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1 Rin2070-AJ36_EO12866_3-Chemical-SNUR-NPRM_FRdocument_2011-06-24

2 EO 12866 REVIEW DRAFT – As submitted. 

3 BILLING CODE 6560–50–P

4 ENVIRONMENTAL PROTECTION AGENCY 

5 40 CFR Part 721 

6 EPA-HQ-OPPT-2010-0573; FRL-8865-2 

7 RIN 2070–AJ36 

8 Benzidine-Based Chemical Substances; Di-n-pentyl phthalate (DnPP); and Alkanes, C12-13, 

9 Chloro; Proposed Significant New Use Rules 

10 

11 AGENCY: Environmental Protection Agency (EPA). 

12 ACTION: Proposed rule. 

13 SUMMARY: Under section 5(a)(2) of the Toxic Substances Control Act (TSCA), EPA is 

14 proposing: to add nine benzidine-based chemical substances to the Significant New Use Rule 

15 (SNUR) at § 721.1660 on benzidine-based chemical substances; a SNUR for Di-n-pentyl 

16 phthalate (DnPP) (1,2-Benzenedicarboxylic acid, 1,2-dipentyl ester) (CAS No. 131-18-0); and a 

17 SNUR for Alkanes, C12-13, chloro (CAS No. 71011-12-6). If finalized this rule would require 

18 persons who intend to manufacture, import, or process these chemical substances for an activity 

19 that is designated as a significant new use to notify EPA at least 90 days before commencing that 

20 activity. In the case of the benzidine-based chemical substances, EPA is also proposing to make 

21 inapplicable the exemption at § 721.45(f) relating to persons that import or process substances as 

22 part of an article. If finalized this would require persons who intend to import or process all 

23 listed benzidine-based chemical substances, i.e., the newly proposed nine benzidine-based 

24 chemical substances as well as the currently listed benzidine-based chemical substances, as part 

25 of an article to notify EPA at least 90 days before commencing that activity. The required 

26 notification would provide EPA with the opportunity to evaluate activities associated with a 
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27 significant new use and an opportunity to protect against potential unreasonable risks, if any, 

28 from exposure to the chemical substance. 

29 DATES: Comments must be received on or before [insert date [90] days after date of 

30 publication in the Federal Register]. 

31 ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA32 HQ-OPPT-2010-0573 by one of the following methods: 

33 • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line 

34 instructions for submitting comments. 

35 • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics 

36 (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

37 20460-0001. 

38 • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 

39 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID number EPA-HQ-OPPT40 2010-0573. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 

41 holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only 

42 accepted during the DCO’s normal hours of operation, and special arrangements should be made 

43 for deliveries of boxed information. 

44 • Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2010-0573. 

45 EPA's policy is that all comments received will be included in the docket without change and 

46 may be made available on-line at http://www.regulations.gov, including any personal 

47 information provided, unless the comment includes information claimed to be Confidential 

48 Business Information (CBI) or other information whose disclosure is restricted by statute. Do not 

49 submit information that you consider to be CBI or otherwise protected through regulations.gov 

50 or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA 
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51 will not know your identity or contact information unless you provide it in the body of your 

52 comment. If you send an e-mail comment directly to EPA without going through 

53 regulations.gov, your e-mail address will be automatically captured and included as part of the 

54 comment that is placed in the docket and made available on the Internet. If you submit an 

55 electronic comment, EPA recommends that you include your name and other contact information 

56 in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read 

57 your comment due to technical difficulties and cannot contact you for clarification, EPA may not 

58 be able to consider your comment. Electronic files should avoid the use of special characters, 

59 any form of encryption, and be free of any defects or viruses. 

60 • Docket: All documents in the docket are listed in the docket index available at 

61 http://www.regulations.gov. Although listed in the index, some information is not publicly 

62 available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other 

63 material, such as copyrighted material, will be publicly available only in hard copy. Publicly 

64 available docket materials are available electronically at http://www.regulations.gov, or, if only 

65 available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 

66 Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, 

67 DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 

68 through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading 

69 Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. 

70 Docket visitors are required to show photographic identification, pass through a metal detector,

71 and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and 

72 subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in 

73 the building and returned upon departure. 

74 FOR FURTHER INFORMATION CONTACT: For technical information contact: Sara 
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75 Kemme, National Program Chemicals Division (7404T), Environmental Protection Agency, 

76 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 566-0511 

77 e-mail address: sara.kemme@epa.gov. 

78 For general information contact: The TSCAHotline, ABVI-Goodwill, 422 South Clinton Ave., 

79 Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: TSCA80 Hotline@epa.gov. 

81 SUPPLEMENTARY INFORMATION: 

82 I. General Information 

83 A. Does this Action Apply to Me? 

84 These three different SNURs may apply to different entities. 

85 1. Benzidine-based chemical substances. You may be potentially affected by this action 

86 if you manufacture, import or process, including as part of an article, any of the benzidine-based 

87 chemical substances listed in Tables 1 and 2 of the regulatory text in this document. Potentially 

88 affected entities may include, but are not limited to: 

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

90 substances. 

91 • Entities which plan to use the listed chemical substances in conjunction with apparel 

92 and other finished products made from fabrics, leather, and similar materials. 

93 • Entities which plan to use the listed chemical substances in conjunction with paper 

94 and allied products. 

95 • Manufacturers, importers, or processors of the subject chemical substances in printing 

96 inks. 

97 These entities may include those described by the North American Industrial 

98 Classification System (NAICS) codes 325- chemical manufacturing, 313- textile manufacturers, 
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99 316 – leather and allied products manufacturers, 322- paper manufacturers, 4243- apparel, piece 

100 goods, and notions wholesalers, or 443- clothing and accessories stores. 

101 2. DnPP. For DnPP, you may be potentially affected by this action if you manufacture 

102 (defined by statute to include import), or process DnPP. Potentially affected entities may 

103 include, but are not limited to: chemical industry – plastic material & resins (NAICS code 

104 325211). 

105 3. Alkanes, C12-13, chloro (CAS No. 71011-12-6). You may be potentially affected by this 

106 action if you manufacture, process, or import the following short-chained chlorinated paraffin 

107 (SCCP): alkanes, C12-13, chloro (CAS No. 71011-12-6). Potentially affected entities may include, 

108 but are not limited to: Manufacturers (defined by statute to include importers) of SCCPs 

109 (NAICS codes 325 and 325998), e.g., chemical manufacturing; including miscellaneous 

110 chemical product and preparation manufacturing; and processors of SCCPs (NAICS codes 324 

111 and 324191), e.g., petroleum lubricating oil and grease manufacturing. 

112 This listing is not intended to be exhaustive, but rather provides a guide for readers 

113 regarding entities likely to be affected by this action. Other types of entities not listed in this unit 

114 could also be affected. The NAICS codes have been provided to assist you and others in 

115 determining whether this action might apply to certain entities. To determine whether you or 

116 your business may be affected by this action, you should carefully examine the applicability 

117 provisions in § 721.5 for SNUR-related obligations and with respect to benzidine-based chemical 

118 substances, the applicability provisions in Unit II.C. If you have any questions regarding the 

119 applicability of this action to a particular entity, consult the technical person listed under FOR 

120 FURTHER INFORMATION CONTACT. 

121 This action may also affect certain entities through pre-existing import certification and 

122 export notification rules under TSCA. Persons who import any chemical substance governed by 
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123 a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification 

124 requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 

125 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies 

126 with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA 

127 policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any 

128 persons who export or intend to export a chemical substance that is the subject of this proposed 

129 rule on or after [insert date 30 days after the date of publication in the Federal Register] are 

130 subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see § 

131 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart 

132 D. 

133 B. What Should I Consider as I Prepare My Comments for EPA? 

134 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e135 mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI 

136 information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD137 ROM as CBI and then identify electronically within the disk or CD-ROM the specific 

138 information that is claimed as CBI. In addition to one complete version of the comment that 

139 includes information claimed as CBI, a copy of the comment that does not contain the 

140 information claimed as CBI must be submitted for inclusion in the public docket. Information so 

141 marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 

142 2. Tips for preparing your comments. When submitting comments, remember to: 

143 i. Identify the document by docket ID number and other identifying information (subject 

144 heading, Federal Register date and page number). 

145 ii. Follow directions. The Agency may ask you to respond to specific questions or 

146 organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 
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147 iii. Explain why you agree or disagree; suggest alternatives and substitute language for 

148 your requested changes. 

149 iv. Describe any assumptions and provide any technical information and/or data that you 

150 used. 

151 v. If you estimate potential costs or burdens, explain how you arrived at your estimate in 

152 sufficient detail to allow for it to be reproduced. 

153 vi. Provide specific examples to illustrate your concerns and suggest alternatives. 

154 vii. Explain your views as clearly as possible, avoiding the use of profanity or personal 

155 threats. 

156 viii. Make sure to submit your comments by the comment period deadline identified. 

157 II. Background 

158 A. What Action is the Agency Taking? 

159 EPA is proposing to add nine chemical substances (see Table 1 in Unit III.A.) to the 

160 existing SNUR for certain benzidine-based chemical substances at § 721.1660. That regulation 

161 includes as significant new uses “any use other than as a reagent to test for hydrogen peroxide in 

162 milk; a reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain in 

163 microscopy; a reagent for detecting blood; an analytical standard; and also for Colour Index 

164 (C.I.) Direct Red 28 (Congo Red, CAS No. 573-58-0) as an indicator dye.” § 721.1660(a)(2). 

165 For the nine newly-proposed benzidine-based chemical substances, EPA is proposing to 

166 designate any use as a significant new use. EPA requests comment on whether there are any 

167 ongoing uses of these chemicals. 

168 EPA is also proposing to amend the SNUR at § 721.1660 to make inapplicable the 

169 exemption at § 721.45(f) for persons that import or process benzidine-based chemical substances 

170 as part of an article. 
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171 Additionally, EPA is proposing a SNUR for DnPP that would designate, as a significant 

172 new use, any use of the substance other than as a chemical standard for laboratory use. 

173 EPA is also proposing a SNUR for alkanes, C12-13, chloro (CAS No. 71011-12-6) that 

174 would designate any use of the substance as a significant new use. Because any use of alkanes, 

175 C12-13, chloro (CAS No. 71011-12-6) would be a new use, § 721.5(a)(2) would be inapplicable to 

176 alkanes, C12-13, chloro (CAS No. 71011-12-6). 

177 These proposed SNURs would require persons that manufacture, process, or import any 

178 of the chemicals for a significant new use, consistent with the requirements at 40 CFR part 

179 721.25, to notify EPA at least 90 days before commencing such manufacture, process, or import 

180 of the chemical substance for a significant new use. For the benzidine-based chemical 

181 substances, the proposed elimination of the article exemption at § 721.45(f) would also require 

182 persons to notify EPA at least 90 days before commencing processing or importing as part of an 

183 article any of the currently-listed or newly-proposed benzidine-based chemical substances. The 

184 objectives and rationale for this proposed SNUR are explained in Unit VI. 

185 B. What is the Agency's Authority for Taking this Action? 

186 Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use 

187 of a chemical substance is a "significant new use." EPA must make this determination by rule 

188 after considering all relevant factors, including those listed in TSCA section 5(a)(2). These 

189 factors include: 

190 • The projected volume of manufacturing and processing of a chemical substance. 

191 • The extent to which a use changes the type or form of exposure of human beings 

192 or the environment to a chemical substance. 

193 • The extent to which a use increases the magnitude and duration of exposure of 

194 human beings or the environment to a chemical substance. 
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195 • The reasonably anticipated manner and methods of manufacturing, processing, 

196 distribution in commerce, and disposal of a chemical substance. 

197 Once EPA determines that a use of a chemical substance is a significant new use, TSCA 

198 section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at 

199 least 90 days before they manufacture, import, or process the chemical substance for that use (15 

200 U.S.C. 2604(a)(1)(B)). The general SNUR provisions are found at 40 CFR part 721, subpart A. 

201 C. Applicability of General Provisions

202 General provisions for SNURs appear under 40 CFR part 721, subpart A. These 

203 provisions describe persons subject to the rule, recordkeeping requirements, exemptions to 

204 reporting requirements, and applicability of the rule to uses occurring before the effective date of 

205 the final rule. 

206 Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), 

207 persons subject to SNURs must comply with the same notice requirements and EPA regulatory 

208 procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In 

209 particular, these requirements include the information submissions requirements of TSCA 

210 section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and 

211 (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a Significant New Use Notice 

212 (SNUN), EPA may take regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the 

213 activities on which it has received the SNUN. If EPA does not take action, EPA is required under 

214 TSCA section 5(g) to explain in the Federal Register its reasons for not taking action. 

215 However, § 721.45(f) (which generally exempts persons importing or processing a 

216 substance as part of an article) would not apply to benzidine-based chemical substances listed at 

217 40 CFR 721.1660 and those added by this proposed rule. Therefore, a person who imports or 

218 processes as part of an article a benzidine-based chemical substance that is covered by this 
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219 proposed rule would not be exempt from submitting a SNUN. 

220 Persons who export or intend to export a chemical substance identified in a proposed or 

221 final SNUR are subject to the export notification provisions of TSCA section 12(b). The 

222 regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons 

223 who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 

224 import certification requirements, codified at 19 CFR 12.118 through 12.127; see also 19 CFR 

225 127.28. Those persons must certify that the shipment of the chemical substance complies with 

226 all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy 

227 in support of import certification appears at 40 CFR part 707, subpart B. 

228 III. Overview of Benzidine-Based Chemical Substances 

229 A. What Additional Benzidine-Based Chemical Substances are Subject to this Proposed SNUR?

230 This proposed rule would add nine benzidine-based chemical substances to the list of 

231 twenty four chemical substances currently regulated under § 721.1660. The nine benzidine-based 

232 chemical substances covered by this proposed SNUR are listed in Table 1. The chemicals listed 

233 in Table 1 are identified by Chemical Abstract Service Registry Numbers (CAS number) or if the 

234 chemical’s CAS number is claimed confidential business information (CBI), the chemical is 

235 identified by an EPA Accession Number, along with its corresponding generic name. The 

236 accession numbers are EPA assigned numbers used to identify chemicals in place of confidential 

237 CAS numbers. Table 1 also indicates the availability of the Colour Index (C.I.) name and C.I. 

238 number, which is either not available or CBI for some of the chemicals subject to this rule. 

239 Persons who are interested in determining the precise identity of the chemical designated by a 

240 certain accession number and a generic name should submit a bonafide request to EPA that 

241 complies with the information requirements stipulated in § 721.11(b). 

242 Table 1—Benzidine-Based Chemical Substances 
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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-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 

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-Naphthalenedisulfonic 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 Phenylazoaminohydroxynaphthalenylazobip

henylazo substituted benzene sodium 

sulfonate. 

(Generic Name) 

243 

244 B. What Action has the Agency Previously Taken on Other Benzidine-Based Chemical 

245 Substances?

246 In 1996, EPA promulgated a TSCA section 5(a)(2) SNUR for the benzidine-based 

247 chemical substances listed at § 721.1660 (61 FR 52287, October 7, 1996). That rule considered 
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248 any use of the chemical substances except those listed in § 721.1660(a)(2) as a significant new 

249 use that requires a SNUN to be submitted to the Agency prior to manufacture, import, or 

250 processing of the listed chemical substances. Because they were identified as ongoing, the 

251 SNUR excluded as significant new uses the following uses: As a reagent to test for hydrogen 

252 peroxide in milk; a reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain in 

253 microscopy; as a reagent for detecting blood; and as an analytical standard. In addition, for 

254 Color Index (C.I.) Direct Red 28 (Congo Red) (CAS No. 573-58-0), use as an indicator dye was 

255 excluded as a significant new use. The SNUR did not require a SNUN to be submitted by 

256 persons that import or process a listed substance as part of an article. 

257 C. What is the Production Volume of Newly-Proposed and Currently-Listed Chemical 

258 Substances? 

259 For the newly proposed nine benzidine-based chemical substances, data reported to EPA for 

260 the 2006, 2002 and 1998 reporting cycles, as required by the TSCA Inventory Update Reporting 

261 (IUR) rule, indicate no evidence of production (including import). The IUR regulation requires 

262 manufacturers and importers of certain chemical substances to report site and manufacturing 

263 information for chemicals manufactured (including imported) in amounts of 25,000 pounds or 

264 greater at a single site (prior to 2006, reporting was for 10,000 pounds at a site). 

265 In addition, four of these benzidine-based chemicals were included in EPA’s Benzidine266 based Dyes Action Plan. The additional five chemicals were found in the confidential TSCA 

267 inventory. Designed as a part of a comprehensive approach to enhancing EPA’s Chemical 

268 Management Program, Action Plans summarize hazard, exposure, and use information; outline 

269 the potential risks that each chemical may pose; and identify the specific steps the Agency is 

270 considering to address those concerns (Ref. 1). 
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271 EPA received no public comments (EPA-HQ-OPPT-2010-0570 at 

272 http://www.regulations.gov) on this Action Plan that would provide any indication of ongoing 

273 manufacturing, importing, or processing of any of the nine benzidine-based chemical substances 

274 that are proposed for addition to the existing SNUR at § 721.1660. Finally, a general market 

275 review on these chemical substances indicates no current manufacture (Ref. 2) within or outside 

276 the United States. 

277 For the benzidine-based chemical substances currently listed at § 721.1660, data reported 

278 to EPA for the 2006, 2002 and 1998 reporting cycles, as required by the TSCA IUR rule, 

279 indicate no evidence of domestic production (including import) at IUR reportable levels. 

280 Further, EPA’s general market review on the currently listed benzidine-based chemical 

281 substances suggests that the majority of these chemical substances are not currently being 

282 manufactured domestically or abroad (Ref. 2). Although some of these substances appear to be 

283 manufactured for allowable uses within the United States at a level below current IUR reporting 

284 thresholds, and some substances appear to be manufactured outside the United States generally 

285 and may therefore potentially be imported as part of an article, EPA does not have information to 

286 suggest that the substances are being imported, for use as part of articles. In fact, the market 

287 review did not find evidence of any import of articles containing benzidine-based chemical 

288 substances. 

289 D. What are the Uses of These Benzidine-Based Chemical Substances? 

290 Historically, the benzidine-based chemical substances currently-listed at § 721.1660 were 

291 used as reagents, biological stains in laboratories, and in food industries. Note that TSCA 

292 section 3(2)(B)(vi) excludes foods, food additives, drugs, cosmetics or devices (as defined in the 

293 Federal Food, Drug, and Cosmetic Act) from the statutory definition of a “chemical substance” 

294 when such substances are manufactured, processed, or distributed in commerce for use as a food, 
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295 food additive, drug, cosmetic, or device. Additionally, these previously listed bezidine-based 

296 substances are believed to have been historically used as dyes in the textile industry. 

297 The nine newly-proposed benzidine-based chemical substances are believed to have been 

298 used in the past in the production of textiles, paints, printing inks paper, and pharmaceuticals. 

299 However, based on market information and the fact that the 2006 IUR had no production reports 

300 for the any of the benzidine-based chemical substances, if these chemical substances are used at 

301 all, they are likely used in small volumes, making it difficult to access current production and use 

302 information. 

303 E. What are the Potential Health Effects of These Chemicals? 

304 The 1980 EPA Preliminary Risk Assessment on derivatives of benzidine established that 

305 the primary hazard concern was for the carcinogenic effects to humans from exposure to specific 

306 metabolites of the chemical substances (Ref. 3). There is potential for benzidine-based chemical 

307 substances to metabolize to the parent benzidine molecule, which is a known carcinogen (Refs. 

308 4, 5, and 6). This metabolism occurs in humans by an enzyme-mediated reaction. These enzymes 

309 are found in the liver, in gut bacteria, and in skin bacteria. The result of this enzymatically-aided 

310 reduction is the release of the carcinogenic aromatic amine from the chemical substance. Studies 

311 have demonstrated that the reduction of benzidine-based chemical substances occurs in the 

312 human body as well as on the skin (Ref. 7). Therefore, the primary human health concern for 

313 consumers is exposure to the benzidine-based chemical substances through oral, dermal, or 

314 inhalation routes. Evidence from animal studies suggests that there is early life susceptibility to 

315 benzidine carcinogenesis (Ref. 8). Cancer potency for benzidine was substantially increased 

316 when the dose was given in early life as compared to adults (Ref. 8). For additional information 

317 see Benzidine-Based Chemical Substances; Significant New Uses of Certain Chemical 

318 Substances; Final Rule (61 FR 52287, October 7, 1996). 
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319 F. What are the Potential Routes and Sources of Exposures to These Chemicals? 

320 There are benzidine related exposure concerns as a result of the use of benzidine and 

321 benzidine-based chemical substances. In 1996, EPA identified inhalation, skin absorption, and 

322 ingestion as possible routes of exposure in a variety of settings where benzidine-based chemical 

323 substances are either manufactured or used (61 FR 52287, October 7, 1996). Although EPA 

324 estimated that the highest exposure would be to workers who were involved in dye 

325 manufacturing, EPA determined that it was necessary to apply the SNUR to any use of the listed 

326 benzidine-based chemical substances, with the exception of the limited uses mentioned in Unit 

327 II.A. EPA listed all the benzidine-based chemical substances that it was able to identify on the 

328 TSCA Inventory at that time. Since then, EPA has identified the nine additional benzidine-based 

329 chemical substances listed as part of Table 1 and has similar concerns about potential consumer 

330 and worker exposure to these substances. 

331 Dermal exposure can occur from the leaching of the chemical substances by sweat in 

332 contact with the dyed textiles (Ref. 7). Dermal exposure is also a concern since many of these 

333 chemical substances can be directly absorbed by the skin to some extent. It is well established 

334 that the enzymatically-aided dye reduction to the carcinogenic benzidine unit occurs internally in 

335 the liver and the gut (Refs. 9 and 10). Studies have shown that some human skin bacteria possess 

336 azo-reductases, the enzymes necessary to break down the benzidine-based chemical substances 

337 to release the carcinogenic amines, which can be more readily absorbed (Ref. 11). 

338 Consistent with the information on dermal absorption that EPA reviewed in developing 

339 its recent Benzidine-based Chemical Substances Action Plan (EPA-HQ-OPPT-2010-0570 at 

340 www.regulations.gov), EPA identified the following main routes of consumer exposure to 

341 benzidine-based chemical substances that are of concern: (1) Dermal absorption, the primary 

342 route from wearing dyed clothing or footwear; (2) oral ingestion, an additional route for babies 
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343 and young children who suck on clothing, blankets, and other non-food products which might 

344 contain any of the benzidine-base chemical substances; (3) inhalation exposure, a more prevalent 

345 route in occupational settings; however, it can also occur from the use of dyed inks during "air 

346 brushing" or from off-gassing from the dyed carpets to indoor air; and (4) contact with the 

347 benzidine-based chemical substances entering the environment, through the whole life cycle of 

348 benzidine-based chemical substances in textiles (Ref. 12). 

349 IV. Overview of DnPP 

350 A. What Chemical is Included in the Proposed SNUR?

351 This proposed SNUR would apply to DnPP (1,2-Benzenedicarboxylic acid, 1,2-dipentyl 

352 ester), CAS No. 131-18-0, an ortho-phthalate (or phthalate ester). 

353 B. What is the Production Volume of DnPP? 

354 No IUR production volume data were reported for DnPP during the 2006, 2002, 1998, 

355 and 1994 reporting cycles (Ref. 13). The last reporting of DnPP production to the IUR occurred 

356 in 1990 and corresponds to the lowest reportable production volume range (10,000 to 500,000 

357 pounds) (Ref. 13). 

358 DnPP was included in EPA’s Phthalates Action Plan. As stated in Unit III.C., the 

359 chemical action plans were designed as a part of a comprehensive approach to enhancing EPA’s 

360 Chemical Management Program. These action plans summarize available hazard, exposure, and 

361 use information; outline the risks that each chemical may present; and identify the specific steps 

362 the Agency is considering to address those concerns. EPA received no public comments 

363 submitted to the public docket for this Action Plan (EPA-HQ-OPPT-2010-0342 at 

364 http://www.regulations.gov) that would provide any indication of ongoing manufacturing, 

365 importing or processing of DnPP (Ref. 14). However, subsequent internet queries performed by 

366 EPA identified several companies that either use or sell DnPP as a chemical standard for 
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367 laboratory use. As a result, EPA is proposing a SNUR for DnPP, excluding use of the substance 

368 as a chemical standard for laboratory use.

369 C. What are the Uses of DnPP? 

370 DnPP belongs to a broad category of chemicals commonly referred to as phthalates. 

371 Although a number of phthalates are in common use, EPA believes the individual phthalate 

372 DnPP is not in general use in the United States, and only has a limited application as a chemical 

373 standard for laboratory use. As a chemical category, the major use of phthalates is as plasticizers 

374 (Refs. 15-23) especially in polyvinyl chloride (PVC) products, where they are added to impart 

375 flexibility and other desirable properties. Phthalate-containing PVC products include a variety of 

376 industrial and commercial products, as well as specialized medical and dental applications. The 

377 particular phthalate or combination of phthalates used in a specific product’s formulation 

378 depends on the properties the phthalates impart, as well as their cost. 

379 D. What are the Potential Health and Environmental Effects of DnPP? 

380 1. Human health effects. Exposures of some phthalates in animal studies resulted in 

381 phthalate syndrome effects, which consist of changes in the fetal development of the 

382 reproductive system (Refs. 15-22 and 24-35). The phthalates that are the most potent at causing 

383 phthalate syndrome effects are generally those with linear ester side chains having 4-6 carbons 

384 (Ref. 24). DnPP has a linear carbon chain length of 5 carbons. Of the phthalates studied, DnPP is 

385 the most potent in producing testicular toxicity in pubertal animals (Ref. 24). 

386 Developmental oral exposures in rats to DnPP showed increased resorptions, increased 

387 fetal mortality, and decreased fetal testicular testosterone production (Refs. 36 and 37); and 

388 reduced anogenital distance in male rat offspring (Ref. 38). Effects noted in adult mice exposed 

389 to DnPP include decreased body weight; increased liver weights; decreased kidney weights; 

390 decreases in the weights of the epididymis, cauda epididymis, testes, and seminal vesicles; 
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391 complete absence of detectable sperm; shorter average estrous cycle length in females; and 

392 decreased fertility (Refs. 39 and 40). Gross and microscopic evidence of degenerative changes 

393 have been observed in the testes and epididymis (including testicular atrophy, interstitial cell 

394 hyperplasia, degeneration of the seminiferous tubules, and accumulation of fluid and degenerated 

395 cells in the epididymis) of rodents (Refs. 39 and 40). There are no subchronic or chronic animal 

396 studies of DnPP exposure through any exposure route. 

397 There are no known human studies of exposure to DnPP. However, due to the data 

398 discussed in this section and DnPP’s general structure and categorization as a phthalate, EPA is 

399 concerned that human health effects of DnPP exposure may be similar to that observed for some 

400 other phthalates. Several human studies have reported associations of exposure of some other 

401 phthalates with adverse reproductive outcomes and developmental effects similar to those in the 

402 rat, although no causal link has been established (Refs. 24 and 41-50). The reproductive 

403 developmental effects of some phthalates observed in humans include shortened anogenital 

404 distance observed in newborn boys, shortened pregnancy, lower sex and thyroid hormones, and 

405 reduced sperm quality in adults; however, some studies failed to show these effects (Ref. 42). 

406 Since the pathway for sexual differentiation in the fetus is highly conserved in all mammals, the 

407 reproductive and developmental effects observed in the rat studies are potentially relevant to 

408 humans. 

409 Studies in animals evaluating the cumulative effects of combinations of phthalates on 

410 testosterone fetal mortality, and male and female reproductive development later in life have 

411 demonstrated all mixtures were cumulative for all endpoints (Refs. 36-37 and 51-55). The 

412 reproductive effects of DnPP observed in animal studies, the reproductive effects of other 

413 phthalates observed in humans, and the data on the cumulative effects of mixtures of phthalates, 

414 support EPA’s concern for potential human health hazards following exposure to DnPP. 
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415 2. Environmental effects. EPA does not know of any studies of the environmental 

416 effects of DnPP. Due to the general structure of DnPP, its behavior in an aquatic environment 

417 similar to the close analog mono 2-ethylhexyl phthalate, its log Kow, and water solubility 

418 measurements, and its categorization as a phthalate, EPA is concerned that the environmental 

419 effects of DnPP may be similar to those of other phthalates studied. Other phthalates studied 

420 have been shown to have biological effects in all studied animal groups and have been observed 

421 at environmentally relevant exposures in the nanogram/liter to microgram/liter range. The 

422 combination of the inherent toxicity, variable solubility, log of the octanol-water coefficient 

423 values, and bioconcentration factor (BCF) values among the studied phthalates elicit both acute 

424 and chronic toxicity to aquatic and terrestrial wildlife by targeting thyroid function, liver 

425 function, reproduction, and other physiological mechanisms (Refs. 31-35, 56 and 57). 

426 E. What are the Potential Routes and Sources of Exposure to DnPP? 

427 1. Human exposure. Data from the National Health and Nutrition Examination Survey 

428 (NHANES) indicates widespread exposure of the general population to various phthalates (Ref. 

429 58). Phthalates are used in a wide array of plastic products and may be released into the 

430 environment during use and disposal of these products (Ref. 58). Biomonitoring data from 

431 amniotic fluid and urine have demonstrated that humans are exposed to various phthalates in 

432 utero, as infants, during puberty, and in adult life; and that people are exposed to several 

phthalates at once. The urinary metabolites of DnPP were not specifically included in the 4th 433 

434 National Report on Human Exposure to Environmental Chemicals (2010), so EPA cannot draw 

435 conclusions as to the current exposure of the general population in the United States to DnPP. 

436 2. Environmental exposure. Due to phthalates pervasive use and release, as well as their 

437 propensity for global transport, various phthalates may be found in most environmental media, 

438 including ambient air, surface water, soil, and sediment (Refs. 25-32 and 34-35). Fish and other 
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439 aquatic organisms, as well as terrestrial animals have evidenced exposure to a common 

440 phthalate: di-(2-ethylhexyl) phthalate (DEHP) (Refs. 34 and 57). EPA does not have available 

441 data on environmental exposures to DnPP. 

442 V. Overview of Alkanes, C12-13, Chloro (CAS No. 71011-12-6)

443 A. What Chemical is Included in the Proposed SNUR? 

444 This proposed SNUR would cover alkanes, C12-13, chloro (CAS No. 71011-12-6), one 

445 type of short-chain chlorinated paraffin (SCCP). This consists of C12 and C13 alkanes with 

446 varying degrees of chlorination. 

447 B. What is the Production Volume of Alkanes, C12-13, chloro (CAS No. 71011-12-6)? 

448 No production volumes for alkanes, C12-13 chloro (CAS No. 71011-12-6) were reported to 

449 the IUR during the 2006, 2002, 1998 and 1994 reporting cycles, and EPA found no additional 

450 evidence of any importation or manufacturing of the chemical. 

451 Alkanes, C12-13, chloro (CAS No. 71011-12-6) was included in EPA’s Short-Chain 

452 Chlorinated Paraffins (SCCPs) and Other Chlorinated Paraffins Action Plan (Ref. 59). As stated in 

453 Unit III.C., the chemical action plans were designed as a part of a comprehensive approach to 

454 enhancing EPA’s Chemical Management Program. These action plans summarize available 

455 hazard, exposure, and use information; outline the risks that each chemical may present; and 

456 identify the specific steps the Agency is considering to address those concerns. EPA received no 

457 public comments submitted to the public docket for this Action Plan (EPA-HQ-OPPT-2010-

458 0334 at http://www.regulations.gov) that would provide any indication of ongoing 

459 manufacturing, importing or processing of Alkanes, C12-13, chloro (CAS No. 71011-12-6) (Ref. 

460 59). 

461 C. What Were the Uses of this SCCP? 

462 Alkanes, C12-13, chloro (CAS No. 71011-12-6) is an individual chemical substance that 
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463 belongs to a category of chemicals referred to as short-chain chlorinated paraffins (SCCPs). 

464 There are many different chemical substances that are members of the SCCP category. 

465 Generally these SCCPs have between 10 and 13 carbon atoms and contain 40 – 70 percent 

466 chlorine by weight. Of the different SCCPs that are listed on the TSCA Inventory, EPA believes 

467 the SCCP named “Alkanes, C12-13, chloro (CAS No. 71011-12-6)” is not in use in the United 

468 States and EPA has found no information that indicates it has ever been used. All of the data 

469 discussed in this section associated with the SCCPs general category would pertain to any 

470 individual member of that category, including alkanes, C12-13, chloro (CAS No. 71011-12-6).

471 D. What are the Potential Environmental Effects of Alkanes, C12-13, chloro (CAS No. 71011-12-

472 6)? 

473 The primary concern for SCCPs is ecotoxicity. There are data specifically on the 

474 ecotoxicity of alkanes, C12-13, chloro (CAS No. 71011-12-6). Alkanes, C12-13, chloro (CAS No. 

475 71011-12-6) are highly toxic to aquatic invertebrates following acute and chronic exposures. In 

476 fish, this high toxicity is associated with chronic exposures, but not for acute exposures. For 

477 aquatic plants, there is high toxicity associated with both acute and chronic exposures to SCCPs 

478 in general (Ref. 60). 

479 Both Health Canada and Environment Canada have characterized all chlorinated 

480 paraffins (short chain chlorinated paraffins, medium chain chlorinated paraffins, and long chain 

481 chlorinated paraffins), which include the chemical substance covered by this proposed rule, as 

482 “toxic” under the Canadian Environmental Protection Act (CEPA) (Ref. 61). Their assessment 

483 found that these SCCPs have or may have an immediate or long term harmful effect on the 

484 environment or its biological diversity; and that they are persistent, bioaccumulative, inherently 

485 toxic and present in the environment primarily as a result of human activity (Ref. 61). 

486 E. What are the Potential Routes and Sources of Exposure to Alkanes, C12-13, Chloro (CAS No. 
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487 71011-12-6)? 

488 The mechanisms or pathways by which the SCCPs, including alkanes, C12-13, chloro 

489 (CAS No. 71011-12-6), move into and through the environment and humans are not fully 

490 understood, but are likely to include releases from manufacturing of the chemicals, 

491 manufacturing of products like plastics or textiles, aging and wear of products like sofas and 

492 electronics, and releases at the end of product life (e.g., disposal, recycling). 

493 EPA has concerns regarding the environmental fate and the exposure pathways that lead 

494 to any SCCP presence, including C12 and C13 SCCPs (for example, Alkanes, C12-13, Chloro 

495 (CAS No. 71011-12-6)), in a variety of biota, including freshwater aquatic species, marine 

496 mammals, and avian and terrestrial wildlife (Ref. 60). In addition, SCCPs, including C12 and 

497 C13 SCCPs, have been detected in samples of human breast milk from Canada and the United 

498 Kingdom, as well as in a variety of food items from Japan and various regions of Europe (Ref. 

499 60). SCCPs are routinely found in soil and sediment samples. EPA also has concerns about the 

500 persistence, bioaccumulation, and toxicity (PBT) of SCCPs (Ref. 60). 

501 VI. Rationale and Objectives 

502 A. Rationale

503 Consistent with EPA’s past practice for issuing SNURs under TSCA Section 5(a)(2), 

504 EPA’s decision to propose a SNUR for a particular chemical use need not be based on an 

505 extensive evaluation of the hazard, exposure, or potential risk associated with that use. Rather, 

506 the Agency’s action is based on EPA’s determination that if the use begins or resumes, it may 

507 present a risk that EPA should evaluate under TSCA before the manufacturing or processing for 

508 that use begins. Since the new use does not currently exist, deferring a detailed consideration of 

509 potential risks or hazards related to that use is an effective use of resources. If a person decides 

510 to begin manufacturing or processing the chemical for the use, the notice to EPA allows EPA to 
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511 evaluate the use according to the specific parameters and circumstances surrounding that 

512 intended use. 

513 1. Benzidine-based Chemical Substances. As summarized in Unit III, EPA is concerned 

514 about potential carcinogenic effects on workers and consumers from the manufacture, 

515 processing, importing, or use of these substances. Consumers exposed via dermal exposure to 

516 consumer products containing the benzidine-based chemical substances are a particular concern 

517 because enzymes present in the human body and in bacteria on the skin aid in the reduction of 

518 these chemical substances to the benzidine unit, an established human carcinogen (Ref. 8). The 

519 main consumer products that could result in dermal exposure if containing these chemical 

520 substances include textiles and leather products because they are in prolonged contact with 

521 human skin. 

522 During the review of information on benzidine-based chemical substances, EPA 

523 determined that the newly identified chemical substances covered by this proposed rule present 

524 the same concerns (Ref. 1) as those of the benzidine-based chemical substances currently listed 

525 under § 721.1660. However, based on a review of IUR data and a separate market review, EPA 

526 does not believe there is any current manufacture of these nine benzidine-based chemical 

527 substances within or outside the United States. 

528 In addition, as discussed earlier, although some of the currently listed benzidine-based 

529 chemical substances may be manufactured or processed outside the United States, EPA does not 

530 have specific information that suggests they are entering into the United States in imported 

531 articles (Ref. 4). In fact, an analysis of the benzidine-based chemical substances market (Ref. 2) 

532 revealed no information indicating import of articles containing benzidine-based chemical 

533 substances for non-excluded purposes. Supporting a conclusion that there is no import of textile 

534 articles containing benzidine-based chemical substances, the American Apparel and Footwear 
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535 Association, the national trade association representing apparel, footwear, and other sewn 

536 products companies and their suppliers, which compete in the global market, includes benzidine 

537 on its Restricted Substances List (RSL) (Ref. 62). The RSL is a compilation of chemicals, 

538 regulated or banned, that are used by apparel and footwear industries. 

539 Although it appears there is no ongoing manufacture of the nine newly proposed 

540 benzidine-based chemical substances, or import for a non-excluded use of articles containing any 

541 benzidine-based chemical substances, the manufacture (including import) or processing of the 

542 nine newly proposed benzidine-based chemical substances and the import or processing of 

543 articles containing any benzidine-based chemical substances may begin at any time, without 

544 prior notice to EPA. Thus, EPA is concerned that commencement of the manufacture, import or 

545 processing for any new uses, including resumption of past uses, of benzidine-based chemical 

546 substances could significantly increase the magnitude and duration of exposure to humans over 

547 that which would otherwise exist currently. EPA is concerned that such an increase should not 

548 occur without an opportunity to evaluate activities associated with a significant new use and an 

549 opportunity to protect against potential unreasonable risks, if any, from exposure to the chemical 

550 substance. 

551 Therefore, EPA is proposing a SNUR for the nine benzidine-based chemical substances 

552 by adding them to those currently listed at 40 CFR § 721.1660, and to make inapplicable the 

553 article exemption at 40 CFR § 721.45(f) for those chemical substances newly proposed in this 

554 rulemaking as well as for those already listed at 40 CFR § 721.1660. If finalized, a person who 

555 intends to manufacture (including import) or process any of the benzidine-based chemical 

556 substances for a non-excluded use, or to import or process any listed benzidine-based chemical 

557 substance for a non-excluded use, would be required to submit a SNUN. 
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558 2. DnPP. As summarized in Unit IV., EPA has concerns regarding potential adverse 

559 human health and environmental effects that may be caused by DnPP. EPA has direct 

560 information from animal studies that DnPP specifically can elicit developmental/reproductive 

561 effects that are relevant to human health and also indicate potential effects in wildlife. EPA also 

562 is concerned that due to its general structure and categorization as a phthalate that DnPP may 

563 elicit adverse environmental effects similar to those described for other phthalates. EPA is 

564 concerned that any manufacturing (including import) or processing of DnPP, beyond that for its 

565 limited ongoing use as a chemical standard for laboratory use, could significantly increase the 

566 magnitude and duration of exposure to humans over that which would otherwise exist currently. 

567 EPA is concerned that such an increase should not occur without an opportunity to evaluate 

568 activities associated with a significant new use and an opportunity to protect against potential 

569 unreasonable risks, if any, from exposure to the chemical substance. Therefore, EPA is 

570 proposing a SNUR for DnPP that would designate, as a significant new use, any use of the 

571 chemical substance other than as a chemical standard for laboratory use. If finalized, a person 

572 who intends to manufacture, import or process DnPP for use other than as a chemical standard 

573 for laboratory use would be required to submit a SNUN. 

574 3. Alkanes, C12-13, chloro (CAS No. 71011-12-6). The mechanisms or pathways by 

575 which the SCCPs, including alkanes, C12-13, chloro (CAS No. 71011-12-6), move into and 

576 through the environment and humans are not fully understood, but are likely to include releases 

577 from manufacturing of the chemicals, manufacturing of products like plastics or textiles, aging 

578 and wear of products like sofas and electronics, and releases at the end of product life (e.g., 

579 disposal, recycling). 

580 EPA believes that all manufacture, processing, and import into the United States of 

581 alkanes, C12-13, chloro (CAS No. 71011-12-6) has ceased. Given EPA has no evidence to 
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582 suggest that there is any manufacture, processing, or importation of this chemical substance in 

583 the United States, and taking into consideration the negative commercial and regulatory 

584 environment associated with this chemical internationally (including the EU and Canadian ban 

585 on marketing) and use of the alkanes, C12-13, chloro (CAS No. 71011-12-6) domestically, EPA 

586 does not expect to find such activity. However, EPA is concerned that commencement of the 

587 manufacture, import or processing for any new uses, including resumption of past uses, could 

588 significantly increase the magnitude and duration of exposure to humans over that which would 

589 otherwise exist. EPA is concerned that such an increase should not occur without an opportunity 

590 to evaluate activities associated with a significant new use and an opportunity to protect against 

591 potential unreasonable risks, if any, from exposure to the chemical substance. Therefore, EPA is 

592 proposing a SNUR for alkanes, C12-13, chloro (CAS No. 71011-12-6) that would designate as a 

593 significant new use any use of the chemical substance. If finalized, a person who intends to 

594 manufacture, import or process alkanes, C12-13, chloro (CAS No. 71011-12-6) for any use would 

595 be required to submit a SNUN. 

596 EPA is requesting comment on whether any of the significant new uses identified are 

597 currently ongoing. However, if EPA determines, based on comments on this proposed rule or on 

598 other information the Agency identifies, that any proposed significant new use of any of the 

599 chemical substances has been ongoing (including, in the case of benzidine-based chemical 

600 substances, that an article containing benzidine-based chemical substances was being imported 

601 or processed) prior to date of publication of the final rule, EPA would exclude such ongoing uses 

602 from the final SNUR and consider pursuing other regulatory action, as appropriate. 

603 B. Objectives 

604 Based on the considerations in Unit VI.A.1-3, EPA wants to achieve the following 

605 objectives with regard to the significant new use(s) that are designated in this proposed rule: 
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606 1. EPA would receive notice of any person’s intent to manufacture or process the 

607 specified chemicals for the described significant new uses before that activity begins; 

608 2. EPA would have an opportunity to review and evaluate data submitted in a 

609 SNUN before the notice submitter begins manufacturing or processing of the specified chemicals 

610 for the described significant new use; and 

611 3. EPA would be able to regulate prospective uses of the specified chemicals before the 

612 described significant new uses occur, provided that regulation is warranted pursuant to TSCA 

613 sections 5(e), 5(f), 6 or 7. 

614 VII. Significant New Use Determination 

615 Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical 

616 substance is a significant new use must be made after consideration of all relevant factors 

617 including: 

618 • The projected volume of manufacturing and processing of a chemical substance. 

619 • The extent to which a use changes the type or form of exposure of human beings or the 

620 environment to a chemical substance. 

621 • The extent to which a use increases the magnitude and duration of exposure of human 

622 beings or the environment to a chemical substance. 

623 • The reasonably anticipated manner and methods of manufacturing, processing, 

624 distribution in commerce, and disposal of a chemical substance. 

625 In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes 

626 EPA to consider any other relevant factors. 

627 To determine what would constitute a significant new use of the benzidine-based 

628 chemical substances subject to this proposed rule, DnPP and the alkanes, C12-13, chloro (CAS No. 

629 71011-12-6), as discussed herein, EPA considered relevant information about the toxicity of 
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630 these substances, likely human exposures and environmental releases associated with possible 

631 uses, and the four factors listed in section 5(a)(2) of TSCA. EPA has preliminarily determined 

632 that the manufacture, import, processing, or import or processing as part of an article of any of 

633 the benzidine-based chemical substances subject to this proposed rule, except ongoing uses 

634 specified in § 721.1660(a)(2)(i) of the regulatory text in this document, is a significant new use. 

635 EPA has also preliminarily determined that the manufacture, import, or processing of DnPP for 

636 any use other than as a chemical standard for laboratory use is a significant new use, and the 

637 manufacture, processing, or import of alkanes, C12-13, chloro (CAS No. 71011-12-6) for any use 

638 is a significant new use. 

639 VIII. Request for Public Comment 

640 EPA welcomes comments on any aspect of this proposed SNUR. Information available 

641 about environmental effects, health effects, and exposure would be beneficial. EPA is also 

642 requesting public comment on whether there are any ongoing uses of any of these chemicals for 

643 the proposed significant new uses, and would welcome specific information that documents such 

644 uses. 

645 IX. Alternatives 

646 Before proposing these SNURs, EPA considered the following alternative regulatory 

647 actions: 

648 A. Promulgate a TSCA Section 8(a) Reporting Rule 

649 Under a TSCA section 8(a) rule, EPA could, among other things, generally require 

650 persons to report information to the Agency when they intend to manufacture, import, or process 

651 a listed chemical for a specific use or any use. However, for the chemical substances subject to 

652 this proposed rule, the use of TSCA section 8(a) rather than SNUR authority would have several 

653 limitations. First, if EPA were to require reporting under TSCA section 8(a) instead of TSCA 
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654 section 5(a), EPA would not have the opportunity to review human and environmental hazards 

655 and exposures associated with the proposed significant new use and, if necessary, take 

656 immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) to prohibit or limit the 

657 activity before it begins. In addition, EPA may not receive important information from small 

658 businesses, because such firms generally are exempt from TSCA section 8(a) reporting 

659 requirements. In view of the level of health and environmental concerns about the chemicals 

660 subject to this proposed rule if used for the proposed significant new uses, EPA believes that a 

661 TSCA section 8(a) rule for this substance would not meet EPA's regulatory objectives. 

662 B. Regulate Under TSCA Section 6 

663 EPA may regulate under TSCA section 6 if "the Administrator finds that there is a 

664 reasonable basis to conclude that the manufacture, processing, distribution in commerce, use or 

665 disposal of a chemical substance or mixture presents or will present an unreasonable risk of 

666 injury to health or the environment." (TSCA section 6(a)). Given that the benzidine-based 

667 chemical substances subject to this proposed rule are no longer being used except as provided in 

668 the regulatory text of this document, DnPP is no longer being used except as a chemical standard 

669 for laboratory use, and alkanes, C12-13, chloro (CAS No. 71011-12-6) is no longer used in the 

670 United States, EPA concluded that risk management action under TSCA section 6 is not 

671 necessary at this time. This proposed SNUR would allow the Agency to address the potential 

672 risks associated with the proposed significant new uses. If EPA learns that these chemicals are in 

673 use, EPA may reconsider this decision and pursue additional regulatory action as appropriate. 

674 X. Applicability of Proposed Rule to Uses Occurring Before Effective Date of the Final 

675 Rule 

676 As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided 

677 that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant 
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678 new use as of the date of publication of the proposed rule rather than as of the effective date of 

679 the final rule. If uses begun after publication of the proposed rule were considered ongoing rather 

680 than new, it would be difficult for EPA to establish SNUR notice requirements, because a person 

681 could defeat the SNUR by initiating the proposed significant new use before the rule became 

682 final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, 

683 persons who begin the commercial manufacture, import, or processing of a covered substance as 

684 a significant new use have to cease any such activity as of the effective date of the rule if and 

685 when finalized. To resume their activities, these persons would have to comply with all 

686 applicable SNUR notice requirements and wait until the notice review period, including all 

687 extensions, expires. EPA has promulgated provisions to allow persons to comply with this 

688 SNUR before the effective date. If a person were to meet the conditions of advance compliance 

689 under 40 CFR § 721.45(h), that person would be considered to have met the requirements of the 

690 final SNUR for those activities. 

691 XI. Test Data and Other Information 

692 EPA recognizes that TSCA section 5 does not require developing any particular test data 

693 before submission of a SNUN. There are two exceptions: 1) Development of test data is required 

694 where the chemical substance subject to the SNUR is also subject to a test rule under TSCA 

695 section 4 (see TSCA section 5(b)(1)); and 2) development of test data may be necessary where 

696 the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). 

697 In the absence of a section 4 test rule or a section 5(b)(4) listing covering the chemical substance, 

698 persons are required only to submit test data in their possession or control and to describe any 

699 other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); § 721.25, and 

700 §720.50). However, as a general matter, EPA recommends that SNUN submitters include data 

701 that would permit a reasoned evaluation of risks posed by the chemical substance during its 
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702 manufacture, import, processing, use, distribution in commerce, or disposal. EPA encourages 

703 persons to consult with the Agency before submitting a SNUN. As part of this optional pre704 notice consultation, EPA would discuss specific data it believes may be useful in evaluating a 

705 significant new use. SNUNs submitted for significant new uses without any test data may 

706 increase the likelihood that EPA would take action under TSCA section 5(e) to prohibit or limit 

707 activities associated with this chemical. 

708 SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that 

709 provide detailed information on: 

710 1. Human exposure and environmental releases that may result from the significant new 

711 uses of the chemical substance. 

712 2. Potential benefits of the chemical substance. 

713 3. Information on risks posed by the chemical substances compared to risks posed by 

714 potential substitutes. 

715 XII. SNUN Submissions 

716 According to 40 CFR § 721.1(c), persons submitting a SNUN must comply with the same 

717 notice requirements and EPA regulatory procedures as persons submitting a PMN, including 

718 submission of test data on health and environmental effects as described in § 720.50. SNUNs 

719 must be on EPA Form No. 7710–25, generated using e-PMN software, and submitted to the 

720 Agency in accordance with the procedures set forth in §§ 721.25 and 720.40. E-PMN software is 

721 available electronically at http://www.epa.gov/opptintr/newchems. 

722 XIII. Economic Analysis 

723 A. SNUNs 

724 EPA has evaluated the potential costs of establishing SNUR reporting requirements for 

725 potential manufacturers and processors of these chemicals and for articles containing any of the 
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726 benzidine-based chemical substances included in this proposed rule. These economic analyses, 

727 which are briefly summarized here, are available in the docket for this proposed rule. 

728 The costs of submission of a SNUN would be incurred when a company decides to 

729 pursue a significant new use of one of these chemicals. In the event that a SNUN is submitted, 

730 costs are estimated at approximately $8,112 per SNUN submission, and include the cost for 

731 preparing and submitting the SNUN, recordkeeping, and the payment of a user fee. Businesses 

732 that submit a SNUN are either subject to a $2,500 user fee required by § 700.45(b)(2)(iii), or, if 

733 they are a small business with annual sales of less than $40 million when combined with those of 

734 the parent company (if any), a reduced user fee of $100 (§ 700.45(b)(1)). In its evaluation of this 

735 proposed rule, EPA also considered the potential costs a company might incur by avoiding or 

736 delaying the significant new use in the future, but these costs have not been quantified. 

737 B. Export Notification 

738 EPA regulations under TSCA section 12(b) (15 U.S.C. 2611(b)) at § 707 subpart D 

739 require that, for chemicals subject to a proposed or final SNUR, a company notify EPA of the 

740 first export or intended export to a particular country of an affected chemical substance. EPA 

741 estimated that the one-time cost of preparing and submitting an export notification to be $78.54. 

742 The total costs of export notification would vary per chemical, depending on the number of 

743 required notifications (i.e., number of countries to which the chemical is exported). 

744 XIV. References 

745 As indicated under ADDRESSES, a docket has been established for this proposed rule 

746 under docket ID number EPA–HQ–OPPT–2010-0573. The following is a listing of the 

747 documents that have been placed in the docket for this proposed rule. The docket includes 

748 information considered by EPA in developing this proposed rule, including the documents listed 

749 in this unit, which are physically located in the docket. In addition, interested parties should 
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750 consult documents that are referenced in the documents that EPA has placed in the docket, 

751 regardless of whether these referenced documents are physically located in the docket. For 

752 assistance in locating documents that are referenced in documents that EPA has placed in the 

753 docket, but that are not physically located in the docket, please consult either technical person 

754 listed under FOR FURTHER INFORMATION CONTACT. The docket is available for 

755 review as specified under ADDRESSES. 

756 1. U.S. EPA, 2010. U.S. Environmental Protection Agency. Chemical Substances Derived from 

757 Benzidine and Its Congeners, 

758 http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/DCB%20Action%20Plan_06232010.no

759 header.pdf (Accessed January 24, 2011). 

760 2. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/ Economics, Exposure, and 

761 Technology Division. “Economic Analysis to Support the Proposed SNUR for Benzidine and 

762 Benzidine-based Chemical substances,'' (May 24, 2011). 

763 3. EPA. 1980. Preliminary Risk Assessment: Phase I. Benzidine, its congeners, and their 

764 derivative dyes and pigments. EPA-560/11-80-019, June 1980. 

765 4. IARC (1982). Some industrial chemicals and dyestuffs. IARC monographs on the evaluation 

766 of carcinogenic risk of chemicals to humans, Suppl.7, International Agency for Research on 

767 Cancer, Lyon, France. 

768 5. IARC (1987). Overall evaluation of carcinogenicity. IARC monographs on the evaluation of 

769 carcinogenic risk of chemicals to humans, vol.29, International Agency for Research on Cancer 

6. Report on Carcinogens, 11th 770 ed. (2008). http://ntp.niehs.nih.gov/?objectid=035E5806-F735-

771 FE81-FF769DFE5509AF0A

772 7. Golka, K., Kopps, S., Myslak, Z.W. 2004. Carcinogencitiy of azo colorants: influence of 

773 solubility and bioavailability. Tox Lett 151:203-210. 
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774 8. EPA. 2005. Supplemental Guidance for Assessing Susceptibility from Early Life Exposure 

775 to Carcinogens. EPA 630/R-03/003F, March 2005. 

776 9. Levine, W.G. (1991). Metabolism of azo dyes: implication for detoxification and activation. 

777 Drug Metab. Rev. 23(3&4):253-309. 

778 10. Platzek, T., Lang, C.; Grohmann, G., Giu, -S.; Baltes, W. (1999). Formation of a 

779 carcinogenic aromatic amine from an azo dye by human skin bacteria in vitro. Human & 

780 Experimental Toxicology, 18: 552-559. 

781 11. Stingley, R., Zou, W., Heinze, T., Chen, H. and Cerniglia, C. 2009. Metabolism of azo dyes 

782 by human skin microbiota. J Med Microbiol (2009), DOI: 10.1099/jmm.0.012617-0 

783 12. NIOSH, Special Occupational Hazard Review for Benzidine-Based Dyes (1980). 

784 13. U.S. EPA, 2009. U.S. Environmental Protection Agency. Inventory Update Reporting IUR: 

785 Non Confidential IUR Production Volume Data 1986-2002. Available at: 

786 http://www.epa.gov/oppt/iur/tools/data/2002-vol.html (Updated October 26, 2009). 

787 14. U.S. EPA, 2010. U.S. Environmental Protection Agency. Phthalates Action Plan. 

788 http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/phthalates.html (Accessed January 

789 24, 2011). 

790 15. Australian Government, 2008a. Existing Chemical Hazard Assessment Report for 

791 Butylbenzyl Phthalate. Department of Health and Ageing, National Industrial Chemicals 

792 Notification and Assessment Scheme (NICNAS): Sydney, Australia. Available at: 

793 http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 

794 16. Australian Government, 2008b. Existing Chemical Hazard Assessment Report for Dibutyl 

795 Phthalate. Department of Health and Ageing, National Industrial Chemicals Notification and 

796 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 

797 http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 
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798 17. Australian Government, 2008c. Existing Chemical Hazard Assessment Report for 

799 Diethylhexyl Phthalate. Department of Health and Ageing, National Industrial Chemicals 

800 Notification and Assessment Scheme (NICNAS): Sydney, Australia. Available at: 

801 http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 

802 18. Australian Government, 2008d. Existing Chemical Hazard Assessment Report for Diisobutyl 

803 Phthalate. Department of Health and Ageing, National Industrial Chemicals Notification and 

804 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 

805 http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 

806 19. Australian Government, 2008e. Existing Chemical Hazard Assessment Report for Diisodecyl 

807 Phthalate. Department of Health and Ageing, National Industrial Chemicals Notification and 

808 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 

809 http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 

810 20. Australian Government, 2008f. Existing Chemical Hazard Assessment Report for Diisonoyl 

811 Phthalate. Department of Health and Ageing, National Industrial Chemicals Notification and 

812 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 

813 http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 

814 21. Australian Government, 2008g. Existing Chemical Hazard Assessment Report for Di-n-octyl 

815 Phthalate. Department of Health and Ageing, National Industrial Chemicals Notification and 

816 Assessment Scheme (NICNAS): Sydney, Australia. Available at: 

817 http://www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 

818 22. Australian Government, 2008h. Phthalates Hazard Compendium. A Summary of 

819 Physicochemical and Human Health Hazard Data for 24 Ortho-Phthalate Chemicals. 

820 Department of Health and Ageing, National Industrial Chemicals Notification and Assessment 

821 Scheme (NICNAS): Sydney, Australia. Available at: 
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822 www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 

823 23. HSDB, 2009. Hazardous Substance Data Bank. U.S. National Library of Medicine TOXNET 

824 System. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB (accessed Aug 13, 2009). 

825 24. NAS, 2008. National Academy of Sciences. Phthalates and Cumulative Risk Assessment: 

826 The Tasks Ahead. 

827 25. NTP-CERHR, 2003a. Monograph on the Potential Human Reproductive and Developmental 

828 Effects of Di-n -Butyl Phthalate (DBP). U.S. Department of Health and Human Services. 

829 Available at: http://cerhr.niehs.nih.gov/evals/phthalates/dbp/dbp.html 

830 26. NTP-CERHR, 2003b. National Toxicology Program - Center for the Evaluation of Risks to 

831 Human Reproduction. Monograph on the Potential Human Reproductive and Developmental 

832 Effects of Butyl Benzyl Phthalate (BBP); NIH Pub. No. 03-4487; U.S. Department of Health and 

833 Human Services. Available at:http://cerhr.niehs.nih.gov/evals/phthalates/bb-phthalate/bb834 phthalate.html . 

835 27. NTP-CERHR, 2003c. National Toxicology Program - Center for the Evaluation of Risks to 

836 Human Reproduction. Monograph on the Potential Human Reproductive and Developmental 

837 Effects of Di-n-Octyl Phthalate (DnOP); NIH Pub. No. 03-4488; U.S. Department of Health and 

838 Human Services. Available at: http://cerhr.niehs.nih.gov/evals/phthalates/dnop/dnop.html . 

839 28. NTP-CERHR, 2003d. National Toxicology Program - Center for the Evaluation of Risks to 

840 Human Reproduction. Monograph on the Potential Human Reproductive and Developmental 

841 Effects of Diisononyl Phthalate (DINP); U.S. Department of Health and Human Services. 

842 Available at: http://cerhr.niehs.nih.gov/evals/phthalates/dinp/dinp.html. 

843 29. NTP-CERHR, 2003e. National Toxicology Program - Center for the Evaluation of Risks to 

844 Human Reproduction. Monograph on the Potential Human Reproductive and Developmental 

845 Effects of Di-Isodecyl Phthalate (DIDP); NIH Pub. No. 03-4485; U.S. Department of Health and 
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846 Human Services. Available at: http://cerhr.niehs.nih.gov/evals/phthalates/didp/didp.html . 

847 30. NTP-CERHR, 2006. National Toxicology Program - Center for the Evaluation of Risks to 

848 Human Reproduction. Monograph on the Potential Human Reproductive and Developmental 

849 Effects of Di-(2-ethylhexyl) Phthalate (DEHP); NIH Pub. No. 06-4476; U.S. Department of 

850 Health and Human Services. Available at: 

851 http://cerhr.niehs.nih.gov/evals/phthalates/dehp/dehp.html . 

852 31. EC, 2003a. European Commission. European Union Risk Assessment Report: 1,2-

853 Benzenedicarboxylic Acid, Di-C8-10-Branched Alkyl Esters, C9-Rich And Di-“Isononyl” 

854 Phthalate [DINP], CAS-Nos. 68515-48-0, 28553-12-0. Vol. 35; EUR 20784EN; Office for 

855 Official Publications of the European Communities: Luxembourg. Available at: 

856 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing857 Chemicals/RISK_ASSESSMENT/REPORT/dinpreport046.pdf. 

858 32. EC, 2003b. European Commission. European Union Risk Assessment Report: 1,2-

859 Benzenedicarboxylic Acid, Di-C9-11-Branched Alkyl Esters, C10-Rich And Di-“Isodecyl” 

860 Phthalate [DIDP], CAS-Nos 68515-49-1 and 26761-40-0. Vol. 36; EUR 20785EN; Office for 

861 Official Publications of the European Communities: Luxembourg. Available at: 

862 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing863 Chemicals/RISK_ASSESSMENT/REPORT/didpreport041.pdf. 

864 33. EC, 2004. European Commission. European Union Risk Assessment Report: Dibutyl 

865 Phthalate [DBP], CAS-No. 84-74-2. Vol. 29; EUR 19840EN; Office for Official Publications of 

866 the European Communities: Luxembourg. Available at: 

867 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing868 Chemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf. 

869 34. EC, 2008a. European Commission. European Union Risk Assessment Report Bis(2-
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870 Ethylhexyl) Phthalate (DEHP), CAS-No. 117-81-7. Vol. 80; EUR 23384EN; Office for Official 

871 Publications of the European Communities: Luxembourg. Available at: 

872 http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing873 Chemicals/RISK_ASSESSMENT/REPORT/dehpreport042.pdf. 

874 35. EC, 2008b EC. 2008b. European Commission. European Union Risk Assessment Report 

875 Benzyl Butyl Phthalate (BBP), CASNo. 85-68-7. Vol. 76; EUR 22773EN; Luxembourg: Office 

876 for Official Publications of the European Communities, 

877 36. Howdeshell, K.L.; Rider, C.V.; Wilson, V.S.; Gray, L.E. Jr. 2008a. Mechanisms of action of 

878 phthalate esters, individually and in combination, to induce abnormal reproductive development 

879 in male laboratory rats. Environ Res. 108(2):168-76. 

880 37. Howdeshell K.L., Wilson V.S., Furr J., Lambright C.R., Rider C.V., Blystone C.R., 

881 Hotchkiss A.K., Gray L.E. Jr. 2008b. A mixture of five phthalate esters inhibits fetal testicular 

882 testosterone production in the sprague-dawley rat in a cumulative, dose-additive manner. Toxicol 

883 Sci. 105(1):153-65. 

884 38. Liu et al., 2005. Liu, K; Lehmann, KP; Sar, M; et al. (2005) Gene expression profiling 

885 following in utero exposure to phthalate esters reveals new gene targets in the etiology of 

886 testicular dysgenesis. Biol Reprod 73(1):180–192. 

887 39. Heindel et al.,1989. Heindel, JJ; Gulati, DK; Mounce, RC; et al. (1989) Reproductive toxicity 

888 of three phthalic acid esters in a continuous breeding protocol. Fundam Appl Toxicol 12(3):508–

889 518.

890 40. NTP, 1985. NTP (National Toxicology Program). (1985) Di-n-pentylphthalate: reproduction 

891 and fertility assessment in CD-1 mice when administered in feed. Research Triangle Park, NC: 

892 National Toxicology Program. PB86-118999. 
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893 41. Swan et al, 2005. an, S. H.; Main, K. M.; Stewart, S. L.; Kruse, R. L.; Calafat, A. M.; Mao, 

894 C. S.; Redmon, J. B.; Ternand, C. L.;Sullivan, S.; Teague. J. L. 2005. Study for Future Families 

895 Research Team. Decrease in Anogenital Distance among male Infants with Prenatal Phthalate 

896 Exposure. Environ. Health Perspect. Aug 2005, 113(8), 1056–61. 

897 42. Huang, P.C.; Kuo, P.L.; Chou, Y.Y.; Lin, S.J.; Lee, C.C. 2009. Association between 

898 prenatal exposure to phthalates and the health outcome of newborns. Environ. Int. 35(1):14–20. 

899 43. Meeker, J.D.; Calafat, A.M.; Hauser, R. 2007. Di(2-ethylhexyl) phthalate metabolites may 

900 alter thyroid hormone levels in men. Environ Health Perspect. 115(7):1029-34.

901 44. Qiao, L.; Zheng, L.; Cai, D. 2007. Study on the di-n-butyl phthalate and di-2-ethylhexyl 

902 phthalate level of girl serum related with precocious puberty in Shanghai. Wei Sheng Yan Jiu. 

903 36(1): 93-5 

904 45. Hauser, R.; Williams, P.; Altshul, L.; Calafat, A.M. 2005. Evidence of interaction between 

905 polychlorinated biphenyls and phthalates in relation to human sperm motility. Environ Health 

906 Perspect. 113(4):425-30.

907 46. Hauser, R.; Meeker, J.D.; Duty, S,; Silva, M.J.; Calafat, A.M. 2006. Altered semen quality 

908 in relation to urinary concentrations of phthalate monoester and oxidative metabolites. 

909 Epidemiology. 17(6):682-91. 

910 47. Hauser, R.; Meeker, J.D.; Singh, N.P.; Silva, M.J.; Ryan, L.; Duty, S.; Calafat, A.M. 2007. 

911 DNA damage in human sperm is related to urinary levels of phthalate monoester and oxidative 

912 metabolites. Hum Reprod. 22(3):688-95. 

913 48. Duty, S.M.; Calafat, A.M.; Silva, M.J.; Ryan, L.; Hauser, R. 2005. Phthalate exposure and 

914 reproductive hormones in adult men. Hum Reprod. 20(3):604-10. 

915 49. Colón, I.; Caro, D,; Bourdony, C.J.; Rosario, O. 2000. Identification of phthalate esters in 

916 the serum of young Puerto Rican girls with premature breast development. Environ Health 
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917 Perspect. 108(9):895-900.

918 50. Latini, G.; De Felice, C.; Presta, G.; Del Vecchio, A.; Paris, I.; Ruggieri, F.; Mazzeo, P. 

919 2003. Exposure to Di(2-ethylhexyl)phthalate in humans during pregnancy. A preliminary report. 

920 Biol Neonate. 83(1):22-4. 

921 51. Rider, C.V.; Furr, J.; Wilson, V.S.; Gray, L.E. Jr. 2008. A mixture of seven antiandrogens 

922 induces reproductive malformations in rats. Int J Androl. 31(2):249-62. 

923 52. Rider, C.V.; Wilson, V.S.; Howdeshell, K.L.; Hotchkiss, A.K.; Furr, J.R.; Lambright, C.R.; 

924 Gray, LE Jr. 2009. Cumulative effects of in utero administration of mixtures of "antiandrogens" 

925 on male rat reproductive development. Toxicol Pathol. 37(1):100-13. 

926 53. Howdeshell, K.L.; Furr, J.; Lambright, C.R.; Rider, C.V.; Wilson, V.S.; Gray, L.E. Jr. 2007. 

927 Cumulative effects of dibutyl phthalate and diethylhexyl phthalate on male rat reproductive tract 

928 development: altered fetal steroid hormones and genes. Toxicol Sci. 99(1):190-202. 

929 54. Gray, L.E. Jr; Wilson, V.S.; Stoker, T.; Lambright, C.; Furr, J.; Noriega, N.; Howdeshell, K.; 

930 Ankley, G.T.; Guillette, L. 2006. Adverse effects of environmental antiandrogens and 

931 androgens on reproductive development in mammals. Int J Androl. 29(1): 96-108. 

932 55. Hotchkiss, A.K.; Parks-Saldutti. L.G.; Ostby, J.S.; Lambright, C.; Furr, J.; Vandenbergh, 

933 J.G.; Gray, L.E. Jr. 2004. A mixture of the "antiandrogens" linuron and butyl benzyl phthalate 

934 alters sexual differentiation of the male rat in a cumulative fashion. Biol Reprod. 71(6):1852-61. 

935 56. Oehlmann et al., 2008. Oehlmann, J.; Schulte-Oehlmann, U.; Werner, K.; Jagnytsch, O.; 

936 Lutz, I.; Kresten, K.; Wollenberger, L.; Santos, E. .; Paull, G. C.; Van Look, K. J. W.; Tyler, C. 

937 R. 2008. A Critical Analysis of the Biological Impacts of lasticizers on Wildlife. Philos. Trans. 

938 R. Soc., B: Biol. Sci. 2008, 364(1526), 2047–2062. 

939 57. Staples et al., 1997. Staples, C. A.; Adams, W. J.; Parkerton, T. F.; Gorsuch, J. W.; 

940 Biggingers, G. R.; Reiner, K. H. 1997. Aquatic Toxicity of Eighteen Phthalate Esters. Environ. 
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941 Toxicol. Chem. 1997, 16 (5), 875–891. 

942 58. CDC, 2009. Centers for Disease Control and Prevention. Fourth National Report on Human 

943 Exposure to Environmental Chemicals. National Health and Nutrition Examination Survey 

944 (NHANES), Centers for Disease Control and Prevention, Atlanta (GA). Available at: 

945 http://www.cdc.gov/exposurereport/faq.html. 

946 59. U.S. EPA, 2010. U.S. Environmental Protection Agency. Short-Chain Chlorinated Paraffins 

947 (SCCPs) and Other Chlorinated Paraffins Action Plan. Available at: 

948 http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/sccps.html (Accessed March 7, 

949 2011). 

950 60. UNEP. 2009. United Nations Environment Programme. Stockholm Convention on 

951 Persistent Organic Pollutants (POPs). Persistent Organic Pollutants Review Committee. 

952 Revised Draft Risk Profile: Short-Chained Chlorinated Paraffins. 9 July 2009. 

953 UNEP/POPS/POPRC.5/2. Available at: 

954 http://chm.pops.int/Convention/POPsReviewCommittee/hrPOPRCMeetings/POPRC5/POPR 

955 5Documents/tabid/592/language/en-US/Default.aspx. Accessed December 11, 2009. 

956 61. Government of Canada. 2008. Order Adding Toxic Substances to Schedule 1 to the Canadian 

957 Environmental Protection Act, 1999. Canada Gazette. September 20, 2008, 142 (38).

958 62. American Apparel and Footwear Association (AAFA) Restricted Substance List (RSL), 

959 September, 2010. 

960 XV. Statutory and Executive Order Reviews 

961 A. Regulatory Planning and Review 

962 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

963 October 4, 1993), the Office of Management and Budget (OMB) has determined that this 

964 proposed SNUR this action is a “significant regulatory action” under section 3(f) of the 
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965 Executive Order. Accordingly, EPA submitted this action to OMB for review under Executive 

966 Order 12866 and 13563, entitled Improving Regulation and Regulatory Review (76 FR 3821, 

967 January 21, 2011). Changes made in response to OMB recommendations have been documented 

968 in the docket for this rulemaking as required by section 6(a)(3)(E) of the Executive Order. 

969 B. Paperwork Activities 

970 According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency 

971 may not conduct or sponsor, and a person is not required to respond to a collection of 

972 information that requires OMB approval under the PRA, unless it has been approved by OMB 

973 and displays a currently valid OMB control number. The OMB control numbers for EPA's 

974 regulations in Title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR, 

975 part 9, and included on the related collection instrument, or form, if applicable. 

976 The information collection requirements related to this action have already been 

977 approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 

978 1188). This action does not impose any burden requiring additional OMB approval. If an entity 

979 were to submit a SNUN to the Agency, the annual burden is estimated to average 97 hours per 

980 response. This burden estimate includes the time needed to review instructions, search existing 

981 data sources, gather and maintain the data needed, and complete, review, and submit the required 

982 SNUN. 

983 Send any comments about the accuracy of the burden estimate, and any suggested 

984 methods for minimizing respondent burden, including through the use of automated collection 

985 techniques, to the Director, Collection Strategies Division, Office of Environmental Information 

986 (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 

987 20460-0001. Please remember to include the OMB control number in any correspondence, but 

988 do not submit any completed forms to this address.
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989 C. Small Entity Impacts 

990 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), 

991 the Agency hereby certifies that promulgation of this SNUR would not have a significant adverse 

992 economic impact on a substantial number of small entities. The rationale supporting this 

993 conclusion is as follows. 

994 Under the RFA, small entities include small businesses, small organizations, and small 

995 governmental jurisdictions. Small entity is defined in accordance with section 601of the RFA as: 

996 A small business as defined by the Small Business Administration’s (SBA) regulations at 13 

997 CFR 121.201; A small governmental jurisdiction that is a government of a city, county, town, 

998 school district or special district with a population of less than 50,000; and A small organization 

999 that is any not-for-profit enterprise which is independently owned and operated and is not 

1000 dominant in its field. 

1001 For purposes of assessing the impacts of this proposed rule on small entities, EPA has 

1002 determined that this proposed rule is not expected to impact any small not-for-profit 

1003 organizations or small governmental jurisdictions. As such, the Agency estimated potential 

1004 impacts on small business. A SNUR applies to any person (including small or large entities) 

1005 who intends to engage in any activity described in the rule as a “significant new use.” By 

1006 definition of the word “new” and based on all information currently available to EPA, it appears 

1007 that no small or large entities presently engage in such activity. Since this action would require a 

1008 person who intends to engage in such activity in the future to first notify EPA by submitting a 

1009 SNUN, no economic impact would occur unless someone files a SNUN to pursue a significant 

1010 new use in the future or forgoes profits by avoiding or delaying the significant new use. 

1011 Although some small entities may decide to conduct such activities in the future, EPA cannot 

1012 presently determine how many, if any, there may be. 
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1013 EPA's experience to date is that, in response to the promulgation of over 1,000 SNURs, 

1014 the Agency receives on average only 5 notices per year. Of those SNUNs submitted, only one 

1015 appears to be from a small entity in response to any SNUR. Therefore, EPA believes that the 

1016 potential economic impact of complying with this SNUR is not expected to be significant or 

1017 adversely impact a substantial number of small entities. In a SNUR that published as a final rule 

1018 on August 8, 1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general determination 

1019 that proposed and final SNURs are not expected to have a significant economic impact on a 

1020 substantial number of small entities, which was provided to the Chief Counsel for Advocacy of 

1021 the Small Business Administration.

1022 D. State, Local, and Tribal Governments 

1023 In EPA’s experience with proposing and finalizing SNURs since 1980, no State, local, or 

1024 Tribal government has initiated the manufacture of a chemical for a new use. Furthermore, EPA 

1025 does not have any reason to believe that any State, local, or Tribal government would do so for the 

1026 chemicals in this rulemaking. For that reason, EPA has determined that this action does not have 

1027 federalism implications as specified in Executive Order 13132, entitled Federalism (64 FR 43255, 

1028 August 10, 1999), or Tribal implications as specified in Executive Order 13175, entitled 

1029 Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 

1030 2000). 

1031 In addition, this action does not impose any enforceable duty or contain any unfunded 

1032 mandate for State, local, or tribal governments under the provisions of Title II of the Unfunded 

1033 Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538. Nor does it otherwise have any effect on 

1034 small governments, or estimated impacts on the private sector that might exceed $100 million in 

1035 any year. 

1036 Thus, sections 202, 203, 204, or 205 of UMRA, Executive Order 13132, and Executive 
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1037 Order 13175 do not apply to this action. 

1038 E. Protection of Children 

1039 This action is not subject to Executive Order 13045, entitled Protection of Children from 

1040 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this action 

1041 is not an economically significant regulatory action as defined by Executive Order 12866, and it 

1042 is not intended to address environmental health or safety risks for children.

1043 F. Effect on Energy Supply, Distribution, or Use 

1044 This action is not subject to Executive Order 13211, entitled Actions Concerning 

1045 Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 

1046 22, 2001), because this action is not an economically significant regulatory action as defined by 

1047 Executive Order 12866, and it is not expected to affect energy supply, distribution, or use.

1048 G. Technical Standards 

1049 Since this action does not involve any technical standards, section 12(d) of the National 

1050 Technology Transfer and Advancement Act (NTTAA), 15 U.S.C. 272 note, does not apply to 

1051 this action.

1052 H. Environmental Justice 

1053 This action does not entail special considerations of environmental justice related issues 

1054 as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental 

1055 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

1056 

1057 List of Subjects in 40 CFR Part 721 

1058 Environmental protection, Chemicals, Hazardous substances, Reporting and 

1059 recordkeeping requirements.

1060 Dated: ________ 
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1061 Director, Office of Pollution Prevention and Toxics. 

1062 Therefore, it is proposed that 40 CFR Part 721 be amended as follows: 

1063 [AMENDED]

1064 1. The authority citation for part 721 continues to read as follows: 

1065 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 

1066 2. In § 721.1660, revise paragraph (a) and (b) to read as follows: 

1067 §721.1660 Benzidine-based Chemical Substances. 

1068 (a) Chemical substances and significant new uses subject to reporting. (1) The 

1069 benzidine-based chemical substances listed in Table 1 and Table 2 of this section are subject to 

1070 reporting under this section for the significant new uses described in paragraph (a)(2) of this 

1071 section. 

1072 Table 1. Benzidine-Based Chemical Substances 

CAS number C.I. name C.I. number Chemical name 

117-33-9 Not available Not available 1,3-Naphthalenedisulfonic acid, 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'-biphenyl]-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 benzenesulfonic acid, sodium salt. 

(Generic Name) 

Accession No. 

24921 

CAS No. 

CBI CBI 4-(Substituted naphthalenyl )azo diphenylyl azosubstituted carbopolycycle azo benzenesulfonic acid, 

sodium salt. (Generic Name) 
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CBI (NA) 

Accession No. 

26256 

CAS CBI (NA) 

CBI CBI 

4-(Substituted phenyl)azo biphenylyl azo-substituted 

carbopolycycloazo benzenesulfonic acid, sodium salt. 

(Generic Name) 

Accession No. 

21808 

CAS No. 

 CBI (NA) 

CBI CBI 2,7-Naphthalenedisulfonic 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 Phenylazoaminohydroxynaphthalenylazobiphenylazo 

substituted benzene sodium sulfonate. 

(Generic Name) 

1073 

1074 Table 2.—Benzidine-Based Chemical Substances 

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- Naphthalenesulfonic 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 acid, 4-amino-3-[[4’-[(2,4-

diaminophenyl) azo][1,1’-biphenyl]-4-yl]azo]-5-

hydroxy-6-(phenylazo)-, disodium salt 

2302–97–8 C.I. Direct Red 44 22500 1-Naphthalenesulfonic acid, 8,8’-[[1,1’-biphenyl]-4,4’-

diylbis(azo)]bis[7-hydroxy-, disodium salt 

2429–73–4 C.I. Direct Blue 2 22590 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4’-[(7-

amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1’-

biphenyl]-4-yl]azo]-4-hydroxy-,trisodium salt 

2429–79–0 C.I. Direct Orange 

8 

22130 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-methylphenyl]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’-biphenyl]-4-yl]azo]-2-hydroxy-, 

disodium salt 

2429–83–6 Direct Black 4 C.I. 30245 2,7-Naphthalenedisulfonic 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 acid, 5-[[4’-[(2-amino-8-hydroxy-6-sulfo1-naphthalenyl)azo][1,1’-biphenyl]-4-yl]azo]-2-

hydroxy-, disodium salt 
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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-Naphthalenedisulfonic acid, 3,3’-[[1,1’-biphenyl]-

4,4’-diylbis(azo)]bis[5-amino-4-hydroxy-, tetrasodium 

salt 

2893–80–3 C.I. Direct Brown 

6 

30140 Benzoic acid, 5-[[4’-[[2,4-dihydroxy-3-[(4-sulfophenyl) 

azo]phenyl]azo][1,1’-biphenyl]-4-yl]azo]-2-hydroxy-, 

disodium salt 

3530–19–6 C.I. Direct Red 37 22240 1,3-Naphthalenedisulfonic 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-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4’-[[4-

[[(4-methylphenyl) sulfonyl]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-Naphthalenedisulfonic 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-hydroxy-,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-disulfo-1,5-naphthalenediyl)bis 

[azo(6-hydroxy-3,1-phenylene)azo[6(or7)-sulfo-4,1- 

naphthalenediyl]azo[1,1’-biphenyl]-4,4’-diylazo]]bis[6-

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 

1077 (2) The significant new uses are: 

1078 (i) Any use other than use as: 
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1079 (A) For the chemicals listed in Table 2, as reagent to test for hydrogen peroxide in 

1080 milk; a reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain in 

1081 microscopy; a reagent for detecting blood and as an analytical standard 

1082 (B) For Color Index (C.I.) Direct Red 28 (Congo Red) (CAS No. 573-58-0) listed 

1083 in Table 2, as an indicator dye 

1084 (ii) For the 9 chemical substances listed in Table 1: any use. 

1085 (3) Revocation of article exemption. The provisions of § 721.45(f) do not apply to this 

1086 section. A person who imports or processes the chemical substances identified in paragraph 

1087 (a)(1) of this section as part of an article for the significant new use described in paragraph (a)(2) 

1088 of this section must submit a significant new use notice. 

1089 

1090 3. By adding new § 721.10226 to subpart E to read as follows: 

1091 § 721.10226 Di-n-pentyl phthalate (DnPP).

1092 (a) Chemical substance and significant new uses subject to reporting. (1) The chemical 

1093 substance identified as Di-n-pentyl phthalate (DnPP) (1,2-Benzenedicarboxylic acid, 1,2-

1094 dipentyl ester) (CAS No.131-18-0) is subject to reporting under this section for the significant 

1095 new uses described in paragraph (a) (2) of this section. 

1096 (2) The significant new use is: any use other than as a chemical standard for laboratory 

1097 use. 

1098 (b) [Reserved] 

1099 4. Add § 721.10227 to subpart E to read as follows: 

1100 § 721.10227 Alkanes, C12-13, chloro (CAS No. 71011-12-6). 

1101 (a) Chemical substance and significant new uses subject to reporting. 
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1102 (1) The chemical substance identified Alkanes, C12-13, chloro (CAS No. 71011-12-6) is 

1103 subject to reporting under this section for the significant new uses described in paragraph 

1104 (a)(2) of this section. 

1105 (2) The significant new use is: any use. 

1106 (b) Specific requirements. The provisions of subpart A of this part apply to this section 

1107 except as modified by this paragraph. 

1108 (1) Persons who must report. § 721.5 applies to this section except for §721.5(a)(2). A 

1109 person who intends to manufacture or import for commercial purposes a substance identified in 

1110 paragraph (a)(1) of this section and intends to distribute the substance in commerce must submit 

1111 a significant new use notice. 

1112 (2) [Reserved]. 

1113