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1 EO 12866/13563 Review Draft – As Submitted Revised 11/19/14 12/3/2014

2 Rin2070-AJ73_EO12866_3-Chemical-SNUR_FRM_FR Document_Redlined_2014-12-03.docxRin2070-

3 AJ73_EO12866_3-Chemical-SNUR_FRM_FR Document_2014-08-15-Redlined_2014-11-19.docx 

4 __________________________________________________________________________________________ 

5 BILLING CODE 6560-50-P

6 ENVIRONMENTAL PROTECTION AGENCY 

7 40 CFR Parts 9 and 721 

8 [EPA-HQ-OPPT-2010-0573; FRL-xxxx-x-9915-60] 

9 RIN 2070-AJ73 

10 Benzidine-Based Chemical Substances; Di-n-pentyl Phthalate (DnPP); and Alkanes, C12–

11 13, Chloro; Significant New Use Rule 

12 AGENCY: Environmental Protection Agency (EPA). 

13 ACTION: Final rule. 

14 SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is promulgating a 

15 significant new use rule (SNUR) to add nine benzidine-based chemical substances to the existing 

16 SNUR on benzidine-based chemical substances. With respect to both the newly-added 

17 benzidine-based chemical substances and the previously-listed benzidine-based chemical 

18 substances, this rule makes inapplicable the exemption relating to persons that import or process 

19 substances as part of an article. EPA is also promulgating a SNUR for di-n-pentyl phthalate 

20 (DnPP) and a SNUR for alkanes, C12-13, chloro (CAS No. 71011-12-6). These actions require 

21 persons who intend to manufacture (defined by statute to include import) or process these 

22 chemical substances for an activity that is designated as a significant new use to notify EPA at 

23 least 90 days before commencing such manufacture or processing. The required notifications 

24 will provide EPA with the opportunity to evaluate activities associated with a significant new use 

25 and, if necessary based on the information available at that time, an opportunity to protect 

26 against potential unreasonable risks, if any, from that activity before it occurs. EPA is also 
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27 making a technical amendment to the codified list of control numbers for approved information 

28 collection activities so that it includes the control number assigned by the Office of Management 

29 and Budget (OMB) to the information collection activities contained in this rule. 

30 DATES: This final rule is effective [insert date 60 days after date of publication in the Federal 

31 Register]. 

32 ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA33 HQ-OPPT-2010-0573, is available at http://www.regulations.gov or at the Office of Pollution 

34 Prevention and Toxics Docket (OPPT Docket), EPA Docket Center (EPA/DC), EPA West Bldg., 

35 Rm. 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open 

36 from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone 

37 number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT 

38 Docket is (202) 566-0280. Please review the visitor instructions and additional information about 

39 the docket available at http://www.epa.gov/dockets. 

40 FOR FURTHER INFORMATION CONTACT: For technical information contact: Sara 

41 Kemme, National Program Chemicals Division (7404T), Office of Pollution Prevention and 

42 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

43 20460-0001; telephone number: (202) 566-0511; email address: kemme.sara@epa.gov.

44 For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South 

45 Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA46 Hotline@epa.gov. 

47 SUPPLEMENTARY INFORMATION: 

48 I. Executive Summary 

49 A. Does this Action Apply to Me? 
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50 These three different SNURs may apply to different entities. The North American 

51 Industrial Classification System (NAICS) codes have been provided to assist you and others in 

52 determining whether this action might apply to certain entities. 

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

54 you manufacture (defined by statute to include import), or process, including as part of an article, 

55 any of the benzidine-based chemical substances listed in Tables 1 and 2 of the regulatory text in 

56 this document. Potentially affected entities may include, but are not limited to: 

57 • Manufacturers or processors of one or more of the subject chemical substances. 

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

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

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

61 allied products. 

62 • Manufacturers or processors of the subject chemical substances in printing inks. 

63 These entities may include those described by the NAICS codes 325-chemical manufacturing, 

64 31-textile manufacturers, 316-leather and allied products manufacturers, 322-paper 

65 manufacturers, 4243-apparel, piece goods, and notions wholesalers, or 443-clothing and 

66 accessories stores. 

67 2. DnPP. You may be potentially affected by this action if you manufacture (defined by 

68 statute to include import), or process DnPP. Potentially affected entities may include, but are not 

69 limited to: Chemical industry – plastic material and resins (NAICS code 325211). 

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

71 action if you manufacture or process the following short-chained chlorinated paraffin (SCCP): 

72 Alkanes, C12-13, chloro (CAS No. 71011-12-6). Potentially affected entities may include, but are 

73 not limited to: Manufacturers of SCCPs (NAICS codes 325 and 325998), chemical 
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74 manufacturing; including miscellaneous chemical product and preparation manufacturing; and 

75 processors of SCCPs (NAICS codes 324 and 324191), petroleum lubricating oil and grease 

76 manufacturing. 

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

78 export notification rules under TSCA. Persons who import any chemical substance governed by 

79 a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification 

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

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

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

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

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

85 final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 

86 2611(b)) (see 40 CFR 721.20) and must comply with the export notification requirements in 40 

87 CFR part 707, subpart D. 

88 To determine whether you or your business may be affected by this action, you should 

89 carefully examine the applicability provisions in 40 CFR 721.5 for SNUR-related obligations 

90 and with respect to benzidine-based chemical substances, the applicability provisions in Unit V. 

91 If you have any questions regarding the applicability of this action to a particular entity, consult 

92 the technical person listed under FOR FURTHER INFORMATION CONTACT. 

93 B. What Is the Agency's Authority for Taking this Action? 

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

95 of a chemical substance is a “significant new use.” EPA must make this determination by rule 

96 after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA 

97 determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
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98 requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before 

99 they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As 

100 described in Unit V., the general SNUR provisions are found at 40 CFR Part 721, Subpart A. 

101 C. What Action is the Agency Taking? 

102 In a single Federal Register notice on of March 28, 2012 (77 FR 18752) (FRL-8865-2), 

103 EPA proposed three chemical specific SNURs being addressed in this final rule (Ref. 1). EPA’s 

104 response to public comments received on the proposed rule appears in Unit X. Please consult the 

105 March 28, 2012 Federal Register document (Ref. 1) for further background information for this 

106 final rule. 

107 These final SNURs will require persons to notify EPA at least 90 days before commencing 

108 the manufacture (including import) or processing of: 

109 • The nine benzidine-based chemical substances identified in Table 1, which are being added 

110 to § 721.1660 with a designation of any use as a significant new use; 

111 • DnPP with a designation of any use other than as a chemical standard for analytical 

112 experiments as a significant new use; and 

113 • Alkanes, C12-13, chloro (CAS No. 71011-12-6) with a designation of any use as a 

114 significant new use. 

115 In addition, this final rule amends the SNUR at § 721.1660 to make inapplicable the 

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

117 part of an article. For the benzidine-based chemical substances, the elimination of the article 

118 exemption at 40 CFR 721.45(f) will require persons to notify EPA at least 90 days before 

119 commencing processing or importing as part of an article any of the newly-added benzidine-based 

120 chemical substances, as well as those already covered (61 FR 52287, October 7, 1996 (FRL–5396–

121 6), codified at 40 CFR 721.1660).

122 D. Why is the Agency Taking this Action? 
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123 These SNURs are necessary to ensure that EPA receives timely advance notice of any future 

124 manufacturing and processing of these chemical substances for new uses that may produce changes 

125 in human and environmental exposures. The rationale and objectives for this SNUR are explained in 

126 Unit III. 

127 E. What are the Estimated Incremental Impacts of this Action? 

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

129 potential manufacturers and processors of the chemical substances included in this final rule. This 

130 analysis, which is available in the docket, is discussed in Unit IX., and is briefly summarized here. 

131 In the event that a SNUN is submitted, costs are estimated to be less than $8,700 per SNUN 

132 submission for large business submitters and $6,300 for small business submitters. These estimates 

133 include the cost to prepare and submit the SNUN and the payment of a user fee. In addition, for 

134 persons exporting a substance that is the subject of a SNUR, a one-time notice must be provided for 

135 the first export or intended export to a particular country, which is estimated to cost less than $100 on 

136 average per notification. The rule may also affect firms that import or process articles that may 

137 contain benzidine-based chemicals, because, while not required by the SNUR, these parties may take 

138 additional steps to determine whether benzidine-based chemicals are part of the articles that they are 

139 considering to import or process. Since EPA is unable to predict whether anyone might engage in 

140 future activities that would require reporting, potential total costs were not estimated. 

141 II. Overview of the Chemical Substances Subject to this Rule 

142 The SNURs in this final rule involve certain benzidine-based chemical substances in the 

143 existing SNUR at 40 CFR 721.1660 (77 FR 18752, 18756 (FRL-8865-2)), the nine benzidine144 based chemical substances listed in Table A, DnPP (CAS No. 131-18-0), and alkanes, C12-13, 

145 chloro (CAS No. 71011-12-6). 
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146 Table A.—Newly Added Benzidine-Based Chemical Substances

CAS or

accession 

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. 

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. 

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. 

26267 

CAS No. 

CBI (NA) 

CBI CBI 4-(Substituted phenyl)azo biphenylyl azo -

substituted carbopolycycle azo 

benzenesulfonic acid, sodium salt. (generic 

name) 

Accession No. 

26701 

CAS No. 

CBI (NA) 

CBI CBI Phenylazoaminohydroxynaphthalenylazobiph

enylazo substituted benzene sodium sulfonate. 

(generic name) 

147 

148 CAS = Chemical Abstracts Services. CBI = Confidential Business Information. CBI (NA) = 

149 Confidential Business Information (Not Available). C.I. = Chemical Index. 

150 III. Rationale and Objectives 

151 A. Rationale 
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152 Consistent with EPA’s past practice for issuing SNURs under TSCA section 

153 5(a)(2), EPA’s decision to issue a SNUR for a particular chemical use need not be based on an 

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

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

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

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

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

159 begin manufacturing or processing the chemical for the use, the notice to EPA allows EPA to 

160 evaluate the use according to the specific parameters and circumstances surrounding that 

161 intended use. 

162 1. Benzidine-based chemical substances. As described in the proposal (77 FR 18752, 

163 March 28, 2012) (FRL 8865-2), EPA is concerned about potential carcinogenic effects on 

164 workers and consumers from the manufacture, processing, or use of these substances. Consumers 

165 exposed via dermal exposure to consumer products containing the benzidine-based chemical 

166 substances are a particular concern because enzymes present in the human body and in bacteria 

167 on the skin aid in the reduction of these chemical substances to the benzidine unit, an established 

168 human carcinogen (Ref. 2). The main consumer products that could result in dermal exposure if 

169 containing these chemical substances include textiles and leather products because they are in 

170 prolonged contact with human skin. 

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

172 determined that the newly identified chemical substances that are being added to 40 CFR 

173 721.1660 by this final rule present the same concerns (Ref. 3) as those of the benzidine-based 

174 chemical substances already listed in the rule (61 FR 52287, October 7, 1996 (FRL–5396–6), 

175 codified at 40 CFR 721.1660). EPA does not believe there is any current use of these nine 
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176 benzidine-based chemical substances within or outside the United States. This conclusion is 

177 based on a review of EPA’s own Inventory Update Reporting (IUR) data, and more recent 

178 Chemical Data Reporting (CDR) data as well as other sources including the Colour Index 

179 International, published by the Society of Dyers and Colourists and American Association of 

180 Textile Chemists and Colorists; IHS Chemical Economics Handbook, Dyes; and ICIS Directory 

181 of World Chemical Producers. 

182 In addition, as discussed earlier, although some of the benzidine-based chemical 

183 substances subject to the 1996 SNUR may be manufactured or processed outside the United 

184 States, an analysis of the benzidine-based chemical substances market (Ref. 3) revealed no 

185 information indicating import of articles containing benzidine-based chemical substances for 

186 non-excluded purposes. 

187 Although it appears there is no ongoing domestic manufacture of the nine newly added 

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

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

190 nine newly added benzidine-based chemical substances and the import or processing of articles 

191 containing any benzidine-based chemical substances may begin at any time, without prior notice 

192 to EPA. Thus, EPA is concerned that commencement of the manufacture (including import) or 

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

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

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

196 occur without an opportunity for the Agency to evaluate activities associated with a significant 

197 new use and an opportunity to protect against potential unreasonable risks, if any, from exposure 

198 to the chemical substance. 
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199 Accordingly, EPA is finalizing a SNUR for the nine benzidine-based chemical substances 

200 by adding them to those currently listed at § 721.1660, and making inapplicable the article 

201 exemption at § 721.45(f) for those chemical substances newly added in this rulemaking as well 

202 as for those already listed at § 721.1660. This final rule will require persons who intend to 

203 manufacture (including import) or process any of the benzidine-based chemical substances for a 

204 non-excluded use, including importing or processing any listed benzidine-based chemical 

205 substance for a non-excluded use as part of an article, to submit a SNUN. 

206 2. DnPP. As described in the proposal (77 FR 18752, March 28, 2012) (FRL 8865-2), 

207 EPA has concerns regarding potential adverse human health and environmental effects that may 

208 be caused by DnPP. EPA has direct information from animal studies that DnPP specifically can 

209 elicit developmental/reproductive effects that are relevant to human health and also indicate 

210 potential effects in wildlife. EPA also is concerned that due to its general structure and 

211 categorization as a phthalate that DnPP may elicit adverse environmental effects similar to those 

212 described for other phthalates. EPA is concerned that any manufacturing (including import) or 

213 processing of DnPP, beyond that for its limited ongoing use as a chemical standard for laboratory 

214 use, could significantly increase the magnitude and duration of exposure to humans over that 

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

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

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

218 substance. Accordingly, EPA is finalizing a SNUR for DnPP that would designate, as a 

219 significant new use, any use of the chemical substance other than use as a chemical standard for 

220 analytical experiments. A person who intends to manufacture or process DnPP for use other than 

221 use as a chemical standard for analytical experiments would be required to submit a SNUN. 
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222 3. Alkanes, C12-13, chloro (CAS No. 71011-12-6). As described in the proposal (77 FR 

223 18752, March 28, 2012) (FRL 8865-2), EPA has a primary concern regarding adverse 

224 environmental effects that may be caused by alkanes, C12-13, chloro (CAS No. 71011-12-6), 

225 one type of SCCP. For example, alkanes, C12–13, chloro, have been shown to be highly toxic to 

226 aquatic invertebrates following acute and chronic exposures and to fish following chronic 

227 exposures. EPA also has concerns about the persistence and bioaccumulation potential of 

228 SCCPs, including alkanes, C12–13, chloro, since these substances have been measured in a 

229 variety of biota (i.e., freshwater aquatic species, marine mammals, and avian and terrestrial 

230 wildlife) and have also been measured in human breast milk from Canada and the United 

231 Kingdom. The mechanisms or pathways by which SCCPs, including alkanes, C12-13, chloro 

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

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

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

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

236 EPA believes that all manufacture and processing into the United States of alkanes, C12-

237 13, chloro (CAS No. 71011-12-6) has ceased. Given that EPA has no evidence to suggest that 

238 there is any manufacture or processing of this chemical substance in the United States, and 

239 taking into consideration the negative commercial and regulatory environment associated with 

240 this chemical internationally (including the European Union (EU) and Canadian ban on 

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

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

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

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

245 otherwise exist. EPA is concerned that such an increase should not occur without an opportunity 
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246 to evaluate activities associated with a significant new use and an opportunity to protect against 

247 potential unreasonable risks, if any, from exposure to the chemical substance. Accordingly, EPA 

248 is finalizing a SNUR for alkanes, C12-13, chloro (CAS No. 71011-12-6) that designates as a 

249 significant new use any use of the chemical substance. This SNUR requires a person who intends 

250 to manufacture or process alkanes, C12-13, chloro (CAS No.71011-12-6) for any use to submit a 

251 SNUN. 

252 B. Objectives 

253 Based on the considerations described in the proposal (77 FR 18752, March 28, 2012) 

254 (FRL 8865-2) and in the response to public comments, EPA expects to achieve the following 

255 objectives with regard to the significant new uses that are designated in this final rule: 

256 1. EPA will receive notice of any person’s intent to manufacture or process the specified 

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

258 2. EPA will have an opportunity to review and evaluate data submitted in the SNUN 

259 before the notice submitter begins manufacturing or processing of the specified chemicals for the 

260 described significant new use; 

261 3. EPA will be able to regulate prospective uses of the specified chemicals before the 

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

263 sections 5(e), 5(f), 6 or 7; and 

264 4. EPA would receive a notice alerting the Agency to a reversal of an industry trend 

265 toward deselecting for a chemical. 

266 IV. Significant New Use Determination 

267 Section 5(a)(2) of TSCA states that EPA’s determination that a use of a chemical 

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

269 including: 
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270 • The projected volume of manufacturing and processing of a chemical substance. 

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

272 environment to a chemical substance. 

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

274 beings or the environment to a chemical substance. 

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

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

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

278 EPA to consider any other relevant factors. 

279 To determine what constitutes a significant new use of the benzidine-based chemical 

280 substances, DnPP, and alkanes, C12-13, chloro (CAS No. 71011-12-6) subject to this rule, EPA 

281 considered relevant information about the toxicity of these substances, likely human exposures 

282 and environmental releases associated with possible uses, and the four factors listed in section 

283 5(a)(2) of TSCA. EPA has determined that the manufacture or processing, of any of the 

284 benzidine-based chemical substances subject to the 1996 SNUR or being newly added to 40 CFR 

285 721.1660 by this final rule, except for ongoing uses specified in 40 CFR 721.1660(a)(2)(i) of the 

286 regulatory text in this document, is a significant new use. EPA has also determined that the 

287 manufacture or processing of DnPP for any use other than use as a chemical standard for 

288 analytical experiments is a significant new use, and the manufacture or processing of alkanes, 

289 C12-13, chloro (CAS No. 71011-12-6) for any use is a significant new use. 

290 V. Applicability of the General Provisions 

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

292 provisions describe persons subject to the rule, recordkeeping requirements, exemptions to 
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293 reporting requirements, and applicability of the rule to uses occurring before the effective date of 

294 the final rule. 

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

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

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

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

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

300 (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take 

301 regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the activities on which it has 

302 received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to 

303 explain in the Federal Register its reasons for not taking action. 

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

305 substance as part of an article) will not apply to the benzidine-based chemical substances listed at 

306 40 CFR 721.1660 and those added by this final rule. Therefore, a person who imports or 

307 processes as part of an article a benzidine-based chemical substance that is covered by this rule 

308 would not be exempt from submitting a SNUN. 

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

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

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

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

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

314 127.28. Those persons must certify that the shipment of the chemical substance complies with all 

315 applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in 

316 support of import certification appears at 40 CFR part 707, subpart B. 
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317 VI. Applicability of the Final Rule to Uses Occurring Before the Effective Date of the Final 

318 Rule 

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

320 that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant 

321 new use as of the date of publication of the proposed rule rather than as of the effective date of 

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

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

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

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

326 persons who begin the commercial manufacture or processing of a covered substance as a 

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

328 finalized. To resume their activities, these persons would have to comply with all applicable 

329 SNUR notice requirements and wait until the notice review period, including all extensions, 

330 expires. If a person were to meet the conditions of advance compliance under 40 CFR 721.45(h), 

331 that person would be considered to have met the requirements of the final SNUR for those 

332 activities. 

333 VII. Test Data and Other Information 

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

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

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

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

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

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

340 persons are required only to submit test data in their possession or control and to describe any 
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341 other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, 

342 and 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters 

343 include data that would permit a reasoned evaluation of risks posed by the chemical substance 

344 during its manufacture, import, processing, use, distribution in commerce, or disposal. EPA 

345 encourages persons to consult with the Agency before submitting a SNUN. As part of this 

346 optional pre-notice consultation, EPA would discuss specific data it believes may be useful in 

347 evaluating a significant new use. SNUNs submitted for significant new uses without any test data 

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

349 limit activities associated with this chemical. SNUN submitters should be aware that EPA will be 

350 better able to evaluate SNUNs that provide detailed information on: 

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

352 uses of the chemical substance. 

353 2. Potential benefits of the chemical substance. 

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

355 potential substitutes. 

356 VIII. SNUN Submissions 

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

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

359 submission of test data on health and environmental effects as described in 40 CFR 720.50. 

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

361 the Agency in accordance with the procedures set forth in 40 CFR 721.25 and 720.40. E-PMN 

362 software is available electronically at http://www.epa.gov/opptintr/newchems. 

363 IX. Economic Analysis

364 A. SNUNs
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365 EPA has evaluated the potential costs of establishing SNUR reporting 

366 requirements for potential manufacturers and processors of these chemicals and for 

367 articles containing any of the benzidine-based chemical substances included in the 1996 

368 SNUR and those newly added by this final rule when imported or processed as part of an 

369 article. These economic analyses, which are briefly summarized here, are available in the 

370 docket for this rule. EPA added additional information to the economic analysis for the 

371 benzidine-based chemical substances in response to public comments. 

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

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

374 costs are estimated at approximately $8,600 per SNUN submission, and include the cost for 

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

376 that submit a SNUN are either subject to a $2,500 user fee required by 40 CFR 

377 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than $40 million 

378 when combined with those of the parent company (if any), a reduced user fee of $100 (40 CFR 

379 700.45(b)(1)). In its evaluation of this final rule, EPA also considered the potential costs a 

380 company might incur by avoiding or delaying the significant new use in the future, but these 

381 costs have not been quantified.

382 B. Export Notification

383 EPA regulations under TSCA section 12(b) (15 U.S.C. 2611(b)) at 40 CFR part 707, 

384 subpart D require that, for chemicals subject to a proposed or final SNUR, a company notify 

385 EPA of the first export or intended export to a particular country of an affected chemical 

386 substance. EPA estimated that the one-time cost of preparing and submitting an export 

387 notification to be $84. The total costs of export notification would vary per chemical, depending 

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

390 C. Import or Processing Benzidine-based Chemical Substances as Part of an Article

391 In the case of the benzidine-based chemical substances, this rule makes inapplicable the 

392 exemption relating to persons that import or process substances as part of an article. In the 

393 proposal EPA preliminarily determined, based on the Agency’s market research, that there was 

394 no ongoing manufacturing (including import) or processing of these chemical substances for 

395 significant new uses as part of articles or otherwise. For the nine newly-added benzidine-based 

396 chemical substances, EPA found no evidence of manufacture either domestically or abroad, and 

397 thus also no evidence of importation or processing of these chemical substances as part of 

398 articles (Ref. 1). For the majority of the 24 previously listed benzidine-based chemical 

399 substances, EPA found no evidence of manufacture, either domestically or abroad. While, EPA 

400 found that some of the previously listed benzidine-based were being manufactured domestically 

401 for discrete uses that are not subject to this SNUR, EPA found no evidence that these chemical 

402 substances were being imported or processed as part of articles (Ref. 1). EPA received no public 

403 comments indicating otherwise. Based on the global trend away from using these chemical 

404 substances, the fact that they are regulated in numerous jurisdictions, and the absence of public 

405 comments indicating their ongoing use for significant new uses, EPA is finalizing its 

406 determination that these benzidine-based chemical substances are not being manufactured 

407 (including import) or processed for a significant new use as part of articles or otherwise. 

408 Therefore However, the rule may affect firms that plan to import or process types of 

409 articles that benzidine-based chemicals are potentially a part of. Some firms have an 

410 understanding of the contents of the articles they import or process. However, EPA 

411 acknowledges that importers and processors of articles may have varying levels of knowledge 

412 about the chemical content of the articles that they import or process. These parties may need to 
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413 become familiar with the requirements of the rule. And, while not required by the SNUR, these 

414 parties may take additional steps to determine whether benzidine-based chemicals are part of 

415 the articles that they are considering to import or process. This determination may involve 

416 activities such as gathering information from suppliers along the supply chain, and/or testing 

417 samples of the article itself. Costs vary across the activities chosen and the extent of familiarity 

418 a firm has regarding the articles it imports or processes. Cost ranges are presented in the 

419 Economic Analysis of the Final Significant New Use Rule for Nine Benzidine Based Chemical 

420 Substances (Ref. 3). Given existing regulatory limitations on certain benzidine-based substances 

421 both internationally and within the U.S., industry-wide processes, resources that support 

422 companies in understanding and managing their supply chains, and evidence showing minimal 

423 worldwide availability of the dyes regulated under the SNUR, EPA believes that article 

424 importers that choose to investigate their products would incur costs at the lower end of the 

425 ranges presented in the Economic Analysis as a result of this rule. For those companies 

426 choosing to undertake actions to assess the composition of the articles they import or process, 

427 EPA expects that in all likelihood, these importers and processors would take actions that are 

428 commensurate with the company’s perceived likelihood that a chemical substance might level 

429 of risk (of a chemical to be a part of an article they intend to import into the United States) that 

430 each company perceives, and the resources it has available. 

431 X. Response to Public Comment 

432 The Agency reviewed and considered all comments received related to the proposed rule. 

433 Copies of all non-CBI comments are available in the docket for this action. A discussion of the 

434 major comments germane to the rulemaking and the Agency’s responses follow

435 A. Legal Authority to Make Inapplicable the Exemption for Persons who Import or Process 

436 Chemical Substances as Part of Articles. 
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437 One commenter suggests that if chemical substances are not exempted from the SNUR at 

438 the point they are incorporated into articles, then EPA should consider whether it is 

439 inappropriately regulating “articles under the chemical management authorities of TSCA,” 

440 (emphasis original) inconsistent with Congressional intent in enacting TSCA. The commenter 

441 argues further that the regulation of articles is not the primary purpose of TSCA and that such 

442 regulation should be addressed by other agencies operating under other statutes such as the 

443 Occupational Safety and Health Act of 1970 and the Consumer Product Safety Act of 1972. 

444 Another comment raises similar issues. 

445 EPA responded that the SNUR for benzidine-based chemical substances does not 

446 regulate articles per se, but rather persons who manufacture or process these chemical 

447 substances, including when the chemical substances are present as part of articles. TSCA clearly 

448 contemplates such regulation, as certain articles are expressly removed from TSCA jurisdiction 

449 at TSCA section 3(2). Indeed, EPA has a long history of regulating chemical substances as part 

450 of articles under TSCA. For polychlorinated biphenyls (the only chemical substance specifically 

451 addressed in TSCA as it was originally enacted), section 6(e) of TSCA provides authority for 

452 EPA to promulgate rules related to polychlorinated biphenyls in articles, such as electrical 

453 transformers. Other examples include the regulation of asbestos (40 CFR 763.160) and 

454 regulation of manufacturers of consumer products intended for use by children who also 

455 manufacture (including import) lead (40 CFR 716.21(a)(8)). 

456 TSCA section 5 provides EPA with authority to regulate chemical substances, including 

chemical substances that are part of articles.1 457 Under this section, EPA has previously regulated 

 

1 It should be noted that there is no general SNUN exemption for uses of a chemical substances involving articles 

and EPA routinely defines significant new uses to include use in articles. The exemption at 40 CFR 721.45(f) relates 

to a different question: whether the SNUR applies to persons who process or import a chemical substance by 

processing or importing the substance as part of an article. 
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458 persons that import or process chemical substances as part of articles, including articles 

459 containing erionite fiber (40 CFR 721.2800) and mercury (40 CFR 721.10068). This is in 

460 keeping with the statutory language authorizing the Administrator to designate a “use of a 

461 chemical substance as a significant new use” and to require SNUN submissions from persons 

462 that intend to manufacture or process a chemical for a designated significant new use. 

463 The commenter is incorrect in suggesting that regulation to address chemical substances 

464 in articles is beyond the originally intended functions of TSCA. When TSCA was being drafted, 

465 legislators characterized it as “a mechanism to protect against dangerous chemical materials 

466 contained in consumer and industrial products”; by way of example, the drafters cited “the 

467 presence of mercury in such consumer products as paint, home thermometers, sponges, and a 

468 variety of other products.” S. Rep. No. 94-698, 94th Cong., 2d Sess., 5-6 (1976). 

469 Furthermore, this application of the regulations (to persons who manufacture or process 

470 the chemical substance as part of articles) is consistent with legislators’ observation, in drafting 

471 this section, that: 

472 [T]he most desirable time to determine the health and environmental effects of a 

473 substance, and to take action to protect against any potential adverse effects, occurs 

474 before commercial production begins. Not only is human and environmental harm 

475 avoided or alleviated, but the cost of any regulatory action in terms of loss of jobs and 

476 capital investment is minimized. 

477 H.R. Rep. 94-1679, 94th Cong., 2d Sess., 65 (1976). 

478 When a chemical substance is domestically produced, the substance generally exists in non479 article form at the earliest point of commercial production in the United States. When a chemical 

480 substance is imported, however, it may in many instances already be part of an article, even at 

481 the earliest point that it enters U.S. commerce. By this action, EPA makes importers of specific 

482 chemical substances subject to the same SNUN requirements as domestic manufacturers of the 

483 same substance, irrespective of whether such import is as part of an article. This action is 
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484 consistent with the plain text of TSCA 5(a)(1)(B) (generally, “no person may . . . manufacture or 

485 process” for a significant new use without proper notice) and with one of the intended goals of 

486 TSCA: to hold importers to “the same responsibilities and obligations as domestic 

487 manufacturers,” H.R. Rep. No. 94-1341, 94th Cong. 2d. Sess., 12-13 (1976). This action is also 

488 consistent with EPA’s identified concerns regarding benzidine-based chemical substances when 

489 they are present as part of an article (See 77 FR 18752, 18756, March 28, 2012 (FRL-8865-2)). 

490 Moreover, when originally promulgating the presumptive SNUN submission exemption 

491 for persons who import or process chemical substances as part of articles (40 CFR 721.45(f)), 

492 EPA did so based on a belief that people and the environment would generally not be exposed to 

493 chemical substances in articles. To address those cases where the assumption may not be valid, 

494 EPA specifically noted that, “EPA may decide to eliminate one or all of these . . . exemptions 

495 [including the exemption for importers and processors of chemicals as part of articles] if EPA 

496 decides that review under a SNUR is warranted for specific substances . . . in articles.” (49 FR 

497 35014, September 5, 1984) (FRL-2541-8). Thus, while EPA clearly has statutory authority to 

498 subject importers and processors of chemical substances in articles to SNUN requirements, they 

499 are presumptively excluded by rule at 40 CFR 721.45(f), based on an assumption that people and 

500 the environment will generally not be exposed to substances in articles. (49 FR 35014, 

501 September 5, 1984) (FRL-2541-8). To the extent that potential exposure to a chemical substance 

502 as part of an article contributes to the EPA’s determination pursuant to the factors in section 

503 5(a)(2) of TSCA that the new use is significant (i.e., EPA has reason to anticipate that use as part 

504 of an article would raise important questions, related to potential exposure, that EPA should have 

505 an opportunity to review before such use could resume or occur), it is appropriate to make the 

506 exemption inapplicable. 

507 EPA notes that one of the commenters appears to have conflated the Federal Register
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508 notice establishing the article importers’ and article processors’ exemption from PMN 

509 requirements (48 FR 21726, May 13, 1983) (FRL 2998-5), discussing 40 CFR 720.22(b)) with 

510 another Federal Register notice establishing the comparable exemptions from SNUR 

511 requirements ((49 FR 35014, September 5, 1984) (FRL-2541-8)), discussing 40 CFR 721.45(f)). 

512 While EPA recognizes that Parts 720 and 721 deal with many similar issues, they are also 

513 distinct from each other in important respects. It is significant that in the 1984 action, whereby 

514 EPA established the article importers’ and article processors’ exemption for SNURs, it did not 

515 simply mirror the 1983 rationale for the comparable exemption from PMN obligations. For 

516 PMNs, EPA noted the difficulties associated with determining the identity and Inventory status 

517 of each chemical substance in imported articles (e.g., automobiles) (48 FR 21726, May 13, 1983) 

518 (FRL 2998-5)). But for SNURs, EPA placed special emphasis on its assumption that import of 

519 the substance as part of an article would not affect human or environmental exposure to the 

520 substance, while taking particular care to reserve ongoing discretion to revise its assumption as 

521 warranted in the case of specific substances. EPA had reason to differentiate between the two 

522 rationales. SNURs are for specified chemical substances for which EPA has identified exposure523 based concerns for the defined significant new use (per the TSCA section 5(a)(2) factors). By 

524 contrast, PMNs are required for all new chemicals (i.e., those not on the TSCA inventory), not a 

525 specified set of chemicals. 

526 Finally, there is no basis for the commenter’s suggestion that EPA should decline to 

527 review significant new uses, in deference to the Occupational Safety and Health Administration 

528 (OSHA) or the Consumer Product Safety Commission (CPSC), simply because a significant new 

529 use notice would be submitted by a person who imports or processes the chemical substance as 

530 part of an article. Neither the Occupational Safety and Health Act of 1970 nor the Consumer 

531 Product Safety Act of 1972 contains a comparable mechanism to ensure advance notice and 
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532 opportunity to review significant new uses of chemical substances, as part of articles or 

533 otherwise. 

534 B. Development of a Separate Policy Framework for Making Inapplicable the Exemption for 

535 Persons who Import or Process Chemical Substances as Part of Articles 

536 1. Comment. Some commenters suggest that before finalizing a rulemaking to make the 

537 “articles exemption” inapplicable to the benzidine-based chemical substances, the EPA should 

538 complete a separate public comment process to develop a general “policy framework for the 

539 issuance of article SNURs.” Commenters suggest that this policy framework should include 

540 science based criteria, feasibility criteria, costs, and other factors. 

541 One comment suggests that, in formulating the “policy framework” or criteria for making 

542 the exemption for importers and processors of chemical substances as part of articles 

543 inapplicable, EPA should address the following questions: 

544  Can the risk posed by the chemical of concern be addressed through the standard 

545 regulation? 

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

547  What conditions make direct regulation of articles necessary? 

548  What gaps in health and environmental protection are likely to occur if a SNUR only 

549 regulates chemicals and mixtures? 

550 1. Response. The comments conflate two separate issues: the determination of a 

551 significant new use under TSCA section 5(a)(2), and the decision to make the regulatory 

552 exemption at 40 CFR 721.45(f) inapplicable. (40 CFR 721.45(f) provides that persons who 

553 import or process a chemical substance as part of an article are not subject to the notification 

554 requirements at 40 CFR 721.25; this exemption is referred to as the “articles exemption” by 

555 some commenters). EPA first makes a determination on whether a use of a chemical substance is 
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556 a significant new use considering the factors listed in TSCA section 5(a)(2). Once that 

557 determination is made, EPA separately determines whether it would be appropriate to revoke the 

558 regulatory exemption at 40 CFR 721.45(f) for persons who import or process a chemical 

559 substance as part of an article. 

560 EPA notes that there may be a variety of cases in which it may be appropriate for EPA to 

561 include persons who import or process the chemical substance as part of an article among the 

562 persons subject to SNUN submission obligations. Knowledge regarding chemical exposures 

563 from articles has evolved since the Agency established the exemption at 40 CFR 721.45(f) in 

564 1984, and there has been a steady increase in international trade of chemicals in articles. 

565 Accumulated data illustrate that SNURs (and section 5(e) consent orders) that include the 

566 exemption for persons who import or process a chemical substance as part of an article are 

567 sometimes insufficient to appropriately flag significant new exposures from downstream uses. 

568 For example, there have been instances in which a section 5(e) consent order for a new chemical 

569 substance was issued, prohibiting the release of the chemical substance to water, and yet the 

570 chemical substance at issue was later found in the environment and biota. The presence of the 

571 chemical substance in the environment and in biota then appears to be associated with the use of 

572 the substance in articles (Ref. 4). There are also documented exposures (and resulting toxicity) of 

573 children to lead and cadmium and their compounds from a variety of articles, such as toys (Ref. 

574 5), and exposures to other heavy metals from articles, as measured in indoor air and house dust 

575 samples, which are direct routes of exposure accounting for children’s levels and toxicity (Ref. 

576 6). Other well-documented examples are the presence of brominated flame retardants (e.g., 

577 polybrominated diphenyl ethers and brominated phthalates and benzoates) in samplings of 

578 articles, indoor air, people, and house dust. The low exchange rate of indoor air and house dust to 

579 sources outside the home support the flame retardant release from articles postulate. Likewise, 
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580 other semi-sealed environments, such as automobiles, have demonstrated migration of flame 

581 retardants from treated articles to interior surfaces and indoor air, as no other source was 

582 possible. In addition, high flame retardant levels have been observed in biota raised in proximity 

583 to articles and living near article recyling sites. Further, observed flame retardant levels in biota 

584 and in the environment at locations remote from manufacturing sites suggest transport of these 

585 non-volatile chemical substances on associated particulate matter from distributed treated 

586 articles, which strongly suggest release from articles as one potential source (Ref. 7-11). 

587 The information discussed above – the well-documented exposures (and resulting 

588 toxicity) of children to lead, cadmium, and other metals from a variety of articles; the data on 

589 other chemicals used in articles; and the presence in the environment and biota of certain 

590 brominated flame retardants (e.g., polybrominated diphenyl ethers and brominated phthalates 

591 and benzoates) – all illustrate that there can be exposure to the chemicals associated with their 

592 presence in articles (Refs. 5-11). 

593 The scope of the suggested criteria (which the commenters suggest EPA should now 

594 develop to govern its exercise of its authority to make the exemption at 40 CFR 721.45(f) 

595 inapplicable) is incommensurate with the level of analysis supporting the original development 

596 of the exemption. EPA notes that TSCA section 5(a)(1) establishes a general prohibition on 

597 manufacturing or processing a chemical substance for a significant new use without prior notice 

598 to EPA. 40 CFR 721.45(f) establishes an exemption from this prohibition, but it is based on a 

599 fairly minimal rationale: “EPA believes people and the environment will generally not be 

600 exposed to substances in articles.” (49 FR 35014, September 5, 1984) (FRL-2541-8). EPA 

601 counterbalanced its reliance on this generalized assumption (about all chemicals that exist as part 

602 of articles) with a broad reservation of case-by-case discretion to make the exemption 

603 inapplicable as “warranted for specific substances.” (49 FR 35014, September 5, 1984) (FRL-
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604 2541-8). 

605 EPA does not think that development of a “policy framework” is necessary before 

606 reaching the conclusion, with respect to benzidine-based chemical substances, that persons who 

607 import or process these substances as part of articles should be subject to the notification 

608 provisions of 40 CFR 721.25. Dermal exposure can occur from the leaching of the benzidine609 based chemical substances by sweat in contact with the dyed textiles (77 FR 18756, March 28, 

610 2012) (FRL 8865-2). In addition, data indicate that exposure to other chemicals in materials such 

611 as textiles and foam can result from the dust that is generated from abrasion and/or degradation 

612 of the materials (Ref. 12). EPA notes that the commenter did not offer data to undercut the 

613 conclusion that such exposure can occur. Because of this information, and other information 

614 described in Unit III.E. of the proposal (77 FR 18756, March 28, 2012) (FRL 8865-2) (Ref. 1), 

615 EPA does not assume that new types or forms of exposure associated with new use of benzidine616 based chemical substances would be insignificant merely because the chemical substance is 

617 imported or processed as part of an article. Thus, EPA does not believe the default assumption 

618 used to support 40 CFR 721.45(f) (that people and the environment will generally not be exposed 

619 to substances in articles) holds with respect to benzidine-based chemical substances. 

620 2. Comment. Comments also suggest that EPA analyze the “variety of products” that 

621 could be construed as articles, the “practical questions that will arise” if the import and 

622 processing of such products were not exempt from SNURs, and the “unique channels of trade,” 

623 through which different varieties of products move. Commenters encouraged EPA to develop 

624 and articulate publicly a policy framework, considering the following factors on an article625 specific basis, before proceeding to revoke the article exemption with respect to a particular 

626 chemical substance: 

627 • Whether there is, or will be, direct exposure to the chemical substance in the article 
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628 during the course of the article’s use. 

629 • Whether there is, or will be, a release of the regulated substance, or a metabolite or 

630 breakdown product from the substance, during subsequent processing, distribution, use or 

631 disposal of the article. 

632 • Whether there is, or will be, a link between import or export of an article and cross633 border exposure to the U.S. population. 

634 2. Response. Given the variety of substances and uses addressed under SNUR 

635 regulations, EPA believes it is more efficient to address article-specific issues as they actually 

636 arise within each regulatory action than to develop, as suggested by the commenter, an 

637 anticipatory “policy framework” document. 

638 The importers and processors of chemical substances present in articles are generally in 

639 the best position to know which chemical substances are used in which types of articles. When 

640 EPA identifies a particular chemical substance in a SNUR, such stakeholders have an 

641 opportunity to identify, in their public comments, any article-specific issues that concern them. 

642 Furthermore, these issues are likely to be more accurately identified and more appropriately 

643 addressed in connection with the development of a SNUR for particular chemical substances 

644 than they would be if they were reviewed generically. In this case, commenters did not raise any 

645 issues specific to certain articles. 

646 C. A Compelling Basis Standard for Making Inapplicable the Exemption for Persons who Import 

647 or Process Chemical Substances as Part of Articles 

648 1. Comment. Some commenters made the point that revocation of the exemption at 40 

649 CFR 721.45(f) should not be a presumed component of all SNURs. This was part of a broader 

650 comment that EPA should not make this exemption inapplicable unless there was a “compelling 

651 basis" to do so. One commenter was concerned that if EPA proceeds on a case-by-case basis, 
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652 following reasoning that “could be applied to many chemicals,” then elimination of the 

653 exemption would come to be a “kind of ‘default’ step” in future SNURs. One commenter also 

654 argues that, where the SNUN submission requirement is to apply to importers and processors of 

655 substances as part of articles, the TSCA section 5(a)(2) criteria require EPA to undertake a 

656 compelling analysis of how the use and distribution of the “specific articles or article categories,” 

657 would “contribute to potential exposures of concern.” 

658 1. Response. As an initial matter, the comments conflate two separate issues: the 

659 determination of a significant new use under TSCA section 5(a)(2), and the decision to make the 

660 regulatory exemption at 40 CFR 721.45(f) inapplicable. The TSCA section 5(a)(2) factors do not 

661 impose a “compelling analysis” requirement on the elimination of the 40 CFR 721.45(f) 

662 exemption because (among other reasons) these two actions concern two discrete issues. The 

663 section 5(a)(2) factors speak to the significant new use itself. 40 CFR 721.45(f) speaks to who is 

664 required to notify EPA of the significant new use. 

665 In this case, EPA identified its reasons, under the TSCA section 5(a)(2) factor analysis, to 

666 anticipate that the new use would pose important new questions related to the substances’ 

667 potential to threaten health or the environment (77 FR 18752, 18756, March 28, 2012 (FRL668 8865-2)), and that EPA should have an opportunity to consider those questions before such use 

669 could occur. (In essence, a SNUR puts a particular set of uses on the same footing as a new 

670 chemical, which is subject to automatic review under TSCA section 5(a)(1) unless EPA 

671 specifically excludes it from such review.) EPA also identified a basis, specific to benzidine672 based chemical substances, to question the assumption that people and the environment will 

673 generally not be exposed to the chemical substances in articles. Therefore, EPA is also making 

674 inapplicable the exemption at 40 CFR 721.45(f) for persons who import or process a chemical 

675 substance as part of an article. No commenter provided data or other information to undercut the 
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676 factual basis for either decision. 

677 Neither TSCA nor the implementing regulations for SNURs establish a separate 

678 “compelling basis” standard, either with respect to the determination of a significant new use or 

679 with respect to the decision to make the exemption at 40 CFR 721.45(f) inapplicable. Nor have 

680 commenters identified a persuasive basis for EPA to adopt such a standard under either scenario. 

681 EPA’s specific action with respect to benzidine-based chemical substances is not, as 

682 commenters suggest, tantamount to the presumptive revocation of the SNUN submission 

683 exemption for importers and processors of chemical substances as part of articles in all future 

684 instances. EPA has not proposed to globally modify or eliminate the SNUR exemption for 

685 persons who import or process chemical substances as part of articles. EPA need not presently 

686 address the merits of an action it is not presently taking, and did not previously propose to take. 

687 TSCA sections 5(a)(2)(B) and (C) require EPA to consider the extent to which a new use 

688 “changes the type or form of exposure” or “increases the magnitude and duration of exposure” 

689 before making a determination that a particular use is a “significant new use.” EPA disagrees 

690 that it must therefore, as one commenter suggests, conduct a multiplicity of separate significant 

691 new use analyses whenever the use under consideration involves an article (i.e., one for each 

692 specific article or article category, comparing the relative significance of each particular article 

693 or article category). In particular, the commenter’s interpretation of TSCA section 5(a)(2) 

694 misconstrues the baseline against which the “newness” and the “significance” of a significant 

695 new use are evaluated. As EPA has long maintained, the single analytical baseline is the set of 

696 uses that were ongoing “as of the date of publication” of the SNUR proposal. (See e.g., 77 FR 

697 18760, March 28, 2012 (FRL 8865-2)). 

698 Furthermore, the particular analytical standards the commenter suggests are not 

699 commensurate with the establishment of a one-time notice requirement intended to give EPA an 
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700 opportunity to later evaluate the need for testing or other regulatory action under TSCA. 

701 Requiring upfront answers to the very questions EPA would evaluate after receiving a significant 

702 new use notice, as a pre-condition of requiring the notices, would undermine the statutory 

703 authorization to issue SNURs in the first place. EPA’s decision to propose a SNUR for a 

704 particular chemical use and to make the exemption at 40 CFR 721.45(f) inapplicable to that 

705 SNUR need not be based on an extensive evaluation of the hazard, exposure, or potential risk 

706 associated with that use. Rather, the Agency is acting because it has reason to anticipate that such 

707 use would raise important new questions related to the substance’s potential to threaten health or 

708 the environment, and that EPA should have an opportunity to consider those questions before 

709 such use could occur. Since the use designated as a significant new use does not currently exist, 

710 deferring a detailed consideration of potential risks or hazards related to that use is an effective 

711 use of resources. If a person decides to begin manufacturing or processing the chemical for the 

712 significant new use, in articles or otherwise, the notice to EPA allows EPA to evaluate the use 

713 according to the specific parameters and circumstances surrounding that intended use. 

714 Even if it were appropriate to construe the decision to make the 40 CFR 721.45(f) 

715 exemption inapplicable as a subcomponent of the significant new use determination under 

716 section 5(a)(2) (rather than as a subsequent determination), EPA adequately considered the 

717 section 5(a)(2) factors. 

718 The first factor is the “projected volume of manufacturing and processing of a chemical 

719 substance” (TSCA section 5(a)(2)(A)). EPA projects that these substances will not be 

720 manufactured or processed at any volume for the new uses in question and notes that for the 

721 newly proposed nine benzidine-based chemical substances, data reported to EPA for the 2012, 

722 2006, 2002, and 1998 reporting cycles, as required by the TSCA IUR rule, indicate no evidence 

723 of manufacture (including import) (Ref. 13). (77 FR 18755, March 28, 2012) (FRL 8865-2). Any 
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724 increase in the projected volume of manufacturing (including import) or processing of these 

725 substances, beyond the very limited uses currently ongoing, would reflect a significant departure 

726 from prior trends. Given that these chemical substances are anticipated to metabolize to the 

727 parent benzidine molecule, which is a known human carcinogen, EPA anticipates that 

728 information presented in the SNUN on the quantities manufactured (including imported) and 

729 processed of benzidine based chemical substances would be important to EPA’s overall 

730 evaluation of whether the new use may present an unreasonable risk to human health or the 

731 environment. The necessary increase in volume of this substance from any new use weighs in 

732 favor of determining that the new use is a significant new use. 

733 The second factor is "the extent to which a use changes the type or form of exposure of 

734 human beings or the environment to a chemical substance” (TSCA section 5(a)(2)(B)). For the 

735 newly added benzidine-based chemical substances, a general market review on these chemical 

736 substances indicates no current manufacture within or outside the United States. Although some 

737 of the chemical substances subject to the 1996 SNUR may still have certain limited ongoing uses 

738 (e.g., as a test reagent, lab standard, or microscopy stain), such uses are expected to be confined 

739 to limited laboratory or technical applications that are not expected to represent an appreciable 

740 amount of overall exposure. Furthermore, EPA did not find evidence of actual ongoing 

741 importation or domestic production for these uses. No comments provided evidence of ongoing 

742 manufacture (including import) or processing of these chemical substances as part of articles or 

743 otherwise. Thus, EPA believes that there is no, or almost no, current exposure to these chemical 

744 substances in the United States. 

745 Should a significant new use be planned, EPA anticipates that the new use would raise 

746 important new questions such as the following: 

747 • To what extent would the use be expected to involve dermal contact with the substance? 
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748 • Would the substance be used in a setting where oral exposure is likely (e.g., would 

749 young children be able to mouth the article)? 

750 • How would potential occupational exposures and releases to the environment over the 

751 substance’s lifecycle be expected to be managed? 

752 Given that these chemical substances are anticipated to metabolize to the parent 

753 benzidine molecule, which is a known human carcinogen, EPA anticipates that the answers to 

754 such questions would be important to EPA’s evaluation of whether the new use may present an 

755 unreasonable risk to human health or the environment. The potential for a new use to change the 

756 type or form of exposure weighs in favor of determining that the new use is a significant new 

757 use. 

758 The third factor is "the extent to which a use increases the magnitude and duration of 

759 exposure of human beings or the environment to a chemical substance” (TSCA section 

760 5(a)(2)(C)). Should one of the designated significant new uses be planned, EPA anticipates that 

761 the planned new use would raise important new questions relating to the concentration in which 

762 the substance would be used, the potential for repeated exposure, and the potential for continuous 

763 exposure. Given these chemical substances are anticipated to metabolize to the parent benzidine 

764 molecule, which is a known human carcinogen, EPA anticipates that the answers to these 

765 questions would be important to EPA’s overall evaluation of whether the new use may present 

766 an unreasonable risk to human health or the environment. EPA also notes that dermal exposure 

767 can occur from the leaching of the chemical substances by sweat in contact with the dyed textiles 

768 (77 FR 18756, March 28, 2012) (FRL 8865-2). Because of this information, and the information 

769 described in Unit III.E. of the proposal (77 FR 18756, March 28, 2012) (FRL 8865-2), EPA does 

770 not assume that new types or forms of exposure associated with new use of these substances 

771 would be insignificant merely because they relate to new use in an article or because the 
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772 pertinent manufacturing or processing of the substance occurred as part of an article. The 

773 potential for activities related to a new use to increase the magnitude and duration of exposure 

774 weighs in favor of determining that any non-ongoing use is a significant new use. 

775 The fourth factor is “the reasonably anticipated manner and methods of manufacturing, 

776 processing, distribution in commerce, and disposal of a chemical substance” (TSCA section 

777 5(a)(2)(D)). EPA anticipates that any new use, beyond the very limited uses currently ongoing, 

778 would raise important new questions such as the following: 

779 • To what extent can the anticipated manufacturing, processing, distribution in 

780 commerce, and disposal of the chemical substance be expected to result in worker exposure, user 

781 exposure, or release of the chemical substance to the environment? 

782 • What potential controls are available to limit such releases? 

783 Given these chemical substances are anticipated to metabolize to the parent benzidine 

784 molecule, which is a known human carcinogen, EPA anticipates that the answers to these 

785 questions would be important to EPA’s overall evaluation of whether the new use “may present 

786 an unreasonable risk to human health or the environment.” The potential for manufacturing, 

787 processing, distribution in commerce or disposal of these benzidine-based chemical substances to 

788 change the overall exposure picture weighs in favor of determining that consumer textile use is a 

789 significant new use. 

790 After considering each of the four TSCA 5(a)(2) factors, EPA has concluded that the 

791 factors taken together weigh in favor of determining that manufacture or processing of these 

792 benzidine-based chemical substances for any non-ongoing use would be a significant new use 

793 such that the Agency should have an opportunity to analyze the new use before such use (and 

794 potential exposures) occurs. This determination would still hold even if one were to consider the 

795 40 CFR 721.45(f) exemption as a subcomponent of the significant new use determination under 
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796 section 5(a)(2). 

797 D. Narrowing the Scope of SNURs where the Exemption for Importers and Processors of 

798 Chemical Substances as Part of Articles is Made Inapplicable 

799 Some comments suggest that significant new uses should not be “open-ended” but 

800 instead must be targeted to specific articles, particularly in cases where the exemption at 40 CFR 

801 721.45(f) is made inapplicable. The concern expressed is that if the SNUN applies to “any use of 

802 a substance, then regulated parties and the EPA would be obligated to proceed through the 

803 SNUR process for an article that would have little relevance to the perceived hazard that drove 

804 the original SNUR.” The commenter further writes that “open-ended article SNUR’s can trigger 

805 reviews for articles that may have no relationship to the hazard or exposure concerns that 

806 motivated EPA’s decision to initiate the rule.” 

807 EPA’s concern with these benzidine-based dyes is not limited to certain exposure 

808 pathways to specific articles. EPA’s concern is specific to the benzidine-based dyes and thus to 

809 the range of exposures that could occur for these chemical substances. The preamble of the 

810 proposed rule notes multiple potential routes and sources of exposure including inhalation, skin 

811 absorption via dyed textiles, and ingestion. (77 FR 18752, 18756, March 28, 2012) (FRL-8865-

812 2). Furthermore, SNURs need not be narrowly focused on the mitigation of currently foreseeable 

813 exposure scenarios—it is proper that they will also ensure EPA has timely notice of future (and 

814 currently unforeseeable) exposure scenarios. An additional requirement to make targeted 

815 predictions of the particular uses that "may be proposed in the future" would undermine this 

816 intended function of the SNUR. 

817 More generally, an exhaustive list of all applications that could possibly fall within the 

818 ambit of a significant new use definition is not a prerequisite for issuing a SNUR. Since the 

819 significant new use does not currently exist, deferring a detailed consideration of potential risks 
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820 related to the importation or processing of these chemical substances (including as part of 

821 articles) is an effective use of resources. If a person decides to begin importing or processing the 

822 chemical, as part of an article or otherwise, the notice to EPA allows EPA to evaluate the 

823 significant new use according to the specific parameters and circumstances surrounding that 

824 intended use. 

825 E. EPA Should Have a Reasonable Basis to Conclude that Identified Articles Would be 

826 Distributed in the United States 

827 One comment states that “EPA presents an exposure-based rationale for why certain 

828 articles could be a concern, but indicates that there is no current expectation that these chemical 

829 substances will be used in such articles.” The commenter believes that before issuing an article 

830 SNUR, EPA should have a reasonable basis to conclude that identified articles of concern would 

831 be distributed in the United States. The commenter contends that EPA should identify an article 

832 containing such a chemical that is currently in global commerce and explain why it is likely to be 

833 distributed in the United States. The commenter believes that it might also be possible to identify 

834 an article at the research and development stage that is likely to proceed to commercial 

835 development. Without such findings, however, the commenter is concerned that EPA would be 

836 issuing an article SNUR for a situation that presents no current or likely future threats to health 

837 or the environment, and thus that the rule would be a waste of public resources. Another 

838 comment raises similar issues, arguing that EPA should provide even more specific information 

839 on how the significant new uses contribute to risk. 

840 Alternatively, the first commenter suggests that EPA include a specific provision 

841 suspending enforcement of the SNUR until a determination is made that there is a reasonable 

842 basis to believe that an article containing the specific chemical had been, or would be, distributed 

843 in the United States. 
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844 EPA disagrees with the suggestion to limit the application of SNUN submission 

845 requirements for importers and processors of the chemical substances as part of articles to 

846 situations where importation or processing as part of an article is known to be imminent. SNURs 

847 address situations in which EPA is concerned about the potential for use to commence without 

848 prior opportunity for review and risk management action where appropriate. For purposes of 

849 SNURs, EPA cannot be expected to predict specific situations where new uses may be imminent, 

850 or how those specific uses may contribute to risk, before designating significant new uses. The 

851 purpose of a SNUR is to obtain such information so that EPA can evaluate risks associated with, 

852 and take risk management action where appropriate regarding, any notified activities. These rules 

853 serve the important function of alerting EPA when a significant new use is intended. Without 

854 them, EPA would have no expectation of timely identification of new uses of these chemicals. 

855 Notice relating to the import or processing of articles is particularly important in this case, as the 

856 proposal specifically identified a concern related to the potential for dermal exposure via dyed 

857 articles (i.e., from the leaching of the benzidine-based chemical substances by sweat in contact 

858 dyed articles, such as textiles). (77 FR 18756, March 28, 2012) (FRL 8865-2). 

859 It would not be an efficient use of government resources for EPA to continually monitor 

860 global commerce to try to predict which chemicals are about to be imported as part of articles 

861 (but have not yet been imported) into the United States. Persons who wish to manufacture 

862 (including import) or process these chemical substances for a significant new use, as part of an 

863 article or otherwise, are in a better position than EPA to evaluate when they are about to initiate 

864 a particular significant new use. 

865 Given that SNURs cannot be issued for ongoing uses, the commenter’s suggestion (that 

866 EPA must itself make an upfront demonstration that a particular new use is about to begin, to 

867 secure the opportunity to be notified of when significant new uses involving importation or 
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868 processing of chemical substances as part of articles are about to begin) is impracticable. It 

869 would likely result in a scenario in which an otherwise significant new use would be allowed to 

870 commence prior to the issuance of a SNUR proposal, thereby placing that use outside of EPA’s 

871 SNUR authority. Furthermore, EPA has already considered and rejected (in 2006, following 

872 public comment on a 2004 proposal) the position that it must defer revocation of the 40 CFR 

873 721.45(f) exemption for a SNUR until it appears likely “that these chemical substances will be 

874 imported as part of articles.” (69 FR 70409, December 6, 2004) (FRL 7633-1). EPA concluded 

875 in 2006, after a re-evaluation of the issue prompted by public comments, that “if the subject 

876 substances when imported as a part of articles are not subject to the SNUR, EPA could miss the 

877 opportunity to obtain notifications that would provide information of potential regulatory and 

878 assessment value.” (71 FR 34018, June 13, 2006) (FRL 7743-2) (ultimately declining to make 

879 the exemption inapplicable, based on a separate concern that the use with respect to articles 

880 appeared to be already ongoing). 

881 Finally, for essentially the same reasons as set forth above, EPA believes it would be 

882 inappropriate to follow one commenter’s alternative suggestion: to promulgate a SNUR without 

883 the exemption for importers and processors of chemical substances as part of articles, while 

884 somehow “suspending enforcement” until the precise moment that manufacture or processing for 

885 a significant new use as part of an article is about to begin, but has not yet begun. 

886 In sum, EPA believes commenter’s suggestions would turn the regulatory process on its 

887 head. EPA would likely need to already have a SNUR in place in order to obtain the kind of 

888 timely information about significant new use that the commenter asserts should be prerequisite to 

889 issuing the SNUR in the first place. 

890 F. Intended Coverage of the Benzidine-Based Chemical Substances SNUR 

891 1. Comment. One commenter writes that “A proposed rule offering a clear explanation of 
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892 what uses EPA intends to cover, including an explanation of the alternatives if certain situations 

893 are unclear, will greatly increase the chances that useful information about business practices and 

894 common terms of art in an industry will be identified.” EPA should define the scope of the uses 

895 to be regulated as clearly and precisely as possible. 

896 The commenter also contended that soliciting public comment on the appropriate scope 

897 of new uses to be regulated, for a specific chemical substance, constitutes “an abdication of the 

898 role that EPA should be undertaking.” The commenter suggests that before soliciting public 

899 comments, EPA should have first pursued an informal coordination with downstream industries 

900 and (as necessary) an exercise of its “ample authority under TSCA, either through regulatory 

901 action under section 8 or order authority under section 11 (c).” Finally, the commenter suggests 

902 that to the extent the proposed significant new uses admit ambiguity or potential need for 

903 adjustment in response to public comment, that is evidence that EPA “should have learned more 

904 about the uses” before issuing the proposal and is improperly seeking “to shift the responsibility 

905 to stakeholders.” 

906 1. Response. The description of the scope of the significant new uses in the benzidine907 based chemical substances proposed SNUR and the Agency’s basis for the proposal were 

908 explicit. The SNUR proposal fairly apprised stakeholders as to the chemical at issue and the 

909 particular concerns driving the proposed action. It further indicated that based on information 

910 available to EPA, the significant new uses identified are not currently on-going. Stakeholders 

911 had an opportunity to oppose any of these preliminary findings by supplying countervailing 

912 information thorough the rulemaking process itself. Grafting additional pre-proposal steps onto 

913 the SNUR rulemaking process would be unnecessarily time-consuming and an unsound use of 

914 agency resources. The timelier, less resource-intensive, and more transparent process is for 

915 interested stakeholders, through the public comment process itself, to simply provide any 
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916 pertinent countervailing information they wish to add to the initial collection of information EPA 

917 presented in the proposal. 

918 As noted earlier, TSCA section 5(a)(2) does not compel nor contemplate an article by 

919 article analysis to identify every conceivable significant new use of a chemical substance. EPA 

920 evaluates whether a new use is “significant” consistent with the evidence of Congressional intent 

921 underlying the enactment of TSCA. See H.R. Rep. No. 94-1341 at 24 (1976) (“[B]ecause of the 

922 nature of a substance, it is possible that any new use of it will be significant. Thus, a potentially 

923 dangerous substance which is manufactured for a particular use may, if manufactured for a 

924 different use present additional health or environmental problems and consequently there should 

925 be notice of the intent to manufacture it for such different use.” H.R. Rep. No 94-1679 at 66 

926 (1976) (“[T]he conferees intend that any potential threats to health or the environment from the 

927 manufacture, processing, distribution in commerce, or disposal of a substance associated with a 

928 new use be considered by the Administrator when determining the significance of a new use.”) 

929 Finally, a broad construction of the significant new use is particularly appropriate where (as in 

930 the case of benzidine-based dyes) any increase in the projected volume of manufacturing 

931 (including import) or processing of these substances, beyond the very limited uses currently 

932 ongoing, would reflect a significant departure from prior trends. 

933 2. Comment. “It does not make sense to issue article SNUR’s [sic] for full size machines 

934 or structures. An article SNUR should focus on the specific components of more complex 

935 machines or structures that involve the chemical of concern.”

936 2. Response. The commenter neither explains what the commenter means by “full size,” 

937 nor offers any specific evidence to support their general view that new uses of chemical 

938 substances in “full size machines or structures,” are any less likely to be significant than new 

939 uses of chemical substances in “specific components.” Nor does the commenter indicate why 
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940 persons who import or process chemical substances as part of articles would be more likely to be 

941 importing or processing the chemical substances for use in “full size” articles. Attempting to 

942 define and distinguish between “full size” article uses and other uses, and correlating such 

943 distinctions to whether persons are importing or processing these chemical substances as part of 

944 articles, would delay the rulemaking and increase its complexity, in a manner that does not seem 

945 warranted on the basis of the limited information supplied in the comment. 

946 3. Comment. “Chemicals used in articles may sometimes be incorporated into 'internal' 

947 mechanisms of the article that are unlikely to come into contact with people or be released into 

948 the environment during normal use of the article.” 

949 3. Response. The commenter does not explain why the basis for a SNUR should be 

950 limited to those exposures that occur concurrent with the article fulfilling its intended function, 

951 when TSCA section 5(a)(2)(D) contemplates that EPA will consider the value of ensuring it has 

952 a future opportunity to review the whole life-cycle impact (e.g., “manufacturing, processing, 

953 distribution in commerce, and disposal”) of a significant new use of a chemical substance. The 

954 exposure to the chemical substance, including when it is in an article, may be larger during 

955 disposal or recycling than during the “normal use” of the chemical. Further, chemical substances 

956 that are ‘internal’ to an article may still result in exposure if the chemical substance has certain 

957 physical- chemical properties (e.g., a relatively volatile chemical used as a plasticizer in interior 

958 automobile parts) or due to abrasion of the article (e.g., a dye incorporated into furniture 

959 covering.) 

960 Nor does the commenter indicate why persons who import or process chemical 

961 substances as part of articles would be more likely than any other manufacturers or processors to 

962 be manufacturing or processing for use in the internal mechanisms of articles. Attempting to 

963 define and meaningfully distinguish between “internal” article uses and other uses, and 
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964 correlating such distinctions to whether manufacturing or processing of the substance occurs as 

965 part of an article, would delay the rulemaking and increase its complexity, in a manner that does 

966 not seem warranted on the basis of the limited information supplied in the comment. 

967 4. Comment. “EPA should clarify whether the SNUR applies to articles containing the 

968 chemical of concern in a solid, liquid, particle or gaseous form.” 

969 4. Response. This SNUR applies to the chemical substances regardless of form. To the 

970 extent the commenter seeks to continue some aspect of the exemption at 40 CFR 721.45(f), 

971 depending on the form of the chemical substance in the article that is being imported or 

972 processed, the commenter has not offered any specific support for that proposition, either 

973 generally or in any particular case. In the SNUR at issue, EPA does not believe it is prudent to 

974 limit the application of the rule based on the form (solid, liquid, or gaseous) of the chemical 

975 substances at issue. Chemicals that may have been used in one form during the manufacture of 

976 the article may be released from the article in a different physical form. Also, fluids and particles 

977 are not covered under the applicable definition of article at 40 CFR 704.3. EPA received no 

978 comments suggesting that use of these chemicals in one form or another may not be significant 

979 based on the TSCA section 5(a)(2) factors. Moreover, information relevant to a specific form of 

980 a chemical substance can be submitted in a SNUN and may be considered by EPA in review of 

981 that SNUN in determining whether follow-up action is warranted, and may support EPA’s 

982 amendment of the SNUR to limit its scope. 

983 5. Comment. “[A] chemical may be present at a very low concentration that is unlikely to 

984 be associated with a risk warranting EPA risk management action. . . . EPA should consider 

985 whether it can establish a de minimus exclusion [from the SNUR].”

986 5. Response. EPA notes that the SNUR already contains a general exemption for 

987 unintentionally present impurities at 40 CFR 721.45(d). To the extent chemical substances are 
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988 intentionally added to articles at very low concentrations, the question of whether the substance 

989 warrants risk management action is one that EPA can address upon receipt of the SNUN, not an 

990 analytical prerequisite to deciding whether it should receive the SNUN in the first place. 

991 G. Screening for Benzidine-Based Chemical Substances 

992 Some commenters faulted the proposal for not identifying precise screening operations to 

993 be taken in response to the SNUR, and for not conducting additional analyses of the cost and 

994 feasibility of such screening operations. One commenter suggests, in particular, that an article 

995 importer should be deemed in compliance with the SNUR if the chemical is present below an 

996 established de minimis level (based on mass or concentration), or if it simply does not know the 

997 article’s content after conducting a reasonable inquiry for such information. 

998 With respect to processors, given the requirements of 40 CFR 721.5(a)(2), a processor of 

999 the chemical substance should have received notification that the chemical substance is the 

1000 subject of a SNUR. A processor is not required to submit a SNUN for its unknowing processing 

1001 of a chemical substance subject to a SNUR if (upon obtaining knowledge) the processor can 

1002 document that when the past processing occurred, the processor neither knew the chemical 

1003 identity of the substance it was processing nor knew that substance was subject to a SNUR. See 

1004 40 CFR 721.5(c). EPA would generally expect that processors would only fail to be aware of the 

1005 presence of a chemical subject to a SNUR if the manufacturer (including importer) or upstream 

1006 processor of the chemical substances failed to meet their obligations under 40 CFR 721.5(a)(2). 

1007 With respect to importers, EPA disagrees that it would be appropriate or necessary for the 

1008 SNUR itself to define screening procedures to be employed for compliance purposes. The 

1009 Agency did not propose to require a particular screening procedure and, for the following 

1010 reasons, it does not agree that particular screening procedures should be specified and 

1011 incorporated into the final rule. 
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1012 First, EPA believes that adding these sort of screening-effort exemptions, specifically for 

1013 importers of chemical substances as part of articles, would be especially difficult to reconcile 

1014 with the general statutory prohibition (under TSCA section 5(a)(1)) on manufacturing or 

1015 processing a chemical substance for a significant new use without prior notice to EPA. The issue 

1016 under the statute is whether or not an importer actually imports a substance. This is a separate 

1017 question from the importers’ level of knowledge or level of effort to obtain knowledge respecting 

the content of the imports.2 1018 With respect to SNURs, EPA notes that its direct rulemaking 

1019 authority is to identify significant new uses under section 5(a)(2). The Agency has been 

1020 appropriately cautious in exercising its implicit rulemaking authority to limit the applicability of 

1021 section 5(a)(1). EPA recognizes that it did previously exercise such implicit rulemaking authority 

1022 when establishing 40 CFR 721.45(f). However, as noted above, the exemption at 40 CFR 

1023 721.45(f) was established along with a broad reservation of authority to withdraw the exemption 

1024 where, as here, it is inaccurate to assume that there would not be exposure to the substance 

1025 simply because it is present as part of an article. And a screening-effort exemption is especially 

1026 difficult to reconcile with the statute in the case of importers. With importers, unlike with 

1027 processors, there are no upstream entities with a duty under TSCA to notify importers of the 

1028 presence of a chemical substance subject to a SNUR. 

1029 Second, establishing a safe-harbor for importers based on lack of knowledge would 

1030 create incentives for foreign suppliers to deliberately withhold information from importers. This 

1031 could greatly reduce the efficacy of this SNUR. Currently, when an importer wishes to import a 

1032 substance it knows would be subject to notification requirements, but for which the chemical 

 

2

 The limiting clause in the definition of “principal importer” at 40 CFR 721.3—“knowing that a chemical substance 

will be imported”—is a limit based on the person’s knowledge that he or she is engaged in an import transaction, not 

a limit based on the person’s knowledge of a particular chemical’s identity and regulatory status. (48 FR 21727, 

May 13, 1983) (FRL 2998-5). 
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1033 identity is claimed as CBI by a foreign manufacturer, EPA’s longstanding practice when 

1034 reviewing PMNs and SNUNs is to accept the relevant information on chemical identity directly 

1035 from the foreign manufacturer. See, 48 FR 21726, May 13, 1983 (FRL 2998-5) (“[t]he principal 

1036 importer need not know the specific chemical identity of the imported substance” and “may have 

1037 its foreign manufacturer or supplier, or some other person, report the chemical identity to EPA.”) 

1038 Offering an outright regulatory exemption to an importer simply because it is ignorant of the 

1039 existence of a SNUR-regulated substance in the imported article (after conducting a prescribed 

1040 inquiry) would allow foreign suppliers to short-circuit this process simply by refusing to divulge 

1041 to the importer whether the import contains a chemical substance subject to SNUR. 

1042 Third, to the extent the chemical substance subject to the SNUR is only “unintentionally 

1043 present” at the point of foreign manufacture, it is already exempt from reporting by the importer 

1044 as an imported impurity. See 40 CFR 721.3 (chapeau), 40 CFR 720.3(m), and 40 CFR 721.45(d). 

1045 Thus, importers are not required to submit a SNUN for a substance based simply on that 

1046 substance’s presence as an impurity (i.e., a chemical substances unintentionally present with 

1047 another chemical substance). 

1048 Fourth, whether and how it may appropriate for importers to screen for benzidine-based 

1049 chemical substances will depend on many factors, including their current state of knowledge 

1050 about the articles that they import and the potential risk of unknowingly importing articles that 

1051 contain these chemical substances. The relevant factors are largely impossible for EPA to 

1052 establish at this time, given that there is currently no on-going import of these substances for the 

1053 designated significant new uses. 

1054 Finally, EPA did conduct additional analysis of potential screening burden to explore 

1055 commenters’ concerns. As described below, EPA acknowledges the costs of the various 

1056 activities that certain entities may choose to undertake, in response to this rule, to ensure that the 
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1057 chemicals they import or process as part of articles do not trigger SNUN submission 

1058 requirements (Ref. 14). Based on EPA’s economic analysis and the responses to the proposed 

1059 rule, EPA does not believe that these costs will be significant for any individual entity.

1060 H. Costs Associated with Making the Exemption for Persons that Import or Process Chemical 

1061 Substances as Part of Articles Inapplicable 

1062 Some comments note that the economic analysis, which focuses on the cost of filing a 

1063 SNUN, does not include any analysis of the costs that might be associated with screening articles 

1064 to determine whether these SNURs would apply. One comment also notes that “the preambles to 

1065 the proposed rules do not discuss what, if any obligations companies have to screen articles for 

1066 the chemicals included in the SNUR’s.” 

1067 With respect to processors: existing SNUR regulations already provide that the 

1068 unknowing processing of a chemical substance does not itself trigger SNUN requirements if the 

1069 processor can (upon obtaining knowledge) document that when the past processing occurred, the 

1070 processor neither knew the chemical identity of the substance it was processing nor knew that 

1071 substance was subject to a SNUR. See 40 CFR 721.5(c). 

1072 With respect to importers: based on an assessment of current market activity in the 

1073 economic analysis, EPA believes that the chemicals subject to the final SNUR are not currently 

1074 being imported into the United States for the identified significant new uses in articles. EPA 

1075 received no public comments on the proposed SNUR that indicate that importation of these 

1076 benzidine-based chemical substances for the finalized significant new uses, in articles or 

1077 otherwise, is ongoing. However, because this SNUR makes inapplicable the exemption for 

1078 persons that import or process chemical substances as part of articles, companies may take 

1079 actions to ensure that they do not import any articles containing the subject chemical substances 

1080 after promulgation of this rule, by such means they deem appropriate. This is not necessarily a 
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1081 new consideration for importers given that importers of mixtures have needed to be aware of 

1082 chemical substances subject to a SNUR that may be a component of imported mixtures. Whether 

1083 and how companies respond will depend on many factors, including their current state of 

1084 knowledge about articles that they import and their own assessments of the potential risk of 

1085 unknowingly importing articles that contain these chemicals. As noted above, EPA did conduct 

1086 additional analysis of burdens that may be associated with activities entities may undertake to 

1087 ensure the chemicals they import or process as part of articles do not trigger SNUN submission 

1088 requirements (Ref. 14). 

1089 In any event, EPA did not propose to mandate any particular level of screening of 

1090 imported or processed articles. The preamble to the proposed SNUR did not discuss the precise 

1091 steps that an importer or processor must take in this regard because there is no precise level of 

1092 screening by which the manufacturer or processor could be separately liable under the rule (if not 

1093 performed) or by which a manufacturer or processor could obtain “safe harbor” from what would 

1094 otherwise be a violation of the rule. While EPA might potentially take screening practices into 

1095 consideration when evaluating a particular instance in which the SNUR was nevertheless 

1096 violated, that would be as a matter of enforcement policy, not as a provision of the rule itself. 

1097 EPA has included estimates for some activities that importers may undertake (e.g., 

1098 supplier inquiries) in order to evaluate the likelihood of chemicals being imported as part of 

1099 articles. These costs will vary for individual companies and their experience with suppliers. 

1100 Awareness of article components and constituents is becoming more commonplace as companies 

1101 frequently operate on a global scale and are subject to numerous regulatory requirements around 

1102 the world that affect product stewardship responsibilities. Existing requirements that may compel 

1103 a company to investigate an article’s components include the Consumer Product Safety Act, 

1104 California’s Proposition 65, and the EU’s regulation on Registration, Evaluation, Authorization 
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1105 and Restriction of Chemical (REACH), which requires customer notification about the presence 

1106 of certain chemical in articles that a company distributes. U.S. importing companies may already 

1107 be familiar with the process of determining whether the articles they import contain restricted 

1108 chemical substances, if they are subject to the requirements cited above or various U.S. 

1109 regulations, such as the Product Safety Improvement Act (CPSIA) of 2008, Washington’s 

1110 Children’s Safe Product Act, and Maine’s Act to Protect Children’s Health and the Environment 

1111 from Toxic Chemicals in Toys and Children’s Products (Ref. 14). 

1112 Given the existing regulatory limitations on certain chemicals both internationally and 

1113 within the United States, regulated industries have begun to develop industry-wide processes and 

1114 other resources to obtain information on chemical substances in articles. Policies and procedures 

1115 could include supplier agreements, such as Hewlett Packard’s requirement that suppliers meet 

1116 their General Specifications for the Environment (GSE) (Ref. 15) and Walmart’s requirement 

1117 that suppliers participate in International Compliance Information Exchange (iCiX) to manage 

1118 and share compliance information throughout the supply chain (Ref. 16). More extensive policies 

1119 and procedures could even include product testing. Companies may choose to use existing 

1120 procedures or develop new ones that could range from document review, to supplier agreements, 

1121 to product testing. 

1122 Additional analysis conducted by EPA on activities that companies may choose to 

1123 undertake to ensure that the chemicals they import or process as part of articles do not trigger 

1124 requirements of the SNUR shows a wide range of potential activities and associated costs. The 

1125 conduct of these activities and associated costs are at the discretion of the company. Table B 

1126 shows EPA’s estimated a range of costs associated with some of these potential activities for 

1127 importers of articles. 
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1128 Table B: Range of Costs Associated with an Importer’s Identification of Chemicals Subject 

1129 to SNURs in Articles 

Activity Cost 

US ($) Notes 

Per Rule Costs 

1. Rule familiarization $55 Cost typically already included in SNUR 

Economic Analyses 

2. Identify the type of imported 

articles that potentially contain 

the restricted substances 

$130 to 

$1,550 

Actual costs may vary based on number of 

articles imported and the complexity of the 

article itself (number of components) 

3. Identify all suppliers involved 

$950 

Actual costs may vary depending on the 

number of articles imported, number of 

suppliers, and frequency of supplier changes 

6. Recordkeeping $10 Cost typically already included in SNUR 

Economic Analyses 

Article-Related Costs 

4. Collect data from suppliers $5 to 

$515 per 

article 

reviewed. 

$0 if no 

data 

collected. 

Actual costs only apply to those companies 

that choose to collect data from suppliers. 

They will vary depending on the specific data 

collection method chosen. Total costs depend 

on considerations including the number of 

articles imported, number of suppliers, and 

frequency of supplier changes. 

5. Chemical testing 

$130 per 

article 

tested. $0 

if no 

testing. 

Actual costs only apply to those companies 

that choose to collect data from suppliers. 

Total costs per company will depend on 

considerations including the number of 

articles tested, which may be affected by the 

number of suppliers and risk associated with 

each, and frequency of supplier changes. 

1130 

1131 Should processors of articles need to demonstrate compliance with a SNUR, it is 

1132 expected that they could use the shipping or labeling documents received with the article in the 

1133 ordinary course of business. As these documents would be received and stored anyway, as per 

1134 standard business practices, the elimination of the exemption in the SNUR for persons that 

1135 import or process chemical substances as part of articles would be unlikely to lead such persons 

1136 to incur significant additional costs. To the extent that processors choose to undertake more steps 

1137 to identify regulated chemicals as part of articles, the costs of these activities would be similar to 
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1138 those in Table B for importers of similar size, supply chain complexity, and level of compliance 

1139 with other chemical regulations. 

1140 There are a number of regulations, including California’s Proposition 65 and the EU’s 

1141 REACH that currently restrict or otherwise affect the use of certain benzidine-based substances, 

1142 particularly in their use as dyes in textiles and leather. California’s Proposition 65 Chemical List 

1143 includes benzidine-based dyes as a potential carcinogen and requires that firms provide a clear 

1144 and reasonable warning before knowingly and intentionally exposing anyone to a listed 

1145 chemical. This warning may include the labeling of consumer products (Refs. 17-18). 

1146 The EU has banned, in textile and leather articles which may come into direct and 

1147 prolonged contact with humans, the use of azo dyes which can break down to release any of 22 

1148 listed carcinogenic aromatic amines (including benzidine and its congeners) in amounts above 30 

1149 ppm (Ref. 19). The European Commission’s Directorate General for Health and Consumers 

1150 maintains the RAPEX database that member countries can use to report dangerous products and 

1151 the measures they have taken to prevent or restrict those products. Despite the EU ban, small 

1152 numbers of products containing such azo dyes have recently been listed on RAPEX. The 

1153 products are typically voluntarily withdrawn from the market and/or destroyed by the importer or 

1154 have been placed under an order by the authorities to cease sales (Refs. 20, 21). Therefore, azo 

1155 dyes in imported articles still remain a potential issue in the EU. Other countries have also 

1156 banned the manufacture and use of the azo dyes in textiles. Currently the manufacture of azo 

1157 dyes is banned in South Korea and Japan (Ref. 22). Use of these chemicals is banned by Egypt, 

1158 India, China, South Korea, Taiwan and Vietnam (Ref. 23), and Indonesia has banned the use of 

1159 the dyes in children’s and baby’s clothing (Ref. 24). In 2012, the Japanese textiles and leather 

1160 industry announced voluntary restrictions of the chemicals (Refs. 23, 24). Canada has also 

1161 expressed concern about the potential release of benzidine or its congeners from azo dyes and is 
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1162 evaluating potential approaches for addressing azo dyes (Ref. 25). Organizations, such as the 

1163 American Apparel & Footwear Association (AAFA), have developed a comprehensive 

1164 Restricted Substances List (RSL) as a reference for companies and have developed a toolkit to 

1165 help apparel and footwear companies to better manage chemicals throughout the supply chain. 

1166 Given the current level of international and domestic regulation and attention to benzidine1167 related chemicals, EPA believes that importers and processors of articles may already have 

1168 undertaken a number of activities to manage chemicals within their supply chains and generally 

1169 to deselect for these chemicals. Therefore, EPA expects that companies that could potentially 

1170 commence importing or processing benzidine-based chemicals as part of articles may already 

1171 have some knowledge of the chemicals within their supply chain and would undertake few of the 

1172 activities listed in Table B and would fall toward the lower end of the cost range for any 

1173 activities undertaken. More detailed information is included in EPA’s economic analysis. 

1174 EPA does not believe that the subject chemicals are entering the United States in 

1175 imported articles for the significant new uses defined by the final regulation. However, 

1176 companies may screen or initiate other activities to determine if articles they import in the future 

1177 contain chemicals included in this SNUR. EPA notes that no commenters provided data that 

1178 could be used to estimate what, if any, costs might be associated with continued assurance that 

1179 imported articles are free from the chemical substances subject to this SNUR. The number of 

1180 companies that may take such actions is not known, nor is the level of action that may be taken 

1181 by a particular company. Based on EPA’s economic analysis and the responses to the proposed 

1182 rule, EPA does not believe that these costs will be significant for any individual entity. 

1183 I. Import and Export Regulations for Chemical Substances as Part of Articles 

1184 One comment noted that EPA is not proposing to change the way in which TSCA’s 

1185 export and import rules (pursuant to TSCA sections 12(b) and 13, respectively) apply to articles 
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1186 containing these chemical substances. The comment indicates that (under the status quo of the 

1187 import rules) the U.S. Customs and Border Protection (CBP) will not be screening articles for the 

1188 chemical substances in the proposed SNURs. 

1189 EPA agrees that the TSCA import rules are important TSCA compliance mechanisms and 

1190 that 19 CFR 12.119 allows EPA to establish section 13 import certification requirements for 

1191 chemicals in articles. However, declining to subject importers to one notice requirement (section 

1192 13 import certification) does not render another notice requirement (section 5 SNUN submission) 

1193 unenforceable. 

1194 In this case, EPA did not propose to require section 13 import certification or section 12 

1195 export notification for the subject chemical substances when part of articles. This is consistent 

1196 with EPA’s past practice of making the exemption at 40 CFR 721.45(f) inapplicable without also 

1197 requiring import certification or export notification for these chemical substances as part of 

1198 articles (40 CFR 721.2800; 40 CFR 721.10068). However, the Agency continues to study this 

1199 issue and has not ruled out a later proposal to require import certification and/or export 

1200 notification for these chemical substances as part of articles. 

1201 With or without an import certification requirement, it is the importer that is “responsible 

1202 for insuring that chemical importation complies with TSCA just as domestic manufacturers are 

1203 responsible for insuring that chemical manufacture compliance with TSCA.” 40 CFR 

1204 707.20(b)(1). 

1205 J. Distinguishing Between Chemicals in Non-Article Form and Other Products 

1206 One comment contends that the rule, as proposed, “would not allow [EPA] to distinguish 

1207 between a chemical being brought into the United States in its raw form and a chemical being 

1208 brought in on a shift as a dye or finish.” The comment goes on to state that treating them the 

1209 same way is unrealistic and scientifically unsound. 
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1210 EPA disagrees with the comment and notes that it was not proposing to eliminate all 

1211 distinctions, in all regulatory provisions under TSCA, between import of a chemical substance in 

1212 non-article form, and import of a chemical substance as part of an article. The rule simply 

1213 removes one particular distinction between persons who import or process a chemical substance 

1214 in non-article form and persons who import or process a chemical substance as part of an article. 

1215 Thus, while the raw chemical manufacturer and the article importer may both be required to 

1216 submit a SNUN, EPA would be able distinguish between the two scenarios, as appropriate, in its 

1217 review of the SNUN. The SNUN review process will allow case-by-case analysis of each 

1218 circumstance. 

1219 With respect to the commenter’s comparison of the volume at which these chemical 

1220 substances are currently manufactured in non-article form and the volume at which these 

1221 chemical substances are currently manufactured in article form (i.e., via import of a chemical 

1222 substance as part of an article), EPA’s conclusion, with respect to the significant new uses, is that 

1223 the two volumes are currently the same. This is because EPA has concluded that there is no 

1224 current manufacture of these chemical substances for the significant new uses, either through 

1225 domestic manufacture of the substances in non-article form, or through import of articles 

1226 containing the substances. Thus, both production volumes are currently zero. 

1227 K. Provisions for Processors 

1228 In a comment submitted after the closing of the public comment period, one commenter 

1229 questions the utility of a provision for processors at 40 CFR 721.5(c), as applied to notice 

1230 requirements under this rule. The commenter states that 40 CFR 721.5(c) would not protect 

1231 companies unless they could document lack of knowledge that a SNUR applies. The commenter 

1232 believes that this requirement is therefore impossible to meet, explaining that it is impossible to 

1233 document what one does not know. 
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1234 EPA will respond to this comment, although it was submitted after the closing of the 

1235 public comment period for this action, because it relates closely to the timely submitted 

1236 comments. EPA disagrees that applying 40 CFR 721.5(c) is impossible or impracticable. The 

1237 provisions at 40 CFR 721.5(c) provide that the unknowing processing of a chemical substance 

1238 does not itself trigger SNUN submission requirements, subject to meeting certain documentation 

1239 requirements. Upon obtaining knowledge that it previously engaged in activities covered by the 

1240 SNUR, a processor can at that time assemble evidence relating to the period when the past 

1241 processing occurred. Specifically, this would be evidence bearing on whether the processor 

1242 previously knew the chemical identity of the substance it was processing or previously knew that 

1243 that substance was subject to a SNUR. Evidence to establish a prior lack of knowledge could 

1244 include items such as a purchase order and, where applicable, an material safety data sheet 

1245 (MSDS) that indicates neither the relevant chemical identity nor the presence of a chemical 

1246 subject to a SNUR. Another type of evidence would be the affidavit of a person in a position of 

1247 appropriate authority swearing to the prior lack of knowledge. EPA would generally consider the 

1248 wording on a purchase order and, where applicable, an MSDS, along with an affidavit as 

1249 described above, in determining whether there is sufficiently clear documentation for purposes of 

1250 40 CFR 721.5(c). However, if there was also contrary documentary evidence, indicative of the 

1251 prior possession of knowledge (e.g., receipt of a notice given to the processor pursuant to 40 

1252 CFR 721.5(a)(1)(i)) then the overall documentary evidence would not allow the processor to take 

1253 advantage of the provisions of 40 CFR 721.5(c). 

1254 L. Potential Ongoing Use of DnPP 

1255 One commenter identified a potential ongoing use of DnPP in grease in automotive 

1256 switches. The commenter requested that EPA exclude the identified use from the SNUR. 

1257 After investigation, EPA has determined that there is no ongoing use of DnPP in grease 
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1258 in automotive switches. 

1259 The commenter states that “[b]ased on current use information . . . [the commenter] 

1260 believes that DnPP is being used in grease in some automotive switches.” The proposal stated 

1261 that EPA "welcome[d] specific information that documents [ongoing] use.” Yet the commenter 

1262 does not provide any current use information to substantiate this belief. When raising a potential 

1263 ongoing use, it is generally preferable to include information substantiating that use, especially 

1264 where the entity raising that use is not an actual manufacturer (including importer) or processor 

1265 of that chemical substance for that use and thus would not be anticipated to have direct 

1266 knowledge of that use. 

1267 In order to determine whether there is an ongoing use of DnPP in grease in automotive 

1268 switches, EPA performed targeted searches of sources including IHS Chemical Economics 

1269 Handbook, MSDS search tools such as Seton’s MSDS Hazard Communication Library and 

1270 patent searches and was unable to substantiate this use as an ongoing use of DnPP. EPA 

1271 reviewed several grease MSDS, and no grease MSDS listed any phthalate in its composition. 

1272 EPA’s DfE alternatives analysis also has not identified use in grease in automotive switches as 

1273 an ongoing use of DnPP. 

1274 EPA also conducted patent searches for grease in automotive switches, and dampening 

1275 greases in general. A patent search found mentions of the term phthalates with electronic 

1276 components, but not DnPP specifically for automotive switches. However, one patent gave a 

1277 very broad alkyl range that release of phthalates C4 and C8 were observed during the vacuum 

1278 burn pretreatment of electronic components [disc drives]. This process is routine treatment to 

1279 remove volatiles from electronic components, including electronic switches (Vacuum baking 

1280 process USP 6,051,169 and Electric switches USP 3,694,601). EPA does not believe the 

1281 existence of this information is indicative of current use of DnPP in grease in automotive 
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1282 switches because, patents do not necessarily indicate current use. As noted in the proposed rule 

1283 (77 FR 18756, March 28, 2012) (FRL 8865-2), no IUR production volume data were reported for 

1284 DnPP during the 2006, 2002, 1998 and 1994 reporting cycles. In addition, no production volume 

1285 data were reported for the 2012 CDR (Ref. 13) 

1286 Accordingly, EPA is declining to exclude use “in grease in automotive switches” from 

1287 the significant new uses of DnPP. 

1288 M. Reliance on Inventory Update Rule (IUR) Data in Assessing Ongoing Use of DnPP 

1289 One commenter suggests that EPA relied solely on the IUR data for determining ongoing 

1290 uses of DnPP, and that such reliance may be misleading or incomplete. The commenter notes 

1291 that ongoing uses below the IUR reporting threshold of 10,000 lbs would not be reported to EPA 

1292 through the IUR process. 

1293 EPA uses IUR data to identify ongoing uses of chemical substances. However, this is not 

1294 the sole source of information relied upon to support the SNUR. EPA first identified a SNUR as 

1295 a regulatory alternative for DnPP in the Phthalates Action Plan because EPA found that the most 

1296 recent IUR data contained no reports of DnPP being produced in or imported into the United 

1297 States. In proposing the SNUR, EPA prepared the Economic Analysis of the Proposed 

1298 Significant New Use Rule for Di-n-pentyl Phthalate (DnPP) (Ref. 25) and conducted internet 

1299 queries in order to ascertain whether there were any ongoing uses of DnPP at levels below the 

1300 IUR reporting threshold. During the course of this research EPA identified several companies 

1301 which either use or sell DnPP as a chemical standard for use in phthalates testing. Accordingly, 

1302 the significant new uses of DnPP does not include use of DnPP as a chemical standard for 

1303 analytical experiments as a significant new use. 

1304 N. Design for the Environment (DfE) Assessment for Phthalates 

1305 One commenter noted that EPA has undertaken a DfE project focused on phthalates, 
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1306 including but not limited to, DnPP. The commenter believes that the DfE phthalates alternative 

1307 assessment will provide valuable information about potential alternatives to industries using 

1308 phthalates. The commenter recommends that EPA refrain from further action on any phthalate 

1309 until the DfE project is finalized. 

1310 EPA disagrees that finalization of the DnPP SNUR should be delayed until the DfE 

1311 project is complete. (To the extent the comment is discussing the timing of other potential EPA 

1312 actions to address phthalates, it is outside the scope of this proposal.) 

1313 The comment states that the final DfE report would identify alternatives, their viability as 

1314 substitutes, and EPA’s comparative hazard information. EPA disagrees that this report is likely 

1315 to provide information relevant to this SNUR. When defining the “significant new use,” EPA is 

1316 limited to uses of the chemical substance that are not ongoing. The DfE report is not expected to 

1317 identify alternatives for chemical substances that are generally no longer in use. It is already 

1318 clear that there are many alternatives to DnPP use, because there are almost no ongoing uses of 

1319 DnPP. Furthermore, the DfE report is not expected to suggest DnPP itself as an alternative to 

1320 another phthalate because of its toxicity relative to other phthalates. Even if the DfE report were 

1321 to identify a significant new use of DnPP as an alternative to some other chemical substance, 

1322 then EPA would have the opportunity to consider that information at such time as it received the 

1323 significant new use notice for DnPP. 

1324 EPA notes that it is a regular practice to finalize SNURs for chemical substances that 

1325 have not undergone a DfE assessment. Given that the DfE report is unlikely to provide additional 

1326 information relevant to EPA’s significant new use determination for DnPP, that newly available 

1327 information respecting any particular use of DnPP could be included in the significant new use 

1328 notice itself, and that further delay would increase regulatory uncertainty, EPA disagrees that it 

1329 would be appropriate to delay issuance of the SNUR on DnPP pending the release of the DfE 
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1330 report. 

1331 XI. References 

1332 The following is a listing of the documents that are specifically referenced in this action. 

1333 The docket includes these documents and other information considered by EPA, including 

1334 documents that are referenced within the documents that are in the docket, even if the referenced 

1335 document is not physically located in the docket. For assistance in locating these other 

1336 documents, please consult the technical person listed under FOR FURTHER INFORMATION 

1337 CONTACT. 

1338 1. U.S. EPA. Proposed Rule; Benzidine-Based Chemical Substances; Di-n-pentyl 

1339 phthalate (DnPP); and Alkanes, C12–13, Chloro; Significant New Use Rules. 77 FR 18752, 

1340 March 28, 2012 (FRL-8865-2). 

1341 2. U.S. EPA, 2010. U.S. Environmental Protection Agency. Chemical Substances 

1342 Derived from Benzidine and Its Congeners, 

1343 http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/DCB%20Action%20Plan_062320

1344 10.noheader.pdf (Accessed January 24, 2011). 

1345 3. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/ Economics, Exposure, and 

1346 Technology Division. “Economic Analysis to Support the Final SNUR for Benzidine and 

1347 Benzidine-based Chemical substances.” 

1348 4. Testimony of James J. Jones, Acting Assistant Administrator Office of Chemical 

1349 Safety and Pollution Prevention, U.S. Environmental Protection Agency before the Committee 

1350 on Environment and Public Works and the Subcommittee on Superfund, Toxic and 

1351 Environmental Health United States Senate, July 24, 2012, available at 

1352 http://www.epa.gov/ocir/hearings/pdf/2012_jjones_testimony1.pdf. 
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1353 5. CPSC, 2011. Staff Briefing Package. Petition HP 10-2. Requesting Restriction of 

1354 Cadmium in Toy Jewelry (Consumer Product Safety Commission (February 9, 2011). Staff 

1355 Report, Cadmium in Children’s Metal Jewelry. Toxicity Review of Cadmium. TAB B pp19-39 

1356 http://www.cpsc.gov/PageFiles/96192/cadmiumtoy.pdf (October 14, 2010). 

1357 6. Danish Environmental Protection Agency, Survey of Chemical Substances in 

1358 Consumer Products Survey No. 25 2003, Mapping the Liberation of Organic Tin Compounds in 

1359 Mattress Pads, To Mattresses, and Baby/Junior Duvets. 

1360 7. Stapleton, et al., 2008, Alternate and New Brominated Flame Retardants Detected in 

1361 U.S. House Dust, Environ. Sci. Technol. 

1362 8. CPSC Staff Preliminary Risk Assessment of Flame Retardant [FR] Chemicals in 

1363 Upholstered Furniture Foam, December 21, 2006. 

1364 9. Muller, et al., 2011, Car Indoor Air Pollution- Analysis of Potential Sources, Journal 

1365 of Occupations Medicine and Toxicology 2011, 6:33. 

1366 10. Wu, et al., 2009, Residues of Polybrominated Diphenyl Ethers in Frogs (Rana 

1367 limnocharis) from a Contaminated Site, South China: Tissue Distribution, Biomagnification, and 

1368 Maternal Transfer, Environ. Sci. Technol. 2009, 42: 5212-5217. 

1369 11. Gaylor, et al. 2012, House Crickets Can Accumulate Polybrominated Diphenyl Ethers 

1370 (PBDEs) Directly from Polyurethane Foam Common in Consumer Products, Chemosphere, 

1371 2012, 86: 500-505. 

1372 12. Covaci, et al. 2006, Hexabromocyclododecanes (HBCDs) in the Environment and 

1373 Humans: A Review. Environ. Sci. Technol. 2006, 40: 3679-3688. 

1374 13. U.S. EPA, Chemical Data Access Tool (CDAT), 

1375 http://java.epa.gov/oppt_chemical_search/. 

1376 14. U.S. EPA, Understanding the Costs Associated with Eliminating Exemptions for 
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1377 Articles in SNURs, May 1, 2013. 

1378 15. Hewlett-Packard Development Company, LP. (2010). “International Material Data 

1379 System.” Retrieved from http://www.mdsystem.com/. 

1380 16. Wal-Mart. (2012). Become a Supplier: Requirements. Retrieved from 

1381 http://www.walmartstores.com/Suppliers/248.aspx. 

1382 17. CAEPA, 2013a. State of California Environmental Protection Agency. Chemicals 

1383 Known to the State to Cause Cancer or Reproductive Toxicity. Office of Environmental Health 

1384 Hazard Assessment, 04 February 2013. 

1385 http://oehha.ca.gov/prop65/prop65_list/files/P65list020813.pdf.

1386 18. CAEPA, 2013b. State of California Environmental Protection Agency. Proposition 65 

1387 in Plain Language! Febuary 2013. http://oehha.ca.gov/prop65/background/p65plain.html. 

1388 19. European Commission. 2009. Commission Regulation EC No. 552/2009 Commission 

1389 Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the 

1390 European Parliament and of the Council on REACH as regards Annex XVII. 

1391 20. European Commission. 2010. RAPEX – Latest Notifications. Directorate General for 

1392 Health and Consumers. http://ec.europa.eu/consumers/dynex/rapex/rapex_achives_en.cfm. 

1393 21. IARC, 2012. International Agency for the Research on Cancer. IARC Monographs on 

1394 the Evaluation of Carcinogenic Risks to Humans—Benzidine.Volume 100F: 53-63. 

1395 22. Textination, 2012. Textination “Textile and Apparel Weekly June, 8 2012”. 

1396 http://textination.de/en/tiw/2012/TIW08062012.pdf. 

1397 23. Intertek, 2013. Intertek, “Requirements of Azo dyes and Formaldehyde content in 

1398 fabric for babies and children clothing in Indonesia” Jan 4, 2013. 

1399 24. Intertek, 2013. Intertek, “Requirements of Azo dyes and Formaldehyde content in 

1400 fabric for babies and children clothing in Indonesia” Jan 4, 2013. 
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1401 25. Environment Canada. 2009. Strategic options for the management of toxic substances 

1402 benzidine and 3,3-dichlorobenzidine. Available at: 

1403 http://www.ec.gc.ca/toxics/docs/sor/bdine/EN/sum.cfm (Accessed 10 September, 2009). 

1404 26. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/ Economics, Exposure, 

1405 and Technology Division. “Economic Analysis of the Final Significant New Use Rule for Di-n1406 pentyl phthalate (DnPP).”

1407 27. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/ Economics, Exposure, 

1408 and Technology Division. “Economic Analysis of the Final Significant New Use Rule for 

1409 Alkanes, C12-13, chloro (CAS RN: 71011-12-6).” 

1410 XII. Statutory and Executive Order Reviews 

1411 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: 

1412 Improving Regulation and Regulatory Review

1413 This final rule has been designated by OMB as a “significant regulatory action” under 

1414 section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993). Accordingly, EPA 

1415 submitted this action to OMB for review under Executive Order 12866 and 13563 (76 FR 3821, 

1416 January 21, 2011), and any changes made in response to OMB recommendations are documented 

1417 in the docket. 

1418 B. Paperwork Reduction Act (PRA)

1419 This action does not impose any new information collection burden under the PRA, 44 

1420 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b). The information collection activities 

1421 associated with existing chemical SNURs are already approved by OMB under OMB control 

1422 number 2070-0038 (EPA ICR No. 1188); and the information collection activities associated 

1423 with export notifications are already approved by OMB under OMB control number 2070-0030 

1424 (EPA ICR No. 0795). If an entity were to submit a SNUN to the agency, the annual burden is 
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1425 estimated to be less than 100 hours per response, and the estimated burden for an export 

1426 notifications is less than 1.5 hours per notification. In both cases, burden is estimated to be 

1427 reduced for submitters who have already registered to use the electronic submission system. 

1428 Additional burden, estimated to be less than 10 hours, could be incurred where additional record 

1429 keeping requirements are specified under 40 CFR §721.125(a), (b), and (c). 

1430 An Agency may not conduct or sponsor, and a person is not required to respond to a 

1431 collection of information that requires OMB approval under the PRA, unless it has been 

1432 approved by OMB and displays a currently valid OMB control number. The OMB control 

1433 numbers for EPA’s regulations in Title 40 of the CFR, after appearing in the Federal Register, 

1434 are listed in 40 CFR part 9 and included on the related collection instrument, or form, if 

1435 applicable. EPA is amending the table in 40 CFR part 9 to list this SNUR. This listing of the 

1436 OMB control numbers and their subsequent codification in the CFR satisfies the display 

1437 requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320. Since the 

1438 existing OMB approval was previously subject to public notice and comment before OMB 

1439 approval, and given the technical nature of the table, EPA finds that further notice and 

1440 comment to amend the table is unnecessary. As a result, EPA finds that there is “good cause” 

1441 under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to 

1442 amend this table without further notice and comment. 

1443 C. Regulatory Flexibility Act (RFA)

1444 Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I hereby certify that 

1445 promulgation of this SNUR will not have a significant economic impact on a substantial number 

1446 of small entities. The rationale supporting this conclusion is as follows. 

1447 EPA generally finds that proposed and final SNURs are not expected to have a significant 

1448 economic impact on a substantial number of small entities (See, e.g., Ref. 34). Since these 
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1449 SNURs will require a person who intends to engage in such activity in the future to first notify 

1450 EPA by submitting a SNUN, no economic impact will occur unless someone files a SNUN to 

1451 pursue a significant new use in the future or forgoes profits by avoiding or delaying the 

1452 significant new use. Although some small entities may decide to engage in such activities in the 

1453 future, EPA cannot presently determine how many, if any, there may be. However, EPA’s 

1454 experience to date is that, in response to the promulgation of SNURs covering over 1,000 

1455 chemical substances, the Agency receives only a handful of notices per year. During the six year 

1456 period from 2005-2011, only three submitters self-identified as small in their SNUN submission 

1457 (Refs. 5, 32, 33). EPA believes the cost of submitting a SNUN is relatively small compared to 

1458 the cost of developing and marketing a chemical new to a firm and that the requirement to 

1459 submit a SNUN generally does not have a significant economic impact. 

1460 A SNUR applies to any person (including small or large entities) who intends to engage 

1461 in any activity described in the rule as a “significant new use.” In the proposed SNUR EPA 

1462 preliminarily determined, based in part, on the Agency’s market research, that these chemical 

1463 substances are not being manufactured (including imported) or processed for a significant new 

1464 use. In the case of the benzidine-based dyes, this preliminary determination also included 

1465 importation and processing of these chemical substances as part of articles (Ref. 1). EPA 

1466 received no public comment indicating any ongoing importation of the benzidine-based chemical 

1467 substances as part of articles or otherwise. Therefore, EPA is finalizing its determination that 

1468 these uses, including the importation and processing of benzidine-based dyes as part of articles, 

1469 are new and not ongoing. Thus no small entities presently engage in a significant new use. By 

1470 definition of the word “new” and based on all information currently available to EPA, it appears 

1471 that no small or large entities presently engage in such activities. Since these SNURs will require 

1472 a person who intends to engage in such activity in the future to first notify EPA by submitting a 
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1473 SNUN, no economic impact will occur unless someone files a SNUN to pursue a significant new 

1474 use in the future or forgoes profits by avoiding or delaying the significant new use. Although 

1475 some small entities may decide to engage in such activities in the future, EPA cannot presently 

1476 determine how many, if any, there may be. However, EPA’s experience to date is that, in 

1477 response to the promulgation of SNURs covering over 1,000 chemical substances, the Agency 

1478 receives only a handful of notices per year. During the six year period from 2005-2011, only 

1479 three submitters self-identified as small in their SNUN submission (Refs. 3, 26, 27). EPA 

1480 believes the cost of submitting a SNUN is relatively small compared to the cost of developing 

1481 and marketing a chemical new to a firm and that the requirement to submit a SNUN generally 

1482 does not have a significant economic impact. 

1483 Therefore, EPA believes that the potential economic impact of complying with this 

1484 SNUR is not expected to be significant or adversely impact a substantial number of small 

1485 entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-

1486 4), the Agency presented its general determination that proposed and final SNURs are not 

1487 expected to have a significant economic impact on a substantial number of small entities, which 

1488 was provided to the Chief Counsel for Advocacy of the Small Business Administration.

1489 D. Unfunded Mandates Reform Act (UMRA)

1490 Based on EPA’s experience with proposing and finalizing SNURs, State, local, and Tribal 

1491 governments have not been impacted by these rulemakings, and EPA does not have any reason to 

1492 believe that any State, local, or Tribal government would be impacted by this rulemaking. As 

1493 such, EPA has determined that this regulatory action would not impose any enforceable duty, 

1494 contain any unfunded mandate, or otherwise have any effect on small governments subject to the 

1495 requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538. 

1496 E. Executive Order 13132: Federalism 
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1497 This action does not have a substantial direct effect on States, on the relationship between 

1498 the national government and the States, or on the distribution of power and responsibilities 

1499 among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, 

1500 August 10, 1999). 

1501 F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments 

1502 This action does not have Tribal implications because it will not have any effect (i.e., 

1503 there will be no increase or decrease in authority or jurisdiction) on Tribal governments, on the 

1504 relationship between the Federal government and the Indian tribes, or on the distribution of 

1505 power and responsibilities between the Federal government and Indian tribes. Thus, Executive 

1506 Order 13175 (65 FR 67249, November 9, 2000), does not apply to this action. 

1507 G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety 

1508 Risks 

1509 This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), 

1510 because this action is not intended to address environmental health or safety risks for children. 

1511 H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy 

1512 Supply, Distribution, or Use 

1513 This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), 

1514 because it is not expected to affect energy supply, distribution, or use. 

1515 I. National Technology Transfer and Advancement Act (NTTAA) 

1516 Since this action does not involve any technical standards, section 12(d) of NTTAA, 

1517 15 U.S.C. 272 note, does not apply to this action. 

1518 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

1519 Populations and Low-Income Populations

1520 This action does not entail special considerations of environmental justice related issues 
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1521 as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has 

1522 determined that this action will not have disproportionately high and adverse human health or 

1523 environmental effects on minority or low-income populations. This action does not affect the 

1524 level of protection provided to human health or the environment. 

1525 K. Congressional Review Act (CRA) 

1526 Pursuant to the CRA, 5 U.S.C. 801 et seq., EPA will submit a report containing this rule 

1527 and other required information to the U.S. Senate, the U.S. House of Representatives, and the 

1528 Comptroller General of the United States prior to publication of the rule in the Federal Register. 

1529 This action is not a “major rule” as defined by 5 U.S.C. 804(2). 

1530 List of Subjects 

1531 40 CFR Part 9 

1532 Environmental protection, Reporting and recordkeeping requirements. 

1533 40 CFR Part 721 

1534 Environmental protection, Chemicals, Hazardous substances, Reporting and 

1535 recordkeeping requirements. 

1536 Dated: 

1537 

1538 ___________________________________________ 

1539 Director, Office of Pollution Prevention and Toxics. 
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1540 Therefore, 40 CFR parts 9 and 721 are amended as follows: 

1541 PART 9--[AMENDED] 

1542 1. The authority citation for part 9 continues to read as follows: 

1543 Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-

1544 2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 

1545 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1546 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 

1547 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-

1548 7671q, 7542, 9601-9657, 11023, 11048. 

1549 2. In § 9.1, add the following sections in numerical order under the undesignated center 

1550 heading “Significant New Uses of Chemical Substances” to read as follows: 

1551 § 9.1 OMB approvals under the Paperwork Reduction Act.

1552 * * * * * 

40 CFR citation OMB control No. 

* * * * *

Significant New Uses of Chemical Substances

* * * * *

721.10226 2070-0038 

721.10227 2070-0038 

* * * * * 

1553 

1554 * * * * * 

1555 PART 721--[AMENDED]

1556 3. The authority citation for part 721 continues to read as follows: 
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1557 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 

1558 

1559 4. Revise § 721.1660 to read as follows: 

1560 

1561 § 721.1660 Benzidine-based chemical substances.

1562 

1563 (a) Chemical substances and significant new uses subject to reporting. (1) The 

1564 benzidine-based chemical substances listed in Table 1. and Table 2. of this section are subject to 

1565 reporting under this section for the significant new uses described in paragraph (a)(2) of this 

1566 section. 

1567 Table 1.— Benzidine-Based Chemical Substances

1568 

CAS or

accession 

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 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-

hydroxy-3-[2-[4'-[2-[2-hydroxy-4-[(2- 

methylphenyl)amino]phenyl]diazenyl][

1,1'- biphenyl]-4-yl]diazenyl]-6-(2-

phenyldiazenyl)- 

Accession No. 

21808 

CAS No. CBI 

(NA) 

CBI CBI 2,7-Naphthalenedisulfonic acid, 4-amino-5- 

hydroxy [[[(substituted phenylamino)] 

substituted phenylazo] diphenyl]azo-, 

phenylazo-, disodium salt. (generic name) 

Accession No. 

24921 

CAS No. 

CBI CBI 4-(Substituted naphthalenyl )azo diphenylyl 

azo-substituted carbopolycycle azo 

benzenesulfonic acid, sodium salt. (generic 

name) 
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Accession No. 

26256 

CAS No. 

CBI (NA) 

CBI CBI 

4-(Substituted phenyl)azo biphenylyl azosubstituted carbopolycycloazo 

benzenesulfonic acid, sodium salt. 

(generic name) 

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. 

26701 

CAS No. 

CBI (NA) 

CBI CBI Phenylazoaminohydroxynaphthalenylazobiph

enylazo substituted benzene sodium 

sulfonate. (generic name) 

1569 

1570 Table 2.—Benzidine-Based Chemical Substances

1571 

CAS number C.I. name C.I. number Chemical name

92–87–5 Benzidine Not available [1,1’-Biphenyl]-4,4’-diamine 

531–85–1 Benzidine · 2HCl Not available [1,1’-Biphenyl]-4,4’-diamine, 

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 
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2429–83–6 Direct Black 4 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-

sulfo-1-naphthalenyl)azo][1,1’-biphenyl]-4-

yl]azo]-2-hydroxy-, disodium salt 

2586–58–5 C.I. Direct 

Brown 1:2 

30110 Benzoic acid, 5-[[4’-[[2,6-diamino-3-methyl5-[(4-sulfophenyl)azo]phenyl]azo][1,1’-

biphenyl]-4- yl]azo]-2-hydroxy-, disodium 

2602–46–2 C.I. Direct Blue

6 

22610 2,7-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 
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6360–29–8 C.I. Direct 

Brown 27 

31725 Benzoic acid, 5-[[4’-[[4-[(4-amino-7-sulfo-1-

naphthalenyl)azo]-6-sulfo-1- 

naphthalenyl]azo][1,1’-biphenyl]-4-yl] 

azo]-2- hydroxy-, trisodium salt 

6360–54–9 C.I. Direct 

Brown 154 

30120 Benzoic acid, 5-[[4’-[[2,6-diamino-3-methyl5-[(4-sulfophenyl)azo]phenyl] azo][1,1’-

biphenyl]-4- yl]azo]-2- hydroxy-3-methyl-, 

disodium salt 

8014–91–3 C.I. Direct 

Brown 74 

36300 Benzoic acid, 3,3’-[(3,7-disulfo-1,5-

naphthalenediyl)bis [azo(6-

hydroxy-3,1- 

phenylene)azo[6(or7)-sulfo-4,1- 

naphthalenediyl]azo[1,1’-

biphenyl]-4,4’- diylazo]]bis[6-

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 

1572 

1573 

1574 (2) The significant new uses are: 

1575 (i) For each of the chemical substances listed in Table 2, any use other than use as a 

1576 reagent to test for hydrogen peroxide in milk; a reagent to test for hydrogen sulfate, hydrogen 

1577 cyanide, and nicotine; a stain in microscopy; a reagent for detecting blood; an analytical 

1578 standard; and, additionally for Colour Index (C.I.) Direct Red 28 (Congo Red) (CAS No. 573-58-

1579 0), an indicator dye. 

1580 (ii) For the chemical substances listed in Table 1: Any use. 

1581 

1582 (b) Specific requirements. The provisions of subpart A of this part apply to this section 

1583 except as modified by this paragraph (b). 

1584 (1) Revocation of certain notification exemptions. The provisions of § 721.45(f) do not 

1585 apply to this section. A person who imports or processes a chemical substance identified in 

1586 paragraph (a)(1) of this section as part of an article for a significant new use described 

1587 in paragraph (a)(2) of this section is not exempt from submitting a significant new use notice. 

1588 (2) [Reserved] 
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1589 5. Add § 721.10226 to subpart E to read as follows:

1590 § 721.10226 Di-n-pentyl phthalate (DnPP). 

1591 (a) Chemical substance and significant new uses subject to reporting. (1) The chemical 

1592 substance identified as di-n-pentyl phthalate (DnPP) (1,2-benzenedicarboxylic acid, 1,2-dipentyl 

1593 ester) (CAS No. 131-18-0) is subject to reporting under this section for the significant new uses 

1594 described in paragraph (a)(2) of this section. 

1595 (2) The significant new use is: any use other than use as a chemical standard for 

1596 analytical experiments.

1597 (b) [Reserved] 

1598 

1599 6. Add § 721.10227 to subpart E to read as follows: 

1600 § 721.10227 Alkanes, C12-13, chloro (CAS No. 71011-12-6).

1601 (a) Chemical substance and significant new uses subject to reporting. (1) The chemical 

1602 substance identified as alkanes, C12-13, chloro (CAS No. 71011-12-6) is subject to reporting 

1603 under this section for the significant new uses described in paragraph (a)(2) of this section. 

1604 (2) The significant new use is: Any use. 

1605 (b) Specific requirements. The provisions of subpart A of this part apply to this section 

1606 except as modified by this paragraph. 

1607 (1) Persons who must report. § 721.5 applies to this section except for 

1608 § 721.5(a)(2). A person who intends to manufacture for commercial purposes a substance 

1609 identified in paragraph (a)(1) of this section and intends to distribute the substance in commerce 

1610 must submit a significant new use notice. 

1611 (2) [Reserved] 

1612