazo]]bis[6- hydroxy-, hexasodium salt 16071–86–6 C.I. Direct Brown 95 30145 Cuprate(2-), [5-[[4’-[[2,6-dihydroxy-3-[(2-hydroxy-5- sulfophenyl)azo]phenyl] azo][1,1’-biphenyl]-4-yl]azo]- 2-hydroxybenzoato(4-)]-,disodium salt 1076 (2) The significant new uses are: 1077 (i) Any use other than use as: 1078*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 49 of 50 (A) For the chemicals listed in Tabl e 2, as reagent to test for hydrogen peroxide in 1079 milk; a reagent to test for hydrogen sulfate, hydrogen cyanid e, and nicotine; a stain in 1080 microscopy; a reagent for detecting bl ood and as an analytical standard 1081 (B) For Color Index (C.I.) Direct Red 28 (Congo Red) (CAS No. 573-58-0) listed 1082 in Table 2, as an indicator dye 1083 (ii) For the 9 chemical substances listed in Table 1: any use. 1084 (3) Revocation of article exemption. The provisions of § 721.45(f) do not apply to this 1085 section. A person who imports or processes the chemical substances identified in paragraph 1086 (a)(1) of this section as part of an article for the significant new use described in paragraph (a)(2) 1087 of this section must submit a significant new use notice. 1088 1089 3. By adding new § 721.10226 to subpart E to read as follows: 1090 § 721.10226 Di- n -pentyl phthalate (DnPP). 1091 (a) Chemical substance and significant new us es subject to reporting. (1) The chemical 1092 substance identified as Di-n-pentyl phthalat e (DnPP) (1,2-Benzened icarboxylic acid, 1,2- 1093 dipentyl ester) (CAS No.131-18-0) is subject to reporting under th is section for the significant 1094 new uses described in paragraph (a) (2) of this section. 1095 (2) The significant new use is: any use othe r than as a chemical standard for laboratory 1096

use. 1097 (b) [Reserved] 1098 4. Add § 721.10227 to subpart E to read as follows: 1099 § 721.10227 Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). 1100 (a) Chemical substance and significant new uses subject to reporting. 1101*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ36 Page 50 of 50 (1) The chemical substance identified Alkanes, C 12-13 , chloro (CAS No. 71011-12-6) is 1102 subject to reporting under this section for the significant new uses described in paragraph 1103 (a)(2) of this section. 1104 (2) The significant new use is: any use. 1105 (b) Specific requirements . The provisions of subpart A of th is part apply to this section 1106 except as modified by this paragraph. 1107 (1) Persons who must report . § 721.5 applies to this sect ion except for §721.5(a)(2). A 1108 person who intends to manufacture or import for commercial purposes a substance identified in 1109 paragraph (a)(1) of this section and intends to distribute the s ubstance in commerce must submit 1110 a significant new use notice. 1111 (2) [Reserved]. 1112 1113